0001354488-15-005479.txt : 20151210 0001354488-15-005479.hdr.sgml : 20151210 20151210161632 ACCESSION NUMBER: 0001354488-15-005479 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20151031 FILED AS OF DATE: 20151210 DATE AS OF CHANGE: 20151210 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TENAX THERAPEUTICS, INC. CENTRAL INDEX KEY: 0000034956 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 262593535 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-34600 FILM NUMBER: 151281038 BUSINESS ADDRESS: STREET 1: ONE COPLEY PARKWAY STREET 2: SUITE 490 CITY: MORRISVILLE STATE: NC ZIP: 27560 BUSINESS PHONE: 919-806-4414 MAIL ADDRESS: STREET 1: ONE COPLEY PARKWAY STREET 2: SUITE 490 CITY: MORRISVILLE STATE: NC ZIP: 27560 FORMER COMPANY: FORMER CONFORMED NAME: OXYGEN BIOTHERAPEUTICS, INC. DATE OF NAME CHANGE: 20080703 FORMER COMPANY: FORMER CONFORMED NAME: SYNTHETIC BLOOD INTERNATIONAL INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: SINEQUANON CORP DATE OF NAME CHANGE: 19901219 10-Q 1 tenx_10q.htm QUARTERLY REPORT tenx_10q.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
 
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE QUARTERLY PERIOD ENDED October 31, 2015
 
OR
 
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE TRANSITION PERIOD FROM              TO              
 
Commission File Number 001-34600
 
TENAX THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
26-2593535
(State of incorporation)
 
(I.R.S. Employer Identification No.)
 
ONE Copley Parkway, Suite 490, Morrisville, North Carolina 27560
(Address of principal executive offices)
 
(919) 855-2100
(Registrant’s telephone number, including area code)
 
 
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   þ     No   ¨
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   þ     No   ¨
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large accelerated filer o
 
Accelerated filer þ
 
Non-accelerated filer o
 
Smaller reporting company o
       
(Do not check if a smaller reporting company)
   
 
Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act).    Yes   ¨     No   þ
 
As of December 8, 2015, the registrant had outstanding 28,119,694 shares of Common Stock.
 


 
 
 
 
 
TABLE OF CONTENTS
 
   
PAGE
PART I. FINANCIAL INFORMATION
 
     
3
     
 
3
     
 
4
     
 
5
     
 
7
     
17
     
26
     
26
     
PART II. OTHER INFORMATION
 
     
27
     
27
     
27
     
27
 
 
 
2

 
 
PART I - FINANCIAL INFORMATION
 
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 

CONDENSED CONSOLIDATED BALANCE SHEETS
 
   
October 31,
2015
   
April 30,
2015
 
   
(Unaudited)
       
ASSETS
           
Current assets
           
Cash and cash equivalents
  $ 5,099,183     $ 7,926,491  
Marketable securities
    16,584,777       9,200,082  
Accounts receivable
    86,271       76,475  
Prepaid expenses
    93,433       249,505  
Other current assets
    -       58,623  
Total current assets
    21,863,664       17,511,176  
Marketable securities
    19,176,661       30,974,961  
Property and equipment, net
    42,054       50,322  
Intangible assets, net
    22,000,000       22,000,000  
Goodwill
    11,265,100       11,265,100  
Other assets
    1,106,785       1,106,785  
Total assets
  $ 75,454,264     $ 82,908,344  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities
               
Accounts payable
  $ 521,232     $ 1,183,939  
Accrued liabilities
    2,538,659       2,660,666  
Warrant liabilities
    502,693       572,445  
Notes payable, net
    -       100,160  
Total current liabilities
    3,562,584       4,517,210  
Deferred tax liability
    7,962,100       7,962,100  
Total liabilities
    11,524,684       12,479,310  
                 
Commitments and contingencies; see Note 6
               
                 
Stockholders' equity
               
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,119,694 and 28,119,520,  respectively
    2,812       2,812  
Additional paid-in capital
    221,171,247       221,067,239  
Accumulated other comprehensive (loss)/gain
    (17,873 )     26,718  
Accumulated deficit
    (157,226,606 )     (150,667,735 )
Total stockholders’ equity
    63,929,580       70,429,034  
Total liabilities and stockholders' equity
  $ 75,454,264     $ 82,908,344  
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
 
 
3

 
 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
 
   
Three months ended October 31,
   
Six months ended October 31,
 
   
2015
   
2014
   
2015
   
2014
 
   
(Unaudited)
   
(Unaudited)
   
(Unaudited)
   
(Unaudited)
 
                         
Operating expenses
                       
General and administrative
  $ 1,230,618     $ 1,586,343     $ 2,599,222     $ 3,036,202  
Research and development
    2,518,588       2,556,852       4,264,489       3,523,365  
Total operating expenses
    3,749,206       4,143,195       6,863,711       6,559,567  
                                 
Net operating loss
    3,749,206       4,143,195       6,863,711       6,559,567  
                                 
Interest expense
    404       59       1,506       46,320  
Other income
    (225,238 )     (88,291 )     (306,346 )     (379,512 )
Net loss
  $ 3,524,372     $ 4,054,963     $ 6,558,871     $ 6,226,375  
                                 
Unrealized loss (gain) on marketable securities
    (21,283 )     (23,254 )     44,591       42,306  
Total comprehensive loss
  $ 3,503,089     $ 4,031,709     $ 6,603,462     $ 6,268,681  
                                 
Net loss per share, basic and diluted
  $ (0.13 )   $ (0.14 )   $ (0.23 )   $ (0.22 )
Weighted average number of common shares outstanding, basic and diluted
    28,119,609       28,107,395       28,119,565       28,037,204  
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
 
 
4

 
 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
   
Six months ended October 31,
 
   
2015
   
2014
 
   
(Unaudited)
   
(Unaudited)
 
             
CASH FLOWS FROM OPERATING ACTIVITIES
           
Net Loss
  $ (6,558,871 )   $ (6,226,375 )
Adjustments to reconcile net loss to net cash used in operating activities
               
Depreciation and amortization
    24,956       76,379  
Interest on debt instruments
    -       45,606  
Issuance and vesting of compensatory stock options and warrants
    103,437       142,207  
Issuance of common stock as compensation
    572       49,708  
Change in the fair value of warrants
    (69,752 )     (238,117 )
Amortization of premium on marketable securities
    534,626       237,147  
Changes in operating assets and liabilities
               
Accounts receivable, prepaid expenses and other assets
    204,899       (817,813 )
Accounts payable and accrued liabilities
    (784,714 )     1,836,433  
Net cash used in operating activities
    (6,544,847 )     (4,894,825 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES
               
Purchase of marketable securities
    (5,222,046 )     (41,655,184 )
Sale of marketable securities
    9,056,433       2,469,327  
Purchase of property and equipment
    (16,688 )     -  
Capitalization of patent costs and license rights
    -       (64,162 )
Net cash provided by (used in) investing activities
    3,817,699       (39,250,019 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES
               
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
    -       543,998  
Payments on notes - short-term
    (100,160 )     (363,569 )
Net cash (used in) provided by financing activities
    (100,160 )     180,429  
                 
Net change in cash and cash equivalents
    (2,827,308 )     (43,964,415 )
Cash and cash equivalents, beginning of period
    7,926,491       58,320,555  
Cash and cash equivalents, end of period
  $ 5,099,183     $ 14,356,140  
                 
Cash paid for:
               
Interest
  $ 1,507     $ 714  
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
 
 
5

 
 
TENAX THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS, Continued
(Unaudited)
 
Non-cash financing activities during the six months ended October 31, 2014:
 
(1)  
The Company issued 255 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $45.10 per share for the payment of $11,500 interest payable on convertible notes with a gross carrying value of $300,000.
 
 
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
 
 
6

 
 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
 
NOTE 1. DESCRIPTION OF BUSINESS
 
Tenax Therapeutics, Inc. (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008 by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics was the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted to one share of Oxygen Biotherapeutics common stock. On September 19, 2014, the Company changed its name to Tenax Therapeutics, Inc.
 
On October 18, 2013, the Company created a wholly owned subsidiary, Life Newco, Inc., a Delaware corporation (“Life Newco”), to acquire certain assets of Phyxius Pharma, Inc., a Delaware corporation (“Phyxius”) pursuant to an Asset Purchase Agreement, dated October 21, 2013 (the “Asset Purchase Agreement”), by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius (the “Phyxius Stockholders”). As further discussed in Note 6 below, on November 13, 2013, under the terms and subject to the conditions of the Asset Purchase Agreement, Life Newco acquired certain assets, including a license granting Life Newco an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada.
 
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation
 
The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at April 30, 2015 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended April 30, 2015. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. Operating results for the three and six month periods ended October 31, 2015 are not necessarily indicative of results for the full year or any other future periods. As such, it is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended April 30, 2015.
 
Use of Estimates
 
In preparing the unaudited condensed consolidated financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full fiscal year.
 
On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.
 
Principles of Consolidation
 
The accompanying condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc. and Life Newco, Inc. All material intercompany transactions and balances have been eliminated in consolidation.
 
 
7

 
 
Goodwill
 
Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired, including identifiable intangible assets, and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized.
 
Goodwill is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate potential impairment. The Company’s goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company assesses qualitative factors to determine if its sole reporting unit’s fair value is more likely than not to exceed its carrying value, including goodwill. In the event the Company determines that it is more likely than not that its reporting unit’s fair value is less than its carrying amount, quantitative testing is performed comparing recorded values to estimated fair values. If the fair value exceeds the carrying value, goodwill is not impaired. If the carrying value exceeds the fair value, an impairment charge is recognized through a charge to operations based upon the excess of the carrying value of goodwill over the implied fair value.  There was no impairment to goodwill recognized during the three and six months ended October 31, 2015.
 
Liquidity and Managements’ Plan
 
 
At October 31, 2015, the Company had cash and cash equivalents, including the fair value of its marketable securities, of approximately $40.9 million. The Company used $6.5 million of cash for operating activities during the six months ended October 31, 2015 and had stockholders’ equity of $63.9 million, versus $70.4 million at April 30, 2015. The Company expects that it has sufficient cash to manage the business through calendar year 2017, although this assumes that the Company does not accelerate the development of other opportunities that are available to the Company or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements.
 
 
Additional capital will likely be required to support the Company’s future commercialization activities, including the anticipated commercial launch of levosimendan for low cardiac output syndrome (“LCOS”), and the development of other products or indications which may be acquired or licensed by the Company, and general working capital requirements. Based on product development timelines the ability to scale up or reduce personnel and associated costs are factors considered throughout the product development life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Readers are cautioned that additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all.
 
 
To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates, or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.
 
Net Loss per Share
 
Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock and warrants.
 
The following outstanding options, warrants and restricted stock were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.
 
   
Six months ended October 31,
 
   
2015
   
2014
 
             
Options to purchase common stock
    3,777,698       3,694,407  
Warrants to purchase common stock
    2,728,236       2,553,236  
Restricted stock
    214       229  
 
 
8

 
 
Recent Accounting Pronouncements
 
In November 2015, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard that changes the balance sheet classifications of deferred income taxes. This standard amends existing guidance to require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.
 
In April 2015, the FASB issued a new accounting standard that changes the reporting of debt issuance costs. This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.
 
In May 2014, the FASB issued a new accounting standard that supersedes nearly all existing revenue recognition guidance under GAAP. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. In July 2015, the FASB agreed to defer the effective date of the standard from annual periods beginning after December 15, 2016, to annual periods beginning after December 15, 2017, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company has not yet selected a transition method and does not believe adoption of the standard will have a material impact on its condensed consolidated financial statements.
 
NOTE 3: FAIR VALUE
 
The Company records its financial assets and liabilities in accordance with the FASB Accounting Standards Codification (“ASC”) 820 Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities, short-term notes payable, and warrant liabilities. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments.
 
Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” The fair value measurement hierarchy consists of three levels:
 
Level one
Quoted market prices in active markets for identical assets or liabilities;
   
Level two
Inputs other than level one inputs that are either directly or indirectly observable, and
   
Level three
Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.
 
The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s condensed consolidated financial statements.
 
Investments in Marketable Securities
 
The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive income/(loss), unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Condensed Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At October 31, 2015, the Company believes that the costs of its investments are recoverable in all material respects.
 
 
9

 
 
The following table summarizes the fair value of the Company’s investments by type. The estimated fair value of the Company’s fixed income investments are classified as Level 2 in the fair value hierarchy as defined in U.S. GAAP. These fair values are obtained from independent pricing services which utilize Level 2 inputs:
 
   
October 31, 2015
 
   
Amortized Cost
   
Accrued Interest
   
Gross Unrealized Gains
   
Gross Unrealized losses
   
Estimated Fair Value
 
Corporate debt securities
  $ 35,482,306     $ 297,005     $ 3     $ (17,876 )   $ 35,761,438  
 
The following table summarizes the scheduled maturity for the Company’s investments at October 31, 2015 and April 30, 2015.
 
   
October 31,
2015
   
April 30,
2015
 
Maturing in one year or less
  $ 16,584,777     $ 9,200,082  
Maturing after one year through three years
    19,176,661       30,974,961  
Total investments
  $ 35,761,438     $ 40,175,043  
 
Warrant liability
 
On July 23, 2013, the Company issued common stock warrants in connection with the issuance of Series C 8% Preferred Stock (the “Series C Warrants”). These Series C Warrants contain certain “down-round” price protection clauses and in accordance with ASC 815-40-35-9, the Company classifies these warrants as a current liability and the subsequent changes in fair value are recorded as a component of other expense.
 
Financial assets or liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable. The Series C Warrants are measured using the Monte Carlo valuation model which is based, in part, upon inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions.  The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment.  As a result, if factors change and different assumptions are used, the warrant liabilities and the change in estimated fair value of the warrants could be materially different.
 
