Tyra Biosciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
TYRA$21.15+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0000950170-25-108899
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001193125-25-266967
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 128 previous paragraphs and 128 current paragraphs.
102 unchanged; 23 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
SURF303: We recently expanded our development of dabogratinib into low-grade upper tract urothelial carcinoma (LG-UTUC). This study is a multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered LG-UTUC. An investigational new drug application was cleared by the U.S. Food and Drug Administration in October 2025 to enable a Phase 2 study of dabogratinib in LG-UTUC. We expect to initiate this study in 2026.
Current report
Offset by a decrease of $0.7 million in compensation and other personnel expenses, primarily driven by a one-time stock-based-compensation charge recorded in 2024 in connection with the modification and acceleration of stock options held by a former executive.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Removed paragraphs (3)
Previous report
Offset by a decrease in facilities and other operating costs of $0.2 million.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
$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.
Reworded paragraphs (23)
Previous wording
Our FGFR3 Programs - Dabogratinib for Bladder Cancer and Skeletal Conditions
Current wording
Our FGFR3 Programs - Dabogratinib for Skeletal Conditions and Bladder Cancer
Previous wording
Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: bladder cancer and skeletal conditions. In bladder cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth.
Current wording
Mutations in the protein receptor FGFR3 are a key driver in two indications with large market opportunities: skeletal conditions and bladder cancer. In skeletal conditions, increased activity of FGFR3 expressed in growth plate chondrocytes (cartilage cells) results in excessive limitation of long bone growth. In bladder cancer, uncontrolled activation of FGFR3 on the cell surface stimulates cellular proliferation.
Previous 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.
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 skeletal conditions and bladder cancer.
Previous 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).
Current wording
The current planned clinical development for dabogratinib includes Phase 2 clinical studies for the treatment of pediatric achondroplasia (BEACH301), treatment of low-grade intermediate risk non-muscle invasive bladder cancer (SURF302), our recent expansion into the treatment of low-grade upper tract urothelial carcinoma (SURF303), and potentially for the treatment of metastatic urothelial carcinoma (SURF301).
Previous 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.
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 planned for at least 3 participants per dose level in children ages 5 to 10. We dosed the first child in this study in August 2025. We expect to report interim results from the safety sentinel cohort in the second half of 2026.
Previous 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.
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.
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 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.
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.
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 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.
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 nine months ended September 30, 2025 and 2024 were $86.1 million and $60.9 million, respectively. As of September 30, 2025, we had an accumulated deficit of $337.4 million. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $274.9 million.
Previous 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:
Current wording
Research and development expenses were $25.5 million and $22.7 million for the three months ended September 30, 2025 and 2024, respectively. The overall increase of $2.8 million was related to a:
Previous wording
$4.1 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431 and ongoing CMC activities;
Current wording
$3.5 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431; and
Previous 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.
Current wording
General and administrative expenses were $7.5 million and $5.9 million for the three months ended September 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 $1.2 million, driven by headcount growth.
Previous 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.
Current wording
Other income was $3.1 million and $4.6 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of $1.5 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Previous wording
Research and development expenses were $49.3 million and $35.2 million for the six months ended June 30, 2025 and 2024, respectively. The overall increase of $14.1 million was primarily related to a:
Current wording
Research and development expenses were $74.7 million and $57.9 million for the nine months ended September 30, 2025 and 2024, respectively. The overall increase of $16.8 million was related to a:
Previous wording
$9.6 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431 and ongoing CMC activities; and
Current wording
$13.0 million increase in costs primarily driven by clinical start-up and enrollment activities for BEACH301, SURF302 and SURF431 and ongoing CMC activities; and
Previous wording
$2.4 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.0 million, driven by headcount growth; and
Current wording
$3.8 million increase in compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $1.0 million, driven by headcount growth, offset by a one-time stock-based-compensation charge recorded in 2024 in connection with the modification and acceleration of stock options held by a former executive.
Previous wording
General and administrative expenses were $14.0 million and $10.7 million for the six months ended June 30, 2025 and 2024, respectively. The increase of $3.3 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $2.0 million, driven by headcount growth.
Current wording
General and administrative expenses were $21.5 million and $16.5 million for the nine months ended September 30, 2025 and 2024, respectively. The increase of $5.0 million was primarily related to higher compensation and other personnel expenses, including an increase in non-cash stock-based compensation costs of $3.3 million, driven by headcount growth.
Previous wording
Other income was $7.1 million and $9.0 million for the six months ended June 30, 2025 and 2024, respectively. The decrease of $1.9 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Current wording
Other income was $10.1 million and $13.5 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of $3.4 million was due to lower interest rates and reduced balances in cash, cash equivalents and marketable securities.
Previous 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.
Current wording
The increase of $21.3 million in net cash used in operating activities for the nine months ended September 30, 2025, compared to the same period in 2024, was primarily due to an increase of $25.2 million in net loss and a decrease in net changes in operating assets and liabilities of $3.1 million, offset by an increase of $4.3 million in non-cash stock-based compensation expense and a decrease of $2.7 million in non-cash net accretion on marketable securities.
Previous 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.
Current wording
The increase of $143.4 million in net cash provided by investing activities for the nine months ended September 30, 2025, compared to the same period in 2024, was driven by a reduction in purchases of marketable securities of $133.4 million, a $9.4 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 $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.
Current wording
The decrease of $198.0 million in net cash provided by financing activities for the nine months ended September 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 nine months ended September 30, 2024. This decrease was partially offset by an increase of $1.6 million in proceeds from issuances of common stock under benefit plans.
Previous 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.
Current wording
Other than disclosed below, there were no material changes outside the ordinary course of our business during the nine months ended September 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 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.
Current wording
As of September 30, 2025, total future aggregate operating lease commitments were $8.0 million, with approximately $0.2 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 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.
Current wording
There have been no material changes to our critical accounting policies and estimates during the nine months ended September 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.