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

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 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.

Previous wording

Research and development expenses were $3.9 million and $1.9 million for the three months ended June 30, 2024 and 2023, respectively, an increase of approximately $2.0 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, partially offset by lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.1 million and $0.3 million for the three months ended June 30, 2024 and 2023, respectively.

Current 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.

Previous 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.

Current 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.

Previous wording

Foreign exchange losses were $5 thousand and $7 thousand for the three months ended June 30, 2024 and 2023, respectively, a decrease of $2 thousand, primarily due to currency movements.

Current 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.

Previous 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.

Current 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.

Previous wording

Comparison of Six Months Ended June 30,2024 versus June 30, 2023

Current wording

Comparison of Nine Months Ended September 30,2024 versus September 30, 2023

Previous 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.

Current wording

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 wording

General and administrative expenses were $4.9 million and $5.3 million for the six months ended June 30, 2024 and 2023, respectively, a decrease of approximately $0.4 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 $0.5 million for both the six months ended June 30, 2024 and 2023.

Current wording

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 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.

Current wording

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 wording

Investment income was $719 thousand and $730 thousand for the six months ended June 30, 2024 and 2023, respectively, a decrease of approximately $11 thousand, primarily due to cash and cash equivalents balances and interest rates.

Current wording

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.

Previous 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.

Current 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.

Previous 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).

Current 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).

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, including the recent disruptions to and volatility in the credit and financial markets in the U.S. and worldwide resulting from the COVID-19 pandemic, 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. 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.

Previous 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.

Current 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.

Previous 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.

Current 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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

Net cash provided by financing activities was zero during the nine months ended September 30, 2024.

Previous wording

Net cash provided by financing activities of approximately $19.7 million during the six months ended June 30, 2023 was primarily due to the net proceeds from our Private Placement closed in June 2023.

Current wording

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.

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 six months ended June 30, 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 nine months ended September 30, 2024.