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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

FOR THE QUARTERLY PERIOD ENDED June 30, 2020

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: 001-33185

 

MEDICINOVA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

33-0927979

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

4275 Executive Square, Suite 300

La Jolla, CA

 

92037

(Address of Principal Executive Offices)

 

(Zip Code)

 

(858) 373-1500

(Registrant’s Telephone Number, Including Area Code)

 

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

 

Common Stock, $0.001 par value

 

MNOV

 

The Nasdaq Stock Market LLC

(Title of each class)

 

(Trading symbol(s))

 

(Name of each exchange on which registered)

 

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

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

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

Large accelerated filer

Accelerated filer

          

 

 

 

 

 

 


 

Non-accelerated filer

  

Smaller reporting company

 

Emerging growth company           

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

 

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

As of July 27, 2020, the registrant had 44,372,943 shares of Common Stock ($0.001 par value) outstanding.

 

 


 

2


 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q, in particular "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations," and the information incorporated by reference herein contains “forward-looking statements”. The forward-looking statements are contained principally in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this report. Forward-looking statements include all statements that are not historical facts and, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or the negative version of these words and similar expressions.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including those described in "Risk Factors" and elsewhere in this report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our beliefs and assumptions only as of the date of this report. Considering the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. You should read this report completely and with the understanding that our actual future results may be materially different from what we expect.

The following factors are among those that may cause actual results to differ materially from our forward-looking statements:

 

The widespread outbreak of an illness or any other communicable disease, such as COVID-19, or any other public health crisis, could adversely affect our business, results of operations and financial condition;

 

Inability to raise additional capital if needed;

 

Inability to generate revenues from product sales to continue business operations;

 

Inability to develop and commercialize our product candidates;

 

Failure or delay in completing clinical trials or obtaining Food and Drug Administration or foreign regulatory approval for our product candidates in a timely manner;

 

Unsuccessful clinical trials stemming from clinical trial designs, failure to enroll a sufficient number of patients, undesirable side effects and other safety concerns;

 

Inability to demonstrate sufficient efficacy of product candidates;

 

Reliance on the success of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates;

 

Delays in commencement or completion of clinical trials or suspension or termination of clinical trials;

 

Loss of our licensed rights to develop and commercialize a product candidate as a result of the termination of the underlying licensing agreement;

 

Competitors may develop products rendering our product candidates obsolete and noncompetitive;

 

Inability to successfully attract partners and enter into collaborations on acceptable terms;

 

Dependence on third parties to conduct clinical trials and to manufacture product candidates;

 

Dependence on third parties to market and distribute products;

 

Our product candidates, if approved, may not gain market acceptance or obtain adequate coverage for third party reimbursement;

 

Disputes or other developments concerning our intellectual property rights;

 

Actual and anticipated fluctuations in our quarterly or annual operating results;

 

Price and volume fluctuations in the overall stock markets;

 

Litigation or public concern about the safety of our potential products;

 

International trade or foreign exchange restrictions, increased tariffs, foreign currency exchange;

 

High quality material for our products may become difficult to obtain or expensive;

 

3


 

 

Strict government regulations on our business;

 

Regulations governing the production or marketing of our product candidates;

 

Loss of, or inability to attract, key personnel; and

 

Economic, political, foreign exchange and other risks associated with international operations.

 

 

 

 

 

4


 

MEDICINOVA, INC.

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

6

 

 

 

ITEM 1.

 

CONSOLIDATED FINANCIAL STATEMENTS (unaudited)

6

ITEM 2.

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

16

ITEM 3.

 

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

21

ITEM 4.

 

CONTROLS AND PROCEDURES

21

 

 

 

 

PART II. OTHER INFORMATION

22

 

 

 

 

ITEM 1.

 

LEGAL PROCEEDINGS

22

ITEM 1A.

 

RISK FACTORS

22

ITEM 2.

 

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

22

ITEM 3.

 

DEFAULTS UPON SENIOR SECURITIES

22

ITEM 4.

 

MINE SAFETY DISCLOSURES

22

ITEM 5.

 

OTHER INFORMATION

22

ITEM 6.

 

EXHIBITS

23

 

 

SIGNATURES

24

 

 

 

 

5


 

PART I. FINANCIAL INFORMATION

ITEM 1.

