Tyra Biosciences, Inc. — 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual report, not a standalone fourth-quarter report. Tyra is a preclinical-stage precision oncology company; it had no product revenue and had not begun clinical trials as of the filing.
Business context and development outlook
- The company’s proprietary SNÅP platform is intended to design targeted therapies that address acquired resistance to cancer drugs. Its initial focus is selective inhibitors of the FGFR family.
- Lead candidates are TYRA-300, an FGFR3 inhibitor initially aimed at metastatic urothelial cancer, and TYRA-200, an FGFR2 inhibitor initially aimed at intrahepatic cholangiocarcinoma. Both remained in preclinical development.
- Management anticipated filing an IND for TYRA-300 in mid-2022 and TYRA-200 in the second half of 2022, followed by clinical development, subject to regulatory clearance and successful studies. These were plans, not approvals or guaranteed milestones.
- Discovery programs also target FGFR3-related skeletal dysplasias, RET and FGFR4. The company retained worldwide rights to its candidates and said it might pursue partnerships opportunistically.
Financial performance and liquidity
| Metric | 2021 | 2020 |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $20.6 million | $7.2 million |
| General and administrative expense | $5.7 million | $2.1 million |
| Total operating expenses | $26.3 million | $9.3 million |
| Net loss | $26.3 million | $9.3 million |
| Net loss per share, basic and diluted | $1.91 | $6.05 |
| Net cash used in operating activities | $23.7 million | $7.8 million |
- R&D expense rose $13.4 million, primarily reflecting increased candidate-development and preclinical spending and higher personnel costs. G&A rose $3.6 million, including personnel, professional services and other operating costs.
- At December 31, 2021, cash and cash equivalents were $302.2 million, versus $15.2 million a year earlier; current assets were $304.1 million and current liabilities were $3.6 million. Accumulated deficit was $40.4 million.
- Financing cash inflow was $311.3 million, principally from IPO net proceeds of $181.2 million and preferred-stock financing. The September 2021 IPO sold 12.42 million shares at $16.00 per share.
- Management believed existing cash would fund operations and capital expenditures through at least 2024, including the planned Phase 1 development of TYRA-300 and Phase 1 development of TYRA-200. This estimate depends on assumptions and could change.
- No borrowings or material debt are reported. Lease liabilities totaled $1.2 million, including $0.2 million current and $1.0 million noncurrent. Operating margins are not meaningful because the company had no revenue.
Material changes, risks and unusual items
- Net loss increased by $17.0 million year over year as operating expenses increased. Cash and cash equivalents increased substantially following the IPO and preferred-stock financings.
- TYRA-300 and TYRA-200 had encouraging preclinical findings reported by the company, including activity against selected resistance mutations. These were not human clinical results, and the filing cautions that preclinical outcomes may not predict clinical safety or efficacy.
- Key risks include early-stage development and clinical/regulatory uncertainty; possible delays in IND submissions, trials or patient enrollment; safety risks; reliance on third-party manufacturers and research providers; competition; and the need for future financing if spending or timelines differ from plan.
- Intellectual property is a notable risk: as of March 1, 2022, Tyra reported no issued patents and no pending U.S. non-provisional patent applications; its portfolio consisted of pending provisional, PCT and Taiwanese applications. Patent grant, scope and enforceability were uncertain.
- The company reported no material legal proceedings and no off-balance-sheet arrangements. It reported that disclosure controls were effective at a reasonable-assurance level; the filing included neither management’s internal-control assessment nor auditor attestation, citing applicable newly public company and emerging-growth-company exemptions.
- After year-end, on March 2, 2022, Tyra amended its existing lease and agreed to lease approximately 7,377 additional square feet, expected to commence in April 2023. The expansion lease has an estimated 10-year term, base rent of about $39,467 per month plus operating expenses, and an early-termination fee provision.
Important facts for investors to verify
- Whether TYRA-300 and TYRA-200 IND submissions and clinical starts occurred on the stated timelines, and what regulatory feedback or trial results followed.
- Current cash, operating burn, forecast runway and any financing needs relative to management’s stated through-2024 estimate.
- Progression of patent applications into national phases, issuance and scope of patents, and any third-party intellectual-property challenges.
- Whether preclinical selectivity and resistance findings translate into human safety, tolerability and efficacy; the filing contains no clinical evidence.
- Costs and obligations under the expanded facilities lease and any changes to development spending or other commitments.