BMEA
Biomea FusionDDocument history
Earnings documents stored for BMEA.
Investor releaseQuarter not tagged2026-08-05Biomea Fusion Reports Second Quarter 2026 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports Second Quarter 2026 Financial Results and Corporate Highlights
Enrollment ongoing for the Phase II COVALENT-211 clinical trial in patients with insulin deficiency in Type 2 diabetes (“T2D”); data expected in the first quarter of 2027 Enrollment also ongoing for the Phase II COVALENT-212 clinical trial in patients with T2D not achieving glycemic targets while on glucagon-like peptide-1 receptor agonists (“GLP-1 RA”)-based therapy; data expected in the second quarter of 2027 Phase I GLP-131 (BMF-650) obesity clinical trial on track with initial 28-day weight reduction data expected in the third quarter of 2026 Research collaboration initiated with the University of Leicester to evaluate icovamenib in combination with semaglutide in a Phase II clinical trial in obesity Cash runway projected into the second quarter of 2027 SAN CARLOS, Calif., Aug. 05, 2026 (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, 2026, and provided a business update. “The second quarter marked continued execution across our diabetes and obesity programs. We are near completion of enrollment in our COVALENT-211 Phase II clinical trial, continue to advance enrollment in COVALENT-212, and remain on track to report initial 28-day clinical weight reduction data from our BMF-650 Phase I clinical trial in the third quarter,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion. “The Type 1 diabetes data presented at the American Diabetes Association’s Scientific Sessions strengthened our confidence in icovamenib’s potential to preserve and improve endogenous insulin secretion, providing additional evidence that this program may have potential to address a significant unmet need. We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program.” Recent Corporate Highlights: IcovamenibPotential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes Two Phase II clinical trials evaluating icovamenib in T2D are ongoing: The Company presented 52-week follow-up data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in Type 1 diabetes (“T1D”) patients at the American Diabetes Association’s (“ADA”) Scientific Sessions: Announced a resea…Read full documentShow less
Enrollment ongoing for the Phase II COVALENT-211 clinical trial in patients with insulin deficiency in Type 2 diabetes (“T2D”); data expected in the first quarter of 2027 Enrollment also ongoing for the Phase II COVALENT-212 clinical trial in patients with T2D not achieving glycemic targets while on glucagon-like peptide-1 receptor agonists (“GLP-1 RA”)-based therapy; data expected in the second quarter of 2027 Phase I GLP-131 (BMF-650) obesity clinical trial on track with initial 28-day weight reduction data expected in the third quarter of 2026 Research collaboration initiated with the University of Leicester to evaluate icovamenib in combination with semaglutide in a Phase II clinical trial in obesity Cash runway projected into the second quarter of 2027 SAN CARLOS, Calif., Aug. 05, 2026 (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, 2026, and provided a business update. “The second quarter marked continued execution across our diabetes and obesity programs. We are near completion of enrollment in our COVALENT-211 Phase II clinical trial, continue to advance enrollment in COVALENT-212, and remain on track to report initial 28-day clinical weight reduction data from our BMF-650 Phase I clinical trial in the third quarter,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer of Biomea Fusion. “The Type 1 diabetes data presented at the American Diabetes Association’s Scientific Sessions strengthened our confidence in icovamenib’s potential to preserve and improve endogenous insulin secretion, providing additional evidence that this program may have potential to address a significant unmet need. We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program.” Recent Corporate Highlights: IcovamenibPotential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes Two Phase II clinical trials evaluating icovamenib in T2D are ongoing: The Company presented 52-week follow-up data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in Type 1 diabetes (“T1D”) patients at the American Diabetes Association’s (“ADA”) Scientific Sessions: Announced a research collaboration with the University of Leicester to evaluate icovamenib in a Phase II clinical trial in combination with semaglutide in obesity through a newly activated experimental arm of the Open Label Adaptive Platform Trial. The randomized, double-blind study will assess physical function, body weight, body composition, muscle health and metabolic outcomes, with the primary endpoint assessed at Week 24. Enrollment is expected to begin in the third quarter of 2026. BMF-650 Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing. The Company expanded its Phase I BMF-650 trial to evaluate a rapid one-step titration and enhanced weight loss potential with its oral GLP-1 receptor agonist. Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the third quarter of 2026. Second Quarter 2026 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2026, the Company had cash, cash equivalents and restricted cash of $35.2 million. Net Loss: The Company reported a net loss attributable to common stockholders of $8.3 million for the three months ended June 30, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $20.7 million for the same period in 2025, which included $2.6 million of stock-based compensation. The Company reported a net loss attributable to common stockholders of $20.7 million for the six months ended June 30, 2026, which included $3.2 million of stock-based compensation, compared to a net loss of $50.0 million for the same period in 2025, which included $5.7 million of stock-based compensation. Research and Development (“R&D”) Expenses: R&D expenses were $9.1 million for the three months ended June 30, 2026, compared to $16.6 million for the same period in 2025. The decrease of $7.4 million was primarily driven by a decrease of $1.5 million related to preclinical and exploratory programs, a decrease of $1.3 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs, offset by an increase of $0.6 million related to clinical activities. Personnel-related expenses decreased by $2.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs. R&D expenses were $18.3 million for the six months ended June 30, 2026, compared to $39.5 million for the same period in 2025. The decrease of $21.2 million was primarily driven by a decrease of $10.7 million in external costs primarily driven by a decrease of $3.1 million related to clinical activities, a decrease of $3.4 million related to preclinical and exploratory programs, a decrease of $3.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, and a decrease of $1.0 million of manufacturing costs. Personnel-related expenses decreased by $7.0 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $3.5 million due to a decrease in rent and facilities-related costs. General and Administrative (“G&A”) Expenses: G&A expenses were $3.6 million for the three months ended June 30, 2026, compared to $4.7 million for the same period in 2025. The decrease of $1.1 million was primarily driven by a decrease of $0.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.1 million. G&A expenses were $7.3 million for the six months ended June 30, 2026, compared to $11.5 million for the same period in 2025. The decrease of $4.2 million was primarily driven by a decrease of $2.7 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.3 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 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 and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for 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 plans to initiate a Phase II clinical trial in T1D, our Phase II COVALENT-211 clinical trial, our Phase II COVALENT-212 clinical trial and our Phase I GLP-131 clinical trial; 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 WeissSr. Director of Investor Relations and Corporate Development [email protected]
Investor releaseQuarter not tagged2026-05-12Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports First Quarter 2026 Financial Results and Corporate Highlights
Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12-week clinical dosing that has been used to date Topline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1 diabetes (“T1D”), supporting proposed mechanism of action First patients dosed in the Phase II COVALENT-211 and COVALENT-212 clinical trials of icovamenib in type 2 diabetes (“T2D”); both trials are on track with topline 26-week data expected in the fourth quarter of 2026 The Phase I GLP-131 (BMF-650) obesity clinical trial is on track; initial 28-day weight reduction data expected in the second quarter of 2026 Cash runway projected into the first quarter of 2027 SAN CARLOS, Calif., May 11, 2026 (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 first quarter ended March 31, 2026, and provided a business update. “Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety…Read full documentShow less