Inherent in the Monte Carlo valuation model are assumptions related to expected stock-price volatility, expected life, risk-free interest rate and dividend yield.  The Company estimates the volatility of its common stock based on historical volatility that matches the expected remaining life of the warrants.  The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants.  The expected life of the warrants is assumed to be equivalent to their remaining contractual term.  The dividend rate is based on the historical rate, which the Company anticipates to remain at zero.
 
The Monte Carlo model is used for the Series C Warrants to appropriately value the potential future exercise price adjustments triggered by the anti-dilution provisions. This requires Level 3 inputs which are based on the Company’s estimates of the probability and timing of potential future financings and fundamental transactions.  The other assumptions used by the Company are summarized in the following table for the Series C Warrants that were outstanding as of October 31, 2015 and April 30, 2015
 
Series C Warrants
 
October 31,
2015
   
April 30,
2015
 
Closing stock price
  $ 3.18     $ 3.42  
Expected dividend rate
    0 %     0 %
Expected stock price volatility
    82.09 %     83.53 %
Risk-free interest rate
    1.22 %     1.23 %
Expected life (years)
    3.73       4.23  
 
As of October 31, 2015, the fair value of the warrant liability was $502,693. The Company recorded a gain of $103,425 and $69,752 for the change in fair value as a component of other expense on the condensed consolidated statement of comprehensive loss for the three and six months ended October 31, 2015, respectively.
 
 
10

 
 
As of October 31, 2015, there were 240,523 Series C Warrants outstanding.
 
The following tables summarize information regarding assets and liabilities measured at fair value on a recurring basis as of October 31, 2015 and April 30, 2015:
 
         
Fair Value Measurements at Reporting Date Using
 
   
Balance as of October 31, 2015
   
Quoted prices in Active Markets for Identical Securities (Level 1)
   
Significant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Current Assets
                       
Cash and cash equivalents
  $ 5,099,183     $ 5,099,183     $ -     $ -  
Marketable securities
  $ 16,584,777     $ -     $ 16,584,777     $ -  
                                 
Long-term Assets
                               
Marketable securities
  $ 19,176,661     $ -     $ 19,176,661     $ -  
                                 
Current Liabilities
                               
Warrant liabilities
  $ 502,693     $ -     $ -     $ 502,693  
 
           
Fair Value Measurements at Reporting Date Using
 
   
Balance as of April 30, 2015
   
Quoted prices in Active Markets for Identical Securities (Level 1)
   
Significant Other Observable Inputs (Level 2)
   
Significant Unobservable Inputs (Level 3)
 
Current Assets
                               
Cash and cash equivalents
  $ 7,926,491     $ 7,926,491     $ -     $ -  
Marketable securities
  $ 9,200,082     $ -     $ 9,200,082     $ -  
                                 
Long-term Assets
                               
Marketable securities
  $ 30,974,961     $ -     $ 30,974,961     $ -  
                                 
Current Liabilities
                               
Warrant liabilities
  $ 572,445     $ -     $ -     $ 572,445  
 
There were no significant transfers between levels in the six months ended October 31, 2015.
 
NOTE 4. BALANCE SHEET COMPONENTS
 
Other current assets
 
Other current assets consist of the following as of October 31, 2015 and April 30, 2015:
 
   
October 31,
2015
   
April 30,
2015
 
R&D materials
  $ -     $ 29,479  
Other
    -       29,144  
    $ -     $ 58,623  
 
 
11

 
 
Property and equipment, net
 
Property and equipment consist of the following as of October 31, 2015 and April 30, 2015:
 
   
October 31,
2015
   
April 30,
2015
 
Laboratory equipment
  $ 514,214     $ 514,214  
Computer equipment and software
    139,984       123,295  
Office furniture and fixtures
    130,192       130,192  
      784,390       767,701  
Less: Accumulated depreciation
    (742,336 )     (717,379 )
    $ 42,054     $ 50,322  
 
Depreciation and amortization expense was approximately $12,000 and $21,000 for the three months ended October 31, 2015 and 2014, and $25,000 and $43,000 for the six months ended October 31, 2015 and 2014, respectively.
 
Accrued liabilities
 
Accrued liabilities consist of the following as of October 31, 2015 and April 30, 2015:
 
   
October 31,
2015
   
April 30,
2015
 
Operating costs
  $ 2,456,738     $ 2,053,597  
Employee related
    81,921       596,137  
Restructuring liability
    -       10,932  
    $ 2,538,659     $ 2,660,666  
 
NOTE 5. INTANGIBLE ASSETS
 
The following table summarizes the Company’s intangible assets as of October 31, 2015:
 
Asset Category
 
Weighted Average Amortization Period (in Years)
   
Value Assigned
   
Accumulated Amortization
   
Impairments
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
IPR&D
    N/A       22,000,000       -       -       22,000,000  
Total
          $ 22,000,000             $ -     $ 22,000,000  
 
The following table summarizes the Company’s intangible assets as of April 30, 2015:
 
Asset Category
 
Weighted Average Amortization Period (in Years)
   
Value Assigned
   
Accumulated Amortization
   
Impairments
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
IPR&D
    N/A     $ 22,000,000     $ -     $ -     $ 22,000,000  
Patents
    10.3       806,771       (327,476 )     (479,295 )     -  
License Rights
    13.6       630,666       (181,484 )     (449,182 )     -  
Trademarks
    N/A       106,386               (106,386 )     -  
Total
          $ 23,543,823             $ (1,034,863 )   $ 22,000,000  
 
12

 
 
The aggregate amortization expense on the above intangibles was approximately $0 and $17,000, for the three months ended October 31, 2015 and 2014, respectively, and $0 and $34,000, for the six months ended October 31, 2015 and 2014, respectively.
 
In Process Research and Development
 
The levosimendan product in Phase III clinical trial represents an in process research and development (“IPR&D”) asset. The IPR&D asset is a research and development project rather than a product or process already in service or being sold. Research and development intangible assets are considered indefinite-lived until the abandonment or completion of the associated research and development efforts. If abandoned, the assets would be impaired. Research and development expenditures that are incurred after the acquisition, including those for completing the research and development activities related to the acquired intangible research and development assets, are generally expensed as incurred.
 
Patents and License Rights
 
The Company previously held, had filed for, or owned exclusive rights to, U.S. and worldwide patents covering 9 various methods and uses of its perfluorocarbon (“PFC”) technology. It capitalized amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its patent applications. These capitalized costs were amortized on a straight-line method over their useful life or legal life, whichever was shorter.
 
During the fourth quarter of fiscal year 2015, the Company completed its annual impairment test of its patents and license rights. The Company wrote-off approximately $929,000 of capitalized costs for patent applications that were withdrawn or abandoned during the year ended April 30, 2015. These asset impairment charges primarily related to the Company’s PFC formulations which were determined not to be a core component of the Company’s development strategy.
 
The Company capitalized patent costs of approximately $0 and $64,000, for the six months ended October 31, 2015 and 2014, respectively.
 
Trademarks
 
The Company currently holds, or has filed for, trademarks to protect the use of names and descriptions of its products and technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its trademark applications. These trademarks are evaluated annually for impairment in accordance with ASC 350, Intangibles – Goodwill and Other. The Company evaluates (i) its expected use of the underlying asset, (ii) any laws, regulations, or contracts that may limit the useful life, (iii) the effects of obsolescence, demand, competition, and stability of the industry, and (iv) the level of costs to be incurred to commercialize the underlying asset.
 
The Company wrote-off trademark costs of approximately $106,000 for the year ended April 30, 2015. These asset impairment charges primarily related to the Company’s PFC formulations which were determined not to be a core component of the Company’s development strategy.
 
The Company did not capitalize any trademark costs for the six months ended October 31, 2015 and 2014.
 
NOTE 6. COMMITMENTS AND CONTINGENCIES
 
Simdax license agreement
 
On November 13, 2013, the Company acquired, through its wholly owned subsidiary, Life Newco, that certain License Agreement (the “License”), dated September 20, 2013 by and between Phyxius and Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”), and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion, The License grants the Company an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan (the “Product”) in the United States and Canada (the “Territory”) from Orion.  Pursuant to the License, the Company must use Orion’s “Simdax®” trademark to commercialize the Product.  The License also grants to the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication.  Orion’s ongoing role under the License includes sublicense approval, serving as the sole source of manufacture, holding a first right to enforce intellectual property rights in the Territory, and certain regulatory participation rights.  Additionally, the Company must grant back to Orion a broad non-exclusive license to any patents or clinical trial data related to the Product developed by the Company under the License.  The License has a fifteen (15) year term, provided, however, that the License will continue after the end of the fifteen year term in each country in the Territory until the expiration of Orion’s patent rights in the Product in such country.  
 
Pursuant to the terms of the License, the Company paid to Orion a non-refundable up-front payment in the amount of $1.0 million.  The License also includes the following development milestones for which the Company shall make non-refundable payments to Orion no later than twenty-eight (28) days after the occurrence of the applicable milestone event: (i) $2.0 million upon the grant of FDA approval, including all registrations, licenses, authorizations and necessary approvals, to develop and/or commercialize the Product in the United States; and (ii) $1.0 million upon the grant of regulatory approval for the Product in Canada. Once commercialized, the Company is obligated to make certain non-refundable commercialization milestone payments to Orion, aggregating up to $13.0 million, contingent upon achievement of certain cumulative net sales amounts in the Territory.  The Company must also pay Orion tiered royalties based on net sales of the Product in the Territory made by the Company and its sublicensees. After the end of the Term, the Company must pay Orion a royalty based on net sales of the Product in the Territory for as long as Life Newco sells the Product in the Territory.
 
 
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As of October 31, 2015, the Company has not met any of the developmental milestones and, accordingly, has not recorded any liability for the contingent payments due to Orion.
 
Agreement with Virginia Commonwealth University
 
In May 2008 the Company entered into a license agreement with Virginia Commonwealth University (“VCU”) whereby it obtained a worldwide, exclusive license to valid claims under three of the VCU's patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license included the right to sub-license to third parties. The term of the agreement was the life of the patents covered by the patent applications unless the Company elected to terminate the agreement prior to patent expiration.  Under the agreement the Company had an obligation to diligently pursue product development and pursue, at its own expense, prosecution of the patent applications covered by the agreement. As part of the agreement, the Company was required to pay to VCU non-refundable payments upon achieving development and regulatory milestones. Prior to termination of the license agreement, as discussed below, the Company had not met any of the developmental milestones.
 
The agreement with VCU also required the Company to pay royalties to VCU at specified rates based on annual net sales derived from the licensed technology. Pursuant to the agreement, the Company was required make minimum annual royalty payments to VCU totaling $70,000 as long as the agreement is in force. These payments were fully creditable against royalty payments due for sales and sublicense revenue earned during the fiscal year as described above. In the prior year, this fee was recorded as an other current asset and was amortized over the fiscal year. Amortization expense was approximately $0 and $17,500 for the three months ended October 31, 2015 and 2014; and $0 and $35,000 for the six months ended October 31, 2015 and 2014, respectively.
 
In September 2014, the Company discontinued the development of its PFC product candidates.  As part of this change in business strategy, on May 5, 2015 the Company provided VCU its 90 day notice terminating the license agreement entered into with VCU. The license agreement gave the Company exclusive rights to intellectual property that was used for the development and commercialization of its PFC product candidates and was therefore no longer needed.
 
NOTE 7. STOCKHOLDERS’ EQUITY
 
Preferred Stock
 
Under the Company’s Certificate of Incorporation, the Board of Directors is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. As of October 31, 2015, no shares of preferred stock are designated, issued or outstanding.
 
Common Stock
 
The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of October 31, 2015, there were 28,119,694 shares of common stock issued and outstanding.
 
Warrants
 
As of October 31, 2015, the Company has 2,728,236 warrants outstanding. During the six months ended October 31, 2015, no warrants were issued, exercised, or cancelled.
 
1999 Amended Stock Plan
 
In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “Plan”). Under the Plan, with the approval of the Compensation Committee of the Board of Directors, the Company may grant stock options, restricted stock, stock appreciation rights and new shares of common stock upon exercise of stock options. On March 13, 2014, the Company’s stockholders approved an amendment to the Plan which increased the number of shares of common stock authorized for issuance to a total of 4,000,000 shares, up from 300,000 previously authorized. On September 15, 2015, the Company’s stockholders approved an additional amendment to the Plan which increased the number of shares of common stock authorized for issuance to a total of 5,000,000 shares, up from 4,000,000 previously authorized. As of October 31, 2015 the Company had 1,224,893 shares of common stock available for grant under the Plan.
 
 
14

 
 
The following table summarizes the shares available for grant under the Plan for the six months ended October 31, 2015:
 
   
Shares Available for Grant
 
Balances, at April 30, 2015
    122,399  
Additional shares reserved
    1,187,192  
Options granted
    (85,050 )
Options cancelled/forfeited
    650  
Restricted stock granted
    (430 )
Restricted stock cancelled/forfeited
    132  
Balances, at October 31, 2015
    1,224,893  

Plan Stock Options
 
Stock options granted under the Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the Plan may be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.
 
The following table summarizes the outstanding stock options under the Plan for the six months ended October 31, 2015:
 
   
Outstanding Options
 
   
Number of Shares
   
Weighted Average Exercise Price
 
Balances, at April 30, 2015
    3,693,298     $ 5.70  
Options granted
    85,050     $ 3.48  
Options cancelled
    (650 )   $ 35.09  
Balances, at October 31, 2015
    3,777,698     $ 5.65  
 
The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.
 
The Company recorded compensation expense for these stock options grants of $59,440 and $103,437 for the three and six months ended October 31, 2015, respectively.
 
