Tyra Biosciences, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. Tyra is a clinical-stage biotechnology company developing precision medicines focused on FGFR biology. It has not generated revenue.
Financial performance and liquidity
- Revenue: None. The company reported no product revenue and expects no product sales revenue until a candidate is approved, if ever.
- Operating expenses: $14.3 million, down $0.5 million from $14.8 million in Q1 2022. R&D was $10.4 million, up $0.8 million; G&A was $3.9 million, down $1.3 million.
- Net loss: $11.9 million, compared with $14.8 million in Q1 2022. Net loss per share was $0.28 versus $0.36.
- Other income: $2.5 million, principally interest income, versus less than $0.1 million in Q1 2022. The filing attributes the increase to higher returns on cash.
- Cash flow: Operating cash use was $9.8 million, compared with $8.9 million in Q1 2022. Investing cash use was $0.04 million; financing provided $0.4 million. Cash, cash equivalents and restricted cash decreased $9.5 million during the quarter.
- Cash and liquidity: Cash and cash equivalents were $241.7 million at March 31, 2023; an additional $1.0 million was restricted. Management believes existing cash and cash equivalents will fund operating expenses and capital expenditures through at least 2024, subject to forecast uncertainty.
- Debt and obligations: The balance sheet shows no debt balance. Lease liabilities totaled $2.6 million; aggregate future operating lease commitments were $9.0 million, including leases not yet commenced. Total liabilities were $6.3 million.
- Margins: Not meaningful to assess because the company has no revenue.
Material changes versus Q1 2022
- R&D expense increased 8% to $10.4 million, primarily due to higher personnel-related costs.
- G&A expense decreased 24% to $3.9 million, mainly reflecting lower compensation and stock-based compensation costs, partly offset by higher other operating expenses.
- Net loss narrowed by $2.9 million, largely because interest income rose by $2.4 million and operating expenses declined by $0.5 million.
- Operating cash use increased by $0.9 million. Cash and cash equivalents were $241.7 million at quarter-end, down from $251.2 million at December 31, 2022.
Programs, outlook and risks
- TYRA-300: The Phase 1/2 SURF301 trial for FGFR3-altered advanced solid tumors began dosing patients in November 2022. In March 2023, Tyra announced expansion into achondroplasia based on preclinical results and anticipated an IND submission for a pediatric Phase 2 study in 2024.
- TYRA-200: The FDA cleared the IND in January 2023. The company anticipated dosing the first patient in a Phase 1 trial focused on intrahepatic cholangiocarcinoma in the second half of 2023.
- Management expects R&D and G&A expenses to increase as programs advance, trials and preclinical work continue, and the company expands its operations. These are forward-looking expectations, not assured outcomes.
- Future funding may be needed. Tyra has an at-the-market facility permitting up to $150 million of sales, but had issued no shares under it by March 31, 2023. Additional equity financing could dilute shareholders; financing or partnership terms may also restrict the company or require it to relinquish rights.
- Key uncertainties include clinical and preclinical results, patient enrollment, safety and efficacy, regulatory decisions, manufacturing, trial costs and timing, and the company’s ability to obtain future financing. The company reported no material legal proceedings and no material changes to its previously disclosed risk factors.
Important facts for investors to verify
- Whether TYRA-300 and TYRA-200 trials meet the company’s stated development timelines and produce acceptable safety and efficacy results.
- Whether the anticipated 2024 achondroplasia IND submission remains on track.
- How actual cash burn compares with management’s runway estimate through at least 2024, particularly as clinical activity expands.
- Whether Tyra uses its $150 million ATM facility or pursues other financing, and the resulting dilution or terms.
- The timing, costs and obligations associated with the uncommenced expansion lease and other future commitments.