Tyra Biosciences, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Tyra is a clinical-stage biotechnology company developing precision medicines targeting FGFR biology; it has not generated revenue.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 / prior period |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $17.2 million | $10.4 million |
| General and administrative expense | $5.1 million | $3.9 million |
| Total operating expenses | $22.3 million | $14.3 million |
| Interest and other income, net | $4.1 million | $2.5 million |
| Net loss | $18.2 million | $11.9 million |
| Net loss per share, basic and diluted | $0.35 | $0.28 |
| Net cash used in operating activities | $22.0 million | $9.8 million |
At March 31, 2024, cash and cash equivalents were $254.4 million and marketable securities were $128.1 million, totaling $382.5 million. Management expects these resources to fund operating expenses and capital expenditures through at least 2026, subject to execution and other uncertainties. The company reported total liabilities of $14.9 million, including $6.5 million of operating lease liabilities; no material borrowings are reported. No operating margin is meaningful because the company has no revenue.
Material changes and financing
- Net loss increased $6.3 million year over year, as operating expenses grew $8.0 million, partly offset by a $1.7 million increase in interest and other income.
- R&D expense rose $6.8 million, primarily from higher CRO and drug-manufacturing costs ($4.5 million), personnel costs ($1.2 million), stock-based compensation ($1.0 million), and facilities and other costs ($0.5 million), partly offset by lower preclinical expenses.
- G&A expense increased $1.2 million, mainly due to higher stock-based compensation, professional services, and personnel costs.
- In February 2024, Tyra raised approximately $200 million gross through a private placement of common stock and pre-funded warrants. The transaction contributed to a substantial increase in cash and equity; issued common shares rose from 43.0 million at year-end 2023 to 52.5 million at March 31, 2024. The warrants cover another 6.1 million shares and are exercisable for nominal consideration.
- Stock-based compensation was $4.1 million, versus $2.4 million in Q1 2023. Accumulated deficit reached $183.0 million.
Pipeline, outlook, and risks
- TYRA-300: The FGFR3-selective candidate is in the Phase 1 SURF301 trial for advanced solid tumors. Dose escalation concluded without determining a maximum tolerated dose; expansion cohorts are assessing once- and twice-daily doses. Initial Phase 1 results are expected for presentation in the second half of 2024.
- TYRA-300 for achondroplasia: The company is conducting IND-enabling work and plans to submit an IND application in the second half of 2024 for a planned Phase 2 study in children. The FDA granted Orphan Drug Designation and Rare Pediatric Disease Designation.
- TYRA-200: The FGFR1/2/3 inhibitor is being evaluated in the Phase 1 SURF201 study for FGFR2-altered cholangiocarcinoma and other advanced solid tumors.
- TYRA-430: The FGFR4/3-selective candidate is in IND-enabling development.
- Tyra expects significant expenses and operating losses to continue as it advances research and clinical programs. It has no product revenue and may need additional financing; equity financing could dilute shareholders, while collaborations could require granting rights to technologies or candidates.
- Clinical and regulatory outcomes, trial timing and costs, manufacturing, enrollment, and market conditions could differ from expectations. The company cautions that its runway estimate relies on assumptions and that it could use capital sooner than anticipated.
- Future operating lease commitments totaled $9.3 million. The company reported no material pending or threatened legal proceedings and no material changes to its previously disclosed risk factors.
Key facts for investors to verify
- Whether SURF301 results are presented in the second half of 2024 and what safety and antitumor activity they show.
- Whether the TYRA-300 achondroplasia IND is submitted on the stated timeline and the proposed trial design.
- Enrollment, dose selection, and emerging data for SURF201 and other pipeline programs.
- Quarterly cash burn, investment income, and whether the stated runway through at least 2026 remains supportable.
- Potential dilution from the 6.1 million pre-funded warrants, equity awards, and any future financing.
- How increased R&D spending and stock-based compensation evolve as clinical development advances.