Pluri Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
PLUR$1.24+3.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001213900-25-042637
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001213900-25-109174
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 86 previous paragraphs and 80 current paragraphs.
23 unchanged; 32 reworded; 22 added; 28 removed; 3 previous and 3 current paragraphs rearranged.
Tables are not compared: 16 previous and 17 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (22)
Current report
Our operations pursue a variety of initiatives that leverage the Company’s technology across diverse applications and industries, as set forth below:
Current report
(c) the development of cell-cultured coffee and cacao through business activities operated via our subsidiaries in the plant-based vertical, Coffeesai and Kokomodo, respectively:
Current report
***Coffeesai -***In 2024, we established Coffeesai Ltd., an Israeli subsidiary focused on developing cultivated, cell-cultured coffee. This initiative addresses key challenges facing the traditional coffee industry, such as climate-related crop instability, supply chain disruptions, and environmental impact. By leveraging controlled, scalable bioprocess, Coffeesai aims to deliver consistent product quality, reduced resource consumption, and long-term cost efficiency.
Current report
Coffeesai has successfully demonstrated a POC coffee beverage, validating the potential of its technology. Ongoing efforts are focused on enhancing flavor and aroma profiles through bioprocess optimization and downstream refinement.
Current report
***Kokomodo -***On April 28, 2025, we completed the acquisition of approximately 79% of the equity in Kokomodo (held as a majority owned subsidiary of our wholly owned subsidiary, Pluri Biotech). Kokomodo, an Israeli company, is an innovative agfood startup pioneering the sustainable production of cacao using cellular agriculture technology. Instead of relying on traditional tropical farming, Kokomodo cultivates real cacao directly from plant cells in controlled environments, such as bioreactors, making climate-resilient cacao accessible year-round on a global scale. Founded in 2024, Kokomodo aims to transform the cacao industry, reducing environmental impact while ensuring a steady, high-quality supply for chocolate and related products.
Current report
Aesthetics and Wellness
Current report
Cellav - In November 2025, we established Cellav, a wholly owned subsidiary focused on developing regenerative skin and hair solutions using its proprietary 3D cell expansion technology. Cellav develops cell-derived ingredients, including exosomes and cell extracts, for integration into partner formulations and for use in professional and consumer skincare and haircare products.
Current report
During the first quarter of fiscal year 2026, and through the date of this report, we continued to advance our activities across our foodtech, AgTech and cell-based aesthetics and wellness subsidiaries. Each of Ever After Foods, Kokomodo, Coffeesai and Cellav entered into collaboration agreements with leading counterparties in Asia, Europe, and the United States to evaluate and potentially further develop applications of our proprietary technologies in their respective fields. These collaborations are structured around initial, partner-funded POC or pilot programs, designed to assess the application of our technologies in cultivated meat, cacao, coffee, and cell-based skincare, and may, subject to positive outcomes, be expanded into subsequent development or commercialization activities. Collectively, we believe that these collaborations underscore the growing commercial and technological validation of our platform and enhance our strategic positioning across multiple industries.
Current report
Revenues for the three-month period ended September 30, 2025 were $316,000, as compared to $326,000 for the three-month period ended September 30, 2024. The revenues for the three-month period ended September 30, 2025 and 2024, were primarily generated from services provided to CDMO clients for process and product development, as well as income from fees in the AgTech sector.
Current report
General and administrative expenses for the three-month period ended September 30, 2025 increased by 1% from $2,509,000 for the three-month period ended September 30, 2024 to $2,534,000, mainly due to an increase in share-based compensation expenses related to RS which were granted during the first quarter of fiscal year 2026 to consultants, partially offset by a decrease in expenses related to corporate activities, such as professional services expenses and public relations.
Current report
Loss per share for the three-month period ended September 30, 2025, was $0.65, compared to $1.08 loss per share for the three-month period ended September 30, 2024. The decrease in the loss per share was primarily an increase in our weighted average number of shares outstanding which reflects the issuance of additional shares upon the vesting of RSUs and restricted shares issued to directors, employees and consultants and pre-funded warrants, partially offset by an increase in the loss for the year.
