Tyra Biosciences Announces Q2 2024 Financial Results and Highlights

Tyra Biosciences, Inc., a clinical-stage biotechnology company, is making significant strides in developing precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology. The company, based in Carlsbad, California, recently released its financial outcomes for the quarter ending June 30, 2024, alongside updates on corporate progress.

CEO Todd Harris expressed enthusiasm over the company's progress, particularly highlighting the recent clearance of the IND for TYRA-430, a biased inhibitor targeting FGFR4/3. This development positions Tyra with three promising precision molecules in clinical phases for oncology. Tyra has also advanced significantly in skeletal dysplasias, with preclinical proof-of-concept data for hypochondroplasia, in addition to preparations for an upcoming IND submission for achondroplasia in the latter half of 2024, which will support a planned Phase 2 study.

The company is undergoing a transition in its Chief Medical Officer (CMO) position, with Hiroomi Tada, M.D., Ph.D., set to step down by the end of the year. Dr. Tada's contributions over the past four years have been pivotal, particularly in translating the SNÅP drug discovery platform into a robust pipeline. Tyra's Board, with new members Susan Moran, M.D., M.S.C.E., and S. Michael Rothenberg, M.D., Ph.D., will guide the search for an external CMO candidate. Dr. Tada will continue in an advisory role during the transition.

Dr. Moran expressed her support for the Tyra team as they advance early-stage clinical programs toward later-stage development, aiming to harness the broad potential of their precision molecules in oncology and rare diseases.

Key developments in Tyra's programs include:

TYRA-300:
The SURF301 Phase 1/2 study for oncology is progressing, focusing on untreated and resistant FGFR3+ advanced solid tumors. This multi-center, open-label study aims to determine the optimal and recommended Phase 2 dose of TYRA-300 and evaluate its preliminary antitumor activity. Initial results from the Phase 1 portion are expected in the second half of 2024, which will inform dosing schedules for potential future studies in metastatic urothelial carcinoma and non-muscle invasive bladder cancer.

For achondroplasia, Tyra plans to submit an IND in the second half of 2024 for a Phase 2 clinical trial to test multiple doses of TYRA-300 in children. The study's primary goal is to assess safety and tolerability, with secondary objectives focusing on growth metrics and pharmacokinetics. Exploratory assessments will include clinical outcomes, quality of life measures, and biomarker evaluations.

In July 2024, Tyra expanded the development of TYRA-300 into hypochondroplasia based on positive preclinical results. TYRA-300 demonstrated increases in long bone length and binding against the altered protein in a preclinical HCH model.

TYRA-200:
The Phase 1 SURF201 study, targeting previously treated and resistant FGFR2+ cholangiocarcinoma and other advanced solid tumors, is advancing. This multi-center, open-label study aims to evaluate the safety, tolerability, and pharmacokinetics of TYRA-200, determining the optimal and maximum tolerated dose, as well as its preliminary antitumor activity. The study is currently enrolling participants.

TYRA-430:
The FDA has cleared the IND for TYRA-430, allowing for a Phase 1 clinical study targeting FGF19+/FGFR4-driven cancers. This multi-center, open-label, first-in-human study will explore TYRA-430's potential in advanced hepatocellular carcinoma and other solid tumors with activating FGF/FGFR pathway aberrations.

Corporate Developments:
Tyra has bolstered its Board of Directors with the appointments of Susan Moran, M.D., M.S.C.E., and S. Michael Rothenberg, M.D., Ph.D., as independent directors, following the resignation of Isan Chen, M.D.

Financial Snapshot:
For the second quarter of 2024, Tyra reported a net loss of $18.7 million, compared to $13.3 million in the same period of 2023. Research and development expenses increased to $18.0 million from $12.2 million, while general and administrative expenses rose to $5.5 million from $3.9 million. As of June 30, 2024, Tyra had $373.8 million in cash, cash equivalents, and marketable securities, which are expected to support the company’s plans through at least 2026.

Tyra’s lead program, TYRA-300, leverages the in-house SNÅP platform and is in development for cancer and skeletal dysplasias, including achondroplasia and hypochondroplasia. TYRA-200 is another investigational FGFR inhibitor, while TYRA-430 targets FGFR4/3-biased pathways in specific cancers.

With continued advancements and a strong financial position, Tyra Biosciences remains focused on developing next-generation precision medicines to address significant unmet needs in oncology and rare diseases.