10-Q

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 September 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 October 22, 2020, the registrant had 44,927,560 shares of Common Stock ($0.001 par value) outstanding.

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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;

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• 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	20
ITEM 4.	CONTROLS AND PROCEDURES	20
PART II. OTHER INFORMATION		21
ITEM 1.	LEGAL PROCEEDINGS	21
ITEM 1A.	RISK FACTORS	21
ITEM 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS	21
ITEM 3.	DEFAULTS UPON SENIOR SECURITIES	21
ITEM 4.	MINE SAFETY DISCLOSURES	21
ITEM 5.	OTHER INFORMATION	21
ITEM 6.	EXHIBITS	22
SIGNATURES		23

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PART I. FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS.

MEDICINOVA, INC.

CONSOLIDATED BALANCE SHEETS 

	September 30,			December 31,
	2020			2019
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	61,661,341		$	63,792,657
Prepaid expenses and other current assets		893,843			511,916
Total current assets		62,555,184			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		28,857			40,550
Other non-current assets		309,112			459,811
Total assets	$	77,293,393		$	79,205,174
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	376,271		$	451,326
Accrued expenses and other liabilities		1,428,003			1,776,912
Total current liabilities		1,804,274			2,228,238
Long-term deferred revenue		1,694,163			1,694,163
Deferred tax liability		201,792			201,792
Other non-current liabilities		39,891			186,358
Total liabilities		3,740,120			4,310,551
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019; 44,927,560 and 43,908,065 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively		44,928			43,908
Additional paid-in capital		453,539,933			444,016,341
Accumulated other comprehensive loss		(90,035	)		(92,681	)
Accumulated deficit		(379,941,553	)		(369,072,945	)
Total stockholders’ equity		73,553,273			74,894,623
Total liabilities and stockholders' equity	$	77,293,393		$	79,205,174

See accompanying notes.

6

MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

	Three months ended						Nine months ended
	September 30,						September 30,
	2020			2019			2020			2019
Operating expenses:
Research, development and patents	$	2,237,877		$	1,150,815		$	5,687,658		$	4,250,205
General and administrative		1,492,139			1,494,750			5,477,223			7,556,740
Total operating expenses		3,730,016			2,645,565			11,164,881			11,806,945
Operating loss		(3,730,016	)		(2,645,565	)		(11,164,881	)		(11,806,945	)
Interest income		37,204			288,643			324,175			900,462
Other expense		(11,008	)		(21,582	)		(27,902	)		(51,087	)
Net loss applicable to common stockholders	$	(3,703,820	)	$	(2,378,504	)	$	(10,868,608	)	$	(10,957,570	)
Basic and diluted net loss per common share	$	(0.08	)	$	(0.05	)	$	(0.25	)	$	(0.26	)
Shares used to compute basic and diluted net    loss per common share		44,643,736			43,343,329			44,229,715			42,963,287
Net loss applicable to common stockholders	$	(3,703,820	)	$	(2,378,504	)	$	(10,868,608	)	$	(10,957,570	)
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustments		2,761			(782	)		2,646			792
Comprehensive loss	$	(3,701,059	)	$	(2,379,286	)	$	(10,865,962	)	$	(10,956,778	)

See accompanying notes.

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MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

	Nine Months Ended September 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
Share-based compensation		—		—		1,033,971		—			—			1,033,971
Issuance of common stock for option exercises		60,000		60		187,990	—			—				188,050
Issuance of shares under an employee stock purchase plan (ESPP)		1,855		2		5,452		—			—			5,454
Issuance of common stock under at-the-market equity distribution    and sales agreements, net of offering costs		602,127		602		4,933,312		—			—			4,933,914
Net loss		—		—		—		—			(3,703,820	)		(3,703,820	)
Foreign currency translation adjustments		—		—		—		2,761			—			2,761
Balance at September 30, 2020		44,927,560	$	44,928	$	453,539,933	$	(90,035	)	$	(379,941,553	)	$	73,553,273

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	Nine Months Ended September 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
Share-based compensation		—		—		373,844			—			—			373,844
Issuance of shares under an employee stock purchase plan (ESPP)		1,541		2		10,415			—			—			10,417
Issuance of common stock, net of offering costs		347,902		348		3,164,107			—			—			3,164,455
Net loss		—		—		—			—			(2,378,504	)		(2,378,504	)
Foreign currency translation adjustments		—		—		—			(782	)		—			(782	)
Balance at September 30, 2019		43,448,604	$	43,449	$	441,488,806		$	(92,358	)	$	(367,088,857	)	$	74,351,040

See accompanying notes.

