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, 2022 ☐ 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) (State or Other Jurisdiction of Incorporation or Organ ...

Drug Development and Clinical Trials - The company is focused on developing MN-166 (ibudilast) for various neurological disorders, including progressive multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) [18] - In the SPRINT-MS Phase 2b clinical trial, MN-166 (ibudilast) demonstrated a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo (p=0.04) [21] - The same trial showed a 26% reduction in the risk of confirmed disability progression compared to placebo (hazard ratio = 0.74) [21] - The company has initiated a Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS, following positive results from earlier trials [24] - The company is conducting ongoing clinical trials for MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy and degenerative cervical myelopathy [30][31] - Positive preclinical findings for MN-166 (ibudilast) as an adjunctive treatment for glioblastoma were published, with ongoing clinical trials [32] - MN-166 (ibudilast) achieved the primary endpoint of safety and tolerability in a clinical trial for ALS, with a higher rate of responders on the ALSFRS-R total score compared to placebo [56] - The trial evaluating MN-166 (ibudilast) for degenerative cervical myelopathy is funded by a grant from the National Institute for Health Research (NIHR) in the UK [67] - The Phase 2 clinical trial for MN-166 (ibudilast) for ARDS caused by COVID-19 has completed 75% of planned enrollment as of August 2021 [70] - The ongoing clinical trial for MN-166 (ibudilast) for ARDS has received FDA acceptance and is currently in progress [70] - The company is aware of multiple competitors in the clinical development space for both NASH and IPF, indicating a competitive market [143][144] - The clinical development program may not lead to commercial products due to various risks, including failure to demonstrate safety and efficacy in clinical trials [186] Regulatory Designations and Approvals - The FDA has granted Fast Track designation for MN-166 (ibudilast) for both progressive MS and ALS, providing expedited development and review [22][25] - MN-001 (tipelukast) has received Fast Track designation from the FDA for the treatment of nonalcoholic steatohepatitis (NASH) with fibrosis [37] - MN-166 (ibudilast) has received Fast Track designation from the FDA for three indications: progressive MS, ALS, and methamphetamine dependence, facilitating expedited development [46] - The FDA granted Orphan-Drug designation to MN-166 (ibudilast) for ALS, providing seven years of marketing exclusivity if approved [58] - MN-001 (tipelukast) received Orphan-Drug designation from the FDA for Idiopathic Pulmonary Fibrosis (IPF), providing seven years of marketing exclusivity upon approval [38] - The FDA granted orphan-drug designation to MN-166 (ibudilast) as adjunctive therapy to temozolomide for the treatment of glioblastoma [69] - The FDA has granted Fast Track designation to MN-001 (tipelukast) for the treatment of patients with NASH with fibrosis [85] - The company has obtained regulatory authorization to conduct clinical trials for its product development programs, with INDs approved by the FDA [191] Financial Performance and Projections - For the year ended December 31, 2021, the company reported a net loss of $10.1 million, with an accumulated deficit of $393.1 million since inception [176] - As of December 31, 2021, the company had available cash and cash equivalents of $71.4 million and working capital of $69.2 million [176] - The company expects to incur significant operating losses for the foreseeable future as it continues to develop its product candidates MN-166 (ibudilast) and MN-001 (tipelukast) [179] - The company anticipates an increase in research and development expenses in 2022 compared to 2021 due to ongoing development activities [179] - The company may apply for patent term restoration for its currently owned or licensed patents, potentially extending patent life beyond current expiration dates [160] - The company anticipates that out-licensing upfront and milestone payments will be its primary source of revenue prior to commercialization [183] Market Opportunities and Competition - The economic burden of methamphetamine use in the United States is approximately $23.4 billion [60] - There are approximately 1.5 million people aged 12 or older with methamphetamine use disorder in the United States [60] - The prevalence of chemotherapy-induced peripheral neuropathy (CIPN) was 68% in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more [66] - Approximately 28.3 million people aged 12 or older in the United States have alcohol use disorder [64] - There are no approved pharmaceuticals for chemotherapy-induced peripheral neuropathy or degenerative cervical myelopathy, highlighting a market