MEDICINOVA INC
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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Sep 30, 2025 · Filed Nov 12, 2025
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Item 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $32,562,612 | $40,359,738 |
| Prepaid expenses and other current assets | 359,909 | 714,541 |
| Total current assets | 32,922,521 | 41,074,279 |
| Goodwill | 9,600,240 | 9,600,240 |
| In-process research and development | 4,800,000 | 4,800,000 |
| Property and equipment, net | 12,933 | 25,507 |
| Right-of-use asset | 223,698 | 356,904 |
| Other non-current assets | 18,996 | 18,996 |
| Total assets | $47,578,388 | $55,875,926 |
| Liabilities and Stockholders’ Equity | ||
| Current liabilities: | ||
| Accounts payable | $745,958 | $1,102,494 |
| Accrued liabilities and other current liabilities | 1,888,833 | 1,662,860 |
| Deferred revenue | 521,899 | — |
| Operating lease liability | 180,751 | 193,769 |
| Total current liabilities | 3,337,441 | 2,959,123 |
| Deferred tax liability | 201,792 | 201,792 |
| Other non-current liabilities | 74,399 | 211,460 |
| Total liabilities | 3,613,632 | 3,372,375 |
| Commitments and contingencies (Note 4) | ||
| Stockholders’ equity: | ||
| Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2025 and December 31, 2024; 49,046,246 and 49,046,246 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | 49,046 | 49,046 |
| Additional paid-in capital | 479,989,433 | 479,340,901 |
| Accumulated other comprehensive loss | (126,803) | (135,154) |
| Accumulated deficit | (435,946,920) | (426,751,242) |
| Total stockholders’ equity | 43,964,756 | 52,503,551 |
| Total liabilities and stockholders' equity | $47,578,388 | $55,875,926 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Three months ended · Nine months ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Revenues | $123,319 | $— | $257,918 | $— |
| Operating expenses: | ||||
| Costs of services | 115,272 | — | 231,621 | — |
| Research, development and patents | 1,582,975 | 1,859,400 | 5,611,429 | 5,287,318 |
| General and administrative | 1,806,070 | 1,449,728 | 4,605,468 | 4,204,299 |
| Total operating expenses | 3,504,317 | 3,309,128 | 10,448,518 | 9,491,617 |
| Operating loss | (3,380,998) | (3,309,128) | (10,190,600) | (9,491,617) |
| Interest income | 340,850 | 447,847 | 1,001,916 | 1,280,708 |
| Other income (expense), net | (10,225) | 9,102 | (6,994) | (23,988) |
| Net loss | $(3,050,373) | $(2,852,179) | $(9,195,678) | $(8,234,897) |
| Basic and diluted net loss per common share | $(0.06) | $(0.06) | $(0.19) | $(0.17) |
| Shares used to compute basic and diluted net loss per common share | 49,046,246 | 49,046,246 | 49,046,246 | 49,046,246 |
| Net loss | $(3,050,373) | $(2,852,179) | $(9,195,678) | $(8,234,897) |
| Other comprehensive loss, net of tax: | ||||
| Foreign currency translation adjustments | 568 | 7,724 | 8,351 | (5,713) |
| Comprehensive loss | $(3,049,805) | $(2,844,455) | $(9,187,327) | $(8,240,610) |
CONDENSED CONSOLIDATED STATEM ENTS OF STOCKHOLDERS’ EQUITY
| Common stock · Additionalpaid-in · Accumulatedothercomprehensive · Accumulated · Totalstockholders’ | ||||||
|---|---|---|---|---|---|---|
| Shares | Amount | capital | loss | deficit | equity | |
| Balance at December 31, 2024 | 49,046,246 | $49,046 | $479,340,901 | $(135,154) | $(426,751,242) | $52,503,551 |
| Share-based compensation | — | — | 285,943 | — | — | 285,943 |
| Net loss | — | — | — | — | (2,864,120) | (2,864,120) |
| Foreign currency translation adjustments | — | — | — | 5,102 | — | 5,102 |
| Balance at March 31, 2025 | 49,046,246 | 49,046 | 479,626,844 | (130,052) | (429,615,362) | 49,930,476 |
| Share-based compensation | — | — | 204,897 | — | — | 204,897 |
