On May 2, 2023 Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported first quarter 2023 financial results and business highlights (Press release, Biomea Fusion, MAY 2, 2023, View Source [SID1234630837]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In 2023, we expect to continue to advance our clinical programs in diabetes and oncology and plan to report multiple data readouts throughout the remainder of the year, including late-breaking clinical data from COVALENT-111 at the upcoming American Diabetes Association, or ADA, Scientific Sessions," said Thomas Butler, CEO and Chairman of Biomea. "Loss of mass and function of beta cells is an underlying cause of type 2 diabetes. There is biological precedent, reinforced by our extensive preclinical data for BMF-219, that suggests inhibiting menin may enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 2 diabetes. We believe that none of the currently approved therapies for diabetes adequately addresses the beta cell mass and function loss. With its intended disease-modifying mechanism of action, BMF-219 could potentially represent a monumental shift for the treatment of patients with diabetes. The initial data we reported from COVALENT-111 in the first quarter of 2023 demonstrated that after just four weeks of treatment with BMF-219, the majority of patients in our lowest dose cohorts showed HbA1c improvements, with indications of potential longer-term disease modification and control. We are excited to report additional data from COVALENT-111 to the diabetes-focused scientific community at ADA in June."
First Quarter 2023 Clinical and Regulatory Highlights
DIABETES
COVALENT-111 (BMF-219 for Type 2 Diabetes)
BMF-219 is the first investigational menin inhibitor in clinical development for the treatment of type 2 diabetes patients.
Reported initial clinical data in March 2023 from the first two cohorts of the Phase II portion of COVALENT-111. As reported, 89% of patients enrolled in Cohort 3 (n=10 patients at 100 mg without food) achieved a reduction in HbA1c, 78% achieved ≥ 0.5% reduction in HbA1c and 56% achieved ≥ 1% reduction in HbA1c (median and mean reduction over the cohort: -1.0% and -0.81%, respectively). BMF-219 was well tolerated and demonstrated a favorable safety profile with no dose discontinuations.
Anticipated Upcoming Milestones:
Report further clinical updates from COVALENT-111 at ADA in June 2023.
ONCOLOGY
COVALENT-101 (BMF-219 for Genetically Defined Liquid Tumors)
BMF-219 is the first investigational menin inhibitor in clinical development to be evaluated as a therapeutic agent in hematologic malignancies outside of MLLr and NPM1 mutated AML/ALL patients, specifically in subsets of DLBCL, MM and CLL patients.
Continued site activation and patient enrollment across four liquid tumor cohorts including patients with AML/ALL, DLBCL, MM and CLL.
Anticipated Upcoming Milestones:
Report initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the second quarter of 2023.
COVALENT-102 (BMF-219 for KRAS-Mutant Solid Tumors)
BMF-219 is the first investigational menin inhibitor in clinical development for the treatment of solid tumors. A targeted pan-KRAS inhibitor could have the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.
Dosed first patient in January 2023 in COVALENT-102, a study of BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation.
Continued site activation and patient enrollment across all three solid tumor indications (NSCLC, CRC and PDAC with an activating KRAS mutation).
COVALENT-103 (BMF-500 for Acute Leukemias)
BMF-500 is a potential best-in-class oral covalent inhibitor of FLT3, designed and developed in-house, and the second investigational compound, discovered by Biomea’s FUSION System.
Demonstrated approximately 20-fold greater potency compared to Gilteritinib and more than 50-fold greater potency compared to the clinically investigated reversible menin/MLL inhibitors in acute myeloid leukemia (AML) cell lines, MV-4-11 and MOLM-13.
BMF-219 and BMF-500 preclinical combination shows greater than additive cell killing in acute leukemia cell lines and patient samples.
Anticipated Upcoming Milestones:
Initiate enrollment of BMF-500 in Phase I study (COVALENT-103) examining safety and efficacy in patients with relapsed or refractory acute leukemia with FLT3 wild-type and FLT3 mutations, including those with MLLr / NPM1 mutations.
FUSION SYSTEM DISCOVERY PLATFORM
Continued to advance third development candidate derived from Biomea’s proprietary FUSION System platform to discover novel covalently binding small molecules. Both BMF-219 and BMF-500 were discovered via the FUSION System, each within 18 months from target identification to IND candidate selection.
Anticipated Upcoming Milestones:
Provide update on third development candidate in the second quarter of 2023.
FIRST QUARTER 2023 FINANCIAL RESULTS
Cash, Cash Equivalents, Restricted Cash, and Investments: As of March 31, 2023, the Company had cash, cash equivalents, restricted cash, and investments of $86.7 million, compared to $113.4 million as of December 31, 2022, excluding gross proceeds of $172.5 million from a public offering of common stock in early April 2023.
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $29.1 million for the three months ended March 31, 2023, compared to a net loss of $16.4 million for the same period in 2022.
Research and Development (R&D) Expenses: R&D expenses were $24.4 million for the three months ended March 31, 2023, compared to $11.4 million for the same period in 2022. The increase of $13.0 million was primarily due to an increase personnel-related costs as well as an increase in clinical and preclinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
General and Administrative (G&A) Expenses: G&A expenses were $5.6 million for the three months ended March 31, 2023, compared to $5.1 million for the same period in 2022. The increase of $0.6 million was primarily due to higher personnel-related costs and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.