opportunity for MN-166 [137][138] - Current treatments for opioid dependence include generic methadone and Suboxone Film, with additional products like Vivitrol and Zubsolv approved [135] - Competitors may develop more effective products, posing a risk to the company's market opportunities and potentially rendering its product candidates obsolete [214] - The company faces competition from pharmaceutical and biotechnology companies with greater resources and advanced development products targeting the same diseases [131] Safety and Efficacy Findings - An interim analysis of a clinical trial for MN-001 (tipelukast) showed a significant reduction in mean serum triglycerides, a primary endpoint [37] - In a Phase 2 clinical trial for MN-001 (tipelukast), there were no worsening IPF events in the treatment group compared to one event in the placebo group, indicating a favorable safety profile [38] - MN-001 (tipelukast) significantly reduced mean serum triglycerides by 135.7 mg/dL, resulting in a 41.3% reduction (p=0.02) in a Phase 2 clinical trial for NASH [85] - MN-001 (tipelukast) demonstrated significant anti-fibrotic effects in preclinical studies, reducing fibrosis area compared to placebo (p<0.01) and improving NAFLD activity score (p<0.01) [83] - MN-166 (ibudilast) significantly decreased basal, daily alcohol craving over the course of a study (p<0.05) [64] - In a study, 33% of subjects with recurrent glioblastoma were progression-free at six months after treatment with MN-166 (ibudilast) in combination with temozolomide [69] Strategic Partnerships and Collaborations - The company has partnered with BARDA to develop MN-166 (ibudilast) as a potential medical countermeasure against chlorine gas-induced lung injury [34] - The company is pursuing strategic partnerships with leading pharmaceutical companies to support the development and commercialization of its product candidates [42] - The company relies on strategic collaborations and third-party manufacturers for the development and commercialization of its product candidates [176] - The company relies on third-party manufacturers for the production of active pharmaceutical ingredients and finished products for clinical trials and future commercial needs [101] Risks and Challenges - The company faces risks related to regulatory compliance, including potential fines and withdrawal of approvals if foreign regulatory requirements are not met [168] - The company currently has no products approved for commercial sale and does not expect to generate any revenues from product sales in the foreseeable future [183] - The company is largely dependent on the success of its MN-166 (ibudilast) and MN-001 (tipelukast) product candidates, which have not completed the clinical development process [185] - Delays in clinical trials could result in increased costs and limit the ability to obtain regulatory approval for product candidates [205] - The inability to secure adequate funding could require the company to delay or scale back clinical or regulatory activities [182] - The company may face significant setbacks in advanced clinical trials, even after earlier trials show promising results [188] - The loss of rights to develop and market product candidates could significantly harm the company's business [209]

Financial Performance - Revenues for the three months ended September 30, 2021, were $37,500, compared to $0 for the same period in 2020, indicating a significant increase[16] - The net loss applicable to common stockholders for the nine months ended September 30, 2021, was $8.05 million, compared to a net loss of $10.87 million for the same period in 2020, showing an improvement of 26.0%[16] - The company reported a comprehensive loss of $8.06 million for the nine months ended September 30, 2021, compared to $10.87 million for the same period in 2020, indicating a reduction of 25.8%[16] - For the nine months ended September 30, 2021, the net loss was $8,051,107, an improvement from a net loss of $10,868,608 in the same period of 2020, representing a decrease of approximately 26%[20] - Revenues for the nine months ended September 30, 2021, were $4.0 million, an increase from $0.0 million in the same period in 2020, primarily due to milestone payments under the Genzyme Agreement[80] Assets and Equity - Total assets increased to $91.62 million as of September 30, 2021, up from $75.42 million at December 31, 2020, representing a growth of 21.5%[15] - Cash and cash equivalents increased to $75.03 million as of September 30, 2021, compared to $60.04 million at December 31, 2020, a rise of 25.0%[15] - Total stockholders' equity rose to $86.48 million as of September 30, 2021, up from $71.33 million at December 31, 2020, marking an increase of 21.3%[15] - Cash and cash equivalents at the end of the period were $75,025,384, up from $61,661,341 at the end of the same period in 2020, indicating an increase of approximately 21.5%[20] - As of September 