MediciNova(MNOV) - 2022 Q4 - Annual Report

PART I Forward-Looking Statements and Summary Risk Factors The report contains forward-looking statements subject to risks and uncertainties, including capital needs, product development, and market acceptance - Forward-looking statements carry inherent risks and uncertainties that could cause actual results to differ materially[11] - Key risks include the inability to raise additional capital, generate product revenues, develop and commercialize candidates, or face clinical trial and regulatory delays[12][17] - The company has incurred significant operating losses and expects continued losses, with an accumulated deficit of $407.1 million as of December 31, 2022[181] - Success is highly dependent on MN-166 (ibudilast) and MN-001 (tipelukast) product candidates, neither of which has received regulatory approval[17][189] Item 1. Business MediciNova is a biopharmaceutical company developing novel therapeutics for serious diseases, focusing on MN-166 and MN-001, relying on third parties and strategic partnerships - MediciNova is a biopharmaceutical company developing novel therapeutics for serious diseases with unmet medical needs, focusing on the U.S. market[21] - Primary product candidates are MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic diseases[21][51][89] - The company's strategy involves advancing MN-166 and MN-001 development through non-dilutive financing and seeking strategic partnerships for commercialization[47] Overview MediciNova develops novel therapeutics for unmet medical needs in the U.S., with key candidates MN-166 for neurological disorders and MN-001 for fibrotic diseases - The company focuses on developing MN-166 (ibudilast) for progressive MS, ALS, chemotherapy-induced peripheral neuropathy, and ARDS prevention[21] - MN-001 (tipelukast) is under development for nonalcoholic fatty liver disease (NAFLD) and idiopathic pulmonary fibrosis (IPF)[21] - Additional pipeline candidates include MN-221 (bedoradrine) for acute asthma and MN-029 (denibulin) for solid tumor cancers[21] Our Product Candidates and Programs MediciNova develops product candidates for unmet medical needs, primarily MN-166 (anti-inflammatory/neuroprotective) and MN-001 (anti-fibrotic/inflammatory), with MN-221 license terminated - MN-166 (ibudilast) is a novel, first-in-class, oral, anti-inflammatory and neuroprotective agent, licensed from Kyorin Pharmaceuticals in 2004[51] - MN-166 has received FDA Fast Track designation for progressive MS, ALS, and methamphetamine dependence, and Orphan-Drug designation for ALS and glioblastoma[52][53] - MN-001 (tipelukast) is a novel, orally bioavailable small molecule with anti-fibrotic and anti-inflammatory activity, licensed from Kyorin in 2002[89][90] - MN-001 has received FDA Fast Track designation for NASH with fibrosis and IPF, and Orphan-Drug designation for IPF[90][101] - The license agreement for MN-221 (bedoradrine) for acute asthma exacerbations was terminated in October 2022[46][84] MN-166 (ibudilast) MN-166 (ibudilast) is a first-in-class anti-inflammatory and neuroprotective agent showing positive Phase 2b results in progressive MS and Phase 2 results in ALS and ARDS prevention - MN-166 (ibudilast) is a novel, first-in-class, oral, anti-inflammatory and neuroprotective agent, inhibiting MIF and PDEs, and attenuating activated glia cells[51] - In the SPRINT-MS Phase 2b trial for progressive MS, MN-166 demonstrated a statistically significant 48% reduction in whole brain atrophy and a 26% reduction in confirmed disability progression risk compared to placebo[57] - A Phase 2 clinical trial of MN-166 in ALS achieved its primary safety and tolerability endpoint, showing a higher responder rate in functional activity compared to placebo[62] - A Phase 2 clinical trial of MN-166 in alcohol use disorder reduced the odds of heavy drinking by 45% and attenuated alcohol cue-elicited activation in the ventral striatum[70] - In a Phase 2 clinical trial for ARDS prevention in COVID-19 patients, MN-166 achieved statistical significance for subjects free of respiratory failure at Day 7 (71% vs 35% for placebo, p=0.02) and discharged from hospital (65% vs 29% for placebo, p=0.02)[80] MN-221 (bedoradrine) MN-221 (bedoradrine), a beta-2-adrenergic receptor agonist for acute asthma, showed some clinical improvements despite not meeting its primary endpoint, and its license was terminated in October 2022 - MN-221 (bedoradrine) is a novel, highly selective beta-2-adrenergic receptor agonist for acute asthma exacerbations, designed for intravenous infusion[84][85] - A Phase 2b trial