Neumora Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
Neumora Therapeutics (NMRA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Phase 3 KOASTAL-1 study data for navacaprant in major depressive disorder (MDD) expected in Q4 2024.
2. Ongoing clinical studies in MDD, bipolar depression, and Alzheimer's disease agitation.
3. Strong financial position with $371.6 million in cash, cash equivalents, and marketable securities, expected to support operations into 2026.
4. Q2 2024 R&D expenses increased to $48.6 million from $32.8 million in Q2 2023.
5. Net loss for Q2 2024 was $58.7 million, compared to $38.5 million in Q2 2023.
6. Narrowed guidance to submit an IND for an additional M4 compound in H1 2025.
Neumora Therapeutics (NMRA) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:
1. I dati dello studio di Fase 3 KOASTAL-1 per il navacaprant nel trattamento del disturbo depressivo maggiore (MDD) sono attesi nel quarto trimestre del 2024.
2. Studi clinici in corso nel MDD, nella depressione bipolare e nell'agitazione associata alla malattia di Alzheimer.
3. Una posizione finanziaria robusta con 371,6 milioni di dollari in liquidità, equivalenti di liquidità e titoli negoziabili, che si prevede supportino le operazioni fino al 2026.
4. Le spese per R&S del secondo trimestre del 2024 sono aumentate a 48,6 milioni di dollari rispetto ai 32,8 milioni nel secondo trimestre del 2023.
5. La perdita netta per il secondo trimestre del 2024 è stata di 58,7 milioni di dollari, rispetto ai 38,5 milioni nel secondo trimestre del 2023.
6. Guida ristretta per presentare un'indicazione (IND) per un ulteriore composto M4 nella prima metà del 2025.
Neumora Therapeutics (NMRA) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización empresarial. Los puntos destacados incluyen:
1. Se esperan los datos del estudio de Fase 3 KOASTAL-1 para el navacaprant en el trastorno depresivo mayor (MDD) en el cuarto trimestre de 2024.
2. Estudios clínicos en curso en MDD, depresión bipolar y agitación en la enfermedad de Alzheimer.
3. Una fuerte posición financiera con 371,6 millones de dólares en efectivo, equivalentes de efectivo y valores negociables, que se espera respalden las operaciones hasta 2026.
4. Los gastos de I+D del segundo trimestre de 2024 aumentaron a 48,6 millones de dólares desde 32,8 millones en el segundo trimestre de 2023.
5. La pérdida neta para el segundo trimestre de 2024 fue de 58,7 millones de dólares, en comparación con los 38,5 millones en el segundo trimestre de 2023.
6. Guía reducida para presentar una solicitud de IND para un compuesto M4 adicional en la primera mitad de 2025.
Neumora Therapeutics (NMRA)는 2024년 2분기 재무 결과를 보고하고 비즈니스 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:
1. 3상 KOASTAL-1 연구에서 주요 우울 장애(MDD) 치료를 위한 navacaprant 데이터가 2024년 4분기에 예정되어 있습니다.
2. MDD, 양극성 우울증 및 알츠하이머 병 관련 동요에 대한 임상 연구가 진행 중입니다.
3. 강력한 재무 상태를 보유하고 있으며, 3억 7,160만 달러의 현금, 현금성 자산 및 유가 증권이 있어 2026년까지 운영을 지원할 것으로 예상됩니다.
4. 2024년 2분기 R&D 비용은 3,280만 달러에서 4,860만 달러로 증가했습니다.
5. 2024년 2분기 순손실은 5,870만 달러로, 2023년 2분기의 3,850만 달러와 비교됩니다.
6. 2025년 상반기에 추가 M4 화합물에 대한 IND를 제출할 예정입니다.
Neumora Therapeutics (NMRA) a publié les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour de l'entreprise. Les points clés incluent :
1. Les données de l'étude de Phase 3 KOASTAL-1 pour le navacaprant dans le traitement du trouble dépressif majeur (MDD) sont attendues au quatrième trimestre 2024.
