Biomea Fusion Reports Third Quarter 2024 Financial Results and Corporate Highlights
Biomea Fusion reported Q3 2024 financial results and corporate updates. The FDA lifted clinical holds on COVALENT-111 (Type 2 Diabetes) and COVALENT-112 (Type 1 Diabetes) trials. The company expects topline data from both studies in December 2024. Cash position stood at $88.3 million as of September 30, 2024. Q3 net loss was $32.8 million, with R&D expenses at $27.2 million and G&A expenses at $6.8 million. The company plans to announce its third clinical candidate, BMF-650, an oral GLP-1 receptor agonist for diabetes and obesity treatment.
Biomea Fusion ha riportato i risultati finanziari e gli aggiornamenti aziendali del terzo trimestre del 2024. La FDA ha revocato i divieti clinici sui trial COVALENT-111 (Diabete di tipo 2) e COVALENT-112 (Diabete di tipo 1). L'azienda prevede di divulgare i dati principali di entrambi gli studi a dicembre 2024. La posizione di cassa ammontava a 88,3 milioni di dollari al 30 settembre 2024. La perdita netta nel terzo trimestre è stata di 32,8 milioni di dollari, con spese per ricerca e sviluppo pari a 27,2 milioni di dollari e spese generali e amministrative di 6,8 milioni di dollari. L'azienda intende annunciare il suo terzo candidato clinico, BMF-650, un agonista del recettore GLP-1 orale per il trattamento del diabete e dell'obesità.
Biomea Fusion reportó los resultados financieros del tercer trimestre de 2024 y las actualizaciones corporativas. La FDA levantó las restricciones clínicas sobre los ensayos COVALENT-111 (Diabetes tipo 2) y COVALENT-112 (Diabetes tipo 1). Se espera que la empresa publique los datos principales de ambos estudios en diciembre de 2024. La posición de efectivo era de 88,3 millones de dólares al 30 de septiembre de 2024. La pérdida neta en el tercer trimestre fue de 32,8 millones de dólares, con gastos de I+D de 27,2 millones de dólares y gastos generales de 6,8 millones de dólares. La empresa planea anunciar su tercer candidato clínico, BMF-650, un agonista del receptor GLP-1 oral para el tratamiento de la diabetes y la obesidad.
Biomea Fusion는 2024년 3분기 재무 결과 및 기업 업데이트를 보고했습니다. FDA는 COVALENT-111 (제2형 당뇨병) 및 COVALENT-112 (제1형 당뇨병) 임상 시험에 대한 제재를 해제했습니다. 회사는 두 연구의 주요 데이터를 2024년 12월에 발표할 것으로 예상하고 있습니다. 2024년 9월 30일 기준 현금 잔고는 8,830만 달러였습니다. 3분기 순손실은 3,280만 달러였으며, R&D 비용은 2,720만 달러, 일반 관리 비용은 680만 달러였습니다. 회사는 당뇨병 및 비만 치료를 위한 경구 GLP-1 수용체 작용제인 BMF-650이라는 세 번째 임상 후보를 발표할 계획입니다.
Biomea Fusion a publié les résultats financiers du troisième trimestre 2024 et des mises à jour d'entreprise. La FDA a levé les restrictions cliniques sur les essais COVALENT-111 (Diabète de type 2) et COVALENT-112 (Diabète de type 1). La société prévoit de publier les données principales des deux études en décembre 2024. La position de trésorerie s'élevait à 88,3 millions de dollars au 30 septembre 2024. La perte nette du troisième trimestre était de 32,8 millions de dollars, avec des dépenses de R&D de 27,2 millions de dollars et des frais généraux de 6,8 millions de dollars. L'entreprise prévoit d'annoncer son troisième candidat clinique, BMF-650, un agoniste des récepteurs GLP-1 oral pour le traitement du diabète et de l'obésité.
Biomea Fusion hat die finanziellen Ergebnisse und Unternehmensaktualisierungen für das dritte Quartal 2024 veröffentlicht. Die FDA hat die klinischen Einschränkungen für die Studien COVALENT-111 (Typ-2-Diabetes) und COVALENT-112 (Typ-1-Diabetes) aufgehoben. Das Unternehmen erwartet, dass die Hauptdaten beider Studien im Dezember 2024 bekannt gegeben werden. Die liquide Mittel beliefen sich am 30. September 2024 auf 88,3 Millionen Dollar. Der Nettoverlust im dritten Quartal betrug 32,8 Millionen Dollar, wobei die F&E-Ausgaben bei 27,2 Millionen Dollar und die allgemeinen Verwaltungskosten bei 6,8 Millionen Dollar lagen. Das Unternehmen plant, seinen dritten klinischen Kandidaten, BMF-650, einen oralen GLP-1-Rezeptoragonisten zur Behandlung von Diabetes und Fettleibigkeit, bekannt zu geben.