CONSOLIDATED FINANCIAL STATEMENTS.

 

 

MEDICINOVA, INC.

CONSOLIDATED BALANCE SHEETS 

 

 

 

June 30,

 

 

 

 

December 31,

 

 

 

2020

 

 

 

 

2019

 

 

 

(Unaudited)

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

60,440,450

 

 

 

 

$

63,792,657

 

Prepaid expenses and other current assets

 

 

605,677

 

 

 

 

 

511,916

 

Total current assets

 

 

61,046,127

 

 

 

 

 

64,304,573

 

Goodwill

 

 

9,600,240

 

 

 

 

 

9,600,240

 

In-process research and development

 

 

4,800,000

 

 

 

 

 

4,800,000

 

Property and equipment, net

 

 

32,927

 

 

 

 

 

40,550

 

Other non-current assets

 

 

359,147

 

 

 

 

 

459,811

 

Total assets

 

$

75,838,441

 

 

 

 

$

79,205,174

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

576,506

 

 

 

 

$

451,326

 

Accrued expenses and other liabilities

 

 

2,197,254

 

 

 

 

 

1,776,912

 

Total current liabilities

 

 

2,773,760

 

 

 

 

 

2,228,238

 

Long-term deferred revenue

 

 

1,694,163

 

 

 

 

 

1,694,163

 

Deferred tax liability

 

 

201,792

 

 

 

 

 

201,792

 

Other non-current liabilities

 

 

75,783

 

 

 

 

 

186,358

 

Total liabilities

 

 

4,745,498

 

 

 

 

 

4,310,551

 

Commitments and contingencies

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized at June 30, 2020 and December 31, 2019; 44,263,578 and 43,908,065 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

 

 

44,264

 

 

 

 

 

43,908

 

Additional paid-in capital

 

 

447,379,208

 

 

 

 

 

444,016,341

 

Accumulated other comprehensive loss

 

 

(92,796

)

 

 

 

 

(92,681

)

Accumulated deficit

 

 

(376,237,733

)

 

 

 

 

(369,072,945

)

Total stockholders’ equity

 

 

71,092,943

 

 

 

 

 

74,894,623

 

Total liabilities and stockholders' equity

 

$

75,838,441

 

 

 

 

$

79,205,174

 

 

See accompanying notes.

 

6


 

MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

  

 

 

Three months ended

 

 

Six months ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and patents

 

$

2,199,036

 

 

$

1,465,512

 

 

$

3,449,781

 

 

$

3,099,390

 

General and administrative

 

 

2,311,330

 

 

 

2,716,509

 

 

 

3,985,084

 

 

 

6,061,990

 

Total operating expenses

 

 

4,510,366

 

 

 

4,182,021

 

 

 

7,434,865

 

 

 

9,161,380

 

Operating loss

 

 

(4,510,366

)

 

 

(4,182,021

)

 

 

(7,434,865

)

 

 

(9,161,380

)

Interest income

 

 

63,691

 

 

 

307,574

 

 

 

286,971

 

 

 

611,819

 

Other expense

 

 

(4,554

)

 

 

(7,429

)

 

 

(16,894

)

 

 

(29,505

)

Net loss applicable to common stockholders

 

$

(4,451,229

)

 

$

(3,881,876

)

 

$

(7,164,788

)

 

$

(8,579,066

)

Basic and diluted net loss per common share

 

$

(0.10

)

 

$

(0.09

)

 

$

(0.16

)

 

$

(0.20

)

Shares used to compute basic and diluted net

   loss per common share

 

 

44,091,568

 

 

 

43,069,007

 

 

 

44,020,429

 

 

 

42,770,117

 

Net loss applicable to common stockholders

 

$

(4,451,229

)

 

$

(3,881,876

)

 

$

(7,164,788

)

 

$

(8,579,066

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

5

 

 

 

3,355

 

 

 

(115

)

 

 

1,574

 

Comprehensive loss

 

$

(4,451,224

)

 

$

(3,878,521

)

 

$

(7,164,903

)

 

$

(8,577,492

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.