9

MEDICINOVA, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	Nine months ended
	September 30,
	2020			2019
Operating activities:
Net loss	$	(10,868,608	)	$	(10,957,570	)
Adjustments to reconcile net loss to net cash used in operating    activities:
Non-cash stock-based compensation		2,777,503			4,915,858
Depreciation and amortization		15,487			18,347
Changes in assets and liabilities:
Prepaid expenses and other assets		(225,543	)		(452,515	)
Accounts payable, accrued liabilities and other liabilities		(576,116	)		(244,725	)
Net cash used in operating activities		(8,877,277	)		(6,720,605	)
Investing activities:
Acquisition of property and equipment		(3,794	)		(4,013	)
Net cash used in investing activities		(3,794	)		(4,013	)
Financing activities:
Proceeds from issuance of common stock, exercise of common stock options and warrants, net of issuance costs		6,735,401			7,257,028
Proceeds from issuance of equity awards under ESPP		11,708			27,320
Net cash provided by financing activities		6,747,109			7,284,348
Effect of exchange rate changes on cash and cash equivalents		2,646			(241	)
Net change in cash and cash equivalents		(2,131,316	)		559,489
Cash and cash equivalents, beginning of period		63,792,657			62,313,418
Cash and cash equivalents, end of period	$	61,661,341		$	62,872,907

See accompanying notes.

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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 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 BC-PIV vaccine for COVID-19 (Coronavirus Disease 2019), MN-166 (ibudilast) for neurological and other 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

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in a single operating segment – the acquisition and development of 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 $1.1 million for the three months ended September 30, 2020 and 2019, respectively and $5.4 million and $4.0 million for the nine months ended September 30, 2020 and 2019, respectively.

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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 September 30, 2020 and 2019, respectively and $0.3 million for each of the nine months ended September 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. 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.

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

12

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 September 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 nine months ended September 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 $694,109 and $691,649 measured at fair value as of September 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 September 30, 2020, 2,872,135 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 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 September 30, 2020 and in 2019, was equal to the market value of the Company’s common stock on the date of grant.

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

	Number of Option Shares			Weighted Average Exercise Price
Outstanding at December 31, 2019		6,802,093		$	5.61
Granted		1,367,000			6.69
Exercised		(203,863	)		3.07
Cancelled		(454,843	)		8.92
Outstanding at September 30, 2020		7,510,387		$	5.68
Exercisable at September 30, 2020		6,174,387		$	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 nine months ended September 30, 2020, an aggregate of 3,834 shares were issued under the ESPP. As of September 30, 2020, there were 214,102 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 nine months ended September 30, 2020 and 2019, respectively:

	Three months ended				Nine months ended
	September 30,				September 30,
	2020		2019		2020		2019
Research, development and patents	$	331,126	$	91,089	$	843,117	$	1,424,737
General and administrative		702,845		282,755		1,934,386		3,491,121
Total stock-based compensation expense	$	1,033,971	$	373,844	$	2,777,503	$	4,915,858

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 nine months ended September 30, 2020 and 2019, and to estimate the fair value of performance-based stock options as of September 30, 2020 and 2019.

	Nine months ended
	September 30, 2020	September 30, 2019
Stock Option assumptions:
Risk-free interest rate	0.16 - 1.68%	1.55 - 2.19%
Expected volatility of common stock	57.44 - 75.82%	60.64 - 61.9%
Dividend yield	0%	0%
Expected term (in years)	4.5 - 5.8	4.8 - 5.3
ESPP assumptions:
Risk-free interest rate	0.14%	1.83%
Expected volatility of common stock	81.70%	59.7%
Dividend yield	0.0%	0.0%
Expected term (in years)	0.5	0.5

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As of September 30, 2020, there was $1.4 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 0.43 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 nine months ended September 30, 2020 the Company generated net proceeds of $6.1 million under the 2019 ATM Agreement, on sales of 811,798 shares of the Company’s common stock at a weighted average price of $7.77 per share.

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 stock options excluded from diluted net loss per common share due to their anti-dilutive effect totaled 7,510,387 shares and 6,804,493 shares for the three and nine months ended September 30, 2020 and 2019, respectively.

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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, 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 BC-PIV vaccine for COVID-19, MN-166 (ibudilast) for neurological and other 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 September 30, 2020, from inception, our accumulated deficit was $379.9 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 BC-PIV vaccine for the prevention of COVID-19.

• 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.

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• 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 BC-PIV vaccine, 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 September 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 September 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):

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	Three months ended				Nine months ended
	September 30,				September 30,
		2020		2019		2020			2019
External development expense:
MN-221	$	4	$	4	$	(1	)	$	18
MN-166		1,313		563		3,346			1,459
MN-001		33		46		129			109
MN-029		1		1		3			2
BC-PIV vaccine for COVID-19		110		—		110			—
Total external development expense		1,461		614		3,587			1,588
R&D personnel expense		596		347		1,630			2,213
R&D facility and depreciation expense		12		12		36			35
Patent expenses		97		102		295			259
Other R&D expense		72		76		140			155
Total research, development and patent expense	$	2,238	$	1,151	$	5,688		$	4,250

General and Administrative

Our general and administrative costs primarily consist of salaries, stock-based compensation, benefits and consulting and professional fees related to our administrative, finance, human resources, business development, legal, information systems support functions, facilities and insurance costs. General and administrative costs are expensed as incurred.

Our general and administrative expenses may increase in future periods if we are required to expand our infrastructure based on the success of our product development programs and in raising capital to support our product development programs or otherwise in connection with increased business development activities related to partnering, out-licensing or product disposition.

Critical Accounting Policies and Estimates

This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which we have prepared in accordance with United States generally accepted accounting principles. The preparation of these condensed financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting periods. We base our estimates on historical experience and on various other factors and assumptions that we believe are reasonable under the circumstances at the time the estimates are made, the results of which form the basis for making judgments about the book values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We periodically evaluate our estimates and judgments in light of changes in circumstances, facts and experience.

Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting policies, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Policies and Significant Judgments and Estimates” contained in our Annual Report on Form 10-K for the year ended December 31, 2019. There have not been any material changes to the critical accounting policies discussed therein during the three and nine months ended September 30, 2020. 

Results of Operations

Comparison of the three months ended September 30, 2020 and 2019

Research, Development and Patents Expenses

Research, development and patents expenses were $2.2 million and $1.2 million for the three months ended September 30, 2020 and 2019, respectively. The increase of $1.0 million was primarily due to higher clinical trial expenses from the ongoing clinical trial of MN-166 (ibudilast) in ALS.

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General and Administrative

General and administrative expenses were $1.5 million for each of the three months ended September 30, 2020 and 2019, respectively.

Comparison of the nine months ended September 30, 2020 and 2019

Research, Development and Patents Expenses

Research, development and patents expenses were $5.7 million and $4.3 million for the nine months ended September 30, 2020 and 2019, respectively. The increase of $1.4 million was due to higher clinical trial expenses offset by lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price.

General and Administrative

General and administrative expenses were $5.5 million and $7.6 million for the nine months ended September 30, 2020 and 2019, respectively. The decrease of $2.1 million was primarily due to lower stock compensation expense for performance-based stock options resulting from a decrease in our stock price and a decrease in legal expenses.

Liquidity and Capital Resources

Net cash used in operating activities during the nine months ended September 30, 2020 was $8.9 million compared to $6.7 million during the same period in 2019. Net cash used in operating activities primarily reflects the net loss and changes in operating assets and liabilities for those periods, which was partially offset by non-cash stock-based compensation expense.

Net cash provided by financing activities was $6.7 million during the nine months ended September 30, 2020 compared to $7.3 million during the same period in 2019. Net cash provided by financing activities during the nine months ended September 30, 2020 is primarily due to the sale of 811,798 shares of common stock under the 2019 ATM Agreement for net proceeds of $6.1 million and cash proceeds of $0.6 million from the exercise of options to purchase 203,863 shares of common stock. Net cash provided by financing activities during the nine months ended September 30, 2019 is primarily due to the exercise of 1,015,454 options to purchase common stock for cash proceeds of $4.1 million as well as the sale of 347,902 shares of common stock under the 2015 ATM Agreement and 2019 ATM Agreement for net proceeds of $3.2 million. Cash proceeds from financing activities are used for working capital and general corporate purposes.

On May 22, 2015, we entered into an at-the-market issuance sales agreement (the “2015 ATM Agreement”) with MLV & Co. LLC (MLV), pursuant to which we could sell common stock through MLV from time to time up to an aggregate offering price of $30.0 million. Sales of our 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 our prior approval. We 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. We were 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, we amended the 2015 ATM agreement 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, we entered into an at market issuance sales agreement (the “2019 ATM Agreement”) with B. Riley FBR, Inc. (B. Riley FBR) pursuant to which we may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million. Sales of our 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 our prior approval. We 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 nine months ended September 30, 2020, we generated net proceeds of $6.1 million under the 2019 ATM agreement, on sales of 811,798 shares of our common stock at a weighted average price of $7.77 per share.

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For the nine months ended September 30, 2019, we generated net proceeds of $2.8 million and $0.4 million under the 2015 ATM Agreement and 2019 ATM Agreement respectively, on sales of 347,902 shares of our common stock at a weighted average price of $9.51 per share.

As of September 30, 2020, we had available cash and cash equivalents of $61.7 million and working capital of $60.8 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through the end of 2021. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.

Off-Balance Sheet Arrangements

At September 30, 2020, we did not have any relationship with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance variable interest, or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements. In addition, we did not engage in trading activities involving non-exchange traded contracts. As a result, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships. We do not have relationships and transactions with persons and entities that derive benefits from their non-independent relationship with us or our related parties except as disclosed herein.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Our primary exposure to market risks are due to changes in interest rates, which relates primarily to the increase or decrease in the amount of interest income we can earn on our investment portfolio. The primary objective of our investment activities is to preserve principal. Our risk associated with fluctuating interest rates is limited to our investments in interest rate sensitive financial instruments and we do not use interest rate derivative instruments to manage exposure to interest rate changes. We mitigate default risk by investing in investment grade securities. A hypothetical 100 basis point adverse move in interest rates along the entire interest rate yield curve would not materially affect the fair value of our interest-rate sensitive financial instruments due to their relatively short-term nature.

Cash and cash equivalents as of September 30, 2020 were $61.7 million and were primarily invested in money market interest bearing accounts and money market funds. A hypothetical 10% adverse change in the average interest rate on our cash and cash equivalents would have had no material effect on net loss for the three and nine months ended September 30, 2020.

ITEM 4. CONTROLS AND PROCEDURES.

We maintain disclosure controls and procedures that are designed to provide reasonable assurance that the information required to be disclosed in our filings under the Securities Exchange Act of 1934, as amended, or the Exchange Act, is (1) recorded, processed, summarized and reported within the time periods specified in SEC’s rules and forms, and (2) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our procedures or our internal controls will prevent or detect all errors and all fraud. Any internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of our controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Evaluation of Disclosure Controls and Procedures

As required by Rule 13a-15(b) of the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS.