As of October 31, 2015, there were unrecognized compensation costs of approximately $166,000 related to non-vested stock option awards that will be recognized on a straight-line basis over the weighted average remaining vesting period of 0.76 year. Additionally, there were unrecognized compensation costs of approximately $7.9 million related to non-vested stock option awards subject to performance-based vesting milestones with a weighted average remaining life of 4.4 years. As of October 31, 2015, none of these milestones have been achieved.
 
The Company used the following assumptions to estimate the fair value of options granted under its stock option plans for the six months ended October 31, 2015 and 2014:
 
   
For the six months ended October 31,
 
   
2015
   
2014
 
Risk-free interest rate (weighted average)
    1.87 %     2.23 %
Expected volatility (weighted average)
    87.45 %     98.43 %
Expected term (in years)
    7       7  
Expected dividend yield
    0.00 %     0.00 %
 
 
15

 
 
Risk-Free Interest Rate
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
   
Expected Volatility
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
   
Expected Term
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience with its stock option grants.
   
Expected Dividend Yield
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.
   
Forfeitures
Stock compensation expense recognized in the statements of operations for the six months ended October 31, 2015 and 2014 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
 
Inducement Stock Options
 
On February 15, 2015, an employment inducement stock option award for 25,000 shares of common stock made to the Company’s chief medical officer. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by NASDAQ Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest over a three year period, with one-third vesting per year, beginning one year from the grant date. The options have a 10-year term and an exercise price of $3.22 per share, the February 13, 2015 closing price of the Company’s common stock.
 
Inducement stock option compensation expense was approximately $9,830 and $0 for the three months ended October 31, 2015 and 2014, and $19,660 and $0 for the six months ended October 31, 2015 and 2014, respectively.
 
At October 31, 2015, there was $34,853 of remaining unrecognized compensation expense related to the inducement stock options. Inducement stock options outstanding as of October 31, 2015 had a weighted average remaining contractual life of 9.30 years.
 
The estimated weighted average fair value per inducement option share granted was $64,343 in 2015 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: weighted average risk-free interest rate of 1.84%, dividend yield of 0%, volatility factor for the Company’s common stock of 93.90% and a weighted average expected life of 7 years for inducement options not forfeited.
 
Restricted Stock Grants
 
The following table summarizes the restricted stock grants under the Plan for the six months ended October 31, 2015.
 
   
Outstanding Restricted Stock Grants
 
   
Number of Shares
 
Weighted Average Grant Date Fair Value
Balances, at April 30, 2015
    90     $ 4.01  
Restricted stock granted
    430     $ 3.42  
Restricted stock vested
    (174 )   $ 3.61  
Restricted stock cancelled
    (132 )   $ 3.57  
Balances, at October 31, 2015
    214     $ 3.42  
 
The Company recorded compensation expense for these restricted stock grants of $548 and $1,096 for the three and six months ended October 31, 2015, respectively.
 
As of October 31, 2015, there were unrecognized compensation costs of approximately $700 related to the non-vested restricted stock grants that will be recognized on a straight-line basis over the remaining vesting period of 0.5 years.
 
 
16

 
 
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to them. In some cases you can identify forward-looking statements by words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Examples of these statements include, but are not limited to, statements regarding: the implications of interim or final results of our clinical trials, the progress of our research programs, including clinical testing, the extent to which our issued and pending patents may protect our products and technology, our ability to identify new product candidates, the potential of such product candidates to lead to the development of commercial products, our anticipated timing for initiation or completion of our clinical trials for any of our product candidates, our future operating expenses, our future losses, our future expenditures for research and development, and the sufficiency of our cash resources. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us and described in Part II, Item 1A of this Quarterly Report on Form 10-Q, Part I, Item 1A of our Annual Report on Form 10-K, and our other filings with the Securities and Exchange Commission, or SEC. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from those we expect. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise.
 
The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with the audited consolidated financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended April 30, 2015.
 
All references in this Quarterly Report to “Tenax Therapeutics”, “we”, “our” and “us” means Tenax Therapeutics, Inc.
 
Overview
 
Strategy
 
We are a specialty pharmaceutical company focused on identifying, developing and commercializing drugs for critical care patients. Our principal business objective is to acquire or discover, develop, and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and commercial opportunity. Our lead product is levosimendan, which was acquired in an asset purchase agreement with Phyxius Pharma, Inc., or Phyxius. Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. The treatment is currently approved in more than 60 countries for this indication. The United States Food and Drug Administration, or FDA, has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome, or LCOS. In addition, the FDA has agreed to the Phase III protocol design under Special Protocol Assessment, or SPA, and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
 
We had been developing Oxycyte®, a systemic perfluorocarbon, or PFC, product we believe is a safe and effective oxygen carrier for use in situations of acute ischemia. However, on September 11, 2014, our Board of Directors determined to stop the Phase II-b trial for the treatment of traumatic brain injury, or TBI, and consider strategic alternatives for the program moving forward. There are no assurances about the availability, on favorable terms or at all, of strategic alternatives for the continued development of the Oxycyte program.
 
Our current strategy is to:
 
●  
Efficiently conduct clinical development to establish clinical proof of concept with our lead product candidates;
 
●  
Efficiently explore new high-potential therapeutic applications, leveraging third-party research collaborations and our results from related areas;
 
●  
Continue to expand our intellectual property portfolio; and
 
●  
Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas.
 
 
17

 
 
We believe that this strategy will allow us to develop a portfolio of high quality product development opportunities, expand our clinical development and commercialization capabilities, and enhance our ability to generate value from our proprietary technologies
 
Second Quarter 2016 Highlights
 
The following summarizes certain key financial measures for the three months ended October 31, 2015:
 
●  
Cash and cash equivalents, including the fair-value of our marketable securities, were $40.9 million at October 31, 2015.
 
●  
Our loss from operations was $3.5 million for the second quarter of fiscal 2016 compared to $4.0 million for the three months ended October 31, 2014.
 
●  
Net cash used in operating activities was $2.7 million and $2.9 million for the three months ended October 31, 2015 and 2014, respectively.
 
Consistent with our strategy as of December 8, 2015, (i) we have activated 72 sites in the U.S. and Canada to enroll patients in our Phase III LCOS clinical trial, (ii) we have enrolled 295 patients of the planned 760 patients in our Phase III LCOS clinical trial, and (iii) the Imperial College London has enrolled 506 of the planned 516 patients in the ongoing Phase II-B Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS) clinical trial.
 
Opportunities and Trends
 
We initiated the Phase III trial for levosimendan and activated the initial sites in the three months ended July 31, 2014. Duke University’s Duke Clinical Research Institute, or DCRI, is conducting the Phase III trial. DCRI is the world’s largest academic clinical research organization, or CRO, with substantial experience in conducting cardiac surgery trials. The DCRI is serving as the coordinating center and Drs. John H. Alexander and Rajendra Mehta are serving as lead investigators for this trial.
 
The Phase III trial is being conducted in approximately 60 targeted major cardiac surgery centers in North America.  The trial is enrolling patients undergoing coronary artery bypass graphs and/or mitral valve surgery who are at risk for developing LCOS.  The trial is a double blind, randomized, placebo controlled study enrolling 760 patients. We enrolled our first patient on September 18, 2014, and we anticipate enrollment will continue through the second half of calendar year 2016.
 
As we focus on the development of our existing products and product candidates, we also continue to position ourselves to execute upon licensing and other partnering opportunities. In order to do so, we will need to continue to maintain our strategic direction, manage and deploy our available cash efficiently and strengthen our collaborative research development and partner relationships.
 
During the remainder of calendar year 2015 and into calendar year 2016, we are focused on the following four key initiatives:
 
●  
Conducting well-designed studies early in the clinical development process to establish a robust foundation for subsequent development, partnership and expansion into complementary areas;
 
●  
Working with collaborators and partners to accelerate product development, reduce our development costs, and broaden our commercialization capabilities;
 
●  
Gaining regulatory approval for the continued development and commercialization of our products in the United States; and
 
●  
Developing new intellectual property to enable us to file patent applications that cover new applications of our existing technologies and product candidates.
 
Critical Accounting Policies and Significant Judgments and Estimates
 
There have been no significant changes in critical accounting policies, as compared to the critical accounting policies described in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Summary of Significant Accounting Policies” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2015.
 
 
18

 
 
Financial Overview
 
Results of Operations- Comparison of the Three Months Ended October 31, 2015 and 2014
 
General and Administrative Expenses
 
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the three months ended October 31, 2015 and 2014, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
   
% Increase/
 
   
2015
   
2014
    (Decrease)     (Decrease)  
Personnel costs
  $ 543,542     $ 756,310     $ (212,768 )     (28 ) %
Legal and professional fees
    420,097       595,600       (175,503 )     (29 ) %
Other costs
    221,415       162,257       59,158       36 %
Facilities
    36,522       42,852       (6,330 )     (15 ) %
Depreciation and amortization
    9,042       29,324       (20,282 )     (69 ) %
 
Personnel costs:
 
Personnel costs decreased approximately $213,000 for the three months ended October 31, 2015 compared to the same period in the prior year. This decrease was due primarily to accrued severance payments recorded in the same period of the prior year.
 
Legal and professional fees:
 
Legal and professional fees consist of the costs incurred for legal fees, accounting fees, consulting fees, recruiting costs and investor relations services, as well as fees paid to our Board of Directors. Legal and professional fees decreased approximately $176,000 for the three months ended October 31, 2015 compared to the same period in the prior year. This decrease was primarily due to a reduction in costs incurred for investor relations services and the vested value of stock option grants to our Board of Directors.
 
-  
Costs associated with investor relations and communication decreased approximately $126,000 in the current period. This decrease was due primarily to fees paid in the prior year to a third party investor relations firm that is no longer providing marketing and corporate communications services to us in the current period.
 
-  
Board of Directors fees decreased in the current period by approximately $24,000. This decrease was due primarily to a reduction in the recognized expense for the vesting of stock options awarded in the current period as compared to the recognized expense for stock options awarded in the same period of the prior year.
 
-  
Consulting costs, legal fees, capital market costs and accounting fees all decreased slightly which resulted in an overall decrease of approximately $26,000 in the current period as compared to the same period of the prior year.
 
Other costs:
 
Other costs include costs incurred for banking fees, travel, supplies, insurance and other miscellaneous charges. The approximately $59,000 increase in other costs for the three months ended October 31, 2015 was due primarily to an approximately $70,000 increase in franchise taxes paid and approximately $20,000 in costs incurred for our sponsorship of the National Sepsis Foundation, partially offset by a reduction of approximately $31,000 in employee relocation costs as compared to the same period in the prior year.
 
Facilities:
 
Facilities expenses include costs paid for rent and utilities at our corporate headquarters in North Carolina. Facilities costs remained relatively consistent for the three months ended October 31, 2015 and 2014.
 
Depreciation and Amortization:
 
Depreciation and amortization costs decreased approximately $20,000 for the three months ended October 31, 2015 compared to the same period in the prior year. The decrease in costs was due primarily to amortization costs incurred in the same period of the prior year on our PFC-based intellectual property portfolio that was fully impaired as of April 30, 2015.
 
 
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Research and Development Expenses
 
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three months ended October 31, 2015 and 2014, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
   
% Increase/
 
   
2015
   
2014
    (Decrease)     (Decrease)  
Clinical and preclinical development
  $ 2,163,688     $ 2,383,710     $ (220,022 )     (9 ) %
Consulting
    202,013       10,699       191,314       1788 %
Personnel costs
    140,883       149,613       (8,730 )     (6 ) %
Other costs
    12,004       12,830       (826 )     (6 ) %
 
Clinical and preclinical development:
 
Clinical and preclinical development costs include, primarily, the costs associated with our Phase III clinical trial for levosimendan and, in previous years, a Phase II clinical trial and preclinical trials for Oxycyte. The decrease of approximately $220,000 in clinical and preclinical development costs for the three months ended October 31, 2015, compared to the same period in the prior year, was primarily due to increased expenditures for CRO costs to manage the Levo-CTS Phase III clinical trial, offset by a reduction of approximately $500,000 in costs to support the LeoPARDS trial for septic shock in the prior period and a reduction in costs incurred in the current period for the development and clinical testing of Oxycyte, which development we decided to suspend in the prior year.
 
Levosimendan
 
We incurred approximately $2.2 million in research and development costs for levosimendan during the three months ended October 31, 2015, an increase of approximately $415,000 compared to the same period in the prior year. The increase in levosimendan development costs is due primarily to the direct costs of our Phase III Levo-CTS clinical trial for LCOS, partially offset by a reduction of approximately $500,000 in costs to support the LeoPARDS trial for septic shock that was conducted during the same period of the prior year. For the three months ended October 31, 2015, we recorded CRO costs of approximately $2.1 million for the management of the Phase III trial which includes approximately $903,000 in pass-through site activation and enrolled patient costs, compared to CRO costs of approximately $1.2 million during the same period in the prior year.
 
Oxycyte
 
We incurred approximately $12,000 in research and development costs for Oxycyte during the three months ended October 31, 2015, a decrease of approximately $635,000 compared to the same period in the prior year. The decrease in Oxycyte development costs was due to our decision to suspend development of the Oxycyte product in the prior year and close out all of our sites for the Phase II-B clinical trial for TBI. We do not anticipate any significant additional costs in the future related to this clinical trial or other close-out activities related to the discontinuance of the Oxycyte product development.
 
Consulting fees:
 
Consulting fees increased approximately $191,000 for the three months ended October 31, 2015 compared to the same period in the prior year, primarily due to an increase in fees paid to a third party consulting firm for services provided to improve training and communication with active sites in support of our Phase III Levo-CTS clinical trial.
 
Personnel costs:
 
Personnel costs decreased approximately $9,000 for the three months ended October 31, 2015 compared to the same period in the prior year, primarily due to headcount reductions in positions responsible for the development of our Oxycyte products as compared to the same period in the prior year.
 
