Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights
Biomea Fusion (Nasdaq: BMEA) reported Q2 2025 financial results and key developments for its diabetes and obesity pipeline. The company presented three significant studies at ADA 2025 highlighting icovamenib's therapeutic potential in type 2 diabetes, showing durable HbA1c reduction and improved beta-cell function. Their next-generation oral GLP-1 receptor agonist, BMF-650, demonstrated up to 15% weight reduction in non-human primates.
The company raised $42.8 million through a public offering, extending cash runway into H2 2026. Q2 2025 resulted in a net loss of $20.7 million, compared to $37.3 million in Q2 2024. Biomea reduced its workforce and expects quarterly operational expenses to be approximately 40% lower than the previous quarter.
Biomea Fusion (Nasdaq: BMEA) ha comunicato i risultati finanziari del secondo trimestre 2025 e gli sviluppi chiave relativi alla sua pipeline per il diabete e l'obesità. L'azienda ha presentato tre studi significativi all'ADA 2025, evidenziando il potenziale terapeutico di icovamenib nel diabete di tipo 2, con una riduzione duratura dell'HbA1c e un miglioramento della funzione delle cellule beta. Il loro agonista orale di nuova generazione del recettore GLP-1, BMF-650, ha mostrato una riduzione del peso fino al 15% nei primati non umani.
La società ha raccolto 42,8 milioni di dollari tramite un'offerta pubblica, estendendo la liquidità fino alla seconda metà del 2026. Il secondo trimestre 2025 si è chiuso con una perdita netta di 20,7 milioni di dollari, rispetto ai 37,3 milioni del secondo trimestre 2024. Biomea ha ridotto il personale e prevede che le spese operative trimestrali saranno circa il 40% inferiori rispetto al trimestre precedente.
Biomea Fusion (Nasdaq: BMEA) informó los resultados financieros del segundo trimestre de 2025 y los avances clave en su pipeline para diabetes y obesidad. La compañía presentó tres estudios importantes en ADA 2025 que destacaron el potencial terapéutico de icovamenib en diabetes tipo 2, mostrando una reducción duradera de HbA1c y una mejora en la función de las células beta. Su agonista oral de próxima generación del receptor GLP-1, BMF-650, demostró una reducción de peso de hasta un 15% en primates no humanos.
La empresa recaudó 42,8 millones de dólares a través de una oferta pública, extendiendo su liquidez hasta la segunda mitad de 2026. El segundo trimestre de 2025 registró una pérdida neta de 20,7 millones de dólares, en comparación con 37,3 millones en el segundo trimestre de 2024. Biomea redujo su plantilla y espera que los gastos operativos trimestrales sean aproximadamente un 40% menores que el trimestre anterior.
Biomea Fusion (나스닥: BMEA)는 2025년 2분기 재무 실적과 당뇨병 및 비만 파이프라인의 주요 발전 사항을 발표했습니다. 회사는 ADA 2025에서 세 가지 중요한 연구를 발표하며 icovamenib의 제2형 당뇨병 치료 가능성을 강조했으며, HbA1c의 지속적인 감소와 베타 세포 기능 개선을 보여주었습니다. 차세대 경구용 GLP-1 수용체 작용제인 BMF-650은 비인간 영장류에서 최대 15% 체중 감소를 입증했습니다.
회사는 공개 모집을 통해 4,280만 달러를 조달하여 2026년 하반기까지 현금 유동성을 연장했습니다. 2025년 2분기에는 2,070만 달러의 순손실을 기록했으며, 이는 2024년 2분기 3,730만 달러에 비해 감소한 수치입니다. Biomea는 인력을 감축했으며 분기별 운영비가 이전 분기 대비 약 40% 감소할 것으로 예상하고 있습니다.
Biomea Fusion (Nasdaq : BMEA) a annoncé ses résultats financiers du deuxième trimestre 2025 ainsi que les développements clés de sa pipeline pour le diabète et l'obésité. La société a présenté trois études majeures lors de l'ADA 2025 mettant en avant le potentiel thérapeutique d'icovamenib dans le diabète de type 2, montrant une réduction durable de l'HbA1c et une amélioration de la fonction des cellules bêta. Leur agoniste oral de nouvelle génération du récepteur GLP-1, BMF-650, a démontré une réduction de poids allant jusqu'à 15 % chez des primates non humains.
La société a levé 42,8 millions de dollars via une offre publique, prolongeant ainsi sa trésorerie jusqu'au second semestre 2026. Le deuxième trimestre 2025 s'est soldé par une perte nette de 20,7 millions de dollars, contre 37,3 millions au deuxième trimestre 2024. Biomea a réduit ses effectifs et prévoit que les dépenses opérationnelles trimestrielles seront environ 40 % inférieures à celles du trimestre précédent.
