What changed in MEDICINOVA INC's 2025 10-K compared to 2024?

Across the narrative sections we track, MEDICINOVA INC (MNOV) added 206 paragraphs, removed 290, and edited 177 between the 2024 and 2025 10-K filings. The biggest movers are Item 1. Business (+83/−162), Item 1A. Risk Factors (+80/−92), Item 7. Management's Discussion & Analysis (+39/−32).

Did MEDICINOVA INC add new Risk Factors in the 2025 10-K?

Yes — Item 1A Risk Factors shows 80 new/edited paragraphs and 92 removed paragraphs versus the 2024 10-K.

What changed in MEDICINOVA INC's MD&A (Item 7) in 2025?

Item 7 Management's Discussion & Analysis shows 39 new/edited paragraphs and 32 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did MEDICINOVA INC update its Cybersecurity disclosure (Item 1C) in 2025?

Item 1C Cybersecurity has 3 paragraph-level changes between the 2024 and 2025 filings.

Where does this MNOV 10-K diff come from?

The source filings are MEDICINOVA INC's official 2024 and 2025 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

MEDICINOVA INCMNOV決算レポート

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詳細分析

Medicinova Inc. is a clinical-stage biopharmaceutical firm developing novel therapies for unmet medical needs, focusing on immunology, inflammatory disorders and oncology. It operates across North America and Asia, advancing pipeline candidates through clinical trials to serve patients with limited treatment options.

What changed in MEDICINOVA INC's 10-K — 2024 vs 2025

Top changes in MEDICINOVA INC's 2025 10-K

206 paragraphs added · 290 removed · 177 edited across 5 sections

Item 1. Business+83 / −162 · 72 edited
Item 1A. Risk Factors+80 / −92 · 75 edited
Item 7. Management's Discussion & Analysis+39 / −32 · 26 edited
Item 1C. Cybersecurity+3 / −3 · 3 edited
Item 5. Market for Registrant's Common Equity+1 / −1 · 1 edited

Item 1. Business

Business — how the company describes what it does

72 edited+11 added−90 removed205 unchanged

2024 filing

2025 filing

In February 2018, we announced the presentation of positive clinical efficacy trends from this trial regarding the important secondary endpoint of confirmed disability progression. MN-166 (ibudilast) demonstrated a 26% reduction in the risk of confirmed disability progression compared to placebo (hazard ratio=0.74), as measured by Expanded Disability Status Scale (EDSS).

In December 2021, we announced that a poster with an overview of our ongoing Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS was presented at the 32nd International Symposium on ALS/MND.

In January 2019, we received a Notice of Allowance from the USPTO for a new patent which covers the combination of MN-166 (ibudilast) and riluzole for the treatment of ALS and other neurodegenerative diseases.

In December 2022, we announced the presentation of positive results from a subgroup analysis of the completed Phase 2 clinical trial which evaluated MN-001 (tipelukast) in participants with NAFLD and hypertriglyceridemia (HTG) at the International Diabetes Federation (IDF) World Diabetes Congress 2022.

In the absence of a valid patent claim and generic competition in a particular country, the agreement will expire on the earlier of five years from the date of the first commercial sale of the product by us or the end of the second consecutive calendar quarter in which generic competition exists in such country.

Clinical Trials. Human clinical trials are typically conducted in three sequential phases that may overlap: • Phase 1: The drug candidate is initially introduced into a small number of healthy human subjects or patients and tested for safety, dosage tolerance, absorption, distribution, excretion and metabolism.

Human clinical trials are typically conducted in three sequential phases that may overlap: • Phase 1: The drug candidate is initially introduced into a small number of healthy human subjects or patients and tested for safety, dosage tolerance, absorption, distribution, excretion and metabolism.

Any failure to comply with applicable requirements, both before and after approval, may subject us, our third party manufacturers, contractors, suppliers and partners to administrative and judicial sanctions, such as a delay in approving or refusal to approve pending 29 applications, fines, warning letters, product recalls, product seizures, total or partial suspension of manufacturing or marketing, injunctions and/or criminal prosecution.

Any failure to comply with applicable requirements, both before and after approval, may subject us, our third party manufacturers, contractors, suppliers and partners to administrative and judicial sanctions, such as a delay in approving or refusal to approve pending applications, fines, warning letters, product recalls, product seizures, total or partial suspension of manufacturing or marketing, injunctions and/or criminal prosecution.

SPRINT-MS is the name of the Phase 2b, randomized, double-blind, 11 placebo-controlled trial that evaluated the safety and tolerability of MN-166 (ibudilast) (up to 100 mg/day) in PPMS and SPMS patients. Recruitment and enrollment at 28 medical centers in the United States commenced in late 2013 and randomization of 255 subjects was completed in June 2015.

SPRINT-MS is the name of the Phase 2b, randomized, double-blind, placebo-controlled trial that evaluated the safety and tolerability of MN-166 (ibudilast) (up to 100 mg/day) in PPMS and SPMS patients. Recruitment and enrollment at 28 medical centers in the United States commenced in late 2013 and randomization of 255 subjects was completed in June 2015.

We utilize the existing 10 data in preparing IND Applications or their foreign equivalents, and in designing and implementing additional preclinical or clinical trials to advance the development programs in the United States or abroad. Following are the details of our product development programs: MN-166 (ibudilast) MN-166 (ibudilast) is a novel, first-in-class, oral, anti-inflammatory and neuroprotective agent.

We utilize the existing data in preparing IND Applications or their foreign equivalents, and in designing and implementing additional preclinical or clinical trials to advance the development programs in the United States or abroad. Following are the details of our product development programs: MN-166 (ibudilast) MN-166 (ibudilast) is a novel, first-in-class, oral, anti-inflammatory and neuroprotective agent.

The term of this agreement is determined on a country-by-country basis and extends until the later of the expiration of the obligation to make payments under the agreement or the last date on which the manufacture, use or sale of the product would infringe a valid patent claim held by Kyorin but for the license granted by the agreement 25 or the last date of the applicable market exclusivity period.

The term of this agreement is determined on a country-by-country basis and extends until the later of the expiration of the obligation to make payments under the agreement or the last date on which the manufacture, use or sale of the product would infringe a valid patent claim held by Kyorin but for the license granted by the agreement or the last date of the applicable market exclusivity period.

The data from this trial indicated that MN-166 (ibudilast) may have potential in the treatment of progressive MS. We partnered with investigators on a Phase 2b clinical trial of MN-166 (ibudilast) in primary progressive and secondary progressive MS which was conducted by NeuroNEXT and funded by the National Institute of Health’s (NIH) National Institute of Neurological Diseases and Stroke (NINDS).

The data from this trial indicated that MN-166 (ibudilast) may have potential in the treatment of progressive MS. 5 We partnered with investigators on a Phase 2b clinical trial of MN-166 (ibudilast) in primary progressive and secondary progressive MS which was conducted by NeuroNEXT and funded by the National Institute of Health’s (NIH) National Institute of Neurological Diseases and Stroke (NINDS).

All of these OCT measures showed less loss of retinal tissue for MN-166 (ibudilast) compared to placebo. In July 2021, we received a Notice of Allowance from the USPTO for a new patent which covers MN-166 (ibudilast) for the treatment of an ophthalmic disease/disorder or injury associated with a neurodegenerative disease/disorder or a neuro-ophthalmologic disorder.

All of these OCT measures showed less loss of retinal tissue for MN-166 10 (ibudilast) compared to placebo. In July 2021, we received a Notice of Allowance from the USPTO for a new patent which covers MN-166 (ibudilast) for the treatment of an ophthalmic disease/disorder or injury associated with a neurodegenerative disease/disorder or a neuro-ophthalmologic disorder.

According to the United States National Institute of 19 Diabetes and Digestive and Kidney Diseases (NIDDK), NASH prevalence in adults in the United States is 1.5 - 6.5%, and approximately 24% of U.S. adults have NAFLD. The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese.

According to the United States National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NASH prevalence in adults in the United States is 1.5 - 6.5%, and approximately 24% of U.S. adults have NAFLD. The underlying cause of NASH is unclear, but it most often occurs in persons who are middle-aged and overweight or obese.

The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and the inhibitory effect of MN-001 (tipelukast) on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 (tipelukast) has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1.

The 5-LO/LT pathway has been postulated as a pathogenic factor in fibrosis development and the inhibitory effect 14 of MN-001 (tipelukast) on 5-LO and the 5-LO/LT pathway is considered to be a novel approach to treat fibrosis. MN-001 (tipelukast) has been shown to down-regulate expression of genes that promote fibrosis including LOXL2, Collagen Type 1 and TIMP-1.

Market exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications of other companies seeking to reference another company’s NDA. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity.

The FDCA also provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability 32 studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug.

The FDCA also provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug.

In November 2020, we announced positive results of in-vitro and in-vivo studies that evaluated MN-001 (tipelukast) for its anti-liver fibrotic effect in human hepatic stellate cells (HSCs) and in an acute liver injury model at the 9 annual meeting of the American Association for the Study of Liver Diseases (AASLD).

In November 2020, we announced positive results of in-vitro and in-vivo studies that evaluated MN-001 (tipelukast) for its anti-liver fibrotic effect in human hepatic stellate cells (HSCs) and in an acute liver injury model at the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

Specifically, new drugs and biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being 31 studied.

The European Commission also granted Orphan Medicinal Product Designation for MN-166 (ibudilast) for the treatment of ALS which offers potential benefits including ten years of marketing exclusivity if it is approved for ALS in Europe. The FDA has also granted Orphan-Drug designation to MN-166 (ibudilast) as adjunctive therapy to temozolomide for the treatment of glioblastoma.

The European Commission also granted Orphan Medicinal Product Designation for MN-166 (ibudilast) for the treatment of ALS which offers potential benefits including ten years of marketing exclusivity if it is approved for ALS in Europe. The FDA has 9 also granted Orphan-Drug designation to MN-166 (ibudilast) as adjunctive therapy to temozolomide for the treatment of glioblastoma.

Prevention of ARDS in patients with COVID-19: In March 2020, we announced plans to initiate development of MN-166 (ibudilast) for severe pneumonia and ARDS based on positive results of a preclinical study in an animal model of ARDS. In April 2020, we announced plans to initiate a clinical trial of MN-166 (ibudilast) for ARDS caused by COVID-19.

Results of the glioblastoma mouse model study showed that median survival was higher in the group that received combination treatment with MN-166 (ibudilast) plus temozolomide compared to the group that received temozolomide alone. In May 2018, we announced that the IND for MN-166 (ibudilast) for treatment of glioblastoma was accepted and 16 opened with the FDA.

