0001193125-19-264542.txt : 20191008 0001193125-19-264542.hdr.sgml : 20191008 20191008172550 ACCESSION NUMBER: 0001193125-19-264542 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 69 CONFORMED PERIOD OF REPORT: 20190831 FILED AS OF DATE: 20191008 DATE AS OF CHANGE: 20191008 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CytoDyn Inc. CENTRAL INDEX KEY: 0001175680 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 753056237 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-49908 FILM NUMBER: 191143340 BUSINESS ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 BUSINESS PHONE: 360-980-8524 MAIL ADDRESS: STREET 1: 1111 MAIN STREET, SUITE 660 CITY: VANCOUVER STATE: WA ZIP: 98660 FORMER COMPANY: FORMER CONFORMED NAME: CYTODYN INC DATE OF NAME CHANGE: 20031114 FORMER COMPANY: FORMER CONFORMED NAME: REXRAY CORP DATE OF NAME CHANGE: 20020617 10-Q 1 d803215d10q.htm 10-Q 10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

 

FORM 10-Q

 

 

 

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended August 31, 2019

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1933

For the transition period from                  to                 

Commission File Number: 000-49908

 

 

CYTODYN INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   83-1887078

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer or

Identification No.)

1111 Main Street, Suite 660

Vancouver, Washington

  98660
(Address of principal executive offices)   (Zip Code)

(Registrant’s telephone number, including area code) (360) 980-8524

(Former name, former address and former fiscal year, if changed since last report)

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class

 

Trading

Symbol(s)

 

Name of Each Exchange

on Which Registered

None.   None.   None.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer      Accelerated Filer  
Non-accelerated Filer      Smaller Reporting Company  
     Emerging Growth Company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act):    Yes  ☐    No  ☒

On October 4, 2019, there were 388,254,196 shares outstanding of the registrant’s $0.001 par value common stock.

 

 

 


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Table of Contents

PART I

Item 1. Financial Statements.

CytoDyn Inc.

Consolidated Balance Sheets

(Unaudited)

 

     August 31, 2019     May 31, 2019  
     (unaudited)        

Assets

    

Current assets:

    

Cash

   $ 1,795,822     $ 2,612,910  

Restricted Cash

     —         853,599  

Miscellaneous Receivables

     5,213       90,824  

Prepaid expenses

     272,581       107,211  

Prepaid service fees

     1,126,382       1,704,876  
  

 

 

   

 

 

 

Total current assets

     3,199,998       5,369,420  

Operating lease right-of-use assets

     208,255       —    

Property, plant and equipment

     31,278       29,251  

Intangibles, net

     14,947,122       15,475,454  
  

 

 

   

 

 

 

Total assets

   $ 18,386,653     $ 20,874,125  
  

 

 

   

 

 

 

Liabilities and Stockholders’ (Deficit) Equity

    

Current liabilities:

    

Accounts payable

   $ 12,048,474     $ 16,239,434  

Accrued liabilities and compensation

     1,444,429       1,588,552  

Accrued license fees

     382,700       208,600  

Accrued interest on convertible notes

     350,400       212,777  

Accrued dividends on Series C Preferred Stock

     148,179       37,351  

Convertible notes payable, net

     4,900,247       3,586,035  

Current portion of operating leases payable

     106,827       —    

Current portion of long term convertible notes payable

     3,685,351       4,200,000  

Warrant tender offer proceeds held in trust

     —         853,599  
  

 

 

   

 

 

 

Total current liabilities

     23,066,607       26,926,348  
  

 

 

   

 

 

 

Long-term liabilities:

    

Convertible notes payable, net

     230,614       454,568  

Operating lease liability

     102,091       —    

Derivative liability

     1,781,936       2,407,269  
  

 

 

   

 

 

 

Total long-term liabilities

     2,114,641       2,861,837  
  

 

 

   

 

 

 

Total liabilities

     25,181,248       29,788,185  
  

 

 

   

 

 

 

Commitments and Contingencies

     —         —    

Stockholders’ (Deficit) equity

    

Preferred Stock, $0.001 par value; 5,000,000 shares authorized

    

Series C convertible preferred stock, $0.001 par value; 5,000 authorized; 5,000 and 3,246 issued and outstanding at August 31, 2019 and May 31, 2019, respectively

     5       3  

Series B convertible preferred stock, $0.001 par value; 400,000 shares authorized, 92,100 shares issued and outstanding at August 31, 2019 and May 31, 2019, respectively

     92       92  

Common stock, $0.001 par value; 700,000,000 shares authorized, 383,584,367 and 329,554,763 issued and 383,425,356 and 329,395,752 outstanding at August 31, 2019 and May 31, 2019, respectively

     383,586       329,555  

Additional paid-in capital

     238,460,113       220,119,856  

Accumulated (deficit)

     (245,638,232     (229,363,407

Less: treasury stock, at par (159,011 shares at $0.001)

     (159     (159
  

 

 

   

 

 

 

Total stockholders’ (deficit)

     (6,794,595     (8,914,060
  

 

 

   

 

 

 

Total liabilities and stockholders’ (deficit) equity

   $ 18,386,653     $ 20,874,125  
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

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CytoDyn Inc.

Consolidated Statements of Operations

(Unaudited)

 

     Three Months Ended August 31,  
     2019     2018  

Operating expenses:

    

General and administrative

   $ 3,045,965     $ 1,996,428  

Research and development

     9,055,289       11,403,294  

Amortization and depreciation

     531,043       88,971  
  

 

 

   

 

 

 

Total operating expenses

     12,632,297       13,488,693  
  

 

 

   

 

 

 

Operating loss

     (12,632,297     (13,488,693

Interest income

     —         979  

Change in fair value of derivative liabilities

     625,333       (747,467

Interest expense:

    

Amortization of discount on convertible notes

     (1,030,151     (64,580

Amortization of debt issuance costs

     (284,061     (9,178

Inducement interest related to warrant exercise

     (2,430,514     —    

Finance charges

     (8,289     —    

Interest on convertible notes payable

     (404,020     (104,630
  

 

 

   

 

 

 

Total interest expense

     (4,157,035     (178,388
  

 

 

   

 

 

 

Loss before income taxes

     (16,163,999     (14,413,569

Income tax benefit

     —         —    
  

 

 

   

 

 

 

Net loss

   $ (16,163,999   $ (14,413,569
  

 

 

   

 

 

 

Basic and diluted loss per share

   $ (0.04   $ (0.07
  

 

 

   

 

 

 

Basic and diluted weighted average common shares outstanding

     364,639,410       218,594,628  
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

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CytoDyn Inc.

Consolidated Statements of Cash Flows

(Unaudited)

 

     Three Months Ended August 31,  
     2019     2018  

Cash flows from operating activities:

    

Net loss

   $ (16,163,999   $ (14,413,569

Adjustments to reconcile net loss to net cash used in operating activities:

    

Amortization and depreciation

     531,045       88,971  

Amortization of debt issuance costs

     284,060       9,178  

Amortization of discount on convertible notes

     1,030,151       64,580  

Inducement interest expense on warrant tender offers

     2,430,514       —    

Interest expense associated with accretion of convertible notes payable

     266,397       —    

Change in fair value of derivative liabilities

     (625,333     747,467  

Stock-based compensation

     580,727       283,346  

Changes in current assets and liabilities:

    

(Increase) decrease in miscellaneous receivables

     85,611       —    

(Increase) decrease in prepaid expenses

     413,124       (701,185

(Decrease) increase in accounts payable and accrued expenses

     (4,022,694     4,950,552  
  

 

 

   

 

 

 

Net cash used in operating activities

     (15,190,397     (8,970,660
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Furniture and equipment purchases

     (4,739     (2,262
  

 

 

   

 

 

 

Net cash used in investing activities

     (4,739     (2,262
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Proceeds from sale of common stock and warrants

     2,255,800       8,499,300  

Proceeds from sale of preferred stock

     1,754,000       —    

Proceeds from warrant tender offers

     11,900,260       —    

Release of funds held in trust for warrant tender offer

     (853,599     —    

Proceeds from convertible notes payable, net

     —         5,000,000  

Payment of offering costs

     (1,532,012     (1,008,410
  

 

 

   

 

 

 

Net cash provided by financing activities

     13,524,449       12,490,890  
  

 

 

   

 

 

 

Net change in cash

     (1,670,687     3,517,968  

Cash, beginning of period

     3,466,509       1,231,445  
  

 

 

   

 

 

 

Cash, end of period

   $ 1,795,822     $ 4,749,413  
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information:

    

Cash paid during the period for interest

   $ 9,765     $ —    
  

 

 

   

 

 

 

Non-cash investing and financing transactions:

    

Common stock issued for conversion redemption

   $ 1,005,000     $ —    
  

 

 

   

 

 

 

Dividends accrued on Series C convertible preferred stock

   $ 110,826     $ —    
  

 

 

   

 

 

 

Debt discount associated with convertible notes payable

   $ —       $ 700,000  
  

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements.

 

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CytoDyn Inc.

Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity

(Unaudited)

 

     Preferred Stock      Common Stock      Treasury Stock  
     Shares      Amount      Shares      Amount      Shares      Amount  

Balance May 31, 2019

     95,346      $ 95        329,554,763      $ 329,555        159,011      $ (159
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

First Quarter Fiscal Year Ended May 31, 2020

                 

Issuance of stock for note payable redemption

     —          —          3,014,181        3,015        —          —    

Proceeds from registered direct offering ($0.50/share)

     —          —          5,639,500        5,640        —          —    

Offering costs related to registered direct offering

     —          —          —          —          —          —    

Proceeds from public warrant tender offers

     —          —          45,375,923        45,376        —          —    

Offering costs related to public warrant tender offers

     —          —                

Inducement interest expense—public warrant tender offers

     —          —          —          —          —          —    

Proceeds from Series C Preferred offering

     1,754        2              

Offering costs related to Series C Preferred offering

     —          —          —          —          —          —    

Dividends on Series C Preferred shares

     —          —          —          —          —          —    

Legal fees in connection with equity offerings

     —          —          —          —          —          —    

Stock-based compensation

     —          —          —          —          —          —    

Net Loss August 31, 2019

     —          —          —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance August 31, 2019

     97,100      $ 97        383,584,367      $ 383,586        159,011      $ (159
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

     Preferred Stock      Common Stock      Treasury Stock  
     Shares      Amount      Shares      Amount      Shares      Amount  

Balance May 31, 2018

     92,100      $ 92        216,881,790      $ 216,881        159,011      $ (159
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

First Quarter Fiscal Year Ended May 31, 2019

                 

Proceeds from registered direct offering ($0.50/share)

     —          —          1,970,000        1,970        —          —    

Offering costs related to registered direct offering

     —          —          —          —          —          —    

Proceeds from private equity offering ($0.50/share)

     —          —          15,028,600        15,029        —          —    

Offering costs related to private equity offering

     —          —          —          —          —          —    

Legal fees in connection with equity offerings

     —          —          —          —          —          —    

Stock-based compensation

     —          —          —          —          —          —    

Net Loss August 31, 2018

     —          —          —          —          —          —    
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Balance August 31, 2018

     92,100      $ 92        233,880,390      $ 233,880        159,011      $ (159
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

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CytoDyn Inc.

Consolidated Statement of Changes in Stockholders’ (Deficit)/ Equity

(Unaudited)

 

     Additional
Paid-In Capital
    Accumulated
Deficit
    Total  

Balance May 31, 2019

   $ 220,119,856     $ (229,363,407   $ (8,914,060
  

 

 

   

 

 

   

 

 

 

First Quarter Fiscal Year Ended May 31, 2020

      

Issuance of stock for note payable redemption

     1,001,985       —         1,005,000  

Proceeds from registered direct offering ($0.50/share)

     2,250,160       —         2,255,800  

Offering costs related to registered direct offering

     (260,208     —         (260,208

Proceeds from public warrant tender offers

     11,854,884       —         11,900,260  

Offering costs related to public warrant tender offers

     (1,058,466     —         (1,058,466

Inducement interest expense—public warrant tender offers

     2,430,514       —         2,430,514  

Proceeds from Series C Preferred offering

     1,753,998       —         1,754,000  

Offering costs related to Series C Preffered offering

     (197,460     —         (197,460

Dividends on Series C Preferred shares

     —         (110,826     (110,826

Legal fees in connection with equity offerings

     (15,877     —         (15,877

Stock-based compensation

     580,727       —         580,727  

Net Loss August 31, 2019

     —         (16,163,999     (16,163,999
  

 

 

   

 

 

   

 

 

 

Balance August 31, 2019

   $ 238,460,113     $ (245,638,232   $ (6,794,595
  

 

 

   

 

 

   

 

 

 

 

     Additional
Paid-In Capital
    Accumulated
Deficit
    Total  

Balance May 31, 2018

   $ 159,764,611     $ (173,139,396   $ (13,157,971
  

 

 

   

 

 

   

 

 

 

First Quarter Fiscal Year Ended May 31, 2019

      

Proceeds from registered direct offering ($0.50/share)

     983,030       —         985,000  

Offering costs related to registered direct offering

     (75,151     —         (75,151

Proceeds from private equity offering ($0.50/share)

     7,499,271       —         7,514,300  

Offering costs related to private equity offering

     (882,716     —         (882,716

Legal fees in connection with equity offerings

     (50,544     —         (50,544

Stock-based compensation

     283,346       —         283,346  

Net Loss August 31, 2018

     —         (14,413,569     (14,413,569
  

 

 

   

 

 

   

 

 

 

Balance August 31, 2018

   $ 167,521,847     $ (187,552,965   $ (19,797,305
  

 

 

   

 

 

   

 

 

 

See accompanying notes to unaudited consolidated financial statements

 

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Table of Contents

CYTODYN INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

AS OF AUGUST 31, 2019

(UNAUDITED)

Note 1 – Organization

CytoDyn Inc. (the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002 under the name RexRay Corporation (its previous name) and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of Human Immunodeficiency Virus (“HIV”) to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in human metastasis and in immune-mediated illnesses such as graft-vs-host disease (“GvHD”) and Non-Alcoholic Steatohepatitis (“NASH”). The Company’s lead product candidate, leronlimab, belongs to a class of HIV therapies known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells.

The Company has developed a class of therapeutic monoclonal antibodies to address unmet medical needs in the areas of HIV and GvHD. In addition, the Company is expanding the clinical focus with leronlimab to include the evaluation in certain cancer and immunological indications where CCR antagonism has shown initial promise.

Note 2 – Summary of Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect all adjustments, which consist solely of normal recurring adjustments, needed to fairly present the financial results for these periods. The consolidated financial statements and notes thereto are presented as prescribed by Form 10-Q. Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted. The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May 31, 2019 and 2018 and notes thereto in the Company’s Annual Report on Form 10-K for the fiscal year ended May 31, 2019, filed with the Securities and Exchange Commission on August 14, 2019. Operating results for the three months ended August 31, 2019 are not necessarily indicative of the results that may be expected for the entire year. In the opinion of management, all adjustments have been made, which consist only of normal recurring adjustments necessary for a fair statement of (a) the results of operations for the three months ended August 31, 2019 and August 31, 2018, (b) the financial position at August 31, 2019 and (c) cash flows for the three month periods ended August 31, 2019 and August 31, 2018.

Principles of Consolidation

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, CytoDyn Operations Inc., Advanced Genetic Technologies, Inc. (“AGTI”) and CytoDyn Veterinary Medicine LLC (“CVM”), of which both AGTI and CVM are dormant entities. All intercompany transactions and balances are eliminated in consolidation.

Reclassifications

Certain prior year amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the 2020 presentation. These reclassifications did not have any effect on total current assets, total assets, total current liabilities, total liabilities, total stockholders’ (deficit) equity, net loss or loss per share.

Going Concern

The consolidated accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $16,163,999 for the three months ended August 31, 2019 and has an accumulated deficit of $245,638,232 as of August 31, 2019. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

 

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The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidate, obtain U.S. Food & Drug Administration (“FDA”) approval, outsource manufacturing of the product candidate, and ultimately achieve initial revenues and attain profitability. The Company is currently engaging in significant research and development activities related to its product candidate for multiple indications, and expects to incur significant research and development expenses in the future primarily related to its clinical trials. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional sources. There can be no assurance, however, that the Company will be successful in these endeavors.

Use of Estimates

The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Cash

Cash is maintained at federally insured financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances. Balances in excess of federally insured limits at August 31, 2019 and May 31, 2019 approximated $1.7 million and $3.3 million, respectively.

Identified Intangible Assets

The Company follows the provisions of Financial Accounting Standards Board (“FASB”) ASC Topic 350 Intangibles-Goodwill and Other, which establishes accounting standards for the impairment of long-lived assets such as intangible assets subject to amortization. The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. If the sum of the undiscounted expected future cash flows over the remaining useful life of a long-lived asset group is less than its carrying value, the asset is considered impaired. Impairment losses are measured as the amount by which the carrying amount of the asset group exceeds the fair value of the asset. There were no impairment charges for the three months ended August 31, 2019 and 2018. The value of the Company’s patents would be significantly impaired by any adverse developments as they relate to the clinical trials pursuant to the patents acquired as discussed in Notes 7 and 9.

Research and Development

Research and development costs are expensed as incurred. Clinical trial costs incurred through third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development collaboration arrangements or other contractual agreements, the milestone payment obligations are expensed when the milestone conditions are probable and the amount of payment is reasonably estimable.

Pre-launch Inventory

The Company may scale-up and make commercial quantities of its product candidate prior to the date it anticipates that such product will receive final FDA approval. The scale-up and commercial production of pre-launch inventories involves the risk that such products may not be approved for marketing by the FDA on a timely basis, or ever. This risk notwithstanding, the Company may scale-up and build pre-launch inventories of product that have not yet received final governmental approval when the Company believes that such action is appropriate in relation to the commercial value of the product launch opportunity. The determination to capitalize is made once the Company (or its third party development partners) has filed a Biologics License Application (“BLA”) that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal requirements will be satisfied. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered. As of August 31, 2019, and May 31, 2019, the Company did not have pre-launch inventory that qualified for capitalization pursuant to U.S. GAAP ASC 330 “Inventory.”

 

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Fair Value of Financial Instruments

Fair Value Hierarchy

The three levels of inputs that may be used to measure fair value are as follows:

Level 1. Quoted prices in active markets for identical assets or liabilities.

Level 2. Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. Level 2 inputs also include non-binding market consensus prices that can be corroborated with observable market data, as well as quoted prices that were adjusted for security-specific restrictions.

Level 3. Unobservable inputs to the valuation methodology are significant to the measurement of the fair value of assets or liabilities. These Level 3 inputs also include non-binding market consensus prices or non-binding broker quotes that the Company was unable to corroborate with observable market data.

Liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of August 31, 2019 and May 31, 2019 is as follows:

 

     Fair Value Measurement at
August 31, 2019 (1)
     Fair Value Measurement at
May 31, 2019 (1)
 
     Using
Level 3
     Total      Using
Level 3
     Total  

Liabilities:

           

Derivative liability—convertible note redemption provision

   $ 1,442,764      $ 1,442,764      $ 2,005,137      $ 2,005,137  

Derivative liability—warrants

   $ 339,172        339,172        402,132        402,132  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

   $ 1,781,936      $ 1,781,936      $ 2,407,269      $ 2,407,269  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(1)

The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.

A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurements. These instruments are not quoted on an active market. The Company uses a Binomial Lattice Model to estimate the value of the warrant derivative liability and a Monte Carlo Simulation to value the derivative liability of the redemption provision within a convertible promissory note. These valuation models were used because management believes they reflect all the assumptions that market participants would likely consider in negotiating the transfer of the instruments. The Company’s derivative liabilities are classified within Level 3 of the fair value hierarchy because certain unobservable inputs were used in the valuation models.

 

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The following is a reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended August 31, 2019 and the year ended May 31, 2019:

 

Investor warrants issued with registered direct equity offering

   $ 4,360,000  

Placement agent warrants issued with registered direct equity offering

     819,200  

Fair value adjustments

     (3,855,468
  

 

 

 

Balance at May 31, 2018

     1,323,732  

Inception date value of redemption provision—warrants

     2,750,006  

Fair value adjustments—warrants

     (744,869

Fair value adjustments—convertible notes

     (921,600
  

 

 

 

Balance at May 31, 2019

     2,407,269  

Fair value adjustments—warrants

     (62,960

Fair value adjustments—convertible notes

     (562,373
  

 

 

 

Balance at August 31, 2019

   $ 1,781,936  
  

 

 

 

Operating Leases

Effective June 1, 2019, the Company determined if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately.

Stock-Based Compensation

U.S. GAAP requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award (requisite service period) or when designated milestones have been achieved.

The Company accounts for stock-based awards established by the fair market value of the instrument using the Black-Scholes option pricing model utilizing certain weighted average assumptions including stock price volatility, expected term and risk-free interest rates, as of the grant date. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of the stock-based award. The expected volatility is based on the historical volatility of the Company’s common stock on monthly intervals. The computation of the expected option term is based on the “simplified method,” as the Company issuances are considered “plain vanilla” options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period or when designated milestones have been achieved. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to third parties as compensation for services rendered. Such stock awards are valued at fair market value on the effective date of the Company’s obligation.

Common Stock

On June 7, 2018, at a special meeting of the Company’s stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 375,000,000 to 450,000,000. On November 8, 2018, at the 2018 Annual Meeting of Stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 450,000,000 to 600,000,000. Subsequently, on May 22, 2019, at a special meeting of stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 600,000,000 to 700,000,000.

 

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Preferred Stock

The Company’s Board of Directors is authorized to issue up to 5,000,000 shares of preferred stock without stockholder approval. As of August 31, 2019, the Company has authorized the issuance of 400,000 shares of Series B convertible preferred stock and 5,000 shares of Series C convertible preferred stock, of which 92,100 shares and 5,000 shares, respectively, were outstanding. The remaining preferred shares authorized have no specified rights.

Treasury Stock

Treasury stock purchases are accounted for under the par value method, whereby the cost of the acquired stock is recorded at par value. As of August 31, 2019, the Company has purchased 159,011 shares of $0.001 par value treasury stock.

Debt Discount

During year ended May 31, 2019, the Company incurred approximately $4.2 million of debt discount related to the issuance of convertible notes, as described in Note 4. The discount is amortized over the life of the convertible promissory notes. During the three months ended August 31, 2019 and August 31, 2018, the Company recorded approximately $1.03 million and $0.06 million of related amortization, respectively.

Debt Issuance Cost

During the year ended May 31, 2019, the Company incurred direct costs associated with the issuance of convertible notes, as described in Note 4, and recorded approximately $1.0 million of debt issuance costs. During the three months ended August 31, 2019 and August 31, 2018, the Company recognized related amortization of approximately $284,000 and $9,000, respectively.

Offering Costs

During the three months ended August 31, 2019 and the year ended May 31, 2019, the Company incurred direct incremental costs associated with the sale of equity securities, as described in Notes 10 and 11. The costs were approximately $1.5 million and $4.3 million for the three months ended August 31, 2019 and year ended May 31, 2019, respectively. The offering costs were recorded as a component of equity upon receipt of proceeds.

Stock for Services

The Company periodically issues warrants to consultants for various services. The Black-Scholes option pricing model, as described more fully above, is utilized to measure the fair value of the equity instruments on the date of issuance. The Company recognizes the compensation expense associated with the equity instruments over the requisite service or vesting period.

Loss per Common Share

Basic loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share would include the weighted average number of shares of common stock outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on the loss per share. For this reason, common stock options and warrants to purchase 154,635,055 and 145,856,851 shares of common stock were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the three months ended August 31, 2019 and August 31, 2018, respectively. Additionally, as of August 31, 2019, shares of Series C and Series B convertible preferred stock in the aggregate of 97,100 shares can potentially convert into 10,921,000 shares of common stock.

Income Taxes

Deferred taxes are provided on the asset and liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Future tax benefits for net operating loss carry forwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized.

 

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The Company follows the provisions of FASB Accounting Standards Codification (“ASC”) ASC 740-10 “Uncertainty in Income Taxes”. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits for all periods presented. The Company has not recognized interest expense or penalties as a result of the implementation of ASC 740-10. If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefit in interest expense and penalties in operating expenses.

In accordance with Section 15 of the Internal Revenue Code, the Company utilized a federal statutory rate of 21% and 28.62% for the three months ended August 31, 2019 and August 31, 2018, respectively. The net tax expense for the three months ended August 31, 2019 and August 31, 2018, is zero. The Company has a full valuation allowance as of August 31, 2019 and May 31, 2019, as management does not consider it more than likely than not that the benefits from the deferred taxes will be realized.

Note 3 – Recent Accounting Pronouncements

Recent accounting pronouncements, other than below, issued by the FASB (including its EITF), the AICPA and the SEC did not or are not believed by management to have a material effect on the Company’s present or future financial statements.

In February 2016, the FASB issued a new accounting standard which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The ASU also requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. The standard is effective for fiscal years beginning after December 15, 2018. The Company adopted the standard as of June 1, 2019, using the modified retrospective approach in which prior comparative periods are not adjusted. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carry forward historical lease classification. The Company has operating leases for two office facilities, one which expires on April 30, 2021 and the other on March 31, 2022. As of June 1, 2019, the Company recognized additional right-of-use assets and corresponding operating lease liabilities related to its facility leases on the consolidated balance sheet. No cumulative effect adjustment was recognized as the amount was not material. The standard did not materially impact the Company’s consolidated statement of operations or cash flows.

In June 2016, the FASB issued a new accounting standard intended to provide financial statement users with more decision-useful information about expected credit losses and other commitments to extend credit held by the reporting entity. The standard replaces the incurred loss impairment methodology in current GAAP with one that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The update is effective on January 1, 2020, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.

In August 2018, the FASB issued a new accounting standard to reduce, modify, and add to the disclosure requirements on fair value measurements. The standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.

In August 2018, the FASB issued a new accounting standard to align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software. The standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.

Note 4 – Convertible Instruments

Series C Convertible Preferred Stock

On March 20, 2019, the Company authorized 5,000 shares and issued 3,246 shares of Series C Convertible Preferred Stock, $0.001 par value per share (“Series C Preferred Stock”), at $1,000.00 per share for cash proceeds totaling $3,083,700, net of placement agent fees of $162,300. On August 29, 2019 the Company issued the remaining 1,754 shares of Series C Preferred Stock at $1,000.00 per share for cash proceeds totaling $1,542,545, net of placement agent fees and legal fees totaling $211,455. As of August 31, 2019, 5,000 shares of Series C Preferred Stock remain outstanding. The Series C Preferred Stock Certificate of Designation (the “Certificate of Designation”) provides, among other things, that holders of Series C Preferred Stock shall be entitled to receive, at the option of the holder, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series C Preferred Stock, to be paid per share of Series C Preferred Stock. Any dividends paid by the Company will first

 

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be paid to the holders of Series C Preferred Stock prior and in preference to any payment or distribution to holders of common stock. Dividends on the Series C Preferred Stock are mandatory and cumulative and there are no sinking fund provisions applicable to the Series C Preferred Stock. The Series C Preferred Stock does not have redemption rights. The stated value per share for the Series C Preferred Stock is $1,000 (the “Stated Value”). In the event of any liquidation, dissolution or winding up of the Company, the Series C Preferred Stock will be paid, prior and in preference to any payment or distribution on any shares of common stock, currently outstanding series of preferred stock, or subsequent series of preferred stock, an amount per share equal to the Stated Value and the amount of any accrued and unpaid dividends. The holders of the Series C Preferred Stock will then receive distributions along with the holders of common stock on a pari passu basis according to the number of shares of common stock the Series C Preferred holders would be entitled if they converted their shares of Series C Preferred Stock at the time of such distribution. If, at any time while the Series C Preferred Stock is outstanding, the Company effects any reorganization, merger or sale of the Company or substantially all of its assets (each a “Fundamental Transaction”), a holder of the Series C Preferred Stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C Preferred Stock immediately prior to the Fundamental Transaction. Each share of Series C Preferred Stock is convertible at any time at the holder’s option into that number of fully paid and nonassessable shares of the Company’s common stock determined by dividing the Stated Value by the conversion price of $0.50 per share (subject to adjustment as set forth in the Certificate of Designation). No fractional shares will be issued upon the conversion of the Series C Preferred Stock. Except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series C Preferred Stock has no voting rights. As of August 31, 2019, the accrued dividends were approximately $148,000 or 296,000 shares of common stock.

Series B Convertible Preferred Stock

During fiscal 2010, the Company issued 400,000 shares of Series B Convertible Preferred Stock, $0.001 par value per share (“Series B Preferred Stock”) at $5.00 per share for cash proceeds totaling $2,009,000, of which 92,100 shares remain outstanding at August 31, 2019. Each share of the Series B Preferred Stock is convertible into ten shares of the Company’s common stock, including any accrued dividends, with an effective fixed conversion price of $0.50 per share. The holders of the Series B Preferred Stock can only convert their shares to shares of common stock provided the Company has sufficient authorized shares of common stock at the time of conversion. Accordingly, the conversion option was contingent upon the Company increasing its authorized common shares, which occurred in April 2010, when the Company’s stockholders approved an increase in the authorized shares of common stock to 100,000,000. At the commitment date, which occurred upon such stockholder approval, the conversion option related to the Series B Preferred Stock was beneficial. The intrinsic value of the conversion option at the commitment date resulted in a constructive dividend to the Series B Preferred Stock holders of approximately $6,000,000. The constructive dividend increased and decreased additional paid-in capital by identical amounts. The Series B Preferred Stock has liquidation preferences over the common shares at $5.00 per share plus any accrued dividends. Dividends are payable to the Series B Preferred Stock holders when declared by the Board of Directors at the rate of $0.25 per share per annum. Such dividends are cumulative and accrue whether or not declared and whether or not there are any profits, surplus or other funds or assets of the Company legally available. The Series B holders have no voting rights. As of August 31, 2019 and May 31, 2019, the undeclared dividends were approximately $227,000 or 454,000 shares of common stock and approximately $216,000 or 432,000 shares of common stock, respectively.

