Tyra Biosciences, Inc. — FY 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; comparisons are with FY 2022. Filed March 19, 2024. Tyra is a clinical-stage biotechnology company developing precision medicines targeting FGFR biology. It has no approved products and has generated no revenue.
Financial performance and position
| Metric | FY 2023 / Dec. 31, 2023 | FY 2022 / Dec. 31, 2022 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $62.5 million | $43.0 million |
| General and administrative expense | $17.4 million | $15.9 million |
| Total operating expenses | $79.9 million | $58.9 million |
| Operating loss | $79.9 million | $58.9 million |
| Interest income | $10.9 million | $3.7 million |
| Net loss | $69.1 million; $1.62 per share | $55.3 million; $1.32 per share |
| Operating cash used | $50.1 million | $50.3 million |
| Cash, cash equivalents and marketable securities | $203.5 million | $251.2 million |
| Total assets / total liabilities | $225.9 million / $21.6 million | $266.2 million / $8.4 million |
Margins: Not meaningful because the company had no revenue. The filing reports no material debt; reported liabilities were primarily operating lease liabilities and payables/accruals. Current assets were $211.7 million and current liabilities $15.3 million at year-end.
Material changes versus FY 2022
- Net loss increased by $13.8 million, while operating expenses rose by $21.0 million. R&D increased $19.5 million, mainly from clinical-trial and drug-manufacturing costs, personnel, and stock-based compensation; G&A increased $1.5 million.
- Higher interest income ($10.9 million versus $3.7 million) partly offset increased operating costs.
- Year-end cash and cash equivalents fell to $58.0 million from $251.2 million, while marketable securities rose to $145.5 million. The $144.6 million investing cash outflow chiefly reflected purchases of marketable securities, not operating expenditure. Operating cash use was broadly unchanged.
- Accumulated deficit reached $164.8 million. Lease commitments totaled $9.5 million, with lease liabilities of $6.5 million on the balance sheet.
Programs, outlook and key risks
- TYRA-300: Oral selective FGFR3 inhibitor in the Phase 1 SURF301 study for advanced urothelial carcinoma and other FGFR3-altered solid tumors. By March 2024, dose escalation was complete without establishing an MTD; expansion cohorts were assessing once- and twice-daily doses. The company expected initial trial results at a scientific congress in the second half of 2024.
- Achondroplasia: TYRA-300 showed growth effects in a preclinical mouse model. The company planned to submit an IND in the second half of 2024 for a pediatric Phase 2 study. FDA granted Orphan Drug Designation in July 2023 and Rare Pediatric Disease Designation in January 2024. These designations do not establish efficacy or ensure approval or a priority review voucher.
- TYRA-200: Oral FGFR1/2/3 inhibitor; Phase 1 SURF201 began in December 2023, initially targeting FGFR2-altered cholangiocarcinoma and other advanced solid tumors. TYRA-430 remains a discovery program.
- Funding outlook: In February 2024, after year-end, Tyra completed a private placement for approximately $200 million gross proceeds, issuing 9.3 million common shares and pre-funded warrants for 6.1 million shares. Management estimates available resources, including the financing, will fund operations through at least 2026; this is based on assumptions and is not assured. The company expects continued losses and may need further financing.
- Principal risks: Early-stage development and uncertain clinical outcomes; patient-enrollment, safety, regulatory and manufacturing risks; dependence on third-party manufacturers and research providers; competition; and ongoing financing needs. The company had no issued U.S. patents as of March 15, 2024, with patent applications pending. It has no commercial, sales or marketing infrastructure.
- No material legal proceedings were reported. Management concluded disclosure controls and internal control over financial reporting were effective as of year-end; the auditor did not provide an internal-control attestation because of the company’s emerging-growth-company exemption.
Important facts for investors to verify
- Review subsequent SURF301 and SURF201 clinical data, including safety, dose selection, response durability and enrollment.
- Confirm the timing and regulatory progress of the planned TYRA-300 achondroplasia IND and assess the clinical relevance of the preclinical findings.
- Track cash burn against the stated runway through at least 2026, and the impact of the February 2024 financing, warrant exercises and resale registration on share dilution.
- Assess whether pending patent applications provide meaningful, enforceable protection, given the absence of issued U.S. patents disclosed in the filing.
- Monitor clinical-trial costs, third-party manufacturing and supply arrangements, and any need for additional capital or partnerships.