0001564590-22-037391 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 08, 2022
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2022
Document Fiscal Year Focus	2022
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	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		49,046,246
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

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 52,507,263	$ 71,430,954
Prepaid expenses and other current assets	641,732	577,992
Total current assets	53,148,995	72,008,946
Investments	10,021,849
Goodwill	9,600,240	9,600,240
In-process research and development	4,800,000	4,800,000
Property and equipment, net	45,894	57,565
Right-of-use asset	673,092	824,215
Other non-current assets	101,700	115,492
Total assets	78,391,770	87,406,458
Current liabilities:
Accounts payable	552,720	402,740
Accrued liabilities and other current liabilities	3,808,474	2,298,203
Operating lease liability	167,073	131,965
Total current liabilities	4,528,267	2,832,908
Deferred tax liability	201,792	201,792
Other non-current liabilities	555,840	694,674
Total liabilities	5,285,899	3,729,374
Commitments and contingencies (Note 4)
Stockholders’ equity:
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2022 and December 31, 2021; 49,046,246 and 49,043,246 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	49,046	49,043
Additional paid-in capital	477,309,782	476,788,012
Accumulated other comprehensive loss	(124,264)	(98,877)
Accumulated deficit	(404,128,693)	(393,061,094)
Total stockholders’ equity	73,105,871	83,677,084
Total liabilities and stockholders' equity	$ 78,391,770	$ 87,406,458

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
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	49,046,246	49,043,246
Common stock, shares outstanding	49,046,246	49,043,246

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Statement [Abstract]
Revenues		$ 37,500		$ 4,037,500
Operating expenses:
Research, development and patents	$ 2,454,203	2,088,618	$ 7,131,168	6,761,015
General and administrative	1,443,264	1,550,821	4,266,246	5,389,466
Total operating expenses	3,897,467	3,639,439	11,397,414	12,150,481
Operating loss	(3,897,467)	(3,601,939)	(11,397,414)	(8,112,981)
Interest income	253,755	36,153	382,369	107,159
Other expense	(8,472)	(13,381)	(52,554)	(45,285)
Net loss applicable to common stockholders	$ (3,652,184)	$ (3,579,167)	$ (11,067,599)	$ (8,051,107)
Basic net loss per common share	$ (0.07)	$ (0.07)	$ (0.23)	$ (0.17)
Diluted net loss per common share	$ (0.07)	$ (0.07)	$ (0.23)	$ (0.17)
Shares used to compute basic net loss per common share	49,046,246	48,987,836	49,045,037	48,445,840
Shares used to compute diluted net loss per common share	49,046,246	48,987,836	49,045,037	48,445,840
Net loss applicable to common stockholders	$ (3,652,184)	$ (3,579,167)	$ (11,067,599)	$ (8,051,107)
Other comprehensive income (loss), net of tax:
Foreign currency translation adjustments	(5,972)	(1,362)	(25,387)	(6,820)
Comprehensive loss	$ (3,658,156)	$ (3,580,529)	$ (11,092,986)	$ (8,057,927)