2. Des études cliniques en cours dans le MDD, la dépression bipolaire et l'agitation liée à la maladie d'Alzheimer.
3. Une position financière solide avec 371,6 millions de dollars en liquidités, équivalents de liquidités et titres négociables, qui devraient soutenir les opérations jusqu'en 2026.
4. Les dépenses de R&D du deuxième trimestre 2024 ont augmenté à 48,6 millions de dollars contre 32,8 millions de dollars au deuxième trimestre 2023.
5. La perte nette pour le deuxième trimestre 2024 s'élevait à 58,7 millions de dollars, contre 38,5 millions de dollars au deuxième trimestre 2023.
6. Prévision ajustée pour soumettre un IND pour un composé supplémentaire M4 au premier semestre 2025.
Neumora Therapeutics (NMRA) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Geschäftsupdate bereitgestellt. Die wichtigsten Punkte umfassen:
1. Die Daten der Phase 3 KOASTAL-1 Studie zum navacaprant bei schwerer depressiver Störung (MDD) werden im vierten Quartal 2024 erwartet.
2. Laufende klinische Studien zu MDD, bipolaren Depressionen und Agitation bei Alzheimer-Krankheit.
3. Eine solide finanzielle Position mit 371,6 Millionen Dollar in Bargeld, liquiden Mitteln und marktfähigen Wertpapieren, die voraussichtlich die Geschäftsaktivitäten bis 2026 unterstützen werden.
4. Die F&E-Ausgaben im zweiten Quartal 2024 stiegen auf 48,6 Millionen Dollar von 32,8 Millionen Dollar im zweiten Quartal 2023.
5. Der Nettverlust für das zweite Quartal 2024 betrug 58,7 Millionen Dollar, im Vergleich zu 38,5 Millionen Dollar im zweiten Quartal 2023.
6. Die Prognose wurde eingeengt, um einen IND-Antrag für eine zusätzliche M4-Verbindung in der ersten Jahreshälfte 2025 einzureichen.
- Strong cash position of $371.6 million, expected to fund operations into 2026
- Phase 3 KOASTAL-1 study data for navacaprant in MDD expected in Q4 2024
- Initiated Phase 2 study of navacaprant for bipolar depression
- Initiated Phase 1b study of NMRA-511 in Alzheimer's disease agitation
- Narrowed guidance for IND submission of additional M4 compound to H1 2025
- Increased net loss to $58.7 million in Q2 2024 from $38.5 million in Q2 2023
- R&D expenses increased to $48.6 million in Q2 2024 from $32.8 million in Q2 2023
- G&A expenses increased to $15.2 million in Q2 2024 from $9.3 million in Q2 2023
- Clinical hold on Phase 1 study of NMRA-266 by FDA
Neumora's Q2 2024 results reveal a mixed financial picture. While R&D expenses increased by
The net loss widened to
Neumora's pipeline progress is promising, with multiple potential catalysts in the next 18 months. The KOASTAL-1 Phase 3 study for navacaprant in MDD is the nearest-term and most significant. Positive results could position Neumora as a strong competitor in the lucrative antidepressant market.
The expansion into bipolar depression and Alzheimer's agitation demonstrates a strategic diversification of the pipeline. These indications represent significant unmet needs and could provide additional value drivers. The narrowed guidance for an IND submission for a new M4 compound in H1 2025 suggests confidence in the preclinical data and could offset concerns about the clinical hold on NMRA-266.
Neumora's focus on novel mechanisms for neuropsychiatric and neurodegenerative diseases positions it in a high-potential market. The MDD market alone is projected to reach
However, the company faces stiff competition from both established players and other biotechs. The success of navacaprant will be important for Neumora's market position. Positive Phase 3 data could spark investor interest and potentially lead to partnership opportunities with larger pharma companies. The diverse pipeline provides multiple shots on goal, which could mitigate risk and enhance long-term value proposition for investors.
