Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — JP Morgan Healthcare Conference 2023
53 slides from Biomea Fusion's conference presentation, Jan 12, 2023
Slide 1: JP Morgan 2023 Corporate Presentation
Exhibit 99.2 JP Morgan 2023 Corporate Presentation 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: Excellent Science - Combining Validated Targets with Breakthrough Chemistry
Excellent Science - Combining Validated Targets with Breakthrough Chemistry We aim to cure TM Experienced Management Team Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small-molecule drugs to treat Novel FUSION™ System patients
Slide 4: Developing some of the most impactful medicines of our time
Developing some of the most impactful medicines of our time A long history of developing successful drugs together Heow Tan Steve Morris MD Ramses Erdtmann Naomi Cretcher Franco Valle Thomas Butler Thorsten Kirschberg Jim Palmer Chief Technical & Chief Medical President & COO Chief of People Chief F
Slide 5: Biomea leverages the FUSION System to Create a Suite of Novel Covalent Agents
TM Biomea leverages the FUSION System to Create a Suite of Novel Covalent Agents to Improve and Extend the Lives of Patients Biomea’s Development Principles Drugs pursuing Validated Disease Targets have a ~2x higher likelihood of approval than molecules pursuing Validated Validated Targets Breakthro
Slide 6: Our Technology Platform – The FUSION SYSTEM
TM Our Technology Platform – The FUSION SYSTEM TM Biomea created the Fusion System specifically to address unique targets and rapidly create highly potent and safe covalent inhibitors for them. Protein-protein interactions Shallow, limited, or dynamic binding sites Difficult to target kinases, inclu
Slide 7: The FUSION SYSTEM provided Program leads over the past 4 years
TM Our Technology Platform – The FUSION SYSTEM – provided 3 Program leads over the past 4 years! Target identification to IND candidate in 18 months IND Target to Hit Custom Lead Lead Optimization Custom scaffold creation Target validation Library of custom engagers Refinement Proprietary AI platfor
Slide 8: Covalent Chemistry creates very powerful results
Covalent Chemistry creates very powerful results Covalent Inhibitors - a History of Medical & Commercial Success Notable Covalent Inhibitors • Aspirin was the first commercialized covalent drug Aspirin Penicillin Osimertinib (TAGRISSO) • Notable precision oncology and infectious disease programs lev
Slide 9: Case Study PCI-32765 IMBRUVICA - Prolonged Target Occupancy Effect
Case Study PCI-32765 IMBRUVICA - Prolonged Target Occupancy Effect Without prolonged Systemic Exposure Imbruvica – a Covalent Inhibitor with Long Kinetic but very Short Biological Half Life High Selectivity Long Kinetic Half Life Two-step inhibition: 1) Initial reversible binding followed by % Activ
Slide 10: JPM 2022 Announcement: Goals for the year 2022
JPM 2022 Announcement BMF-219 Goals for the year 2022 Initiation of “Clinical Trials in 7 tumor types and in Diabetes” – and WE DID IT! Completion of Healthy Volunteer Completed Portion of Study Enrollment of First Diabetes Patient Completed Plus CLL Additional Programs nd 2 Pipeline Candidate H1 20
Slide 11: Biomea's Pipeline as of January 2023
In 2022 Biomea Expanded into Eight Different Solid and Liquid Tumors as well as Type 2 Diabetes Biomea’s Pipeline as of January 2023 Addressable Population IND Discovery Phase 1 Phase 2 Phase 3 Enabling (US Incidence) AML/ALL (Leukemia) ~2.5K MLL-r ~6K NPM1 DLBCL (Lymphoma) ~6.5K DLBCL (r/r MYC) COV
Slide 12: BMF-219 and BMF-500 Patient Populations in the US
