Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 15

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 15
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 factor. Uncontrolled activation of FGFR3 has been implicated in the oncogenesis of multiple solid tumor types, including bladder cancer. 

TYRA-300 was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4, to minimize side effects resulting from inhibition of these related proteins and achieve greater potency against the FGFR3 driver mutation.  TYRA-300 is currently being studied in the global Phase 1/2 SURF301 trial in patients with mUC; TYRA-300 will also be evaluated in the global Phase 2 SURF302 trial in patients with IR NMIBC, expected to initiate in the second quarter of 2025.

Disease background

Urothelial cancer (UC) is one of the most common malignancies of the genitourinary system, with over 730,000 people living with bladder cancer in the United States in 2021. Bladder cancer is classified into three broad categories: NMIBC where the cancer is restricted to surface lining of the bladder, MIBC, which is a cancer that has grown deeper into the bladder wall, and mUC in which cancer has spread beyond the bladder.  NMIBC comprises the largest population of bladder cancer patients, representing 70-75% of cases diagnosed annually in the United States. NMIBC can be categorized as low, intermediate and high risk for recurrence or progression, with a significant proportion categorized as intermediate and high risk. Whereas between 2014 to 2020, the five-year survival for early stage NMIBC was 97.2%, it was 8.8% for mUC.

The incidence of activating FGFR3 mutations in bladder cancer has been estimated to be between 60-80% of IR NMIBC and between 10-20% of mUC, making FGFR3 an attractive target for development. 

We estimate that in 2023, across NIMBC, MIBC and mUC, approximately 163,000 patients were seeking therapy for first-time treatment or to address a recurrence. Applying FGFR3 alteration incidence to these estimates, 

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we believe that approximately 66,000-72,000 FGFR3+ patients are addressable across intermediate and high risk NMIBC, MIBC and mUC in the United States alone. The majority of FGFR3+ patients are estimated to be IR, ranging from 22-41,000, and approximately 3,400 patients are estimated to be addressable in the post-frontline