Pluri Announces Exclusive Collaboration Agreement with Hemafund to Enhance Ukraine's Radiation Emergency Preparedness

Rhea-AI Summary

Pluri Inc. (PLUR) has signed an exclusive collaboration agreement with Hemafund to enhance Ukraine's radiation emergency preparedness. The three-year partnership focuses on stockpiling and distributing Pluri's PLX-R18 cell therapy as a countermeasure against Hematopoietic Acute Radiation Syndrome (H-ARS).

The collaboration aims to build an initial capacity of 12,000 doses of PLX-R18, sufficient to treat 6,000 individuals. If successful, the initiative could generate over $100 million in value for both parties. Hemafund will leverage its biobank infrastructure for storage and distribution across Ukraine.

This strategic initiative comes in response to recent security concerns, including a Russian drone strike on the Chernobyl nuclear power plant. The partnership encompasses:

• Secure storage and distribution systems
• Regulatory compliance support
• Clinical advancement opportunities
• Public and private funding initiatives

Positive

• Potential $100M+ revenue opportunity
• Exclusive partnership securing market access in Ukraine
• Initial stockpile capacity of 12,000 doses
• Strategic positioning in emergency preparedness market

Negative

• Agreement subject to securing external funding
• Revenue generation dependent on emergency situations
• Requires additional regulatory approvals
• Clinical trials still needed for registration

Insights

Financial Analyst

Pluri's exclusive collaboration with Hemafund represents a potentially transformative opportunity for this microcap biotech company. With Pluri's current market cap at just $32.5 million, the collaboration's stated potential value of $100+ million could significantly impact the company's financial trajectory.

The agreement strategically positions Pluri to address Ukraine's critical need for radiation countermeasures following security incidents at nuclear facilities. The planned stockpile of 12,000 PLX-R18 doses (treating 6,000 individuals) demonstrates meaningful scale, particularly as it follows the model used by the U.S. Strategic National Stockpile.

However, investors should note several key contingencies that must be resolved before any value materializes. Most critically, the collaboration depends on securing external funding to build the initial treatment capacity. Additionally, regulatory approvals from Ukraine's Ministry of Health will be necessary, adding another layer of execution risk.

The partnership's structure leverages complementary strengths – Pluri's cell therapy production capabilities paired with Hemafund's infrastructure, storage facilities, and regional regulatory expertise. The three-year agreement (extendable to six) provides a solid timeframe for implementation.

Beyond the immediate financial opportunity, this collaboration could validate Pluri's technology in emergency preparedness applications, potentially leading to similar partnerships with other countries concerned about radiation readiness. For a company of Pluri's size, successfully executing this single partnership could fundamentally alter its growth trajectory and market position.

Biotech Specialist

This collaboration represents a significant advancement for Pluri's PLX-R18 cell therapy program targeting Hematopoietic Acute Radiation Syndrome (H-ARS). The partnership strategically addresses an urgent medical need in Ukraine, where recent incidents highlight the genuine requirement for radiation countermeasures.

PLX-R18's application for radiation exposure aligns with its mechanism of action. H-ARS causes dose-dependent bone marrow suppression leading to neutropenia, thrombocytopenia, and anemia – conditions where cell therapies could potentially provide meaningful intervention by supporting hematopoietic recovery.

From a clinical development perspective, the collaboration's mention of potential clinical trials presents an opportunity to generate valuable data that could advance PLX-R18's regulatory pathway beyond emergency use. This aspect represents an underappreciated benefit beyond the immediate stockpiling initiative.

The planned capacity of 12,000 doses (sufficient for 6,000 patients) indicates meaningful scale, particularly as it's benchmarked against established preparedness models used by the U.S. Strategic National Stockpile. This approach brings credibility to the collaboration's scope and potential impact.

Hemafund's expertise in cell preservation and cryostorage addresses a critical logistical challenge – maintaining cell therapy viability until deployment. Their established infrastructure provides the necessary cold chain management essential for preserving PLX-R18's therapeutic efficacy until needed in emergency situations.

• Strategic initiative to address Ukraine’s urgent need for radiation countermeasures
• Hemafund's infrastructure ensures secure storage and rapid deployment of emergency treatments
• Collaboration may potentially generate over $100 million in value for both parties
  

HAIFA, Israel, March 05, 2025 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it has signed an exclusive collaboration agreement with Hemafund Ltd. (“Hemafund”), a Ukrainian umbilical cord blood bank with clinical and research laboratories and facilities specializing in cell preservation and cryostorage (the “Collaboration” or the “Collaboration Agreement”). This Collaboration aims to establish a strategic initiative for stockpiling, distribution, and potential clinical advancement of Pluri’s innovative PLX-R18 cell therapy (“PLX-R18”) as a countermeasure against Hematopoietic Acute Radiation Syndrome (“H-ARS”) in Ukraine. Subject to certain conditions, the Collaboration Agreement will be effective for an initial period of three years and can be extended by the parties for an additional period of three years.

