Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — 43rd Annual J.P. Morgan Healthcare Conference (January 2025)
39 slides from Biomea Fusion's conference presentation, Jan 15, 2025
Slide 1: Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference
Corporate Presentation 43rd Annual J.P. Morgan Healthcare Conference—January 15, 2025
Slide 2: Legal Disclaimer & Forward-Looking Statements
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 know
Slide 3: Biomea Fusion: A Diabetes and Obesity Medicines Company
Biomea Fusion: A Diabetes and Obesity Medicines Company Study Indications Anticipated Milestones for 2025 COVALENT-111 Type 2 Diabetes 2H 2025: 52 Week Data Phase 2 Icovamenib COVALENT-112 Type 1 Diabetes 2H 2025: Open Label Data (BMF-219) Phase 2 Menin Program (Potential Type 2 Diabetes COVALENT- 3
Slide 4: A Long History of Developing Multi-Billion Dollar Drugs—Together
A Long History of Developing Multi-Billion Dollar Drugs—Together Thomas Butler Ramses Erdtmann Juan Frías, M.D. Naomi Cretcher Heow Tan Franco Valle Chairman & CEO President & COO Chief Medical Chief of People Chief Technical & Chief Financial Officer Quality Officer Officer Co-Founder Co-Founder Th
Slide 5: Icovamenib & BMF-650 to Become Cornerstones of Our Metabolic Franchise
Icovamenib & BMF-650 (Oral Small Molecule GLP-1 RA) to Become Cornerstones of Our Metabolic Franchise Our Strategic Focus Anticipated Key Milestones for 2025 • Biomea to prioritize the development of 1H: 2025 icovamenib to address critical needs in the metabolic disease space • Meet with the FDA to
Slide 6: Icovamenib Value Proposition
Icovamenib Value Proposition Key Benefits of Icovamenib • First-in-class therapy with a novel mechanism of action • Unique treatment effect: Durable treatment impact on beta cell function and incretin effect • Oral, once-daily, 12-week treatment • Has enhanced endogenous insulin production • Has imp
Slide 7: Diabetes Burden in the U.S.
1 in 3 Americans will Develop Diabetes During Their Lifetime—CDC In the U.S. 80% of people with diabetes will die from diabetes.1 Premature mortality caused by diabetes results in an estimated 12-14 years of life lost.2 Diabetes creates one of the largest economic burdens on the U.S. health care sys
Slide 8: Challenges with Current Standard of Care
Challenges with Current Standard of Care 6 months 12 months 18 months GLP-1 RAs 50-75% Discontinue @ 12mos1 SGLT2i 69% Discontinue @ 18mos2 DPP-4i 74% Discontinue @ 18mos2 Reasons for Discontinuations • Side Effects • Glycemic Control Not Met • Injection Aversion • Cost and Affordability 1. Khan, et
Slide 9: Current Diabetes Treatments: Despite Initial Effectiveness There is No Lasting Impact
Current Diabetes Treatments: Despite Initial Effectiveness There is No Lasting Impact Mean time to Loss of Glucose Control (A1c>7%) Nathan, et al. N Engl J Med 2022;387:1063-107 Impact of tirzepatide on HbA1c: Sustained Reduction During Treatment, Rebound After Discontinuation Kubota M, et al. Cureu
Slide 10: Type 2 Diabetes Today—Chronic and Stacked Treatments to Overcome B-cell Loss
Type 2 Diabetes Today—Chronic and Stacked Treatments to Overcome B-cell Loss Adapted from IQVIA disease analyser Nov 2022; UCSF FAQ; Diabetes.org Fast Facts J.P. Morgan Healthcare Conference – January 15, 2025 Slide 10
Slide 11: Current Treatment Landscape in Type 2 Diabetes
Current Treatment Landscape in Type 2 Diabetes Adults with type 2 diabetes see multiple agents over time Agents are prescribed to drive Medication patients to glycemic target Stacking Agents are prescribed for extra-glycemic benefit Higher the baseline HbA1c, higher # of agents are needed Current ty
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 DEFICIENT DIABETES Severe insulin-deficient diabetes (SIDD) low BMI, severe beta-cell dysfunction, low insulin resistance, and high HbA1c, often with ea
Slide 13: What is a SIDD patient?