Condensed Consolidated Statements of Stockholders' Equity - USD ($)	Total	Common stock	Additional paid-in capital	Accumulated other comprehensive loss	Accumulated deficit
Balance at Dec. 31, 2020	$ 71,326,500	$ 45,025	$ 454,296,536	$ (88,219)	$ (382,926,842)
Balance, shares at Dec. 31, 2020		45,024,560
Share-based compensation	1,139,636		1,139,636
Issuance of common stock for option exercises	212,175	$ 86	212,089
Issuance of common stock for option exercises, shares		86,250
Issuance of shares under an employee stock purchase plan (ESPP)	6,110	$ 2	6,108
Issuance of shares under an employee stock purchase plan (ESPP), shares		1,424
Issuance of common stock in a private placement transaction, net of issuance costs	19,881,648	$ 3,656	19,877,992
Issuance of common stock in a private transaction, net of issuance costs, shares		3,656,307
Net loss	(187,799)				(187,799)
Foreign currency translation adjustments	(6,821)			(6,821)
Balance at Mar. 31, 2021	92,371,449	$ 48,769	475,532,361	(95,040)	(383,114,641)
Balance, shares at Mar. 31, 2021		48,768,541
Balance at Dec. 31, 2020	$ 71,326,500	$ 45,025	454,296,536	(88,219)	(382,926,842)
Balance, shares at Dec. 31, 2020		45,024,560
Issuance of shares under an employee stock purchase plan (ESPP), shares	1,424
Net loss	$ (8,051,107)
Foreign currency translation adjustments	(6,820)
Balance at Sep. 30, 2021	86,482,340	$ 49,028	477,506,300	(95,039)	(390,977,949)
Balance, shares at Sep. 30, 2021		49,028,246
Balance at Mar. 31, 2021	92,371,449	$ 48,769	475,532,361	(95,040)	(383,114,641)
Balance, shares at Mar. 31, 2021		48,768,541
Share-based compensation	755,905		755,905
Issuance of common stock for option exercises	389,738	$ 155	389,583
Issuance of common stock for option exercises, shares		155,622
Net loss	(4,284,141)				(4,284,141)
Foreign currency translation adjustments	1,363			1,363
Balance at Jun. 30, 2021	89,234,314	$ 48,924	476,677,849	(93,677)	(387,398,782)
Balance, shares at Jun. 30, 2021		48,924,163
Share-based compensation	578,944		578,944
Issuance of common stock for option exercises	249,611	$ 104	249,507
Issuance of common stock for option exercises, shares		104,083
Net loss	(3,579,167)				(3,579,167)
Foreign currency translation adjustments	(1,362)			(1,362)
Balance at Sep. 30, 2021	86,482,340	$ 49,028	477,506,300	(95,039)	(390,977,949)
Balance, shares at Sep. 30, 2021		49,028,246
Balance at Dec. 31, 2021	83,677,084	$ 49,043	476,788,012	(98,877)	(393,061,094)
Balance, shares at Dec. 31, 2021		49,043,246
Share-based compensation	81,053		81,053
Net loss	(3,386,417)				(3,386,417)
Foreign currency translation adjustments	(7,435)			(7,435)
Balance at Mar. 31, 2022	80,364,285	$ 49,043	476,869,065	(106,312)	(396,447,511)
Balance, shares at Mar. 31, 2022		49,043,246
Balance at Dec. 31, 2021	$ 83,677,084	$ 49,043	476,788,012	(98,877)	(393,061,094)
Balance, shares at Dec. 31, 2021		49,043,246
Issuance of common stock for option exercises, shares	3,000
Net loss	$ (11,067,599)
Foreign currency translation adjustments	(25,387)
Balance at Sep. 30, 2022	73,105,871	$ 49,046	477,309,782	(124,264)	(404,128,693)
Balance, shares at Sep. 30, 2022		49,046,246
Balance at Mar. 31, 2022	80,364,285	$ 49,043	476,869,065	(106,312)	(396,447,511)
Balance, shares at Mar. 31, 2022		49,043,246
Share-based compensation	274,502		274,502
Issuance of common stock for option exercises	7,920	$ 3	7,917
Issuance of common stock for option exercises, shares		3,000
Net loss	(4,028,998)				(4,028,998)
Foreign currency translation adjustments	(11,980)			(11,980)
Balance at Jun. 30, 2022	76,605,729	$ 49,046	477,151,484	(118,292)	(400,476,509)
Balance, shares at Jun. 30, 2022		49,046,246
Share-based compensation	158,298		158,298
Net loss	(3,652,184)				(3,652,184)
Foreign currency translation adjustments	(5,972)			(5,972)
Balance at Sep. 30, 2022	$ 73,105,871	$ 49,046	$ 477,309,782	$ (124,264)	$ (404,128,693)
Balance, shares at Sep. 30, 2022		49,046,246

Condensed Consolidated Statements of Cash Flows - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Operating activities:
Net loss	$ (11,067,599)	$ (8,051,107)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash stock-based compensation	513,853	2,474,485
Depreciation and amortization	13,376	19,775
Non-cash interest on investments	(21,849)
Change in carrying amount of right-of-use asset	151,123	163,282
Changes in assets and liabilities:
Prepaid expenses and other assets	(49,947)	(510,486)
Accounts payable, accrued liabilities and other liabilities	1,660,250	330,492
Operating lease liabilities	(103,726)	(169,080)
Net cash used in operating activities	(8,904,519)	(5,742,639)
Investing activities:
Purchases of investments	(10,000,000)
Acquisition of property and equipment		(28,732)
Net cash used in investing activities	(10,000,000)	(28,732)
Financing activities:
Proceeds from issuance of common stock and exercise of common stock options	7,920	20,851,540
Common stock issuance costs		(118,368)
Proceeds from issuance of equity awards under ESPP		6,110
Net cash provided by financing activities	7,920	20,739,282
Effect of exchange rate changes on cash and cash equivalents	(27,092)	20,710
Net change in cash and cash equivalents	(18,923,691)	14,988,621
Cash and cash equivalents, beginning of period	71,430,954	60,036,763
Cash and cash equivalents, end of period	$ 52,507,263	75,025,384
Supplemental disclosure of non-cash investing activities:
Right-of-use asset obtained in exchange for operating lease liability		$ 875,515

