Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — Corporate Update (June 2025)
56 slides from Biomea Fusion's corporate update, Jun 17, 2025
Slide 1: Corporate Update June 2025
Exhibit 99.1 Corporate Update June 2025 Slide 1
Slide 2: Legal Disclaimer & Forward-Looking Statement
Legal Disclaimer & Forward-Looking Statement 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
Slide 3: Biomea Fusion: Oral Small Molecules For Diabetes and Obesity
Biomea Fusion: Oral Small Molecules For Diabetes and Obesity Potentially transformative disease-modifying activity in type 2 diabetes (T2D): Targets a root cause by restoring functional beta cells to enable endogenous insulin production – A result not achieved by currently available therapies Icovam
Slide 4: Biomea Fusion: A Diabetes and Obesity Medicines Company
Biomea Fusion: A Diabetes and Obesity Medicines Company “We believe we may have a method to reverse diabetes, to reset the body, so diabetes patients no longer require ongoing medication.” Study Indications Anticipated Milestones for 2H 2025 52 Week Follow-up Data COVALENT-111 Type 2 Diabetes Phase
Slide 5: Biomea Fusion Pipeline Summary: Two High-Value Programs
Biomea Fusion Pipeline Summary: Two High-Value Programs Targeting Unmet Needs in Diabetes & Obesity ICOVAMENIB BMF-650 Novel Menin Inhibition Oral GLP-1 RA Mechanism of Demonstrated in preclinical studies, appetite suppression comparable Enhanced insulin production driven by a restored and functiona
Slide 6: Biomea Pipeline: Advancing First-in-Class and Best-in-Class Approaches
Biomea Pipeline: Advancing Potential First-in-Class and Best-in-Class Approaches for Diabetes and Obesity Next Milestone Program/ Route of Global Pre-Clinical Phase I Phase II Phase III in Asset Admin Rights 2H 2025 Icovamenib Oral Type 2 Diabetes Potential First-in-Class 52 Week Follow up Oral Meni
Slide 7: Short Course of Icovamenib Demonstrated Clinically Significant HbA1c Reductions
Short Course of Icovamenib Demonstrated Clinically Significant Impact on HbA1c Reductions in a Severe Insulin-Deficient Population Placebo-Adjusted Mean Change in HbA1c at Week 26 = 1.5% (p=0.02) Patients Uncontrolled with at Least 1 Prior Therapy Oral Icovamenib Regimen Ends at 12 Weeks, HbA1c Cont
Slide 8: High Unmet Need in Patients with Severe Insulin-Deficient Type 2 Diabetes
High Unmet Need in Patients with Severe Insulin-Deficient Type 2 Diabetes $6B + Estimated U.S. Revenue Potential (based on 10% penetration at 10K/yearly) 150M 7M 60+ approved T2D Severe Insulin- Severe Insulin- therapies, all chronic Deficient T2D Deficient T2D agents and none worldwide cases US cas
Slide 9: Current Chronic Diabetes Treatments: No Lasting Impact
Current Chronic Diabetes Treatments: Despite Initial Effectiveness, There is No Lasting Impact Impact of tirzepatide on HbA1c: Sustained Reduction Mean Time to Loss of Glucose Control (HbA1c>7%) During Treatment, Rebound After Discontinuation Nathan, et al. N Engl J Med 2022;387:1063-107 Kubota M, e
Slide 10: Challenges with Current Standard of Care
Challenges with Current Standard of Care: Many Patients Fail to Achieve Glycemic Control or Stay on Therapy Poor Adherence is a Key Driver of the Efficacy Gap 1-2 Discontinuation rates of T2D Therapies 3 Between Clinical Trial Results and Real-World Results b 1. Khan, et al. JAMA 2024 doi:10.1001/ja
Slide 11: Today's T2D Agents are not Addressing a Root Cause of Diabetes
Today’s T2D Agents are not Addressing a Root Cause of Diabetes: The Progressive Decline in Beta-Cell Mass and Function Currently Approved Therapies Loss of Beta-Cell Function Target the Symptoms of T2D, Not a Root Cause A Root Cause of Diabetes Leading to Insulin Deficiency HYPERGLYCEMIA Years from
Slide 12: Type 2 Diabetes is a Heterogeneous Disease – Two Core Drivers