 

7


 

MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

 

 

 

 

Six Months Ended June 30, 2020

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

Balance at December 31, 2019

 

 

43,908,065

 

 

$

43,908

 

 

$

444,016,341

 

 

$

(92,681

)

 

$

(369,072,945

)

 

$

74,894,623

 

Share-based compensation

 

 

 

 

 

 

596,378

 

 

 

 

 

 

 

596,378

 

Issuance of shares under an employee stock purchase plan (ESPP)

 

 

1,979

 

 

 

2

 

 

 

6,252

 

 

 

 

 

 

 

6,254

 

Issuance of common stock under at-the-market equity distribution

   and sales agreements, net of offering costs

 

 

68,952

 

 

 

69

 

 

 

412,623

 

 

 

 

 

 

 

 

 

412,692

 

Net loss

 

 

 

 

 

 

 

 

 

 

(2,713,559

)

 

 

(2,713,559

)

Foreign currency translation adjustments

 

 

 

 

 

 

 

 

(120

)

 

 

 

 

(120

)

Balance at March 31, 2020

 

 

43,978,996

 

 

 

43,979

 

 

 

445,031,594

 

 

 

(92,801

)

 

 

(371,786,504

)

 

 

73,196,268

 

Share-based compensation

 

 

 

 

 

 

 

 

1,147,154

 

 

 

 

 

 

 

 

 

1,147,154

 

Issuance of common stock for option exercises

 

 

143,863

 

 

 

144

 

 

 

438,118

 

 

 

 

 

 

 

438,262

 

Issuance of common stock under at-the-market equity distribution

   and sales agreements, net of offering costs

 

 

140,719

 

 

 

141

 

 

 

762,342

 

 

 

 

 

 

 

 

 

762,483

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,451,229

)

 

 

(4,451,229

)

Foreign currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

5

 

 

 

 

 

 

5

 

Balance at June 30, 2020

 

 

44,263,578

 

 

$

44,264

 

 

$

447,379,208

 

 

$

(92,796

)

 

$

(376,237,733

)

 

$

71,092,943

 

 

 

 

 

Six Months Ended June 30, 2019

 

 

 

Common stock

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total

stockholders’

 

 

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

Balance at December 31, 2018

 

 

42,081,306

 

 

$

42,081

 

 

$

429,289,968

 

 

$

(93,150

)

 

$

(356,131,287

)

 

$

73,107,612

 

Share-based compensation

 

 

 

 

 

 

 

 

2,699,500

 

 

 

 

 

 

 

 

 

2,699,500

 

Issuance of shares under an employee stock purchase plan

 

 

2,401

 

 

 

2

 

 

 

16,901

 

 

 

 

 

 

 

 

 

16,903

 

Issuance of common stock under at-the-market equity distribution

   and sales agreements, net of offering costs

 

 

 

 

 

 

 

 

(8,532

)

 

 

 

 

 

 

 

 

(8,532

)

Issuance of common stock for option exercises

 

 

977,454

 

 

 

978

 

 

 

3,919,757

 

 

 

 

 

 

 

 

 

3,920,735

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,697,190

)

 

 

(4,697,190

)

Foreign currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

(1,781

)

 

 

 

 

 

(1,781

)

Balance at March 31, 2019

 

 

43,061,161

 

 

 

43,061

 

 

 

435,917,594

 

 

 

(94,931

)

 

 

(360,828,477

)

 

 

75,037,247

 

Share-based compensation

 

 

 

 

 

 

 

 

1,842,514

 

 

 

 

 

 

 

 

 

1,842,514

 

Issuance of common stock for option exercises

 

 

38,000

 

 

 

38

 

 

 

180,332

 

 

 

 

 

 

 

 

 

180,370

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,881,876

)

 

 

(3,881,876

)

Foreign currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

3,355

 

 

 

 

 

 

3,355

 

Balance at June 30, 2019

 

 

43,099,161

 

 

$

43,099

 

 

$

437,940,440

 

 

$

(91,576

)

 

$

(364,710,353

)

 

$

73,181,610

 

 

See accompanying notes.

