MNOV 10-K & 10-Q changes, risk factors and insider trading
Medicinova Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1226616 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “The sale of additional common stock, including under our existing shelf registration statement and at market issuance sales agreement may cause substantial dilution to our existing stockholders and/or the price of our common stock to decline.”
Largest changes
“The sale of additional common stock, including under our existing shelf registration statement and at market issuance sales agreement may cause substantial dilution to our existing stockholders and/or the price of our common stock to decline.”see in full comparison
“On August 26, 2022, we filed a shelf registration statement (Shelf Registration Statement) on Form S-3 with the SEC (that was declared effective by the SEC on September 6, 2022), which permits us to offer up to $200.0 million of our common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination, including units from time to time. Our Shelf Registration Statement is intended to provide us with flexibility to raise capital in the future for general corporate purposes. …”see in full comparison
“Further, we have registered and intend to continue to register all shares of common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates. We cannot predict what effect, if any, sales of our shares in the public market or the availability of shares for sale will have on the market price of our common stock. …”see in full comparison
“Sales of a substantial number of shares of our common stock could cause our stock price to decline. Sales of a substantial number of shares of our common stock could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of February 17, 2025, we had 49,046,246 shares of common stock outstanding. …”see in full comparison
It is our policy to consult with our licensors in the maintenance of granted patents we have licensed and in their pursuit of patent applications that we have licensed, but each of our licensors generally remains primarily responsible for or in control of the maintenance of the granted patents. We have limited control, if any, over the amount or timing of resources that each licensor devotes on our behalf. As a result of this lack of control, we cannot be sure that our licensed patents will be maintained and that any additional patents will ever mature from our licensed applications. Issued U.S. patents require the payment of maintenance fees to continue to be in force. We typically rely on our licensors to do this and their failure to do so could result in the forfeiture of patents not timely maintained. Many foreign patent offices also require the payment of periodic annuities to keep patents and patent applications in good standing. As we generally do not maintain control over the payment of annuities, we cannot be certain that our licensors will timely pay such annuities and that the granted patents will not become abandoned.see in full comparisonFor example, certain annuities were not paid in a timely manner with respect to foreign patents licensed under MN-002 (the active metabolite of MN-001 (tipelukast) and, as a result, our patent rights may be impaired in those territories.In addition, our licensors may have selected a limited amount of foreign patent protection, and therefore applications have not been filed in, and foreign patents may not have been perfected in, all commercially significant countries.
Our product candidates are subject to the risks of failure inherent in drug development. We will be required to demonstrate through well-controlled clinical trials that our product candidates are safe and effective for use in a diverse population for the relevant target indications before we can seek regulatory approvals for their commercial sale. Success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing, even at statistically significant levels.see in full comparisonFor example, we may not be able replicate the positive results from our Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder in clinical trials for other indications in the future.Clinical trial failure may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, patient enrollment criteria, relatively smaller sample size in earlier trials, and failure to demonstrate favorable safety or efficacy traits. As such, failure in clinical trials can occur at any stage of testing.
Full comparison: every changed paragraph (14)
We currently have no products that are approved for commercial sale and we have never had any products approved for commercial sale. We cannot guarantee that we will ever have any drug products approved for sale. The research, testing, manufacturing, labeling, approval, sales, marketing and distribution of drug products are subject to extensive regulation by the Food and Drug Administration (FDA) and comparable regulatory authorities in other countries. We are not permitted to market any of our product candidates in the United States or other jurisdictions until we submit and receive approval of a New Drug Application (NDA) for a product candidate from the FDA or its foreign equivalent from a foreign regulatory authority, as applicable. Obtaining FDA approval is a lengthy, expensive and uncertain process. To date we have invested a substantial majority of our business efforts and financial resources toin the development and commercialization of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates. Our future success is dependent on our ability to successfully develop, obtain regulatory approval for, and commercialize MN-166 (ibudilast) and MN-001 (tipelukast) and we cannot accurately predict when or if either MN-166 (ibudilast) or MN-001 (tipelukast) will receive regulatory approval. Neither of these product candidates have completed the clinical development process, and therefore we have not submitted an NDA or foreign equivalent or received marketing approval for either product candidate.