BMF-219 and BMF-500 Patient Populations in the US Cancer Indications: >200K and Diabetes: >125M Addressable Annual US Patient Population for BMF-219 Diabetes Patient Population Oncology Patient Population 70,000 100 M ~90M 60K 90 M ~58K 60,000 ~53K 80 M MLL-R and 50,000 70 M NPM1 AML Initial Target
Slide 13: BMF-219 a covalent inhibitor of menin with unique properties
BMF-219 a covalent inhibitor of menin with unique properties Restoring Balance in Menin Dependents Diseases is Context Specific Pathological State Effector Genes CDK inhibition results in beta-cell quiescence Treating Cancer Treating Diabetes • Menin dependent effector genes • Menin dependent effect
Slide 14: BMF-219 in MLL Fusion and NPM1 Driven Tumors
First Development Success with BMF-219 in MLL Fusion and NPM1 Driven Tumors BMF-219 has the Potential to Impact Important Binding Partners in Multiple Tumors Mechanism of Action Target Patient Population • Acute Leukemia: MLL-r MLL HOXA9/ BMF-219 covalent binding to MEIS1 • Acute Leukemia: NPM1 muta
Slide 15: BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications
Novel Covalent Inhibitor of Menin BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications MLL Fusion & NPM1 Driven Tumors Initial clinical validation in r/r acute leukemias with MLL fusions in addition to NPM1 mutations MYC Addicted and MYC Driven Tumors Expansion into r/r diffuse large b
Slide 16: BMF-219 in MLL Fusion and NPM1 Driven Tumors In Acute Leukemia
First Development Success with BMF-219 in MLL Fusion and NPM1 Driven Tumors In Acute Leukemia Development Stage: Phase I Clinical Trial (COVALENT-101) enrolling patients with relapsed/refractory acute leukemia Key Facts MOA Relevant Pathway BMF-219 covalently blocks menin / MLL Menin / MLL interacti
Slide 17: BMF-219 Highly Selective in Key Screening and Safety Panels
GLP and non-GLP IND-Enabling Toxicology Studies BMF-219 Was Highly Selective in Key Screening and Safety Panels No Histopathology Findings Were Observed with BMF-219 in GLP and non-GLP IND-Enabling Toxicology Studies Kinase Screening P BMF-219 Vehicle Metabolic Activity (%) 169 kinases screened; onl
Slide 18: BMF-219 Rapid and Near Complete Reduction of Oncogene Expression
First Development Success with BMF-219 in MLL Fusion and NPM1 Driven Tumors BMF-219 Demonstrated Rapid and Near Complete Reduction of Expression of Oncogenes Gene Expression Changes in AML cells following treatment • Covalent inhibitor, BMF-219, w/ BMF-219 (0.500µM dose) downregulates expression of
Slide 19: BMF-219 Superior Cell killing of Target AML Cell Lines
First Development Success with BMF-219 in MLL Fusion and NPM1 Driven Tumors BMF-219 Superior Cell killing of the Target AML Cell Lines at Half the Dose vs Reversible Competitive Menin Inhibitors Source Data from ASH 2021 Publications BMF-219 Non-covalent Inhibitors KO-539 is 15% effective @ 1000nM i
Slide 20: BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications
Novel Covalent Inhibitor of Menin BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications MLL Fusion & NPM1 Driven Tumors Initial clinical validation in r/r acute leukemias with MLL fusions in addition to NPM1 mutations MYC Addicted and MYC Driven Tumors Expansion into r/r diffuse large b
Slide 21: Menin Dependencies Observed in Multiple Tumors
Menin Dependencies Observed in Multiple Tumors Acute Leukemia, DLBCL, MM & Other Tumor Types Have High Menin Dependency Based on Broad Institute DEPMAP Dataset BROAD Institute Cancer Dependency Map (DEPMAP) for Menin (MEN1) • Cell viability scores have shown that menin plays a key role in survival o