Other costs:
 
Other costs remained relatively consistent for the three months ended October 31, 2015 and 2014.
 
Conducting a significant amount of research and development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of clinical trials. We plan to incur substantial research and development expenses for the foreseeable future in order to complete development of our most advanced product candidate, levosimendan, and to continue with the development of other potential product candidates.
 
 
20

 
 
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the FDA is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our most advanced product candidate, levosimendan; however, we will need substantial additional capital in the future in order to complete the development and potential commercialization of levosimendan, and to continue with the development of other potential product candidates.
 
Other income and expense
 
Other income and expense includes non-operating income and expense items not otherwise recorded in our condensed consolidated statement of comprehensive loss. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, changes in the fair value of financial assets and derivative liabilities, interest income earned and fixed asset disposals. Other income for the three months ended October 31, 2015 and 2014, respectively, is as follows:
 
   
Three months ended October 31,
   
(Increase)/
 
   
2015
   
2014
    Decrease  
Other income, net
  $ (225,238 )   $ (88,291 )   $ (136,947 )
 
Other income increased approximately $137,000 for the three months ended October 31, 2015 compared to the same period in the prior year. This increase is due to primarily to change in fair value of our Series C warrant derivative liability in the current period.
 
During the three months ended October 31, 2015, we recorded a derivative gain of approximately $104,000 which compared to a derivative loss of approximately $36,000 for the same period in the prior year. These charges to income are derived from the free standing Series C warrants which are measured at their fair market value each period using the Monte Carlo simulation model.
 
During the three months ended October 31, 2015, we recorded interest income of approximately $117,000 from our investments in marketable securities. This income is derived from approximately $369,000 in bond interest paid, partially offset by approximately $254,000 in charges for amortization of premiums paid and fair-value adjustments measured each period, which compares to approximately $340,000 in bond interest paid, partially offset by approximately $216,000 in charges for amortization of premiums paid and fair-value adjustments during the same period in the prior year.
 
 
Results of Operations- Comparison of the Six Months Ended October 31, 2015 and 2014
 
General and Administrative Expenses
 
General and administrative expenses and percentage changes for the six months ended October 31, 2015 and 2014, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/
   
% Increase/
 
   
2015
   
2014
    (Decrease)     (Decrease)  
Personnel costs
  $ 1,180,568     $ 1,318,512     $ (137,944 )     (10 ) %
Legal and professional fees
    894,270       1,288,699       (394,429 )     (31 ) %
Other costs
    427,601       286,955       140,646       49 %
Facilities
    78,425       82,817       (4,392 )     (5 ) %
Depreciation and amortization
    18,358       59,219       (40,861 )     (69 ) %
 
Personnel costs:
 
Personnel costs decreased approximately $138,000 for the six months ended October 31, 2015 compared to the same period in the prior year. The decrease was due primarily a $215,000 accrual for severance payments during the six months ended October 31, 2014 due to certain employees following the stoppage of the TBI trials, partially offset by an overall increase of approximately $52,000 and $27,000 in salaries and benefits paid during the current period.
 
 
21

 
 
Legal and professional fees:
 
Legal and professional fees decreased approximately $394,000 for the six months ended October 31, 2015 compared to the same period in the prior year. This decrease was primarily due to a reduction in costs incurred for investor relations services and the vested value of stock option grants to our Board of Directors.
 
●  
Costs associated with investor relations and communication decreased approximately $339,000 in the current period. This decrease was due primarily to fees paid in the prior year to a third party investor relations firm that is no longer providing marketing and corporate communications services to us in the current period.
 
●  
Board of Directors fees decreased in the current period by approximately $54,000. This decrease was due primarily to a reduction in the recognized expense for the vesting of stock options awarded in the current period as compared to the recognized expense for stock options awarded in the same period of the prior year.
 
Other costs:
 
The approximately $141,000 increase in other costs for the six months ended October 31, 2015 was due primarily to an approximately $132,000 increase in franchise taxes paid, approximately $20,000 in costs incurred for our sponsorship of the National Sepsis Foundation and approximately $18,000 in proxy-related data services, partially offset by a reduction of approximately $31,000 in employee relocation costs as compared to the same period in the prior year.
 
Facilities:
 
Facilities costs remained relatively consistent for the six months ended October 31, 2015 and 2014.
 
Depreciation and Amortization:
 
Depreciation and amortization costs decreased approximately $41,000 for the six months ended October 31, 2015 compared to the same period in the prior year. The decrease in costs was due primarily to amortization costs incurred in the same period of the prior year on our PFC-based intellectual property portfolio that was fully impaired as of April 30, 2015.
 
Research and Development Expenses
 
Research and development expenses and percentage changes for the six months ended October 31, 2015 and 2014, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/
   
% Increase/
 
   
2015
   
2014
    (Decrease)      (Decrease)  
Clinical and preclinical development
  $ 3,703,823     $ 3,161,726     $ 542,097       17 %
Consulting
    269,981       14,931       255,050       1708 %
Personnel costs
    267,046       308,175       (41,129 )     (13 ) %
Other costs
    23,639       38,533       (14,894 )     (39 ) %
 
Clinical and preclinical development:
 
The increase of approximately $542,000 in clinical and preclinical development costs for the six months ended October 31, 2015, compared to the same period in the prior year, was primarily due to increased expenditures for CRO costs to manage the Levo-CTS Phase III clinical trial, partially offset by reduction of approximately $500,000 in costs to support the LeoPARDS trial for septic shock in the prior period and a reduction in costs incurred in the current period for the development and clinical testing of Oxycyte, which development we decided to suspend in the prior year.
 
Levosimendan
 
We incurred approximately $3.7 million in research and development costs for levosimendan during the six months ended October 31, 2015, an increase of approximately $1.4 million compared to the same period in the prior year. The increase in levosimendan development costs is due primarily to the direct costs of our Phase III Levo-CTS clinical trial for LCOS, partially offset by a reduction of approximately $500,000 in costs to support the LeoPARDS trial for septic shock that was conducted during the same period of the prior year. For the six months ended October 31, 2015, we recorded CRO costs of approximately $3.7 million for the management of the Phase III trial which includes approximately $1.5 million in pass-through site activation and enrolled patient costs, compared to CRO costs of approximately $1.8 million during the same period in the prior year.
 
 
22

 
 
Oxycyte
 
We incurred approximately $23,000 in research and development costs for Oxycyte during the six months ended October 31, 2015, a decrease of approximately $875,000 compared to the same period in the prior year. The decrease in Oxycyte development costs was due to our decision to suspend development of the Oxycyte product in the prior year and close out all of our sites for the Phase II-B clinical trial for TBI. We do not anticipate any significant additional costs in the future related to this clinical trial or other close-out activities related to the discontinuance of the Oxycyte product development.
 
Consulting fees:
 
Consulting fees increased approximately $255,000 for the six months ended October 31, 2015 compared to the same period in the prior year, primarily due to an increase in fees paid to a third party consulting firm for services provided to improve training and communication with active sites in support of our Phase III Levo-CTS clinical trial.
 
Personnel costs:
 
Personnel costs decreased approximately $41,000 for the six months ended October 31, 2015 compared to the same period in the prior year, primarily due to headcount reductions in positions responsible for the development of our Oxycyte products as compared to the same period in the prior year.
 
Other costs:
 
Other costs decreased approximately $15,000 for the six months ended October 31, 2015 compared to the same period in the prior year. This decrease was due primarily to depreciation of lab equipment and other lab related costs that were written off and disposed of on April 30, 2015.
 
Interest expense
 
Interest expense includes the interest payments due under our convertible debt, amortization of debt issuance costs and accretion of discounts recorded against our convertible notes, and noncash amortization of premiums paid on our marketable securities. Interest expense and percentage changes for the six months ended October 31, 2015 and 2014, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/
   
% Increase/
 
   
2015
   
2014
    (Decrease)     (Decrease)  
Interest expense
  $ 1,506     $ 46,320     $ (44,814 )     (97 ) %
 
During the six months ended October 31, 2015, interest expense decreased approximately $45,000 compared to the same period in the prior year. The decrease was due to the maturity and settlement of our outstanding convertible notes in June 2014.
 
Other income and expense
 
Other income and expense for the six months ended October 31, 2015 and 2014, respectively, is as follows:
 
   
Six months ended October 31,
   
(Increase)/
 
   
2015
   
2014
    Decrease  
Other income, net
  $ (306,346 )   $ (379,512 )   $ 73,166  
 
Other income decreased approximately $73,000 for the six months ended October 31, 2015 compared to the same period in the prior year. This decrease is due to primarily to change in fair value of our Series C warrant derivative liability in the current period, partially offset by an increase of approximately $90,000 in income earned from our investments in marketable securities.
 
 
23

 
 
During the six months ended October 31, 2015, we recorded a derivative gain of approximately $70,000 which compared to a derivative gain of approximately $238,000 for the same period in the prior year. These charges to income are derived from the free standing Series C warrants which are measured at their fair market value each period using the Monte Carlo simulation model.
 
During the six months ended October 31, 2015, we recorded interest income of approximately $230,000 from our investments in marketable securities. This income is derived from approximately $685,000 in bond interest paid, partially offset by approximately $455,000 in charges for amortization of premiums paid and fair-value adjustments measured each period, which compares to approximately $366,000 in bond interest paid, partially offset by approximately $226,000 in charges for amortization of premiums paid and fair-value adjustments during the same period in the prior year.
 
Liquidity, Capital Resources and Plan of Operation
 
We have incurred losses since our inception and as of October 31, 2015 we had an accumulated deficit of $157 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur increased expenses related to our development and potential commercialization of levosimendan and other product candidates and, as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
 
Liquidity
 
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had $21,863,664 and $17,511,176 of total current assets and working capital of $18,301,080 and $12,993,966 as of October 31, 2015 and April 30, 2015, respectively. Based on our working capital and the value of our investments in marketable securities at October 31, 2015, we believe we have sufficient capital to fund our operations through calendar year 2017.
 
We are in the clinical trial stages in the development of our product candidates. We are currently conducting a Phase III clinical trial for levosimendan, and we expect our primary focus will be on funding the Phase III clinical trial for levosimendan, since this product is the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond calendar year 2017 depends on obtaining license income or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining the necessary resources.
 
Cash Flows
 
The following table shows a summary of our cash flows for the three months ended October 31, 2015 and 2014:
 
   
Six months ended October 31,
 
   
2015
   
2014
 
Net cash used in operating activities
  $ (6,544,847 )   $ (4,894,825 )
Net cash provided by (used in) investing activities
    3,817,699       (39,250,019 )
Net cash (used in) provided by financing activities
    (100,160 )     180,429  

Net cash used in operating activities.  Net cash used in operating activities was approximately $6.5 million for the six months ended October 31, 2015 compared to net cash used in operating activities of approximately $4.9 million for the six months ended October 31, 2014. The increase in cash used for operating activities was due primarily to an increase in our costs incurred for the Phase III clinical trial for levosimendan.
 
Net cash provided by (used in) investing activities. Net cash provided by investing activities was approximately $3.8 million for the six months ended October 31, 2015 compared to net cash used in investing activities of approximately $39.3 million for the six months ended October 31, 2014. The increase in cash provided by investing activities was primarily due the sale of marketable securities that were purchased during the same period of the prior year.
 
 
24

 
 
Net cash (used in) provided by financing activities. Net cash used in financing activities was approximately $100,000 for the six months ended October 31, 2015 compared to net cash provided by financing activities of approximately $180,000 for the six months ended October 31, 2014. The decrease of approximately $280,000 in net cash provided by financing activities was due primarily to proceeds of approximately $544,000 received from the exercise of outstanding warrants, partially offset by the payment of $300,000 upon the maturity of previously issued convertible notes during the same period of the prior year.
 
Operating Capital and Capital Expenditure Requirements
 
Our future capital requirements will depend on many factors that include, but are not limited to the following:
 
●  
the initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
 
●  
the outcome, timing and cost of regulatory approvals and the regulatory approval process;
 
●  
delays that may be caused by changing regulatory requirements;
 
●  
the number of product candidates that we pursue;
 
●  
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
 
●  
the timing and terms of future in-licensing and out-licensing transactions;
 
●  
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
 
●  
the cost of procuring clinical and commercial supplies of our product candidates;
 
●  
the extent to which we acquire or invest in businesses, products or technologies; and
 
●  
the possible costs of litigation.
 
We believe that our existing cash and cash equivalents, along with our investment in marketable securities, will be sufficient to fund our projected operating requirements through calendar year 2017. We will need substantial additional capital in the future in order to complete the development and commercialization of levosimendan and to fund the development and commercialization of other future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding, if needed, may not be available on favorable terms, if at all. In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
 
To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
 
Critical Accounting Policies
 
Our consolidated financial statements have been prepared in accordance with GAAP. For information regarding our critical accounting policies and estimates, please refer to “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Summary of Significant Accounting Policies” contained in our annual report on Form 10-K for the year ended April 30, 2015. There have not been material changes to the critical accounting policies previously disclosed in that report.
 
Recent Accounting Pronouncements
 
In November 2015, the Financial Accounting Standards Board, or FASB, issued a new accounting standard that changes the balance sheet classifications of deferred income taxes. This standard amends existing guidance to require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted. We do not expect adoption of this standard will have a material impact on our condensed consolidated financial statements.
 
In April 2015, the FASB issued a new accounting standard that will change the reporting of debt issuance costs. This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. We do not expect adoption of this standard will have a material impact on our condensed consolidated financial statements.
 
In May 2014, the FASB issued a new accounting standard that supersedes nearly all existing revenue recognition guidance under GAAP. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. In July 2015, the FASB agreed to defer the effective date of the standard from annual periods beginning after December 15, 2016, to annual periods beginning after December 15, 2017, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. We have not yet selected a transition method and we do not believe adoption of this standard will have a material impact on our condensed consolidated financial statements and related disclosures.
 