2019 Short-term Convertible Notes

During the year ended May 31, 2019, the Company issued approximately $5.5 million of nine-month unsecured Convertible Notes (the “2019 Short-term Convertible Notes”) and related warrants to investors for cash. The principal amount of the 2019 Short-term Convertible Notes, including any accrued but unpaid interest thereon, is convertible at the election of the holder at any time into shares of common stock at any time prior to maturity at a conversion price of $0.50 per share. The 2019 Short-term Convertible Notes bear simple interest at the annual rate of 10%. Principal and accrued interest, to the extent not previously paid or converted, is due and payable on the maturity date. At the commitment dates, the Company determined that the conversion feature related to these 2019 Short-term Convertible Notes to be beneficial to the investors. As a result, the Company determined the intrinsic value of the beneficial conversion feature utilizing the fair value of the underlying common stock on the commitment dates and the effective conversion price after discounting the 2019 Short-term Convertible Notes for the fair value of the related warrants. In connection with the sale of the 2019 Short-term Convertible Notes, detachable common stock warrants to purchase a total of 5,460,000 common shares, with an exercise price of $0.30 per share and a five-year term were issued to the investors. The Company determined the fair value of the warrants at issuance using the Black-Scholes option pricing model utilizing certain weighted average assumptions, such as expected stock price volatility, expected term of the warrants, risk-free interest rates and expected dividend yield at the grant date.

 

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     2018 - 2019

Expected dividend yield

   0%

Stock price volatility

   55.8 - 55.88%

Expected term

   5 year

Risk-free interest rate

   2.48 - 2.56%

Grant-date fair value

   $0.30 - $0.38

The fair value of the warrants, coupled with the beneficial conversion features, were recorded as a debt discount to the 2019 Short-term Convertible Notes and a corresponding increase to additional paid-in capital and will be amortized over the life of the 2019 Short-term Convertible Notes. In connection with the 2019 Short-term Convertible Notes, the placement agent earned a “tail fee” comprised of warrants covering 972,000 shares of common stock and a cash fee of $583,200. The placement agent warrants are exercisable at a price of $0.50 per share and will expire five years from the date of issuance and include a cashless exercise provision. During the year ended May 31, 2019, and in connection with the 2019 Short-term Convertible Notes, the Company incurred debt discount and issuance costs of approximately $3.0 million, related to the beneficial conversion feature and detachable warrants issued with the 2019 Short-term Convertible Notes and approximately $0.8 in issuance costs. The debt discount and issuance costs are being amortized over the term of the 2019 Short-term Convertible Notes. Accordingly, the Company recognized approximately $1.0 million and $0.3 million of debt discount and issuance costs, respectively, during the three months ended August, 31, 2019. Activity related to the 2019 Short-term Convertible Notes was as follows:

 

     August 31, 2019      May 31, 2019  

Face amount of Short-term Convertible Notes

   $ 5,460,000      $ 5,460,000  
  

 

 

    

 

 

 

Unamortized discount

     (439,000      (1,470,000

Unamortized issuance costs

     (120,000      (404,000
  

 

 

    

 

 

 

Carrying value of Short-term Convertible Notes

   $ 4,901,000      $ 3,586,000  
  

 

 

    

 

 

 

The Company recognized approximately $138,000 and $0 of interest expense during the three months ended August 31, 2019 and August 31, 2018, respectively.

Long-term Convertible Notes—June 2018 Note

On June 26, 2018, the Company entered into a securities purchase agreement, pursuant to which the Company issued a convertible promissory note (the “June 2018 Note”) with a two-year term to an institutional accredited investor in the initial principal amount of $5.7 million. The investor gave consideration of $5.0 million to the Company. The June 2018 Note bears interest of 10% and is convertible into common stock, at $0.55 per share. The June 2018 Note is convertible in total, or in part, of the outstanding balance, at any time after six months from the issue date upon five trading days’ notice, subject to certain adjustments and ownership limitations specified in the June 2018 Note. The Investor may redeem any portion of the June 2018 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000. The securities purchase agreement requires the Company to reserve shares for future conversions or redemptions by dividing the outstanding principal balance plus accrued interest by the conversion price of $0.55 per share times 1.5. As a result of the entry into the January 2019 Note (as defined below), the Company’s obligations under the June 2018 Note are now secured by all of the assets of the Company, excluding the Company’s intellectual property.

Effective November 15, 2018, the June 2018 Note was amended to allow the Investor to redeem the monthly redemption amount of $350,000 in cash or stock, at the lesser of (i) $0.55, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%. The variable rate redemption provision meets the definition of a derivative instrument and subsequent to the amendment, it no longer meets the criteria to be considered indexed to the Company’s own stock. As of November 15, 2018, the redemption provision requires bifurcation as a derivative liability at fair value under the guidance in ASC Topic No. 815, “Derivatives and Hedging.”

The amendment of the June 2018 Note was also evaluated under ASC Topic 470-50-40, “Debt Modifications and Extinguishments.” Based on the guidance, the instruments were determined to be substantially different, and debt extinguishment accounting was applied. The Company recorded approximately $1.5 million as an extinguishment loss, which was the difference in the net carrying value of the June 2018 Note prior to the amendment of approximately $5.4 million, and the fair value of the June 2018 Note and embedded derivatives after the amendment of approximately $6.9 million. The extinguishment loss includes a write-off of unamortized debt issuance costs and the debt discount associated with the original the June 2018 Note.

 

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During the three months ended August 31, 2019 and August 31, 2018, the Company recognized approximately $162,000 and $104,000, of interest expense related to the June 2018 Note, respectively. During the three months ended August 31, 2019, the Company received redemption notices from the holder of the Company’s June 2018 Note, requesting an aggregate redemption of $1,005,000 of the outstanding balance thereof. In satisfaction of the redemption notices, the Company issued shares of common stock totaling 3,014,181 to the June 2018 Note holder in accordance with the terms of the June 2018 Note. Following the redemptions, the outstanding balance of the convertible June 2018 Note, including accrued but unpaid interest, was approximately $3.7 million.

Long-term Convertible Notes—January 2019 Note

On January 30, 2019, the Company entered into a securities purchase agreement, pursuant to which the Company issued a convertible promissory note (the “January 2019 Note”) with a two-year term to the holder of the June 2018 Note in the initial principal amount of $5.7 million. In connection with the issuance of the January 2019 Note, the Company granted a lien against all of the assets of the Company, excluding the Company’s intellectual property, to secure all obligations owed to the investor by the Company (including those under both the January 2019 Note and the June 2018 Note). The investor gave consideration of $5.0 million to the Company, reflecting original issue discount of $0.6 million and issuance costs of $0.1 million. The January 2019 Note bears interest of 10% and is convertible into common stock, at $0.50 per share. The January 2019 Note is convertible in total, or in part, of the outstanding balance, at any time after six months from the issue date upon five trading days’ notice, subject to certain adjustments and ownership limitations specified in the Note. The Company analyzed the conversion option for derivative accounting treatment under ASC 815 and determined that the embedded conversion option did not qualify for derivative accounting.

The investor may redeem any portion of the January 2019 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000. The monthly redemption amount may be paid in cash or stock, at the Company’s election, at the lesser of (i) $0.50, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%. The redemption provision meets the definition of a derivative instrument and does not meet the criteria to be considered indexed to the Company’s own stock. Therefore, the redemption provision requires bifurcation as a derivative liability at fair value under the guidance in ASC Topic No. 815 (“ASC 815”). The securities purchase agreement requires the Company to reserve 20,000,000 shares for future conversions or redemptions. In conjunction with the January 2019 Note, the investor received a warrant to purchase 5,000,000 shares of common stock with an exercise price of $0.30 which is exercisable until the 5-year anniversary of the date of issuance. The warrant achieved equity classification at inception. The net proceeds of $5.0 million were allocated first to the redemption provision at its fair value, then to the warrants at their relative fair value and the beneficial conversion feature at its intrinsic value as follows:

 

     January 30, 2019  

Fair value of redemption provision

   $ 1,465,008  

Relative fair value of equity classified warrants

     858,353  

Beneficial conversion feature

     2,676,639  
  

 

 

 
   $ 5,000,000  
  

 

 

 

Under the guidance of ASC 815, after allocation of proceeds to the redemption provision, relative fair value of equity classified warrants and the beneficial conversion feature, there were no proceeds remaining to allocate to convertible note payable. Therefore, principal, accrued interest, debt discount and offering costs will be recognized as interest expense, which represents the accretion of the convertible note payable and related debt discount and issuance costs. During the three months ended August 31, 2019 and August 31, 2018, the Company recognized approximately $104,000 and $-0-, respectively, of interest expense related to the January 2019 Note.

 

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Activity related to the June 2018 Note and the January 2019 Note is as follows:

 

     Short Term      Long Term      Total  

June 2018 Note

   $ 2,100,000      $ 3,600,000      $ 5,700,000  

Monthly redemption provision

     2,100,000        (2,100,000      —    

Note amendment, net

     —          111,410        111,410  

Redemptions

     (676,582      (1,783,418      (2,460,000

Interest accretion—June 2018 and January 2019 Notes

     161,933        402,622        564,555  
  

 

 

    

 

 

    

 

 

 

Carrying value of Notes at August 31, 2019

   $ 3,685,351      $ 230,614      $ 3,915,965  
  

 

 

    

 

 

    

 

 

 

Note 5 – Derivative Liabilities

The investor and placement agent warrants, issued in connection with a registered direct offering in September 2016, contained a provision for net cash settlement in the event that there is a fundamental transaction (contractually defined as a merger, sale of substantially all assets, tender offer or share exchange, whereby such other Person or group acquires more than 50% of the outstanding common stock). If a fundamental transaction occurs in which the consideration issued consists principally of cash or stock in a successor entity, then the warrant holder has the option to receive cash equal to the fair value of the remaining unexercised portion of the warrant. Due to this contingent cash settlement provision, the investor and placement agent warrants require liability classification as derivatives in accordance with ASC 480 and ASC 815 and are recorded at fair value.

The following tables summarize the fair value of the warrant derivative liability and related common shares as of inception date September 15, 2016, May 31, 2019 and August 31, 2019:

 

     Shares Indexed      Derivative Liability  

Inception date September 15, 2016

     7,733,334      $ 5,179,200  

Balance May 31, 2019

     7,733,334        402,132  

Balance August 31, 2019

     7,733,334      $ 339,172  

The Company recognized approximately $63,000 of non-cash gain and $747,000 of non-cash loss, due to the changes in the fair value of the liability associated with such classified warrants during the three months ended August 31, 2019 and August 31, 2018, respectively.

ASC 820 provides requirements for disclosure of liabilities that are measured at fair value on a recurring basis in periods subsequent to the initial recognition. Fair values for the warrants were determined using a Binomial Lattice (“Lattice”) valuation model.

The Company estimated the fair value of the warrant derivative liability as of inception date September 15, 2016, May 31, 2019 and August 31, 2019, using the following assumptions:

 

     September 15,
2016
    May 31,
2019
    August 31,
2019
 

Fair value of underlying stock

   $ 0.78     $ 0.39     $ 0.40  

Risk free rate

     1.20     1.94     1.50

Expected term (in years)

     5       2.29       2.04  

Stock price volatility

     106     61     60

Expected dividend yield

     —         —         —    

Probability of Fundamental Transaction

     50     50     50

Probability of holder requesting cash payment

     50     50     50

Due to the fundamental transaction provision contained in the warrants, which could provide for early redemption of the warrants, the model also considered subjective assumptions related to the fundamental transaction provision. The fair value of the warrants will be significantly influenced by the fair value of the Company’s stock price, stock price volatility, changes in interest rates and management’s assumptions related to the fundamental transaction provisions.

 

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As described above in Note 4 above, the redemption provision embedded in the June 2018 and January 2019 Notes required bifurcation and measurement at fair value as a derivative. The fair value of the Note redemption provision derivative liabilities was calculated using a Monte Carlo Simulation which uses randomly generated stock-price paths obtained through a Geometric Brownian Motion stock price simulation. The fair value of the redemption provision will be significantly influenced by the fair value of the Company’s stock price, stock price volatility, changes in interest rates and management’s assumptions related to the redemption factor. The Company estimated the fair value of the redemptive provision using the following assumptions on the closing date of November 15, 2018, January 30, 2019 and August 31, 2019:

 

     November 15,
2018
    January 30,
2019
    August 31, 2019  
    Note 1     Note 2  

Fair value of underlying stock

   $ 0.57     $ 0.49     $ 0.40     $ 0.40  

Risk free rate

     2.78     2.52     1.76     1.76

Expected term (in years)

     1.61       2       0.82       1.42  

Stock price volatility

     58.8     61     63.8     61.6

Expected dividend yield

     —         —         —         —    

Discount factor

     85     85     85     85

The following table summarizes the fair value of the convertible note redemption provision derivative liability as of inception dates November 15, 2018, January 30, 2019 and August 31, 2019:

 

     Net Proceeds      Derivative Liability  
     Inception date      August 31, 2019  

Inception date June 2018 Note, November 15, 2018

   $ 5,000,000      $ 1,284,988      $ 372,458  

Inception date January 2019 Note, January 30, 2019

     5,000,000        1,465,008        1,070,306  
        

 

 

 
                   $1,442,764  
        

 

 

 

The Company recognized approximately $562,000 of non-cash gain, due to the changes in the fair value of the liability associated with such classified redemption provision for the three months ended August 31, 2019.

Note 6 – Stock Options and Warrants

The Company has one active stock-based equity plan at August 31, 2019, the CytoDyn Inc. 2012 Equity Incentive Plan, as amended (the “2012 Plan”) and one stock-based equity plan that is no longer active, but under which certain prior awards remain outstanding, the CytoDyn Inc. 2004 Stock Incentive Plan (the “2004 Plan” and, together with the 2012 Plan, the “Incentive Plans”). The 2012 Plan was approved by stockholders at the Company’s 2012 annual meeting to replace the 2004 Plan. The 2012 Plan was amended by stockholder approval in February 2015 to increase the number of shares available for issuance from 3,000,000 to 5,000,000 shares of common stock and in March 2016 to increase the number of shares available for issuance from 5,000,000 to 7,000,000 shares of common stock. At the annual meeting of stockholders held on August 24, 2017, the stockholders approved an amendment to the 2012 Plan to increase the number of shares available for issuance from 7,000,000 to 15,000,000 shares of common stock. At a special meeting of stockholders held on May 22, 2019, the stockholders approved an amendment to the 2012 Plan to increase the number of shares available for issuance from 15,000,000 to 25,000,000 shares of common stock. As of August 31, 2019, the Company had 9,949,144 shares available for future stock-based grants under the 2012 Plan, as amended.

Stock Options

During the three months ended August 31, 2019, the Company granted annual stock option awards to directors to purchase a total of 600,000 shares of common stock. The exercise price of the stock option awards is $0.52 per share. These stock option awards vest quarterly over one year and have a ten-year term. The grant date fair value related to these stock options was $0.26 per share.

During the three months ended August 31, 2019, the Company granted stock options, covering an aggregate of 275,000 shares of common stock, to executive management and employees with exercise prices ranging between $0.43 and $0.52 per share, except for one award of 50,000 shares which has an exercise price of $0.90 and represented a supplemental award related to a previous rescission, and which vested immediately. The remaining stock option awards vest annually over three years, with a ten-year term and grant date fair values ranging between $0.23 and $0.30 per share.

 

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On August 12, 2019, Gregory Gould, a member of the Company’s Board of Directors, resigned. On September 12th, Carl Dockery, a member of the Company’s Board of Directors did not stand for re-election. 90 days after the cessation of their service, any vested and unexercised options in their names will be returned to the pool of shares available for future stock-based grants under the 2012 Plan.

Warrants

On August 29, 2019, in connection with a registered direct offering, as fully described in Note 11, the Company issued warrants covering 2,819,750 shares of common stock to investors. The investor warrants have a five-year term and an exercise price of $0.45 per share. In connection with the registered direct offering, the Company also issued warrants covering 498,105 shares of common stock to the placement agent. The placement agent warrants have a five-year term and an exercise price of $0.40 per share.

During the three months ended August 31, 2019, in connection with a Series C convertible preferred offering, as fully described in Note 4, the Company issued common stock warrants covering a total of 2,631,000 shares of common stock to investors. The investor warrants have a five-year term and an exercise price of $0.50 per share.

Compensation expense related to stock options, compensatory warrants and common stock reserved for advisory services for the three months ended August 31, 2019 and August 31, 2018 was approximately $581,000 and $283,000, respectively. The grant date fair value of options and compensatory warrants vested during the three month periods ended August 31, 2019 and August 31, 2018 was approximately $542,000 and $692,000, respectively. As of August 31, 2019, there was approximately $1.0 million of unrecognized compensation expense related to share-based payments for unvested options, which is expected to be recognized over a weighted average period of 0.84 years.

The following table represents stock option and warrant activity as of and for the three months ended August 31, 2019:

 

     Number of
Shares
     Weighted
Average
Exercise Price
     Weighted
Average
Remaining
Contractual Life
in Years
     Aggregate
Intrinsic Value
 

Options and warrants outstanding—May 31, 2019

     178,591,849      $ 0.71        3.75      $ 896,400  
  

 

 

          

Granted

     6,823,855        0.45        —          —    

Exercised

     (30,250,649      0.39        —          —    

Forfeited/expired/cancelled

     (530,000      0.79        —          —    
  

 

 

          

Options and warrants outstanding—August 31, 2019

     154,635,055        0.70        3.71        796,000  
  

 

 

          

Outstanding exercisable—August 31, 2019

     151,793,153      $ 0.71        3.59      $ 796,000  
  

 

 

          

Note 7 – Acquisition of Patents and Intangibles

As discussed in Note 9 below, the Company consummated an asset purchase on October 16, 2012, and paid $3,500,000 for certain assets, including intellectual property, certain related licenses and sublicenses, FDA filings and various forms of the leronlimab (PRO 140) drug substance. The Company followed the guidance in Financial Accounting Standards Topic 805 to determine if the Company acquired a business. Based on the prescribed accounting, the Company acquired assets and not a business. As of August 31, 2019, the Company has recorded and is amortizing $3,500,000 of intangible assets in the form of patents. The Company estimates the acquired patents have an estimated life of ten years. Subsequent to the acquisition date, the Company has continued to expand, amend and file new patents central to its current clinical trial strategies, which, in turn, have extended the protection period for certain methods of using leronlimab (PRO 140) and formulations comprising leronlimab (PRO 140) out through at least 2031 and 2038, respectively, in various countries.

On November 16, 2018, the Company completed the acquisition of substantially all of the assets of ProstaGene, LLC (“ProstaGene”), a biotechnology start-up company, which included patents related to clinical research, a proprietary CCR5 technology for early cancer diagnosis, and a noncompetition agreement with ProstaGene’s founder and Chief Executive Officer, Richard G. Pestell, M.D., Ph.D. The acquisition of ProstaGene’s assets expands the Company’s clinical development of leronlimab (PRO 140) into cancer indications and commercialization of certain cancer diagnostic tests.

 

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The aggregate purchase price paid for the ProstaGene acquisition was $11,558,000 based on the issuance of 20,278,000 shares of common stock of CytoDyn at $0.57 per share, including 1,620,000 shares earned, but not yet issued, by the investment bank for advisory services. In connection with the purchase, the Company entered into a Stock Restriction Agreement (“Agreement”), restricting the transfer of 8,342,000 shares of common stock payable to Dr. Pestell for a three-year period from the closing date of the transaction. Dr. Pestell’s employment with the Company was terminated on July 25, 2019, and as defined in the employment agreement, on September 17, 2019 the Company exercised its option to repurchase such Restricted Shares from Dr. Pestell at a purchase price of $0.001 per share. The repurchase is currently the subject of a legal proceedings between Dr. Pestell and the Company, as fully described in Part II, Item 1.

A summary of the net purchase price and allocation to the acquired assets is as follows:

 

     ProstaGene, LLC  

CytoDyn Inc. Equity

   $ 11,558,000  

Acquisition Expenses

     741,297  

Release of Deferred Tax Asset

     2,826,919  
  

 

 

 

Total Cost of Acquisition

   $ 15,126,216  
  

 

 

 

Intangible assets

   $ 15,126,216  

Other

     —    
  

 

 

 

Allocation of Acquisition Costs

   $ 15,126,216  
  

 

 

 

Assets acquired from ProstaGene include (1) patents issued in the United States and Australia related to “Prostate Cancer Cell Lines, Gene Signatures and Uses Thereof” and “Use of Modulators of CCR5 in the Treatment of Cancer and Cancer Metastasis,” (2) an algorithm used to identify a 14-gene signature to predict the likelihood and severity of cancer diagnoses, and (3) a noncompetition agreement in connection with an employment agreement with Dr. Pestell as Chief Medical Officer of the Company. The fair value of the assets acquired approximates the consideration paid. The Company did not assume any liabilities. The Company accounted for the ProstaGene acquisition as an asset acquisition under ASC 805-10-55 “Business Combinations” because the assets retained from ProstaGene do not include an assembled workforce, and the gross value of the assets acquired meets the screen test in ASC 805-10-55-5A related to substantially all of the fair value being concentrated in a single asset or group of assets (i.e., the proprietary technology and patents) and, thus, is not considered a business. Thus, management concluded that the acquisition did not include both an input and substantive processes that together significantly contribute to the ability to create outputs.

The fair value of the technology acquired is identified using the Income Approach. The fair value of the patents acquired is identified using the Cost to Reproduce Method. The fair value of noncompetition agreement acquired is identified using the Residual Value Method. Goodwill is not recorded as the transaction represents an asset acquisition in accordance with ASU 2017-01. Acquisition costs for asset acquisitions are capitalized and included in the total cost of the transaction. In addition, pursuant to ASC 805, the net tax effect of the deferred tax liability arising from the book to tax basis differences is recorded as a cost of the acquisition.

The following presents intangible assets activity:

 

     August 31, 2019      May 31, 2019  

Gross carrying amounts

   $ 3,500,000      $ 3,500,000  

Development of new Company website

     19,552      $ 19,553  

Intangible asset acquisition:

     

ProstaGene, LLC

     15,126,216        15,126,216  

Accumulated amortization

     (3,698,646      (3,170,315
  

 

 

    

 

 

 

Total amortizable intangible assets, net

     14,947,122        15,475,454  
  

 

 

    

 

 

 

Patents currently not amortized

     —          —    
  

 

 

    

 

 

 

Carrying value of intangibles, net

   $ 14,947,122      $ 15,475,454  
  

 

 

    

 

 

 

Amortization expense related to intangible assets patents was approximately $528,400 and $87,500 for the three months ended August 31, 2019 and 2018, respectively. The estimated aggregate future amortization expense related to the Company’s intangible assets with finite lives is estimated to be approximately $2 million per year for the next two years, approximately $1.5 million the following year, approximately $1.1 million the year thereafter, and approximately $1.0 million the year following that.

 

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Note 8 – License Agreements

The Company has a license agreement with a third-party licensor covering the licensor’s “system know-how” technology with respect to the Company’s use of proprietary cell lines to manufacture new leronlimab (PRO 140) material. The Company accrues an annual license fee of £300,000 (approximately US$400,000 utilizing current exchange rates), which is payable annually in December, except for the December 2017 and 2018 payments, which were extended to March 15, 2018 and April 15, 2019, respectively. Future annual license fees and royalty rate will vary depending on whether the Company manufactures leronlimab (PRO 140), utilizes the third-party licensor as a contract manufacturer, or utilizes an independent party as a contract manufacturer. The licensor does not charge an annual license fee when it serves as the manufacturer. In addition, the Company will incur royalties of up to 0.75% to 2% of net sales, depending upon who serves as the manufacturer, when the Company commences their first commercial sale, which will continue as long as the license agreement is maintained.

Note 9 – Commitments and Contingencies

Under the Progenics Purchase Agreement, the Company acquired rights to the HIV viral-entry inhibitor drug candidate PRO 140, a humanized anti-CCR5 monoclonal antibody, as well as certain other related assets, including the existing inventory of bulk PRO 140 drug product, intellectual property, certain related licenses and sublicenses, and FDA regulatory filings. In connection with purchase, the Company has one remaining milestone payment of $5.0 million, which will become due at the time of the first U.S. new drug application approval by the FDA or other non-U.S. approval for the sale of PRO 140. In addition, the Company will incur royalty payments of up to 5% on net sales during the period beginning on the date of the first commercial sale of PRO 140 until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years, in each case determined on a country-by country basis. During the year ended May 31, 2016 the Company paid a milestone obligation of $1.5 million owed to Progenics as a result of the first dosing in a U.S. Phase 3 trial. To the extent that the remaining milestone payment and royalties are not timely made, under the terms of the Progenics Purchase Agreement, Progenics has certain repurchase rights relating to the assets sold to the Company thereunder. As of the date of this filing, it is management’s conclusion that the probability of achieving the subsequent future scientific research milestone is not reasonably determinable, thus the future milestone payments payable to Progenics and its sub-licensors are deemed contingent consideration and, therefore, are not currently accruable. Payments to the third-party licensor and to Progenics are in addition to payments due under a Development and License Agreement, dated April 30, 1999 (the “PDL License”), between Protein Design Labs (now AbbVie Inc.) (“PDL”) and Progenics, which was assigned to the Company in the Progenics Purchase Agreement, pursuant to which the Company has an exclusive worldwide license to develop, make, have made, import, use, sell, offer to sell or have sold products that incorporate the humanized form of the PRO 140 antibody developed by PDL under the agreement the Company has paid various milestone obligations, with two remaining milestone payments of $0.5 million each, one payment of $0.5 million upon filing a BLA with the FDA or non-U.S. equivalent regulatory body and a second payment of $0.5 million, which will become due upon FDA approval or approval by anothernon-U.S. equivalent regulatory body. In addition, the Company will incur royalties of up to 3.5% of net sales for the longer of 10 years and the date of expiration of the last to expire licensed patent. Additionally, the PDL License provides for an annual maintenance fee of $150,000 or until annual royalties paid exceed that amount. To the extent the remaining milestone payment and royalties are not timely made, under the terms of the PDL License, AbbVie Inc. has certain termination rights relating to the Company’s license of PRO 140 thereunder. As of the date of this filing, it is management’s conclusion that the probability of achieving the subsequent future scientific research milestones is not reasonably determinable, thus the future milestone payments payable to PDL, Progenics and its sub-licensors are deemed contingent consideration and, therefore, are not currently accruable.

During the fourth quarter of fiscal 2019, the Company entered into a Master Services Agreement and Product Specific Agreement (collectively, the “Samsung Agreement”) with Samsung BioLogics Co., Ltd. (“Samsung”), pursuant to which Samsung will perform technology transfer, process validation, manufacturing and supply services for the commercial supply of leronlimab. In April 2019 the Company delivered to Samsung a purchase order for $33 million worth of process validation and technology transfer services related to the manufacture of leronlimab, with payments by the Company scheduled to be made throughout calendar 2020. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the full amount of the purchase order. Under the terms of the Samsung Agreement, the Company is obligated to make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which the Company will provide to Samsung. The first forecast will be delivered to Samsung by March 31, 2020. Thereafter, the Company must provide Samsung with a rolling quarterly forecast setting forth the total quantity of commercial grade leronlimab that the Company expects to require in the following years. The Company estimates that initial ramp-up costs to manufacture commercial grade leronlimab at scale could total approximately $60 million, with approximately $30 million payable over the course of calendar 2020, and approximately $30 million payable in the first quarter of 2021. Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement. The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional two year periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the other party’s insolvency or uncured material breach, and the Company may terminate the agreement in the event of a voluntary or involuntary complete market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.

 

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In addition to the Company’s manufacturing agreement with Samsung, the Company also previously entered into an arrangement with another third party contract manufacturer to provide process transfer, validation and manufacturing services for leronlimab. In the event that the Company terminates the agreement with this manufacturer, the Company may incur certain financial penalties which would become payable to the manufacturer. Conditioned upon the timing of termination, the financial penalties may total approximately $8.3 million. These amount and timing of the financial commitments under an agreement with the Company’s secondary contract manufacturer will depend on the timing of the anticipated approval of the Company’s BLA and the initial product demand forecast, which is critical to align the timing of capital resources in order to ensure availability of sufficient quantities of commercial product.

The Company has entered into project work orders, as amended, for each of its CRO and related laboratory vendors. Under the terms of these agreements, the Company incurs execution fees for direct services costs, which are recorded as a current asset. In the event the Company were to terminate any trial, it may incur certain financial penalties which would become payable to the CRO. Conditioned upon the form of termination of any one trial, the financial penalties may range up to $0.7 million. In the remote circumstance that the Company would terminate all clinical trials, the collective financial penalties may range from an approximate low of $0.5 million to an approximate high of $1.1 million.

From time to time, the Company is involved in routine litigation that arises in the ordinary course of business. Other than specified in Part II, Item 1, there are no pending significant legal proceedings to which the Company is a party for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.

Note 10 – Public Warrant Tender Offerings

During the three months ended August 31, 2019, the Company conducted two public warrant tender offers, in which accredited investors purchased unregistered common stock at either $0.30 or $0.40 per share. Pursuant to the offering, the Company sold a total of 45,375,923 shares of common stock, $0.001 par value, for aggregate gross proceeds of approximately $11.9 million. The Company paid placement agent fees of approximately $1.1 million for services in connection with the offering. The Company also recorded a non-cash inducement interest expense of approximately $2.4 million in connection with the offerings.

Note 11 – Registered Direct Equity Offering

On August 29, 2019, the Company entered into subscription agreements with certain investors for the sale of 5,639,500 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“August Offering”), pursuant to a registration statement on Form S-3. The investors in the August offering also received warrants to purchase 2,819,750 shares of common stock with an exercise price of $0.45 per share and a five-year term. The Company received net proceeds from the offering of approximately $2.0 million. In addition, the placement agent received warrants covering 498,105 shares of common stock (or 8.8% of total shares sold to investors) with a per share exercise price of $0.40, a five-year term and include a cashless exercise provision.