 


 

8


 

MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six months ended

 

 

 

June 30,

 

 

 

2020

 

 

2019

 

Operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(7,164,788

)

 

$

(8,579,066

)

Adjustments to reconcile net loss to net cash used in operating

   activities:

 

 

 

 

 

 

 

 

Non-cash stock-based compensation

 

 

1,743,532

 

 

 

4,542,014

 

Depreciation and amortization

 

 

10,270

 

 

 

12,337

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

8,583

 

 

 

(508,053

)

Accounts payable, accrued liabilities and other liabilities

 

 

433,224

 

 

 

(148,832

)

Net cash used in operating activities

 

 

(4,969,179

)

 

 

(4,681,600

)

Investing activities:

 

 

 

 

 

 

 

 

Acquisition of property and equipment

 

 

(2,604

)

 

 

(4,013

)

Net cash used in investing activities

 

 

(2,604

)

 

 

(4,013

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, exercise of common

stock options and warrants, net of issuance costs

 

 

1,613,437

 

 

 

4,092,573

 

Proceeds from issuance of equity awards under ESPP

 

 

6,254

 

 

 

16,903

 

Net cash provided by financing activities

 

 

1,619,691

 

 

 

4,109,476

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(115

)

 

 

561

 

Net change in cash and cash equivalents

 

 

(3,352,207

)

 

 

(575,576

)

Cash and cash equivalents, beginning of period

 

 

63,792,657

 

 

 

62,313,418

 

Cash and cash equivalents, end of period

 

$

60,440,450

 

 

$

61,737,842

 

 

See accompanying notes.

 

 

 

9


 

MEDICINOVA, INC.

Notes to Consolidated Financial Statements

(Unaudited)

 

 

1. Interim Financial Information

Organization and Business

MediciNova, Inc. (the “Company” or “MediciNova”) was incorporated in the state of Delaware in September 2000 and is a public company. The Company’s common stock is listed in both the United States and Japan and trades on the NASDAQ Global Market and the JASDAQ Market of the Tokyo Stock Exchange. MediciNova is a biopharmaceutical company focused on developing novel, small molecule therapeutics for the treatment of serious diseases with unmet medical needs with a commercial focus on the United States market. The Company’s current strategy is to focus its development activities on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence and alcohol dependence), as well as for acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). The Company’s pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.

These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2019 included in the Company’s Annual Report on Form 10-K filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2019 has been derived from the audited financial statements at that date but does not include all the information and footnotes required by GAAP for complete financial statements.

Principles of Consolidation

The consolidated financial statements include the accounts of MediciNova, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances are eliminated in consolidation.  

Segment Reporting

The Company operates in a single operating segment – the acquisition and development of small molecule therapeutics for the treatment of serious diseases with unmet medical needs.

Cash and Cash Equivalents

         Cash and cash equivalents consist of cash and other highly liquid investments including money market accounts.

Research, Development and Patents

Research and development costs are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, facilities and depreciation, research and development supplies, licenses and outside services. Such research and development costs totaled $2.1 million and $1.4 million for the three months ended June 30, 2020 and 2019, respectively and $3.3 million and $2.9 million for the six months ended June 30, 2020 and 2019, respectively.

 

 

10


 

Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain. The Company includes all external costs related to the filing of patents on developments in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for each of the three months ended June 30, 2020 and 2019, respectively and $0.2 million for each of the six months ended June 30, 2020 and 2019, respectively.

Clinical Trial Accruals and Prepaid Expenses

Costs for preclinical studies, clinical studies and manufacturing activities are recognized as research and development expenses based on an evaluation of the progress by Company vendors towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided to the Company by such vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services are performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of studies, or the services completed. The Company’s estimates of accrued expenses as of each balance sheet date are based on the facts and circumstances known at the time. Costs that are paid in advance of performance are deferred as a prepaid expense and amortized over the service period as the services are provided.

Impact of COVID-19 on the Company’s Business

The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect the Company’s business. Although the pandemic resulted in a decrease in the number of patient visits at certain of the Company’s clinical trial sites, the Company expects this effect to be temporary. The Company has seen an increase in the number of patient visits compared to earlier in the pandemic and the Company continues to enroll patients in clinical trials. Throughout the pandemic, the Company has continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, the Company designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, which was based on positive results of a recently published study of MN-166 (ibudilast) in an animal model of ARDS.  During the pandemic, the Company has been able to continue with routine regulatory activities.  For example, the Company successfully submitted an Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) which was accepted and is now open with the U.S. Food and Drug Administration (FDA). The Company was also informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed. Based on the Company’s current assessment, the Company does not expect a material negative impact on its clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, the Company is actively monitoring this situation and the possible effects on its financial condition, liquidity, operations, suppliers, industry, and workforce.