 
25

 
 
Contractual Obligations
 
Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude contingent contractual liabilities for which we cannot reasonably predict future payment, including contingencies related to potential future development, financing, contingent royalty payments and/or scientific, regulatory or commercial milestone payments under development agreements. The following table summarizes our contractual obligations as of October 31, 2015:
 
 
Payments Due by Period
 
         
Less than
             
More than
 
 
Total
   
1 Year
 
1-3 Years
 
3-5 Years
 
5 Years
 
Operating Lease Obligations
  $ 621,697     $ 74,683     $ 344,360     $ 202,654     $ -  
 
Off-Balance Sheet Arrangements
 
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.
 
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Interest Rate Risk
 
We are subject to interest rate risk on our investment portfolio.
 
We invest in marketable securities in accordance with our investment policy. The primary objectives of our investment policy are to preserve capital, maintain proper liquidity to meet operating needs and maximize yields. Our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment. We place our excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of credit exposure. Some of the securities we invest in may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate.
 
Our investment exposure to market risk for changes in interest rates relates to the increase or decrease in the amount of interest income we can earn on our portfolio, changes in the market value due to changes in interest rates and other market factors as well as the increase or decrease in any realized gains and losses. Our investment portfolio includes only marketable securities and instruments with active secondary or resale markets to help ensure portfolio liquidity. A hypothetical 100 basis point drop in interest rates along the entire interest rate yield curve would not significantly affect the fair value of our interest sensitive financial instruments. We generally have the ability to hold our fixed-income investments to maturity and therefore do not expect that our operating results, financial position or cash flows will be materially impacted due to a sudden change in interest rates. However, our future investment income may fall short of expectations due to changes in interest rates, or we may suffer losses in principal if forced to sell securities which have declined in market value due to changes in interest rates or other factors, such as changes in credit risk related to the securities’ issuers. To minimize this risk, we schedule our investments to have maturities that coincide with our expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, we do not believe that we have material exposure to interest rate risk arising from our investments. Generally, our investments are not collateralized. We have not realized any significant losses from our investments.
 
We do not use interest rate derivative instruments to manage exposure to interest rate changes. We ensure the safety and preservation of invested principal funds by limiting default risk, market risk and reinvestment risk. We reduce default risk by investing in investment grade securities.
 
CONTROLS AND PROCEDURES
 
Evaluation of Disclosure Controls and Procedures
 
As required by paragraph (b) of Rules 13a-15 and 15d-15 promulgated under the Exchange Act, our management, including our Chief Executive Officer and Chief Financial Officer, conducted an evaluation as of the end of the period covered by this report, of the effectiveness of our disclosure controls and procedures as defined in Exchange Act Rule 13a-15(e) and 15d-15(e). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of October 31, 2015, the end of the period covered by this report in that they provide reasonable assurance that the information we are required to disclose in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods required by the SEC and is accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
 
Changes in Internal Control over Financial Reporting
 
There were no significant changes in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We routinely review our internal controls over financial reporting and from time to time make changes intended to enhance the effectiveness of our internal control over financial reporting. We will continue to evaluate the effectiveness of our disclosure controls and procedures and internal controls over financial reporting on an ongoing basis and will take action as appropriate.
 
 
26

 
 
PART II – OTHER INFORMATION
 
 
There are no material pending legal proceedings to which we are a party or to which any of our property is subject.
 
 
The risks we face have not materially changed from those disclosed in our Annual Report on Form 10-K for the year ended April 30, 2015.
 
 
Repurchases of Common Stock
 
The following table lists all repurchases during the second quarter of fiscal 2016 of any of our securities registered under Section 12 of the Exchange Act by or on behalf of us or any affiliated purchaser.
 
Issuer Purchases of Equity Securities
 
Period
   
Total Number of Shares Purchased (1)
     
Average Price Paid per Share (2)
    Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs     Approximate Dollar Value of Shares that May Yet Be Purchased Under the Plans or Programs  
August 1, 2015 - August 31, 2015
    -     $ -       -     $ -  
September 1, 2015 - September 30, 2015
    -     $ -       -     $ -  
October 1, 2015 - October 31, 2015
    59     $ 3.19       -     $ -  
Total
    59     $ 3.19       -     $ -  
 
(1)  
Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
(2)  
Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
 
The exhibits listed in the accompanying exhibit index are filed as part of this quarterly report on Form 10-Q, and such exhibit index is incorporated by reference herein.
 
 
27

 
 
 
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.
 

 
 
TENAX THERAPEUTICS, INC.
 
       
Date: December 10, 2015
By:
/s/ Michael B. Jebsen  
    Michael B. Jebsen  
   
Chief Financial Officer
 
   
(On behalf of the Registrant and as Principal Financial Officer)
 

 
 
 
28

 
 
EXHIBIT INDEX
 
No.
 
Description
     
 
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.*
     
 
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.*
     
 
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
     
 
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
     
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*
 
* Filed herewith
 
29

EX-31.1 2 tenx_ex311.htm CERTIFICATION tenx_ex311.htm
Exhibit 31.1
 
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, John P. Kelley, certify that:
 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Tenax Therapeutics, 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 consolidated 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 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 consolidated 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 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: December 10, 2015
 
   
 
/s/ John P. Kelley
 
John P. Kelley
 
Chief Executive Officer
(Principal Executive Officer)

EX-31.2 3 tenx_ex312.htm CERTIFICATION tenx_ex312.htm
Exhibit 31.2
 
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
 
I, Michael B. Jebsen, certify that:
 
1.  
I have reviewed this Quarterly Report on Form 10-Q of Tenax Therapeutics, 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 consolidated 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 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 consolidated 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 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: December 10, 2015
 
   
 
/s/ Michael B. Jebsen
 
Michael B. Jebsen
 
Chief Financial Officer
(Principal Financial Officer)

EX-32.1 4 tenx_ex321.htm CERTIFICATION tenx_ex321.htm
Exhibit 32.1
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Quarterly Report of Tenax Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended October 31, 2015 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John P. Kelley, Chief Executive Officer (Principal Executive Officer) of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: December 10, 2015
 
   
 
/s/ John P. Kelley
 
John P. Kelley
 
Chief Executive Officer
(Principal Executive Officer)
 
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 

 
EX-32.2 5 tenx_ex322.htm CERTIFICATION tenx_ex322.htm
Exhibit 32.2
 
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Quarterly Report of Tenax Therapeutics, Inc. (the “Company”) on Form 10-Q for the period ended October 31, 2015 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael B. Jebsen, Chief Financial Officer (Principal Financial Officer) of the Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
 
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: December 10, 2015
 
   
 
/s/ Michael B. Jebsen
 
Michael B. Jebsen
 
Chief Financial Officer
(Principal Financial Officer)
 
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
 
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
 
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7. STOCKHOLDERS EQUITY (Details 3)
6 Months Ended
Oct. 31, 2015
$ / shares
shares
Stockholders Equity Details 3  
Number of Restricted Stock Grants, Beginning | shares 90
Granted | shares 430
Vested | shares (174)
Cancelled | shares (132)
Number of Restricted Stock Grants Ending | shares 214
Weighted Average Grant Date Fair Value, Beginning | $ / shares $ 4.01
Weighted Average Grant Date Fair Value, Granted | $ / shares 3.42
Weighted Average Grant Date Fair Value, Vested | $ / shares 3.61
Weighted Average Grant Date Fair Value, Cancelled | $ / shares 3.57
Weighted Average Grant Date Fair Value, Ending | $ / shares $ 3.42

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4. BALANCE SHEET COMPONENTS (Details 1) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
Balance Sheet Components Details 1    
Laboratory equipment $ 514,214 $ 514,214
Computer equipment and software 139,984 123,295
Office furniture and fixtures 130,192 130,192
Subtotal 784,390 767,701
Less: Accumulated depreciation and amortization (742,336) (717,379)
Property Plant and Equipment $ 42,054 $ 50,322
XML 16 R9.htm IDEA: XBRL DOCUMENT v3.3.1.900
4. BALANCE SHEET COMPONENTS
6 Months Ended
Oct. 31, 2015
Notes to Financial Statements  
4. BALANCE SHEET COMPONENTS

Other current assets

 

Other current assets consist of the following as of October 31, 2015 and April 30, 2015:

 

   

October 31,

2015

   

April 30,

2015

 
R&D materials   $ -     $ 29,479  
Other     -       29,144  
    $ -     $ 58,623  

  

 

Property and equipment, net

 

Property and equipment consist of the following as of October 31, 2015 and April 30, 2015:

 

   

October 31,

2015

   

April 30,

2015

 
Laboratory equipment   $ 514,214     $ 514,214  
Computer equipment and software     139,984       123,295  
Office furniture and fixtures     130,192       130,192  
      784,390       767,701  
Less: Accumulated depreciation     (742,336 )     (717,379 )
    $ 42,054     $ 50,322  

 

Depreciation and amortization expense was approximately $12,000 and $21,000 for the three months ended October 31, 2015 and 2014, and $25,000 and $43,000 for the six months ended October 31, 2015 and 2014, respectively.

 

Accrued liabilities

 

Accrued liabilities consist of the following as of October 31, 2015 and April 30, 2015:

 

   

October 31,

2015

   

April 30,

2015

 
Operating costs   $ 2,456,738     $ 2,053,597  
Employee related     81,921       596,137  
Restructuring liability     -       10,932  
    $ 2,538,659     $ 2,660,666  

 

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5. INTANGIBLE ASSETS (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
Oct. 31, 2015
Oct. 31, 2014
Intangible Assets Details Narrative        
Amortization Of Intangible Assets $ 0 $ 17,000 $ 0 $ 34,000
Capitalized patent costs     $ 0 $ 64,000
XML 19 R28.htm IDEA: XBRL DOCUMENT v3.3.1.900
5. INTANGIBLE ASSETS (Details) - USD ($)
12 Months Ended
Apr. 30, 2015
Oct. 31, 2015
Value Assigned $ 23,543,823 $ 22,000,000
Impairments   0
Accumulated Amortization (1,034,863) 0
Carrying Value (Net of Impairments and Accumulated Amortization) 22,000,000 22,000,000
IPR and D    
Value Assigned 22,000,000 22,000,000
Impairments 0 0
Accumulated Amortization 0 0
Carrying Value (Net of Impairments and Accumulated Amortization) $ 22,000,000 $ 22,000,000
Patents    
Weighted Average Amortization Period (in Years) 10 years 3 months 18 days  
Value Assigned $ 806,771  
Impairments (327,476)  
Accumulated Amortization (479,295)  
Carrying Value (Net of Impairments and Accumulated Amortization) $ 0  
License Rights    
Weighted Average Amortization Period (in Years) 13 years 7 months 6 days  
Value Assigned $ 630,666  
Impairments (181,484)  
Accumulated Amortization (449,182)  
Carrying Value (Net of Impairments and Accumulated Amortization) 0  
Trademarks    
Value Assigned 106,386  
Accumulated Amortization (106,386)  
Carrying Value (Net of Impairments and Accumulated Amortization) $ 0  
XML 20 R30.htm IDEA: XBRL DOCUMENT v3.3.1.900
7. STOCKHOLDERS EQUITY (Details)
6 Months Ended
Oct. 31, 2015
shares
Stockholders Equity Details  
1999 Amended Stock Plan Shares available for grant balance April 30, 2015 122,399
Additional shares reserved 1,187,192
Options granted (85,050)
Options cancelled/forfeited 650
Restricted stock granted (430)
Restricted stock cancelled/forfeited 132
1999 Amended Stock Plan Shares available for grant balance July 31, 2015 1,224,893
XML 21 R31.htm IDEA: XBRL DOCUMENT v3.3.1.900
7. STOCKHOLDERS EQUITY (Details 1)
6 Months Ended
Oct. 31, 2015
$ / shares
shares
Stockholders Equity Details 1  
Number of Options Outstanding, Beginning | shares 3,693,298
Number of Options Granted | shares 85,050
Number of Options Cancelled | shares (650)
Number of Options Outstanding, Ending | shares 3,777,698
Weighted Average Exercise Price Outstanding, Beginning | $ / shares $ 5.70
Weighted Average Exercise Price Granted | $ / shares 3.48
Weighted Average Exercise Price Canceled | $ / shares 35.09
Weighted Average Exercise Price Outstanding, Ending | $ / shares $ 5.65
XML 22 R8.htm IDEA: XBRL DOCUMENT v3.3.1.900
3. FAIR VALUE
6 Months Ended
Oct. 31, 2015
Fair Value Disclosures [Abstract]  
3. FAIR VALUE

The Company records its financial assets and liabilities in accordance with the FASB Accounting Standards Codification (“ASC”) 820 Fair Value Measurements. The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, investments in marketable securities, short-term notes payable, and warrant liabilities. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments.

 

Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” The fair value measurement hierarchy consists of three levels:

 

Level one Quoted market prices in active markets for identical assets or liabilities;
   
Level two Inputs other than level one inputs that are either directly or indirectly observable, and
   
Level three Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.

 

The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s condensed consolidated financial statements.

 

Investments in Marketable Securities

 

The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive income/(loss), unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Condensed Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At October 31, 2015, the Company believes that the costs of its investments are recoverable in all material respects.

 

The following table summarizes the fair value of the Company’s investments by type. The estimated fair value of the Company’s fixed income investments are classified as Level 2 in the fair value hierarchy as defined in U.S. GAAP. These fair values are obtained from independent pricing services which utilize Level 2 inputs:

 

    October 31, 2015  
    Amortized Cost     Accrued Interest     Gross Unrealized Gains     Gross Unrealized losses     Estimated Fair Value  
Corporate debt securities   $ 35,482,306     $ 297,005     $ 3     $ (17,876 )   $ 35,761,438  

 

The following table summarizes the scheduled maturity for the Company’s investments at October 31, 2015 and April 30, 2015.

