Biomea Fusion (NASDAQ: BMEA) details icovamenib and BMF-650 trial milestones
Rhea-AI Filing Summary
Biomea Fusion filed an 8-K to share an updated corporate presentation outlining its pipeline for diabetes and obesity. The company highlights icovamenib, a potential first-in-class oral menin inhibitor designed to restore beta-cell function in type 2 diabetes, with two Phase II trials (COVALENT-211 and COVALENT-212) underway and 26-week primary endpoint data anticipated in 4Q 2026. Earlier Phase IIa data showed durable HbA1c reductions and increased C-peptide up to 52 weeks after a 12-week course, along with a generally favorable safety profile. Biomea also presents BMF-650, an investigational next-generation oral GLP-1 receptor agonist for obesity that achieved up to about 15% weight loss over 28 days in obese monkeys, with Phase I 28-day weight reduction data in obese volunteers expected in 2Q 2026. The company states it is funded through key readouts for icovamenib and BMF-650 into Q1 2027 and emphasizes large target populations across insulin-deficient diabetes, GLP-1 inadequate responders, and obesity.
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| Item 7.01 | Regulation FD Disclosure. |
On February 25, 2026, Biomea Fusion, Inc. (the “Company”) updated its corporate presentation to be used from time to time with investors, analysts and other third parties (the “Corporate Presentation”). The Company posted a copy of the presentation to the “Investors & Media” section of the Company’s website at www.biomeafusion.com. A copy of the Corporate Presentation is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Forward-Looking Statements
This Current Report on Form 8-K and certain materials furnished within 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 could be deemed forward-looking, including any projections of financial information or profitability, including the Company’s expected cash runway, the initiation, timing and results of pending or future preclinical studies and clinical trials, the actual or potential actions of the U.S. Food and Drug Administration (FDA), the status and timing of ongoing research, development and corporate partnering activities, any statements about historical results that may suggest trends for the Company’s business; any statements of the plans, strategies, and objectives of management for future operations and any statements of expectation or belief regarding future events, potential markets or market size, or technology developments. The Company intends 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 is making this statement for purposes of complying with those safe harbor provisions.
Any forward-looking statements made in this Current Report on Form 8-K or included in certain of the materials furnished herewith are based on the Company’s current expectations, estimates and projections only as of the date of this Current Report on Form 8-K 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 ongoing or 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 the Company’s ongoing and planned clinical trials and other research and development activities. These risks concerning the Company’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
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| 99.1 | Biomea Fusion Corporate Presentation | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BIOMEA FUSION, INC. | ||||||
| Date: February 25, 2026 | By: | /s/ Michael J.M. Hitchcock | ||||
| Michael J.M. Hitchcock | ||||||
| Interim Chief Executive Officer, Director (Principal Executive Officer) | ||||||
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Exhibit 99.1 st 1 QUARTER 2026 Biomea Fusion Corporate Presentation 1
Legal disclaimer & forward-looking statements Certain statements in this presentation and the accompanying oral commentary are forward-looking statements. These statements relate to future events or the future business and financial performance of Biomea Fusion, Inc. (the “Company”) and involve known and unknown risks, uncertainties, and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. All statements other than statements of historical fact could be deemed forward-looking, including any projections of financial information or profitability, including our expected cash runway, the initiation, timing and results of pending or future preclinical studies and clinical trials, the actual or potential actions of the U.S. Food and Drug Administration (FDA), the status and timing of ongoing research, development and corporate partnering activities, any statements about historical results that may suggest trends for the Company's business; any statements of the plans, strategies, and objectives of management for future operations and any statements of expectation or belief regarding future events, potential markets or market size, or technology developments. The Company has based these forward-looking statements on its current expectations, assumptions, estimates, and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission (the SEC), as well as discussions of potential risks, uncertainties, and other important factors in our other subsequent filings with the SEC. The forward-looking statements in this presentation are made only as of the date hereof. Except as required by law, the Company assumes no obligation and does not intend to update these forward-looking statements or to conform these statements to actual results or to changes in the Company's expectations. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. 2
Transforming diabetes and obesity with novel oral medicines Biomea Fusion founded in 2017 (public in 2021; NASDAQ: BMEA ) Clinical-stage company advancing two differentiated metabolic investigative programs ICOVAMENIB Potential first-in-class oral menin inhibitor - the control switch to beta cell restoration Restores functional beta-cell mass to address disease biology in type 2 diabetes • Increased insulin production and synergy with GLP-1 shown in preclinical models • Durable HbA1c reduction and C-peptide increase through 52 weeks after a 12-week course in the first Phase II trial in T2D patients failing standard of care • Two Phase II studies underway with 26 weeks primary endpoint data anticipated in 4Q 2026 with the potential to address over 10M U.S. T2D diabetes patients Critical unmet need: 1/3 of all diabetes patients fail standard of care and progress to insulin dependence 1-3 driving complications such as kidney disease, nerve damage, vision loss, and cardiovascular issues. BMF-650 Next-generation oral GLP-1 receptor agonist Designed for consistent exposure, higher bioavailability and improved tolerability with scalable weight reduction • Improved bioavailability, better plasma protein binding, greater oral exposure with lower variability • Demonstrated weight reduction and generally well tolerated in preclinical models • Phase I clinical study in obese healthy volunteers ongoing with 28-day weight reduction data anticipated in 2Q 26, aiming to address over 100M U.S. obese patients Critical unmet need: Real world evidence indicates that up to 70% of patients on currently available GLP-1 based therapies drop out 4 within the first year due to gastrointestinal adverse events and other tolerability considerations. Biomea funded through key clinical readouts for icovamenib and BMF-650 into Q1 of 2027. 3 1.Scherer et al., Scientific Reports, 2020; 2. Nichols et al., Diabetes Care, 2015; 3.UKPDS Group. Lancet, 1998; 4. Prime Therapeutics & Magellan Rx Management, 2023 real-world claims analysis.