- FDA lifted clinical holds on COVALENT-111 and COVALENT-112 trials
- On track for key clinical data readouts in December 2024
- Formation of Global Scientific Advisory Board with 22 diabetes experts
- Net loss increased to $32.8M in Q3 2024 vs $28.4M in Q3 2023
- Cash position decreased to $88.3M from $177.2M at end of 2023
- R&D expenses increased to $27.2M from $25.3M year-over-year
- G&A expenses rose to $6.8M from $5.8M year-over-year
Insights
The Q3 financial results reveal concerning cash burn trends.
Clinical progress with FDA hold removal and upcoming diabetes trial readouts in December could provide catalysts, but the deteriorating cash position may necessitate near-term financing. The expansion into GLP-1 space with BMF-650 adds strategic value but will require significant additional capital investment for development.
The lifting of FDA clinical holds on COVALENT-111 and COVALENT-112 trials represents a critical development, enabling progression of both Type 1 and Type 2 diabetes programs. The imminent December readouts from these trials, particularly the Phase 2b data from approximately 200 T2D patients, will be pivotal in determining icovamenib's efficacy profile and identifying responsive patient populations.
The strategic expansion into GLP-1 receptor agonists with BMF-650 and exploration of combination therapy with icovamenib shows promise, especially given the massive market potential in diabetes and obesity. The formation of a 22-member scientific advisory board adds credibility and expertise to guide clinical development strategy.
- U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trials
- COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024
- COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024
- On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and obesity – a next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA) - and preclinical data combining icovamenib (BMF-219) with a GLP-1 RA-based therapy on October 30th
- Announced formation of Biomea’s Global Scientific Advisory Board with 22 world-renowned diabetes experts
REDWOOD CITY, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today reported third quarter 2024 financial results and corporate highlights.
“Our third quarter was a pivotal quarter for the company. Through collaborative efforts with the FDA, we efficiently resolved the clinical hold on our studies for diabetes, while keeping the expansion study readout in type 2 diabetes on track and continuing to make fundamental progress with the third development program, BMF-650. We are pleased to announce the advancement of our third clinical development candidate – a next-generation oral small molecule GLP-1 receptor agonist. Incretins have become the backbone of obesity treatment, and we believe icovamenib in combination with an incretin together can potentially become the backbone of both diabetes and obesity treatments. We have done extensive preclinical work combining icovamenib with a GLP-1 RA-based therapy and will be sharing this data together with an update on BMF-650 during our conference call on October 30th,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “We are very excited for the planned remaining readouts this year, in particular the topline Week 26 data of Phase 2b COVALENT-111 with approximately 200 type 2 diabetes patients, which will help us define those patients that demonstrate response to icovamenib and will shape the Phase 3 patient population we should target.”
DIABETES & OBESITY
COVALENT-111 (icovamenib for Type 2 Diabetes) & COVALENT-112 (icovamenib for Type 1 Diabetes)
- Announced that the FDA lifted the clinical hold on the ongoing Phase 1/2 clinical trials in type 2 and type 1 diabetes (COVALENT-111 and COVALENT-112), respectively.
- Announced the formation of our global scientific advisory board with 22 world-renowned experts in beta cell science and diabetes therapeutics.
- Announced upcoming attendance at the 1st Asian Conference on Innovative Therapies for Diabetes Management, taking place in Singapore on November 18-20, 2024, with two trial-in-progress oral presentations featuring the study designs of our ongoing diabetes studies, and one late breaker oral presentation to highlight two case studies assessing icovamenib in persons with poorly-controlled severe insulin-deficient (SIDD) type 2 diabetes.
- Announced that World Health Organization (WHO) has approved “icovamenib” as the International Nonproprietary Name (INN) for its lead product candidate BMF-219, and that the United States Adopted Name Council has adopted “icovamenib” as the United States Adopted Name (USAN) for BMF-219.
Anticipated Milestones:
- Topline Week 26 data readout of Phase 2b of COVALENT-111 (type 2 diabetes) dose expansion cohorts with approximately 200 patients.
- Topline Week 26 data readout of Phase 2a of COVALENT-112 (type 1 diabetes) with approximately 20 patients.
BMF-650 (Oral, Small-Molecule GLP-1 RA)
Anticipated Milestones:
- Provide preclinical data on our third clinical candidate, BMF-650 – a next-generation, selective, oral small-molecule GLP-1 receptor agonist (GLP-1 RA).
- Share results of preclinical studies investigating the benefits of combining icovamenib with a GLP-1-based therapies.
ONCOLOGY
COVALENT-101 (icovamenib for Liquid Tumors)
Anticipated Milestone:
- Complete dose escalation portion of COVALENT-101 in acute myeloid leukemia.
COVALENT-102 (icovamenib for Solid Tumors)
Anticipated Milestone:
- Complete dose escalation portion of COVALENT-102.
COVALENT-103 (BMF-500 for Acute Leukemias)
Anticipated Milestone:
- Complete dose escalation portion of COVALENT-103.