Type 2 Diabetes (T2D) is a Heterogeneous Disease – Two Core Drivers Analysis from two independent 4,000 patient studies, (ADOPT and RECORD) INSULIN RESISTANT DIABETES INSULIN-DEFICIENT DIABETES Severe insulin- Mild age-related Severe insulin Mild obesity- deficient diabetes resistant related diabete
Slide 13: Icovamenib: Potential First-in-Class Disease Modifying Candidate for Diabetes
Icovamenib: Potential First-in-Class Disease Modifying Candidate for Diabetes Mechanism of Action: Selective & Partial Menin Inhibition Dual Effect Icovamenib Differentiating Features Beta Cell Quantity & Function GLP-1 Receptor Expression ü Oral – Convenient, once- daily oral therapy Increased GLP-
Slide 14: COVALENT-111 Phase 2a Study Topline Results at 26 Weeks
COVALENT-111 Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes Topline Results at 26 Weeks
Slide 15: COVALENT-111 Expansion Cohort Trial Design
COVALENT-111 Expansion Cohort Trial Design Phase 2a Randomized, Double-Blind, Placebo-controlled Study in Participants with T2D Eligibility Criteria • Adults (18-65 years) with T2D (<7 years) • HbA1c 7.0-10.5% N=216 icovamenib • BMI 25-40 kg/m2 Planned x12 wks 100 mg (QD) • Treated with up to 3 Part
Slide 16: COVALENT-111 Expansion Cohort Baseline Demographics and Characteristics
COVALENT-111 Expansion Cohort Baseline Demographics and Characteristics Per Protocol Population on 1 or more antihyperglycemic agents at baseline (N=165) Arm A Arm B Arm C Combined Arms Combined Arms Icovamenib Icovamenib Icovamenib Parameter icovamenib Placebo (8 weeks of dosing 100mg (12 weeks of
Slide 17: COVALENT-111 Expansion Cohort Antihyperglycemic Agents at Baseline
COVALENT-111 Expansion Cohort Antihyperglycemic Agents at Baseline Per Protocol Population on 1 or more antihyperglycemic agents at baseline (N=165) Arm A Arm C Arm B Combined Arms Combined Arms Icovamenib Icovamenib Icovamenib icovamenib Placebo Parameter (8 weeks of dosing 100mg (8 weeks of 100 mg
Slide 18: COVALENT-111 Expansion Cohort T2D Subtype at Baseline
COVALENT-111 Expansion Cohort T2D Subtype at Baseline Per Protocol Population on 1 or more antihyperglycemic agents at baseline (N=165) Arm B Arm C Arm A Combined Arms Combined Arms Icovamenib Icovamenib Icovamenib Parameter icovamenib Placebo (12 weeks of dosing 100 mg) (8 weeks of 100 mg QD + 4 (8
Slide 19: Change in HbA1c from Baseline at Week 26 by Study Arm
COVALENT-111 Expansion Cohort Change in HbA1c from Baseline at Week 26 by Study Arm Per Protocol Population taking 1 or more antihyperglycemic medications at baseline, by study arm (A, B, C, and Placebo) All Participants Across Arms A, B, and C Mean Change in HbA1c Over Time (n=115 Active; n=50 Plac
Slide 20: Change in HbA1c from Baseline at Week 26, SIDD Participants
COVALENT-111 Expansion Cohort Change in HbA1c from Baseline at Week 26, SIDD Participants Per Protocol Population taking 1 or more antihyperglycemic medications at baseline (study arms combined and placebo) Participants with Pre-specified Severe Insulin-Deficient Diabetes Mean Change in HbA1c Over T
Slide 21: Icovamenib Performed in Line with GLP-1 RA Therapies on HbA1c Reduction
Despite Short Course Oral Dosing, Icovamenib Performed in Line with GLP-1 RA Therapies on HbA1c Reduction within Severe Insulin-Deficient Subgroup Currently Approved Type 2 Diabetes Agents w/Chronic Dosing Mean HbA1c Dosing Administration Observation Therapy Reduction Regimen Route Period (placebo a
Slide 22: SIDD Patients Had the Lowest Baseline Insulin, Measured by C-peptide Index
Pre-specified Patients with Severe Insulin-Deficient Diabetes had the Lowest Baseline Insulin, as Measured by the C-peptide Index during a 2-hour OGTT C-peptide Index at Baseline • The C-peptide Index is a well-validated measure of (mITT Population) beta-cell function (C-peptide per unit of glucose
