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Tyra Biosciences (Nasdaq: TYRA) boosts R&D and outlines 2026 trial catalysts

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Form Type
8-K

Rhea-AI Filing Summary

Tyra Biosciences reported fourth-quarter and full-year 2025 results and outlined progress on its FGFR-focused pipeline. The company ended 2025 with $256.0 million in cash, cash equivalents and marketable securities and expects this to fund operations through at least 2027.

Research and development expenses rose to $28.2 million in Q4 and $102.9 million for 2025, driven mainly by oral dabogratinib clinical programs, including BEACH301 and SURF302 plus start-up for SURF303. General and administrative costs increased to $8.3 million in Q4 and $29.8 million for the year due to higher headcount-related spending.

Net loss was $33.8 million in Q4 and $119.9 million for 2025 as the company continues to invest in development. Tyra emphasized its “dabogratinib 3x3” strategy, concentrating on three Phase 2 studies in LG-UTUC, IR NMIBC and achondroplasia, with key data readouts expected in 2026.

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Insights

Tyra increases R&D spending, extends cash runway, and concentrates its pipeline around dabogratinib.

Tyra Biosciences is leaning into its FGFR3 strategy, with the “dabogratinib 3x3” plan anchoring three Phase 2 programs in LG-UTUC, IR NMIBC and achondroplasia. Exiting metastatic bladder cancer reallocates resources toward indications management views as stronger risk-adjusted opportunities.

R&D expenses increased to $102.9 million in 2025, reflecting multiple active trials and new study start-up costs. This heavier spend, together with rising G&A, drove a larger full-year net loss of $119.9 million as the company remains in a pre-revenue stage.

Liquidity appears robust, with $256.0 million in cash, cash equivalents and marketable securities as of December 31, 2025, supporting guidance for a runway through at least 2027. Key upcoming catalysts include initial three-month complete response data from SURF302 by the end of 1H 2026 and interim BEACH301 safety cohort results in 2H 2026.

0001863127false00018631272026-03-022026-03-02

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 02, 2026

 

 

Tyra Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40800

83-1476348

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

2656 State Street

 

Carlsbad, California

 

92008

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (619) 728-4760

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

TYRA

 

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 


Item 2.02 Results of Operations and Financial Condition.

On March 2, 2026, Tyra Biosciences, Inc. issued a press release announcing its financial results for the year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release Issued on March 2, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)


 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

TYRA BIOSCIENCES, INC.

 

 

 

 

Date:

March 2, 2026

By:

/s/ Alan Fuhrman

 

 

 

Alan Fuhrman
Chief Financial Officer

 


 

Exhibit 99.1

 

img74818929_0.jpg

 

Tyra Biosciences Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights

 

- Launched dabogratinib 3x3 strategy to pursue 3 late-stage clinical studies in LG-UTUC, IR NMIBC and ACH, 3 potential blockbuster indications -

- Interim Ph2 data readouts on track: SURF302 expected by end of 1H‘26 and BEACH301 in 2H ‘26 -

- Cash, cash equivalents and marketable securities of $256.0 million at Q4 2025; runway through at least 2027 -

 

CARLSBAD, Calif., March 2, 2026 – 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, 2025 and highlighted recent corporate progress.

 

“At TYRA, we are following the science,” said Todd Harris, Ph.D., CEO of TYRA. “The strength of the genetic and biological validation behind FGFR3 gives us conviction to concentrate our resources and strategy around indications where this target plays a central role. Through our “dabogratinib 3x3” strategy, we are deliberately deploying capital toward high unmet needs – low grade upper tract urothelial carcinoma (LG-UTUC), intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH) – where selective FGFR3 inhibition has the potential to make a meaningful impact for patients, while creating significant potential long-term value.”

 

“Oral dabogratinib reflects years of deliberate molecular optimization to achieve highly selective FGFR3 inhibition with a profile designed to balance potency, safety and convenience,” said Doug Warner, MD, Chief Medical Officer of TYRA. “The clinical data generated to date – with more than 100 participants dosed – reinforces our confidence in its potential efficacy and tolerability and supports once-daily (QD) dosing across our targeted indications. We believe this target profile positions oral dabogratinib to deliver meaningful benefit for patients, and we look forward to expanding our clinical database this year.”

 

Fourth Quarter and Recent Corporate Highlights

 

Dabogratinib 3x3 Strategy

 

TYRA is focused on executing our “dabogratinib 3x3” strategy: developing the first orally available, FGFR3 selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

 

“In Q4 2025, we prioritized our portfolio to maximize potential return on invested capital,” commented Alan Fuhrman, Chief Financial Officer of TYRA. “Exiting metastatic bladder cancer allows us to focus financial and operational resources on the three core indications within our “dabogratinib 3x3” strategy that we believe offer the most compelling risk-adjusted opportunities.”

 

Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with LG-UTUC, a rare cancer where approximately 85% of tumors are driven by FGFR3. Study startup is ongoing, and the first patient is anticipated to be dosed in 2026.