A sponsor may also request a Special Protocol Assessment (SPA), the purpose of which is to reach agreement with the FDA on the Phase 3 clinical trial protocol design and analysis that will form the primary basis of an efficacy claim.

A sponsor may also request a Special Protocol Assessment (SPA), the purpose of which is to reach 24 agreement with the FDA on the Phase 3 clinical trial protocol design and analysis that will form the primary basis of an efficacy claim.

In addition, 12 there was a higher rate of responders on the ALSFRS-R total score in the MN-166 (ibudilast) group compared to the placebo group. The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score measures the functional activity of an ALS subject.

In addition, there was a higher rate of responders on the ALSFRS-R total score in the MN-166 (ibudilast) group compared to the placebo group. The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score measures the functional activity of an ALS subject.

Government Regulation Government authorities in the United States and other countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution, sampling, marketing and import and export of pharmaceutical products and biologics such as those we are developing.

Government Regulation 22 Government authorities in the United States and other countries extensively regulate the research, development, testing, manufacture, labeling, promotion, advertising, distribution, sampling, marketing and import and export of pharmaceutical products and biologics such as those we are developing.

In December 2019, we announced that additional analyses of the completed clinical trial of MN-166 (ibudilast) in ALS was presented at the 30th 6 International Symposium on amyotrophic lateral sclerosis/motor neuron disease (ALS/MND) in Perth, Australia.

In December 2019, we announced that additional analyses of the completed clinical trial of MN-166 (ibudilast) in ALS was presented at the 30th International Symposium on amyotrophic lateral sclerosis/motor neuron disease (ALS/MND) in Perth, Australia.

In July 2020, we announced that the IND for MN-166 (ibudilast) for prevention of ARDS was accepted and opened with the FDA. We were also informed by the FDA that the proposed clinical 8 investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed.

In July 2020, we announced that the IND for MN-166 (ibudilast) for prevention of ARDS was accepted and opened with the FDA. We were also informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) for the prevention of ARDS in patients with COVID-19 may proceed.

In June 2017, we announced positive results from an animal model study that examined the potential clinical efficacy of MN-166 (ibudilast) for the treatment of glioblastoma which were presented at the 2017 ASCO Annual Meeting.

In June 2017, we announced positive results from an animal model study that examined the potential clinical efficacy of MN-166 12 (ibudilast) for the treatment of glioblastoma which were presented at the 2017 ASCO Annual Meeting.

In February 2021, the FDA issued an EUA for Eli Lilly's bamlanivimab and etesevimab, administered together, for the treatment of COVID-19 28 patients who are at high risk for progression to severe COVID-19. In May 2021, the FDA issued an EUA for GlaxoSmithKline’s sotrovimab for the treatment of COVID-19 patients who are at high risk for progression to severe COVID-19.

In February 2021, the FDA issued an EUA for Eli Lilly's bamlanivimab and etesevimab, administered together, for the treatment of COVID-19 patients who are at high risk for progression to severe COVID-19. In May 2021, the FDA issued an EUA for GlaxoSmithKline’s sotrovimab for the treatment of COVID-19 patients who are at high risk for progression to severe COVID-19.

We have been granted a U.S. patent which covers the use of MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS) and it expires no earlier than January 2029.

We have been 19 granted a U.S. patent which covers the use of MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS) and it expires no earlier than January 2029.

We are aware of compounds in clinical development for the treatment of NASH or NAFLD at other companies including Galectin Therapeutics, Gilead Sciences, Galmed Pharmaceuticals, Pfizer, Novo Nordisk, Merck, and Madrigal Pharmaceuticals.

We believe that there are several manufacturing sources available at commercially reasonable terms to meet our clinical requirements and any future commercial production requirements for the API of our products and the finished drug products. 23 For the MN-166 (ibudilast) development program, we have historically sourced and imported delayed-release ibudilast capsules, marketed in Japan as Pinatos ® , from Taisho Pharmaceutical Co., Ltd.

We believe that there are several manufacturing sources available at commercially reasonable terms to meet our clinical requirements and any future commercial production requirements for the API of our products and the finished drug products. 17 For the MN-166 (ibudilast) development program, we have historically sourced and imported delayed-release ibudilast capsules, marketed in Japan as Pinatos ® , from Taisho Pharmaceutical Co., Ltd.

We have also entered into license agreements with universities which cover additional intellectual property related to our product candidates. In general, we seek to procure patent protection for our anticipated products, or obtain such protection from the relevant patents owned by our licensors. We hold 40 issued U.S. patents and have filed 4 additional U.S. patent applications.

Ongoing Degenerative Cervical Myelopathy A multi-centre, double-blind, randomized, placebo-controlled trial assessing the efficacy of Ibudilast as an adjuvant treatment to decompressive surgery for degenerative cervical myelopathy University of Cambridge / Multicenter National Institute for Health Research (NIHR) in the U.K.

Enrollment Completed Degenerative Cervical Myelopathy A multi-centre, double-blind, randomized, placebo-controlled trial assessing the efficacy of Ibudilast as an adjuvant treatment to decompressive surgery for degenerative cervical myelopathy University of Cambridge / Multicenter National Institute for Health Research (NIHR) in the U.K.

In April 2019, we announced that the FDA completed its review of the protocol and determined that we may proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS. In June 2019, we announced a kick-off meeting for the Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS.

MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) Our MN-166 (ibudilast) product candidate is also in development for the treatment of ALS. Generic riluzole, which is also sold under the brand names Rilutek and Tiglutik, Radicava (edaravone), Relyvrio (sodium phenylbutyrate and taurursodiol), and Qalsody (tofersen) are approved for the treatment of ALS.

MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis (ALS) Generic riluzole, which is also sold under the brand names Rilutek and Tiglutik, Radicava (edaravone), Relyvrio (sodium phenylbutyrate and taurursodiol), and Qalsody (tofersen) are approved for the treatment of ALS.

MN-166 (ibudilast) for Prevention of ARDS in patients with COVID-19 Our MN-166 (ibudilast) product candidate is also in development for the prevention of ARDS in patients with COVID-19. While we are not aware of any other therapeutics that are in development specifically for this indication, we are aware of other therapeutics approved or in development for the treatment COVID-19.

MN-166 (ibudilast) for Prevention of ARDS in patients with COVID-19 While we are not aware of any other therapeutics that are in development specifically for this indication, we are aware of other therapeutics approved or in development for the treatment COVID-19.

Cleveland Clinic / Multicenter National Institute on Neurological Diseases and Stroke MediciNova, Inc. Completed Completed 21 Amyotrophic Lateral Sclerosis (ALS) A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Six Month Clinical Trial Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects with Amyotrophic Lateral Sclerosis (ALS) Carolinas HealthCare System Neurosciences Institute MediciNova, Inc.

Amyotrophic Lateral Sclerosis (ALS) A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Six Month Clinical Trial Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Clinical Endpoint Responsiveness of Ibudilast (MN-166) in Subjects with Amyotrophic Lateral Sclerosis (ALS) Carolinas HealthCare System Neurosciences Institute MediciNova, Inc.

Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD): We announced positive results of MN-001 (tipelukast) in two different NASH mouse models in 2014 and we opened the IND (Investigational New Drug) application for MN-001 (tipelukast) for the treatment of NASH with the FDA in 2015.

MN-001 (tipelukast) is in development for fibrotic and other metabolic disorders as described below. Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD): We announced positive results of MN-001 (tipelukast) in two different NASH mouse models in 2014 and we opened the IND (Investigational New Drug) application for MN-001 (tipelukast) for the treatment of NASH with the FDA in 2015.

Moreover, positive results in preclinical tests or prior human studies do not necessarily predict positive results in subsequent clinical trials. 30 Annual progress reports detailing the results of the clinical trials must be submitted to the FDA and written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events or any findings from tests in laboratory animals that suggest a significant risk for human subjects.

Annual progress reports detailing the results of the clinical trials must be submitted to the FDA and written IND safety reports must be promptly submitted to the FDA and the investigators for serious and unexpected adverse events or any findings from tests in laboratory animals that suggest a significant risk for human subjects. Clinical Trials.

Mean HDL increase was significantly greater in subjects with T2DM than subjects without T2DM at Week 8 (15.8% versus 1.0%, p Table 1: MN-166 (ibudilast) Clinical Trials and Programs Indication Clinical Study Institution and Funding Agency(s) Status Long COVID Recovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine (RECLAIM) Trial Multicenter University Health Network Ongoing COVID-19 Primary Progressive and Secondary Progressive Multiple Sclerosis A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and PK of MN-166 (Ibudilast) in COVID-19 Subjects at Risk for Developing ARDS A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis Multicenter MediciNova, Inc.

Mean HDL increase was significantly greater in subjects with T2DM than subjects without T2DM at Week 8 (15.8% versus 1.0%, p Table 1: MN-166 (ibudilast) Clinical Trials and Programs Indication Clinical Study Institution and Funding Agency(s) Status Prevention of ARDS in severe COVID-19 Primary Progressive and Secondary A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, Tolerability, Biomarkers and PK of MN-166 (Ibudilast) in COVID-19 Subjects at Risk for Developing ARDS A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast Multicenter MediciNova, Inc.

We own, co-own or hold licenses to 21 issued U.S. patents and 4 pending U.S. patent applications as well as 50 issued foreign patents and 21 pending foreign patent applications covering MN-166 (ibudilast) and 24 its analogs.

We own, co-own or hold licenses to 22 issued U.S. patents and 5 pending U.S. patent applications as well as more than 50 issued foreign patents and more than 25 pending foreign patent applications covering MN-166 (ibudilast) and its analogs.

We obtained an exclusive, worldwide (excluding Japan, China, South Korea and Taiwan) sub-licensable license to the patent rights and know-how related to MN-001 (tipelukast) and its active metabolite, MN-002, disclosed and included in, or covered by, these patents, in all indications, except for ophthalmic solution formulations.

We obtained an exclusive, worldwide (excluding Japan, China, South Korea and Taiwan) sub-licensable license to the patent rights and know-how related to MN-001 (tipelukast) disclosed and included in, or covered by, these patents, in all indications, except for ophthalmic solution formulations. This license included an exclusive, sub-licensable license under two U.S. patents and certain corresponding patents in foreign countries.

In December 2024, a study update and interim analysis of phase 2/3 clinical data of MN-166 (ibudilast) in the COMBAT-ALS trial was presented at the 35 th international symposium on ALS/MND at 6 Montreal, Canada. In September 2025, we announced the completion of patient enrollment in the COMBAT-ALS Phase 2/3 clinical trial, evaluating MN-166 (ibudilast) for the treatment of ALS.

