Item 8.01. Other Events.
On
Copies of the press release and the Company's presentation are attached to this Current Report on Form 8-K as Exhibits 99.1 and 99.2 and are incorporated herein by reference.
Forward-Looking Statements
Statements made or incorporated by reference in this Current Report on Form 8-K may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of the Company's product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-500 as an FLT3 inhibitor, the potential of BMF-219 as a treatment for various types of cancer and diabetes, the Company's research, development and regulatory plans, the progress of the Company's ongoing clinical trials, including COVALENT-101, COVALENT-102 and the Company's Phase I/II clinical COVALENT-111 study of BMF-219 in Type 2 diabetes, the Company's plans to present clinical data from the Company's COVALENT-101 study and the first two cohorts of the Phase II portion of the Company's COVALENT-111 study, the Company's plans to dose the first patient in the Company's COVALENT-102 study, the Company's plans to submit an IND application for BMF-500 in patients with FLT3 mutations, the Company's plans to provide clinical updates on the healthy volunteer section of the Company's Phase I/II Type 2 diabetes study of BMF-219, the Company's plans to announce a third development candidate from the FUSION platform, and the timing of such events, may be deemed to be forward-looking statements. The Company intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions.
Any forward-looking statements made or incorporated by reference in this Current
Report on Form 8-K are based on the Company's current expectations, estimates
and projections only as of the date of this Current Report on Form 8-K and are
subject to a number of risks and uncertainties that could cause actual results
to differ materially and adversely from those set forth in or implied by such
forward-looking statements, including the risk that the Company may encounter
delays in preclinical or clinical development, the preparation, filing and
clearance of INDs, patient enrollment and in the initiation, conduct and
completion the Company's ongoing and planned clinical trials and other research
and development activities. These risks concerning the Company's business and
operations are described in additional detail in its periodic filings with the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits Exhibit Number Description 99.1 Press release titled, "Biomea Fusion to Present at 41st Annual J.P.Morgan Healthcare Conference and Highlight 2023 Corporate Milestones." 99.2 Corporate Slide Presentation ofBiomea Fusion, Inc. , titled "JP Morgan 2023 Corporate Presentation" 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 1
--------------------------------------------------------------------------------
© Edgar Online, source