What is a SIDD patient? • SIDD Patients have the lowest insulin production out of all adults with type 2 diabetes • They represent the highest unmet medical need, displaying the highest all-cause mortality and worst CV outcomes • They have the highest treatment failure rate among adults with type 2
Slide 14: Icovamenib: First-in-Class Product Candidate for the Treatment of Diabetes
Icovamenib: First-in-Class Product Candidate for the Treatment of Diabetes Mechanism of Action: Selective & Partial Menin Inhibition Dual Effect Beta Cell Quantity & Function Increased beta cell mass and function Increased Insulin Synthesis and Secretion GLP-1 Expression Increased GLP-1 Receptor Exp
Slide 15: COVALENT-111 Phase 2a Double-Blinded, Randomized Placebo Controlled Study
COVALENT-111 Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes
Slide 16: Phase 2a Double-Blinded, Randomized Placebo Controlled Study in T2D
Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes (T2D) An ongoing dose-finding study evaluating the addition of icovamenib in T2D patients with uncontrolled glycemia on standard of care Patients receive icovamenib for a fixed treatment period, up to 12 weeks Durability
Slide 17: Phase 2a Study: Statistical Analysis Plan
Phase 2a Double-Blinded, Randomized Placebo Controlled Study in Type 2 Diabetes A dose-finding study in T2D patients on standard of care with uncontrolled glycemia Prespecified subgroup analysis to include review of HbA1c reduction within each subgroup (SIDD, MARD, MOD, and SIRD) Statistical Subgrou
Slide 18: Icovamenib Met the Primary Endpoint
Icovamenib Met the Primary Endpoint: Statistically Significant in Key Patient Population Arm A: 8 weeks of dosing 100mg QD Arm B: 12 weeks of dosing 100 mg QD Arm C: 8 weeks of 100 mg QD + 4 weeks of 100 BID MARD/SIDD: Mild Age-Related and Severe Insulin-Deficient Diabetes (insulin deficient) MOD/SI
Slide 19: Icovamenib Demonstrated Significant Reductions in HbA1c Across All Patient Segments
Icovamenib Dosed at 100mg for 12 Weeks Demonstrated Statistically Significant Reductions in HbA1c Across All Patient Segments Placebo-Adjusted Mean Change in HbA1c at Week 26 Patients Uncontrolled with at Least 1 Prior Therapy The SIDD Patient population is approximately 14 Million in the U.S./EU an
Slide 20: Summary Table of Efficacy Analysis
Summary Table of Efficacy Analysis Targeted Patients – Severe Insulin Deficient Patients (SIDD) Number of Reduction in P Value Patients HbA1C ARM B & C All patients 12 weeks dosing 69 -0.42% 0.015 * ARM B & C SIDD/MARD (12 weeks) 22 -0.84% 0.008 * ARM B & C SIDD (12 weeks) 11 -1.17% 0.038 * Number o
Slide 21: SIDD Subgroup Performed In-line with GLP-1 RA Based Therapies
Prespecified SIDD Subgroup Performed In-line with GLP-1 RA Based Therapies Currently Approved Type 2 Diabetes Agents w/Chronic Dosing Drug Dosing Medication Observation Mean HbA1c Reduction (Mechanism of Action) Frequency Route Period (placebo adj., %) ICOVAMENIB (Menin Inhibitor) 12 Weeks Oral Week
Slide 22: HbA1c Reduction Has Continued Over Time – Outside the Treatment Period
HbA1c Reduction Has Continued Over Time – Outside the Treatment Period Severe Insulin Deficient Diabetes (SIDD) Patients Mean Change in HbA1c – All Arms 0 k 12 Week 16 Week 22 Week 26 -0.2 -0.4 Icovamenib Icovamenib Mean Treatment Off-Treatment HbA1c in Period Period -0.6 Adjusted Patients continued
Slide 23: Icovamenib Drives Continued Glycemic Control During Off-Therapy
Icovamenib Drives Continued Glycemic Control During Off-Therapy Week 12 Week 26 (last day of dose) (14 weeks after last dose) 0 – 12 weeks 12 – 26 weeks Icovamenib Icovamenib Treatment Off-Treatment HbA1c Period Period in change Response Rate of SIDD Patients in COVALENT 111: 100% (All severe insuli
Slide 24: Baseline HbA1c and BMI Can Enrich for the Desired Phenotype
Baseline HbA1c and BMI Can Enrich for the Desired Phenotype BMI and baseline HbA1c inclusion criteria can COVALENT-111 Week 26 enrich for SIDD to over 90% (12 Weeks at 100mg) Baseline HbA1c 8.5 HbA1c BMI <32 in of higher Change Mean Adjusted Placebo—-1.47% -1.54% Low Insulin Resistance SIDDs All pat
Slide 25: Icovamenib in Combination with GLP-1 Based Therapies
icovamenib in combination with GLP-1 based therapies
Slide 26: Menin Suppresses GLP-1 Receptor Transcript Levels
Menin Suppresses GLP-1 Receptor Transcript Levels J.P. Morgan Healthcare Conference – January 15, 2025 Slide 26
Slide 27: Icovamenib Enhanced Responsiveness of Islets to Tirzepatide
Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to GLP-1/GIP Dual Receptor Agonist—Tirzepatide Day Culture 7 days under glucotox conditions Day 1 (8 mM glucose) 8 Cadaver derived DMSO human islets Icovamenib, 30 nM Icovamenib, 100 nM Perform GSIS -/+ Tirzepatide Non-diabetic dono
Slide 28: Icovamenib Enhanced Responsiveness of Islets to Semaglutide
Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to GLP-1 Receptor Agonist—Semaglutide Day 1 Culture 7 days under glucotox conditions Day 8 Cadaver derived (8mM glucose) human islets DMSO Icovamenib, 100 nM Perform GSIS -/+ Semaglutide Non-diabetic donor: Icovamenib, 300 nM (200nM
Slide 29: Icovamenib Enhanced Islet Responsiveness to Orforglipron and BMF-650
Combination Treatment: Icovamenib Enhanced Responsiveness of Islets to the Small Molecule GLP-1 Receptor Agonists—Orforglipron and BMF-650 J.P. Morgan Healthcare Conference – January 15, 2025 Slide 29
Slide 30: Icovamenib and Low Dose Semaglutide Extends Glycemic Control in Diabetic Animals
Combination Treatment of Icovamenib and Low Dose Semaglutide Extends Marked Glycemic Control in Diabetic Animals Fasting Blood Glucose OGTT – Day 28 500 450 p<0.0001 400 p<0.001 60000 350 min) 50000 300 . 250 40000 ~-50% mg/dL 200 ~-60% 30000 150 (mg/dL 100 20000 50 AUC 10000 0 Baseline day 28 0 veh
Slide 31: Combination Reduced Insulin Resistance and Elevates C-peptide Index
Combination Treatment of Icovamenib and Low Dose Semaglutide Significantly Reduced Insulin Resistance and Elevates C-peptide Index HOMA-IR C-peptide Index p<0.0001 0.02 60 ~2x 50 0.015 40 index IR—~-75% 0.01 HOMA 30 peptide 1x 20 c—0.005 10 0 0 day -3 day 28 day -3 day 28 vehicle + semaglutide icova
Slide 32: Combination Reduces Body Weight and Boosts Lean Mass
Combination Treatment of Icovamenib and Low Dose Semaglutide Reduces Body Weight and Boosts Lean Mass Body Weight Lean Mass Composition Fat Mass Composition 0.00 14.00 0.00 -2.00 BW) 12.00 +43% BW) -1.00 -4.00 10.00 total total -2.00 -6.00to 8.00 additional to -3.00 change -8.00 6.00 % 11.5% -4.00 -
Slide 33: Icovamenib Drove Additional HbA1c Reduction in Patients on GLP-1 RA Therapy
Icovamenib Drove Additional HbA1c Reduction in Patients on a GLP-1 RA Based Therapy Placebo-Adjusted Mean Change in HbA1c at Week 26 Uncontrolled with GLP-1 Agonist-Based Therapy Icovamenib displays clinically meaningful 1.0% reduction in HbA1c in patients currently uncontrolled on GLP-1 RA based th
Slide 34: Overview of Adverse Events
Overview of Adverse Events Through 26 Weeks (mITT Population, N=225) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=59) (N=54) (N=55) (N=168) (N=57) Patients with ≥1 TEAE 18 (31) 19 (35) 13 (24) 50 (30) 18 (32) SAEs 0 (0) 0 (0) 0 (0) 0
Slide 35: Safety and Tolerability
Safety and Tolerability (mITT Population, N=225) Arm A Arm B Arm C Combined Arms Combined Arms Parameter icovamenib icovamenib icovamenib icovamenib placebo (N=59) (N=54) (N=55) (N=168) (N=57) Diarrhea 4 (7) 2 (4) 1 (2) 7 (4) 0 (0) Nausea 2 (3) 3 (6) 2 (4) 7 (4) 1 (2) Hyperglycemia 1 (2) 4 (7) 1 (2)
Slide 36: Icovamenib: Late-Stage Clinical Development in Type 2 Diabetes
Icovamenib: Late-Stage Clinical Development in Type 2 Diabetes Development of icovamenib to focus on two key patient segments—Severe Insulin Deficient Diabetes Patients—All Patients in Combination with a GLP-1 RA 1. Severely Insulin Deficient Diabetes (SIDD) Subjects We aim to improve glycemic contr
Slide 37: Biomea Fusion: A Diabetes and Obesity Medicines Company
Biomea Fusion: A Diabetes and Obesity Medicines Company Study Indications Anticipated Milestones for 2025 COVALENT-111 Type 2 Diabetes 2H 2025: 52 Week Data Phase 2 Icovamenib COVALENT-112 Type 1 Diabetes 2H 2025: Open Label Data (BMF-219) Phase 2 Menin Program (Potential Type 2 Diabetes COVALENT- 3
Slide 38: JP Morgan 2025 Summary
JP MORGAN 2025 Summary Advancing a First-in-Class, Precision-Based Treatment for Diabetes • Icovamenib is an oral, once daily, simple, 12-week treatment for diabetes • Icovamenib displayed comparable efficacy to a GLP-1 RA chronic therapy in the target patient population at Week 26, with just 12 wee
Slide 39: Company Financials
Company Financials (NASDAQ: BMEA) As of September 30, 2024 Three Months Ended September 30, 2024 Operating expenses: R&D $ 27,244 G&A 6,795 Total Operating Expenses 34,039 Loss from operations (34,039) Interest and other income, net 1,252 Net loss $ (32,787) Other comprehensive loss: Changes in unre
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