Note 12 – Employee Benefit Plan

The Company has an employee savings plan (the “Plan”) pursuant to Section 401(k) of the Internal Revenue Code (the “Code”), covering all of its employees. The Company makes a qualified non-elective contribution of 3%, which consequently vests immediately. In addition, participants in the Plan may contribute a percentage of their compensation, but not in excess of the maximum allowed under the Code. During the three months ended August 31, 2019 and 2018, the Company incurred an expense of approximately $26,000 and $15,800, respectively, for qualified non-elective contributions.

Note 13 – Related Party Transactions

The Audit Committee of the Board of Directors, comprised of independent directors, or the full Board of Directors, reviews and approves all related party transactions.

On July 15, 2019, the Company entered into consulting agreements with two of its directors, one with Scott A. Kelly, M.D. in the capacity of non-executive Chief Science Officer, the other with David F. Welch, Ph.D. in the capacity of non-executive Strategy Advisor. On September 12, 2019, the Company and Dr. Welch agreed to amend his consulting agreement to eliminate any cash compensation (including previously earned entitlements) thereunder. The company has issued options for an aggregate of 1,375,000 shares of common stock to Dr. Kelly and Dr. Welch as compensation pursuant to such agreements, including options to Dr. Kelly for 750,000 shares at an exercise price of $0.385, on September 12, 2019, and 187,500 shares at an exercise price of $0.39, on October 7, 2019; and options to Dr. Welch for 250,000 shares at an exercise price of $0.385, on September 12, 2019, and 187,500 shares at an exercise price of $0.39, on October 7, 2019. The options granted on September 12, 2019 vested immediately upon issuance and have a 10-year expiration term. The options issued on October 7, 2019 vest in four equal quarterly installments beginning on the grant date and have a 10-year expiration term.

On June 12, 2019, the Company concluded a warrant tender offer (the “June 2019 Warrant Tender Offer”) for certain outstanding series of eligible warrants, offering the holders of such warrants the opportunity to amend and exercise their warrants at a reduced exercise price equal to the lower of (i) their respective existing exercise price or (ii) $0.40 per share of common stock. As an inducement to holders to participate in the June 2019 Warrant Tender Offer, the Company offered to issue to participating holders shares of common stock equal to an additional 50% of the number of shares issuable upon exercise of the eligible warrants (collectively, the “Additional Shares”). Dr. Kelly validly tendered warrants beneficially owned by him, covering an aggregate of 50,000 shares of common stock, and received 25,000 Additional Shares. Dr. Kelly participated on terms identical to those applicable to other holders in the June 2019 Warrant Tender Offer.

On July 31, 2019, the Company concluded an additional warrant tender offer on terms identical to the June 2019 Warrant Tender Offer (the “July 2019 Warrant Tender Offer”). Dr. Welch tendered warrants beneficially owned by him, covering an aggregate of 1,000,000 shares of common stock, and received 500,000 Additional Shares. Dr. Welch participated on terms identical to those applicable to other holders in the July 2019 Warrant Tender Offer”).

On September 30, 2019, an entity controlled by Dr. Welch exchanged a 2019 Short-term Convertible Note in the principal amount of $1 million and accrued but unpaid interest of $75,343, for an Exchange Note (as defined in Note 14 below) in the principal amount of $1,075,343 and a warrant to purchase 1,000,000 shares of common stock. The terms of the exchange, the Exchange Note and the related warrant are further described in Note 14. The entity controlled by Dr. Welch participated on terms identical to the other holders in the exchange.

 

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Note 14 – Subsequent Events

On September 10 and September 24, 2019, the Company received redemption notices from the holder of the Company’s June 2018 Convertible Note, requesting redemptions of $175,000 each, of the outstanding balance thereof. In satisfaction of the redemption notices, the Company issued, in the aggregate, 1,116,340 shares of common stock to the note holder in accordance with the terms of the convertible note. Following the redemptions, the outstanding balance of the convertible note, including accrued but unpaid interest, was approximately $3.5 million.

On September 12, 2019, the Company issued a stock option covering 200,000 shares of its common stock to a consultant. The stock option award has a per share exercise price of $0.385. The stock option vested immediately upon issuance with respect to 100,000 shares of common stock, and will vest with respect to the remaining 100,000 shares on December 12, 2019. It has a ten-year expiration term.

On September 19, 2019, the Company entered into subscription agreement with certain investors for the sale of 2,330,000 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“September 2019 Offering”), pursuant to a registration statement on Form S-3. The investors in the September 2019 Offering also received warrants to purchase 1,165,000 of common stock with an exercise price of $0.45 per share and a five year term. The Company received net proceeds from the September Offering of approximately $0.9 million.

Since August 31, 2019, the Company has been in negotiations with various holders of its 2019 Short-term Convertible Notes, with an aggregate outstanding balance as of September 30, 2019 of approximately $5.87 million and maturity dates between September 30, 2019 and November 14, 2019, to induce such holders either to convert such notes to equity or to extend the maturity dates of such notes. Thus far, the Company and holders of such notes having an aggregate outstanding balance of approximately $2.2 million have negotiated the extension of the maturity dates for such notes to April 1, 2020 and approximately $215,000 in aggregate outstanding balance has negotiated conversion into common stock. In certain cases, the Company and such holders have entered into exchange agreements pursuant to which, in exchange for notes having an aggregate outstanding balance of approximately $2.3 million, the Company issued (i) new convertible promissory notes, in an aggregate principal amount of approximately $2.2 million, upon similar terms and conditions as the 2019 Short-term Convertible Notes, but with an extended maturity date of April 1, 2020 (each, an “Exchange Note”) and (ii) warrants to purchase an aggregate of 2,100,000 shares of common stock, with an exercise price of $0.30 per share and a five-year term. In certain cases, as negotiated by each holder, the accrued but unpaid interest on the 2019 Short-term Convertible Notes was paid in cash, and not included in the outstanding principal amount of the Exchange Note, on the date of the exchange. Additionally, the Company and a holder of such notes have converted approximately $215,000 of outstanding balance of the 2019 Short-term Convertible Notes into common stock at a conversion rate of $0.40 per share and warrants covering 200,000 shares of common stock, with an exercise price of $0.30 per share and a five-year expiration term.

On October 3, 2019, the Company entered into subscription agreements with certain investors for the sale of 1,382,500 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“October 2019 Offering”), pursuant to a registration statement on Form S-3. The investors in the October 2019 Offering also received warrants to purchase 691,250 shares of common stock with an exercise price of $0.45 per share and a five-year term. The Company received net proceeds from the October 2019 Offering of approximately $0.6 million.

On October 7, 2019, the Company granted stock option awards covering 1,062,500 shares of common stock to employees and a consultant, with exercise prices of $0.39 per share. The stock option awards for employees covering 862,500 shares vest monthly over twelve months, and those for the consultant covering 200,000 shares vest in two equal installments, the first on the grant date, the second six months after the grant date. The stock option awards have a ten-year term and grant date fair values of $0.19 per share.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

This filing, contains forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “predict,” “plan,” “seek,” “estimate,” “project,” “continue,” “could,” “may,” and similar terms and expressions are intended to identify forward-looking statements. These statements include, among others, information regarding future operations, future capital expenditures and future net cash flows. Such statements reflect current views with respect to future events and financial performance and involve risks and uncertainties, including, without limitation, regulatory initiatives and compliance with governmental regulations, the sufficiency of the Company’s cash position and the ability to raise additional capital, clinical priorities, the results of clinical trials for the Company’s drug candidate, and various other matters, many of which are beyond our control. Should one or more of these risks or uncertainties occur, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated. Consequently, all of the forward-looking statements made in this filing are qualified by these cautionary statements and there can be no assurance of the actual results or developments.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the other sections of this Quarterly Report, including our financial statements and related notes appearing elsewhere herein. To the extent not otherwise defined herein, capitalized terms shall have the same meanings as in such financial statements and related notes. This discussion and analysis contains forward-looking statements including information about possible or assumed results of our financial condition, operations, plans, objectives and performance that involve risk, uncertainties and assumptions. The actual results may differ materially from those anticipated and set forth in such forward-looking statements.

Overview

Our current business strategy is to prioritize the completion our BLA filing for leronlimab as a combination therapy for highly treatment experienced HIV patients, to advance our Phase 1b/2 clinical trial metastatic triple-negative breast cancer, to continue our Phase 2 trial for graft-versus-host disease (“GvHD”), to finalize with the FDA our submitted protocol for a pivotal Phase 3 clinical trial with leronlimab as a monotherapy for HIV patients and concurrently to explore other cancer and immunologic indications for leronlimab. We continue to pursue licensing opportunities and other potential strategic partnerships for leronlimab with pharmaceutical companies and other potential business partners.

Clinical Trials Update for HIV Applications

Phase 2b Extension Study for HIV, as Monotherapy

Currently, there are four patients in this ongoing extension study and each has surpassed four and one-half years of suppressed viral load with PRO 140 as a single agent therapy. This extension study will be discontinued upon any FDA approval of leronlimab as combination therapy for HIV.

Phase 2b/3 Pivotal Trial for HIV, as Combination Therapy

This trial was successfully completed and is the basis for our current BLA, for which the first of three sections was submitted to the FDA in March 2019. We expect to submit the remaining two sections of the BLA in the fourth quarter of 2019. This trial for leronlimab as a combination therapy to existing HAART drug regimens for highly treatment experienced HIV patients achieved its primary endpoint with a p-value of 0.0032. Nearly all patients who have completed this trial have transitioned to an FDA-cleared rollover study, as requested by the treating physicians to enable the patients to have continued access to leronlimab.

 

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Rollover Study for HIV as Combination Therapy

This study is designed for patients who successfully completed the pivotal Phase 2b/3 Combination Therapy trial and for whom the treating physicians request a continuation of leronlimab therapy in order to maintain suppressed viral load. This extension study will be discontinued upon any FDA approval of leronlimab.

Phase 2b Investigative Trial for HIV, as Long-term Monotherapy

Enrollment for this trial is now closed after reaching 500 patients. This trial assesses the subcutaneous use of leronlimab as a long-acting single agent maintenance therapy for 48 weeks in patients with suppressed viral load with CCR5-tropic HIV-1 infection. The primary endpoint is the proportion of participants with a suppressed viral load to those who experienced virologic failure. The secondary endpoint is the length of time to virologic failure. The trial evaluates three dose arms, 350 mg, 525 mg and 700 mg. We recently reported that interim data suggested that both the 525 mg and the 700 mg dosages are achieving a responder rate of approximately 90% after the initial 10 weeks. This trial is also being used to provide safety data for the BLA filing for leronlimab as a combination therapy. In view of the high responder rate at the increased dosage levels, coupled with the newly developed CCR5 occupancy test, we recently filed a pivotal trial protocol with the FDA for leronlimab as a monotherapy. We are discussing finalization of that protocol with FDA and expect to initiate the Phase 3 trial in the first quarter of 2020. Upon finalization with the FDA of the pivotal trial protocol for monotherapy, the Phase2b/3 investigative trial will likely be discontinued.

We will require a significant amount of additional capital to complete the foregoing clinical trials for HIV and complete our BLA submission, as well as to advance our trials in the oncology and immunology space, including but not limited to triple-negative breast cancer, certain cancer indications and GvHD. See “Liquidity and Capital Resources” below.

Cancer and Immunological Applications

We are continuing to advance our exploration of opportunities for clinical applications for leronlimab involving the CCR5 receptor, other than HIV-related treatments, such as cancer, inflammatory conditions and autoimmune diseases.

The target of leronlimab is the important G protein coupled receptor CCR5. CCR5 is more than the pathway to HIV replication; it is also a crucial component of inflammatory responses and is a key mediator in many cancer metastasis. We believe this opens the potential for multiple pipeline opportunities for leronlimab. CCR5 is a protein located on the surface of white blood cells and cancer epithelial cells that serves as a receptor for attractants called chemokines. Chemokines are the key orchestrators of leukocyte trafficking by attracting immune cells to the sites of inflammation.

At the site of an inflammatory reaction, chemokines are released. These chemokines are specific for CCR5 and cause the migration of T-cells to these sites promoting further inflammation. We believe the mechanism of action of leronlimab has the potential to block the movement of T-cells to inflammatory sites, which could be instrumental in diminishing or eliminating inflammatory responses. CCR5 is also expressed on the surface of epithelial cells in certain cancers. Some disease processes that we believe could benefit from CCR5 blockade include many types of common cancers, GvHD (a reaction occurring in some patients after bone marrow transplantation), autoimmunity and chronic inflammation, such as rheumatoid arthritis and psoriasis. Recent published data has shown that the cancer cells within a tumor consist of two types of cells - one with CCR5 and others without them. The published data indicated that cancer cells that can metastasize express CCR5. Metastases are the cause of death in the vast majority of cancer patients. A prior publication indicates that CCR5 antagonists can turn off certain calcium signaling and reduce the migration of CCR5 positive cancer cells. Inhibition of CCR5 signaling blocks the guided migration and reduces the metastasis. Leronlimab has demonstrated (in an in-vitro study) that it also turns off calcium signaling and blocks breast cancer cellular invasion. Furthermore, published studies showed current chemotherapy induces CCR5, and CCR5 antagonists enhance the effectiveness of current chemotherapies, potentially allowing a reduction in chemotherapy, which may provide an improved quality of life for patients.

Research has demonstrated three potential key properties of CCR5’s MOA in cancer. The first is that the CCR5 receptor on cancer cells was responsible for the migration and invasion of cells into the blood stream, which leads to metastasis of breast, prostate, and colon cancer. The second is that blocking CCR5 also turns on anti-tumor fighting properties restoring immune function. The third key finding was that blockage of the CCR5/CCL5 interaction had a synergistic effect with chemotherapeutic therapy and controlled cancer progression. Chemotherapy traditionally increased expression of CCR5 so blocking it is expected to reduce the levels of invasion of metastasis.

 

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Due to its MOA, we believe leronlimab may have significant advantages over other CCR5 antagonists. Prior studies have demonstrated that leronlimab does not cause direct activation of T-cells. We have already reported encouraging human safety data for our clinical trials with leronlimab in HIV-infected patients.

We also previously initiated our first clinical trial with leronlimab in an immunological indication – a Phase 2 clinical trial with leronlimab for GvHD in patients with AML or MDS who are undergoing bone marrow stem cell transplantation. As noted below, enrollment under the amended protocol for the GvHD trial has been delayed subject to increased capital resources.

The following overview provides an update on our immune-oncology pipeline:

Phase 1b/2 Trial for Triple-Negative Breast Cancer

We recently received clearance from the FDA for our IND submission to initiate a Phase 1b/2 clinical trial for metastatic triple-negative breast cancer patients and has dosed the first patient in this trial. In May 2019, the FDA granted leronlimab Fast Track designation for use in combination with carboplatin. Five clinical trial sites have been identified, and the first patient was treated before the end of September 2019. The change in circulating tumor cells (“CTCs”) number will be evaluated every 21 days during treatment and will be used as an initial prognostic marker for efficacy. Up to 48 patients are expected to be enrolled in this study.

Pre-clinical Studies for Multiple Cancer Indications

We are initiating multiple pre-clinical studies with leronlimab for melanoma, pancreatic, breast, prostate colon, lung, liver and stomach cancers. An ongoing pre-clinical study conducted by us recently reported that leronlimab reduces by more than 98% human breast cancer metastasis in a murine xenograft model. Based upon these strong results, we filed for Orphan Drug Designation for leronlimab for use in triple negative breast cancer. In addition, pre-clinical results in a colorectal cancer study are likewise encouraging.

Phase 2 Trial for Graft-versus-Host Disease

This Phase 2 multi-center, 100-day study with 60 patients is designed to evaluate the feasibility of the use of leronlimab as an add-on therapy to standard GvHD prophylaxis treatment for prevention of acute GvHD in adult patients with acute myeloid leukemia (“AML”) or myelodysplastic syndrome (“MDS”) undergoing allogeneic hematopoietic stem cell transplantation (“HST”). Enrollment of the first patient was announced in May of 2017. On October 5, 2017, we announced that the FDA had granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. In March 2018, we announced that the Independent Data Monitoring Committee (“IDMC”) for leronlimab (PRO 140) Phase 2 trial in GvHD had completed a planned interim analysis of trial data on the first 10 patients enrolled. Following this review of data from the first 10 patients in the Phase 2 trial, we filed amendments to the protocol with the FDA. The amendments included switching the pretreatment conditioning regimen from aggressive myeloablative (“MA”) conditioning to a reduced intensity conditioning (“RIC”), and switching from a blinded one-for-one randomized placebo-controlled design to an open-label design under which all enrollees receive leronlimab. The amendments also provide for a 100% increase in the dose of leronlimab, to 700 mg, to more closely mimic pre-clinical dosing. The next review of data by the IDMC will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days. Due to the necessary prioritization of limited capital, enrollment under the amended protocol has been temporarily delayed.

Phase 2 Trial for Metastatic Colorectal Cancer

The FDA recently granted clearance to proceed with Phase 2 studies of leronlimab and regorafenib as a combination therapy for metastatic colorectal cancer in early September 2019. This Phase 2 study will enroll 30 patients and is designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.

 

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Phase 2 Trial and IND for NASH

The FDA recently granted clearance to CytoDyn to proceed with Phase 2 studies to test whether leronlimab may control the devastating effects of liver fibrosis associated with Nonalcoholic steatohepatitis (“NASH”). This trial is designed to be a 60-patient, multi-center, randomized, double blind, placebo-controlled Phase 2 study of the safety and efficacy of leronlimab in adult patients with NASH.

Results of Operations

Results of Operations for the three months ended August 31, 2019 and 2018 are as follows:

For the three months ended August 31, 2019 and 2018, we had no activities that produced revenues from operations.

For the three months ended August 31, 2019 and 2018, we had a net loss of approximately $16.2 million and $14.4 million, respectively. The increase in net loss of approximately $1.8 million was due largely to higher general and administrative (“G&A”) expenses, a reduction in research and development (“R&D”) expenses, and higher amortization and interest expense. The reduction in loss per share in contrast to the increased net loss of $1.8 million over the comparable period a year ago was primarily attributable to a significant increase in the number of common shares outstanding.

For the three months ended August 31, 2019 and 2018, operating expenses totaled approximately $12.6 million and $13.5 million, respectively, consisting of R&D expenses, G&A expenses, and amortization and depreciation. The reduction in operating expenses of approximately $0.9 million, or 6.3%, was attributable to reductions in R&D expenses of approximately $2.3 million, offset in part by increased G&A expenses and amortization of approximately $1.0 million and $0.4 million, respectively.

G&A expenses totaled approximately $3.0 million for the three months ended August 31, 2019, and were comprised of salaries and benefits, non-cash stock-based compensation expense, professional fees, insurance and various other expenses. The increase in general and administrative expenses of approximately $1.0 million, or 53%, for the three months ended August 31, 2019 was due to increased salaries and benefits for new employees, increased stock-based compensation that included acceleration of vesting of certain awards, coupled with increases in other corporate and administrative expenses.

R&D expenses, which totaled approximately $9.0 million for the three months ended August 31, 2019, decreased approximately $2.3 million, or 20.6%, over the comparable 2018 quarter due a reduction of $3.2 million in manufacturing activity related to the BLA, offset by an increase of $0.9 million in clinical trial costs for our Phase 2b/3 investigative monotherapy trial. For the quarter ended August 30, 2019, R&D expenditures continue to be primarily devoted to: (1) increased CMC (chemistry, manufacturing and controls) activities to address regulatory compliance requirements for our BLA filing and leronlimab, (2) our pivotal Phase 2b/3 combination therapy trial and our investigative Phase 2b/3 monotherapy trial, (3) increase in clinical trials in our oncology indications, and (4) continuing activities necessary to complete the BLA filing with the FDA.

We expect future R&D expenses to be dependent on the timing of FDA approval of our BLA filing, the timing of FDA clearance of our pivotal trial protocol for leronlimab as a monotherapy for HIV patients, the clinical progression of our oncology trials, along with the outcome of the pre-clinical studies for several other cancer indications. R&D expenses are also expected to increase due to CMC activities in preparation for approval and commercialization of leronlimab. Until we meet the criteria under general accepted accounting principles (“GAAP”) to capitalize CMC activities associated with commercial product manufacturing, all CMC manufacturing costs will continue to be expensed as R&D.

Amortization and depreciation expenses totaled approximately $0.5 million increased approximately $0.4 million, or 496%. The increase was primarily attributable to the amortization of intangible assets recognized with the acquisition of ProstaGene.

For the three months ended August 30, 2019, we recognized an unrealized non-cash benefit from the decrease in fair value of derivative liabilities of approximately $0.6 million, as compared to a non-cash charge of approximately $0.7 in the comparable 2018 period. The warrants and two convertible note instruments containing a contingent cash settlement provision that give rise to a derivative liability, originated in September 2016, June 2018 and January 2019, respectively. For each reporting period, we determine the fair value of the derivative liability and record a corresponding non-cash benefit or non-cash charge, as a consequence of a decrease or increase, respectively, in the calculated derivative liability.

Interest expense for the three months ended August 31, 2019 totaled approximately $4.2 million, increased approximately $4.0 million over the comparable quarter in 2018 driven primarily by increases in (1) non-cash amortization of debt issuance and debt discount costs of approximately $1.2 million; (2) non-cash inducement interest expense related to warrant exercises of approximately $2.4 million; and (3) interest on convertible notes payable of approximately $0.3 million.

 

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The future trends in all expenses will be driven, in large part, by the future outcomes of pre-clinical studies and clinical trials and their related effect on research and development expenses, general and administrative expenses, the manufacturing of new commercial leronlimab, and the increasing activities associated with the filing of a BLA. We require a significant amount of additional capital, and our ability to continue to fund operations will continue to depend on its ability to raise such capital. See in particular, “Liquidity and Capital Resources” below and Item 1A Risk Factors in our Annual Report on Form 10-K for the year ended May 31, 2019.

Liquidity and Capital Resources

Our cash position at August 31, 2019 decreased approximately $1.7 million to approximately $1.8 million, as compared to a balance of approximately $3.5 million as of May 31, 2019. The net decrease in cash for the three months ended August 31, 2019 was attributable to net cash provided by financing activities of approximately $13.5 million, offset in part by cash used in operating activities of approximately $15.2 million.

As of August 31, 2019, we had significant negative working capital of approximately $19.9 million compared to negative working capital of approximately $21.6 million at May 31, 2019, a decrease in negative working capital of approximately $1.7 million driven by a reduction in amounts owed to suppliers, offset by a reduction in cash balances and prepaid service fees.

Cash Flows

Net cash used in operating activities totaled approximately $15.2 million during the three months ended August 31, 2019, which reflects an increase of approximately $6.2 million of net cash used in operating activities over the three months ended August 31, 2018. The increase in net cash used in operating activities was due primarily to $7.8 million of cash used to pay down net working capital in the three months ended August 31, 2019.

Net cash used in investing activities was immaterial during the three months ended August 31, 2019.

Net cash provided by financing activities of approximately $13.5 million during the three months ended August 31, 2019, increased approximately $1.0 million over net cash provided by financing activities during the three months ended August 31, 2018. The increase in net cash provided from financing activities was attributable to net proceeds from several forms of equity raises of varying amounts compared to the same period in the prior year.

Capital Requirements

We have not generated revenue to date, and we do not expect to generate product revenue until FDA approval of leronlimab. We expect that we will continue to incur operating losses as expenses continue to increase as we proceed with completion of our BLA, prepare for commercialization of leronlimab and continue our pre-clinical and clinical trial programs. The future trends of all expenses will be driven, in large part, by the timing of the anticipated approval of our BLA, the magnitude of our commercialization readiness, future clinical trial strategy and timing of the commencement of our future revenue stream. We will require a significant amount of additional capital in the future in anticipation of a fully commercialized leronlimab product.

Contract Manufacturing

During the fourth quarter of fiscal 2019, we entered into a Master Services Agreement and Product Specific Agreement (collectively, the “Samsung Agreement”) with Samsung BioLogics Co., Ltd. (“Samsung”), pursuant to which Samsung will perform technology transfer, process validation, manufacturing and supply services for the commercial supply of leronlimab. In April 2019, we delivered to Samsung a purchase order for $33 million worth of process validation and technology transfer services related to the manufacture of leronlimab, with payments by us scheduled to be made throughout calendar 2020. Under the Samsung Agreement, the purchase order is binding and we are obligated to pay the full amount.

Under the terms of the Samsung Agreement, we are obligated to make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which we will provide to Samsung. The first forecast will be delivered to Samsung by March 31, 2020. Thereafter, we must provide Samsung with a rolling quarterly forecast setting forth the total quantity of commercial grade leronlimab that we expect to require in the following years. We estimate that initial ramp-up costs to manufacture commercial

 

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grade leronlimab at scale could total approximately $60 million, with approximately $30 million payable over the course of calendar 2020, and approximately $30 million payable in the first quarter of 2021. Thereafter, we will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement.

The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional two year periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the other party’s insolvency or uncured material breach, and we may terminate the agreement in the event of a voluntary or involuntary complete market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.

In addition to the Samsung Agreement, we have also previously entered into an arrangement with another third party contract manufacturer to provide process transfer, validation and manufacturing services for leronlimab. In the event that we terminate the agreement with this manufacturer, we may incur certain financial penalties which would become payable to the manufacturer. Conditioned upon the timing of termination, the financial penalties may total approximately $8.3 million. These amount and timing of the financial commitments under an agreement with our secondary contract manufacturer will depend on the timing of the anticipated approval of our BLA and the initial product demand forecast, which is critical to align the timing of capital resources in order to ensure availability of sufficient quantities of commercial product.

Management believes that two contract manufacturers may best serve our strategic objectives for the anticipated BLA filing and, if approved, the long-term commercial manufacturing capabilities for leronlimab. Management will continue to assess manufacturing capacity requirements as new market information becomes available regarding anticipated demand, subject to FDA approval.

Contract Research

We have entered into project work orders for each of our clinical trials with our CRO and related laboratory vendors. Under the terms of these agreements, we have prepaid certain execution fees for direct services costs. In connection with our clinical trials, we have entered into separate project work orders for each trial with our CRO. In the event that we terminate any trial, we may incur certain financial penalties which would become payable to the CRO. Conditioned upon the form of termination of any one trial, the financial penalties may range up to $0.7 million. In the remote circumstance that we terminate all clinical trials, the collective financial penalties may range from an approximate low of $0.5 million to an approximate high of $1.1 million.

Licensing

Under the Progenics Purchase Agreement, we are required to pay Progenics the following ongoing milestone payments and royalties: (i) $5.0 million at the time of the first U.S. new drug application approval by the FDA or other non-U.S. approval for the sale of leronlimab (PRO 140); and (ii) royalty payments of up to five percent (5%) on net sales during the period beginning on the date of the first commercial sale of leronlimab (PRO 140) until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years, in each case determined on a country-by country basis. In addition, under a Development and License Agreement, dated April 30, 1999 (the “PDL License”), between Protein Design Labs (now AbbVie Inc.) and Progenics, which was previously assigned to us, we are required to pay AbbVie Inc. additional milestone payments and royalties as follows: (i) $0.5 million upon filing a BLA with the FDA or non-U.S. equivalent regulatory body; (ii) $0.5 million upon FDA approval or approval by another non-U.S. equivalent regulatory body; and (iii) royalties of up to 3.5% of net sales for the longer of 10 years and the date of expiration of the last to expire licensed patent. Additionally, the PDL License provides for an annual maintenance fee of $150,000 until royalties paid exceed that amount. As of the date of this filing, while we have completed and filed the first of three portions of our BLA, it remains uncertain as to when the remaining two portions will be filed. Further, if the BLA is accepted by the FDA, it is management’s conclusion that the probability of achieving the subsequent future clinical development and regulatory milestones is not reasonably determinable, thus the future milestone payments payable to Progenics and its sub-licensors are deemed contingent consideration and, therefore, are not currently accruable.

Going Concern

As reported in the accompanying consolidated financial statements, for the three months ended August 31, 2019 and August 31, 2018, we incurred net losses of approximately $16.2 million and $14.4 million, respectively. We have no activities that produced revenue in the periods presented and have sustained operating losses since inception.

 

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We currently require and will continue to require a significant amount of additional capital to fund operations, pay our accounts payables, and our ability to continue as a going concern is dependent upon our ability to raise such additional capital, commercialize our product and achieve profitability. If we are not able to raise such additional capital on a timely basis or on favorable terms, we may need to scale back our operations or slow down or cease certain clinical trials or CMO activities, which could materially delay the timeframe to BLA submission. Our failure to raise additional capital could also affect our relationships with key vendors, disrupting our ability to timely execute our business plan. In extreme cases, we could be forced to file for bankruptcy protection, discontinue our operations or liquidate our assets.

Since inception, we have financed our activities principally from the sale of public and private equity securities and proceeds from convertible notes payable and related party notes payable. We intend to finance our future operating activities and our working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional financing sources. As of the date of this filing, we have approximately 85 million shares of common stock authorized, unreserved and available for issuance under our certificate of incorporation, as amended, and approximately $151 million available for future registered offerings of securities under our universal shelf registration statement on Form S-3, which was declared effective on March 7, 2018 (assuming the full exercise of outstanding warrants, at the currently applicable exercise prices, that were previously issued in registered transactions thereunder).

The sale of equity and convertible debt securities to raise additional capital may result in dilution to stockholders and those securities may have rights senior to those of common shares. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these activities or other debt could contain covenants that would restrict our operations. On January 30, 2019, we entered into a long-term convertible note, which is secured by all of our assets, except for our intellectual property and also includes certain restrictive provisions, such as a limitation on additional indebtedness and future dilutive issuances of securities, any of which could impair our ability to raise additional capital on acceptable terms and conditions. Any other third-party funding arrangements could require us to relinquish valuable rights. We may require additional capital beyond currently anticipated needs. Additional capital, if available, may not be available on reasonable or non-dilutive terms. Please refer to the matters discussed under the heading “Risk Factors” above.

The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have incurred losses for all periods presented and have a substantial accumulated deficit. As of August 31, 2019, these factors, among several others, raise substantial doubt about our ability to continue as a going concern.

The consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should we be unable to continue as a going concern. Our continuation as a going concern is dependent upon our ability to obtain a significant amount of additional operating capital, complete development of our product candidate, obtain FDA approval, outsource manufacturing of our product, and ultimately to attain profitability. We intend to seek additional funding through equity or debt offerings, licensing agreements or strategic alliances to implement our business plan. There are no assurances, however, that we will be successful in these endeavors.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

Not applicable.

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

Under the supervision and with the participation of management, including the Chief Executive Officer and the Chief Financial Officer of the Company, the Company has evaluated the effectiveness of its disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of August 31, 2019. Based on that evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that the Company’s disclosure controls and procedures were effective as of August 31, 2019.

 

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Internal Control Over Financial Reporting

No changes occurred during the quarter ended August 31, 2019, that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II

Item 1. Legal Proceedings.

On July 26, 2019, our Board of Directors terminated the employment of Dr. Richard G. Pestell, our former Chief Medical Officer, for cause pursuant to the terms of his employment agreement. On August 22, 2019, we received notice that a lawsuit naming the Company and its Chief Executive Officer and the Chairman of the Board was filed by Dr. Pestell in the United States District Court for the District of Delaware, alleging breach of Dr. Pestell’s employment agreement, among other claims, and seeking damages in the amount of certain severance entitlements thereunder pertaining to non-cause termination, among other relief. The treatment of those entitlements and of certain previously granted unvested stock options and shares of restricted common stock, which were subject to a repurchase option, will be determined by the outcome of this litigation. On September 17, 2019, CytoDyn and the other defendants moved to dismiss the complaint. On September 27, 2019, Dr. Pestell amended his complaint. We intend to move to dismiss the amended complaint and otherwise vigorously to defend this action.

From time to time, we are involved in claims and suits that arise in the ordinary course of our business. Management currently believes that the resolution of any such claims against us, if any, will not have a material adverse effect on our business, financial condition or results of operations.

Item 1A. Risk Factors.

There have been no material changes in the risk factors applicable to us from those identified in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on August 14, 2019.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

From June 6, 2019 through August 27, 2019, we received six redemption notices from the holder of the our convertible note issued on June 26, 2018 requesting redemptions in the aggregate amount of $1,005,000 of the outstanding balance thereof. In satisfaction of the redemption notices, we issued 3,014,181 shares of common stock to the note holder in accordance with the terms of the convertible note. Following the redemptions, the outstanding balance of the convertible note, including accrued but unpaid interest, was approximately $3.7 million.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not Applicable.

Item 5. Other Information.

None.

 

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Item 6. Exhibits.

(a) Exhibits:

 

    4.1    Form of Warrant to Purchase Common Stock (August 2019 Offering) (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K filed August 29, 2019).
    4.2    Form of Series C Warrant Agreement (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on March 20, 2019).
  10.1*    Consulting Agreement, dated July 15, 2019, between CytoDyn Inc. and Scott A. Kelly, M.D. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed July 19, 2019).
  10.2*    Consulting Agreement, dated July 15, 2019, between CytoDyn Inc. and David F. Welch, Ph.D. (incorporated by reference to Exhibit  10.2 to the Registrant’s Current Report on Form 8-K filed July 19, 2019).
  10.3    Form of Subscription Agreement (August 2019 Offering) (incorporated by reference to Exhibit  10.1 to the Registrant’s Current Report on Form 8-K filed August 29, 2019).
  10.4    Form of Subscription Agreement (August 2019 Series C Convertible Preferred Stock Offering) (incorporated by reference to Exhibit  10.2 to the Registrant’s Current Report on Form 8-K filed August 29, 2019).
  10.5    Placement Agent Agreement (August 2019 Offering) (incorporated by reference to Exhibit 10.3 to the Registrant’s Current Report on Form 8-K filed August 29, 2019).
  31.1**    Rule 13a-14(a) Certification by CEO of Registrant.
  31.2**    Rule 13a-14(a) Certification by CFO of the Registrant.
  32.1**    Certification of CEO of the Registrant pursuant to 18 U.S.C. Section 1350.
  32.2**    Certification of CFO of the Registrant pursuant to 18 U.S.C. Section 1350.
101.INS **    XBRL Instance Document.
101.SCH **    XBRL Taxonomy Extension Schema Document.
101.CAL **    XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF **    XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB **    XBRL Taxonomy Extension Label Linkbase Document.
101.PRE **    XBRL Taxonomy Extension Presentation Linkbase Document.

 

*

Management contract or compensatory plan or arrangement.

**

Filed herewith.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

     

CYTODYN INC.

(Registrant)

Dated: October 8, 2019

     

/s/ Nader Z. Pourhassan

      Nader Z. Pourhassan
      President and Chief Executive Officer
   

Dated: October 8, 2019

     

/s/ Michael D. Mulholland

      Michael D. Mulholland
      Chief Financial Officer, Treasurer and Corporate Secretary

 

32

EX-31.1 2 d803215dex311.htm EX-31.1 EX-31.1

Exhibit 31.1

Certification of Chief Executive Officer

I, Nader Z. Pourhassan, certify that:

 

  1.

I have reviewed this Quarterly Report on Form 10-Q of CytoDyn Inc.;

 

  2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

 

  4.

The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

  a.

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and

 

  d.

disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the registrant’s most-recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

  5.

The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

 

  a.

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

 

  b.

any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: October 8, 2019      

/s/ Nader Z. Pourhassan

      Nader Z. Pourhassan
      President and Chief Executive Officer

 

33

EX-31.2 3 d803215dex312.htm EX-31.2 EX-31.2

Exhibit 31.2

Certification of Chief Financial Officer

I, Michael D. Mulholland, certify that:

 

  1.

I have reviewed this Quarterly Report on Form 10-Q of CytoDyn Inc.;

 

  2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

 

  4.

The Registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

  a.

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;

 

  b.

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c.

evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and

 

  d.

disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the registrant’s most-recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and

 

  5.

The Registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant’s auditors and the audit committee of the Registrant’s board of directors (or persons performing the equivalent functions):

 

  a.

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and

 

  b.

any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.

 

Date: October 8, 2019      

/s/ Michael D. Mulholland

      Michael D. Mulholland
      Chief Financial Officer

 

34

EX-32.1 4 d803215dex321.htm EX-32.1 EX-32.1

Exhibit 32.1

Certification of Chief Executive Officer

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350

In connection with the Quarterly Report of CytoDyn Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended August 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), I, Nader Z. Pourhassan, President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that based on my knowledge:

 

  (1)

The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and

 

  (2)

The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: October 8, 2019      

/s/ Nader Z. Pourhassan

      Nader Z. Pourhassan
      President and Chief Executive Officer

 

35

EX-32.2 5 d803215dex322.htm EX-32.2 EX-32.2

Exhibit 32.2

Certification of Chief Financial Officer

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350

In connection with the Quarterly Report of CytoDyn Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended August 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (the “Form 10-Q”), I, Michael D. Mulholland, Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that based on my knowledge:

 

  (1)

The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)); and

 

  (2)

The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: October 8, 2019      

/s/ Michael D. Mulholland

      Michael D. Mulholland
      Chief Financial Officer

 

36

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(the &#8220;Company&#8221;) was originally incorporated under the laws of Colorado on May&#160;2, 2002 under the name RexRay Corporation (its previous name) and, effective August&#160;27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of Human Immunodeficiency Virus (&#8220;HIV&#8221;) to enter and infect healthy <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">T-cells.</div> The CCR5 receptor also appears to be implicated in human metastasis and in immune-mediated illnesses such as <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">graft-vs-host</div></div> disease (&#8220;GvHD&#8221;) and <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Non-Alcoholic</div> Steatohepatitis (&#8220;NASH&#8221;). The Company&#8217;s lead product candidate, leronlimab, belongs to a class of HIV therapies known as entry inhibitors. 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The consolidated financial statements and notes thereto are presented as prescribed by <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Form&#160;10-Q.</div> Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted. The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May&#160;31, 2019 and 2018 and notes thereto in the Company&#8217;s Annual Report on <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Form&#160;10-K&#160;for</div> the fiscal year ended May&#160;31, 2019, filed with the Securities and Exchange Commission on August&#160;14, 2019. Operating results for the three months ended August&#160;31, 2019 are not necessarily indicative of the results that may be expected for the entire year. 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The Company incurred a net loss of $16,163,999 for the three months ended August&#160;31, 2019 and has an accumulated deficit of $245,638,232 as of August&#160;31, 2019. These factors, among others, raise substantial doubt about the Company&#8217;s ability to continue as a going concern. </div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt; line-height: 12pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. 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The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award (requisite service period) or when designated milestones have been achieved. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The Company accounts for stock-based awards established by the fair market value of the instrument using the Black-Scholes option pricing model utilizing certain weighted average assumptions including stock price volatility, expected term and risk-free interest rates, as of the grant date. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of the stock-based award. The expected volatility is based on the historical volatility of the Company&#8217;s common stock on monthly intervals. The computation of the expected option term is based on the &#8220;simplified method,&#8221; as the Company issuances are considered &#8220;plain vanilla&#8221; options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period or when designated milestones have been achieved. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to third parties as compensation for services rendered. 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During the three months ended August&#160;31, 2019 and August&#160;31, 2018, the Company recognized related amortization of approximately $284,000 and $9,000, respectively. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Offering Costs </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">During the three months ended August&#160;31, 2019 and the year ended May&#160;31, 2019, the Company incurred direct incremental costs associated with the sale of equity securities, as described in Notes 10 and 11. The costs were approximately $1.5&#160;million and $4.3&#160;million for the three months ended August&#160;31, 2019 and year ended May&#160;31, 2019, respectively. The offering costs were recorded as a component of equity upon receipt of proceeds. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Stock for Services </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The Company periodically issues warrants to consultants for various services. The Black-Scholes option pricing model, as described more fully above, is utilized to measure the fair value of the equity instruments on the date of issuance. 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Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on the loss per share. For this reason, common stock options and warrants to purchase 154,635,055 and 145,856,851 shares of common stock were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the three months ended August&#160;31, 2019 and August&#160;31, 2018, respectively. 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Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Future tax benefits for net operating loss carry forwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">The Company follows the provisions of FASB Accounting Standards Codification (&#8220;ASC&#8221;) ASC <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">740-10</div> &#8220;Uncertainty in Income Taxes&#8221;. 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The net tax expense for the three months ended August&#160;31, 2019 and August&#160;31, 2018, is zero. The Company has a full valuation allowance as of August&#160;31, 2019 and May&#160;31, 2019, as management does not consider it more than likely than not that the benefits from the deferred taxes will <div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">be realized. </div></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Basis of Presentation </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;">The accompanying consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (&#8220;U.S. GAAP&#8221;) and reflect all adjustments, which consist solely of normal recurring adjustments, needed to fairly present the financial results for these periods. The consolidated financial statements and notes thereto are presented as prescribed by <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Form&#160;10-Q.</div> Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted. The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May&#160;31, 2019 and 2018 and notes thereto in the Company&#8217;s Annual Report on <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Form&#160;10-K&#160;for</div> the fiscal year ended May&#160;31, 2019, filed with the Securities and Exchange Commission on August&#160;14, 2019. Operating results for the three months ended August&#160;31, 2019 are not necessarily indicative of the results that may be expected for the entire year. 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These reclassifications did not have any effect on total current assets, total assets, total current liabilities, total liabilities, total stockholders&#8217; (deficit) equity, net loss or loss per share. </div></div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Going Concern </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The consolidated accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $16,163,999 for the three months ended August&#160;31, 2019 and has an accumulated deficit of $245,638,232 as of August&#160;31, 2019. These factors, among others, raise substantial doubt about the Company&#8217;s ability to continue as a going concern. </div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt; line-height: 12pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company&#8217;s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidate, obtain U.S. Food&#160;&amp; Drug Administration (&#8220;FDA&#8221;) approval, outsource manufacturing of the product candidate, and ultimately achieve initial revenues and attain profitability. The Company is currently engaging in significant research and development activities related to its product candidate for multiple indications, and expects to incur significant research and development expenses in the future primarily related to its clinical trials. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional sources. 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These instruments are not quoted on an active market. The Company uses a Binomial Lattice Model to estimate the value of the warrant derivative liability and a Monte Carlo Simulation to value the derivative liability of the redemption provision within a convertible promissory note. These valuation models were used because management believes they reflect all the assumptions that market participants would likely consider in negotiating the transfer of the instruments. 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Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Future tax benefits for net operating loss carry forwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">The Company follows the provisions of FASB Accounting Standards Codification (&#8220;ASC&#8221;) ASC <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">740-10</div> &#8220;Uncertainty in Income Taxes&#8221;. 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The computation of the expected option term is based on the &#8220;simplified method,&#8221; as the Company issuances are considered &#8220;plain vanilla&#8221; options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period or when designated milestones have been achieved. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to third parties as compensation for services rendered. 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Operating leases are included in operating lease right-of-use (&#8220;ROU&#8221;) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.</div><div style="margin: 12pt 0in 0.0001pt; font-family: &quot;times new roman&quot;, serif; font-size: 10pt;">Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company&#8217;s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company&#8217;s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately.</div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div style="font-family: times new roman; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Note 3 &#8211; Recent Accounting Pronouncements </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Recent accounting pronouncements, other than below, issued by the FASB (including its EITF), the AICPA and the SEC did not or are not believed by management to have a material effect on the Company&#8217;s present or future financial statements. </div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt; line-height: 12pt;">In February 2016, the FASB issued a new accounting standard which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The ASU also requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. The standard is effective for fiscal years beginning after December&#160;15, 2018. The Company adopted the standard as of June&#160;1, 2019, using the modified retrospective approach in which prior comparative periods are not adjusted. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carry forward historical lease classification. The Company has operating leases for two office facilities, one which expires on April&#160;30, 2021 and the other on March&#160;31, 2022. As of June&#160;1, 2019, the Company recognized additional&#160;right-of-use&#160;assets and corresponding operating lease liabilities related to its facility leases on the consolidated balance sheet. No cumulative effect adjustment was recognized as the amount was not material. The standard did not materially impact the Company&#8217;s consolidated statement of operations or cash flows.</div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In June 2016, the FASB issued a new accounting standard intended to provide financial statement users with more decision-useful information about expected credit losses and other commitments to extend credit held by the reporting entity. The standard replaces the incurred loss impairment methodology in current GAAP with one that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The update is effective on January&#160;1, 2020, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">In August 2018, the FASB issued a new accounting standard to reduce, modify, and add to the disclosure requirements on fair value measurements. The standard is effective for fiscal years beginning after December&#160;15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements. </div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 12pt; margin-bottom: 0pt;">In August 2018, the FASB issued a new accounting standard to align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">internal-use</div> software. The standard is effective for fiscal years beginning after December&#160;15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.</div><table border="0" style="width:100%; table-layout:fixed;" cellspacing="0" cellpadding="0"><tr><td></td></tr></table> <div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 0pt; margin-bottom: 0pt; line-height: 12pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-weight:bold;display:inline;">Note 4 &#8211; Convertible Instruments </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Series C Convertible Preferred Stock </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">On March&#160;20, 2019, the Company authorized 5,000 shares and issued 3,246 shares of Series C&#160;</div>Convertible Preferred Stock<div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">, $0.001 par value per&#160;share&#160;(&#8220;Series C Preferred Stock&#8221;), at $1,000.00 per share for cash proceeds totaling $3,083,700, net of placement agent fees of $162,300. On August&#160;29, 2019 the&#160;Company&#160;issued the remaining 1,754 shares of Series C Preferred Stock at $1,000.00 per share for cash proceeds totaling $1,542,545, net of placement agent fees and legal fees totaling $211,455. As of August&#160;31, 2019, 5,000 shares of&#160;Series&#160;C&#160;Preferred&#160;&#160;Stock&#160;remain outstanding. The </div>Series&#160;C&#160;Preferred&#160;Stock&#160;<div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">Certificate of Designation (the&#160;</div>&#8220;Certificate of Designation&#8221;)&#160;<div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">provides, among other things, that holders of Series C Preferred Stock shall be entitled to receive, at the option of the holder, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series C Preferred Stock, to be paid per share of Series C Preferred Stock. Any dividends paid by the Company will first be paid to the holders of Series C Preferred Stock prior and in preference to any payment or distribution to holders of common stock. Dividends on the Series C Preferred Stock are mandatory and cumulative and there are no sinking fund provisions applicable to the Series C Preferred Stock. The Series C Preferred Stock does not have redemption rights. The stated value per share for the Series C Preferred Stock is $1,000 (the &#8220;Stated Value&#8221;). In the event of any liquidation, dissolution or winding up of the Company, the Series C Preferred Stock will be paid, prior and in preference to any payment or distribution on any shares of common stock, currently outstanding series of preferred stock, or subsequent series of preferred stock, an amount per share equal to the Stated Value and the amount of any accrued and unpaid dividends. The holders of the Series C Preferred Stock will then receive distributions along with the holders of common stock on a pari passu basis according to the number of shares of common stock the Series C Preferred holders would be entitled if they converted their shares of Series C Preferred Stock at the time of such distribution. If, at any time while the Series C Preferred Stock is outstanding, the Company effects any reorganization, merger or sale of the Company or substantially all of its assets (each a &#8220;Fundamental Transaction&#8221;), a holder of the Series C Preferred Stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C Preferred Stock immediately prior to the Fundamental Transaction. Each share of Series C Preferred Stock is convertible at any time at the holder&#8217;s option into that number of fully paid and nonassessable shares of the Company&#8217;s common stock determined by dividing the Stated Value by the conversion price of $0.50 per share (subject to adjustment as set forth in the Certificate of Designation). No fractional shares will be issued upon the conversion of the Series C Preferred Stock. Except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series C Preferred Stock has no voting rights. As of August&#160;31, 2019, the accrued dividends were approximately $148,000 or 296,000 shares of common stock. </div></div><div style="font-size: 1px; margin-top: 0px; margin-bottom: 0px; background: none;"><div style="color: rgb(0, 0, 0); background: none; text-decoration: none; letter-spacing: 0px; top: 0px;;display:inline;">&#160;</div></div><div style="font-family: &quot;times new roman&quot;; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt; line-height: 12pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">Series B Convertible Preferred Stock </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;">During fiscal 2010, the Company issued 400,000 shares of Series B&#160;Convertible Preferred Stock, $0.001 par value per&#160;share&#160;(&#8220;Series B&#160;Preferred&#160;Stock&#8221;) at $5.00 per share for cash proceeds totaling $2,009,000, of which 92,100 shares remain outstanding at August&#160;31, 2019. Each share of the Series B Preferred&#160;Stock&#160;is convertible into ten shares of the Company&#8217;s common stock, including any accrued dividends, with an effective fixed conversion price of $0.50 per share. The holders of the Series B Preferred&#160;Stock&#160;can only convert their shares to shares&#160;of&#160;common stock provided the Company has sufficient authorized shares&#160;of&#160;common stock at the time of conversion. Accordingly, the conversion option was contingent upon the Company increasing its authorized common shares, which occurred in April 2010, when the Company&#8217;s stockholders approved an increase in the authorized shares of common stock to 100,000,000. At the commitment date, which occurred upon such stockholder approval, the conversion option related to the Series B Preferred&#160;Stock&#160;was beneficial. The intrinsic value of the conversion option at the commitment date resulted in a constructive dividend to the Series B Preferred&#160;Stock&#160;holders of approximately $6,000,000. The constructive dividend increased and decreased <div style="white-space: nowrap; color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">additional&#160;paid-in&#160;capital</div> by identical amounts. The Series B Preferred&#160;Stock&#160;has liquidation preferences over the common shares at $5.00 per share plus any accrued dividends. Dividends are payable to the Series B Preferred&#160;Stock&#160;holders when declared by the Board of Directors at the rate of $0.25 per share per annum. Such dividends are cumulative and accrue whether or not declared and whether or not there are any profits, surplus or other funds or assets of the Company legally available. The Series B holders have no voting rights. As of August&#160;31, 2019 and May&#160;31, 2019, the undeclared&#160;dividends were approximately $227,000 or 454,000 shares of common stock and approximately $216,000 or 432,000 shares of common stock, respectively.</div><div style="font-family: times new roman; font-size: 10pt; margin-top: 18pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;"><div style="font-style:italic;display:inline;;font-style:italic;display:inline;">2019 Short-term Convertible Notes </div></div></div><div style="font-family: times new roman; font-size: 10pt; margin-top: 6pt; margin-bottom: 0pt;"><div style="color: rgb(0, 0, 0); letter-spacing: 0px; top: 0px;;display:inline;">During the year ended May&#160;31, 2019, the Company issued approximately $5.5&#160;million of nine-month unsecured Convertible Notes (the &#8220;2019 Short-term Convertible Notes&#8221;) and related warrants to investors for cash. The principal amount of the 2019 Short-term Convertible Notes, including any accrued but unpaid interest thereon, is convertible at the election of the holder at any time into shares of common stock at any time prior to maturity at a conversion price of $0.50 per share. The 2019 Short-term Convertible Notes bear simple interest at the annual rate of 10%. Principal and accrued interest, to the extent not previously paid or converted, is due and payable on the maturity date. At the commitment dates, the Company determined that the conversion feature related to these 2019 Short-term Convertible Notes to be beneficial to the investors. As a result, the Company determined the intrinsic value of the beneficial conversion feature utilizing the fair value of the underlying common stock on the commitment dates and the effective conversion price after discounting the 2019 Short-term Convertible Notes for the fair value of the related warrants. 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Acquisition of Patents and Intangibles - Additional Information (Detail) - USD ($)
3 Months Ended
Oct. 16, 2012
Aug. 31, 2019
Aug. 31, 2018
May 31, 2019
Acquired Finite-Lived Intangible Assets [Line Items]        
Intangible asset acquired gross   $ 3,500,000    
Estimated aggregate future amortization expense in next twelve months   2,000,000    
Estimated aggregate future amortization expense in year two   2,000,000    
Estimated aggregate future amortization expense in year three   1,500,000    
Estimated aggregate future amortization expense in year four   1,100,000    
Estimated aggregate future amortization expense in year five   $ 1,000,000    
Issuance of common stock shares   383,584,367   329,554,763
Common stock per shares   $ 0.001   $ 0.001
ProstaGene, LLC        
Acquired Finite-Lived Intangible Assets [Line Items]        
Acquisition of ProstaGene LLC, value   $ 11,558,000    
Issuance of common stock shares   20,278,000    
Common stock per shares   $ 0.57    
ProstaGene, LLC | Dr .Pestell | Stock Restriction Agreement        
Acquired Finite-Lived Intangible Assets [Line Items]        
Restricted common stock, shares   8,342,000    
Common stock shares restriction period   3 years    
Stock repurchase price, per share   $ 0.001    
ProstaGene, LLC | Investment Advisory, Management and Administrative Service        
Acquired Finite-Lived Intangible Assets [Line Items]        
Investment earned shares   1,620,000    
Patents        
Acquired Finite-Lived Intangible Assets [Line Items]        
Asset purchase, cash paid $ 3,500,000      
Estimated useful life of acquired asset   10 years    
Amortization expense related to acquired patents   $ 528,400 $ 87,500  
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Summary of Fair Value of Convertible Note Redemption Provision Derivative Liability (Detail) - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Net Proceeds $ 0 $ 5,000,000
Convertible Note Redemption Provision Derivative Liability [Member]    
Derivative Liability 1,442,764  
Convertible Note Redemption Provision Derivative Liability [Member] | Inception date June 2018 Note, November 15, 2018 [Member]    
Net Proceeds 5,000,000  
Inception Date 1,284,988  
Derivative Liability 372,458  
Convertible Note Redemption Provision Derivative Liability [Member] | Inception date January 2019 Note, January 30, 2019 [Member]    
Net Proceeds 5,000,000  
Inception Date 1,465,008  
Derivative Liability $ 1,070,306  
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Commitments and Contingencies - Additional Information (Detail) - USD ($)
1 Months Ended 3 Months Ended 12 Months Ended
Apr. 30, 2019
Aug. 31, 2019
May 31, 2016
Commitments and Contingencies [Line Items]      
Asset Purchase Agreement Aggregate Consideration Paying Period   10 years  
Payment to acquire other assets     $ 1,500,000
Minimum      
Commitments and Contingencies [Line Items]      
Royalty on every net sales   0.75%  
Maximum      
Commitments and Contingencies [Line Items]      
Royalty on every net sales   2.00%  
Development Milestone Payments      
Commitments and Contingencies [Line Items]      
Asset Purchase Agreement Aggregate Consideration Paying Period   10 years  
Minimum annual license maintenance fees   $ 150,000  
Project Work Order | Termination of Any One Clinical Trial      
Commitments and Contingencies [Line Items]      
Financial penalties   8,300,000  
Project Work Order | Termination of Any One Clinical Trial | Minimum      
Commitments and Contingencies [Line Items]      
Financial penalties   700,000  
Project Work Order | Termination of All Clinical Trials | Minimum      
Commitments and Contingencies [Line Items]      
Financial penalties   500,000  
Project Work Order | Termination of All Clinical Trials | Maximum      
Commitments and Contingencies [Line Items]      
Financial penalties   1,100,000  
Samsung Agreement [Member] | Manufacturing and Supply Service [Member]      
Commitments and Contingencies [Line Items]      
Supply Commitment Delivered $ 33,000,000    
Remaining Supply commitment Cost 60,000,000    
Obligation Due in Next Twelve Months 30,000,000    
Obligation Due in Next Two years $ 30,000,000    
Biologic License Application with the FDA or non-U.S. equivalent regulatory body | Milestone Payments      
Commitments and Contingencies [Line Items]      
Potential future milestone and royalties payments   500,000  
First US new drug application approval by the FDA or other non-U.S. approval | Milestone Payments      
Commitments and Contingencies [Line Items]      
Potential future milestone and royalties payments   $ 5,000,000  
Royalty on every net sales   5.00%  
FDA approval or approval by another non-U.S. equivalent regulatory body | Development Milestone Payments      
Commitments and Contingencies [Line Items]      
Potential future milestone and royalties payments   $ 500,000  
Royalty on every net sales   3.50%  
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Liability Measured at Fair Value on Recurring Basis by Level within Fair Value Hierarchy (Detail) - USD ($)
Aug. 31, 2019
May 31, 2019
Liability:    
Total liability [1] $ 1,781,936 $ 2,407,269
warrants    
Liability:    
Derivative liability [1] 339,172 402,132
convertible note redemption provision    
Liability:    
Derivative liability [1] 1,442,764 2,005,137
Level 3    
Liability:    
Total liability [1] 1,781,936 2,407,269
Level 3 | warrants    
Liability:    
Derivative liability [1] 339,172 402,132
Level 3 | convertible note redemption provision    
Liability:    
Derivative liability [1] $ 1,442,764 $ 2,005,137
[1] The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.
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Subsequent Events
3 Months Ended
Aug. 31, 2019
Subsequent Events
Note 14 – Subsequent Events
On September 10 and September 24, 2019, the Company received redemption notices from the holder of the Company’s June 2018 Convertible Note, requesting redemptions of $175,000 each, of the outstanding balance thereof. In satisfaction of the redemption notices, the Company issued, in the aggregate, 1,116,340 shares of common stock to the note holder in accordance with the terms of the convertible note. Following the redemptions, the outstanding balance of the convertible note, including accrued but unpaid interest, was approximately $3.5 million.
On September 12, 2019,
the Company issued a stock option covering 200,000 shares of its common stock to a consultant. The stock option award has a per share exercise price
 of $0.385.
The stock option vested immediately upon issuance with respect to 100,000 shares of common stock, and will vest with respect to the remaining 100,000 shares on December 12, 2019. It has a ten-year expiration term.
On September 19, 2019, the Company entered into subscription agreement with certain investors for the sale of 2,330,000 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“September 2019 Offering”), pursuant to a registration statement on Form S-3. The investors in the September 2019 Offering also received warrants to purchase 1,165,000 of common stock with an exercise price of $0.45 per share and a five year term. The Company received net proceeds from the September Offering of approximately $0.9 million.
Since August 31, 2019, the Company has been in negotiations with various holders of its 2019 Short-term Convertible Notes, with an aggregate outstanding balance as of September 30, 2019 of approximately $5.87 million and maturity dates between September 30, 2019 and November 14, 2019, to induce such holders either to convert such notes to equity or to extend the maturity dates of such notes. Thus far, the Company and holders of such notes having an aggregate outstanding balance of approximately $2.2 million have negotiated the extension of the maturity dates for such notes to April 1, 2020 and approximately $215,000 in aggregate outstanding balance has negotiated conversion into common stock. In certain cases, the Company and such holders have entered into exchange agreements pursuant to which, in exchange for notes having an aggregate outstanding balance of approximately $2.3 million, the Company issued (i) new convertible promissory notes, in an aggregate principal amount of approximately $2.2 million, upon similar terms and conditions as the 2019 Short-term Convertible Notes, but with an extended maturity date of April 1, 2020 (each, an “Exchange Note”) and (ii) warrants to purchase an aggregate of 2,100,000 shares of common stock, with an exercise price of $0.30 per share and a five-year term. In certain cases, as negotiated by each holder, the accrued but unpaid interest on the 2019 Short-term Convertible Notes was paid in cash, and not included in the outstanding principal amount of the Exchange Note, on the date of the exchange. Additionally, the Company and a holder of such notes have converted approximately $215,000 of outstanding balance of the 2019 Short-term Convertible Notes into common stock at a conversion rate of $0.40 per share and warrants covering 200,000 shares of common stock, with an exercise price of $0.30 per share and a five-year expiration term.
On October 3, 2019, the Company entered into subscription agreements with certain investors for the sale of 1,382,500 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“October 2019 Offering”), pursuant to a registration statement on Form S-3. The investors in the October 2019 Offering also received warrants to purchase 691,250 shares of common stock with an exercise price of $0.45 per share and a five-year term. The Company received net proceeds from the October 2019 Offering of approximately $0.6 million.
On October 7, 2019, the Company granted stock option awards covering 1,062,500 shares of common stock to employees and a consultant, with exercise prices of $0.39 per share. The stock option awards for employees covering 862,500 shares vest monthly over twelve months, and those for the consultant covering 200,000 shares vest in two equal installments, the first on the grant date, the second six months after the grant date. The stock option awards have a ten-year term and grant date fair values of $0.19 per share.
XML 18 R25.htm IDEA: XBRL DOCUMENT v3.19.3
Derivative Liabilities (Tables)
3 Months Ended
Aug. 31, 2019
Schedule of Derivative Liabilities at Fair Value
The following tables summarize the fair value of the warrant derivative liability and related common shares as of inception date September 15, 2016, May 31, 2019 and August 31, 2019:
 
