Tyra Biosciences, Inc. announced that it has initiated the SURF201 Phase 1 study of TYRA-200 and provided positive updates on its oral FGFR3-selective inhibitor, TYRA-300. The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200 and determine the optimal and maximum tolerated doses (MTD), as well as evaluate the preliminary antitumor activity of TYRA-200. TYRA is planning to initiate a randomized Phase 2 clinical trial with multiple dose cohorts of TYRA-300 for children with achondroplasia.TYRA plans to submit an Investigational New Drug (IND) application to the US FDA in the second half of 2024 for the initiation of the Phase 2 study.

In oncology, TYRA-300 is being evaluated in a multi-center, openlabel Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors). In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND in the second half of 2024 to the initiation of a Phase 2 clinical study in pediatric achondroplasia; In July 2023, TYRA-300 was granted Orphan Drug Designation for the treatment of achondroplasia from the FDA. The forward-looking statements are based on current beliefs and expectations and include, but are not limited to: the potential to develop next-generation precision medicines and a best-in-class agent and the potential safety and therapeutic benefits of TYRA-300, TYRA-200 and other product candidates; the ability to drive significant value for patients and shareholders; the expected timing, design (including dosing levels) and phase of clinical development of TYRA-300 and TYRA-200, including timing of a submission of an IND for TYRA-300 in pediatric achondro Plasia and submission of initial results from the SURF301 Phase 1 portion of the study to a scientific congress; and the potential for SNAP to develop therapies in targeted oncology and genetically defined conditions.

Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the business, including, without limitation: the company are early in development efforts, have only recently begun testing TYRA-300 andTYRA-200 for oncology in clinical trials and the approach the company are taking to discover and develop drugs based on its product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, enrollment, and completion of preclinical studies and clinical trials; interim results of a clinical trial do not predict final results and clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become availabl e; results from preclinical studies or early clinical trials not necessarily being predictive of future results; dependence on third parties in connection with manufacturing, research and preclinical testing; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of TYRA-300 in pediatricachondroplasia; unexpected adverse side effects or inadequate efficacy of product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for programs and prospects to be negatively impacted by developments relating to competitors, including the results of studies or regulatory determinations relating to competitors; regulatory developments relating to competitors; regulatory developments related to the company; regulatory developments related to company's development and development.