TYRA 8-K
Tyra Biosciences, Inc. (TYRA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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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:
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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 May 13, 2026, Tyra Biosciences, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. 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. |
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Description |
99.1 |
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104 |
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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.
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TYRA BIOSCIENCES, INC. |
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Date: |
May 13, 2026 |
By: |
/s/ Alan Fuhrman |
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Alan Fuhrman |
Exhibit 99.1
Tyra Biosciences Reports First Quarter 2026 Financial Results and Recent Highlights
- Advanced “dabogratinib 3x3” strategy to pursue 3 late-stage clinical studies in LG-UTUC, IR NMIBC and ACH -
- First LG-UTUC patient dosed with dabogratinib in SURF303; initial results expected in 2027 -
- Initial Ph2 data readout from SURF302 expected in August 2026 (n>20 enrolled to date) -
- Initial Ph2 data readout from safety sentinel cohort in BEACH301 expected in Q4 2026 (4th dose level cleared) -
- Cash, cash equivalents and marketable securities of $383.5 million at Q1 2026; runway into 2H 2028 -
CARLSBAD, Calif., May 13, 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 first quarter ended March 31, 2026, and highlighted recent corporate progress.
“Our dabogratinib ‘3x3’ strategy continues to advance with steady progress across all three programs,” said Todd Harris, Ph.D., Chief Executive Officer of TYRA. “We are taking a differentiated, data-driven approach by aligning our development strategy with the patient journey in FGFR3-driven diseases and conditions. The dosing of the first patient in SURF303 marks an important milestone, as we initiate a potentially registrational study in LG-UTUC that could support TYRA’s first NDA submission. With multiple clinical data readouts expected this year, we remain focused on unlocking the full potential of selective FGFR3 inhibition with oral dabogratinib.”
Doug Warner, M.D., Chief Medical Officer of TYRA, commented, “In urologic cancers, we see a significant opportunity to address what we believe is a very challenging treatment paradigm for patients that is currently dominated by procedure-based, intravesical therapies. We are developing dabogratinib as a once-daily (QD) oral therapy designed to maintain continuous pressure on the tumor and, if successful, may represent a meaningful shift in how these patients are treated.”
Dr. Warner continued, “In achondroplasia, we believe our approach with oral dabogratinib may also be transformational. Recently presented data demonstrate that prenatal dosing further delayed premature fusion of synchondroses and increased the area of the foramen magnum. These data expand our perspective on the potential benefits of earlier FGFR3 inhibition as we advance BEACH301. We have now cleared the fourth dose level in our safety sentinel cohort and remain on track to report initial results in the fourth quarter of this year.”
First Quarter and Recent Corporate Highlights
Dabogratinib 3x3 Strategy
In the first quarter of 2026, TYRA advanced its “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.
Corporate
SNÅP Platform and Pipeline
First Quarter Financial Results
Upcoming Anticipated Clinical Milestones:
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.
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 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: initial or 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; geopolitical instability, war, inflation and interest rate changes; 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
Tyra Biosciences, Inc.
Condensed Balance Sheets
(in thousands)
(unaudited)
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March 31, |
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December 31, |
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
84,955 |
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$ |
77,387 |
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Marketable securities |
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298,511 |
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178,616 |
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Prepaid expenses and other current assets |
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11,147 |
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9,447 |
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Total current assets |
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394,613 |
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265,450 |
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Restricted cash |
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884 |
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1,000 |
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Property and equipment, net |
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1,215 |
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1,314 |
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Right-of-use assets |
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5,443 |
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5,573 |
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Other long-term assets |
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9,885 |
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9,272 |
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Total assets |
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$ |
412,040 |
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$ |
282,609 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,642 |
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$ |
1,178 |
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Lease liabilities, current |
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488 |
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472 |
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Accrued expenses and other current liabilities |
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15,126 |
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16,444 |
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Total current liabilities |
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19,256 |
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18,094 |
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Lease liabilities, noncurrent |
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5,209 |
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5,338 |
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Total liabilities |
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24,465 |
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23,432 |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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6 |
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5 |
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Additional paid-in capital |
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798,025 |
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630,037 |
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Accumulated other comprehensive income |
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107 |
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393 |
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Accumulated deficit |
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(410,563 |
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(371,258 |
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Total stockholders’ equity |
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387,575 |
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259,177 |
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Total liabilities and stockholders’ equity |
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$ |
412,040 |
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$ |
282,609 |
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Tyra Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
33,470 |
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$ |
24,964 |
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General and administrative |
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8,528 |
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6,886 |
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Total operating expenses |
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41,998 |
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31,850 |
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Loss from operations |
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(41,998 |
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(31,850 |
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Other income: |
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Interest and other income, net |
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2,693 |
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3,703 |
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Total other income |
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2,693 |
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3,703 |
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Net loss |
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(39,305 |
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(28,147 |
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Unrealized loss on marketable securities, net |
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(286 |
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(82 |
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Comprehensive loss |
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$ |
(39,591 |
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$ |
(28,229 |
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Net loss per share, basic and diluted |
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$ |
(0.64 |
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$ |
(0.47 |
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Weighted-average shares used to compute net |
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61,746,050 |
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59,336,550 |
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