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Biomea Fusion(BMEA) - 2024 Q2 - Quarterly Results
2024-07-31 20:13
Exhibit 99.1 Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights • COVALENT-111 Phase 2b on track for Q4 2024 readout • COVALENT-112 Phase 2a on track for Q4 2024 readout • Announcement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to trea ...
Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights
Newsfilter· 2024-07-31 20:05
Core Insights - Biomea Fusion, Inc. is progressing with its clinical trials and anticipates key data readouts for its diabetes programs in Q4 2024 [1][2][4] Diabetes Programs - The company is focused on resolving a clinical hold from the FDA regarding BMF-219 for diabetes, with COVALENT-111 (Type 2 Diabetes) and COVALENT-112 (Type 1 Diabetes) both set for topline readouts in Q4 2024, involving approximately 195 and 20 patients respectively [2][3][4] - Initial data from COVALENT-112 shows early signs of clinical activity in Type 1 diabetes patients, with improved beta-cell function observed [3] Obesity Program - A third program targeting obesity, which is an oral small molecule GLP-1 receptor agonist, is expected to be announced in Q3 2024 [5] Oncology Programs - Biomea is also advancing its oncology pipeline, with milestones for COVALENT-101 (liquid tumors), COVALENT-102 (solid tumors), and COVALENT-103 (acute leukemias) all expected to complete dose escalation by the end of 2024 [6] Financial Results - As of June 30, 2024, the company reported cash, cash equivalents, and restricted cash of $113.7 million, down from $177.2 million at the end of 2023 [8][15] - The net loss for Q2 2024 was $37.3 million, compared to a net loss of $24.9 million in Q2 2023, with R&D expenses increasing to $31.8 million from $21.9 million year-over-year [8][13] - General and administrative expenses also rose to $7.1 million in Q2 2024 from $5.7 million in Q2 2023 [8][13]
Biomea Fusion Reports Second Quarter 2024 Financial Results and Corporate Highlights
GlobeNewswire News Room· 2024-07-31 20:05
COVALENT-111 Phase 2b on track for Q4 2024 readout COVALENT-112 Phase 2a on track for Q4 2024 readout Announcement of the third program in obesity on track for Q3 2024 REDWOOD CITY, Calif., July 31, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea" or "the Company") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported se ...
ROSEN, GLOBAL INVESTOR COUNSEL, Encourages Biomea Fusion, Inc. Investors to Inquire About Securities Class Action Investigation – BMEA
GlobeNewswire News Room· 2024-07-08 20:58
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Biomea Fusion, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Announcement - On June 6, 2024, Biomea Fusion announced that the FDA placed a full clinical hold on its Phase I/II clinical trials for the investigational covalent menin inhibitor BMF-219 in type 1 and type 2 diabetes [2]. - The company will continue to collect ongoing safety and efficacy data during the clinical hold period [2]. Group 2: Market Reaction - Following the announcement of the clinical hold, Biomea Fusion's stock experienced a significant decline, falling by 63% on June 7, 2024 [8]. Group 3: Legal Action - The Rosen Law Firm is preparing a class action lawsuit seeking recovery of investor losses, allowing affected investors to potentially receive compensation without upfront fees [7].
BMEA Investors Have Opportunity to Lead Biomea Fusion, Inc. Securities Fraud Lawsuit
Prnewswire· 2024-06-24 17:00
NEW YORK, June 24, 2024 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Biomea Fusion, Inc. (NASDAQ: BMEA) resulting from allegations that Biomea Fusion may have issued materially misleading business information to the investing public. So what: If you purchased Biomea Fusion securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arran ...
Rosen Law Firm Encourages Biomea Fusion, Inc. Investors With Losses in Excess of $100K to Inquire About Securities Class Action Investigation – BMEA
GlobeNewswire News Room· 2024-06-20 15:26
NEW YORK, June 20, 2024 (GLOBE NEWSWIRE) -- Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Biomea Fusion, Inc. (NASDAQ: BMEA) resulting from allegations that Biomea Fusion may have issued materially misleading business information to the investing public. What is this about: On June 6, 2024, after the market closed, Biomea Fusion issued a press release entitled "Biomea Fusion Announces BMF-219 in Diabetes Placed ...
BMEA ANNOUNCEMENT: If You Have Suffered Losses in Biomea Fusion, Inc. (NASDAQ: BMEA), You Are Encouraged to Contact The Rosen Law Firm About Your Rights
GlobeNewswire News Room· 2024-06-16 19:56
So what: If you purchased Biomea Fusion securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement. The Rosen Law Firm is preparing a class action seeking recovery of investor losses. | --- | --- | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biomea Fusion, Inc. - BMEA
GlobeNewswire News Room· 2024-06-13 18:22
Core Viewpoint - Biomea Fusion, Inc. is under investigation for potential securities fraud and unlawful business practices, coinciding with a significant setback in its clinical trials due to FDA intervention [1][2]. Group 1: Investigation and Legal Context - The investigation focuses on whether Biomea and its officers or directors have engaged in securities fraud or other unlawful business practices [1]. - Pomerantz LLP, a prominent law firm specializing in corporate and securities litigation, is leading the investigation on behalf of Biomea's investors [2][3]. Group 2: Clinical Trial Setback - On June 6, 2024, Biomea announced that the FDA placed a full clinical hold on its Phase I/II trials for the investigational drug BMF-219, due to concerns over drug-induced hepatotoxicity observed in earlier trial phases [2]. - The specific trials affected are COVALENT-111 and COVALENT-112, which are focused on type 2 and type 1 diabetes, respectively [2]. Group 3: Market Reaction - Following the announcement of the FDA's clinical hold, Biomea's stock price plummeted by $7.13 per share, representing a 63.27% decrease, closing at $4.14 per share on June 7, 2024 [5].
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Biomea Fusion, Inc. - BMEA
Prnewswire· 2024-06-08 02:02
[Click here for information about joining the class action] CONTACT: Danielle Peyton Pomerantz LLP [email protected] 646-581-9980 ext. 7980 On this news, Biomea's stock price fell $7.13 per share, or 63.27%, to close at $4.14 per share on June 7, 2024. NEW YORK, June 7, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Biomea Fusion, Inc. ("Biomea" or the "Company") (NASDAQ: BMEA). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ...
Why Is Biomea Fusion (BMEA) Stock Down 63% Today?
Investor Place· 2024-06-07 12:16
Core Viewpoint - Biomea Fusion has announced a clinical hold on its Phase I/II trials for BMF-219 due to safety concerns related to potential drug-induced hepatotoxicity, which has resulted in significant stock price decline [1][4]. Company Summary - Biomea Fusion's candidate BMF-219 is intended for the treatment of type 1 and type 2 diabetes, and the company will continue to gather safety and efficacy data during the clinical hold [5]. - The company asserts that preliminary results indicate BMF-219 is generally well-tolerated and can improve glycemic control and insulin production [5]. Stock Performance - Following the announcement of the clinical hold, BMEA stock has dropped 63% as of Friday morning, and it was down 23.2% year-to-date as of the previous market close [5]. - Approximately 500,000 shares of BMEA stock were traded during pre-market hours, compared to the company's daily average trading volume of about 952,000 shares [7].