Biomea Fusion reports Q4 EPS (98c), consensus (85c)

“2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes. We also announced initial positive data in AML in 2023. It has been gratifying to see the ongoing and continued improvement in HbA1c after only a 4-week dosing period with BMF-219 in type 2 diabetes patients with poorly controlled diabetes. Critically, we have now evaluated BMF-219 out to 26 weeks, or 5 months, after the last dose of BMF-219, and reported promising longer-term data. Based on these clinical and our preclinical findings we have observed with confidence, that the inhibition of menin is correlated with beta cell proliferation and function, and is providing durable effects for patients,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “Our preclinical data showed also that longer inhibition of menin at higher doses increased beta cell mass and function, as well as promoted controlled proliferation and enhanced insulin content in beta cells. We have now initiated expansion cohorts to evaluate the translation of these preclinical findings in the clinical setting. We believe BMF-219 has the potential to address the root cause of diabetes and modify disease progression in patients across a broad spectrum of clinical profiles, from early to later stage treatment. Our goal is to deliver a short-term, non-chronic treatment that will reconstitute insulin-producing beta cells, allowing the patients’ own bodies to normalize blood sugar levels. Importantly, we continued to build a first-class pipeline of covalent inhibitors. In 2023 BMF-500 entered the clinic as the only covalent FLT3 inhibitor in clinical development. We anticipate 2024 will be an even more momentous year for Biomea, as we steadily march toward late-stage clinical development in both type 2 and type 1 diabetes. This year, we plan to complete and report the results of dosing and follow-up of over 200 type 2 diabetes patients enrolled in our Phase 2 expansion cohorts. We expect these data will inform potentially registrational studies, which we plan to start in 2025, pending discussions with regulatory authorities. In 2024, we also expect to report data from 40 patients enrolled in the open label portion of our Phase 2 study in type 1 diabetes patients. On the oncology front, we will continue patient enrollment in our liquid and solid tumor studies of BMF-219 and BMF-500 and anticipate completing the dose escalation steps in each of the cohorts as well this year. Since our launch as a public company just over three years ago, we have consistently demonstrated the ability to accelerate innovative science and execute against aggressive development timelines. In 2024, we’ll continue to work methodically yet quickly to deliver the patient data required for potentially registrational studies we are planning to begin in the following year.”