UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒ MEDICINOVA, INC. (Exact Name of Registrant as Specified in its Chart ...

FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-33185 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 MEDICINOVA, INC. (Exact name of registrant as specified in its charter) Delaware 33-0927979 (State or Other Jurisdiction o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-33185 MEDICINOVA, INC. (Exact name of registrant as specified in its charter) Delaware 33-0927979 (State or Other Jurisdiction of Inc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2019 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-33185 MEDICINOVA, INC. (Exact name of registrant as specified in its charter) Delaware 33-0927979 (State or Other Jurisdiction of In ...

Clinical Trials and Efficacy - MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo in progressive MS patients[17]. - The Phase 2b clinical trial of MN-166 (ibudilast) in progressive MS achieved both primary endpoints of whole brain atrophy and safety and tolerability[17]. - The SPRINT-MS trial completed randomization of 255 subjects, exceeding the planned goal of 250 participants[17]. - MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy in progressive MS compared to placebo (p=0.04) in the SPRINT-MS Phase 2b trial[37]. - The same trial showed a 26% reduction in the risk of confirmed disability progression compared to placebo (hazard ratio = 0.74) as measured by EDSS[37]. - The ALS trial at Carolinas Neuromuscular/ALS-MDA Center achieved the primary endpoint of safety and tolerability, with a higher rate of responders on the ALSFRS-R total score in the MN-166 group compared to placebo[40]. - The ongoing ALS/Biomarker study aims to evaluate the effects of MN-166 (ibudilast) on reducing brain microglial activation in ALS subjects[19]. - The ongoing clinical trial for chemotherapy-induced peripheral neuropathy is assessing the effects of MN-166 (ibudilast) in patients receiving oxaliplatin[47]. - MN-166 (ibudilast) has shown promise in reducing alcohol craving and is currently being evaluated in a Phase 2b clinical trial for alcohol dependence[46]. - The clinical trial for MN-166 (ibudilast) in DCM is funded by a grant from the National Institute for Health Research (NIHR) in the UK, aiming to evaluate its effectiveness as an adjuvant treatment post-spinal surgery[48]. - The FDA accepted the Investigational New Drug Application (IND) for MN-166 (ibudilast) for glioblastoma treatment, allowing clinical investigation to proceed[50]. - A Phase 2b clinical trial of MN-221 (bedoradrine) showed significant improvements in Dyspnea Index scores, with a treatment failure rate of 43% in the MN-221 group compared to 74% in the placebo group[54]. - In a Phase 2 clinical trial for NASH, MN-001 (tipelukast) significantly reduced mean serum triglycerides by 135.7 mg/dL, resulting in a 41.3% reduction (p=0.02)[61]. - MN-001 (tipelukast) is currently undergoing a Phase 2 clinical trial for IPF at Penn State, with significant anti-fibrogenic effects observed in preclinical studies[63]. - In the first Phase 1 trial, stable disease was observed in 12 out of 34 patients, indicating some anti-tumor activity[67]. - The second Phase 1 study showed one patient had a partial response lasting 74 days, with stable disease in seven out of 20 subjects[68]. Regulatory Designations and Approvals - The FDA has granted Fast Track designation to MN-166 (ibudilast) for the treatment of progressive MS, ALS, and methamphetamine dependence[32]. - MN-001 (tipelukast) received Fast Track designation for the treatment of patients with NASH with fibrosis and is currently in a Phase 2 clinical trial for IPF[27]. - MN-166 (ibudilast) received Orphan-Drug designation from the FDA for ALS, providing seven years of marketing exclusivity upon approval in the U.S.[33]. - The European Commission granted Orphan Medicinal Product Designation for MN-166 (ibudilast) for ALS, offering potential 10 years of marketing exclusivity if approved in Europe[33]. - The FDA has granted Orphan-Drug designation and Fast Track designation to MN-001 (tipelukast) for the treatment of idiopathic pulmonary fibrosis (IPF)[62]. - The FDA requires extensive data supporting safety and efficacy for drug approval, and none of the product candidates have been approved yet[117]. - The IND process involves several stages, including preclinical tests, submission of an IND, and completion of human clinical trials[120]. - The FDA's Fast Track program aims to expedite the review process for drugs addressing serious conditions and unmet medical needs[126]. - The FDA may grant priority review for drugs that offer significant improvements over existing therapies, which can facilitate the approval process[129]. - Patent term restoration under the Hatch-Waxman Amendments can extend patent life by up to five years, but cannot exceed a total of 14 years from the product's approval date[130]. - The FDCA provides a five-year period of non-patent marketing exclusivity for the first applicant to obtain NDA approval for a new chemical entity[131]. Financial Performance and Projections - For the year ended December 31, 2018, the company reported a net loss of $14.7 million, with an accumulated deficit of $356.1 million since inception[143]. - As of December 31, 2018, the company had available cash and cash equivalents of $62.3 million and working capital of $60.6 million[143]. - The company expects research and development expenses to increase in 2019 compared to 2018, focusing on the development of MN-166 (ibudilast) and MN-001 (tipelukast)[147]. - The company does not expect to generate any revenues from product sales for at least the next several years, relying on out-licensing upfront and milestone payments as primary revenue sources[151]. - The success of the company is largely dependent on the regulatory approval and commercialization of MN-166 (ibudilast) and MN-001 (tipelukast), which have not yet completed the clinical development process[152]. - The company has incurred significant operating losses and expects to continue doing