 

Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade IR NMIBC. TYRA opened additional US and international trial sites in Q4 2025, and the Company expects to report initial three-month complete response data by the end of 1H 2026.

 


 

Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia. The study is enrolling a safety sentinel cohort of at least 3 participants per dose level in children ages 5 to 10, and TYRA has successfully cleared two of the four dose levels with no safety events to report. The Company remains on track and is expected to report interim results from the safety sentinel cohort – which will include 6-month average height velocity data and safety results – in 2H 2026.
Phase 1/2 mUC Study – SURF301. At ASCO GU 2026, TYRA presented a poster detailing the response, safety, pharmacokinetics/pharmacodynamics and circulating tumor DNA data from the SURF301 mUC study. These translational data were leveraged to select doses that have the potential to achieve the target product profiles for efficacy and safety in the SURF303, SURF302 and BEACH301 studies. TYRA is planning to publish final Phase 1 results from SURF301 in a future scientific publication. The SURF301 study is no longer recruiting patients.

 

Corporate

Strengthened Leadership Team. In Q4 2025, TYRA announced the appointments of Bhavesh Ashar as Chief Operating Officer, and Heather Faulds as Chief Regulatory Officer. Together, Mr. Ashar and Ms. Faulds will be essential in advancing oral dabogratinib through potentially global Phase 2 studies in skeletal dysplasia and urothelial cancers, and preparing for future potential pivotal studies.

 

SNÅP Platform and Pipeline

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

 

Fourth Quarter and Full-Year 2025 Financial Results

Cash, Cash Equivalents and Short-Term Investments. As of December 31, 2025, TYRA had cash, cash equivalents and marketable securities of $256.0 million. TYRA’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. R&D expenses for the three months ended December 31, 2025 were $28.2 million compared to $22.2 million for the same period in 2024, and $102.9 million for the full year 2025 compared to $80.1 million for the same period in 2024. The increases were primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, as well as development expenditures for SURF431.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended December 31, 2025 were $8.3 million compared to $7.6 million for the same period in 2024, and $29.8 million for the full year 2025 compared to $24.1 million for the same period in 2024. The increases were primarily driven by higher compensation and other personnel costs driven by headcount growth.
Net Loss. Fourth quarter net loss was $33.8 million compared to $25.6 million for the same period in 2024, and $119.9 million for the full year 2025 compared to $86.5 million for the same period in 2024.

 

Upcoming Clinical Milestones:

SURF303: dose first patient with LG-UTUC – 2026
SURF302: initial three-month complete response data – end of 1H 2026
BEACH301: initial results from safety sentinel cohort – 2H 2026

 

About Dabogratinib (formerly TYRA-300)

 

Dabogratinib is TYRA's lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3 selective inhibitor to enter clinical development and it has been studied in more than 100 patients to

 


 

date across multiple clinical studies. To date, oral dabogratinib has demonstrated very positive target engagement with FGFR3, favorable anti-tumor effects and safety results in oncology, and an optimized QD dosing regimen.

 

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

 

Please visit the Patients page of our website for more information on our clinical trials.

 

About Tyra Biosciences

 

Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. TYRA's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help TYRA design and predict which candidates may demonstrate the highest potency, selectivity and tolerability in the clinic. TYRA's expertise in FGFR biology has created a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions. TYRA's lead precision medicine stemming from SNÅP, oral dabogratinib, is a potential first-in-class selective FGFR3 inhibitor in development for LG-UTUC, IR NMIBC and ACH. TYRA is also developing TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, in the SURF431 study for advanced hepatocellular carcinoma, and TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma. TYRA is based in Carlsbad, CA.

 

For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn.

 

Forward-Looking Statements

 

TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the expected advancement of our pipeline and our growth; the potential to execute on our “dabogratinib 3x3 strategy”; the potential to develop next-generation precision medicines and their potential to be first-in-class; the potential safety and therapeutic benefits of, and market opportunities for, our product candidates, including the potential for them to be blockbusters; the potential to create significant long-term value and maximize return on invested capital and the potential for selected indications to provide the most compelling risk-adjusted opportunities; the expected trial design, timing and phase of development of our product candidates, including timing for data readouts and patient dosing and the potential for trials to be registrational or global; the potential for SNÅP to develop therapies; our commercialization plan for oral dabogratinib; and our expected cash runway. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of oral dabogratinib; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, recruitment, enrollment, data readouts and completion of preclinical studies and clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; our dependence on third parties in connection with manufacturing, research and preclinical testing; we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for oral dabogratinib or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory and

 


 

legislative developments in the United States and foreign countries, including with respect to healthcare and trade policies; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; our ability to establish marketing and sales capabilities to successfully commercialize any approved products; we may use our capital resources sooner than we expect; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

 

Contact:

 

Amy Conrad

aconrad@tyra.bio

 


 

Tyra Biosciences, Inc.