  Shares Indexed  Derivative Liability 
Inception date September 15, 2016
  7,733,334  $ 5,179,200 
Balance May 31, 2019
  7,733,334   402,132 
Balance August 31, 2019
  7,733,334  $339,172 
Assumptions used in Estimating Fair Value of Warrant Derivative Liability
The Company estimated the fair value of the warrant derivative liability as of inception date September 15, 2016, May 31, 2019 and August 31, 2019, using the following assumptions:
 
  September 15,
2016
  May 31,
2019
  August 31,
2019
 
Fair value of underlying stock
 $ 0.78  $ 0.39  $ 0.40 
Risk free rate
  1.20  1.94  1.50
Expected term (in years)
  5   2.29   2.04 
Stock price volatility
  106  61  60
Expected dividend yield
  —     —     —   
Probability of Fundamental Transaction
  50  50  50
Probability of holder requesting cash payment
  50  50  50
Registered Direct Equity Offering [Member] | Investor Warrants Issued With Registered Direct Equity Offering [Member]  
Assumptions used in Estimating Fair Value of Warrant Derivative Liability
  November 15,  January 30,  August 31, 2019 
  2018  2019  Note 1  Note 2 
Fair value of underlying stock
 $ 0.57  $ 0.49  $ 0.40  $ 0.40 
Risk free rate
  2.78  2.52  1.76  1.76
Expected term (in years)
  1.61   2   0.82   1.42 
Stock price volatility
  58.8  61  63.8  61.6
Expected dividend yield
  —     —     0   0 
Discount factor
  85  85  85  85
Convertible Note Redemption Provision Derivative Liability [Member]  
Schedule of Derivative Liabilities at Fair Value
The following table summarizes the fair value of the convertible note redemption provision derivative liability as of inception dates November 15, 2018, January 30, 2019 and August 31, 2019:
 
     Derivative Liability 
  Net Proceeds  Inception date  August 31, 2019 
Inception date June 2018 Note, November 15, 2018
 $5,000,000  $1,284,988  $372,458 
Inception date January 2019 Note, January 30, 2019
  5,000,000   1,465,008   1,070,306 
          
 
 
 
          $1,442,764 
          
 
 
 
XML 19 R34.htm IDEA: XBRL DOCUMENT v3.19.3
Activity Related to Notes (Detail) - USD ($)
Aug. 31, 2019
May 31, 2018
Debt Instrument [Line Items]    
Face amount of Note $ 3,915,965  
Short-Term Convertible Notes    
Debt Instrument [Line Items]    
Face amount of Note 5,460,000 $ 5,460,000
Unamortized discount (439,000) (1,470,000)
Carrying value of Note 4,901,000 3,586,000
2019 Short Term Convertible Notes    
Debt Instrument [Line Items]    
Unamortized issuance costs $ (120,000) $ (404,000)
XML 20 R30.htm IDEA: XBRL DOCUMENT v3.19.3
Liability Measured at Fair Value on Recurring Basis by Level within Fair Value Hierarchy (Parenthetical) (Detail) - USD ($)
Aug. 31, 2019
May 31, 2019
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Liabilities fair value [1] $ 1,781,936 $ 2,407,269
Level 1    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Assets fair value 0 0
Level 2    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Liabilities fair value $ 0 $ 0
[1] The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.
XML 21 R38.htm IDEA: XBRL DOCUMENT v3.19.3
Summary of Fair Value Warrant Derivative Liability and Related Common Shares (Detail) - Registered Direct Equity Offering - Investor Warrants Issued with Registered Direct Equity Offering - USD ($)
Aug. 31, 2019
May 31, 2019
Sep. 15, 2016
Derivative [Line Items]      
Shares indexed 7,733,334 7,733,334 7,733,334
Derivative liability $ 339,172 $ 402,132 $ 5,179,200
XML 22 R13.htm IDEA: XBRL DOCUMENT v3.19.3
Stock Options and Warrants
3 Months Ended
Aug. 31, 2019
Stock Options and Warrants
Note 6 – Stock Options and Warrants
The Company has one active stock-based equity plan at August 31, 2019, the CytoDyn Inc. 2012 Equity Incentive Plan, as amended (the “2012 Plan”) and one stock-based equity plan that is no longer active, but under which certain prior awards remain outstanding, the CytoDyn Inc. 2004 Stock Incentive Plan (the “2004 Plan” and, together with the 2012 Plan, the “Incentive Plans”). The 2012 Plan was approved by stockholders at the Company’s 2012 annual meeting to replace the 2004 Plan. The 2012 Plan was amended by stockholder approval in February 2015 to increase the number of shares available for issuance from 3,000,000 to 5,000,000 shares of common stock and in March 2016 to increase the number of shares available for issuance from 5,000,000 to 7,000,000 shares of common stock. At the annual meeting of stockholders held on August 24, 2017, the stockholders approved an amendment to the 2012 Plan to increase the number of shares available for issuance from 7,000,000 to 15,000,000 shares of common stock. At a special meeting of stockholders held on May 22, 2019, the stockholders approved an amendment to the 2012 Plan to increase the number of shares available for issuance from 15,000,000 to 25,000,000 shares of common stock. As of August 31, 2019, the Company had 9,949,144 shares available for future stock-based grants under the 2012 Plan, as amended.
Stock Options
During the three months ended August 31, 2019, the Company granted annual stock option awards to directors to purchase a total of 600,000 shares of common stock. The exercise price of the stock option awards is $0.52 per share. These stock option awards vest quarterly over one year and have
a ten-year term.
The grant date fair value related to these stock options was $0.26 per share.
During the three months ended August 31, 2019, the Company granted stock options, covering an aggregate of 275,000 shares of common stock, to executive management and employees with exercise prices ranging between $0.43 and $0.52 per share, except for one award of 50,000 shares which has an exercise price of $0.90 and represented a supplemental award related to a previous rescission, and which vested immediately. The remaining stock option awards vest annually over three years, with
a ten-year term
and grant date fair values ranging between $0.23 and $0.30 per share.
On August 12, 2019, Gregory Gould, a member of the Company’s Board of Directors, resigned. On September 12
th
, Carl Dockery, a member of the Company’s Board of Directors did not stand for
re-election.
90 days after the cessation of their service, any vested and unexercised options in their names will be returned to the pool of shares available for future stock-based grants under the 2012 Plan.
Warrants
On August 29, 2019, in connection with a registered direct offering, as fully described in Note 11, the Company issued warrants covering 2,819,750 shares of common stock to investors. The investor warrants have a five-year term and an exercise price of $0.45 per share. In connection with the registered direct offering, the Company also issued warrants covering 498,105 shares of common stock to the placement agent. The placement agent warrants have a five-year term and an exercise price of $0.40 per share.
During the three months ended August 31, 2019, in connection with a Series C convertible preferred offering, as fully described in Note 4, the Company issued common stock warrants covering a total of 2,631,000 shares of common stock to investors. The investor warrants have a five-year term and an exercise price of $0.50 per share.
Compensation expense related to stock options, compensatory warrants and common stock reserved for advisory services for the three months ended August 31, 2019 and August 31, 2018 was approximately $581,000 and $283,000, respectively. The grant date fair value of options and compensatory warrants vested during the three month periods ended August 31, 2019 and August 31, 2018 was approximately $542,000 and $692,000, respectively. As of August 31, 2019, there was approximately $1.0 million of unrecognized compensation expense related to share-based payments for unvested options, which is expected to be recognized over a weighted average period of 0.84 years.
The following table represents stock option and warrant activity as of and for the three months ended August 31, 2019:
 
  Number of
Shares
  Weighted
Average
Exercise Price
  Weighted
Average
Remaining
Contractual Life
in Years
  Aggregate
Intrinsic Value
 
Options and warrants outstanding—May 31, 2019
  178,591,849  $ 0.71   3.75  $896,400 
Granted
  6,823,855   0.45   —     —   
Exercised
  (30,250,649  0.39   —     —   
Forfeited/expired/cancelled
  (530,000  0.79   —     —   
Options and warrants outstanding—August 31, 2019
  154,635,055   0.70   3.71   796,000 
Outstanding exercisable—August 31, 2019
  151,793,153  $0.71   3.59  $ 796,000 
XML 23 R17.htm IDEA: XBRL DOCUMENT v3.19.3
Public Warrant Tender Offerings
3 Months Ended
Aug. 31, 2019
Public Warrant Tender Offerings [Abstract]  
Public Warrant Tender Offerings
Note 10 – Public Warrant Tender Offerings
During the three months ended August 31, 2019, the Company conducted two public warrant tender offers, in which accredited investors purchased unregistered common stock at either $0.30 or $0.40 per share. Pursuant to the offering, the Company sold a total of 45,375,923 shares of common stock, $0.001 par value, for aggregate gross proceeds of approximately $11.9 million. The Company paid placement agent fees of approximately $1.1 million for services in connection with the offering. The Company also recorded a
non-cash
inducement interest expense of approximately $2.4 million in connection with the offerings.
XML 24 R8.htm IDEA: XBRL DOCUMENT v3.19.3
Organization
3 Months Ended
Aug. 31, 2019
Organization
Note 1 – Organization
CytoDyn Inc. (the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002 under the name RexRay Corporation (its previous name) and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of Human Immunodeficiency Virus (“HIV”) to enter and infect healthy
T-cells.
The CCR5 receptor also appears to be implicated in human metastasis and in immune-mediated illnesses such as
graft-vs-host
disease (“GvHD”) and
Non-Alcoholic
Steatohepatitis (“NASH”). The Company’s lead product candidate, leronlimab, belongs to a class of HIV therapies known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells.
The Company has developed a class of therapeutic monoclonal antibodies to address unmet medical needs in the areas of HIV and GvHD. In addition, the Company is expanding the clinical focus with leronlimab to include the evaluation in certain cancer and immunological indications where CCR antagonism has shown initial promise.
XML 25 R4.htm IDEA: XBRL DOCUMENT v3.19.3
Consolidated Statements of Operations - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Operating expenses:    
General and administrative $ 3,045,965 $ 1,996,428
Research and development 9,055,289 11,403,294
Amortization and depreciation 531,043 88,971
Total operating expenses 12,632,297 13,488,693
Operating loss (12,632,297) (13,488,693)
Interest income 0 979
Change in fair value of derivative liabilities 625,333 (747,467)
Interest expense:    
Amortization of discount on convertible notes (1,030,151) (64,580)
Amortization of debt issuance costs (284,061) (9,178)
Inducement interest related to warrant exercise (2,430,514) 0
Finance charges (8,289) 0
Interest on convertible notes payable (404,020) (104,630)
Total interest expense (4,157,035) (178,388)
Loss before income taxes (16,163,999) (14,413,569)
Income tax benefit 0 0
Net loss $ (16,163,999) $ (14,413,569)
Basic and diluted loss per share $ (0.04) $ (0.07)
Basic and diluted weighted average common shares outstanding 364,639,410 218,594,628
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Employee Benefit Plan - Additional Information (Detail) - Employee Savings Plan - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Defined Contribution Plan Disclosure [Line Items]    
Qualified non-elective contribution 3.00%  
Qualified non-elective contribution expense $ 26,000 $ 15,800
XML 28 R39.htm IDEA: XBRL DOCUMENT v3.19.3
Assumptions used in Estimating Fair Value of Warrant Derivative Liability (Detail) - $ / shares
3 Months Ended 12 Months Ended
Sep. 15, 2016
Aug. 31, 2019
May 31, 2019
Grant Date Fair Value      
Derivative [Line Items]      
Fair value of underlying stock $ 0.78 $ 0.40 $ 0.39
Risk Free Interest Rate      
Derivative [Line Items]      
Risk free rate 1.20% 1.50% 1.94%
Expected Term (In Years)      
Derivative [Line Items]      
Expected term (in years) 5 years 2 years 14 days 2 years 3 months 14 days
Stock Price Volatility      
Derivative [Line Items]      
Stock price volatility 106.00% 60.00% 61.00%
Expected Dividend Yield      
Derivative [Line Items]      
Expected dividend yield   0.00%  
Probability of Fundamental Transaction      
Derivative [Line Items]      
Probability of Fundamental Transaction 50.00% 50.00% 50.00%
Probability of Holder Requesting Cash Payment      
Derivative [Line Items]      
Probability of holder requesting cash payment 50.00% 50.00% 50.00%
XML 29 R35.htm IDEA: XBRL DOCUMENT v3.19.3
Warrants At Relative Fair Value and Beneficial Conversion Feature at Intrinsic Value (Details)
1 Months Ended
Jan. 30, 2019
USD ($)
Convertible Promisssory Notes [Abstract]  
Warrants At Fair Value Of Redemption Provision $ 1,465,008
Relative Fair Value Of Equity Classified Warrants 858,353
Warrants At Beneficial Conversion Feature 2,676,639
Proceeds From Issuance Of Convertible Promissory Notes $ 5,000,000
XML 30 R31.htm IDEA: XBRL DOCUMENT v3.19.3
Reconciliation of Liability Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs (Level 3) (Detail) - USD ($)
3 Months Ended 12 Months Ended
Aug. 31, 2019
May 31, 2019
May 31, 2018
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Beginning Balance $ 2,407,269 $ 1,323,732  
Fair value adjustments     $ (3,855,468)
Ending Balance 1,781,936 2,407,269 1,323,732
Convertible notes [Member]      
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Fair value adjustments (562,373) (921,600)  
Warrant [Member]      
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Fair value adjustments $ (62,960) (744,869)  
Investor Warrants Issued with Registered Direct Equity Offering      
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Warrants issued     4,360,000
Placement Agent Warrants Issued with Registered Direct Equity Offering      
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Warrants issued     $ 819,200
Inception date value of redemption provision - warrants      
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]      
Warrants issued   $ 2,750,006  
XML 31 R12.htm IDEA: XBRL DOCUMENT v3.19.3
Derivative Liabilities
3 Months Ended
Aug. 31, 2019
Derivative Liability
Note 5 – Derivative Liabilities
The investor and placement agent warrants, issued in connection with a registered direct offering in September 2016, contained a provision for net cash settlement in the event that there is a fundamental transaction (contractually defined as a merger, sale of substantially all assets, tender offer or share exchange, whereby such other Person or group acquires more than 50% of the outstanding common stock). If a fundamental transaction occurs in which the consideration issued consists principally of cash or stock in a successor entity, then the warrant holder has the option to receive cash equal to the fair value of the remaining unexercised portion of the warrant. Due to this contingent cash settlement provision, the investor and placement agent warrants require liability classification as derivatives in accordance with ASC 480 and ASC 815 and are recorded at fair value.
The following tables summarize the fair value of the warrant derivative liability and related common shares as of inception date September 15, 2016, May 31, 2019 and August 31, 2019:
 
  Shares Indexed  Derivative Liability 
Inception date September 15, 2016
  7,733,334  $ 5,179,200 
Balance May 31, 2019
  7,733,334   402,132 
Balance August 31, 2019
  7,733,334  $339,172 
The Company recognized approximately $63,000 of non-cash gain and $747,000 of
non-cash
loss, due to the changes in the fair value of the liability associated with such classified warrants during the three months ended August 31, 2019 and August 31, 2018, respectively.
ASC 820 provides requirements for disclosure of liabilities that are measured at fair value on a recurring basis in periods subsequent to the initial recognition. Fair values for the warrants were determined using a Binomial Lattice (“Lattice”) valuation model.
The Company estimated the fair value of the warrant derivative liability as of inception date September 15, 2016, May 31, 2019 and August 31, 2019, using the following assumptions:
 
  September 15,
2016
  May 31,
2019
  August 31,
2019
 
Fair value of underlying stock
 $ 0.78  $ 0.39  $ 0.40 
Risk free rate
  1.20  1.94  1.50
Expected term (in years)
  5   2.29   2.04 
Stock price volatility
  106  61  60
Expected dividend yield
  —     —     —   
Probability of Fundamental Transaction
  50  50  50
Probability of holder requesting cash payment
  50  50  50
Due to the fundamental transaction provision contained in the warrants, which could provide for early redemption of the warrants, the model also considered subjective assumptions related to the fundamental transaction provision. The fair value of the warrants will be significantly influenced by the fair value of the Company’s stock price, stock price volatility, changes in interest rates and management’s assumptions related to the fundamental transaction provisions.
As described above in Note 4 above, the redemption provision embedded in the June 2018 and January 2019 Notes required bifurcation and measurement at fair value as a derivative. The fair value of the Note redemption provision derivative liabilities was calculated using a Monte Carlo Simulation which uses randomly generated stock-price paths obtained through a Geometric Brownian Motion stock price simulation. The fair value of the redemption provision will be significantly influenced by the fair value of the Company’s stock price, stock price volatility, changes in interest rates and management’s assumptions related to the redemption factor. The Company estimated the fair value of the redemptive provision using the following assumptions on the closing date of November 15, 2018, January 30, 2019 and August 31, 2019:
 
  November 15,  January 30,  August 31, 2019 
  2018  2019  Note 1  Note 2 
Fair value of underlying stock
 $ 0.57  $ 0.49  $ 0.40  $ 0.40 
Risk free rate
  2.78  2.52  1.76  1.76
Expected term (in years)
  1.61   2   0.82   1.42 
Stock price volatility
  58.8  61  63.8  61.6
Expected dividend yield
  —     —     —     —   
Discount factor
  85  85  85  85
 
The following table summarizes the fair value of the convertible note redemption provision derivative liability as of inception dates November 15, 2018, January 30, 2019 and August 31, 2019:
 
     Derivative Liability 
  Net Proceeds  Inception date  August 31, 2019 
Inception date June 2018 Note, November 15, 2018
 $5,000,000  $1,284,988  $372,458 
Inception date January 2019 Note, January 30, 2019
  5,000,000   1,465,008   1,070,306 
          
 
 
 
          $1,442,764 
          
 
 
 
The Company recognized approximately $562,000 of
non-cash
gain, due to the changes in the fair value of the liability associated with such classified redemption provision for the three months ended August 31, 2019.
XML 32 R16.htm IDEA: XBRL DOCUMENT v3.19.3
Commitments and Contingencies
3 Months Ended
Aug. 31, 2019
Commitments and Contingencies
Note 9 – Commitments and Contingencies
Under the Progenics Purchase Agreement, the Company acquired rights to the HIV viral-entry inhibitor drug candidate PRO 140, a humanized anti-CCR5 monoclonal antibody, as well as certain other related assets, including the existing inventory of bulk PRO 140 drug product, intellectual property, certain related licenses and sublicenses, and FDA regulatory filings. In connection with purchase, the Company has one remaining milestone payment of $5.0 million, which will become due at the time of the first U.S. new drug application approval by the FDA or other
non-U.S.
approval for the sale of PRO 140. In addition, the Company will incur royalty payments of up to 5% on net sales during the period beginning on the date of the first commercial sale of PRO 140 until the later of (a) the expiration of the last to expire patent included in the acquired assets, and (b) 10 years, in each case determined on a
country-by
country basis. During the year ended May 31, 2016 the Company paid a milestone obligation of $1.5 million owed to Progenics as a result of the first dosing in a U.S. Phase 3 trial. To the extent that the remaining milestone payment and royalties are not timely made, under the terms of the Progenics Purchase Agreement, Progenics has certain repurchase rights relating to the assets sold to the Company thereunder. As of the date of this filing, it is management’s conclusion that the probability of achieving the subsequent future scientific research milestone is not reasonably determinable, thus the future milestone payments payable to Progenics and its
sub-licensors
are deemed contingent consideration and, therefore, are not currently accruable. Payments to the third-party licensor and to Progenics are in addition to payments due under a Development and License Agreement, dated April 30, 1999 (the “PDL License”), between Protein Design Labs (now AbbVie Inc.) (“PDL”) and Progenics, which was assigned to the Company in the Progenics Purchase Agreement, pursuant to which the Company has an exclusive worldwide license to develop, make, have made, import, use, sell, offer to sell or have sold products that incorporate the humanized form of the PRO 140 antibody developed by PDL under the agreement the Company has paid various milestone obligations, with two remaining milestone payments of $0.5 million each, one payment of $0.5 million upon filing a BLA with the FDA or
non-U.S.
equivalent regulatory body and a second payment of $0.5 million, which will become due upon FDA approval or approval by
anothernon-U.S.
equivalent regulatory body. In addition, the Company will incur royalties of up to 3.5% of net sales for the longer of 10 years and the date of expiration of the last to expire licensed patent. Additionally, the PDL License provides for an annual maintenance fee of $150,000 or until annual royalties paid exceed that amount. To the extent the remaining milestone payment and royalties are not timely made, under the terms of the PDL License, AbbVie Inc. has certain termination rights relating to the Company’s license of PRO 140 thereunder. As of the date of this filing, it is management’s conclusion that the probability of achieving the subsequent future scientific research milestones is not reasonably determinable, thus the future milestone payments payable to PDL, Progenics and its
sub-licensors
are deemed contingent consideration and, therefore, are not currently accruable.
During the fourth quarter of fiscal 2019, the Company entered into a Master Services Agreement and Product Specific Agreement (collectively, the “Samsung Agreement”) with Samsung BioLogics Co., Ltd. (“Samsung”), pursuant to which Samsung will perform technology transfer, process validation, manufacturing and supply services for the commercial supply of leronlimab. In April 2019 the Company delivered to Samsung a purchase order for $33 million worth of process validation and technology transfer services related to the manufacture of leronlimab, with payments by the Company scheduled to be made throughout calendar 2020. Under the Samsung Agreement, the purchase order is binding and the Company is obligated to pay the full amount of the purchase order. Under the terms of the Samsung Agreement, the Company is obligated to make specified minimum purchases of leronlimab from Samsung pursuant to forecasted requirements which the Company will provide to Samsung. The first forecast will be delivered to Samsung by March 31, 2020. Thereafter, the Company must provide Samsung with a rolling quarterly forecast setting forth the total quantity of commercial grade leronlimab that the Company expects to require in the following years. The Company estimates that initial
ramp-up
costs to manufacture commercial grade leronlimab at scale could total approximately $60 million, with approximately $30 million payable over the course of calendar 2020, and approximately $30 million payable in the first quarter of 2021. Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Samsung Agreement. The Samsung Agreement has an initial term ending in December 2027 and will be automatically extended for additional two year periods unless either party gives notice of termination at least six months prior to the then current term. Either party may terminate the Samsung Agreement in the event of the other party’s insolvency or uncured material breach, and the Company may terminate the agreement in the event of a voluntary or involuntary complete market withdrawal of leronlimab from commercial markets, with one and half year’s prior notice. Neither party may assign the agreement without the consent of the other, except in the event of a sale of all or substantially all of the assets of a party to which the agreement relates.
In addition to the Company’s manufacturing agreement with Samsung, the Company also previously entered into an arrangement with another third party contract manufacturer to provide process transfer, validation and manufacturing services for leronlimab. In the event that the Company terminates the agreement with this manufacturer, the Company may incur certain financial penalties which would become payable to the manufacturer. Conditioned upon the timing of termination, the financial penalties may total approximately $8.3 million. These amount and timing of the financial commitments under an agreement with
the Company’s
 secondary contract manufacturer will depend on the timing of the anticipated approval of
the Company’s
 BLA and the initial product demand forecast, which is critical to align the timing of capital resources in order to ensure availability of sufficient quantities of commercial product.
The Company has entered into project work orders, as amended, for each of its CRO and related laboratory vendors. Under the terms of these agreements, the Company incurs execution fees for direct services costs, which are recorded as a current asset. In the event the Company were to terminate any trial, it may incur certain financial penalties which would become payable to the CRO. Conditioned upon the form of termination of any one trial, the financial penalties may range up to $0.7 million. In the remote circumstance that the Company would terminate all clinical trials, the collective financial penalties may range from an approximate low of $0.5 million to an approximate high of $1.1 million.
From time to time, the Company is involved in routine litigation that arises in the ordinary course of business. Other than specified in Part II, Item 1, there are no pending significant legal proceedings to which the Company is a party for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.
XML 33 R1.htm IDEA: XBRL DOCUMENT v3.19.3
Cover Page - shares
3 Months Ended
Aug. 31, 2019
Oct. 04, 2019
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Aug. 31, 2019  
Document Fiscal Year Focus 2020  
Document Fiscal Period Focus Q1  
Entity Registrant Name CytoDyn Inc.  
Entity Central Index Key 0001175680  
Current Fiscal Year End Date --05-31  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Shell Company false  
Entity Filer Category Accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Address, State or Province WA  
Entity Common Stock, Shares Outstanding   388,254,196
XML 34 R5.htm IDEA: XBRL DOCUMENT v3.19.3
Consolidated Statements of Cash Flows - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Cash flows from operating activities:    
Net loss $ (16,163,999) $ (14,413,569)
Adjustments to reconcile net loss to net cash used in operating activities:    
Amortization and depreciation 531,043 88,971
Amortization of debt issuance costs 284,060 9,178
Amortization of discount on convertible notes 1,030,151 64,580
Inducement interest expense on warrant tender offers 2,430,514 0
Interest expense associated with accretion of convertible notes payable 266,397 0
Change in fair value of derivative liabilities (625,333) 747,467
Stock-based compensation 580,727 283,346
Changes in current assets and liabilities:    
(Increase) decrease in miscellaneous receivables 85,611 0
(Increase) decrease in prepaid expenses 413,124 (701,185)
(Decrease) increase in accounts payable and accrued expenses (4,022,694) 4,950,552
Net cash used in operating activities (15,190,397) (8,970,660)
Cash flows from investing activities:    
Furniture and equipment purchases (4,739) (2,262)
Net cash used in investing activities (4,739) (2,262)
Cash flows from financing activities:    
Proceeds from sale of common stock and warrants 2,255,800 8,499,300
Proceeds from sale of preferred stock 1,754,000 0
Proceeds from warrant tender offers 11,900,260 0
Release of funds held in trust for warrant tender offer (853,599) 0
Proceeds from convertible notes payable, net 0 5,000,000
Payment of offering costs (1,532,012) (1,008,410)
Net cash provided by financing activities 13,524,449 12,490,890
Net change in cash (1,670,687) 3,517,968
Cash, beginning of period 3,466,509 1,231,445
Cash, end of period 1,795,822 4,749,413
Supplemental disclosure of cash flow information:    
Cash paid during the period for interest 9,765 0
Non-cash investing and financing transactions:    
Common stock issued for conversion redemption 1,005,000 0
Dividends accrued on Series C convertible preferred stock 110,826 0
Debt discount associated with convertible notes payable $ 0 $ 700,000
XML 35 R9.htm IDEA: XBRL DOCUMENT v3.19.3
Summary of Significant Accounting Policies
3 Months Ended
Aug. 31, 2019
Summary of Significant Accounting Policies
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect all adjustments, which consist solely of normal recurring adjustments, needed to fairly present the financial results for these periods. The consolidated financial statements and notes thereto are presented as prescribed by
Form 10-Q.
Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted. The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May 31, 2019 and 2018 and notes thereto in the Company’s Annual Report on
Form 10-K for
the fiscal year ended May 31, 2019, filed with the Securities and Exchange Commission on August 14, 2019. Operating results for the three months ended August 31, 2019 are not necessarily indicative of the results that may be expected for the entire year. In the opinion of management, all adjustments have been made, which consist only of normal recurring adjustments necessary for a fair statement of (a) the results of operations for the three months ended August 31, 2019 and August 31, 2018, (b) the financial position at August 31, 2019 and (c) cash flows for the three month periods ended August 31, 2019 and August 31, 2018.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, CytoDyn Operations Inc., Advanced Genetic Technologies, Inc. (“AGTI”) and CytoDyn Veterinary Medicine LLC (“CVM”), of which both AGTI and CVM are dormant entities. All intercompany transactions and balances are eliminated in consolidation.
Reclassifications
Certain prior year amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the 2020 presentation. These reclassifications did not have any effect on total current assets, total assets, total current liabilities, total liabilities, total stockholders’ (deficit) equity, net loss or loss per share.
Going Concern
The consolidated accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $16,163,999 for the three months ended August 31, 2019 and has an accumulated deficit of $245,638,232 as of August 31, 2019. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidate, obtain U.S. Food & Drug Administration (“FDA”) approval, outsource manufacturing of the product candidate, and ultimately achieve initial revenues and attain profitability. The Company is currently engaging in significant research and development activities related to its product candidate for multiple indications, and expects to incur significant research and development expenses in the future primarily related to its clinical trials. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional sources. There can be no assurance, however, that the Company will be successful in these endeavors.
Use of Estimates
The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash
Cash is maintained at federally insured financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances. Balances in excess of federally insured limits at August 31, 2019 and May 31, 2019 approximated $1.7 million and $3.3 million, respectively.
Identified Intangible Assets
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) ASC Topic 350 Intangibles-Goodwill and Other, which establishes accounting standards for the impairment of long-lived assets such as intangible assets subject to amortization. The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. If the sum of the undiscounted expected future cash flows over the remaining useful life of a long-lived asset group is less than its carrying value, the asset is considered impaired. Impairment losses are measured as the amount by which the carrying amount of the asset group exceeds the fair value of the asset. There were no impairment charges for the three months ended August 31, 2019 and 2018. The value of the Company’s patents would be significantly impaired by any adverse developments as they relate to the clinical trials pursuant to the patents acquired as discussed in Notes 7 and 9.
Research and Development
Research and development costs are expensed as incurred. Clinical trial costs incurred through third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development collaboration arrangements or other contractual agreements, the milestone payment obligations are expensed when the milestone conditions are probable and the amount of payment is reasonably estimable.
Pre-launch
Inventory
The Company
may scale-up and
make commercial quantities of its product candidate prior to the date it anticipates that such product will receive final FDA approval.
The scale-up and
commercial production
of pre-launch inventories
involves the risk that such products may not be approved for marketing by the FDA on a timely basis, or ever. This risk notwithstanding, the Company
may scale-up and 
build pre-launch inventories
of product that have not yet received final governmental approval when the Company believes that such action is appropriate in relation to the commercial value of the product launch opportunity. The determination to capitalize is made once the Company (or its third party development partners) has filed a Biologics License Application (“BLA”) that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal requirements will be satisfied. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered. As of August 31, 2019, and May 31, 2019, the Company did not
have pre-launch inventory
that qualified for capitalization pursuant to U.S. GAAP ASC 330 “Inventory.”
 
