Tyra Biosciences Q3 2024 Financial Results Highlights

Tyra Biosciences, Inc., a clinical-stage biotechnology firm, announced its financial outcomes for Q3 2024, alongside notable corporate developments. The company, specializing in next-generation precision medicines targeting FGFR biology, reported a net loss of $24 million for the third quarter, up from $21.2 million in the same period the previous year. Research and development expenses were $22.7 million, reflecting an increase due to ongoing and planned clinical trials and related personnel costs. General and administrative expenses also rose to $5.9 million, driven by higher personnel-related costs, including stock-based compensation. As of September 30, 2024, Tyra had $360.1 million in cash, expected to support its plans through at least 2026.

Tyra's lead program, TYRA-300, a selective FGFR3 inhibitor, showed promising interim clinical results in the Phase 1/2 SURF301 study for metastatic urothelial cancer (mUC). The study revealed significant anti-tumor activity at daily doses of 90 mg or more, with a 54.5% partial response rate in a heavily pretreated patient group, and demonstrated a favorable safety profile with minimal FGFR1 and FGFR2-related toxicities. These interim results are encouraging, prompting the company to prioritize once-daily dosing in further studies. TYRA-300 is being prepared for Phase 2 studies in non-muscle invasive bladder cancer (NMIBC) and further development in mUC, with an IND submission for NMIBC expected by the end of 2024.

Additionally, TYRA-300 received IND clearance from the FDA for a Phase 2 study in pediatric achondroplasia (BEACH301). This study will be a multicenter, open-label, dose-escalation/dose-expansion trial involving children aged 3 to 10 with achondroplasia. The study aims to evaluate the safety and efficacy of various doses of TYRA-300. The company expects to begin dosing in the first quarter of 2025.

Another highlight for Tyra is the publication of a peer-reviewed manuscript in the Journal of Medicinal Chemistry, detailing the discovery of TYRA-300. The paper provides preclinical evidence supporting TYRA-300's potential as a best-in-class FGFR3 inhibitor, emphasizing its selectivity and effectiveness in avoiding FGFR1 and FGFR2-related toxicities and resistance mutations.

Tyra is also advancing its other programs, including TYRA-200, an FGFR1/2/3 inhibitor currently in a Phase 1 SURF201 study for advanced solid tumors with FGFR2 alterations. This study is designed to determine the safety, tolerability, and optimal dosing of TYRA-200 and is actively enrolling participants.

Moreover, the company is preparing for a Phase 1 clinical trial of TYRA-430, an FGFR4/3-biased inhibitor for cancers driven by FGF19+/FGFR4. This trial will focus on advanced hepatocellular carcinoma (HCC) and other solid tumors with related genetic aberrations.

In a bid to strengthen its leadership, Tyra appointed Dr. Doug Warner as Chief Medical Officer (CMO) in September 2024. Dr. Warner brings extensive clinical development experience from his previous roles at Amgen and eFFECTOR Therapeutics, where he led various oncology and bone disease programs.

Tyra continues to leverage its in-house precision medicine platform, SNÅP, to drive advancements in targeted oncology and genetically defined conditions. This platform supports the rapid and precise design of drugs tailored to address specific genetic alterations and resistance mechanisms. The company's current developments underscore its commitment to delivering innovative therapies for cancer and skeletal dysplasias.