Full Press Release Details
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 and
unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking
statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan,"
"anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. All statements other than statements of historical fact could be deemed
forward-looking, including any projections of financial information or profitability, the initiation, timing and results of pending or future preclinical studies and clinical trials, the actual or potential actions of the Food and Drug
Administration (FDA), the status and timing of ongoing research, development and corporate partnering activities, any statements about historical results that may suggest trends for the Company's business; any statements of the plans, strategies,
and objectives of management for future operations and any statements of expectation or belief regarding future events, potential markets or market size, or technology developments. The Company has based these forward-looking statements on its
current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown
risks and uncertainties, many of which are beyond the Company's control. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the
forward-looking statements, see the section entitled Risk Factors in our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the Securities and Exchange Commission (the SEC), as well as discussions of potential risks,
uncertainties, and other important factors in our other subsequent filings with the SEC. The forward-looking statements in this presentation are made only as of the date hereof. Except as required by law, the Company assumes no obligation and does
not intend to update these forward-looking statements or to conform these statements to actual results or to changes in the Company's expectations. This presentation also contains estimates and other statistical data made by independent parties and
by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions, and
estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. Certain information contained in this presentation relates to or is based on studies,
publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not
independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of
assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. This
presentation shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful
prior to registration or qualification under the securities laws of any such state or jurisdiction. Corporate Presentation June 2025 2
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 Icovamenib is a menin
inhibitor showing an emerging competitive clinical profile, demonstrating significant and durable HbA1c reductions, up to ~1.5% sustained well beyond end of treatment Oral, short-course therapy designed for durability and boost adherence and
persistence, addressing a key barrier in chronic T2D management Addresses a critical unmet need in insulin-deficient T2D, the most vulnerable patient group at highest risk of macrovascular (CV) complications, rapid treatment failure, and fastest
progression to insulin dependence Synergistic with GLP-1 therapies, expanding reach across broader T2D populations, and demonstrating additional benefits in weight loss, glucose control and muscle mass preservation in preclinical combination studies
Efficient and cost-effective clinical pathway, with potential for a shorter Phase III program due to short term treatment - based on initial regulatory feedback Advancing BMF-650, a next-generation oral GLP-1 RA with best-in-class potential, into
clinical development later this year Corporate Presentation June 2025 3
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 II
(26 Week Follow-up Data announced 12/24) COVALENT-112 52 Week Follow-up Data from those patients that ICOVAMENIB Type 1 Diabetes Phase II completed original 12 weeks of dosing Menin Program (Potential Type 2 Diabetes FDA Type C Meeting Update
First-In- COVALENT- 211 Severe Insulin Deficient Planned Initiation of Phase IIb in Severe Insulin Phase IIb Class) Diabetes Deficient Patients (discuss Phase III Pgm requirements) Type 2 Diabetes Planned Initiation of Phase II in Patients