Biomea Fusion pipeline – targeting diabetes & obesity Biomea Fusion retains full worldwide rights across all programs Program Indications Pre-clinical Phase I Phase II Phase III Key Catalysts Phase II 26-week data Type 2 diabetes (study initiated) ICOVAMENIB COVALENT-211 (primary endpoint) Patients with Insulin- deficiency anticipated 4Q 2026 Type 2 diabetes Phase II 26-week data ICOVAMENIB (study initiated) COVALENT-212 Patients not controlled on (primary endpoint) GLP-1-based therapies anticipated 4Q 2026 52-week follow-up data Type 2 diabetes (study completed) COVALENT-111 presented 4Q 2025 Patients – all comers ICOVAMENIB Type 1 diabetes 52-week follow-up data (study completed) COVALENT-112 Patients – all comers expected in Q2 2026 Phase I weight reduction BMF-650 (study enrolling) GLP-131 Obesity data expected Q2 2026 4
ICOVAMENIB Severe insulin-deficient diabetes patients after 12-weeks of dosing Potential first-in-class menin inhibitor aimed to restore functional beta-cells Aims to serve a significant unmet need for millions of diabetes patients failing on standard of care Icovamenib is developed to: GLP-1 RA uncontrolled diabetes patients after 12 weeks of dosing Employ and enhance body’s natural response to + hyperglycemia as evidenced in pregnancy Conditionally drive beta-cell proliferation and activity + only in presence of high glucose levels Enhance GLP-1 efficacy by upregulating GLP-1 + receptors on the beta-cell surface Post-hoc analysis of patients on GLP-1 based therapy not achieving stable HbA1c <7% Target beta-cell restoration and potentially delay at enrollment (9 months after last dose) + or prevent onset of end-stage disease Early signs of clinical activity with 12 weeks of dosing 5 in diabetes patients failing standard of care therapies
Two transformative phase II trials ongoing Near term readouts expected in 4Q 2026 ICOVAMENIB Two Phase II trials underway Phase IIa completed and proposed mechanism supported COVALENT-211 • Persistent 52-week HbA1c reduction Insulin-deficient T2D failing standard of care after 12 weeks of treatment • Enrollment ongoing • 26-week topline data expected 4Q 2026 • Increased C-peptide OFF DRUG in both responding patient populations validating mechanism of action of COVALENT-212 restored beta-cell mass T2D inadequately controlled on GLP-1 therapy • Go-forward regimen generally well- • Enrollment ongoing tolerated • 26-week topline data expected 4Q 2026 6
Diabetes patients are poorly controlled with over 7M US patients currently needing insulin as a last resort Icovamenib targets beta-cell restoration and may delay or prevent onset of end-stage disease 1 38M of people with diabetes will die from the disease 4 PEOPLE IN THE US WITH DIABETES The end-stage in the evolution of diabetes is insulin-dependence, which 80% drives complications such as kidney disease, nerve damage, vision loss, and cardiovascular issues. 35M 5 PEOPLE IN US WITH T2D 2 of life lost from diabetes 12-14 Diabetes today remains poorly controlled in 50% of patients treated 3 with standard of care agents The burden to the healthcare system is years immense. There is no current therapy except for insulin replacement 7M PEOPLE IN US WITH T2D 6 USING INSULIN Approved therapies are not adequately resolving the growing problem of type 2 diabetes. 60+ No current therapy restores beta-cell function 1.Tabish Int J Health Sci. 2007 Jul;1(2):V–VIII. 4. CDC, Natl. Diabetes Stat. Rep., 2022 2.National library of Medicine 1(2); 2007 Jul PMC3068646 5. ADA, Standards of Care in Diabetes, Diabetes Care, 2024 3.Zohu Lancet 2024; 404: 2077–93 6. Ahlqvist, Lancet Diabetes Endocrinol., 2018 7
BMF-650 Oral GLP-1 RA developed for improved patient friendly tolerability ~15% Body Weight Reduction Aims to serve a significant unmet need with millions of in 28-day Obese Monkey Study obese Americans dropping off the available GLP-1 1 RAs agents within the first year BMF-650 is developed to: Built on the orforglipron scaffold with key structural + improvements Greater oral exposure and bioavailability with lower + variability observed in preclinical models Higher plasma protein binding supporting better + tolerability Potential for simplified dose escalation schedule + with generally well-tolerated safety profile 8 1. Prime Therapeutics & Magellan Rx Management, 2023 real-world claims analysis.