| Net loss | — | — | — | — | (3,281,185) | (3,281,185) |
| Foreign currency translation adjustments | — | — | — | 2,681 | — | 2,681 |
| Balance at June 30, 2025 | 49,046,246 | 49,046 | 479,831,741 | (127,371) | (432,896,547) | 46,856,869 |
| Share-based compensation | — | — | 157,692 | — | — | 157,692 |
| Net loss | — | — | — | — | (3,050,373) | (3,050,373) |
| Foreign currency translation adjustments | — | — | — | 568 | — | 568 |
| Balance at September 30, 2025 | 49,046,246 | $49,046 | $479,989,433 | $(126,803) | $(435,946,920) | $43,964,756 |
| Common stock · Additionalpaid-in · Accumulatedothercomprehensive · Accumulated · Totalstockholders’ | ||||||
|---|---|---|---|---|---|---|
| Shares | Amount | capital | loss | deficit | equity | |
| Balance at December 31, 2023 | 49,046,246 | $49,046 | $478,149,161 | $(118,090) | $(415,701,693) | $62,378,424 |
| Share-based compensation | — | — | 215,430 | — | — | 215,430 |
| Net loss | — | — | — | — | (2,754,518) | (2,754,518) |
| Foreign currency translation adjustments | — | — | — | (8,892) | — | (8,892) |
| Balance at March 31, 2024 | 49,046,246 | 49,046 | 478,364,591 | (126,982) | (418,456,211) | 59,830,444 |
| Share-based compensation | — | — | 207,455 | — | — | 207,455 |
| Net loss | — | — | — | — | (2,628,200) | (2,628,200) |
| Foreign currency translation adjustments | — | — | — | (4,545) | — | (4,545) |
| Balance at June 30, 2024 | 49,046,246 | 49,046 | 478,572,046 | (131,527) | (421,084,411) | 57,405,154 |
| Share-based compensation | — | — | 504,862 | — | — | 504,862 |
| Net loss | — | — | — | — | (2,852,179) | (2,852,179) |
| Foreign currency translation adjustments | — | — | — | 7,724 | — | 7,724 |
| Balance at September 30, 2024 | 49,046,246 | $49,046 | $479,076,908 | $(123,803) | $(423,936,590) | $55,065,561 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| Nine months ended | ||
|---|---|---|
| September 30, | ||
| 2025 | 2024 | |
| Operating activities: | ||
| Net loss | $(9,195,678) | $(8,234,897) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Non-cash stock-based compensation | 648,532 | 927,747 |
| Depreciation and amortization | 15,544 | 15,900 |
| Gain on disposal of property and equipment | — | (199) |
| Change in carrying amount of right-of-use asset | 134,433 | 129,179 |
| Changes in assets and liabilities: | ||
| Prepaid expenses and other assets | 356,117 | (755,820) |
| Accounts payable, accrued liabilities and other liabilities | (122,519) | (665,592) |
| Deferred revenue | 521,899 | — |
| Operating lease liability | (151,592) | (127,550) |
| Net cash used in operating activities | (7,793,264) | (8,711,232) |
| Investing activities: | ||
| Proceeds from sale of property and equipment | — | 199 |
| Acquisitions of property and equipment | (2,899) | (897) |
| Net cash used in investing activities | (2,899) | (698) |
| Effect of exchange rate changes on cash and cash equivalents | (963) | (6,894) |
| Net change in cash and cash equivalents | (7,797,126) | (8,718,824) |
| Cash and cash equivalents, beginning of period | 40,359,738 | 50,999,442 |
| Cash and cash equivalents, end of period | $32,562,612 | $42,280,618 |
| Supplemental disclosure of non-cash investing activities: | ||
| Right-of-use asset obtained in exchange for operating lease liability | $— | $42,281 |
| Change in carrying amount of right-of-use asset due to termination of lease | $— | $79,229 |
Notes to Condensed Consolidated Financial Statements
- 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 Standard 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) and prevention of acute respiratory distress syndrome (ARDS), and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD) and hypertriglyceridemia.
