PMV Pharmaceuticals, Inc. — Q2 2021 Form 10-Q
Reporting period: Three and six months ended June 30, 2021. Unaudited financial statements. PMV is a clinical-stage oncology company developing small-molecule therapies targeting p53 mutations; it has no approved products and has generated no revenue.
Financial performance and liquidity
| Metric | Q2 2021 | Q2 2020 | Six months 2021 | Six months 2020 |
|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 |
| Research and development expense | $7.7m | $5.8m | $15.2m | $11.8m |
| General and administrative expense | $5.4m | $2.3m | $9.6m | $4.0m |
| Total operating expense | $13.1m | $8.1m | $24.7m | $15.7m |
| Net loss | $12.9m | $8.0m | $24.5m | $15.2m |
| Basic and diluted loss per share | $0.29 | $2.62 | $0.54 | $5.00 |
| Cash used in operating activities | — | $22.1m | $15.0m |
At June 30, 2021, cash and cash equivalents were $189.4m, restricted cash $0.8m, and marketable securities $149.5m, totaling approximately $339.8m in cash, restricted cash and securities. Total assets were $355.9m and stockholders’ equity $337.8m. The company reported no borrowings; operating lease liabilities were $11.2m. No profit margin is meaningful given the absence of revenue.
Material changes versus the prior comparable period
- Q2 operating expenses rose $5.0m year over year; six-month expenses rose $9.0m. Management attributed R&D growth mainly to discovery research and advancing lead candidate PC14586 through its Phase 1/2 trial.
- G&A increased substantially, principally from higher staffing and office costs, finance and legal support, directors’ and officers’ insurance, and Princeton facility costs.
- Six-month operating cash use increased by $7.1m year over year. Cash, cash equivalents and restricted cash declined $171.2m during the half, largely reflecting purchases of marketable securities; investing cash use was $150.5m.
- Loss per share is not directly comparable year over year because weighted-average shares increased from approximately 3.0m to 45.0m following the 2020 IPO and preferred-stock conversion.
Outlook, commentary and risks
- PC14586 is in a Phase 1/2 trial; the company received FDA Fast Track Designation for locally advanced or metastatic solid tumors with a p53 Y220C mutation. The first patient was dosed in Q4 2020.
- Management expects substantial additional losses and rising R&D spending. It stated that June 30 cash, cash equivalents and marketable securities are expected to fund operations at least through 2023, subject to assumptions; the notes also state resources are adequate for at least the next 12 months from issuance.
- Future funding may be required to complete development and commercialization. Financing may dilute shareholders, add debt obligations, or require concessions in collaborations. Management says development costs and timelines cannot be reliably estimated.
- The company signed a lease for approximately 50,581 square feet of Princeton office and laboratory space, with a planned headquarters move in early 2022. The lease extends through 2032; stated payments total $19.6m through May 2032, with a $4.1m buildout incentive expected to be reimbursed. No reimbursement had been received by June 30.
- Key risks include clinical and regulatory uncertainty, reliance on third-party research and manufacturing providers, competition, financing needs, intellectual-property protection, COVID-19 effects, and potential regulatory review delays. The filing reports no material litigation and no third-party supplier purchase commitments at quarter-end.
- Management expected to lose emerging-growth-company status on December 31, 2021, potentially increasing reporting and compliance costs. Disclosure controls were assessed as effective; no material change in internal control over financial reporting was reported.
Investor verification points
- Review subsequent PC14586 trial enrollment, safety and efficacy updates, and any changes to clinical timelines or spending plans.
- Reconcile cash runway assumptions and monitor quarterly operating cash use, marketable-security balances, and any financing or collaboration activity.
- Verify Princeton lease commencement, incentive reimbursements, relocation costs, and the company’s total future lease obligations.
- Assess the impact of increased G&A and expected loss of emerging-growth-company exemptions on expenses and reporting obligations.
- Confirm share-count and per-share comparisons account for the IPO, preferred-stock conversion and reverse split.