Pliant Therapeutics, Inc. — Q2 2023 Form 10-Q
Reporting period: Quarter and six months ended June 30, 2023. Pliant is a clinical-stage biotechnology company developing therapies for fibrosis; it had no product sales.
Financial results and liquidity
| Metric | Q2 2023 | Q2 2022 | Six months 2023 | Six months 2022 |
|---|---|---|---|---|
| Revenue | $0.2 million | $5.0 million | $1.6 million | $6.2 million |
| Research and development expense | $33.0 million | $26.3 million | $62.3 million | $47.2 million |
| General and administrative expense | $14.6 million | $8.3 million | $28.7 million | $16.9 million |
| Net loss | $41.2 million | $29.5 million | $78.7 million | $57.6 million |
| Net loss per share | $0.70 | $0.82 | $1.37 | $1.59 |
At June 30, cash and cash equivalents were $55.0 million and short-term investments were $500.2 million, totaling $555.2 million. Current assets were $565.7 million and current liabilities $29.5 million. Stockholders’ equity was $533.1 million; accumulated deficit was $417.2 million. Long-term debt was $10.0 million, plus $4.6 million in lease liabilities. The term loan bears interest at one-month SOFR plus 8.5%; its effective rate was 12.69%.
For the first six months, operating cash use was $55.0 million, investing cash use was $197.2 million, and financing provided $273.5 million. Cash increased $21.3 million. The filing does not provide a clear gross margin measure; product sales have not begun.
Material changes versus the prior comparable period
- Q2 revenue fell $4.7 million year over year, primarily because Novartis collaboration research and development services ended when the agreement terminated in April 2023.
- Q2 operating expenses increased $12.9 million. Higher employee-related costs, clinical-trial and drug-supply spending, and stock-based compensation were partly offset by lower preclinical manufacturing costs.
- Q2 net loss increased $11.6 million year over year. Higher investment income partly offset the larger operating loss.
- Six-month stock-based compensation was $25.0 million, versus $6.9 million a year earlier.
- In January 2023, Pliant raised approximately $269.5 million net through a public offering of 9.58 million shares. Shares outstanding were 59.2 million at June 30, compared with 48.9 million at December 31, 2022.
Outlook, management commentary, risks and unusual items
- Management expects existing cash, cash equivalents and short-term investments to fund projected operating requirements into the second half of 2026. The estimate depends on assumptions that may change; the company expects continued losses and rising R&D and G&A expenses.
- Bexotegrast: the company initiated BEACON-IPF, a 52-week Phase 2b trial expected to enroll about 270 patients. Management reported favorable tolerability and exploratory efficacy trends in Phase 2a INTEGRIS-IPF data; these are not confirmatory findings. PSC interim data from the lower-dose cohorts were expected in Q3 2023, and from the 320 mg cohort in Q1 2024.
- PLN-101095 entered a recruiting Phase 1 trial for solid tumors in Q2. An IND submission for the preclinical muscular-dystrophy program PLN-101325 was expected in Q1 2024.
- Novartis returned PLN-1474 rights to Pliant and ended future milestone, royalty and R&D funding obligations. Pliant may need to fund further development itself or seek another partner.
- The company reported $10.0 million of Oxford debt, secured by substantially all current and future assets. It declined the option to draw a further $40 million from the first two tranches; additional potential borrowing is subject to development conditions and lender discretion.
- Key risks include clinical efficacy, safety and enrollment uncertainty; reliance on third-party and single-source manufacturing, including suppliers in China; capital needs and potential future dilution; competition; and the possibility that development timelines or costs differ from plans. No material legal proceedings were reported. Disclosure controls were deemed effective as of June 30.
Most important facts for investors to verify
- Whether BEACON-IPF and the PSC studies meet enrollment, timing, safety and efficacy objectives, and how exploratory results compare with later controlled-trial outcomes.
- Whether the stated runway into the second half of 2026 remains achievable as clinical and operating spending rises.
- How Pliant plans to advance PLN-1474 after Novartis’ termination, including any new collaboration or company-funded development.
- Future cash burn, financing needs and dilution, including any use of the registered $150 million at-the-market offering and equity compensation.
- Continuity and quality of clinical drug supply, particularly reliance on a sole bexotegrast supplier and foreign manufacturing.