[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]

Summary of Tyra Biosciences (TYRA) 2025 Conference Call Company Overview - **Company**: Tyra Biosciences (TYRA) - **Focus**: Development of small molecule precision medicines, particularly targeting FGFR (Fibroblast Growth Factor Receptor) inhibitors, with a lead molecule that is FGFR3 selective [3][4] Key Points and Arguments Platform Differentiation - Tyra utilizes a proprietary **Snap Chemistry Design Platform** for structure-based drug design, allowing for the creation of selective FGFR3 inhibitors, unlike existing pan FGFR inhibitors [3][4][5] - The FGFR3 selective molecule is the first of its kind to enter clinical trials, showing positive results in Phase 1 studies [5] Unmet Needs in NMIBC - In **Non-Muscle Invasive Bladder Cancer (NMIBC)**, 70-80% of cases have FGFR3 alterations, with high recurrence rates (30% at one year, 40% at two years) under standard treatments [7][8] - Tyra's oral therapy, TYR-300, addresses the need for non-procedure-based treatments, contrasting with existing intra-vesical therapies [8] Safety and Efficacy - Emphasis on safety and tolerability is crucial due to the long treatment duration in MIBC [9][10] - Initial signals of activity will be assessed through complete response rates at three months, with expectations for data release in early next year [11][12] Achondroplasia Treatment - Tyra is also evaluating TYR-300 in **achondroplasia**, where existing therapies fall short in addressing the height gap compared to non-affected children [14][15] - Current treatments yield limited height increases, while Tyra aims to achieve an annualized height velocity of 8-8.5 cm, significantly higher than existing options [20][30] Competitive Landscape - TYR-300 is differentiated from competitors like Erdafitinib and Loxo in terms of side effect profiles and efficacy [23][24] - TYR-300 shows lower rates of nail toxicity and stomatitis compared to Erdafitinib, and better tolerability than Loxo's BID dosing regimen [23][24] Benchmarks for Success - For NMIBC, achieving a complete response rate of at least 70% with a well-tolerated dose is a key benchmark [28][29] - In achondroplasia, exceeding a height velocity of 6 cm to reach 8-8.5 cm is targeted [30] Financial Position and Prioritization - Tyra is well-capitalized with $318 million available, projected to last through 2027 [31] - Focus on prioritizing cash management and key Phase 2 readouts in NMIBC and achondroplasia while being cautious about entering Phase 3 trials prematurely [32] Additional Important Content - The discussion highlighted the importance of managing cash effectively while pursuing multiple clinical trials across different indications [31][32] - The company is strategically opening more sites for NMIBC and achondroplasia while limiting expansion in other areas to ensure resource allocation aligns with priority programs [32]

Financial Performance - For the three months ended March 31, 2025, the company reported a net loss of $28.1 million, compared to a net loss of $18.2 million for the same period in 2024, indicating a year-over-year increase of approximately 54.4% in losses[82] - The net loss for the three months ended March 31, 2025, was $28.1 million, compared to a net loss of $18.2 million in the same period of 2024, an increase of 54.7%[96] - Other income decreased to $3.7 million in Q1 2025 from $4.1 million in Q1 2024, a decline of 9.8% due to lower interest rates[100] - Net cash used in operating activities was $25.5 million for Q1 2025, compared to $22.0 million in Q1 2024, an increase of 15.5%[104] Cash and Funding - As of March 31, 2025, the company had an accumulated deficit of $279.5 million and cash, cash equivalents, and marketable securities totaling $318.9 million, which is expected to fund operations through at least 2027[84] - The company anticipates that its cash needs will be financed through equity offerings, debt financings, or other capital sources until significant revenue generation occurs[84] - The company believes existing cash, cash equivalents, and marketable securities will be sufficient to meet anticipated operating expenses through at least 2027[111] - The company completed a private placement on February 6, 2024, raising approximately $199.6 million in net proceeds[101] Operating Expenses - For the three months ended March 31, 2025, total operating expenses increased to $31.9 million from $22.3 million in 2024, representing a 42.7% increase[96] - Research and development expenses