Use of Estimates

The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.

Recent Accounting Pronouncements

In August 2018, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2018-13, Fair Value Measurement (Topic 820), which eliminates, adds and modifies certain disclosure requirements for fair value measurements. The modified standard eliminates the requirement to disclose changes in unrealized gains and losses included in earnings for recurring Level 3 fair value measurements and requires that changes in unrealized gains and losses be included in other comprehensive income for recurring Level 3 fair value measurements of instruments. The standard also requires the disclosure of the range and weighted average used to develop significant unobservable inputs and how weighted average is calculated for recurring and nonrecurring Level 3 fair value measurements. The amendment was effective for fiscal years beginning after December 15, 2019 and interim periods within that fiscal year with early adoption permitted. The Company adopted ASU 2018-13 on January 1, 2020 with no material impact on its consolidated financial statements.

 

 

11


 

2. Revenue Recognition

Revenue Recognition Policy

Revenues consist mainly of research and development services performed under a contract with a customer. The Company evaluates the separate performance obligation(s) under each contract, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations over time or at a point in time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance (2) the vendor creates or enhances an asset controlled by the customer (3) the vendor’s performance does not create an asset for which the vendor has an alternative use, and the vendor has an enforceable right to payment for performance completed to date.

Kissei Pharmaceutical Co., Ltd

In October 2011, the Company entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., (“Kissei”), to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $2.5 million. Under the terms of the agreement, the Company is responsible for all costs to be incurred in the performance of these services. The Company assessed the services in accordance with the authoritative guidance and concluded that the two studies to be performed under the agreement represented two separate performance obligations. The transaction price was allocated among the two studies that were deemed separate performance obligations based on the expected costs to be incurred for each obligation. Revenue is recognized proportional to the total costs expected for each performance obligation as incurred over the service period. The first study was completed in 2013 and the timing of the second study is undetermined as of June 30, 2020. The amount received from Kissei and allocated, net of the amount recorded as revenue, is included on the balance sheet as long-term deferred revenue and will be recognized as revenue as the remaining performance obligation is satisfied. No revenue was recognized for the three and six months ended June 30, 2020 and 2019 in connection with the collaboration agreement with Kissei.

3. Fair Value Measurements

Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1: 

Observable inputs such as quoted prices in active markets;

 

 

Level 2: 

Inputs are quoted prices for similar items in active markets or quoted prices for identical or similar items in markets that are not active near the measurement date; and

 

 

Level 3: 

Unobservable inputs due to little or no market data, which require the reporting entity to develop its own assumptions.

Cash equivalents, including money market accounts of $694,042 and $691,649 measured at fair value as of June 30, 2020 and December 31, 2019, respectively, are classified within Level 1.

 

4. Stock-based Compensation

Stock Incentive Plans

In June 2013, the Company adopted the 2013 Equity Incentive Plan, or 2013 Plan, under which the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. The 2013 Plan is the successor to the Company’s Amended and Restated 2004 Stock Incentive Plan, or 2004 Plan. A total of 8,700,000 shares of common stock are reserved for issuance under the 2013 Plan. In addition, “returning shares” that may become available from time to time are added back to the plan. “Returning shares” are shares that are subject to outstanding awards granted under the 2004 Plan that expire or terminate prior to exercise or settlement, are forfeited because of the failure to vest, are repurchased, or are withheld to satisfy tax withholding or purchase price obligations in connection with such awards. Although the Company no longer grants equity awards under the 2004 Plan, all outstanding stock awards granted under the 2004 Plan will continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the 2004 Plan. As of June 30, 2020, 2,833,135 shares remain available for future grants under the 2013 Plan.

The Company occasionally issues employee performance-based stock options, the vesting of which is based on a determination made by the board of directors as to the achievement of certain corporate objectives at the end of the performance period. The grant

 

12


 

date of such awards is the date on which the board of directors makes its determination. For periods preceding the grant date, the expense related to these awards is measured based on their fair value at each reporting date.

Stock Options

Options granted under the 2013 Plan and the 2004 Plan have terms of ten years from the date of grant unless earlier terminated and generally vest over a three or four year period. The exercise price of all options granted through June 30, 2020 and in 2019, was equal to the market value of the Company’s common stock on the date of grant.

