Tyra Biosciences, Inc. — Q3 2023 Form 10-Q
Reporting period: Three and nine months ended September 30, 2023. Tyra is a clinical-stage biotechnology company developing precision medicines targeting FGFR biology. It has not generated revenue; its programs include TYRA-300 and TYRA-200.
Financial highlights
Amounts below are in millions, except per-share data. The company reported no product revenue, so profit margins are not meaningful.
| Metric | Q3 2023 | Q3 2022 | Nine months 2023 | Nine months 2022 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense | $19.3 | $10.9 | $41.8 | $32.6 |
| General and administrative expense | $4.7 | $2.7 | $12.5 | $11.3 |
| Total operating expenses | $24.0 | $13.6 | $54.3 | $43.9 |
| Net loss | $(21.2) | $(12.5) | $(46.3) | $(42.4) |
| Net loss per share, diluted | $(0.49) | $(0.30) | $(1.09) | $(1.02) |
| Interest income | $2.8 | $1.1 | $8.0 | $1.5 |
- Operating cash used was $36.6 million for the first nine months of 2023, compared with $38.3 million in 2022. Investing activities used $0.2 million; financing activities provided $1.2 million. Cash, cash equivalents and restricted cash declined $35.6 million during the period.
- At September 30, 2023, cash and cash equivalents were $215.7 million; restricted cash was $1.0 million. Current assets were $224.6 million and current liabilities were $10.1 million. Total liabilities were $16.2 million, including $6.1 million of operating lease liabilities. No borrowings are reported.
- Accumulated deficit was $142.0 million. The company reported 42.9 million common shares outstanding at September 30, 2023; 43,058,747 were outstanding as of November 6, 2023.
Material changes and operating performance
- Q3 operating expenses rose $10.3 million year over year, and net loss widened $8.6 million. For the first nine months, operating expenses increased $10.4 million and net loss widened $3.9 million.
- Management attributed higher R&D costs mainly to clinical-trial and drug-manufacturing work, compensation and stock-based compensation; Q3 R&D also included increased TYRA-300, TYRA-300 achondroplasia and FGFR4 program spending. G&A growth reflected compensation, stock-based compensation and professional services.
- Higher interest income partly offset operating losses, increasing $6.5 million for the nine-month period, primarily due to better returns on cash and cash equivalents.
- Cash and cash equivalents fell from $251.2 million at December 31, 2022 to $215.7 million at September 30, 2023. Total assets declined to $238.4 million from $266.2 million, while stockholders’ equity declined to $222.2 million from $257.8 million.
Outlook, risks and other notable items
- Management believes existing cash and cash equivalents will fund operating expenses and capital expenditures through at least 2024. This is an estimate subject to uncertainty; the company expects continuing significant expenses and operating losses.
- TYRA-300 is in a Phase 1/2 oncology study; the first patient was dosed in November 2022. The company is also developing TYRA-300 for achondroplasia and anticipated an IND submission in 2024. The FDA granted orphan drug designation for achondroplasia in July 2023.
- TYRA-200 received FDA clearance to proceed with a Phase 1 trial, with first-patient dosing anticipated by the end of 2023.
- Future funding may require equity, debt or collaboration arrangements. Additional financing may be unavailable or unfavorable, could dilute shareholders or restrict operations, and failure to raise funds could require program delays, reductions or termination.
- Development costs and timing depend on clinical progress, enrollment, safety, regulatory decisions and manufacturing, among other factors. The company has no product revenue and may never obtain approval or generate revenue.
- Future operating lease commitments totaled $9.0 million at September 30, 2023. The company reported no material legal proceedings, no material changes to previously disclosed risk factors, and effective disclosure controls and procedures.
Important facts for investors to verify
- Whether cash burn and program spending remain consistent with management’s stated runway through at least 2024.
- Clinical progress, safety, enrollment and data for TYRA-300 and TYRA-200, and the timing and requirements for the planned achondroplasia IND.
- Whether the company draws on its $150 million at-the-market facility; no shares had been sold under it as of September 30, 2023.
- Potential dilution from equity awards: 8.1 million stock options were outstanding at September 30, 2023.
- The effect of trial, regulatory, manufacturing and financing risks on development timelines, cash needs and potential future commercialization.