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, 2024 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, 2024 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.
Liquidity
The Company has incurred net losses since its inception and has negative operating cash flows. As of September 30, 2025, the Company had $32.6 million in cash and cash equivalents and believes it has sufficient cash to meet its funding requirements for at least the next 12 months following the issuance date of these consolidated financial statements. For the foreseeable future, the Company expects to continue to incur losses and require additional capital to further advance its clinical trial programs and support its other operations. The Company cannot be certain that additional funding will be available on acceptable terms, or at all.
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, MediciNova Canada, Inc. 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
An operating segment is identified as a component of an enterprise that engages in business activities about which separate discrete financial information and operating results is regularly reviewed by the chief operating decision-maker (CODM) in making decisions regarding resource allocation and assessing performance. The Company's CODM is the senior executive committee which is comprised of the Chief Executive Officer, Chief Medical Officer, and the Chief Financial Officer. The Company operates in asingle operating segment – the acquisition and development of small molecule therapeutics for the treatment of serious diseases with unmet medical needs. The CODM assesses performance for the segment and decides how to allocate resources based on consolidated net loss as reported on the statement of operations, after taking into account the Company's strategic priorities, its cash balance, and its expected use of cash. Further, the CODM reviews and utilizes functional expenses (i.e., research, development, and patent expense, and general and administrative) at the consolidated level to manage the Company's operations. Other segment items included in consolidated net loss are revenues, cost of services, stock-based compensation, depreciation and amortization, interest income, other expense, net, and income tax expense, which are reflected in the consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets.
The following table presents financial information, including significant segment expenses, which are regularly provided to the CODM and included within segment and consolidated net loss:
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Revenues | $123,319 | $— | $257,918 | $— |
| Operating expenses, excluding stock-based compensation | ||||
| Costs of services | 115,272 | — | 231,621 | — |
| Research, development and patents | 1,523,489 | 1,643,659 | 5,355,670 | 4,911,359 |
| General and administrative | 1,707,864 | 1,160,607 | 4,212,695 | 3,652,511 |
| Total operating expenses, excluding stock-based compensation | 3,346,625 | 2,804,266 | 9,799,986 | 8,563,870 |
| Stock-based compensation | ||||
| Research, development and patents | 59,486 | 215,741 | 255,759 | 375,959 |
| General and administrative | 98,206 | 289,121 | 392,773 | 551,788 |
| Total stock-based compensation | 157,692 | 504,862 | 648,532 | 927,747 |
| Total operating expenses | 3,504,317 | 3,309,128 | 10,448,518 | 9,491,617 |
| Operating loss | (3,380,998) | (3,309,128) | (10,190,600) | (9,491,617) |
| Interest income | 340,850 | 447,847 | 1,001,916 | 1,280,708 |
| Other income (expense), net | (10,225) | 9,102 | (6,994) | (23,988) |
| Segment and consolidated net loss | $(3,050,373) | $(2,852,179) | $(9,195,678) | $(8,234,897) |
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and other highly liquid investments including money market and mutual fund accounts, with original maturities of three months or less from the date of purchase.
Accounts Receivable
Accounts receivable is recorded net of allowance for credit losses. There wasno allowance for credit losses required as of September 30, 2025. The accounts receivable balance as of September 30, 2025 and December 31, 2024 was $0.
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 $1.5 million and $1.8 million for the three months ended September 30, 2025 and 2024, respectively, and $5.3 million and $5.0 million for the nine months ended September 30, 2025 and 2024, 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 both the three months ended September 30, 2025 and 2024, and $0.3 million for both the nine months ended September 30, 2025 and 2024.
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.
