Minerva Neurosciences 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
NERV$2.42+5.2%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 2024-11-05.
0000950170-24-121063
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.
0000950170-25-069780
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 79 previous paragraphs and 80 current paragraphs.
50 unchanged; 12 reworded; 16 added; 16 removed; 1 previous and 2 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 (16)
Current report
Recent Developments
Current report
Nasdaq Listing Requirement Compliance Notice
Current report
On March 17, 2025, we were formally notified that the Nasdaq Hearings Panel, or the Panel, of the Nasdaq Stock Market LLC, or Nasdaq, determined that we have regained compliance with Nasdaq Listing Rule 5550(b)(3), which requires listed companies to maintain a minimum of $500,000 of net income from continuing operations. Pursuant to Nasdaq Listing Rule 5815(d)(4)(A), we will be subject to a discretionary panel monitor for a period of one year from March 17, 2025. If, within that one-year monitoring period, we fail to maintain compliance with any Nasdaq continued listing requirement, the Listing Qualifications Staff of Nasdaq, or the Staff, will issue a Delist Determination Letter, and we will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to any deficiency that arises during the one-year monitoring period, and the Staff will not be permitted to grant additional time for us to regain compliance with respect to any deficiency.
Current report
There can be no assurance that the Company will be able to maintain compliance with Nasdaq’s listing standards or that the Company will be able to continue its listing on Nasdaq.
Current report
Complete Response Letter (CRL)
Current report
Macroeconomic Considerations
Current report
Results of our operations have varied and may vary in the future based on the impact of changes in the domestic or global economy. Negative conditions in the general economy both in the United States and abroad, including conditions resulting from changes in inflation and fluctuations in interest rates, financial and credit market fluctuations, international trade relations and tariffs, pandemics, political turmoil, natural catastrophes and warfare in the United States or elsewhere, could negatively affect our business. It is not possible at this time to estimate the long-term impact that these and related events could have on our business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Investment Income
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Foreign Exchange (Losses) Gains
Current report
Investment Income
Current report
Non-cash interest expense for the sale of future royalties was zero and $2.3 million for the three months ended March 31, 2025 and 2024, respectively, a decrease of $2.3 million. The decrease in non-cash interest expense for the sale of future royalties was due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of
Current report
$60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024.
Removed paragraphs (16)
Previous report
Complete Response Letter
Previous report
Phase 1b Clinical Trial (MIN-101C18)
Previous report
In the first quarter of 2024, we completed a clinical trial initiated in October 2023 to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of the co-administration of roluperidone and olanzapine in adult subjects with moderate to severe negative symptoms of schizophrenia. This clinical trial (NCT06107803) was designed to investigate the pharmacodynamic and pharmacokinetic effects and safety of the concomitant therapy of roluperidone with an established and widely used antipsychotic.
Previous report
We enrolled 17 male and female subjects with moderate to severe negative symptoms of schizophrenia for this study. Out of the 17 enrolled subjects, 13 completed all 17 days of daily dosing with roluperidone 64 mg (for 7 days) and roluperidone with olanzapine 10 mg (for 10 additional days). Two subjects withdrew consent after enrollment, one patient was discontinued due to a major protocol deviation, and one was discontinued due to a treatment-unrelated serious adverse event. Roluperidone administered concomitantly with olanzapine was generally well tolerated and no unexpected safety signals were detected, with few treatment-emergent adverse events (TEAEs) reported, most of which were mild, and all resolved without sequelae. We observed no emergent clinically significant electrocardiogram or laboratory abnormalities during the study. We observed no symptomatic worsening during the administration of roluperidone alone (7 days) or when administered in combination with olanzapine at 10 mg (10 days). The study demonstrated that pharmacokinetic interactions between the two drugs were not relevant.
Previous report
Other income consists of the gain associated with the adjustment to the carrying amount of the liability related to the sale of future royalties.
Previous report
Foreign Exchange Losses
Previous report
Non-cash interest expense for the sale of future royalties was zero and $2.1 million for the three months ended September 30, 2024 and 2023, respectively, a decrease of $2.1 million. The decrease was primarily due to the change in the effective annual interest rate of the liability related to the sale of future royalties, whereby we no longer recognize interest on the liability as the effective annual interest rate is negative.
Previous report
Other income was $26.6 million and zero for the three months ended September 30, 2024 and 2023, respectively, an increase of $26.6 million, due to the gain associated with the adjustment to the carrying amount of the liability related to the sale of future royalties.