uncontrolled COVALENT- 212 Combination with on GLP-1 based therapies Phase II GLP-1 based therapies Weight Reduction in Obese Monkeys Preclinical Update - 2Q 2025 BMF-650 IND-Enabling Diabetes/Obesity Studies Planned Initiation of Phase I
Study in Obese Healthy Oral GLP-1RA Volunteers 2H 2025 Corporate Presentation June 2025 4
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 functionally Action to
orforglipron with potential improved tolerability improved pool of pancreatic beta cells Route of Oral Oral Administration Built on similar scaffold as orforglipron Greatest HbA1c reductions were observed in insulin-deficient diabetes Drive for
Best-in-Class Status with optimized exposure profile patients among all patients in the study (a population with poor Improved PK properties (greater bioavailability, less variability, and glycemic control and limited treatment options) Program well
sustained exposure during dosing intervals) Durable HbA1c improvement sustained through week 26, over 3 Increased AUC to drive greater weight loss and tolerability (higher Highlights months after last dose (follow-up through week 52 is ongoing)
plasma protein binding for better tolerability) In combination with GLP-1 RA, icovamenib enhanced insulin secretion, Superior glucose regulation and robust weight loss efficacy in non- drove quality weight loss, and preserved muscle mass human
primates 1 Over 7M Addressable U.S. Target Patients 2 and over 11M in the EU Current estimates for U.S. obesity drug market is Market 3 $6B current US gross revenue potential approximately $50B annual US Opportunity 3 (10% uptake x $10k in target
T2D patients ) gross revenue potential by 2030 Weight Reduction in Obese Monkeys Anticipated 52 Week Data Read Out expected in 2H 2025 Preclinical Update - Expected 2Q 2025 Phase IIb study proposal expected to be shared with FDA in 2H 2025
Milestone IND submission targeted for 2H 2025 1. Zohu Lancet 2024; 404: 2077-93 Corporate Presentation June 2025 5 2. IDF www.diabetesatlas.org 3. Horizon Grand View Research and Morgan Stanely research estimates
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 Menin Inhibitor data
expected COVALENT-111 - T2D ongoing Monotherapy with combo 2H 2025 potential Type 2 Diabetes - Severe Insulin Deficiency Commencement of Phase IIb study COVALENT-211 - T2D planned expected in 2H 2025 Type 2 Diabetes - Combo Study
with GLP-1 - RA Commencement of Phase IIa study COVALENT-212 - T2D planned expected in 2H 2025 Obesity/ Type 2 Diabetes BMF-650 Oral Potential Best-in-Class IND clearance Oral GLP-1 RA IND Enabling Studies expected in 2H 2025 Monotherapy
Commencement of Phase I in 2H 2025 Corporate Presentation June 2025 6
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 Continues to Decrease:
52-week Data Expected 2H 25 Corporate Presentation June 2025 7
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 cases address a
root cause of the disease 1 2 2022 Global Estimates 2025 U.S. Estimates of all T2D patients are severely insulin-deficient, this group has the 18-44% 3 highest failure rates among all T2D subgroups Depending on ethnicity 1. Zohu Lancet 2024; 404:
2077-93 (adjusted by company to account for Severe Insulin-deficient patients). 2. IDF www.diabetesatlas.org. 3. Fendo2022 doi: 10.3389/fendo.2022.927661 https://doi.org/10.1371/journal.pone.0304036. Corporate Presentation June 2025
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, et al. Cureus.
2023 Oct 4;15(10) Despite a multitude of standard-of-care therapies, 50% of people with diabetes continue to have uncontrolled glucose levels. There is a need for novel, durable solutions to improve long-term outcomes. Corporate Presentation June
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/jama.2024.22284.
Optum/Humedica SmartFile database (2007-2014) was used [GLP-1 RA (221 patients); DPP-4i (652 2. Alkabbani W, et al. Diabetes Obes Metab. 2023;25:3490-3500 patients)]. Change in HbA1c measured from drug initiation to 365 90 days later. c
Medical adherence classified as poorly adherent if percentage of days covered (PDC) <80%. 3. Edelman S. Diabetes Care 2017;40(11):1425-1432 Corporate Presentation June 2025 10
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 diagnosis Nat
