Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — Technical Presentation (December 2024)
25 slides from Biomea Fusion's technical presentation, Dec 20, 2024
Slide 1: COVALENT-111 Topline Results
Exhibit 99.2 COVALENT-111 Topline Results December 17, 2024
Slide 2: Agenda
COVALENT-111 Topline Results - Conference Call December 17, 2024 Agenda Thomas Butler Introduction & Chief Executive Officer, Chairman of the Board & Co-Founder of Biomea Fusion Executive Summary COVALENT-111 Dr. Juan Pablo Frias Chief Medical Officer of Biomea Fusion Topline Results Dr. Alex Abitbo
Slide 3: Legal Disclaimer & Forward-Looking Statements
COVALENT-111 Topline Results - Conference Call December 17, 2024 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 pe
Slide 4: Introduction & Executive Summary
Introduction & Executive Summary COVALENT-111 Topline Results December 17, 2024 Thomas Butler Chief Executive Officer, Chairman of the Board & Co-Founder of Biomea Fusion
Slide 5: None of Today's Type 2 Diabetes Agents Address the Root Cause of Diabetes
COVALENT-111 Topline Results - Conference Call December 17, 2024 None of Today’s Type 2 Diabetes Agents Address the Root Cause of Diabetes - The Progressive Decline of Beta Cell Mass and Function - Loss of Beta Cell Function Currently Approved Therapies The Root Cause of Diabetes Targeting the Sympt
Slide 6: Top-Line Results
COVALENT-111 Top-Line Results COVALENT-111 Topline Results December 17, 2024 Dr. Juan Pablo Frias Chief Medical Officer of Biomea Fusion
Slide 7: Heterogeneity in Type 2 Diabetes
COVALENT-111 Topline Results - Conference Call December 17, 2024 Heterogeneity in Type 2 Diabetes Slide 7
Slide 8: Type 2 Diabetes Subtypes and icovamenib Target Population
COVALENT-111 Topline Results - Conference Call December 17, 2024 SAID = Severe Autoimmune Diabetes SIDD = Severe Insulin-Deficient Diabetes icovamenib Target SIRD = Severe Insulin-Resistant Diabetes US Patient Population >50% of T2D MOD = Mild Obesity-Related Diabetes MARD = Mild Age-Related Diabete
Slide 9: Key Eligibility Criteria and Study Design
COVALENT-111 Topline Results - Conference Call December 17, 2024 Key Eligibility Criteria and Study Design • Adults (18-65 years old) with T2D (<7 yr T2D duration) 2 • HbA1c 7.0-10.5%; BMI 25-40 kg/m • Treated with up to 3 antidiabetic agents (excluding insulin or insulin secretagogues) • N=72 parti
Slide 10: Placebo-Adjusted Change in HbA1c as Presented during ATTD ASIA
COVALENT-111 Topline Results - Conference Call December 17, 2024 Placebo-Adjusted Change in HbA1c as Presented during ATTD ASIA 18 Nov. 2024 Week 26 from cohorts dosed during the Escalation Phase of COVALENT-111 SIDD and MARD are insulin deficient patients They make up approx. 50% -70% of T2D MOD an
Slide 11: Baseline Patient Population
COVALENT-111 Topline Results - Conference Call December 17, 2024 Baseline Patient Population • mITT population: Defined as all randomized participants who took at least one dose of study drug (N=225) • The efficacy analysis focuses on those patients that completed the dosing period prior to the clin
Slide 12: Baseline Demographics and Characteristics
COVALENT-111 Topline Results - Conference Call December 17, 2024 Baseline Demographics and Characteristics (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) Age (yr) 55 (7) 55 (8) 5
Slide 13: Placebo-Adjusted Change in HbA1c at 26 Weeks, Per Protocol Patients
