Pluri Inc. has expanded its 2024 manufacturing agreement with Remedy Cell Ltd., completing the full implementation of Remedy Cell’s proprietary process in Pluri’s GMP facility. The collaboration now includes GMP training, qualification of Remedy Cell’s manufacturing team, engineering runs to confirm process robustness, and the production of several clinical‑grade batches for Remedy Cell’s lead candidate, RC‑0315, slated for a Phase 1b trial in idiopathic pulmonary fibrosis.
The expansion demonstrates Pluri’s CDMO division’s capability to handle complex, cell‑derived and cell‑free biologics at scale. By delivering clinical‑grade material for a first‑in‑class secretome therapy, Pluri not only generates immediate service revenue but also strengthens its pipeline of future CDMO contracts in the regenerative medicine and fibrotic disease space. The successful production of clinical‑grade batches signals operational readiness and scalability, key factors for attracting additional CDMO clients and supporting Pluri’s long‑term growth objectives.
Pluri’s Q1 2026 earnings report, released on November 12 2025, showed revenue of $0.32 million and a net loss of $5.85 million, a modest improvement from the $7.60 million loss in the prior quarter. Earnings per share were –$0.65, beating analyst expectations of –$0.74 by $0.09. Despite the earnings beat, the company’s stock fell 5 % to $3.23 on the day of the announcement, reflecting investor concern about Pluri’s ongoing negative profitability and limited cash reserves.
CEO Yaky Yanay said, “We are proud to continue strengthening our agreement with Remedy Cell, working together to achieve every project milestone—from technology implementation and engineering runs to the successful manufacture of clinical‑grade batches for their first human trial. Remedy Cell’s scientific approach is highly innovative, and it has been a privilege to contribute to their progress. This success further positions PluriCDMO™ as a trusted partner for companies developing complex, cell‑derived therapies.”
Remedy Cell CEO Ayelet Dilion‑Mashiah added, “Working with Pluri has been highly productive. Pluri’s expertise and professionalism have been invaluable in helping us reach this critical milestone. Completing our clinical‑grade manufacturing and preparing for our first clinical trial is a defining achievement for Remedy Cell, and we look forward to continuing this productive partnership.”
The market reaction— a 5 % decline in the share price—was not directly tied to the milestone itself. Analysts noted that while the CDMO expansion is a positive operational development, investors remain wary of Pluri’s persistent net losses and the company’s limited financial cushion. The decline suggests that the market is weighing the short‑term operational success against longer‑term profitability risks.
In summary, Pluri’s expanded partnership with Remedy Cell marks a significant step in its CDMO strategy, showcasing its ability to scale complex biologics production. However, the company’s financial challenges and negative profitability metrics temper enthusiasm, underscoring the need for continued cost discipline and revenue growth to sustain investor confidence.
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