Minerva Neurosciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 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.
Sep 30, 2025 · Filed Nov 5, 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 2025-06-30; filed 2025-08-14.
0000950170-25-108840
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-265685
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 78 previous paragraphs and 77 current paragraphs.
37 unchanged; 25 reworded; 15 added; 16 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 (15)
Current report
Recent Developments
Current report
On October 21, 2025, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain accredited investors, pursuant to which we agreed to issue and sell, in a private placement (the “Private Placement”), (i) 80,000 shares of Series A Convertible Preferred Stock, par value $0.0001 per share (“Series A Preferred Stock”), at a purchase price of $1,000 per share, (ii) tranche A warrants (the “Preferred Tranche A Warrants”) to acquire shares of Series A Preferred Stock (the “Tranche A Warrant Shares”) and (iii) tranche B warrants (the “Preferred Tranche B Warrants,” together with the Preferred Tranche A Warrants, the “Preferred Warrants”) to acquire shares of Series A Preferred Stock for an aggregate offering price of up to $200 million. The closing of the Private Placement took place on October 23, 2025.
Current report
The gross proceeds of the Private Placement are estimated to be up to approximately $200 million, before deducting fees paid to the placement agent of the Private Placement and other estimated offering expenses payable by us, including initial upfront gross proceeds of $80 million in exchange for shares of the Series A Preferred Stock, up to an additional $80 million in gross proceeds if all Preferred Tranche A Warrants are exercised, subject to the terms and conditions specified therein, and up to an additional $40 million in gross proceeds if all Preferred Tranche B Warrants are exercised by cash payment upon the achievement of certain milestone event.
Current report
This private placement followed our announcement in August 2025 of our alignment with the FDA on the design of a confirmatory Phase 3 trial of roluperidone. We expect the net proceeds of this private placement will be sufficient to fund the confirmatory Phase 3 trial of roluperidone and our resubmission of our NDA, to prepare for a potential commercial launch of roluperidone in the U.S., if approved, and for working capital and general corporate purposes.
Current 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.
Current report
Other income was zero and $26.6 million for the three months ended September 30, 2025 and 2024, respectively, a decrease of $26.6 million, due to recognizing other income in the third quarter of 2024 as a result of the adjustment to the carrying amount of the liability related to the sale of future royalties.
Current report
Other income was zero and $26.6 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of $26.6 million, due to recognizing other income in the third quarter of 2024 as a result of the adjustment to the carrying amount of the liability related to the sale of future royalties.
Current report
Private Placement
Current report
On October 21, 2025, we entered into the Securities Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue and sell, in the Private Placement, (i) 80,000 shares of Series A Convertible Preferred Stock, at a purchase price of $1,000 per share, (ii) Preferred Tranche A Warrants to acquire shares of Series A Preferred Stock and (iii) Preferred Tranche B Warrants to acquire shares of Series A Preferred Stock for an aggregate offering price of up to $200 million. The closing of the Private Placement took place on October 23, 2025 (the “Closing Date”).
Current report
Pursuant to the Certificate of Designation of Preferences, Rights and Limitations of the Series A Convertible Voting Preferred Stock (the “Certificate of Designation”), each share of Series A Preferred Stock is, subject to the stockholder approval and certain beneficial ownership conversion limitations, automatically convertible into shares of common stock, par value $0.0001 per share, of the Company.
Current report
Each Preferred Tranche A Warrant has an exercise price of $1,000 and may only be exercised for cash. The Preferred Tranche A Warrants are immediately exercisable for an aggregate of 80,000 shares of Series A Preferred Stock for an aggregate cash exercise price of $80 million until the tenth day following the date of our public announcement that we have achieved, on a statistically significant basis, the primary endpoint of our Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week timepoint (the “Milestone Event”).
Current report
Each Preferred Tranche B Warrant has an exercise price of $1,000 and may be exercised by a cashless exercise. The Preferred Tranche B Warrants are exercisable for an aggregate of 40,000 shares of Series A Preferred Stock for an aggregate cash exercise price of $40 million commencing on the earlier of (i) our public announcement of the Milestone Event and (ii) the three year anniversary of the Closing Date. The Preferred Tranche B Warrants will expire on the four (4)-year anniversary of the Closing Date.