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 December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures(ASU 2023-09). ASU 2023-09 enhances the transparency and decision usefulness of income tax disclosures. Specifically, it requires that a public business entity: 1) disclose, on an annual basis, an income tax rate reconciliation in a tabular form, disclosing specific categories and providing additional information for reconciling items that meet a quantitative threshold, 2) disclose on an annual basis the following information about income taxes paid: i) the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes, ii) the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received), 3) all entities are required to disclose: i) income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign, and ii) income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. For public business entities, the amendments are effective for annual periods beginning after December 15, 2024. For all other entities, the amendments are effective for annual periods beginning after December 15, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The amendments in this ASU should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the potential impact that this standard will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. ASU 2024-03 requires additional disclosure of the nature of expenses included in the financial statements. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the potential impact that this standard will have on its consolidated financial statements and related disclosures.
- Revenue Recognition
Revenue Recognition Policy
Revenues historically have consisted mainly of research and development services performed under contracts with customers. 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.
Mayo Foundation for Medical Education and Research
In December 2024, the Company entered into an agreement with Mayo Foundation for Medical Education and Research (Mayo), to support clinical research services to evaluate the efficacy of MN-166 (ibudilast) in ALS. The agreement has an initial one year term, with automatic successive one year terms unless either party gives written notice of non-renewal to the other party not less than 90 days prior to the end of the end of the then-current term, with payment for services due within 60 days from invoice. The agreement can be terminated by either party upon the occurrence of certain events, including by either party, without cause, upon not less than 30 days prior written notice. In August 2025, the Mayo agreement was amended to extend the initial term until August 2026. The Company assessed the services in accordance with the authoritative guidance and concluded that it met the definition of a contract per ASC 606 with one performance obligation. The performance obligation identified was for pharmacovigilance and clinical research support services satisfied over time using the cost-to-cost method. In March 2025, the first study site enrolled the first patients into the study and principal services under the agreement began in April 2025. In August 2025, the Company received $0.8 million from Mayo, of which $0.5 million is a current liability recognized as deferred revenue. The Company recognized revenue of $0.1 million and $0.3 million for the three and nine months ended September 30, 2025, respectively. The remaining performance obligation under this agreement relates to pharmacovigilance and clinical research support services, which will be satisfied over the remaining term of the agreement.
- 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 amount and approximate fair value of financial instruments as of September 30, 2025 and December 31, 2024, were as follows:
| September 30, 2025 · December 31, 2024 | |||||
|---|---|---|---|---|---|
| Carrying Amount | Fair Value | Carrying Amount | Fair Value | Valuation Inputs | |
| Cash and cash equivalents: | |||||
| Mutual funds | $31,807,348 | $31,807,348 | $21,501,081 | $21,501,081 | Level 1 |
- 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 offive years ending January 31, 2027, with annual escalations. In April 2024, the Company provided notice to terminate its previous lease agreement for its Tokyo office, effective October 2024, and in May 2024, the Company entered into a new lease agreement, effective June 2024, for a different office space for its Tokyo location. The new lease had an initial lease term of 12 months ending May 2025, following which the Company exercised its option to extend for an additionaltwo months. Thereafter, there will be automatictwo-month renewals until the lease is terminated. In measuring the lease liability, the Company determined that it was reasonably certain that it would exercise one renewal option. Accordingly, the Company used a lease term of 14 months in measuring the lease liability. The Company measured the lease liability based on the present value of the future lease payments, including the one extension option that is reasonably certain to be exercised, discounted using the estimated incremental borrowing rate of 6.51%, which is the interest rate that the Company would have to pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments at initial commencement. The real estate operating leases are included in “Right-of-use asset” on the Company's consolidated balance sheets 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 sheets.