Our product candidates are subject to the risks of failure inherent in drug development. We will be required to demonstrate through well-controlled clinical trials that our product candidates are safe and effective for use in a diverse population for the relevant target indications before we can seek regulatory approvals for their commercial sale. Success in early clinical trials does not mean that later clinical trials will be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety or efficacy despite having progressed through initial clinical testing, even at statistically significant levels. For example, we may not be able replicate the positive results from our Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder in clinical trials for other indications in the future. Clinical trial failure may result from a multitude of factors including flaws in trial design, dose selection, placebo effect, patient enrollment criteria, relatively smaller sample size in earlier trials, and failure to demonstrate favorable safety or efficacy traits. As such, failure in clinical trials can occur at any stage of testing.
We have received Fast Track designation for certain of our product candidates, including MN-001 (tipelukast) for the potential treatment of NASH with fibrosis and MN-166 (ibudilast) for the potential treatment of progressive MS, the potential treatment of Amyotrophic Lateral Sclerosis (ALS), and the potential treatment of methamphetamine dependence and we hope to benefit from the FDA’s Fast Track and priority review programs.
Macroeconomic pressures, including those resulting from ongoing geopolitical matters, tariffs, unfavorable market conditions, health epidemics, and regulatory and policy changes, may have an adverse impact on our business, financial results, stock price and results of operations as well as the business of our current and potential customers.
Our results of operations could be adversely affected by unfavorable global and geopolitical economic conditions, such as increased tariffs, decreases in per capital income and level of disposable income, inflation, rising interest rates, and supply chain issues. Ongoing geopolitical matters have also contributed to difficult macroeconomic conditions and exacerbated supply chain issues, resulting in significant economic uncertainty as well as volatility in the financial markets and new regulatory and policy initiatives particularly in the United States. Such conditions may adversely impact our business, financial results, and prospects and our target customers’ businesses. In addition, such macroeconomic conditions could impact our ability to access the public markets as and when appropriate or necessary to carry out our operations or our strategic goals. We cannot predict the ongoing extent, duration or severity of these conditions, nor the extent to which we may be impacted.
We may be adversely affected by the effects of inflation.inflation, including as a result of increased tariffs.
InflationInflation, including as a result of increased tariffs, has the potential to adversely affect our business, results of operations, financial position and liquidity by increasing our overall cost structure, particularly if we are unable to achieve commensurate increases in the prices we charge our customers. The existence of inflation in the economy has the potential to result in higher interest rates and capital costs, supply shortages, increased costs of labor and other similar effects. As a result of inflation, we may experience increases in the costs of labor, materials, and other inputs, such as engineering consultants. Although we may take measures to mitigate the impact of this inflation, if these measures are not effective our business, results of operations, financial position and liquidity could be materially adversely affected. Even if such measures are effective, there could be a difference between the timing of when these beneficial actions impact our results of operations and when the cost of inflation is incurred.
A significant amount of our business activity is outside of the United States. We face risks associated with our international operations, including possible unfavorable regulatory, pricing and reimbursement, political, tariffs, tax and labor conditions, which could harm our business. We are subject to numerous risks associated with international business activities, including, but not limited to:
It is our policy to consult with our licensors in the maintenance of granted patents we have licensed and in their pursuit of patent applications that we have licensed, but each of our licensors generally remains primarily responsible for or in control of the maintenance of the granted patents. We have limited control, if any, over the amount or timing of resources that each licensor devotes on our behalf. As a result of this lack of control, we cannot be sure that our licensed patents will be maintained and that any additional patents will ever mature from our licensed applications. Issued U.S. patents require the payment of maintenance fees to continue to be in force. We typically rely on our licensors to do this and their failure to do so could result in the forfeiture of patents not timely maintained. Many foreign patent offices also require the payment of periodic annuities to keep patents and patent applications in good standing. As we generally do not maintain control over the payment of annuities, we cannot be certain that our licensors will timely pay such annuities and that the granted patents will not become abandoned. For example, certain annuities were not paid in a timely manner with respect to foreign patents licensed under MN-002 (the active metabolite of MN-001 (tipelukast) and, as a result, our patent rights may be impaired in those territories. In addition, our licensors may have selected a limited amount of foreign patent protection, and therefore applications have not been filed in, and foreign patents may not have been perfected in, all commercially significant countries.
The sale of additional common stock, including under our existing shelf registration statement and at market issuance sales agreement may cause substantial dilution to our existing stockholders and/or the price of our common stock to decline.
Sales of a substantial number of shares of our common stock could cause our stock price to decline. Sales of a substantial number of shares of our common stock could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of February 17, 2025, we had 49,046,246 shares of common stock outstanding. Shares held by directors, executive officers and other affiliates will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.