Current report
The Preferred Warrants are subject to forfeiture in the event the applicable investor engages in any short sales involving our securities during the 48-months period following the Closing Date. In addition, the Tranche B Warrant Shares are subject to reduction if the applicable investor sells or transfers any shares of Series A Preferred Stock or shares of our common stock received upon conversion of the Series A Preferred Stock, except to affiliates for no consideration.
Current report
Subject to the terms and limitations contained in the Certificate of Designation, the Series A Preferred Stock issued in the Private Placement will not become convertible until our stockholders approve the issuance of all common stock issuable upon conversion of the Series A Preferred Stock and the Preferred Warrants Shares (the “Stockholder Approval”). On the first (1st) trading day following the announcement of the Stockholder Approval, each share of Series A Preferred Stock shall automatically convert into the number of shares of common stock, at the conversion price of $2.11 per share, rounded down to the nearest whole share, subject to the terms and limitations contained in the Certificate of Designation, including that shares of Series A Preferred Stock shall not be convertible if the conversion would result in a holder beneficially owning more than 9.99% of outstanding shares of our common stock as of the applicable conversion date.
Current report
Net cash used in financing activities of approximately $0.1 million during the nine months ended September 30, 2025 was primarily due to fees paid in connection with the private placement.
Removed paragraphs (16)
Previous report
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases. Leveraging our scientific insights and clinical experience, we have acquired or in-licensed compounds that we believe have innovative mechanisms of actions and therapeutic profiles that potentially address the unmet needs of patients with these diseases.
Previous report
The trial’s potential sole key secondary endpoint would be the comparison of the change from Baseline in the Personal and Social Performance scale total score (“PSP”) to Week 12, which is a scale to assess patients’ social functioning. The trial will also potentially measure the change from Baseline in Clinical Global Impression of Severity (“CGI-S”), change from Baseline in NSFS, PSP, and CGI-S at earlier timepoints and safety & tolerability.
Previous report
The FDA has agreed that an adjunctive trial with antipsychotics would not be required for resubmission of the NDA if we could provide robust, controlled data demonstrating the efficacy and safety of long-term monotherapy with roluperidone in subjects with negative symptoms of schizophrenia.
Previous report
Review of Strategic Alternatives
Previous report
As a result of the requirement for the confirmatory study and our current cash position, we are taking additional steps to reduce costs. We have also initiated a review process to explore strategic alternatives to maximize value for our stockholders. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. We do not intend to discuss or disclose further developments regarding the exploration of strategic alternatives unless and until our board of directors has approved a definitive action or otherwise determined that further disclosure is appropriate or required by law.
Previous report
Complete Response Letter (CRL)
Previous report
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 report
Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness.
Previous report
The NDA submission lacks data on concomitant antipsychotic administration.
Previous report
The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.
Previous report
The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
Previous report
To address these deficiencies, the FDA stated that we must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms. We must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support the observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.
Previous report
In addition to the clinical deficiencies described above, the FDA also provided comments on, among other items, clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues.
Previous report
Foreign Exchange (Losses) Gains
Previous report
Foreign Exchange Losses
Previous report
Foreign Exchange (Losses) Gains
Reworded paragraphs (25)
Previous wording
You should read the following discussion of our financial condition and results of operations in conjunction with our condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our annual audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the Securities and Exchange Commission on February 25, 2025. This discussion and analysis contains forward-looking statements that involve significant risks and uncertainties. Our actual results, performance or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
You should read the following discussion of our financial condition and results of operations in conjunction with our condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our annual audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the Securities and Exchange Commission (“SEC”) on February 25, 2025. This discussion and analysis contains forward-looking statements that involve significant risks and uncertainties. Our actual results, performance or experience could differ materially from what is indicated by any forward-looking statement due to various important factors, risks and uncertainties, including, but not limited to, those set forth under “Risk Factors” included elsewhere in this Quarterly Report on Form 10-Q.
