Minerva Neurosciences, Inc. (NASDAQ:NERV) is a clinical-stage biopharmaceutical company focused on the development and commercialization of proprietary product candidates to treat patients suffering from central nervous system diseases. The company's lead product candidate is roluperidone, which it is developing for the treatment of negative symptoms in patients with schizophrenia.
Business Overview
Minerva has acquired or in-licensed compounds that the company believes have innovative mechanisms of action and therapeutic profiles to address the unmet needs of patients with central nervous system diseases. In addition to roluperidone, the company has exclusive rights to develop and commercialize MIN-301 for the treatment of Parkinson's disease. Minerva previously co-developed seltorexant with Janssen Pharmaceutica NV for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (MDD), but in 2020, Minerva exercised its right to opt out of the joint development agreement with Janssen for the future development of seltorexant.Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Minerva's lead product candidate, roluperidone, is being developed for the treatment of negative symptoms in patients with schizophrenia. In August 2022, the company submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for roluperidone. However, in October 2022, the FDA issued a refusal-to-file letter for the NDA, citing potential review issues. Following a Type A meeting with the FDA in November 2022, the agency confirmed the refusal-to-file decision in December 2022.In April 2023, Minerva announced that the FDA had accepted the company's NDA for roluperidone and assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. This decision followed Minerva's request for formal dispute resolution and appeal of the refusal-to-file letter. However, on February 26, 2024, the FDA issued a Complete Response Letter (CRL) to Minerva's NDA for roluperidone.
In the CRL, the FDA cited several clinical deficiencies, including: 1. The single positive study (MIN-101C03) is insufficient on its own to establish substantial evidence of effectiveness. 2. The NDA submission lacks data on concomitant antipsychotic administration. 3. The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful. 4. The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.
To address these deficiencies, the FDA stated that Minerva 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. The company 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.
Financials
Minerva has not received any regulatory approvals to commercialize any of its product candidates and has not generated any revenue from the sales or license of its product candidates. The company has incurred significant operating losses since inception and expects 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 its product candidates.As of March 31, 2023, Minerva had an accumulated deficit of $405.4 million and recorded a net loss of $8.6 million for the three months ended March 31, 2023, compared to a net loss of $7.0 million for the same period in 2022. The company's research and development expenses were $4.2 million and $2.7 million for the three months ended March 31, 2023 and 2022, 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 the NDA and the conduct of the MIN-101C18 study.
General and administrative expenses were $2.5 million and $2.7 million for the three months ended March 31, 2023 and 2022, respectively, a decrease of approximately $0.2 million. The decrease in general and administrative expenses was primarily due to lower professional service fees.
As of March 31, 2023, Minerva had approximately $34.9 million in cash, cash equivalents, and restricted cash, which the company believes will be sufficient to meet its operating commitments for the next 12 months from the date the financial statements are issued.
Liquidity
Minerva's cash requirements primarily relate to expenditures to support the development of roluperidone, which includes advancing the program through the regulatory process. The company routinely evaluates the status of its clinical development programs as well as potential strategic options and believes that it will be able to obtain additional working capital through equity financings or other arrangements to fund future operations.In June 2023, Minerva entered into a securities purchase agreement with certain institutional accredited investors, pursuant to which the company issued and sold in a private placement 1,425,000 shares of common stock at a purchase price of $10.00 per share and pre-funded warrants to purchase an aggregate of 575,575 shares of common stock at a purchase price of $9.99 per pre-funded warrant. The company received aggregate gross proceeds of $20.0 million from the private placement.
Minerva also has an at-the-market equity offering program in place, under which the company may offer and sell shares of its common stock from time to time. As of March 31, 2023, an aggregate of $22.6 million was eligible for sale pursuant to this program.
Risks and Challenges
Minerva faces several risks and challenges in its pursuit of regulatory approval and commercialization of its product candidates. The company's ability to obtain regulatory approval for roluperidone is highly uncertain, as evidenced by the FDA's issuance of a Complete Response Letter for the NDA. Minerva must now address the deficiencies cited by the FDA, which may require additional clinical trials and data, further delaying the potential approval and commercialization of the product.Additionally, Minerva has not generated any revenue from product sales and has incurred significant operating losses since inception. The company's future success is dependent on its ability to obtain regulatory approvals, successfully commercialize its product candidates, and generate sufficient revenue to fund its operations. Failure to do so could result in the need to raise additional capital, which may not be available on favorable terms, or at all.
Minerva also faces competition from other biopharmaceutical companies developing products for the treatment of central nervous system diseases, as well as potential risks related to intellectual property, manufacturing, and other operational challenges.
Outlook
Minerva's path forward with roluperidone remains uncertain following the FDA's issuance of a Complete Response Letter. The company must now address the deficiencies cited by the agency, which may require additional time and resources. Minerva's ability to obtain regulatory approval and successfully commercialize roluperidone will be critical to the company's future success and its ability to generate revenue and achieve profitability.Despite the challenges, Minerva remains committed to the development of roluperidone and its other product candidates. The company's cash position, as of March 31, 2023, provides some runway to continue its operations and advance its pipeline. However, Minerva will likely need to secure additional funding, either through equity offerings, debt financing, or strategic partnerships, to support its long-term growth and development efforts.