Tyra Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights

PR Newswire

CARLSBAD, Calif., March 27, 2025

- Three INDs cleared by US FDA for TYRA's proprietary precision small molecules -

- TYRA-300 to be evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia $(ACH)$ and SURF301 for metastatic urothelial cancer (mUC) -

- Cash, cash equivalents, and marketable securities of $341.4 million at YE 2024; runway through at least 2027 -

CARLSBAD, Calif., March 27, 2025 /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 fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress.

"2024 was a momentous year for TYRA and the patient communities we serve, highlighted by the positive interim results from our SURF301 study, which demonstrated a combination of high anti-tumor activity with favorable tolerability results in very sick, heavily pre-treated cancer patients. Importantly, the oncology doses tested in SURF301 are significantly higher than those to be tested in BEACH301, giving us confidence as we advance TYRA-300 in ACH," said Todd Harris, CEO of TYRA. "Our conviction in TYRA-300 has never been stronger and we are working diligently to advance this potential best-in-class agent for multiple high-value indications in oncology and skeletal dysplasia into three Phase 2 studies in NMIBC, ACH and mUC."

Fourth Quarter and Full Year 2024 and Recent Corporate Highlights

TYRA-300

   -- Advanced Clinical Evaluation of TYRA-300 into Three Phase 2 Studies. 
      During 2024, TYRA progressed TYRA-300, an oral, investigational 
      FGFR3-selective inhibitor, for the treatment of IR NMIBC, mUC and ACH, 
      and achieved the following milestones: 
 
          -- Cleared Phase 2 NMIBC IND with US FDA -- SURF302. TYRA expanded 
             the clinical development of TYRA-300 into NMIBC to address the 
             unmet needs in this cancer population for an efficacious, orally 
             available therapy. SURF302 is an open-label Phase 2 clinical study 
             evaluating the efficacy and safety of TYRA-300 in participants 
             with FGFR3-altered low-grade, IR NMIBC. The study will enroll up 
             to 90 participants at multiple sites primarily in the United 
             States. Participants will be randomized initially to treatment 
             with TYRA-300 at 50 mg once-daily $(QD)$ (Cohort 1) or treatment 
             with TYRA-300 at 60 mg QD (Cohort 2). Following a review of 
             efficacy and safety, an additional dosing cohort may be evaluated. 
             The primary endpoint is complete response $(CR)$ rate at three 
             months. Secondary endpoints include time to recurrence, the median 
             duration of response, recurrence free survival (RFS), progression 
             free survival $(PFS)$, safety and tolerability. 
 
          -- Cleared Phase 2 ACH IND with US FDA - BEACH301. The study is a 
             Phase 2, multicenter, open-label, dose-escalation/dose-expansion 
             study evaluating TYRA-300 in children ages 3 to 10 with 
             achondroplasia with open growth plates. The study will enroll 
             children who are treatment-naïve (Cohort 1) and those who 
             have received prior growth-accelerating therapy (Cohort 2) at 
             multiple sites across the globe. Each of these cohorts is expected 
             to enroll up to 10 participants per dose level (0.125, 0.25, 
             0.375, 0.50 mg/kg) for up to 12 months. The study will initially 
             enroll a safety sentinel cohort of up to 3 treatment-naïve 
             participants per dose level in children ages 5 to 10. 
 
          -- Reported Interim Clinical Proof-of-Concept Results in mUC Patients 
             -- SURF301. TYRA-300 demonstrated encouraging preliminary 
             anti-tumor activity in a heavily pre-treated population: at >= 90 
             mg QD, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a 
             confirmed partial response $(PR)$, with 100% disease control rate 
             and sustained duration of activity; positive safety results were 
             reported across all QD doses, with infrequent 
             FGFR2/FGFR1-associated toxicities (data cutoff of August 15, 
             2024). TYRA-300 is being evaluated in Part B of SURF301 
             (NCT05544552) at potentially therapeutic QD doses in preparation 
             for potential future Phase 2 studies. 