We are not involved in any material legal proceedings as of September 30, 2020. We may become involved in various disputes and legal proceedings which arise in the ordinary course of business or otherwise. While it is not possible to accurately predict or determine the outcome of these matters, an adverse result in any litigation matter may occur which could harm our business.

ITEM 1A. RISK FACTORS.

In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019, which are incorporated herein by reference and which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. Other than the risk factor set forth below, we do not believe that there have been any material changes from the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2019.

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.

We could be negatively impacted by the widespread outbreak of an illness or any other communicable disease, or any other public health crisis that results in economic and trade disruptions, including the disruption of global supply chains. In December 2019, an outbreak of COVID-19 began in Wuhan, Hubei Province, China. In March 2020, the World Health Organization declared COVID-19 a pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and created significant volatility and disruption of financial markets. The extent of the impact of the COVID-19 pandemic on our financial condition, liquidity, and future results of operations, including our ability to continue to advance our product development programs in the expected time frame, will depend on future developments, including the duration and spread of the pandemic and related restrictions on travel and transports, all of which are uncertain and cannot be predicted. An extended period of global supply chain and economic disruption could materially affect our business, results of operations, access to sources of liquidity and financial condition.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

None

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

None

ITEM 4. MINE SAFETY DISCLOSURES.

Not applicable

ITEM 5. OTHER INFORMATION.

None

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ITEM 6. EXHIBITS.

Exhibit Number	Description
3.1	Restated Certificate of Incorporation of the Registrant, as amended (incorporated by reference to Exhibit 3.1 of the Registrant’s Quarterly Report on Form 10-Q filed August 9, 2012).
3.2	Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed April 25, 2019).
31.1(1)	Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2(1)	Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1(1)	Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002).
32.2(1)	Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350 (Section 906 of the Sarbanes-Oxley Act of 2002).
101(1)	The following financial statements from the MediciNova, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 formatted in Inline Extensible Business Reporting Language (iXBRL): (i) Consolidated Balance Sheets; (ii) Consolidated Statements of Operations and Comprehensive Loss; (iii) Consolidated Statements of Stockholders’ Equity; (iv) Consolidated Statements of Cash Flows; and (v) the notes to the consolidated financial statements.
104(1)	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

(1) Filed Herewith

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SIGNATURES

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

	MEDICINOVA, INC.
Date:  October 26, 2020	By:	/s/    YUICHI IWAKI
		Yuichi Iwaki, M.D., Ph.D.
		President and Chief Executive Officer
		(on behalf of the registrant and
		as the registrant’s Principal Executive Officer)
	By:	/s/    EDWARD STEPANOW
		Edward Stepanow
		Chief Financial Officer
		(on behalf of the registrant and
		as the registrant’s Principal Financial Officer)

23

EX-31.1

Exhibit 31.1

MEDICINOVA, INC.

Certification of the Principal Executive Officer Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002 for the Period Ended September 30, 2020

I, Yuichi Iwaki, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2020 of MediciNova, Inc.;

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

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

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

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

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

Date: October 26, 2020
By:	/s/    YUICHI IWAKI
	Yuichi Iwaki, M.D., Ph.D.
	President and Chief Executive Officer
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

MEDICINOVA, INC.

Certification of the Principal Financial Officer Pursuant to

Section 302 of the Sarbanes-Oxley Act of 2002 for the Period Ended September 30, 2020

I, Edward Stepanow, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2020 of MediciNova, Inc.;

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

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

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

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

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

Date: October 26, 2020
By:	/s/    EDWARD STEPANOW
	Edward Stepanow
	Chief Financial Officer
	(Principal Financial Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION OF

PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350

(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)

In connection with the accompanying Quarterly Report on Form 10-Q of MediciNova, Inc. (the “Company”) for the period ended September 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yuichi Iwaki, as President and Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

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: October 26, 2020
By:	/s/    Yuichi Iwaki
	Yuichi Iwaki, M.D., Ph.D.
	President and 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 such certification 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 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

Exhibit 32.2

CERTIFICATION OF

ACTING PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350

(SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002)

In connection with the accompanying Quarterly Report on Form 10-Q of MediciNova, Inc. (the “Company”) for the period ended September 30, 2020, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Edward Stepanow, as Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

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: October 26, 2020
By:	/s/    EDWARD STEPANOW
	Edward Stepanow
	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 such certification 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 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.

