Tyra Biosciences, Inc. — Q3 2022 Form 10-Q
Reporting period: Three and nine months ended September 30, 2022. Tyra is a clinical-stage precision oncology company developing therapies intended to address cancer treatment resistance. It has not generated revenue and expects continued operating losses while advancing its programs.
Financial performance and liquidity
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense | $10.9 million | $5.5 million | $32.6 million | $13.4 million |
| General and administrative expense | $2.7 million | $1.2 million | $11.3 million | $3.0 million |
| Net loss | $12.5 million | $6.6 million | $42.4 million | $16.4 million |
| Net loss per share, basic and diluted | $0.30 | $0.72 | $1.02 | $3.63 |
| Net cash used in operating activities | Not stated for quarter | Not stated for quarter | $38.3 million | $14.7 million |
- At September 30, 2022, cash and cash equivalents were $263.2 million; restricted cash was $1.0 million. Cash, cash equivalents and restricted cash declined $38.2 million during the first nine months.
- Current assets were $267.5 million versus current liabilities of $5.5 million. Total liabilities were $8.2 million, including $2.6 million of lease liabilities. The filing reports no borrowings or other financial debt.
- Accumulated deficit was $82.8 million. No revenue or operating margins were reported; the company is pre-commercial.
Changes versus comparable periods
- Q3 net loss increased $5.9 million year over year as operating expenses rose $7.0 million, partly offset by $1.1 million more other income, primarily interest income.
- Q3 R&D expense increased $5.4 million, principally reflecting higher spending on TYRA-300, TYRA-200 and the SNÅP platform, and higher personnel costs. Q3 G&A expense increased $1.6 million, including higher personnel, professional-services and other operating costs.
- For the first nine months, net loss increased $26.1 million year over year. R&D rose $19.2 million and G&A rose $8.3 million; higher interest income partially offset the increase in expenses.
- Stock-based compensation was $7.7 million for the nine-month period, compared with $1.0 million in 2021.
Business developments, outlook and risks
- The FDA cleared the TYRA-300 IND in July 2022. The company is conducting the Phase 1/2 SURF301 study, designed to determine dosing and assess preliminary antitumor activity. It anticipated submitting a TYRA-200 IND in Q4 2022.
- Other development programs include FGFR3-related skeletal dysplasias, FGFR4-driven cancers and RET-driven cancers.
- Management estimated existing cash and cash equivalents would fund operating expenses and capital expenditures through at least 2024. Separately, the financial-statement note says working capital is sufficient for at least 12 months from issuance. Both estimates are forward-looking and depend on assumptions.
- On October 3, 2022, after quarter-end, Tyra entered an at-the-market agreement allowing it to offer up to $150 million of common stock; sales are optional and the agent’s commission may be up to 3% of gross proceeds. Potential sales could dilute shareholders.
- The company expects rising R&D and public-company costs and may need additional capital. If financing is unavailable or unfavorable, it may have to delay, reduce or discontinue development programs or grant rights to third parties. Development, regulatory, manufacturing, enrollment, COVID-19, geopolitical, inflation and supply-chain uncertainties may affect costs and timelines.
- A new expansion lease is expected to commence in the second half of 2023, with projected payments of $5.5 million over its 10-year term. Total operating lease obligations, including the uncommenced expansion lease, were $9.1 million.
- No material legal proceedings or material changes to previously disclosed risk factors were reported. Management concluded disclosure controls were effective; internal-control-over-financial-reporting evaluation was not yet required under the transition period for newly public companies.
Investor verification points
- Track TYRA-300 trial enrollment, safety, dose-finding and data timing, and confirm whether the anticipated TYRA-200 IND submission occurred.
- Monitor quarterly cash use and R&D spending against the stated cash runway through at least 2024.
- Check whether the company sells shares under the $150 million ATM, and assess resulting dilution.
- Review the assumptions behind the cash runway, the expansion lease commitment, and any changes to development plans or financing needs.