On February 28, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported fourth quarter and full year 2021 financial results and business highlights (Press release, Biomea Fusion, FEB 28, 2022, View Source [SID1234609110]).

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"I am proud of all that we, TEAM FUSION, accomplished in 2021 laying a firm foundation to enable our ambitious clinical development strategy for BMF-219, our irreversible covalent menin inhibitor. In January 2022, we began dosing our first patient in our initial Phase I leukemia study of BMF-219, and we are aiming to initiate human studies in up to seven different tumor types as well as diabetes over the next 12 months," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "We also have made significant progress advancing our lead preclinical programs and plan to announce our second irreversible covalent inhibitor pipeline candidate in the coming months. We anticipate that the next 12 months will be enormously productive and catalyst rich for Biomea Fusion."

Clinical and Regulatory Highlights Last 12 months

Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219, Biomea’s irreversible covalent menin inhibitor, in patients with relapsed/refractory (r/r) acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
Announced 2022 clinical development plan, which includes initiating studies with BMF-219 in up to seven cancers and diabetes, subject to the submission and clearance of additional Investigational New Drug applications (INDs). These studies plan to evaluate patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), diffuse large B-Cell lymphoma (DLBCL), non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC). Preclinical data suggests the menin complex plays a critical role in MYC-dependent oncogenic signaling, whereby menin enhances MYC-mediated transcription to promote cancer progression. Inhibition of menin is a novel approach to cancer treatment. Nonclinical studies of BMF-219 have shown sustained potent abrogation of menin-dependent cancers.
Published preclinical abstract at ASH (Free ASH Whitepaper) 2021, highlighting impact of BMF-219 on MYC activity and substantial growth inhibition compared to other menin inhibitors in DLBCL. BMF-219 was observed to elicit broad impact on the complexes surrounding menin resulting in strong modulation of MYC expression, highlighting potential in multiple cancer types.
Expanded the Phase I study to include two additional tumor types, one with diffuse large B-cell lymphoma (DLBCL) patients and one with multiple myeloma (MM) patients.
Corporate Highlights Last 12 months

Completed initial public offering, with net proceeds of $152.8 million.
Opened Biomea R&D Innovation Center in Redwood City, accelerating the discovery and development of additional irreversible covalent programs via the company’s proprietary FUSION System.
Grew the Biomea Fusion team to 51 employees and expanded the executive team with the hires of Chief Financial Officer, Franco Valle, and Chief Medical Officer, Steve Morris, M.D.
Strengthened board of directors with the appointments of Michael J. M. Hitchcock, Ph.D., a tenured employee and long-time advisor to Gilead Sciences and Adjunct Professor of Microbiology at the University of Nevada Medical School; and Sumita Ray, J.D., Chief Legal and Administrative Officer at Calithera Biosciences, Inc.
Expected Milestones in 2022

Initiate enrollment of patients with MM and DLBCL in Phase I clinical trial of BMF-219.
Announce further preclinical data for BMF-219 in liquid and solid tumors.
Announce preclinical validation for BMF-219 in diabetes.
Announce second irreversible covalent inhibitor pipeline candidate in the first half of 2022.
Submission of an IND for BMF-219 in diabetes in the second half of 2022.
Submission of an IND for BMF-219 in KRAS-mutant solid tumors, including patients with non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC) in the fourth quarter of 2022.
Fourth Quarter and Full Year 2021 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $41.6 million for year ended December 31, 2021, compared to a net loss of $5.3 million for the same period in 2020.
R&D Expenses: Research and development expenses were $28.0 million for the year ended December 31, 2021, compared to $3.7 million for the same period in 2020. The increase of $24.3 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s lead product candidate, BMF-219.
G&A Expenses: General and administrative expenses were $13.7 million for the year ended December 31, 2021, compared to $1.7 million for the same period in 2020. The increase of $12.0 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.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of December 31, 2021, the Company had cash, cash equivalents, restricted cash, and investments of $175.7 million.