BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter of 2025 ended on March 31, 2025. Corporate Update On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed ...

Financial Performance - The company reported an accumulated deficit of approximately $399.1 million as of March 31, 2025, compared to $395.4 million as of December 31, 2024[76]. - For the three months ended March 31, 2025, the company recorded a net loss of $3.8 million, a decrease from a net loss of $8.6 million for the same period in 2024, representing a reduction of approximately 56%[76]. - Net cash used in operating activities was approximately $4.1 million for the three months ended March 31, 2025, compared to $6.1 million for the same period in 2024[107][109]. - The net loss for the three months ended March 31, 2025, was $3.8 million, down from a net loss of $8.6 million in the same period of 2024[108][109]. Expenses - Research and development expenses decreased to $1.4 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024, a decrease of approximately 67%[90]. - General and administrative expenses remained constant at $2.5 million for both the three months ended March 31, 2025, and 2024[91]. - Investment income decreased to $158 thousand for the three months ended March 31, 2025, down from $358 thousand in the same period of 2024, a decrease of approximately 44%[93]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials as it seeks regulatory approval for product candidates[104]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates, as none have been approved for commercialization[82]. - The company has not generated any revenue from product sales to date, only collaborative revenue from a licensing agreement with Janssen[104]. Cash and Financing - As of March 31, 2025, the company had approximately $17.4 million in cash, cash equivalents, and restricted cash, which is expected to meet operating commitments for the next 12 months[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[105]. - The company believes its existing cash and equivalents will be sufficient to meet cash commitments for at least the next 12 months[105]. - A $60 million payment from Royalty Pharma for the sale of royalty interests in seltorexant is recorded as a liability related to future royalties[104]. Regulatory and Operational Outlook - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing the need for additional studies to support its safety and effectiveness[75]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates and supports its operations as a public company[96]. Company Classification and Accounting Policies - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures under the Securities Exchange Act[114]. - Critical accounting policies include research and development costs, goodwill, and liabilities related to future royalties[112].

Core Viewpoint - Minerva Neurosciences, Inc. reported its fourth quarter and full year financial results for 2024, highlighting a significant reduction in net loss and an increase in net income for the year, primarily due to adjustments related to the sale of future royalties [1][7]. Corporate Update - The FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for roluperidone, and the company is actively engaging with the FDA to address the concerns raised [2]. Financial Results Research and Development (R&D) Expenses - R&D expenses for Q4 2024 were $2.0 million, down from $4.7 million in Q4 2023, and for the full year, R&D expenses were $11.9 million compared to $12.7 million in 2023, primarily due to lower costs associated with the FDA review and the C18 study [3]. General and Administrative (G&A) Expenses - G&A expenses remained stable at $2.5 million for both Q4 2024 and Q4 2023. For the full year, G&A expenses decreased to $9.9 million from $10.4 million, mainly due to lower compensation expenses [4]. Non-Cash Interest Expense - Non-cash interest expense for the sale of future royalties was $0 for Q4 2024 and $4.6 million for the full year, down from $2.2 million and $8.3 million in the previous year, respectively, due to revised estimates for future royalty payments [5]. Other Income - Other income for the full year 2024 was $26.6 million, compared to $0 in 2023, resulting from adjustments related to the sale of future royalties [6]. Net Income (Loss) - The net loss for Q4 2024 was $4.3 million, or $0.56 per share, an improvement from a net loss of $9.0 million, or $1.19 per share, in Q4 2023. For the full year, the company reported a net income of $1.4 million, or $0.19 per share, compared to a net loss of $30.0 million, or $4.61 per share, in 2023 [7]. Cash Position - As of December 31, 2024, the company had approximately $21.5 million in cash, cash equivalents, and restricted cash, down from $41.0 million at the end of 2023 [8]. Company Overview - Minerva Neurosciences, Inc. is focused on developing therapies for central nervous system disorders, including roluperidone for schizophrenia and MIN-301 for Parkinson's disease [9].