rose to $25.0 million in Q1 2025, up from $17.2 million in Q1 2024, marking a 45.1% increase[97] - General and administrative expenses increased to $6.9 million in Q1 2025, compared to $5.1 million in Q1 2024, reflecting a 35.3% rise[98] - General and administrative expenses are expected to rise due to increased research and development activities and costs associated with operating as a public company[93] Clinical Development - The company has not generated any revenue to date and does not expect to do so until successful completion and regulatory approval of its product candidates, which may take several years[84] - The lead program, TYRA-300, is expected to be evaluated in three Phase 2 studies, with the first patient dosing anticipated in the second quarter of 2025 for both BEACH301 and SURF302 studies[75][76] - In the ongoing SURF301 study for metastatic urothelial carcinoma, interim data showed that 6 out of 11 patients (54.5%) achieved a confirmed partial response at doses ≥ 90 mg once daily[77] - The company is focused on developing next-generation precision medicines targeting FGFR biology, with three clinical-stage product candidates: TYRA-300, TYRA-200, and TYRA-430[70][71] - TYRA-200 is currently being evaluated in a Phase 1 clinical study aimed at addressing resistance mutations in intrahepatic cholangiocarcinoma[79] Lease Commitments - As of March 31, 2025, total future aggregate operating lease commitments were $8.5 million, with approximately $0.7 million due during 2025[116]

Financial Position - As of March 31, 2025, Tyra Biosciences had cash, cash equivalents, and marketable securities totaling $318.9 million, providing a runway through at least 2027[11]. - Total current assets decreased from $347,463,000 on December 31, 2024, to $324,566,000 on March 31, 2025, a decline of approximately 6.6%[21]. - Total liabilities decreased slightly from $20,407,000 on December 31, 2024, to $19,942,000 on March 31, 2025, a reduction of about 2.3%[21]. - Stockholders' equity decreased from $343,151,000 on December 31, 2024, to $323,534,000 on March 31, 2025, a decline of approximately 5.7%[21]. Research and Development - Research and Development (R&D) expenses for Q1 2025 were $25.0 million, up from $17.2 million in Q1 2024, primarily due to increased clinical costs for BEACH301, SURF302, and SURF431[11]. - Research and development expenses increased significantly from $17,203,000 in Q1 2024 to $24,964,000 in Q1 2025, representing a rise of about 45.4%[23]. - The BEACH301 study for TYRA-300 in pediatric achondroplasia is now open for enrollment, with plans to dose the first child in Q2 2025[11]. - The SURF302 study for TYRA-300 in intermediate risk non-muscle invasive bladder cancer (IR NMIBC) is set to dose its first patient in Q2 2025[11]. - TYRA-300 is being evaluated in multiple studies, including a Phase 2 study for IR NMIBC with an enrollment target of up to 90 participants[4]. - The SURF431 study for TYRA-430 in advanced hepatocellular carcinoma (HCC) has initiated patient dosing, focusing on safety and preliminary antitumor activity[7]. - Preclinical results for TYRA-300 demonstrated significant increases in bone growth in FGFR3-driven models, indicating its potential for treating skeletal dysplasia[5]. - Tyra Biosciences continues to advance its SNÅP platform for precision medicine, aimed at developing targeted therapies for oncology and genetically defined conditions[8]. Operating Expenses and Losses - General and Administrative (G&A) expenses for Q1 2025 were $6.9 million, compared to $5.1 million in Q1 2024, driven by higher personnel-related costs[11]. - The net loss for Q1 2025 was $28.1 million, an increase from $18.2 million in the same period in 2024[11]. - Total operating expenses rose from $22,322,000 in Q1 2024 to $31,850,000 in Q1 2025, an increase of approximately 42.7%[23]. - Net loss for Q1 2025 was $28,147,000, compared to a net loss of $18,192,000 in Q1 2024, reflecting an increase in losses of about 54.9%[23]. - Net loss per share, basic and diluted, increased from $0.35 in Q1 2024 to $0.47 in Q1 2025[23]. - Comprehensive loss for Q1 2025 was $28,229,000, compared to $18,579,000 in Q1 2024, indicating an increase of approximately 52.5%[23]. - Weighted-average shares used to compute net loss per share increased from 52,228,934 in Q1 2024 to 59,336,550 in Q1 2025, an increase of about 13.5%[23]. Income and Revenue - Interest and other income decreased from $4,130,000 in Q1 2024 to $3,703,000 in Q1 2025, a decline of about 10.3%[23].

