On March 28, 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 fourth quarter and full year 2022 financial results and business highlights (Press release, Biomea Fusion, MAR 28, 2023, View Source [SID1234629417]).
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"During 2022 we transformed Biomea from a preclinical company to a fully integrated clinical-stage company, pursuing ten indications, with two distinct molecules in three different trials. I am incredibly proud of our team’s performance and dedication, which has enabled our rapid clinical progress," said Thomas Butler, CEO and Chairman of Biomea. "In 2023, we will significantly advance all three programs and plan to deliver on multiple data readouts, beginning with initial data reported this quarter from our COVALENT-111 study in patients with type 2 diabetes. Loss of mass and function of beta cells is an underlying cause of type 2 diabetes. There is biological precedent, reinforced by our 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. None of the currently approved therapies for diabetes are effectively addressing the loss and function of beta cells. We believe the data from COVALENT-111 of our oral agent BMF-219, which we have started to report this quarter, could represent a monumental event for the treatment of patients with diabetes and a transformative milestone for our company."
2022 and Recent Clinical and Regulatory Highlights
ONCOLOGY
COVALENT-101 (BMF-219 for Genetically Defined Liquid Tumors)
Presented robust anti-tumor activity of covalent, small molecule menin inhibitor, BMF-219, as a single agent and mechanistic evidence for novel inhibition of the menin protein in preclinical models of DLBCL, MM, and CLL. BMF-219 displayed significant single agent activity, surpassing greater than 90% cell killing at clinically relevant exposures in DLBCL, MM and CLL cell lines and patient-derived samples.
BMF-219 is the first investigational menin inhibitor in clinical development to show potential 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 Milestone in 2023:
On track to present initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the first half of 2023.
COVALENT-102 (BMF-219 for KRAS-Mutant Solid Tumors)
Presented strong and highly specific pan-KRAS anti-cancer activity of BMF-219 as a single agent across KRAS G12C, G12D, G12V and G13D mutant cell lines including in NSCLC, CRC and PDAC.
BMF-219 is the first investigational menin inhibitor in development to enter clinical trials 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.
COVALENT-103 (BMF-500 for Acute Leukemias)
Announced second Investigational New Drug (IND) candidate, BMF-500, a potential best-in-class oral covalent inhibitor of FLT3, designed and developed in-house, from target to IND candidate, utilizing Biomea’s proprietary FUSION System.
Presented data showing multi-fold higher potency and increased cytotoxicity of Biomea’s covalent FLT3 small molecule inhibitor BMF-500 compared to the commercially available reversible, non-covalent FLT3 inhibitor gilteritinib, and complete, sustained tumor regression in mouse models of FLT3-ITD AML with maintenance of effect after cessation of therapy.
Anticipated Milestone in 2023:
On track to file IND for BMF-500 in the first half of 2023 to initiate COVALENT-103 study in patients with acute leukemias.
DIABETES
COVALENT-111 (BMF-219 for Type 2 Diabetes)
Presented preclinical data highlighting the ability of BMF-219 in a type 2 diabetes rat model to restore normal HOMA-B, a measure of pancreatic beta cell function, following only four weeks of treatment and to significantly lower HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively.
BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the improvement of glycemic control and insulin sensitivity in type 2 diabetes patients.
Completed the Phase I healthy volunteer portion of Phase I/II (COVALENT-111) study of BMF-219 in Canada. BMF-219 was well tolerated with a favorable pharmacokinetic and pharmacodynamic profile in healthy volunteers and with no safety signals detected.
Received FDA clearance in December 2022 to expand the Phase II portion of COVALENT-111 to sites in the U.S. and dosed the first diabetic patient in the U.S. in January 2023. Biomea continues to enroll type 2 diabetes patients in the Phase II portion of the study in the U.S. and Canada.
In March 2023, Biomea reported initial clinical data from the first two cohorts of the Phase II portion of COVALENT-111, with initial data in its Cohort 3 (n=10 patients at 100 mg without food) showing 89% patients achieving a reduction in HbA1c, 78% of subjects achieving a ≥ 0.5% reduction in HbA1c and 56% achieving a >1.0% reduction in HbA1c (median and mean reduction over the cohort: -1.0% and -0.81%, respectively). BMF-219 demonstrated a well-tolerated safety profile with no dose discontinuations.
Anticipated Milestone in 2023:
Further clinical updates at higher treatment doses expected including follow up on the initial dosing cohorts reported in the first quarter of 2023.
FUSION SYSTEM DISCOVERY PLATFORM
Developed two covalently binding small molecules (BMF-219 and BMF-500), each within 18 months from target identification to IND candidate, leveraging the proprietary FUSION System Discovery Platform and showing promising preclinical profiles.
Anticipated Milestone in 2023:
On track to announce a third development candidate from the FUSION platform in the first half of 2023.
FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS
Cash, Cash Equivalents, Restricted Cash, and Investments: As of December 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $113.4 million, compared to $175.7 million as of December 31, 2021.
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $25.3 million for the three months ended December 31, 2022, compared to a net loss of $14.7 million for the same period in 2021. Net loss attributable to common stockholders was $81.8 million for the year ended December 31, 2022, compared to a net loss of $41.6 million for the same period in 2021.
Research and Development (R&D) Expenses: R&D expenses were $20.5 million for the three months ended December 31, 2022, compared to $11.1 million for the same period in 2021. The increase of $9.5 million was primarily due to an increase in clinical and preclinical development costs as well as an increase in personnel-related expenses. R&D expenses were $62.7 million for the year ended December 31, 2022, compared to $28.0 million for the same period in 2021. The increase of $34.7 million was primarily due to an increase in personnel-related expenses, 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 $5.7 million for the three months ended December 31, 2022, compared to $3.6 million for the same period in 2021. The increase of $2.1 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company. G&A expenses were $20.9 million for the year ended December 31, 2022, compared to $13.7 million for the same period in 2021. The increase of $7.3 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
About COVALENT-101
COVALENT-101 is a Phase I, open-label, multi-center, dose escalation and dose expansion study originally designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of oral dosing of BMF-219 in patients with R/R acute leukemias —including subpopulations where menin inhibition is expected to provide maximal therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations), multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). The study design has now been expanded to include a cohort for patients with R/R CLL. Additional information about the Phase I clinical trial of BMF-219 in genetically defined liquid tumors can be found at ClinicalTrials.gov using the identifier NCT05153330.
About COVALENT-102
COVALENT-102 is an open-label, multi-cohort, multicenter, Phase I/Ib dose finding study evaluating the safety, tolerability, and clinical activity of escalating doses of oral BMF-219 administered to patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and PDAC with a KRAS mutation. Additional information about the Phase I/Ib clinical trial of BMF-219 in KRAS-mutant solid tumors can be found at ClinicalTrials.gov using the identifier NCT05631574.
About COVALENT-111
COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts to ensure safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544