Successfully completed chronic toxicology studies for icovamenib, providing the nonclinical support for advancing to chronic clinical dosing, beyond the 12-week clinical dosing that has been used to date Topline data reported from the Phase II COVALENT-112 clinical trial of icovamenib in type 1 diabetes (“T1D”), supporting proposed mechanism of action First patients dosed in the Phase II COVALENT-211 and COVALENT-212 clinical trials of icovamenib in type 2 diabetes (“T2D”); both trials are on track with topline 26-week data expected in the fourth quarter of 2026 The Phase I GLP-131 (BMF-650) obesity clinical trial is on track; initial 28-day weight reduction data expected in the second quarter of 2026 Cash runway projected into the first quarter of 2027 SAN CARLOS, Calif., May 11, 2026 (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 first quarter ended March 31, 2026, and provided a business update. “Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes Chronic toxicology studies in two species were successfully completed for icovamenib, providing nonclinical support for chronic clinical dosing beyond the 12-week duration used to date; findings demonstrated a favorable safety profile consistent with previously reported preclinical and clinical data. With more than 400 subjects dosed to date, icovamenib was generally well tolerated and demonstrated a favorable safety profile throughout the observation periods. Two Phase II clinical trials evaluating icovamenib in T2D have been initiated and enrollment is ongoing: COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled trial in patients with insulin-deficient T2D not achieving glycemic targets despite standard of care therapy. COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled trial in patients with T2D not achieving glycemic targets while on a GLP-1 RA-based therapy. Both trials include a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026. Topline data from the Phase II COVALENT-112 clinical trial evaluating icovamenib in T1D patients were reported from the 52-week follow-up: A 52% increase from baseline in mean C-peptide AUC at Week 12, after completion of the dosing period, in patients diagnosed within 0-3 years (n=5) receiving icovamenib 200 mg, with a dose response observed vs 100 mg (n=6). Persistence observed through Week 52, with mean C-peptide AUC largely preserved in the 200 mg group (~7% decline from baseline). Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9). Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52. Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release scheduled for June 5, 2026 at 6:30 pm CDT). Planning a Phase II trial in recently diagnosed T1D patients (≤ 3 years since diagnosis), in collaboration with four U.S. academic centers, to evaluate extended dosing (6–12 months) of icovamenib 200 mg and assess potential combination with an immunosuppressive agent; trial initiation expected in the second half of the year at leading centers including the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute. BMF-650 Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing. Initial 28-day clinical weight reduction data from the Phase I GLP-131 clinical trial is anticipated in the second quarter of 2026. First Quarter 2026 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2026, the Company had cash, cash equivalents and restricted cash of $45.1 million. Net Loss: The Company reported a net loss attributable to common stockholders of $12.4 million for the three months ended March 31, 2026, which included $1.6 million of stock-based compensation, compared to a net loss of $29.3 million for the same period in 2025, which included $3.2 million of stock-based compensation. Research and Development (“R&D”) Expenses: R&D expenses were $9.1 million for the three months ended March 31, 2026, compared to $22.9 million for the same period in 2025. The decrease of approximately $13.8 million was primarily driven by a decrease of $7.6 million in external costs primarily driven by a decrease of $3.8 million related to clinical activities, a decrease of $1.9 million related to preclinical and exploratory programs, and a decrease of $1.9 million in other external costs related to consultants, advisors and other professional services to support our clinical trials. Personnel-related expenses decreased by $4.5 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $1.7 million due to a decrease in rent and facilities-related costs. General and Administrative (“G&A”) Expenses: G&A expenses were $3.7 million for the three months ended March 31, 2026 compared to $6.8 million for the same period in 2025. The decrease of $3.2 million was primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $1.1 million of corporate-related expenses. Facilities and other allocated expenses decreased by $0.2 million. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 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 and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for 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 plans to initiate a Phase II clinical trial in T1D, our Phase II COVALENT-211 clinical trial, our Phase II COVALENT-212 clinical trial and our Phase I GLP-131 clinical trial; 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 [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):
Investor releaseQuarter not tagged2026-04-28Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes Showing C-Peptide Improvement and Durability Following 12-Weeks of Icovamenib Treatment
GlobeNewswire
Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes Showing C-Peptide Improvement and Durability Following 12-Weeks of Icovamenib Treatment
A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6) Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosing Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9) Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release on June 5th at 6:30 pm CST) Company to host a conference call to discuss results on Tuesday, April 28 at 8:30 am ET SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes (“T1D”). These data are based on a proof-of-concept study enrolling small subsets of Stage 3 T1D patients dosed with icovamenib at 100 mg and 200 mg in two cohorts (patients diagnosed within 3 years and those diagnosed within 3-15 years). “The results we presented today mark an encouraging step forward for Biomea. The magnitude and durability observed are not typically seen in type 1 diabetes, which makes these findings particularly compelling. These data further validate targeting menin as a potential approach across both type 1 and type 2 diabetes,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We look forward to presenting additional data at an upcoming scientific meeting and advancing our type 1 diabetes program in collaboration with leading clinical centers in the United States” The COVALENT-112 trial demonstrated encouraging results in patients with T1D. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published…Read full documentShow less
A 52% increase from baseline in mean C-peptide AUC at Week 12 in patients diagnosed within 0–3 years (n=5) receiving icovamenib 200 mg, with a clear dose response observed vs 100 mg (n=6) Persistence observed through Week 52, with mean C-peptide AUC largely preserved in 200 mg group (~7% decline from baseline) following only 12 weeks of dosing Preservation of C-peptide also observed in patients diagnosed between 3-15 years (n=9) Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Comprehensive dataset to be presented at the American Diabetes Association’s (ADA) Scientific Sessions (abstract is preliminary until time of presentation; full release on June 5th at 6:30 pm CST) Company to host a conference call to discuss results on Tuesday, April 28 at 8:30 am ET SAN CARLOS, Calif., April 27, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase 2 COVALENT-112 trial evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 1 diabetes (“T1D”). These data are based on a proof-of-concept study enrolling small subsets of Stage 3 T1D patients dosed with icovamenib at 100 mg and 200 mg in two cohorts (patients diagnosed within 3 years and those diagnosed within 3-15 years). “The results we presented today mark an encouraging step forward for Biomea. The magnitude and durability observed are not typically seen in type 1 diabetes, which makes these findings particularly compelling. These data further validate targeting menin as a potential approach across both type 1 and type 2 diabetes,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We look forward to presenting additional data at an upcoming scientific meeting and advancing our type 1 diabetes program in collaboration with leading clinical centers in the United States” The COVALENT-112 trial demonstrated encouraging results in patients with T1D. In patients diagnosed within 0-3 years, treatment with icovamenib 200 mg once daily for 12 weeks resulted in a 52% increase in mean C-peptide area under the curve (AUC) at Week 12 (p < 0.001; n=5), representing a magnitude of improvement that is not commonly reported in published studies of T1D. Importantly, the effect was durable following only 12 weeks of dosing, mean C-peptide AUC was largely preserved through Week 52, representing approximately a 7% decline from baseline. A dose response was observed, with the 200 mg dose demonstrating greater activity compared to 100 mg. Published natural history data suggest that patients with Stage 3 T1D typically experience substantial declines in C-peptide over time, underscoring the significance of preserved C-peptide following only a 12-week dosing period. In patients with longer-standing disease (3-15 years since diagnosis), C-peptide levels were generally preserved through Week 52 (12-week treatment period + 40-week follow-up), with only a modest decline from baseline. A comprehensive dataset will be presented at the upcoming American Diabetes Association’s (ADA) Scientific Sessions in June. Icovamenib was generally well tolerated, with no new or unexpected safety signals identified throughout the 52-week observation period. Unlike investigational approaches in T1D that rely primarily on immune suppression or cellular transplantation, icovamenib is designed as a short course, orally administered therapy targeting beta cell biology, with effects that appear to persist beyond the treatment period. Based on these data, Biomea, in collaboration with four U.S. academic centers, is planning a Phase 2 trial in patients with T1D diagnosed within the past 3 years. The study will evaluate whether extended dosing (up to 6 or 12 months) at 200 mg further improves C-peptide and whether the addition of an immunosuppressive agent enhances clinical outcomes. This study is planned to be initiated within the second half of this year at the Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio Diabetes Center, and the University of Miami Diabetes Research Institute. “Efforts to intervene against T1D have historically focused on preserving remaining insulin secretion in people just diagnosed with T1D,” said G. Alexander Fleming, MD, Founder & Executive Chairman of Kinexum and former FDA Senior Medical Officer and Division Leader for Metabolic & Endocrine Drugs, involved in the review of landmark diabetes and metabolic therapies including metformin, the first rapid acting insulin analogs, early statins, and PPAR agonists. “These icovamenib data are unique in showing increased C-peptide-reflected insulin secretion in patients with established T1D during dosing and persistence of this effect