Summary of Tyra Biosciences FY Conference Call Company Overview - **Company**: Tyra Biosciences - **Focus**: Precision medicine, specifically targeting FGFR (Fibroblast Growth Factor Receptor) biology through drug discovery and development using the SNAP chemistry platform [4][5] Key Programs and Initiatives - **Lead Drug**: FGFR3 selective inhibitor, the first of its kind in clinical trials, aimed at treating bladder cancer and growth disorders like achondroplasia [4][6] - **Bladder Cancer**: Approximately 50% of bladder cancer cases are driven by FGFR3 mutations, with over 70% positivity in intermediate-risk non-muscle invasive bladder cancer (NMIBC) [5][6] - **Growth Disorders**: FGFR3 alterations lead to conditions like dwarfism, with the potential for a once-a-day oral agent to restore typical bone growth [7][8] Clinical Development - **Phase Two Studies**: Ongoing for both bladder cancer and achondroplasia, with a focus on identifying the right dosing for each indication [9][10] - **Efficacy Data**: Phase one data showed over 50% overall response rate (ORR) in FGFR3 positive metastatic cases, with a favorable safety profile [8][11] Market Opportunity - **Unmet Need**: High demand for effective treatments in both bladder cancer and achondroplasia, with Tyra's oral FGFR3 selective inhibitor positioned as a potential best-in-class option [39][40] - **Market Size**: The NMIBC market is projected to exceed $5 billion, while the total addressable market for growth conditions could reach $5 to $10 billion [39][40] Competitive Landscape - **Differentiation**: Tyra's oral FGFR3 selective inhibitor offers a less invasive alternative to existing therapies, which often require surgical interventions or intravesical therapies [16][18] - **Comparison with Competitors**: Other companies like Johnson & Johnson and BioMarin are also developing FGFR inhibitors, but Tyra's selective approach aims to avoid the toxicities associated with pan-FGFR inhibitors [25][39] Safety and Tolerability - **Safety Profile**: Tyra's FGFR3 selective inhibitor is designed to minimize adverse effects associated with FGFR1 and FGFR2, which are common with pan-FGFR therapies [32][34] - **Key Pediatric Safety Events**: Hyperphosphatemia and other toxicities related to FGFR2 are significant concerns that Tyra aims to mitigate with its selective approach [32][34] Future Outlook - **Underappreciated Aspects**: The size of the unmet need and the potential market opportunities for Tyra's single drug are significant, with a strong clinical data foundation supporting its efficacy [38][39] - **Strategic Positioning**: Tyra aims to optimize dosing and move quickly into phase three trials, leveraging its first-mover advantage in FGFR3 selective therapies [35][39] This summary encapsulates the key points discussed during the Tyra Biosciences FY Conference Call, highlighting the company's strategic focus, clinical development, market opportunities, and competitive positioning in the biotech landscape.

Tyra Biosciences (TYRA) Conference Summary Company Overview - **Company**: Tyra Biosciences (TYRA) - **Focus**: Discovery and development of selective FGFR3 inhibitors for cancer and achondroplasia treatment - **Key Products**: Lead compound is an FGFR3 selective inhibitor, dabogratinib (formerly TYR3-100) Pipeline Initiatives - **Active Phase II Trials**: - **Bladder Cancer**: Targeting intermediate risk FGFR3 positive non-muscle invasive bladder cancer (NMIBC) with a patient population of approximately 700,000 in the US, where FGFR3 positivity is 70-80% [5][11] - **Achondroplasia**: Addressing skeletal dysplasia caused by FGFR3 alterations, which leads to significant health complications [6][11] Study Design and Efficacy - **NMIBC Study**: - Phase II study randomizing patients to receive either 50 mg or 60 mg of dabogratinib daily [12] - Primary endpoint: 3-month complete response (CR) rate; secondary endpoints include duration of response and time to recurrence [12] - Anticipated CR rate benchmark is around 70% based on expert feedback [26] - **Achondroplasia Study**: - Initiated with a focus on pediatric dosing, starting at 0.125 to 0.5 mg/kg [73] - Emphasis on FGFR3 selectivity to optimize growth and reduce complications associated with the condition [78][86] Safety and Tolerability - **Dabogratinib Safety Profile**: - Demonstrated a pristine safety profile with low-grade adverse events (AEs) such as diarrhea and asymptomatic ALT/AST elevations [19][40] - No hyperphosphatemia observed at doses of 50-60 mg, contrasting with other pan FGFR inhibitors [40][64] Competitive Landscape - **Comparison with Other Treatments**: - Dabogratinib shows a significantly improved safety profile compared to erdafitinib, with lower rates of nail toxicity and stomatitis [63] - The oral administration of dabogratinib is expected to enhance patient adherence compared to intravesical therapies [50][51] Market Dynamics - **Community Channel Dynamics**: - The evolution of oral therapies in urology, supported by EuroGPO, has facilitated the adoption of oral drugs in community practices [55][58] - Oral drug spend in urology has reportedly increased from 5% to 15% since 2008, with indications that it may be as high as 40% today [57] Future Outlook - **Prioritization of Trials**: - The company is focusing on the intermediate risk NMIBC and achondroplasia settings due to larger patient populations and unmet needs [70][72] - Future discussions with the FDA regarding the metastatic urothelial carcinoma setting are planned, but current focus remains on ongoing Phase II trials [69][72] Key Takeaways - Tyra Biosciences is advancing innovative treatments for bladder cancer and achondroplasia with a strong emphasis on safety and patient convenience - The company is well-positioned in the market with a promising pipeline and a clear strategy for commercialization and patient engagement - Ongoing studies are expected to provide critical data that will shape the future of treatment options in these therapeutic areas [21][72]

-Dabogratinib is the only oral FGFR3-selective inhibitor in clinical development for achondroplasia- -Initial results from safety sentinel cohort expected in 2H 2026- CARLSBAD, Calif., Aug. 21, 2025 /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, announced today that the first child has been dosed in BEACH301, a Phase 2 c ...