ICOVAMENIB Biology, mechanism of action & preclinical findings
ICOVAMENIB | PRECLINICAL Icovamenib’s mechanism of action IMPROVED BETA CELL MASS & FUNCTION Induction of beta Increase in insulin cell proliferation Decrease in blood glucose Pancreatic islet Icovamenib promotes selective and partial reduction in menin levels Lowering menin levels releases the break on beta cell proliferation and GLP-1 and IMPROVED INCRETIN EFFECTS GLP-1 receptor expression Synergistic with GLP-1 based therapies Improved beta cell function Increased expression of Decrease in blood glucose • GLP-1 • GLP-1 receptor Potential for weight loss Potential for lean mass/muscle preservation 10
ICOVAMENIB | PRECLINICAL Icovamenib increased beta cell quantity, function & GLP-1 receptor expression following a short treatment period Improved beta cell mass and function BUILDING OF THE ICOVAMENIB MATURATION OF BETA CELL POOL BETA CELL POOL Dosing Follow-up period Long-term follow-up 12 weeks additional 14 period additional 26 Use of icovamenib weeks weeks for patients failing standard of care INSULIN FURTHER DECREASE INSULIN DECREASE IN BETA DEPENDENCE IN BETA CELL MASS DEPENDENCE CELL MASS Diagnosis of Type 2 Diabetes 1/3 of Type 2 Diabetes patients Use of standard of end up on insulin care agents 11
ICOVAMENIB | PRECLINICAL ICOVAMENIB | PRECLINICAL Icovamenib downregulated menin protein levels & promoted beta cell proliferation in ex vivo human islet cultures ICOVAMENIB CONDITIONALLY PROMOTED BETA CELL PROLIFERATION MENIN LEVELS DOWNREGULATED ONLY UNDER HYPERGLYCEMIC CONDITIONS Standard Glucose (5.5 mM) High Glucose (8 mM) 12
ICOVAMENIB | PRECLINICAL ICOVAMENIB | PRECLINIAL Icovamenib enhanced GLP-1 receptor & insulin expression and demonstrated potential synergy in combination with semaglutide ex vivo Culture 7 days under glucotox conditions (8mM glucose) Cadaver derived • Gene expression & Protein analysis human islets • Glucose Stimulated Insulin Secretion -/+ Semaglutide (200nM) ICOVAMENIB INCREASED GLP-1 RECEPTOR ICOVAMENIB IN COMBINATION WITH SEMAGLUTIDE AND INSULIN EXPRESSION INCREASED GLUCOSE-STIMULATED INSULIN SECRETION GLP-1 Receptor Insulin 13 13
ICOVAMENIB WITH GLP-1RA Combination treatment of icovamenib & low-dose semaglutide reduced food intake & body weight APPETITE SUPPRESSION BODY WEIGHT REDUCTION ❑ SUPERIOR APPETITE SUPPRESSION WITH ABOUT 10% GREATER BODY WEIGHT REDUCTION THAN LOW-DOSE SEMAGLUTIDE ALONE ❑ THE OBSERVED BODY WEIGHT REDUCTION WAS PRIMARILY DUE TO FAT MASS LOSS WITH PRESERVATION OF LEAN MASS 14
ICOVAMENIB Potential first-in-class oral menin inhibitor clinical study results
ICOVAMENIB | COVALENT-111 Baseline demographics & characteristics Per Protocol Population* on 1 or More Antihyperglycemic Agents at Baseline (N=163) Arm C Arm A Arm B Combined Arms Combined Arms icovamenib Parameter icovamenib icovamenib (8 wks 100 mg QD then 4 icovamenib placebo (8 wks 100mg QD) (12 wks 100 mg QD) Mean (SD) or % wks of 100 mg BID) (N=114) (N=49) (N=45) (N=36) (N=33) Age (yr) 55 (7) 56 (6) 51 (10) 54 (8) 55 (7) Duration of T2D Diagnosis (yr) 4.3 (1.8) 4.7 (1.8) 4.2 (2.2) 4.4 (1.9) 4.3 (2.0) Sex (% Female) (31) (56) (36) (40) (43) HbA1c % (SD) 8.3 (1.1) 8.3 (1.0) 8.0 (0.8) 8.2 (1.0) 8.3 (1.0) Fasting C-peptide (ng/mL) 3.4 (1.2) 3.8 (1.5) 3.7 (1.8) 3.6 (1.5) 3.5 (1.4) 2 BMI (kg/m ) 30.9 (4.7) 32.7 (4.5) 32.4 (4.9) 31.9 (4.7) 32.6 (4.2) 2 BMI <30 kg/m (%) (49) (22) (30) (35) (27) 2 BMI ≥30 kg/m (%) (51) (75) (70) (64) (73) Number of T2D Medications, n (%) 1 39 (87) 23 (64) 23 (70) 85 (75) 41 (84) 2 4 (9) 11 (31) 7 (21) 22 (19) 6 (12) 3 2 (4) 2 (6) 3 (9) 7 (6) 2 (4) *Per the COVALENT-111 Protocol the population analyzed includes only subjects who received ≥80% of their planned dosing. A clinical hold interrupted the dosing. Patients were also excluded if they 16 had significant protocol deviation.