after treatment was stopped. In people with established T1D, endogenous insulin secretion progressively declines to very low levels. Any evidence of improvement in endogenous insulin secretion even among a few T1D individuals is unprecedented and of immense biologic and clinical significance. These findings warrant rigorous and longer-term evaluation.” COVALENT-112 Study Design COVALENT-112 (NCT06152042) was an open label Phase 2 trial evaluating icovamenib in adult patients with T1D. The study enrolled patients aged 18 to 60 years with Stage 3 T1D, including those diagnosed within 0–3 years with residual beta cell function at baseline, defined by a screening C-peptide level ≥0.2 nmol/L (Cohort 1), as well as a broader population with disease duration of 3–15 years and residual beta cell function at baseline, defined by a screening C-peptide level ≥0.08 nmol/L (Cohort 2). Participants were assigned to receive icovamenib at 100 mg or 200 mg once daily for 12 weeks, followed by a 40-week post-treatment follow-up to assess durability of effect. Study enrollment and dosing were interrupted in May 2024 due to an FDA clinical hold, which was subsequently resolved. As a result, these data reflect approximately half of the originally intended patient population. A planned placebo-controlled Part 2 of the study was not completed. The primary endpoint was the mean change from baseline in stimulated C-peptide area under the curve (AUC), measured during a mixed-meal tolerance test (MMTT), to evaluate endogenous insulin secretion. Secondary endpoints included additional measures of beta cell function, glycemic control, insulin use, and safety. Conference Call and Webcast Details Webcast of Biomea’s investor update on Tuesday, April 28, 2026 at 8:30 am ET will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events. A replay of the presentation will be archived on Biomea’s website following the event. About Icovamenib Icovamenib is an orally administered investigational small molecule currently in Phase 2 clinical development for the treatment of diabetes. Icovamenib targets menin, a transcriptional regulator implicated in beta cell dysfunction, and has been shown in preclinical and clinical studies to induce transient reductions in menin protein levels in pancreatic islets, thereby modulating pathways associated with insulin secretion and glycemic control. Through this mechanism, icovamenib has the potential to restore beta cell mass and function and improve endogenous insulin production. As a potential short-course therapy, icovamenib could represent a novel treatment approach for patients with diabetes, particularly those who have not achieved adequate control with standard-of-care therapies. About Menin’s Role in Diabetes Loss of functional beta cell mass is a core component of the natural history in both major types of diabetes, T1D (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover and growth, supporting the hypothesis that inhibition of menin may enable pathways associated with beta cell regeneration and improved function. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to treat T1D and T2D. About Type 1 Diabetes Type 1 diabetes (T1D) is a chronic autoimmune disease in which the body’s immune system destroys insulin-producing beta cells in the pancreas, leading to a loss of endogenous insulin production. Approximately 9.5 million people worldwide live with T1D, with an estimated 513,000 new diagnoses each year. In the United States, about 1.8 million individuals are affected. At diagnosis, patients often have already lost a significant portion of their functional beta cell mass, and this decline typically continues over time. As a result, individuals with T1D require lifelong insulin therapy and continuous glucose monitoring to manage blood sugar levels. Despite advances in care, T1D remains associated with meaningful risks, including severe hypoglycemia and diabetic ketoacidosis (DKA), as well as long-term complications such as cardiovascular disease, kidney disease, nerve damage, and vision loss. There are currently no approved therapies that address the underlying progressive loss of beta cell function in established (Stage 3) T1D beyond insulin replacement, highlighting a significant unmet medical need for disease-modifying treatments. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of all Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 clinical and therapeutic potential of our product candidates and development programs, including icovamenib and the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; 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 2COVALENT-112 trial; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events 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 [email protected] A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/65d84e8f-dc21-4794-a041-80bf6b8ede2c
Investor releaseQuarter not tagged2026-03-26Analysts Sentiment on Biomea Fusion (BMEA) Remains Strong Amid Strong Diabetes Trial Results
Insider Monkey
Analysts Sentiment on Biomea Fusion (BMEA) Remains Strong Amid Strong Diabetes Trial Results
Biomea Fusion, Inc. (NASDAQ:BMEA) earns a place on our list of the top 10 stocks under $5 that could triple. As of March 19, 2026, almost 88% of covering analysts keep bullish ratings on the stock. With a consensus price target of $6.00, indicating a potential upside of 415.02%, analyst sentiment remains positive toward Biomea Fusion, Inc. (NASDAQ:BMEA). On March 14, 2026, Biomea Fusion, Inc. (NASDAQ:BMEA) reported positive 52-week follow-up findings from its Phase II COVALENT-111 study of icovamenib in type 2 diabetes at the ATTD conference in Barcelona. This clinical progress serves as the foundation for analyst optimism. Of the 267 patients assessed in the randomized, placebo-controlled trial, 163 completed at least 80% of their dosage before a clinical hold. The findings showed statistically significant declines in HbA1c, with severe insulin-deficient individuals experiencing reductions of up to 1.50% at Week 52. Efficacy was further supported by improvements in beta-cell activity and long-lasting glucose control nine months after therapy. There were no significant side effects or treatment-related discontinuations, and the therapy was well tolerated. Biomea Fusion, Inc. (NASDAQ:BMEA) formulates covalent small-molecule therapeutics aimed at treating cancers and metabolic disorders, with its primary candidate, icovamenib, targeting diabetes and BMF-219 addressing oncogenic signaling in genetically characterized tumors. While we acknowledge the potential of BMEA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2026-03-25Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports Full Year 2025 Financial Results and Corporate Highlights
Initiated two Phase II trials COVALENT-211 and COVALENT-212 (icovamenib in type 2 diabetes) with 26-week primary endpoint data anticipated in the fourth quarter of 2026 Completed 52-week follow-up from Phase II trial COVALENT-112 (icovamenib in type 1 diabetes) with data expected in the second quarter of 2026 Initiated Phase I trial enrollment of GLP-131 (BMF-650 in obesity) with initial 28-day weight reduction data expected in the second quarter of 2026 Projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., March 24, 2026 (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 full year ended December 31, 2025, and provided a business update. “The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical experiments to now generating durable, clinical data in patients with type 2 diabetes with our lead asset, icovamenib,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “We reported persistent 52-week clinical activity with icovamenib following a short 12-week treatment course. Following these initial findings, we initiated two Phase II studies in type 2 diabetes from which we expect to have primary end point data before year end. We also advanced our own next-generation oral GLP-1 receptor agonist, BMF-650, into a Phase I study which we expect will read out in the second quarter. We are excited about the current momentum as we believe Biomea is well positioned to execute on key value-creating milestones with multiple data readouts from our four clinical studies, while predicting a cash runway into the first quarter of 2027.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes The Company presented 52-week follow-up data from the Phase II COVALENT-111 study in patients with type 2 diabetes not achieving glycemic targets despite standard of care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course. In patients with severe insulin-deficient type 2 diabetes receiving one or more antihyperglycemic agents at baseline, ic…Read full documentShow less
Initiated two Phase II trials COVALENT-211 and COVALENT-212 (icovamenib in type 2 diabetes) with 26-week primary endpoint data anticipated in the fourth quarter of 2026 Completed 52-week follow-up from Phase II trial COVALENT-112 (icovamenib in type 1 diabetes) with data expected in the second quarter of 2026 Initiated Phase I trial enrollment of GLP-131 (BMF-650 in obesity) with initial 28-day weight reduction data expected in the second quarter of 2026 Projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., March 24, 2026 (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 full year ended December 31, 2025, and provided a business update. “The past year was a year of execution for Biomea as we advanced from validating the menin pathway in primarily preclinical experiments to now generating durable, clinical data in patients with type 2 diabetes with our lead asset, icovamenib,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “We reported persistent 52-week clinical activity with icovamenib following a short 12-week treatment course. Following these initial findings, we initiated two Phase II studies in type 2 diabetes from which we expect to have primary end point data before year end. We also advanced our own next-generation oral GLP-1 receptor agonist, BMF-650, into a Phase I study which we expect will read out in the second quarter. We are excited about the current momentum as we believe Biomea is well positioned to execute on key value-creating milestones with multiple data readouts from our four clinical studies, while predicting a cash runway into the first quarter of 2027.” Recent Corporate Highlights: Icovamenib Potential First-in-Class Oral Small Molecule Product