COVALENT-111 Topline Results - Conference Call December 17, 2024 Placebo-Adjusted Change in HbA1c at 26 Weeks Per Protocol Patients Uncontrolled with at least 1 Medication at Baseline (N=113) Placebo-Adjusted Mean Change in HbA1c at Week 26 of Patients Uncontrolled with at least 1 Prior Therapy Dose
Slide 14: Placebo-Adjusted Mean Change in HbA1c at Week 26, Arms B/C
Placebo-Adjusted Mean Change in HbA1c at Week 26 COVALENT-111 Topline Results - Conference Call December 17, 2024 of Patients Uncontrolled with at least 1 Prior Therapy Placebo-Adjusted Mean Change in MARD MARD SIDD SIDD All Arms B/C + + (all patients) (Arms B/C) N=69 HbA1c at 26 Weeks in Per Protoc
Slide 15: Placebo-Adjusted Mean Change in HbA1c at Week 26, Arm B
Placebo-Adjusted Mean Change in HbA1c at Week 26 COVALENT-111 Topline Results - Conference Call December 17, 2024 of Patients Uncontrolled with at least 1 Prior Therapy Placebo-Adjusted Mean Change in SIDD MARD MARD SIDD All Arms B (all patients) + + (Arms B) N=37 HbA1c at 26 Weeks in Per Protocol p
Slide 16: Summary Table of Efficacy Analysis
COVALENT-111 Topline Results - Conference Call December 17, 2024 Summary Table of Efficacy Analysis Targeted Patients - Insulin Deficient Number of Reduction in P Value Patients HbA1C ARM B & C comb All patients 12 weeks dosing 69 -0.42% 0.015 * ARM B & C comb SIDD/MARD (12 weeks) 22 -0.84% 0.008 *
Slide 17: HbA1c Change in Patients Uncontrolled with GLP-1 Agonist-Based Therapy
COVALENT-111 Topline Results - Conference Call December 17, 2024 Placebo-Adjusted Mean Change in HbA1c at Week 26 Uncontrolled with GLP-1 Agonist-Based Therapy Interesting Finding in Other Subtypes Insulin Resistant Patients icovamenib displays clinically meaningful reductions in HbA1c also in the i
Slide 18: Overview of Adverse Events Through 26 Weeks
COVALENT-111 Topline Results - Conference Call December 17, 2024 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
Slide 19: Safety and Tolerability
COVALENT-111 Topline Results - Conference Call December 17, 2024 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) Nau
Slide 20: Efficacy and Safety Analysis of Per Protocol Patient Population
COVALENT-111 Topline Results - Conference Call December 17, 2024 Efficacy and Safety Analysis of Per Protocol Patient Population • Icovamenib met the primary endpoint, displaying a clinically meaningful and statistically significant placebo-corrected reduction in HbA1c in the prespecified Per Protoc
Slide 21: Key Opinion Leader Insights
Key Opinion Leader INSIGHTS COVALENT-111 Topline Results December 17, 2024 Dr. Alex Abitbol Endocrinologist, Scientific Advisory Board Member of Biomea Fusion
Slide 22: Typical Treatment Sequence/Stacking of Therapeutics in Type 2 Diabetes
COVALENT-111 Topline Results - Conference Call December 17, 2024 Typical Treatment Sequence/Stacking of Therapeutics in Type 2 Diabetes • Initiation of therapy typically begins with an oral anti-diabetic drugs, like metformin, added/followed by DPP-4 Inhibitors, SGLT2 Inhibitors and oral / injectabl
Slide 23: Type 2 Diabetes – Phenotypic Subtypes
COVALENT-111 Topline Results - Conference Call December 17, 2024 Type 2 Diabetes – Phenotypic Subtypes Fig. The phenotype characteristics were identified using five clinical parameters (age at diabetes onset, HbA1c, BMI, and measures of insulin resistance (HOMA2-IR) and insulin secretion (HOMA2-B))
Slide 24: Q&A
Q&A bioME|A we aimtocure FUSION
Slide 25: Thank You
THANK YOU Slide 25
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