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]

Core Insights - Tyra Biosciences, Inc. announced the acceptance of two abstracts for presentation at the 2025 ASCO Gastrointestinal Cancers Symposium, highlighting its focus on FGFR biology and precision medicine development [1][4] Group 1: Company Overview - Tyra Biosciences is a clinical-stage biotechnology company specializing in next-generation precision medicines targeting FGFR biology [4] - The company utilizes an in-house precision medicine platform called SNÅP for rapid drug design and predicting genetic alterations that may cause resistance to existing therapies [4] - Tyra has a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions [4] Group 2: Clinical Programs - TYRA-200 is an oral FGFR1/2/3 inhibitor currently in a Phase 1 clinical study (SURF201) for advanced intrahepatic cholangiocarcinoma and other solid tumors with FGFR2 gene alterations [2][4] - TYRA-430 is an oral FGFR4/3-biased inhibitor, with FDA clearance for a Phase 1 study in advanced hepatocellular carcinoma and other solid tumors driven by the FGF19/FGFR pathway [3][4] - The SURF201 study for TYRA-200 is designed to evaluate the maximum tolerated dose and preliminary antitumor activity, currently enrolling patients [2]

Core Insights - Tyra Biosciences has received FDA clearance for its IND application for TYRA-300, allowing the initiation of a Phase 2 clinical trial for low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) [1][4] - The company has appointed Dr. Erik Goluboff as SVP of Clinical Development to lead the NMIBC program, bringing over thirty years of experience in urologic oncology [1][4][5] - TYRA-300 is a first-in-class, oral FGFR3-selective inhibitor, targeting a significant patient population with FGFR3 alterations in NMIBC [2][8] Company Overview - Tyra Biosciences is a clinical-stage biotechnology company focused on developing precision medicines targeting FGFR biology, with its lead program being TYRA-300 [9] - The company utilizes its proprietary SNÅP platform for rapid drug design and has a differentiated pipeline with three clinical-stage programs [9] - TYRA-300 is also being evaluated for other indications, including pediatric achondroplasia and metastatic urothelial carcinoma [8][9] Clinical Development - The SURF302 study will enroll up to 90 participants with FGFR3-altered low-grade IR NMIBC, evaluating the efficacy and safety of TYRA-300 [3] - The primary endpoint of the study is the complete response rate at three months, with secondary endpoints including time to recurrence and progression-free survival [3] - Initial patient dosing is expected to begin in Q2 2025, with preliminary data anticipated shortly thereafter [1][4] Market Context - There are over 730,000 individuals living with bladder cancer in the U.S., with many suffering from IR NMIBC, highlighting a significant unmet medical need for better treatment options [6][7] - Current treatments involve invasive procedures and chemotherapy, which can adversely affect patients' quality of life, underscoring the importance of developing more tolerable therapies like TYRA-300 [7]