Candidate Targeting Menin for Diabetes The Company presented 52-week follow-up data from the Phase II COVALENT-111 study in patients with type 2 diabetes not achieving glycemic targets despite standard of care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course. In patients with severe insulin-deficient type 2 diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.01) that was maintained through Week 52 following 12 weeks of dosing. In a subgroup of patients receiving GLP-1 RA-based therapy who had not achieved glycemic targets at study entry, icovamenib achieved a 1.2% mean reduction in HbA1c (p=0.05) that was maintained through Week 52 following 12 weeks of dosing. In both populations, icovamenib treatment was associated with increased C-peptide levels measured off treatment, supporting the proposed mechanism of action of restoration of beta cell function. Icovamenib was generally well tolerated across all dosing arms, with no treatment-related serious adverse events or treatment discontinuations observed during the 52-week observation period. The Company completed the COVALENT-121 food-effect study which demonstrated that icovamenib achieved optimal pharmacokinetic exposure and a safety profile consistent with prior clinical experience when administered within 30 minutes after a meal. These findings informed our dosing strategy for ongoing Phase II studies. The Company also completed the 52-week follow-up from the Phase II COVALENT-112 study in patients with type 1 diabetes. Patients who completed at least 80% of their planned dosing will be reviewed for their 52-week follow-up data per the study protocol. This read-out is expected in the second quarter of 2026. Two Phase II clinical studies evaluating icovamenib in type 2 diabetes have been initiated: COVALENT-211, a Phase II, randomized, double-blind, placebo-controlled study in patients with insulin-deficient type 2 diabetes not achieving glycemic targets despite standard of care therapy. COVALENT-212, a Phase II, randomized, double-blind, placebo-controlled study in patients with type 2 diabetes not achieving glycemic targets while on a GLP-1 RA-based therapy. Both studies are designed with a 26-week primary endpoint, with topline data anticipated in the fourth quarter of 2026. BMF-650 Next-generation Oral Small Molecule GLP-1 RA Product Candidate for Obesity In preclinical studies, BMF-650 demonstrated robust, dose-dependent weight reduction of up to approximately 15% in obese non-human primates and was generally well tolerated. GLP-131, a Phase I randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMF-650 in otherwise healthy overweight or obese participants is ongoing. Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the second quarter of 2026. Year End 2025 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2025, the Company had cash, cash equivalents and restricted cash of $56.2 million, compared to $58.6 million as of December 31, 2024. Net Loss: The Company reported a net loss attributable to common stockholders of $61.8 million for the year ended December 31, 2025, which included $9.5 million of stock-based compensation, compared to a net loss of $138.4 million for the same period in 2024, which included $19.1 million of stock-based compensation. Research and Development (R&D) Expenses: R&D expenses were $62.0 million for the year ended December 31, 2025 compared to $118.1 million for the same period in 2024. The decrease of $56.1 million was primarily due the decrease of $42.7 million in external costs primarily driven by a decrease of $28.5 million related to clinical activities due to our strategic realignment to focus on our core assets and ceasing internal development of our oncology programs, a decrease of $4.4 million in manufacturing costs, a decrease of $4.0 million related to consultants, advisors and other professional services to support our clinical studies, discovery research and overall research and development program, and a decrease of $5.8 million related to preclinical and exploratory programs. Personnel-related expenses, including stock-based compensation, decreased by $11.3 million due to a decrease in headcount. Facilities and other allocated expenses decreased by $2.1 million due to a decrease in rent and facilities-related costs. General and Administrative (G&A) Expenses: G&A expenses were $19.3 million for the year ended December 31, 2025 compared to $26.0 million for the same period in 2024. The decrease of $6.7 million was primarily driven by a decrease of $5.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. Consulting and professional expenses decreased by $0.7 million due to legal, accounting, consulting and other services. Facilities and other allocated expenses decreased by $0.1 million due to a decrease in rent and facilities-related costs. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 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 and BMF-650, the potential of icovamenib as a treatment for type 1 diabetes and type 2 diabetes, the potential of BMF-650 as a treatment for 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 II COVALENT-111 study , our Phase II COVALENT-112 study , our Phase II COVALENT-211 study, our Phase II COVALENT-212 study and our Phase I GLP-131 study; 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 [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):
Investor releaseQuarter not tagged2025-12-05Biomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
GlobeNewswire
Biomea Fusion Presents COVALENT-111 Study Results at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes. “I am very pleased that our data was selected for an oral presentation at the WCIRDC meeting this year. Over the past 24 months, our clinical studies have shown that selective inhibition of menin can meaningfully influence the clinical response of patients with insulin deficient diabetes. The results we presented at this meeting highlight the lasting and continuous benefits observed in in our study, with durable glycemic and C-peptide improvements 9 months after the last dose,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “Targeting menin offers promise for people living with diabetes, with the potential to support the natural insulin producing capacity of the pancreatic beta cells. Icovamenib, as a selective menin inhibitor, represents a first in class approach in this area of research.” Key Highlights from WCIRDC showing HbA1c and C-peptide responses at week 52 – 9 months post the last dose: Icovamenib demonstrated durable and continuous treatment effect in severe insulin-deficient type 2 diabetes (T2D) Higher HbA1c reduction was associated with higher icovamenib exposure Icovamenib improved long-term insulin secretion in severe insulin-deficient T2D Treatment effect in GLP-1 “failures” continued to improve with durable and clinically significant improvements in HbA1c Icovamenib was generally well-tolerated, with no adverse-event related discontinuations and no related serious adverse events The abstract will be published in the peer-reviewed Metabolism: Experimental and Clinical. The presentation will be available on Biomea Fusion's Investor Relations Page under the Events. Please find a link here to our website where the poster will be available. COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that e…Read full documentShow less
Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic and c-peptide improvements with icovamenib, a menin inhibitor targeting beta-cell restoration in insulin deficient type 2 diabetes. “I am very pleased that our data was selected for an oral presentation at the WCIRDC meeting this year. Over the past 24 months, our clinical studies have shown that selective inhibition of menin can meaningfully influence the clinical response of patients with insulin deficient diabetes. The results we presented at this meeting highlight the lasting and continuous benefits observed in in our study, with durable glycemic and C-peptide improvements 9 months after the last dose,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “Targeting menin offers promise for people living with diabetes, with the potential to support the natural insulin producing capacity of the pancreatic beta cells. Icovamenib, as a selective menin inhibitor, represents a first in class approach in this area of research.” Key Highlights from WCIRDC showing HbA1c and C-peptide responses at week 52 – 9 months post the last dose: Icovamenib demonstrated durable and continuous treatment effect in severe insulin-deficient type 2 diabetes (T2D) Higher HbA1c reduction was associated with higher icovamenib exposure Icovamenib improved long-term insulin secretion in severe insulin-deficient T2D Treatment effect in GLP-1 “failures” continued to improve with durable and clinically significant improvements in HbA1c Icovamenib was generally well-tolerated, with no adverse-event related discontinuations and no related serious adverse events The abstract will be published in the peer-reviewed Metabolism: Experimental and Clinical. The presentation will be available on Biomea Fusion's Investor Relations Page under the Events. Please find a link here to our website where the poster will be available. COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. About Icovamenib Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The proposed mechanism of action for icovamenib in diabetes is selective and partial inhibition of menin, a regulator of beta cell quantity and function, thereby enabling the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the first non-chronic therapy for T2D, icovamenib could become an important addition to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies. About Biomea Fusion Biomea Fusion is a clinical-stage biopharmaceutical company advancing oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 clinical and therapeutic potential of our product candidates and development programs, including icovamenib and the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; 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 Food Effect Study (COVALENT-121), the initiation of our Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, to initiate in fourth quarter of 2025 and the initiation of our Phase II trial with GLP-1 therapy (COVALENT-212) in type 2 diabetes patients, in the fourth quarter of 2025; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events 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 [email protected]