Fair Value of Financial Instruments
Fair Value Hierarchy
The three levels of inputs that may be used to measure fair value are as follows:
Level 1. Quoted prices in active markets for identical assets or liabilities.
Level 2. Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. Level 2 inputs also
include non-binding market
consensus prices that can be corroborated with observable market data, as well as quoted prices that were adjusted for security-specific restrictions.
Level 3. Unobservable inputs to the valuation methodology are significant to the measurement of the fair value of assets or liabilities. These Level 3 inputs also
include non-binding market
consensus prices
or non-binding broker
quotes that the Company was unable to corroborate with observable market data.
Liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of August 31, 2019 and May 31, 2019 is as follows:
 
  Fair Value Measurement at
August 31, 2019
(1)
  Fair Value Measurement at
May 31, 2019
(1)
 
  Using     Using    
  Level 3  Total  Level 3  Total 
Liabilities:
                
Derivative liability—convertible note redemption provision
 $ 1,442,764  $ 1,442,764  $ 2,005,137  $ 2,005,137 
Derivative liability—warrants
 $339,172   339,172   402,132   402,132 
  
 
 
  
 
 
  
 
 
  
 
 
 
Total liabilities
 $1,781,936  $1,781,936  $2,407,269  $2,407,269 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
(1)
The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurements. These instruments are not quoted on an active market. The Company uses a Binomial Lattice Model to estimate the value of the warrant derivative liability and a Monte Carlo Simulation to value the derivative liability of the redemption provision within a convertible promissory note. These valuation models were used because management believes they reflect all the assumptions that market participants would likely consider in negotiating the transfer of the instruments. The Company’s derivative liabilities are classified within Level 3 of the fair value hierarchy because certain unobservable inputs were used in the valuation models.
The following is a reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended August 31, 2019 and the year ended May 31, 2019:
 
Investor warrants issued with registered direct equity offering
 $4,360,000 
Placement agent warrants issued with registered direct equity offering
  819,200 
Fair value adjustments
  (3,855,468
Balance at May 31, 2018
  1,323,732 
Inception date value of redemption provision—warrants
  2,750,006 
Fair value adjustments—warrants
  (744,869)
Fair value adjustments—convertible notes
  (921,600)
Balance at May 31, 2019
 
 
2,407,269
 
Fair value adjustments—warrants
 
 
(62,960
)
Fair value adjustments—convertible notes
 
 
(562,373
)
Balance at August 31, 2019
 $1,781,936 
Operating Leases
Effective June 1, 2019, the Company determined if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately.
Stock-Based Compensation
U.S. GAAP requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award (requisite service period) or when designated milestones have been achieved.
The Company accounts for stock-based awards established by the fair market value of the instrument using the Black-Scholes option pricing model utilizing certain weighted average assumptions including stock price volatility, expected term and risk-free interest rates, as of the grant date. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of the stock-based award. The expected volatility is based on the historical volatility of the Company’s common stock on monthly intervals. The computation of the expected option term is based on the “simplified method,” as the Company issuances are considered “plain vanilla” options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period or when designated milestones have been achieved. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to third parties as compensation for services rendered. Such stock awards are valued at fair market value on the effective date of the Company’s obligation.
Common Stock
On June 7, 2018, at a special meeting of the Company’s stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 375,000,000 to 450,000,000. On November 8, 2018, at the 2018 Annual Meeting of Stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 450,000,000 to 600,000,000. Subsequently, on May 22, 2019, at a special meeting of stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 600,000,000 to 700,000,000.
Preferred Stock
The Company’s Board of Directors is authorized to issue up to 5,000,000 shares of preferred stock without stockholder approval. As of August 31, 2019, the Company has authorized the issuance of 400,000 shares of Series B convertible preferred stock and 5,000 shares of Series C convertible preferred stock, of which 92,100 shares and 5,000 shares, respectively, were outstanding. The remaining preferred shares authorized have no specified rights.
Treasury Stock
Treasury stock purchases are accounted for under the par value method, whereby the cost of the acquired stock is recorded at par value.
As of August 31, 2019, the Company has purchased
159,011 shares of $0.001 par value treasury stock.
 
Debt Discount
During year ended May 31, 2019, the Company incurred approximately $4.2 million of debt discount related to the issuance of convertible notes, as described in Note 4. The discount is amortized over the life of the convertible promissory notes. During the three months ended August 31, 2019 and August 31, 2018, the Company recorded approximately $1.03 million and $0.06 million of related amortization, respectively.
Debt Issuance Cost
During the year ended May 31, 2019, the Company incurred direct costs associated with the issuance of convertible notes, as described in Note 4, and recorded approximately $1.0 million of debt issuance costs. During the three months ended August 31, 2019 and August 31, 2018, the Company recognized related amortization of approximately $284,000 and $9,000, respectively.
Offering Costs
During the three months ended August 31, 2019 and the year ended May 31, 2019, the Company incurred direct incremental costs associated with the sale of equity securities, as described in Notes 10 and 11. The costs were approximately $1.5 million and $4.3 million for the three months ended August 31, 2019 and year ended May 31, 2019, respectively. The offering costs were recorded as a component of equity upon receipt of proceeds.
Stock for Services
The Company periodically issues warrants to consultants for various services. The Black-Scholes option pricing model, as described more fully above, is utilized to measure the fair value of the equity instruments on the date of issuance. The Company recognizes the compensation expense associated with the equity instruments over the requisite service or vesting period.
Loss per Common Share
Basic loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share would include the weighted average number of shares of common stock outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on the loss per share. For this reason, common stock options and warrants to purchase 154,635,055 and 145,856,851 shares of common stock were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the three months ended August 31, 2019 and August 31, 2018, respectively. Additionally, as of August 31, 2019, shares of
Series C and 
Series B convertible preferred stock in the aggregate of 97,100 shares can potentially convert into 10,921,000 shares of common stock.
Income Taxes
Deferred taxes are provided on the asset and liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Future tax benefits for net operating loss carry forwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company follows the provisions of FASB Accounting Standards Codification (“ASC”) ASC
740-10
“Uncertainty in Income Taxes”. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits for all periods presented. The Company has not recognized interest expense or penalties as a result of the implementation of ASC
740-10.
If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefit in interest expense and penalties in operating expenses.
In accordance with Section 15 of the Internal Revenue Code, the Company utilized a federal statutory rate of 21% and 28.62%
 for the three months ended August 31, 2019 and August 31, 2018, respectively. The net tax expense for the three months ended August 31, 2019 and August 31, 2018, is zero. The Company has a full valuation allowance as of August 31, 2019 and May 31, 2019, as management does not consider it more than likely than not that the benefits from the deferred taxes will
be realized.
XML 36 R50.htm IDEA: XBRL DOCUMENT v3.19.3
Registered Direct Equity Offerings - Additional Information (Detail)
$ / shares in Units, $ in Millions
Aug. 29, 2019
USD ($)
$ / shares
shares
Placement Agent  
Stockholders Equity Note [Line Items]  
Warrants to purchase common shares, shares | shares 498,105
Class of warrants, exercise price | $ / shares $ 0.40
Term of warrants 5 years
Percentage of shares, issued as warrants 8.80%
Subscription Agreements  
Stockholders Equity Note [Line Items]  
Number of shares to be sold | shares 5,639,500
Purchase price, per share | $ / shares $ 0.40
Warrants to purchase common shares, shares | shares 2,819,750
Class of warrants, exercise price | $ / shares $ 0.45
Term of warrants 5 years
Proceeds from issuance of common shares | $ $ 2.0
XML 37 R49.htm IDEA: XBRL DOCUMENT v3.19.3
Public Warrant Tender Offerings - Additional Information (Detail) - USD ($)
$ / shares in Units, $ in Millions
3 Months Ended
Aug. 31, 2019
May 31, 2019
Public Warrant Tender Offerings [Line Items]    
Common stock, par value $ 0.001 $ 0.001
Public Warrant Tender Offerings [Member]    
Public Warrant Tender Offerings [Line Items]    
Common stock sold at private equity offering 45,375,923  
Common stock, par value $ 0.001  
Proceeds from issuance of common shares $ 11.9  
Placement agent fees and expenses 1.1  
Noncash inducement interest expense $ 2.4  
Public Warrant Tender Offerings [Member] | Minimum [Member]    
Public Warrant Tender Offerings [Line Items]    
Purchase price, per share $ 0.30  
Public Warrant Tender Offerings [Member] | Maximum [Member]    
Public Warrant Tender Offerings [Line Items]    
Purchase price, per share $ 0.40  
XML 38 R45.htm IDEA: XBRL DOCUMENT v3.19.3
Summary of the Net Purchase Price and Allocation to the Acquired Assets (Detail) - ProstaGene, LLC - USD ($)
3 Months Ended
Aug. 31, 2019
May 31, 2019
Business Acquisition, Contingent Consideration [Line Items]    
CytoDyn Inc. Equity $ 11,558,000  
Acquisition Expenses 741,297  
Release of Deferred Tax Asset 2,826,919  
Total Cost of Acquisition 15,126,216  
Intangible assets 15,126,216 $ 15,126,216
Other 0  
Allocation of Acquisition Costs $ 15,126,216  
XML 39 R41.htm IDEA: XBRL DOCUMENT v3.19.3
Assumptions used in Estimating Fair Value of Convertible Note Redemption Provision Derivative Liability (Detail)
1 Months Ended 3 Months Ended
Jan. 30, 2019
yr
$ / shares
Nov. 15, 2018
yr
$ / shares
Aug. 31, 2019
yr
$ / shares
Fair value of underlying stock      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, price per share | $ / shares $ 0.49 $ 0.57  
Fair value of underlying stock | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, price per share | $ / shares     $ 0.40
Fair value of underlying stock | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, price per share | $ / shares     $ 0.40
Risk free rate      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input 2.52 2.78  
Risk free rate | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     1.76
Risk free rate | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     1.76
Expected Term (In Years)      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, expected term 2 years 1 year 7 months 9 days  
Expected Term (In Years) | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, expected term     9 months 25 days
Expected Term (In Years) | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, expected term     1 year 5 months 1 day
Stock price volatility      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input 61 58.8  
Stock price volatility | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     63.8
Stock price volatility | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     61.6
Expected dividend yield      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, dividend yield 0.00% 0.00%  
Expected dividend yield | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, dividend yield     0.00%
Expected dividend yield | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded derivative liability, dividend yield     0.00%
Discount factor      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input 85 85  
Discount factor | Note 1      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     85
Discount factor | Note 2      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Embedded Derivative Liability, Measurement Input     85
XML 40 R20.htm IDEA: XBRL DOCUMENT v3.19.3
Related Party Transactions
3 Months Ended
Aug. 31, 2019
Related Party Transactions
Note 13 – Related Party Transactions
The Audit Committee of the Board of Directors, comprised of independent directors, or the full Board of Directors, reviews and approves all related party transactions.
On July 15, 2019, the Company entered into consulting agreements with two of its directors, one with Scott A. Kelly, M.D. in the capacity of non-executive Chief Science Officer, the other with David F. Welch, Ph.D. in the capacity of non-executive Strategy Advisor. On September 12, 2019, the Company and Dr. Welch agreed to amend his consulting agreement to eliminate any cash compensation (including previously earned entitlements) thereunder. The company has issued options for an aggregate of 1,375,000 shares of common stock to Dr. Kelly and Dr. Welch as compensation pursuant to such agreements, including options to Dr. Kelly for 750,000 shares at an exercise price of $0.385, on September 12, 2019, and 187,500 shares at an exercise price of $0.39, on October 7, 2019; and options to Dr. Welch for 250,000 shares at an exercise price of $0.385, on September 12, 2019, and 187,500 shares at an exercise price of $0.39, on October 7, 2019. The options granted on September 12, 2019 vested immediately upon issuance and have a 10-year expiration term. The options issued on October 7, 2019 vest in four equal quarterly installments beginning on the grant date and have a 10-year expiration term.
On June 12, 2019, the Company concluded a warrant tender offer (the “June 2019 Warrant Tender Offer”) for certain outstanding series of eligible warrants, offering the holders of such warrants the opportunity to amend and exercise their warrants at a reduced exercise price equal to the lower of (i) their respective existing exercise price or (ii) $0.40 per share of common stock. As an inducement to holders to participate in the June 2019 Warrant Tender Offer, the Company offered to issue to participating holders shares of common stock equal to an additional 50% of the number of shares issuable upon exercise of the eligible warrants (collectively, the “Additional Shares”). Dr. Kelly validly tendered warrants beneficially owned by him, covering an aggregate of 50,000 shares of common stock, and received 25,000 Additional Shares. Dr. Kelly participated on terms identical to those applicable to other holders in the June 2019 Warrant Tender Offer.
On July 31, 2019, the Company concluded an additional warrant tender offer on terms identical to the June 2019 Warrant Tender Offer (the “July 2019 Warrant Tender Offer”). Dr. Welch tendered warrants beneficially owned by him, covering an aggregate of 1,000,000 shares of common stock, and received 500,000 Additional Shares. Dr. Welch participated on terms identical to those applicable to other holders in the July 2019 Warrant Tender Offer”).
On September 30, 2019, an entity controlled by Dr. Welch exchanged a 2019 Short-term Convertible Note in the principal amount of $1 million and accrued but unpaid interest of $75,343, for an Exchange Note (as defined in Note 14 below) in the principal amount of $1,075,343 and a warrant to purchase 1,000,000 shares of common stock. The terms of the exchange, the Exchange Note and the related warrant are further described in Note 14. The entity controlled by Dr. Welch participated on terms identical to the other holders in the exchange.
XML 41 R24.htm IDEA: XBRL DOCUMENT v3.19.3
Convertible Instruments (Tables)
3 Months Ended
Aug. 31, 2019
Warrants At Fair Value And Beneficial Conversion Feature At Intrinsic Value The net proceeds of $
5.0
 million were allocated first to the redemption provision at its fair value, then to the warrants at their relative fair value and the beneficial conversion feature at its intrinsic value as follows:
 
  January 30, 2019 
Fair value of redemption provision
 $ 1,465,008 
Relative fair value of equity classified warrants
  858,353 
Beneficial conversion feature
  2,676,639 
  
 
 
 
  $5,000,000 
  
 
 
 
Activity Related to Notes
Activity related to the June 2018 Note and the January 2019 Note is as follows:
 
  Short Term  Long Term  Total 
June 2018 Note
 $ 2,100,000  $3,600,000  $5,700,000 
Monthly redemption provision
  2,100,000   (2,100,000  0 
Note amendment, net
  0   111,410   111,410 
Redemptions
  (676,582  (1,783,418  (2,460,000
Interest accretion - June 2018 and January 2019 Notes
  161,933   402,622   564,555 
  
 
 
  
 
 
  
 
 
 
Carrying value of Notes at May 31, 2019
 $3,685,351  $230,614  $3,915,965 
  
 
 
  
 
 
  
 
 
 
  
 
 
  
 
 
  
 
 
 
Two Thousand And Nineteen Short Term Convertible Notes [Member]  
Summary of Fair Value Valuation Technique
The Company determined the fair value of the warrants at issuance using the Black-Scholes option pricing model utilizing certain weighted average assumptions, such as expected stock price volatility, expected term of the warrants, risk-free interest rates and expected dividend yield at the grant date.
 
  2018 - 2019
Expected dividend yield
 0%
Stock price volatility
 
55.8 - 55.88%
Expected term
 5 year
Risk-free interest rate
 
2.48 - 2.56%
Grant-date fair value
 
$0.30 - $0.38
Activity Related to Notes
Activity related to the 2019 Short-term Convertible Notes was as follows:
 
  August 31, 2019  May 31, 2018 
Face amount of Short-term Convertible Notes
 $ 5,460,000  $5,460,000 
  
 
 
  
 
 
 
Unamortized discount
  (439,000  (1,470,000
Unamortized issuance costs
  (120,000  (404,000
  
 
 
  
 
 
 
Carrying value of Short-term Convertible Notes
 $4,901,000  $3,586,000 
  
 
 
  
 
 
 
XML 42 R28.htm IDEA: XBRL DOCUMENT v3.19.3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)
3 Months Ended 12 Months Ended
Aug. 31, 2019
Aug. 31, 2018
May 31, 2019
May 22, 2019
Nov. 08, 2018
Jun. 07, 2018
May 31, 2018
Apr. 30, 2010
Summary Of Significant Accounting Policies [Line Items]                
Net loss $ (16,163,999) $ (14,413,569)            
Accumulated (deficit) (245,638,232)   $ (229,363,407)          
Balance in excess of federally insured limits 1,700,000   3,300,000          
Impairment charges 0 0            
Pre-launch inventory qualified for capitalization $ 0   $ 0          
Estimated future unvested forfeitures 0.00%              
Common stock, shares authorized 700,000,000   700,000,000         100,000,000
Preferred Stock Shares authorized to be issued 5,000,000   5,000,000          
Treasury stock, par value $ 0.001              
Treasury stock, shares 159,011              
Amortization of discount on convertible notes $ 1,030,151 64,580            
Amortization of debt issuance costs $ 284,060 $ 9,178            
Federal statutory income tax rate, percent 21.00% 28.62%            
Interest Expense $ 4,157,035 $ 178,388            
Common stock options and warrants to purchase 154,635,055 145,856,851            
Income Tax Expense (Benefit) $ 0 $ 0            
Convertible Notes Payable | Debt Discount [Member]                
Summary Of Significant Accounting Policies [Line Items]                
Interest Expense 600,000              
Convertible Notes Payable | Debt Issuance Cost [Member]                
Summary Of Significant Accounting Policies [Line Items]                
Interest Expense 100,000              
Equity Securities                
Summary Of Significant Accounting Policies [Line Items]                
Deferred offering costs 1,500,000   $ 4,300,000          
Short-Term Convertible Notes                
Summary Of Significant Accounting Policies [Line Items]                
Debt discount 439,000           $ 1,470,000  
Direct costs associated with the convertible notes     1,000,000          
Amortization of debt issuance costs 284,000 9,000            
Short-Term Convertible Notes | Detachable Common Stock Warrants                
Summary Of Significant Accounting Policies [Line Items]                
Debt discount     $ 4,200,000          
Amortization of discount on convertible notes $ 1,030,000 $ 60,000            
Series B Convertible Preferred Stock                
Summary Of Significant Accounting Policies [Line Items]                
Preferred Stock Shares authorized to be issued 400,000   400,000          
Preferred stock, shares outstanding 92,100   92,100          
Series C Convertible Preferred Stock                
Summary Of Significant Accounting Policies [Line Items]                
Preferred stock, shares outstanding 5,000              
Common Stock                
Summary Of Significant Accounting Policies [Line Items]                
Common shares issued upon conversion of preferred stock     10,921,000          
Series C and B Preferred Stock                
Summary Of Significant Accounting Policies [Line Items]                
Preferred stock, shares outstanding 97,100              
Maximum                
Summary Of Significant Accounting Policies [Line Items]                
Common stock, shares authorized       700,000,000 600,000,000 450,000,000    
Preferred Stock Shares authorized to be issued     5,000,000          
Minimum                
Summary Of Significant Accounting Policies [Line Items]                
Common stock, shares authorized       600,000,000 450,000,000 375,000,000    
XML 43 R18.htm IDEA: XBRL DOCUMENT v3.19.3
Registered Direct Equity Offerings
3 Months Ended
Aug. 31, 2019
Registered Direct Equity Offerings
Note 11 – Registered Direct Equity Offering
On August 29, 2019, the Company entered into subscription agreements with certain investors for the sale of 5,639,500 shares of common stock at a purchase price of $0.40 per share in a registered direct offering (“August Offering”), pursuant to a registration statement on
Form S-3. The
investors in the August offering also received warrants to purchase 2,819,750 shares of common stock with an exercise price of $0.45 per share and a five-year term. The Company received net proceeds from the offering of approximately $2.0 million. In addition, the placement agent received warrants covering 498,105 shares of common stock (or 8.8% of total shares sold to investors) with a per share exercise price of $0.40, a five-year term and include a cashless exercise provision.
XML 44 R10.htm IDEA: XBRL DOCUMENT v3.19.3
Recent Accounting Pronouncements
3 Months Ended
Aug. 31, 2019
Recent Accounting Pronouncements
Note 3 – Recent Accounting Pronouncements
Recent accounting pronouncements, other than below, issued by the FASB (including its EITF), the AICPA and the SEC did not or are not believed by management to have a material effect on the Company’s present or future financial statements.
In February 2016, the FASB issued a new accounting standard which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. The ASU also requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. The standard is effective for fiscal years beginning after December 15, 2018. The Company adopted the standard as of June 1, 2019, using the modified retrospective approach in which prior comparative periods are not adjusted. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carry forward historical lease classification. The Company has operating leases for two office facilities, one which expires on April 30, 2021 and the other on March 31, 2022. As of June 1, 2019, the Company recognized additional right-of-use assets and corresponding operating lease liabilities related to its facility leases on the consolidated balance sheet. No cumulative effect adjustment was recognized as the amount was not material. The standard did not materially impact the Company’s consolidated statement of operations or cash flows.
In June 2016, the FASB issued a new accounting standard intended to provide financial statement users with more decision-useful information about expected credit losses and other commitments to extend credit held by the reporting entity. The standard replaces the incurred loss impairment methodology in current GAAP with one that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The update is effective on January 1, 2020, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.
In August 2018, the FASB issued a new accounting standard to reduce, modify, and add to the disclosure requirements on fair value measurements. The standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.
In August 2018, the FASB issued a new accounting standard to align the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain
internal-use
software. The standard is effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption to have a material impact on its consolidated financial statements.
XML 45 R14.htm IDEA: XBRL DOCUMENT v3.19.3
Acquisition of Patents and Intangibles
3 Months Ended
Aug. 31, 2019
Acquisition of Patents
Note 7 – Acquisition of Patents and Intangibles
As discussed in Note 9 below, the Company consummated an asset purchase on October 16, 2012, and paid $3,500,000 for certain assets, including intellectual property, certain related licenses and sublicenses, FDA filings and various forms of the leronlimab (PRO 140) drug substance. The Company followed the guidance in Financial Accounting Standards Topic 805 to determine if the Company acquired a business. Based on the prescribed accounting, the Company acquired assets and not a business. As of August 31, 2019, the Company has recorded and is amortizing $3,500,000 of intangible assets in the form of patents. The Company estimates the acquired patents have an estimated life of ten years. Subsequent to the acquisition date, the Company has continued to expand, amend and file new patents central to its current clinical trial strategies, which, in turn, have extended the protection period for certain methods of using leronlimab (PRO 140) and formulations comprising leronlimab (PRO 140) out through at least 2031 and 2038, respectively, in various countries.
On November 16, 2018, the Company completed the acquisition of substantially all of the assets of ProstaGene, LLC (“ProstaGene”), a biotechnology
start-up
company, which included patents related to clinical research, a proprietary CCR5 technology for early cancer diagnosis, and a noncompetition agreement with ProstaGene’s founder and Chief Executive Officer, Richard G. Pestell, M.D., Ph.D. The acquisition of ProstaGene’s assets expands the Company’s clinical development of leronlimab (PRO 140) into cancer indications and commercialization of certain cancer diagnostic tests.
The aggregate purchase price paid for the ProstaGene acquisition was $11,558,000 based on the issuance of 20,278,000 shares of common stock of CytoDyn at $0.57 per share, including 1,620,000 shares earned, but not yet issued, by the investment bank for advisory services. In connection with the purchase, the Company entered into a Stock Restriction Agreement (“Agreement”), restricting the transfer of 8,342,000 shares of common stock payable to Dr. Pestell for a three-year period from the closing date of the transaction. Dr. Pestell’s employment with the Company was terminated on July 25, 2019, and as defined in the employment agreement, on September 17, 2019 the Company exercised its option to repurchase such Restricted Shares from Dr. Pestell at a purchase price of $0.001 per share. The repurchase is currently the subject of a legal proceedings between Dr. Pestell and the Company, as fully described in Part II, Item 1.
 
A summary of the net purchase price and allocation to the acquired assets is as follows:
 
  ProstaGene, LLC 
CytoDyn Inc. Equity
 $11,558,000 
Acquisition Expenses
  741,297 
Release of Deferred Tax Asset
  2,826,919 
  
 
 
 
Total Cost of Acquisition
 $15,126,216 
  
 
 
 
Intangible assets
 $15,126,216 
Other
   
  
 
 
 
Allocation of Acquisition Costs
 $15,126,216 
  
 
 
 
Assets acquired from ProstaGene include (1) patents issued in the United States and Australia related to “Prostate Cancer Cell Lines, Gene Signatures and Uses Thereof” and “Use of Modulators of CCR5 in the Treatment of Cancer and Cancer Metastasis,” (2) an algorithm used to identify a
14-gene
signature to predict the likelihood and severity of cancer diagnoses, and (3) a noncompetition agreement in connection with an employment agreement with Dr. Pestell as Chief Medical Officer of the Company. The fair value of the assets acquired approximates the consideration paid. The Company did not assume any liabilities. The Company accounted for the ProstaGene acquisition as an asset acquisition under ASC
805-10-55
“Business Combinations” because the assets retained from ProstaGene do not include an assembled workforce, and the gross value of the assets acquired meets the screen test in ASC
805-10-55-5A
related to substantially all of the fair value being concentrated in a single asset or group of assets (i.e., the proprietary technology and patents) and, thus, is not considered a business. Thus, management concluded that the acquisition did not include both an input and substantive processes that together significantly contribute to the ability to create outputs.
The fair value of the technology acquired is identified using the Income Approach. The fair value of the patents acquired is identified using the Cost to Reproduce Method. The fair value of noncompetition agreement acquired is identified using the Residual Value Method. Goodwill is not recorded as the transaction represents an asset acquisition in accordance with ASU
2017-01.
Acquisition costs for asset acquisitions are capitalized and included in the total cost of the transaction. In addition, pursuant to ASC 805, the net tax effect of the deferred tax liability arising from the book to tax basis differences is recorded as a cost of the acquisition.
The following presents intangible assets activity:
 
  August 31, 2019  May 31, 2019 
Gross carrying amounts
 $3,500,000  $3,500,000 
Development of new Company website
  19,552  $19,553 
Intangible asset acquisition:
        
ProstaGene, LLC
  15,126,216   15,126,216 
Accumulated amortization
  (3,698,646  (3,170,315)
Total amortizable intangible assets, net
   14,947,122   15,475,454 
Patents currently not amortized
      