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, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Cash paid for operating lease liabilities | $53,284 | $70,720 | $174,427 | $204,177 |
| Operating lease costs | 48,613 | 74,378 | 158,885 | 206,228 |
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| Current operating lease liabilities | $180,751 | $193,769 |
| Non-current operating lease liabilities | 74,399 | 211,460 |
| Total operating lease liabilities | $255,150 | $405,229 |
| Weighted-average remaining lease term (in years) | 1.34 | 1.98 |
| Weighted-average discount rate | 9.8% | 9.6% |
| Maturities of operating lease liabilities as of September 30, 2025 were as follows: | |
|---|---|
| 2025 (remaining three months) | $49,572 |
| 2026 | 206,483 |
| 2027 | 17,269 |
| 2028 | — |
| 2029 | — |
| Thereafter | — |
| Total minimum payments | 273,324 |
| Less imputed interest | (18,174) |
| Total lease liabilities | $255,150 |
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 milestone payments have been made under these agreements during thenine months ended September 30, 2025 and 2024. 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, 2025. For all other products, future potential milestone payments related to development milestones and commercialization milestones totaled $16.5 million as of September 30, 2025. 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
Stock Incentive Plans
In June 2013, the Company adopted the 2013 Equity Incentive Plan (2013 Plan) under which the Company granted equity-based awards, including stock options, stock appreciation rights, restricted stock, and restricted stock units to individuals who were then employees, officers, non-employee directors or consultants of the Company or its subsidiaries. A total of 8,700,000 shares of common stock were reserved for issuance under the 2013 Plan. In addition, “returning shares” that may become available from time to time were added back to the 2013 Plan. “Returning shares” included shares that were subject to outstanding awards granted under the Company's prior 2004 Equity Incentive Plan that expired or terminated prior to exercise or settlement, were forfeited because of the failure to vest, were repurchased, or were withheld to satisfy tax withholding or purchase price obligations in connection with such awards. Although the Company no longer grants equity awards under the 2013 Plan, all outstanding stock awards granted under the 2013 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 2013 Plan.
In June 2023, the Company adopted the 2023 Equity Incentive Plan (2023 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 2023 Plan is the successor to the 2013 Plan. The number of shares of common stock that may be issued under the 2023 Plan is equal to the sum of (a) shares subject to awards granted under the 2013 Plan that were outstanding upon expiration of the 2013 Plan and are subsequently forfeited, expire or lapse unexercised or unsettled and shares issued pursuant to awards granted under the 2013 Plan that were outstanding upon expiration of the 2013 Plan and are subsequently forfeited to or reacquired by the Company and (b) shares reserved under the 2013 Plan that were not issued or subject to outstanding awards under the 2013 Plan upon expiration of the 2013 Plan. While a maximum of 9,934,567 shares may become available for issuance under the 2023 Plan from the 2013 Plan, since this figure assumes that all awards outstanding under the 2013 Plan upon expiration of the 2013 Plan will be forfeited, the Company expects the actual number of shares added to the 2023 Plan to be less. In general, to the extent that awards under the 2023 Plan are forfeited, cancelled or expire for any reason before being exercised or settled in full, the shares subject to such awards will again become available for issuance under the 2023 Plan. If stock appreciation rights are exercised or restricted stock units are settled, then only the number of shares (if any) actually issued to the participant will reduce the number of shares available under the 2023 Plan. If restricted shares or shares issued upon exercise of options are reacquired by the Company pursuant to a forfeiture provision, repurchase right or for any other reason, then such shares shall again become available for issuance under the 2023 Plan. Shares withheld to pay the exercise price of options or satisfy tax withholding obligations related to an award shall again become available for issuance under the 2023 Plan. Further, to the extent an award is settled in cash rather than shares, the cash settlement shall not reduce the number of shares available for issuance under the 2023 Plan.
As of September 30, 2025,2,032,173 shares remain available for future grants under the 2023 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. As of September 30, 2025, there were a total of 970,000 shares underlying performance options that were subject to vesting based on achievement of corporate objectives and employee performance for 2025.
