Biomea Fusion : COVALENT 112 52 Week Icovamenib Data in Type 1 Diabetes Conference Call Presentation

Published: 2026-04-28 08:33:13 ET BMEA

Published on 04/28/2026 at 08:33 am EDT

BIOMEA FUSION CONFERENCE CALL 28 APRIL 2026

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

~9.5M

People live with T1D globally in 20251

~1.8M in the US2

~513K

New diagnoses per year globally in 20251

~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 4. American Diabetes Association. Standards of Care in Diabetes-2025

Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2023 5. Diabetes Care. 2018 Jun 7;41(7):1486-1492 4

Mayer-Davis et al., NEJM / CDC updates 6. Front. Endocrinol., 05 November 2024

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

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

800

600

400

200

* p<0.05 vs Vehicle

120

Minutes

Vehicle Pioglitazone (30 mg/kg) Icovamenib (175mg/kg)

(insulin desensitizer) (menin inhibitor)

ORAL GLUCOSE TOLERANCE TEST (DAY 17)

Blood Glucose (mg/dL) Mean ± SEM

STZ TREATMENT TYPICALLY RESULTS IN

~50% BETA CELL LOSS

BMF-219 (175mg/kg)

Butler, eta al. Diabetologia 65 (Suppl 1), 1-469 (2022) presentation #197

STZ=Streptozotocin, an antibiotic that produces pancreatic islet beta cell destruction and is widely used experimentally to produce a model in diabetes 7

MENIN LEVELS DECREASED

ICOVAMENIB CONDITIONALLY PROMOTED BETA CELL PROLIFERATION ONLY UNDER HYPERGLYCEMIC CONDITIONS

Standard Glucose (5.5 mM) High Glucose (8 mM)

Somanath, et al. Diabetologia 68 (Suppl 1), 1-754 (2025). Oral presentation #66 Frias, et al. Metabolism,Vol153, Supplement,2023,#88

Preclinical Validation

T1D Disease and Market

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

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

Verapamil

Nature. 2018 Aug;24(8):1108-1112

Rituximab

NEJM. 2009 361:2143-2152

DRUG

Mean C-PEPTIDE AUC VS PLACEBO

Teplizumab (Tzield)

ESPE Yearbook of Paediatric Endocrinology (2024) 21 10.2

Baricitinib

N Engl J Med 2023;389:2140-2150

SAB-142

SAB Bio website corporate presentation (March 10, 2026) https://www.sab.bio/

DRUG

Mean C-PEPTIDE AUC VS PLACEBO

Ustekinumab

Nature Medicine 2024 vol 30, 2657-2666

ATG

(TrialNet)

Diabetes Care 2018 Jul 16;41(9):1917-1925

MELD-ATG

Lancet 2025 Sep 27;406(10510):1375-1388

*Ladarixin and Diamyd, both Immune modulating, not mentioned here as they demonstrated no meaningful difference compared to placebo

T1D Disease and Market

Preclinical Validation

Investigational Therapies Exploring T1D

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

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

FOLLOW-UP: 40 WEEKS

Cohort 1

T1D diagnosed within 3 years with a C-peptide

≥0.2 nmol/L

ARM A N = 10

Icovamenib 200 mg QD

Icovamenib 100 mg QD

ARM B N = 10

Cohort 2

T1D diagnosed between

3-15 years with a C-peptide

≥0.08 nmol/L

ARM A N = 10

ARM B N = 10

Icovamenib 200 mg QD

Icovamenib 100 mg QD

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.

Readout at Week 12

2.5

Mean C-peptide AUC (pmol/L·min)*

2.0

1.5

52% mean increase from baseline

Cohort 1 (< 3 years since diagnosis)

200mg icovamenib 100mg icovamenib

Historical Control1

(n=3)

2.1

(n=6) 1.4

1.4 (n=5)

1.3 1.21 (n=5)

12 WEEKS TREATMENT

+0.7

P<0.001

1.0

0.5

0.0

Baseline Week 4 Week 8 Week 12

Weeks

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 14

* 4-hour Mixed Meal Tolerance Test (MMTT)

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

200mg icovamenib

100mg icovamenib

(n=4)

(n=5)

40 WEEKS OFF TREATMENT

12 WEEKS TREATMENT

(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)

2.5

Mean C-peptide AUC*

1.5

Change in mean C-peptide AUC at

Week 52 vs baseline

-7%

-32%

-47%1

0.5

Baseline 4 8 12 16 26 52

Weeks

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 15

* 4-hour Mixed Meal Tolerance Test (MMTT)

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

Final Remarks

ICOVAMENIB

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

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

Inclusion Criteria

Adult participants with T1D diagnosed within 3 years with a C-peptide ≥0.2 nmol/L

Background therapy maintained unless rescue required

6 Months Primary endpoint C-peptide AUC

12 Months Secondary endpoint C-peptide AUC

15 Months Secondary endpoint C-peptide AUC

SCREENING: XX DAYS

TREATMENT: 6 MONTHS

UNBLINDED/FOLLOW UP:

ADD 6 MONTHS

UNBLINDED/FOLLOW UP:

ADD 3 MONTHS

Month 0 Month 3 Month 6 Month 9 Month 12 Month 15

Off Therapy

(n=8)

Icovamenib 200 mg QD ((nn==88))

Icovamenib 100>>>200 mg QD

(n=32)

Immune Suppressant

(JAK inhibitor)

(n=8)

Icovamenib +

Immune Suppressant (n=8)

(JAK inhibitor)

Active

(n=32)

Placebo

(n=8)

Placebo

(n=8)

*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)

Disclaimer

Biomea Fusion Inc. published this content on April 28, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 28, 2026 at 12:32 UTC.