On May 16, 2022 Biomea Fusion, Inc. (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 2022 financial results and business highlights (Press release, Biomea Fusion, MAY 16, 2022, View Source [SID1234614653]).
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"We had a very exciting start to the year as we initiated our first Phase I study of BMF-219, COVALENT-101, in AML and ALL patients. We have now expanded enrollment to include also DLBCL and MM patients. Targeting menin with our covalent inhibitor is an innovative approach with potential safety, tolerability, efficacy, and durability advantages. Our COVALENT-101 investigators are enthusiastic to use BMF-219 for many of their patients who currently have relapsed from or not responded to traditional approaches," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board.
Mr. Butler continued, "We believe covalent inhibitors afford the optimal profile for a therapeutic. The aim is to maximize depth and durability of response, to support improved survival, while minimizing exposure, which is the source for unwanted toxicity. We have now provided preclinical evidence highlighting BMF-219’s profound anti-tumor effects in MYC-driven cancers and pan-KRAS mutant solid tumors. By indirectly targeting MYC and KRAS via the scaffold protein menin, our preclinical data demonstrates that BMF-219 can affect these oncoproteins in a very meaningful way. We are managing our expenses and will continue to execute on the clinical development of this first-in-human and first-in-class covalent menin inhibitor not only in the various tumor types, but also in type 2 diabetic patients."
Clinical and Regulatory Highlights
Enrolled first patient in first-in-human Phase I clinical trial evaluating BMF-219 in patients with relapsed or refractory acute leukemias, including those with MLL1/KMT2A gene rearrangements or NPM1 mutations.
Presented preclinical data at AACR (Free AACR Whitepaper) 2022 highlighting impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines.
Announced upcoming presentation of preclinical BMF-219 data from multiple in vivo models of diabetes at ADA Scientific Sessions 2022.
Announced upcoming presentation of preclinical BMF-219 data from multiple ex vivo models of CLL at ASCO (Free ASCO Whitepaper) 2022.
Corporate Highlights
Appointed Steve Morris, M.D. as Chief Medical Officer. Dr. Morris led a basic and translational research laboratory at St. Jude Children’s Research Hospital, where he served for 25 years. Among his lab’s pioneering work at St. Jude was the discovery and characterization of anaplastic lymphoma kinase, or ALK.
First Quarter 2022 Financial Results
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $16.4 million for quarter ended March 31, 2022, compared to a net loss of $5.9 million for the same period in 2021.
R&D Expenses: Research and development expenses were $11.4 million for the quarter ended March 31, 2022, compared to $3.8 million for the same period in 2021. The increase of $7.6 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 $5.1 million for the quarter ended March 31, 2022, compared to $2.1 million for the same period in 2021. The increase of $3.0 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 March 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $165.6 million, compared to $175.7 million as of December 31, 2021.