did not statistically meet the primary FEV1 endpoint but showed significant improvements in Dyspnea Index scores and a reduced treatment failure rate (74% placebo vs 43% MN-221) in a subgroup[87] - The license agreement for MN-221 was terminated in October 2022, with no further financial obligations to Kissei Pharmaceutical Co., Ltd[84] MN-001 (tipelukast) MN-001 (tipelukast) is an orally bioavailable small molecule with anti-fibrotic and anti-inflammatory properties, showing significant triglyceride reduction in NASH/NAFLD and positive biomarker effects in IPF - MN-001 (tipelukast) acts through leukotriene receptor antagonism, PDE inhibition, and 5-lipoxygenase inhibition, down-regulating genes promoting fibrosis and inflammation[89][90] - In a Phase 2 clinical trial for NASH/NAFLD, MN-001 significantly reduced mean serum triglycerides by 41.3% (p=0.02) in an interim analysis[95] - A subgroup analysis showed Type 2 diabetes mellitus patients treated with MN-001 experienced a greater reduction in serum triglyceride levels (50.8% vs 17.8%) and a significantly greater increase in HDL (15.8% vs 1.0%, p<0.0002) compared to non-T2DM subjects[97] - In a Phase 2 IPF trial, MN-001 demonstrated no worsening IPF events and a substantial reduction in the LOXL2 biomarker, while being safe and well-tolerated[101] MN-029 (denibulin) MN-029 (denibulin) is a novel tubulin binding agent for solid tumors, showing anti-tumor activity in preclinical studies and well-tolerated in Phase 1 trials with some stable disease - MN-029 (denibulin) is a novel tubulin binding agent for solid tumors, licensed from Angiogene Pharmaceuticals, inhibiting tubulin polymerization and disrupting cell cytoskeleton[102] - Preclinical studies showed MN-029 damaged tumor blood vessels and caused vascular shutdown within tumors, in addition to direct effects on cancer cells[103] - Phase 1 clinical trials indicated MN-029 was well-tolerated at doses that reduced tumor blood flow, with stable disease in 12 patients in the first trial and one partial response in the second[104][106] Our Strategy MediciNova's strategy is to build a sustainable biopharmaceutical business by developing differentiated products for unmet medical needs, advancing MN-166 and MN-001, and seeking strategic partnerships - The company aims to build a sustainable biopharmaceutical business by developing differentiated products for serious diseases with unmet medical needs[47] - Strategy includes advancing MN-166 (ibudilast) and MN-001 (tipelukast) development with non-dilutive financings, government grants, and investigator-sponsored trials[47] - MediciNova plans to consider strategic partnerships with leading pharmaceutical companies to complete product development and commercialization[47] Sales and Marketing MediciNova lacks internal marketing and sales capabilities, planning to rely on strategic partners for product commercialization - The company has no current marketing and sales capabilities[111] - MediciNova expects to rely on strategic partners for product commercialization[111] Manufacturing MediciNova relies entirely on third-party manufacturers for API and finished products for all development stages and future commercial production - MediciNova relies on third parties to manufacture bulk API and finished investigational products for research, development, preclinical, and clinical trials[112] - The company expects to continue this reliance for future commercial production[112] - For MN-166 (ibudilast), the company has historically sourced capsules from Taisho Pharmaceutical Co., Ltd. and uses contract manufacturers[113] Intellectual Property and License Agreements MediciNova holds licenses and a robust patent portfolio, primarily method-of-use patents for MN-166 and MN-001, despite expired composition of matter patents, and faces intellectual property risks - MediciNova holds 32 issued U.S. patents and 89 issued foreign patents, with 12 pending U.S. and 31 pending foreign applications[114] - The company's patent portfolio for MN-166 (ibudilast) primarily covers methods of treating progressive MS, ALS, glioblastoma, and drug addiction, with expirations ranging from 2025 to 2039[121][122][123] - Composition of matter patents for MN-166 (ibudilast), MN-001 (tipelukast), and MN-221 (bedoradrine) have expired, allowing competitors to develop products with the same API if method-of-use patents are not infringed[117][126][137] - The exclusive license agreement for MN-221 (bedoradrine) with Kissei Pharmaceutical Co., Ltd. was terminated in October 2022[124] - MediciNova is obligated to make future milestone payments