TYRA-200

   -- Advanced Phase 1 SURF201 Study. TYRA-200 is an FGFR1/2/3 inhibitor with 
      potency against activating FGFR2 gene alterations and resistance 
      mutations. 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 of TYRA-200 and determine the optimal 
      and maximum tolerated dose and recommended Phase 2 dose, as well as 
      evaluate the preliminary antitumor activity of TYRA-200. The SURF201 
      study is currently enrolling and dosing adults with unresectable locally 
      advanced/metastatic intrahepatic cholangiocarcinoma and other advanced 
      solid tumors with activating FGFR2 gene alterations. 

TYRA-430

   -- Cleared Phase 1 IND with US FDA -- SURF431. TYRA-430 is an oral, 
      investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. 
      The Phase 1 study will be a multicenter, open-label, first-in-human study 
      of TYRA-430 in advanced hepatocellular carcinoma $(HCC)$ and other solid 
      tumors with activating FGF/FGFR pathway aberrations (SURF431). We believe 
      TYRA-430 has the potential to address a significant unmet need in HCC, 
      where there are no approved biomarker-driven, targeted therapies. 

Corporate

   -- Strengthened Leadership Team and Board of Directors. In 2024, TYRA 
      appointed Doug Warner, MD, as Chief Medical Officer, and Erik Goluboff, 
      MD, as SVP, Clinical Development to lead the Company's oncology strategy 
      and clinical development plans. In 2025, TYRA appointed accomplished drug 
      developer Adele Gulfo to its Board of Directors, Sinette Heys as SVP, 
      Clinical Operations to lead the Company's clinical operations team, and 
      Will Charlton, MD, as SVP, Clinical Development to lead the Company's 
      skeletal dysplasia clinical development group. 

SNÅP Platform and Pipeline

   -- TYRA continued to advance its in-house precision medicine discovery 
      engine, SNÅP, to develop therapies in targeted oncology and 
      genetically defined conditions. 

Fourth Quarter and Full-Year 2024 Financial Results

   -- Cash, Cash Equivalents and Short-Term Investments. As of December 31, 
      2024, TYRA had cash, cash equivalents, and marketable securities of 
      $341.4 million, compared to $203.5 million at the end of 2023. The 
      increase was primarily due to the completion of a private placement 
      financing for net proceeds of $199.6 million in the first quarter of 
      2024. The Company's current cash, cash equivalents and marketable 
      securities are expected to allow TYRA to execute on its plans through at 
      least 2027. 
 
   -- Research and Development (R&D) Expenses. Research and development 
      expenses for the three months ended December 31, 2024 were $22.2 million 
      compared to $20.7 million for the same period in 2023, and $80.1 million 
      for the full year 2024 compared to $62.5 million for the same period in 
      2023. The increases were primarily driven by increased expenses incurred 
      in connection with our ongoing and planned clinical trials and 
      personnel-related costs, including stock-based compensation, partially 
      offset by decreased drug manufacturing and preclinical costs. 
 
   -- General and Administrative (G&A) Expenses. General and administrative 
      expenses for the three months ended December 31, 2024 were $7.6 million 
      compared to $5.0 million for the same period in 2023, and $24.1 million 
      for the full year 2024 compared to $17.4 million for the same period in 
      2023. The increases were primarily driven by increased personnel-related 
      costs, including stock-based compensation. 
 
   -- Net Loss. Fourth quarter 2024 net loss was $25.6 million compared to 
      $22.8 million for the same period in 2023, and $86.5 million for the full 
      year 2024 compared to $69.1 million for the same period in 2023. 

Upcoming Anticipated Milestones and Events

   -- BEACH301: dose first child with achondroplasia with TYRA-300 -- Q2 2025 
 
   -- SURF302: dose first NMIBC patient with TYRA-300 -- Q2 2025 
 
   -- SURF431: dose first HCC patient with TYRA-430 -- Q2 2025 

About TYRA-300

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