Group 1 - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology [2] - The company utilizes its in-house precision medicine platform, SNÅP, for rapid and precise drug design, predicting genetic alterations that may cause resistance to existing therapies [2] - Tyra's lead product, dabogratinib, is a potential first-in-class selective FGFR3 inhibitor designed to minimize toxicities associated with other FGFR inhibitors [2] Group 2 - Current clinical development plans for dabogratinib include studies for intermediate risk non-muscle invasive bladder cancer, pediatric achondroplasia, and potential future studies for metastatic urothelial cancer [2] - Tyra is also developing TYRA-430, an oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, and TYRA-200, an oral FGFR1/2/3 inhibitor for metastatic intrahepatic cholangiocarcinoma [2] - The company will participate in investor events, including a virtual fireside chat on August 21, 2025, and the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025 [1]

Tyra Biosciences, Inc. (TYRA) closed the last trading session at $10.81, gaining 1.9% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $30.14 indicates a 178.8% upside potential. The average comprises seven short-term price targets ranging from a low of $28.00 to a high of $33.00, with a standard deviation of $1.86. While the lowest estimate indicates an increase of 159% from the cu ...

PART I. FINANCIAL INFORMATION This part presents unaudited condensed financial statements, notes, MD&A, market risk, and controls [Item 1. Condensed Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Financial%20Statements) This section presents Tyra Biosciences' unaudited condensed financial statements and comprehensive notes for interim periods [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric (in thousands) | June 30, 2025 (unaudited) | December 31, 2024 | | :-------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $98,490 | $91,966 | | Marketable securities | $197,781 | $249,475 | | Total current assets | $302,155 | $347,463 | | Total assets | $321,499 | $363,558 | | Total current liabilities | $13,770 | $14,594 | | Total liabilities | $19,352 | $20,407 | | Total stockholders' equity | $302,147 | $343,151 | | Accumulated deficit | $(307,556) | $(251,311) | - **Total assets decreased by $42.06 million** from December 31, 2024, to June 30, 2025, primarily due to a reduction in marketable securities[10](index=10&type=chunk) - **Accumulated deficit increased significantly from $(251.311) million to $(307.556) million**, reflecting ongoing net losses[10](index=10&type=chunk) [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss over specific interim periods | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $24,309 | $17,997 | $49,273 | $35,199 | | General and administrative | $7,143 | $5,535 | $14,029 | $10,654 | | Total operating expenses | $31,452 | $23,532 | $63,302 | $45,853 | | Loss from operations | $(31,452) | $(23,532) | $(63,302) | $(45,853) | | Interest and other income, net | $3,354 | $4,830 | $7,057 | $8,959 | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - **Net loss increased by $9.4 million (50.2%)** for the three months ended June 30, 2025, compared to the same period in 2024, and by **$19.35 million (52.5%)** for the six months ended June 30, 2025, driven by higher operating expenses[12](index=12&type=chunk) - **Research and development expenses increased by $6.3 million (35.1%)** for the three months and **$14.1 million (40.0%)** for the six months ended June 30, 2025, reflecting increased clinical activities[12](index=12&type=chunk) [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in the company's equity accounts, including net loss and stock issuances - **Total stockholders' equity decreased from $343.151 million** at December 31, 2024, to **$302.147 million** at June 30, 2025, primarily due to the net loss incurred during the period[17](index=17&type=chunk) - **Additional paid-in capital increased by $15.575 million**, mainly from stock-based compensation and issuance of common stock under benefit plans[17](index=17&type=chunk) - **The number of common shares outstanding increased from 50,749,945** at December 31, 2024, to **53,233,494** at June 30, 2025, due to warrant exercises and benefit plan issuances[17](index=17&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section summarizes cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(49,138) | $(32,286) | | Net cash provided by (used in) investing activities | $52,892 | $(126,918) | | Net cash provided by financing activities | $2,770 | $200,688 | | Net cash increase for the period | $6,524 | $41,484 | | Cash, cash equivalents and restricted cash at end of period | $99,490 | $100,490 | - **Net cash used in operating activities increased by $16.85 million**, primarily due to the higher net loss[20](index=20&type=chunk)[112](index=112&type=chunk) - **Investing activities shifted from a net cash outflow of $126.9 million** in 2024 to a net cash inflow of **$52.9 million** in 2025, driven by a significant reduction in marketable securities purchases[20](index=20&type=chunk)[113](index=113&type=chunk) - **Financing activities provided significantly less cash in 2025 ($2.77 million)** compared to 2024 (**$200.69 million**), as the prior year included proceeds from a large private placement[20](index=20&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [Notes to the Condensed Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) These notes provide detailed information on accounting policies, fair value, marketable securities, equity, leases, and commitments [1. Organization and Summary of Significant Accounting Policies](index=8&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes the company's business and the significant accounting policies applied in the financial statements - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision medicines for Fibroblast Growth Factor Receptor (FGFR) biology, utilizing its SNÅP platform for drug design[22](index=22&type=chunk) - The unaudited condensed financial statements are prepared in accordance with GAAP for interim financial information and SEC Form 10-Q, and should be read in conjunction with the 2024 Annual Report on Form 10-K[23](index=23&type=chunk) - No changes to significant accounting policies were made during the three and six months ended June 30, 2025[24](index=24&type=chunk) [2. Fair Value Measurements](index=10&type=section&id=2.