Business context and reporting period
Pluri Inc. is a biotechnology company developing cell-based technologies for regenerative medicine, food technology and agriculture, and has launched a contract development and manufacturing organization (CDMO) business. This Form 10-Q covers the fiscal quarter and nine months ended March 31, 2024 (fiscal Q3 2024), compared with the periods ended March 31, 2023. Financial statement amounts below are in U.S. dollars; unless noted, figures are in millions.
The filing describes a 1-for-8 reverse stock split effective April 1, 2024; share and per-share amounts presented have been retroactively adjusted. The company reported 5,388,792 shares outstanding as of May 3, 2024.
Financial performance and liquidity
| Metric | Three months ended March 31, 2024 | Three months ended March 31, 2023 | Nine months ended March 31, 2024 | Nine months ended March 31, 2023 |
|---|---|---|---|---|
| Revenue | $0.071 | $0.087 | $0.230 | $0.176 |
| Net R&D expense | $3.094 | $4.167 | $9.051 | $12.223 |
| General and administrative expense | $2.511 | $3.020 | $7.303 | $8.655 |
| Operating loss | $5.534 | $7.100 | $16.124 | $20.702 |
| Net loss | $5.390 | $7.758 | $15.482 | $22.281 |
| Net loss per share, basic and diluted | $1.01 | $1.52 | $2.92 | $5.04 |
Revenue was principally from CDMO services and an agtech proof-of-concept collaboration with ICL Group in 2024. The filing does not report a gross profit or gross margin measure. Other financial income was $1.290 million for the nine months, versus $0.956 million of expense in the prior-year period, primarily reflecting currency movements, deposit interest and hedging income. Interest expense was $0.648 million for the nine months.
Operating cash use was $13.708 million for the nine months, down from $19.960 million. Investing activities provided $15.389 million, mainly from net withdrawals of short-term deposits; financing activities provided no cash. Cash and cash equivalents were $7.081 million at March 31, 2024. Cash, short-term deposits and restricted cash/deposits totaled $26.917 million, including $18.926 million of short-term bank deposits.
Current assets were $27.367 million and current liabilities $4.526 million, yielding reported working capital of $22.841 million. Total liabilities were $34.545 million, including a $24.065 million long-term EIB loan balance (principal of $21.620 million plus accrued interest of $2.445 million) and $6.018 million of lease liabilities. Total consolidated equity was $1.845 million, but equity attributable to Pluri shareholders was a deficit of $0.356 million. Accumulated deficit was $414.743 million.
Changes versus the prior comparable periods
- Nine-month revenue increased 31% to $0.230 million, while quarterly revenue declined to $0.071 million from $0.087 million. Revenue remains small relative to operating costs.
- Net R&D expense fell 26% for both the quarter and nine-month period, reflecting completed clinical studies, cost reductions and NIAID contract participation, partly offset by lower other grant participation.
- G&A expense declined 16% for the nine months and 17% for the quarter, attributed to cost controls, lower compensation and insurance costs, and reduced share-based compensation.
- Nine-month net loss narrowed to $15.482 million from $22.281 million; operating cash use also declined. Cash and deposits fell from $41.409 million of current assets at June 30, 2023 to $27.367 million at March 31, 2024, with deposit withdrawals contributing to reported investing cash inflows.
- Shares outstanding increased to 5,228,737 at March 31, 2024 from 5,155,687 at June 30, 2023, before subsequent-period ATM sales.
Outlook, risks and notable items
- Management stated that existing resources and the operating plan are expected to fund obligations for at least 12 months from issuance of the statements. It does not expect significant product-sales revenue in the next 12 months and cautioned that collaboration, licensing and service revenues are unlikely to exceed operating costs in the short to medium term.
- Potential funding sources include licensing and commercial partnerships, CDMO services, grants and contracts, and equity sales. A February 2024 sales agreement allows up to $10 million of shares to be sold through A.G.P.; after quarter-end, 42,729 shares were sold at an average $5.93 per share. A separate effective shelf registration permits offerings up to $200 million, including ATM sales.
- Pluri reported that it did not believe it met Nasdaq’s $2.5 million shareholders’ equity continued-listing standard, based on its $0.356 million shareholders’ deficit, and anticipated a deficiency notice. Delisting could impair share liquidity and access to capital.
- The company reported no material operational impact from the Israel conflict as of the filing, but warned that escalation, employee reserve-duty call-ups, supply disruption or limits on travel could delay work or affect operations and fundraising. Insurance does not cover war-related losses; government compensation for direct damage is not assured.
- Potential future obligations include IIA royalties of 3% on qualifying sales until grants and applicable interest are repaid; the contingent royalty balance was $27.746 million at March 31, 2024. The EIB loan is due June 1, 2026, bears 4% annual interest, and also carries revenue-based royalties through fiscal 2030. The EIB agreement includes restrictions on certain business, asset, financing and distribution actions.
- After the reporting date, Pluri announced an immune-cell expansion patent and a MAIT-cell immunotherapy platform. The filing also describes the NIAID contract as a three-year $4.2 million contract, with performance initially through June 30, 2024 and a possible two-year extension; future extensions and funding are not assured.
Key facts for investors to verify
- Whether Pluri receives a Nasdaq deficiency notice and satisfies the applicable continued-listing requirements.
- Cash runway and actual operating cash use, including the accessibility and maturity profile of bank deposits and restricted funds.
- Progress in converting CDMO, ICL/agtech and other collaborations into recurring, material revenue.
- Availability and terms of future funding, including subsequent ATM issuance, dilution, grant receipts and any new partnerships.
- Clinical, regulatory and commercialization milestones, and any changes to the NIAID contract or the PROTO study timeline.
- Effects of the Israel conflict on staff availability, supply chains, operations and the company’s ability to raise capital.