Further, we have registered and intend to continue to register all shares of common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates. We cannot predict what effect, if any, sales of our shares in the public market or the availability of shares for sale will have on the market price of our common stock. However, future sales of substantial amounts of our common stock in the public market, including shares issued upon exercise of our outstanding warrant or options, or the perception that such sales may occur, could adversely affect the market price of our common stock. We also expect that significant additional capital may be needed in the future to continue our planned operations.
On August 26, 2022, we filed a shelf registration statement (Shelf Registration Statement) on Form S-3 with the SEC (that was declared effective by the SEC on September 6, 2022), which permits us to offer up to $200.0 million of our common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination, including units from time to time. Our Shelf Registration Statement is intended to provide us with flexibility to raise capital in the future for general corporate purposes. As part of this Shelf Registration Statement, we also entered into an amendment to an at market issuance sales agreement (as amended, the ATM Agreement) with B. Riley Securities, Inc. (formerly B. Riley FBR, Inc.) (B. Riley Securities) pursuant to which we may offer and sell common stock through B. Riley Securities from time to time up to an aggregate offering price of $75.0 million, of which $10.3 million of our common stock was sold under a previous shelf registration statement on Form S-3, which expired on August 22, 2022 (Prior Shelf Registration Statement). In connection with the ATM Agreement and as part of the Shelf Registration Statement, we filed a prospectus supplement to register up to $64.7 million of our common stock, which represents the remaining shares that we previously registered for sale under the sales agreement and the Prior Shelf Registration Agreement. From time to time, we may sell additional shares of our common stock under the Shelf Registration Statement or the ATM Agreement. Depending upon market liquidity at the time, sales of shares of our common stock under the Shelf Registration Statement or the ATM Agreement may cause the trading price of our common stock to decline and may result in substantial dilution to the interests of other holders of our common stock. The sale of a substantial number of shares of our common stock, including under the Shelf Registration Statement or the ATM Agreement, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to sell equity or equity-related securities.
Sales of substantial amounts of our common stock,stock through our Standby Equity Purchase Agreement with YA II PN, LTD, our Equity Distribution Agreement with Lucid Capital Markets, LLC or otherwise, or the availability of such common stock for sale, could adversely affect the prevailing market prices for our common stock. If this occurs and continues, it could impair our ability to raise additional capital through the sale of securities if we should desire to do so. In addition, it may be difficult, or even impossible, to find a buyer for shares of our common stock.
Management's Discussion & Analysis (MD&A)
New heading “Clinical Trial Accruals”
New heading “Cost of Services”
Removed heading “Research, Development and Patent Expenses and Accrued Liabilities”
Removed heading “Other Expense, net”
Largest changes
“Research, Development and Patent Expenses and Accrued Liabilities”see in full comparison
“On December 29, 2025, we entered into an equity distribution agreement, with Lucid Capital Markets, LLC (Lucid) pursuant to which we may sell common stock through Lucid from time to time up to an aggregate offering price of $50.0 million (the Equity Distribution Agreement). …”see in full comparison
“Sales of our common stock through B. Riley Securities, 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 Securities may also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay B. …”see in full comparison
Full comparison: every changed paragraph (25)
We are a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on 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), prevention of acute respiratory distress syndrome (ARDS), and Long COVID, and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD) and hypertriglycedemia.hypertriglyceridemia. We were incorporated in Delaware in September 2000.
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. Our most critical accounting estimates include research, development and patent expenses which impacts operating expenses, accrued liabilities, in-process research and development ("IPR&D") and goodwill. We review our estimates and assumptions periodically and reflect the effects of revisions in the period in which they are deemed to be necessary. We believe that the following accounting policies are critical to the judgments and estimates used in preparation of our consolidated financial statements.
Clinical Trial Accruals
Research, Development and Patent Expenses and Accrued Liabilities
As of December 31, 2024,2025, the Companywe performed a qualitative impairment assessment of goodwill and indefinite-lived intangible assets which included an evaluation of changes in industry, market, and macroeconomic conditions as well as consideration of itsour financial performance and any significant trends. The qualitative assessment indicated that it was not more likely than not that goodwill and indefinite-lived intangible assets are impaired as of December 31, 2024.2025. If thewe Company experiencesexperience a sustained decline in itsour stock price or other material changes in the significant assumptions that affect the determination of the fair value of the Company’sour single reporting unit, it may result in a goodwill and/or intangible asset impairment charge in future periods, and such charge may be material.