A summary of stock option activity and related information as of June 30, 2020 is as follows:

 

 

 

Number of

Option Shares

 

 

Weighted Average

Exercise Price

 

 

Outstanding at December 31, 2019

 

 

6,802,093

 

 

$

5.61

 

 

Granted

 

 

1,331,000

 

 

 

6.70

 

 

Exercised

 

 

(143,863

)

 

 

3.05

 

 

Cancelled

 

 

(379,843

)

 

 

9.17

 

 

Outstanding at June 30, 2020

 

 

7,609,387

 

 

$

5.67

 

 

Exercisable at June 30, 2020

 

 

6,285,887

 

 

$

5.45

 

 

 

Employee Stock Purchase Plan

Under the Company’s 2007 Employee Stock Purchase Plan (ESPP), 300,000 shares of common stock were originally reserved for issuance. In addition, the shares reserved automatically increase each year by a number equal to the lesser of: (i) 15,000 shares; (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser amount as determined by the Board. The ESPP permits full-time employees to purchase common stock through payroll deductions (which cannot exceed 15% of each employee’s compensation) at the lower of 85% of fair market value at the beginning of the offering period or the end of each six-month offering period. The ESPP is considered a compensatory plan and the Company records compensation expense included in the Company’s statement of operations.

For the six months ended June 30, 2020, an aggregate of 1,979 shares were issued under the ESPP. As of June 30, 2020, there were 215,957 shares available for future issuance under the ESPP.

Compensation Expense

Stock-based compensation expense for stock option awards and ESPP shares are reflected in total operating expenses for each respective year.

The following table summarizes stock-based compensation expenses for the three and six months ended June 30, 2020 and 2019, respectively:

 

 

Three months ended

 

 

Six months ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Research, development and patents

 

$

349,294

 

 

$

540,591

 

 

$

511,991

 

 

$

1,333,648

 

General and administrative

 

 

797,860

 

 

 

1,301,923

 

 

 

1,231,541

 

 

 

3,208,366

 

Total stock-based compensation expense

 

$

1,147,154

 

 

$

1,842,514

 

 

$

1,743,532

 

 

$

4,542,014

 

 

13


 

The Company uses the Black-Scholes valuation model for determining the estimated fair value for stock-based awards granted to employees and stock purchased under the ESPP. The following table provides the assumptions used in the Black-Scholes valuation model used to estimate the fair value of options granted and stock purchased under the ESPP during the six months ended June 30, 2020 and 2019, and to estimate the fair value of performance-based stock options as of June 30, 2020 and 2019.

 

 

 

Six months ended

 

 

 

June 30, 2020

 

 

June 30, 2019

 

Stock Option assumptions:

 

 

 

 

 

 

 

 

Risk-free interest rate

 

0.29 - 1.68%

 

 

1.76 - 2.19%

 

Expected volatility of common stock

 

57.44 - 66.49%

 

 

61.9 - 62.58%

 

Dividend yield

 

0%

 

 

0%

 

Expected term (in years)

 

4.5 - 5.6

 

 

5.0 - 5.3

 

ESPP assumptions:

 

 

 

 

 

 

 

 

Risk-free interest rate

 

0.14%

 

 

2.46%

 

Expected volatility of common stock

 

81.70%

 

 

72.5%

 

Dividend yield

 

0.0%

 

 

0.0%

 

Expected term (in years)

 

 

0.5

 

 

 

0.5

 

 

As of June 30, 2020, there was $2.0 million of unamortized compensation cost related to unvested stock option awards which is expected to be recognized over a remaining weighted-average vesting period of 0.63 years, on a straight-line basis.

5. Stockholders’ Equity

At-The-Market Issuance Sales Agreements

On May 22, 2015, the Company entered into an at-the-market issuance sales agreement (the “2015 ATM Agreement”) with MLV & Co. LLC (MLV), pursuant to which the Company could sell common stock through MLV from time to time up to an aggregate offering price of $30.0 million. Sales of the Company’s common stock through MLV, if any, were to be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or to or through a market maker. MLV could also sell the common stock in privately negotiated transactions, subject to the Company’s prior approval. The Company agreed to pay MLV an aggregate commission rate of up to 4.0% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock depended on the number of shares of common stock sold to MLV and the per share purchase price of each transaction. 

