Tyra Biosciences, Inc.

Previous wording

Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP approach to develop TYRA-300, TYRA-200 and TYRA-430: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.

Current wording

Our in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help us design and predict which product candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. We have initially leveraged our SNÅP approach to develop dabogratinib (formerly TYRA-300), TYRA-430 and TYRA-200: three clinical-stage, novel small molecules designed to overcome the toxicity and resistance liabilities of first generation pan-FGFR inhibitors.

Previous wording

Our FGFR3 Programs - TYRA-300 for Bladder Cancer and Skeletal Conditions

Current wording

Our FGFR3 Programs - Dabogratinib for Bladder Cancer and Skeletal Conditions

Previous wording

Our lead program, TYRA-300, was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4 to minimize off-target side effects, providing potential clinical advantages over less selective first-generation compounds and potentially addressing key unmet needs across both bladder cancer and skeletal conditions.

Current wording

Our lead program, dabogratinib, was designed to be more selective for FGFR3 over FGFR1, FGFR2, and FGFR4 to minimize off-target side effects, providing potential clinical advantages over less selective first-generation compounds and potentially addressing key unmet needs across both bladder cancer and skeletal conditions.

Previous wording

TYRA-300 is expected to be evaluated in three Phase 2 studies: BEACH301, for the treatment of pediatric achondroplasia (ACH); SURF302, for the treatment of non-muscle invasive bladder cancer (NMIBC); and SURF301, for the treatment of metastatic urothelial carcinoma (mUC).

Current wording

The current planned clinical development for dabogratinib includes Phase 2 clinical studies for the treatment of non-muscle invasive bladder cancer (SURF302) and the treatment of pediatric achondroplasia (BEACH301) and potentially for the treatment of metastatic urothelial carcinoma (SURF301).

Previous wording

BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating TYRA-300 at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with ACH with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the second quarter of 2025.

Current wording

BEACH301: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating dabogratinib at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with achondroplasia (ACH) with open growth plates. Prior to initiation of the first two cohorts, the study has commenced enrolling a safety sentinel cohort of up to 3 participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the third quarter of 2025.

Previous wording

SURF302 for NMIBC: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of TYRA-300 at lower doses (50 and 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.

Current wording

SURF302: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, intermediate risk (IR) non-muscle invasive bladder cancer (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 dabogratinib at 50 mg once daily (QD) (Cohort 1) or treatment with dabogratinib 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, progression free survival, safety and tolerability. We dosed the first patient in this study in June 2025. We expect to report initial three-month CR data in the first half of 2026.

Previous wording

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.

Current wording

SURF301: This ongoing study is an international, multicenter, 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 dabogratinib, as well as to evaluate the preliminary antitumor activity of dabogratinib. In late October 2024, we reported interim data that in patients with FGFR3+ metastatic urothelial carcinoma (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 dabogratinib was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study in preparation for potential future Phase 2 studies.

Previous wording

TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. 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 (PK) of TYRA-200, determine the optimal dose for 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 ICC resistant to previous FGFR inhibitors.

Current wording

TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. TYRA-200 is currently being evaluated in a multicenter, 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 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 ICC resistant to previous FGFR inhibitors.

Previous wording

Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, the issuance of Simple Agreements for Future Equity and the issuance of common stock and pre-funded common stock warrants through a private placement. Our net losses for the three months ended March 31, 2025 and 2024 were $28.1 million and $18.2 million, respectively. As of March 31, 2025, we had an accumulated deficit of $279.5 million. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $318.9 million.

Current wording

Since the commencement of our operations in 2018, we have devoted substantially all of our resources to organizing and staffing the company, business planning, raising capital, developing our proprietary SNÅP platform, undertaking research and development activities for our development programs, establishing our intellectual property portfolio, and providing general and administrative support for our operations. We have not generated any revenue to date and have funded our operations primarily from our initial public offering (IPO), private placements of our convertible preferred stock, the issuance of Simple Agreements for Future Equity and the issuance of common stock and pre-funded common stock warrants through a private placement. Our net losses for the six months ended June 30, 2025 and 2024 were $56.2 million and $36.9 million, respectively. As of June 30, 2025, we had an accumulated deficit of $307.6 million. As of June 30, 2025, we had cash, cash equivalents and marketable securities of $296.3 million.

Previous wording

the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and o

Current wording

the cost of manufacturing compounds for use in our preclinical studies, including under agreements with third parties, such as consultants and third-party manufacturers; and

Previous wording

We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external expenses on a development program and other program-specific basis. However, we do not track internal costs on a program-specific basis because these costs primarily relate to compensation, early research and consumable costs, which are deployed across multiple programs under development.

Current wording

We expense research and development expenses in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external expenses on a development program and other program-specific basis. However, we do not track internal costs, such as personnel-related expenses, stock-based compensation expense, facility-related costs, and supplies, and certain external consultant costs on a program-specific basis because these costs are primarily deployed across multiple programs under development.

Previous wording

adverse effects on the financial markets, the global economy, the supply chain and our expenses due to pandemic or epidemic diseases, geopolitical instability, inflation, interest rates and other factors; and

Current wording

adverse effects on the financial markets, the global economy, the supply chain and our expenses due to tariffs and trade policies, pandemic or epidemic diseases, geopolitical instability, inflation, interest rates and other factors; and

Previous wording

Other income consist primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.

Current wording

Other income consists primarily of interest income from cash, cash equivalents and marketable securities and accretion income from marketable securities.