Current report
Cash used in operating activities increased to $5,428,000 during the three months ended September 30, 2025,
Current report
compared to $4,064,000 during the three months ended September 30, 2024, primarily due to a decrease in grants received from the IIA and NIAID contract funding, effect of exchange rate, and continued payments to employees, partially offset by a decrease in continued payments to suppliers and subcontractors.
Current report
Cash provided by investing activities was $3,850,000 and $585,000 during the three months ended September 30, 2025, and 2024, respectively. Cash provided by investing activities for the three months ended September 30, 2025, consisted primarily of proceeds from short-term deposits, net of $3,966,000, partially offset by payments of $116,000 related to investments in property and equipment. Cash provided by investing activities for the three months ended September 30, 2024, consisted primarily of proceeds from short-term deposits, net of $793,000, partially offset by payments of $208,000 related to investments in property and equipment.
Current report
In July 2025, our Chief Executive Officer (“CEO”) agreed to forgo 25% percent of his monthly base salary for a period of six months commencing July 2025.
Current report
On October 15, 2025, the Company’s Board of Directors (the “Board”) approved a grant of equity awards to our CEO, in recognition of the achievement of certain performance objectives and other accomplishments during fiscal year 2025. The approved equity awards consist of (i) 39,050 RSUs which are fully vested, and (ii) stock options to purchase 39,050 common shares of the Company which are fully vested and exercisable for a period of three years at an exercise price of $5.00 per share. Since only share-based awards, rather than cash compensation, were granted for such achievement of performance objectives for fiscal year 2025, the provision previously recorded in the amount of approximately $41,000, was reversed.
Current report
The Board further approved, contingent upon the achievement of certain objectives and accomplishments by December 31, 2025, the future grant to the CEO of (i) 9,266 RSUs, and (ii) stock options to purchase 9,266 common shares of the Company. The grant date of such RSUs and stock options, if awarded, will be the date on which the applicable objectives are satisfied, and the stock options will be exercisable for three years at an exercise price of $5.00 per share.
Current report
The IIA may impose certain conditions on any arrangement under which the IIA permits the Company to transfer technology or development out of Israel or outsource manufacturing out of Israel. While the grant is given to the Company over a certain period of time (usually a year), the requirements and restrictions under the Israeli Law for the Encouragement of Industrial Research and Development, 1984, continue and do not have a set expiration period, except for the royalties, which requirement to pay them expires after payment in full.
Current report
On October 28, 2024, we announced that the IIA will fund our collaboration with Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), to support the continued development of MAIT cells for the treatment of solid tumors. As part of this collaboration, novel Chimeric Switch Receptors, developed by Prof. Cohen, head of laboratory of tumor immunology and immunotherapy at Bar-Ilan University, will be integrated into our CAR-MAIT cell therapy platform to enhance tumor specificity and therapeutic efficacy. The collaboration leverages our proprietary MAIT cell technology alongside BIRAD’s expertise in engineering clinically optimized T-cell modification vectors. The IIA has committed to fund the collaboration for an initial term of one year, with an option to extend it for an additional year, subject to the IIA’s approval. During October 2025, we received approval for an additional month to finish the program until November 30, 2025. The total approved budget for the first year is NIS 549,067 (approximately $166,000).
Current report
As of September 30, 2025, our cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled $16,393,000. We are addressing our liquidity issues by implementing initiatives to allow the continuation of our activities. Our current operating plan includes various assumptions concerning the level and timing of cash outflows for operating activities and capital expenditures, which include a cost-reduction plan.
Current report
Our ability to successfully carry out our business plan, is primarily dependent upon our ability to (1) obtain sufficient additional capital, (2) enter licensing or other commercial, partnerships and collaboration agreements, (3) provide CDMO services to clients, (4) enter into agreement with the EIB regarding the EIB Loan restructuring and (5) receive other sources of funding, including non-diluting sources such as grants. There are no assurances, however, that we will be successful in obtaining an adequate level of financing needed for the long-term development and commercialization of our products, or any financing at all. In the event that we are unable to obtain the required level of financing, our operations may need to be scaled down or discontinued.
Current report
According to our management’s estimates, we do not have sufficient resources to meet our operating obligations for at least twelve months from the issuance date of our interim unaudited condensed consolidated financial statements, which was November 12, 2025. These conditions raise substantial doubt about our ability to continue as a going concern.