30, 2021, the company had available cash and cash equivalents of $75.0 million and working capital of $72.0 million, sufficient to fund operations at least through the end of 2022[87] Expenses - Operating expenses for the nine months ended September 30, 2021, totaled $12.15 million, up from $11.16 million in the same period of 2020, reflecting an increase of 8.9%[16] - Research and development costs for the nine months ended September 30, 2021, totaled $6.4 million, compared to $5.4 million for the same period in 2020, reflecting an increase of approximately 18.5%[30] - General and administrative expenses for the nine months ended September 30, 2021, were $5.4 million, a slight decrease from $5.5 million in 2020[82] - Research, development, and patents expenses for the nine months ended September 30, 2021, were $6.8 million, up from $5.7 million in 2020, mainly due to higher clinical trial expenses for MN-166 (ibudilast) in ALS[81] - Total stock-based compensation expense for the nine months ended September 30, 2021, was $2,474,485, compared to $2,777,503 for the same period in 2020[54] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2021, was $5,742,639, a decrease from $8,877,277 in the same period of 2020, representing a reduction of approximately 35%[20] - Net cash provided by financing activities was $20.7 million during the nine months ended September 30, 2021, compared to $6.7 million in 2020, primarily due to the sale of 3,656,307 shares of common stock[84] Stock and Equity Transactions - The company issued 3,656,307 shares in a private placement transaction, net of issuance costs, contributing to the increase in additional paid-in capital to $477.51 million[18] - The Company issued 3,656,307 shares of common stock at a price of $5.47 per share for approximately $20 million in cash proceeds in a private placement on January 29, 2021[57] - The Company had 8,099,250 stock options outstanding as of September 30, 2021, with a weighted average exercise price of $5.82[51] - As of September 30, 2021, there were 212,678 shares available for future issuance under the Employee Stock Purchase Plan[53] Clinical Development and Strategy - The company is focusing on developing MN-166 (ibudilast) for various neurological disorders and MN-001 (tipelukast) for fibrotic diseases, indicating a strategic emphasis on addressing serious diseases with unmet medical needs[23] - The company intends to advance the development of MN-166 (ibudilast) through a combination of investigator-sponsored clinical trials and government grants[65] - The company plans to pursue strategic partnerships with leading pharmaceutical companies to support the clinical development and commercialization of its products[67] - The company has designed a clinical trial for MN-166 (ibudilast) to evaluate its effectiveness in preventing acute respiratory distress syndrome (ARDS) caused by COVID-19[68] Liabilities and Commitments - The total current liabilities increased to $4.20 million as of September 30, 2021, from $2.19 million at December 31, 2020, an increase of 91.7%[15] - The company reported a right-of-use asset obtained in exchange for operating lease liability amounting to $875,515, indicating ongoing commitments in lease agreements[20] - The total operating lease liabilities as of September 30, 2021, amounted to $888,398, with current operating lease liabilities of $150,682[47] - The weighted-average remaining lease term for operating leases was 4.51 years, with a weighted-average discount rate of 9.7%[47] Risk and Compliance - The company does not have any off-balance sheet arrangements or relationships with unconsolidated entities as of September 30, 2021, mitigating exposure to financing, liquidity, market, or credit risk[89] - The company is not involved in any material legal proceedings as of September 30, 2021, although it may face various disputes in the ordinary course of business[98] - The company has not identified any new risk factors that could materially affect its business, financial condition, or future results since its last annual report[99] - The company expects no material negative impact on its clinical development plans or liquidity due to the COVID-19 pandemic, reflecting confidence in its operational resilience[34] Accounting and Controls - The company is currently evaluating the potential impact of new accounting standards on its consolidated financial statements, indicating proactive financial management[38] - The company maintains disclosure controls and procedures designed to provide reasonable assurance that required information is recorded and reported timely[93] - The company does not expect any changes in internal control over financial reporting that would materially affect its controls[96]

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, 2021 ☐ 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) (State or Other Jurisdiction of Incorporation or Organi ...