ICOVAMENIB | COVALENT-111 Change in HbA1c from baseline through week 52 – all subtypes Across treatment durations (Arm A = 8 weeks 100 mg, Arm B = 12 weeks 100 mg, Arm C = 8 weeks 100 mg 4 weeks at 200 mg) per protocol participants taking one or more antihyperglycemic medications at baseline 0.2 TREATMENT OFF-TREATMENT 0.1 Pooled Placebo (N=49) 0.0 Arm A (N=45) Arm B (N=36) -0.1 Arm C (N=33) -0.2 -0.3 -0.4 -0.5% threshold for clinical significance -0.5 CMS Clinical Endpoints Review (2024) -0.6 0 8 12 26 36 42 52 Weeks 17 All presented data utilized a while-on-treatment estimand with mixed model repeated measures (MMRM) analysis and was censored for use of rescue medication, defined as any modification in anti-diabetic therapy. Mean Change HbA1c (%)
ICOVAMENIB | COVALENT-111 Higher HbA1c reduction was associated with higher icovamenib exposure Week 52, All Dosing Arms (N=114), HbA1c Reduction vs. Icovamenib Exposure (Mean AUC) • Dosing timing relative to food will 184 ≥0.5% impact icovamenib’s pharmacokinetics (PK) 207 ≥1.0% • In a ‘Food Effect Study’ icovamenib achieved optimal PK exposure when administered within 30 minutes after a 218 ≥1.5% meal • These findings now inform the dosing strategy for the ongoing Phase II studies 273 ≥2.0 0 50 100 150 200 250 300 PK (Mean AUC) 18 Reduction HbA1c % at Week 52
ICOVAMENIB 12 weeks of dosing (arms B&C) delivered lasting benefit through 52 weeks for severe insulin-deficient diabetes patients 1.0 INITIAL TARGET TREATMENT OFF-TREATMENT POPULATION FOR ICOVAMENIB 0.5 0.3 Pooled Placebo (N=12) 0.1 icovamenib (N=10) 0.0 -0.3 -0.5 -0.5% threshold for clinical significance -0.5 CMS Clinical Endpoints Review (2024) -0.8 -1.0 -1.2 P=0.01 -1.5 -2.0 0 8 12 26 36 42 52 Week 19 Arm A was excluded from this analysis because it included only 8 weeks of dosing which the company is not planning to pursue. Mean Change HbA1c (%)
ICOVAMENIB Icovamenib increased insulin secretion as measured by C-peptide index in severe insulin-deficient patients (arms B&C) 1.6 TREATMENT OFF-TREATMENT Icovamenib (N=10) 1.5 Placebo (N=12) 1.4 1.3 24% 1.2 1.1 2% 1.0 0.9 0.8 0.7 0 12 52 Weeks 20 Data censored at onset of rescue medication, defined as any modification in antihyperglycemic therapy Fold Change in C-peptide Index
ICOVAMENIB Patients on a GLP-1 based therapy at enrollment showed durable & clinically meaningful response in reduction of blood sugar (HbA1c) 1.5 TREATMENT OFF-TREATMENT 1.1 1.0 0.6 0.5 Pooled Placebo (N=4) 0.1 icovamenib (N=12) 0.0 -0.3 -0.5% threshold for clinical significance -0.5 CMS Clinical Endpoints Review (2024) -0.7 -1.2 P=0.05 -1.0 -1.5 -2.0 0 8 12 52 Weeks 21 Mean Change HbA1c (%)
ICOVAMENIB Icovamenib increased insulin secretion as measured by C-peptide index in GLP-1 RA treated patients – 9 months post last dose 1.6 TREATMENT OFF-TREATMENT 35% 1.4 Icovamenib (N=11) Placebo (N=4) 1.2 -4% 1.0 0.8 0.6 0.4 0 12 52 Weeks 22 Data censored at onset of rescue medication, defined as any modification in antihyperglycemic therapy Mean Change HbA1c (%)