Degenerative Cervical Myelopathy: DCM, also known as cervical spondylotic myelopathy, involves spinal cord dysfunction from compression in the neck. DCM is the most common form of spinal cord impairment in adults and results in disability and reduced quality of life. Patients report neurological symptoms such as pain and numbness in limbs, poor coordination, imbalance, and bladder problems.

DCM is the most common form of spinal cord impairment in adults and results in disability and reduced quality of life. Patients report neurological symptoms such as pain and numbness in limbs, poor coordination, imbalance, and bladder problems.

CD36 enhances cellular fatty acid uptake in the liver and is known to be involved in the pathogenesis of fatty liver. 20 In April 2022, we announced that the FDA completed its review of a proposed Phase 2 clinical trial to evaluate MN-001 (tipelukast) for the treatment of patients with NAFLD, type 2 diabetes mellitus, and hypertriglyceridemia and the study may proceed.

In April 2022, we announced that the FDA completed its review of a proposed Phase 2 clinical trial to evaluate MN-001 (tipelukast) for the treatment of patients with NAFLD, type 2 diabetes mellitus, and hypertriglyceridemia and the study may proceed.

In November 2020, we announced positive results of in-vitro and in-vivo studies that evaluated MN-001 (tipelukast) for its anti-liver fibrotic effect in HSCs and in an acute liver injury model at the annual meeting of the AASLD.

The FDA has granted Fast Track designation to MN-001 (tipelukast) for the treatment of patients with NASH with fibrosis. 15 In November 2020, we announced positive results of in-vitro and in-vivo studies that evaluated MN-001 (tipelukast) for its anti-liver fibrotic effect in HSCs and in an acute liver injury model at the annual meeting of the AASLD.

While it has been in use for more than 20 years in Japan and Korea for the treatment of asthma and post-stroke dizziness, we are developing MN-166 (ibudilast) for the treatment of progressive MS, ALS, chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence, prevention of acute respiratory distress syndrome, and Long COVID.

While it has been in use for more than 40 years in Japan and Korea for the treatment of asthma and post-stroke dizziness, we are developing MN-166 (ibudilast) for the treatment of progressive MS, ALS, degenerative cervical myelopathy, glioblastoma, and prevention of acute respiratory distress syndrome. We licensed MN-166 (ibudilast) from Kyorin Pharmaceuticals (Kyorin) in 2004.

Manufacturing We rely on third parties to manufacture bulk active pharmaceutical ingredients (API) and finished investigational products for research, development, preclinical and clinical trials. We expect to continue to rely on third party manufacturers for the manufacture of the API and finished products for our clinical and any future commercial production requirements.

We expect to continue to rely on third party manufacturers for the manufacture of the API and finished products for our clinical and any future commercial production requirements.

In January 2023, we announced that the Phase I clinical trial of MN-166 (ibudilast) 10 mg IV infusion in healthy volunteers was completed with a favorable safety profile and was well tolerated. Chlorine Gas-Induced Lung Injury: Chlorine gas is a toxic chemical that can be released in industrial accidents and terrorist attacks.

In January 2023, we announced that the Phase I clinical trial of MN-166 (ibudilast) 10 mg IV infusion in healthy volunteers was completed with a favorable safety profile and was well tolerated.

Fast track designation is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need.

The FDA has granted Fast Track designations to MN-166 (ibudilast) for two separate indications: the treatment of progressive MS and the treatment of ALS. Fast track designation is a process designed to facilitate the development and expedite the review of drugs that are intended to treat serious diseases and have the potential to fill an unmet medical need.

The following is a description of our existing license agreements and intellectual property rights for each of our clinical product candidates. MN-166 (ibudilast) On October 22, 2004, we entered into an exclusive license agreement with Kyorin for the development and commercialization of MN-166 (ibudilast). Kyorin is a fully integrated Japanese pharmaceutical company and is listed on the Tokyo Stock Exchange.

Certain of our license agreements provide for reduced or foregone royalties in the event of generic competition. MN-166 (ibudilast) On October 22, 2004, we entered into an exclusive license agreement with Kyorin for the development and commercialization of MN-166 (ibudilast). Kyorin is a fully integrated Japanese pharmaceutical company and is listed on the Tokyo Stock Exchange.

If we or our strategic alliance partners fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. 26 Human Capital Resources We have assembled an experienced and cohesive management and support team, with core competencies in general management, clinical development, regulatory affairs and corporate development.

Our website is www.medicinova.com, which includes links to reports we have filed with the Securities and Exchange Commission (SEC). The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report on Form 10-K.

The information contained in, or that can be accessed through, our website is not part of, and is not incorporated into, this Annual Report on Form 10-K.

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. 5 Progressive Multiple Sclerosis: We completed a Phase 2b clinical trial of MN-166 (ibudilast) for the treatment of relapsing MS, in which positive safety and neuroprotective efficacy indicators were observed.

We intend to advance our diverse MN-166 (ibudilast) program through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, and trials funded by us. We intend to pursue additional strategic alliances to help support further clinical development of MN-166 (ibudilast). • Pursue the development of MN-001 (tipelukast) for fibrotic and other metabolic disorders.

We intend to pursue additional strategic alliances to help support further clinical development of MN-166 (ibudilast). • Pursue the development of MN-001 (tipelukast) for fibrotic and other metabolic disorders.

Foreign composition of matter patents for MN-001 (tipelukast) and MN-002 have also expired. We own 9 U.S. patents and 65 foreign patents covering certain compositions, uses and manufacturing processes associated with MN-001 (tipelukast) and MN-002.

The United States composition of matter patent for MN-001 (tipelukast) underlying the license expired on February 23, 2009. Foreign composition of matter patents for MN-001 (tipelukast) has also expired. We own 15 issued U.S. patents and 65 foreign patents covering certain compositions, uses and manufacturing processes associated with MN-001 (tipelukast).

The results of the preclinical tests, together with manufacturing information, analytical data and other available information about the product candidate, are submitted to the FDA as part of an IND. Preclinical tests and studies can take several years to complete and, despite completion of those tests and studies, the FDA may not permit clinical testing to begin. The IND Process.

The results of the preclinical tests, together with manufacturing information, analytical data and other available information about the product candidate, are submitted to the FDA as part of an IND.

This data was presented at the International Liver Congress 2018, the 53rd annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France in April 2018. The FDA has granted Fast Track designation to MN-001 (tipelukast) for the treatment of patients with NASH with fibrosis.

This data was presented at the International Liver Congress 2018, the 53rd annual meeting of the European Association for the Study of the Liver (EASL) in Paris, France in April 2018.

We are aware of additional compounds in clinical development for the treatment of ALS at other companies including BrainStorm Cell Therapeutics, AB Science, Biogen, Ionis Pharmaceuticals, and Clene. MN-166 (ibudilast) for Substance Dependence and Addiction Our MN-166 (ibudilast) product candidate is also in development for the treatment of opioid dependence, methamphetamine addiction, and alcohol dependence.

We are aware of additional compounds in clinical development for the treatment of ALS at other companies including BrainStorm Cell Therapeutics, AB Science, Ionis Pharmaceuticals, and Clene. MN-166 (ibudilast) for Degenerative Cervical Myelopathy There are no pharmaceuticals currently approved for the treatment of degenerative cervical myelopathy.

According to the ARDS Foundation, there are an estimated 150,000 ARDS cases per year in the U.S. and the rate of death is approximately 40% for ARDS patients.

Difficulty breathing is usually the first symptom of ARDS. Infections are the most common risk factors for ARDS and these infections may include influenza, coronavirus, or other viruses. According to the ARDS Foundation, there are an estimated 150,000 ARDS cases per year in the U.S. and the rate of death is approximately 40% for ARDS patients.

Surgery, radiation, and chemotherapy with the drug temozolomide is the current standard of treatment for glioblastoma. GLIADEL® WAFER (carmustine implant) and AVASTIN® (bevacizumab) are also approved for the treatment for glioblastoma. We are aware of additional compounds in development for the treatment of glioblastoma at other companies including Kazia Therapeutics, Kintara Therapeutics, Denovo Biopharma, Laminar Pharmaceuticals, and TVAX Biomedical.

We are aware of additional compounds in development for the treatment of 21 glioblastoma at other companies including Kazia Therapeutics, Kintara Therapeutics, Denovo Biopharma, Laminar Pharmaceuticals, and TVAX Biomedical.

As a result, unrelated third parties may develop products with the same API as MN-166 (ibudilast) so long as such parties do not infringe our method of use patents, other patents we have exclusive rights to through our licensors or any patents we may obtain for MN-166 (ibudilast). 18 In addition, if we develop certain products that are not covered by any patents, we will be dependent on obtaining market exclusivity under the new chemical entity exclusivity provisions of the Hatch-Waxman Act for such products in the United States and/or data exclusivity provisions in Europe.

Progressive Multiple Sclerosis: MS is a complex disease with predominantly unknown etiology and affects approximately 2.8 million people worldwide, according to the National Multiple Sclerosis Society (NMSS).

For example, we have been granted separate U.S. patents that cover the use of MN-166 (ibudilast) for the treatment of progressive MS, for the treatment of ALS, and for the treatment of glioblastoma. Progressive Multiple Sclerosis: MS is a complex disease with predominantly unknown etiology and affects approximately 2.8 million people worldwide, according to the National Multiple Sclerosis Society (NMSS).

Certain of our license agreements provide for reduced or foregone royalties in the event of generic competition. Competition 26 The development and commercialization of new drugs is extremely competitive and characterized by extensive research efforts and rapid technological progress.

Competition 20 The development and commercialization of new drugs is extremely competitive and characterized by extensive research efforts and rapid technological progress.

At any time thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold if the FDA deems it appropriate. In such case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin or continue.

The IND will automatically become effective 30 days after its receipt by the FDA unless the FDA, before that time, places the IND on clinical hold. At any time thereafter, the FDA may raise concerns or questions about the conduct of the trials as outlined in the IND and impose a clinical hold if the FDA deems it appropriate.

However, because of the open-label design of this study, there was no placebo group to compare with the MN-166 (ibudilast) group, so it is not possible to draw any definitive conclusions from this study. Methamphetamine Addiction: Methamphetamine is a central nervous system stimulant drug that is similar in structure to amphetamine.

However, because of the open-label design of this study, there was no placebo group to compare with the MN-166 (ibudilast) group, so it is not possible to draw any definitive conclusions from this study. Degenerative Cervical Myelopathy: DCM, also known as cervical spondylotic myelopathy, involves spinal cord dysfunction from compression in the neck.

The publication, which was written by researchers at Columbia University Medical Center, discussed the metastatic UM mouse model study in which quantified bioluminescence signal intensity in the abdominal region was dramatically reduced by MN-166 (ibudilast) treatment (p 17 mice showed the presence of tumor cell clusters which were not present in the liver tissues of mice treated with MN-166 (ibudilast).

