Biomea Fusion made a bold move, as it announced today, May 5th of 2025, that it had decided to reduce its workforce, and one of the reasons being was to conserve cash. This cost-cutting measure is going to allow it be in a position to fund its operations into Q4 of 2025.
There is a lot more to be said here because, besides reducing its workforce by as much as 35%, it also made the decision to end its advancement of BMF-500 as an oral small molecule FLT3 inhibitor for the treatment of patients with acute leukemia. The intended goal of this molecule was to be used either alone or in combination with standard of care (SOC) to target FLT3 mutant patients with this type of cancer.
This comes as a shock that it is terminating further advancement of this program. Especially since back in December of 2024, it revealed positive preliminary data from the ongoing Phase I COVALENT-103 study. This particular trial recruited relapsed/refractory acute leukemia patients with FLT3 gene mutations who have failed on gilteritinib. Preliminary data showed that there was a first complete responder with incomplete hematologic recovery (CRi). Not only that, but 5 out of 6 FLT3-mutated patients had a reduction in bone marrow blasts.
This particular drug, sold under the brand name XOSPATA from Astellas Pharma, is an approved drug to treat patients with relapsed or refractory acute myeloid leukemia (AML). It is not clear why the company has chosen to abandon pouring further resources into this program, but it stated that it wants to focus on its two other programs, which are oral small molecule inhibitor icovamenib for the treatment of patients with Type 1 and Type 2 diabetes (T1D/T2D) and next-generation oral small molecule GLP-1 receptor agonist BMF-650 for the treatment of patients with obesity.
Regardless, it is not going to be long for investors to see clinical data from the COVALENT-101 phase I study. The reason why is because results from this trial are anticipated any day now in Q2 of 2025. The icovamenib program is ideal and could be huge considering that there are several milestones expected in the 2nd half of 2025 alone. These include 52-week results from the phase II COVALENT-111 trial targeting patients with T2D, an FDA meeting to design phase 2 and possibly phase 3 studies targeting T2D patients, and clinical data from a phase II COVALENT-112 trial targeting patients with T1D.
It may have a shot at doing well with its next-generation GLP-1 receptor agonist BMF-650, but it is too early to say. Especially since an IND application to begin a phase 1 study for this program is not expected to happen until the 2nd half of 2025. Plus, it is not going to be easy to enter the crowded obesity treatment market space. You have the likes of Novo Nordisk with WEGOVY and Eli Lilly with ZEPBOUND.
It is hoping to find a partner to fund further development of BMF-500 for the targeting of patients with FLT3 acute leukemia, but this remains to be seen. There is no assurance that it will be able to find a pharmaceutical company willing to pour resources into advancing it. Not only that, but whether it can attain this goal highly depends upon the next set of data to be released this quarter from the COVALENT-103 phase I study. If results released from this study are not ideal, then that throws a huge wrench into the plans of finding a partner to further fund the development of BMF-500.
