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biomea FUSION ™ Biomea Fusion Reports Third Quarter 2021 Financial Results and Business Highlights November 3 , 2021 • Announced FDA clearance of Investigational New Drug Application ( IND ) for BMF - 219 , the company's first development candidate from the FUSION platform • Phase I trial to enroll adult patients with relapsed or refractory acute leukemia , including those with an MLL / KMT2A gene rearrangement or NPM1 mutation • Scientific rationale for irreversible menin inhibition in diffuse large B cell lymphoma ( DLBCL ) now expected in Q4 2021 • Pathway validation in diabetes anticipated in Q1 2022 • Opened Biomea Innovation Research Center , to enable the Research & Development ( R & D ) team to rapidly discover and develop novel irreversible covalent small molecules by leveraging the FUSION platform to build a broad portfolio of therapeutics REDWOOD CITY , Calif . , Nov. 03 , 2021 ( GLOBE NEWSWIRE ) -- Biomea Fusion , Inc. ( " Biomea ” ) ( Nasdaq : BMEA ) , a clinical - stage biopharmaceutical company dedicated to the discovery and development of novel small molecules to treat and improve the lives of patients with genetically defined cancers , reported financial results for the third quarter of 2021 . " The Third Quarter was a historic one for the company as it advanced its first investigational drug into a clinical stage program . BMF - 219 , our internally discovered and developed small molecule , has shown broad anti - cancer activity pre - clinically and we now have the opportunity to explore this potential in patients in need . " said Thomas Butler , Biomea's CEO and Chairman of the Board . " In September , we received FDA clearance of our IND for BMF - 219 , and we are now working diligently to initiate a Phase I study for the treatment of relapsed or refractory acute leukemia . We look forward to providing clinical development updates as we deepen our understanding of menin's role in various cancers and the potential impact of irreversible inhibition for these patient populations . Our vision for this company has always been to develop a suite of novel covalent inhibitors that can act as single agent therapies or in combination , together , to build best - in - class medicine for patients . We have executed on this promise by hiring world - class drug hunters , and developers , and by custom designing and opening a state - of - the - art Research Center . We now have our first molecule ready for the clinic , and a number of exciting programs advancing through pre - clinical development . " Mr. Butler continued , " As we move BMF - 219 into the clinic , we intend to also focus on leveraging our novel chemistry across multiple indications . To that end , we anticipate announcing our next pipeline candidate in the first half of 2022. " Business Highlights • FDA clearance of IND for First - in - Human Phase I Clinical Trial of BMF - 219 . In September 2021 , Biomea received FDA clearance of its IND for BMF - 219 , an irreversible menin inhibitor for the treatment of relapsed or refractory acute leukemias including those with an MLL / KMT2A gene rearrangement or NPM1 mutation . • Preclinical studies underway for DLBCL and multiple myeloma ( MM ) as potential indications for BMF - 219 . Biomea is conducting preclinical studies to demonstrate the potential for BMF - 219 in genetically defined patient subsets of DLBCL and MM . • Pathway validation studies of irreversible menin inhibition in diabetes . Biomea is continuing preclinical studies to explore the potential of its irreversible menin inhibitor approach for the treatment of type 2 diabetes . The company plans to report findings from these studies in the first quarter of 2022 . • Launch of Biomea Innovation Center ; scale - up of R & D organization . Biomea recently opened the Biomea Innovation Center with laboratory space and a dedicated R & D team focused on leveraging the company's FUSION platform to generate a broad portfolio of next generation covalent inhibitors . " Our CEO's vision for the company is to build a fully sustainable , world - class R & D organization , which mines the deep potential of our FUSION platform and irreversible binding small molecule approach . With our recently opened Biomea Innovation Research Center and our continued scale - up of an extremely talented , forward - and creative - thinking scientific team , we will aggressively interrogate our irreversible binding approach against known and validated biological targets with the goal of rapidly advancing a broad portfolio of therapies designed to deliver enhanced efficacy and safety for patients . Thanks to our successful IPO and considering our current programs ' quarterly expenses , we expect our cash balance to sustain our operations well into 2024 , " concluded Ramses Erdtmann , Biomea's COO and President . Financial Highlights Third Quarter 2021 Year to Date Financial Results