Interim Financial Information

9 Months Ended

Sep. 30, 2022

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. 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. The Company 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 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, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), and prevention of acute respiratory distress syndrome, and MN-001 (tipelukast) for fibrotic and other diseases such as nonalcoholic fatty liver disease (NAFLD), 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 condensed 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 8-03 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 condensed 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 condensed 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, 2021 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, 2021 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, MediciNova Japan, Inc., MediciNova (Europe) Limited, MediciNova Europe GmbH and Avigen Inc. The financial statements of the Company’s foreign subsidiaries are measured using their local currency as the functional currency. The resulting translation adjustments are recorded as a component of other comprehensive income or loss. Intercompany transaction gains or losses at each period end are included as translation adjustments and recorded within other comprehensive income or loss. 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 small molecule therapeutics for the treatment of serious diseases with unmet medical needs.

Cash and Cash Equivalents

Cash and cash equivalents consist of cash and other highly liquid investments including money market accounts, with original maturities of three months or less from the date of purchase.

Investments

Investments purchased with an original maturity of greater than three months are classified as investments. Investments are stated at fair value and are classified as current or non-current based on the nature of the securities as well as their stated maturities. As of September 30, 2022, investments consisted of a bank certificate of deposit with an original purchased maturity of thirteen months.

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 $2.4 million and $2.0 million for the three months ended September 30, 2022 and 2021, respectively, and $6.8 million and $6.4 million for the nine months ended September 30, 2022 and 2021, 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 in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for the three months ended September 30, 2022 and 2021, respectively, and $0.3 million and $0.4 million for the nine months ended September 30, 2022 and 2021, 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.

Leases

The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as an operating or finance lease. The Company does not recognize right-of-use assets and lease liabilities for leases with a term of 12 months or less and does not separate non-lease components from lease components. Operating lease right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term and is included in general and administrative expenses. As most of the Company’s operating leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The incremental borrowing rate is the rate that the Company would expect to pay to borrow on a collateralized and fully amortizing basis over a similar term an amount equal to the lease payments in a similar economic environment.

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 and completed 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 condensed consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.

Recently Issued Accounting Pronouncements

In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments— Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The new standard will be effective for the Company on January 1, 2023 or at such earlier time where it is no longer a smaller reporting company. The Company has determined that there will not be a material impact on its consolidated financial statements upon adoption of this standard on January 1, 2023.

In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt instruments by reducing the number of accounting models and the number of embedded features that could be recognized separately from the host contract. Consequently, more convertible debt instruments will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. ASU 2020-06 also requires use of the if-converted method in the diluted earnings per share calculation for convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years for smaller reporting companies, with early adoption permitted. The new standard will be effective for the Company on January 1, 2024 or at such earlier time where it is no longer a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.

Revenue Recognition

9 Months Ended

Sep. 30, 2022

Revenue From Contract With Customer [Abstract]

Revenue Recognition

2. Revenue Recognition

Revenue Recognition Policy

Revenues historically have consisted 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 at a point in time or over 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 (4) 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. The Company assessed the services in accordance with the authoritative guidance and concluded that it met the definition of a collaborative arrangement per Accounting Standards Codification (“ASC”) 808, Collaborative Arrangements (“ASC 808”), which was outside the scope of ASC 606, Revenue from Contracts with Customers (“ASC 606”). Since ASC 808 did not provide recognition and measurement guidance for collaborative arrangements, the Company analogized to ASC 606 and concluded the two studies to be performed under the agreement represented two separate performance obligations. No services have been provided under the collaboration agreement subsequent to completion of the first study in 2013. In October 2021, the Company refunded $1.3 million of the prepayment. On October 24, 2022, the Company and Kissei finalized the termination of the collaboration agreement and canceled the second study contemplated thereunder.

