Tyra Biosciences FY Conference Summary Company Overview - **Company**: Tyra Biosciences (NasdaqGS:TYRA) - **Lead Drug**: Dabogratinib - **Focus**: Development of oral therapies targeting FGFR3-driven conditions Key Points Industry and Market Opportunity - Tyra is pursuing three potential blockbuster indications for dabogratinib, including: - **Upper Tract Urothelial Carcinoma (UTUC)**: High unmet need with a rapid registrational path [2][3] - **Non-Muscle Invasive Bladder Cancer (NMIBC)**: Targeting intermediate-risk patients with a focus on FGFR3-driven lesions [3][4] - **Achondroplasia**: Aiming to provide a significant height benefit through oral administration [4][42] Clinical Development Strategy - **Dabo 3x3 Strategy**: Focused on advancing dabogratinib into pivotal studies for the three indications [2] - **Phase 2 Data**: Expected mid-year for NMIBC, which will inform the design of a Phase 3 study [3][10] - **Safety and Efficacy**: Initial safety data from 22 patients showed a tolerable profile with low adverse events [14][15] Competitive Advantage - Tyra is the only company pursuing an oral option for these conditions, contrasting with current intravesical and surgical treatments [4][10] - The oral administration model is expected to enhance patient compliance and reduce the burden of treatment [26][28] Patient Journey and Adoption - The current standard of care involves invasive procedures, which patients and physicians are eager to replace with oral therapies [26][27] - Community practices are well-equipped to dispense oral medications, which could drive adoption of dabogratinib [27][29] Regulatory Pathway - The registrational path for UTUC is supported by previous FDA references to single-arm studies, allowing for a potentially expedited approval process [31][37] - Tyra plans to submit a briefing book to the FDA based on mid-year data to justify a Phase 3 design [16][37] Financial Projections - Tyra anticipates a significant market opportunity, projecting a billion-plus revenue potential for dabogratinib across all indications [39][55] - The company believes its internal projections exceed general analyst expectations, indicating strong future growth potential [55] Additional Insights - The company is focused on optimizing dosing strategies to enhance efficacy while maintaining safety [40][46] - There is a clear interest from the medical community in oral therapies, which could lead to favorable market dynamics for Tyra's products [28][30] Conclusion Tyra Biosciences is positioned to address significant unmet needs in oncology and rare diseases with its lead drug, dabogratinib. The company's strategic focus on oral therapies, combined with a robust clinical development plan and favorable market dynamics, suggests a strong potential for growth and success in the coming years.

FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40800 TYRA BIOSCIENCES, INC. (Exact name of Registrant as specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 83-1476348 (State or other jurisdiction ...

Exhibit 99.1 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 - Dabogratinib 3x3 Strategy TYRA is focused on ...

Tyra Biosciences Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights [Accessibility Statement] Skip Navigation- 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., Ma ...

Tyra Biosciences FY Conference Summary Company Overview - **Company**: Tyra Biosciences (NasdaqGS:TYRA) - **Focus**: Development of dabogratinib, an FGFR3 inhibitor for various indications including bladder cancer and skeletal dysplasias Key Points Drug Development and Indications - **Dabogratinib** is being explored for multiple uses, initially in metastatic bladder cancer and now expanding to earlier-stage bladder cancer and bone growth disorders like achondroplasia [3][4] - The drug targets **FGFR3** alterations, which are prevalent in specific cancer types and skeletal dysplasias [4] - Tyra is focusing on high-value opportunities with strong validation, particularly in low-grade upper tract urothelial carcinoma and intermediate-risk non-muscle invasive bladder cancer [4] Clinical Data and Safety - Tyra has conducted a Phase I trial demonstrating significant reduction in FGFR1 and FGFR2-associated toxicities, with a favorable safety profile compared to existing treatments [5][11] - Over 100 patients have been dosed, with ongoing studies to ensure safety and efficacy [11][12] - The drug has shown a favorable toxicity profile, with low-grade diarrhea being the most common side effect, which is manageable [15][16] Efficacy Expectations - Tyra anticipates improved efficacy in achondroplasia, aiming for additional growth benefits beyond current treatments [10][21] - The company is testing various doses (10, 20, 30, and 40 mg) to optimize growth outcomes while minimizing risks [29][31] - The expected outcomes for achondroplasia include significant height increases, with a target of achieving growth rates comparable to existing therapies [21][24] Bladder Cancer Focus - Tyra is prioritizing intermediate-risk non-muscle invasive bladder cancer due to the high prevalence of FGFR3 positivity (over 70%) in this group, which is crucial for treatment efficacy [42][47] - The company aims to reduce the need for invasive TURBT procedures, which are costly and burdensome for patients [50][63] - Tyra's oral therapy could significantly lower recurrence rates and improve patient quality of life compared to current treatment options [69][70] Future Trials and Pipeline - Tyra has multiple ongoing trials, including SURF301, SURF302, SURF303, and BEACH301, with data expected in the second half of the year for achondroplasia and mid-year for non-muscle invasive bladder cancer [87][88] - The company is also exploring new indications for FGFR3 and maintaining an active discovery program for additional therapeutic options [89] Market Potential - The unmet need in conditions like UTUC (upper tract urothelial carcinoma) is significant, with an estimated 40% of patients potentially losing their kidneys due to ineffective treatments [79][81] - Tyra's oral treatment could provide a compelling alternative, potentially leading to a market opportunity similar to that of Gleevec as the patient population grows [84] Conclusion - Tyra Biosciences is positioned to make significant advancements in the treatment of bladder cancer and skeletal dysplasias with its FGFR3 inhibitor, dabogratinib, focusing on safety, efficacy, and patient quality of life while addressing substantial unmet medical needs in these areas [90]

