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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

Key Takeaway: Biomea Fusion, Inc. has shared forward-looking statements regarding future business and financial performance. The presentation emphasizes the uncertain nature of these predictions, which are influenced by various risks, including regulatory approvals and market dynamics. Specifically, the discussion touches on the investigational therapies for Type 1 Diabetes and the limitations associated with existing treatment options. A focus is placed on the anticipated clinical trials and the goals of restoring beta cell function, although challenges persist in achieving durable therapeutic outcomes.

Market Sentiment Analysis

CONCERNS & RISKS

  • Many forward-looking statements entail risks and uncertainties that could significantly impact the actual performance of the company.
  • Dependence on FDA decisions adds to the uncertainty surrounding future projections.
  • There are limitations in currently investigational therapies for Type 1 Diabetes which may hinder market expectations.

Full Press Release Details

COVALENT-112 Topline Results BIOMEA
FUSION CONFERENCE CALL 28 APRIL 2026 Icovamenib in Type 1 Diabetes Exhibit 99.1
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 U.S. 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 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. Legal disclaimer & forward-looking statements
Type 1 Diabetes and Market Preclinical
Validation Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio
Diabetes Center and the University of Miami Diabetes Research Institute) Final Remarks Table of contents
Type 1 diabetes at-a-glance ~9.5M
~513K People live with T1D globally in 20251 New diagnoses per year globally in 20251 ~1.8M in the US2 ~64K new diagnoses/year in the US3 T1D is caused by autoimmune destruction of insulin-producing pancreatic islet beta cells T1D is considered
a lifelong chronic disease and carries substantial acute risk (severe hypoglycemia, DKA) as well as long-term complications including kidney disease, nerve damage, vision loss, and cardiovascular issues4 Patients with symptomatic T1D (Stage 3)
typically lose yearly ~50% of their beta cell capacity over the first 7 years5 There are no approved therapies other than exogenous insulin that address the dysglycemia associated with the progressive decline of C-peptide in Stage 3 T1D 6 Ogle, et
al. Diabetes Research and Clinical Practice 2025, 225, 112277 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2023 Mayer-Davis et al., NEJM / CDC updates American Diabetes Association. Standards of Care in
Diabetes-2025 Diabetes Care. 2018 Jun 7;41(7):1486-1492 Front. Endocrinol., 05 November 2024
T1D Disease and Market Preclinical
Validation Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio
Diabetes Center and the University of Miami Diabetes Research Institute) Final Remarks Table of Contents
Physiologic evidence Natural states
such as pregnancy and lactation reduce menin, enabling beta cell expansion and increased insulin output Preclinical and translational validation Across animal models and human islet studies, reduced menin is consistently linked to improved beta-cell
mass and function Icovamenib MOA Icovamenib reduced menin levels to replicate a validated biological process and restore beta cell function Karnik SK, et al. Science. 2007;318:806-809 Lowering menin is a natural biological process that drives beta
cell expansion and is expected to reduce diabetes risk
ORAL GLUCOSE TOLERANCE TEST (DAY 17)
Icovamenib significantly reduced blood glucose in STZ rats (a model in which only insulin decreases blood glucose levels) STZ TREATMENT TYPICALLY RESULTS IN ~50% BETA CELL LOSS Icovamenib (175mg/kg) (insulin desensitizer) (menin
inhibitor) STZ=Streptozotocin, an antibiotic that produces pancreatic islet beta cell destruction and is widely used experimentally to produce a model in diabetes Butler, eta al. Diabetologia 65 (Suppl 1), 1-469 (2022) presentation
Icovamenib decreased menin protein
levels & promoted beta cell proliferation in ex vivo human islet cultures MENIN LEVELS DECREASED ICOVAMENIB CONDITIONALLY PROMOTED BETA CELL PROLIFERATION ONLY UNDER HYPERGLYCEMIC CONDITIONS Standard Glucose (5.5 mM) High Glucose (8 mM) Frias,
et al. Metabolism,Vol153, Supplement,2023,#88 Somanath, et al. Diabetologia 68 (Suppl 1), 1-754 (2025). Oral presentation #66
Preclinical Validation T1D Disease and
Market Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio Diabetes
Center and the University of Miami Diabetes Research Institute) Final Remarks Table of contents
Treatment Landscape: Limitations of
current approaches in stage 3 T1D Most investigational therapies in T1D focus on immune modulation to slow autoimmune destruction or on preserving residual beta cell function1 C-peptide area under the curve (AUC) has become the accepted endpoint,