Genzyme Corporation

In December 2005, Avigen, Inc. and Genzyme Corporation (“Genzyme”) entered into an Assignment Agreement (the “Genzyme Agreement”) in which Genzyme acquired certain gene therapy intellectual property, programs and other related assets from Avigen, Inc. in exchange for an initial $12.0 million payment. Avigen could also receive additional development milestone payments, sublicensing fees, and royalty payments based on the successful development of products by Genzyme utilizing technologies previously developed by Avigen. The Company subsequently acquired Avigen in December 2009 along with Avigen’s rights and obligations under the Genzyme Agreement. If Genzyme fails to diligently pursue the commercialization or marketing of products using the assigned technology, as specified in the Genzyme Agreement, some of the rights assigned could revert back to the Company at a future date.

The development milestones outlined in the Genzyme Agreement did not meet the definition of a substantive milestone obligation under authoritative guidance on revenue recognition for milestone payments, as Genzyme was responsible for the development of the products and there is no further substantive service effort required by the Company. In March 2021, the Company received notice that a gene therapy product based on AAV (adeno-associated virus) vector technology, which was covered under the Genzyme Agreement, achieved two clinical development milestones, triggering two milestone payments. Accordingly, the Company recognized revenue of $4.0 million during the nine months ended September 30, 2021.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

+ Details

Fair Value Measurements

9 Months Ended

Sep. 30, 2022

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.

The carrying amounts, estimated fair values and valuation inputs levels of the Company’s assets that are measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021, were as follows:

	September 30, 2022				December 31, 2021
	Carrying Amount		Fair Value		Carrying Amount		Fair Value		Valuation Inputs
Cash and cash equivalents:
Money market funds	$	698,842	$	698,842	$	694,293	$	694,293	Level 1
Investments
Bank certificates of deposit	$	10,021,849	$	10,021,849		—		—	Level 2

Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingencies

4. Commitments and Contingencies

Lease Commitments

The Company has operating leases primarily for real estate in the United States and Japan. The United States lease is for the Company’s headquarters in San Diego and has a term of five years ending January 31, 2027, with annual escalations. The Company’s lease in Tokyo, Japan has a term of two years ending May 2023 with an auto-renewal, two-year extension. The real estate operating leases are included in "Right-of-use asset” on the Company's balance sheet and represents the Company’s right to use the underlying assets for the lease term. The Company’s obligation to make lease payments are included in "Operating lease liability" and "Other non-current liabilities" on the Company's balance sheet.

Information related to the Company’s right-of-use assets and related lease liabilities are as follows:

	Three months ended				Nine months ended
	September 30,				September 30,
	2022		2021		2022		2021
Cash paid for operating lease liabilities	$	62,045	$	61,129	$	128,280	$	183,909
Operating lease costs		64,004		57,778		176,896		173,856

	September 30,			December 31,
	2022			2021
Current operating lease liabilities	$	167,073		$	131,965
Non-current operating lease liabilities		555,840			694,674
Total operating lease liabilities	$	722,913		$	826,639
Weighted-average remaining lease term		4.10			4.54
Weighted-average discount rate		9.8	%		9.8	%

Maturities of operating lease liabilities as of September 30, 2022 were as follows:
2022	$	63,072
2023		212,066
2024		189,170
2025		197,586
2026		206,483
Thereafter		17,269
Total minimum payments		885,646
Less imputed interest		(162,733	)
Total lease liabilities	$	722,913

Product Liability

The Company’s business exposes it to liability risks from its potential drug products. A successful product liability claim or series of claims brought against the Company could result in the payment of significant amounts of money and divert management’s attention from running the business. The Company may not be able to maintain insurance on acceptable terms, or the insurance may not provide adequate protection in the case of a product liability claim. To the extent that product liability insurance, if available, does not cover potential claims, the Company would be required to self-insure the risks associated with such claims. The Company believes it carries reasonably adequate insurance for product liability.

License and Research Agreements

The Company has entered into in-licensing agreements with various pharmaceutical companies. Under the terms of these agreements, the Company has received licenses to research, know-how and technology claimed in specified patents or patent applications. Under these license agreements, the Company is generally required to make upfront payments and additional payments upon the achievement of milestones and/or royalties on future sales of products until the later of the expiration of the applicable patent or the applicable last date of market exclusivity after the first commercial sale, on a country-by-country basis.

No amounts have been expended under these agreements during the three and nine months ended September 30, 2022 and 2021. For products currently in development, future potential milestone payments based on product development of MN-166 (ibudilast) and MN-001 (tipelukast) are $10 million as of September 30, 2022. For all other products, future potential milestone payments related to development milestones and commercialization milestones totaled $33.5 million as of September 30, 2022. There are no minimum royalties required under any of the license agreements. The Company is unable to estimate with certainty the timing on when these milestone payments will occur as these payments are dependent upon the progress of the Company’s product development programs.