XML

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2020	Oct. 22, 2020
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Trading Symbol	MNOV
Entity Registrant Name	MEDICINOVA, INC.
Entity Central Index Key	0001226616
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		44,927,560
Entity Shell Company	false
Entity File Number	001-33185
Entity Tax Identification Number	33-0927979
Entity Address, Address Line One	4275 Executive Square
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	La Jolla
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92037
City Area Code	858
Local Phone Number	373-1500
Entity Current Reporting Status	Yes
Document Quarterly Report	true
Document Transition Report	false
Entity Incorporation, State or Country Code	DE
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock, $0.001 par value
Security Exchange Name	NASDAQ

XML

Consolidated Balance Sheets - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 61,661,341	$ 63,792,657
Prepaid expenses and other current assets	893,843	511,916
Total current assets	62,555,184	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	28,857	40,550
Other non-current assets	309,112	459,811
Total assets	77,293,393	79,205,174
Current liabilities:
Accounts payable	376,271	451,326
Accrued expenses and other liabilities	1,428,003	1,776,912
Total current liabilities	1,804,274	2,228,238
Long-term deferred revenue	1,694,163	1,694,163
Deferred tax liability	201,792	201,792
Other non-current liabilities	39,891	186,358
Total liabilities	3,740,120	4,310,551
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2020 and December 31, 2019; 44,927,560 and 43,908,065 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	44,928	43,908
Additional paid-in capital	453,539,933	444,016,341
Accumulated other comprehensive loss	(90,035)	(92,681)
Accumulated deficit	(379,941,553)	(369,072,945)
Total stockholders’ equity	73,553,273	74,894,623
Total liabilities and stockholders' equity	$ 77,293,393	$ 79,205,174

XML

Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement Of Financial Position [Abstract]
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	44,927,560	43,908,065
Common stock, shares outstanding	44,927,560	43,908,065

XML

Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Operating expenses:
Research, development and patents	$ 2,237,877	$ 1,150,815	$ 5,687,658	$ 4,250,205
General and administrative	1,492,139	1,494,750	5,477,223	7,556,740
Total operating expenses	3,730,016	2,645,565	11,164,881	11,806,945
Operating loss	(3,730,016)	(2,645,565)	(11,164,881)	(11,806,945)
Interest income	37,204	288,643	324,175	900,462
Other expense	(11,008)	(21,582)	(27,902)	(51,087)
Net loss applicable to common stockholders	$ (3,703,820)	$ (2,378,504)	$ (10,868,608)	$ (10,957,570)
Basic and diluted net loss per common share	$ (0.08)	$ (0.05)	$ (0.25)	$ (0.26)
Shares used to compute basic and diluted net loss per common share	44,643,736	43,343,329	44,229,715	42,963,287
Net loss applicable to common stockholders	$ (3,703,820)	$ (2,378,504)	$ (10,868,608)	$ (10,957,570)
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustments	2,761	(782)	2,646	792
Comprehensive loss	$ (3,701,059)	$ (2,379,286)	$ (10,865,962)	$ (10,956,778)

XML

Consolidated Statements of Stockholders' Equity - USD ($)	Total	Common stock	Additional paid-in capital	Accumulated other comprehensive income (loss)	Accumulated deficit
Balance at Dec. 31, 2018	$ 73,107,612	$ 42,081	$ 429,289,968	$ (93,150)	$ (356,131,287)
Balance, shares at Dec. 31, 2018		42,081,306
Share-based compensation	2,699,500		2,699,500
Issuance of shares under an employee stock purchase plan (ESPP)	16,903	$ 2	16,901
Issuance of shares under an employee stock purchase plan (ESPP), shares		2,401
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	3,920,735	$ 978	3,919,757
Issuance of common stock for option exercises, shares		977,454
Net loss	(4,697,190)				(4,697,190)
Foreign currency translation adjustments	(1,781)			(1,781)
Balance at Mar. 31, 2019	75,037,247	$ 43,061	435,917,594	(94,931)	(360,828,477)
Balance, shares at Mar. 31, 2019		43,061,161
Balance at Dec. 31, 2018	73,107,612	$ 42,081	429,289,968	(93,150)	(356,131,287)
Balance, shares at Dec. 31, 2018		42,081,306
Net loss	(10,957,570)
Foreign currency translation adjustments	792
Balance at Sep. 30, 2019	74,351,040	$ 43,449	441,488,806	(92,358)	(367,088,857)
Balance, shares at Sep. 30, 2019		43,448,604
Balance at Mar. 31, 2019	75,037,247	$ 43,061	435,917,594	(94,931)	(360,828,477)
Balance, shares at Mar. 31, 2019		43,061,161
Share-based compensation	1,842,514		1,842,514
Issuance of common stock for option exercises	180,370	$ 38	180,332
Issuance of common stock for option exercises, shares		38,000
Net loss	(3,881,876)				(3,881,876)
Foreign currency translation adjustments	3,355			3,355
Balance at Jun. 30, 2019	73,181,610	$ 43,099	437,940,440	(91,576)	(364,710,353)
Balance, shares at Jun. 30, 2019		43,099,161
Share-based compensation	373,844		373,844
Issuance of shares under an employee stock purchase plan (ESPP)	10,417	$ 2	10,415
Issuance of shares under an employee stock purchase plan (ESPP), shares		1,541
Issuance of common stock, net of offering costs	3,164,455	$ 348	3,164,107
Issuance of common stock, net of offering costs, shares		347,902
Net loss	(2,378,504)				(2,378,504)
Foreign currency translation adjustments	(782)			(782)
Balance at Sep. 30, 2019	74,351,040	$ 43,449	441,488,806	(92,358)	(367,088,857)
Balance, shares at Sep. 30, 2019		43,448,604
Balance at Dec. 31, 2019	74,894,623	$ 43,908	444,016,341	(92,681)	(369,072,945)
Balance, shares at Dec. 31, 2019		43,908,065
Share-based compensation	596,378		596,378
Issuance of shares under an employee stock purchase plan (ESPP)	6,254	$ 2	6,252
Issuance of shares under an employee stock purchase plan (ESPP), shares		1,979
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs	412,692	$ 69	412,623
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs, shares		68,952
Net loss	(2,713,559)				(2,713,559)
Foreign currency translation adjustments	(120)			(120)
Balance at Mar. 31, 2020	73,196,268	$ 43,979	445,031,594	(92,801)	(371,786,504)
Balance, shares at Mar. 31, 2020		43,978,996
Balance at Dec. 31, 2019	$ 74,894,623	$ 43,908	444,016,341	(92,681)	(369,072,945)
Balance, shares at Dec. 31, 2019		43,908,065
Issuance of shares under an employee stock purchase plan (ESPP), shares	3,834
Issuance of common stock for option exercises, shares	203,863
Issuance of common stock, net of offering costs, shares		811,798
Net loss	$ (10,868,608)
Foreign currency translation adjustments	2,646
Balance at Sep. 30, 2020	73,553,273	$ 44,928	453,539,933	(90,035)	(379,941,553)
Balance, shares at Sep. 30, 2020		44,927,560
Balance at Mar. 31, 2020	73,196,268	$ 43,979	445,031,594	(92,801)	(371,786,504)
Balance, shares at Mar. 31, 2020		43,978,996
Share-based compensation	1,147,154		1,147,154
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs	762,483	$ 141	762,342
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs, shares		140,719
Issuance of common stock for option exercises	438,262	$ 144	438,118
Issuance of common stock for option exercises, shares		143,863
Net loss	(4,451,229)				(4,451,229)
Foreign currency translation adjustments	5			5
Balance at Jun. 30, 2020	71,092,943	$ 44,264	447,379,208	(92,796)	(376,237,733)
Balance, shares at Jun. 30, 2020		44,263,578
Share-based compensation	1,033,971		1,033,971
Issuance of shares under an employee stock purchase plan (ESPP)	5,454	$ 2	5,452
Issuance of shares under an employee stock purchase plan (ESPP), shares		1,855
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs	4,933,914	$ 602	4,933,312
Issuance of common stock under at-the-market equity distribution and sales agreements, net of offering costs, shares		602,127
Issuance of common stock for option exercises	188,050	$ 60	187,990
Issuance of common stock for option exercises, shares		60,000
Net loss	(3,703,820)				(3,703,820)
Foreign currency translation adjustments	2,761			2,761
Balance at Sep. 30, 2020	$ 73,553,273	$ 44,928	$ 453,539,933	$ (90,035)	$ (379,941,553)
Balance, shares at Sep. 30, 2020		44,927,560