Financial Performance - The company incurred significant net losses of $86.5 million and $69.1 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $251.3 million as of December 31, 2024[216]. - The company expects to continue incurring significant net losses for the foreseeable future as it develops and seeks marketing approval for its product candidates[216]. - The company believes its existing cash, cash equivalents, and marketable securities will fund operations through at least 2027, but may need to seek additional funds sooner than planned[221]. - The company may not achieve or sustain profitability, adversely affecting its business and financial condition[324]. - The company has U.S. federal and state net operating loss (NOL) carryforwards of approximately $80.5 million and $52.2 million, respectively, as of December 31, 2024[396]. - U.S. federal NOLs generated after December 31, 2017, can be carried forward indefinitely but can only offset 80% of taxable income starting from years after December 31, 2020[397]. - The company may face limitations on its ability to utilize NOL carryforwards due to ownership changes, which could increase future income tax liabilities[398]. Product Development and Clinical Trials - The company has three product candidates in clinical development, with other programs in preclinical or discovery stages, and has not completed any clinical trials or obtained regulatory approvals[213]. - The company has not yet demonstrated an ability to successfully commercialize biopharmaceutical products, making future predictions about success uncertain[214]. - Successful completion of preclinical studies and favorable results are critical for the acceptance of INDs by the FDA, which is necessary to initiate clinical trials[229]. - The company has never completed any clinical trials or submitted a marketing application, which may hinder the development of its product candidates[231]. - Preclinical and clinical development is lengthy and expensive, with a high historical failure rate for product candidates in the biopharmaceutical industry[232]. - The company may face delays in clinical trials due to various factors, including regulatory approvals and patient enrollment challenges[240]. - Any delays in clinical trials could harm the commercial prospects of the product candidates and delay revenue generation[244]. - The company must establish commercial manufacturing capabilities and sales, marketing, and distribution capabilities to launch products if approved[229]. - The company is focused on developing targeted therapeutics for genomically defined cancers, an emerging and unproven field[237]. - The proprietary SNÅP platform is still in early development stages, with no completed clinical trials or proven product candidates yet[245]. - Patient enrollment for clinical trials is critical and may be affected by factors such as disease severity and proximity to clinical sites[247]. - The patient populations for product candidates are limited and may not be large enough to support successful commercialization[248]. - Delays in patient recruitment could significantly impact the timeline for clinical trials and marketing approval[249]. - The company faces risks related to side effects and adverse events that could hinder clinical trials and market acceptance[251]. - Regulatory authorities may impose additional requirements or delays in the approval process, impacting commercialization efforts[259]. - The company may need to conduct additional studies to support broader claims for its product candidates, potentially impacting revenue generation[274]. - The company has conducted clinical trials for certain product candidates outside the United States, but the FDA may not accept data from these trials, delaying development plans[287]. Regulatory and Compliance Risks - The regulatory landscape for clinical trials in the EU has changed, which may impact the company's development plans[236]. - Companion diagnostics are essential for patient selection, and the company plans to rely on third parties for their development[265]. - The FDA generally requires that companion diagnostics be approved simultaneously with the therapeutic product[268]. - The FDA announced plans to reclassify most in vitro diagnostic tests (IVDs) from Class III to Class II, which may simplify the approval process for companion diagnostics[273]. - The new In Vitro Medical Devices Regulation (IVDR) became applicable on May 26, 2022, establishing a uniform regulatory framework across the EU for medical devices[270]. - Companion diagnostics now require a conformity assessment by a notified body, which must seek a scientific opinion from the European Medicine Agency (EMA) for certain medicinal products[271]. - The company may face challenges in obtaining regulatory approvals for companion diagnostics, which could delay the marketing of related product candidates[272]. - The company may seek FDA approval through the accelerated approval pathway, which could expedite the commercialization of product