Financial Performance - Total revenues for the three months ended March 31, 2021, were $4,000,000, compared to $0 for the same period in 2020[17] - Operating expenses increased to $4,201,529 for Q1 2021, up from $2,924,499 in Q1 2020, representing a 43.7% increase[17] - The net loss applicable to common stockholders for Q1 2021 was $187,799, a significant reduction from a net loss of $2,713,559 in Q1 2020[17] - The company reported a basic and diluted net loss per common share of $0.00 for Q1 2021, compared to $0.06 for Q1 2020[17] - The company expects to incur substantial net losses for the next several years as it continues to develop its existing product development programs[60] Cash and Assets - Cash and cash equivalents at the end of Q1 2021 were $76,301,840, an increase from $60,036,763 at the end of 2020, reflecting a 27% growth[15][22] - The total assets of the company increased to $96,100,719 as of March 31, 2021, compared to $75,419,110 at the end of 2020, marking a 27.5% increase[15] - The total stockholders' equity increased to $92,371,449 as of March 31, 2021, compared to $71,326,500 at the end of 2020, reflecting a 29.5% increase[15] - As of March 31, 2021, available cash and cash equivalents were $76.3 million, with working capital of $79.6 million, indicating sufficient resources to fund operations at least through the end of 2022[79] Research and Development - Research and development expenses for Q1 2021 were $2,145,274, up from $1,250,745 in Q1 2020, indicating a 71.6% increase[17] - The company reported total research, development, and patent expenses of $2.145 million for the three months ended March 31, 2021, compared to $1.251 million for the same period in 2020, reflecting an increase in development activities[68] - The company incurred external development expenses of $1.287 million for MN-166 (ibudilast) in the three months ended March 31, 2021, compared to $618,000 in the same period in 2020[68] - The company is focusing on developing therapeutics for serious diseases, including MN-166 for neurological disorders and MN-001 for fibrotic diseases[25] - The company intends to advance the development of MN-166 (ibudilast) through a combination of investigator-sponsored clinical trials and trials funded by government grants[61] Financing Activities - The company raised $20,212,175 from the issuance of common stock and exercise of stock options during Q1 2021[22] - Net cash provided by financing activities surged to $20.1 million in Q1 2021 from $0.4 million in Q1 2020, a significant increase of 4925%[77] - The company sold 3,656,307 shares of common stock at a price of $5.47 per share for approximately $20 million in cash proceeds on January 29, 2021[53] - The company did not sell any shares under the 2019 ATM Agreement during Q1 2021, maintaining a total offering price of $75.0 million available for future sales[78] Stock Options and Compensation - Total stock-based compensation expense for the three months ended March 31, 2021 was $1,139,636, compared to $596,378 for the same period in 2020[50] - As of March 31, 2021, there were 212,678 shares available for future issuance under the Employee Stock Purchase Plan (ESPP)[49] - The Company has 8,279,887 stock options outstanding as of March 31, 2021, with a weighted average exercise price of $5.73[47] - The Company expects to recognize $3.4 million of unamortized compensation cost related to unvested stock option awards over a remaining weighted-average vesting period of 0.81 years[51] - Potentially dilutive outstanding stock options excluded from diluted net loss per common share totaled 8,279,887 shares for the three months ended March 31, 2021[55] Operational Resilience - The Company continues to enroll patients in clinical trials despite the temporary decrease in patient visits due to COVID-19[34] - The Company has seen an increase in patient visits compared to earlier in the pandemic and continues routine clinical trial activities[34] - The company has continued to enroll patients in clinical trials despite the impact of COVID-19, indicating resilience in its operational activities[64] Legal and Regulatory - The Company adopted ASU 2019-12 on January 1, 2021 with no material impact on its consolidated financial statements[36] - The Company is currently evaluating the potential impact of ASU 2016-13 on its consolidated financial statements, effective January 1, 2023[37] - The company has no material legal proceedings as of March 31, 2021, indicating a stable legal environment[91] - There were no material changes to contractual obligations and commitments during Q1 2021, suggesting consistent operational commitments[80] - The company does not engage in off-balance sheet arrangements, minimizing exposure to financing, liquidity, market, or credit risks[81]