ICOVAMENIB | COVALENT-111 Favorable 52-week safety profile Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=67) (N=67) (N=67) (N=201) (N=66) Patients with ≥1 TEAE, N (%) 19 (28) 22 (33) 14 (21) 55 (27) 18 (27) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) Treatment-Related SAEs, N (%) SAEs*, N (%) 1 (1) 0 (0) 1 (1) 2 (1) 1 (1) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) Treatment Discontinuation due to TEAE, N (%) Study Discontinuation due to TEAE, N (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 3 (4) 0 2 (3) 5 (3) 0 ALT increase, N (%) 3 (4) 0 1 (1) 4 (2) 0 AST increase, N (%) Resolution of ALT/AST w/o treatment interruption (%) 100 100 100 100 N/A Deaths, N (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) Data are n (%) TEAE = Treatment Emergent Adverse event. SAE = Serious Adverse Event. Data are n (%) of TEAE with ≥5% frequency in any arm. ALT (alanine aminotransferase) or AST (aspartate aminotransferase) increase irrespective of incidence %. *Arm A had an SAE of atrial fibrillation, unrelated to study treatment and occurred during the treatment period. *Arm C had an SAE of COVID-19. Unrelated to study treatment and occurred during the treatment period. *Placebo Arm had an SAE of nephrolithiasis. Unrelated to study treatment and occurred during the treatment period. ALT increase: In the icovamenib arms, 4 of the 5 events were Grade 1 and 1 event was Grade 2. 23 AST increase: In the icovamenib arms, all 4 events were Grade 1. All incidences of ALT and AST elevations resolved without interruption.
ICOVAMENIB Key findings through week 52 after a short treatment course Menin Inhibition Durable Clinical Activity Durable Clinical Activity Potentially Leads to in T2D Not Controlled on Favorable Safety in Insulin Deficient T2D Increased Clinical Benefit GLP-1-based Therapies Profile Higher exposure aligned with 1.2% mean HbA1c reduction 1.3% mean HbA1c reduction Generally well tolerated, deeper HbA1c reductions. (p=0.01) maintained through (p=0.05) maintained through no treatment-related Data also supports potential for Week 52 after 12 weeks of Week 52 after 12 weeks of serious adverse events exposure improvements dosing dosing • COVALENT-211 PHASE IIB IN SEVERE INSULIN DEFICIENT T2D, FIRST PATIENT ENROLLMENT IN 1Q 2026. NEXT STEPS: • COVALENT-212 PHASE II T2D PATIENTS NOT CONTROLLED ON GLP-1 BASED THERAPIES. FIRST PATIENT ENROLLED IN 1Q 2026. 24
ICOVAMENIB Potential first-in-class oral menin inhibitor Ongoing Phase II Studies
Optimal dose, dose-duration, target population identified for phase IIb program ICOVAMENIB Direct application in Phase II/IIb’s COVALENT-211 Phase IIa key derisking-insights Phase IIb trial in type 2 insulin deficient diabetes patients • Optimal dose selected failing standard of care • Adult participants with Type 2 Diabetes who were treated • Food Effect Study confirmed optimal PK exposure of with 1-3 antidiabetic medications icovamenib within 30 minutes after a meal • HbA1c 7.5%-10.5% • 12-week treatment observed to drive durable and • BMI ≤ 32 kg/m2 lasting effects, no chronic treatment required • Background therapy maintained unless rescue required • Strong clinical activity in insulin-deficient and GLP-1 COVALENT-212 inadequate responder populations Phase II trial in Type 2 Diabetes Patients failing standard of care • Treatment-emergent AEs comparable to placebo while on a GLP-1 RA • Adult participants with T2D who are not achieving glycemic targets despite GLP-1-based therapy • HbA1c ≥7.5% and ≤9.5% • BMI 25 to 40 kg/m2 • Background therapy maintained unless rescue required 26