Core Insights - Tyra Biosciences, Inc. announced the acceptance of two abstracts for presentation at the 2026 ASCO Genitourinary Cancers Symposium, highlighting its focus on FGFR biology and precision medicine development [1] Group 1: Presentation Details - The first presentation is titled "ctDNA monitoring of FGFR3-altered metastatic urothelial cancer treated with dabogratinib (formerly TYRA-300) in the SURF301 trial," scheduled for February 27, 2026, from 11:30 AM to 12:45 PM PST [1] - The second presentation is a phase 2 multicenter, open-label study evaluating the efficacy and safety of dabogratinib in participants with FGFR3-altered low-grade, intermediate risk non-muscle invasive bladder cancer (SURF302), also on February 27, 2026, from 11:30 AM to 12:45 PM PST [1] Group 2: Company Overview - Tyra Biosciences is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting FGFR biology, with a proprietary platform called SNÃ…P for rapid drug design [1] - The company has a differentiated pipeline with clinical-stage programs in targeted oncology and genetically defined conditions, including oral dabogratinib, a potential first-in-class selective FGFR3 inhibitor [1] - Current planned clinical development includes three Phase 2 studies: SURF303 for low-grade upper tract urothelial carcinoma, SURF302 for intermediate risk non-muscle invasive bladder cancer, and BEACH301 for pediatric achondroplasia [1]

Tyra Biosciences to Participate in Upcoming Investor Conferences [Accessibility Statement] Skip NavigationCARLSBAD, Calif., Feb. 19, 2026 /PRNewswire/ -- 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 announced participation at the following investor conferences:36th Annual Oppenheimer Life Sciences Healthcare ConferenceFormat: Vi ...

Core Viewpoint - Wedbush analyst Robert Driscoll has raised the price target for Tyra Biosciences (TYRA) to $53 from $37 while maintaining an Outperform rating on the shares, indicating a positive outlook for the company based on recent developments in the industry [1]. Group 1: Company Analysis - The price target for Tyra Biosciences (TYRA) has been increased to $53 from $37, reflecting a bullish sentiment from Wedbush [1]. - The firm maintains an Outperform rating on Tyra Biosciences, suggesting confidence in the company's future performance [1]. Group 2: Industry Insights - BridgeBio (BBIO) announced positive topline Phase 3 data for infigratinib in achondroplasia, which validates FGFR3 inhibition as an effective mechanism for increasing height velocity in patients with skeletal dysplasia [1]. - The positive data from BridgeBio is seen as encouraging for dabogratinib, a more selective FGFR3 inhibitor, which is expected to show significant increases in absolute annual height velocity (AHV) and potentially lead to clinically important changes in proportionality [1].