XML

Consolidated Statements of Cash Flows - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Operating activities:
Net loss	$ (10,868,608)	$ (10,957,570)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash stock-based compensation	2,777,503	4,915,858
Depreciation and amortization	15,487	18,347
Changes in assets and liabilities:
Prepaid expenses and other assets	(225,543)	(452,515)
Accounts payable, accrued liabilities and other liabilities	(576,116)	(244,725)
Net cash used in operating activities	(8,877,277)	(6,720,605)
Investing activities:
Acquisition of property and equipment	(3,794)	(4,013)
Net cash used in investing activities	(3,794)	(4,013)
Financing activities:
Proceeds from issuance of common stock, exercise of common stock options and warrants, net of issuance costs	6,735,401	7,257,028
Proceeds from issuance of equity awards under ESPP	11,708	27,320
Net cash provided by financing activities	6,747,109	7,284,348
Effect of exchange rate changes on cash and cash equivalents	2,646	(241)
Net change in cash and cash equivalents	(2,131,316)	559,489
Cash and cash equivalents, beginning of period	63,792,657	62,313,418
Cash and cash equivalents, end of period	$ 61,661,341	$ 62,872,907

XML

Interim Financial Information

9 Months Ended

Sep. 30, 2020

Quarterly Financial Information Disclosure [Abstract]

Interim Financial Information

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 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 BC-PIV vaccine for COVID-19 (Coronavirus Disease 2019), MN-166 (ibudilast) for neurological and other 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

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in a single operating segment – the acquisition and development of 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 $1.1 million for the three months ended September 30, 2020 and 2019, respectively and $5.4 million and $4.0 million for the nine months ended September 30, 2020 and 2019, respectively.

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 September 30, 2020 and 2019, respectively and $0.3 million for each of the nine months ended September 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. 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.

XML

Revenue Recognition

9 Months Ended

Sep. 30, 2020

Revenue From Contract With Customer [Abstract]

Revenue Recognition

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 September 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 nine months ended September 30, 2020 and 2019 in connection with the collaboration agreement with Kissei.

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Fair Value Measurements

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Fair Value Measurements

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 $694,109 and $691,649 measured at fair value as of September 30, 2020 and December 31, 2019, respectively, are classified within Level 1.