The publication, which was written by 13 researchers at Columbia University Medical Center, discussed the metastatic UM mouse model study in which quantified bioluminescence signal intensity in the abdominal region was dramatically reduced by MN-166 (ibudilast) treatment (p Prevention of ARDS in patients with COVID-19: ARDS is a serious lung condition that causes low blood oxygen.

We also hold 124 issued foreign patents and 26 pending foreign patent applications corresponding to these U.S. patents and patent applications. We are not aware of any third party infringement of the patents owned or licensed by us and are not party to any material claims by third parties of infringement by us of such third parties’ intellectual property rights.

We are not aware of any third party infringement of the patents owned or licensed by us and are not party to any material claims by third parties of infringement by us of such third parties’ intellectual property rights. The following is a description of our existing license agreements and intellectual property rights for each of our clinical product candidates.

We believe that our relations with our employees are good, and we have no history of work stoppages. 33 Company Information We were originally incorporated in the State of Delaware in September 2000. Our principal executive offices are located at 4275 Executive Square, Suite 300, La Jolla, CA 92037. Our telephone number is 858-373-1500.

We have six employees as of the date of this report, all of which are full-time. We believe that our relations with our employees are good, and we have no history of work stoppages. Company Information We were originally incorporated in the State of Delaware in September 2000.

Our Strategy Our goal is to build a sustainable biopharmaceutical business through the successful development of differentiated products for the treatment of serious diseases with unmet medical needs in high-value therapeutic areas. Key elements of our strategy are as follows: • Pursue the development of MN-166 (ibudilast) for multiple potential indications with the support of non-dilutive financings.

In May 2024, we presented an update of ongoing trial design at the 92 nd European Atherosclerosis Society (EAS) 2024 Congress. Our Strategy Our goal is to build a sustainable biopharmaceutical business through the successful development of differentiated products for the treatment of serious diseases with unmet medical needs in high-value therapeutic areas.

We are aware of additional treatments in development for the treatment of COVID-19 at other companies including Merck, AstraZeneca, Gilead Sciences, and Rigel Pharmaceuticals. MN-166 (ibudilast) for Long COVID Our MN-166 (ibudilast) product candidate is also in development for the treatment of patients with Long COVID, the lingering symptoms of COVID-19.

We are aware of additional treatments in development for the treatment of COVID-19 at other companies including Merck, AstraZeneca, Gilead Sciences, and Rigel Pharmaceuticals. MN-001 (tipelukast) for Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD) There is currently one pharmaceutical approved for the treatment of NASH or NAFLD, which is Rezdiffera developed by Madrigal Pharmaceuticals.

In December 2022, we announced that positive results from a secondary analysis of a Phase 2 trial of MN-166 (ibudilast) in alcohol use disorder were published in The American Journal of Drug and Alcohol Abuse . In January 2023, we announced that the Phase 2b clinical trial of MN-166 (ibudilast) for the treatment of alcohol use disorder had completed enrollment.

Progressive Multiple Sclerosis: We completed a Phase 2b clinical trial of MN-166 (ibudilast) for the treatment of relapsing MS, in which positive safety and neuroprotective efficacy indicators were observed.

Removed

Substance Dependence and Addiction: In November 2017, we announced a collaboration with Oregon Health & Science University to initiate a biomarker study for evaluating MN-166 (ibudilast) in methamphetamine use disorder and this trial is ongoing.

Added

A total of 234 patients have been randomized across two treatment arms at multiple clinical sites in the United States and Canada. In December 2025, we announced the study update and patient characteristics of the COMBAT-ALS phase 2/3 clinical trial at the 36th International Symposium of ALS/MND at San Diego, California.

Removed

Investigators at Columbia University and the New York State Psychiatric Institute (NYSPI) previously completed a Phase 1b/2a clinical trial of MN-166 (ibudilast) in opioid withdrawal that was funded by National Institute Drug Abuse (NIDA).

Added

Key elements of our strategy are as follows: • Pursue the development of MN-166 (ibudilast) for multiple potential indications with the support of non-dilutive financings. 8 We intend to advance our diverse MN-166 (ibudilast) program through a combination of investigator-sponsored clinical trials, trials funded through government grants or other grants, and trials funded by us.

Removed

Investigators at Columbia University and the NYSPI also conducted a NIDA-funded, Phase 2a clinical trial to evaluate the efficacy of MN-166 (ibudilast) in the treatment of patients addicted to prescription opioids or heroin.

Added

In December 2025, we announced the successful completion of patient enrollment in the COMBAT-ALS Phase 2/3 11 clinical trial, evaluating MN-166 (ibudilast) for the treatment of ALS. A total of 234 patients have been randomized across two treatment arms at multiple clinical sites in the United States and Canada.

Removed

In March 2016, we announced that positive findings from the results of this completed study in opioid dependence were presented at the Behavior, Biology and Chemistry: Translational Research in Addiction Meeting.

Added

CD36 enhances cellular fatty acid uptake in the liver and is known to be involved in the pathogenesis of fatty liver.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

75 edited+5 added−17 removed330 unchanged

2024 filing

2025 filing

These provisions: • establish that members of our board of directors may be removed only for cause upon the affirmative vote of stockholders owning at least a majority of our capital stock; 63 • authorize the issuance of “blank check” preferred stock that could be issued by our board of directors in a discriminatory fashion designed to increase the number of outstanding shares and prevent or delay a takeover attempt; • limit who may call a special meeting of stockholders; • establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; • prohibit our stockholders from making certain changes to our restated certificate of incorporation or amended and restated bylaws except with 66-2/3% stockholder approval; and • provide for a classified board of directors with staggered terms.

These provisions: • establish that members of our board of directors may be removed only for cause upon the affirmative vote of stockholders owning at least a majority of our capital stock; • authorize the issuance of “blank check” preferred stock that could be issued by our board of directors in a discriminatory fashion designed to increase the number of outstanding shares and prevent or delay a takeover attempt; • limit who may call a special meeting of stockholders; • establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; • prohibit our stockholders from making certain changes to our restated certificate of incorporation or amended and restated bylaws except with 66-2/3% stockholder approval; and • provide for a classified board of directors with staggered terms.

The GDPR puts in place stringent operational requirements for processors and controllers of personal data, including, for example, high standards for obtaining consent from individuals to process their personal data (or reliance on another appropriate legal basis), the provision of robust and detailed disclosures to individuals about how personal data is collected and processed (in a concise, intelligible and easily accessible form), a comprehensive individual data rights regime (including access, erasure, objection, restriction, rectification and portability), maintaining a record of data processing, data export restrictions governing transfers of data from the EEA, short timelines for certain data breach notifications to be given to data protection regulators or supervisory authorities (and in certain cases, affected individuals), and limitations on retention of personal data.

The GDPR puts in place stringent operational requirements for processors and controllers of personal data, including, for example, high standards for obtaining consent from individuals to process their personal data (or reliance on another appropriate legal basis), the provision of robust and detailed disclosures to individuals about how personal data is collected and processed (in a concise, intelligible and easily accessible form), 44 a comprehensive individual data rights regime (including access, erasure, objection, restriction, rectification and portability), maintaining a record of data processing, data export restrictions governing transfers of data from the EEA, short timelines for certain data breach notifications to be given to data protection regulators or supervisory authorities (and in certain cases, affected individuals), and limitations on retention of personal data.

In addition, a clinical trial may be delayed, suspended or terminated by us, the FDA or other regulatory authorities due to a number of factors, including: • ongoing discussions with regulatory authorities regarding the scope or design of our clinical trials or requests by them for supplemental information with respect to our clinical trial results, which may result in the imposition of a clinical hold on the IND for any clinical trial, as well as the inability to resolve any outstanding concerns with the FDA so that a clinical hold already placed on the IND may be lifted and the clinical trial may begin; • inspections of our own clinical trial operations, the operations of our CROs or our clinical trial sites by the FDA or other regulatory authorities, which may result in the imposition of a clinical hold or potentially prevent us from using some of the data generated from our clinical trials to support requests for regulatory approval of our product candidates; 43 • our failure or inability, or the failure or inability of our CROs, clinical trial site staff or other third party service providers involved in the clinical trial, to conduct clinical trials in accordance with regulatory requirements or our clinical protocols; • lower than anticipated enrollment or retention rates of patients in clinical trials; • new information suggesting unacceptable risk to subjects or unforeseen safety issues or any determination that a clinical trial presents unacceptable health risks; • insufficient supply or deficient quality of product candidates or other materials necessary for the conduct of our clinical trials; • lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; and • the formulation or dosing regimen of a product candidate may result, unintentionally, in patient non-compliance, leading to low patient retention rates, incomplete data to conduct an adequate analysis, and failure to complete the trial.

In addition, a clinical trial may be delayed, suspended or terminated by us, the FDA or other regulatory authorities due to a number of factors, including: • ongoing discussions with regulatory authorities regarding the scope or design of our clinical trials or requests by them for supplemental information with respect to our clinical trial results, which may result in the imposition of a clinical hold on the IND for any clinical trial, as well as the inability to resolve any outstanding concerns with the FDA so that a clinical hold already placed on the IND may be lifted and the clinical trial may begin; 36 • inspections of our own clinical trial operations, the operations of our CROs or our clinical trial sites by the FDA or other regulatory authorities, which may result in the imposition of a clinical hold or potentially prevent us from using some of the data generated from our clinical trials to support requests for regulatory approval of our product candidates; • our failure or inability, or the failure or inability of our CROs, clinical trial site staff or other third party service providers involved in the clinical trial, to conduct clinical trials in accordance with regulatory requirements or our clinical protocols; • lower than anticipated enrollment or retention rates of patients in clinical trials; • new information suggesting unacceptable risk to subjects or unforeseen safety issues or any determination that a clinical trial presents unacceptable health risks; • insufficient supply or deficient quality of product candidates or other materials necessary for the conduct of our clinical trials; • lack of adequate funding to continue the clinical trial, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our CROs and other third parties; and • the formulation or dosing regimen of a product candidate may result, unintentionally, in patient non-compliance, leading to low patient retention rates, incomplete data to conduct an adequate analysis, and failure to complete the trial.