Revenues were $0.0$0.4 million and $1.0$0.0 million for the years ended December 31, 20242025 and 2023,2024, respectively. The decreaseincrease of $1.0$0.4 million was due to therevenue receipt of a milestone paymentrecognized under anour agreement with GenzymeMayo CorporationFoundation for Medical Education and Research (Mayo), which was entered into in 2023,December 2024 and which didbegan notenrolling recurpatients in theMarch current2025, year.and under which principal services began in April 2025.
Cost of Services
Cost of services were $0.4 million and $0.0 million for the years ended December 31, 2025 and 2024, respectively. The increase of $0.4 million was due to the costs incurred related to our performance of services under the Mayo agreement.
Research, development and patent expenses were $7.2 million for both the years ended December 31, 2025 and 2024. While overall expense was relatively the same year over year, changes to the component costs included an increase of $0.6 million in MN-166 related expenses for a MRC-001 PK study and a degenerative cervical myelopathy (DCM) study, and an increase of $0.2 million in MN-001 clinical trial expenses, offset by a decrease of $0.8 million in MN-166 manufacturing costs, payroll costs and stock-based compensation expense.
Research, development and patent expenses for the year ended December 31, 2024 increased by $1.5 million to $7.2 million as compared to $5.7 million for the prior year, primarily due to an increase in MN-166 expenses. The increase in MN-166 related expenses is primarily due to ALS clinical trial related expenses and the evaluation of a new formulation. Additionally, in 2023 we received a $0.7 million payment from BARDA to partially reimburse us for pre-clinical study costs, which was recorded as an offset to MN-166 research and development expense.
General and administrative expenses for the year ended December 31, 20242025 increased by $0.3$0.7 million to $5.5$6.2 million compared to $5.2$5.5 million for the prior year, primarily driven by fees of $0.4 million related to the Standby Equity Purchase Agreement, or the SEPA, that we entered into in July 2025, and an increase of $0.5 million in performance-based stock option expenseprofessional and professionalinvestor fees,relation expenses, partially offset by adecreased reductionstock-based incompensation headcount.expense of $0.2 million.
Other Expense, net
Other expense for the years ended December 31, 2024 and 2023 was approximately $0.0 million and $0.5 million, respectively. The decrease of $0.5 million was primarily driven by penalties on early disposal of bank certificates of deposit in 2023, which did not recur in the current year.
Interest income for the year ended December 31, 20242025 decreased by $0.1$0.4 million to $1.7$1.3 million compared to $1.8$1.7 million for the prior year, primarily driven by lowera interestdecrease ratesin on availableour cash andbalance bankgenerating certificates of deposit.interest. Interest income consists of interest earned on our cash and cash equivalents and investments.equivalents.
As of December 31, 2024,2025, we had available cash and cash equivalents of $40.4$30.8 million and working capital of $38.1$27.2 million. As of the date of this report, we believe we have sufficient working capital to fund operations at least throughtwelve months from the enddate ofthese Februaryfinancial 2026.statements are issued. This is based on our expected operating cash needs for 20252026 to be approximately $21.3$16.2 million and assuming we keep our spend at a similar level for 20262027 including expected inflation increases. We expect that this level of operating spend will be sufficient to meetcover the businesses needs for research and development expenses needed to help monetize our productsproduct candidates in development.
On August 26, 2022, we entered into an amendment to an at market issuance sales agreement (as amended, the “ATM Agreement”) with B. Riley Securities, Inc. (formerly B. Riley FBR, Inc.) (B. Riley Securities) for the offer and sale of common stock through B. Riley Securities from time to time up to an aggregate offering price of $75.0 million.
On August 26, 2022, we filed a shelf registration statement (Shelf Registration Statement) on Form S-3 with the SEC (that was declared effective by the SEC on September 6, 2022), which permits us to offer up to $200.0 million of our common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination, including units from time to time. Our Shelf Registration Statement is intended to provide us with flexibility to raise capital in the future for general corporate purposes. As part of this Shelf Registration Statement, we also entered into an amendment to an at market issuance sales agreement (as amended, the “ATM Agreement”) with B. Riley Securities, Inc. (formerly B. Riley FBR, Inc.) (B. Riley Securities) pursuant to which we may offer and sell common stock through B. Riley Securities from time to time up to an aggregate offering price of $75.0 million, of which $10.3 million of our common stock was sold under a previous shelf registration statement on Form S-3, which expired in August 2022 (Prior Shelf Registration Statement). In connection with the ATM Agreement and as part of the Shelf Registration Statement, we filed a prospectus supplement to register up to $64.7 million of our common stock, which represents the remaining shares that we previously registered for sale under the sales agreement and the Prior Shelf Registration Agreement.
