UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On August 21, 2025, Tyra Biosciences, Inc. (Tyra or the Company) announced the first child has been dosed in the BEACH301 Phase 2 clinical study of dabogratinib (formerly TYRA-300) in children with achondroplasia. The Company expects to report initial results from the safety sentinel cohort of the BEACH301 study in the second half of 2026.
Forward-Looking Statements
Tyra cautions you that statements contained in this report regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: expected reporting of initial results from the BEACH301 study and the timing thereof. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in our business, including, without limitation: potential delays in the commencement, recruitment, enrollment, data readouts and completion of clinical trials and preclinical studies; results from preclinical studies or early clinical trials not necessarily being predictive of future results; interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of dabogratinib; later developments with the U.S. Food and Drug Administration (FDA) may be inconsistent with prior feedback from the FDA; our dependence on third parties in connection with manufacturing, research and preclinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory developments in the United States and foreign countries; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| TYRA BIOSCIENCES, INC. | ||||||
| Date: August 21, 2025 | By: | /s/ Alan Fuhrman | ||||
| Alan Fuhrman Chief Financial Officer | ||||||