driving enrollment early after diagnosis (<90 days, new-onset T1D) to preserve residual beta-cell function2 To date, most investigational therapies have not demonstrated durable restoration of beta cell function or sustained increases in
C-peptide, outside of cell-based transplantation approaches3 The Next Frontier: Restoring beta cell function and mass, beyond only slowing the decline of C-peptide Expanding the treatment window beyond early, new onset T1D populations Enabling
persistence of newly generated beta cells despite autoimmune pressure Zarei M et al. Diabetes Epidemiology and Management 2025;17 Diabetes Care 2025 NIDDK. Diabetes in America, 2024
DRUG Mean C-PEPTIDE AUC VS PLACEBO
Ustekinumab ATG (TrialNet) MELD-ATG Most therapies in development for stage 3 T1D show limited and non-durable C-peptide impact *Ladarixin and Diamyd, both Immune modulating, not mentioned here as they demonstrated no meaningful difference compared
to placebo Nature Medicine 2024 vol 30, 2657-2666 Diabetes Care 2018 Jul 16;41(9):1917-1925 DRUG Mean C-PEPTIDE AUC VS PLACEBO Teplizumab (Tzield) Baricitinib SAB-142 SAB Bio website corporate presentation (March 10, 2026)
https://www.sab.bio/ ESPE Yearbook of Paediatric Endocrinology (2024) 21 10.2 N Engl J Med 2023;389:2140-2150 DRUG Mean C-PEPTIDE AUC VS PLACEBO Verapamil Rituximab NEJM. 2009 361:2143-2152 Nature. 2018 Aug;24(8):1108-1112
Lancet 2025 Sep 27;406(10510):1375-1388
T1D Disease and Market Preclinical
Validation Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio
Diabetes Center and the University of Miami Diabetes Research Institute) Final Remarks Table of contents
COVALENT-112 (NCT06152042) was a
Phase 2 trial designed to examine beta cell function (as measured by C-peptide change and the change of exogenous insulin usage) and glucose and lipid metabolism in participants with T1D treated with standard of care insulin and icovamenib.
SCREENING: 5 WEEKS DOSING PERIOD: 12 WEEKS Icovamenib 200 mg QD Icovamenib 100 mg QD ARM A N = 10 ARM B N = 10 COVALENT-112 | Study Design FOLLOW-UP: 40 WEEKS ARM A N = 10 ARM B N = 10 Cohort 1 T1D diagnosed within 3 years with a C-peptide
0.2 nmol/L Cohort 2 T1D diagnosed between 3-15 years with a C-peptide 0.08 nmol/L Study enrollment and dosing were interrupted in May 2024 due to an FDA clinical hold, which was subsequently resolved, but reduced the number of patients
enrolled and followed through to the 52-week readout. Icovamenib 200 mg QD Icovamenib 100 mg QD
52% mean increase from baseline 12
WEEKS TREATMENT 52% mean increase in C-peptide during the 12 weeks treatment period of icovamenib Readout at Week 12 Data represents post-hoc analysis of patients who received per statistical analysis plan, 80% of planned doses 1 Historical control
in T1D patients (n=1549) C-peptide declining over first 7 years at 47% yearly. Diabetes Care. 2018 Jun 7;41(7):1486-1492 * 4-hour Mixed Meal Tolerance Test (MMTT) 1.21 +0.7 P<0.001 (n=5) (n=3) (n=5) (n=6) Cohort 1 (< 3 years since
diagnosis) Historical Control1
-7% -32% 12 WEEKS TREATMENT Data
represents post-hoc analysis of patients who received per statistical analysis plan, 80% of planned doses 1 Historical control in T1D patients (n=1549) C-peptide declining over first 7 years at 47% yearly. Diabetes Care. 2018 Jun
7;41(7):1486-1492 * 4-hour Mixed Meal Tolerance Test (MMTT) -47%1 Readout at week 52 Baseline C-peptide levels sustained through week 52 with minimal decline (only -7.1%) observed post 12 weeks of 200mg daily icovamenib 40 WEEKS OFF TREATMENT
(n=4) (n=5) Change in mean C-peptide AUC at Week 52 vs baseline (n=6) (n=5) Demographics (means) | n=6 Age: 28 years Sex: 67% female BMI: 25 kg/m2 Disease course: 2.4y HbA1c: 7.4% Fasting Plasma Glucose: 178 mg/dL Fasting C-Peptide: 0.7 ng/mL
Demographics (means) | n=5 Age: 31 years Sex: 40% female BMI: 24 kg/m2 Disease course: 2.1y HbA1c: 8.3% Fasting Plasma Glucose: 155 mg/dL Fasting C-Peptide: 0.8 ng/mL Cohort 1 (< 3 years since diagnosis)
Topline results of icovamenib
demonstrated marked C-peptide increase in T1D with observed persistence Observed 52% increase in mean C-peptide AUC at Week 12 (p < 0.001) in Cohort 1 patients dosed at 200 mg (diagnosed within 0-3 years; n=5), a magnitude of improvement
not commonly reported in published T1D studies Mean C-peptide AUC remained largely preserved through Week 52 in Cohort 1 patients dosed at 200 mg (~7% decline from baseline), supporting persistence of effect. Patients dosed in Cohort 2 demonstrated
stable AUC during and post dosing. Generally well-tolerated, with a favorable safety profile throughout the 52-week observation period Validation of menin as a target for diabetes (T1D & T2D) further supported by these results Presentation at
American Diabetes Association's (ADA) Scientific Session, comprehensive dataset of Cohort 1 and Cohort 2 to be presented (full release on June 5th at 6:30 pm CST)
T1D Disease and Market Preclinical
Validation Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio
Diabetes Center and the University of Miami Diabetes Research Institute) Final Remarks Table of contents