Sales of our common stock through B. Riley Securities, 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 Securities may also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay B. Riley Securities 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 Securities and the per share purchase price of each transaction.
On February 26, 2026 we notified B. Riley Securities that we were terminating the ATM agreement effective as of March 8, 2026.
On July 30, 2025, we entered into a SEPA, with YA II PN, LTD., a Cayman Islands exempt limited company, or Yorkville. Pursuant to the SEPA, we have the right, but not the obligation, to sell to Yorkville from time to time up to $30.0 million of our 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 our 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 we, subject to certain limitations, deliver to Yorkville a notice that we are committing Yorkville to purchase such shares of common stock. We 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, we 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 we 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) we obtain 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 our 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 our common stock.
Pursuant to a financial advisory agreement between us and D. Boral Capital LLC (D. Boral), we have also agreed to pay D. Boral a fee equal to three percent of the gross proceeds received from any shares that we sell to Yorkville pursuant to the SEPA.
For the year ended December 31, 2025, we sold 175,000 shares of our common stock at prices ranging from $1.39 to $1.40 per share for proceeds of $0.2 million under the SEPA.
On December 29, 2025, we entered into an equity distribution agreement, with Lucid Capital Markets, LLC (Lucid) pursuant to which we may sell common stock through Lucid from time to time up to an aggregate offering price of $50.0 million (the Equity Distribution Agreement). Sales of our common stock through Lucid, 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. Lucid may also sell the common stock in privately negotiated transactions, subject to our prior approval. We agreed to pay Lucid an aggregate commission rate of 3.0% 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 Lucid and the per share purchase price of each transaction.
No shares of common stock were sold under the Equity Distribution Agreement in the year ended December 31, 2025.
TheWe Company hashave entered into in-licensing agreements with various pharmaceutical companies. Under the terms of these agreements, thewe Company hashave received licenses to research, know-how and technology claimed, in certain patents or patent applications. Under these license agreements, thewe Company isare 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. Assuming the milestones are met, total future potential milestone payments aggregate to $26.5 million.
What changed in the latest 10-Q
Risk Factors
In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K, for the year ended December 31, 2025, which are incorporated herein by reference and which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our Company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or operating results. We do not believe that there have been any material changes from the risk factors previously disclosed in our Annual Report on Form 10-K, for the year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Revenues — Mayo Foundation for Medical Education and Research”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Cost of Services”
New heading “Research, Development and Patents Expenses”
New heading “General and Administrative Expenses”
New heading “Interest Income”
Largest changes
Full comparison: every changed paragraph (29)
We have incurred significant net losses since our inception. As of MarchJune 31,30, 2026, from inception, our accumulated deficit was $441.3$443.6 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Revenues — Mayo Foundation for Medical Education and Research
In December 2024, we 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. In March 2025, the first study site enrolled the first patients into the study and principal services under the agreement began in April 2025. 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 then-current term, with payment for services due within 60 days from invoice. In August 2025, the Mayo agreement was amended to extend the initial term until August 2026. We perform pharmacovigilance and clinical research support services under this agreement and recognize revenue using the cost-to-cost method.
Our research, development and patents expenses consist primarily of license fees related to our product candidates, salaries and related employee benefits, costs associated with the preclinical and clinical development of our product development programs, costs associated with non-clinical activities, such as regulatory expenses, and pre-commercialization manufacturing development activities. We use external service providers to manufacture our compounds to be used in clinical trials and for the majority of the services performed in connection with the preclinical and clinical development of our product candidates. Research, development and patents expenses include fees paid to consultants, contract research organizations, contract manufacturers and other external service providers, including professional fees and costs associated with legal services, patents and patent applications for our intellectual property. Internal research and development expenses include costs of compensation and other expenses for research and development personnel, supplies, facility costs and depreciation. Research, development and patents costs are expensed as incurred and we expect to increasemaintain such costs through the remainder of 2026 as our development programs progress.
Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting estimates, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” contained in our Annual Report on Form 10-K, for the year ended December 31, 2025. There have not been any material changes to the critical accounting policies discussed therein during the threesix months ended MarchJune 31,30, 2026.
