On October 30, 2023, Biomea Fusion Inc (BMEA, Financial), a clinical-stage biopharmaceutical company, released its third-quarter 2023 financial results and business highlights. The company reported a net loss attributable to common stockholders of $28.4 million for the three months ended September 30, 2023, compared to a net loss of $22.9 million for the same period in 2022. The company's cash position stood at $199.5 million at the end of the third quarter of 2023.
Key Clinical and Regulatory Highlights
Biomea Fusion Inc (BMEA, Financial) reported significant progress in its key clinical trials. The company's investigational diabetes therapy, BMF-219, has shown promising blood glucose control in adults with uncontrolled type 2 diabetes. In the escalation phase of the COVALENT-111 trial, 84% of all patients dosed for four weeks with BMF-219 showed a reduction in HbA1c at Week 4 and 74% at Week 12.
In the field of oncology, the company reported initial topline data from the ongoing Phase I clinical trial (COVALENT-101) which showcased initial responses in relapsed/refractory AML patients with menin-dependent mutations. The data revealed 2 complete responses (CRs) out of 5 pretreated patients with relapsed/refractory AML patients carrying menin-dependent mutations (MLL1r, NMP1, MLL1-PTD, and NUP98 fusion) treated at Dose Level 4.
Financial Results
As of September 30, 2023, the company had cash, cash equivalents, restricted cash, and investments of $199.5 million, compared to $113.4 million as of December 31, 2022. Research and Development (R&D) expenses were $25.3 million for the three months ended September 30, 2023, compared to $18.2 million for the same period in 2022. General and Administrative (G&A) expenses were $5.8 million for the three months ended September 30, 2023, compared to $5.2 million for the same period in 2022.
The increase in R&D expenses was primarily due to an increase in clinical development cost and external consulting related to the company’s product candidates, BMF-219 and BMF-500, as well as an increase in personnel-related costs. The increase in G&A expenses was primarily due to increased personnel-related expenses, including stock-based compensation, due to an increase in headcount.
Looking Ahead
Biomea Fusion Inc (BMEA, Financial) continues to advance its clinical trials and is looking forward to reporting on its pipeline progress in both diabetes and oncology in the upcoming quarters. The company's commitment to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases remains strong.
Explore the complete 8-K earnings release (here) from Biomea Fusion Inc for further details.
