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biomea FUSION Biomea Fusion Reports Second Quarter 2021 Financial Results and Business Highlights August 11 , 2021 • Completed investigational new drug ( " IND ” ) enabling studies for lead program , BMF - 219 , an irreversibly binding menin inhibitor . On track to complete IND submission for Phase I / II study of BMF - 219 as treatment for patients with menin- dependent acute myeloid leukemia ( " AML " ) and acute lymphocytic leukemia ( " ALL " ) during the second half of this year • Continued to advance ongoing preclinical studies of BMF - 219 in a number of menin - dependent liquid and solid tumors , including Diffuse Large B Cell Lymphoma ( " DLBCL " ) , to expand potential impact of novel drug • Initiated pathway validation studies in type 2 diabetes • Continued to expand team and laboratory facilities to support long - term growth and clinical and preclinical development plans • Strengthened Board of Directors with appointment of Sumita Ray , J.D. , Chief Legal and Administrative Officer at Calithera Biosciences , Inc. REDWOOD CITY , Calif . , Aug. 11 , 2021 ( GLOBE NEWSWIRE ) -- Biomea Fusion , Inc. ( " Biomea " ) ( Nasdaq : BMEA ) , a preclinical - stage biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers , reported financial results for the second quarter of 2021 . " We continue to make notable progress as we rapidly advance BMF - 219 toward a planned entry into the clinic and continue to grow our company and pipeline , ” said Thomas Butler , Biomea's CEO and Chairman of the Board . “ In the second quarter , we successfully completed IND - enabling studies for BMF - 219 and are now in the final stages of completing our IND submission to the FDA to advance BMF - 219 to a Phase I study for the treatment of patients with menin - dependent AML and ALL . We also continued to make important progress pursuing our broad , ambitious , preclinical strategy focused on exploring the potential of this novel irreversible small molecule across a number of menin - dependent liquid and solid tumors , including DLBCL . " Mr. Butler continued , " While our primary focus is oncology drug development , there are multiple diseases where the menin pathway is implicated and where an irreversibly binding small molecule approach may have an important impact , including for patients with type 2 diabetes . At our core , we feel a profound responsibility to help patients with our novel chemistry . To that end , we look forward to seeing the results of our exploratory pathway validation in type 2 diabetes next year . " Business Highlights • Completed IND - enabling studies with irreversibly binding menin inhibitor BMF - 219 . Biomea successfully conducted IND - enabling studies with BMF - 219 , an irreversible menin inhibitor for the treatment of patients with menin - dependent AML and ALL . Biomea anticipates submitting the IND during the second half of 2021 . • Continued preclinical studies of BMF - 219 in DLBCL . Biomea continues to explore the potential of BMF - 219 for a number of menin - dependent liquid and solid tumor cancers , including a subset of DLBCL , with a number of preclinical studies currently underway . The Company plans to report its findings in DLBCL in the first quarter of 2022. Despite the high dependency of several cancers on menin , Biomea Fusion is not aware of any menin inhibitors currently in clinical development for these cancer types . • Initiated pathway validation studies in diabetes . Based on a growing body of internal and external scientific evidence , Biomea has initiated key preclinical studies to explore the potential of its irreversible menin inhibitors as a treatment for type 2 diabetes . The Company plans to report its findings in the first quarter of 2022. Biomea Fusion is not aware of any menin inhibitors currently in clinical development for diabetes . • Expanded team and in - house research capabilities to support long - term growth and clinical and preclinical development plans . Biomea strengthened its executive team with the appointments of Franco Valle as Chief Financial Officer , Alex Cacovean , M.D. as Executive Medical Director and Sasha Blaug Ph.D. as Senior VP of Corporate Development . Biomea has successfully grown its headcount this year to date by 29 for a total of 41 current team members . The Company has also completed the buildout of its own laboratory facilities to further support the research and preclinical pipeline development of its irreversible platform .