Drug Development and Clinical Trials - 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[19] - The Phase 2b clinical trial of MN-166 (ibudilast) in progressive MS achieved a 26% reduction in the risk of confirmed disability progression compared to placebo[19] - The SPRINT-MS trial of MN-166 (ibudilast) in progressive MS exceeded its enrollment goal, randomizing 255 subjects[19] - Positive findings from a clinical trial of MN-166 (ibudilast) in opioid dependence were presented at a major addiction research meeting[24] - A Phase 2 clinical trial of MN-221 (bedoradrine) for acute exacerbations of asthma was completed, with the FDA advising that a reduction in hospitalizations should be a primary endpoint for further development[35] - The company has initiated clinical trials for MN-166 (ibudilast) in various conditions including ALS, chemotherapy-induced peripheral neuropathy, and glioblastoma[36] - The company is currently conducting a randomized, double-blind, placebo-controlled study for MN-166 (ibudilast) in COVID-19 patients at risk for developing ARDS, which is ongoing[87] - A Phase 2b/3 clinical trial for MN-166 (ibudilast) in subjects with Amyotrophic Lateral Sclerosis (ALS) is ongoing, evaluating efficacy and safety over 12 months[88] - The company has completed several clinical trials for MN-166 (ibudilast) in various indications, including ALS and chemotherapy-induced peripheral neuropathy[88] Regulatory Designations and Approvals - The FDA has granted Fast Track designation to MN-166 (ibudilast) for the treatment of both progressive MS and ALS, providing expedited development and review[20][22] - MN-001 (tipelukast) received Fast Track designation for the treatment of NASH with fibrosis and demonstrated significant reduction in mean serum triglycerides in a clinical trial[32] - The FDA granted Orphan-Drug designation to MN-001 (tipelukast) for the treatment of IPF, which will provide seven years of marketing exclusivity if approved[33][34] - MN-166 (ibudilast) has received Fast Track designations from the FDA for three indications: progressive MS, ALS, and methamphetamine dependence[42] - MN-166 (ibudilast) has been granted Orphan-Drug designation for ALS, providing seven years of marketing exclusivity if approved in the U.S.[43] - The FDA has approved a Phase 2 clinical trial protocol for MN-001 (tipelukast) for the treatment of IPF, which is currently ongoing at Penn State[80] Financial and Operational Status - The company incurred a net loss of $13.9 million for the year ended December 31, 2020, with an accumulated deficit of $382.9 million since inception[166] - As of December 31, 2020, the company had available cash and cash equivalents of $60.0 million and working capital of $58.5 million[166] - The company does not expect to generate any revenues from product sales for the foreseeable future, if ever[173] - The company is largely dependent on the success of its product candidates MN-166 (ibudilast) and MN-001 (tipelukast), which have not yet received regulatory approval[175] - Research and development expenses are expected to increase in 2021 relative to 2020 as the company continues development of its product candidates[169] - The company has no products approved for commercial sale and anticipates that out-licensing will be its primary source of revenue prior to commercialization[173] Market and Competitive Landscape - Approximately 2.3 million people worldwide are affected by MS, with a significant unmet medical need for effective therapies, particularly for progressive forms of the disease[45] - The economic burden of methamphetamine use in the U.S. is estimated at $23.4 billion, highlighting the need for effective treatments[55] - The company faces competition from larger pharmaceutical and biotechnology companies with greater resources and advanced products targeting similar diseases[120] - Competitors may develop more effective products, which could reduce or eliminate the company's commercial opportunities[204] Strategic Partnerships and Collaborations - The company has established strategic partnerships with leading pharmaceutical companies to support the development and commercialization of its products[37] - The company is pursuing additional strategic alliances to further support the clinical development of MN-166 (ibudilast)[37] - The company relies on strategic collaborations for development and commercialization, and failure to secure these partnerships could hinder revenue generation[211] Manufacturing and Supply Chain - The company relies on third-party manufacturers for the production of active pharmaceutical ingredients (API) and finished products for clinical trials and future commercial needs[91][92] - The company does not have manufacturing facilities and does not plan to develop them in the foreseeable future[215] - The company depends on third parties for conducting clinical trials, which may incur additional development costs and delays[213] Risks and Challenges - The complexity and high cost of obtaining regulatory approval for product candidates pose significant risks to the company's operations[164] - The company faces risks related to the potential failure of clinical trials, which could delay or prevent regulatory approval[176] - The company may need to raise additional capital to fund operations and product development, with no guarantee of adequate financing being available[172] - Regulatory approval processes vary by country, and a failure or delay in one country may negatively impact approvals in others[189] - If the company fails to comply with regulatory requirements, it may face severe consequences, including fines, delays, or withdrawal of approvals[190] Research and Development Focus - The company is pursuing development of multiple product candidates across various indications, including COVID-19 and fibrotic diseases[36] - MN-001 (tipelukast) is being developed for the treatment of Nonalcoholic Steatohepatitis (NASH), with no current approved therapies available for this condition[132] - MN-001 (tipelukast) is also in development for Idiopathic Pulmonary Fibrosis (IPF), with existing approved treatments including Roche's Esbriet and Boehringer Ingelheim's OFEV[133] - MN-029 (denibulin) is being developed for solid tumor cancers, with approved treatments including Roche's Kadcyla and Bayer's Stivarga[134]