Previous wording
We are developing roluperidone for the treatment of negative symptoms in patients with schizophrenia and have exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson’s disease. In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”), for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). In June 2020, we exercised our right to opt out of our agreement with Janssen for the Phase 3 development of seltorexant and as a result, we were entitled to collect royalties in the mid-single digits on potential future worldwide sales of seltorexant in certain indications, with no further financial obligations to Janssen. In January 2021, we sold our rights to these potential royalties to Royalty Pharma plc (“Royalty Pharma”) for a $60 million cash payment and up to an additional $95 million in potential future milestone payments, subject to completion of Phase 3 trials by Janssen and regulatory approvals.
Current wording
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases. We are currently developing roluperidone for the treatment of negative symptoms in patients diagnosed with schizophrenia. In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV (“Janssen”), a subsidiary of Johnson & Johnson, for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). As a result of our collaboration with Janssen, we were entitled to collect royalties in the mid-single digits on potential future worldwide sales of seltorexant in certain indications, with no further financial obligations to Janssen. In January 2021, we sold our rights to these potential royalties to Royalty Pharma plc (“Royalty Pharma”) for a $60 million cash payment and up to an additional $95 million in potential future milestone payments, subject to completion of Phase 3 trials by Janssen and regulatory approvals. To our knowledge, Janssen is currently recruiting patients under a Phase 3 trial with seltorexant.
Previous wording
As in the two previous studies (C03 and C07), the required confirmatory clinical trial would include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms. Patients would be selected based on stable positive symptoms and impairing negative symptoms for the six months prior to entering the trial. We agreed with the FDA that best efforts will be made to secure 25-30% of patients from the United States (subject to competitive recruitment). The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. The FDA has also confirmed that, the primary endpoint would be the change from Baseline in PANSS Marder negative symptoms factor score (“NSFS”) at 12 weeks of treatment with roluperidone compared to placebo. The FDA advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks, in patients treated in monotherapy with roluperidone, placebo or antipsychotics. The FDA has stated that it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks.
Current wording
As in the two previous clinical trials of roluperidone (C03 and C07), the confirmatory trial will include patients diagnosed with schizophrenia who present with stable impairing negative symptoms and stable positive symptoms for the six months prior to entering the trial. We agreed with the FDA that best efforts will be made to secure 25-30% of patients from the United States, subject to competitive recruitment. The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. The FDA has also confirmed that, the sole primary endpoint to assess efficacy would be the change from Baseline in PANSS Marder negative symptoms factor score (“NSFS”) at 12 weeks of treatment with roluperidone compared to placebo. The FDA advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks, in patients treated in monotherapy with roluperidone, placebo or antipsychotics. The FDA has stated that it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks with the efficacy primary endpoint at week 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 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.
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. As of September 30, 2025 and December 31, 2024, we had an accumulated deficit of $405.1 million and $395.4 million, respectively. For the nine months ended September 30, 2025 and 2024, we recorded net loss of $9.8 million and a net income of $5.7 million, respectively. We expect our clinical and administrative costs will increase as we begin to incur clinical trial costs and hire additional support staff to support the Phase 3 trial of roluperidone.
Previous 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).
Current wording
Foreign exchange losses are comprised primarily of 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 (loss) or gain.
Previous wording
Research and development expenses were $1.3 million and $3.9 million for the three months ended June 30, 2025 and 2024, respectively, a decrease of approximately $2.6 million. The decrease in research and development expenses was primarily due to lower costs associated with our drug substance validation campaign and lower consultant fees. Non-cash stock compensation costs included in research and development expenses were $0.1 million for both the three months ended June 30, 2025 and 2024.
Current wording
Research and development expenses were $0.9 million and $1.9 million for the three months ended September 30, 2025 and 2024, respectively, a decrease of approximately $1.0 million. The decrease in research and development expenses was primarily due to lower costs associated with our drug substance validation campaign, consultant fees, and lower compensation expenses. Non-cash stock compensation costs included in research and development expenses were $0.1 million for both the three months ended September 30, 2025 and 2024.
Previous 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.
Current wording
General and administrative expenses were $1.9 million and $2.5 million for the three months ended September 30, 2025 and 2024, respectively, a decrease of approximately $0.6 million. The decrease in general and administrative expenses was primarily due to lower professional service fees and insurance costs. Non-cash stock compensation costs included in general and administrative expenses were $0.2 million for both the three months ended September 30, 2025 and 2024.