Previous wording

Research and development expenses were $25.0 million and $17.2 million for the three months ended March 31, 2025 and 2024, respectively. The overall increase of $7.8 million was primarily driven by:

Current wording

Research and development expenses were $24.3 million and $18.0 million for the three months ended June 30, 2025 and 2024, respectively. The overall increase of $6.3 million was primarily related to a:

Previous wording

General and administrative expenses were $6.9 million and $5.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase of $1.8 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.1 million, driven by headcount growth.

Current wording

General and administrative expenses were $7.1 million and $5.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase of $1.6 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $0.9 million, driven by headcount growth.

Previous wording

Other income was $3.7 million and $4.1 million for the three months ended March 31, 2025 and 2024, respectively. The decrease of $0.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.

Current wording

Other income was $3.4 million and $4.8 million for the three months ended June 30, 2025 and 2024, respectively. The decrease of $1.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.

Previous wording

$2.1 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.2 million, driven by headcount growth.

Current wording

$4.5 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $2.2 million, driven by headcount growth.

Previous wording

On October 3, 2022, we entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2022 Sales Agent. As of March 31, 2025, we have not sold any shares under the 2022 Sales Agreement. In connection with the 2025 Sales Agreement (as defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement.

Current wording

On October 3, 2022, we entered into an ATM Sales Agreement (the 2022 Sales Agreement) with Virtu Americas LLC (the 2022 Sales Agent), under which we could have, from time to time, sold shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2022 Sales Agent. We did not sell any shares under the 2022 Sales Agreement. In connection with the 2025 Sales Agreement (as defined below), effective May 8, 2025, we terminated the 2022 Sales Agreement.

Previous wording

On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the 2025 Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the 2025 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale or as otherwise agreed with the 2025 Sales Agent. The 2025 Sales Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement.

Current wording

On May 8, 2025, we entered into a Sales Agreement (the 2025 Sales Agreement) with TD Securities (USA) LLC (the Sales Agent), under which we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $150.0 million in “at the market” offerings through the Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale or as otherwise agreed with the Sales Agent. The Sales Agent will receive a commission from us of up to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. As of June 30, 2025, we had not sold any shares under the 2025 Sales Agreement.

Previous wording

The increase of $3.4 million in net cash used in operating activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase of $10.0 million in net loss, offset by increases of $2.3 million in non-cash stock-based compensation expense, $0.4 million in non-cash net accretion on marketable securities, and changes in operating assets and liabilities of $3.9 million.

Current wording

The increase of $16.9 million in net cash used in operating activities for the six months ended June 30, 2025, compared to the same period in 2024, was primarily due to an increase of $19.4 million in net loss and an increase in net changes in operating assets and liabilities of $3.3 million, offset by an increase of $4.3 million in non-cash stock-based compensation expense and a decrease of $1.5 million in non-cash net accretion on marketable securities.

Previous wording

The increase of $14.0 million in net cash provided by investing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to an increase in maturities of marketable securities of $8.9 million, a decrease in purchases of marketable securities of $5.0 million and a decrease in purchases of property and equipment of $0.1 million.

Current wording

The increase of $179.8 million in net cash provided by investing activities for the six months ended June 30, 2025, compared to the same period in 2024, was driven by a reduction in purchases of marketable securities of $162.2 million, a $17.0 million increase in maturities of marketable securities, and a $0.6 million decrease in capital expenditures for property and equipment.

Previous wording

The decrease of $198.1 million in net cash provided by financing activities for the three months ended March 31, 2025, compared to the same period in 2024, was primarily due to the $199.8 million in net proceeds from the 2024 Private Placement received during the three months ended March 31, 2024. This decrease was partially offset by an increase of $1.7 million in proceeds from issuances of common stock under benefit plans.

Current wording

The decrease of $197.9 million in net cash provided by financing activities for the six months ended June 30, 2025, compared to the same period in 2024, was primarily due to the $199.6 million in net proceeds from the 2024 Private Placement received during the six months ended June 30, 2024. This decrease was partially offset by an increase of $1.7 million in proceeds from issuances of common stock under benefit plans.

Previous wording

Our primary uses of cash to date have been to fund our research and development activities, including with respect to TYRA-300, TYRA-430 and TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Current wording

Our primary uses of cash to date have been to fund our research and development activities, including with respect to dabogratinib, TYRA-430, TYRA-200 and other research programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Previous wording

delays or issues with any of the above, including that the risk of each may be exacerbated by any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.

Current wording

delays or issues with any of the above, including that the risk of each may be exacerbated by tariffs or trade policies, any future pandemics or epidemic diseases, potential geopolitical instability and war, inflation or rising interest rates.

Previous wording

Other than disclosed below, there were no material changes outside the ordinary course of our business during the three months ended March 31, 2025 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.

Current wording

Other than disclosed below, there were no material changes outside the ordinary course of our business during the six months ended June 30, 2025 to the information regarding our contractual obligations that was disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.

Previous wording

As of March 31, 2025, total future aggregate operating lease commitments were $8.5 million, with approximately $0.7 million due during 2025, and the remaining due in periods from 2026 through 2033.

Current wording

As of June 30, 2025, total future aggregate operating lease commitments were $8.3 million, with approximately $0.4 million due during 2025, and the remaining due in periods from 2026 through 2033.

Previous wording

There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2025, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.

Current wording

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2025, as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in the 2024 Annual Report.