 

   

October 31,

2015

   

April 30,

2015

 
Maturing in one year or less   $ 16,584,777     $ 9,200,082  
Maturing after one year through three years     19,176,661       30,974,961  
Total investments   $ 35,761,438     $ 40,175,043  

 

Warrant liability

 

On July 23, 2013, the Company issued common stock warrants in connection with the issuance of Series C 8% Preferred Stock (the “Series C Warrants”). These Series C Warrants contain certain “down-round” price protection clauses and in accordance with ASC 815-40-35-9, the Company classifies these warrants as a current liability and the subsequent changes in fair value are recorded as a component of other expense.

 

Financial assets or liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable. The Series C Warrants are measured using the Monte Carlo valuation model which is based, in part, upon inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions.  The assumptions used in calculating the estimated fair value of the warrants represent the Company’s best estimates; however, these estimates involve inherent uncertainties and the application of management judgment.  As a result, if factors change and different assumptions are used, the warrant liabilities and the change in estimated fair value of the warrants could be materially different.

 

Inherent in the Monte Carlo valuation model are assumptions related to expected stock-price volatility, expected life, risk-free interest rate and dividend yield.  The Company estimates the volatility of its common stock based on historical volatility that matches the expected remaining life of the warrants.  The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants.  The expected life of the warrants is assumed to be equivalent to their remaining contractual term.  The dividend rate is based on the historical rate, which the Company anticipates to remain at zero.

 

The Monte Carlo model is used for the Series C Warrants to appropriately value the potential future exercise price adjustments triggered by the anti-dilution provisions. This requires Level 3 inputs which are based on the Company’s estimates of the probability and timing of potential future financings and fundamental transactions.  The other assumptions used by the Company are summarized in the following table for the Series C Warrants that were outstanding as of October 31, 2015 and April 30, 2015

 

Series C Warrants  

October 31,

2015

   

April 30,

2015

 
Closing stock price   $ 3.18     $ 3.42  
Expected dividend rate     0 %     0 %
Expected stock price volatility     82.09 %     83.53 %
Risk-free interest rate     1.22 %     1.23 %
Expected life (years)     3.73       4.23  

 

As of October 31, 2015, the fair value of the warrant liability was $502,693. The Company recorded a gain of $103,425 and $69,752 for the change in fair value as a component of other expense on the condensed consolidated statement of comprehensive loss for the three and six months ended October 31, 2015, respectively.

  

As of October 31, 2015, there were 240,523 Series C Warrants outstanding.

 

The following tables summarize information regarding assets and liabilities measured at fair value on a recurring basis as of October 31, 2015 and April 30, 2015:

 

          Fair Value Measurements at Reporting Date Using  
    Balance as of October 31, 2015     Quoted prices in Active Markets for Identical Securities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)  
Current Assets                        
Cash and cash equivalents   $ 5,099,183     $ 5,099,183     $ -     $ -  
Marketable securities   $ 16,584,777     $ -     $ 16,584,777     $ -  
                                 
Long-term Assets                                
Marketable securities   $ 19,176,661     $ -     $ 19,176,661     $ -  
                                 
Current Liabilities                                
Warrant liabilities   $ 502,693     $ -     $ -     $ 502,693  

 

            Fair Value Measurements at Reporting Date Using  
    Balance as of April 30, 2015     Quoted prices in Active Markets for Identical Securities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)  
Current Assets                                
Cash and cash equivalents   $ 7,926,491     $ 7,926,491     $ -     $ -  
Marketable securities   $ 9,200,082     $ -     $ 9,200,082     $ -  
                                 
Long-term Assets                                
Marketable securities   $ 30,974,961     $ -     $ 30,974,961     $ -  
                                 
Current Liabilities                                
Warrant liabilities   $ 572,445     $ -     $ -     $ 572,445  

 

There were no significant transfers between levels in the six months ended October 31, 2015.

XML 23 R32.htm IDEA: XBRL DOCUMENT v3.3.1.900
7. STOCKHOLDERS EQUITY (Details 2)
6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
Stockholders Equity Details 2    
Risk-free interest rate (weighted average) 1.87% 2.23%
Expected volatility (weighted average) 87.45% 98.43%
Expected term (in years) 7 years 7 years
Expected dividend yield 0.00% 0.00%
XML 24 R2.htm IDEA: XBRL DOCUMENT v3.3.1.900
Balance Sheets (Unaudited) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
ASSETS    
Cash and cash equivalents $ 5,099,183 $ 7,926,491
Marketable securities 16,584,777 9,200,082
Accounts receivable 86,271 76,475
Prepaid expenses 93,433 249,505
Other current assets 0 58,623
Total current assets 21,863,664 17,511,176
Marketable securities 19,176,661 30,974,961
Property and equipment, net 42,054 50,322
Intangible assets, net 22,000,000 22,000,000
Goodwill 11,265,100 11,265,100
Other assets 1,106,785 1,106,785
Total assets 75,454,264 82,908,344
Current liabilities    
Accounts payable 521,232 1,183,939
Accrued liabilities 2,538,659 2,660,666
Warrant liabilities 502,693 572,445
Notes payable, net 0 100,160
Total current liabilities 3,562,584 4,517,210
Deferred tax liability 7,962,100 7,962,100
Total liabilities 11,524,684 12,479,310
Stockholders' equity (deficit)    
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 28,119,694 and 28,119,520, respectively 2,812 2,812
Additional paid-in capital 221,171,247 221,067,239
Accumulated other comprehensive (loss) gain (17,873) 26,718
Accumulated deficit (157,226,606) (150,667,735)
Total stockholders' equity 63,929,580 70,429,034
Total liabilities and stockholders' equity $ 75,454,264 $ 82,908,344
XML 25 R6.htm IDEA: XBRL DOCUMENT v3.3.1.900
1. DESCRIPTION OF BUSINESS
6 Months Ended
Oct. 31, 2015
Accounting Policies [Abstract]  
1. DESCRIPTION OF BUSINESS

Tenax Therapeutics, Inc. (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008 by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics was the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted to one share of Oxygen Biotherapeutics common stock. On September 19, 2014, the Company changed its name to Tenax Therapeutics, Inc.

 

On October 18, 2013, the Company created a wholly owned subsidiary, Life Newco, Inc., a Delaware corporation (“Life Newco”), to acquire certain assets of Phyxius Pharma, Inc., a Delaware corporation (“Phyxius”) pursuant to an Asset Purchase Agreement, dated October 21, 2013 (the “Asset Purchase Agreement”), by and among the Company, Life Newco, Phyxius and the stockholders of Phyxius (the “Phyxius Stockholders”). As further discussed in Note 6 below, on November 13, 2013, under the terms and subject to the conditions of the Asset Purchase Agreement, Life Newco acquired certain assets, including a license granting Life Newco an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan, 2.5 mg/ml concentrate for solution for infusion / 5ml vial in the United States and Canada.

XML 26 R22.htm IDEA: XBRL DOCUMENT v3.3.1.900
3. FAIR VALUE (Details 2) - $ / shares
6 Months Ended 12 Months Ended
Oct. 31, 2015
Apr. 30, 2015
Fair Value Details 2    
Closing stock price $ 3.18 $ 3.42
Expected dividend rate 0.00% 0.00%
Expected stock price volatility 82.09% 83.53%
Risk-free interest rate 1.22% 1.23%
Expected life (years) 3 years 8 months 23 days 4 years 2 months 23 days
XML 27 R24.htm IDEA: XBRL DOCUMENT v3.3.1.900
4. BALANCE SHEET COMPONENTS (Details) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
Balance Sheet Components Details    
R&D materials $ 0 $ 29,479
Deferred cost of sales 0 29,144
Total Other Assets $ 0 $ 58,623
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2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Oct. 31, 2015
Accounting Policies [Abstract]  
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at April 30, 2015 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended April 30, 2015. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. Operating results for the three and six month periods ended October 31, 2015 are not necessarily indicative of results for the full year or any other future periods. As such, it is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended April 30, 2015.

 

Use of Estimates

 

In preparing the unaudited condensed consolidated financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full fiscal year.

 

On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.

 

Principles of Consolidation

 

The accompanying condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc. and Life Newco, Inc. All material intercompany transactions and balances have been eliminated in consolidation.

 

Goodwill

 

Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired, including identifiable intangible assets, and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized.

 

Goodwill is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate potential impairment. The Company’s goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company assesses qualitative factors to determine if its sole reporting unit’s fair value is more likely than not to exceed its carrying value, including goodwill. In the event the Company determines that it is more likely than not that its reporting unit’s fair value is less than its carrying amount, quantitative testing is performed comparing recorded values to estimated fair values. If the fair value exceeds the carrying value, goodwill is not impaired. If the carrying value exceeds the fair value, an impairment charge is recognized through a charge to operations based upon the excess of the carrying value of goodwill over the implied fair value.  There was no impairment to goodwill recognized during the three and six months ended October 31, 2015.

 

Liquidity and Managements’ Plan

 

 

At October 31, 2015, the Company had cash and cash equivalents, including the fair value of its marketable securities, of approximately $40.9 million. The Company used $6.5 million of cash for operating activities during the six months ended October 31, 2015 and had stockholders’ equity of $63.9 million, versus $70.4 million at April 30, 2015. The Company expects that it has sufficient cash to manage the business through calendar year 2017, although this assumes that the Company does not accelerate the development of other opportunities that are available to the Company or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements.

 

 

Additional capital will likely be required to support the Company’s future commercialization activities, including the anticipated commercial launch of levosimendan for low cardiac output syndrome (“LCOS”), and the development of other products or indications which may be acquired or licensed by the Company, and general working capital requirements. Based on product development timelines the ability to scale up or reduce personnel and associated costs are factors considered throughout the product development life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Readers are cautioned that additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all.

 

 

To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates, or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.

 

Net Loss per Share

 

Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock and warrants.

 

The following outstanding options, warrants and restricted stock were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.

 

    Six months ended October 31,  
    2015     2014  
             
Options to purchase common stock     3,777,698       3,694,407  
Warrants to purchase common stock     2,728,236       2,553,236  
Restricted stock     214       229  

 

 

Recent Accounting Pronouncements

 

In November 2015, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard that changes the balance sheet classifications of deferred income taxes. This standard amends existing guidance to require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.

In April 2015, the FASB issued a new accounting standard that changes the reporting of debt issuance costs. This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.

In May 2014, the FASB issued a new accounting standard that supersedes nearly all existing revenue recognition guidance under GAAP. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. In July 2015, the FASB agreed to defer the effective date of the standard from annual periods beginning after December 15, 2016, to annual periods beginning after December 15, 2017, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company has not yet selected a transition method and does not believe adoption of the standard will have a material impact on its condensed consolidated financial statements.

XML 30 R3.htm IDEA: XBRL DOCUMENT v3.3.1.900
Balance Sheets (Parenthetical) - $ / shares
Oct. 31, 2015
Apr. 30, 2015
Stockholders' equity    
Common stock, par value $ .0001 $ .0001
Common stock, authorized 400,000,000 400,000,000
Common stock, issued 28,119,694 28,119,520
Common stock, outstanding 28,119,694 28,119,520
XML 31 R17.htm IDEA: XBRL DOCUMENT v3.3.1.900
5. INTANGIBLE ASSETS (Tables)
6 Months Ended
Oct. 31, 2015
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets

The following table summarizes the Company’s intangible assets as of October 31, 2015:

 

Asset Category   Weighted Average Amortization Period (in Years)     Value Assigned     Accumulated Amortization     Impairments     Carrying Value (Net of Impairments and Accumulated Amortization)  
                               
IPR&D     N/A       22,000,000       -       -       22,000,000  
Total           $ 22,000,000             $ -     $ 22,000,000  

 

The following table summarizes the Company’s intangible assets as of April 30, 2015:

 

Asset Category   Weighted Average Amortization Period (in Years)     Value Assigned     Accumulated Amortization     Impairments     Carrying Value (Net of Impairments and Accumulated Amortization)  
                               
IPR&D     N/A     $ 22,000,000     $ -     $ -     $ 22,000,000  
Patents     10.3       806,771       (327,476 )     (479,295 )     -  
License Rights     13.6       630,666       (181,484 )     (449,182 )     -  
Trademarks     N/A       106,386               (106,386 )     -  
Total           $ 23,543,823             $ (1,034,863 )   $ 22,000,000  

 

