Tyra Biosciences(TYRA) - 2025 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2025, the company reported net losses of $86.1 million, compared to $60.9 million for the same period in 2024, indicating a year-over-year increase of approximately 41% in losses[86]. - Net loss for the three months ended September 30, 2025, was $29.9 million, compared to a net loss of $24.0 million in 2024, representing an increase of $5.9 million[98]. - Total operating expenses for the nine months ended September 30, 2025, were $96.2 million, an increase of $21.8 million from $74.4 million in 2024[104]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $71.5 million, compared to $50.2 million in 2024, reflecting an increase of $21.3 million[112]. - Research and development expenses increased to $25.5 million for the three months ended September 30, 2025, compared to $22.7 million in 2024, reflecting a $2.8 million increase[99]. - Research and development expenses for the nine months ended September 30, 2025, totaled $74.7 million, an increase of $16.8 million from $57.9 million in 2024[105]. - General and administrative expenses rose to $7.5 million for the three months ended September 30, 2025, up from $5.9 million in 2024, primarily due to higher personnel costs[100]. - Other income decreased to $3.1 million for the three months ended September 30, 2025, down from $4.6 million in 2024, a decline of $1.5 million[101]. - The company reported a decrease in total other income for the nine months ended September 30, 2025, to $10.1 million from $13.5 million in 2024, a decline of $3.4 million[108]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $337.4 million and cash, cash equivalents, and marketable securities totaling $274.9 million[86]. - The company expects to continue incurring significant operating losses, particularly as it conducts preclinical studies and clinical trials, and anticipates that its cash reserves will be sufficient to fund operations through at least 2027[88]. - The company plans to finance its operations through equity offerings and other capital sources until it can generate significant revenue from product sales[88]. - 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 2027[119]. - Future capital requirements will depend on various factors, including the ability to generate substantial product revenues to support the cost structure[120]. - The company may finance cash needs through equity offerings, debt financings, or other capital sources, but may be unable to raise additional funds on favorable terms[120]. - The company has material cash requirements for expected operating expenses related to clinical trials and research and development activities[117]. Clinical Development - The lead program, dabogratinib, is currently in multiple Phase 2 clinical studies targeting pediatric achondroplasia and low-grade bladder cancer, with initial results expected in the second half of 2026[78][79]. - In the SURF301 study, 54.5% of patients with FGFR3+ metastatic urothelial carcinoma achieved a confirmed partial response when receiving doses of dabogratinib ≥ 90 mg once daily[81]. - TYRA-430 is currently being evaluated in a global Phase 1 study for advanced hepatocellular carcinoma, with patient dosing commenced in April 2025[83]. - The research and development expenses are expected to increase substantially as the company advances its product candidates through clinical trials and expands its pipeline[90]. - The process of conducting preclinical studies and clinical trials is costly, and the timing of progress and expenses is uncertain[119]. Risks and Uncertainties - The costs and timing of manufacturing for current or future product candidates, including commercial scale manufacturing, are uncertain[121]. - The company faces risks related to the costs and timing of regulatory review of current or future product candidates[121]. - The company may need to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations[122]. - As of September 30, 2025, there have been no material changes to critical accounting policies and estimates compared to the previous annual report[125]. - There have been no material changes surrounding market risk, including interest rate risk and inflation risk, from the previous annual report[127]. Other Information - The company completed a private placement on February 6, 2024, raising approximately $199.6 million in net proceeds[109]. - As of September 30, 2025, the total future aggregate operating lease commitments were $8.0 million, with approximately $0.2 million due during 2025, and the remaining due from 2026 through 2033[124].