Legal Proceedings

From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. The Company is not aware of any such proceedings or claims that it believes will have, individually or in aggregate, a material adverse effect on its business, financial condition or results of operations.

Stock-based Compensation

9 Months Ended

Sep. 30, 2022

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Stock-based Compensation

5. 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, 2022, 1,949,317 shares remain available for future grants under the 2013 Plan.

Certain of the employee stock options granted contain performance conditions, the vesting of which is based on a determination made by the compensation committee followed by an approval of 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. The estimated fair value of the performance awards granted and the resulting expense is based upon a certain level of achievement of the corporate objectives and other assumptions in determining fair value. The amount of expense ultimately recognized upon the grant date at completion of the performance period could change from the estimate as a result of various factors, including the level of achievement of the corporate objectives, changes in the assumptions used in the Black-Scholes model in determining fair value or fluctuations in the Company’s stock price during the performance period.

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 one or four year period. The exercise price of all options granted through September 30, 2022 and in 2021, was equal to the fair 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, 2022 is as follows:

	Number of Option Shares			Weighted Average Exercise Price
Outstanding at December 31, 2021		7,974,250		$	5.81
Granted		591,700			2.28
Exercised		(3,000	)		2.64
Cancelled		(577,700	)		5.85
Outstanding at September 30, 2022		7,985,250		$	5.55
Exercisable at September 30, 2022		7,377,380		$	5.81

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, 2021, an aggregate of 1,424 shares were issued under ESPP. No further shares will be issued 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 expense for the three and nine months ended September 30, 2022 and 2021, respectively:

	Three months ended				Nine months ended
	September 30,				September 30,
	2022		2021		2022		2021
Research, development and patents	$	53,948	$	207,521	$	192,819	$	866,486
General and administrative		104,350		371,423		321,034		1,607,999
Total stock-based compensation expense	$	158,298	$	578,944	$	513,853	$	2,474,485

The Company uses the Black-Scholes valuation model for determining the estimated fair value for stock-based awards granted to employees and considers management’s current expectations of the achievement of the performance objectives for the year. The following table provides the assumptions used in the Black-Scholes valuation model used to estimate the fair value of options granted during the nine months ended September 30, 2022 and 2021, and to estimate the fair value of performance-based stock options as of September 30, 2022 and 2021.

	Nine months ended
	September 30, 2022	September 30, 2021
Stock Option assumptions:
Risk-free interest rate	2.42 - 4.06%	0.42 - 0.98%
Expected volatility of common stock	75.13 - 79.35%	74.31 - 77.51%
Dividend yield	0.00%	0.00%
Expected term (in years)	4.87 - 5.77	4.5 - 5.8

As of September 30, 2022, there was $0.4 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 0.47 years, on a straight-line basis. Such compensation cost will ultimately be adjusted based upon actual performance compared to the corporate objectives as described above.

The weighted-average fair value of stock option granted during the nine months ended September 30, 2022 and 2021, estimated as of the grant date using the Black-Scholes option valuation model, was $1.47 and $3.33, respectively.

Stockholders' Equity

9 Months Ended

Sep. 30, 2022

Equity [Abstract]

Stockholders' Equity

6. Stockholders’ Equity

At-The-Market Issuance Sales Agreements and Private Placement Transactions

On August 23, 2019, the Company entered into an at the market issuance sales agreement, which was amended on August 26, 2022 (the “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.

No shares of common stock were sold under the ATM Agreement in the three and nine months ended September 30, 2022 and 2021, respectively.

On January 29, 2021, the Company sold and issued to an investor 3,656,307 shares of the Company’s common stock at a price of $5.47 per share for approximately $20 million in cash proceeds, net of approximately $0.1 million in issuance costs, in a private placement pursuant to the terms and conditions of a Securities Purchase Agreement dated as of January 11, 2021 by and between the Company and such investor.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Net Loss Per Share

9 Months Ended

Sep. 30, 2022

Earnings Per Share [Abstract]

Net Loss Per Share

7. 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 loss 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 7,985,250 shares and 8,099,250 shares for the three and nine months ended September 30, 2022 and 2021, respectively.