ICOVAMENIB | COVALENT-211 A Phase II trial of icovamenib in T2D insulin deficient participants who are not achieving glycemic targets Objectives Endpoints Inclusion Criteria Objectives Endpoints Inclusion Criteria • Adult participants with Type 2 Diabetes who were • Mean change in HbA1c from baseline at treated with 1-3 antidiabetic medications Week 26 and 52 To demonstrate that icovamenib • HbA1c 7.5%-10.5% 100 mg once daily for 12 weeks is • Mean change in fasting plasma glucose (FPG) from baseline at Week 26 superior to placebo for glycemic • BMI ≤ 32 kg/m2 control at Week 26 and Week 52 • Safety • Background therapy maintained unless rescue required Week 52: Week 26: Secondary endpoint Primary endpoint SCREENING: 28 DAYS TREATMENT: 12 WEEKS FOLLOW-UP: 26 WEEKS FOLLOW-UP: 52 WEEKS ARM A Icovamenib 100 mg QD (n=40) ARM B Placebo 100 mg QD (n=20) Stable Background Therapy 27
ICOVAMENIB | COVALENT-212 Phase II trial of icovamenib in participants with T2D who are not achieving glycemic targets while using GLP-1-based therapy Objectives Endpoints Inclusion Criteria Objectives Endpoints Inclusion Criteria • Adult participants with T2D who are not achieving • Mean change in HbA1c from baseline at glycemic targets despite GLP-1-based therapy Week 26 and 52 To demonstrate that icovamenib 100 mg once daily for 12 weeks is • HbA1c ≥7.5% and ≤9.5% • Mean change in fasting plasma glucose (FPG) from baseline at Week 26 superior to placebo for glycemic • BMI 25 to 40 kg/m2 control at Week 26 and Week 52 • Safety • Background therapy maintained unless rescue required Week 52: Week 26: Secondary endpoint Primary endpoint SCREENING: 28 DAYS TREATMENT: 12 WEEKS FOLLOW-UP: 26 WEEKS FOLLOW-UP: 52 WEEKS ARM A Icovamenib 100 mg QD (n=40) ARM B Placebo 100 mg QD (n=20) Background Therapy: Stable GLP-1-based-therapy 28
BMF-650 An investigational next-generation oral GLP-1 receptor agonist for obesity Preclinical results and clinical overview
BMF-650 Developed to deliver strong efficacy with improved oral tolerability An Investigational Next-Generation Oral GLP-1 Receptor Agonist Greater therapeutic Proposed differentiated properties of BMF-650 window matters • Only 3 of 10 patients remain on GLP-1 therapy at one year due to tolerability, GI effects and 1 complexity of use. • An oral agent with improved tolerability could potentially expand the long-term use. Improved Generally Patient Friendly PK Profile Favorable Design Intellectual Property • U.S. patent allowance received December 2025 Safety Profile covering BMF-650 composition. Oral delivery with the Greater oral exposure with Better tolerability associated potential for simplified dose lower variability observed in with higher plasma protein • U.S. and PCT applications published and escalation preclinical studies binding in preclinical proceeding through examination. models 30 1. Khan, et al. JAMA 2024 doi:10.1001/jama.2024.22284.