Pursuant to the Collaboration Agreement, Pluri will produce and supply PLX-R18 as a potential treatment for H-ARS following nuclear radiation exposure. Hemafund will leverage its infrastructure and expertise in biostorage, logistics, and regulatory processes to support local distribution and ensure compliance with Ukrainian and European biobank standards. The parties will seek funding to build the necessary capacity of PLX-R18 and expect to enter into a specific separate definitive agreement once such funding becomes available.

This Collaboration comes in response to recent escalations, including a recent Russian drone strike on the Chernobyl nuclear power plant, which caused a fire in the containment shell. Although the blaze was extinguished without an increase in radiation levels, the incident underscores the critical need for effective and readily available radiation countermeasures in the region.

As part of this Collaboration, Pluri and Hemafund will work toward securing external funding to build an initial capacity of 12,000 doses of PLX-R18, ensuring preparedness for radiation-related emergencies. The PLX-R18 doses will be stored and managed by Hemafund, leveraging its state-of-the-art biobank infrastructure and logistics network to enable rapid deployment in case of need.

The Collaboration, if successful, could potentially generate over $100 million in value for both parties, based on the estimated cost per dose and the projected stockpile of 12,000 doses, which is expected to be sufficient to treat 6,000 individuals (as each patient is expected to require two doses). The calculation of 12,000 doses is based on the actual availability of countermeasures in the U.S. Strategic National Stockpile for the U.S. population. This approach aligns with established preparedness measures designed to ensure the availability of countermeasures against H-ARS in response to public health emergencies¹.

H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow suppression, leading to severe neutropenia, thrombocytopenia, anemia, and a heightened risk of mortality.

Strategic Goals of the Collaboration:

• Stockpiling and Distribution: Hemafund will establish secure storage and facilitate the logistics of PLX-R18 delivery to medical institutions across Ukraine.
• Regulatory and Compliance Support: The Collaboration will seek necessary approvals from Ukraine’s Ministry of Health and ensure adherence to regional regulations for PLX-R18 use.
• Clinical Advancement: Pluri and Hemafund will explore opportunities for clinical trials to register the PLX-R18 as a radiation countermeasure.
• Public and Private Funding: This Collaboration aims to attract government and private sector funding to support the development and accessibility of PLX-R18 in Ukraine and potentially other regions.

“As a company committed to leveraging cell-based technology for humanity’s greatest challenges, we see this Collaboration as a proactive measure to ensure our PLX-R18 therapy is readily available where it is needed,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We believe that Hemafund’s deep-rooted expertise in Ukraine’s biotech landscape makes them an ideal partner to facilitate local accessibility, storage, and regulatory integration of our solution.”

Yaroslav Issakov, Founder of Hemafund Ltd., added, “We are excited to combine our efforts with Pluri to address this urgent medical need together. We believe that our state-of-the-art cryostorage facilities and logistics network position us well to support the introduction of PLX-R18 as a potential vital tool for radiation emergency preparedness in Ukraine. While we hope such treatments remain precautionary, our goal is to stand ready to distribute this potential therapy in the event of an emergency.”

About Hemafund

Hemafund is a family cord blood bank, located in a biotechnological complex in Ukraine, and specializing in the preservation of umbilical cord blood, placenta, and umbilical cord tissues. The company also provides long-term cryostorage services for human cells and tissues, with a focus on stem cell preservation. Hemafund operates a comprehensive facility that includes facilities such as clinical diagnostic laboratories, processing laboratories, and cryostorage facilities, and is a member of the international Cord Blood Association, coordinating a nationwide program for the application of cord blood in Ukraine. Learn more at https://international.hemafund.com/

About PLURI

Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits of the Collaboration and each party’s obligation pursuant to the Collaboration Agreement, the potential for PLX-R18 to be used for the potential treatment of H-ARS, the potential doses required and potential revenue to be derived from the Collaboration, the potential for both parties to secure necessary funds to build the necessary capacity of PLX-R18 and the expectation of the parties to enter into a separate definitive agreement when such funds become available. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.

Media Contacts

Investors: investor.relations@pluri-biotech.com

Israel Media: Or Erez at Or.Erez@gitam.co.il

U.S. Media: Jennifer Ringler at jringler@quantum-corp.com

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¹ HHS boosts stockpile of products to treat acute radiation syndrome | HHS.govBARDA Awards $37.6 million Contract to Sanofi to Supply Leukine® (sargramostim) for Potential Public Health Emergency | Business WireGoLocalProv | U.S. Shells Out $290M to Stockpile Radiation Sickness Pills — Made by Amgen

FAQ

What is the potential value of Pluri's (PLUR) collaboration agreement with Hemafund?

The collaboration could potentially generate over $100 million in value for both parties, based on 12,000 doses of PLX-R18 therapy.

How many patients can be treated with Pluri's (PLUR) initial PLX-R18 stockpile in Ukraine?

The initial 12,000-dose stockpile can treat 6,000 individuals, as each patient requires two doses.

What triggered Pluri's (PLUR) radiation preparedness initiative in Ukraine?

Recent security concerns, including a Russian drone strike on the Chernobyl nuclear power plant, highlighted the need for radiation countermeasures.

How long is the collaboration agreement between Pluri (PLUR) and Hemafund?

The agreement is effective for an initial period of three years, with the option to extend for an additional three years.