up to $5.0 million for MN-166 and MN-001, and up to $16.5 million for MN-029, plus royalties on net sales[120][130][133] Competition The biopharmaceutical industry is highly competitive, with MediciNova facing numerous entities and existing treatments that pose significant threats across its target indications - The biopharmaceutical industry is highly competitive, characterized by extensive research and rapid technological progress[139] - Competitors include pharmaceutical and biotechnology companies, academic institutions, and governmental agencies, many possessing greater resources[139][140] - For progressive MS, approved drugs include Ocrevus (PPMS) and several for SPMS with relapses; other compounds are in clinical development[142] - For ALS, generic riluzole, Radicava, and Relyvrio are approved, with numerous other compounds in clinical development[143] - There are no currently approved pharmaceuticals for methamphetamine addiction or chemotherapy-induced peripheral neuropathy[144][145] Government Regulation MediciNova's product development is subject to extensive, lengthy, and costly government regulation by the FDA and foreign authorities, with compliance critical to avoid severe sanctions - The research, development, testing, manufacture, labeling, promotion, advertising, distribution, sampling, marketing, and import/export of pharmaceutical products are extensively regulated by government authorities[154] - The U.S. regulatory approval process involves preclinical tests, an effective IND application, multi-phase clinical trials, NDA submission, cGMP compliance, and FDA review and approval[160] - Fast Track designation, Priority Review, and Accelerated Approval programs are available to expedite development and review for serious conditions with unmet medical needs[165][167] - Market exclusivity provisions under the FDCA include five-year exclusivity for new chemical entities and three-year exclusivity for new clinical investigations, plus potential six-month pediatric exclusivity[169][170] - Failure to comply with applicable regulatory requirements can result in sanctions such as fines, delays, suspension or withdrawal of approvals, product recalls, and criminal prosecution[154][176] Human Capital Resources MediciNova has a small, experienced team of 13 full-time employees with core competencies in management, clinical development, regulatory, and corporate development - MediciNova has 13 full-time employees as of the report date[177] - The company's team possesses core competencies in general management, clinical development, regulatory affairs, and corporate development[177] - Employee relations are reported as good, with no history of work stoppages[177] Company Information MediciNova, Inc. was incorporated in Delaware in September 2000, with principal executive offices in La Jolla, CA - MediciNova, Inc. was incorporated in Delaware in September 2000[179] - Principal executive offices are located at 4275 Executive Square, Suite 300, La Jolla, CA 92037[179] Item 1A. Risk Factors This section details significant risks, including operating losses, funding needs, dependence on MN-166 and MN-001, regulatory uncertainties, competition, third-party reliance, and intellectual property issues - MediciNova has incurred significant operating losses since inception and expects continued losses, with an accumulated deficit of $407.1 million as of December 31, 2022[181] - The company will need additional funding to complete product development and commercialization, with current working capital projected to fund operations only through the end of 2024[185][186][325] - Future success is highly dependent on the regulatory approval and commercialization of MN-166 (ibudilast) and MN-001 (tipelukast), neither having completed clinical development[189] - The drug development process is lengthy, costly, and uncertain, with high risks of clinical trial failure, delays, or denial of regulatory approval[195][196] - The company relies heavily on third parties for clinical trials and manufacturing, exposing it to risks of delays, increased costs, and lack of control[229][233] - The expiration of composition of matter patents for key product candidates (MN-166, MN-001, MN-221) means competitors could offer products with the same active pharmaceutical ingredient if method-of-use patents are not infringed[267][137] Item 1B. Unresolved Staff Comments MediciNova has no unresolved staff comments from the SEC as of the report date Item 2. Properties MediciNova maintains its San Diego headquarters and Tokyo office space under leases, relying on third parties for