%20Fair%20Value%20Measurements) This note details the fair value hierarchy and valuation techniques used for financial assets and liabilities | Asset Category (in thousands) | June 30, 2025 Total | Level 1 | Level 2 | | :---------------------------- | :------------------ | :------ | :------ | | Money market funds | $72,922 | $72,922 | $— | | U.S. government agency securities (cash equivalents) | $2,992 | $— | $2,992 | | U.S. Treasury securities (marketable) | $110,878 | $— | $110,878| | U.S. government agency securities (marketable) | $86,903 | $— | $86,903 | | **Total** | **$273,695** | **$72,922** | **$200,773**| - The Company's cash equivalents and marketable securities are measured at fair value, primarily classified as **Level 1** (money market funds) and **Level 2** (U.S. Treasury and government agency securities) within the fair value hierarchy[25](index=25&type=chunk)[27](index=27&type=chunk)[36](index=36&type=chunk) [3. Marketable Securities](index=11&type=section&id=3.%20Marketable%20Securities) This note provides details on the composition and fair value of the company's marketable securities portfolio | Marketable Securities (in thousands) | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :----------------------- | :--------------------------- | | U.S. Treasury securities | $110,878 | $122,980 | | U.S. government agency securities | $86,903 | $126,495 | | **Total marketable securities** | **$197,781** | **$249,475** | - **Marketable securities, classified as available-for-sale, decreased by $51.69 million** from December 31, 2024, to June 30, 2025[38](index=38&type=chunk) - As of June 30, 2025, **$34.3 million** of available-for-sale securities were in gross unrealized loss positions for less than **12 months**, attributed to market factors and interest rate fluctuations, not credit risk[38](index=38&type=chunk)[39](index=39&type=chunk) [4. Accrued Expenses and Other Current Liabilities](index=12&type=section&id=4.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the components of accrued expenses and other current liabilities on the balance sheet | Accrued Expense Category (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Accrued payroll and other employee benefits | $2,724 | $6,451 | | Accrued research and development expenses | $7,864 | $6,612 | | Accrued legal and professional fees | $209 | $296 | | Accrued other general and administrative fees | $287 | $233 | | **Total accrued and other current liabilities** | **$11,084** | **$13,592** | - **Total accrued expenses and other current liabilities decreased by $2.508 million** from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued payroll and other employee benefits[41](index=41&type=chunk) [5. Stockholders' Equity](index=12&type=section&id=5.%20Stockholders%27%20Equity) This note provides information on common stock, warrants, and shares reserved for future issuance under equity plans | Common Stock Reserved for Future Issuance | June 30, 2025 | December 31, 2024 | | :---------------------------------------- | :------------ | :---------------- | | Common stock options granted and outstanding | 10,408,456 | 10,462,129 | | Shares available for future issuance under 2021 Incentive Award Plan | 5,189,786 | 3,051,588 | | Shares available for future issuance under 2021 Employee Stock Purchase Plan | 1,972,762 | 1,491,195 | | Pre-funded warrants issued and outstanding | 6,381,950 | 8,382,187 | | **Total common stock reserved for future issuance** | **23,952,954**| **23,387,099** | - **The Company terminated its 2022 ATM Sales Agreement and entered into a new 2025 Sales Agreement** with TD Securities (USA) LLC to sell up to **$150.0 million** of common stock in 'at the market' offerings[42](index=42&type=chunk)[43](index=43&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) - **During the six months ended June 30, 2025, 2,000,069 shares of common stock were issued** from the exercise of pre-funded warrants by Boxer Capital[47](index=47&type=chunk) [6. Equity Incentive Plans and Stock-Based Compensation](index=13&type=section&id=6.%20Equity%20Incentive%20Plans%20and%20Stock-Based%20Compensation) This note details stock option activity and the recognition of stock-based compensation expense | Stock Option Activity | Outstanding at Dec 31, 2024 | Granted | Exercised | Cancelled | Outstanding at Jun 30, 2025 | | :-------------------- | :-------------------------- | :------ | :-------- | :-------- | :-------------------------- | | Options | 10,462,129 | 1,030,100 | (453,188) | (630,585) | 10,408,456 | | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development expense | $3,690 | $2,658 | $7,368 | $5,133 | | General and administrative expense | $2,690 | $1,753 | $5,434 | $3,393 | | **Total** | **$6,380** | **$4,411** | **$12,802** | **$8,526** | - **Total stock-based compensation expense increased by $1.969 million (44.6%)** for the three months and **$4.276 million (50.2%)** for the six months ended June 30, 2025, compared to the prior year periods[52](index=52&type=chunk) [7. Net Loss Per Share](index=15&type=section&id=7.%20Net%20Loss%20Per%20Share) This note explains the calculation of basic and diluted net loss per share for the periods presented | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Weighted-average common shares outstanding | 59,550,771 | 58,668,712 | 59,442,646 | 55,448,823 | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - **Potentially dilutive securities**, including stock options and ESPP shares, were excluded from diluted EPS calculation due to the Company's net loss position, making their inclusion anti-dilutive[32](index=32&type=chunk)[56](index=56&type=chunk)[57](index=57&type=chunk) [8. Leases](index=15&type=section&id=8.%20Leases) This note describes the company's operating lease arrangements for office and laboratory facilities - The Company has two operating leases for office and laboratory space in Carlsbad, California, expiring in **November 2033**[58](index=58&type=chunk) | Lease Cost Component (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $239 | $239 | $478 | $478 | | Short-term lease cost | $22 | $24 | $45 | $48 | | Variable lease cost | $35 | $32 | $67 | $63 | | **Total lease cost** | **$296** | **$295** | **$590** | **$589** | - **Total minimum lease payments** as of June 30, 2025, are **$8.255 million**, with a weighted-average remaining lease term of **8.4 years** and a weighted-average incremental borrowing rate of **8.07%**[61](index=61&type=chunk) [9. Commitments and Contingencies](index=16&type=section&id=9.