Slide 23: Icovamenib Increased Insulin Secretion in Insulin-Deficient T2D
COVALENT-111 Expansion Cohort Icovamenib Increased Insulin Secretion (measured by C-peptide) in Insulin-Deficient, but Not in Insulin-Resistant T2D Insulin-Deficient participants demonstrated an increase in C-peptide over time Active (N=23) Active (N=22) Placebo (N=11) Placebo (N=8) Week Week Insuli
Slide 24: Icovamenib Increased Insulin Secretion as Measured by C-peptide
COVALENT-111 Expansion Cohort Icovamenib Increased Insulin Secretion as Measured by C-peptide At Week 26, there was a 53% increase in insulin secretion, with more than half of the increase occurring after icovamenib treatment ended Pre-specified Patients with Severe Insulin-Deficient Diabetes C-pept
Slide 25: Change at Week 6 in C-peptide Index Versus HbA1c
COVALENT-111 Expansion Cohort Change from Baseline at Week 26 in C-peptide Index Versus HbA1c Pre-specified Severe Insulin-Deficient Diabetes Participants (Arms A, B, and C) n=23 Active (N=23) 4 C-peptide Index (CPI) = 10 x Mean AUC C-peptide/Mean AUC glucose Corporate Presentation June 2025 25
Slide 26: Overview of Treatment Emergent Adverse Events Through 26 Weeks
COVALENT-111 Expansion Cohort Overview of Treatment Emergent Adverse Events Through 26 Weeks (Safety Population, N=267) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=67) (N=66) (N=67) (N=200) (N=67) Patients with ≥1 TEAE 18 (27) 20 (30
Slide 27: Treatment Emergent Adverse Events Occurring in ≥5% in Any Arm
COVALENT-111 Expansion Cohort Treatment Emergent Adverse Events (TEAEs) Occurring in ≥5% in any Study Arm and TEAEs reported for ALT and/or AST Elevations (Safety Population, N=267) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=67) (N=
Slide 28: Subjects with TEAE of Hypoglycemia
COVALENT-111 Expansion Cohort Subjects with TEAE of Hypoglycemia (Safety Population, N=267) Corporate Presentation June 2025 28
Slide 29: Summary and Conclusions
Summary and Conclusions Simple, easy and § 12-week oral dosing led to 1.5% placebo-adjusted HbA1c reduction at Week 26 (p=0.02) in only short term patients with severe insulin-deficient diabetes § Improvements in glycemic control were most significant in participants with severe insulin- Addresses t
Slide 30: Key Opinion Leader First Responses
Key Opinion Leader FIRST RESPONSES “Icovamenib's recent data has shown an impressive restoration of beta cell function as demonstrated by significant elevations in C-peptide even after the treatment period ended. This data validates the mechanism of action of this menin inhibitor as a disease modify
Slide 31: Key Opinion Leader First Responses
Key Opinion Leader FIRST RESPONSES “Icovamenib is a very interesting molecule that acts quite differently than anything I have seen before. We are observing glucose controlled and beta cell-specific proliferation and an increase in stimulated C-peptide secretion leading to patient benefits that cont
Slide 32: Icovamenib In Combination with GLP-1 Based Therapies
Icovamenib In Combination with GLP-1 Based Therapies in Preclinical / Clinical Experiments
Slide 33: Menin suppresses GLP-1 receptor signaling
Menin suppresses GLP-1 receptor signaling* *AJP-Endocrinol Metab • doi:10.1152/ajpendo.00241.2016 • www.ajpendo.org; J. Cell Biol. 2019 Vol. 218 No. 3 855–870; The FASEB Journal. 2025;39:e70370. Corporate Presentation June 2025 33
Slide 34: Icovamenib enhanced responsiveness of islets to Tirzepatide
Combination Treatment: Icovamenib enhanced responsiveness of islets to GLP-1/GIP dual receptor agonist Tirzepatide Day Day Culture 7 days under glucotox conditions 8 (8 mM glucose) 1 DMSO Cadaver derived human islets Icovamenib, 30 nM Icovamenib, 100 nM Perform Glucose Stimulated Non-diabetic donor:
Slide 35: Icovamenib and low-dose semaglutide reduces body weight and boosts lean mass