Phase 3 data from KOASTAL-1 study of navacaprant in MDD expected in fourth quarter of 2024
Progressing clinical studies in MDD, bipolar depression and Alzheimer’s disease agitation, providing opportunity for multiple value-creating catalysts over next 18 months
Strong financial position with
WATERTOWN, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
“The first half of the year was marked by considerable progress across our robust clinical development pipeline as we seek to pioneer a new era in brain diseases,” said Henry Gosebruch, president and chief executive officer, Neumora. “We are excited for the topline data readout from our pivotal Phase 3 KOASTAL-1 study of navacaprant to treat major depressive disorder (MDD), which we continue to expect in the fourth quarter. We are committed to bringing navacaprant to the millions of patients suffering with MDD as expeditiously as possible.”
“Additionally, we’re making significant progress across the rest of our pipeline with the recent initiations of a Phase 2 study of navacaprant as a treatment for bipolar depression and a Phase 1b study of NMRA-511 in Alzheimer's disease agitation, as well as narrowing guidance to submit an IND for an additional M4 compound in the first half of 2025. These are areas of substantial unmet medical need, and we are confident that our novel mechanisms have strong rationales with the potential for favorable benefit-risk profiles,” added Mr. Gosebruch.
KEY PIPELINE HIGHLIGHTS
Neumora is advancing a therapeutic pipeline of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases.
Navacaprant (NMRA-140): Phase 3 Data from KOASTAL-1 Study in Major Depressive Disorder (MDD) Expected in Fourth Quarter of 2024
Navacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for MDD and other neuropsychiatric disorders. The KOR antagonist approach has been clinically validated in three independent studies.
Neumora is currently enrolling the registrational Phase 3 KOASTAL program, which is designed to evaluate the efficacy and safety of navacaprant monotherapy for the treatment of MDD. KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3, randomized, placebo-controlled, double-blind studies in adult patients with MDD.
- Neumora remains on-track to report data from the KOASTAL studies within previously guided timeframes. The Company expects to report topline data from the KOASTAL-1 study in the fourth quarter of 2024, and topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025.
Beyond MDD, Neumora recently initiated a Phase 2 clinical trial evaluating the potential of navacaprant as treatment for bipolar depression. The randomized, double-blind, placebo-controlled, Phase 2 clinical trial is designed to evaluate the safety and efficacy of navacaprant in people with depression associated with bipolar II disorder. Neumora expects to report topline data from this trial in the second half of 2025.
NMRA-511: Ongoing Phase 1b Study in Alzheimer’s Disease (AD) Agitation
NMRA-511 is a highly selective, novel antagonist of the vasopressin 1a receptor (V1aR) being developed for the treatment of agitation associated with dementia due to AD and other neuropsychiatric disorders.
- In June 2024, the Company initiated a Phase 1b study in investigating NMRA-511 initially in healthy elderly adult participants and then people with agitation associated with dementia due to AD. The Company expects to report data from this study in the second half of 2025.
M4 Positive Allosteric Modulator (PAM) Franchise: Advancing Preclinical Work Across Compounds, with IND expected in the first half of 2025
Neumora’s M4 franchise is comprised of multiple novel compounds that each have different properties and chemical composition, including NMRA-266.
- The Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 is currently paused following a clinical hold determination by the U.S. Food and Drug Administration (FDA). Neumora is working with the FDA to evaluate the potential to resolve the clinical hold and will provide an update when available.
Beyond NMRA-266, additional compounds in Neumora’s M4 PAM franchise also demonstrated robust activity in preclinical efficacy models, as well as high selectivity for the M4 receptor subtype and the potential for an oral once-daily dosing profile.
- Neumora is advancing preclinical safety and toxicology work with its additional M4 PAM compounds and has narrowed the guidance for bringing an additional M4 PAM compound into the clinic from its prior guidance of 2025. The Company now expects to submit an IND in the first half of 2025.