candidates designed to treat serious conditions[292]. - If the FDA does not accept data from clinical trials conducted outside the U.S., it may result in costly and time-consuming additional trials, delaying product development[288]. - The FDA's new authority to mitigate risks from ineffective drugs could complicate the accelerated approval process for the company's product candidates[294]. - The company faces potential delays in clinical development and marketing approvals due to reliance on third-party manufacturers and the limited number of compliant facilities[303]. - Regulatory compliance is critical, and failure to adhere to GLP and GCP requirements may result in unreliable clinical data and additional studies[315]. - Legislative changes, such as the Affordable Care Act, may increase the difficulty and cost of obtaining marketing approval for product candidates[365]. - The Budget Control Act of 2011 resulted in reductions to Medicare payments, which will remain in effect until 2032 unless further action is taken[368]. - The Inflation Reduction Act of 2022 (IRA) mandates price negotiations for certain drugs with Medicare starting in 2026, which may impact future revenue[369]. - The IRA imposes penalties for price increases that exceed inflation, with rebates due in 2023[369]. - Increased state-level regulations on pharmaceutical pricing may lead to reduced demand and pressure on product pricing[370]. - Future healthcare reforms could result in additional reductions in Medicare funding and downward pressure on product prices[372]. Competition and Market Risks - The company faces significant competition in the biopharmaceutical industry, which could adversely affect its ability to develop and commercialize products[215]. - The company faces significant competition from larger, better-funded pharmaceutical companies and ongoing development of competitive products in the precision oncology field[336]. - There are currently three marketed pan-FGFR inhibitors, indicating a competitive landscape for the company's product candidates[338]. - The company’s revenue may be adversely affected if the market opportunities for its product candidates are smaller than anticipated[340]. Operational and Strategic Risks - The company will require substantial additional capital to achieve its goals, and failure to obtain this capital could delay or terminate development programs[219]. - The company relies on third parties for clinical trials and manufacturing, increasing the risk of delays or insufficient product quantities[215]. - The company may seek collaborations and licenses for product development but faces challenges in establishing favorable terms and may relinquish valuable rights[312]. - The success of collaborations is uncertain, and unfavorable terms may hinder the company's ability to maintain these partnerships[313]. - The company currently lacks a marketing and sales organization, necessitating significant investment to develop these capabilities or collaborate with third parties[327]. - The company faces risks in building a sales organization, including hiring and retaining qualified personnel, which could impact product commercialization[329]. - The company is subject to litigation and government investigations, which could result in significant fines and operational impacts[388]. - Noncompliance with regulatory standards by employees or contractors could expose the company to legal risks and penalties[390]. - The company may incur substantial costs related to compliance with health and safety regulations, which could adversely affect financial condition[375]. - Cybersecurity threats pose a risk to the company's information technology systems, potentially disrupting product development and harming reputation[383]. - The company faces risks related to patent protection, as competitors may develop similar technologies if adequate protection is not obtained[400]. - The patent prosecution process is complex and costly, and the company may not be able to secure necessary patent protections in a timely manner[403]. - The company may struggle to protect its intellectual property rights globally due to varying enforcement standards in different jurisdictions[408]. - Competitors may exploit the company's technologies in regions where patent protection is not secured, potentially impacting market competitiveness[409]. Workforce and Growth - As of March 25, 2025, the company had 60 full-time employees, with plans to expand its workforce to support development and commercialization efforts[350]. - The company's future growth may depend on its ability to navigate foreign markets, which involve additional regulatory burdens and uncertainties[342]. - The company's future financial performance will depend on its ability to manage growth effectively and may require significant management attention[351]. - Failure to expand the organization by hiring new employees or engaging third-party service providers could hinder the development and commercialization of product candidates[352].