Slide 22: BMF-219 Covalent Binding of Menin has Broad Impact
BMF-219 Covalent Binding of Menin has Broad Impact BMF-219 Shown to Disrupt MYC Genomic Function via Broad Impact on the Complexes Surrounding Menin Covalent Menin Inhibitor – BMF-219 Non-Covalent Menin Inhibitor – SNDX-50469 TF activity inference scores greater than 10 are highly significant TF act
Slide 23: BMF-219 in MYC Addicted and MYC Driven Tumors: DLBCL
First Development Success with BMF-219 in MYC Addicted and MYC Driven Tumors BMF-219 Led to near Complete Inhibition of Growth at 1μM in DLBCL in ex-vivo Samples Triple Hit Lymphoma MYC Amplified DLBCL • At ~1µM exposure, BMF-219 produces robust growth BM-101 125 BM-100 inhibition in both THL (tripl
Slide 24: BMF-219 Achieves >98% Cell Lethality Against CLL ex vivo models
First Development Success with BMF-219 in MYC Addicted and MYC Driven Tumors BMF-219 Achieves >98% Cell Lethality Against Diverse CLL ex vivo models Growth inhibition of BMF-219 in CLL ex vivo models grouped by genetic background and Rai stage Growth Inhibition of Ex Vivo CLL Models Response based o
Slide 25: COVALENT-101 (Enrolling Cohorts)
COVALENT-101 (ENROLLING 4 COHORTS) Phase I first-in-human dose-escalation and dose-expansion study of BMF-219 enrolling adult patients with r/r acute leukemia, r/r diffuse large B cell lymphoma, r/r multiple myeloma, and r/r chronic lymphocytic leukemia (CLL) (NCT05153330) Dose Escalation Dose Expan
Slide 26: BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications
Novel Covalent Inhibitor of Menin BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications MLL Fusion & NPM1 Driven Tumors Initial clinical validation in r/r acute leukemias with MLL fusions in addition to NPM1 mutations MYC Addicted and MYC Driven Tumors Expansion into r/r diffuse large b
Slide 27: BMF-219 Near Complete Inhibition of Growth in KRAS Mutant Cell Lines
First Development Success with BMF-219 in RAS/RAF Driven Solid Tumors BMF-219 Produced Near Complete Inhibition of Growth at 1.1μM Across KRAS G12C, G12D, G13D, and G12V Mutant Cell Lines but not WT KRAS Growth inhibition of In Vitro KRAS Mutant Cell Lines Growth Inhibition of In Vitro KRAS Mutant C
Slide 28: BMF-219 Inhibition in KRAS G12C and G12D ex-vivo Patient Samples
First Development Success with BMF-219 in RAS/RAF Driven Solid Tumors BMF-219 Produced Near Complete Inhibition of Growth at 1.1μM in KRAS G12C and G12D ex-vivo Patient Samples Growth Inhibition of ex-vivo KRAS mutant Cells from Patients (1μM Exposure) % Growth Inhibition of Ex Vivo PDX Tumors BM-20
Slide 29: COVALENT-102 (Enrolling Cohorts)
COVALENT-102 (ENROLLING 3 COHORTS) Phase I/Ib Study of BMF-219, an oral covalent menin inhibitor, in patients with KRAS Mutant, Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PDAC), and Colorectal Carcinoma (CRC) (NCT05631574) Study Treatment: BM
Slide 30: BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications
Novel Covalent Inhibitor of Menin BMF-219 Pipeline-in-a-Pill – Single Agent for Multiple Indications MLL Fusion & NPM1 Driven Tumors Initial clinical validation in r/r acute leukemias with MLL fusions in addition to NPM1 mutations MYC Addicted and MYC Driven Tumors Expansion into r/r diffuse large b
Slide 31: Diabetes – the biggest Epidemic of the century
st Diabetes – the biggest Epidemic of the 21 century 1 in 3 Americans will develop Diabetes in their life 34.2 million US Adults have • One of the largest economic burdens on the US diabetes today a total of $380 health care system and the 7th leading cause of Billion was spent in 2021 death in the