Combination treatment of icovamenib and low-dose semaglutide reduces body weight and boosts lean mass fraction relative to baseline Fasting blood glucose reduced to normal range in Significant reduction in combination group vs. combination group semaglutide Corporate Presentation June 2025 35
Slide 36: Change in HbA1c to Week 26 in Patients Taking GLP1-RA
COVALENT-111 Expansion Cohort Change in HbA1c from Baseline to Week 26 in Patients Taking GLP1-RA of Clinical Study COVALENT-111 (n=10) Icovamenib displayed clinically meaningful 0.8% reduction in HbA1c in participants uncontrolled on GLP-1-based therapies at Baseline GLP-1-Based Medicine 0 § 0.8% r
Slide 37: BMF-650 Next-Generation Oral Small Molecule GLP-1 Receptor Agonist
BMF-650 Next-Generation, Oral Small Molecule GLP-1 Receptor Agonist Overview of Pre-Clinical Findings Status: IND enabling Studies First Patient Enrollment: Expected H2 2025
Slide 38: Achieving a Greater Therapeutic Window with BMF-650
Achieving a Greater Therapeutic Window with BMF-650 A Next-Generation Oral GLP-1 Receptor Agonist Better properties exhibited by BMF-650 in preclinical studies than Orforglipron Higher plasma Improved PK properties: Patient-friendly protein binding for a • Greater bioavailability titration propertie
Slide 39: BMF-650 Favorable In Vitro On-Target Activity and Off-Target Selectivity
BMF-650 Showed Favorable In Vitro On-Target Activity and Off-Target Selectivity GLP-1 human ECβ-arrestin1β-arrestin2 50 Compound EC EC 50 50 25 °C 37 °C BMF-650 8.6 nM 2.6 nM > 10 µM > 10 µM orforglipron 2.6 nM 0.1 nM > 10 µM > 10 µM • Good potency on-target to achieve more efficient drug titration
Slide 40: Pharmacokinetics of BMF-650 Showed Very Good Preclinical Bioavailability
Pharmacokinetics of BMF-650 Showed Very Good Preclinical Bioavailability with Low Inter-Individual Variability Cynomolgus monkey PO PK Sprague-Dawley rat PO PK 1000 1000 BMF-650 5 mg/kg PO BMF-650 0.36 mg/kg PO orforglipron 5 mg/kg PO orforglipron 0.36 mg/kg PO 100 100 Compound cyno PO T (h) %F Comp
Slide 41: Projected Human Dose for BMF-650 Similar Among Oral Agents
Projected Human Dose for BMF-650 is Similar Among the Oral Agents All titration doses shown target obesity indications GSBR-1290 Orforglipron BMF-650 CT-996 (Structure (Eli Lilly) (Biomea) (Roche/Carmot) Therapeutics) Doses tested in cynomolgus monkeys 0.05 to 1 2 to 30 mg/kg 2 to 10 mg/kg 3 to 30 m
Slide 42: BMF-650 Potentiated Blood Glucose Reduction in Cynomolgus Monkeys
BMF-650 Potentiated Blood Glucose Reduction in Cynomolgus Monkeys Glucose levels Glucose AUC 30 600 vehicle BMF-650 (0.05) BMF-650 (0.10) orforglipron LD 400 20 orforglipron HD 200 10 0 0 0 50 100 time [min] BMF-650 BMF-650 orforglipron orforglipron Vehicle 0.05mg/kg 0.1mg/kg Low dose (lit)* high do
Slide 43: BMF-650 demonstrated good appetite suppression in cynomolgus monkeys
BMF-650 demonstrated good appetite suppression in cynomolgus monkeys Averages of First 90-Minute Window and Across All Six Days of the Experiment Food Consumption for 90 min, 3hr post dose Daily food intake 100 100 Vehicle Vehicle BMF-650 (10 mg/kg) 80 80 BMF-650 (10 mg/kg) 60 60 40 40 20 20 0 0 • F
Slide 44: BMF-650 meaningful appetite suppression compared to orforglipron
BMF-650 demonstrated meaningful appetite suppression in cynomolgus monkeys Averages of First 90-Minute Window and Across All Six Days of the Experiment in Comparison to Orfoglipron Food Consumption for 90 min, 3hr post dose Daily food intake Vehicle Vehicle 100 100 BMF-650 (10 mg/kg) BMF-650 (10 mg/
Slide 45: Set up of Weight Loss Study in Obese Cynomolgus Monkeys
Key Evaluation of Preclinical Activity: Set up of Weight Loss Study in Obese Cynomolgus Monkeys • 15 Obese cynomolgus monkeys were selected for the study and followed for 14 days prior to study start • Monkeys were distributed among 3 groups of 5 individuals at day -2 Group 1 Group 2 Group 3 Weight
