Pluri Inc. — Form 10-Q Summary
Reporting period: Quarter ended September 30, 2023 (the first quarter of Pluri’s fiscal year 2024; not calendar-year Q1). Unaudited consolidated figures are in U.S. dollars. Financial statement amounts below are shown in millions unless otherwise noted.
Business context
Pluri is a biotechnology company developing cell-based products and technologies using its 3D cell-expansion platform, with activities in regenerative medicine and food technology. Its pipeline includes PLX cell therapies; it also collaborates on cultivated food and biologics applications. The quarter’s reported revenue was limited and did not represent significant product sales.
Financial performance and liquidity
| Metric | Quarter ended Sep. 30, 2023 | Comparable 2022 quarter |
|---|---|---|
| Revenue | $0.054m | $0.087m |
| Net R&D expense | $2.993m | $4.270m |
| General and administrative expense | $2.438m | $2.740m |
| Operating loss | $5.377m | $6.923m |
| Net loss | $5.098m | $6.269m |
| Net loss per share | $0.12 | $0.19 |
| Cash used in operating activities | $5.857m | $7.609m |
- Revenue fell approximately 38%. Net R&D expense declined 30%, and G&A expense declined 11%. Management attributed lower costs mainly to completed clinical studies, cost-efficiency measures, reduced headcount, and favorable currency effects; increased NIAID participation partly offset lower R&D costs.
- Net loss improved by about 19%; weighted-average shares rose to 41.3 million from 32.6 million, primarily reflecting the December 2022 private placement and vested RSUs.
- At September 30, 2023, cash and cash equivalents were $5.253m, short-term bank deposits $28.356m, and restricted cash and long-term restricted deposits totaled $0.906m. The company reported total cash and deposit resources of $34.515m. Cash, cash equivalents and restricted cash decreased $0.097m during the quarter; investing activities provided $5.802m, mainly from net withdrawals of short-term deposits. There were no financing cash flows.
- Current assets were $35.258m and current liabilities $4.322m, yielding working capital of $30.936m. Total assets were $44.542m and total equity $11.038m, including $2.137m attributable to non-controlling interests. Accumulated deficit was $404.545m.
- Long-term EIB loan liability was $23.172m, including principal and accrued interest; the loan is due June 1, 2026 and bears 4% annual interest payable with principal. Lease liabilities totaled $6.073m. No operating margin is presented; revenue remains very small relative to operating expenses.
Outlook, risks and unusual items
- Management believes existing resources and its operating plan are sufficient to meet obligations for at least 12 months from issuance of the financial statements. It does not expect significant product-sale revenue in the next 12 months and says collaboration and licensing revenue is unlikely to exceed operating costs in the short to medium term. Additional funding may be needed for commercialization and continued R&D.
- Pluri signed a three-year, $4.2m NIAID contract in July 2023 to advance PLX-R18 for hematopoietic acute radiation syndrome, working with U.S. government research partners. The company expected approximately $0.382m from the grant as of September 30, 2023.
- An Ever After Foods SAFE for $2.5m had not closed as of the financial statement date because funds had not been transferred. The company’s Jefferies ATM agreement terminated effective September 8, 2023. A new effective shelf registration permits offerings of up to $200m; no securities had been sold under it as of November 13, 2023.
- Nasdaq granted an extension through April 15, 2024 to regain the $1.00 minimum bid-price requirement and approved transfer from the Nasdaq Global Market to the Nasdaq Capital Market, effective October 19, 2023. The company reported its shares were still below $1.00 as of the filing date and may consider a reverse stock split.
- Pluri disclosed that the Israel-Hamas war had not materially affected operations as of the filing, but escalation, employee reserve-duty call-ups, supply delays, or damage not covered by insurance could disrupt operations or impair access to capital.
- Contingent IIA royalties were estimated at $27.564m, excluding applicable LIBOR interest; royalties are payable from sales of qualifying products and services. EIB royalties on future revenue begin in fiscal 2024 and continue through fiscal 2030; the accrued liability was described as immaterial.
Important facts for investors to verify
- Whether the $34.515m cash-and-deposit resource figure remains available as planned, and the resulting cash runway given recurring operating losses.
- Progress toward Nasdaq’s minimum bid-price compliance deadline of April 15, 2024, including any reverse split or other action.
- Whether the Ever After $2.5m SAFE closes and whether Pluri raises capital under its $200m shelf registration.
- Timing, funding receipts, and development milestones under the NIAID contract and other grant or collaboration programs.
- Potential operational, personnel, insurance, and financing effects from developments in Israel, and the implications of future IIA and EIB royalties.