Slide 32: Diabetes Progression: Beta Cell Loss
st Diabetes – the biggest Epidemic of the 21 century Types 2 Diabetes Progression: Beta Cell Loss Type 2 Diabetic Healthy Individual Pancreatic Islet • Type 1 and Type 2 Diabetes = Islet alpha-cell results in Beta Cell Loss and a Reduction in Beta = Islet beta-cell Cell Mass = Islet beta-cell contai
Slide 33: Diabetes Progression Driven by Beta Cell Loss
st Diabetes – the biggest Epidemic of the 21 century Diabetes Progression of Type 1 and Type 2 Driven by Beta Cell Loss Prior Paradigm Current Paradigm Causes Type 1 and Type 2 Diabetes results in Beta Cell Loss and Insulin Resistance leads to an increase in Beta Cell Workload which ultimately leads
Slide 34: Diabetes Patient Segments
st Diabetes – the biggest Epidemic of the 21 century Diabetes Patient Segments Patient Population Proposed BMF-219 MOA Initial Decline in Glycemic Control Pre-Diabetes Increasing HbA1c, Increasing Insulin Resistance 90M Beta Cell Preservation Decreasing beta cell numbers and function Beta Cell Growt
Slide 35: BMF-219 Value Proposition in Diabetes
st Diabetes – the biggest Epidemic of the 21 century BMF-219 Value Proposition in Diabetes First in class molecule with paradigm shifting potential for the treatment of diabetes Oral Treatment for the Regeneration, Preservation, and Reactivation of Beta Cells • Disease modification as the first trea
Slide 36: Potential for Menin Inhibition Demonstrated by Beta Cell Ablation Model
First Development Success with BMF-219 in Type II Diabetes Potential for Menin Inhibition Demonstrated by Beta Cell Ablation Diabetes Model in MEN1 Excised Mice MEN1 Excision Prevents Development of STZ-induced Hyperglycemia Control Control Men1-excised Men1-excised Multiple low-dose streptozotocin
Slide 37: STZ Rat Model Study Design
First Development Success with BMF-219 in Type II Diabetes STZ Rat Model Study Design The Streptozotocin (STZ)-Induced Rat Model Study Design Only direct insulin injection shows an effect in this model with high fat diet STZ treatment typically results in ~50% Beta Cell Loss Page 37
Slide 38: BMF-219 Demonstrates Strong Efficacy in Beta Cell Loss Animal Model
First Development Success with BMF-219 in Type II Diabetes BMF-219 Demonstrates Strong Efficacy in Beta Cell Loss Animal Model (STZ Rat) BMF-219 Achieves Glycemic Control in STZ (Beta Cell Loss) Rat Model STZ + HFD model Oral Glucose Tolerance Test (Day 17) Non-Fasting Glucose Vehicle Non-fasting Gl
Slide 39: BMF-219 Demonstrates Recovery of Beta Cell Activity
First Development Success with BMF-219 in Type II Diabetes BMF-219 Demonstrates Recovery of Beta Cell Activity • HOMA-Beta, a measurement of Beta Cell Function, was analyzed using 4-hr fasting glucose and insulin levels in animal plasma. • BMF-219 displayed a significant level of Beta Cell function
Slide 40: Zucker Diabetic Fatty Rat - a Model of Insulin Resistance
First Development Success with BMF-219 in Type II Diabetes Zucker Diabetic Fatty Rat - a Model of Insulin Resistance The ZDF Rat Study Design Day • The ZDF rat is a model of pancreatic exhaustion, thus Treatment groups (n = 10/group): mimicking some aspects of human diabetes. 1. Vehicle 2. BMF-219 1
Slide 41: BMF-219 Displays Durable Glycemic Control during Drug Washout
First Development Success with BMF-219 in Type II Diabetes BMF-219 Displays Durable Glycemic Control during Drug Washout and Two Weeks after the Last Dose After 2-week Drug Washout Oral Glucose Tolerance Test (OGTT) Day 29 800 OGTT AUC on day 29 100000 600 80000 *p<0.05 vs Vehicle 400 60000 * 75% gl