T1D insights: Dose response: 200 mg
demonstrated stronger clinical activity vs 100 mg Potential early intervention advantage: T1D patients dosed 3 years showed greater response vs those 3-15 years from diagnosis 12-week treatment showed continuous and improved responses,
supporting potential for greater benefit with extended dosing Preclinical chronic toxicology studies support longer term dosing Generally well-tolerated, with a favorable safety profile maintained through the 52-week observation period Optimal dose
and target population identified for T1D phase 2 program ICOVAMENIB T1D development focus: Potential to further increase C-peptide AUC in T1D with extended or continuous dosing Opportunity to potentially enhance outcomes through combination with
immunomodulation therapies
Immune Suppressant (JAK inhibitor)
6 Months Primary endpoint C-peptide AUC Off Therapy Icovamenib 100>>>200 mg QD (n=32) Placebo (n=8) 15 Months Secondary endpoint C-peptide AUC Month 0 Month 3 Month 6 Month 9 Month 12 Month 15 icovamenib 200 mg QD (n=8) (n=8) (n=8) (n=8)
Icovamenib + Immune Suppressant (JAK inhibitor) Icovamenib 200 mg QD (n=8) SCREENING: XX DAYS TREATMENT: 6 MONTHS UNBLINDED/FOLLOW UP: ADD 6 MONTHS UNBLINDED/FOLLOW UP: ADD 3 MONTHS Active (n=32) Placebo (n=8) Proposed phase 2 trial design*
Inclusion Criteria Adult participants with T1D diagnosed within 3 years with a C-peptide 0.2 nmol/L Background therapy maintained unless rescue required 12 Months Secondary endpoint C-peptide AUC *Subject to regulatory and investigator
alignment, and feedback from applicable health authorities.
T1D Disease and Market Preclinical
Validation Investigational Therapies Exploring T1D COVALENT-112 Study Design Cohort 1 (0-3 Years Since Diagnosis) Summary Next T1D Study Planned with Icovamenib (Barbara Davis Center for Diabetes, Joslin Diabetes Center, UT Health San Antonio
Diabetes Center and the University of Miami Diabetes Research Institute) Final Remarks Table of Contents
Thank you (NASDAQ: BMEA)) For
questions or inquiries, please reach out to Meichiel Weiss at ir@biomeafusion.com www.biomeafusion.com
Fleming, MD FOUNDER & EXECUTIVE CHAIRMAN, KINEXUM FORMER FDA SENIOR MEDICAL OFFICER AND DIVISION LEADER FOR METABOLIC & ENDOCRINE DRUGS, INVOLVED IN THE REVIEW OF LANDMARK DIABETES AND METABOLIC THERAPIES INCLUDING METFORMIN, THE FIRST
RAPID-ACTING INSULIN ANALOGS, EARLY STATINS, AND PPAR AGONISTS Efforts to intervene against type 1 diabetes (T1D) have historically focused on preserving remaining insulin secretion in people just diagnosed with T1D. These icovamenib data are unique
in showing increased C-peptide-reflected insulin secretion in patients with established T1D during dosing and persistence of this effect after treatment was stopped. In people with established T1D, endogenous insulin secretion progressively declines
to very low levels. Any evidence of improvement in endogenous insulin secretion-even among a few T1D individuals-is unprecedented and of immense biologic and clinical significance. These findings warrant rigorous and longer-term
evaluation. KOL perspectives across clinical significance, biology, and future development in T1D The new data presented today with icovamenib in patients with type 1 diabetes suggest a potential new therapeutic avenue in a disease where fundamental
unmet need has long persisted. To date, approved therapies have not directly addressed the progressive loss of functional beta cells that underlies diabetes. Biomea has made critical progress in identifying and characterizing this molecule, which
has demonstrated the ability to reduce menin protein levels and activate pathways associated with beta cell function. Today's icovamenib type 1 data further validates and deepens our understanding of icovamenib's mechanism of action. Congratulations
to the Biomea team on reaching this important therapeutic milestone. What stands out to me in the icovamenib diabetes data is not only the emerging signal of biological activity, but also the safety profile observed to date with using icovamenib in

Frequently Asked Questions

What is Type 1 Diabetes (T1D)?

Type 1 Diabetes is a lifelong chronic disease caused by the autoimmune destruction of insulin-producing pancreatic beta cells.

What is Icovamenib's mechanism of action?

Icovamenib lowers menin levels to enhance beta cell function and mimic natural biological processes that promote beta cell expansion.

What are the risks of forward-looking statements?

Forward-looking statements involve known and unknown risks that may lead to actual results differing from predictions.

What is C-peptide AUC in T1D therapy?

C-peptide area under the curve (AUC) measures beta cell function, commonly used as a study endpoint in T1D treatments.

What challenges exist in T1D treatment?

Most treatments only slow autoimmune destruction or preserve beta cell function, lacking durable restoration or sustained improvement.

Last updated: Apr 28, 2026