Tyra Biosciences, Inc. — FY2022 Form 10-K
Reporting period: Fiscal year ended December 31, 2022. The filing was signed March 22, 2023. Tyra is a clinical-stage biotechnology company developing precision medicines, primarily targeting FGFR biology. It had no approved products and generated no revenue.
Financial performance and position
| Metric | FY2022 | FY2021 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $43.0 million | $20.6 million |
| General and administrative expense | $15.9 million | $5.7 million |
| Total operating expenses | $58.9 million | $26.3 million |
| Net loss | $55.3 million | $26.3 million |
| Net loss per share, basic and diluted | $1.32 | $1.91 |
| Net cash used in operations | $50.3 million | $23.7 million |
| Cash and cash equivalents at year-end | $251.2 million | $302.2 million |
Operating margins are not meaningful because the company had no revenue. The wider loss reflected increased development activity and public-company costs; research and development expense rose $22.4 million and general and administrative expense rose $10.3 million. Interest income was $3.7 million in 2022, compared with $13,000 in 2021.
At December 31, 2022, total assets were $266.2 million and total liabilities were $8.4 million, including $2.6 million in current and noncurrent lease liabilities. The filing reports no funded debt on the balance sheet. Cash, cash equivalents and restricted cash totaled $252.2 million. Management expected existing cash and cash equivalents to fund operations and capital expenditures through at least 2024, based on its current operating plan; it cautioned that actual cash needs could differ.
Business developments and comparison with prior year
- TYRA-300, a selective FGFR3 inhibitor, received FDA IND clearance in July 2022; the first patient was dosed in the Phase 1/2 SURF301 trial in November 2022. The trial is designed to assess safety, dosing and preliminary antitumor activity, initially in FGFR3-altered advanced solid tumors.
- Tyra submitted an IND for TYRA-200, an FGFR1/2/3 inhibitor, in December 2022. FDA clearance followed in January 2023; first-patient dosing was anticipated in the second half of 2023.
- In March 2023, after year-end, Tyra announced expansion of TYRA-300 development into achondroplasia, based on preclinical findings. It anticipated submitting an IND to support a pediatric Phase 2 study in 2024.
- R&D spending also supported the SNÅP discovery platform and earlier-stage FGFR4 and RET programs. No human clinical efficacy results for Tyra’s candidates were reported in this filing.
Outlook, risks and notable items
- Tyra expects losses and expenses to increase as it advances clinical and preclinical programs. Product revenue, if any, is not expected for several years and depends on successful development, regulatory approval and commercialization.
- The company may need additional financing. Its October 2022 at-the-market sales agreement permits up to $150 million of common-stock sales; no shares were sold under it in 2022. Future equity issuance could dilute shareholders, and financing may not be available on acceptable terms.
- Key risks include early-stage clinical uncertainty, safety and efficacy failures, trial enrollment and execution, reliance on third-party manufacturers and research organizations, competition, and the need to obtain and maintain regulatory approvals and intellectual-property protection. As of March 15, 2023, Tyra reported no issued U.S. patents.
- Tyra had no material legal proceedings. It reported $9.1 million of aggregate future operating lease commitments at year-end, including planned expansion space; the expansion lease was expected to commence in the second half of 2023.
- The financial statements received an unqualified audit opinion from Ernst & Young LLP. Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2022; the auditor did not provide an internal-control attestation because Tyra was an emerging growth company.
Investor verification checklist
- Confirm current cash, cash burn and runway against the company’s stated forecast through at least 2024, including subsequent financing or ATM activity.
- Track SURF301 enrollment, dose escalation, safety findings and any disclosed clinical data; distinguish human results from preclinical evidence.
- Verify timing and progress of TYRA-200’s Phase 1 trial and the planned achondroplasia IND and pediatric study.
- Assess dilution from outstanding options, equity plans and any future ATM sales; compare share counts with the filing’s year-end figures.
- Review updated patent filings and issued protections, as well as manufacturing, trial-enrollment and regulatory risks.