%20Commitments%20and%20Contingencies) This note discloses information regarding the company's contractual commitments and potential contingent liabilities - The Company has ongoing clinical and pre-clinical studies with cancellable contracts for research, consulting, and manufacturing, generally without significant cancellation penalties[62](index=62&type=chunk) - As of June 30, 2025, the Company was not subject to any material legal proceedings, nor were any material legal proceedings currently pending or threatened[63](index=63&type=chunk) [10. Segment Information](index=16&type=section&id=10.%20Segment%20Information) This note identifies the company's operating segments and provides financial information for each segment - The Company operates as a **single reportable segment**, focusing on research, development, and potential commercialization of small molecule drug candidates, with the CEO acting as the chief operating decision maker (CODM)[64](index=64&type=chunk)[65](index=65&type=chunk) | Research and Development Expenses by Program (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | ACH Dabogratinib (TYRA-300) | $2,588 | $2,133 | $6,175 | $3,538 | | NMIBC Dabogratinib (TYRA-300) | $2,436 | $— | $3,725 | $— | | mUC Dabogratinib (TYRA-300) | $1,993 | $3,529 | $5,248 | $8,063 | | TYRA-430 | $2,142 | $936 | $4,436 | $1,892 | | TYRA-200 | $1,329 | $1,051 | $2,794 | $1,955 | | FGFR discovery | $3,311 | $1,816 | $6,443 | $3,193 | | Other development programs | $457 | $734 | $971 | $1,570 | | Personnel costs (unallocated) | $8,660 | $6,248 | $16,683 | $12,138 | | Facilities and other costs (unallocated) | $1,393 | $1,550 | $2,798 | $2,850 | | **Total Research and Development Expenses** | **$24,309** | **$17,997** | **$49,273** | **$35,199** | [11. Subsequent Events](index=17&type=section&id=11.%20Subsequent%20Events) This note discloses significant events that occurred after the balance sheet date but before the financial statements were issued - **The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025**, modifying corporate income tax code, including immediate expensing of domestic R&D and **100% bonus depreciation** for qualified assets[68](index=68&type=chunk) - **The Company is evaluating the OBBBA's impact but does not anticipate a material change** to its effective income tax rate or net deferred federal income tax assets due to a full valuation allowance[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Tyra Biosciences' financial condition, operations, expense drivers, and liquidity and capital resources [Overview](index=18&type=section&id=Overview) This section provides a general business description and strategic focus of Tyra Biosciences - Tyra Biosciences is a clinical-stage biotechnology company developing next-generation precision medicines for targeted oncology and genetically defined conditions, with an initial focus on Fibroblast Growth Factor Receptor (FGFR) biology[72](index=72&type=chunk) - The company utilizes its in-house SNÅP precision medicine platform for rapid and precise drug design, aiming to overcome toxicity and resistance issues of first-generation FGFR inhibitors[73](index=73&type=chunk) - Lead programs include dabogratinib (TYRA-300) for bladder cancer (SURF302, SURF301) and skeletal conditions (BEACH301), TYRA-430 for hepatocellular carcinoma, and TYRA-200 for intrahepatic cholangiocarcinoma, all in clinical stages[74](index=74&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[81](index=81&type=chunk)[84](index=84&type=chunk) [Financial Overview](index=20&type=section&id=Financial%20Overview) This section summarizes the company's financial performance, accumulated deficit, and liquidity position - **Since inception in 2018, the Company has incurred significant operating losses**, with net losses of **$56.2 million** and **$36.9 million** for the six months ended June 30, 2025 and 2024, respectively[85](index=85&type=chunk) - **As of June 30, 2025, the accumulated deficit was $307.6 million, and cash, cash equivalents, and marketable securities totaled $296.3 million**[85](index=85&type=chunk) - **The Company expects to continue incurring significant expenses and operating losses, projecting current cash resources to fund operations through at least 2027**, but anticipates needing additional financing for future development and commercialization[86](index=86&type=chunk)[87](index=87&type=chunk) [Components of Results of Operations](index=20&type=section&id=Components%20of%20Results%20of%20Operations) This section details the Company's operating expenses (R&D, G&A) and other income, outlining their nature and future trends [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses) This section describes the nature of R&D expenses and factors influencing their future trends - **R&D expenses primarily consist** of external costs for clinical trials, preclinical development, CMC, and internal costs like personnel, laboratory supplies, and facilities[88](index=88&type=chunk)[91](index=91&type=chunk) - **The Company expects R&D expenses to increase substantially** as product candidates advance through clinical trials, new candidates are discovered, and intellectual property is expanded[90](index=90&type=chunk) - **Future R&D expenses are highly variable**, depending on factors such as trial scope, patient enrollment, regulatory approvals, manufacturing costs, and geopolitical stability[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk)[97](index=97&type=chunk) [General and Administrative Expenses](index=22&type=section&id=General%20and%20Administrative%20Expenses) This section describes the nature of G&A expenses and factors influencing their future trends - **G&A expenses primarily include** personnel-related costs (salaries, benefits, stock-based compensation), legal fees, facility costs, and professional fees[95](index=95&type=chunk) - **G&A expenses are expected to increase** to support growing R&D activities, manufacturing, and the costs associated with operating as a public company, including hiring additional personnel and compliance[95](index=95&type=chunk) [Other Income](index=22&type=section&id=Other%20Income) This section describes the sources of other income, primarily interest income from investments - **Other income primarily consists** of interest income from cash, cash equivalents, and marketable securities, as well as accretion income from marketable securities[96](index=96&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) This section compares the Company's financial performance for the three and six months ended June 30, 2025 and 2024 [Comparison of the Three Months Ended June 