Elevation Oncology Inc. filed SEC Form 8-K: Other Events
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Item 8.01. | Other Events. |
On January 13, 2025, Elevation Oncology, Inc. (the “Company”) issued a press release announcing program updates and upcoming milestones. The Company announced that, with respect to its ongoing Phase 1 clinical trial of EO-3021, a Claudin 18.2 antibody-drug conjugate (“ADC”): (i) patient dosing is ongoing in the combination portion of the trial, which evaluates EO-3021 in combination with dostarlimab, a PD-1 inhibitor, in the first line setting and with ramucirumab, a VEGFR2 inhibitor, in the second line setting; (ii) the Company expects to report initial data from the combination cohorts in the fourth quarter of 2025 or the first quarter of 2026; (iii) as of January 2025, the Company has implemented prospective Claudin 18.2 expression testing as part of the patient screening process for the monotherapy dose expansion portion, focusing enrollment on patients with ≥25% of tumor cells at IHC 1+/2+/3+; and (iv) the Company plans to report additional safety and efficacy data from the monotherapy dose escalation and expansion portions in the first half of 2025.
The Company also announced that, with respect to EO-1022, a HER3 ADC, the Company expects to present preclinical data in the first half of 2025 and to file an Investigational New Drug application in 2026. In addition, the Company announced that it expects that its cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund its current operations into 2026.
This current report contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical and preclinical results and the Company’s expectations about its cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “will,” “would,” and other words and terms of similar meaning. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Further information on potential risk factors that could affect the Company’s business and financial results are detailed in its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”), and its other reports as filed with the SEC. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.