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Tyra Biosciences Reports Third Quarter 2024 Financial Results and Highlights

Core Insights - Tyra Biosciences reported positive interim clinical proof-of-concept results for TYRA-300 in metastatic urothelial cancer (mUC) and received IND clearance for a Phase 2 study in pediatric achondroplasia [1][5] - The company appointed Doug Warner, MD, as Chief Medical Officer, enhancing its leadership team [10] - As of Q3 2024, Tyra had cash, cash equivalents, and marketable securities totaling $360.1 million, providing a strong financial position for ongoing and future clinical trials [12][19] Clinical Development Highlights - Interim data from the SURF301 Phase 1/2 study showed that at a dose of ≥ 90 mg once daily, 54.5% of patients with FGFR3+ mUC achieved a confirmed partial response, with a 100% disease control rate [3] - The company plans to expand the clinical development of TYRA-300 into non-muscle invasive bladder cancer (NMIBC) and aims to submit an IND application for this indication by the end of 2024 [4] - The FDA cleared the IND application for a Phase 2 clinical trial of TYRA-300 in children with achondroplasia, expected to begin in Q1 2025 [5] Financial Performance - For Q3 2024, Tyra reported a net loss of $24.0 million, compared to a net loss of $21.2 million in Q3 2023 [11][20] - Research and development expenses increased to $22.7 million in Q3 2024 from $19.3 million in the same period of 2023, driven by ongoing clinical trials [11] - General and administrative expenses rose to $5.9 million in Q3 2024 from $4.7 million in Q3 2023, primarily due to increased personnel-related costs [11] Pipeline and Research Initiatives - TYRA-300 is being evaluated in the SURF301 study for both oncology and skeletal dysplasias, with a focus on achieving best-in-class status [13][15] - The company is also advancing TYRA-200, an FGFR1/2/3 inhibitor, in a Phase 1 study for advanced solid tumors [14] - TYRA-430, an FGFR4/3-biased inhibitor, has received IND clearance for a Phase 1 study targeting advanced hepatocellular carcinoma and other solid tumors [9]