Company: TYRA
Filing Date: 2025-05-08
Form Type: S-3
Source: 0001193125-25-116008
Chunk: 46

Company: Tyra Biosciences, Inc.
Filing Date: 2025-05-08
Form: S-3
Chunk 46
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60mg QD) in participants with FGFR3-altered low-grade, intermediate risk (IR) NMIBC. We expect to dose the first patient in this study in the second quarter of 2025.

SURF301 for mUC: This ongoing study is an international, multi-center, open label Phase 1/2 clinical trial that 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. In late
October 2024, we reported interim data that in patients with FGFR3+ mUC who received doses ≥ 90 mg once daily (QD), 6 out of 11 (54.5%) patients achieved a confirmed partial response. Preliminary data, as of the August 15, 2024 data
cutoff, suggested TYRA-300 was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study.

Our FGFR2 Program - TYRA-200for Intrahepatic Cholangiocarcinoma

TYRA-200 is currently being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 that is designed to
evaluate the safety, tolerability, and pharmacokinetics of TYRA-200, determine the optimal dose for

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further development and the MTD and RP2D, and evaluate preliminary antitumor activity, with a focus on achieving
proof-of-concept in a cohort of FGFR2-driven intrahepatic cholangiocarcinoma resistant to previous FGFR inhibitors.

Our FGF19+ Program - TYRA-430for Hepatocellular Carcinoma

TYRA-430 is currently being evaluated in a global Phase 1 multicenter, open-label, study, SURF431, that is designed to
evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TYRA-430 and determine the maximum tolerated dose and recommended Phase 2 dose, as well as evaluate the preliminary antitumor activity of TYRA-430. TYRA-430 is initially
being studied in advanced hepatocellular carcinoma and other solid tumors with activating FGF/FGFR pathway aberrations. In April 2025, we commenced patient dosing in this study.

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