Previous report
Comparison of Nine Months Ended September 30,2024 versus September 30, 2023
Previous report
Research and development expenses were $9.9 million and $8.0 million for the nine months ended September 30, 2024 and 2023, respectively, an increase of approximately $1.9 million. The increase in research and development expenses was primarily due to higher subcontractor fees related to costs associated with our drug substance validation campaign, and the conduct of the MIN-101C18 study, partially offset by lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.4 million and $0.7 million for the nine months ended September 30, 2024 and 2023, respectively.
Previous report
General and administrative expenses were $7.4 million and $8.0 million for the nine months ended September 30, 2024 and 2023, respectively, a decrease of approximately $0.6 million. The decrease in general and administrative expenses was primarily due to lower compensation expenses and professional service fees. Non-cash stock compensation costs included in general and administrative expenses were $0.7 million for both the nine months ended September 30, 2024 and 2023.
Previous report
Foreign Exchange Losses
Previous report
Foreign exchange losses were $12 thousand and $21 thousand for the nine months ended September 30, 2024 and 2023, respectively, an increase of $9 thousand, primarily due to currency movements.
Previous report
Non-cash interest expense for the sale of future royalties was $4.6 million and $6.1 million for the nine months ended September 30, 2024 and 2023, respectively, a decrease of $1.5 million. The decrease was primarily due to the change in the effective annual interest rate of the liability related to the sale of future royalties, whereby we no longer recognize interest on the liability as the effective annual interest rate is negative.
Previous report
Other income was $26.6 million and zero for the nine months ended September 30, 2024 and 2023, respectively, an increase of $26.6 million, due to the gain associated with the adjustment to the carrying amount of the liability related to the sale of future royalties.
Previous report
Net cash provided by financing activities of approximately $19.6 million during the nine months ended September 30, 2023 was primarily due to the net proceeds from our Private Placement closed in June 2023.
Reworded paragraphs (12)
Previous wording
We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have incurred significant operating losses since inception and expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future in connection with the clinical and regulatory activities associated with advancing our product candidates. As of September 30, 2024 and December 31, 2023, we had an accumulated deficit of $391.1 million and $396.8 million, respectively. For the nine months ended September 30, 2024 and 2023, we recorded net income of $5.7 million and a net loss of $21.0 million, respectively.
Current wording
We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have incurred significant operating losses since inception and expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future in connection with the clinical and regulatory activities associated with advancing our product candidates. As of March 31, 2025 and December 31, 2024, we had an accumulated deficit of $399.1 million and $395.4 million, respectively. For the three months ended March 31, 2025 and 2024, we recorded net losses of $3.8 million and $8.6 million, respectively.
Previous wording
Research and development expenses were $1.9 million and $3.4 million for the three months ended September 30, 2024 and 2023, respectively, a decrease of approximately $1.5 million. The decrease in research and development expenses was primarily due to lower costs associated with the FDA’s review of our NDA for roluperidone and lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.1 million and $0.2 million for the three months ended September 30, 2024 and 2023, respectively.
Current wording
Research and development expenses were $1.4 million and $4.2 million for the three months ended March 31, 2025 and 2024, respectively, a decrease of approximately $2.8 million. The decrease in research and development expenses was primarily due to costs associated with the FDA’s review of our NDA for roluperidone, costs for the C18 study, and lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.1 million and $0.2 million for the three months ended March 31, 2025 and 2024, respectively.
Previous wording
General and administrative expenses were $2.5 million and $2.6 million for the three months ended September 30, 2024 and 2023, respectively, a decrease of approximately $0.1 million. The decrease in general and administrative expenses was primarily due to lower compensation expenses. Non-cash stock compensation costs included in general and administrative expenses were $0.2 million for both the three months ended September 30, 2024 and 2023.
Current wording
General and administrative expenses were $2.5 million for both the three months ended March 31, 2025 and 2024. Non-cash stock compensation costs included in general and administrative expenses were $0.2 million also for both the three months ended March 31, 2025 and 2024.
Previous wording
Foreign exchange losses were $13 thousand and $5 thousand for the three months ended September 30, 2024 and 2023, respectively, a decrease of $8 thousand, primarily due to currency movements.
Current wording
Foreign exchange losses were $8 thousand and foreign exchange gains were $5 thousand for the three months ended March 31, 2025 and 2024, respectively, a decrease of $13 thousand, primarily due to currency movements.
Previous wording
Investment income was $314 thousand and $349 thousand for the three months ended September 30, 2024 and 2023, respectively, a decrease of approximately $35 thousand, primarily due to cash and cash equivalents balances and interest rates.
Current wording
Investment income was $158 thousand and $358 thousand for the three months ended March 31, 2025 and 2024, respectively, a decrease of approximately $200 thousand, primarily due to cash and cash equivalents balances and interest rates.