Financial Performance - Cash, cash equivalents, and marketable securities totaled $341.4 million at the end of 2024, up from $203.5 million at the end of 2023, primarily due to a private placement financing that generated net proceeds of $199.6 million[10]. - The net loss for Q4 2024 was $25.6 million, compared to $22.8 million in Q4 2023, with a full-year net loss of $86.5 million versus $69.1 million in 2023[11]. - Total operating expenses for the year ended December 31, 2024, were $104,177,000, compared to $79,945,000 in 2023, reflecting a 30% increase[24]. - Net loss for the year ended December 31, 2024, was $86,481,000, compared to $69,134,000 in 2023, indicating a 25% increase in losses[24]. - Comprehensive loss for the year ended December 31, 2024, was $86,092,000, up from $68,753,000 in 2023, a 25% increase[24]. - Net loss per share, basic and diluted, improved to $(1.51) in 2024 from $(1.62) in 2023[24]. Research and Development - Research and development expenses for Q4 2024 were $22.2 million, compared to $20.7 million in Q4 2023, and full-year R&D expenses were $80.1 million, up from $62.5 million in 2023[10]. - Research and development expenses increased to $80,077,000 in 2024 from $62,518,000 in 2023, a rise of 28%[24]. - TYRA-300 is being evaluated in three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial cancer[4]. - In the SURF301 study, 54.5% of patients with FGFR3+ metastatic urothelial cancer achieved a confirmed partial response at doses of ≥ 90 mg QD, with a 100% disease control rate[5]. - The SURF302 study will enroll up to 90 participants with FGFR3-altered low-grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer, with a primary endpoint of complete response rate at three months[4]. - TYRA-200 is currently in a Phase 1 study (SURF201) for advanced cholangiocarcinoma and other solid tumors, while TYRA-430 has received IND clearance for a Phase 1 study in advanced hepatocellular carcinoma[6][7]. Leadership and Strategy - The company appointed new leadership, including Doug Warner as Chief Medical Officer and Erik Goluboff as SVP of Clinical Development, to enhance its oncology strategy[8]. Assets and Equity - Total assets increased to $363,558,000 in 2024 from $225,857,000 in 2023, representing a growth of 61%[22]. - Total stockholders' equity increased to $343,151,000 in 2024 from $204,262,000 in 2023, a growth of 68%[22]. Cash Position - Cash and cash equivalents rose to $91,966,000 in 2024, up from $58,006,000 in 2023, a 58% increase[22]. - The company expects its current cash position to support operations through at least 2027, allowing for continued advancement of its clinical programs[10]. - Total current liabilities decreased to $14,594,000 in 2024 from $15,333,000 in 2023, a reduction of 5%[22]. Income and Expenses - General and administrative expenses for Q4 2024 were $7.6 million, compared to $5.0 million in Q4 2023, with full-year G&A expenses increasing to $24.1 million from $17.4 million[11]. - Interest and other income, net, increased to $17,696,000 in 2024 from $10,811,000 in 2023, a growth of 64%[24].

Core Insights - Tyra Biosciences has received FDA clearance for three Investigational New Drug (IND) applications for its precision small molecule, TYRA-300, which will be evaluated in three Phase 2 studies targeting various cancers and skeletal dysplasia [1][2][3] Clinical Development - TYRA-300 is being advanced into three Phase 2 studies: SURF302 for Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC), BEACH301 for pediatric achondroplasia (ACH), and SURF301 for metastatic urothelial cancer (mUC) [1][3] - The SURF302 study will enroll up to 90 participants and aims to evaluate the efficacy and safety of TYRA-300 in patients with FGFR3-altered low-grade, IR NMIBC [3] - The BEACH301 study will focus on children aged 3 to 10 with achondroplasia, enrolling treatment-naïve and previously treated participants [3] - Interim results from the SURF301 study showed that 54.5% of heavily pre-treated mUC patients achieved a confirmed partial response at a dose of ≥ 90 mg QD, with a 100% disease control rate [2][3] Financial Performance - As of December 31, 2024, Tyra Biosciences reported cash, cash equivalents, and marketable securities totaling $341.4 million, an increase from $203.5 million at the end of 2023, primarily due to a private placement financing [10] - Research and development expenses for Q4 2024 were $22.2 million, up from $20.7 million in Q4 2023, while full-year R&D expenses rose to $80.1 million from $62.5 million [10][22] - General and administrative expenses for Q4 2024 were $7.6 million, compared to $5.0 million in Q4 2023, with full-year G&A expenses increasing to $24.1 million from $17.4 million [10][22] - The net loss for Q4 2024 was $25.6 million, compared to $22.8 million in Q4 2023, and the full-year net loss was $86.5 million, up from $69.1 million [10][22] Corporate Developments - In 2024, Tyra strengthened its leadership team by appointing new executives to lead its oncology strategy and clinical development plans [6] - The company continues to advance its precision medicine discovery engine, SNÅP, aimed at developing therapies for targeted oncology and genetically defined conditions [7] Upcoming Milestones - The company plans to dose the first child with achondroplasia in the BEACH301 study and the first patient with IR NMIBC in the SURF302 study in Q2 2025 [10][11]