Financial Performance - The company reported an accumulated deficit of $395.4 million as of December 31, 2024, compared to $396.8 million in 2023[414]. - For the year ended December 31, 2024, the company recorded a net income of $1.4 million, a significant improvement from a net loss of $30.0 million in 2023[414]. - Other income increased to $26.6 million in 2024, compared to zero in 2023, due to adjustments related to the sale of future royalties[444]. - The company reported net cash used in operating activities of approximately $19.6 million for the year ended December 31, 2024, compared to $14.8 million in 2023[456][457]. - The accumulated deficit as of December 31, 2024, was approximately $395.4 million, indicating ongoing financial challenges[445]. - The company has not generated any revenue from product sales to date and may not achieve profitability in the foreseeable future[445]. Research and Development - Research and development expenses for roluperidone were $11.4 million in 2024, slightly down from $11.8 million in 2023[431]. - Research and development expenses were $11.9 million in 2024, down from $12.7 million in 2023, reflecting a decrease of $0.8 million primarily due to lower compensation expenses[439]. - Research and development costs are expensed as incurred, including licensing fees and salaries, with no material adjustments to prior period estimates for clinical trials[462][464]. - A Phase 1b clinical trial for roluperidone co-administered with olanzapine was completed in Q1 2024, enrolling 17 subjects, with no unexpected safety signals detected[418][419]. - The NDA submission for roluperidone is supported by results from two late-stage studies, with the 64 mg dose showing statistically significant reductions in negative symptoms of schizophrenia[422][424]. Regulatory and Development Challenges - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[413][415]. - The company deferred the development of MIN-301 due to limited resources, recognizing a non-cash charge of $15.2 million related to the impairment of this intangible asset[428]. - The company anticipates needing to raise additional capital or seek product collaborations to continue the development and commercialization of its product candidates[431]. Expenses and Liabilities - For the year ended December 31, 2024, total expenses decreased to $21.8 million from $23.1 million in 2023, a reduction of approximately 5.5%[438]. - General and administrative expenses decreased to $9.9 million in 2024 from $10.4 million in 2023, a decline of approximately 4.8% attributed to lower compensation expenses[440]. - Non-cash interest expense for the sale of future royalties decreased to $4.6 million in 2024 from $8.3 million in 2023, a reduction of approximately 44.5%[443]. - The upfront payment of $60 million from the sale of future royalties to Royalty Pharma is recorded as a liability, with potential additional milestone payments of up to $95 million[466]. Cash Position - As of December 31, 2024, the company had approximately $21.5 million in cash and cash equivalents, expected to meet operating commitments for the next 12 months[445]. - During Q3 2024, the estimate of undiscounted royalty payments was revised, leading to a recognition of $26.6 million as Other Income[468]. Company Classification - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue thresholds are met[471].

Financial Performance - As of September 30, 2024, the accumulated deficit was approximately $391.1 million, down from $396.8 million as of December 31, 2023[64]. - For the nine months ended September 30, 2024, research and development expenses increased to $9.9 million from $8.0 million for the same period in 2023, an increase of approximately 23.8%[85]. - General and administrative expenses decreased to $7.4 million for the nine months ended September 30, 2024, from $8.0 million in 2023, a decrease of approximately 7.5%[86]. - The company recorded other income of $26.6 million for the three months ended September 30, 2024, compared to zero for the same period in 2023, an increase of $26.6 million[84]. - Investment income for the three months ended September 30, 2024, was $314 thousand, down from $349 thousand in 2023, a decrease of approximately 10%[81]. - Non-cash interest expense for the sale of future royalties was zero for the three months ended September 30, 2024, down from $2.1 million in 2023, a decrease of 100%[82]. - Net cash used in operating activities was approximately $14.4 million for the nine months ended September 30, 2024, compared to $8.8 million for the same period in 2023[104][105]. - Net cash provided by financing activities was approximately $19.6 million during the nine months ended September 30, 2023, primarily from the Private Placement[106]. Revenue Generation - The company has not generated any revenue from the sales or licensing of its product candidates to date[70]. - The company has not generated any revenue from product sales to date, relying on collaborative revenue from the sale of royalty interests in seltorexant[99]. - The company sold its royalty interest in seltorexant for an upfront payment of $60 million, with potential future milestone payments of up to $95 million[98]. - The company has not generated significant revenue from product sales and does not expect to do so until regulatory approval is obtained[99]. Cash Position and Financing - The company had approximately $26.6 million in cash, cash equivalents, and restricted cash as of September 30, 2024, sufficient to meet operating commitments for the next 12 months[90]. - The company received aggregate gross proceeds of $20.0 million from a Private Placement, incurring approximately $0.4 million in offering expenses[94]. - As of September 30, 2024, an aggregate of $22.6 million was eligible for sale under the At-the-Market Equity Offering Program[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholder interests[101]. Development and Regulatory Matters - The FDA issued a Complete Response Letter for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[63]. - The company anticipates increased expenses related to ongoing development activities and commercialization efforts for product candidates[99]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures[109].

Core Viewpoint - Minerva Neurosciences, Inc. reported its second quarter 2024 financial results and business updates, highlighting ongoing challenges with the FDA regarding its New Drug Application for roluperidone and increased research and development expenses [1][2]. Financial Performance - Research and Development (R&D) expenses for Q2 2024 were $3.9 million, up from $1.9 million in Q2 2023, primarily due to higher subcontractor fees related to drug substance validation [3]. - General and Administrative (G&A) expenses for Q2 2024 were $2.4 million, slightly down from $2.6 million in Q2 2023, attributed to lower compensation expenses [4]. - Non-cash interest expense for the sale of future royalties was $2.3 million for Q2 2024, compared to $2.0 million in Q2 2023, reflecting increased amortization of non-cash interest [5]. - The net loss for Q2 2024 was $8.2 million, or a net loss per share of $1.09, compared to a net loss of $6.2 million, or $1.12 per share in Q2 2023 [6]. Cash Position - As of June 30, 2024, the company had approximately $31.0 million in cash, cash equivalents, and restricted cash, down from $41.0 million at the end of 2023 [7]. Assets and Liabilities - Total assets as of June 30, 2024, were $46.3 million, a decrease from $56.9 million at the end of 2023 [11]. - Total liabilities increased to $90.8 million as of June 30, 2024, compared to $85.4 million at the end of 2023, with a notable rise in liabilities related to the sale of future royalties [12].

