PMV Pharmaceuticals, Inc. — Q2 2023 Form 10-Q
Reporting period: Three and six months ended June 30, 2023. Unaudited results; amounts below are in U.S. dollars. PMV is a clinical-stage precision oncology company developing small-molecule therapies targeting mutant p53. It has no approved products and has not generated revenue.
Financial performance and liquidity
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Revenue | None | None | None | None |
| Research and development expense | $13.8 million | $11.5 million | $28.9 million | $23.3 million |
| General and administrative expense | $6.3 million | $6.4 million | $12.7 million | $13.2 million |
| Total operating expenses | $20.1 million | $17.9 million | $41.6 million | $36.5 million |
| Net loss | $17.4 million | $17.3 million | $36.6 million | $35.7 million |
| Net loss per share, basic and diluted | $0.38 | $0.38 | $0.80 | $0.79 |
| Net cash used in operating activities | Not provided by quarter | $27.9 million | $31.7 million |
- Q2 R&D expense increased $2.4 million year over year, mainly from PC14586 development and higher personnel and stock-based compensation costs. Six-month R&D increased $5.6 million; G&A declined $0.5 million.
- Interest income was $2.7 million in Q2 and $5.0 million for the first half, up from $0.6 million and $0.8 million, respectively, primarily due to higher interest rates. The operating loss remained the principal driver of net loss.
- At June 30, cash and cash equivalents were $68.2 million and marketable securities were $150.6 million, totaling $218.8 million. Working capital was $179.0 million. Total liabilities were $24.4 million, including $13.0 million of operating lease liabilities; the filing reports no debt financing.
- Cash, cash equivalents and restricted cash fell $40.1 million in the first half to $69.0 million. Investing activities used $14.3 million, largely reflecting purchases of marketable securities net of maturities; financing provided $2.1 million, including $2.0 million net proceeds from ATM sales.
- No meaningful operating margin is applicable because the company has no revenue. Accumulated deficit was $277.6 million.
Business developments, outlook and risks
- PC14586 is the lead candidate, in a Phase 1/2 trial for locally advanced or metastatic solid tumors with a p53 Y220C mutation; it received FDA Fast Track Designation in 2020. Following a July 2023 End-of-Phase 1 meeting, management reported alignment with FDA on the recommended Phase 2 dose and key elements of the single-arm registrational Phase 2 portion of the PYNNACLE study. Management planned to initiate that portion in early 2024.
- Management expects operating expenses and losses to increase as development advances and stated that the June 30 cash, equivalents and securities were expected to fund operations at least through 2024. The filing also says management believes resources are adequate for the 12 months following issuance of the statements. These estimates depend on assumptions and may prove inaccurate.
- PMV may need additional equity, debt, collaboration or other financing before product revenue, which could dilute shareholders, impose debt obligations, or require granting rights to partners. If funding is unavailable, development could be delayed, scaled back or discontinued. There can be no assurance of clinical success, regulatory approval or commercialization.
- Commitments include a Princeton office and laboratory lease extending through 2032; future minimum lease payments net of reimbursements were $16.9 million, with $1.8 million due in 2024. Management reported no litigation likely to have a material adverse effect and no material changes to previously disclosed risk factors.
- Disclosure controls and procedures were assessed as effective at the reasonable assurance level as of June 30, 2023; no material change in internal control over financial reporting was reported.
Important facts for investors to verify
- Whether the early-2024 Phase 2 initiation plan and clinical milestones remain on schedule, and what subsequent trial data show.
- Whether the $218.8 million liquidity position supports the stated runway as development spending increases.
- Future R&D spending, cash burn and financing needs, including any additional ATM issuance or dilution.
- Clinical, regulatory, manufacturing and competitive risks for PC14586 and the company’s other programs.