Investor releaseQuarter not tagged2025-11-05Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports Third Quarter 2025 Financial Results and Corporate Highlights
Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next-generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trial Presented preclinical activity of icovamenib in combination with semaglutide in type 2 diabetes (“T2D”) animal model at EASD Annual Meeting, demonstrating enhanced glycemic control and body weight reduction with preservation of lean mass Raised approximately $68 million in gross proceeds through two public offerings, extending projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., Nov. 04, 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 third quarter ended September 30, 2025, and provided a business update. "Since I joined the company we have reduced our expenses and focused the team on our core assets, advancing them to the next clinical milestones. During the third quarter we streamlined the operations, bringing the workforce down to approximately 40 employees. In addition, we released promising Phase II icovamenib data, which then provided the necessary tailwind to gain funding into 2027,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “Icovamenib demonstrated continued reduction in HbA1c, nine months-post dosing in both of our identified target populations while maintaining a safety profile similar to placebo. These findings support our thesis that menin inhibition can potentially address the underlying cause of diabetes. Icovamenib is now moving rapidly into two Phase II studies enrolling each of these patient subtypes. With BMF-650, we also made great progress and have now dosed our first patient in a Phase I study.” Third Quarter Highlights: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (“T1D”)) Reported positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study of icovamenib in T2D. The study demonstrated durable and clinically meaningful HbA1c reductions nine months after completion of dosing. In patients with severe insulin-deficient diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib…Read full documentShow less
Advances diabetes and obesity programs with icovamenib demonstrating durable 52-Week Phase II data and with BMF-650, Biomea’s next-generation, oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), dosing its first patient in a Phase I clinical trial Presented preclinical activity of icovamenib in combination with semaglutide in type 2 diabetes (“T2D”) animal model at EASD Annual Meeting, demonstrating enhanced glycemic control and body weight reduction with preservation of lean mass Raised approximately $68 million in gross proceeds through two public offerings, extending projected cash runway into the first quarter of 2027 SAN CARLOS, Calif., Nov. 04, 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 third quarter ended September 30, 2025, and provided a business update. "Since I joined the company we have reduced our expenses and focused the team on our core assets, advancing them to the next clinical milestones. During the third quarter we streamlined the operations, bringing the workforce down to approximately 40 employees. In addition, we released promising Phase II icovamenib data, which then provided the necessary tailwind to gain funding into 2027,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “Icovamenib demonstrated continued reduction in HbA1c, nine months-post dosing in both of our identified target populations while maintaining a safety profile similar to placebo. These findings support our thesis that menin inhibition can potentially address the underlying cause of diabetes. Icovamenib is now moving rapidly into two Phase II studies enrolling each of these patient subtypes. With BMF-650, we also made great progress and have now dosed our first patient in a Phase I study.” Third Quarter Highlights: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (“T1D”)) Reported positive 52-week follow-up results from the Company’s Phase II COVALENT-111 study of icovamenib in T2D. The study demonstrated durable and clinically meaningful HbA1c reductions nine months after completion of dosing. In patients with severe insulin-deficient diabetes receiving one or more antihyperglycemic agents at baseline, icovamenib achieved a sustained 1.5% mean reduction in HbA1c at Week 52, following only 12 weeks of dosing (Arm B, p = 0.01). The 52-week analysis also showed clinically meaningful benefit in study participants who were receiving GLP-1-based therapy but had not achieved glycemic targets at study entry (all arms, n=11). In this subgroup, 8 or 12 weeks of icovamenib resulted in a 1.3% reduction in HbA1c. Icovamenib was generally well tolerated across all dosing arms, with no treatment-related serious adverse events or discontinuations due to adverse events observed during the 52-week observation period. Presentation at the 61st European Association for the Study of Diabetes (EASD) Annual Meeting: Presented preclinical data demonstrating enhanced activity of icovamenib in combination with semaglutide in a T2D animal model. The combination therapy achieved superior glycemic control, improved beta-cell function, and greater body-weight reduction while preserving lean mass, compared to semaglutide alone. These findings further support the potential of icovamenib to complement GLP-1 RAs and enhance long-term metabolic outcomes. BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity) The Investigational New Drug application was accepted, and the first patient has been dosed in a Phase I study. The study will assess in several single ascending and multiple ascending dose cohorts the 28-day weight loss potential of BMF-650 in obese, otherwise healthy volunteers. Presented new preclinical findings from a 28-day weight loss study in obese nonhuman primates evaluating BMF-650, which led to marked reductions in food intake and progressive body weight reductions. These data compared favorably to published preclinical data of another leading oral GLP-1 RA candidate in development. Financing & Operations In October 2025, Biomea completed its previously announced underwritten public offering. The gross proceeds from the offering were approximately $25.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea. During the third quarter, Biomea continued to reduce its expenses, achieving a year-over-year decrease of more than 50% in operating expenses. Key Anticipated Milestones: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D) Food Effect Study (COVALENT-121) is ongoing, to optimize the dosing criteria for icovamenib, and expected to be completed by December 2025. Initiation of Phase IIb trial (COVALENT-211) in severe insulin-deficient T2D patients is expected in the fourth quarter of 2025, with First Patient In ("FPI") expected in the first quarter of 2026. Initiation of Phase II trial (COVALENT-212) in T2D patients currently not achieving glycemic targets on a GLP-1 based therapy is expected in the fourth quarter of 2025, with FPI expected in the first quarter of 2026. BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity) Phase I trial (GLP-131) Biomea’s oral GLP-1 RA (BMF-650) in obese, otherwise healthy volunteers is ongoing and anticipated to deliver 28-day weight reduction data in the first half of 2026. Third Quarter 2025 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of September 30, 2025, the Company had cash, cash equivalents and restricted cash of $47.0 million. Net Loss: The Company reported a net loss attributable to common stockholders of $16.4 million for the three months ended September 30, 2025, which included $1.9 million of stock-based compensation, compared to a net loss of $32.8 million for the same period in 2024, which included $4.7 million of stock-based compensation. Net loss attributable to common stockholders was $66.4 million for the nine months ended September 30, 2025, which included $7.7 million of stock-based compensation, compared to a net loss of $109.1 million for the same period in 2024, which included $14.6 million of stock-based compensation. Research and Development ("R&D") Expenses: R&D expenses were $14.4 million for the three months ended September 30, 2025, compared to $27.2 million for the same period in 2024. The decrease of approximately $12.8 million was primarily driven by a decrease of $4.7 million related to clinical activities, a decrease of $2.6 million in other external costs related to consultants, advisors and other professional services to support our clinical studies and a decrease of $0.5 million related to preclinical and exploratory programs, partially offset by an increase of $0.5 million in manufacturing costs. Personnel-related expenses decreased by $4.8 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $0.7 million due to a decrease in rent and facilities-related costs. R&D expenses were $53.8 million for the nine months ended September 30, 2025, compared to $92.8 million for the same period in 2024. The decrease of $39.0 million was primarily driven by a decrease of $21.1 million related to clinical activities, a decrease of $3.6 million related to preclinical and exploratory programs, a decrease of $2.0 million in other external costs related to consultants, advisors and other professional services to support our clinical studies, a decrease of $1.3 million of manufacturing costs. Personnel-related expenses decreased by $10.2 million, including stock-based compensation, due to a decrease in headcount. Facilities and other allocated expenses decreased by $0.7 million due to a decrease in rent and facilities-related costs. General and Administrative ("G&A") Expenses: G&A expenses were $4.2 million for the three months ended September 30, 2025, compared to $6.8 million for the same period in 2024. The decrease of $2.6 million was primarily driven by a decrease of $2.5 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.1 million related to facilities-related costs. G&A expenses were $15.7 million for the nine months ended September 30, 2025, compared to $21.2 million for the same period in 2024. The decrease of $5.4 million was primarily driven by a decrease of $5.4 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 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 and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for 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 Phase I trial for BMF-650; 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 [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):