so for the foreseeable future, with no guarantee of adequate future financing[143][150]. Strategic Partnerships and Licensing - The company is pursuing strategic partnerships with leading pharmaceutical companies to support late-stage product development and commercialization[28]. - The company has acquired licenses for MN-166 (ibudilast), MN-001 (tipelukast), MN-221 (bedoradrine), and MN-029 (denibulin) for various therapeutic indications[24]. - The license agreement with Kissei for MN-221 (bedoradrine) includes exclusive rights for commercial supply, contingent on FDA approval[75]. - The company has entered into multiple license agreements covering its product candidates, holding 24 issued U.S. patents and 36 issued foreign patents[76]. - The company has paid Kyorin $700,000 to date under the license agreement for MN-166 (ibudilast) and is obligated to pay up to $5.0 million based on clinical milestones[81]. - The company has paid Kissei $1.0 million to date and is obligated to make payments of up to $17.0 million based on achieving certain clinical and regulatory milestones[89]. - The company has paid Kyorin $4.0 million to date and is obligated to make payments of up to $5.0 million based on achieving clinical and regulatory milestones[93]. - The company has paid Angiogene $1.4 million to date and is obligated to make payments of up to $16.5 million based on achieving clinical and regulatory milestones[97]. Market and Competitive Landscape - Approximately 20,000 ALS patients are in the U.S., with 5,000 new diagnoses each year, highlighting a significant medical need for effective treatments[38]. - There are approximately 964,000 individuals in the U.S. with methamphetamine use disorder, with an economic burden estimated at $23.4 billion[43]. - The company faces competition from pharmaceutical and biotechnology companies with greater resources and advanced products targeting the same diseases[103][104]. - Competitors may develop more effective products, posing a risk to the company's market opportunities[180]. Manufacturing and Supply Chain - The company relies on third-party manufacturers for active pharmaceutical ingredients (API) and finished products for clinical trials and future commercial production[73]. - The company relies on third-party manufacturers for production, which may result in delays and increased costs for clinical trials and commercialization[192]. - The company may struggle to manufacture product candidates in commercial quantities, which is essential for successful commercialization[197]. - Availability of materials necessary for manufacturing may not be guaranteed, potentially delaying development and commercialization of product candidates[198]. - Compliance with FDA-mandated current good manufacturing practices (cGMPs) is critical; failure to adhere could result in significant delays in clinical trials and product launches[195]. - The company may face challenges in establishing commercial manufacturing and supply arrangements, which could lead to interruptions in supply and adversely affect business operations[194]. Risks and Challenges - The company is subject to extensive regulation by the FDA and other authorities, which could delay the development and commercialization of its product candidates[161]. - The company faces risks related to the clinical development of its product candidates, including potential failure to demonstrate safety and efficacy in trials[153][155]. - The company has not yet received FDA approval for any of its product candidates, and the approval process is lengthy and costly[161]. - The company may need to perform additional testing or amend clinical trial protocols due to changes in regulatory requirements, which could increase costs and delay approvals[161]. - The company faces potential regulatory difficulties even after obtaining U.S. FDA approval, which may include significant restrictions on product use and marketing[167]. - Approved products are subject to ongoing FDA requirements, including labeling, packaging, and post-market safety information submissions[168]. - The company may incur increased costs and delays in clinical trials due to undesirable side effects of product candidates, which could limit commercial potential[170]. - Regulatory authorities may impose restrictions or withdraw approval if unknown problems with a product are discovered, potentially leading to product recalls[173]. - The company may face significant dilution of stockholder ownership if additional equity or debt financing is raised[187]. - The company is obligated to comply with license agreements, and any breach could lead to termination of rights to develop and market product candidates[178]. - The company relies on CROs and other third parties for clinical trials, and any failure on their part could adversely affect the development timeline[188]. - The company's operating results are expected to fluctuate, making it difficult to predict future performance due to various factors including clinical trial dynamics and market demand[215]. Product Development Focus - The company is developing MN-166 (ibudilast) for multiple indications, including progressive MS, ALS, and substance dependence, with no current approved treatments for some of these conditions[105][106][107]. - MN-001 (tipelukast) is being developed for the treatment of Nonalcoholic Steatohepatitis (NASH), with no current approved therapies available for this condition[112]. - MN-001 (tipelukast) is also under development for Idiopathic Pulmonary Fibrosis (IPF), with existing approved treatments including Roche's Esbriet and Boehringer Ingelheim's OFEV[113]. - MN-029 (denibulin) is being developed for solid tumor cancers, with approved treatments including Roche's Kadcyla and Bayer's Stivarga[114]. - The company has initiated clinical development of MN-166 (ibudilast) for glioblastoma, with current standard treatments including surgery and chemotherapy[110]. - The company has been granted 14 U.S. patents covering various uses of MN-001 (tipelukast), including indications for nonalcoholic fatty liver disease and ulcerative colitis[90].