Pluri Inc. - PLUR STOCK NEWS

Pluri Inc. (Nasdaq: PLUR) has been shortlisted for the CDMO of the Year Award by the Advanced Therapies Awards 2025 for its PluriCDMO™ business division. Launched in January 2024, PluriCDMO™ offers contract development and manufacturing services to life science companies, providing access to their 47,000 square foot GMP facilities and patented bioreactor system for 3D cell expansion.

The nomination comes less than a year after the division's launch, highlighting Pluri's rapid progress in supporting transformative therapies. The company's technology enables mass-scale production through a fully controlled, automated, and validated process, serving a growing number of innovative clients in the cell therapy industry.

Pluri Inc. (Nasdaq: PLUR) is evaluating its readiness for mass production of PLX-R18, a potential treatment for hematopoietic complications of acute radiation syndrome (H-ARS). The assessment comes amid heightened global nuclear threats, particularly in Ukraine. PLX-R18 has shown promise in improving survival and accelerating recovery from H-ARS in preclinical studies, with support from U.S. defense agencies. The treatment has received FDA's Orphan Drug Designation and IND approval for H-ARS treatment. The company's manufacturing facility is equipped for large-scale cellular therapy production and could be mobilized for mass production if needed.

Pluri Inc. (NASDAQ: PLUR), a biotechnology company specializing in cell-based solutions, has announced its participation in the upcoming Q4 Virtual Investor Summit Microcap Event on November 21st. The company will deliver a presentation from 9:00 AM to 9:30 AM ET and will be available for one-on-one meetings throughout the day.

The event showcases 40 micro-cap companies with catalysts and strong market performance. It features live Q&A sessions and is complimentary for qualified investors. The presentation will be accessible via webcast.

BrainStorm Cell Therapeutics has signed a Memorandum of Understanding (MOU) with Pluri to manufacture NurOwn® for the planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This agreement will enable BrainStorm to transfer its manufacturing technology and start production at Pluri's GMP-compliant facility in Israel upon finalizing a definitive agreement. The collaboration aims to meet the supply requirements for the Phase 3b trial and explore future commercial distribution options, pending NurOwn's approval. The trial will enroll up to 200 participants and is designed in two parts: a 24-week double-blind period followed by a 24-week open-label period. The primary endpoint is the change in ALSFRS-R score from baseline to week 24. BrainStorm will provide further updates in Q4 2024.

Pluri Inc. (PLUR) announces a collaboration with Bar-Ilan University's BIRAD, funded by the Israel Innovation Authority, to advance cancer immunotherapy using Placental Mucosal Associated Invariant T (MAIT) cells for solid tumors. The partnership combines Pluri's proprietary MAIT cell expansion platform with Prof. Cyrille Cohen's Siglec-based Chimeric Switch Receptors technology to enhance CAR-MAIT's efficacy and tumor specificity. The project aims to develop innovative allogeneic cell therapies targeting solid tumors, addressing a significant unmet medical need. Pluri's MAIT cells, derived from human placentas, offer unique advantages including potency, multiple tumor-targeting mechanisms, and reduced risk of Graft versus Host Disease.

Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) has signed a tech transfer and manufacturing agreement with Kadimastem (TASE: KDST) through its PluriCDMO™ division. PluriCDMO™ will manufacture two cell therapy product candidates for Kadimastem: AstroRx® for ALS treatment and IsletRx for diabetes treatment. This collaboration leverages Pluri's 47,000 square foot GMP cell production facility and expertise in developing and manufacturing cell-based products. The agreement supports Kadimastem's preparation for clinical trials and expansion into the U.S. market, particularly for an upcoming FDA Phase 2a study of AstroRx®. This partnership highlights PluriCDMO™'s versatility and commitment to advancing innovative life-saving therapies.

Pluri has entered a €1 million proof of concept (POC) agreement with an international agriculture The collaboration aims to boost global vegetable supply, shorten supply chains, and promote sustainable agriculture. Pluri’s 3D cell expansion technology and the partner's market expertise will work together to minimize environmental impact and enhance food security. This initiative aligns with Pluri's strategy to partner with global companies and generate revenue through innovative projects. The global vegetable farming market, valued at $1.3 trillion, is projected to grow to $1.6 trillion by 2029, driven by a rising global population.

Pluri's subsidiary, Ever After Foods, has secured $10 million in strategic investments from U.S. and EU investors, including Tnuva Group. This funding aims to tackle scalability challenges in cultivated food production. Ever After Foods' innovative platform can produce cultivated meat, fish, and seafood with significant cost-efficiency, reducing production costs by over 90% and increasing protein and lipid yields substantially.

Leveraging Pluri's technology, Ever After Foods aims to expand its global market presence. The technology enables natural production of muscle and fat tissues, ensuring taste and texture akin to conventional meat. The new funding will also broaden Ever After Foods' scope to include cultivated fish, reinforcing its position as a leading technology enabler in the food industry.

Pluri announced that the U.S. National Institute of Allergy and Infectious Diseases (NIAID) has exercised a $1.4 million second-year funding option for a contract to develop PLX-R18, a cell therapy for Acute Radiation Syndrome (H-ARS). The contract, part of a $4.2 million three-year agreement, supports manufacturing, in vitro, and in vivo studies for PLX-R18. The therapy aims to counteract hematopoietic complications from ionizing radiation. Significant survival rate increases in both animal and human studies have been reported. PLX-R18 has also received FDA Orphan Drug Designation.