Interim Financial Information (Policies)	9 Months Ended
Interim Financial Information (Policies)	Sep. 30, 2022
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed 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 8-03 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 condensed 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 condensed 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, 2021 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, 2021 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, MediciNova Japan, Inc., MediciNova (Europe) Limited, MediciNova Europe GmbH and Avigen Inc. The financial statements of the Company’s foreign subsidiaries are measured using their local currency as the functional currency. The resulting translation adjustments are recorded as a component of other comprehensive income or loss. Intercompany transaction gains or losses at each period end are included as translation adjustments and recorded within other comprehensive income or loss. 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 small molecule 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, with original maturities of three months or less from the date of purchase.
Investments	Investments Investments purchased with an original maturity of greater than three months are classified as investments. Investments are stated at fair value and are classified as current or non-current based on the nature of the securities as well as their stated maturities. As of September 30, 2022, investments consisted of a bank certificate of deposit with an original purchased maturity of thirteen months.
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 $2.4 million and $2.0 million for the three months ended September 30, 2022 and 2021, respectively, and $6.8 million and $6.4 million for the nine months ended September 30, 2022 and 2021, 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 in Research, Development and Patents expenses. Such patent-related expenses totaled $0.1 million for the three months ended September 30, 2022 and 2021, respectively, and $0.3 million and $0.4 million for the nine months ended September 30, 2022 and 2021, 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.
Leases	Leases The Company determines if an arrangement is a lease at inception and if so, determines whether the lease qualifies as an operating or finance lease. The Company does not recognize right-of-use assets and lease liabilities for leases with a term of 12 months or less and does not separate non-lease components from lease components. Operating lease right-of-use assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Operating lease expense is recognized on a straight-line basis over the lease term and is included in general and administrative expenses. As most of the Company’s operating leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The incremental borrowing rate is the rate that the Company would expect to pay to borrow on a collateralized and fully amortizing basis over a similar term an amount equal to the lease payments in a similar economic environment.
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 and completed 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 condensed consolidated financial statements and the accompanying notes. Actual results could differ from those estimates.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments— Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). The ASU introduced a new credit loss methodology, the Current Expected Credit Losses (“CECL”) methodology, which requires earlier recognition of credit losses, while also providing additional transparency about credit risk. The CECL methodology utilizes a lifetime “expected credit loss” measurement objective for the recognition of credit losses for loans, held-to maturity debt securities, trade receivables and other receivables measured at amortized cost at the time the financial asset is originated or acquired. Subsequent to the issuance of ASU 2016-13, the FASB issued several additional ASUs to clarify implementation guidance, provide narrow-scope improvements and provide additional disclosure guidance. In November 2019, the FASB issued an amendment making this ASU effective for fiscal years beginning after December 15, 2022 for smaller reporting companies. The new standard will be effective for the Company on January 1, 2023 or at such earlier time where it is no longer a smaller reporting company. The Company has determined that there will not be a material impact on its consolidated financial statements upon adoption of this standard on January 1, 2023. In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt instruments by reducing the number of accounting models and the number of embedded features that could be recognized separately from the host contract. Consequently, more convertible debt instruments will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. ASU 2020-06 also requires use of the if-converted method in the diluted earnings per share calculation for convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years for smaller reporting companies, with early adoption permitted. The new standard will be effective for the Company on January 1, 2024 or at such earlier time where it is no longer a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures.
Revenue Recognition Policy	Revenue Recognition Policy Revenues historically have consisted 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 at a point in time or over 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 (4) the vendor has an enforceable right to payment for performance completed to date.

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Disclosures [Abstract]

Schedule of Carrying Amount Estimated Fair Values and Valuation Inputs Levels of Assets Are Measured at Fair Value on Recurring Basis

	September 30, 2022				December 31, 2021
	Carrying Amount		Fair Value		Carrying Amount		Fair Value		Valuation Inputs
Cash and cash equivalents:
Money market funds	$	698,842	$	698,842	$	694,293	$	694,293	Level 1
Investments
Bank certificates of deposit	$	10,021,849	$	10,021,849		—		—	Level 2

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2022

Commitments And Contingencies Disclosure [Abstract]

Schedule of Information Related to Right-of-Use Assets and Related Lease Liabilities

Information related to the Company’s right-of-use assets and related lease liabilities are as follows:

	Three months ended				Nine months ended
	September 30,				September 30,
	2022		2021		2022		2021
Cash paid for operating lease liabilities	$	62,045	$	61,129	$	128,280	$	183,909
Operating lease costs		64,004		57,778		176,896		173,856

	September 30,			December 31,
	2022			2021
Current operating lease liabilities	$	167,073		$	131,965
Non-current operating lease liabilities		555,840			694,674
Total operating lease liabilities	$	722,913		$	826,639
Weighted-average remaining lease term		4.10			4.54
Weighted-average discount rate		9.8	%		9.8	%

