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 regarding our NDA for roluperidone.

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. Since receiving the CRL, we have continued to have interactions with the FDA with the goal of addressing questions raised in the CRL.

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, 2024 and December 31, 2023, we had an accumulated deficit of $405.4 million and $396.8 million, respectively. For the three months ended March 31, 2024 and 2023, we recorded net losses of $8.6 million and $7.0 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 June 30, 2024 and December 31, 2023, we had an accumulated deficit of $413.6 million and $396.8 million, respectively. For the six months ended June 30, 2024 and 2023, we recorded net losses of $16.8 million and $13.2 million, respectively.

Previous wording

On February 26, 2024, the FDA issued a Complete Response Letter (“CRL”) to our NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies:

Current wording

On February 26, 2024, the FDA issued a CRL to our NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies:

Previous wording

We enrolled 17 patients for this study who received at least one dose of roluperidone at 64 mg. Out of the 17 patients enrolled, 13 patients completed all 17 days of daily dosing. Two patients 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. We observed no new safety signals during the study, with few treatment-emergent adverse events (TEAEs), 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.

Current wording

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 wording

General and administrative expenses were $2.5 million and $2.7 million for the three months ended March 31, 2024 and 2023, respectively, a decrease of approximately $0.2 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 March 31, 2024 and 2023.

Current wording

General and administrative expenses were $2.4 million and $2.6 million for the three months ended June 30, 2024 and 2023, respectively, a decrease of approximately $0.2 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 and $0.3 million for the three months ended June 30, 2024 and 2023, respectively.

Previous wording

Investment income was $358 thousand and $364 thousand for the three months ended March 31, 2024 and 2023, respectively, a decrease of approximately $6 thousand, primarily due to cash and cash equivalents balances and interest rates.

Current wording

Investment income was $361 thousand and $366 thousand for the three months ended June 30, 2024 and 2023, respectively, a decrease of approximately $5 thousand, primarily due to cash and cash equivalents balances and interest rates.

Previous wording

Research and development expenses were $4.2 million and $2.7 million for the three months ended March 31, 2024 and 2023, respectively, an increase of approximately $1.5 million. The increase in research and development expenses was primarily due to costs associated with the FDA’s review of our NDA and the conduct of the MIN-101C18 study. Non-cash stock compensation costs included in research and development expenses were $0.2 million for both the three months ended March 31, 2024 and 2023.

Current wording

Research and development expenses were $8.0 million and $4.5 million for the six months ended June 30, 2024 and 2023, respectively, an increase of approximately $3.5 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. Non-cash stock compensation costs included in research and development expenses were $0.3 million and $0.5 million for the six months ended June 30, 2024 and 2023, respectively.

Previous wording

Foreign exchange gains were $5 thousand and foreign exchange losses were $9 thousand for the three months ended March 31, 2024 and 2023, respectively, an increase of $14 thousand, primarily due to currency movements.

Current wording

Foreign exchange gains were $1 thousand and foreign exchange losses were $16 thousand for the six months ended June 30, 2024 and 2023, respectively, an increase of $17 thousand, primarily due to currency movements.

Previous wording

As of March 31, 2024, we had an accumulated deficit of approximately $405.4 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 March 31, 2024, we had approximately $34.9 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, 2024, we had an accumulated deficit of approximately $413.6 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, 2024, we had approximately $31.0 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 three months ended March 31, 2024, no shares of our common stock were issued or sold under the Sales Agreement. As of March 31, 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 six months ended June 30, 2024, no shares of our common stock were issued or sold under the Sales Agreement. As of June 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).

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 used in operating activities of approximately $0.1 million during the three months ended March 31, 2023 was primarily due to our net loss of $7.0 million, partially offset by a $3.1 million decrease in refundable regulatory fees, non-cash interest expense for the sale of future royalties of $2.0 million, an increase in accrued expenses of $1.1 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 $4.0 million during the six months ended June 30, 2023 was primarily due to our net loss of $13.2 million and an approximately $0.6 million decrease in accounts payable, partially offset by non-cash interest expense for the sale of future royalties of $4.0 million, a $3.1 million decrease in refundable regulatory fees, a $1.2 million increase in accrued expenses, stock-based compensation expense of $1.0 million, and a $0.5 million decrease in prepaid expenses.

Previous wording

Net cash provided by investing activities was zero during the three months ended March 31, 2024 and 2023.

Current wording

Net cash provided by investing activities was zero during the six months ended June 30, 2024 and 2023.

Previous wording

Net cash provided by financing activities was zero during the three months ended March 31, 2024 and 2023.

Current wording

Net cash provided by financing activities was zero during the six months ended June 30, 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 three months ended March 31, 2024.

Current 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 six months ended June 30, 2024.