Investor releaseQuarter not tagged2025-10-07Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations
GlobeNewswire
Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations
Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52 Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials in severe insulin-deficient diabetes patients and diabetes patients not achieving glycemic target with a GLP-1-based therapy are expected to begin in the fourth quarter of 2025 Company to host a conference call to discuss results on Tuesday, October 7 at 8:30 am ET SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D). “We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. Icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology.” COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icova…Read full documentShow less
Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin-deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52 Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials in severe insulin-deficient diabetes patients and diabetes patients not achieving glycemic target with a GLP-1-based therapy are expected to begin in the fourth quarter of 2025 Company to host a conference call to discuss results on Tuesday, October 7 at 8:30 am ET SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D). “We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. Icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology.” COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat (mITT) population. As previously reported, dosing was interrupted by an interim clinical hold imposed by the U.S. Food and Drug Administration (FDA). The topline efficacy analysis presented here includes the patient population (N=163) who had completed at least 80% of their planned dosing prior to the clinical hold (without other significant protocol deviations) and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm. The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment (n=10). Among these severe insulin-deficient patients, icovamenib achieved a durable HbA1c reduction of 1.2% (p=0.01) sustained through Week 52. The strongest performing arm for this prespecified population was Arm B (n=6; 100mg QD for 12 weeks), with a mean HbA1c reduction of 1.5% (p=0.01). Severe insulin-deficient diabetes is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need. The 52-week analysis also showed clinically meaningful benefit in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry (all arms n=11). In this subgroup, 8 or 12 weeks of icovamenib resulted in a 1.3% reduction in HbA1c (p=0.05) with effects sustained through Week 52. Icovamenib maintained a favorable safety profile throughout the 52-week observation period. There were no treatment-related serious adverse events or discontinuations due to adverse events. Across all dosing arms, icovamenib was generally well tolerated. “The 52-week durability in severe insulin-deficient patients is remarkable. These are the most difficult to treat patients, and no current therapy provides this kind of lasting benefit for them without chronic dosing,” said Professor Ralph DeFronzo, M.D., University of Texas Health Science Center. “The HbA1c reductions we are seeing in this study readout, sustained long after the treatment had stopped, suggest a restoration of beta cell function. I believe icovamenib represents a major advancement, with the potential to become a new pillar of diabetes care as it addresses the root cause of diabetes, the dysfunction of beta cells. Of note, and also very exciting, is the interplay with GLP-1 based agents, whereby icovamenib seems to have given renewed impact to these agents.” Planned Next Steps Food Effect Study (COVALENT-121) is ongoing, to optimize the dosing criteria for icovamenib, and expected to be completed by December 2025 Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, is expected to be initiated in the fourth quarter of 2025 Phase II trial (COVALENT-212) with GLP-1 based therapy in type 2 diabetes patients, is expected to be initiated in the fourth quarter of 2025 Phase I trial (GLP-131) Biomea’s oral GLP-1 RA (BMF-650) in obese, otherwise healthy volunteers, initiation is ongoing, and data anticipated in the first half of 2026 Conference Call and Webcast Details Webcast of Biomea’s investor update on Tuesday, October 7, 2025, at 8:30 am ET will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events. A replay of the presentation will be archived on Biomea’s website following the event. About Icovamenib Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The proposed mechanism of action for icovamenib in diabetes is selective and partial inhibition of menin, a regulator of beta cell quantity and function, thereby enabling the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the first non-chronic therapy for T2D, icovamenib could become an important addition to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies. About Menin’s Role in Diabetes Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to treat T2D. About Type 2 Diabetes and Severe Insulin-Deficient Diabetes Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in excessive glucose in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease. The Centers for Disease Control and Prevention estimates about two in five adults in the United States are now expected to develop diabetes during their lifetime. More than 38 million people of all ages (about 11% of the US population) have diabetes today. 98 million adults (more than one in three) have prediabetes, blood glucose levels that are higher than normal but not high enough to be classified as diabetes. Diabetes is also one of the largest economic burdens on the United States health care system with one out of every four dollars in US health care spending on caring for people with diabetes. Despite the current availability of many diabetes medications, there remains a significant need in the treatment and care of patients with diabetes. Within the population of people with T2D, severe insulin deficient diabetes is a clinically recognized subtype of T2D characterized by profoundly impaired insulin secretion (significantly reduced beta cell function) and poor glycemic control. People with diabetes with severe insulin deficiency often present with higher HbA1c levels at diagnosis, lower body mass index compared to insulin-resistant patients, and a rapid decline in beta cell function. This group represents a very high unmet medical need, with the highest risk of complications such as retinopathy and neuropathy, and typically progresses the fastest to insulin therapy. Addressing the underlying beta cell dysfunction in this population offers an important opportunity to slow or potentially reverse disease progression. About Biomea Fusion Biomea Fusion is a clinical-stage biopharmaceutical company advancing oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world’s population. Biomea’s mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. 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 clinical and therapeutic potential of our product candidates and development programs, including icovamenib and the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; 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 Food Effect Study (COVALENT-121), the initiation of our Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, to initiate in fourth quarter of 2025 and the initiation of our Phase II trial with GLP-1 therapy (COVALENT-212) in type 2 diabetes patients, in the fourth quarter of 2025; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events 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 [email protected]
Investor releaseQuarter not tagged2025-08-06Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights
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,…Read full documentShow less
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 15% weight reduction and robust dose-dependent appetite suppression. These findings reinforce BMF-650’s potential as an oral GLP-1 RA. With these clinical advances and the completion of our $42.8 million equity financing, we now have the necessary resources to advance these high-priority diabetes and obesity programs.” 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 and 50% 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 $42.8 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea. During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately 40% lower than the most recent quarter, depending on study enrollments and expansion. 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 $56.6 million. The Company expects its cash, cash equivalents, and restricted cash to be sufficient to fund planned operating activities into the second half of 2026. Net Loss: The Company reported a net loss attributable to common stockholders of $20.7 million for the three months ended June 30, 2025, which included $2.6 million of stock-based compensation, compared to a net loss of $37.3 million for the same period in 2024, which included $4.8 million of stock-based compensation. Net loss attributable to common stockholders was $50.0 million for the six months ended June 30, 2025, which included $5.7 million of stock-based compensation, compared to a net loss of $76.3 million for the same period in 2024, which included $9.9 million of stock-based compensation. Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024. The decrease of approximately $15.3 million was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount. R&D expenses were $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024. The decrease of $26.1 million was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount. General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024. The decrease of $2.4 million is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services. G&A expenses were $11.5 million for the six months ended June 30, 2025, compared to $14.4 million for the same period in 2024. The decrease of $2.8 million is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. 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 [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):
Investor releaseQuarter not tagged2025-06-18Biomea Says Preclinical Results Show 'Robust' Weight Loss From Investigational Drug