Comparison of the three months ended MarchJune 31,30, 2026 and 2025
Revenues
Revenues were $0.2$0.5 million and $0.0$0.1 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively.respectively, The increaseall of $0.2which million was duerelated to revenueservices recognizedwe performed under our agreement with Mayo,Mayo. whichThe increase of $0.4 million was enteredprimarily intodue to changes in Decemberestimates 2024related andto whichthe beganmeasure enrollingof patientsprogress inof Marchour 2025,services andto be performed under whichour principalagreement serviceswith began in April 2025.Mayo.
Cost of services were $0.2$0.1 million and $0.0$0.1 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase of $0.2 million was due to the costs incurred for services provided related to the Mayo agreement.agreement were relatively the same quarter over quarter.
Research, development and patents expenses were $1.3$1.0 million and $1.8$2.2 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The decrease of $0.5$1.2 million was primarily driven by a $0.4$1.0 million decrease in MN-166 related expenses relating to a MRC-001 Pharmacokinetic (PK) study, a degenerative cervical myelopathy (DCM) study, and an ALS study, as well as a $0.1 million decrease in MN-001 clinical trial expenses.
General and administrative expenses were $1.6$1.8 million and $1.4 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively. The increase of $0.2$0.4 million was primarily driven by increased professional fees and stock-based compensation expense.fees.
Interest income was $0.2 million and $0.3 million for both the three months ended MarchJune 31,30, 2026 and 2025.2025, respectively. The incomedecrease of $0.1 million was relativelyprimarily thedriven sameby quartera overdecrease quarter.in our cash balance generating interest.
Comparison of the six months ended June 30, 2026 and 2025
Revenues were $0.6 million and $0.1 million for the six months ended June 30, 2026 and 2025, respectively, all of which related to services we performed under our agreement with Mayo. The increase of $0.5 million was primarily due to changes in estimates related to the measure of progress of our services to be performed under our agreement with Mayo and the additional quarter of services provided in 2026 compared to 2025.
Cost of Services
Cost of services were $0.3 million and $0.1 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $0.2 million was due to the additional three months of costs incurred for services provided related to the Mayo agreement in 2026 compared to 2025.
Research, Development and Patents Expenses
Research, development and patents expenses were $2.3 million and $4.0 million for the six months ended June 30, 2026 and 2025, respectively. The decrease of $1.7 million was primarily driven by a $1.5 million decrease in MN-166 related expenses relating to a MRC-001 Pharmacokinetic (PK) study, a degenerative cervical myelopathy (DCM) study, and an ALS study, as well as a $0.2 million decrease in MN-001 clinical trial expenses.
General and Administrative Expenses
General and administrative expenses were $3.4 million and $2.8 million for the six months ended June 30, 2026 and 2025, respectively. The increase of $0.6 million was primarily driven by increased professional fees and stock-based compensation expense.
Interest Income
Interest income was $0.5 million and $0.7 million for the six months ended June 30, 2026 and 2025, respectively. The decrease of $0.2 million was primarily driven by a decrease in our cash balance generating interest.
Net cash used in operating activities during the threesix months ended MarchJune 31,30, 2026 was $3.5$5.4 million compared to $3.8$6.1 million during the same period in 2025. The $0.3$0.7 million change is primarily related to the changes in operating assets and liabilities for those periods.
As of MarchJune 31,30, 2026, we had available cash and cash equivalents of $27.3$25.4 million and working capital of $25.1$23.0 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through MayNovember 2027. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.
In August 2019, we 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 we may sell common stock through B. Riley FBR from time to time up to an aggregate offering price of $75.0 million.
No shares of common stock were sold under the ATM Agreement in the three months ended March 31, 2026 and 2025.
The ATM agreement was terminated effective as of March 8, 2026.
No shares of common stock were sold under the SEPA in threesix months ended MarchJune 31,30, 2026.
No shares of common stock were sold under the Equity Distribution Agreement in the threesix months ended MarchJune 31,30, 2026.
MNOV insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 1 filing (1 insider, 1 trade date, 640,000 shares, about $1.7M). Net open-market shares: -640,000 (purchases minus sales); net value about -$1.7M.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-25 | 3d Opportunity Master Fund |
Open-market sale | 640,000 | $2.70 | $1.7M |
Well-known investors holding MNOV (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 205,400 | $271.1K | 0.0% | Added 8% |
| Two Sigma Investments | 2026-06-30 | 13,526 | $17.9K | 0.0% | Reduced 55% |