Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — JP Morgan Healthcare Conference 2024
32 slides from Biomea Fusion's conference presentation, Jan 10, 2024
Slide 1: JP Morgan 2024 Corporate Presentation
Exhibit 99.1 JP Morgan 2024 Corporate Presentation Page 1
Slide 2: Legal Disclaimer & Forward-Looking Statements
Disclaimer 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 i
Slide 3: Combining Validated Targets with Breakthrough Chemistry
Excellent Science - Combining Validated Targets with Breakthrough Chemistry We Aim to Cure Experienced Management Team TM Novel FUSION™ System Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small-molecule drugs to treat BMF-219 –
Slide 4: A Long History of Developing Successful Drugs - Together
Aiming to Develop Some of the Most Impactful Medicines of Our Time A Long History of Developing Successful Drugs - Together Franco Valle Thomas Butler Ramses Erdtmann Naomi Cretcher Heow Tan Steve Morris, M.D. Juan Frías, M.D. Chief Financial President & COO Chairman & CEO Chief of People Chief Tech
Slide 5: Biomea Leverages the FUSION System to Create Novel Covalent Agents
TM Biomea Leverages the FUSION System to Create a Suite of Novel Covalent Agents to Potentially Improve and Extend the Lives of Patients Biomea’s Development Principles Drugs pursuing Validated Disease Targets have a ~2x Validated Targets Breakthrough higher likelihood of approval than molecules pur
Slide 6: Case Study PCI-32765 IMBRUVICA - Prolonged Target Occupancy
Case Study PCI-32765 IMBRUVICA - Prolonged Target Occupancy Effect without Prolonged Systemic Exposure Covalent Inhibitors Have Long Kinetic but Short Biological Half Life High Selectivity Long Kinetic Half Life % Active-Site Occupancy (left axis) indicates Two-step inhibition: 1) Initial reversible
Slide 7: Our FUSION System
TM Our FUSION System We leverage our FUSION System to discovery and develop Novel covalent inhibitors against targets essential for many diseases. • Novel Target Selection Process • Crystal Structure based Drug Design • Proprietary Scaffold Construction
Slide 8: Fusion System – Discovery and Development of Novel Covalent Inhibitors
Fusion System – Discovery and Development of Novel Covalent Inhibitors Human Genome Wide Covalent Pocket Analysis CYS site spheres hydrophobic • 23,391 human genes as predicted • Top ranking pocket with sufficient • Analyze Apo structures without structures; 14,159 novel vs PDB hydrophobic character
Slide 9: Biomea's Pipeline Expands into Clinical Trials with Novel Agents
Biomea’s Pipeline Expands into 5 Clinical Trials with 2 Novel Agents Multiple Upcoming Milestones in the Near Term Study Indications Milestones Expected Timeline COVALENT-111 Type 2 Diabetes Phase II - Dose Escalation Completion, ATTD 1Q 2024 2024 Phase II - Initial Proof of Concept COVALENT-112 Typ
Slide 10: Juan Pablo Frías, M.D. Appointed Chief Medical Officer
Aiming to Develop Some of the Most Impactful Medicines of Our Time Juan Pablo Frías, M.D. is Appointed as Biomea’s Chief Medical Officer August 31, 2023 Dr. Frías is a board-certified endocrinologist who has served as principal investigator on over 250 clinical diabetes studies, with over half of th
Slide 11: Diabetes – the Biggest Epidemic of the 21st Century
Diabetes – the Biggest Epidemic of the 21st Century 2 in 5 Americans Will Develop Diabetes during Their Lifetime th 37.3 million US adults have • Diabetes is the 7 leading cause of death in the US. 80% of diabetes today; A total of $413 people with diabetes will die from this disease. Premature Bill
Slide 12: Number of Patients Relying on Insulin Continues to Rise
