Tyra Biosciences, Inc. quarterly report, Q2 FY2022

Tyra Biosciences, Inc. — Q2 2022 Form 10-Q

Business context and period. This unaudited quarterly report covers the three and six months ended June 30, 2022. Tyra is a pre-revenue precision oncology company developing therapies intended to address acquired cancer-drug resistance, with programs focused primarily on FGFR targets.

Financial performance and position

Amounts below are in millions of dollars, except per-share data. The company reported no revenue; profit margins are therefore not meaningful.

MetricQ2 2022Q2 2021H1 2022H1 2021
Research and development expense$12.0$4.4$21.7$7.9
General and administrative expense$3.4$1.1$8.6$1.8
Total operating expenses$15.4$5.5$30.3$9.7
Net loss$15.1$5.5$29.9$9.7
Net loss per share, basic and diluted$0.36$2.43$0.72$4.54

At June 30, 2022, cash and cash equivalents were $275.1 million, restricted cash was $1.0 million, total assets were $287.1 million, and total liabilities were $8.3 million. The company reported no borrowings; liabilities included $2.7 million of operating lease obligations ($0.1 million current and $2.5 million noncurrent). Stockholders’ equity was $278.9 million and accumulated deficit was $70.3 million.

For the first half of 2022, operating cash use was $26.1 million, investing cash use was $0.5 million, and financing provided $0.3 million, resulting in a $26.3 million decrease in cash, cash equivalents, and restricted cash. Management said existing cash and cash equivalents were expected to fund operating expenses and capital expenditures through at least 2024.

Material changes versus the prior comparable period

  • Q2 net loss widened to $15.1 million from $5.5 million; first-half net loss increased to $29.9 million from $9.7 million.
  • First-half R&D expense rose $13.8 million, primarily reflecting increased spending to advance TYRA-300, TYRA-200, and the SNÅP platform, as well as higher personnel and stock-based compensation costs.
  • First-half G&A expense increased $6.8 million, driven mainly by personnel-related costs, including stock-based compensation, professional services, and other operating expenses.
  • Interest income increased with the company’s larger cash balance. First-half 2021 financing included $129.4 million of preferred-stock proceeds; first-half 2022 financing was $0.3 million, principally from employee stock-plan issuances.

Outlook, risks, and notable items

  • The FDA cleared the TYRA-300 IND in July 2022, following submission in June, for the planned Phase 1/2 SURF301 study. Management anticipated submitting a TYRA-200 IND in the second half of 2022.
  • The company expects continued significant operating losses and rising R&D costs as it advances candidates and expands its pipeline. It has never generated revenue and does not expect product revenue for several years, if ever.
  • Future funding needs depend on trial progress, development and manufacturing costs, regulatory outcomes, hiring, and other factors. Additional financing may be needed; equity or convertible-debt financing could dilute shareholders, while collaborations could require granting valuable rights.
  • COVID-19-related effects on development timelines, vendors, manufacturers, regulators, and personnel remained uncertain. The filing reported no material change in previously disclosed risk factors or market risks.
  • A new office and laboratory expansion lease was signed in March 2022, expected to commence in Q2 2023, with projected payments of $5.5 million over its term. Total operating lease obligations at June 30 were $3.8 million.
  • Stock-based compensation was $6.7 million in H1 2022 versus $0.5 million in H1 2021. Unrecognized compensation cost for employee and nonemployee options was $21.8 million, expected to be recognized over a weighted-average 2.5 years.
  • The company reported no material legal proceedings and no loss-contingency liabilities recorded at June 30, 2022. Disclosure controls were assessed as effective; management had not yet been required to evaluate internal control over financial reporting for this newly public company.

Important facts for investors to verify

  • Whether TYRA-300’s clinical study starts on the anticipated schedule and whether TYRA-200’s IND is submitted as planned.
  • Whether the cash-runway estimate through at least 2024 remains achievable as clinical, manufacturing, and operating spending grows.
  • How program-level spending and clinical progress develop, including the effect of stock-based compensation and hiring on cash burn and dilution.
  • Potential dilution: 4.5 million options were outstanding at June 30, 2022, and 11.0 million shares were reserved for future issuance under equity plans and outstanding options.
  • Whether COVID-19 or other operational, regulatory, safety, or financing risks affect development timelines or capital requirements.