Slide 42: BMF-219 Increases Β-islets in Pancreas Sections of ZDF Model
Fir Firs st t De Dev ve elo lop pm me en nt t S Su uc cc ce es ss s w wit ith h B BM MF F- -2 21 19 9 in in T Ty yp pe e I II I Diab Diabe et te es s BMF-219 Increases Β-islets in Pancreas Sections of ZDF Diabetic Model +2.0% • Quantitative Analysis of pancreatic islet tissue cross sections shows BM
Slide 43: BMF-219 Demonstrates Strong Β-cell Activity
First Development Success with BMF-219 in Type II Diabetes BMF-219 Demonstrates Strong Β-cell Activity - Supporting Quantitative Analysis +351% Normal (Adequate) State • HOMA-Beta, a measurement of Beta Cell Function, was analyzed using 4-hr fasting glucose and insulin levels in animal plasma. • BMF
Slide 44: BMF-219 Strong Efficacy in Insulin Resistant Animal Model (ZDF Rat)
First Development Success with BMF-219 in Type II Diabetes BMF-219 Demonstrates Strong Efficacy in Insulin Resistant Animal Model (ZDF Rat) BMF-219 Reduces HbA1c After 28 days of Treatment and Maintains Effect After 14-day Washout * p<0.05 ** p<0.01 BMF-219 demonstrated significant decrease HbA1c (%
Slide 45: BMF-219 Treated Groups Display Body Weight and Cholesterol Reduction
First Development Success with BMF-219 in Type II Diabetes BMF-219 Treated Groups Display Body Weight and Cholesterol Reduction BMF-219 200 mg/kg group reduces body weight during BMF-219 reduces blood lipemic levels treatment in ZDF rats measured on Day 29 Triglycerides Total Cholesterol Body weight
Slide 46: COVALENT Phase 1/2 Study in Type 2 Diabetes (Enrolling)
First Development Success with BMF-219 in Type II Diabetes COVALENT – 111 (Enrolling) A Phase 1/2 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-219, an Oral Covalent Menin Inhi
Slide 47: BMF-500 A Third Generation FLT3 Inhibitor
Second Development Success with BMF-500 BMF-500 A Third Generation FLT3 Inhibitor Generation Second Generation First Generation Third Generation of FLT3 FLT3 / multi-kinase Inhibitors FLT3 Inhibitors FLT3 Inhibitors Inhibitor Quizartinib Midostaurin Lestaurtinib Sorafenib Gilteritinib Crenolanib BMF
Slide 48: BMF-500 Highly Effective FLT3 Inhibitor Against Resistance Mutations
Second Development Success with BMF-500 BMF-500 Highly Effective FLT3 Inhibitor Against Resistance Mutations Page 48
Slide 49: BMF-500 Highly Potent and Durable FLT3 Inhibitor
Second Development Success with BMF-500 BMF-500 Highly Potent and Durable FLT3 Inhibitor Page 49
Slide 50: BMF-500: Highly Potent and Durable FLT3 Inhibitor
Second Development Success with BMF-500 BMF-500: Highly Potent and Durable FLT3 Inhibitor Individual Tumor Volume MV-4-11 Subcutaneous MV-4-11 Xenograft Model Xenograft Model
Slide 51: 2023: Exploring Different Tumor Types and Type II Diabetes in the Clinic
Biome Fusion WE AIM TO CURE 2023 : Exploring 8 Different Tumor Types and Type II Diabetes in the Clinic Present initial Phase II clinical data in Type 2 Diabetes: 1Q 2023 Present initial Phase I clinical data in AML: 1H 2023 Continue enrolling patients in trials exploring BMF-219 utility in KRAS dri
Slide 52: Company Financials as of September 30, 2022
As of September 30, 2022 Company Financials (NASDAQ: BMEA) Three Months Ended Sept 30 2022 2021 Operating expenses: R&D $ 18,242 $ 7,886 G&A $ 5,242 $ 4,752 Total Operating Expenses $ 23,484 $ 12,638 $ (23,484) $ (12,638) Loss from operations $ 594 $ 32 Interest and other income, net $ (22,890) $ (1
Slide 53: Thank You
THANK YOU Biomea Fusion 900 Middlefield Road, 4th floor Redwood City, CA, 94063 biomeafusion.com 53