MEDICINOVA INC
For the period ended Mar 31, 2025. Filed May 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
MNOV$1.46+0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-13.
0000950170-24-126343
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0000950170-25-070461
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 51 previous paragraphs and 39 current paragraphs.
25 unchanged; 8 reworded; 6 added; 18 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Research, Development and Patents Expenses
Current report
General and Administrative Expenses
Current report
Research, Development and Patents Expenses
Current report
Research, development and patents expenses were $1.8 million for both the three months ended March 31, 2025 and 2024. The expense was relatively the same quarter over quarter. Changes were primarily due to an increase in MN-001 related expenses and stock option expense offset by decreased payroll costs from a reduction in headcount.
Current report
General and Administrative Expenses
Current report
General and administrative expenses were $1.4 million for both the three months ended March 31, 2025 and 2024. The expense was relatively the same quarter over quarter.
Removed paragraphs (18)
Previous report
Impact of COVID-19 and the Macroeconomic Environment on Our Business
Previous report
The COVID-19 pandemic resulted in significant national and global economic disruption and has, and may continue to adversely affect our business. To date, we have experienced certain adverse effects on our business as well as been provided certain opportunities as a result of the pandemic. The pandemic caused a decrease in the number of patient visits at some clinical trial sites which we believe resulted in slower enrollment in our clinical trials than would have occurred without the pandemic. However, we have seen an increase in the number of patient visits compared to earlier in the pandemic and we continue to enroll patients in clinical trials. Throughout the pandemic, we continued with routine clinical trial activities including executing new clinical trial agreements, negotiating budgets, institutional review board approvals, site training, and other activities related to the initiation of new clinical trials and the opening of new clinical trial sites, although some of these activities took longer to complete than what we experienced prior to the pandemic.
Previous report
The pandemic created certain opportunities for our clinical development and we have pursued those opportunities. Following the outbreak of the pandemic, we designed a clinical trial to evaluate MN-166 (ibudilast) for prevention of ARDS caused by COVID-19. In June 2022, we announced positive top-line results from this Phase 2 clinical trial in which MN-166 (ibudilast) demonstrated large improvements compared to placebo for all four clinical endpoints analyzed. Separately, in August 2022, we announced plans to participate in Recovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial (the RECLAIM trial), a grant-funded clinical trial to evaluate MN-166 (ibudilast) and other therapies for the treatment of Long COVID, the lingering symptoms of COVID-19. In February 2023, we announced that Health Canada completed its review of the clinical trial application and granted authorization to commence the RECLAIM trial.
Previous report
We continue to actively monitor the possible effects on our financial condition, liquidity, operations, suppliers, industry, and workforce resulting from the recent pandemic and the macroeconomic environment. To the extent that there is a resurgence in the COVID-19 pandemic, or other health epidemics or outbreaks, our operations could be disrupted and our business adversely impacted.
Previous report
Further, certain global COVID-19 pandemic and government responses to the pandemic resulted in, and may continue to result in, downward pressure, extreme volatility, and disruptions in the capital and credit markets, reducing our ability to raise additional capital through equity, equity-linked or debt financings, which could negatively impact our short-term and long-term liquidity, access to capital markets, and our ability to operate in accordance with our operating plan, or at all.
Previous report
In addition, we may be exposed to credit risk on deposits at financial institutions to the extent our account balances exceed the amount insured by the Federal Deposit Insurance Corporation. We are monitoring ongoing events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions.
Previous report
Revenues
Previous report
Revenues were $0.0 million and $1.0 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of $1.0 million was due to the receipt of a milestone payment under the Genzyme Agreement in September 2023.
Previous report
Research, development and patents expenses were $1.9 million and $0.8 million for the three months ended September 30, 2024 and 2023, respectively. The increase of $1.1 million was primarily driven by an increase in ALS related expenses and new drug safety tests for MN-166 and MRC-001, respectively. Additionally, during the three months ended September 30, 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.
Previous report
General and administrative expenses were $1.5 million and $1.4 million for the three months ended September 30, 2024 and 2023, respectively. The increase of $0.1 million was primarily driven by increases in performance-based stock option expense and increases in professional fees, partially offset by a reduction in headcount.
Previous report
Comparison of the nine months ended September 30, 2024 and 2023
Previous report
Revenues
Previous report
Revenues were $0.0 million and $1.0 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $1.0 million was due to the receipt of a milestone payment under the Genzyme Agreement in September 2023.
Previous report
Research, development and patents expenses were $5.3 million and $4.0 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $1.3 million was primarily due to an increase in MN-166 manufacturing costs. Additionally, during the nine months ended September 30, 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.
Previous report
General and administrative expenses were $4.2 million and $4.4 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $0.2 million was primarily driven by a decrease in performance-based stock option expense partially offset by an increase in professional fees.
