Tyra Biosciences, Inc.NASDAQ: TYRA

Tyra Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights

· Issued by Tyra Biosciences, Inc. via PR Newswire

-Initiated patient dosing with TYRA-300 in SURF301 oncology study-

-Expanded pipeline beyond oncology into genetically defined conditions with TYRA-300 for achondroplasia-

-Cleared IND for TYRA-200 Phase 1 study; first patient dosed expected in 2H 2023 -

-Well-capitalized with cash and cash equivalents of $251.2 million as of YE 2022-

CARLSBAD, Calif., March 22, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today reported financial results for the quarter and year ended December 31, 2022, and highlighted recent corporate progress.

"2022 was a momentous year for TYRA – we achieved significant milestones, evolved into a clinical-stage company, and leveraged our expertise in FGFR biology to expand our therapeutic focus beyond oncology to include genetically defined conditions," said Todd Harris, CEO of TYRA. "We believe TYRA-300 has the potential to become a best-in-class agent and we look forward to advancing it in both oncology and achondroplasia. Further, we have made steady progress utilizing our SNÅP discovery engine and expect to nominate additional clinical candidates."

Alan Fuhrman, CFO of TYRA, added, "TYRA is in a very strong financial position to begin 2023, with $251.2 million in cash and cash equivalents at year-end 2022, representing more than two years of expected cash runway to support our current development plans across our precision medicine platform."

Fourth Quarter 2022 and Recent Corporate Highlights

TYRA-300

  • Initiated SURF301 Phase 1/2 Study for Oncology. In November 2022, TYRA announced that patient dosing had commenced in its Phase 1/2 SURF301 clinical study of TYRA-300. SURF301 (NCT05544552) was designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300.
  • Expanded Development into Achondroplasia. In March 2023, TYRA announced the expansion of development of TYRA-300 into achondroplasia (ACH) based on positive preclinical results in a study performed in collaboration with the Imagine Institute in Paris, France. TYRA-300, an investigational agent, is a once-daily oral FGFR3 selective inhibitor whose design may have a meaningful impact on achondroplasia and other skeletal dysplasias.
    • In the study, TYRA-300 was evaluated in FGFR3 wild-type and mutant preclinical models to measure increases in growth and bone length, compared to vehicle-treated mice. In an FGFR3 Y367C/+ model, TYRA-300 was administered daily at a 1.2 mg/kg dose for 15 days. TYRA-300 increased body length in mice by 17.6% compared to the vehicle (p