The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock, many of which are beyond our control: • the development status of our product candidates, including clinical trial results and determinations by regulatory authorities with respect to our product candidates; • the initiation, termination, or reduction in the scope of any collaboration arrangements or any disputes or developments regarding such collaborations; • FDA or foreign regulatory actions, including failure to receive regulatory approval for any of our product candidates; • announcements of technological innovations, new commercial products or other material events by us or our competitors; • disputes or other developments concerning our intellectual property rights; • market conditions in the pharmaceutical and biotechnology sectors; • actual and anticipated fluctuations in our quarterly or annual operating results; 60 • price and volume fluctuations in the overall stock markets; • changes in, or failure to meet, securities analysts’ or investors’ expectations of our financial performance; • additions or departures of key personnel; • the economy as a whole and market conditions in our industry; • discussions of our business, management, products, financial performance, prospects or stock price by the financial and scientific press and online investor communities; • litigation or public concern about the safety of our potential products; • public concern as to, and legislative action with respect to, the pricing and availability of prescription drugs or the safety of drugs and drug delivery techniques; or • regulatory developments in the United States and in foreign countries.

The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock, many of which are beyond our control: • the development status of our product candidates, including clinical trial results and determinations by regulatory authorities with respect to our product candidates; • the initiation, termination, or reduction in the scope of any collaboration arrangements or any disputes or developments regarding such collaborations; • FDA or foreign regulatory actions, including failure to receive regulatory approval for any of our product candidates; • announcements of technological innovations, new commercial products or other material events by us or our competitors; • disputes or other developments concerning our intellectual property rights; • market conditions in the pharmaceutical and biotechnology sectors; • actual and anticipated fluctuations in our quarterly or annual operating results; 53 • price and volume fluctuations in the overall stock markets; • changes in, or failure to meet, securities analysts’ or investors’ expectations of our financial performance; • additions or departures of key personnel; • the economy as a whole and market conditions in our industry; • discussions of our business, management, products, financial performance, prospects or stock price by the financial and scientific press and online investor communities; • litigation or public concern about the safety of our potential products; • public concern as to, and legislative action with respect to, the pricing and availability of prescription drugs or the safety of drugs and drug delivery techniques; or • regulatory developments in the United States and in foreign countries.

As a result, competitors that obtain the requisite regulatory approval will be able to offer products with the same API as found in our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates so long as such competitors do not infringe any methods of use, methods of manufacture, formulation or, in the case of 56 MN-001 (tipelukast), specific polymorph patents that we hold or have exclusive rights to through our licensors.

As a result, competitors that obtain the requisite regulatory approval will be able to offer products with the same API as found in our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates so long as such competitors do not infringe any methods of use, methods of manufacture, formulation or, in the case of MN-001 (tipelukast), specific polymorph patents that we hold or have exclusive rights to through our licensors.

Our future cash requirements will also depend on many factors, including: • progress in, and the costs of future planned clinical trials and other research and development activities; • the scope, prioritization and number of our product development programs; • our obligations under our license agreements, pursuant to which we may be required to make future milestone payments upon the achievement of various milestones related to clinical, regulatory or commercial events; • our ability to establish and maintain strategic collaborations, including licensing agreements and other arrangements; • the time and costs involved in obtaining regulatory approvals; • the costs of securing manufacturing arrangements for clinical or commercial production of our product candidates; • the costs associated with any expansion of our management, personnel, systems and facilities; 34 • the costs associated with any litigation; • the costs associated with the operations or wind-down of any business we may acquire; • inflation and rapid increases in interest rates; • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and • the costs of establishing or contracting for sales and marketing capabilities and commercialization activities if we obtain regulatory approval to market our product candidates.

Our future cash requirements will also depend on many factors, including: • progress in, and the costs of future planned clinical trials and other research and development activities; • the scope, prioritization and number of our product development programs; • our obligations under our license agreements, pursuant to which we may be required to make future milestone payments upon the achievement of various milestones related to clinical, regulatory or commercial events; • our ability to establish and maintain strategic collaborations, including licensing agreements and other arrangements; • the time and costs involved in obtaining regulatory approvals; 27 • the costs of securing manufacturing arrangements for clinical or commercial production of our product candidates; • the costs associated with any expansion of our management, personnel, systems and facilities; • the costs associated with any litigation; • the costs associated with the operations or wind-down of any business we may acquire; • inflation and rapid increases in interest rates; • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and • the costs of establishing or contracting for sales and marketing capabilities and commercialization activities if we obtain regulatory approval to market our product candidates.

Although we believe these provisions collectively provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In any event, these provisions may delay or prevent a third party from acquiring us.

Although we believe these provisions collectively provide for an opportunity to receive higher bids by requiring potential acquirers to negotiate with our board of directors, they would apply even if the offer may be considered beneficial by some stockholders. In any 56 event, these provisions may delay or prevent a third party from acquiring us.

Any delay or failure in obtaining required approvals could substantially reduce or negate our ability to generate revenues from the particular product candidate. In addition, both before and after regulatory approval, we, our partners and our product candidates are subject to numerous FDA requirements, including requirements related to testing, manufacturing, quality control, labeling, 38 advertising, promotion, distribution and export.

We may not be able to establish or maintain any commercial manufacturing and supply arrangements on commercially reasonable terms that we require for purposes of commercializing a product. Any failure by us to 47 secure or maintain any such required commercial supply agreements could result in interruption of supply and lost or delayed revenues, which would adversely affect our business.

We may not be able to establish or maintain any commercial manufacturing and supply arrangements on commercially reasonable terms that we require for purposes of commercializing a product. Any failure by us to secure or maintain any such required commercial supply agreements could result in interruption of supply and lost or delayed revenues, which would adversely affect our business.

In addition, if any product candidates we may develop receives marketing approval and we or others later identify undesirable side effects caused by the product, a number of significant negative consequences could result, including: • regulatory authorities may withdraw their approval of the product or place restrictions on the way it is prescribed; • regulatory authorities may require a larger clinical benefit for approval to offset the risk; • regulatory authorities may require the addition of labeling statements that could diminish the usage of the product or otherwise limit the commercial success of the product; • we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product or implement a risk evaluation and mitigation strategy; • we may choose to discontinue sale of the product; 42 • we could be sued and held liable for harm caused to patients; • we may not be able to enter into collaboration agreements on acceptable terms and execute our business model; and • our reputation may suffer.

In addition, if any product candidates we may develop receives marketing approval and we or others later identify undesirable side effects caused by the product, a number of significant negative consequences could result, including: • regulatory authorities may withdraw their approval of the product or place restrictions on the way it is prescribed; • regulatory authorities may require a larger clinical benefit for approval to offset the risk; 35 • regulatory authorities may require the addition of labeling statements that could diminish the usage of the product or otherwise limit the commercial success of the product; • we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product or implement a risk evaluation and mitigation strategy; • we may choose to discontinue sale of the product; • we could be sued and held liable for harm caused to patients; • we may not be able to enter into collaboration agreements on acceptable terms and execute our business model; and • our reputation may suffer.

Further, if a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, if a prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could 33 significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Future changes in Trade Laws and enforcement could also result in increased compliance requirements and related costs which could materially adversely affect our business, results of operations, financial condition and/or cash flows. 52 We may be sued for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.

Future changes in Trade Laws and enforcement could also result in increased compliance requirements and related costs which could materially adversely affect our business, results of operations, financial condition and/or cash flows. We may be sued for product liability, which could result in substantial liabilities that exceed our available resources and damage our reputation.

These third parties are not our employees, and except for remedies available to us under our agreements with such third party, we have limited ability to control the amount or timing of resources that any such third party will devote to our clinical trials. Some of these third parties may terminate their engagements with us at any time.

These third parties are not our 39 employees, and except for remedies available to us under our agreements with such third party, we have limited ability to control the amount or timing of resources that any such third party will devote to our clinical trials. Some of these third parties may terminate their engagements with us at any time.

The FDA requires us and our third parties to comply with regulations and standards, commonly referred to as good clinical practices (GCPs) for conducting, monitoring, recording and reporting the results of clinical trials to 46 ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

The FDA requires us and our third parties to comply with regulations and standards, commonly referred to as good clinical practices (GCPs) for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

However, we face competition for experienced professional personnel from numerous companies and academic and other research institutions. Competition for qualified personnel is particularly intense in the San Diego, California area, where our corporate headquarters is located. In addition, we have scientific and clinical advisors who assist us in our product development and clinical strategies.

However, we face competition for experienced professional personnel 43 from numerous companies and academic and other research institutions. Competition for qualified personnel is particularly intense in the San Diego, California area, where our corporate headquarters is located. In addition, we have scientific and clinical advisors who assist us in our product development and clinical strategies.

For example: • we or our licensor might not have been the first to make the inventions covered by each of our pending patent applications or issued patents; • we or our licensor might not have been the first to file patent applications for these inventions; • others may independently develop similar or alternative technologies or duplicate any of our technologies; 57 • it is possible that none of our pending patent applications will result in issued patents; • any patents under which we hold rights may not provide us with a basis for maintaining market exclusivity for commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties as invalid, not infringed or unenforceable under United States or foreign laws; or • any of the issued patents under which we hold rights may not be valid or enforceable or may be circumvented successfully in light of the continuing evolution of domestic and foreign patent laws.

For example: • we or our licensor might not have been the first to make the inventions covered by each of our pending patent applications or issued patents; • we or our licensor might not have been the first to file patent applications for these inventions; 50 • others may independently develop similar or alternative technologies or duplicate any of our technologies; • it is possible that none of our pending patent applications will result in issued patents; • any patents under which we hold rights may not provide us with a basis for maintaining market exclusivity for commercially viable products, may not provide us with any competitive advantages or may be challenged by third parties as invalid, not infringed or unenforceable under United States or foreign laws; or • any of the issued patents under which we hold rights may not be valid or enforceable or may be circumvented successfully in light of the continuing evolution of domestic and foreign patent laws.

If our product candidates fail to comply with applicable regulatory requirements, such as commercial good manufacturing practices (cGMPs), a regulatory agency may: • issue warning letters or untitled letters; • require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for non-compliance; • impose other civil or criminal penalties; • suspend regulatory approval; 39 • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or • seize or detain products or require a product recall.

If our product candidates fail to comply with applicable regulatory requirements, such as commercial good manufacturing practices (cGMPs), a regulatory agency may: • issue warning letters or untitled letters; 32 • require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for non-compliance; • impose other civil or criminal penalties; • suspend regulatory approval; • suspend any ongoing clinical trials; • refuse to approve pending applications or supplements to approved applications filed by us; • impose restrictions on operations, including costly new manufacturing requirements; or • seize or detain products or require a product recall.

In addition, 44 some patients may not be able to comply with clinical trial protocols and the ability to conduct follow-up visits with treated patients may be limited if patients do not want to participate in follow up visits due to concerns regarding health epidemics or if quarantines impede patient movement or interrupt healthcare services.

In addition, some patients may not be able to comply with clinical trial protocols and the ability to conduct follow-up visits with treated patients may be limited if patients do not want to participate in follow up visits due to concerns regarding health epidemics or if quarantines impede patient movement or interrupt healthcare services.