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Stock-based Compensation

9 Months Ended

Sep. 30, 2020

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Stock-based Compensation

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 September 30, 2020, 2,872,135 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 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 September 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 September 30, 2020 is as follows:

	Number of Option Shares			Weighted Average Exercise Price
Outstanding at December 31, 2019		6,802,093		$	5.61
Granted		1,367,000			6.69
Exercised		(203,863	)		3.07
Cancelled		(454,843	)		8.92
Outstanding at September 30, 2020		7,510,387		$	5.68
Exercisable at September 30, 2020		6,174,387		$	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 nine months ended September 30, 2020, an aggregate of 3,834 shares were issued under the ESPP. As of September 30, 2020, there were 214,102 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 nine months ended September 30, 2020 and 2019, respectively:

	Three months ended				Nine months ended
	September 30,				September 30,
	2020		2019		2020		2019
Research, development and patents	$	331,126	$	91,089	$	843,117	$	1,424,737
General and administrative		702,845		282,755		1,934,386		3,491,121
Total stock-based compensation expense	$	1,033,971	$	373,844	$	2,777,503	$	4,915,858

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 nine months ended September 30, 2020 and 2019, and to estimate the fair value of performance-based stock options as of September 30, 2020 and 2019.

	Nine months ended
	September 30, 2020	September 30, 2019
Stock Option assumptions:
Risk-free interest rate	0.16 - 1.68%	1.55 - 2.19%
Expected volatility of common stock	57.44 - 75.82%	60.64 - 61.9%
Dividend yield	0%	0%
Expected term (in years)	4.5 - 5.8	4.8 - 5.3
ESPP assumptions:
Risk-free interest rate	0.14%	1.83%
Expected volatility of common stock	81.70%	59.7%
Dividend yield	0.0%	0.0%
Expected term (in years)	0.5	0.5

As of September 30, 2020, there was $1.4 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 0.43 years, on a straight-line basis.

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Stockholders' Equity

9 Months Ended

Sep. 30, 2020

Equity [Abstract]

Stockholders' Equity

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 nine months ended September 30, 2020 the Company generated net proceeds of $6.1 million under the 2019 ATM Agreement, on sales of 811,798 shares of the Company’s common stock at a weighted average price of $7.77 per share.

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Net Loss Per Share

9 Months Ended

Sep. 30, 2020

Earnings Per Share [Abstract]

Net Loss Per Share

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 stock options excluded from diluted net loss per common share due to their anti-dilutive effect totaled 7,510,387 shares and 6,804,493 shares for the three and nine months ended September 30, 2020 and 2019, respectively.

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Interim Financial Information (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation

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

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

Segment Reporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company operates in a single operating segment – the acquisition and development of therapeutics for the treatment of serious diseases with unmet medical needs.

Cash and Cash Equivalents

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, 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 $1.1 million for the three months ended September 30, 2020 and 2019, respectively and $5.4 million and $4.0 million for the nine months ended September 30, 2020 and 2019, respectively.

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 September 30, 2020 and 2019, respectively and $0.3 million for each of the nine months ended September 30, 2020 and 2019, respectively.

Clinical Trial Accruals and Prepaid Expenses

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

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. 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

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

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.

Revenue Recognition Policy

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.

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Stock-based Compensation (Tables)

9 Months Ended

Sep. 30, 2020

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Summary of Stock Option Activity and Related Information

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

	Number of Option Shares			Weighted Average Exercise Price
Outstanding at December 31, 2019		6,802,093		$	5.61
Granted		1,367,000			6.69
Exercised		(203,863	)		3.07
Cancelled		(454,843	)		8.92
Outstanding at September 30, 2020		7,510,387		$	5.68
Exercisable at September 30, 2020		6,174,387		$	5.45

Summary of Stock-based Compensation Expenses

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

	Three months ended				Nine months ended
	September 30,				September 30,
	2020		2019		2020		2019
Research, development and patents	$	331,126	$	91,089	$	843,117	$	1,424,737
General and administrative		702,845		282,755		1,934,386		3,491,121
Total stock-based compensation expense	$	1,033,971	$	373,844	$	2,777,503	$	4,915,858

Schedule of Assumptions Used in Estimating Fair Value of Options Granted, Stock Purchased Under ESPP and Performance-Based Stock Options

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 nine months ended September 30, 2020 and 2019, and to estimate the fair value of performance-based stock options as of September 30, 2020 and 2019.

	Nine months ended
	September 30, 2020	September 30, 2019
Stock Option assumptions:
Risk-free interest rate	0.16 - 1.68%	1.55 - 2.19%
Expected volatility of common stock	57.44 - 75.82%	60.64 - 61.9%
Dividend yield	0%	0%
Expected term (in years)	4.5 - 5.8	4.8 - 5.3
ESPP assumptions:
Risk-free interest rate	0.14%	1.83%
Expected volatility of common stock	81.70%	59.7%
Dividend yield	0.0%	0.0%
Expected term (in years)	0.5	0.5

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Interim Financial Information - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Quarterly Financial Information Disclosure [Abstract]
Research and development costs	$ 2.1	$ 1.1	$ 5.4	$ 4.0
Patent-related expenses	$ 0.1	$ 0.1	$ 0.3	$ 0.3
Change in Accounting Principle, Accounting Standards Update, Adoption Date	Jan. 01, 2020		Jan. 01, 2020
Change in Accounting Principle, Accounting Standards Update, Adopted [true false]	true		true
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false]	true		true
Accounting Standards Update [Extensible List]			us-gaap:AccountingStandardsUpdate201813Member