Financial Performance - The company reported an accumulated deficit of approximately $413.6 million as of June 30, 2024, compared to $396.8 million as of December 31, 2023[56]. - The net cash used in operating activities for the six months ended June 30, 2024, was approximately $10.0 million, primarily due to a net loss of $16.8 million[83]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates[73]. Revenue Generation - The company has not generated any revenue from product sales to date and has no products approved for commercial sale[61]. - The company has not generated any revenue from product sales to date and does not expect significant revenue until regulatory approval and commercialization of product candidates[78]. - The company has not generated revenue from product sales and relies on collaborative revenue from the sale of royalty interests[78]. Expenses - Research and development expenses increased to $8.0 million for the six months ended June 30, 2024, from $4.5 million for the same period in 2023, representing an increase of approximately 77.8%[70]. - General and administrative expenses decreased to $4.9 million for the six months ended June 30, 2024, down from $5.3 million in the same period in 2023, a decrease of approximately 7.5%[71]. - Non-cash interest expense for the sale of future royalties increased to $4.6 million for the six months ended June 30, 2024, from $4.0 million in the same period in 2023, an increase of approximately 15%[72]. - The company anticipates ongoing increases in expenses related to research, development, and clinical trials[78]. Cash Position - As of June 30, 2024, the company had approximately $31.0 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[73]. - The company’s existing cash and equivalents are expected to meet cash commitments for at least the next 12 months[79]. - As of June 30, 2024, an aggregate of $22.6 million was eligible for sale under the Sales Agreement[76]. Financing Activities - The net cash provided by financing activities was approximately $19.7 million during the six months ended June 30, 2023, primarily from a Private Placement[84]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[79]. Clinical Development - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing clinical deficiencies that need to be addressed[55]. - The company completed a Phase 1b clinical trial evaluating the co-administration of roluperidone and olanzapine, enrolling 17 subjects, with 13 completing the study[60]. Company Classification - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures[87].

Minerva Neurosciences (NERV) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.The ...

BURLINGTON, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Appli ...

Financial Performance - The company reported an accumulated deficit of $405.4 million as of March 31, 2024, compared to $396.8 million as of December 31, 2023[70]. - For the three months ended March 31, 2024, the company recorded a net loss of $8.6 million, an increase from a net loss of $7.0 million for the same period in 2023[70]. - The company has not generated any revenue from the sales or licensing of its product candidates, and it anticipates continuing to incur net losses for the foreseeable future[70]. - Net cash used in operating activities for Q1 2024 was approximately $6.1 million, compared to $0.1 million in Q1 2023, primarily due to a net loss of $8.6 million[102][103]. - The company reported a net loss of $8.6 million for the three months ended March 31, 2024, which was higher than the net loss of $7.0 million for the same period in 2023[102][103]. - There were no cash flows from investing or financing activities during the three months ended March 31, 2024 and 2023, resulting in a net decrease in cash of $6.1 million for Q1 2024[101][104][105]. Expenses - Research and development expenses increased to $4.2 million for the three months ended March 31, 2024, up from $2.7 million in the same period in 2023, primarily due to costs associated with the FDA's review of the NDA and the MIN-101C18 study[83]. - General and administrative expenses decreased to $2.5 million for the three months ended March 31, 2024, down from $2.7 million in the same period in 2023, mainly due to lower professional service fees[84]. Cash Position - As of March 31, 2024, the company had approximately $34.9 million in cash, cash equivalents, and restricted cash, expected to meet operating commitments for the next 12 months[89]. - The company expects to finance its cash needs through equity offerings, debt financings, and collaborations, but additional funding may dilute existing stockholder interests[99]. - Existing cash, cash equivalents, and restricted cash are believed to be sufficient to meet cash commitments for at least the next 12 months[99]. Regulatory and Clinical Developments - The FDA issued a Complete Response Letter on February 26, 2024, citing clinical deficiencies in the NDA for roluperidone, requiring additional studies to support its safety and effectiveness[71]. - The company completed a Phase 1b clinical trial in Q1 2024, enrolling 17 patients to evaluate the safety and pharmacokinetics of roluperidone co-administered with olanzapine[74]. Funding Activities - The company raised $20.0 million in gross proceeds from a private placement of common stock and warrants on June 30, 2023[92]. - The company sold its royalty interest in seltorexant to Royalty Pharma for an upfront payment of $60 million, with potential future milestone payments of up to $95 million[96]. Accounting and Reporting - The company identified critical accounting policies related to research and development costs and the liability for the sale of future royalties as significant for its financial status[106]. - The company is classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures as long as certain market value and revenue thresholds are met[108].