Some of the factors that could cause our operating results to fluctuate from period to period include: • the status of development of our product candidates and, in particular, the advancement or termination of activities related to our product development programs and the timing of any milestone payments payable under our licensing agreements; • the execution of other collaboration, licensing and similar arrangements and the timing of payments we may make or receive under these arrangements; • variations in the level of expenses related to our product development programs; • the unpredictable effects of collaborations during these periods; • the timing of our satisfaction of applicable regulatory requirements, if at all; 53 • the rate of expansion of our clinical development and other internal research and development efforts; • the costs of any litigation; • the effect of competing technologies and products and market developments; and • general and industry-specific economic conditions.

Some of the factors that could cause our operating results to fluctuate from period to period include: • the status of development of our product candidates and, in particular, the advancement or termination of activities related to our product development programs and the timing of any milestone payments payable under our licensing agreements; • the execution of other collaboration, licensing and similar arrangements and the timing of payments we may make or receive under these arrangements; 46 • variations in the level of expenses related to our product development programs; • the unpredictable effects of collaborations during these periods; • the timing of our satisfaction of applicable regulatory requirements, if at all; • the rate of expansion of our clinical development and other internal research and development efforts; • the costs of any litigation; • the effect of competing technologies and products and market developments; and • general and industry-specific economic conditions.

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. 55 A variety of risks associated with operating our business and marketing our products internationally could materially adversely affect our business.

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 variety of risks associated with operating our business and marketing our products internationally could materially adversely affect our business.

Patents that remain under 58 the jurisdiction of the UPC will be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of any potential changes.

Patents that remain under the jurisdiction of the UPC will be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of any potential changes.

We anticipate that, prior to our commercialization of a product candidate, out-licensing upfront and milestone payments will be our primary source 35 of revenue if we can enter into collaborations, strategic alliances or other agreements that would provide us with such revenues.

We anticipate that, prior to our commercialization of a product candidate, out-licensing upfront and milestone payments will be our primary source of revenue if we can enter into collaborations, strategic alliances or other agreements that would provide us with such revenues.

Significant clinical trial delays could also allow our competitors to bring products to market before we do or shorten any periods during which we have the exclusive right to commercialize 36 our product candidates and impair our ability to commercialize our product candidates and may harm our business and results of operations.

Significant clinical trial delays could also allow our competitors to bring products to market before we do or shorten any periods during which we have the exclusive right to commercialize our product candidates and impair our ability to commercialize our product candidates and may harm our business and results of operations.

Our clinical trials may produce 37 negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or non-clinical testing. Interim results of clinical trials do not necessarily predict final results, and success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful.

Our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical and/or non-clinical testing. Interim results of clinical trials do not necessarily predict final results, and success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful.

Macroeconomic pressures, including those resulting from ongoing geopolitical matters, 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.

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.

Any legal action against us or our collaborators could lead to: • payment of actual damages, royalties, lost profits, potential enhanced damages and attorneys’ fees, if any infringement for which we are found liable is deemed willful, or a case against us is determined by a judge to be exceptional; 59 • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize and sell our products; • having to enter into license arrangements that may not be available on reasonable or commercially acceptable terms; or • significant cost and expense, as well as distraction of our management from our business.

Any legal action against us or our collaborators could lead to: • payment of actual damages, royalties, lost profits, potential enhanced damages and attorneys’ fees, if any infringement for which we are found liable is deemed willful, or a case against us is determined by a judge to be exceptional; 52 • injunctive or other equitable relief that may effectively block our ability to further develop, commercialize and sell our products; • having to enter into license arrangements that may not be available on reasonable or commercially acceptable terms; or • significant cost and expense, as well as distraction of our management from our business.

Any of our planned clinical trials for our product candidates may not be successful for a variety of reasons, including the clinical trial designs, the failure to enroll a sufficient number of patients, undesirable side effects and other safety concerns and the inability to demonstrate sufficient efficacy.

Any of our planned clinical trials for our product candidates may not be successful for a variety of reasons, 29 including the clinical trial designs, the failure to enroll a sufficient number of patients, undesirable side effects and other safety concerns and the inability to demonstrate sufficient efficacy.

Moreover, we currently do not have any agreements for the production of these materials. If our manufacturers are unable to obtain these materials for our clinical trials, testing of the affected product candidate would be delayed, which may significantly impact our ability to develop the product candidate.

Moreover, we currently do not have any agreements for the production of 41 these materials. If our manufacturers are unable to obtain these materials for our clinical trials, testing of the affected product candidate would be delayed, which may significantly impact our ability to develop the product candidate.

Further, the GDPR provides that EEA member states may establish their own laws and regulations limiting the processing of genetic, biometric, or health data, which 51 could limit our ability to collect, use, and share such data and/or could cause our costs to increase.

Further, the GDPR provides that EEA member states may establish their own laws and regulations limiting the processing of genetic, biometric, or health data, which could limit our ability to collect, use, and share such data and/or could cause our costs to increase.

Our business, operations and clinical development timelines could be adversely affected by health pandemics, epidemics or any other health crisis in regions where we have clinical trial sites or other business operations, and could cause significant disruption in the operations of CROs upon whom we rely.

Our business, operations and clinical development timelines could be adversely affected by health pandemics, epidemics or any other health crisis in regions where we have clinical trial sites or other business 37 operations, and could cause significant disruption in the operations of CROs upon whom we rely.

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.

We also expect our non-United States activities to increase over time. We expect to rely on third parties for research, preclinical studies, and clinical trials and/or to obtain necessary permits, licenses, patent registrations, and other marketing approvals.

We also expect our non-United States activities to increase over time. We expect to rely on third parties for research, preclinical studies, and clinical trials 45 and/or to obtain necessary permits, licenses, patent registrations, and other marketing approvals.

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, tax and labor conditions, which could harm our business.

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.

Under the unitary patent system, European applications will have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court (UPC). As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation.

We do not have compound patent protection for the API in our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates, although we do have patent protection for a particular crystalline polymorph of MN-001 (tipelukast) and we have composition of matter protection on an analog of MN-166 (ibudilast).

We do not have compound patent protection for the API in our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates, although we do have patent protection for a 49 particular crystalline polymorph of MN-001 (tipelukast) and we have composition of matter protection on an analog of MN-166 (ibudilast).

Any additional unanticipated testing would add costs and could delay or result in the denial of regulatory approval for a product candidate. These regulatory requirements may limit the size of the market for the product candidate or result in the incurrence of additional costs.

Any additional unanticipated testing would add costs and could delay or result in the denial of regulatory approval for a product candidate. These regulatory requirements may limit the 31 size of the market for the product candidate or result in the incurrence of additional costs.

To date, we have obtained regulatory authorization to conduct clinical trials for our product development programs. Investigational New Drug Applications were approved by the FDA and are active for our product candidates.

To date, we have obtained regulatory 30 authorization to conduct clinical trials for our product development programs. Investigational New Drug Applications were approved by the FDA and are active for our product candidates.

In addition, the global health pandemics or epidemics may impact our third party manufacturers from producing sufficient quantities of any product candidate. Also, our manufacturers may not perform as agreed.

In addition, the global health pandemics or epidemics may impact our third party manufacturers from producing sufficient quantities 40 of any product candidate. Also, our manufacturers may not perform as agreed.

In addition, our directors and officers may in the future establish programmed selling plans under Rule 10b5-1 of the Exchange Act, for the purpose of effecting sales of our common stock.

In addition, our directors and officers may in the future establish programmed selling plans under Rule 10b5-1 of the Exchange Act, for the purpose of 54 effecting sales of our common stock.

To date we have invested a substantial majority of our business efforts and financial resources to the development and commercialization of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates.

To date we have invested a substantial majority of our business efforts and financial resources in the development and commercialization of our MN-166 (ibudilast) and MN-001 (tipelukast) product candidates.

In addition, our efforts to educate the medical community and third party payers on the benefits of our product candidates may require significant resources and may never be successful.

In addition, our efforts to educate the medical community and third 42 party payers on the benefits of our product candidates may require significant resources and may never be successful.

Additionally, we are subject to attestation by our independent registered public accounting firm regarding our internal controls over financial reporting as of December 31, 2024 under Japanese securities laws. Our efforts to comply with Section 404 and related regulations have required, and continue to require, the commitment of significant financial and managerial resources.

Additionally, we are subject to attestation by our independent registered public accounting firm regarding our internal controls over financial reporting as of December 31, 2025 under Japanese securities laws. Our efforts to comply with Section 404 and related regulations have required, and continue to require, the commitment of significant financial and managerial resources.

For example, as of December 31, 2024, we 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 our financial performance and any significant trends.

For example, as of December 31, 2025, we 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 our financial performance and any significant trends.

We expect our research and development expenses to increase moderately in 2025 relative to 2024 as we continue development of MN-166 (ibudilast), MN-001 (tipelukast), and any other future product candidates. We do expect to continue to incur significant operating losses for the foreseeable future.

We expect our research and development expenses to increase moderately in 2026 relative to 2025 as we continue development of MN-166 (ibudilast), MN-001 (tipelukast), and any other future product candidates. We do expect to continue to incur significant operating losses for the foreseeable future.

For example, since the date of our initial public offering in Japan on February 8, 2005 through December 31, 2024, our common stock has traded as high as approximately $42.00 and as low as approximately $1.13.

For example, since the date of our initial public offering in Japan on February 8, 2005 through December 31, 2025, our common stock has traded as high as approximately $42.00 and as low as approximately $1.13.

Our results of operations could be adversely affected by unfavorable global and geopolitical economic conditions, such as decreases in per capital income and level of disposable income, inflation, rising interest rates, and supply chain issues.

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.

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 40 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.

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 we hope to benefit from the FDA’s Fast Track and priority review programs.

We, or our third party CROs or other contractors or consultants, may be subject to information technology systems failures, network disruptions, breaches in data security and computer crime and cyber-attacks, which could result in a material disruption of our product candidates' development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.

We have incurred significant net losses since our inception in September 2000. For the years ended December 31, 2024 and 2023, we had a net loss of $11.0 million and $8.6 million, respectively. As of December 31, 2024 and December 31, 2023, our accumulated deficit was $426.8 million and $415.7 million, respectively.

We have incurred significant net losses since our inception in September 2000. For the years ended December 31, 2025 and 2024, we had a net loss of $12.0 million and $11 million, respectively. As of December 31, 2025 and December 31, 2024, our accumulated deficit was $438.7 million and $426.8 million, respectively.

If we are successful in obtaining regulatory approvals for any of our product candidates or acquiring other approved products, we will need to establish sales, marketing and distribution capabilities on our own or with partners in order to commercialize an approved product.