Schedule of Maturities of Operating Lease Liabilities

Maturities of operating lease liabilities as of September 30, 2022 were as follows:
2022	$	63,072
2023		212,066
2024		189,170
2025		197,586
2026		206,483
Thereafter		17,269
Total minimum payments		885,646
Less imputed interest		(162,733	)
Total lease liabilities	$	722,913

Stock-based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

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, 2022 is as follows:

	Number of Option Shares			Weighted Average Exercise Price
Outstanding at December 31, 2021		7,974,250		$	5.81
Granted		591,700			2.28
Exercised		(3,000	)		2.64
Cancelled		(577,700	)		5.85
Outstanding at September 30, 2022		7,985,250		$	5.55
Exercisable at September 30, 2022		7,377,380		$	5.81

Summary of Stock-based Compensation Expenses

The following table summarizes stock-based compensation expense for the three and nine months ended September 30, 2022 and 2021, respectively:

	Three months ended				Nine months ended
	September 30,				September 30,
	2022		2021		2022		2021
Research, development and patents	$	53,948	$	207,521	$	192,819	$	866,486
General and administrative		104,350		371,423		321,034		1,607,999
Total stock-based compensation expense	$	158,298	$	578,944	$	513,853	$	2,474,485

Schedule of Assumptions Used in Estimating Fair Value of Options Granted 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 during the nine months ended September 30, 2022 and 2021, and to estimate the fair value of performance-based stock options as of September 30, 2022 and 2021.

	Nine months ended
	September 30, 2022	September 30, 2021
Stock Option assumptions:
Risk-free interest rate	2.42 - 4.06%	0.42 - 0.98%
Expected volatility of common stock	75.13 - 79.35%	74.31 - 77.51%
Dividend yield	0.00%	0.00%
Expected term (in years)	4.87 - 5.77	4.5 - 5.8

Interim Financial Information - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Quarterly Financial Information Disclosure [Abstract]
Research and development costs	$ 2.4	$ 2.0	$ 6.8	$ 6.4
Patent-related expenses	$ 0.1	$ 0.1	$ 0.3	$ 0.4

Revenue Recognition - Additional Information (Detail) - USD ($) $ in Millions	1 Months Ended	9 Months Ended
	Oct. 31, 2021	Sep. 30, 2021	Oct. 31, 2011	Dec. 31, 2005
Kissei Pharmaceutical Co., Ltd
Revenue Recognition Milestone Method [Line Items]
Deferred revenue related to research and development services			$ 2.5
Performance obligations payment refunded	$ 1.3
Genzyme Corporation
Revenue Recognition Milestone Method [Line Items]
Business acquisition, payments				$ 12.0
Recognized revenue		$ 4.0

Fair Value Measurements - Schedule of Carrying Amount Estimated Fair Values and Valuation Inputs Levels of Assets Are Measured at Fair Value on Recurring Basis (Detail) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash and cash equivalents	$ 52,507,263	$ 71,430,954
Fair Value Measurements Recurring [Member] \| Money Market Funds [Member] \| Fair Value Inputs Level 1 [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash and cash equivalents	698,842	694,293
Fair Value	698,842	$ 694,293
Fair Value Measurements Recurring [Member] \| Bank Certificates Of Deposit \| Fair Value Inputs Level 2 [Member]
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]
Cash and cash equivalents	10,021,849
Fair Value	$ 10,021,849

Commitments and Contingencies - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Loss Contingencies [Line Items]
Research and development costs	$ 2,400,000	$ 2,000,000.0	$ 6,800,000	$ 6,400,000
Licensing Agreements
Loss Contingencies [Line Items]
Research and development costs	0	$ 0	0	$ 0
Product Development
Loss Contingencies [Line Items]
Future potential milestone payments	10,000,000		10,000,000
Development Milestone
Loss Contingencies [Line Items]
Future potential milestone payments	33,500,000		33,500,000
Commercialization Milestone
Loss Contingencies [Line Items]
Future potential milestone payments	$ 33,500,000		$ 33,500,000
U.S
Loss Contingencies [Line Items]
Operating lease term	5 years		5 years
Operating lease expiration date			Jan. 31, 2027
Tokyo, Japan
Loss Contingencies [Line Items]
Operating lease expiration month and year			2023-05
Operating lease, auto-renewal term	2 years		2 years
Operating lease, extension term			2 years
Lessee, operating lease, existence of option to extend			true