Stock Options
Options granted under the 2023 Plan and the 2013 Plan have terms often years from the date of grant unless earlier terminated and generally vest over aone orfour year period. The exercise price of all options granted through September 30, 2025 and 2024, 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, 2025 is as follows:
| Number ofOption Shares | Weighted AverageExercise Price | |
|---|---|---|
| Outstanding at December 31, 2024 | 7,040,894 | $5.12 |
| Granted | 1,380,500 | 2.00 |
| Exercised | — | — |
| Forfeited | (103,000) | 1.86 |
| Expired | (416,000) | 3.08 |
| Outstanding at September 30, 2025 | 7,902,394 | $4.73 |
| Exercisable at September 30, 2025 | 6,758,306 | $5.18 |
Compensation Expense
Stock-based compensation expense for stock option awards are reflected in total operating expenses for each respective period. The following table summarizes stock-based compensation expense for thethree and nine months ended September 30, 2025 and 2024, respectively:
| Three months ended · Nine months ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Research, development and patents | $59,486 | $215,741 | $255,759 | $375,959 |
| General and administrative | 98,206 | 289,121 | 392,773 | 551,788 |
| Total stock-based compensation expense | $157,692 | $504,862 | $648,532 | $927,747 |
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 thenine months ended September 30, 2025 and 2024, and to estimate the fair value of performance-based stock options as of September 30, 2025 and 2024.
| Nine months ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock Options | ||
| Risk-free interest rate | 3.74 - 4.48% | 4.21 - 4.41% |
| Expected volatility of common stock | 60.50 - 75.66% | 72.83 - 74.05% |
| Dividend yield | 0.00% | 0.00% |
| Expected term (in years) | 4.53 - 5.31 | 5.30 - 5.77 |
As of September 30, 2025, therewas $0.3 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 0.31 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 each stock option granted during the nine months ended September 30, 2025 and 2024, estimated as of the grant date using the Black-Scholes option valuation model, was $1.34 and $0.99 per option, respectively.
- 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 (as amended, 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 thenine months ended September 30, 2025 and 2024, respectively.
Standby Equity Purchase Agreement
On July 30, 2025, the Company entered into a Standby Equity Purchase Agreement, or the SEPA with YA II PN, LTD., a Cayman Islands exempt limited company, or Yorkville. Pursuant to the SEPA, the Company has the right, but not the obligation, to sell to Yorkville from time to time up to $30.0 million of its common stock, during the 36 months following the execution of the SEPA, subject to the restrictions and satisfaction of the conditions in the SEPA. At the Company's option, the shares of common stock would be purchased by Yorkville from time to time at a price equal to 97% of the lowest of the three daily volume weighted average prices (VWAPs), during a three consecutive trading day period commencing on the date that the Company, subject to certain limitations, delivers to Yorkville a notice that the Company is committing Yorkville to purchase such shares of common stock. The Company may also specify a certain minimum acceptable price per share for a drawdown under the SEPA. As consideration for Yorkville's irrevocable commitment to purchase common stock, the Company paid Yorkville a $25,000 structuring fee along with a commitment fee of $375,000, recorded as General and Administrative expense. Under the applicable rules of Nasdaq and pursuant to the SEPA, in no event may the Company issue or sell to Yorkville more than 9,804,345 shares of common stock, or the Exchange Cap, which is 19.99% of the shares of common stock outstanding immediately prior to the execution of the SEPA, unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable shares of common stock under the SEPA equals or exceeds $1.33 per share (which represents the lower of (i) the Nasdaq Official Closing Price (as reflected on Nasdaq.com) on the trading day immediately preceding July 30, 2025 or (ii) the average Nasdaq Official Closing Price of the common stock (as reflected on Nasdaq.com) for the five trading days immediately preceding July 30, 2025). Pursuant to the SEPA, Yorkville shall not be obliged to purchase or acquire any shares of common stock under the SEPA which, when aggregated with all other shares of the Company's common stock beneficially owned by Yorkville and its affiliates, would result in the beneficial ownership of Yorkville and its affiliates (on an aggregated basis) exceeding 4.99% of the then outstanding voting power or number of outstanding shares of the Company's common stock.
Pursuant to a financial advisory agreement between the Company and D. Boral Capital LLC (D. Boral), the Company has also agreed to pay D. Boral a fee equal to three percent of the gross proceeds received from any shares that the Company sells to Yorkville pursuant to the SEPA.
No shares of common stock were sold under the SEPA in nine months ended September 30, 2025.
- 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 7,902,394 shares for thethree and nine months ended September 30, 2025 and 8,359,844 shares for the three and nine months ended September 30, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.