laboratory, research, and manufacturing facilities - The San Diego headquarters sublease was extended for an additional 5 years through January 31, 2027[293] - Office space in Tokyo, Japan, was renewed in May 2021 for a two-year term with an auto-renewal option[294] - MediciNova has no laboratory, research, or manufacturing facilities, relying on third-party service providers[294] Item 3. Legal Proceedings MediciNova is not currently involved in any material legal proceedings, with no expected material adverse effects from ordinary course disputes - MediciNova is not involved in any material legal proceedings as of the report date[295] - The company may become involved in disputes in the ordinary course of business, but none are currently expected to have a material adverse effect[295] Item 4. Mine Safety Disclosures MediciNova has no disclosures related to mine safety PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities MediciNova's common stock is listed on NASDAQ and TSE, with approximately 11 record holders, no cash dividends paid, and a $20 million private placement completed in January 2021 - Common stock is listed on NASDAQ Global Market (MNOV) and Tokyo Stock Exchange (4875)[298] - As of February 13, 2023, there were approximately 11 holders of record of common stock[298] - The company has never declared or paid cash dividends and does not anticipate paying any in the foreseeable future[299] - On January 29, 2021, MediciNova sold 3,656,307 shares of common stock in a private placement for approximately $20 million in cash proceeds[301] Item 6. [Reserved] This item is reserved and contains no information Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations MediciNova incurred a $14.1 million net loss in 2022, increasing its accumulated deficit to $407.1 million, with decreased revenues, increased R&D, and liquidity projected to fund operations through 2024 Net Loss and Accumulated Deficit | Metric | 2022 (Millions) | 2021 (Millions) | | :------------------- | :-------------- | :-------------- | | Net Loss | $(14.1) | $(10.1) | | Accumulated Deficit | $(407.1) | $(393.1) | Key Financial Highlights (Years Ended December 31) | Metric | 2022 (Millions) | 2021 (Millions) | Change (YoY) (Millions) | | :-------------------------------- | :-------------- | :-------------- | :---------------------- | | Revenues | $0.0 | $4.0 | $(4.0) | | Research, Development and Patents | $9.1 | $8.5 | $0.6 | | General and Administrative | $5.5 | $5.7 | $(0.2) | | Other Expense, net | $0.247 | $0.059 | $0.188 | | Interest Income | $0.8 | $0.1 | $0.7 | Cash Flow Summary (Years Ended December 31) | Cash Flow Activity | 2022 (Thousands) | 2021 (Thousands) | | :----------------- | :--------------- | :--------------- | | Operating activities | $(12,912) | $(9,382) | | Investing activities | $(40,005) | $(29) | | Financing activities | $8 | $20,778 | | Total | $(52,909) | $11,367 | - As of December 31, 2022, the company had $18.5 million in cash and cash equivalents and $40.0 million in investments, with working capital of $55.8 million[325] - MediciNova believes it has sufficient working capital to fund operations at least through the end of 2024, with expected operating cash needs of approximately $21.2 million for 2023[325] - A shelf registration statement allows the company to offer up to $200.0 million of various securities, including common stock, for future capital raising[327][328] Item 7A. Quantitative and Qualitative Disclosures About Market Risk MediciNova has no material quantitative or qualitative disclosures about market risk Item 8. Financial Statements and Supplementary Data This section presents MediciNova's audited consolidated financial statements for 2022 and 2021, reflecting a $14.1 million net loss in 2022, an accumulated deficit of $407.1 million, and detailed accounting policies Consolidated Balance Sheet Highlights (as of December 31) | Metric | 2022 (Thousands) | 2021 (Thousands) | | :-------------------------------- | :--------------- | :--------------- | | Cash and cash equivalents | $18,505 | $71,431 | | Investments | $39,982 | $0 | | Total current assets | $58,987 | $72,009 | | Total assets | $74,155 | $87,406 | | Total current liabilities | $3,187 | $2,833 | | Total liabilities | $3,913 | $3,729 | | Total stockholders' equity | $70,242 | $83,677 | Consolidated Statements of Operations and Comprehensive Loss (Years Ended December 31) | Metric | 2022 (Thousands) | 2021 (Thousands) | | :-------------------------------- | :--------------- | :--------------- | | Revenues | $0 | $4,038 | | Research, development and patents | $9,144 | $8,538 | | General and administrative | $5,485 | $5,715 | | Operating loss | $(14,629) | $(10,216) | | Net loss applicable to common stockholders | $(14,069) | $(10,134) | | Basic and diluted net loss per common share | $(0.29) | $(0.21) | Consolidated Statements of Cash Flows (Years Ended December 31) | Cash Flow Activity | 2022 (Thousands) | 2021 (Thousands) | | :----------------- | :--------------- | :--------------- | | Net cash used in operating activities | $(12,912) | $(9,382) | | Net cash used in investing activities | $(40,005) | $(29) | | Net cash provided by financing activities | $8 | $20,778 | | Net change in cash and cash equivalents | $(52,925) | $11,394 | | Cash and cash equivalents, end of year | $18,505 | $71,431 | - The company's accumulated deficit reached $407.1 million as of December 31, 2022[351] - Research, development, and patent expenses increased to $9.1 million in 2022 from $8.5 million in 2021[354] 1. Organization and Summary of Significant Accounting Policies This note outlines MediciNova's organizational structure, business focus on small molecule therapeutics, key accounting policies, and critical accounting estimates, including the impact of COVID-19 - MediciNova operates in a single operating segment: acquisition and development of small molecule therapeutics[366] - The COVID-19 pandemic caused slower patient enrollment in clinical trials but also created opportunities for new clinical development, such as MN-166 for ARDS and Long COVID[367][368] - Research, development, and patent expenses are expensed as incurred, totaling $9.1 million in 2022 and $8.5 million in 2021[316][379] - Clinical trial accruals are estimated based on vendor progress, patient enrollment, and site activations, with $1.5 million accrued as of December 31, 2022[382][346] - The company uses the Black-Scholes model to estimate the fair value of stock options and recognizes share-based compensation expense over the vesting period[384] 2. Revenue Recognition MediciNova recognizes revenue upon satisfying performance obligations, including $4.0 million in 2021 from Genzyme milestone payments, while the MN-221 collaboration was terminated in October 2022 - Revenue is recognized upon the satisfaction of performance obligations, either at a point in time or over time[391] - In March 2021, MediciNova recognized $4.0 million in revenue from two clinical development milestone payments from Genzyme Corporation, related to a gene therapy product[394] - The collaboration agreement with Kissei Pharmaceutical Co., Ltd. for MN-221 was terminated in October 2022, with no revenue recognized from it since 2013[392] 3. Fair Value Measurements MediciNova measures financial instruments at fair value using a three-tier hierarchy, with cash equivalents at Level 1 and investments at Level 2 as of December 31, 2022 - Fair value is determined using a three-tier hierarchy: Level 1 (quoted prices in active markets), Level 2 (quoted prices for similar items or non-active markets), and Level 3 (unobservable inputs)[396] Fair Value of Financial Instruments (as of December 31, 2022) | Instrument | Carrying Amount (Dollars) | Fair Value (Dollars) | Valuation Inputs | | :----------------------- | :------------------------ | :------------------- | :--------------- | | Money market funds | $704,882 | $704,882 | Level 1 | | Bank certificates of deposit | $39,982,213 | $39,982,213 | Level 2 | 4. Balance Sheet Details This note details MediciNova's property and equipment, net, totaling $45,269, and accrued liabilities of $2,605,308 as of December 31, 2022 Property and Equipment, Net (as of December 31) | Category | 2022 (Dollars) | 2021 (Dollars) | | :-------------------------------- | :------------- | :------------- | | Leasehold improvements | $13,532 | $15,409 | | Furniture and equipment | $121,909 | $124,731 | | Software | $342,628 | $342,628 | | Less accumulated depreciation and amortization | $(432,800) | $(425,203) | | Property and equipment, net | $45,269 | $57,565 | Accrued Liabilities and Other Current Liabilities (as of December 31) | Category | 2022 (Dollars) | 2021 (Dollars) | | :-------------------------------- | :------------- | :------------- | | Accrued compensation | $920,166 | $636,481 | | Clinical trial accruals | $1,462,354 | $1,076,411 | | Professional services fees | $38,688 | $38,041 | | Other | $184,100 | $547,270 | | Total accrued liabilities and other current liabilities | $2,605,308 | $2,298,203 | 5. Commitments and Contingencies MediciNova's commitments include $681,124 in operating lease liabilities and $26.5 million in potential milestone payments, with