Removed paragraphs (28)
Previous report
All references to common shares, or price per common share, in this Quarterly Report on Form 10-Q, reflect the 1-for-8 reverse stock split effectuated by us on April 1, 2024.
Previous report
In April 2024, we unveiled a novel method for expansion of immune cells using proprietary technology and announced we were granted a new U.S. patent titled, “System and Methods for Immune Cells Expansion and Activation in Large Scale.” This innovative approach ensures that the produced immune cells retain their integrity, functionality, and therapeutic efficacy, thus offering a promising solution to meet the escalating demand for advanced cell-based therapies for immune disorders and neurodegenerative diseases.
Previous report
In April 2025, we announced that the U.S. Patent and Trademark Office (the “USPTO”), has issued a patent covering our immune cell expansion technologies. The patent claims a proprietary system and method for immune cell activation, genetic engineering, and large-scale 3D expansion. Additionally, we announced that we were issued a patent in Israel, which mirrors a previously granted U.S. patent. Following these recent patent grants, our intellectual property estate includes over 250 patents pending, allowed, and granted.
Previous report
PluriCDMO™
Previous report
In March 2024, we announced an important expansion to our intellectual property portfolio with a new patent approval from the Israel Patent Office, that is designed to reshape the agricultural technology landscape. The patent represents a major breakthrough in our proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various applications, from sustainable agriculture to critical healthcare solutions.
Previous report
On January 23, 2025, the Company entered into a binding term sheet (the “Term Sheet”) for the purchase of certain shares representing approximately 71% of the equity of Kokomodo Ltd. (“Kokomodo”) (on a fully diluted basis), an Israeli agtech company specializing in cultivated cacao production, for an aggregate purchase price of $4.5 million, payable in Common Shares of the Company. Following the execution of the Term Sheet, on March 13, 2025, the Company and the Subsidiary (collectively, the “Purchaser”), entered into a Share Purchase Agreement (the “Share Purchase Agreement”), effective as of March 12, 2025, with Chutzpah Holdings Limited, a company wholly owned by Mr. Alejandro Weinstein, a director of the Company, and Plantae Bioscience Ltd., a corporation controlled by Mr. Weinstein (collectively, the “Seller”), pursuant to which, on April 28, 2025, the Seller sold to the Purchaser 400,000 ordinary shares and 175,000 preferred seed-1 shares (the “Purchased Shares”), representing approximately 71% of the equity of Kokomodo, for an aggregate purchase price of $4.5 million, payable in 976,139 of our common shares (the “Consideration Shares”). Pursuant to the Share Purchase Agreement, the Seller also transferred, assigned and conveyed in favor of the Purchaser a convertible loan, pursuant to an assignment and assumption agreement (the “Assignment Agreement”), reflecting a principal aggregate amount of $0.5 million (together with the Purchased Shares, the “Purchased Interests” and such transactions are referred to as the “Kokomodo Transaction”).
Previous report
Revenues for the nine-month and three-month periods ended March 31, 2025, were $938,000 and $427,000, respectively, as compared to $230,000 and $71,000, respectively, during the nine-month and three-month periods ended March 31, 2024. Revenues for the nine-month and three-month periods ended March 31, 2025, and 2024 were mainly related to services provided to CDMO clients in the field of process and product development and in the agtech fields. The increase in revenues is mainly attributed to the launch of new business verticals, specifically in the CDMO field and an increase related to a POC collaboration with a leading international agriculture corporation in the agtech field.
Previous report
R&D expenses, net (costs less participation by the IIA, Horizon Europe and the NIAID) for the nine-month period ended March 31, 2025, decreased by 2% from $9,051,000 for the nine-month period ended March 31, 2024, to $8,857,000. The decrease is mainly attributed to (1) a decrease in clinical studies expenses following the completion of our clinical studies, partially offset by an increase related to subcontractors activity in our NIAID and immunotherapy projects, and (2) a decrease in materials costs related to a supplier credit, partially offset by (3) an increase in material purchases in line with our manufacturing needs and plans, and (4) a decrease in R&D expenses due to classification of expanses into cost of revenues.