The Company was not obligated to make any sales of common stock under the sales agreement and could terminate the sales agreement at any time upon written notice. On September 16, 2016, the Company amended the original sales agreement with MLV to also include FBR Capital Markets & Co. as a sales agent. The 2015 ATM Agreement was terminated on August 23, 2019.

On August 23, 2019, the Company entered into an at market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which the Company may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million. Sales of the Company’s common stock through B. Riley FBR, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on NASDAQ, on any other existing trading market for the common stock or through a market maker. B. Riley FBR may also sell the common stock in privately negotiated transactions, subject to the Company’s prior approval. The Company agreed to pay B. Riley FBR an aggregate commission rate of up to 3.5% of the gross proceeds of any common stock sold under this agreement. Proceeds from sales of common stock will depend on the number of shares of common stock sold to B. Riley FBR and the per share purchase price of each transaction.

For the six months ended June 30, 2020 the Company generated net proceeds of $1.2 million under the 2019 ATM Agreement, on sales of 209,671 shares of the Company’s common stock at a weighted average price of $5.83 per share.

 

 

 

14


 

6. Net Loss Per Share

The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option agreements. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive.

Potentially dilutive outstanding securities excluded from diluted net loss per common share due to their anti-dilutive effect totaled 7,609,387 shares and 6,826,193 shares as of June 30, 2020 and 2019, respectively.

 

7. Subsequent Events

At-The-Market Issuance

Subsequent to June 30, 2020 and through July 23, 2020, the Company sold 109,365 shares of common stock under the ATM Agreement at a weighted average price of $5.73 per share for net proceeds of $0.6 million.

 

 

 

15


 

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q and the audited financial statements and notes thereto as of and for the year ended December 31, 2019 included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 13, 2020. Past operating results are not necessarily indicative of results that may occur in future periods.

This Quarterly Report on Form 10-Q contains forward-looking statements that are subject to risks and uncertainties, many of which are beyond our control. Our actual results may differ from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II of this Quarterly Report on Form 10-Q under the caption “Item 1A. Risk Factors” and under the caption “Item 1A. Risk Factors” in our Annual Report on Form 10-K. The differences may be material. Forward-looking statements discuss matters that are not historical facts. Forward-looking statements include, but are not limited to, statements regarding our plans, strategies, objectives, product development programs, clinical trials, industry, financial condition, liquidity and capital resources, future performance and other statements that are not historical facts. Such forward-looking statements include statements preceded by, followed by or that otherwise include the words “may,” “might,” “will,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “estimate,” “anticipate,” “predict,” “potential,” “plan” or similar words. For such statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not rely unduly on these forward-looking statements, which speak only as of the date hereof. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.

Overview

We are a biopharmaceutical company focused on developing novel, small molecule therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, and substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), as well as for acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). Our pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers. We were incorporated in Delaware in September 2000.

We have incurred significant net losses since our inception. As of June 30, 2020, from inception, our accumulated deficit was $376.2 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.

Our goal is to build a sustainable biopharmaceutical business through the successful development of differentiated products for the treatment of serious diseases with unmet medical needs in high-value therapeutic areas. Key elements of our strategy are as follows:

 

Pursue the development of MN-166 (ibudilast) for multiple potential indications with the support of non-dilutive financings.

We intend to advance our diverse MN-166 (ibudilast) program through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, and trials funded by us. In addition to providing drug supply and regulatory support, we have funded portions of some of the consortium-sponsored trials. For example, we contributed financially to the Secondary and Primary Progressive Ibudilast NeuroNEXT Trial in Multiple Sclerosis (SPRINT-MS) Phase 2b clinical trial of MN-166 (ibudilast) for the treatment of progressive MS, which was primarily funded by the NIH. In addition, we contributed financially to the clinical trials of MN-166 (ibudilast) that enrolled ALS patients. We intend to pursue additional strategic alliances to help support further clinical development of MN-166 (ibudilast).

 

Pursue the development of MN-001 (tipelukast) for fibrotic and other diseases.

We intend to advance development of MN-001 (tipelukast) through a variety of means, which may include investigator-sponsored trials with or without grant funding as well as trials funded by us.

 

16


 

 

Consider strategic partnerships with one or more leading pharmaceutical companies to complete product development and successfully commercialize our products.