FUSION™ SYSTEM DISCOVERY PLATFORM
Anticipated Milestone:
- Deliver a fourth IND candidate in 2025 based on the Biomea FUSION™ Platform technology.
THIRD QUARTER 2024 FINANCIAL RESULTS
- Cash, Cash Equivalents, and Restricted Cash: As of September 30, 2024, the Company had cash, cash equivalents and restricted cash of
$88.3 million , compared to$177.2 million as of December 31, 2023. - Net Income/Loss: The Company reported a net loss attributable to common stockholders of
$32.8 million for the three months ended September 30, 2024, which included$4.7 million of stock-based compensation, compared to a net loss of$28.4 million for the same period in 2023, which included$3.6 million of stock-based compensation. Net loss attributable to common stockholders was$109.1 million for the nine months ended September 30, 2024, which included$14.6 million of stock-based compensation, compared to a net loss of$82.4 million for the same period in 2023, which included$10.3 million of stock-based compensation. - Research and Development (R&D) Expenses: R&D expenses were
$27.2 million for the three months ended September 30, 2024, compared to$25.3 million for the same period in 2023. The increase of$1.9 million was primarily due to an increase of$1.7 million in expenses related to clinical activities,$1.2 million increased in personnel-related expenses and$2.7 million related to external consultants and professional services. The increase is offset by the decrease of$1.4 million in preclinical related activities and$2.1 million decrease in manufacturing related costs. R&D expenses were$92.8 million for the nine months ended September 30, 2024, compared to$71.7 million for the same period in 2023. The increase of$21.2 million was primarily due to an increase of$13.5 million related to clinical activities related expenses,$1.2 million related to preclinical related activities, and$6.1 million in personnel-related expenses. The increase is offset by the decrease of$3.9 million in manufacturing-related costs. - General and Administrative (G&A) Expenses: G&A expenses were
$6.8 million for the three months ended September 30, 2024, compared to$5.8 million for the same period in 2023. The increase of$1.0 million was primarily due to increased personnel-related expenses, including stock-based compensation. G&A expenses were$21.2 million for the nine months ended September 30, 2024, compared to$17.1 million for the same period in 2023. The increase of$4.0 million was primarily due to an increase in personnel-related expenses, including stock-based compensation of$3.0 million and$1.6 million related to general external consultants and legal-related expenses. The increase is offset by the decrease in insurance and facilities related expenses of$0.5 million .
About Biomea Fusion
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.
We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure.
Visit us at 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 clinical and therapeutic potential of our product candidates and development programs, our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials, the anticipated enrollment of patients and availability of data from our clinical trials, anticipated milestones, and the timing of such events, and our expectations regarding the Biomea FUSION™ Platform and our plans to announce a third development candidate, 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 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 (the “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.
- See attached for financial tables -
| BIOMEA FUSION, INC. | ||||||||||||||||
| Condensed Statement of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 27,244 | $ | 25,347 | $ | 92,845 | $ | 71,680 | ||||||||
| General and administrative (1) | 6,795 | 5,772 | 21,151 | 17,127 | ||||||||||||
| Total operating expenses | 34,039 | 31,119 | 113,996 | 88,807 | ||||||||||||
| Loss from operations | (34,039 | ) | (31,119 | ) | (113,996 | ) | (88,807 | ) | ||||||||
| Interest and other income, net | 1,252 | 2,690 | 4,872 | 6,436 | ||||||||||||
| Net loss | $ | (32,787 | ) | $ | (28,429 | ) | $ | (109,124 | ) | $ | (82,371 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) on investments, net | — | — | — | — | ||||||||||||
| Comprehensive loss | $ | (32,787 | ) | $ | (28,429 | ) | $ | (109,124 | ) | $ | (82,371 | ) | ||||
| Net loss per common share, basic and diluted | $ | (0.91 | ) | $ | (0.80 | ) | $ | (3.03 | ) | $ | (2.46 | ) | ||||
| Weighted-average number of shares used to compute basic and diluted net loss per common share | 36,220,736 | 35,653,988 | 36,052,173 | 33,551,808 | ||||||||||||
(1) Includes stock-based compensation as follows (non-cash operating expenses):
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Research and development | $ | 2,478 | $ | 1,778 | $ | 7,472 | $ | 4,902 | ||||||||
| General and administrative | 2,264 | 1,820 | 7,132 | 5,365 | ||||||||||||
| Total stock-based compensation expense | $ | 4,742 | $ | 3,598 | $ | 14,604 | $ | 10,267 | ||||||||
| BIOMEA FUSION, INC. | ||||||||
| Condensed Balance Sheet Data | ||||||||
| (Unaudited) | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash, cash equivalents, and restricted cash | $ | 88,321 | $ | 177,236 | ||||
| Working capital | 66,026 | 156,321 | ||||||
| Total assets | 110,419 | 199,927 | ||||||
| Stockholders' equity | 75,972 | 169,237 | ||||||
FAQ
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