Slide 46: Weight Loss Study in Obese Monkeys: Food Intake Assessment
Weight Loss Study in Obese Cynomolgus Monkeys: Food Intake Assessment Total Food intake (mean of day 1-28) Total Food intake 250 250 Vehicle BMF-650, 10mg/kg BMF-650, 30mg/kg 200 200 150 150 109 mean (day 1-28) = 109 100 100 50 mean (day 1-28) = 35 35 50 mean (day 1-28) = 16 16 0 0 Time (day) Day 28
Slide 47: Weight Loss Study in Obese Monkeys: Total Food Intake Change
Weight Loss Study in Obese Cynomolgus Monkeys: Food Intake Assessment Total food intake change 0 Day 27 -13.6% -50 -73.6% -80.4% -100 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 Time (day) Day 28 Vehicle -30.3% BMF-650, 10mg/kg BMF-650, 30mg/kg -69.0% -79.2% Literatu
Slide 48: Weight Loss Study in Obese Monkeys: Body Weight Reduction
Weight Loss Study in Obese Cynomolgus Monkeys: Body Weight Reduction Body weight reduction 5 Vehicle BMF-650, 10mg/kg 0 BMF-650, 30mg/kg -2.3 -5 -2.7 -4.8 -2.8 -3.4 -7.5 -7.5 -10 -10.7 -10.2 -12.3 -15 -13.5 -15.2 -20 week 1 week 2 week 3 week 4 Meaningful, dose dependent, and continuous body weight
Slide 49: Weight Loss Study in Obese Monkeys: Body Weight Change
Weight Loss Study in Obese Cynomolgus Monkeys: Body Weight Reduction Body weight change 0 -5 -10 Day 8 Day 15 Day 22 Day 29 -15 -2.30% -2.70% -2.80% -3.40% -4.77% -7.54% -10.20% -12.31% -7.48% -10.66% -13.49% -15.18% -20 0 1 2 3 4 5 6 7 8 9 1011121314151617181920212223242526272829 Time (day) Vehicle
Slide 50: Oral BMF-650 Promotes Body Weight Reduction in Obese Monkeys
Oral BMF-650 Promotes Body Weight Reduction in Obese Cynomolgus Monkeys Body Weight Change (Individual) 2 Mean reduction in BW 0 (Day 29) -2 -4 Vehicle -3.4% -6 -8 BMF-650 10mg/kg -12.3% -10 -12 BMF-650 30mg/kg -15.2% -14 Vehicle (5 animals per dose group) -16 BMF-650, 10mpg -18 BMF-650, 30mpg -20 0
Slide 51: BMF-650 Preclinical Observation of Adverse Events
BMF-650 - Preclinical Observation of Adverse Events Low number of adverse events and decreasing frequency over time • BMF-650 generally well tolerated • No elevations of AST & ALT • 420 dosing occurrences (280 active / 140 placebo) • Total events of emesis in the active group 18 (6.4%) • Most of the
Slide 52: BMF-650 Demonstrated a Preclinical Profile Supporting Advancement
BMF-650 Demonstrated a Preclinical Profile Supporting Advancement IND Submission Expected 2H 2025 • BMF-650 is similar to the broader orforglipron chemotype • Superior oral bioavailability vs. orforglipron (across species) • Intrinsic potency • Robust glucose lowering and appetite suppression in pri
Slide 53: Biomea Fusion: Oral Small Molecules For Diabetes and Obesity
Biomea Fusion: Oral Small Molecules For Diabetes and Obesity Potentially transformative disease-modifying activity in type 2 diabetes (T2D): Targets a root cause by restoring functional beta cells to enable endogenous insulin production – A result not achieved by currently available therapies Icovam
Slide 54: Company Financials
Company Financials (NASDAQ: BMEA) For the three months ended March 31, 2025 Three Months Ended March 31, 2025 (unaudited) Operating expenses: R&D $ 22,897 G&A 6,815 Total Operating Expenses 29,712 Loss from operations (29,712) Interest and other income, net 450 Net loss $ (29,262) Other comprehensiv
Slide 55: Biomea Fusion: A Diabetes and Obesity Medicines Company
Biomea Fusion: A Diabetes and Obesity Medicines Company “We believe we may have a method to reverse diabetes, to reset the body, so diabetes patients no longer require ongoing medication.” Study Indications Anticipated Milestones for 2H 2025 52 Week Follow-up Data COVALENT-111 Type 2 Diabetes Phase
Slide 56: Thank you
Thank you Corporate Presentation June 2025 56 56