Previous report
General and administrative expenses for the nine-month period ended March 31, 2025, decreased by 2% to $7,145,000, compared to $7,303,000 for the nine-month period ended March 31, 2024. This decrease was primarily driven by a reduction in share-based compensation expenses, mainly attributed to employee terminations and amortization of restricted stock unit (“RSU”), expenses over time. This reduction was partially offset by the following increases: (1) an increase in salaries and related expenses due to the reinstatement of the salary of Mr. Yaky Yanay, our Chief Executive Officer (“CEO”) (following his salary reduction from January 2023 through December 2023, whereby he waived 75% of his salary and converted it to RSUs, and options), (2) an increase in salaries and related expenses due to reinstatement of temporary reduction in employees’ regular working hours for a limited period in December 2023, (3) an increase in bonus expenses for certain employees, including our CEO and Mrs. Chen Franco-Yehuda, our former Chief Financial Officer (“CFO”), related to performance-based bonuses pursuant to their respective employment agreements, and (4) increased share-based compensation expenses related to RSUs and options granted during the prior year to employees, officers, directors and consultants.
Previous report
General and administrative expenses for the three-month period ended March 31, 2025, decreased by 1% from $2,511,000 for the three-month period ended March 31, 2024, to $2,493,000. The decrease is mainly attributed to (1) a decrease in share-based compensation expenses related to employee terminations and RSUs, and (2) expenses amortization over time, partially offset by (3) an increase in salaries and related expenses due to reinstatement of temporary reduction in employees’ regular working hours for a limited period in December 2023, (4) an increase in bonus expenses for certain employees, including our CEO and our former CFO for certain performance-based bonuses as defined in their employment agreement, and (5) an increase in share-based compensation expenses related to RSUs and options which were granted during the third quarter of fiscal year 2024 and the first quarter of fiscal year 2025 to employees, officers, directors and consultants.
Previous report
Other financial income (expenses), net, decreased from $1,290,000 in financial income for the nine-month period ended March 31, 2024, to $714,000 in financial income for the nine-month period ended March 31, 2025. This decrease is mainly attributed to (1) exchange rate differences expenses related to a loan obtained from EIB (the “EIB Loan”) in April 2020 pursuant to the EIB Finance Agreement, following fluctuation between the U.S. dollar against the Euro, (2) a decrease in interest income from deposits, resulting from lower interest rates and reduced deposit levels due to withdrawals, (3) a decrease due to exchange rate expenses on a lease liability due to the strength of the New Israeli Shekel (“NIS”), against the U.S Dollar, and (4) less income from hedging transactions.
Previous report
The increase in weighted average common shares outstanding reflects the issuance of additional shares pursuant to a securities purchase agreement entered into on January 23, 2025 and an additional securities purchase agreement entered into on February 3, 2025 (the “Securities Purchase Agreement” and the “Additional Securities Purchase Agreement”, respectively), and additional shares upon the vesting of RSUs and restricted shares issued to directors, officers, employees and consultants.
Previous report
Net cash used for operating activities was $12,995,000 in the nine months ended March 31, 2025, compared to $13,708,000 in the nine-month ended March 31, 2024. Cash used in operating activities in the nine months ended March 31, 2025, and 2024 consisted primarily of payments of fees to our suppliers, subcontractors, professional services providers and consultants, and payments of salaries to our employees, partially offset by income from our CDMO clients, agtech fields activities and by grants from the IIA, the Horizon Europe program, and funds received from the NIAID contract.
Previous report
Investing activities provided cash of $4,998,000 in the nine months ended March 31, 2025, compared to cash provided of $15,389,000 for the nine months ended March 31, 2024. The investing activities in the nine-month period ended March 31, 2025, and 2024 consisted primarily of the proceeds from withdrawal of short-term deposits, net of $5,895,000 and $15,702,000, respectively.
Previous report
On December 14, 2022, our CEO agreed to forgo, starting January 1, 2023, $375,000 of his annual cash salary for the next twelve months in return for equity grants, issuable under our existing equity compensation plans. In that regard, we granted Mr. Yanay (i) 41,853 RSUs, vesting ratably each month, and (ii) options to purchase 41,853 common shares, vesting ratably each month, with a term of 3 years from vesting date, at an exercise price of $8.96 per share. In addition, the Board of Directors also agreed to grant Mr. Yanay options to purchase 187,500 common shares, with a term of 3 years from vesting date, with the following terms: (i) options to purchase 62,500 common shares at an exercise price of $12.48 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, (ii) options to purchase 62,500 common shares at an exercise price of $16.64 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, and (iii) options to purchase 62,500 common shares at an exercise price of $20.8 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023.
