Tyra Biosciences, Inc. — Q2 2023 Form 10-Q
Reporting period: Quarter and six months ended June 30, 2023. Tyra is a clinical-stage biotechnology company developing precision medicines focused on FGFR biology. It has not generated revenue.
Financial performance and liquidity
| Metric | Q2 2023 | Six months ended June 30, 2023 |
|---|---|---|
| Revenue | No revenue | No revenue |
| Research and development expense | $12.2 million | $22.6 million |
| General and administrative expense | $3.9 million | $7.8 million |
| Total operating expenses | $16.0 million | $30.3 million |
| Net loss | $13.3 million | $25.2 million |
| Net loss per share, basic and diluted | $0.31 | $0.59 |
| Net cash used in operating activities | Not separately presented | $19.5 million |
Gross profit and operating margins are not meaningful because the company reported no revenue. Interest income was $2.8 million for Q2 and $5.2 million for the first half, substantially above the prior-year periods as returns on cash increased.
At June 30, cash and cash equivalents were $232.4 million, plus $1.0 million of restricted cash. Cash and cash equivalents fell $18.8 million from December 31, 2022. Total assets were $250.0 million; total liabilities were $11.4 million, including $6.1 million of lease liabilities. No borrowings or other debt are reported. Undiscounted future operating lease payments were $9.1 million. Management expects current cash to fund operating expenses and capital expenditures through at least 2024, subject to forecast uncertainty.
Changes versus prior comparable periods
- Q2 operating expenses increased $0.6 million year over year. R&D rose $0.1 million, with higher clinical-trial, drug-manufacturing, facility, and personnel costs partly offset by lower preclinical spending; G&A rose $0.5 million.
- First-half operating expenses were nearly flat year over year at $30.3 million. R&D increased $0.9 million as clinical and personnel costs rose, partly offset by lower preclinical expenses; G&A declined $0.8 million.
- Net loss improved to $13.3 million for Q2 from $15.1 million, and to $25.2 million for the first half from $29.9 million. Higher interest income contributed materially to the improvement.
- First-half operating cash use decreased to $19.5 million from $26.1 million in 2022. The company reported $0.7 million of financing cash inflow, mainly from employee stock-plan issuances, and $0.1 million of investing cash use.
Outlook, development, and risks
- TYRA-300 is in a Phase 1/2 trial for FGFR3-altered advanced solid tumors, including metastatic urothelial carcinoma. The company plans additional IND-enabling work for achondroplasia and anticipated an FDA IND submission to enable a pediatric Phase 2 study in 2024. In July 2023, after quarter-end, TYRA-300 received FDA Orphan Drug Designation for achondroplasia.
- TYRA-200 received IND clearance in January 2023; the company anticipated dosing the first patient in its Phase 1 trial in the second half of 2023.
- Tyra expects significant expenses and operating losses to continue, particularly as it advances clinical and preclinical programs. It may need additional financing; equity financing could dilute shareholders, while debt or collaboration arrangements could impose restrictions or require relinquishing rights. The $150 million ATM facility had not been used as of June 30, 2023.
- Clinical, regulatory, manufacturing, enrollment, and funding outcomes remain uncertain. Management said risk factors were not materially changed from the 2022 annual report. No material legal proceedings were reported, and management concluded disclosure controls were effective at a reasonable assurance level.
Key facts investors should verify
- Whether cash use and program spending remain consistent with management’s runway estimate through at least 2024.
- Progress and timing of TYRA-300 and TYRA-200 trials, including the anticipated TYRA-200 first-patient dosing and TYRA-300 achondroplasia IND plans.
- Clinical and regulatory evidence supporting TYRA-300’s potential, including the preclinical findings cited for achondroplasia.
- Potential dilution or changes in financing plans, including any future use of the $150 million ATM facility.
- Growth in lease commitments and stock-based compensation; $24.1 million of unrecognized option compensation remained at quarter-end.