Pluri Inc. — Form 10-K Summary
Reporting period: Fiscal year ended June 30, 2022, compared with the fiscal year ended June 30, 2021. This is an annual report, not a quarterly filing; the filing’s fiscal period does not correspond to “2021 Q4.” Financial figures below are in U.S. dollars unless noted.
Business context
Pluri is a development-stage biotechnology company using a proprietary 3D cell-expansion platform and in-house GMP manufacturing facility. Its work centers on placenta-derived PLX cell therapies and, through Plurinuva, cultivated-meat technology. The company reported no significant or steady product revenue to date.
Financial results and liquidity
| Metric | FY2022 | FY2021 |
|---|---|---|
| Revenue | $234,000 | $0 |
| Net R&D expense | $24.377 million | $30.066 million |
| General and administrative expense | $17.450 million | $20.557 million |
| Operating loss | $41.593 million | $50.623 million |
| Net loss | $41.374 million | $49.865 million |
| Basic and diluted loss per share | $1.28 | $1.77 |
| Cash used in operating activities | $36.501 million | $30.910 million |
FY2022 revenue came from the Takeda patent license and PLX-cell sales for research use. The smaller net loss reflected lower R&D and G&A expenses, partly offset by higher interest expense and other financial effects. Revenue remains too small to make margins a meaningful measure of operating performance.
At June 30, 2022, current assets were $57.747 million and current liabilities were $6.829 million, producing working capital of $50.918 million. Cash, cash equivalents and restricted cash were $10.779 million; short-term bank deposits were $45.244 million. Including restricted long-term bank deposits, total cash and deposits were $56.657 million. Total assets were $68.065 million, total equity was $32.186 million, and accumulated deficit was $371.263 million.
Long-term liabilities included a $21.678 million EIB loan balance and $7.124 million in operating lease liabilities. The EIB’s first €20 million tranche bears 4% annual interest, is due June 1, 2026, and carries potential revenue-based royalties for fiscal years 2024–2030. The company said it did not expect additional EIB funding.
Investing activities provided $11.783 million, primarily reflecting withdrawal of long-term deposits; financing activities provided $7.5 million from Tnuva’s investment in Plurinuva. Cash and cash equivalents plus restricted cash declined by $20.425 million during the year. A separate exchange-rate effect reduced cash by $3.207 million.
Material changes and notable developments
- Net R&D expense fell 19%, mainly as clinical enrollment and spending declined or concluded in certain studies, including the CLI and COVID-19 ARDS programs. G&A expense fell 15%, largely due to lower share-based compensation.
- Cash used in operations increased from $30.910 million to $36.501 million despite the lower net loss.
- Tnuva invested $7.5 million in Plurinuva for 15.79% ownership and warrants; Pluri retained majority ownership. Plurinuva received an exclusive, royalty-bearing license for cultivated meat. A post-year-end amendment extended the first warrant’s exercise period.
- Pluri changed its name from Pluristem Therapeutics Inc. to Pluri Inc. on July 26, 2022, and changed its Nasdaq ticker from PSTI to PLUR.
- The company reduced headcount under a cost-efficiency plan launched in June 2022: from 159 employees at June 30 to 135 at August 30, 2022.
Outlook, risks and unusual items
- Management said it expected no significant product-sale revenue in the next 12 months; potential licensing revenue was not expected to cover operating costs in the short or medium term. It stated that available resources were sufficient to fund operations for at least 12 months, while warning that additional liquidity may be needed for longer-term development and commercialization.
- In July 2022, Pluri announced topline results from its Phase III hip-fracture muscle-recovery study. The study did not meet its primary endpoint, the SPPB test at week 26. The company reported statistically significant hip-abduction-strength results at weeks 26 and 52 for the injured leg, and at week 52 for the uninjured leg; follow-up was to continue for safety and other measures.
- The COVID-19 ARDS Phase II studies did not meet their primary endpoint of statistically significant improvement in ventilator-free days. The Phase III CLI study was terminated after an independent monitoring committee concluded it was unlikely to meet its primary endpoint.
- Pluri reported a November 2021 vendor-impersonation payment fraud involving approximately $616,000. It recovered approximately $412,000 from the false account and, with insurance reimbursement, recovered the full amount lost. The filing said the incident caused no material operational or financial-obligation impact and no other company information was found stolen or damaged.
- Key risks include continued losses and cash burn, the possibility of needing additional and potentially dilutive capital, clinical and regulatory uncertainty, manufacturing and supplier dependence, intellectual-property challenges, foreign-exchange exposure, EIB restrictions, geopolitical risks in Israel, and early-stage cultivated-meat development. The filing also noted that shares were trading below Nasdaq’s $1 minimum bid-price threshold as of the filing date.
- The independent auditor issued an unqualified opinion on the financial statements. Management reported effective disclosure controls and internal control over financial reporting as of June 30, 2022; the auditor did not audit internal control effectiveness.
Important facts for investors to verify
- Confirm current cash, deposit balances, operating cash burn and financing runway against subsequent filings; the company’s 12-month sufficiency statement is management’s estimate.
- Review final follow-up and analyses from the hip-fracture Phase III study, including the unmet primary endpoint and reported secondary strength results.
- Track the EIB loan repayment terms, accrued interest, revenue-based royalty obligations and any covenant or consent requirements.
- Verify Plurinuva’s ownership, warrant exercise status, development progress and the terms of its technology license and Tnuva relationship.
- Check subsequent share-count changes, equity issuance, warrant dilution and Nasdaq listing compliance.