Neumora Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Neumora Therapeutics (NMRA) reported Q3 2024 financial results with a net loss of $72.5 million, compared to $53.0 million in Q3 2023. R&D expenses increased to $60.6 million from $41.6 million year-over-year. The company maintains a strong financial position with $341.3 million in cash and equivalents, expected to fund operations into mid-2026.
Key pipeline updates include expected Phase 3 KOASTAL-1 study data for navacaprant in major depressive disorder (MDD) by end of 2024, with KOASTAL-2 and KOASTAL-3 results anticipated in H1 2025. Additional studies include Phase 2 trials for bipolar depression and Phase 1b study of NMRA-511 for Alzheimer's disease agitation, both with data expected in H2 2025.
Neumora Therapeutics (NMRA) ha riportato i risultati finanziari del terzo trimestre 2024 con una perdita netta di 72,5 milioni di dollari, rispetto ai 53,0 milioni di dollari nel terzo trimestre 2023. Le spese per ricerca e sviluppo sono aumentate a 60,6 milioni di dollari, rispetto ai 41,6 milioni di dollari dell'anno precedente. L'azienda mantiene una solida posizione finanziaria con 341,3 milioni di dollari in contante e equivalenti, che si prevede finanzieranno le operazioni fino a metà 2026.
Le principali novità della pipeline includono i dati previsti dello studio di Fase 3 KOASTAL-1 per navacaprant nel disturbo depressivo maggiore (MDD) entro la fine del 2024, con i risultati di KOASTAL-2 e KOASTAL-3 attesi nel primo semestre del 2025. Studi aggiuntivi includono studi di Fase 2 per la depressione bipolare e uno studio di Fase 1b di NMRA-511 per l'agitazione nell'Alzheimer, con dati attesi nel secondo semestre del 2025.
Neumora Therapeutics (NMRA) informó resultados financieros del tercer trimestre de 2024 con una pérdida neta de 72,5 millones de dólares, en comparación con 53,0 millones de dólares en el tercer trimestre de 2023. Los gastos en I+D aumentaron a 60,6 millones de dólares desde 41,6 millones de dólares año tras año. La compañía mantiene una sólida posición financiera con 341,3 millones de dólares en efectivo y equivalentes, que se espera financien las operaciones hasta mediados de 2026.
Las actualizaciones clave de la pipeline incluyen los datos esperados del estudio de Fase 3 KOASTAL-1 para navacaprant en el trastorno depresivo mayor (MDD) para finales de 2024, con resultados de KOASTAL-2 y KOASTAL-3 anticipados en la primera mitad de 2025. Estudios adicionales incluyen ensayos de Fase 2 para la depresión bipolar y un estudio de Fase 1b de NMRA-511 para la agitación en la enfermedad de Alzheimer, ambos con datos esperados para la segunda mitad de 2025.
Neumora Therapeutics (NMRA)는 2024년 3분기 재무 결과를 발표하며 7,250만 달러의 순손실을 기록했다고 밝혔습니다. 이는 2023년 3분기 5,300만 달러와 비교됩니다. 연구개발(R&D) 비용은 연간 4,160만 달러에서 6,060만 달러로 증가했습니다. 이 회사는 현금 및 현금성 자산이 3억 4,130만 달러로 강력한 재무 상태를 유지하고 있으며, 이는 2026년 중반까지 운영 자금을 지원할 예정입니다.
주요 파이프라인 업데이트에는 주요 우울 장애(MDD)에 대한 navacaprant의 3상 KOASTAL-1 연구 데이터가 2024년 말까지 예상되며, KOASTAL-2 및 KOASTAL-3 결과는 2025년 상반기에 기대되고 있습니다. 추가 연구로는 조울증에 대한 2상 임상시험과 알츠하이머병의 동요를 치료하기 위한 NMRA-511의 1b상 연구가 포함되며, 두 연구 모두 2025년 하반기에 데이터가 예상됩니다.
