Tyra Biosciences(TYRA) - 2024 Q3 - Quarterly Report

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].