Financial Performance - As of September 30, 2024, the company reported net losses of $60.9 million, compared to $46.3 million for the same period in 2023, with an accumulated deficit of $225.7 million[72]. - The company has not generated any revenue to date and relies on funding from its IPO and private placements, with significant operating losses expected to continue[72][74]. - Net loss for the three months ended September 30, 2024, was $24.0 million, compared to a net loss of $21.2 million in 2023, an increase of $2.9 million[85]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $50.2 million, compared to $36.6 million for the same period in 2023, reflecting an increase in net loss from $46.3 million to $60.9 million[99][100]. - Other income for the three months ended September 30, 2024, was $4.6 million, up from $2.8 million in 2023, an increase of $1.8 million[89]. - Other income for the nine months ended September 30, 2024, was $13.5 million, compared to $8.0 million in 2023, an increase of $5.5 million[94]. Cash and Funding - The company has cash, cash equivalents, and marketable securities totaling $360.1 million as of September 30, 2024, which is expected to fund operations through at least 2026[75]. - The company completed a private placement in February 2024, raising approximately $200 million before expenses[73]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $201.4 million, a substantial increase from $1.2 million in 2023, mainly from proceeds of $200 million from the 2024 Private Placement[103][104]. - The company believes that existing cash, cash equivalents, and marketable securities will be sufficient to meet anticipated operating expenses and capital expenditures through at least 2026[105]. - The company may need to finance cash needs through equity offerings, debt financings, or other capital sources, which could dilute existing stockholders' ownership[107][108]. Research and Development - The lead product candidate, TYRA-300, is currently in a Phase 1 clinical trial (SURF301) for FGFR3+ advanced solid tumors, with preliminary data showing a 54.5% confirmed partial response rate at doses ≥ 90 mg QD[64][65]. - The company plans to submit an Investigational New Drug (IND) application for a Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by the end of 2024[63]. - In October 2024, the FDA allowed the IND application for TYRA-300 to proceed with a Phase 2 trial for children with achondroplasia, expected to start in Q1 2025[67]. - The company expanded the development of TYRA-300 into hypochondroplasia based on positive preclinical results, demonstrating increases in long bone length[68]. - The second oncology product candidate, TYRA-200, is currently in a Phase 1 clinical study (SURF201) targeting FGFR2+ cholangiocarcinoma and other advanced solid tumors[69][70]. - The company is developing a third candidate, TYRA-430, for advanced hepatocellular carcinoma, with the FDA allowing its IND to proceed with a Phase 1 study[71]. - The company expects research and development expenses to increase substantially over the next several years as it advances product candidates through clinical trials and expands its pipeline[79]. - Research and development expenses increased to $22.7 million for the three months ended September 30, 2024, up from $19.3 million in 2023, representing a $3.4 million increase[86]. - Research and development expenses for the nine months ended September 30, 2024, were $57.9 million, up from $41.8 million in 2023, a $16.1 million increase[91]. Operating Expenses - General and administrative expenses rose to $5.9 million for the three months ended September 30, 2024, compared to $4.7 million in 2023, an increase of $1.2 million[88]. - General and administrative expenses for the nine months ended September 30, 2024, were $16.5 million, compared to $12.5 million in 2023, an increase of $4.0 million[93]. - Total operating expenses for the three months ended September 30, 2024, were $28.6 million, up from $24.0 million in 2023, reflecting a $4.6 million increase[85]. Future Commitments and Risks - As of September 30, 2024, total future aggregate operating lease commitments were $8.9 million, with approximately $0.2 million due during 2024[110]. - Future capital requirements will depend on various factors, including the costs and timing of ongoing and planned preclinical studies and clinical trials[106]. - There have been no material changes to critical accounting policies and estimates during the three and nine months ended September 30, 2024[111]. - As of September 30, 2024, there have been no material changes surrounding market risk, including interest rate risk and inflation risk[113].

Financial Performance - Reported a net loss of $24.0 million for Q3 2024, compared to $21.2 million for the same period in 2023[10] - The net loss for the three months ended September 30, 2024, was $24,016,000, compared to a net loss of $21,152,000 for the same period in 2023, indicating a 13.5% increase in losses[17] - Comprehensive loss for the three months ended September 30, 2024, was $22,080,000, compared to $21,152,000 for the same period in 2023[17] - The accumulated deficit increased to $(225,740,000) as of September 30, 2024, from $(164,830,000) at the end of 2023[16] Expenses - Research and development expenses for Q3 2024 were $22.7 million, up from $19.3 million in Q3 2023, driven by ongoing clinical trials and personnel costs[10] - General and administrative expenses increased to $5.9 million in Q3 2024 from $4.7 million in Q3 2023, primarily due to higher personnel-related costs[10] - Research and development expenses for the three months ended September 30, 2024, were $22,697,000, compared to $19,271,000 for the same period in 2023, representing a 12.6% increase[17] - General and administrative expenses increased to $5,907,000 for the three months ended September 30, 2024, from $4,692,000 in the prior year, a rise of 25.9%[17] - Total operating expenses for the nine months ended September 30, 2024, were $74,433,000, up from $54,311,000 in the same period of 2023, reflecting a 37.1% increase[17] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $360.1 million as of September 30, 2024, expected to support operations through at least 2026[10] - Cash, cash equivalents, and marketable securities increased to $360,130,000 as of September 30, 2024, compared to $203,469,000 on December 31, 2023[16] - Total assets rose to $380,592,000 as of September 30, 2024, up from $225,857,000 at the end of 2023[16] - Total stockholders' equity rose to $362,288,000 as of September 30, 2024, compared to $204,262,000 on December 31, 2023[16] Clinical Development - TYRA-300 demonstrated a 54.5% confirmed partial response rate in 6 out of 11 patients with FGFR3+ metastatic urothelial cancer at doses of ≥ 90 mg once daily[3] - The company plans to submit an IND application for a Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (NMIBC) by year-end 2024[3] - IND clearance received for the Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), expected to dose the first child in Q1 2025[4] - TYRA-200 is advancing in the Phase 1 SURF201 study for FGFR2+ cholangiocarcinoma and other advanced solid tumors[5] - The FDA cleared the IND for TYRA-430, an FGFR4/3-biased inhibitor, to proceed with a Phase 1 study in advanced hepatocellular carcinoma[7] Leadership - Doug Warner, MD, appointed as Chief Medical Officer, bringing over 20 years of clinical development experience[8] Share Information - The weighted-average shares used to compute net loss per share increased to 58,874,497 for the three months ended September 30, 2024, compared to 42,868,340 in the prior year[17]