Previous report
On January 23, 2025, we entered into the Securities Purchase Agreement with the Investor, relating to the offering of: (i) 1,383,948 of our common shares, par value $0.00001 per share, (ii) pre-funded warrants (the “Pre-Funded Warrants”), to purchase up to 26,030 common shares, and (iii) warrants (the “Common Warrants”), to purchase up to 84,599 common shares (the “Offering”). On April 25, 2025, we entered into an amendment to the Securities Purchase Agreement, pursuant to which we and the Investor agreed to exchange 976,139 of the common shares for additional Pre-Funded Warrants to purchase up to 976,139 common shares. The Offering price per share and accompanying warrant is $4.61. The Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable at any time following the receipt certain approvals from our shareholders, required by the applicable rules of the Nasdaq Capital Market, and until exercised in full. The Common Warrants have an exercise price of $5.568 per share, will not be exercisable until we receive approval from our shareholders, and will be exercisable for three years following the date of receipt of such approval. The Pre-Funded Warrants and Common Warrants contain customary anti-dilution provisions and are subject to a 19.99% beneficial ownership limitation until approval from our shareholders is obtained. The Securities Purchase Agreement contains customary representations and warranties and agreements of the Company and the Investor and customary indemnification rights and obligations of the parties.
Previous report
Under the terms of the Securities Purchase Agreement, we appointed Mr. Weinstein to our Board, effective February 5, 2025, and agreed to recommend his election to our shareholders provided that he continues to hold at least 10% of our issued and outstanding common shares.
Previous report
The gross proceeds from the Offering were $6.5 million and we intend to use the proceeds from the Offering for working capital and general corporate purposes. The Offering closed on February 5, 2025, following the satisfaction of customary closing conditions.
Previous report
On January 23, 2025, the Company entered into the Term Sheet for the purchase of certain shares representing approximately 71% of the equity of Kokomodo (on a fully diluted basis), for an aggregate purchase price of $4.5 million, payable in Common Shares of the Company. Following the execution of the Term Sheet, on March 13, 2025, the Purchaser entered into the Share Purchase Agreement, effective as of March 12, 2025, with the Seller, pursuant to which, on April 28, 2025, the Seller (i) sold to the Purchaser 400,000 ordinary shares and 175,000 preferred seed-1 shares, representing approximately 71% of the equity of Kokomodo (on a fully diluted basis), and (ii) transferred, assigned and conveyed in favor of the Purchaser a convertible loan, pursuant to the Assignment Agreement, reflecting a principal aggregate amount of $0.5 million.
Previous report
In consideration for the sale, transfer and conveyance of the Purchased Interests, the Company paid the Seller an aggregate purchase price of $4.5 million, which was paid in 976,139 common shares of the Company.
Previous report
The Company also executed leak-out agreements (the “Leak-Out Agreement”), pursuant to which the Seller agreed to sell, dispose or otherwise transfer the Consideration Shares on the Nasdaq Capital Market or the Tel Aviv Stock Exchange, subject to certain limitations and restrictions for a period commencing on the date of closing of the Kokomodo Transaction and ending on the earlier of (i) 36 months, (ii) the time when the Seller holder holds less than 10% of the outstanding shares of the Company or (iii) the occurrence of a breach of the Company’s commitment to register the Consideration Shares under the Securities Act of 1933, as amended.
Previous report
On April 28, 2025, we completed the Kokomodo Transaction, Kokomodo will continue to operate as an independent company and a majority owned subsidiary of our Company.
Previous report
On February 3, 2025, we entered into the Additional Securities Purchase Agreement, with Merchant Adventure Fund L.P., an existing investor of the Company, relating to a private placement offering, (the “Second Offering”), of: (i) 759,219 of our common shares, par value $0.00001 per share, and (ii) warrants, to purchase up to 45,553 common shares. The Second Offering price per share and accompanying warrant is $4.61. The Second Offering warrants have an exercise price of $5.568 per share and a term of three years commencing on the date of issuance. On March 19, 2025, the Second Offering closed and the Company received gross proceeds in the amount of $3.5 million, which it intends to use for working capital and general corporate purposes.
