Minerva Neurosciences, Inc.

Previous wording

In August 2022, we submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for our lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia. On February 26, 2024, the FDA issued a Complete Response Letter (“CRL”) regarding our NDA for roluperidone. Since receiving the CRL, we have continued to have interactions with the FDA with the goal of addressing the questions raised in the CRL.

Current wording

In August 2022, we submitted a New Drug Application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) for our lead product candidate, roluperidone, for the treatment of negative symptoms in schizophrenia. On February 26, 2024, the FDA issued a Complete Response Letter (“CRL”) regarding our NDA for roluperidone. We have had multiple interactions with the FDA following receipt of the CRL for our NDA in February 2024 and the FDA has confirmed the requirement for an additional confirmatory clinical trial to address the deficiencies cited in the CRL and resubmit the NDA.

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 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.

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 June 30, 2025 and December 31, 2024, we had an accumulated deficit of $402.4 million and $395.4 million, respectively. For the six months ended June 30, 2025 and 2024, we recorded net losses of $7.0 million and $16.8 million, respectively.

Previous wording

Foreign exchange gains (losses) are comprised primarily of gains and (losses) on foreign currency transactions primarily related to research and development expenses. We incur certain expenses, primarily in Euros, and record these expenses in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date that an expense is recorded and the payment date is recorded as a foreign currency gain or (loss).

Current wording

Foreign exchange (losses) gains are comprised primarily of gains and (losses) on foreign currency transactions primarily related to research and development expenses. We incur certain expenses, primarily in Euros, and record these expenses in United States Dollars at the time the liability is incurred. Changes in the applicable foreign currency rate between the date that an expense is recorded and the payment date is recorded as a foreign currency gain or (loss).

Previous 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.

Current wording

General and administrative expenses were $2.1 million and $2.4 million for the three months ended June 30, 2025 and 2024, respectively, a decrease of approximately $0.3 million. The decrease in general and administrative expenses was primarily due to lower professional service fees. Non-cash stock compensation costs included in general and administrative expenses were $0.2 million for both the three months ended June 30, 2025 and 2024.

Previous 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.

Current wording

Investment income was $137 thousand and $361 thousand for the three months ended June 30, 2025 and 2024, respectively, a decrease of approximately $224 thousand, primarily due to cash and cash equivalents balances and interest rates.

Previous wording

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 wording

Non-cash interest expense for the sale of future royalties was zero and $2.3 million for the three months ended June 30, 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 $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.

Previous 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.

Current wording

Research and development expenses were $2.7 million and $8.0 million for the six months ended June 30, 2025 and 2024, respectively, a decrease of approximately $5.3 million. The decrease in research and development expenses was primarily due to lower costs associated with our drug substance validation campaign, costs for the C18 study, consultant fees, and lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.2 million and $0.3 million for the six months ended June 30, 2025 and 2024, respectively.

Previous 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.

Current wording

Foreign exchange losses were $29 thousand and foreign exchange gains were $1 thousand for the six months ended June 30, 2025 and 2024, respectively, a decrease of $30 thousand, primarily due to currency movements.

Previous 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.

Current wording

As of June 30, 2025, we had an accumulated deficit of approximately $402.4 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 June 30, 2025, we had cash, cash equivalents, and restricted cash of $15.3 million. Given the cash, cash equivalents, and restricted cash balance as of June 30, 2025, along with the current projections of cash to be used for operations, we believe that our existing cash, cash equivalents, and restricted cash will not be sufficient to fund our operating expenses and capital requirements. However, management has the ability to mitigate this condition through cost reduction initiatives. Based on the implementation of these initiatives, we believe we will have sufficient liquidity to meet our obligations for at least twelve months from the date that our interim condensed financial statements are issued.

Previous 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).

Current wording

During the six months ended June 30, 2025, no shares of our common stock were issued or sold under the Sales Agreement. As of June 30, 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

Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Additional debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. There can be no assurance that such additional funding, if available, can be obtained on terms acceptable to us, and our ability to raise additional capital may be adversely impacted by global economic conditions, geopolitical conflicts, such as the war in Ukraine and hostilities in the Middle East, and other factors. If we are unable to obtain additional financing, future operations would need to be scaled back or discontinued. We believe that our existing cash, cash equivalents, and restricted cash will be sufficient to meet our cash commitments for at least the next 12 months after the date that the financial statements are issued. The timing of future capital requirements depends upon many factors including the size and timing of future clinical trials, the timing and scope of any strategic partnering activity and the progress of other research and development activities.

Current wording

Until such time, if ever, as we can generate substantial revenue from product sales, we expect to finance our cash needs through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements and other collaborations, strategic alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Additional debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through government or other third party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. There can be no assurance that such additional funding, if available, can be obtained on terms acceptable to us, and our ability to raise additional capital may be adversely impacted by global economic conditions, geopolitical conflicts, such as the war in Ukraine and hostilities in the Middle East, and other factors. If we are unable to obtain additional financing, future operations would need to be scaled back or discontinued. The timing of future capital requirements depends upon many factors including the size and timing of future clinical trials, the timing and scope of any strategic partnering activity and the progress of other research and development activities.

Previous 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.

Current wording

Net cash used in operating activities of approximately $6.1 million during the six months ended June 30, 2025 was primarily due to our net loss of $7.0 million and a $0.7 million decrease in accounts payable, partially offset by stock-based compensation expense of $0.6 million, a $0.6 million decrease in prepaid expenses, and a $0.4 million increase in accrued expenses.

Previous 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.

Current wording

Net cash used in operating activities of approximately $10.0 million during the six months ended June 30, 2024 was primarily due to our net loss of $16.8 million and a $1.0 million decrease in accounts payable, partially offset by non-cash interest expense for the sale of future royalties of $4.6 million, a $1.8 million increase in accrued expenses, stock-based compensation expense of $0.8 million, and a $0.6 million decrease in prepaid expenses.

Previous wording

Net cash provided by investing activities was zero during the three months ended March 31, 2025 and 2024.

Current wording

Net cash provided by investing activities was zero during the six months ended June 30, 2025 and 2024.

Previous wording

Net cash provided by financing activities was zero during the three months ended March 31, 2025 and 2024.

Current wording

Net cash provided by financing activities was zero during the six months ended June 30, 2025 and 2024.

Previous 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.

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 six months ended June 30, 2025.

Previous wording

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and are adopted by us as of the specified effective date. See Note 2 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Note 2 in our condensed consolidated financial statements appearing elsewhere in this Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements. We believe that the impact of recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the condensed consolidated financial statements or do not apply to our operations.

Current wording

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board and are adopted by us as of the specified effective date. See Note 2 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and Note 2 in our condensed consolidated financial statements appearing elsewhere in this Form 10-Q for a description of recent accounting pronouncements applicable to our financial statements. We believe that the impact of recently issued, but not yet adopted, accounting pronouncements will not have a material impact on the condensed consolidated financial statements or do not apply to our operations.