BMF-650 | PRECLINICAL BMF-650 | PRECLINICAL BMF-650 demonstrated robust, dose dependent weight loss in obese monkeys Weight loss in cross-study comparison with CT-996 (Roche/Carmot), while not head-to-head appeared favorable BMF-650 up to ~15% body weight reduction after 28-days CT-996 body weight change Literature data; Carmot Therapeutics (now part of the Roche group), ADA 2024. Disclaimer: No head-to-head studies of BMF-650 and CT-996 have been conducted. Comparing results from different preclinical studies may be unreliable due to differences in study designs, study endpoints, and other parameters. 31
BMF-650 | GLP-131 A Randomized, Double-blind, Placebo-controlled, FIH Study of an Oral Non-peptide GLP-1 Receptor Agonist Part 1 is a single ascending dose (SAD) study and Part 2 is a multiple ascending dose (MAD) study. Single Ascending Dose (SAD) Multiple Ascending Dose (MAD) Safety and tolerability, PK, and food effect Safety and tolerability, and efficacy (weight-loss) Objectives Healthy overweight or obese patients Healthy overweight or obese patients Eligibility (BMI 25.0–40.0 kg/m²) (BMI 30.0–45.0 kg/m²) N=40 N=40 Design x 5 cohorts x 4 cohorts 7 DAYS → 7 DAYS → 7 DAYS → 21 DAYS 200 mg (fasted) COHORT 4 100 mg (fasted) 100 mg (fed) 75 mg → 200 mg → 400 mg → 400 mg 3 50 mg (fasted) 75 mg → 150 mg → 300 mg → 300 mg Body weight at 2 25 mg (fasted) 25 mg (fed) 50 mg → 100 mg → 200 mg → 200 mg Baseline versus Day 28 and Day 42 1 10 mg (fasted) BMF-650 active drug 10 mg → 25 mg → 50 mg → 100 mg on treatment placebo 32
Biomea pipeline Biomea Fusion retains full worldwide rights across all programs and is currently funded through major catalysts into 1Q 2027 PROGRAM INDICATION PHASE I PHASE II PHASE III UPCOMING MILESTONES Type 1 diabetes ICOVAMENIB 52-week follow-up data of those COVALENT-112 Potential first-in- Patients - All comers patients who completed dosing (study completed) 1 (>2M US Patients) class oral menin expected 2Q 2026 inhibitor Phase II 26-week data Type 2 diabetes COVALENT-211 (primary endpoint) Patients with insulin deficiency (study initiated) anticipated 4Q 2026 2 (~7M US Patients) Type 2 diabetes Phase II 26-week data COVALENT-212 Patients not controlled on (primary endpoint) (study initiated) GLP-1 based therapies anticipated 4Q 2026 3,4 (>3M US Patients) BMF-650 Phase I 28-day weight reduction Obesity GLP-131 Potential best-in- (study enrolling) data expected 2Q 2026 5 (>100M US Patients) class oral GLP-1 RA 1.National Diabetes Statistics Report, Accessed January 28, 2026 2. International Diabetes Federation. IDF Diabetes Atlas www.diabetesatlas.org (Based on company calculations) 3.NCHS Data Brief dated August 2025. Accessed January 28, 2026 (Based on company calculations) 33 4.Chitnis AS. Clinical effectiveness of liraglutide across body mass index in patients with type 2 diabetes in the United States: a retrospective cohort study. Adv Ther. 2014 Sep;31(9):986-99 (Based on company calculations) 5.National Center for Health Statistics August 2023. Accessed January 28, 2026
THANK YOU (NASDAQ: BMEA) For questions or inquiries, please reach out to Meichiel Weiss at ir@biomeafusion.com www.biomeafusion.com
Slowing the clock on diabetes Turning a healthcare crisis into a huge opportunity The problem: Diabetes is a global healthcare crisis, with over 800 million people affected worldwide. The disease is expanding at an estimated ~4% annually. In the United States, one in every four healthcare dollars is spent on people living with diabetes, totaling ov er $400 billion per year. More than 100 million Americans have prediabetes; approximately 40% will progress to diabetes, and ~60% are diagnosed only after reaching late-stage disease. The economic impact: Late-stage diabetes drives over 50% of healthcare related costs due to complications such as kidney failure, cardiovascular disease, amputations and visual loss. With late-stage diabetes the healthcare system is burden by additional $15,000 - $20,000 per patient. Assuming 10m US diabetes patients are in late stage, delaying the progression could save the system $150-200billion. Our breakthrough: We are developing a novel mechanism of action developed to restore beta-cell function and slow the progression of hyperglycemia. By rebuilding a functional beta-cell pool, the body may regain the ability to regulate its own insulin production. The true burden of diabetes is not early disease, but late-stage progression with irreversible organ damage. Slowing that clock by even a few years could generate societal returns exceeding the annual economic output of the entire pharmaceutical sector. Icovamenib would delay the need for unwieldy and often unreliable insulin therapy for years! Our vision: Keeping diabetes patients durably controlled, preventing progression to late-stage disease and avoiding the devastating complications that drive cost, morbidity, and mortality. 36
