Pliant Therapeutics, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Pliant is a clinical-stage biopharmaceutical company developing treatments for fibrosis and related diseases; it has no approved products and has not generated product-sale revenue.
Financial results and liquidity
| Metric | Q1 2024 | Q1 2023 |
|---|---|---|
| Revenue | $0 | $1.3 million |
| Research and development expense | $37.1 million | $29.3 million |
| General and administrative expense | $15.2 million | $14.2 million |
| Operating loss | $52.4 million | $42.1 million |
| Interest and other income, net | $5.9 million | $4.9 million |
| Interest expense | $0.4 million | $0.3 million |
| Net loss | $47.0 million | $37.5 million |
| Basic and diluted net loss per share | $0.78 | $0.67 |
| Net cash used in operating activities | $30.3 million | $30.3 million |
At March 31, 2024, cash and cash equivalents were $114.3 million and short-term investments were $368.1 million, totaling $483.9 million. Current assets were $489.9 million; current liabilities were $30.4 million. Total assets were $521.6 million, total liabilities $84.3 million, and stockholders’ equity $437.3 million. Accumulated deficit was $546.7 million.
Cash, cash equivalents and restricted cash increased by $51.1 million during the quarter. Investing activities provided $59.5 million, primarily reflecting net maturities of short-term investments; financing activities provided $21.8 million, including $19.9 million in net term-loan proceeds. The company reported $30.0 million of long-term debt outstanding. The loan carries a floating rate subject to an 8.75% floor; its effective interest rate was 11.93%.
Profit margins are not meaningful because the company is pre-commercial and reported no Q1 2024 revenue.
Changes versus the prior comparable period
- Revenue declined by $1.3 million following termination of the Novartis collaboration, effective April 2023; the company received no collaboration revenue in Q1 2024.
- R&D expense rose $7.9 million, mainly from higher BEACON-IPF clinical-trial costs and increased headcount, partly offset by lower preclinical manufacturing costs.
- G&A expense increased $1.1 million, primarily due to employee-related costs.
- Net loss increased $9.4 million. Higher investment income partly offset the higher operating loss.
- The March 2024 loan amendment increased the facility to up to $150 million. The company drew $30 million in total, including the previously outstanding $10 million.
- A new South San Francisco office and laboratory lease was recognized in Q1, adding approximately $23.7 million in right-of-use assets and lease liabilities at commencement.
Outlook, developments and risks
- Management expects existing cash, cash equivalents, short-term investments and amounts available under the amended loan facility to fund anticipated operating expenses and capital expenditures through 2026. The filing cautions that estimates rely on assumptions and that additional capital will be needed to complete clinical development.
- BEACON-IPF is being implemented as an adaptive Phase 2b/3 trial. Its Phase 2b portion was increased from 267 to 360 patients; enrollment completion is expected in Q1 2025. Management expects the adaptive design to shorten late-stage development, subject to regulatory acceptance.
- Final 24-week INTEGRIS-PSC Phase 2a data are expected mid-2024. The company also expects topline results in the coming weeks from a completed 12-week PET-imaging study of bexotegrast in IPF.
- PLN-101095 is in a Phase 1 dose-escalation study in solid tumors; preliminary data could be available as early as late 2024. PLN-101325 received regulatory clearance to begin a first-in-human Phase 1 study, anticipated in 2024.
- Management expects R&D and G&A expenses to rise as programs advance and operations expand. The company expects continued losses and has no product revenue in the near term.
- Key risks include clinical safety or efficacy setbacks, trial enrollment or execution delays, reliance on third-party and single-source manufacturing (including bexotegrast supply from China), competition, intellectual-property challenges, and the need for additional financing. The loan is secured by substantially all assets, subject to specified exclusions; default could accelerate repayment and permit enforcement against collateral.
- The company reported no material legal proceedings or off-balance-sheet arrangements. Disclosure controls and procedures were considered effective at a reasonable assurance level as of March 31, 2024.
Important facts for investors to verify
- Progress, enrollment timing and regulatory acceptance of the adaptive BEACON-IPF Phase 2b/3 design, including the Q1 2025 enrollment target.
- INTEGRIS-PSC final data and the PET-imaging study results, and whether results support further development of bexotegrast.
- Cash usage against the stated runway through 2026, and the conditions, timing and availability of the remaining loan commitments.
- Clinical-trial costs, manufacturing continuity and supply-chain exposure, particularly the single-source bexotegrast supplier.
- Potential dilution: 60.3 million common shares were outstanding at March 31, 2024; 15.7 million shares were reserved for future issuance under equity plans and awards.