Carrying value of intangibles, net
 $14,947,122  $15,475,454 
Amortization expense related to intangible assets patents was approximately $528,400 and $87,500 for the three months ended August 31, 2019 and 2018, respectively. The estimated aggregate future amortization expense related to the Company’s intangible assets with finite lives is estimated to be approximately $2 million per year for the next two years, approximately $1.5 million the following year, approximately $1.1 million the year thereafter, and approximately $1.0 million the year following that.
XML 46 R37.htm IDEA: XBRL DOCUMENT v3.19.3
Derivative Liability - Additional Information (Detail) - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Derivative [Line Items]    
Change in fair value of derivative liability $ 625,333 $ (747,467)
Percentage Of Outstanding Common Stock To Be Acquired 50.00%  
Warrant [Member]    
Derivative [Line Items]    
Change in fair value of derivative liability $ 63,000 $ (747,000)
Convertible Note [Member]    
Derivative [Line Items]    
Change in fair value of derivative liability $ 562,000  
XML 47 R33.htm IDEA: XBRL DOCUMENT v3.19.3
Weighted Average Assumptions to Value Investor Warrants (Detail) - $ / shares
3 Months Ended 12 Months Ended
Sep. 15, 2016
Aug. 31, 2019
May 31, 2019
Expected Term (In Years)      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Expected term 5 years 2 years 14 days 2 years 3 months 14 days
Risk Free Interest Rate      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Risk-free interest rate 1.20% 1.50% 1.94%
Grant Date Fair Value      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Grant-date fair value $ 0.78 $ 0.40 $ 0.39
Detachable Common Stock Warrants | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Expected Dividend Yield      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Expected dividend yield     0.00%
Detachable Common Stock Warrants | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Expected Term (In Years)      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Expected term     5 years
Detachable Common Stock Warrants | Minimum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Expected Dividend Yield      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Stock price volatility     55.80%
Detachable Common Stock Warrants | Minimum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Risk Free Interest Rate      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Risk-free interest rate     2.48%
Detachable Common Stock Warrants | Minimum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Grant Date Fair Value      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Grant-date fair value     $ 0.30
Detachable Common Stock Warrants | Maximum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Expected Dividend Yield      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Stock price volatility     55.88%
Detachable Common Stock Warrants | Maximum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Risk Free Interest Rate      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Risk-free interest rate     2.56%
Detachable Common Stock Warrants | Maximum | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Grant Date Fair Value      
Fair Value Measurement Inputs and Valuation Techniques [Line Items]      
Grant-date fair value     $ 0.38
XML 48 R52.htm IDEA: XBRL DOCUMENT v3.19.3
Related Party Transactions - Additional Information (Detail) - USD ($)
1 Months Ended
Oct. 07, 2019
Sep. 12, 2019
Jul. 15, 2019
Sep. 30, 2019
Jul. 31, 2019
Jun. 12, 2019
Related Party Transaction [Line Items]            
Percentage of Shares Issuable Upon Exercise Of Original Warrants           50.00%
Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares       200,000    
Warrant exercise price       $ 0.30    
Stock options, term 10 years 10 years        
Two Thousand And Nineteen Short Term Convertible Notes [Member] | Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Convertible note, aggregate principal       $ 215,000    
Convertible Promissory Notes [Member] | Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares       2,100,000    
Warrant exercise price       $ 0.30    
Convertible note, aggregate principal       $ 2,200,000    
DrKelly [Member]            
Related Party Transaction [Line Items]            
Warrant exercise price           $ 0.40
DrKelly [Member] | Additional Shares [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares           25,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized           50,000
DrKelly [Member] | Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Stock option granted, Shares 187,500 750,000        
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price $ 0.39 $ 0.385        
DrWelch [Member] | Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Stock option granted, Shares 187,500 250,000        
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price $ 0.39 $ 0.385        
DrWelch [Member] | Two Thousand And Nineteen Short Term Convertible Notes [Member]            
Related Party Transaction [Line Items]            
Accrued but unpaid interest       75,343    
DrWelch [Member] | Two Thousand And Nineteen Short Term Convertible Notes [Member] | Subsequent Event [Member] | Tranche Two [Member]            
Related Party Transaction [Line Items]            
Convertible note, aggregate principal       $ 1,000,000    
DrWelch [Member] | Convertible Promissory Notes [Member] | Subsequent Event [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares       1,000,000    
Convertible note, aggregate principal       $ 1,075,343    
DavidF Welch [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares         1,000,000  
DavidF Welch [Member] | Additional Shares [Member]            
Related Party Transaction [Line Items]            
Warrants to purchase common shares, shares         500,000  
DrKelly And DrWelch [Member]            
Related Party Transaction [Line Items]            
Stock option granted, Shares     1,375,000      
XML 49 R3.htm IDEA: XBRL DOCUMENT v3.19.3
Consolidated Balance Sheets (Parenthetical) - $ / shares
Aug. 31, 2019
May 31, 2019
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 5,000,000 5,000,000
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 700,000,000 700,000,000
Common stock, shares issued 383,584,367 329,554,763
Common stock, shares outstanding 383,425,356 329,395,752
Treasury stock, shares 159,011 159,011
Treasury Stock    
Common stock, par value $ 0.001 $ 0.001
Series B Convertible Preferred Stock    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 400,000 400,000
Preferred stock, shares issued 92,100 92,100
Preferred stock, shares outstanding 92,100 92,100
Series C Convertible Preferred Stock    
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 5,000 5,000
Preferred stock, shares issued 5,000 3,246
Preferred stock, shares outstanding 5,000 3,246
XML 50 R7.htm IDEA: XBRL DOCUMENT v3.19.3
Consolidated Statement of Changes in Stockholders' (Deficit) Equity (Parenthetical) - $ / shares
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Common Stock [Member]    
Proceeds from private equity offering, per share   $ 0.50
Proceeds from registered direct offering, per share $ 0.50 0.50
Additional Paid-in Capital [Member]    
Proceeds from private equity offering, per share   0.50
Proceeds from registered direct offering, per share $ 0.50 $ 0.50
XML 51 R47.htm IDEA: XBRL DOCUMENT v3.19.3
License Agreements - Additional Information (Detail)
Aug. 31, 2019
USD ($)
May 31, 2019
USD ($)
Apr. 15, 2019
GBP (£)
Apr. 15, 2019
USD ($)
Licenses Agreements [Line Items]        
Accrued license fee $ 382,700 $ 208,600 £ 300,000 $ 400,000
Minimum        
Licenses Agreements [Line Items]        
Royalty on every net sales 0.75%      
Maximum        
Licenses Agreements [Line Items]        
Royalty on every net sales 2.00%      
XML 52 R43.htm IDEA: XBRL DOCUMENT v3.19.3
Stock Options and Warrants (Detail) - USD ($)
3 Months Ended 12 Months Ended
Aug. 31, 2019
May 31, 2019
Stock option and warrant activity    
Options and warrants outstanding, Number of Shares 178,591,849  
Granted, Number of Shares 6,823,855  
Exercised, Number of Shares (30,250,649)  
Forfeited/expired/cancelled, Number of Shares (530,000)  
Options and warrants outstanding, Number of Shares 154,635,055 178,591,849
Outstanding exercisable, Number of Shares 151,793,153  
Options and warrants outstanding, Weighted Average Exercise Price $ 0.71  
Granted, Weighted Average Exercise Price 0.45  
Exercised, Weighted Average Exercise Price 0.39  
Forfeited/expired/cancelled, Weighted Average Exercise Price 0.79  
Options and warrants outstanding, Weighted Average Exercise Price 0.70 $ 0.71
Outstanding exercisable, Weighted Average Exercise Price $ 0.71  
Options and warrants outstanding, Weighted Average Remaining Contractual Life in Years 3 years 8 months 15 days 3 years 9 months
Outstanding exercisable, Weighted Average Remaining Contractual Life in Years 3 years 7 months 2 days  
Options and warrants outstanding, Aggregate Intrinsic Value $ 796,000 $ 896,400
Outstanding exercisable, Aggregate Intrinsic Value $ 796,000  
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Summary of Significant Accounting Policies (Policies)
3 Months Ended
Aug. 31, 2019
Basis of Presentation
Basis of Presentation
The accompanying consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect all adjustments, which consist solely of normal recurring adjustments, needed to fairly present the financial results for these periods. The consolidated financial statements and notes thereto are presented as prescribed by
Form 10-Q.
Accordingly, certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted. The accompanying consolidated financial statements should be read in conjunction with the financial statements for the fiscal years ended May 31, 2019 and 2018 and notes thereto in the Company’s Annual Report on
Form 10-K for
the fiscal year ended May 31, 2019, filed with the Securities and Exchange Commission on August 14, 2019. Operating results for the three months ended August 31, 2019 are not necessarily indicative of the results that may be expected for the entire year. In the opinion of management, all adjustments have been made, which consist only of normal recurring adjustments necessary for a fair statement of (a) the results of operations for the three months ended August 31, 2019 and August 31, 2018, (b) the financial position at August 31, 2019 and (c) cash flows for the three month periods ended August 31, 2019 and August 31, 2018.
Principles of Consolidation
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, CytoDyn Operations Inc., Advanced Genetic Technologies, Inc. (“AGTI”) and CytoDyn Veterinary Medicine LLC (“CVM”), of which both AGTI and CVM are dormant entities. All intercompany transactions and balances are eliminated in consolidation.
Reclassifications
Reclassifications
Certain prior year amounts shown in the accompanying consolidated financial statements have been reclassified to conform to the 2020 presentation. These reclassifications did not have any effect on total current assets, total assets, total current liabilities, total liabilities, total stockholders’ (deficit) equity, net loss or loss per share.
Going Concern
Going Concern
The consolidated accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company had losses for all periods presented. The Company incurred a net loss of $16,163,999 for the three months ended August 31, 2019 and has an accumulated deficit of $245,638,232 as of August 31, 2019. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.
The consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company’s continuation as a going concern is dependent upon its ability to obtain additional operating capital, complete development of its product candidate, obtain U.S. Food & Drug Administration (“FDA”) approval, outsource manufacturing of the product candidate, and ultimately achieve initial revenues and attain profitability. The Company is currently engaging in significant research and development activities related to its product candidate for multiple indications, and expects to incur significant research and development expenses in the future primarily related to its clinical trials. These research and development activities are subject to significant risks and uncertainties. The Company intends to finance its future development activities and its working capital needs largely from the sale of equity and debt securities, combined with additional funding from other traditional sources. There can be no assurance, however, that the Company will be successful in these endeavors.
Use of Estimates
Use of Estimates
The preparation of the consolidated financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash
Cash
Cash is maintained at federally insured financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances. Balances in excess of federally insured limits at August 31, 2019 and May 31, 2019 approximated $1.7 million and $3.3 million, respectively.
Identified Intangible Assets
Identified Intangible Assets
The Company follows the provisions of Financial Accounting Standards Board (“FASB”) ASC Topic 350 Intangibles-Goodwill and Other, which establishes accounting standards for the impairment of long-lived assets such as intangible assets subject to amortization. The Company reviews long-lived assets to be held and used for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. If the sum of the undiscounted expected future cash flows over the remaining useful life of a long-lived asset group is less than its carrying value, the asset is considered impaired. Impairment losses are measured as the amount by which the carrying amount of the asset group exceeds the fair value of the asset. There were no impairment charges for the three months ended August 31, 2019 and 2018. The value of the Company’s patents would be significantly impaired by any adverse developments as they relate to the clinical trials pursuant to the patents acquired as discussed in Notes 7 and 9.
Research and Development
Research and Development
Research and development costs are expensed as incurred. Clinical trial costs incurred through third parties are expensed as the contracted work is performed. Where contingent milestone payments are due to third parties under research and development collaboration arrangements or other contractual agreements, the milestone payment obligations are expensed when the milestone conditions are probable and the amount of payment is reasonably estimable.
Pre-launch Inventory
Pre-launch
Inventory
The Company
may scale-up and
make commercial quantities of its product candidate prior to the date it anticipates that such product will receive final FDA approval.
The scale-up and
commercial production
of pre-launch inventories
involves the risk that such products may not be approved for marketing by the FDA on a timely basis, or ever. This risk notwithstanding, the Company
may scale-up and 
build pre-launch inventories
of product that have not yet received final governmental approval when the Company believes that such action is appropriate in relation to the commercial value of the product launch opportunity. The determination to capitalize is made once the Company (or its third party development partners) has filed a Biologics License Application (“BLA”) that has been acknowledged by the FDA as containing sufficient information to allow the FDA to conduct its review in an efficient and timely manner and management is reasonably certain that all regulatory and legal requirements will be satisfied. This determination is based on the particular facts and circumstances relating to the expected FDA approval of the drug product being considered. As of August 31, 2019 and May 31, 2019, the Company did not
have pre-launch inventory
that qualified for capitalization pursuant to U.S. GAAP ASC 330 “Inventory.”
Fair Value of Financial Instruments
Fair Value of Financial Instruments
Fair Value Hierarchy
The three levels of inputs that may be used to measure fair value are as follows:
Level 1. Quoted prices in active markets for identical assets or liabilities.
Level 2. Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated with observable market data for substantially the full term of the assets or liabilities. Level 2 inputs also
include non-binding market
consensus prices that can be corroborated with observable market data, as well as quoted prices that were adjusted for security-specific restrictions.
Level 3. Unobservable inputs to the valuation methodology are significant to the measurement of the fair value of assets or liabilities. These Level 3 inputs also
include non-binding market
consensus prices
or non-binding broker
quotes that the Company was unable to corroborate with observable market data.
Liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of August 31, 2019 and May 31, 2019 is as follows:
 
  Fair Value Measurement at
August 31, 2019
(1)
  Fair Value Measurement at
May 31, 2019
(1)
 
  Using     Using    
  Level 3  Total  Level 3  Total 
Liabilities:
                
Derivative liability—convertible note redemption provision
 $ 1,442,764  $ 1,442,764  $ 2,005,137  $ 2,005,137 
Derivative liability—warrants
 $339,172   339,172   402,132   402,132 
  
 
 
  
 
 
  
 
 
  
 
 
 
Total liabilities
 $1,781,936  $1,781,936  $2,407,269  $2,407,269 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
(1)
The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurements. These instruments are not quoted on an active market. The Company uses a Binomial Lattice Model to estimate the value of the warrant derivative liability and a Monte Carlo Simulation to value the derivative liability of the redemption provision within a convertible promissory note. These valuation models were used because management believes they reflect all the assumptions that market participants would likely consider in negotiating the transfer of the instruments. The Company’s derivative liabilities are classified within Level 3 of the fair value hierarchy because certain unobservable inputs were used in the valuation models.
The following is a reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended August 31, 2019 and the year ended May 31, 2019:
 
Investor warrants issued with registered direct equity offering
 $4,360,000 
Placement agent warrants issued with registered direct equity offering
  819,200 
Fair value adjustments
  (3,855,468
Balance at May 31, 2018
  1,323,732 
Inception date value of redemption provision—warrants
  2,750,006 
Fair value adjustments—warrants
  (744,869)
Fair value adjustments—convertible notes
  (921,600)
Balance at May 31, 2019
 
 
2,407,269
 
Fair value adjustments—warrants
 
 
(62,960
)
Fair value adjustments—convertible notes
 
 
(562,373
)
Balance at August 31, 2019
 $1,781,936 
Operating Leases
Operating Leases
Effective June 1, 2019, the Company determined if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and non-lease components, which are generally accounted for separately.
Stock-Based Compensation
Stock-Based Compensation
U.S. GAAP requires companies to measure the cost of employee services received in exchange for the award of equity instruments based on the fair value of the award at the date of grant. The expense is to be recognized over the period during which an employee is required to provide services in exchange for the award (requisite service period) or when designated milestones have been achieved.
The Company accounts for stock-based awards established by the fair market value of the instrument using the Black-Scholes option pricing model utilizing certain weighted average assumptions including stock price volatility, expected term and risk-free interest rates, as of the grant date. The risk-free interest rate assumption is based upon observed interest rates appropriate for the expected term of the stock-based award. The expected volatility is based on the historical volatility of the Company’s common stock on monthly intervals. The computation of the expected option term is based on the “simplified method,” as the Company issuances are considered “plain vanilla” options. For stock-based awards with defined vesting, the Company recognizes compensation expense over the requisite service period or when designated milestones have been achieved. The Company estimates forfeitures at the time of grant and revised, if necessary, in subsequent periods, if actual forfeitures differ from those estimates. Based on limited historical experience of forfeitures, the Company estimated future unvested forfeitures at 0% for all periods presented. Periodically, the Company will issue restricted common stock to third parties as compensation for services rendered. Such stock awards are valued at fair market value on the effective date of the Company’s obligation.
Common Stock
Common Stock
On June 7, 2018, at a special meeting of the Company’s stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 375,000,000 to 450,000,000. On November 8, 2018, at the 2018 Annual Meeting of Stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 450,000,000 to 600,000,000. Subsequently, on May 22, 2019, at a special meeting of stockholders, a proposal was approved to increase the total number of authorized shares of common stock of the Company from 600,000,000 to 700,000,000.
Preferred Stock
Preferred Stock
The Company’s Board of Directors is authorized to issue up to 5,000,000 shares of preferred stock without stockholder approval. As of August 31, 2019, the Company has authorized the issuance of 400,000 shares of Series B convertible preferred stock and 5,000 shares of Series C convertible preferred stock, of which 92,100 shares and 5,000 shares, respectively, were outstanding. The remaining preferred shares authorized have no specified rights.
Treasury Stock
Treasury Stock
Treasury stock purchases are accounted for under the par value method, whereby the cost of the acquired stock is recorded at par value.
As of August 31, 2019, the Company has purchased
159,011 shares of $0.001 par value treasury stock.
Debt Discount
Debt Discount
During year ended May 31, 2019, the Company incurred approximately $4.2 million of debt discount related to the issuance of convertible notes, as described in Note 4. The discount is amortized over the life of the convertible promissory notes. During the three months ended August 31, 2019 and August 31, 2018, the Company recorded approximately $1.03 million and $0.06 million of related amortization, respectively.
Debt Issuance Cost
Debt Issuance Cost
During the year ended May 31, 2019, the Company incurred direct costs associated with the issuance of convertible notes, as described in Note 4, and recorded approximately $1.0 million of debt issuance costs. During the three months ended August 31, 2019 and August 31, 2018, the Company recognized related amortization of approximately $284,000 and $9,000, respectively.
Offering Costs
Offering Costs
During the three months ended August 31, 2019 and the year ended May 31, 2019, the Company incurred direct incremental costs associated with the sale of equity securities, as described in Notes 10 and 11. The costs were approximately $1.5 million and $4.3 million for the three months ended August 31, 2019 and year ended May 31, 2019, respectively. The offering costs were recorded as a component of equity upon receipt of proceeds.
Stock for Services
Stock for Services
The Company periodically issues warrants to consultants for various services. The Black-Scholes option pricing model, as described more fully above, is utilized to measure the fair value of the equity instruments on the date of issuance. The Company recognizes the compensation expense associated with the equity instruments over the requisite service or vesting period.
Loss per Common Share
Loss per Common Share
Basic loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share would include the weighted average number of shares of common stock outstanding and potentially dilutive common stock equivalents. Because of the net losses for all periods presented, the basic and diluted weighted average shares outstanding are the same since including the additional shares would have an anti-dilutive effect on the loss per share. For this reason, common stock options and warrants to purchase 154,635,055 and 145,856,851 shares of common stock were not included in the computation of basic and diluted weighted average number of shares of common stock outstanding for the three months ended August 31, 2019 and August 31, 2018, respectively. Additionally, as of August 31, 2019, shares of
Series C and 
Series B convertible preferred stock in the aggregate of 97,100 shares can potentially convert into 10,921,000 shares of common stock.
Income Taxes
Income Taxes
Deferred taxes are provided on the asset and liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carry forwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Future tax benefits for net operating loss carry forwards are recognized to the extent that realization of these benefits is considered more likely than not. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company follows the provisions of FASB Accounting Standards Codification (“ASC”) ASC
740-10
“Uncertainty in Income Taxes”. A reconciliation of the beginning and ending amount of unrecognized tax benefits has not been provided since there are no unrecognized benefits for all periods presented. The Company has not recognized interest expense or penalties as a result of the implementation of ASC
740-10.
If there were an unrecognized tax benefit, the Company would recognize interest accrued related to unrecognized tax benefit in interest expense and penalties in operating expenses.
In accordance with Section 15 of the Internal Revenue Code, the Company utilized a federal statutory rate of 21% and 28.62%
 for the three months ended August 31, 2019 and August 31, 2018, respectively. The net tax expense for the three months ended August 31, 2019 and August 31, 2018, is zero. The Company has a full valuation allowance as of August 31, 2019 and May 31, 2019, as management does not consider it more than likely than not that the benefits from the deferred taxes will
be realized.

XML 55 R26.htm IDEA: XBRL DOCUMENT v3.19.3
Stock Options and Warrants (Tables)
3 Months Ended
Aug. 31, 2019
Stock Option and Warrant Activity
The following table represents stock option and warrant activity as of and for the three months ended August 31, 2019:
 
  Number of
Shares
  Weighted
Average
Exercise Price
  Weighted
Average
Remaining
Contractual Life
in Years
  Aggregate
Intrinsic Value
 
Options and warrants outstanding—May 31, 2019
  178,591,849  $ 0.71   3.75  $896,400 
Granted
  6,823,855   0.45   —     —   
Exercised
  (30,250,649  0.39   —     —   
Forfeited/expired/cancelled
  (530,000  0.79   —     —   
Options and warrants outstanding—August 31, 2019
  154,635,055   0.70   3.71   796,000 
Outstanding exercisable—August 31, 2019
  151,793,153  $0.71   3.59  $ 796,000 
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Intangible Assets Activity (Detail) - USD ($)
Aug. 31, 2019
May 31, 2019
Acquired Finite-Lived Intangible Assets [Line Items]    
Gross carrying amounts $ 3,500,000 $ 3,500,000
Accumulated amortization (3,698,646) (3,170,315)
Total amortizable intangible assets, net 14,947,122 15,475,454
Patents currently not amortized 0 0
Carrying value of intangibles, net 14,947,122 15,475,454
ProstaGene, LLC    
Acquired Finite-Lived Intangible Assets [Line Items]    
Intangible asset acquisition 15,126,216 15,126,216
Development of new Company website    
Acquired Finite-Lived Intangible Assets [Line Items]    
Gross carrying amounts $ 19,552 $ 19,553
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Stock Options and Warrants - Additional Information (Detail) - USD ($)
3 Months Ended
Aug. 31, 2019
Aug. 31, 2018
Aug. 29, 2019
May 22, 2019
Aug. 24, 2017
Mar. 31, 2016
Feb. 28, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Compensation expense $ 580,727 $ 283,346          
Placement Agent              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Warrants to purchase common shares, shares     498,105        
Term of warrants     5 years        
Exercise price of warrants, per share     $ 0.40        
Investor | Series C Convertible Preferred Stock [Member]              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Warrants to purchase common shares, shares 2,631,000            
Term of warrants 5 years            
Exercise price of warrants, per share $ 0.50            
Subscription Agreements              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Warrants to purchase common shares, shares     2,819,750        
Term of warrants     5 years        
Exercise price of warrants, per share     $ 0.45        
2012 Equity Incentive Plan              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Compensation expense $ 581,000 283,000          
Grant date fair value of options and warrants 542,000 $ 692,000          
Unrecognized compensation expense $ 1,000,000            
Weighted average period over which unrecognized compensation expense is expected to be recognized 10 months 2 days            
2012 Equity Incentive Plan | Employee Stock Option One | Range Two              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock option granted, exerices price $ 0.90            
2012 Equity Incentive Plan | Employee Stock Option One | Director | Range One              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock option granted, Shares 600,000            
Stock option granted, exerices price $ 0.52            
Vesting period 1 year            
Stock options, term 10 years            
2012 Equity Incentive Plan | Employee Stock Option One | Executive Management and Employees | Minimum              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock options grant date fair value $ 0.23            
2012 Equity Incentive Plan | Employee Stock Option One | Executive Management and Employees | Maximum              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock options grant date fair value 0.30            
2012 Equity Incentive Plan | Employee Stock Option One | Managing Director | Range One              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock options grant date fair value $ 0.26            
2012 Equity Incentive Plan | Stock Options              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares available for future stock-based grants 9,949,144            
2012 Equity Incentive Plan | Stock Options | Before Amendment              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares available for future issuance       15,000,000 7,000,000 5,000,000 3,000,000
2012 Equity Incentive Plan | Stock Options | After Amendment              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Shares available for future issuance       25,000,000 15,000,000 7,000,000 5,000,000
2012 Equity Incentive Plan | Stock Options | Executive Management and Employees              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock option granted, Shares 275,000            
Vesting period 3 years            
Stock options, term 10 years            
Warrants to purchase common shares, shares 50,000            
2012 Equity Incentive Plan | Stock Options | Executive Management and Employees | Range One              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock option granted, exerices price $ 0.43            
2012 Equity Incentive Plan | Stock Options | Executive Management and Employees | Range Two              
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]              
Stock option granted, exerices price $ 0.52            
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Summary of Significant Accounting Policies (Tables)
3 Months Ended
Aug. 31, 2019
Liability Measured at Fair Value on Recurring Basis by Level within Fair Value Hierarchy
Liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of August 31, 2019 and May 31, 2019 is as follows:
 
  Fair Value Measurement at
August 31, 2019
(1)
  Fair Value Measurement at
May 31, 2019
(1)
 
  Using     Using    
  Level 3  Total  Level 3  Total 
Liabilities:
                
Derivative liability—convertible note redemption provision
 $ 1,442,764  $ 1,442,764  $ 2,005,137  $ 2,005,137 
Derivative liability—warrants
 $339,172   339,172   402,132   402,132 
  
 
 
  
 
 
  
 
 
  
 
 
 
Total liabilities
 $1,781,936  $1,781,936  $2,407,269  $2,407,269 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
(1)
The Company did not have any assets or liabilities measured at fair value using Level 1 or 2 of the fair value hierarchy as of August 31, 2019 and May 31, 2019.
Reconciliation of Liability Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs (Level 3)
The following is a reconciliation of the beginning and ending balances for liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended August 31, 2019 and the year ended May 31, 2019:
 
Investor warrants issued with registered direct equity offering
 $4,360,000 
Placement agent warrants issued with registered direct equity offering
  819,200 
Fair value adjustments
  (3,855,468
Balance at May 31, 2018
  1,323,732 
Inception date value of redemption provision—warrants
  2,750,006 
Fair value adjustments—warrants
  (744,869)
Fair value adjustments—convertible notes
  (921,600)
Balance at May 31, 2019
 
 
2,407,269
 
Fair value adjustments—warrants
 
 
(62,960
)
Fair value adjustments—convertible notes
 
 
(562,373
)
Balance at August 31, 2019
 $1,781,936 
XML 61 R27.htm IDEA: XBRL DOCUMENT v3.19.3
Acquisition of Patents and Intangibles (Tables)
3 Months Ended
Aug. 31, 2019
Summary of the Net Purchase Price and Allocation to the Acquired Assets
A summary of the net purchase price and allocation to the acquired assets is as follows:
 
  ProstaGene, LLC 
CytoDyn Inc. Equity
 $11,558,000 
Acquisition Expenses
  741,297 
Release of Deferred Tax Asset
  2,826,919 
  
 
 
 
Total Cost of Acquisition
 $15,126,216 
  
 
 
 
Intangible assets
 $15,126,216 
Other
   
  
 
 
 
Allocation of Acquisition Costs
 $15,126,216 
  
 
 
 
Intangible Assets Activity
The following presents intangible assets activity:
 
  August 31, 2019  May 31, 2019 
Gross carrying amounts
 $3,500,000  $3,500,000 
Development of new Company website
  19,552  $19,553 
Intangible asset acquisition:
        
ProstaGene, LLC
  15,126,216   15,126,216 
Accumulated amortization
  (3,698,646  (3,170,315)
Total amortizable intangible assets, net
   14,947,122   15,475,454 
Patents currently not amortized
      
Carrying value of intangibles, net
 $14,947,122  $15,475,454 
XML 62 R11.htm IDEA: XBRL DOCUMENT v3.19.3
Convertible Instruments
3 Months Ended
Aug. 31, 2019
Convertible Instruments
Note 4 – Convertible Instruments
Series C Convertible Preferred Stock
On March 20, 2019, the Company authorized 5,000 shares and issued 3,246 shares of Series C 
Convertible Preferred Stock
, $0.001 par value per share (“Series C Preferred Stock”), at $1,000.00 per share for cash proceeds totaling $3,083,700, net of placement agent fees of $162,300. On August 29, 2019 the Company issued the remaining 1,754 shares of Series C Preferred Stock at $1,000.00 per share for cash proceeds totaling $1,542,545, net of placement agent fees and legal fees totaling $211,455. As of August 31, 2019, 5,000 shares of Series C Preferred  Stock remain outstanding. The
Series C Preferred Stock 
Certificate of Designation (the 
“Certificate of Designation”) 
provides, among other things, that holders of Series C Preferred Stock shall be entitled to receive, at the option of the holder, cumulative dividends at the rate of ten percent (10%) per share per annum of the stated value of the Series C Preferred Stock, to be paid per share of Series C Preferred Stock. Any dividends paid by the Company will first be paid to the holders of Series C Preferred Stock prior and in preference to any payment or distribution to holders of common stock. Dividends on the Series C Preferred Stock are mandatory and cumulative and there are no sinking fund provisions applicable to the Series C Preferred Stock. The Series C Preferred Stock does not have redemption rights. The stated value per share for the Series C Preferred Stock is $1,000 (the “Stated Value”). In the event of any liquidation, dissolution or winding up of the Company, the Series C Preferred Stock will be paid, prior and in preference to any payment or distribution on any shares of common stock, currently outstanding series of preferred stock, or subsequent series of preferred stock, an amount per share equal to the Stated Value and the amount of any accrued and unpaid dividends. The holders of the Series C Preferred Stock will then receive distributions along with the holders of common stock on a pari passu basis according to the number of shares of common stock the Series C Preferred holders would be entitled if they converted their shares of Series C Preferred Stock at the time of such distribution. If, at any time while the Series C Preferred Stock is outstanding, the Company effects any reorganization, merger or sale of the Company or substantially all of its assets (each a “Fundamental Transaction”), a holder of the Series C Preferred Stock will have the right to receive any shares of the acquiring corporation or other consideration it would have been entitled to receive if it had been a holder of the number of shares of common stock then issuable upon conversion in full of the Series C Preferred Stock immediately prior to the Fundamental Transaction. Each share of Series C Preferred Stock is convertible at any time at the holder’s option into that number of fully paid and nonassessable shares of the Company’s common stock determined by dividing the Stated Value by the conversion price of $0.50 per share (subject to adjustment as set forth in the Certificate of Designation). No fractional shares will be issued upon the conversion of the Series C Preferred Stock. Except as otherwise provided in the Certificate of Designation or as otherwise required by law, the Series C Preferred Stock has no voting rights. As of August 31, 2019, the accrued dividends were approximately $148,000 or 296,000 shares of common stock.
 
Series B Convertible Preferred Stock
During fiscal 2010, the Company issued 400,000 shares of Series B Convertible Preferred Stock, $0.001 par value per share (“Series B Preferred Stock”) at $5.00 per share for cash proceeds totaling $2,009,000, of which 92,100 shares remain outstanding at August 31, 2019. Each share of the Series B Preferred Stock is convertible into ten shares of the Company’s common stock, including any accrued dividends, with an effective fixed conversion price of $0.50 per share. The holders of the Series B Preferred Stock can only convert their shares to shares of common stock provided the Company has sufficient authorized shares of common stock at the time of conversion. Accordingly, the conversion option was contingent upon the Company increasing its authorized common shares, which occurred in April 2010, when the Company’s stockholders approved an increase in the authorized shares of common stock to 100,000,000. At the commitment date, which occurred upon such stockholder approval, the conversion option related to the Series B Preferred Stock was beneficial. The intrinsic value of the conversion option at the commitment date resulted in a constructive dividend to the Series B Preferred Stock holders of approximately $6,000,000. The constructive dividend increased and decreased
additional paid-in capital
by identical amounts. The Series B Preferred Stock has liquidation preferences over the common shares at $5.00 per share plus any accrued dividends. Dividends are payable to the Series B Preferred Stock holders when declared by the Board of Directors at the rate of $0.25 per share per annum. Such dividends are cumulative and accrue whether or not declared and whether or not there are any profits, surplus or other funds or assets of the Company legally available. The Series B holders have no voting rights. As of August 31, 2019 and May 31, 2019, the undeclared dividends were approximately $227,000 or 454,000 shares of common stock and approximately $216,000 or 432,000 shares of common stock, respectively.
2019 Short-term Convertible Notes
During the year ended May 31, 2019, the Company issued approximately $5.5 million of nine-month unsecured Convertible Notes (the “2019 Short-term Convertible Notes”) and related warrants to investors for cash. The principal amount of the 2019 Short-term Convertible Notes, including any accrued but unpaid interest thereon, is convertible at the election of the holder at any time into shares of common stock at any time prior to maturity at a conversion price of $0.50 per share. The 2019 Short-term Convertible Notes bear simple interest at the annual rate of 10%. Principal and accrued interest, to the extent not previously paid or converted, is due and payable on the maturity date. At the commitment dates, the Company determined that the conversion feature related to these 2019 Short-term Convertible Notes to be beneficial to the investors. As a result, the Company determined the intrinsic value of the beneficial conversion feature utilizing the fair value of the underlying common stock on the commitment dates and the effective conversion price after discounting the 2019 Short-term Convertible Notes for the fair value of the related warrants. In connection with the sale of the 2019 Short-term Convertible Notes, detachable common stock warrants to purchase a total of 5,460,000 common shares, with an exercise price of $0.30 per share and a
five
-year term were issued to the investors. The Company determined the fair value of the warrants at issuance using the Black-Scholes option pricing model utilizing certain weighted average assumptions, such as expected stock price volatility, expected term of the warrants, risk-free interest rates and expected dividend yield at the grant date.
 