XML 32 R1.htm IDEA: XBRL DOCUMENT v3.3.1.900
Document and Entity Information - shares
6 Months Ended
Oct. 31, 2015
Dec. 08, 2015
Document And Entity Information    
Entity Registrant Name TENAX THERAPEUTICS, INC.  
Entity Central Index Key 0000034956  
Document Type 10-Q  
Document Period End Date Oct. 31, 2015  
Amendment Flag false  
Current Fiscal Year End Date --04-30  
Is Entity a Well-known Seasoned Issuer? No  
Is Entity a Voluntary Filer? No  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   28,119,694
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2015  
XML 33 R18.htm IDEA: XBRL DOCUMENT v3.3.1.900
7. STOCKHOLDERS EQUITY (Tables)
6 Months Ended
Oct. 31, 2015
Equity [Abstract]  
Shares available for grant under the Plan
    Shares Available for Grant  
Balances, at April 30, 2015     122,399  
Additional shares reserved     1,187,192  
Options granted     (85,050 )
Options cancelled/forfeited     650  
Restricted stock granted     (430 )
Restricted stock cancelled/forfeited     132  
Balances, at October 31, 2015     1,224,893  
Outstanding stock options
    Outstanding Options  
    Number of Shares     Weighted Average Exercise Price  
Balances, at April 30, 2015     3,693,298     $ 5.70  
Options granted     85,050     $ 3.48  
Options cancelled     (650 )   $ 35.09  
Balances, at October 31, 2015     3,777,698     $ 5.65  
Fair Value Assumptions
    For the six months ended October 31,  
    2015     2014  
Risk-free interest rate (weighted average)     1.87 %     2.23 %
Expected volatility (weighted average)     87.45 %     98.43 %
Expected term (in years)     7       7  
Expected dividend yield     0.00 %     0.00 %
Restricted Stock Grants
    Outstanding Restricted Stock Grants  
    Number of Shares   Weighted Average Grant Date Fair Value
Balances, at April 30, 2015     90     $ 4.01  
Restricted stock granted     430     $ 3.42  
Restricted stock vested     (174 )   $ 3.61  
Restricted stock cancelled     (132 )   $ 3.57  
Balances, at October 31, 2015     214     $ 3.42  
XML 34 R4.htm IDEA: XBRL DOCUMENT v3.3.1.900
Statements of Operations (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
Oct. 31, 2015
Oct. 31, 2014
Operating expenses        
General and administrative $ 1,230,618 $ 1,586,343 $ 2,599,222 $ 3,036,202
Research and development 2,518,588 2,556,852 4,264,489 3,523,365
Total operating expenses 3,749,206 4,143,195 6,863,711 6,559,567
Net operating loss 3,749,206 4,143,195 6,863,711 6,559,567
Interest expense 404 59 1,506 46,320
Other income (225,238) (88,291) (306,346) (379,512)
Net loss 3,524,372 4,054,963 6,558,871 6,226,375
Unrealized (gain) loss on marketable securities (21,283) (23,254) 44,591 42,306
Total comprehensive loss $ 3,503,089 $ 4,031,709 $ 6,603,462 $ 6,268,681
Net loss per share, basic and diluted $ (0.13) $ (0.14) $ (0.23) $ (0.22)
Weighted average number of common shares outstanding, basic and diluted 28,119,609 28,107,395 28,119,565 28,037,204
XML 35 R12.htm IDEA: XBRL DOCUMENT v3.3.1.900
7. STOCKHOLDERS EQUITY
6 Months Ended
Oct. 31, 2015
Equity [Abstract]  
7. STOCKHOLDERS' EQUITY

Preferred Stock

 

Under the Company’s Certificate of Incorporation, the Board of Directors is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof. As of October 31, 2015, no shares of preferred stock are designated, issued or outstanding.

 

Common Stock

 

The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of October 31, 2015, there were 28,119,694 shares of common stock issued and outstanding.

 

Warrants

 

As of October 31, 2015, the Company has 2,728,236 warrants outstanding. During the six months ended October 31, 2015, no warrants were issued, exercised, or cancelled.

 

1999 Amended Stock Plan

 

In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “Plan”). Under the Plan, with the approval of the Compensation Committee of the Board of Directors, the Company may grant stock options, restricted stock, stock appreciation rights and new shares of common stock upon exercise of stock options. On March 13, 2014, the Company’s stockholders approved an amendment to the Plan which increased the number of shares of common stock authorized for issuance to a total of 4,000,000 shares, up from 300,000 previously authorized. On September 15, 2015, the Company’s stockholders approved an additional amendment to the Plan which increased the number of shares of common stock authorized for issuance to a total of 5,000,000 shares, up from 4,000,000 previously authorized. As of October 31, 2015 the Company had 1,224,893 shares of common stock available for grant under the Plan.

 

The following table summarizes the shares available for grant under the Plan for the six months ended October 31, 2015:

 

    Shares Available for Grant  
Balances, at April 30, 2015     122,399  
Additional shares reserved     1,187,192  
Options granted     (85,050 )
Options cancelled/forfeited     650  
Restricted stock granted     (430 )
Restricted stock cancelled/forfeited     132  
Balances, at October 31, 2015     1,224,893  

 

Plan Stock Options

 

Stock options granted under the Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the Plan may be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.

 

The following table summarizes the outstanding stock options under the Plan for the six months ended October 31, 2015:

 

    Outstanding Options  
    Number of Shares     Weighted Average Exercise Price  
Balances, at April 30, 2015     3,693,298     $ 5.70  
Options granted     85,050     $ 3.48  
Options cancelled     (650 )   $ 35.09  
Balances, at October 31, 2015     3,777,698     $ 5.65  

 

The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.

 

The Company recorded compensation expense for these stock options grants of $59,440 and $103,437 for the three and six months ended October 31, 2015, respectively.

 

As of October 31, 2015, there were unrecognized compensation costs of approximately $166,000 related to non-vested stock option awards that will be recognized on a straight-line basis over the weighted average remaining vesting period of 0.76 year. Additionally, there were unrecognized compensation costs of approximately $7.9 million related to non-vested stock option awards subject to performance-based vesting milestones with a weighted average remaining life of 4.4 years. As of October 31, 2015, none of these milestones have been achieved.

 

The Company used the following assumptions to estimate the fair value of options granted under its stock option plans for the six months ended October 31, 2015 and 2014:

 

    For the six months ended October 31,  
    2015     2014  
Risk-free interest rate (weighted average)     1.87 %     2.23 %
Expected volatility (weighted average)     87.45 %     98.43 %
Expected term (in years)     7       7  
Expected dividend yield     0.00 %     0.00 %

  

 

Risk-Free Interest Rate The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
   
Expected Volatility The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
   
Expected Term The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the Company’s historical experience with its stock option grants.
   
Expected Dividend Yield The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.
   
Forfeitures Stock compensation expense recognized in the statements of operations for the six months ended October 31, 2015 and 2014 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.

 

Inducement Stock Options

 

On February 15, 2015, an employment inducement stock option award for 25,000 shares of common stock made to the Company’s chief medical officer. This employment inducement stock option was awarded in accordance with the employment inducement award exemption provided by NASDAQ Rule 5635(c)(4) and was therefore not awarded under the Company’s stockholder approved equity plan. The option award will vest over a three year period, with one-third vesting per year, beginning one year from the grant date. The options have a 10-year term and an exercise price of $3.22 per share, the February 13, 2015 closing price of the Company’s common stock.

 

Inducement stock option compensation expense was approximately $9,830 and $0 for the three months ended October 31, 2015 and 2014, and $19,660 and $0 for the six months ended October 31, 2015 and 2014, respectively.

 

At October 31, 2015, there was $34,853 of remaining unrecognized compensation expense related to the inducement stock options. Inducement stock options outstanding as of October 31, 2015 had a weighted average remaining contractual life of 9.30 years.

 

The estimated weighted average fair value per inducement option share granted was $64,343 in 2015 using a Black-Scholes option pricing model based on market prices and the following assumptions at the date of inducement option grant: weighted average risk-free interest rate of 1.84%, dividend yield of 0%, volatility factor for the Company’s common stock of 93.90% and a weighted average expected life of 7 years for inducement options not forfeited.

 

Restricted Stock Grants

 

The following table summarizes the restricted stock grants under the Plan for the six months ended October 31, 2015.

 

    Outstanding Restricted Stock Grants  
    Number of Shares   Weighted Average Grant Date Fair Value
Balances, at April 30, 2015     90     $ 4.01  
Restricted stock granted     430     $ 3.42  
Restricted stock vested     (174 )   $ 3.61  
Restricted stock cancelled     (132 )   $ 3.57  
Balances, at October 31, 2015     214     $ 3.42  

 

The Company recorded compensation expense for these restricted stock grants of $548 and $1,096 for the three and six months ended October 31, 2015, respectively.

 

As of October 31, 2015, there were unrecognized compensation costs of approximately $700 related to the non-vested restricted stock grants that will be recognized on a straight-line basis over the remaining vesting period of 0.5 years.

XML 36 R11.htm IDEA: XBRL DOCUMENT v3.3.1.900
6. COMMITMENTS AND CONTINGENCIES
6 Months Ended
Oct. 31, 2015
Commitments and Contingencies Disclosure [Abstract]  
6. COMMITMENTS AND CONTINGENCIES

Simdax license agreement

 

On November 13, 2013, the Company acquired, through its wholly owned subsidiary, Life Newco, that certain License Agreement (the “License”), dated September 20, 2013 by and between Phyxius and Orion Corporation, a global healthcare company incorporated under the laws of Finland (“Orion”), and that certain Side Letter, dated October 15, 2013 by and between Phyxius and Orion, The License grants the Company an exclusive, sublicenseable right to develop and commercialize pharmaceutical products containing levosimendan (the “Product”) in the United States and Canada (the “Territory”) from Orion.  Pursuant to the License, the Company must use Orion’s “Simdax®” trademark to commercialize the Product.  The License also grants to the Company a right of first refusal to commercialize new developments of the Product, including developments as to the formulation, presentation, means of delivery, route of administration, dosage or indication.  Orion’s ongoing role under the License includes sublicense approval, serving as the sole source of manufacture, holding a first right to enforce intellectual property rights in the Territory, and certain regulatory participation rights.  Additionally, the Company must grant back to Orion a broad non-exclusive license to any patents or clinical trial data related to the Product developed by the Company under the License.  The License has a fifteen (15) year term, provided, however, that the License will continue after the end of the fifteen year term in each country in the Territory until the expiration of Orion’s patent rights in the Product in such country.  

 

Pursuant to the terms of the License, the Company paid to Orion a non-refundable up-front payment in the amount of $1.0 million.  The License also includes the following development milestones for which the Company shall make non-refundable payments to Orion no later than twenty-eight (28) days after the occurrence of the applicable milestone event: (i) $2.0 million upon the grant of FDA approval, including all registrations, licenses, authorizations and necessary approvals, to develop and/or commercialize the Product in the United States; and (ii) $1.0 million upon the grant of regulatory approval for the Product in Canada. Once commercialized, the Company is obligated to make certain non-refundable commercialization milestone payments to Orion, aggregating up to $13.0 million, contingent upon achievement of certain cumulative net sales amounts in the Territory.  The Company must also pay Orion tiered royalties based on net sales of the Product in the Territory made by the Company and its sublicensees. After the end of the Term, the Company must pay Orion a royalty based on net sales of the Product in the Territory for as long as Life Newco sells the Product in the Territory.

 

As of October 31, 2015, the Company has not met any of the developmental milestones and, accordingly, has not recorded any liability for the contingent payments due to Orion.

 

Agreement with Virginia Commonwealth University

 

In May 2008 the Company entered into a license agreement with Virginia Commonwealth University (“VCU”) whereby it obtained a worldwide, exclusive license to valid claims under three of the VCU's patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license included the right to sub-license to third parties. The term of the agreement was the life of the patents covered by the patent applications unless the Company elected to terminate the agreement prior to patent expiration.  Under the agreement the Company had an obligation to diligently pursue product development and pursue, at its own expense, prosecution of the patent applications covered by the agreement. As part of the agreement, the Company was required to pay to VCU non-refundable payments upon achieving development and regulatory milestones. Prior to termination of the license agreement, as discussed below, the Company had not met any of the developmental milestones.

 

The agreement with VCU also required the Company to pay royalties to VCU at specified rates based on annual net sales derived from the licensed technology. Pursuant to the agreement, the Company was required make minimum annual royalty payments to VCU totaling $70,000 as long as the agreement is in force. These payments were fully creditable against royalty payments due for sales and sublicense revenue earned during the fiscal year as described above. In the prior year, this fee was recorded as an other current asset and was amortized over the fiscal year. Amortization expense was approximately $0 and $17,500 for the three months ended October 31, 2015 and 2014; and $0 and $35,000 for the six months ended October 31, 2015 and 2014, respectively.

 

In September 2014, the Company discontinued the development of its PFC product candidates.  As part of this change in business strategy, on May 5, 2015 the Company provided VCU its 90 day notice terminating the license agreement entered into with VCU. The license agreement gave the Company exclusive rights to intellectual property that was used for the development and commercialization of its PFC product candidates and was therefore no longer needed.