MT Newswires
Biomea Says Preclinical Results Show 'Robust' Weight Loss From Investigational Drug
Biomea Fusion (BMEA) said Wednesday that preclinical data for its investigational weight loss drug,
Investor releaseQuarter not tagged2025-05-06Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights
Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapy Biomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 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 first quarter ended March 31, 2025, and provided a business update. “In the first quarter of 2025, we executed a focused realignment of our operations to concentrate resources on our highest-value opportunities and extend our cash runway and position Biomea for long-term success,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “With icovamenib advancing in insulin-deficient type 2 diabetes patients and BMF-650 on track for IND submission, we are strategically positioned to deliver meaningful clinical data and drive value across our metabolic pipeline. These actions reflect our commitment to capital efficiency and developing the core therapies that we believe will have the potential to transform the lives of patients with diabetes and obesity.” Strategic Realignment Highlights Prioritizing Core Programs: Biomea will focus development efforts and investments on icovamenib, a novel oral menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist. Operational Streamlining: The Company has implemented a cost-reduction initiative, including a workforce reduction of approximately 35%, to reduce the overall operating expenses and extend its cash runway into the fourth quarter of 2025. As part of this initiative, Biomea is consolidating its workforce at the current research facility known as the Biomea Innovation Lab Center located in San Carlos, CA as of May 31, eliminating the cost of maintaining two separate facilities. Key Anticipated 2025 Milestones: Icovamenib (Oral Small Molecule Menin Inhibitor for Type 2 and Type 1 Diabetes) 52-week data from the Phase II COVALENT-111 study in type 2 diabetes expected in the second ha…Read full documentShow less
Company Announces Strategic Realignment to Focus on Core Programs and Extend Cash Runway Icovamenib progressing toward the next phase of clinical development in insulin deficient type 2 diabetes patients and patients that are currently uncontrolled on a GLP-1 based therapy Biomea's next generation oral GLP-1 receptor agonist (BMF-650) filing for IND All other clinical and preclinical activities are either being partnered or closed REDWOOD CITY, Calif., May 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 first quarter ended March 31, 2025, and provided a business update. “In the first quarter of 2025, we executed a focused realignment of our operations to concentrate resources on our highest-value opportunities and extend our cash runway and position Biomea for long-term success,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “With icovamenib advancing in insulin-deficient type 2 diabetes patients and BMF-650 on track for IND submission, we are strategically positioned to deliver meaningful clinical data and drive value across our metabolic pipeline. These actions reflect our commitment to capital efficiency and developing the core therapies that we believe will have the potential to transform the lives of patients with diabetes and obesity.” Strategic Realignment Highlights Prioritizing Core Programs: Biomea will focus development efforts and investments on icovamenib, a novel oral menin inhibitor for diabetes, and BMF-650, a next-generation oral GLP-1 receptor agonist. Operational Streamlining: The Company has implemented a cost-reduction initiative, including a workforce reduction of approximately 35%, to reduce the overall operating expenses and extend its cash runway into the fourth quarter of 2025. As part of this initiative, Biomea is consolidating its workforce at the current research facility known as the Biomea Innovation Lab Center located in San Carlos, CA as of May 31, eliminating the cost of maintaining two separate facilities. Key Anticipated 2025 Milestones: Icovamenib (Oral Small Molecule Menin Inhibitor for Type 2 and Type 1 Diabetes) 52-week data from the Phase II COVALENT-111 study in type 2 diabetes expected in the second half of 2025. Type-C meeting planned with FDA in the second half of 2025 to discuss a Phase IIb trial design and the requirements to advance icovamenib into later stage clinical development. 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 type 1 diabetes anticipated in the second half of 2025. BMF-650 (Next-generation Oral Small Molecule GLP-1 Receptor Agonist for Obesity) Submission of the Investigational New Drug (“IND”) application for BMF-650 planned for the second half of 2025. BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Leukemia) Survival data from the dose escalation study in relapsed/refractory acute leukemia expected in the second quarter of 2025. The Company concludes its oncology efforts with BMF-500 and is exploring strategic partnerships. Corporate Updates In March 2025, the Company announced a leadership transition, appointing Board Member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler. In January 2025, Biomea formally transitioned to a diabetes and obesity medicines company, ceasing internal development of its oncology programs. First Quarter 2025 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of March 31, 2025, the Company had cash, cash equivalents and restricted cash of $36.2 million. We expect our cash, cash equivalents, and restricted cash to be sufficient to fund our operating plans into the fourth quarter of 2025. Net Loss: The Company reported a net loss attributable to common stockholders of $29.3 million for the three months ended March 31, 2025, which included $3.2 million of stock-based compensation, compared to a net loss of $39.1 million for the same period in 2024, which included $5.0 million of stock-based compensation. Research and Development (“R&D”) Expenses: R&D expenses were $22.9 million for the three months ended March 31, 2025, compared to $33.8 million for the same period in 2024. This decrease of $9.2 million in external costs was primarily driven by a decrease of $7.3 million related to clinical activities, a decrease of $1.8 million related to manufacturing costs and decrease of $1.0 million related to preclinical activities and exploratory programs. This decrease in external costs was partially offset by an increase of $0.9 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $1.7 million, including stock-based compensation. General and Administrative (“G&A”) Expenses: G&A expenses were $6.8 million for the three months ended March 31, 2025, compared to $7.3 million for the same period in 2024. The decrease is primarily due to a decrease in personnel-related expenses, including stock-based compensation of $0.9 million, resulting from a decrease in headcount. The decrease is partially offset by an increase in professional and legal services of $0.4 million. 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 designed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. 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 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, including our planned Type-C meeting with the FDA to discuss Phase II trial design and the advancement of icovamenib and the planned submission of our IND application for BMF-650, and the timing of such events 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 WeissSr. Director of Investor Relations and Corporate [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):
Investor releaseQuarter not tagged2025-04-01Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights
GlobeNewswire
Biomea Fusion Reports Fourth Quarter and Full Year 2024 Financial Results and Corporate Highlights
Mick Hitchcock, Ph.D., appointed Interim Chief Executive Officer Biomea preparing icovamenib for late-stage clinical development Multiple milestones anticipated in 2025 including: FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patients COVALENT-111 (T2D) 52-week data anticipated in second half 2025 COVALENT-112 (T1D) open label data anticipated in second half 2025 BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights. “2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “As we move into this next phase, the Board made a strategic decision to align leadership with the company’s evolution, and I’m honored to step in and contribute decades of experience in late-stage development, regulatory strategy, and commercialization to help guide Biomea forward. This transition reflects the continued confidence in our menin inhibitor program and the strength of our covalent small molecule platform. We remain fully committed to advancing icovamenib and delivering on our mission to transform diabetes treatment through this disease-modifying therapy. With key data readouts and regulatory milestones ahead, 2025 is set to be a pivotal year for the company.” In March 2025, the Company announced a leadership transition, appointing Board member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler. In January 2025, we announced plans to position Biomea as a dedicated diabetes and obesity medicines company. Building on our most recent clinical trial results, our strategic focus for icovamenib is now exclusively centered on metabolic disorders. As a result, we are terminating all ongoing oncology trials involving icovamenib and will conclude the BMF-500 study in patients…Read full documentShow less
