Pliant Therapeutics, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. Pliant is a clinical-stage biopharmaceutical company developing therapies for fibrosis and related diseases. It had no product sales; reported revenue came from its Novartis collaboration.
Financial performance and position
| Metric | Q1 2023 | Q1 2022 |
|---|---|---|
| Revenue | $1.3 million | $1.2 million |
| Research and development expense | $29.3 million | $20.9 million |
| General and administrative expense | $14.2 million | $8.6 million |
| Operating loss | $42.1 million | $28.2 million |
| Net loss | $37.5 million | $28.1 million |
| Net loss per share, basic and diluted | $0.67 | $0.78 |
| Net cash used in operating activities | $30.3 million | $20.5 million |
Cash, cash equivalents and short-term investments totaled $577.3 million at March 31, 2023, versus $331.2 million at December 31, 2022. Total current assets were $588.2 million and current liabilities were $23.2 million. Stockholders’ equity was $561.9 million; accumulated deficit was $376.0 million.
Outstanding long-term debt was $10.0 million, with $0.3 million of interest expense in the quarter. The loan carries interest at one-month SOFR plus 8.5%, subject to a floor and cap; interest-only payments are scheduled through July 2026, with maturity in May 2027, subject to extension provisions. The lender has security over substantially all current and future assets, subject to stated exceptions.
No product gross margin is reported because the company had no product sales. Revenue was primarily collaboration research and development funding.
Material changes versus the prior period
- Net loss increased by $9.4 million year over year. Operating expenses rose $14.0 million, partly offset by a $4.7 million increase in interest and other income, net, reflecting higher yields and a larger investment balance.
- Research and development expense increased $8.4 million, mainly from employee-related costs, clinical trial activity, clinical drug supply manufacturing, and facilities costs. General and administrative expense rose $5.6 million, primarily due to employee-related costs, stock compensation, consulting, and professional services.
- In January 2023, Pliant sold 9.6 million shares at $30.00 per share, raising approximately $269.9 million net of offering costs. Shares issued and outstanding increased to 59.0 million at quarter-end from 48.9 million at year-end 2022.
- Cash used in operations increased $9.8 million year over year. Investing activities used $174.2 million, largely reflecting purchases of short-term investments after the offering; financing activities provided $273.3 million.
Outlook, developments and risks
- Management estimated existing capital would fund projected operating requirements into the second half of 2026. This is based on assumptions that may change; the company expects continued losses and says additional capital will be needed to complete development of its programs.
- Bexotegrast is the wholly owned lead candidate. Management reported positive Phase 2a INTEGRIS-IPF findings, including tolerability and improvements in exploratory measures, and expected to start the approximately 270-patient, 52-week BEACON-IPF Phase 2b trial in mid-2023. The filing also describes planned 2023 data and trial milestones for bexotegrast in PSC.
- Novartis gave notice of termination in February 2023; termination took effect April 18, 2023, after the reporting date. Rights to PLN-1474 and related assets reverted to Pliant, while future Novartis milestone, royalty, and research-funding obligations ended. The company may need to fund or find a partner for further development.
- Pliant expected to begin a Phase 1 trial of PLN-101095 in solid tumors in Q2 2023 and expected an IND submission for its muscular dystrophy program in 2023. These are forward-looking plans, not reported outcomes.
- Key risks include clinical efficacy and safety uncertainty, trial enrollment and execution, reliance on third-party and single-source manufacturers (including suppliers in China), access to additional capital, competition, intellectual property protection, and the loss of collaboration funding. The company reported no material legal proceedings as of the filing date and no off-balance-sheet arrangements.
Important facts for investors to verify
- Progress, timing, enrollment, safety findings, and efficacy results for the BEACON-IPF, INTEGRIS-PSC, and PLN-101095 trials, including whether stated 2023 milestones occurred.
- Whether the estimated cash runway into the second half of 2026 remains achievable as trial scope, costs, and development plans evolve.
- Plans and funding for PLN-1474 following the April 2023 return of rights, and any replacement collaboration or development decision.
- Future spending, cash burn, and dilution, including any use of the registered $150 million at-the-market offering; no ATM shares had been issued as of March 31, 2023.
- Debt terms and repayment capacity, as well as manufacturing continuity and supply-chain concentration for clinical programs.