adequate product liability insurance and no material legal proceedings Operating Lease Liabilities (as of December 31, 2022) | Year | Amount (Dollars) | | :--- | :--------------- | | 2023 | $216,154 | | 2024 | $189,170 | | 2025 | $197,585 | | 2026 | $206,483 | | 2027 | $17,269 | | Total minimum payments | $826,661 | | Less imputed interest | $(145,537) | | Total lease liabilities | $681,124 | - Weighted-average remaining lease term is 3.90 years, with a weighted-average discount rate of 9.8%[401] - Future potential milestone payments under license agreements aggregate to $26.5 million ($10 million for MN-166/MN-001 and $16.5 million for other products)[404] - The company believes it carries reasonably adequate product liability insurance[402] 6. Stock-based Compensation MediciNova grants stock options under its 2013 Equity Incentive Plan, with 1,949,317 shares available, and reported $642,522 in stock-based compensation expense for 2022 - As of December 31, 2022, 1,949,317 shares remain available for future grant under the 2013 Equity Incentive Plan[406] Stock Option Activity (Years Ended December 31) | Metric | 2022 (Shares) | 2021 (Shares) | | :-------------------------------- | :------------ | :------------ | | Outstanding at beginning of year | 7,974,250 | 7,401,387 | | Granted | 591,700 | 1,315,000 | | Exercised | (3,000) | (360,955) | | Cancelled | (577,700) | (381,182) | | Outstanding at end of year | 7,985,250 | 7,974,250 | | Weighted Average Exercise Price (Outstanding) | $5.55 (Dollars) | $5.81 (Dollars) | | Exercisable at end of year | 7,394,381 | N/A | | Weighted Average Exercise Price (Exercisable) | $5.80 (Dollars) | N/A | Stock-Based Compensation Expense (Years Ended December 31) | Category | 2022 (Dollars) | 2021 (Dollars) | | :-------------------------------- | :------------- | :------------- | | Research, development and patents | $237,071 | $640,340 | | General and administrative | $405,451 | $1,077,173 | | Total stock-based compensation expense | $642,522 | $1,717,513 | - As of December 31, 2022, $0.2 million of unamortized compensation cost remains, expected to be recognized over a weighted-average vesting period of 0.20 years[415] 7. Stockholders' Equity MediciNova has an ATM agreement for up to $75.0 million in common stock sales, completed a $20 million private placement in January 2021, and reserved 9,934,567 shares for future equity issuance - The ATM Agreement allows for sales of common stock up to an aggregate offering price of $75.0 million[416] - No shares were sold under the ATM Agreement in 2022 or 2021[417] - In January 2021, 3,656,307 shares of common stock were issued in a private placement for approximately $20 million[418] Common Stock Reserved for Future Issuance (as of December 31, 2022) | Category | Number of Shares | | :-------------------------------- | :--------------- | | For exercise of outstanding options | 7,985,250 | | For future equity awards | 1,949,317 | | Total | 9,934,567 | 8. Income Taxes MediciNova reported a $14.1 million loss before income taxes in 2022, with significant federal and California NOL carryforwards and research tax credits, offset by a full valuation allowance Loss Before Income Taxes (Years Ended December 31) | Location | 2022 (Thousands) | 2021 (Thousands) | | :--------- | :--------------- | :--------------- | | United States | $(14,084) | $(10,146) | | Foreign | $18 | $14 | | Total | $(14,066) | $(10,132) | Deferred Tax Assets and Liabilities (as of December 31) | Category | 2022 (Thousands) | 2021 (Thousands) | | :-------------------------------- | :--------------- | :--------------- | | Net operating loss carryforwards | $70,142 | $68,485 | | Research tax credits | $9,630 | $9,262 | | Total deferred tax assets | $83,667 | $79,999 | | Total deferred tax liabilities | $(1,510) | $(1,539) | | Net deferred tax assets | $82,157 | $78,460 | | Valuation allowance | $(82,359) | $(78,662) | | Net deferred tax liability | $(202) | $(202) | - Federal NOL carryforwards are approximately $276.6 million ($44.3 million carried forward indefinitely, $232.3 million began expiring in 2022)[421] - California NOL carryforwards are approximately $182.9 million, beginning to expire in 2028[421] - A valuation allowance of $82.4 million has been established against net deferred tax assets due to uncertainty of realization, with a $3.7 million increase in 2022[420] 9. Employee Savings Plan MediciNova offers an employee savings plan with discretionary company contributions totaling $75,859 in 2022 and $72,330 in 2021 Company Contributions to Employee Savings Plan (Years Ended December 31) | Year | Contribution Amount (Dollars) | | :--- | :---------------------------- | | 2022 | $75,859 | | 2021 | $72,330 | Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure MediciNova reports no changes in or disagreements with its accountants on accounting and financial disclosure matters Item 9A. Controls and Procedures MediciNova's management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with no material changes in the fourth quarter - Disclosure controls and procedures were deemed effective as of December 31, 2022[428] - Internal control over financial reporting was effective as of December 31, 2022, based on the COSO 2013 framework[433] - No material changes in internal control over financial reporting occurred during the fourth fiscal quarter[430] Item 9B. Other Information MediciNova terminated its exclusive license agreement with Kissei Pharmaceutical Co., Ltd. for MN-221 (bedoradrine) on October 24, 2022, with no further financial obligations except for API purchase - MediciNova terminated its exclusive license agreement with Kissei Pharmaceutical Co., Ltd. for MN-221 (bedoradrine) on October 24, 2022[434] - The termination resulted in no further financial obligations to Kissei, except for the purchase of 7.15kg of active pharmaceutical ingredient for JPY114,400,000 in December 2022[434] Item 9C. Disclosure Regarding Foreign Jurisdiction the Prevent Inspections MediciNova has no disclosures regarding foreign jurisdictions that prevent inspections PART III Item 10. Directors, Executive Officers and Corporate Governance Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 Annual Meeting of Stockholders Proxy Statement - Information on directors, executive officers, and corporate governance is incorporated by reference from the 2023 Proxy Statement[439] - MediciNova has adopted a Code of Ethics for Senior Officers and a Code of Business Conduct, available on its website[440] Item 11. Executive Compensation Executive compensation information is incorporated by reference from MediciNova's 2023 Annual Meeting of Stockholders Proxy Statement - Executive compensation information is incorporated by reference from the 2023 Proxy Statement[441] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters Security ownership information is incorporated by reference from the 2023 Proxy Statement, with 7,985,250 shares reserved for outstanding options and 1,949,317 for future equity awards - Security ownership information is incorporated by reference from the 2023 Proxy Statement[442] Equity Compensation Plan Information (as of December 31, 2022) | Category | Number of Securities to be Issued Upon Exercise of Outstanding Options and Rights | Weighted Average Exercise Price of Outstanding Options and Rights (Dollars) | Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans | | :-------------------------------- | :---------------------------------------------------------------- | :-------------------------------------------------------------- | :------------------------------------------------------------------------------------------- | | Equity Compensation Plans Approved by Stockholders | 7,985,250 | $5.55 | 1,949,317 | Item 13. Certain Relationships and Related Transactions, and Director Independence Information on certain relationships, related transactions, and director independence is incorporated by reference from MediciNova's 2023 Annual Meeting of Stockholders Proxy Statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2023 Proxy Statement[446] Item 14. Principal Accountant Fees and Services Information on principal accountant fees and services is incorporated by reference from MediciNova's 2023 Annual Meeting of Stockholders Proxy Statement - Information on principal accountant fees and services is incorporated by reference from the 2023 Proxy Statement[447] PART IV Item 15. Exhibits and Financial Statement Schedules This section lists documents filed as part of the 10-K report, including consolidated financial statements and a comprehensive list of exhibits - The report includes the audited consolidated financial statements and the Report of Independent Registered Public Accounting Firm[448] - A detailed list of exhibits, including organizational documents, license agreements, employment agreements, and sales agreements, is provided[450][451] SIGNATURES This section contains the required signatures for the Annual Report on Form 10-K, affirming the filing on February 16, 2023 - The Annual Report on Form 10-K was signed by the President & Chief Executive Officer, Chief Financial Officer, and Board of Directors on February 16, 2023[455][458]