Key opinion leaders highlight icovamenib’s potential to redefine diabetes care “Icovamenib's recent data has shown an “The icovamenib data looks exciting. “Great foray into precision medicine. We impressive restoration of beta cell The data presented today help to need to be addressing patients in a function as demonstrated by significant confirm icovamenib’s mechanism of much more individualized manner. By elevations in C-peptide even after the action. We have not previously seen data addressing insulin-deficient diabetes treatment period ended. like this with any antihyperglycemic patients with icovamenib, we have seen agent. post treatment that the beta cell pool is This data validates the mechanism of being restored and producing a higher action of this menin inhibitor as a As more trials are conducted, I believe level of insulin, as measured by C- disease modifying agent and helps that inhibition of menin may lead to peptide. address the poor adherence and benefits across all subtypes of diabetes. persistence commonly seen in type 2 I applaud Biomea for developing a This indicates a fundamental and diabetes.” potential new treatment option that may potentially lasting impact on the be disease modifying for patients with disease and validates the mechanism of diabetes.” action of menin inhibition.” Steve Edelman, M.D. ENDOCRINOLOGIST, PROFESSOR OF Melanie Davies, M.D. Ralph DeFronzo, M.D. MEDICINE UCSD / VA SAN DIEGO DIABETOLOGIST, PROFESSOR OF ENDOCRINOLOGIST, PROFESSOR OF DIABETES MEDICINE AT THE MEDICINE UTHSCSA UNIVERSITY OF LEICESTER 37
Key opinion leaders highlight icovamenib’s potential to redefine diabetes care “We do not have an agent today that “The icovamenib data are quite “Icovamenib is a very interesting addresses one of the root cause of interesting because of the continued molecule that acts quite differently than diabetes - beta cell dysfunction - effects despite having stopped it. anything I have seen before. We are icovamenib would be the first. observing glucose controlled and beta Usually, one would expect to see the cell-specific proliferation and an Patients are achieving lasting benefits HbA1c levels climb towards baseline increase in stimulated C-peptide without continuous chronic dosing, when the medication is stopped, but secretion leading to patient benefits suggesting that icovamenib may be with icovamenib, the HbA1c levels that continued after the icovamenib disease modifying. I am very decreased, which is quite intriguing and dosage ended. impressed.” unprecedented.” I am very excited to further explore the Alice Cheng, M.D. many opportunities that the covalent inhibition of menin will provide to ENDOCRINOLOGIST, ASSOCIATE Julio Rosenstock, M.D. PROFESSOR OF MEDICINE patients.” UNIVERSITY OF TORONTO DIRECTOR VELOCITY CLINICAL RESEARCH AT MEDICAL CITY DALLAS Rohit Kulkarni, AND CLINICAL PROFESSOR OF MEDICINE, UNIV. OF TEXAS M.D., Ph.D. SOUTHWESTERN MEDICAL CENTER PROFESSOR OF MEDICINE AT HARVARD MEDICAL SCHOOL 38
FAQ
What is Biomea Fusion (BMEA) communicating in this updated corporate presentation?
Biomea Fusion is using the updated presentation to outline its clinical pipeline in diabetes and obesity, centered on icovamenib and BMF-650. It details mechanisms, preclinical and clinical data, key Phase II and Phase I trial designs, and milestone timelines extending into 2027.
What is icovamenib in Biomea Fusion (BMEA)’s pipeline and who are the target patients?
Icovamenib is a potential first-in-class oral menin inhibitor aimed at restoring functional beta-cell mass in diabetes. Biomea is focusing on insulin-deficient type 2 diabetes patients and those inadequately controlled on GLP-1 therapies, together representing several million patients in the United States.
What key clinical milestones does Biomea Fusion (BMEA) expect for icovamenib?
Biomea expects 26-week primary endpoint data in 4Q 2026 from two Phase II trials: COVALENT-211 in insulin-deficient type 2 diabetes and COVALENT-212 in patients not controlled on GLP-1-based therapies. Additional 52-week follow-up data from earlier COVALENT studies are expected in 2025 and 2026.
How has icovamenib performed so far in clinical studies shared by Biomea Fusion (BMEA)?
In the COVALENT-111 Phase IIa trial, icovamenib produced durable HbA1c reductions up to around 1–2 percentage points and increased C-peptide through week 52 after only 12 weeks of dosing. The safety profile was generally favorable, with no treatment-related serious adverse events reported.
What is BMF-650 in Biomea Fusion (BMEA)’s obesity program and what data support it?
BMF-650 is an investigational next-generation oral GLP-1 receptor agonist designed for improved tolerability and consistent exposure. In obese monkey studies, it achieved up to about 15% body weight reduction over 28 days, and a Phase I trial in obese volunteers targets 28-day weight-loss data in 2Q 2026.
How long does Biomea Fusion (BMEA) expect its current funding to last based on the presentation?
The presentation states that Biomea Fusion is funded through key clinical readouts for both icovamenib and BMF-650 into the first quarter of 2027. This runway is intended to cover Phase II icovamenib milestones and Phase I obesity data for BMF-650.
What broader healthcare problem is Biomea Fusion (BMEA) aiming to address with icovamenib?
Biomea aims to slow progression to late-stage diabetes, where complications like kidney failure, cardiovascular disease, amputations, and vision loss drive high healthcare costs. The company argues that delaying progression for an estimated 10 million late-stage U.S. patients could significantly reduce system-wide spending.
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