Financial Performance - The company reported a net loss applicable to common stockholders of $3.70 million for the three months ended September 30, 2020, compared to a net loss of $2.38 million for the same period in 2019, indicating an increase in loss of approximately 55.5%[22] - For the nine months ended September 30, 2020, the net loss was $10,868,608, a slight improvement from a net loss of $10,957,570 in the same period of 2019, representing a decrease of approximately 0.8%[29] - Basic and diluted net loss per common share for the three months ended September 30, 2020, was $0.08, compared to $0.05 for the same period in 2019, representing a 60% increase in loss per share[22] - The company expects to incur substantial net losses for the next several years as it continues to develop its product pipeline[67] Assets and Cash Flow - As of September 30, 2020, total assets decreased to $77.29 million from $79.21 million as of December 31, 2019, representing a decline of approximately 2.4%[20] - Cash and cash equivalents decreased to $61.66 million as of September 30, 2020, from $63.79 million as of December 31, 2019, a reduction of approximately 3.3%[20] - Cash and cash equivalents at the end of the period were $61,661,341, down from $62,872,907 at the end of the same period in 2019, reflecting a decrease of approximately 1.9%[29] - As of September 30, 2020, the company had cash and cash equivalents of $61.7 million and working capital of $60.8 million, sufficient to fund operations at least through the end of 2021[89] Expenses - Total operating expenses for the nine months ended September 30, 2020, were $11.16 million, slightly down from $11.81 million for the same period in 2019, reflecting a decrease of about 5.5%[22] - Research, development, and patents expenses for the three months ended September 30, 2020, were $2.24 million, up from $1.15 million in the same period of 2019, indicating an increase of approximately 94.3%[22] - Research and development costs for the nine months ended September 30, 2020, totaled $5.4 million, an increase of 35% compared to $4.0 million for the same period in 2019[38] - General and administrative expenses decreased to $5.5 million for the nine months ended September 30, 2020, down from $7.6 million in 2019, a reduction of $2.1 million primarily due to lower stock compensation expenses[82] Stock and Equity - The total stockholders' equity as of September 30, 2020, was $73.55 million, a slight decrease from $74.89 million as of December 31, 2019, reflecting a decline of about 1.8%[20] - The company issued 68,952 shares under at-the-market equity distribution and sales agreements, netting approximately $412,692[25] - The company raised $6,735,401 from the issuance of common stock and related activities during the nine months ended September 30, 2020, compared to $7,257,028 in the same period of 2019, indicating a decrease of about 7.2%[29] - The company has 7,510,387 stock options outstanding as of September 30, 2020, with a weighted average exercise price of $5.68[51] COVID-19 Impact - The company is actively monitoring the impact of COVID-19 on its business and does not expect a material negative impact on its clinical development plans or liquidity[41] - The COVID-19 pandemic has negatively impacted the global economy and disrupted supply chains, affecting the company's financial condition and operations[100] - The extent of the pandemic's impact on the company's liquidity and future results remains uncertain and depends on future developments[100] - An extended period of economic disruption could materially affect the company's access to liquidity and overall financial condition[100] Clinical Development - The company continues to focus on the development of its BC-PIV vaccine for COVID-19 and other therapeutics for serious diseases, maintaining a strategic emphasis on the U.S. market[32] - The company has seen an increase in patient visits for clinical trials compared to earlier in the COVID-19 pandemic, indicating a recovery in clinical trial activities[41] - The company has continued routine clinical trial activities during the COVID-19 pandemic, including submitting an Investigational New Drug Application (IND) for MN-166 (ibudilast)[70] - The company plans to advance the development of MN-166 (ibudilast) through various clinical trials, including those funded by government grants[68] Revenue and Collaborations - The company has not recognized any revenue from its collaboration agreement with Kissei Pharmaceutical Co., Ltd. for the three and nine months ended September 30, 2020 and 2019[46] - The company intends to pursue strategic partnerships with leading pharmaceutical companies to support the development and commercialization of its products[69]

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, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 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 ...