Condensed Balance Sheets

(in thousands)

 

 

December 31,

 

 

December 31,

 

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

77,387

 

 

$

91,966

 

Marketable securities

 

 

178,616

 

 

 

249,475

 

Prepaid expenses and other current assets

 

 

9,447

 

 

 

6,022

 

Total current assets

 

 

265,450

 

 

 

347,463

 

Restricted cash

 

 

1,000

 

 

 

1,000

 

Property and equipment, net

 

 

1,314

 

 

 

1,651

 

Right-of-use assets

 

 

5,573

 

 

 

6,068

 

Other long-term assets

 

 

9,272

 

 

 

7,376

 

Total assets

 

$

282,609

 

 

$

363,558

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,178

 

 

$

590

 

Lease liabilities, current

 

 

472

 

 

 

412

 

Accrued expenses and other current liabilities

 

 

16,444

 

 

 

13,592

 

Total current liabilities

 

 

18,094

 

 

 

14,594

 

Lease liabilities, noncurrent

 

 

5,338

 

 

 

5,810

 

Other long-term liabilities

 

 

 

 

 

3

 

Total liabilities

 

 

23,432

 

 

 

20,407

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock

 

 

 

 

 

 

Common stock

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

630,037

 

 

 

593,687

 

Accumulated other comprehensive income

 

 

393

 

 

 

770

 

Accumulated deficit

 

 

(371,258

)

 

 

(251,311

)

Total stockholders’ equity

 

 

259,177

 

 

 

343,151

 

Total liabilities and stockholders’ equity

 

$

282,609

 

 

$

363,558

 

 

 


 

Tyra Biosciences, Inc.

Condensed Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

 

 

 

Three Months Ended December 31,

 

 

Year Ended December 31,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

28,186

 

 

$

22,180

 

 

$

102,928

 

 

$

80,077

 

General and administrative

 

 

8,330

 

 

 

7,564

 

 

 

29,834

 

 

 

24,100

 

Total operating expenses

 

 

36,516

 

 

 

29,744

 

 

 

132,762

 

 

 

104,177

 

Loss from operations

 

 

(36,516

)

 

 

(29,744

)

 

 

(132,762

)

 

 

(104,177

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

2,682

 

 

 

4,173

 

 

 

12,815

 

 

 

17,696

 

Total other income

 

 

2,682

 

 

 

4,173

 

 

 

12,815

 

 

 

17,696

 

Net loss

 

 

(33,834

)

 

 

(25,571

)

 

 

(119,947

)

 

 

(86,481

)

Unrealized gain (loss) on marketable
   securities available-for-sale, net

 

 

(49

)

 

 

(982

)

 

 

(377

)

 

 

389

 

Comprehensive loss

 

$

(33,883

)

 

$

(26,553

)

 

$

(120,324

)

 

$

(86,092

)

Net loss per share, basic and diluted

 

$

(0.57

)

 

$

(0.43

)

 

$

(2.01

)

 

$

(1.51

)

Weighted-average shares used to compute
   net loss per share, basic and diluted

 

 

59,834,826

 

 

 

59,060,385

 

 

 

59,602,328

 

 

 

57,217,746

 

 

 


FAQ

What were Tyra Biosciences (TYRA) full-year 2025 financial results?

Tyra Biosciences reported a full-year 2025 net loss of $119.9 million, driven by higher research and development and general and administrative expenses. Total operating expenses reached $132.8 million, reflecting investment in multiple clinical programs centered on its lead FGFR3 inhibitor, dabogratinib.

How much cash does Tyra Biosciences (TYRA) have and what is its runway?

As of December 31, 2025, Tyra Biosciences held $256.0 million in cash, cash equivalents and marketable securities. The company expects this balance to fund planned operations and clinical development activities through at least 2027, supporting ongoing and upcoming Phase 2 studies for dabogratinib.

What is Tyra Biosciences’ dabogratinib 3x3 strategy?

The dabogratinib 3x3 strategy focuses on developing oral, FGFR3-selective dabogratinib in three Phase 2 studies to support potential regulatory submissions across three indications: low grade upper tract urothelial carcinoma, intermediate risk non-muscle invasive bladder cancer and achondroplasia, each viewed as significant commercial opportunities.

Which key clinical milestones did Tyra Biosciences (TYRA) highlight for 2026?

Tyra plans to dose the first LG-UTUC patient in SURF303 in 2026, report initial three-month complete response data from SURF302 by the end of 1H 2026, and share initial safety sentinel cohort results from BEACH301, including six-month height velocity data, in 2H 2026.

How did Tyra Biosciences’ R&D and G&A expenses change in 2025?

In 2025, research and development expenses increased to $102.9 million from $80.1 million, mainly due to dabogratinib clinical activities. General and administrative expenses rose to $29.8 million from $24.1 million, primarily reflecting higher compensation and personnel-related costs from headcount growth.

What designations has dabogratinib received from the FDA?

Dabogratinib has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for achondroplasia. These designations can provide regulatory incentives, such as potential market exclusivity and eligibility for a priority review voucher, if the program successfully advances to approval.

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