Invivyd, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. Financial statements are unaudited. Invivyd is a clinical-stage biopharmaceutical company developing antibody therapies, initially focused on COVID-19. It has not generated revenue.
Financial performance and liquidity
| Metric | Q1 2023 | Q1 2022 / comparison |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $27.2 million | $92.0 million |
| Acquired in-process R&D expense | $0.8 million | None |
| Selling, general and administrative expense | $11.0 million | $8.7 million |
| Total operating expenses | $39.1 million | $100.7 million |
| Operating loss | $39.1 million | $100.7 million |
| Other income | $3.8 million | Less than $0.1 million |
| Net loss | $35.3 million | $100.7 million |
| Basic and diluted loss per share | $0.32 | $0.93 |
| Net cash used in operating activities | $41.2 million | $59.0 million |
At March 31, 2023, cash and cash equivalents were $126.5 million and marketable securities were $207.0 million, totaling $333.4 million. Current assets were $344.6 million and current liabilities were $22.1 million. The company reported no borrowings; operating lease liabilities totaled approximately $3.3 million. No operating margin is meaningful because the company has no revenue.
Cash and cash equivalents rose $34.4 million during the quarter, principally because $75.7 million of marketable securities matured and investing cash inflows exceeded operating cash use. This movement does not represent operating cash generation.
Material changes and operating developments
- R&D expense fell $64.8 million year over year, primarily because adintrevimab manufacturing and clinical-trial costs were substantially lower. VYD222-related costs increased to $8.9 million as development advanced.
- SG&A increased $2.3 million, largely reflecting the absence of a prior-year stock-based compensation credit related to a former CEO’s departure; professional and consulting fees declined.
- Other income increased to $3.8 million, including interest and net accretion of discounts on marketable securities.
- VYD222 entered Phase 1 testing in March. The filing reports that all participants were dosed in May and that the FDA cleared its IND in April; both events occurred after quarter-end. Management anticipated initial Phase 1 data in Q2 2023 and additional program readouts during 2023.
Outlook, risks and unusual items
- Management estimated that cash, cash equivalents and marketable securities would fund operating expenses and capital needs into the second half of 2024, while also stating the resources were expected to cover at least 12 months from issuance of the interim statements. The estimate depends on assumptions and could prove inaccurate.
- The company expects continuing losses and substantial funding needs. It may seek equity, debt, grants, collaborations or other financing; financing may be unavailable or dilute shareholders, and insufficient funding could delay or curtail programs.
- Clinical success, regulatory authorization or approval, manufacturing capacity, trial enrollment, variant evolution, market demand and commercialization remain uncertain. The company depends on third parties, including CROs and CDMOs, and reported some pandemic-related development delays and disruptions.
- Contractually binding VYD222 drug-substance manufacturing costs remaining at quarter-end were $15.1 million, expected to be incurred and paid in 2023. The company also has future lease, licensing and milestone obligations.
- A securities class action filed in January alleges misleading statements concerning adintrevimab and Omicron; the company intends to defend itself, but outcome and materiality could not be assessed. The SEC separately requested documents and information on related testing and communications; the company said it would cooperate.
- Related-party arrangements include Adimab payments and a $1.5 million quarterly R&D expense for Population Health Partners (PHP), whose partners include two Invivyd directors. PHP also holds a warrant for up to 6.8 million shares, subject to market-capitalization or change-of-control vesting conditions.
- Interim CFO Frederick W. Driscoll notified the company on May 5 of planned retirement effective May 31, 2023.
Investor verification priorities
- Verify VYD222 Phase 1 safety, pharmacokinetic and neutralization results, and the timing and design of subsequent trials.
- Track cash burn, spending plans and financing needs against the stated runway into the second half of 2024.
- Assess the progress and cost of VYD222 manufacturing, including the $15.1 million committed balance, and any additional milestone obligations.
- Monitor the securities litigation and SEC inquiry concerning adintrevimab statements, including any material developments.
- Review potential dilution from outstanding options and PHP’s warrant, and governance oversight of related-party arrangements.