Biomea Fusion, Inc. - BMEA STOCK NEWS

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company focused on irreversible small molecules for genetically defined cancers, has been added to the NASDAQ Biotechnology Index, effective December 20, 2021. This index includes NASDAQ-listed companies in the Biotechnology and Pharmaceuticals sectors that meet specific criteria. Biomea’s proprietary FUSION™ discovery platform aims to enhance treatment selection, potentially improving patient outcomes through more selective and durable drug responses.

Biomea Fusion, a clinical-stage biopharmaceutical company (Nasdaq: BMEA), announced participation in two virtual conferences. CEO Thomas Butler will present at the Jefferies London Healthcare Conference on November 18 at 3:00am ET and at the Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22 at 10:00am ET. Biomea will also conduct 1x1 investor meetings during these events. The company is advancing BMF-219, an irreversible inhibitor targeting genetically defined leukemias, into a first-in-human trial.

Biomea Fusion announced the publication of preclinical data for its irreversible menin inhibitor, BMF-219, in the journal Blood. The study showed that BMF-219 disrupts menin globally, yielding potent efficacy against diffuse large B cell lymphoma (DLBCL) cell lines, achieving over 90% cell viability reduction at low dosages. The mechanism involves modulation of MYC expression, with BMF-219 demonstrating a strong impact on MYC-dependent malignancies. Plans for clinical trials in relapsed or refractory acute leukemia patients are underway.

Biomea Fusion (BMEA) announced FDA clearance for its Investigational New Drug Application (IND) for BMF-219, targeting relapsed or refractory acute leukemia. The Phase I trial enrollment will include patients with MLL/KMT2A rearrangements or NPM1 mutations. The company plans to explore BMF-219’s use in diffuse large B cell lymphoma and multiple myeloma. Biomea opened the Biomea Innovation Research Center to enhance R&D efforts. Financially, Biomea reported a net loss of $26.9 million for the first nine months of 2021, with R&D expenses rising significantly to $16.9 million.

Biomea Fusion has announced the initiation of its first-in-human (FIH) clinical trial for BMF-219, an irreversible menin inhibitor targeting relapsed or refractory acute leukemia. The FDA has cleared the Investigational New Drug application for this Phase I trial, which aims to evaluate safety and efficacy in a challenging patient population, including those with MLL/KM2TA rearrangements or NPM1 mutations. The company asserts that the aggressive nature of acute leukemia presents a significant unmet need, providing a strong rationale for its novel therapeutic approach.

Biomea Fusion (BMEA) has achieved significant milestones with its lead program, BMF-219, an irreversible menin inhibitor. The company has completed IND-enabling studies and plans to submit the IND for a Phase I/II study targeting menin-dependent acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) in the latter half of 2021. Financially, Biomea reported a net loss of $14.3 million for the first half of 2021 and increased R&D expenses of $9.0 million. As of June 30, 2021, the company holds $203 million in cash and equivalents to support ongoing initiatives.

Biomea Fusion (Nasdaq: BMEA) announced the appointment of Franco Valle as Chief Financial Officer. Valle, a seasoned financial expert, has a strong background in biotech, previously holding roles at Eidos and Iovance Biotherapeutics. He will also serve as Principal Financial Officer. CEO Tom Butler emphasized Valle's expertise in building financial systems to support growth as they prepare to submit IND for BMF-219 later this year. The company is progressing its pipeline of irreversible small molecules aimed at treating genetically defined cancers.

Biomea Fusion reported significant progress in Q1 2021, with a net loss of $5.9 million compared to $0.4 million in Q1 2020. The company raised $167 million from its IPO in April, totaling $223 million since December 2020, strengthening its financial position. Biomea is advancing its lead program, BMF-219, an irreversible menin inhibitor, aiming for an IND filing in H2 2021. Additionally, Mick Hitchcock, Ph.D., joined the Board, contributing extensive biotech experience.

Biomea Fusion, Inc. (Nasdaq: BMEA) announced the successful closing of its initial public offering, selling 9,000,000 shares at $17.00 each, generating gross proceeds of $153 million. The shares began trading on the Nasdaq Global Select Market on April 16, 2021. The underwriters also received a 30-day option to purchase an additional 1,350,000 shares. J.P. Morgan Securities, Jefferies, and Piper Sandler served as joint book-running managers for this offering, which contributes to Biomea's mission in developing treatments for genetically defined cancers.