Mick Hitchcock, Ph.D., appointed Interim Chief Executive Officer Biomea preparing icovamenib for late-stage clinical development Multiple milestones anticipated in 2025 including: FDA meeting anticipated in first half 2025 to discuss icovamenib late-stage development in severe insulin deficient patients COVALENT-111 (T2D) 52-week data anticipated in second half 2025 COVALENT-112 (T1D) open label data anticipated in second half 2025 BMF-650 IND application submission planned in second half 2025 REDWOOD CITY, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, reported fourth quarter and full year 2024 financial results and corporate highlights. “2024 was a transformative year for Biomea, marked by the advancement of icovamenib into late-stage development and compelling clinical data that reinforced our confidence in its potential to reshape diabetes treatment, particularly for patients with severe insulin deficiency,” said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. “As we move into this next phase, the Board made a strategic decision to align leadership with the company’s evolution, and I’m honored to step in and contribute decades of experience in late-stage development, regulatory strategy, and commercialization to help guide Biomea forward. This transition reflects the continued confidence in our menin inhibitor program and the strength of our covalent small molecule platform. We remain fully committed to advancing icovamenib and delivering on our mission to transform diabetes treatment through this disease-modifying therapy. With key data readouts and regulatory milestones ahead, 2025 is set to be a pivotal year for the company.” In March 2025, the Company announced a leadership transition, appointing Board member Mick Hitchcock, Ph.D., as Interim Chief Executive Officer, succeeding Thomas Butler. In January 2025, we announced plans to position Biomea as a dedicated diabetes and obesity medicines company. Building on our most recent clinical trial results, our strategic focus for icovamenib is now exclusively centered on metabolic disorders. As a result, we are terminating all ongoing oncology trials involving icovamenib and will conclude the BMF-500 study in patients with relapsed/refractory acute leukemia with FLT3 gene mutations following the dose escalation phase. Biomea will seek strategic partnerships to advance its oncology portfolio and the capabilities of its FUSION™ System, while reallocating internal resources to accelerate our metabolic disease programs. In October 2024, we announced the formation of our Global Scientific Advisory Board, comprised of 22 internationally recognized experts in beta cell science and diabetes therapeutics. This board will work closely with our leadership team as we continue to explore menin biology and beta cell regeneration, and advance the clinical development of icovamenib as a novel, disease-modifying treatment targeting a root cause of diabetes. RECENT DIABETES AND OBESITY PROGRAM UPDATES COVALENT-111 (Icovamenib for Type 2 Diabetes (“T2D”)) Study Results: In the dose expansion portion of the COVALENT-111 study, icovamenib demonstrated statistically significant reductions in HbA1c in the prespecified per protocol patient population, with notable effects in the severe insulin deficient patients. In this group, icovamenib achieved a 1.47% reduction in HbA1c at Week 26 following 12 weeks of treatment with 100 mg once a day (“QD”). Severe insulin deficient patients also experienced the largest mean increase in C-peptide index levels, with a 53% mean increase from baseline by Week 26, indicating enhanced endogenous insulin production. In a broader subset of insulin deficient patients, icovamenib treatment led to a 1.0% reduction in HbA1c at Week 26 following 12 weeks of treatment with 100 mg QD. The data showed that icovamenib preferentially increased insulin secretion in insulin-deficient patients, supporting its potential as a targeted therapy for individuals with severe insulin deficiency, a population with limited treatment options and the highest risk profile. Across all dosing groups in the severe insulin deficient subgroup, there was a strong correlation between increases in C-peptide and reductions in HbA1c, consistent with the proposed mechanism through beta cell restoration. HbA1c reductions were durable at 26 weeks, 3 months post last dose, further supporting the long-lasting effect of icovamenib on glycemic control. Icovamenib was generally well tolerated, with no treatment discontinuations due to adverse events, no hypoglycemic episodes, and no drug-related serious adverse events reported. Preclinical Findings: In preclinical experiments, including in ex vivo human islets, icovamenib was able to enhance the activity of GLP-1 RA-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes. These effects were associated with an increase in the expression levels of the GLP-1 receptors (“GLP-1R”). Overall results showed synergy of the combination therapy, which may allow lower doses of GLP-1-based therapies to achieve glycemic targets potentially reducing side effects and improving the tolerability of GLP-1 based therapies. Anticipated 2025 Milestones: Planned U.S. Food and Drug Administration (“FDA”) discussions regarding Phase II/III trial designs and the advancement of icovamenib into late-stage clinical development in the first half of 2025. 52-week data from the COVALENT-111 Phase II study anticipated in the second half of 2025. COVALENT-112 (Icovamenib for Type 1 Diabetes (“T1D”)) Anticipated 2025 Milestones: Initial open label data from the Phase II study is expected in the second half of 2025. BMF-650 (Oral small molecule GLP-1 RA) Preclinical Progress: Preclinical studies evaluating the properties of our investigational, next-generation, oral small molecule GLP-1 RA (BMF-650) demonstrated positive early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, and appetite suppression in cynomolgus monkeys. In comparison to a leading oral GLP-1 RA, BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and enable successful dose escalation in patients. Human donor islet studies confirmed that BMF-650 significantly enhanced glucose-stimulated insulin secretion, aligning with findings from animal models. In cynomolgus monkey studies, BMF-650 demonstrated robust improvements in glucose control and insulin secretion, consistent with its effects in human donor islets. Appetite suppression studies revealed that daily oral dosing of BMF-650 significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period. Anticipated 2025 Milestones: Submission of the Investigational New Drug (“IND”) application for BMF-650 is planned for the second half of 2025. ONCOLOGY PROGRAM COVALENT-103 Study (BMF-500): Preliminary Phase I data for BMF-500 in relapsed/refractory acute leukemia patients with FLT3 gene mutations having failed gilteritinib indicated clinical activity with evidence of responses, including a first complete response with incomplete hematologic recovery (CRi) and reductions in bone marrow blasts in five of six evaluable FLT3 mutated patients. Pharmacokinetic and pharmacodynamic analyses confirmed dose-proportional on-target FLT3 inhibition and good compartmental penetration, and BMF-500 showed a favorable safety and tolerability profile with no dose-limiting toxicities observed. Anticipated 2025 Milestones: After the completion of the dose escalation of BMF-500 in relapsed/refractory acute leukemia patients with FLT3 gene mutations, we intend to conclude our oncology study with BMF-500 and explore strategic partnerships. FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS Cash, Cash Equivalents, and Restricted Cash: As of December 31, 2024, the Company had cash, cash equivalents and restricted cash of $58.6 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 $29.3 million for the three months ended December 31, 2024, compared to a net loss of $34.9 million for the same period in 2023. Net loss attributable to common stockholders was $138.4 million for the year ended December 31, 2024, compared to a net loss of $117.3 million for the same period in 2023. Research and Development (“R&D”) Expenses: R&D expenses were $25.2 million for the three months ended December 31, 2024, compared to $30.9 million for the same period in 2023. The decrease of $5.6 million was primarily due to the decrease in compensation and related expenses, manufacturing related expenses, and clinical related expenses. R&D expenses were $118.1 million for the year ended December 31, 2024, compared to $102.5 million for the same period in 2023. The increase of $15.5 million was primarily due to an increase in clinical development of icovamenib, consultants, advisors and other professional services to support our clinical studies, discovery research and overall research and development programs. General and Administrative (“G&A”) Expenses: G&A expenses were $4.8 million for the three months ended December 31, 2024, compared to $6.5 million for the same period in 2023. The decrease of $1.6 million was primarily due to the decrease in compensation and related expenses. G&A expenses were $26.0 million for the year ended December 31, 2024, compared to $23.6 million for the same period in 2023. The increase of $2.4 million was primarily due to increased personnel-related expenses, including stock-based compensation, due to an increase in headcount, as well as an increase in professional and consulting services to support the growth of the Company. About IcovamenibIcovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea Fusion’s FUSION™ System and is designed to regenerate insulin-producing beta cells with the aim to cure diabetes. Icovamenib’s proposed mechanism of action in diabetes is to enable the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the potentially first disease-modifying therapy for T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed clinical studies. About Biomea FusionBiomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and metabolic diseases. 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 StatementsStatements 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, including icovamenib, BMF-500, and BMF-650, the potential of icovamenib as a treatment for T12 and T2D, the potential of BMF-650 as a treatment for diabetes and obesity, our research, development and regulatory plans, and our expectations regarding the Biomea FUSION™ System; the mechanism of action of our product candidate and development programs, and their potential relative to approved products marketed by third parties; the potential benefits to future trial design and program development of subtyping diabetes patients and their potential to be used in combination with approved products marketed by third parties; our research, development and regulatory plans, the progress 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 IND enabling studies for the BMF-650 program, the anticipated enrollment and dosing of patients and availability of data from our clinical trials, and the timing of such events 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 WeissSr. Director of Investor Relations and Corporate Development [email protected] (1) Includes stock-based compensation as follows (non-cash operating expenses):