Rev Endocrinol. 2016;12:337-346 Adapted from DeFronzo RA. Diabetes. 2009;58:773-795. Corporate Presentation June 2025 11 Beta-cell function (%)
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 diabetes (MARD)
diabetes diabetes (SIDD) (SIRD) (MOD) Initial target group for icovamenib 18% 39% 22% 15% Median HOMA-B 49% Median HOMA-B 64% Median HOMA-B 74% Median HOMA-B 101% Median HbA1c 8.3% Median HbA1c 7.0% Median HbA1c 7.2% Median HbA1c 7.0% 2 2 2 2 Median
BMI 29 kg/m Median BMI 29 kg/m Median BMI 36 kg/m Median BMI 34 kg/m Ahlqvist et al. Lancet Diabetes Endocrinol 2018; 6: 361-69 Corporate Presentation June 2025 12
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 Oral - Convenient, once- daily oral therapy Increased
GLP-1 Increased Beta Cell Non-Chronic - Limited Receptor Expression Mass and Function duration dosing with & Incretin Effect sustained effect Well Tolerated - Favorable safety profile observed to Enhanced Weight Loss
date Increased Insulin with Preservation of MOA complementary to Synthesis and Secretion Muscle Mass in Preclinical Combination other agents used Studies Corporate Presentation June 2025 13
COVALENT-111 Phase 2a Double-Blinded, Randomized Placebo Controlled
Study in Type 2 Diabetes Topline Results at 26 Weeks
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 Participants antidiabetic agents 3:1 (excluding insulin and SFUs) N=72 participants per arm (3:1 ratio, icovamenib: PBO) Corporate Presentation June 2025 15
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 dosing 100 mg (8
weeks of 100 mg QD + 4 Mean (SD) or % QD) QD) weeks of 100 BID) (N=115) (N=50) (N=45) (N=37) (N=33) Age (yr) 55 (7) 56 (6) 51 (10) 54 (8) 55 (7) Duration of T2D Diagnosis (yr) 4.3 (1.8) 4.7 (1.8) 4.2 (2.2) 4.4 (1.9) 4.3 (2.0) Sex (% Female) 31 54 36
40 42 HbA1c (%) 8.3 (1.1) 8.3 (1.0) 8.0 (0.8) 8.2 (1.0) 8.3 (1.0) Fasting C-peptide (ng/mL) 3.4 (1.2) 3.9 (1.7) 3.7 (1.8) 3.7 (1.5) 3.5 (1.4) 2 BMI (kg/m ) 30.9 (4.7) 32.6 (4.5) 32.4 (4.9) 31.9 (4.7) 32.6 (4.1) 2 BMI <30 kg/m (%) 49 24 30 36 26 2
BMI 30 kg/m (%) 51 73 70 63 74 Demographics and baseline characteristics were well matched between icovamenib- and placebo-treated participants Corporate Presentation June 2025 16
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 QD + (12 weeks of
dosing 100 mg QD) QD) 4 weeks of 100 BID) (N=115) (N=50) (N=37) (N=45) (N=33) Number of T2D Medications, n (%) 0 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 39 (87) 23 (62) 23 (70) 85 (74) 41 (82) 2 4 (9) 11 (30) 7 (21) 22 (19) 7 (14) 3 2 (4) 3 (8) 3 (9) 8 (7)
2 (4) Metformin Monotherapy, n (%) 36 (80) 18 (49) 22 (67) 76 (66) 38 (76) SGLT2i, n (%) 6 (13) 13 (35) 8 (24) 27 (23) 8 (16) DPP4i, n (%) 3 (7) 5 (14) 3 (9) 11 (10) 2 (4) GLP-1 based agent, n (%) 3 (7) 3 (8) 5 (15) 11 (10) 4 (8) Most participants
treated with metformin monotherapy with approximately 20% treated with SGLT2i, 10% with DPP4i, and 10% with GLP-based medicines Corporate Presentation June 2025 17
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 weeks of dosing
100mg QD) QD weeks of 100 BID) (N=115) (N=50) (N=45) (N=37) (N=33) SIDD, n (%) 12 (27) 7 (19) 4 (12) 23 (20) 11 (22) MARD, n (%) 11 (24) 6 (16) 5 (15) 22 (19) 8 (16) MOD, n (%) 20 (44) 21 (57) 23 (70) 64 (56) 27 (54) SIRD, n (%) 2 (4) 3 (8) 1 (3) 6
(5) 4 (8) SIDD = Severe Insulin-Deficient Diabetes MARD = Mild Age-Related Diabetes MOD = Mild Obesity-Related Diabetes SIRD = Severe Insulin-Resistant Diabetes Despite all participants being overweight or obese, approximately 40% were in the
insulin-deficient subgroups (SIDD and MARD) Corporate Presentation June 2025 18
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 Placebo) 0.4 0.2 0 -0.2
P=0.13 Placebo (N=50) Arm A (N=45) P=0.16 -0.4 Arm B (N=37) Arm C (N=33) -0.6 P=0.01* I c o va m en i b I c o va m en i b Treatment Period O f f -Treatment Period -0.8 Wk 0 Wk 4 Wk 8 Wk 12 Wk 16 Wk 22 Wk 26 Time (Weeks) Corporate Presentation June
2025 19 Mean Change HbA1c (%)
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 Time Arm A, B, and C
(n=23 Active; n=11 Placebo) Arm B (n=7 Active; n=11 Placebo) 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 Corporate Presentation June 2025 20
Despite Short Course Oral Dosing, Icovamenib Performed in Line with