30, 2025 and 2024](index=23&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares financial results for the three-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $24,309 | $17,997 | $6,312 | | General and administrative | $7,143 | $5,535 | $1,608 | | Interest and other income, net | $3,354 | $4,830 | $(1,476) | | Net loss | $(28,098) | $(18,702) | $(9,396) | - **R&D expenses increased by $6.3 million**, driven by a **$4.1 million** increase in clinical start-up and enrollment activities for BEACH301, SURF302, and SURF431, and a **$2.4 million** increase in personnel costs[99](index=99&type=chunk)[101](index=101&type=chunk) - **G&A expenses rose by $1.6 million**, primarily due to higher compensation and personnel expenses, including a **$0.9 million** increase in stock-based compensation[100](index=100&type=chunk) - **Other income decreased by $1.4 million** due to lower interest rates and reduced balances in cash, cash equivalents, and marketable securities[102](index=102&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares financial results for the six-month periods ended June 30, 2025 and 2024 | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | | :-------------------- | :------------ | :------------ | :----- | | Research and development | $49,273 | $35,199 | $14,074 | | General and administrative | $14,029 | $10,654 | $3,375 | | Interest and other income, net | $7,057 | $8,959 | $(1,902) | | Net loss | $(56,245) | $(36,894) | $(19,351) | - **R&D expenses increased by $14.1 million**, driven by a **$9.6 million** increase in clinical start-up and enrollment activities for BEACH301, SURF302, and SURF431, and a **$4.5 million** increase in personnel costs[104](index=104&type=chunk)[106](index=106&type=chunk) - **G&A expenses rose by $3.3 million**, primarily due to higher compensation and personnel expenses, including a **$2.0 million** increase in stock-based compensation[105](index=105&type=chunk) - **Other income decreased by $1.9 million** due to lower interest rates and reduced balances in cash, cash equivalents, and marketable securities[107](index=107&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the Company's cash sources, uses, liquidity, and future capital requirements [Sources of Liquidity](index=25&type=section&id=Sources%20of%20Liquidity) This section identifies the primary sources of cash and capital available to the company - **In February 2024, the Company completed a private placement**, issuing common stock and pre-funded warrants for net proceeds of approximately **$199.6 million**[108](index=108&type=chunk) - **The Company terminated its 2022 ATM Sales Agreement and entered into a new 2025 Sales Agreement** in **May 2025**, allowing for the sale of up to **$150.0 million** in common stock through 'at the market' offerings, with no sales made as of June 30, 2025[109](index=109&type=chunk)[110](index=110&type=chunk) [Cash Flows](index=25&type=section&id=Cash%20Flows) This section analyzes the changes in cash and cash equivalents from operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | | Operating activities | $(49,138) | $(32,286) | $(16,852) | | Investing activities | $52,892 | $(126,918) | $179,810 | | Financing activities | $2,770 | $200,688 | $(197,918) | | **Net increase in cash and cash equivalents** | **$6,524** | **$41,484** | **$(34,960)** | - **Net cash used in operating activities increased by $16.9 million**, primarily due to the increased net loss[112](index=112&type=chunk) - **Net cash provided by investing activities increased by $179.8 million**, mainly due to a **$162.2 million** reduction in marketable securities purchases and increased maturities[113](index=113&type=chunk) - **Net cash provided by financing activities decreased by $197.9 million**, primarily due to the absence of a large private placement in 2025, which occurred in 2024[114](index=114&type=chunk)[115](index=115&type=chunk) [Material Cash Requirements](index=26&type=section&id=Material%20Cash%20Requirements) This section outlines the company's significant future cash obligations and capital needs - **The Company's primary cash uses are for R&D activities, personnel, and operating lease obligations**[116](index=116&type=chunk)[117](index=117&type=chunk) - **Existing cash, cash equivalents, and marketable securities are believed to be sufficient to fund operations through at least 2027**, but this is a forward-looking estimate subject to risks and uncertainties[118](index=118&type=chunk) - **Future capital requirements depend on factors** such as the scope and timing of clinical trials, manufacturing costs, regulatory review, intellectual property maintenance, and hiring additional personnel[119](index=119&type=chunk)[120](index=120&type=chunk) [Contractual Obligations and Commitments](index=27&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's contractual obligations and commitments as of the reporting date - **As of June 30, 2025, total future aggregate operating lease commitments were $8.3 million**, with approximately **$0.4 million** due in the remaining six months of 2025[123](index=123&type=chunk) - **No material changes to contractual obligations occurred** during the six months ended June 30, 2025, outside the ordinary course of business[122](index=122&type=chunk) [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses accounting policies and estimates requiring significant management judgment - **There have been no material changes to the Company's critical accounting policies and estimates** during the six months ended June 30, 2025[124](index=124&type=chunk) [Recently Adopted Accounting Pronouncements](index=27&type=section&id=Recently%20Adopted%20Accounting%20Pronouncements) This section outlines the impact of recently adopted accounting standards on the financial statements - **The Company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03/2025-01 (Expense Disaggregation Disclosures)** on its financial statements, with ASU 2023-09 effective for annual periods beginning after **December 15, 2024**, and ASU 2024-03 effective for annual periods beginning after **December 15, 2026**[34](index=34&type=chunk)[35](index=35&type=chunk)[125](index=125&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section addresses the Company's exposure to market risks, including interest rate, foreign currency, and inflation risks - **As of June 30, 2025, there have been no material changes to the Company's market risk profile**, including interest rate risk, foreign currency exchange risk, and inflation risk, compared