Financial Performance - Total current assets decreased from $64.3 million as of December 31, 2019, to $62.2 million as of March 31, 2020, a decline of approximately 3.3%[17] - Operating expenses for the three months ended March 31, 2020, were $2.9 million, down 41.2% from $5.0 million for the same period in 2019[19] - The net loss applicable to common stockholders for Q1 2020 was $2.7 million, compared to a net loss of $4.7 million in Q1 2019, representing a reduction of 42.2%[19] - Cash and cash equivalents at the end of Q1 2020 were $61.3 million, down from $63.8 million at the end of 2019, a decrease of 3.9%[25] - Total stockholders' equity decreased from $74.9 million as of December 31, 2019, to $73.2 million as of March 31, 2020, a decline of approximately 2.3%[17] - The company’s total liabilities decreased from $4.3 million at the end of 2019 to $3.8 million at the end of Q1 2020, a reduction of about 11.5%[17] - The company reported a basic and diluted net loss per common share of $0.06 for Q1 2020, an improvement from $0.11 in Q1 2019[19] - Net cash used in operating activities was $2.9 million in Q1 2020 compared to $3.0 million in Q1 2019, reflecting net loss and changes in operating assets and liabilities[81] - Net cash provided by financing activities was $0.4 million in Q1 2020, primarily from the sale of 68,952 shares of common stock, compared to $3.9 million in Q1 2019 from the exercise of options[82] Research and Development - Research and development costs totaled $1.2 million for Q1 2020, compared to $1.5 million for Q1 2019, reflecting a decrease of 20%[34] - Research, development, and patents expenses decreased from $1.6 million in Q1 2019 to $1.3 million in Q1 2020, a reduction of $0.3 million due to lower stock compensation expenses[79] - The company’s strategy focuses on developing therapeutics for serious diseases, including MN-166 for neurological disorders and MN-001 for fibrotic diseases[28] - The company intends to advance the development of MN-166 (ibudilast) for multiple neurological disorders and MN-001 (tipelukast) for fibrotic diseases through various funding sources[63] - The company plans to pursue strategic partnerships with leading pharmaceutical companies to support the clinical development and commercialization of its products[64] COVID-19 Impact - The company does not expect any material impact on its long-term development timeline and liquidity due to COVID-19[37] - The company is actively monitoring the impact of COVID-19 on its business, with uncertainty regarding its effects on financial condition and operations[65] - The COVID-19 pandemic has created significant volatility and disruption in financial markets, potentially impacting the company's financial condition and product development timelines[100] Stock and Equity - The company raised $412.7 thousand from the issuance of common stock and other equity awards in Q1 2020, compared to $3.9 million in Q1 2019[25] - For the three months ended March 31, 2020, total stock-based compensation expense was $596,378, a decrease of 77.9% compared to $2,699,500 for the same period in 2019[50] - As of March 31, 2020, there were 215,957 shares available for future issuance under the Employee Stock Purchase Plan (ESPP)[49] - The company had 7,638,250 potentially dilutive outstanding securities excluded from diluted net loss per common share due to their anti-dilutive effect for the three months ended March 31, 2020[57] - The company has 1,448,135 shares remaining available for future grants under the 2013 Equity Incentive Plan as of March 31, 2020[43] Financial Position - Cash equivalents, including money market accounts, were valued at $693,794 as of March 31, 2020[42] - The company had cash and cash equivalents of $61.3 million and working capital of $60.4 million as of March 31, 2020, sufficient to fund operations at least through the end of 2021[87] - The company did not have any off-balance sheet arrangements or relationships with unconsolidated entities as of March 31, 2020, mitigating exposure to financing, liquidity, market, or credit risk[88] - A hypothetical 100 basis point adverse move in interest rates would not materially affect the fair value of the company's interest-rate sensitive financial instruments due to their short-term nature[89] - Cash and cash equivalents were primarily invested in money market interest-bearing accounts and funds, with a hypothetical 10% adverse change in average interest rates having no material effect on net loss for the three months ended March 31, 2020[90] Internal Controls and Legal Matters - The company maintains effective disclosure controls and procedures, providing reasonable assurance that required information is recorded and reported timely[94] - There have been no changes in internal control over financial reporting that materially affected the company's controls during the most recent fiscal quarter[95] - The company is not involved in any material legal proceedings as of March 31, 2020, but may face disputes in the ordinary course of business[98] - The company assessed the collaboration agreement with Kissei Pharmaceutical Co., Ltd. and recognized no revenue for the three months ended March 31, 2020[41] - The company has incurred no revenue from the collaboration agreement with Kissei Pharmaceutical Co., Ltd. for the three months ended March 31, 2020[66] - The company adopted ASU 2018-13 on January 1, 2020, with no material impact on its consolidated financial statements[39]

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 ...