Previous report
Interest Income
Previous report
Interest income was $1.3 million and $1.4 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $0.1 million was primarily driven by lower interest rates on available cash in 2024 compared to cash and bank certificates of deposit in 2023. Interest income consists of interest earned on our cash and cash equivalents and investments.
Previous report
Net cash provided by investing activities during the nine months ended September 30, 2024 was $0.0 million compared to $39.9 million provided by during the same period in 2023 related to the disposal of certificates of deposit of $39.9 million during the nine months ended September 30, 2023.
Reworded paragraphs (8)
Previous wording
We are a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States market. Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), prevention of acute respiratory distress syndrome (ARDS), and Long COVID, and MN-001 (tipelukast) for fibrotic and other diseases such as nonalcoholic fatty liver disease (NAFLD) and idiopathic pulmonary fibrosis (IPF). Our pipeline also includes MN-221 (bedoradrine) for the treatment of acute exacerbation of asthma and MN-029 (denibulin) for solid tumor cancers. We were incorporated in Delaware in September 2000.
Current wording
We are a biopharmaceutical company focused on developing novel therapeutics for the treatment of serious diseases with unmet medical needs and a commercial focus on the United States (U.S.) market. Our current strategy is to focus our development activities on MN-166 (ibudilast) for neurological and other disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), chemotherapy-induced peripheral neuropathy, degenerative cervical myelopathy, glioblastoma, substance dependence and addiction (e.g., methamphetamine dependence, opioid dependence, and alcohol dependence), prevention of acute respiratory distress syndrome (ARDS), and Long COVID, and MN-001 (tipelukast) for fibrotic and other metabolic disorders such as nonalcoholic fatty liver disease (NAFLD) and hypertriglycedemia. We were incorporated in Delaware in September 2000.
Previous wording
We have incurred significant net losses since our inception. As of September 30, 2024, from inception, our accumulated deficit was $423.9 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Current wording
We have incurred significant net losses since our inception. As of March 31, 2025, from inception, our accumulated deficit was $429.6 million. We expect to incur substantial net losses for the next several years as we continue to develop certain of our existing product development programs, and over the long-term if we expand our research and development programs and acquire or in-license products, technologies or businesses that are complementary to our own.
Previous wording
We develop and maintain relationships with pharmaceutical companies that are therapeutic category leaders. We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as MN-166 (ibudilast), MN-001 (tipelukast), MN-221 (bedoradrine), and MN-029 (denibulin), which could support our clinical development and product commercialization.
Current wording
We develop and maintain relationships with pharmaceutical companies that are therapeutic category leaders. We intend to discuss strategic alliances with leading pharmaceutical companies who seek product candidates, such as MN-166 (ibudilast) and MN-001 (tipelukast), which could support our clinical development and product commercialization.
Previous wording
Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting estimates, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” contained in our Annual Report on Form 10-K, for the year ended December 31, 2023. There have not been any material changes to the critical accounting policies discussed therein during the nine months ended September 30, 2024.
Current wording
Our critical accounting policies are those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. For a description of our critical accounting estimates, please see the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Critical Accounting Estimates” contained in our Annual Report on Form 10-K, for the year ended December 31, 2024. There have not been any material changes to the critical accounting policies discussed therein during the three months ended March 31, 2025.
Previous wording
Interest income was $0.4 million and $0.4 million for the three months ended September 30, 2024 and 2023, respectively. Interest income consists of interest earned on our cash and cash equivalents and investments.
Current wording
Interest income was $0.3 million and $0.4 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $0.1 million was primarily driven by a decrease in our cash balance generating interest. Interest income consists of interest earned on our cash and cash equivalents and investments.
Previous wording
Net cash used in operating activities during the nine months ended September 30, 2024 was $8.7 million compared to $6.9 million during the same period in 2023. The $1.8 million change is primarily related to the increase in prepaid expenses and other assets for those periods, combined with a larger net loss primarily due to no revenues during the nine months ended September 30, 2024.
Current wording
Net cash used in operating activities during the three months ended March 31, 2025 was $3.8 million compared to $3.9 million during the same period in 2024. The $0.1 million change is primarily related to the increasednet loss and changes in operating assets and liabilities for those periods.
Previous wording
As of September 30, 2024, we had available cash and cash equivalents of $42.3 million and working capital of $40.7 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through the end of 2025. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.
Current wording
As of March 31, 2025, we had available cash and cash equivalents of $36.6 million and working capital of $35.5 million. As of the date of this report, we believe we have working capital sufficient to fund operations at least through May 2026. However, we cannot provide assurance that these capital resources will be sufficient to conduct all our research and development programs as planned.
Previous wording
No shares of common stock were sold under the ATM Agreement in the three and nine months ended September 30, 2024 and 2023.
Current wording
No shares of common stock were sold under the ATM Agreement in the three months ended March 31, 2025 and 2024.