To date, we have not sold, marketed or distributed any pharmaceutical products. If we are successful in obtaining regulatory approvals for any of our product candidates or acquiring other approved products, we will need to establish sales, marketing and distribution capabilities on our own or with partners in order to commercialize an approved product.

Additionally, even if priority review is granted for one of our product candidates, the FDA does not always meet its six-month Prescription Drug User Fee Act (PDUFA) goal date for priority review and the review process is often extended by FDA requests for additional information or clarification. 41 We may seek Breakthrough Therapy designation for one or more of our current or future product candidates.

Designation as a Breakthrough Therapy is largely within the discretion of the FDA. Accordingly, even if we believe that a product candidate meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.

We may seek Breakthrough Therapy designation for one or more of our current or future product candidates. Designation as a Breakthrough Therapy is largely within the discretion of the FDA. Accordingly, even if we believe that a product candidate meets the criteria for designation as a Breakthrough Therapy, the FDA may disagree and instead determine not to make such designation.

If we or our manufacturers are unable to purchase these materials after regulatory approval has been obtained for one of our products, the commercial launch of such product would be delayed or there would be a shortage in supply of such product, which would harm our ability to generate revenues from such product and achieve or sustain profitability. 48 Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

Additionally, the net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. As of December 31, 2024, we had available cash and cash equivalents of $40.4 million and working capital of $38.1 million.

Additionally, the net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indicator of our future performance. As of December 31, 2025, we had available cash and cash equivalents of $30.8 million and working capital of $27.2 million.

We are a “smaller reporting company” and may take advantage of certain scaled disclosures available to us. We cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors. We are a “smaller reporting company” as defined in the Exchange Act.

We cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors. We are a “smaller reporting company” as defined in the Exchange Act.

We may be adversely affected by the effects of inflation. Inflation 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.

Inflation, 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.

Despite the listing of our common stock on the Nasdaq Global Market and the TSE in Japan, trading volume in our securities has been light and an active trading market may not develop for our common stock. In 2024, our average trading volume was approximately 49,188 shares per day on Nasdaq and approximately 163,556 shares per day on the TSE.

Despite the listing of our common stock on the Nasdaq Global Market and the TSE in Japan, trading volume in our securities has been light and an active trading market may not develop for our common stock. In 2025, our average trading volume was approximately 268,522 shares per day on Nasdaq and approximately 112,544 shares per day on the TSE.

If our assumptions underlying our estimates and judgments relating to our critical accounting policies change or if actual circumstances differ from our assumptions, estimates or judgments, our operating results may be adversely affected and could fall below the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

We also expect to face similar competition in our efforts to identify appropriate collaborators or partners to help develop or commercialize our product candidates. 45 We will depend on strategic collaborations with third party partners to develop and commercialize selected product candidates and will not have control over a number of key elements relating to the development and commercialization of these product candidates if we are able to achieve such third party arrangements.

We will depend on strategic collaborations with third party partners to develop and commercialize selected product candidates and will not have control over a number of key elements relating to the development and commercialization of these product candidates if we are able to achieve such third party arrangements.

If our products are not accepted by the market or if users of our products are unable to obtain adequate coverage of and reimbursement for our products from government and other third party payers, our revenues and profitability will suffer. 49 Our ability to commercialize our product candidates, if approved, successfully will depend in significant part on pricing and cost effectiveness, including our ability to produce a product at a competitive price and our ability to obtain appropriate coverage of and reimbursement for our products and related treatments from governmental authorities, private health insurers and other organizations, such as health maintenance organizations (HMOs).

Our ability to commercialize our product candidates, if approved, successfully will depend in significant part on pricing and cost effectiveness, including our ability to produce a product at a competitive price and our ability to obtain appropriate coverage of and reimbursement for our products and related treatments from governmental authorities, private health insurers and other organizations, such as health maintenance organizations (HMOs).

We also have outsourced elements of our operations to third parties, and as a result we manage a number of third party contractors who have access to our confidential information. 54 Information technology system failures, network disruptions, breaches of data security and sophisticated and targeted computer crime and cyber-attacks could disrupt our operations by impeding our drug development programs, including delays in our regulatory efforts, the manufacture or shipment of products, the processing of transactions or reporting of financial results, or by causing an unintentional disclosure of confidential information.

Information technology system failures, network disruptions, breaches of data security and sophisticated and targeted computer crime and cyber-attacks could disrupt our operations by impeding our drug development programs, including delays in our regulatory efforts, the manufacture or shipment of products, the processing of transactions or reporting of financial results, or by causing an unintentional disclosure of confidential information.

We do not have any products that are approved for commercial sale and therefore currently generate no revenues from sales of any products and may never generate any revenues from product sales or be profitable in the foreseeable future, if ever. 28 To date, we have funded our operations primarily from sales of our securities and, to a lesser extent, debt financing.

To date, we have funded our operations primarily from sales of our securities and, to a lesser extent, debt financing. We do not have any products that are approved for commercial sale and do not anticipate generating any product revenue unless and until one of our product candidates receives the regulatory approvals necessary for commercialization in one or more jurisdictions.

We do not have any products that are approved for commercial sale and do not anticipate generating any product revenue unless and until one of our product candidates receives the regulatory approvals necessary for commercialization in one or more jurisdictions.

If any of these events cause a large number of our shares to be sold in the public market, the sales could reduce the trading price of our common stock and impede our ability to raise future capital. 62 If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

If our estimates or judgments relating to our critical accounting policies are based on assumptions that change or prove to be incorrect, our results of operation could fall below the expectations of securities analysts and investors, resulting in a decline in the market price of our common stock.

If a product that has Orphan Drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full NDA, to market the same drug or biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. 34 We may seek priority review with the FDA (review within a six-month time frame from the time a complete NDA is accepted for filing compared to 10 months under standard review) for one or more of our current or future product candidates.

These third parties are not our employees and may have commitments to, or contracts with, other entities that may limit their availability to us, or may have arrangements with other companies to assist in the development of products that may compete with our product candidates. 50 Although we have employment agreements with key members of management, each of our employees, subject to applicable notice requirements, may terminate his or her employment at any time.

As a result, these shares can be freely sold in the public market upon issuance, subject to the terms of the underlying agreements governing the grants and the restrictions of the securities laws.

We have also registered all common stock that we may issue under our current employee benefits plans. As a result, these shares can be freely sold in the public market upon issuance, subject to the terms of the underlying agreements governing the grants and the restrictions of the securities laws.

Our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates.

Smaller companies also may prove to be significant competitors, particularly through proprietary research discoveries and collaboration arrangements with large pharmaceutical and established biotechnology companies. 38 Our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates.

It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information.

In the ordinary course of business, we collect, store and transmit confidential information (including but not limited to intellectual property, proprietary business information and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information.

Our competitors may also develop drugs that are more effective and less costly than ours and may also be more successful than us in manufacturing and marketing their products.

Our competitors may also develop drugs that are more effective and less costly than ours and may also be more successful than us in manufacturing and marketing their products. We also expect to face similar competition in our efforts to identify appropriate collaborators or partners to help develop or commercialize our product candidates.

Many of our competitors have substantially greater financial, research and development resources, including personnel and technology, clinical trial experience, manufacturing, sales and marketing capabilities and production facilities than we do. Smaller companies also may prove to be significant competitors, particularly through proprietary research discoveries and collaboration arrangements with large pharmaceutical and established biotechnology companies.

Sales of substantial amounts of our common stock, 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.

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.

If we are unable to establish sales, marketing and distribution capabilities, whether independently or with third parties, we will be unable to commercialize our product candidates successfully. To date, we have not sold, marketed or distributed any pharmaceutical products.

If we lose any of our key management personnel, we may not be able to find suitable replacements, which would adversely affect our business. If we are unable to establish sales, marketing and distribution capabilities, whether independently or with third parties, we will be unable to commercialize our product candidates successfully.

We do not carry “key person” insurance covering members of senior management. If we lose any of our key management personnel, we may not be able to find suitable replacements, which would adversely affect our business.

Although we have employment agreements with key members of management, each of our employees, subject to applicable notice requirements, may terminate his or her employment at any time. We do not carry “key person” insurance covering members of senior management.

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.

If any of these events cause a large number of our shares to be sold in the public market, the sales could reduce the trading price of our common stock and impede our ability to raise future capital.

Removed

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.

Added

Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

Removed

We may seek priority review with the FDA (review within a six-month time frame from the time a complete NDA is accepted for filing compared to 10 months under standard review) for one or more of our current or future product candidates.

Added

Removed

We are increasingly dependent upon information technology systems, infrastructure and data to operate our business. In the ordinary course of business, we collect, store and transmit confidential information (including but not limited to intellectual property, proprietary business information and personal information).

… 17 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

3 edited+0 added−0 removed4 unchanged

2024 filing

2025 filing

Risk Management and Strategy As of December 31, 2024 , we have implemented a set of comprehensive cybersecurity and data protection policies and procedures. Risks from cybersecurity threats are regularly evaluated as a part of our broader risk management activities and as a fundamental component of our internal control system.

Risk Management and Strategy As of December 31, 2025 , we have implemented a set of comprehensive cybersecurity and data protection policies and procedures. Risks from cybersecurity threats are regularly evaluated as a part of our broader risk management activities and as a fundamental component of our internal control system.

Our senior leadership, including our Chief Executive Officer and Chief Financial Officer, regularly meets with and provides periodic briefings to our board of directors regarding our cybersecurity risks and activities, including any recent cybersecurity incidents and related responses, cybersecurity systems testing, activities of third parties, and the like. 64 Cybersecurity Threat Disclosure To date, we are not aware of any cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company.

For further discussion of cybersecurity risks, please see Item 1A, "Risk Factors".

Cybersecurity Threat Disclosure To date, we are not aware of any cybersecurity threats that have materially affected or are reasonably likely to materially affect the Company. For further discussion of cybersecurity risks, please see Item 1A, "Risk Factors". 57

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

1 edited+0 added−0 removed3 unchanged

2024 filing

2025 filing

Market for Registrant’s Common Equity, Related Sto ckholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is listed on the Standard Market of the Tokyo Stock Exchange and trades under the code “4875,” and is listed on the Nasdaq Global Market and trades under the symbol “MNOV.” Holders of Common Stock As of February 17, 2025, there were approximately 11 holders of record of our common stock.