Previous wording
As of September 30, 2024, we had an accumulated deficit of approximately $391.1 million. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the development and potential commercialization of our product candidates and to support our operations as a public company. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we may never generate product revenue or achieve profitability. As of September 30, 2024, we had approximately $26.6 million in cash, cash equivalents, and restricted cash, which we believe will be sufficient to meet our operating commitments for the next 12 months from the date our financial statements are issued. Our cash requirements primarily relate to expenditures to support the development of roluperidone, which includes advancing the program through the regulatory process.
Current wording
As of March 31, 2025, we had an accumulated deficit of approximately $399.1 million. We anticipate that we will continue to incur net losses for the foreseeable future as we continue the development and potential commercialization of our product candidates and to support our operations as a public company. We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we may never generate product revenue or achieve profitability. As of March 31, 2025, we had approximately $17.4 million in cash, cash equivalents, and restricted cash, which we believe will be sufficient to meet our operating commitments for the next 12 months from the date our financial statements are issued. Our cash requirements primarily relate to expenditures to support the development of roluperidone, which includes advancing the program through the regulatory process.
Previous wording
During the nine months ended September 30, 2024, no shares of our common stock were issued or sold under the Sales Agreement. As of September 30, 2024, an aggregate of $22.6 million was eligible for sale pursuant to the Sales Agreement under our effective registration statement on Form S-3 (File No. 333-267424).
Current wording
During the three months ended March 31, 2025, no shares of our common stock were issued or sold under the Sales Agreement. As of March 31, 2025, an aggregate of $22.6 million was eligible for sale pursuant to the Sales Agreement under our effective registration statement on Form S-3 (File No. 333-267424).
Previous wording
Net cash used in operating activities of approximately $14.4 million during the nine months ended September 30, 2024 was primarily due to our net income of $5.7 million, non-cash interest expense for the sale of future royalties of $4.6 million, a $2.4 million increase in accrued expenses and stock-based compensation expense of $1.1 million, offset by the adjustment to the carrying amount of the liability related to the sale of future royalties of $26.6 million, a $1.3 million decrease in accounts payable and a $0.3 million increase in prepaid expenses.
Current wording
Net cash used in operating activities of approximately $4.1 million during the three months ended March 31, 2025 was primarily due to our net loss of $3.8 million, and a $1.0 million decrease in accounts payable, partially offset by stock-based compensation expense of $0.3 million, a $0.3 million decrease in prepaid expenses, and a $0.1 million increase in accrued expenses.
Previous wording
Net cash used in operating activities of approximately $8.8 million during the nine months ended September 30, 2023 was primarily due to our net loss of $21.0 million and a $0.4 million increase in prepaid expenses, partially offset by non-cash interest expense for the sale of future royalties of $6.1 million, a $3.1 million decrease in refundable regulatory fees, a $1.5 million increase in accrued expenses, stock-based compensation expense of $1.4 million, and an approximately $0.5 million increase in accounts payable.
Current wording
Net cash used in operating activities of approximately $6.1 million during the three months ended March 31, 2024 was primarily due to our net loss of $8.6 million, a $0.4 million decrease in accounts payable, and a $0.1 million decrease in accrued expenses, partially offset by non-cash interest expense for the sale of future royalties of $2.3 million, stock-based compensation expense of $0.4 million, and a $0.3 million decrease in prepaid expenses.
Previous wording
Net cash provided by investing activities was zero during the nine months ended September 30, 2024 and 2023.
Current wording
Net cash provided by investing activities was zero during the three months ended March 31, 2025 and 2024.
Previous wording
Net cash provided by financing activities was zero during the nine months ended September 30, 2024.
Current wording
Net cash provided by financing activities was zero during the three months ended March 31, 2025 and 2024.
Previous wording
In our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, our most critical accounting policies and estimates upon which our financial status depends were identified as those relating to research and development costs; in-process research and development; goodwill; income taxes; and the liability related to the sale of future royalties. We reviewed our policies and determined that those policies were our most critical accounting policies for the nine months ended September 30, 2024.
Current wording
In our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our most critical accounting policies and estimates upon which our financial status depends were identified as those relating to research and development costs; goodwill; and the liability related to the sale of future royalties. We reviewed our policies and determined that those policies were our most critical accounting policies for the three months ended March 31, 2025.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Non-Cash Interest Expense for the Sale of Future Royalties
Current report — wording carried from elsewhere
Non-cash interest expense for the sale of future royalties
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Investment income was $1.0 million and $1.1 million for the nine months ended September 30, 2024 and 2023, respectively, a decrease of approximately $0.1 million, primarily due to cash and cash equivalents balances and interest rates.