Biomea Fusion, Inc. · NASDAQ:BMEA
Biomea Fusion — Corporate Update (April 2026)
27 slides from Biomea Fusion's corporate update, Apr 28, 2026
Slide 1: COVALENT-112 Topline Results: Icovamenib in Type 1 Diabetes
COVALENT-112 Topline Results BIOMEA FUSION CONFERENCE CALL 28 APRIL 2026 Icovamenib in Type 1 Diabetes Exhibit 99.1
Slide 2: 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 involve known and unknown risks, uncertainties, and other
Slide 3: Table of contents
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 an
Slide 4: Type 1 diabetes at-a-glance
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 di
Slide 5: Table of contents
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 th
Slide 6: Lowering menin drives beta cell expansion
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 funct
Slide 7: Icovamenib reduced blood glucose in STZ rats
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
Slide 8: Icovamenib decreased menin and promoted beta cell proliferation in human islets
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,Vol
Slide 9: Table of contents
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 th
Slide 10: Treatment Landscape: Limitations of current approaches in stage 3 T1D
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 enrollmen
Slide 11: Most therapies show limited and non-durable C-peptide impact
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 Natur
Slide 12: Table of contents
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 th
Slide 13: COVALENT-112 Study Design
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
Slide 14: 52% mean increase in C-peptide at Week 12
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
Slide 15: C-peptide AUC at Week 52 vs baseline
-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
Slide 16: Topline results summary
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 publish
Slide 17: Table of contents
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 th
Slide 18: T1D insights and development focus
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 gr
Slide 19: Proposed Phase 2 trial design
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 Suppres
Slide 20: Table of contents
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 th
Slide 21: Thank you
Thank you (NASDAQ: BMEA)) For questions or inquiries, please reach out to Meichiel Weiss at ir@biomeafusion.com www.biomeafusion.com
Slide 22: Exhibits
Exhibits biomea FUSION
Slide 23: KOL perspective: G. Alexander Fleming, MD
G. Alexander “Zan” 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,
Slide 24: KOL perspectives across clinical significance, biology, and future development
The icovamenib data in Type 1 diabetes naturally makes us pause and reflect on what it could ultimately mean for people living with Type 1 diabetes. While these early findings require confirmation, they suggest a different way of thinking about treatment, one that extends beyond glucose management a
Slide 25: T1D therapies in development: beta cell protection
DRUG MOA ROUTE & DOSING N AGE (YRS) TIME SINCE TID DX PHASE C-PEPTIDE AUC (~WEEK 52) SAFETY C-PEPTIDE AUC VS PLACEBO Verapamil Beta cell protection Oral daily 88 7–17 ≤31 days 2 ~30–35% less decline vs placebo (inferred; near-stable vs decline) Well-tolerated Rituximab Anti-CD20 monoclonal antibody;
Slide 26: T1D therapies in development: immunomodulation / suppression
DRUG MOA ROUTE & DOSING N AGE (YRS) TIME SINCE T1D DX PHASE C-PEPTIDE AUC (~WEEK 52) SAFETY C-PEPTIDE AUC VS PLACEBO Teplizumab (Tzield) Anti-CD3 IV (12d × 2 cycles) 328 8–17 ≤6 weeks 3 ~59% less decline vs placebo (Week 78 proxy) CRS, lymphopenia-rash Baricitinib JAK1/2 inhibitor Oral dail 91 Adult
Slide 27: T1D therapies in development: immunomodulation / suppression
DRUG MOA ROUTE & DOSING N AGE (YRS) TIME SINCE T1D DX PHASE C-PEPTIDE AUC (~WEEK 52) SAFETY C-PEPTIDE AUC VS PLACEBO Ustekinumab IL-12/23 SC (1x every 12 weeks) 72 12–18 ≤100 days 2 ~30–40% less decline vs placebo Well-tolerated ATG (TrialNet) T-cell depletion IV (1x over 2 days) 89 12–45 ≤100 days