Commitments and Contingencies - Schedule of Right-of-Use Assets and Related Lease Liabilities (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Commitments And Contingencies Disclosure [Abstract]
Cash paid for operating lease liabilities	$ 62,045	$ 61,129	$ 128,280	$ 183,909
Operating lease costs	64,004	$ 57,778	176,896	$ 173,856
Current operating lease liabilities	167,073		167,073		$ 131,965
Non-current operating lease liabilities	$ 555,840		$ 555,840		$ 694,674
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration]	Other non-current liabilities		Other non-current liabilities		Other non-current liabilities
Total operating lease liabilities	$ 722,913		$ 722,913		$ 826,639
Weighted-average remaining lease term	4 years 1 month 6 days		4 years 1 month 6 days		4 years 6 months 14 days
Weighted-average discount rate	9.80%		9.80%		9.80%

Commitments and Contingencies - Schedule of Maturities of Operating Lease Liabilities (Detail) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Commitments And Contingencies Disclosure [Abstract]
2022	$ 63,072
2023	212,066
2024	189,170
2025	197,586
2026	206,483
Thereafter	17,269
Total minimum payments	885,646
Less imputed interest	(162,733)
Total lease liabilities	$ 722,913	$ 826,639

Stock-based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	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
Aggregate shares issued under ESPP		1,424
Shares issued under ESPP	0
Weighted-average fair value, per option	$ 1.47	$ 3.33
2007 Employee Stock Purchase Plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock reserved for future issuance			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	$ 0.4
Unamortized compensation cost, vesting period	5 months 19 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	1,949,317
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	1 year
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	1 year
2004 Plan \| Stock Option \| Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option, vesting period	4 years

Summary of Stock Option Activity and Related Information (Detail)	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of Option Shares
Stock Options, Beginning Balance \| shares	7,974,250
Stock Options, Granted \| shares	591,700
Stock Options, Exercised \| shares	(3,000)
Stock Options, Cancelled \| shares	(577,700)
Stock Options, Ending Balance \| shares	7,985,250
Stock Options, Exercisable at September 30, 2022 \| shares	7,377,380
Weighted Average Exercise Price, Beginning Balance \| $ / shares	$ 5.81
Weighted Average Exercise Price, Granted \| $ / shares	2.28
Weighted Average Exercise Price, Exercised \| $ / shares	2.64
Weighted Average Exercise Price, Cancelled \| $ / shares	5.85
Weighted Average Exercise Price, Ending Balance \| $ / shares	5.55
Weighted Average Exercise Price, Exercisable at September 30, 2022 \| $ / shares	$ 5.81

Summary of Stock-based Compensation Expenses (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 158,298	$ 578,944	$ 513,853	$ 2,474,485
Research, Development and Patents
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	53,948	207,521	192,819	866,486
General and Administrative
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 104,350	$ 371,423	$ 321,034	$ 1,607,999

Schedule of Assumptions Used in Estimating Fair Value of Options Granted and Performance-Based Stock Options (Detail) - Stock Option	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Weighted-average assumptions for stock options and ESPP
Dividend yield	0.00%	0.00%
Minimum
Weighted-average assumptions for stock options and ESPP
Risk-free interest rate	2.42%	0.42%
Expected volatility of common stock	75.13%	74.31%
Expected term (in years)	4 years 10 months 13 days	4 years 6 months
Maximum
Weighted-average assumptions for stock options and ESPP
Risk-free interest rate	4.06%	0.98%
Expected volatility of common stock	79.35%	77.51%
Expected term (in years)	5 years 9 months 7 days	5 years 9 months 18 days

Stockholders' Equity - Additional Information (Detail) - USD ($)			3 Months Ended			9 Months Ended
	Jan. 29, 2021	Aug. 23, 2019	Sep. 30, 2022	Sep. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Payments of stock issuance costs							$ 118,368
Common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock in a private transaction, net of issuance costs, shares					3,656,307
ATM Agreement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock in a private transaction, net of issuance costs, shares			0	0		0	0
Private Placement
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of common stock in a private transaction, net of issuance costs, shares	3,656,307
Private Placement \| Common stock
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share price per share	$ 5.47
Gross proceeds	$ 20,000,000
Payments of stock issuance costs	$ 100,000
B. Riley FBR \| ATM 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 \| ATM 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

Net Loss Per Share - Additional Information (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Earnings Per Share [Abstract]
Potentially dilutive outstanding stock options excluded from diluted net loss per common share	7,985,250	8,099,250	7,985,250	8,099,250