Diabetes – the Biggest Epidemic of the 21st Century Number of Patients with Diabetes Relying on Insulin Continues to Rise despite Novel Diabetic Agents Approved, without Improving the A1c Outcome 7th GLP-1 RA 6th GLP-1 RA 4th SGLT2 First SGLT2 First GLP-1 RAs approved by approved by approved by appr
Slide 13: Investigational BMF-219 - A Unique Value Proposition: Beta Cell Health
Diabetes – the Biggest Epidemic of the 21st Century Investigational BMF-219 - A Unique Value Proposition: Beta Cell Health st BMF-219: 1 in Class Potential for Differentiated Profile Complementary Agent Well-Tolerated Profile Non-Chronic Oral Small Molecule to Available Diabetes After First Read Out
Slide 14: Role of Beta Cells in Diabetes
Role of Beta Cells in Diabetes Beta Cells Proliferate - Just not enough to overcome pre-existing metabolic disorder “We conclude that during pregnancy, placental hormones act through the prolactin receptor to increase beta cell mass by up regulating beta cell “In nondiabetic obesity, an expansion in
Slide 15: Role of Menin in Diabetes
Role of Menin in Diabetes Menin Controls Beta-Cell Proliferation and Mass § Menin is a transcriptional scaffold protein that controls the expression of proteins that regulate beta-cell proliferation. - Menin has been found to control islet growth in pregnant mice. Pregnancy § Menin is thought to act
Slide 16: Beta Cell Compensation in Physiological and Pathophysiological States
Diabetes – the Biggest Epidemic of the 21st Century Beta Cell Compensation in Physiological and Pathophysiological States in Mammals Pregnancy β-Cell Mass β-Cell Replication Pregnancy Pregnancy β-Cell Size Adapted from Science 2005 Page 16
Slide 17: BMF-219 – Mechanism of Action
BMF-219 – Mechanism of Action The Goal for BMF-219 is to Improve Glycemic Control without Continuous Medication BMF-219 is aimed to increase beta cell mass and function, thereby increase insulin Proposed effect of BMF-219 production in order to achieve glycemic control Proposed effect of BMF-219 - w
Slide 18: BMF-219 – Impact on Beta Cell Proliferation and Insulin Secretion
BMF-219 – Impact on Beta Cell Proliferation and Insulin Secretion in Ex Vivo Models BMF-219 Induced a Glucose-Dependent Enhancement in β-Cell Proliferation Proliferating beta cells as a fraction of total beta cells Donor 2 Standard glucose High glucose Donor 2; Day 14, High glucose Proliferating β-c
Slide 19: BMF-219 Preserved, Reactivated and Regenerated Beta Cells in Preclinical Studies
BMF-219 – Mechanism of Action BMF-219 Preserved, Reactivated and Regenerated Beta Cells in Preclinical Studies Reactivation Preservation Regeneration +96% Normal (Adequate) State +351% Quantitative Analysis of pancreatic islet tissue BMF-219 demonstrated a significant level of beta BMF-219 increased
Slide 20: BMF-219 Potential First-in-Class Diabetic Agent
BMF-219 Mechanism of Action BMF-219 is a Potential First-in-Class Diabetic Agent – Addressing the Root Cause of Disease BMF-219: Menin Inhibition a Potential New Class of Diabetes Agents Beta cell reactivation, preservation and proliferation Beta Cell Mass ↑ Beta Cell Health ↑ Nat Rev Endocrinol 12,
Slide 21: COVALENT-111 Study Design
COVALENT-111 Study Design (Type 2 Diabetes Patients Failing Standard of Care) Additional Dose Levels and Various Dosing Durations Are Being Explored in the Escalation and Expansion Portion of COVALENT-111 Part 1 Dose Escalation, Part 2 Dose Expansion, n=216 – 288 incl. 4 weeks dosing+ 12 weeks follo
Slide 22: COVALENT-111 Baseline Characteristics and Demographics
COVALENT-111 Phase 2 Study (Type 2 Diabetes) Baseline Characteristics and Demographics BMF-219 100mg QD B MF -219 100mg QD without food with food Placebo (n=10) (n=10) (n=6) Age (year, min-max) 52 (38-63) 51 (35-60) 46 (31-61) Sex (n, M/F) 6/4 7/3 6/0 Duration of diabetes (year, min-max) 4.2 (0.5-9.