SECOND QUARTER 2024 FINANCIAL RESULTS
- Cash Position: As of June 30, 2024, Neumora had cash, cash equivalents and marketable securities of
$371.6 million . - Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2024, will enable it to fund its operating plan into 2026.
- R&D Expense: Research and development expenses for the second quarter of 2024 were
$48.6 million , as compared to$32.8 million for the same period in 2023. This increase was primarily due to advancement of clinical and preclinical programs and related activities for Phase 3 clinical trials evaluating navacaprant as a monotherapy treatment for MDD. - G&A Expense: General and administrative expenses for the second quarter of 2024 were
$15.2 million , as compared to$9.3 million for the same period in 2023. This increase was primarily due to personnel-related costs, including stock-based compensation and professional services to support the continued expansion of administrative functions. - Net Loss: The Company reported a net loss of
$58.7 million for the second quarter of 2024, as compared to$38.5 million for the same period in 2023.
About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; Neumora’s goal to make navacaprant available as expeditiously as possible for MDD patients; the timing, progress and plans for its therapeutic development programs, including the timing of patient enrollment, initiation and data read outs for its programs and studies, as well as its clinical trial and development plans and the potential for Neumora’s clinical pipeline to create value; timing and expectations related to regulatory filings and interactions; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; the potential for Neumora to advance other compounds in its M4 portfolio; the oral one-daily dosing potential of any M4 compounds; the timing and potential for any INDs in Neumora’s M4 portfolio; and; other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results or to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 that was filed with the SEC on or about the date hereof. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements. Our results for the quarter ended June 30, 2024 are also not necessarily indicative of our operating results for any future periods.
Financial Tables
| NEUMORA THERAPEUTICS, INC. | |||||||||||||||||
| Unaudited Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | $ | 48,628 | $ | 32,769 | $ | 94,385 | $ | 62,254 | |||||||||
| General and administrative | 15,194 | 9,293 | 29,511 | 18,976 | |||||||||||||
| Total operating expenses | 63,822 | 42,062 | 123,896 | 81,230 | |||||||||||||
| Loss from operations | (63,822 | ) | (42,062 | ) | (123,896 | ) | (81,230 | ) | |||||||||
| Other income (expense): | |||||||||||||||||
| Interest income | 5,271 | 3,558 | 11,636 | 7,127 | |||||||||||||
| Other expense, net | (24 | ) | (39 | ) | (36 | ) | (65 | ) | |||||||||
| Total other income | 5,247 | 3,519 | 11,600 | 7,062 | |||||||||||||
| Net loss before income taxes | (58,575 | ) | (38,543 | ) | (112,296 | ) | (74,168 | ) | |||||||||
| Provision for income taxes | 125 | — | 125 | — | |||||||||||||
| Net loss | (58,700 | ) | (38,543 | ) | (112,421 | ) | (74,168 | ) | |||||||||
| Other comprehensive income (loss): | |||||||||||||||||
| Unrealized gain (loss) on marketable securities | (39 | ) | (150 | ) | (111 | ) | 326 | ||||||||||
| Comprehensive loss | $ | (58,739 | ) | $ | (38,693 | ) | $ | (112,532 | ) | $ | (73,842 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (1.28 | ) | $ | (0.71 | ) | $ | (2.50 | ) | |||||
| Weighted-average shares outstanding, basic and diluted | 158,984 | 30,125 | 158,464 | 29,704 | |||||||||||||
| Neumora Therapeutics, Inc. | |||||||
| Unaudited Condensed Consolidated Balance Sheets | |||||||
| (in thousands) | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| Cash, cash equivalents and marketable securities | $ | 371,639 | $ | 463,827 | |||
| Total assets | $ | 404,473 | $ | 496,195 | |||
| Total liabilities | $ | 23,214 | $ | 27,119 | |||
| Total stockholders’ equity | $ | 381,259 | $ | 469,076 | |||
Neumora Contact
Helen Rubinstein
+1 (315) 382-3979
Helen.Rubinstein@neumoratx.com
FAQ
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