Neumora Therapeutics (NMRA) a annoncé ses résultats financiers du troisième trimestre 2024, avec une perte nette de 72,5 millions de dollars, contre 53,0 millions de dollars au troisième trimestre 2023. Les dépenses de R&D ont augmenté à 60,6 millions de dollars, contre 41,6 millions de dollars l'année précédente. L'entreprise maintient une solide position financière avec 341,3 millions de dollars en liquidités et équivalents, qui devraient financer ses opérations jusqu'à mi-2026.
Les mises à jour clés du pipeline incluent les données attendues de l'étude de phase 3 KOASTAL-1 pour le navacaprant dans le trouble dépressif majeur (MDD) d'ici la fin 2024, avec les résultats des KOASTAL-2 et KOASTAL-3 prévus dans la première moitié de 2025. D'autres études comprennent des essais de phase 2 pour la dépression bipolaire et une étude de phase 1b de NMRA-511 pour l'agitation dans la maladie d'Alzheimer, dont les données sont attendues pour le second semestre 2025.
Neumora Therapeutics (NMRA) berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 mit einem Nettoverlust von 72,5 Millionen Dollar, verglichen mit 53,0 Millionen Dollar im 3. Quartal 2023. Die F&E-Ausgaben stiegen im Jahresvergleich von 41,6 Millionen Dollar auf 60,6 Millionen Dollar. Das Unternehmen hat eine starke Finanzlage mit 341,3 Millionen Dollar in bar und in Äquivalenten, die voraussichtlich die Operationen bis Mitte 2026 finanzieren werden.
Wichtige Pipeline-Updates umfassen die erwarteten Phase-3-Daten der KOASTAL-1-Studie für Navacaprant bei major depressive disorder (MDD) bis Ende 2024, während die Ergebnisse der KOASTAL-2 und KOASTAL-3-Studien in der ersten Hälfte von 2025 erwartet werden. Weitere Studien umfassen Phase-2-Studien für bipolare Depression und eine Phase-1b-Studie zu NMRA-511 zur Apathie bei Alzheimer, deren Daten in der zweiten Hälfte von 2025 erwartet werden.
- Strong cash position of $341.3 million expected to fund operations into mid-2026
- Multiple late-stage clinical trials with near-term catalysts
- Pipeline expansion with additional indications for navacaprant
- Increased net loss to $72.5 million from $53.0 million YoY
- R&D expenses increased 45.7% to $60.6 million YoY
- G&A expenses increased to $16.0 million from $15.3 million YoY
Insights
The Q3 results reveal significant financial dynamics for Neumora. With
The heightened spending primarily supports three Phase 3 KOASTAL trials for navacaprant in MDD, with pivotal data expected around year-end 2024 and early 2025. This represents a critical inflection point that could significantly impact the company's market position and future capital needs. The extended cash runway provides adequate buffer for current development plans but may require reassessment based on trial outcomes.
The clinical pipeline shows strategic diversification across multiple CNS indications. The navacaprant program stands out with three parallel Phase 3 trials in MDD and expansion into bipolar depression, demonstrating confidence in the KOR antagonist mechanism. The staggered trial readouts (KOASTAL-1 in late 2024, KOASTAL-2/3 in H1 2025) create multiple catalysts while managing operational risk.
The advancement of NMRA-511 for Alzheimer's agitation and planned IND for a new M4 PAM compound in H1 2025 indicates robust pipeline progression. The company's focus on novel mechanisms targeting underserved neurological conditions positions it well in the competitive CNS space, though success heavily depends on the upcoming KOASTAL-1 results.
Phase 3 data from KOASTAL-1 study of navacaprant in MDD expected around the end of 2024; KOASTAL-2 and KOASTAL-3 topline data expected in the first half of 2025
Ongoing clinical studies evaluating navacaprant in bipolar depression and NMRA-511 in Alzheimer’s disease agitation with data expected in second half of 2025
Clinical study for next M4 PAM program expected to commence clinical in the first half of 2025
Strong financial position with
Conference call today at 8:00am ET
WATERTOWN, Mass., Nov. 12, 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 third quarter ended September 30, 2024, and provided a business update.