Previous 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.
Current wording
Foreign exchange losses were $6 thousand and $13 thousand for the three months ended September 30, 2025 and 2024, respectively, a decrease of $7 thousand, primarily due to currency movements.
Previous 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.
Current wording
Investment income was $107 thousand and $314 thousand for the three months ended September 30, 2025 and 2024, respectively, a decrease of approximately $207 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 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.
Current wording
Non-cash interest expense for the sale of future royalties was zero for both the three months ended September 30, 2025 and 2024.
Previous wording
Comparison of Six Months Ended June 30,2025 versus June 30, 2024
Current wording
Comparison of Nine Months Ended September 30,2025 versus September 30, 2024
Previous 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.
Current wording
Research and development expenses were $3.6 million and $9.9 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of approximately $6.3 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 $0.3 million and $0.4 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
General and administrative expenses were $4.6 million and $4.9 million for the six 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 $0.4 million and $0.5 million for the six months ended June 30, 2025 and 2024.
Current wording
General and administrative expenses were $6.5 million and $7.4 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of approximately $0.9 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 $0.6 million and $0.7 million for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
Foreign exchange losses were $21 thousand and $5 thousand for the three months ended June 30, 2025 and 2024, respectively, an increase of $16 thousand, primarily due to currency movements.
Current wording
Foreign exchange losses were $36 thousand and $12 thousand for the nine months ended September 30, 2025 and 2024, respectively, an increase of $24 thousand, primarily due to currency movements.
Previous wording
Investment income was $295 thousand and $719 thousand for the six months ended June 30, 2025 and 2024, respectively, a decrease of approximately $424 thousand, primarily due to cash and cash equivalents balances and interest rates.
Current wording
Investment income was $0.4 million and $1.0 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of approximately $0.6 million, 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 $4.6 million for the six months ended June 30, 2025 and 2024, respectively, a decrease of $4.6 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.
Current wording
Non-cash interest expense for the sale of future royalties was zero and $4.6 million for the nine months ended September 30, 2025 and 2024, respectively, a decrease of $4.6 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
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.
Current wording
As of September 30, 2025, we had an accumulated deficit of approximately $405.1 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, 2025, we had cash, cash equivalents, and restricted cash of $12.4 million. We believe that this amount, together with the net proceeds from the Private Placement that was closed on October 23, 2025, will be sufficient to meet our operating commitments for at least twelve months from the date that our interim condensed financial statements are issued.
Previous 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).
Current wording
During the nine months ended September 30, 2025, no shares of our common stock were issued or sold under the Sales Agreement. Our Registration Statement on Form S-3 (File No. 333-267424) expired on September 23, 2025, and therefore no sales can be made under the Sales Agreement until such time as we file a new Registration Statement on Form S-3. Based on the public float of our common stock as of the date of the filing of the Annual Report on Form 10-K for the year ended December 31, 2024, we are currently subject to General Instruction I.B.6 of Form S-3 and therefore may not sell more than one-third of the market value of our common stock held by non-affiliates until our public float exceeds $75.0 million.
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. 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, together with the net proceeds from the Private Placement that was closed on October 23, 2025, 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 $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.
Current wording
Net cash used in operating activities of approximately $9.0 million during the nine months ended September 30, 2025 was primarily due to our net loss of $9.8 million and a $0.8 million decrease in accounts payable, partially offset by stock-based compensation expense of $0.9 million, a $0.5 million increase in accrued expenses, and a $0.2 million decrease in prepaid expenses.
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 provided by investing activities was zero during the six months ended June 30, 2025 and 2024.
Current wording
Net cash provided by investing activities was zero during the nine months ended September 30, 2025 and 2024.
Previous wording
Net Cash Provided by Financing Activities
Current wording
Net Cash (Used in) Provided by Financing Activities
Previous wording
Net cash provided by financing activities was zero during the six months ended June 30, 2025 and 2024.
Current wording
Net cash provided by financing activities was zero during the nine months ended September 30, 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 six months ended June 30, 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 nine months ended September 30, 2025.