On October 29, 2024 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, reported third quarter 2024 financial results and corporate highlights (Press release, Biomea Fusion, OCT 29, 2024, View Source [SID1234647476]).
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"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)
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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.
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Announced the formation of our global scientific advisory board with 22 world-renowned experts in beta cell science and diabetes therapeutics.
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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.
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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:
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Topline Week 26 data readout of Phase 2b of COVALENT -111 (type 2 diabetes) dose expansion cohorts with approximately 200 patients.
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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:
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Provide preclinical data on our third clinical candidate, BMF-650 – a next-generation, selective, oral small-molecule GLP-1 receptor agonist (GLP-1 RA).
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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:
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Complete dose escalation portion of COVALENT-101 in acute myeloid leukemia.
COVALENT-102 (icovamenib for Solid Tumors)
Anticipated Milestone:
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Complete dose escalation portion of COVALENT-102.
COVALENT-103 (BMF-500 for Acute Leukemias)
Anticipated Milestone:
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Complete dose escalation portion of COVALENT-103.
FUSIONTM SYSTEM DISCOVERY PLATFORM
Anticipated Milestone:
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Deliver a fourth IND candidate in 2025 based on the Biomea FUSION Platform technology.
THIRD QUARTER 2024 FINANCIAL RESULTS
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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.
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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.
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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.
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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.