“It is an exciting time at Neumora as we continue to execute on our mission to redefine neuroscience drug development. We look forward to announcing topline data from KOASTAL-1, the first of three replicate studies in the pivotal Phase 3 KOASTAL program for the treatment of major depressive disorder (MDD), around the end of the year. This is an important milestone for navacaprant, which we believe has the potential to reshape the treatment of MDD by meeting outstanding unmet needs that current therapies do not adequately address,” said Henry Gosebruch, president and chief executive officer, Neumora.
“Beyond our MDD studies, we made substantial progress across our broader portfolio of additional novel clinical and preclinical programs. Notably, we have expanded navacaprant’s potential with a Phase 2 study in bipolar depression and are advancing a Phase 1b study of NMRA-511, a V1aR antagonist, for the treatment of Alzheimer's disease agitation. Additionally, we continue to have strong conviction in our M4 franchise and plan to submit an Investigational New Drug (IND) application in the first half of 2025. We are confident in our pipeline of next generation, novel therapies that could offer improved treatment outcomes and quality of life for patients suffering from brain diseases,” 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 Around the End 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.
- The Company expects to report topline data from the KOASTAL-1 study around the end of 2024, and topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025.
Beyond MDD, Neumora is advancing 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.
- Neumora is advancing 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 comprises multiple novel compounds that each have different properties and chemical composition, including NMRA-266 and additional M4 PAM compounds, which have demonstrated robust activity in preclinical efficacy models and high selectivity for the M4 receptor subtype. The Company plans to submit an IND for an additional program in the first half of 2025.
THIRD QUARTER 2024 FINANCIAL RESULTS
- Cash Position: As of September 30, 2024, Neumora had cash, cash equivalents and marketable securities of
$341.3 million . - Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2024, will enable it to fund its operating plan into mid-2026.
- R&D Expense: Research and development expenses for the third quarter of 2024 were
$60.6 million , as compared to$41.6 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 third quarter of 2024 were
$16.0 million , as compared to$15.3 million for the same period in 2023. This increase was primarily due to an increase in technology and insurance costs to support operations as a public company. - Net Loss: The Company reported a net loss of
$72.5 million for the third quarter of 2024, as compared to$53.0 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; 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, the potential for positive data from KOASTAL-1 or any other 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 timing and potential for an 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 September 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 September 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 September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 60,630 | $ | 41,601 | $ | 155,015 | $ | 103,855 | ||||||||
| General and administrative | 16,016 | 15,263 | 45,527 | 34,239 | ||||||||||||
| Total operating expenses | 76,646 | 56,864 | 200,542 | 138,094 | ||||||||||||
| Loss from operations | (76,646 | ) | (56,864 | ) | (200,542 | ) | (138,094 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 4,209 | 3,838 | 15,845 | 10,965 | ||||||||||||
| Other expense, net | (57 | ) | (1 | ) | (93 | ) | (66 | ) | ||||||||
| Total other income | 4,152 | 3,837 | 15,752 | 10,899 | ||||||||||||
| Net loss before income taxes | (72,494 | ) | (53,027 | ) | (184,790 | ) | (127,195 | ) | ||||||||
| Provision for income taxes | 53 | — | 178 | — | ||||||||||||
| Net loss | (72,547 | ) | (53,027 | ) | (184,968 | ) | (127,195 | ) | ||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain on marketable securities | 292 | 137 | 181 | 463 | ||||||||||||
| Comprehensive loss | $ | (72,255 | ) | $ | (52,890 | ) | $ | (184,787 | ) | $ | (126,732 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.45 | ) | $ | (1.14 | ) | $ | (1.16 | ) | $ | (3.59 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 159,576 | 46,691 | 158,837 | 35,428 | ||||||||||||
| NEUMORA THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets | ||||||||
| (in thousands) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| Cash, cash equivalents and marketable securities | $ | 341,307 | $ | 463,827 | ||||
| Total assets | $ | 352,537 | $ | 496,195 | ||||
| Total liabilities | $ | 31,798 | $ | 27,119 | ||||
| Total stockholders’ equity | $ | 320,739 | $ | 469,076 | ||||
Neumora Contact
Helen Rubinstein
+1 (315) 382-3979
Helen.Rubinstein@neumoratx.com
FAQ
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