Tyra Biosciences, Inc. — Q3 2021 Form 10-Q
Reporting period: Three and nine months ended September 30, 2021. The company completed its IPO on September 17, 2021 and is a preclinical-stage precision oncology biotechnology company developing therapies intended to overcome cancer drug resistance.
Financial results and liquidity
| Metric | Q3 2021 | Q3 2020 | Nine months 2021 | Nine months 2020 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development | $5.5 million | $1.9 million | $13.4 million | $4.3 million |
| General and administrative | $1.2 million | $0.5 million | $3.0 million | $1.3 million |
| Net loss | $6.6 million | $2.3 million | $16.4 million | $5.7 million |
| Net loss per share, basic and diluted | $0.72 | $1.47 | $3.63 | $3.83 |
As of September 30, 2021, cash and cash equivalents were $312.8 million, current assets $313.5 million, current liabilities $4.8 million and total liabilities $6.2 million. Restricted cash was $0.2 million. The filing reports lease liabilities of $1.2 million; it does not report borrowings or other financial debt. Profit margins are not meaningful given the absence of revenue.
Operating cash outflow was $14.7 million for the first nine months of 2021, compared with $5.2 million in 2020. Investing cash outflow was $0.5 million, while financing provided $312.9 million, principally from the IPO and preferred-stock financings. Cash, cash equivalents and restricted cash increased by $297.6 million.
Material changes versus the prior comparable periods
- Operating expenses rose substantially as the company expanded R&D programs and staffing. Nine-month R&D increased $9.1 million, primarily from preclinical work and chemistry for TYRA-300 and other programs, plus higher personnel costs. G&A increased $1.6 million, including higher professional-service and personnel costs.
- Nine-month net loss increased $10.7 million year over year. Quarterly net loss increased $4.3 million.
- Cash rose from $15.2 million at December 31, 2020 to $312.8 million at September 30, 2021, reflecting the 2021 financings and IPO. The IPO issued 12.42 million shares at $16 per share and generated approximately $181.2 million in net proceeds.
- All convertible preferred stock converted into common stock upon the IPO. Common shares outstanding were 41.2 million at quarter-end.
Outlook, commentary and risks
- Management expected existing cash to fund operating expenses and capital expenditures through at least 2024. It cautioned that projections depend on assumptions and actual cash use could be faster; additional financing may be needed.
- The company had never generated revenue, had not initiated clinical trials, and expected significant future losses and increasing R&D costs. TYRA-300, an FGFR3 inhibitor, was targeted for an IND filing in mid-2022; TYRA-200, an FGFR2 inhibitor, was targeted for an IND filing in the second half of 2022. These were forward-looking targets, not assured milestones.
- Development depends on successful preclinical studies, regulatory clearance, clinical execution, manufacturing and patient recruitment. The company cited potential delays or disruption from COVID-19, third-party providers, regulatory requirements, competition, safety findings and financing needs.
- The company voluntarily gave notice in February 2021 to terminate its Emory University license agreement; it reported no milestone payments met or paid in the first nine months of 2021.
- Related-party services from van den Boom & Associates, whose managing partner became Tyra’s CFO in April 2021, totaled approximately $0.4 million from her employment date through September 30, 2021.
- No material legal proceedings were reported. Disclosure controls and procedures were deemed effective; management was not yet required to evaluate internal control over financial reporting following the IPO.
Most important facts for investors to verify
- Whether TYRA-300 and TYRA-200 preclinical and IND-enabling work supports the stated IND timelines.
- Cash burn trends and whether management’s “through at least 2024” runway estimate remains valid as programs and public-company costs expand.
- Clinical, regulatory, manufacturing and patient-enrollment risks, including any effects of COVID-19 or third-party dependencies.
- Potential dilution from outstanding options and equity plans, and the timing of IPO-related lock-up expirations and registered-share sales.
- The progress and scope of intellectual-property protection: the filing states that the company then had no issued patents and that substantive examination had not begun on pending applications.