XML 37 R23.htm IDEA: XBRL DOCUMENT v3.3.1.900
3. FAIR VALUE (Details 3) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
Current Assets    
Cash and cash equivalents $ 5,099,183 $ 7,926,491
Marketable securities 16,584,777 9,200,082
Long-term Assets    
Marketable securities 19,176,661 30,974,961
Current Liabilities    
Warrant liabilities 502,693 572,445
Level 1    
Current Assets    
Cash and cash equivalents 5,099,183 7,926,491
Marketable securities 0 0
Long-term Assets    
Marketable securities 0 0
Current Liabilities    
Warrant liabilities 0 0
Level 2    
Current Assets    
Cash and cash equivalents 0 0
Marketable securities 16,584,777 9,200,082
Long-term Assets    
Marketable securities 19,176,661 30,974,961
Current Liabilities    
Warrant liabilities 0 0
Level 3    
Current Assets    
Cash and cash equivalents 0 0
Marketable securities 0 0
Long-term Assets    
Marketable securities 0 0
Current Liabilities    
Warrant liabilities $ 502,693 $ 572,445
XML 38 R19.htm IDEA: XBRL DOCUMENT v3.3.1.900
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1) - shares
6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
Options    
Anti-dilutive securities 3,777,698 3,694,407
Warrants    
Anti-dilutive securities 2,728,236 2,553,236
Restricted stock    
Anti-dilutive securities 214 229
XML 39 R15.htm IDEA: XBRL DOCUMENT v3.3.1.900
3. FAIR VALUE (Tables)
6 Months Ended
Oct. 31, 2015
Fair Value Tables  
Schedule of investments in marketable securities
    October 31, 2015  
    Amortized Cost     Accrued Interest     Gross Unrealized Gains     Gross Unrealized losses     Estimated Fair Value  
Corporate debt securities   $ 35,482,306     $ 297,005     $ 3     $ (17,876 )   $ 35,761,438  
Scheduled of investments maturity
   

October 31,

2015

   

April 30,

2015

 
Maturing in one year or less   $ 16,584,777     $ 9,200,082  
Maturing after one year through three years     19,176,661       30,974,961  
Total investments   $ 35,761,438     $ 40,175,043  
Schedule of assumption for warrant liability
Series C Warrants  

October 31,

2015

   

April 30,

2015

 
Closing stock price   $ 3.18     $ 3.42  
Expected dividend rate     0 %     0 %
Expected stock price volatility     82.09 %     83.53 %
Risk-free interest rate     1.22 %     1.23 %
Expected life (years)     3.73       4.23  
Schedule of fair value on a recurring basis
          Fair Value Measurements at Reporting Date Using  
    Balance as of October 31, 2015     Quoted prices in Active Markets for Identical Securities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)  
Current Assets                        
Cash and cash equivalents   $ 5,099,183     $ 5,099,183     $ -     $ -  
Marketable securities   $ 16,584,777     $ -     $ 16,584,777     $ -  
                                 
Long-term Assets                                
Marketable securities   $ 19,176,661     $ -     $ 19,176,661     $ -  
                                 
Current Liabilities                                
Warrant liabilities   $ 502,693     $ -     $ -     $ 502,693  

 

            Fair Value Measurements at Reporting Date Using  
    Balance as of April 30, 2015     Quoted prices in Active Markets for Identical Securities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)  
Current Assets                                
Cash and cash equivalents   $ 7,926,491     $ 7,926,491     $ -     $ -  
Marketable securities   $ 9,200,082     $ -     $ 9,200,082     $ -  
                                 
Long-term Assets                                
Marketable securities   $ 30,974,961     $ -     $ 30,974,961     $ -  
                                 
Current Liabilities                                
Warrant liabilities   $ 572,445     $ -     $ -     $ 572,445  

 

XML 40 R13.htm IDEA: XBRL DOCUMENT v3.3.1.900
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Oct. 31, 2015
Accounting Policies [Abstract]  
Basis of Presentation

The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at April 30, 2015 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended April 30, 2015. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. Operating results for the three and six month periods ended October 31, 2015 are not necessarily indicative of results for the full year or any other future periods. As such, it is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended April 30, 2015.

Use of Estimates

In preparing the unaudited condensed consolidated financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full fiscal year.

 

On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts and transactions of Tenax Therapeutics, Inc. and Life Newco, Inc. All material intercompany transactions and balances have been eliminated in consolidation.

Goodwill

Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired, including identifiable intangible assets, and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized.

 

Goodwill is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate potential impairment. The Company’s goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company assesses qualitative factors to determine if its sole reporting unit’s fair value is more likely than not to exceed its carrying value, including goodwill. In the event the Company determines that it is more likely than not that its reporting unit’s fair value is less than its carrying amount, quantitative testing is performed comparing recorded values to estimated fair values. If the fair value exceeds the carrying value, goodwill is not impaired. If the carrying value exceeds the fair value, an impairment charge is recognized through a charge to operations based upon the excess of the carrying value of goodwill over the implied fair value.  There was no impairment to goodwill recognized during the three and six months ended October 31, 2015.

Liquidity and Capital Resources

At October 31, 2015, the Company had cash and cash equivalents, including the fair value of its marketable securities, of approximately $40.9 million. The Company used $6.5 million of cash for operating activities during the six months ended October 31, 2015 and had stockholders’ equity of $63.9 million, versus $70.4 million at April 30, 2015. The Company expects that it has sufficient cash to manage the business through calendar year 2017, although this assumes that the Company does not accelerate the development of other opportunities that are available to the Company or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements.

 

 

Additional capital will likely be required to support the Company’s future commercialization activities, including the anticipated commercial launch of levosimendan for low cardiac output syndrome (“LCOS”), and the development of other products or indications which may be acquired or licensed by the Company, and general working capital requirements. Based on product development timelines the ability to scale up or reduce personnel and associated costs are factors considered throughout the product development life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Readers are cautioned that additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all.

 

 

To the extent that the Company raises additional funds by issuing shares of its common stock or other securities convertible or exchangeable for shares of common stock, stockholders will experience dilution, which may be significant. In the event the Company raises additional capital through debt financings, the Company may incur significant interest expense and become subject to covenants in the related transaction documentation that may affect the manner in which the Company conducts its business. To the extent that the Company raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to its technologies or product candidates, or grant licenses on terms that may not be favorable to the Company. Any or all of the foregoing may have a material adverse effect on the Company’s business and financial performance.

Net Loss per Share

Basic loss per share, which excludes antidilutive securities, is computed by dividing net loss by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, restricted stock and warrants.

 

The following outstanding options, warrants and restricted stock were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.

 

    Six months ended October 31,  
    2015     2014  
             
Options to purchase common stock     3,777,698       3,694,407  
Warrants to purchase common stock     2,728,236       2,553,236  
Restricted stock     214       229  

 

Recent Accounting Pronouncements

In November 2015, the Financial Accounting Standards Board (“FASB”) issued a new accounting standard that changes the balance sheet classifications of deferred income taxes. This standard amends existing guidance to require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. It is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.

In April 2015, the FASB issued a new accounting standard that changes the reporting of debt issuance costs. This standard amends existing guidance to require the presentation of debt issuance costs in the balance sheet as a deduction from the carrying amount of the related debt liability instead of a deferred charge. It is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The Company does not expect adoption of this standard will have a material impact on its condensed consolidated financial statements.

In May 2014, the FASB issued a new accounting standard that supersedes nearly all existing revenue recognition guidance under GAAP. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. In July 2015, the FASB agreed to defer the effective date of the standard from annual periods beginning after December 15, 2016, to annual periods beginning after December 15, 2017, with an option that permits companies to adopt the standard as early as the original effective date. Early application prior to the original effective date is not permitted. The standard permits the use of either the retrospective or cumulative effect transition method. The Company has not yet selected a transition method and does not believe adoption of the standard will have a material impact on its condensed consolidated financial statements.

XML 41 R14.htm IDEA: XBRL DOCUMENT v3.3.1.900
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended
Oct. 31, 2015
Accounting Policies [Abstract]  
Anti-dilutive securities
    Six months ended October 31,  
    2015     2014  
             
Options to purchase common stock     3,777,698       3,694,407  
Warrants to purchase common stock     2,728,236       2,553,236  
Restricted stock     214       229  
XML 42 R16.htm IDEA: XBRL DOCUMENT v3.3.1.900
4. BALANCE SHEET COMPONENTS (Tables)
6 Months Ended
Oct. 31, 2015
Notes to Financial Statements  
Other current assets
   

October 31,

2015

   

April 30,

2015

 
R&D materials   $ -     $ 29,479  
Other     -       29,144  
    $ -     $ 58,623  
Property Plant and Equipment
   

October 31,

2015

   

April 30,

2015

 
Laboratory equipment   $ 514,214     $ 514,214  
Computer equipment and software     139,984       123,295  
Office furniture and fixtures     130,192       130,192  
      784,390       767,701  
Less: Accumulated depreciation     (742,336 )     (717,379 )
    $ 42,054     $ 50,322  
Accrued Liabilities
   

October 31,

2015

   

April 30,

2015

 
Operating costs   $ 2,456,738     $ 2,053,597  
Employee related     81,921       596,137  
Restructuring liability     -       10,932  
    $ 2,538,659     $ 2,660,666  
XML 43 R21.htm IDEA: XBRL DOCUMENT v3.3.1.900
3. FAIR VALUE (Details 1) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
Fair Value Details 1    
Maturing in one year or less $ 16,584,777 $ 9,200,082
Maturing after one year through two years 19,176,661 30,974,961
Total investments $ 35,761,438 $ 40,175,043
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4. BALANCE SHEET COMPONENTS (Details 2) - USD ($)
Oct. 31, 2015
Apr. 30, 2015
Balance Sheet Components Details 2    
Operating costs $ 2,456,738 $ 2,053,597
Employee related 81,921 596,137
Restructuring liability 0 10,932
Total $ 2,538,659 $ 2,660,666
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Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
CASH FLOWS FROM OPERATING ACTIVITIES    
Net Loss $ (6,558,871) $ (6,226,375)
Adjustments to reconcile net loss to net cash used in operating activities    
Depreciation and amortization 24,956 76,379
Interest on debt instruments 0 45,606
Issuance and vesting of compensatory stock options and warrants 103,437 142,207
Issuance of common stock as compensation 572 49,708
Change in fair value of warrants (69,752) (238,117)
Amortization of premium on marketable securities 534,626 237,147
Changes in operating assets and liabilities    
Accounts receivable, prepaid expenses and other assets 204,899 (817,813)
Accounts payable and accrued liabilities (784,714) 1,836,433
Net cash used in operating activities (6,544,847) (4,894,825)
CASH FLOWS FROM INVESTING ACTIVITIES    
Purchase of marketable securities (5,222,046) (41,655,184)
Sale of marketable securities 9,056,433 2,469,327
Purchase of property and equipment (16,688) 0
Capitalization of patent costs and license rights 0 (64,162)
Net cash provided by (used in) investing activities 3,817,699 (39,250,019)
CASH FLOWS FROM FINANCING ACTIVITIES    
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments 0 543,998
Payments on notes - short-term (100,160) (363,569)
Net cash (used in) provided by financing activities (100,160) 180,429
Net change in cash and cash equivalents (2,827,308) (43,964,415)
Cash and cash equivalents, beginning of period 7,926,491 58,320,555
Cash and cash equivalents, end of period 5,099,183 14,356,140
Cash paid for:    
Interest 1,507 714
Non-cash financing activities:    
Restricted stock issued during period in payment of interest on convertible notes $ 0 $ 11,500
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5. INTANGIBLE ASSETS
6 Months Ended
Oct. 31, 2015
Goodwill and Intangible Assets Disclosure [Abstract]  
5. INTANGIBLE ASSETS

The following table summarizes the Company’s intangible assets as of October 31, 2015:

 

Asset Category   Weighted Average Amortization Period (in Years)     Value Assigned     Accumulated Amortization     Impairments     Carrying Value (Net of Impairments and Accumulated Amortization)  
                               
IPR&D     N/A       22,000,000       -       -       22,000,000  
Total           $ 22,000,000             $ -     $ 22,000,000  

 

The following table summarizes the Company’s intangible assets as of April 30, 2015:

 

Asset Category   Weighted Average Amortization Period (in Years)     Value Assigned     Accumulated Amortization     Impairments     Carrying Value (Net of Impairments and Accumulated Amortization)  
                               
IPR&D     N/A     $ 22,000,000     $ -     $ -     $ 22,000,000  
Patents     10.3       806,771       (327,476 )     (479,295 )     -  
License Rights     13.6       630,666       (181,484 )     (449,182 )     -  
Trademarks     N/A       106,386               (106,386 )     -  
Total           $ 23,543,823             $ (1,034,863 )   $ 22,000,000  

 

The aggregate amortization expense on the above intangibles was approximately $0 and $17,000, for the three months ended October 31, 2015 and 2014, respectively, and $0 and $34,000, for the six months ended October 31, 2015 and 2014, respectively.

 

In Process Research and Development

 

The levosimendan product in Phase III clinical trial represents an in process research and development (“IPR&D”) asset. The IPR&D asset is a research and development project rather than a product or process already in service or being sold. Research and development intangible assets are considered indefinite-lived until the abandonment or completion of the associated research and development efforts. If abandoned, the assets would be impaired. Research and development expenditures that are incurred after the acquisition, including those for completing the research and development activities related to the acquired intangible research and development assets, are generally expensed as incurred.

 

Patents and License Rights

 

The Company previously held, had filed for, or owned exclusive rights to, U.S. and worldwide patents covering 9 various methods and uses of its perfluorocarbon (“PFC”) technology. It capitalized amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its patent applications. These capitalized costs were amortized on a straight-line method over their useful life or legal life, whichever was shorter.

 

During the fourth quarter of fiscal year 2015, the Company completed its annual impairment test of its patents and license rights. The Company wrote-off approximately $929,000 of capitalized costs for patent applications that were withdrawn or abandoned during the year ended April 30, 2015. These asset impairment charges primarily related to the Company’s PFC formulations which were determined not to be a core component of the Company’s development strategy.

 

The Company capitalized patent costs of approximately $0 and $64,000, for the six months ended October 31, 2015 and 2014, respectively.

 

Trademarks

 

The Company currently holds, or has filed for, trademarks to protect the use of names and descriptions of its products and technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its trademark applications. These trademarks are evaluated annually for impairment in accordance with ASC 350, Intangibles – Goodwill and Other. The Company evaluates (i) its expected use of the underlying asset, (ii) any laws, regulations, or contracts that may limit the useful life, (iii) the effects of obsolescence, demand, competition, and stability of the industry, and (iv) the level of costs to be incurred to commercialize the underlying asset.

 

The Company wrote-off trademark costs of approximately $106,000 for the year ended April 30, 2015. These asset impairment charges primarily related to the Company’s PFC formulations which were determined not to be a core component of the Company’s development strategy.

 

The Company did not capitalize any trademark costs for the six months ended October 31, 2015 and 2014.

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4. BALANCE SHEET COMPONENTS (Details Narrative) - USD ($)
3 Months Ended 6 Months Ended
Oct. 31, 2015
Oct. 31, 2014
Oct. 31, 2015
Oct. 31, 2014
Balance Sheet Components Details Narrative        
Depreciation expense $ 12,000 $ 21,000 $ 25,000 $ 43,000
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3. FAIR VALUE (Details) - Corporate debt securities
6 Months Ended
Oct. 31, 2015
USD ($)
Amortized Cost $ 35,482,306
Accrued Interest 297,005
Gross Unrealized Gains 3
Gross Unrealized losses (17,876)
Estimated Fair Value $ 35,761,438