Previous report
In June 2020, we announced that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA. CRISPR-IL brings together the leading experts in life science and computer science from academia, medicine, and industry, to develop AI based end-to-end genome-editing solutions. These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharmaceutical, agriculture, and aquaculture industries. CRISPR-IL is funded by the IIA with a total budget of approximately $10 million of which, an amount of approximately $480 thousand was a direct grant allocated to us, for the initial period of 18 months. During October 2021, we received approval for an additional grant of approximately $583 thousand from the IIA pursuant to the CRISPR-IL consortium program, for an additional period of eighteen months. During January 2023, we received approval for extension of additional two months to finish the program by June 30, 2023. The CRISPR-IL consortium program does not include any obligation to pay royalties.
Previous report
Through March 31, 2025, we received total grants of approximately $1 million in cash from the IIA pursuant to the CRISPR-IL consortium program, and we do not expect to receive any additional funds.
Previous report
On October 28, 2024, we announced that the IIA will fund our collaboration with Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), the commercial arm of the Bar-Ilan University in Israel, to support the continued development of MAIT cells. This collaboration is focused on advancing innovative allogeneic cell therapies targeting solid tumors and other indications. The IIA is funding our collaboration with BIRAD for the first year, with an approved budget of approximately $148,000 allocated to us. The agreement includes an option for additional funding for a second year. The primary objective is to integrate both technologies effectively and progress to preclinical studies. Notably, the program does not require royalty payment. As of March 31, 2025, we received approximately $29,000 from the IIA for this project.
Previous report
We continuously seek funding through various channels, including strategic collaborations with other companies via licensing agreements, joint ventures, and partnerships. We also pursue non-dilutive funding sources such as research grants, including those from the IIA and the European Union, as well as potential proceeds from the sale of our securities.
Previous report
We believe our existing resources will be sufficient to support our operations for at least the next twelve months.
Reworded paragraphs (32)
Previous wording
In addition, historic results of scientific research and development (“R&D”), clinical and preclinical trials do not guarantee that the conclusions of future R&D or trials would not suggest different conclusions. Also, historic results referred to in this periodic report would be interpreted differently considering additional research, development, clinical and preclinical trials results. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2024 (the “2024 Annual Report”), as well as in Part II, Item 1A of this Quarterly Report. Readers are also urged to carefully review and consider the various disclosures we have made in that report.
Current wording
In addition, historic results of scientific research and development (“R&D”), clinical and preclinical trials do not guarantee that the conclusions of future R&D or trials would not suggest different conclusions. Also, historic results referred to in this periodic report would be interpreted differently in light of additional research, development, clinical and preclinical trials results. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2025 (the “2025 Annual Report”), as well as in Part II, Item 1A of this Quarterly Report. Readers are also urged to carefully review and consider the various disclosures we have made in that report.
Previous wording
As used in this Quarterly Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company” and “Pluri” mean Pluri Inc., our wholly owned subsidiaries, Pluri Biotech Ltd., Pluristem GmbH, and Coffeesai Ltd., and our subsidiaries Ever After Foods Ltd. (“Ever After Foods”), unless otherwise indicated or as otherwise required by the context.
Current wording
As used in this Quarterly Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company” and “Pluri” refer to Pluri Inc., together with its wholly owned Israeli subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”) and the subsidiaries of Pluri Biotech Ltd., including its wholly owned Israeli subsidiaries, Coffeesai Ltd. (“Coffeesai”) and Cellav Health and Aesthetics Ltd. (“Cellav”), its majority-owned Israeli subsidiaries, Kokomodo Ltd. (“Kokomodo”) and Ever After Foods Ltd. (“Ever After Foods”) and its wholly owned German subsidiary, Pluristem GmbH (collectively, the “Subsidiaries”), unless otherwise indicated or as otherwise required by the context.
