On August 1, 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 second quarter 2022 financial results and business highlights (Press release, Biomea Fusion, AUG 1, 2022, View Source [SID1234617233]).
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"The team continues to deliver against critical corporate goals as we look to build tremendous value potential for the company in the near and long-term. During the second quarter, we focused specifically on key clinical operations and clinical science activities to support COVALENT-101. Additionally, we continued to design and execute key experiments to support our diabetes effort as we march towards the clinic," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "The scaffold protein menin has many more functional responsibilities than was previously characterized and, thus, is central to multiple disease settings. Moreover, we believe our approach of covalent menin inhibition with BMF-219 offers potential safety, tolerability, efficacy and durability benefits to patients. We are now well positioned to execute a robust clinical development plan for BMF-219, which includes many liquid and solid tumor indications, as well as type 2 diabetes. Beyond menin inhibition, we are advancing toward the clinic with our second IND candidate, BMF-500, a covalent FLT3 inhibitor with best-in-class potential."
Second Quarter 2022 Pipeline Highlights
Cancer
Enrolled first patient with MM in the ongoing first-in-human Phase I clinical trial (COVALENT-101) evaluating BMF-219 in patients with relapsed or refractory acute leukemias, DLBCL, and MM
Presented Trial in Progress posters for COVALENT-101 at multiple prominent oncology conferences in the United States and in Europe
Presented preclinical data in two posters at AACR (Free AACR Whitepaper) 2022 highlighting the 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
On track to submit IND for BMF-219 in KRAS mutant NSCLC, CRC, and pancreatic ductal adenocarcinoma (PDAC) in the fourth quarter of 2022
Presented preclinical data at ASCO (Free ASCO Whitepaper) 2022 demonstrating BMF-219’s potency in multiple ex vivo tumor models of Chronic Lymphocytic Leukemia (CLL) with varying cytogenetic risk profiles, Rai stages, and resistance to standard-of-care agents indicating broad activity across these models
Announced IND candidate selection, BMF-500, a potential best-in-class oral covalent inhibitor of FLT3, one of the most frequently altered genes in AML and associated with poor prognosis
Diabetes
Presented new preclinical data in two posters at the ADA Scientific Sessions 2022, demonstrating BMF-219’s strong, prolonged glycemic control, insulin sensitization, and hemoglobin A1C (HbA1c) reduction in two preclinical rat models of diabetes while on drug and after washout, outperforming standard-of-care agents
Announced upcoming oral presentations of BMF-219 preclinical data from two animal models of diabetes at the EASD 2022 annual meeting which will include additional data not previously presented at the ADA Scientific Sessions 2022
On track to submit IND for BMF-219 in type 2 diabetes in the second half of 2022
Second Quarter 2022 Financial Results
Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $33.6 million for the six months ended June 30, 2022, compared to a net loss of $14.3 million for the same period in 2021.
R&D Expenses: Research and development expenses were $23.9 million for the six months ended June 30, 2022, compared to $9.0 million for the same period in 2021. The increase of $14.9 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 product candidates, BMF-219 and BMF-500.
G&A Expenses: General and administrative expenses were $9.9 million for the six months ended June 30, 2022, compared to $5.3 million for the same period in 2021. The increase of $4.7 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 June 30, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $150.2 million, compared to $175.7 million as of December 31, 2021.