Market for Registrant’s Common Equity, Related Sto ckholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is listed on the Standard Market of the Tokyo Stock Exchange and trades under the code “4875,” and is listed on the Nasdaq Global Market and trades under the symbol “MNOV.” Holders of Common Stock As of March 5, 2026, there were approximately 10 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

26 edited+13 added−6 removed18 unchanged

2024 filing

2025 filing

Contractual Obligations and Commitments We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods. Such arrangements include those related to the contractual obligations described below: Lease Commitments Our operating lease commitments reflect payments due for our lease agreements in San Diego, California and Tokyo, Japan.

Contractual Obligations and Commitments We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods. Such arrangements include those related to the contractual obligations described below: 64 Lease Commitments Our operating lease commitments reflect payments due for our lease agreements in San Diego, California and Tokyo, Japan.

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 expenses include 60 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.

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 67 preclinical and clinical development of our product candidates.

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.

At December 31, 2024, we did not have any off balance sheet activity and we did not have any relationship with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance, variable interest, or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

At December 31, 2025, we did not have any off balance sheet activity and we did not have any relationship with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance, variable interest, or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

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.

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, 2025.

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.

Under these license agreements, we are 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.

Recent Accounting Pronouncements The impact of recent accounting pronouncements is described in Note 1 of our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. 68 Results of Operations Comparison of the Years ended December 31, 2024 and 2023 Revenues Revenues were $0.0 million and $1.0 million for the years ended December 31, 2024 and 2023, respectively.

Recent Accounting Pronouncements The impact of recent accounting pronouncements is described in Note 1 of our consolidated financial statements included elsewhere in this Annual Report on Form 10-K. 61 Results of Operations Comparison of the Years ended December 31, 2025 and 2024 Revenues Revenues were $0.4 million and $0.0 million for the years ended December 31, 2025 and 2024, respectively.

We expect that this level of operating spend will be sufficient to meet the businesses needs for research and development to help monetize our products in development. 69 Our future funding requirements will depend on many factors, including, but not limited to: • progress in, and the costs of, future planned clinical trials and other research and development activities; • the scope, prioritization and number of our product development programs; • our obligations under our license agreements, pursuant to which we may be required to make future milestone payments upon the achievement of various milestones related to clinical, regulatory or commercial events; • our ability to establish and maintain strategic collaborations, including licensing and other arrangements, and to complete acquisitions of additional product candidates; • the time and costs involved in obtaining regulatory approvals; • the costs of securing manufacturing arrangements for clinical or commercial production of our product candidates; • the costs associated with any expansion of our management, personnel, systems and facilities; • the costs associated with any litigation; • the costs associated with the operations or wind-down of any business we may acquire; • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and • the costs of establishing or contracting for sales and marketing capabilities and commercialization activities if we obtain regulatory approval to market any of our product candidates.

Our future funding requirements will depend on many factors, including, but not limited to: • progress in, and the costs of, future planned clinical trials and other research and development activities; • the scope, prioritization and number of our product development programs; • our obligations under our license agreements, pursuant to which we may be required to make future milestone payments upon the achievement of various milestones related to clinical, regulatory or commercial events; • our ability to establish and maintain strategic collaborations, including licensing and other arrangements, and to complete acquisitions of additional product candidates; • the time and costs involved in obtaining regulatory approvals; • the costs of securing manufacturing arrangements for clinical or commercial production of our product candidates; • the costs associated with any expansion of our management, personnel, systems and facilities; • the costs associated with any litigation; • the costs associated with the operations or wind-down of any business we may acquire; • the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and • the costs of establishing or contracting for sales and marketing capabilities and commercialization activities if we obtain regulatory approval to market any of our product candidates.

Research, Development and Patent Expenses and Accrued Liabilities 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.

Clinical Trial Accruals 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.

Goodwill is reviewed for impairment annually (as of December 31st) or more frequently if indicators of impairment exist. As of December 31, 2024, the Company 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 its financial performance and any significant trends.

Goodwill is reviewed for impairment annually (as of December 31st) or more frequently if indicators of impairment exist. As of December 31, 2025, we 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 our financial performance and any significant trends.

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.

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.

As of December 31, 2024, our contractual commitments for our leases were $0.4 million, which will be paid over the lease terms. Milestone Obligations 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 certain patents or patent applications.

As of December 31, 2025, our contractual commitments for our leases were $0.2 million, which will be paid over the lease terms. Milestone Obligations We have entered into in-licensing agreements with various pharmaceutical companies. Under the terms of these agreements, we have received licenses to research, know-how and technology claimed, in certain patents or patent applications.

Liquidity and Capital Resources We incurred losses of $11.0 million and $8.6 million for the years ended December 31, 2024 and 2023, respectively. At December 31, 2024, our accumulated deficit was $426.8 million as compared to $415.7 million for the year ended December 31, 2023.

Liquidity and Capital Resources We incurred losses of $12.0 million and $11 million for the years ended December 31, 2025 and 2024, respectively. At December 31, 2025, our accumulated deficit was $438.7 million as compared to $426.8 million for the year ended December 31, 2024.

If the Company experiences a sustained decline in its stock price or other material changes in the significant assumptions that affect the determination of the fair value of the Company’s single reporting unit, it may result in a goodwill and/or intangible asset impairment charge in future periods, and such charge may be material.

If we experience a sustained decline in our stock price or other material changes in the significant assumptions that affect the determination of the fair value of our single reporting unit, it may result in a goodwill and/or intangible asset impairment charge in future periods, and such charge may be material.

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.

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.

We were incorporated in Delaware in September 2000. We have incurred significant net losses since our inception. For the year ended December 31, 2024, we had a net loss of $11.0 million. At December 31, 2024, from inception, our accumulated deficit was $426.8 million.

We were incorporated in Delaware in September 2000. We have incurred significant net losses since our inception. For the year ended December 31, 2025, we had a net loss of $12.0 million. At December 31, 2025, from inception, our accumulated deficit was $438.7 million.

To the extent that costs, including personnel costs, are not tracked to a specific product development program, such costs are included in the “Other R&D expense” category (in thousands): Year Ended December 31, 2024 2023 External development expense: MN-166 $ 4,485 $ 2,837 MN-001 455 552 Other 12 20 Total external development expense 4,952 3,409 R&D personnel expense 1,608 1,553 R&D facility and depreciation expense 62 58 Patent expense 413 400 Other R&D expense 160 238 Total research, development and patent expense $ 7,195 $ 5,658 IPR&D and Goodwill Amounts incurred related to IPR&D or asset purchases of IPR&D are expensed as incurred.

To the extent that costs, including personnel costs, are not tracked to a specific product development program, such costs are included in the “Other R&D expense” category (in thousands): Year Ended December 31, 2025 2024 External development expense: MN-166 $ 4,622 $ 4,485 MN-001 703 455 Other 12 12 Total external development expense 5,337 4,952 R&D personnel expense 1,149 1,608 R&D facility and depreciation expense 64 62 Patent expense 412 413 Other R&D expense 193 160 Total research, development and patent expense $ 7,155 $ 7,195 IPR&D and Goodwill Amounts incurred related to IPR&D or asset purchases of IPR&D are expensed as incurred.

The following table shows a summary of our cash flows for the years ended December 31, 2024 and 2023 (in thousands): 2024 2023 Net cash (used in) provided by: Operating activities $ (10,643 ) $ (7,431 ) Investing activities (1 ) 39,908 Factors That May Affect Future Financial Condition and Liquidity As of December 31, 2024, we had available cash and cash equivalents of $40.4 million and working capital of $38.1 million.

The following table shows a summary of our cash flows for the years ended December 31, 2025 and 2024 (in thousands): 2025 2024 Net cash (used in) provided by: Operating activities $ (9,810 ) $ (10,643 ) Investing activities (3 ) (1 ) Financing activities 244 — 62 Factors That May Affect Future Financial Condition and Liquidity As of December 31, 2025, we had available cash and cash equivalents of $30.8 million and working capital of $27.2 million.

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. No shares of common stock were sold under the ATM Agreement for the years ended December 31, 2024 and December 31, 2023.

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.

Interest Income Interest income for the year ended December 31, 2024 decreased by $0.1 million to $1.7 million compared to $1.8 million for the prior year, primarily driven by lower interest rates on available cash and bank certificates of deposit. Interest income consists of interest earned on our cash and cash equivalents and investments.

Interest Income Interest income for the year ended December 31, 2025 decreased by $0.4 million to $1.3 million compared to $1.7 million for the prior year, primarily driven by a decrease in our cash balance generating interest. Interest income consists of interest earned on our cash and cash equivalents.

General and Administrative General and administrative expenses for the year ended December 31, 2024 increased by $0.3 million to $5.5 million compared to $5.2 million for the prior year, primarily driven by an increase in performance-based stock option expense and professional fees, partially offset by a reduction in headcount.

General and Administrative General and administrative expenses for the year ended December 31, 2025 increased by $0.7 million to $6.2 million compared to $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 professional and investor relation expenses, partially offset by decreased stock-based compensation expense of $0.2 million.

We do not have relationships and transactions with persons and entities that derive benefits from their non-independent relationship with us or our related parties except as disclosed herein.

We do not have relationships and transactions with persons and entities that derive benefits from their non-independent relationship with us or our related parties except as disclosed herein. Equity Financing 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.

As of the date of this report, we believe we have sufficient working capital to fund operations at least through the end of February 2026. This is based on our expected operating cash needs for 2025 to be approximately $21.3 million and assuming we keep our spend at a similar level for 2026 including expected inflation increases.

This is based on our expected operating cash needs for 2026 to be approximately $16.2 million and assuming we keep our spend at a similar level for 2027 including expected inflation increases. We expect that this level of operating spend will be sufficient to cover the research and development expenses needed to help monetize our product candidates in development.

Research, Development and Patent Expenses 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.

Research, Development and Patent Expenses Research, development and patent expenses were $7.2 million for both the years ended December 31, 2025 and 2024.

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).

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. 63 No shares of common stock were sold under the ATM Agreement for the years ended December 31, 2025 and December 31, 2024.

Removed

The decrease of $1.0 million was due to the receipt of a milestone payment under an agreement with Genzyme Corporation in 2023, which did not recur in the current year.

Added

The increase of $0.4 million was due to revenue recognized under our agreement with Mayo Foundation for Medical Education and Research (Mayo), which was entered into in December 2024 and which began enrolling patients in March 2025, and under which principal services began in April 2025.

Removed

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.

Added

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.

Removed

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.

Added

While overall expense was relatively the same year over year, changes to the component costs included an i ncrease 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.

Removed

Equity Financing 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.

Added

As of the date of this report, we believe we have sufficient working capital to fund operations at least twelve months from the date these financial statements are issued.

Removed

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.

Added

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.

Removed

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. 70 Sales of our common stock through B.

Added

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.

Added

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.

Added

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.

Added

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).

Added

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.

Added

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.

Added

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.

Added

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).