Biomea Fusion (Nasdaq: BMEA) veröffentlichte die Finanzergebnisse für das zweite Quartal 2025 sowie wichtige Entwicklungen in seiner Diabetes- und Adipositas-Pipeline. Das Unternehmen präsentierte auf der ADA 2025 drei bedeutende Studien, die das therapeutische Potenzial von Icovamenib bei Typ-2-Diabetes hervorhoben, mit einer nachhaltigen Senkung des HbA1c und einer verbesserten Betazellfunktion. Ihr oraler GLP-1-Rezeptor-Agonist der nächsten Generation, BMF-650, zeigte bei nicht-menschlichen Primaten eine Gewichtsreduktion von bis zu 15 %.
Das Unternehmen sammelte 42,8 Millionen US-Dollar durch ein öffentliches Angebot ein und verlängerte damit die finanzielle Reichweite bis in die zweite Hälfte des Jahres 2026. Das zweite Quartal 2025 endete mit einem Nettoverlust von 20,7 Millionen US-Dollar, verglichen mit 37,3 Millionen im zweiten Quartal 2024. Biomea reduzierte seine Belegschaft und erwartet, dass die quartalsweisen Betriebsausgaben etwa 40 % niedriger als im Vorquartal ausfallen werden.
- Raised $42.8 million in gross proceeds extending cash runway into H2 2026
- Icovamenib showed durable HbA1c reduction and improved beta-cell function in T2D patients
- BMF-650 achieved 15% weight reduction in obesity studies with non-human primates
- 40% reduction in quarterly operational expenses through workforce optimization
- Net loss decreased to $20.7M in Q2 2025 from $37.3M in Q2 2024
- Workforce reduction implemented to cut operational expenses
- Company discontinued oncology efforts for BMF-500, seeking strategic partnerships instead
Insights
Biomea's icovamenib shows strong potential in diabetes treatment with promising weight loss benefits when combined with semaglutide.
Biomea Fusion's Q2 results highlight significant progress across their metabolic disease pipeline. The most compelling data comes from their menin inhibitor icovamenib, which demonstrated durable HbA1c reduction and improved beta-cell function in Type 2 diabetes patients even after the dosing period ended. This suggests potential disease-modifying effects rather than just symptom management – a crucial differentiator in the diabetes treatment landscape.
The combination data with semaglutide is particularly noteworthy. In preclinical models, icovamenib plus low-dose semaglutide delivered 60% lower fasting blood glucose and 50% lower glucose OGTT AUC versus semaglutide alone. Most remarkably, this combination preserved lean mass completely while achieving superior weight loss, addressing a significant limitation of current GLP-1 therapies which often cause muscle loss alongside fat reduction.
Their second asset, BMF-650, an oral small molecule GLP-1 receptor agonist, demonstrated 15% weight reduction in non-human primates over 28 days – competitive efficacy in the crowded obesity space. The planned IND submission remains on track for late 2025.
The company's strategic pivot away from oncology to focus on metabolic diseases appears well-timed given the explosive growth in the GLP-1 market. With
Biomea strengthens financial position with $42.8M raise and 40% cost reduction while advancing promising metabolic disease pipeline.
Biomea Fusion has executed a strategic financial reset that significantly improves their operational runway. The company raised
As of June 30, 2025, Biomea reported
Biomea's strategic decision to exit oncology and focus exclusively on the diabetes and obesity markets represents a disciplined capital allocation approach. The metabolic disease space offers potentially higher returns on investment given the massive commercial opportunity demonstrated by GLP-1 drugs. Their pipeline now features two promising candidates: icovamenib (menin inhibitor) for diabetes and BMF-650 (oral GLP-1 RA) for obesity.
With multiple catalysts expected in the second half of 2025, including 52-week Phase II data for icovamenib in T2D, initiation of a combination study with GLP-1 therapies, and an IND submission for BMF-650, Biomea has strategically aligned their financial resources with their most promising clinical programs.
- Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health:
- In patients with type 2 diabetes (T2D) not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and improved beta-cell function subsequent to the dosing period
- In a rodent model of T2D, icovamenib in combination with low-dose semaglutide, promoted enhanced glycemic control and weight loss with complete lean mass preservation
- Icovamenib promoted healthy myotube morphology and reduced drug-induced atrophy in ex-vivo human myotube cultures
- Next-generation oral GLP-1 receptor agonist (RA) candidate, BMF-650, demonstrated robust, dose-dependent weight loss and appetite suppression in obese non-human primates; planned Investigational New Drug (IND) submission remains on track for the second half of 2025
- Raised approximately
$42.8 million in gross proceeds through a public offering, extending projected cash runway into the second half of 2026 - Reduced the workforce and quarterly expenses to support the advancement of the ongoing core programs
SAN CARLOS, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the second quarter ended June 30, 2025, and provided a business update.
“In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA, BMF-650, showed encouraging results in a 28-day study in obese cynomolgus monkeys, achieving up to
Second Quarter Highlights:
Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (T1D))
- Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health:
- In patients with T2D not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months subsequent to the dosing period, particularly in severe insulin deficient patients enrolled in its Phase II trial; icovamenib was well tolerated across the dosing arms.
- In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone:
60% lower fasting blood glucose and50% lower glucose OGTT AUC- Greater HbA1c decline of >
1% by Day 28 and >2% by Day 39 - Greater improvement in insulin sensitivity with a
75% lower HOMA-IR (marker of insulin resistance) - 2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function
- Superior appetite suppression with a
10% greater body weight reduction than low-dose semaglutide alone - The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass
- Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)
- In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of
15% at the higher dose of 30 mg/kg/day. - BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations.
- These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development and support BMF-650’s potential as a best-in-class oral small-molecule GLP-1 RA.
BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia (AML))
- Presented updated Phase I data at EHA 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib.
- The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500.
Financing & Operations
In June 2025, Biomea closed its previously announced underwritten public offering and in July 2025 the underwriters partially exercised their over-allotment option to purchase additional shares of common stock. The aggregate gross proceeds from the offering, including the over-allotment option, were approximately
During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately
Key Anticipated 2025 Milestones:
Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)
- 52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025.
- Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025.
- Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)
- Submission of the IND application for BMF-650 is planned for the second half of 2025.
- Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance.
Second Quarter 2025 Financial Results
Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of
Net Loss: The Company reported a net loss attributable to common stockholders of
Research and Development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecules, icovamenib and BMF-650, both being developed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. We aim to cure.
Visit us at www.biomeafusion.com and follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; clinical and therapeutic potential of our product candidates and development programs, including icovamenib, BMF-500, and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for diabetes and obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase I/II COVALENT-111 study of icovamenib in T2D, our Phase II COVALENT-112 study of icovamenib in T1D, and our planned IND submission for the BMF-650 program; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events; and our expected cash runway may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
mweiss@biomeafusion.com
| BIOMEA FUSION, INC. | ||||||||||||||||
| Condensed Statement of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 16,566 | $ | 31,825 | $ | 39,463 | $ | 65,601 | ||||||||
| General and administrative (1) | 4,710 | 7,073 | 11,525 | 14,356 | ||||||||||||
| Total operating expenses | 21,276 | 38,898 | 50,988 | 79,957 | ||||||||||||
| Loss from operations | (21,276 | ) | (38,898 | ) | (50,988 | ) | (79,957 | ) | ||||||||
| Interest and other income, net | 536 | 1,622 | 986 | 3,620 | ||||||||||||
| Net loss and comprehensive loss | $ | (20,740 | ) | $ | (37,276 | ) | $ | (50,002 | ) | $ | (76,337 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.51 | ) | $ | (1.03 | ) | $ | (1.29 | ) | $ | (2.12 | ) | ||||
| Weighted-average number of shares used to compute basic and diluted net loss per common share | 40,630,403 | 36,043,561 | 38,639,834 | 35,966,965 | ||||||||||||
(1) Includes stock-based compensation as follows (non-cash operating expenses):
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | 1,568 | $ | 2,448 | $ | 3,488 | $ | 4,994 | ||||||||
| General and administrative | 1,005 | 2,392 | 2,254 | 4,868 | ||||||||||||
| Total stock-based compensation expense | $ | 2,573 | $ | 4,840 | $ | 5,742 | $ | 9,862 | ||||||||
| BIOMEA FUSION, INC. | ||||||||
| Condensed Balance Sheet Data | ||||||||
| (Unaudited) | ||||||||
| (in thousands) | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Cash, cash equivalents, and restricted cash | $ | 56,593 | $ | 58,648 | ||||
| Working capital | 47,095 | 46,659 | ||||||
| Total assets | 73,163 | 79,938 | ||||||
| Stockholders' equity | 27,510 | 51,573 | ||||||
FAQ
What were the key findings for Biomea Fusion's icovamenib in type 2 diabetes trials?
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