Group 1: Stock Performance - Several healthcare and biotech stocks experienced significant gains in after-hours trading, with movements largely occurring without specific company news [1][2][3][4] - Acumen Pharmaceuticals, Inc. (ABOS) rose by 8.09% to close at $2.94, adding $0.22 to its share price [1] - Fulgent Genetics, Inc. (FLGT) increased by 5.98% to $28.90, gaining $1.63 in extended trading [1] - Fractyl Health, Inc. (GUTS) climbed 5.19% to $2.23, up $0.11 after hours [1] - Coeptis Therapeutics Holdings, Inc. (COEP) finished up 4.14% at $13.85, a gain of $0.55 [2] - Jin Medical International Ltd. (ZJYL) saw an increase of 4.04% to $0.16, up $0.0061 [2] - Alignment Healthcare, Inc. (ALHC) gained 5.92% to $22.20, adding $1.24 in after-hours trading [2] - Orthofix Medical Inc. (OFIX) rose 4.58% to $13.94, up $0.61 [3] - Alto Neuroscience, Inc. (ANRO) advanced 4.52% to $17.57, gaining $0.76 [3] - Immix Biopharma, Inc. (IMMX) increased by 3.87% to $6.17, adding $0.23 [3] - Amneal Pharmaceuticals, Inc. (AMRX) rose 3.76% to $14.35, up $0.52, and is set to replace TTM Technologies in the S&P SmallCap 600 index [3] - Tyra Biosciences, Inc. (TYRA) gained 3.76% to $32.58, adding $1.18 in extended trading [4]

Summary of Key Points from Biotechnology Equity Research Conference Call Industry Overview - The report focuses on the biotechnology sector, specifically highlighting companies with significant potential for growth and upcoming catalysts in 2026. Key Companies and Their Outlook 1. **Dianthus Therapeutics, Inc. (DNTH)** - Market Cap: $1.82 billion - Price Target: $66 - Key catalysts include: - CIDP Phase III interim analysis in Q2 2026 - Initiation of gMG Phase III study in mid-2026 - Phase II MMN topline data in 2H26 - Potential for significant upside based on peak revenue estimates of ~$2 billion across neuromuscular diseases [19][20][24] 2. **Taysha Gene Therapies, Inc. (TSHA)** - Market Cap: $1.50 billion - Price Target: $11 - Focus on pivotal study for TSHA-102 in Rett syndrome with potential for a 6-month interim readout by YE26/1Q27 [26][27] 3. **Tyra Biosciences (TYRA)** - Market Cap: $1.36 billion - Price Target: $32 - Major catalysts include: - Phase III data for achondroplasia in early 2026 - Initial data for IR-NMIBC in 1H26 - Potential to disrupt the market with oral FGFR3 inhibitors [31][35] 4. **Tango Therapeutics, Inc. (TNGX)** - Market Cap: $1.15 billion - Price Target: $14 - Expected to show de-risking data for vopimetostat in combination with RVMD's RAS inhibitors in 2026 [37][40] 5. **ORIC Pharmaceuticals (ORIC)** - Market Cap: $783 million - Price Target: $23 - Key catalysts include dose-optimization data for prostate cancer and validating data from PFE's MEVPRO-1 trial [42][48] 6. **Solid Biosciences (SLDB)** - Market Cap: $463 million - Price Target: $15 - Focus on DMD program with key regulatory feedback expected in 1H26 [49][53] Major Catalysts and Events - **Upcoming Catalysts:** - RARE and MREO Phase III ORBIT final analysis expected in Dec'25/Jan'26 with potential stock movements of +100%/-30% [2] - ALNY, CRSP, and others expected to provide revenue guidance and business plans early in 2026 [1] - Regulatory events including FDA's Rare Disease Day on 2/23/26 [12] - **Drug Launches:** - Expected launches in 2026 include drugs from ALNY, ARWR, KALV, and others targeting various conditions [3] Financial Updates - **Price Target Changes:** - ARWR raised from $67 to $90 - KOD raised from $24 to $39 [6][10] Market Dynamics - **Pricing Stability:** - 2026 net pricing expected to remain stable with current Medicare contracts influencing high gross-to-net (GTN) guidance [12] - **Strategic Interest:** - Potential for M&A activity as companies like ORIC attract interest due to their prostate cancer programs [43] Conclusion - The biotechnology sector is poised for significant developments in 2026, with multiple companies presenting strong investment opportunities based on upcoming catalysts, drug launches, and strategic positioning in the market.