Pliant Therapeutics, Inc. — 2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. This is an annual filing, not a standalone fourth-quarter earnings report. Pliant is a clinical-stage biopharmaceutical company with no product sales; reported revenue came from its Novartis collaboration.
Financial performance and liquidity
| Metric | 2021 | 2020 | Change |
|---|---|---|---|
| Revenue | $7.6 million | $41.8 million | Down 81.9% |
| Research and development expense | $77.5 million | $66.2 million | Up 17.2% |
| General and administrative expense | $27.6 million | $17.3 million | Up 59.6% |
| Operating loss | $97.5 million | $41.6 million | Loss widened |
| Net loss | $97.3 million | $41.5 million | Loss widened |
| Net loss per share, basic and diluted | $2.71 | $1.95 | Loss per share increased |
| Net cash used in operating activities | $75.4 million | $37.3 million | Cash burn increased |
At year-end, cash and cash equivalents were $51.7 million and short-term investments were $148.9 million, totaling $200.6 million. Current assets were $209.4 million versus current liabilities of $16.8 million. Total liabilities were $22.2 million, primarily including $7.2 million of operating lease liabilities; the filing reports no credit facility or other debt financing. Stockholders’ equity was $199.1 million, and accumulated deficit was $215.1 million.
Revenue fell chiefly because 2020 included a $25 million PLN-1474 milestone and more Novartis-funded research and development services. In 2021, revenue consisted of collaboration research and development services. Novartis accounted for all revenue and accounts receivable in 2021. The company recorded no income tax provision and maintained a full valuation allowance on deferred tax assets. Gross margin is not a meaningful disclosed performance measure for this development-stage business.
Business developments and outlook
- Lead candidate PLN-74809, an oral dual integrin inhibitor, is being developed for idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC). The company reported positive interim PET imaging results in IPF, with more than 50% target engagement in all tested patients and no serious adverse events reported in that trial.
- The 12-week Phase 2a INTEGRIS-IPF trial completed enrollment in December 2021; data were expected mid-2022. INTEGRIS-PSC was enrolling, with completion expected mid-2022 and data expected late 2022 or early 2023. The FDA authorized evaluation of PLN-74809 at doses up to 320 mg for long-term IPF treatment; a six-month Phase 2a trial began in early 2022.
- Expanded Phase 1b results announced in February 2022 showed suppression of the lung TGF-β biomarker pSmad2, with reductions of up to 92% at six hours and 76% at 24 hours. These are biological activity findings, not proof of clinical benefit.
- PLN-1474 is licensed to Novartis, which assumed responsibility for its future development, manufacturing and commercialization after the Phase 1 program. Pliant remains eligible for up to $391 million in contingent milestones and royalties; approximately $2 million of research and development funding remained available at year-end.
- Preclinical oncology and muscular dystrophy programs were undergoing IND-enabling studies, with IND submissions planned by the end of 2022. These are management targets, not guaranteed outcomes.
- Management said year-end resources were expected to fund operating expenses and capital requirements into the second half of 2023, based on its then-current plan. It expects significant losses and research and development spending to continue and says additional capital will be required to complete development of its programs.
Key risks, contingencies and unusual items
- Clinical-stage risk is substantial: candidates have not been approved, and clinical efficacy, safety, regulatory approval and commercial success remain uncertain. The business depends particularly on PLN-74809.
- COVID-19 had delayed or slowed clinical activity and could continue to affect enrollment, trial costs, suppliers and timelines.
- Pliant relies on third parties for clinical work and manufacturing. The filing identifies supplier concentration and potential interruption or replacement challenges as risks.
- Dependence on Novartis exposes collaboration revenue and potential milestones and royalties to partner decisions and program progress. The $391 million of remaining milestones are contingent, not assured.
- Research and development accruals require estimates of work performed by third parties. The auditor identified accrued and prepaid R&D expenses as a critical audit matter; year-end accrued R&D expenses were $5.9 million and prepaid R&D expenses were $2.8 million.
- The company adopted lease accounting standard ASC 842 on January 1, 2021, recording operating lease right-of-use assets and liabilities; the adoption did not materially affect 2021 results or cash flows. The auditor issued unqualified opinions on the financial statements and internal control over financial reporting.
Important facts for investors to verify
- Whether the reported and subsequent PLN-74809 trial results support clinical efficacy, acceptable safety and planned dose selection—not only target engagement or biomarker changes.
- Actual timing and outcomes of the IPF and PSC readouts, and whether the stated enrollment and development milestones were achieved.
- Cash burn against the stated runway, including the effect of expanded trials, and the timing and terms of any additional financing.
- Novartis’s progress with PLN-1474 and research targets, and the conditions and likelihood of future milestone or royalty payments.
- Manufacturing and supply resilience, given reliance on external providers, and any material updates to the company’s disclosed supplier risks.