We develop and maintain relationships with pharmaceutical companies that are therapeutic category leaders. We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as MN-166 (ibudilast), MN-001 (tipelukast), MN-221 (bedoradrine) and MN-029 (denibulin), which could further support our clinical development and product commercialization.

Impact of COVID-19 on Our Business

The pandemic caused by an outbreak of a new strain of coronavirus (“COVID-19” or “the pandemic”) has resulted, and is likely to continue to result, in significant national and global economic disruption and may adversely affect our business. Although the pandemic resulted in a decrease in the number of patient visits at certain of our clinical trial sites, we expect this effect to be temporary. We have seen an increase in the number of patient visits compared to earlier in the pandemic and we continue to enroll patients in our clinical trials. Throughout the pandemic, we have continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board (IRB) approvals, site training, and other activities related to the initiation of new clinical trial sites. In addition, following the outbreak of the pandemic, we designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, which was based on positive results of a recently published study of MN-166 (ibudilast) in an animal model of ARDS.  During the pandemic, we have been able to continue with routine regulatory activities.  For example, we successfully submitted an Investigational New Drug Application (IND) for MN-166 (ibudilast) for prevention of Acute Respiratory Distress Syndrome (ARDS) which was accepted and is now open with the U.S. Food and Drug Administration (FDA). We were also informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed. Based on management’s current assessment, we do not expect a material negative impact on our clinical development plans, long-term development timeline or liquidity due to the worldwide spread of the COVID-19 virus. However, we are actively monitoring this situation and the possible effects on our financial condition, liquidity, operations, suppliers, industry, and workforce.

Revenues and Cost of Revenues

In October 2011, we entered into a collaboration agreement with Kissei Pharmaceutical Co., Ltd., or Kissei, to perform research and development services relating to MN-221 (bedoradrine) in exchange for a non-refundable upfront payment of $2.5 million. Under the terms of the agreement, we are responsible for all costs to be incurred in the performance of these services. We assessed the services in accordance with the authoritative guidance and concluded that the two studies to be performed under the agreement represented two separate performance obligations. The transaction price was allocated between the two studies that were deemed separate performance obligations based on the expected costs to be incurred for each obligation. Revenue is recognized proportional to the total costs expected for each performance obligation as incurred over the service period. The first study was completed in 2013 and the timing of the second study is undetermined as of June 30, 2020. The amount received from Kissei and allocated, net of the amount recorded as revenue, is included on the balance sheet as long-term deferred revenue since it is non-refundable and not expected to be started within the next year and will be recognized as revenue as the remaining performance obligation is satisfied. No revenue was recognized in the three months ended June 30, 2020 and 2019, in connection with the collaboration agreement with Kissei.

Research, Development and Patents Expenses

Our research, development and patents expenses consist primarily of license fees related to our product candidates, salaries and related employee benefits, costs associated with the preclinical and clinical development of our product development programs, costs associated with non-clinical activities, such as regulatory expenses, and pre-commercialization manufacturing development activities. We use external service providers to manufacture our compounds to be used in clinical trials and for the majority of the services performed in connection with the preclinical and clinical development of our product candidates. Research, development and patents expenses include fees paid to consultants, contract research organizations, contract manufacturers and other external service providers, including professional fees and costs associated with legal services, patents and patent applications for our intellectual property. Internal research and development expenses include costs of compensation and other expenses for research and development personnel, supplies, facility costs and depreciation. Research, development and patents costs are expensed as incurred and we expect to increase such costs throughout 2020 as our development programs progress.

The following table summarizes our research, development and patents expenses for the periods indicated for each of our product development programs. To the extent that costs, including personnel costs, are not tracked to a specific product development program, such costs are included in the “Other R&D expense” category (in thousands):

 

17


 

 

 

 

Three months ended

 

 

Six months ended

 

 

 

June 30,

 

 

June 30,

 

 

 

 

2020

 

 

 

2019

 

 

 

2020

 

 

 

2019

 

External development expense:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MN-221

 

$

(8

)

 

$

5

 

 

$

(5

)

 

$

14

 

MN-166

 

 

1,415

 

 

 

499

 

 

 

2,033

 

 

 

896

 

MN-001

 

 

48

 

 

 

37