to the disclosures in the 2024 Annual Report[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) This section evaluates disclosure controls and procedures and reports on changes in internal control over financial reporting - **Management, including the CEO and CFO, concluded that the Company's disclosure controls and procedures were effective** at the reasonable assurance level as of June 30, 2025[127](index=127&type=chunk)[128](index=128&type=chunk)[129](index=129&type=chunk) - **No changes in internal control over financial reporting materially affected**, or are reasonably likely to materially affect, the Company's internal control over financial reporting during the quarter ended June 30, 2025[130](index=130&type=chunk) PART II. OTHER INFORMATION This part provides additional information on legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses information regarding any material legal proceedings involving the Company - **The Company is not currently subject to any material legal proceedings**, and no material legal proceedings are pending or threatened as of June 30, 2025[132](index=132&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section refers to risk factors that could materially affect the Company's business and financial condition - **There have been no material changes to the risk factors disclosed** in Item 1A of the Company's 2024 Annual Report[133](index=133&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on any unregistered sales of equity securities and issuer repurchases of equity securities - **There were no unregistered sales of equity securities or issuer repurchases of equity securities** during the period[134](index=134&type=chunk)[135](index=135&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports on any defaults upon senior securities - **This item is not applicable to the Company for the reporting period**[136](index=136&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section provides disclosures related to mine safety - **This item is not applicable to the Company for the reporting period**[137](index=137&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) This section includes other information not disclosed elsewhere, such as director and officer trading arrangements - **During the three months ended June 30, 2025, none of the Company's officers or directors adopted, modified, or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements**[138](index=138&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the 10-Q report, including corporate documents and certifications - **The report includes various exhibits** such as the Amended and Restated Certificate of Incorporation, Bylaws, forms of Pre-Funded and Exchange Warrants, Sales Agreement with TD Securities (USA) LLC, and certifications from the CEO and CFO[139](index=139&type=chunk) Signatures This section contains the required signatures of authorized officers, certifying the quarterly report filing - **The report was signed on August 14, 2025**, by Todd Harris, Ph.D., President, Chief Executive Officer, and Director (Principal Executive Officer), and Alan Fuhrman, Chief Financial Officer (Principal Financial and Accounting Officer)[144](index=144&type=chunk)

[Company Overview & Q2 2025 Highlights](index=1&type=section&id=Company%20Overview%20%26%20Q2%202025%20Highlights) Tyra Biosciences reported Q2 2025 results, highlighting clinical progress in SURF302 and a strong financial position through 2027 [Introduction and Strategic Focus](index=1&type=section&id=Introduction%20and%20Strategic%20Focus) Tyra Biosciences announced Q2 2025 results, emphasizing clinical advancements in SURF302 and a robust financial outlook through 2027 - Dosed the first patient in **SURF302** for intermediate risk non-muscle invasive bladder cancer (IR NMIBC)[1](index=1&type=chunk) - **$296.3 million** in cash, cash equivalents, and marketable securities at Q2 2025 provides a financial runway through at least **2027**[1](index=1&type=chunk) - Strategic focus on transforming bladder cancer and skeletal dysplasia treatment by precisely targeting **FGFR3** with dabogratinib[2](index=2&type=chunk) [About Tyra Biosciences](index=3&type=section&id=About%20Tyra%20Biosciences) Tyra Biosciences is a clinical-stage biotech company developing next-generation precision medicines targeting FGFR biology using its SNÅP platform - A clinical-stage biotechnology company focused on developing next-generation precision medicines targeting large opportunities in **FGFR biology**[13](index=13&type=chunk) - Utilizes its in-house precision medicine platform, **SNÅP**, for rapid and precise drug design to predict genetic alterations causing acquired resistance[13](index=13&type=chunk) - Lead precision medicine, **dabogratinib**, is a potential first-in-class selective **FGFR3 inhibitor** designed to avoid toxicities associated with inhibition of FGFR1, FGFR2, and FGFR4[13](index=13&type=chunk) [Pipeline and Program Updates](index=1&type=section&id=Pipeline%20and%20Program%20Updates) Tyra Biosciences is advancing its pipeline with key updates on dabogratinib for IR NMIBC and achondroplasia, and progress on TYRA-430 and TYRA-200 programs [Dabogratinib (TYRA-300)](index=1&type=section&id=Dabogratinib%20(TYRA-300)) Dabogratinib, an oral FGFR3-selective inhibitor, is Tyra's lead precision medicine for IR NMIBC and achondroplasia, showing interim proof-of-concept - **Dabogratinib** (formerly TYRA-300) is an oral investigational **FGFR3-selective inhibitor** for IR NMIBC and ACH treatment[3](index=3&type=chunk) - It is TYRA's lead precision medicine candidate from its **SNÅP platform**, demonstrating interim clinical proof-of-concept in metastatic urothelial cancer (mUC)[8](index=8&type=chunk) - Designed to avoid toxicities associated with **FGFR1, FGFR2, and FGFR4 inhibition**, while being agnostic for FGFR3 gatekeeper mutations[13](index=13&type=chunk) [SURF302 (IR NMIBC)](index=1&type=section&id=SURF302%20(IR%20NMIBC)) The SURF302 study is evaluating dabogratinib's efficacy and safety in FGFR3-altered intermediate risk non-muscle invasive bladder cancer patients - Dosed the first patient in the Phase 2 NMIBC Study – **SURF302**, an open-label clinical study[3](index=3&type=chunk) - Evaluating efficacy and safety of dabogratinib in participants with **FGFR3-altered low-grade, IR NMIBC**[3](index=3&type=chunk) - Primary endpoint is **complete response (CR) rate at three months**, with participants randomized to **50 mg QD or 60 mg QD**[3](index=3&type=chunk) [BEACH301 (Achondroplasia)](index=1&type=section&id=BEACH301%20(Achondroplasia)) The BEACH301 study is a Phase 2 dose-escalation/expansion study enrolling children with achondroplasia to assess dabogratinib - Advanced Phase 2 ACH Study - **BEACH301**, a multicenter, open-label, dose-escalation/dose-expansion study[3](index=3&type=chunk) - Enrolling children ages **3 to 10** with achondroplasia with open growth plates, including treatment-naïve and prior growth-accelerating therapy cohorts[3](index=3&type=chunk) - Currently enrolling a safety sentinel cohort of up to **3 participants per dose level** in children ages **5 to 10**[3](index=3&type=chunk) [SURF301 (Metastatic Urothelial Cancer)](index=1&type=section&id=SURF301%20(Metastatic%20Urothelial%20Cancer)) Dabogratinib continues evaluation in Part B of SURF301 for metastatic urothelial cancer, preparing for potential future Phase 2 studies - **Dabogratinib** continued evaluation in Part B of **SURF301** (NCT05544552)[3](index=3&type=chunk) - Evaluation at potentially therapeutic QD doses is in preparation for potential future Phase 2 studies in **mUC**[3](index=3&type=chunk) [Preclinical Results](index=1&type=section&id=Preclinical%20Results) Preclinical results for dabogratinib presented at ENDO 2025 showed significant improvements in bone growth and skull development in FGFR3-driven models - Presented preclinical results at **ENDO 2025**, summarizing dabogratinib's effects across three genetic contexts[3](index=3&type=chunk) - **Dabogratinib** significantly improved the size and shape of the skull and foramen magnum in **Fgfr3Y367C/+ mice**[3](index=3&type=chunk) - Studies demonstrated a significant increase in bone growth in two independent **FGFR3-driven preclinical models** and wild-type mice, supporting broader development in skeletal dysplasias beyond ACH[3](index=3&type=chunk) [Upcoming Clinical Milestones](index=2&type=section&id=Upcoming%20Clinical%20Milestones) Key upcoming clinical milestones include dosing the first child in BEACH301 in Q3 2025 and initial SURF302 complete response data in 1H 2026 - **BEACH301**: dose first child with achondroplasia – **3Q 2025**[11](index=11&type=chunk) - **SURF302**: topline initial three-month complete response data – **1H 2026**[11](index=11&type=chunk) [TYRA-430](index=2&type=section&id=TYRA-430) TYRA-430, an oral FGFR4/3-biased inhibitor, is advancing in the Phase 1 SURF431 study for FGF19+/FGFR4-driven cancers, including HCC - Advanced Phase 1 **SURF431 Study** with ongoing patient dosing[4](index=4&type=chunk) - **TYRA-430** is an oral, investigational **FGFR4/3-biased inhibitor** for FGF19+/FGFR4-driven cancers[4](index=4&type=chunk) - Believed to address a significant unmet need in advanced **hepatocellular carcinoma (HCC)**, lacking approved biomarker-driven, targeted therapies[4](index=4&type=chunk) [TYRA-200](index=2&type=section&id=TYRA-200) TYRA-200, an FGFR1/2/3 inhibitor, is progressing in the Phase 1 SURF201 study for advanced solid tumors with activating FGFR2 gene alterations - Advanced Phase 1 **SURF201 Study**, continuing to enroll and dose adults[5](index=5&type=chunk) - **TYRA-200** is an **FGFR1/2/3 inhibitor** potent against activating FGFR2 gene alterations and resistance mutations[5](index=5&type=chunk) - The **SURF201 study** evaluates maximum tolerated dose, recommended Phase 2 dose, and preliminary antitumor activity in advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating **FGFR2 alterations**[12](index=12&type=chunk) [SNÅP Platform](index=2&type=section&id=SN%C3%85P%20Platform) TYRA continues to advance its proprietary in-house precision medicine discovery engine, SNÅP, for targeted oncology and genetically defined conditions - TYRA continued to advance its in-house precision medicine discovery engine, **SNÅP**[6](index=6&type=chunk) - The **SNÅP platform** is used to develop therapies in targeted oncology and genetically defined conditions[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Tyra Biosciences reported increased net loss in Q2 2025 due to higher R&D and G&A expenses, maintaining a strong cash position [Financial Summary](index=2&type=section&id=Financial%20Summary) Tyra Biosciences reported a net loss of $28.1 million for Q2 2025, driven by increased R&D and G&A expenses, with a strong cash position of $296.3 million Q2 2025 Financial Highlights | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :-------------------------------- | :-------------------- | :-------------------- | :------------- | | Research and Development (R&D) Expenses | $24.3 | $18.0 | +$6.3 (+35%) | | General and Administrative (G&A) Expenses | $7.1 | $5.5 | +$1.6 (+29%) | | Net Loss | $(28.1) | $(18.7) | $(9.4) | | Cash, Cash Equivalents, and Marketable Securities | $296.3 (as of June 30, 2025) | N/A | N/A | - **R&D expenses** increased due to start-up and enrollment activities for **BEACH301, SURF302, and SURF431**, alongside increased CMC and personnel-related costs[11](index=11&type=chunk) - **G&A expenses** increased primarily due to higher personnel-related costs, including non-cash stock-based compensation[11](index=11&type=chunk) [Condensed Balance Sheet Data](index=5&type=section&id=Condensed%20Balance%20Sheet%20Data) Total assets decreased to $321.5 million by June 30, 2025, from $363.6 million at December 31, 2024, mainly due to reduced marketable securities Condensed Balance Sheet Data (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | Cash and cash equivalents | $98,490 | $91,966 | | Marketable securities | $197,781 | $249,475 | | Total current assets | $302,155 | $347,463 | | Total assets | $321,499 | $363,558 | | Total current liabilities | $13,770 | $14,594 | | Total liabilities | $19,352 | $20,407 | | Total stockholders' equity | $302,147 | $343,151 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $28.1 million in Q2 2025 from $18.7 million in Q2 2024, driven by higher operating expenses and lower interest income Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $24,309 | $17,997 | $49,273 | $35,199 | | General and administrative | $7,143 | $5,535 | $14,029 | $10,654 | | Total operating expenses | $31,452 | $23,532 | $63,302 | $45,853 | | Loss from operations | $(31,452) | $(23,532) | $(63,302) | $(45,853) | | Interest and other income, net | $3,354 | $4,830 | $7,057 | $8,959 | | Net loss | $(28,098) | $(18,702) | $(56,245) | $(36,894) | | Net loss per share, basic and diluted | $(0.47) | $(0.32) | $(0.95) | $(0.67) | - Total operating expenses increased to **$31,452 thousand** for the three months ended June 30, 2025, from **$23,532 