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Revenue Recognition - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Oct. 31, 2011
Revenue Recognition Milestone Method [Line Items]
Deferred revenue related to research and development services	$ 1,694,163		$ 1,694,163		$ 1,694,163
Kissei Pharmaceutical Co., Ltd
Revenue Recognition Milestone Method [Line Items]
Deferred revenue related to research and development services						$ 2,500,000
Revenue relating to research and development services	$ 0	$ 0	$ 0	$ 0

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Fair Value Measurements - Additional Information (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Level 1 | Money Market Funds
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash equivalents, fair value	$ 694,109	$ 691,649

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Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2017	Jun. 30, 2013
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares reserved, description	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.
Employee stock purchase plan offering period	6 months
Shares issued under ESPP	3,834
2007 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reserved for future issuance	214,102	300,000
Percentage of employee compensation for purchase of common stock under ESPP	15.00%
Common stock fair market value, percentage	85.00%
Maximum | 2007 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Increase in shares reserved for issuance	15,000
Increase in shares reserved for issuance as percentage of outstanding shares	1.00%
Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unamortized compensation cost	$ 1.4
Unamortized compensation cost, vesting period	5 months 4 days
2013 Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reserved for future issuance			8,700,000
Shares available for future grant	2,872,135
2013 Plan | Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted expiration term	10 years
2013 Plan | Stock Option | Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option, vesting period	3 years
2013 Plan | Stock Option | Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option, vesting period	4 years
2004 Plan | Stock Option
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted expiration term	10 years
2004 Plan | Stock Option | Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option, vesting period	3 years
2004 Plan | Stock Option | Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option, vesting period	4 years

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Summary of Stock Option Activity and Related Information (Detail) - $ / shares	9 Months Ended
	Sep. 30, 2020
Number of Option Shares
Stock Options, Beginning Balance	6,802,093
Stock Options, Granted	1,367,000
Stock Options, Exercised	(203,863)
Stock Options, Cancelled	(454,843)
Stock Options, Ending Balance	7,510,387
Stock Options, Exercisable at September 30, 2020	6,174,387
Weighted Average Exercise Price, Beginning Balance	$ 5.61
Weighted Average Exercise Price, Granted	6.69
Weighted Average Exercise Price, Exercised	3.07
Weighted Average Exercise Price, Cancelled	8.92
Weighted Average Exercise Price, Ending Balance	5.68
Weighted Average Exercise Price, Exercisable at September 30, 2020	$ 5.45

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Summary of Stock-based Compensation Expenses (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 1,033,971	$ 373,844	$ 2,777,503	$ 4,915,858
Research, Development and Patents
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	331,126	91,089	843,117	1,424,737
General and Administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 702,845	$ 282,755	$ 1,934,386	$ 3,491,121

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Schedule of Assumptions Used in Estimating Fair Value of Options Granted, Stock Purchased Under ESPP and Performance-Based Stock Options (Detail)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Employee Stock Purchase Plan
Weighted-average assumptions for stock options and ESPP
Risk-free interest rate	0.14%	1.83%
Expected volatility of common stock	81.70%	59.70%
Dividend yield	0.00%	0.00%
Expected term (in years)	6 months	6 months
Stock Option
Weighted-average assumptions for stock options and ESPP
Dividend yield	0.00%	0.00%
Stock Option | Minimum
Weighted-average assumptions for stock options and ESPP
Risk-free interest rate	0.16%	1.55%
Expected volatility of common stock	57.44%	60.64%
Expected term (in years)	4 years 6 months	4 years 9 months 18 days
Stock Option | Maximum
Weighted-average assumptions for stock options and ESPP
Risk-free interest rate	1.68%	2.19%
Expected volatility of common stock	75.82%	61.90%
Expected term (in years)	5 years 9 months 18 days	5 years 3 months 18 days

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Stockholders' Equity - Additional Information (Detail) - USD ($)			3 Months Ended	9 Months Ended
	Aug. 23, 2019	May 22, 2015	Sep. 30, 2019	Sep. 30, 2020
Common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock, net of offering costs (in shares)			347,902	811,798
2019 at-the-market issuance sales agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock purchase agreement, net proceeds				$ 6,100,000
Weighted Average | Common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares purchase & equity issuance, price per share amount				$ 7.77
MLV | 2015 at-the-market issuance sales agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Sales commission as a percentage of gross proceeds		4.00%
Agreement termination date				Aug. 23, 2019
MLV | Maximum | 2015 at-the-market issuance sales agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock purchase agreement, aggregate amount of common stock agreed to be purchased		$ 30,000,000.0
B. Riley FBR | 2019 at-the-market issuance sales agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Sales commission as a percentage of gross proceeds	3.50%
B. Riley FBR | Maximum | 2019 at-the-market issuance sales agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock purchase agreement, aggregate amount of common stock agreed to be purchased	$ 75,000,000.0

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Net Loss Per Share - Additional Information (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Earnings Per Share [Abstract]
Potentially dilutive outstanding stock options excluded from diluted net loss per common share	7,510,387	6,804,493	7,510,387	6,804,493