PMV Pharmaceuticals, Inc. — Q3 2022 Form 10-Q
Reporting period: Quarter and nine months ended September 30, 2022; unaudited. PMV is a pre-revenue precision oncology company developing small-molecule therapies targeting p53 mutations. Its lead candidate, PC14586, is in a Phase 1/2 trial and received FDA Fast Track Designation for tumors with a p53 Y220C mutation. PMV presented initial Phase 1 data in June 2022.
Financial results and liquidity
| Metric | Q3 2022 | Q3 2021 | Nine months 2022 | Nine months 2021 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development | $13.7 million | $9.2 million | $37.0 million | $24.3 million |
| General and administrative | $5.7 million | $5.9 million | $18.9 million | $15.5 million |
| Net loss | $18.2 million | $15.0 million | $54.0 million | $39.5 million |
| Net loss per share, basic and diluted | $0.40 | $0.33 | $1.18 | $0.88 |
| Cash used in operating activities | — | — | $48.4 million | $34.5 million |
At September 30, 2022, cash, cash equivalents and marketable securities totaled $258.9 million, down $55.2 million from December 31, 2021. Working capital was $253.5 million, versus $289.1 million at year-end 2021. The company reported no debt; operating lease liabilities were $12.5 million. Nine-month investing cash outflow was $24.6 million, including $6.3 million of property and equipment purchases, partly offset by net marketable-security maturities. Financing provided $0.4 million. No meaningful operating margin is reported because the company has no revenue.
Changes versus prior comparable periods
- Q3 operating expenses rose $4.3 million year over year, mainly from a $4.5 million increase in R&D as PC14586 advanced through its clinical trial; G&A decreased $0.2 million.
- For the first nine months, operating expenses increased $16.1 million and net loss increased $14.5 million year over year. R&D rose $12.6 million, principally reflecting PC14586 development and higher personnel and stock-based compensation; G&A rose $3.4 million.
- Higher interest rates increased net interest income to $1.1 million in Q3 and $1.8 million for the nine-month period, compared with $0.1 million and $0.3 million, respectively.
- Accumulated deficit reached $221.7 million. Unrealized losses on available-for-sale investments contributed $0.9 million to nine-month comprehensive loss.
Outlook, risks and other notable items
- Management expects substantial additional losses and higher operating expenses as development progresses. It stated that available cash and investments should fund operations at least through 2023, while cautioning that this estimate depends on assumptions and capital could be consumed sooner than expected.
- PMV expects no product-sales revenue in the foreseeable future and may need additional equity, debt or collaboration financing. Additional funding may be unavailable or may involve dilution or surrender of rights.
- Key uncertainties include clinical safety and efficacy, trial timing and costs, regulatory approval, competition, manufacturing, intellectual-property protection, and reliance on third-party research and manufacturing providers. No material changes to previously disclosed risk factors were reported.
- The Princeton office and laboratory facility lease extends through 2032; future minimum lease payments were reported as $17.1 million net of reimbursements, with $12.5 million present-value lease liabilities. The new facility is intended to replace prior sites.
- Management reported effective disclosure controls as of September 30, 2022, with no material change in internal control over financial reporting. The company reported no material litigation.
Investor facts to verify
- PC14586 trial progress, updated efficacy and safety data, and the timing and basis for any planned regulatory strategy.
- Actual cash burn against the stated funding runway through 2023, including how development spending and facility costs evolve.
- Whether additional financing or partnership arrangements will be needed, and their potential dilution or impact on program rights.
- Clinical-trial, manufacturing and R&D accrual estimates, as well as lease reimbursements and remaining facility commitments.