thousand** for the same period in 2024[21](index=21&type=chunk) - Interest and other income, net, decreased to **$3,354 thousand** in Q2 2025 from **$4,830 thousand** in Q2 2024[21](index=21&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with Tyra Biosciences' forward-looking statements regarding its pipeline and financial projections [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This disclaimer highlights that forward-looking statements are subject to inherent business risks, including clinical trial uncertainties and regulatory challenges - Statements regarding pipeline advancement, growth, potential to transform treatment, and development of precision medicines are **forward-looking**[15](index=15&type=chunk) - Actual results may differ from forward-looking statements due to inherent business risks, including interim clinical trial results not being indicative of final outcomes, potential for proof-of-concept to fail, and delays in trials[15](index=15&type=chunk) - Other risks include unexpected adverse side effects, inadequate efficacy, regulatory developments, and the ability to obtain and maintain intellectual property protection[15](index=15&type=chunk)[16](index=16&type=chunk)

Summary of Tyra's Conference Call on Achondroplasia Company Overview - **Company**: Tyra - **Focus**: Structure-based drug design targeting the FGFR family, specifically FGFR3 with their lead compound TYRA-300 [3][4] Industry Context - **Condition**: Achondroplasia, a skeletal dysplasia caused by mutations in FGFR3, affecting growth and development [7][8] - **Market Opportunity**: Estimated 40,000+ children in the US with FGFR3-related conditions and significant potential for growth acceleration therapies [6][78] Key Points and Arguments TYRA-300 Development - **Mechanism**: TYRA-300 is a selective FGFR3 inhibitor designed to reduce toxicity associated with pan-FGFR inhibitors [3][4][14] - **Clinical Data**: Phase 1 data shows potential for significant growth in children with achondroplasia, with preclinical models indicating enhanced long bone growth [9][10][22] - **Target Growth Rates**: Aim to achieve 8-8.5 cm/year in height velocity, surpassing current treatments that yield around 6 cm/year [22][26][73] Selectivity and Safety - **Importance of Selectivity**: FGFR3 selectivity is crucial to avoid side effects seen with pan-FGFR inhibitors, such as phosphate elevation and other toxicities [13][14][19] - **Safety Profile**: Initial data suggests a favorable safety profile with no significant adverse events reported in early trials [31][71] Clinical Trial Design - **Beach 301 Study**: Comprises a sentinel safety cohort and two treatment cohorts for children aged 3-10, with a focus on safety and efficacy [37][38][60] - **Enrollment Status**: Currently open for enrollment with modifications to reduce patient burden, aiming to dose the first patient in the second half of the year [41][42][44] Competitive Landscape - **Comparison with Other Treatments**: Current treatments like vosoritide and TransCon CNP have shown limited efficacy compared to the anticipated outcomes with TYRA-300 [28][79] - **Market Potential**: The total addressable market for FGFR3 inhibitors could reach billions, with a significant population of children with open growth plates [78] Future Outlook - **Efficacy Expectations**: Anticipated that TYRA-300 will demonstrate superior efficacy compared to existing treatments, with a focus on achieving meaningful growth outcomes [66][72] - **Strategic Partnerships**: Open to collaborations but confident in the ability to commercialize TYRA-300 independently [50][51] Additional Important Insights - **Genetic Evidence**: Strong genetic data supports FGFR3's role in growth regulation, with implications for broader applications beyond achondroplasia [8][81] - **Long-term Vision**: Potential to address idiopathic short stature and other growth-related conditions, expanding the therapeutic landscape for FGFR3 inhibitors [78][80] This summary encapsulates the critical insights from Tyra's conference call, highlighting the company's strategic focus, clinical development plans, and the broader implications for the treatment of achondroplasia and related conditions.

Company Overview - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting opportunities in Fibroblast Growth Factor Receptor (FGFR) biology [1] - The company utilizes an in-house precision medicine platform called SNÅP, which enables rapid and precise drug design through iterative molecular SNÅPshots [1] - Tyra has a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions [1] Lead Product and Clinical Development - The lead product, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor designed to avoid toxicities associated with FGFR1, FGFR2, and FGFR4 inhibition [1] - TYRA-300's planned clinical development includes three Phase 2 studies: SURF302 for intermediate risk non-muscle invasive bladder cancer, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial cancer [1] - Other investigational products include TYRA-200, an oral FGFR1/2/3 inhibitor for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers [1] Upcoming Event - Company management will participate in a virtual fireside chat as part of the UBS Biotech Management Live Call Series on July 25, 2025 [2] - The event will feature key management personnel including Todd Harris (CEO), Doug Warner (CMO), and Alan Fuhrman (CFO) [2] - The session is scheduled for 11 am ET and will be hosted by Ellie Merle, a US SMID Cap Biotechnology Analyst at UBS [2]

Group 1 - Tyra Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation precision medicines targeting FGFR biology [4] - The company announced that a late-breaking abstract for TYRA-300 has been accepted for presentation at The Endocrine Society's Annual Meeting (ENDO 2025) [1] - TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for cancer and skeletal dysplasia, with interim clinical proof-of-concept results in metastatic urothelial cancer [2][4] Group 2 - The planned clinical development for TYRA-300 includes three Phase 2 clinical trials: SURF302 for intermediate risk non-muscle invasive bladder cancer, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial cancer [2][4] - Tyra Biosciences utilizes its in-house SNÅP platform for rapid and precise drug design, which helps predict genetic alterations that may cause resistance to existing therapies [4] - The company is also developing additional investigational drugs, including TYRA-200 and TYRA-430, targeting various FGFR-related cancers [4]