  2018 - 2019
Expected dividend yield
 0%
Stock price volatility
 
55.8 - 55.88%
Expected term
 5 year
Risk-free interest rate
 
2.48 - 2.56%
Grant-date fair value
 
$0.30 - $0.38
 
The fair value of the warrants, coupled with the beneficial conversion features, were recorded as a debt discount to the 2019 Short-term Convertible Notes and a corresponding increase to additional
paid-in
capital and will be amortized over the life of the 2019 Short-term Convertible Notes. In connection with the 2019 Short-term Convertible Notes, the placement agent earned a “tail fee” comprised of warrants covering 972,000 shares of common stock and a cash fee of $583,200. The placement agent warrants are exercisable at a price of $0.50 per share and will expire
five
years from the date of issuance and include a cashless exercise provision. During the year ended May 31, 2019, and in connection with the 2019 Short-term Convertible Notes, the Company incurred debt discount and issuance costs of approximately $3.0 million, related to the beneficial conversion feature and detachable warrants issued with the 2019 Short-term Convertible Notes and approximately $0.8 in issuance costs. The debt discount and issuance costs are being amortized over the term of the 2019 Short-term Convertible Notes. Accordingly, the Company recognized approximately $1.0 million and $0.3 million of debt discount and issuance costs, respectively, during the three months ended August, 31, 2019. Activity related to the 2019 Short-term Convertible Notes was as follows:
 
  August 31, 2019  May 31, 2019 
Face amount of Short-term Convertible Notes
 $ 5,460,000  $5,460,000 
  
 
 
  
 
 
 
Unamortized discount
  (439,000  (1,470,000
Unamortized issuance costs
  (120,000  (404,000
  
 
 
  
 
 
 
Carrying value of Short-term Convertible Notes
 $4,901,000  $3,586,000 
The Company recognized approximately $138,000 and $0 of interest expense during the three months ended August 31, 2019 and August 31, 2018, respectively.
Long-term Convertible Notes—June 2018 Note
On June 26, 2018, the Company entered into a securities purchase agreement, pursuant to which the Company issued a convertible promissory note (the “June 2018 Note”) with a
two-year
term to an institutional accredited investor in the initial principal amount of $5.7 million. The investor gave consideration of $5.0 million to the Company. The June 2018 Note bears interest of 10% and is convertible into common stock, at $0.55 per share. The June 2018 Note is convertible in total, or in part, of the outstanding balance, at any time after six months from the issue date upon five trading days’ notice, subject to certain adjustments and ownership limitations specified in the June 2018 Note. The Investor may redeem any portion of the June 2018 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000
. The securities purchase agreement requires the Company to reserve shares for future conversions or redemptions by dividing the outstanding principal balance plus accrued interest by the conversion price of $
0.55
per share times
1.5
. As a result of the entry into the January 2019 Note (as defined below), the Company’s obligations under the June 2018 Note are now secured by all of the assets of the Company, excluding the Company’s intellectual property.
Effective November 15, 2018, the June 2018 Note was amended to allow the Investor to redeem the monthly redemption amount of $350,000 in cash or stock, at the lesser of (i) $0.55, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%. The variable rate redemption provision meets the definition of a derivative instrument and subsequent to the amendment, it no longer meets the criteria to be considered indexed to the Company’s own stock. As of November 15, 2018, the redemption provision requires bifurcation as a derivative liability at fair value under the guidance in ASC Topic No. 815, “Derivatives and Hedging.”
The amendment of the June 2018 Note was also evaluated under ASC Topic
470-50-40,
“Debt Modifications and Extinguishments.” Based on the guidance, the instruments were determined to be substantially different, and debt extinguishment accounting was applied. The Company recorded approximately $1.5 million as an extinguishment loss, which was the difference in the net carrying value of the June 2018 Note prior to the amendment of approximately $5.4 million, and the fair value of the June 2018 Note and embedded derivatives after the amendment of approximately $6.9 million. The extinguishment loss includes a
write-off
of unamortized debt issuance costs and the debt discount associated with the original the June 2018 Note.
During the three months ended August 31, 2019 and August 31, 2018, the Company recognized approximately $162,000 and $104,000, of interest expense related to the June 2018 Note, respectively. During the three months ended August 31, 2019, the Company received redemption notices from the holder of the Company’s June 2018 Note, requesting an aggregate redemption of $1,005,000 of the outstanding balance thereof. In satisfaction of the redemption notices, the Company issued shares of common stock totaling 3,014,181 to the June 2018
 
Note holder in accordance with the terms of the June 2018 Note. Following the redemptions, the outstanding balance of the convertible June 2018 Note, including accrued but unpaid interest, was approximately $
3.7 million.
Long-term Convertible Notes—January 2019 Note
On January 30, 2019, the Company entered into a securities purchase agreement, pursuant to which the Company issued a convertible promissory note (the “January 2019 Note”) with a
two-year
term to the holder of the June 2018 Note in the initial principal amount of $5.7 million. In connection with the issuance of the January 2019 Note, the Company granted a lien against all of the assets of the Company, excluding the Company’s intellectual property, to secure all obligations owed to the investor by the Company (including those under both the January 2019 Note and the June 2018 Note). The investor gave consideration of $5.0 million to the Company, reflecting original issue discount of $0.6 million and issuance costs of $0.1 million. The January 2019 Note bears interest of 10% and is convertible into common stock, at $0.50 per share. The January 2019 Note is convertible in total, or in part, of the outstanding balance, at any time after six months from the issue date upon five trading days’ notice, subject to certain adjustments and ownership limitations specified in the Note. The Company analyzed the conversion option for derivative accounting treatment under ASC 815 and determined that the embedded conversion option did not qualify for derivative accounting.
The investor may redeem any portion of the January 2019 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000. The monthly redemption amount may be paid in cash or stock, at the Company’s election, at the lesser of (i) $0.50, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%. The redemption provision meets the definition of a derivative instrument and does not meet the criteria to be considered indexed to the Company’s own stock. Therefore, the redemption provision requires bifurcation as a derivative liability at fair value under the guidance in ASC Topic No. 815 (“ASC 815”). The securities purchase agreement requires the Company to reserve 20,000,000 shares for future conversions or redemptions. In conjunction with the January 2019 Note, the investor received a warrant to purchase 5,000,000 shares of common stock with an exercise price of $0.30 which is exercisable until the
5-year
anniversary of the date of issuance. The warrant achieved equity classification at inception. The net proceeds of $
5.0
 million were allocated first to the redemption provision at its fair value, then to the warrants at their relative fair value and the beneficial conversion feature at its intrinsic value as follows:
 
  January 30, 2019 
Fair value of redemption provision
 $ 1,465,008 
Relative fair value of equity classified warrants
  858,353 
Beneficial conversion feature
  2,676,639 
  
 
 
 
  $5,000,000 
  
 
 
 
Under the guidance of ASC 815, after allocation of proceeds to the redemption provision, relative fair value of equity classified warrants and the beneficial conversion feature, there were no proceeds remaining to allocate to convertible note payable. Therefore, principal, accrued interest, debt discount and offering costs will be recognized as interest expense, which represents the accretion of the convertible note payable and related debt discount and issuance costs. During the three months ended August 31, 2019 and August 31, 2018, the Company recognized approximately $104,000 and
$-0-,
respectively, of interest expense related to the January 2019 Note.
Activity related to the June 2018 Note and the January 2019 Note is as follows:
 
  Short Term  Long Term  Total 
June 2018 Note
 $ 2,100,000  $3,600,000  $5,700,000 
Monthly redemption provision
  2,100,000   (2,100,000  —   
Note amendment, net
  —     111,410   111,410 
Redemptions
  (676,582  (1,783,418  (2,460,000
Interest accretion—June 2018 and January 2019 Notes
  161,933   402,622   564,555 
  
 
 
  
 
 
  
 
 
 
Carrying value of Notes at August 31, 2019
 $3,685,351  $230,614  $3,915,965 
  
 
 
  
 
 
  
 
 
 
  
 
 
  
 
 
  
 
 
 
 
XML 63 R15.htm IDEA: XBRL DOCUMENT v3.19.3
License Agreements
3 Months Ended
Aug. 31, 2019
License Agreements
N
ote 8 – License Agreements
The Company has a license agreement with a third-party licensor covering the licensor’s
“system know-how” technology
with respect to the Company’s use of proprietary cell lines to manufacture new leronlimab (PRO 140) material. The Company accrues an annual license fee of £300,000 (approximately US$400,000 utilizing current exchange rates), which is payable annually in December, except for the December 2017 and 2018 payments, which were extended to March 15, 2018 and April 15, 2019, respectively. Future annual license fees and royalty rate will vary depending on whether the Company manufactures leronlimab (PRO 140), utilizes the third-party licensor as a contract manufacturer, or utilizes an independent party as a contract manufacturer. The licensor does not charge an annual license fee when it serves as the manufacturer. In addition, the Company will incur royalties of up to 0.75% to 2% of net sales, depending upon who serves as the manufacturer, when the Company commences their first commercial sale, which will continue as long as the license agreement is maintained.
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    Employee Benefit Plan
    3 Months Ended
    Aug. 31, 2019
    Employee Benefit Plan
    Note 12 – Employee Benefit Plan
    The Company has an employee savings plan (the “Plan”) pursuant to Section 401(k) of the Internal Revenue Code (the “Code”), covering all of its employees. The Company makes a
    qualified non-elective contribution
    of 3%, which consequently vests immediately. In addition, participants in the Plan may contribute a percentage of their compensation, but not in excess of the maximum allowed under the Code. During the three months ended August 31, 2019 and 2018, the Company incurred an expense of approximately $26,000 and $15,800, respectively, for qualified
    non-elective
    contributions.

    XML 66 R36.htm IDEA: XBRL DOCUMENT v3.19.3
    Activity Related to Notes (Detail 1)
    3 Months Ended
    Aug. 31, 2019
    USD ($)
    Debt Instrument [Line Items]  
    Monthly redemption provision $ 0
    Note amendment, net 111,410
    Redemptions (2,460,000)
    Interest accretion 564,555
    August 31, 2019 Note 3,915,965
    Short-term Debt [Member]  
    Debt Instrument [Line Items]  
    Monthly redemption provision 2,100,000
    Note amendment, net 0
    Redemptions (676,582)
    Interest accretion 161,933
    August 31, 2019 Note 3,685,351
    Long-term Debt [Member]  
    Debt Instrument [Line Items]  
    Monthly redemption provision (2,100,000)
    Note amendment, net 111,410
    Redemptions (1,783,418)
    Interest accretion 402,622
    August 31, 2019 Note 230,614
    Two Thousand And Eighteen Convertible Notes [Member]  
    Debt Instrument [Line Items]  
    June 2018 Note 5,700,000
    Two Thousand And Eighteen Convertible Notes [Member] | Short-term Debt [Member]  
    Debt Instrument [Line Items]  
    June 2018 Note 2,100,000
    Two Thousand And Eighteen Convertible Notes [Member] | Long-term Debt [Member]  
    Debt Instrument [Line Items]  
    June 2018 Note $ 3,600,000
    XML 67 R32.htm IDEA: XBRL DOCUMENT v3.19.3
    Convertible Instruments - Additional Information (Detail)
    1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
    Jan. 31, 2019
    USD ($)
    $ / shares
    shares
    Jun. 26, 2018
    USD ($)
    $ / shares
    Jan. 30, 2019
    USD ($)
    Nov. 15, 2018
    USD ($)
    $ / shares
    Aug. 31, 2019
    USD ($)
    $ / shares
    shares
    Aug. 31, 2018
    USD ($)
    Feb. 28, 2019
    USD ($)
    May 31, 2019
    USD ($)
    $ / shares
    shares
    May 31, 2010
    USD ($)
    $ / shares
    shares
    Aug. 29, 2019
    shares
    Mar. 20, 2019
    $ / shares
    shares
    May 31, 2018
    USD ($)
    Apr. 30, 2010
    shares
    Class of Stock [Line Items]                          
    Preferred Stock, Share issuance price | $ / shares               $ 1,000          
    Common stock, shares authorized | shares         700,000,000     700,000,000         100,000,000
    Convertible preferred stock, par value | $ / shares         $ 0.001     $ 0.001          
    Amortization of debt discount         $ 1,030,151 $ 64,580              
    Number of shares to be sold | shares         3,014,181                
    Proceeds from sale of common stock and warrant         $ 2,255,800 8,499,300              
    Repayment of note         2,460,000                
    Interest expense         404,020 104,630              
    Proceeds from convertible promissory note     $ 5,000,000                    
    Conversion of Preferred Stock to Common Stock                          
    Class of Stock [Line Items]                          
    Undeclared dividend         227,000     $ 216,000          
    Accrued dividend         454,000     $ 432,000          
    Short-Term Convertible Notes                          
    Class of Stock [Line Items]                          
    Conversion price | $ / shares               $ 0.50          
    Convertible note, aggregate principal               $ 5,500,000          
    Convertible notes, interest rate               10.00%          
    Common stock warrants to purchase shares | shares 972,000                        
    Unamortized discount         439,000             $ 1,470,000  
    Sale of Stock, Price Per Share | $ / shares $ 0.50                        
    Repayment of note $ 3,000,000                        
    Net carrying value of note         4,901,000             3,586,000  
    Short-Term Convertible Notes | Investor Warrants                          
    Class of Stock [Line Items]                          
    Common stock warrants to purchase shares | shares               5,460,000          
    Exercise price of warrants, per share | $ / shares               $ 0.30          
    Short-Term Convertible Notes | Detachable Common Stock Warrants                          
    Class of Stock [Line Items]                          
    Unamortized discount               $ 4,200,000          
    Amortization of debt discount         1,030,000 60,000              
    Unamortized issuance costs         0.3                
    Note                          
    Class of Stock [Line Items]                          
    Convertible notes, interest rate   10.00%                      
    Interest expense         162,000 104,000 $ 1,500,000            
    Convertible promissory note principle amount   $ 5,700,000                      
    Proceeds from convertible promissory note   $ 5,000,000                      
    Common stock conversion price | $ / shares   $ 0.55   $ 0.55                  
    Convertible promissory note maximum redemption amount   $ 350,000   $ 350,000                  
    Convertible promissory note redemption description   The Investor may redeem any portion of the June 2018 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000   Effective November 15, 2018, the June 2018 Note was amended to allow the Investor to redeem the monthly redemption amount of $350,000 in cash or stock, at the lesser of (i) $0.55, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%                  
    Terms of conversion   1.5                      
    Convertible note, redeemed amount         1,005,000                
    Outstanding balance of convertible note including accrued unpaid interest         3,700,000                
    Fair value of Note         6,900,000                
    Net carrying value of note               5,400,000          
    2019 Short Term Convertible Notes                          
    Class of Stock [Line Items]                          
    Unamortized issuance costs         120,000             $ 404,000  
    Proceeds from sale of common stock and warrant             $ 583,200            
    Interest expense         $ 138,000     $ 0          
    2019 Short Term Convertible Notes | Investor Warrants                          
    Class of Stock [Line Items]                          
    Term of warrants               5 years          
    January 2019 Note [Member]                          
    Class of Stock [Line Items]                          
    Convertible notes, interest rate         10.00%                
    Common stock warrants to purchase shares | shares               5,000,000          
    Exercise price of warrants, per share | $ / shares               $ 0.30          
    Unamortized discount         $ 600,000                
    Unamortized issuance costs         100,000                
    Interest expense         104,000 $ 0              
    Convertible promissory note principle amount         5,700,000                
    Proceeds from convertible promissory note         $ 5,000,000     $ 5,000,000          
    Common stock conversion price | $ / shares         $ 0.50     $ 0.50          
    Convertible promissory note redemption description               The Investor may redeem any portion of the January 2019 Note, at any time after six months from the issue date upon five trading days’ notice, subject to a maximum monthly redemption amount of $350,000. The monthly redemption amount may be paid in cash or stock, at the Company’s election, at the lesser of (i) $0.50, or (ii) the lowest closing bid price of the Company’s common stock during the 20 days prior to the conversion, multiplied by a conversion factor of 85%          
    Company Reserves Shares For Future Conversition | shares               20,000,000          
    Common Stock                          
    Class of Stock [Line Items]                          
    Number of common shares issued upon conversion of preferred stock | shares               10          
    Conversion price | $ / shares         $ 0.50                
    Series B Convertible Preferred Stock                          
    Class of Stock [Line Items]                          
    Series C Convertible preferred stock, shares issued | shares | shares         92,100     92,100 400,000        
    Preferred Stock, Share issuance price | $ / shares         $ 5.00                
    Cash proceeds                 $ 2,009,000        
    Series B Convertible preferred stock, shares outstanding | shares | shares         92,100     92,100          
    Constructive dividend to Preferred stock holders         $ 6,000,000                
    Liquidation preference on common shares | $ / shares         $ 5.00                
    Dividends are payable to preferred stock holders | $ / shares         0.25                
    Convertible preferred stock, par value | $ / shares         $ 0.001     $ 0.001 $ 0.001        
    Series C Convertible Preferred Stock                          
    Class of Stock [Line Items]                          
    Series C Convertible preferred stock, shares issued | shares | shares         5,000     3,246   1,754 3,246    
    Preferred Stock, Share issuance price | $ / shares         $ 1,000                
    Cash proceeds         $ 1,542,545     $ 3,083,700          
    Series B Convertible preferred stock, shares outstanding | shares | shares         5,000     3,246          
    Common stock, shares authorized | shares                     5,000    
    Convertible preferred stock, par value | $ / shares         $ 0.001     $ 0.001     $ 0.001    
    Placement agent fee         $ 211,455     $ 162,300          
    Preferred Stock, Dividend Rate, Percentage         10.00%                
    Convertible Preferred Stock Conversion Price | $ / shares         $ 0.50                
    Accrued dividends         $ 148,179     $ 37,351          
    Accrued dividend Shares | shares         296,000                
    XML 68 R53.htm IDEA: XBRL DOCUMENT v3.19.3
    Subsequent Events - Additional Information (Detail) - USD ($)
    1 Months Ended 3 Months Ended
    Oct. 07, 2019
    Oct. 03, 2019
    Sep. 24, 2019
    Sep. 19, 2019
    Sep. 12, 2019
    Sep. 10, 2019
    Aug. 29, 2019
    Sep. 30, 2019
    Aug. 31, 2019
    May 31, 2019
    Subsequent Event [Line Items]                    
    Common stock issuance for redemption of covertible note                 3,014,181  
    Debt outstanding amount                 $ 4,900,247 $ 3,586,035
    Subscription Agreement [Member]                    
    Subsequent Event [Line Items]                    
    Class of warrants, exercise price             $ 0.45      
    Number of shares to be sold             5,639,500      
    Term of warrants             5 years      
    Warrants to purchase common shares, shares             2,819,750      
    Purchase price, per share             $ 0.40      
    Proceeds from issuance of common shares             $ 2,000,000      
    Subsequent Event                    
    Subsequent Event [Line Items]                    
    Class of warrants, exercise price               $ 0.30    
    Warrants to purchase common shares, shares               200,000    
    Stock options, term 10 years       10 years          
    Term of warrants               5 years    
    Stock options grant date fair value $ 0.19                  
    Subsequent Event | 2019 Short Term Convertible Notes                    
    Subsequent Event [Line Items]                    
    Debt outstanding amount               $ 5,870,000    
    Debt Instrument, maturity date               Apr. 01, 2020    
    Convertible note, aggregate principal               $ 215,000    
    Conversion rate price per share               $ 0.40    
    Subsequent Event | 2019 Short Term Convertible Notes | Tranche One [Member]                    
    Subsequent Event [Line Items]                    
    Debt outstanding amount               $ 2,200,000    
    Subsequent Event | 2019 Short Term Convertible Notes | Tranche Two [Member]                    
    Subsequent Event [Line Items]                    
    Debt outstanding amount               $ 2,300,000    
    Subsequent Event | Convertible Promissory Notes                    
    Subsequent Event [Line Items]                    
    Class of warrants, exercise price               $ 0.30    
    Warrants to purchase common shares, shares               2,100,000    
    Debt Instrument, maturity date               Apr. 01, 2020    
    Convertible note, aggregate principal               $ 2,200,000    
    Term of warrants               5 years    
    Subsequent Event | DrScottA Kelly [Member] | Two Thousand Twelve Stock Incentive Plan [Member]                    
    Subsequent Event [Line Items]                    
    Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price         750,000          
    Subsequent Event | DrWelch [Member]                    
    Subsequent Event [Line Items]                    
    Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price 187,500       250,000          
    Stock option granted, exercise price $ 0.39       $ 0.385          
    Subsequent Event | DrWelch [Member] | 2019 Short Term Convertible Notes | Tranche Two [Member]                    
    Subsequent Event [Line Items]                    
    Convertible note, aggregate principal               $ 1,000,000    
    Subsequent Event | DrWelch [Member] | Convertible Promissory Notes                    
    Subsequent Event [Line Items]                    
    Warrants to purchase common shares, shares               1,000,000    
    Convertible note, aggregate principal               $ 1,075,343    
    Subsequent Event | DrWelch [Member] | Two Thousand Twelve Stock Incentive Plan [Member]                    
    Subsequent Event [Line Items]                    
    Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price         250,000          
    Subsequent Event | Subscription Agreement [Member]                    
    Subsequent Event [Line Items]                    
    Class of warrants, exercise price       $ 0.45            
    Number of shares to be sold   1,382,500   2,330,000            
    Term of warrants       5 years            
    Warrants to purchase common shares, shares       1,165,000            
    Purchase price, per share   $ 0.40   $ 0.40            
    Proceeds from issuance of common shares       $ 900,000            
    Subsequent Event | 2019 Subscription Agreement                    
    Subsequent Event [Line Items]                    
    Class of warrants, exercise price   $ 0.45                
    Term of warrants   5 years                
    Warrants to purchase common shares, shares   691,250                
    Proceeds from issuance of common shares   $ 600,000                
    Subsequent Event | Convertible Notes Payable                    
    Subsequent Event [Line Items]                    
    Outstanding balance of convertible note including accrued unpaid interest     $ 3,500,000              
    Convertible note, redeemed amount     $ 175,000     $ 175,000        
    Common stock issuance for redemption of covertible note     1,116,340              
    Subsequent Event | Consultant [Member]                    
    Subsequent Event [Line Items]                    
    Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price         200,000          
    Stock option vested, Shares 200,000                  
    Stock option granted, exercise price         $ 0.385          
    Subsequent Event | Consultant [Member] | Share-based Compensation Award, Tranche One [Member]                    
    Subsequent Event [Line Items]                    
    Stock option vested, Shares         100,000          
    Subsequent Event | Consultant [Member] | Share-based Compensation Award, Tranche Two [Member]                    
    Subsequent Event [Line Items]                    
    Stock options, term         10 years          
    Stock option vested, Shares         100,000          
    Subsequent Event | Consultants And Employees [Member]                    
    Subsequent Event [Line Items]                    
    Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Exercise Price 1,062,500                  
    Stock option granted, exercise price $ 0.39                  
    Subsequent Event | Employees [Member]                    
    Subsequent Event [Line Items]                    
    Stock option vested, Shares 862,500                  
    XML 69 R2.htm IDEA: XBRL DOCUMENT v3.19.3
    Consolidated Balance Sheets
    Aug. 31, 2019
    USD ($)
    May 31, 2019
    USD ($)
    Current assets:    
    Cash $ 1,795,822 $ 2,612,910
    Restricted Cash 0 853,599
    Miscellaneous Receivables 5,213 90,824
    Prepaid expenses 272,581 107,211
    Prepaid service fees 1,126,382 1,704,876
    Total current assets 3,199,998 5,369,420
    Operating lease right-of-use assets 208,255 0
    Property, plant and equipment 31,278 29,251
    Intangibles, net 14,947,122 15,475,454
    Total assets 18,386,653 20,874,125
    Current liabilities:    
    Accounts payable 12,048,474 16,239,434
    Accrued liabilities and compensation 1,444,429 1,588,552
    Accrued license fees 382,700 208,600
    Accrued interest on convertible notes 350,400 212,777
    Convertible notes payable, net 4,900,247 3,586,035
    Current portion of operating leases payable 106,827 0
    Current portion of long term convertible notes payable 3,685,351 4,200,000
    Warrant tender offer proceeds held in trust 0 853,599
    Total current liabilities 23,066,607 26,926,348
    Long-term liabilities:    
    Convertible notes payable, net 230,614 454,568
    Operating lease liability 102,091 0
    Derivative liability 1,781,936 2,407,269
    Total long-term liabilities 2,114,641 2,861,837
    Total liabilities 25,181,248 29,788,185
    Commitments and Contingencies 0 0
    Stockholders' (Deficit) Equity    
    Common stock, $0.001 par value; 700,000,000 shares authorized, 383,584,367 and 329,554,763 issued and 383,425,356 and 329,395,752 outstanding at August 31, 2019 and May 31, 2019, respectively 383,586 329,555
    Additional paid-in capital 238,460,113 220,119,856
    Accumulated (deficit) (245,638,232) (229,363,407)
    Less: treasury stock, at par (159,011 shares at $0.001) (159) (159)
    Total stockholders' (deficit) (6,794,595) (8,914,060)
    Total liabilities and stockholders' (deficit) equity 18,386,653 20,874,125
    Series B Convertible Preferred Stock    
    Stockholders' (Deficit) Equity    
    Preferred Stock Value 92 92
    Series C Convertible Preferred Stock    
    Current liabilities:    
    Accrued dividends on Series C Preferred Stock 148,179 37,351
    Stockholders' (Deficit) Equity    
    Preferred Stock Value $ 5 $ 3
    XML 70 R6.htm IDEA: XBRL DOCUMENT v3.19.3
    Consolidated Statement of Changes in Stockholders' (Deficit) Equity - USD ($)
    Total
    Preferred Stock [Member]
    Common Stock [Member]
    Treasury Stock [Member]
    Additional Paid-in Capital [Member]
    Accumulated Deficit [Member]
    Beginning balance at May. 31, 2018 $ (13,157,971) $ 92 $ 216,881 $ (159) $ 159,764,611 $ (173,139,396)
    Beginning balance, shares at May. 31, 2018   92,100 216,881,790 159,011    
    Proceeds from registered direct offering 985,000 $ 0 $ 1,970 $ 0 983,030 0
    Proceeds from registered direct offering, shares   0 1,970,000 0    
    Offering costs related to registered direct offering, value 0          
    Proceeds from private equity offering 7,514,300 $ 0 $ 15,029 $ 0 7,499,271 0
    Proceeds from private equity offering, shares   0 15,028,600 0    
    Offering costs related to private equity offering (882,716) $ 0 $ 0 $ 0 (882,716)  
    Offering costs related to equity offering (75,151)       (75,151)  
    Legal fees in connection with equity offerings (50,544) 0 0 0 (50,544)  
    Stock-based compensation 283,346 0 0 0 283,346  
    Net loss (14,413,569) 0 0 0   (14,413,569)
    Ending balance at Aug. 31, 2018 (19,797,305) $ 92 $ 233,880 $ (159) 167,521,847 (187,552,965)
    Ending balance, shares at Aug. 31, 2018   92,100 233,880,390 159,011    
    Beginning balance at May. 31, 2019 (8,914,060) $ 95 $ 329,555 $ (159) 220,119,856 (229,363,407)
    Beginning balance, shares at May. 31, 2019   95,346 329,554,763 159,011    
    Issuance of stock payment shares   $ 0 $ 3,015 $ 0    
    Issuance of stock payment shares, shares   0 3,014,181 0    
    Issuance of stock for note payable redemption 1,005,000       1,001,985 0
    Proceeds from registered direct offering 2,255,800 $ 0 $ 5,640 $ 0 2,250,160 0
    Proceeds from registered direct offering, shares   0 5,639,500 0    
    Offering costs related to registered direct offering, value (260,208) $ 0 $ 0 $ 0 (260,208) 0
    Offering costs related to registered direct offering, shares   0 0 0    
    Proceeds from public warrant tender offers 11,900,260 $ 0 $ 45,376 $ 0 11,854,884 0
    Proceeds from public warrant tender offers (shares)   0 45,375,923 0    
    Inducement interest expense - public warrant tender offers 2,430,514 $ 0 $ 0 $ 0 2,430,514 0
    Proceeds from Series C Convertible Preferred offering 1,754,000 $ 2 0 0 1,753,998 0
    Proceeds from Series C Convertible Preferred offering, shares   1,754        
    Offering costs related to Series C Preffered offering (197,460) $ 0 0 0 (197,460) 0
    Dividends on Series C Convertible Preferred shares (110,826) 0 0 0 0 (110,826)
    Legal fees in connection with equity offerings (15,877) 0 0 0 (15,877) 0
    Offering costs related to public warrant tender offers (1,058,466) 0     (1,058,466) 0
    Stock-based compensation 580,727 0 0 0 580,727 0
    Net loss (16,163,999) 0 0 0 0 (16,163,999)
    Ending balance at Aug. 31, 2019 $ (6,794,595) $ 97 $ 383,586 $ (159) $ 238,460,113 $ (245,638,232)
    Ending balance, shares at Aug. 31, 2019   97,100 383,584,367 159,011