Slide 23: COVALENT-111 Glycemic Results Summary at Week 26
COVALENT-111 Phase 2 Study (Type 2 Diabetes) Glycemic Results Summary at Week 26 BMF-219 100mg QD BMF-219 100mg QD without food with food Placebo (n=10) (n=10) (n=6) Mean change in HbA -0.5% 0.1% 0.3% 1c Placebo adjusted mean change in HbA -0.8% -0.2% - 1c Percent of participants with ≥1.0% reductio
Slide 24: Greater BMF-219 Exposure Resulted in Greater HbA1c Reduction
COVALENT-111 Phase 2 Study (Type 2 Diabetes) Greater BMF-219 Exposure at Week 4 Resulted in Greater Reduction in HbA at Week 26 1c 100 mg QD without food 100 mg QD with food BMF-219 mean AUC at Week 4 Change in HbA at Week 26 last 1c 0.3 ± 1.7 0.1 ± 1.1 0 300 224 ± 2.5 -0.5 200 -0.5 ± 1.1 -1.0 100 8
Slide 25: % Increase in HOMA-B and C-peptide AUC in Responders
COVALENT-111 Phase 2 Study (Type 2 Diabetes) % Increase in HOMA-B and C-peptide AUC in Responders Patients with HbA reduction ≥0.5% at Week 26 and baseline HOMA-B <200 1c % change HOMA-B % change C-peptide AUC Page 25
Slide 26: COVALENT-111 Case Study 2
COVALENT-111 Phase 2 Study (Type 2 Diabetes) Case Study 2: 29-Year-Old Man with 4-Year History of T2D • 29-year-old man with 4-year history of T2D • BMF-219 200 mg once daily without food for 4 weeks • Metformin and empagliflozin • CGM at Week 21 with ~90% TIR 70-180 mg/dL 2 • HbA 9.5%; FPG 146 mg/d
Slide 27: COVALENT-111 Case Study 2
COVALENT-111 Phase 2 Study (Type 2 Diabetes) Case Study 2: 29-Year-Old Man with 4-Year History of T2D • 29-year-old man with 4-year history of T2D • BMF-219 200 mg once daily without food for 4 weeks • Metformin and empagliflozin • CGM at Week 21 with ~90% TIR 70-180 mg/dL 2 • HbA 9.5%; FPG 146 mg/d
Slide 28: 2023 Accomplishments
WE AIM TO CURE 2023 Accomplishments DIABETES COVALENT-111: Type 2 Diabetes Patients failing standard of care (Metformin, SGLT2, GLP-1, DPP-4) • 84% of patients responded to BMF-219 while on treatment (any reduction in HbA1c at Week 4) • 74% of patients continued to respond to BMF-219 despite off-tre
Slide 29: 2024 Anticipated Milestones
WE AIM TO CURE 2024 Anticipated Milestones DIABETES - COVALENT-111 Phase II - BMF-219 in type 2 diabetes – Dose Escalation Completed - COVALENT-111 Phase II - BMF-219 in type 2 diabetes - Expansion cohorts fully enrolled (n=216+) - COVALENT-112 Phase II - BMF-219 in type 1 diabetes - Open Label coho
Slide 30: Our Development Plan: Next Years
WE AIM TO CURE Our Development Plan: Next 4 Years BMF-219 in Diabetes 2024 Phase II Expansion Phase Completed in type 2 diabetes Proof of concept in type 1 diabetes established 2025 Pivotal Phase III study in type 1 diabetes initiated Pivotal Phase III studies in type 2 diabetes initiated 2026 NDA f
Slide 31: Company Financials
As of September 30, 2023 Company Financials (NASDAQ: BMEA) Three Months Ended September 30, 2023 Operating expenses: R&D $ 25,347 G&A 5,772 Total Operating Expenses 31,119 Loss from operations (31,119) Interest and other income, net 2,690 Net loss $ (28,429) Other comprehensive loss: Changes in unre
Slide 32: Thank You
THANK YOU Biomea Fusion 900 Middlefield Road, 4th floor Redwood City, CA, 94063 biomeafusion.com Page 32