Previous wording
We are a biotechnology company with an advanced cell-based technology platform, which operates in one operating segment. We have developed a unique three-dimensional (“3D”) cell expansion platform, supported by an in-house, industrial-scale Good Manufacturing Practice (“GMP”) cell manufacturing facility. We are currently applying this technology across the fields of regenerative medicine, immunotherapy, food technology, and agricultural technology. In addition, we have launched a CDMO business and intend to expand the application of our platform to other industries and sectors requiring scalable and cost-efficient cell expansion solutions via partnerships, joint ventures, licensing agreements and other types of collaborations.
Current wording
We are a biotechnology company leveraging our proprietary three-dimensional (“3D”) cell expansion platform to develop scalable, cell-based solutions across multiple sectors. Our technology is supported by an in-house, industrial-scale cell manufacturing facility registered as a manufacturer with the U.S. Food and Drug Administration (FDA) and operated in accordance with Good Manufacturing Practice standards, currently on a self-declared basis. Our operations are dedicated to the research, development, and manufacturing of cell-based products, as well as the commercialization of cell therapeutics and related technologies aimed at delivering innovative solutions across a range of industries. We apply our platform across the fields of regenerative medicine, aesthetics and wellness, food technology, agricultural technology, and through our Contract Development and Manufacturing Organization (“CDMO”) business, and we intend to expand the application of our platform to additional industries that require scalable and cost-efficient cell expansion solutions, including through partnerships, joint ventures, licensing agreements, and other types of collaborations.
Previous wording
In the pharmaceutical area, we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia (“CLI”), Chronic Graft versus Host Disease and a potential treatment for Hematopoietic Acute Radiation Syndrome (“H-ARS”). We believe that each of these indications is a severe unmet medical need.
Current wording
In the pharmaceutical area, we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia, Chronic Graft versus Host Disease (“GvHD”), knee osteoarthritis and a potential treatment for Hematopoietic Acute Radiation Syndrome (“H-ARS”). Some of these studies have been completed while others are still ongoing. We believe that each of these indications is a severe unmet medical need.
Previous wording
Immunotherapy MAIT cells: In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors - a critical area in medicine where effective treatments are currently insufficient. We believe that our MAIT cells, isolated from the human placenta, offer substantial potential benefits compared to conventional T-cells.
Current wording
Immunotherapy Mucosal Associated Invariant T (“MAIT”) cells - In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors - a critical area in medicine where effective treatments are currently insufficient. We believe that our MAIT cells, isolated from the human placenta, offer substantial potential benefits compared to conventional T-cells.
Previous wording
MAIT cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional autologous T-cells typically collected from peripheral blood, our MAIT cells are designed to be allogenic universal products. Benefiting with a very restricted T-cell receptor, the MAIT cells minimize their likelihood of inducing Graft versus Host Disease, a significant advantage over other potential allogeneic products. We are aiming to design the MAIT cells to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
Current wording
Placental MAIT cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional autologous T-cells typically collected from peripheral blood, our MAIT cells are designed to be an allogenic universal product. Benefiting with very restricted T cell receptor, the MAIT cells minimize their likelihood of inducing GvHD, a significant advantage over other potential allogeneic products. We are aiming to design the MAIT cells to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
Previous wording
In January 2024, we launched a new business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers CDMO services to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. We have signed several agreements with clients and are currently generating revenues from PluriCDMO™.
Current wording
**PluriCDMO™-**In January 2024, we launched a new business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers CDMO for cell therapy manufacturing expertise to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients, as well as other services. We have signed several agreements with clients and are currently generating revenues from PluriCDMO™.
Previous wording
We are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the agtech field, such as: (a) cell-based coffee business activity through our PluriAgtech business vertical, which is incorporated into our wholly owned subsidiary, Coffeesai Ltd., (b) an innovative proof-of-concept (“POC”), collaboration with ICL Group Ltd., a leading global specialty minerals company, to revolutionize bio stimulant delivery and enhance yield sustainably, and (c) a strategic POC agreement with a leading international agriculture corporation which is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change, while ensuring a natural and a more sustainable future for agriculture.
Current wording
We are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the AgTech field, including:
Previous wording
In 2022, we announced the establishment of a joint venture with Tnuva Food Industries – Agricultural Co-Operative in Israel Ltd. (“Tnuva”), Ever After Foods (previously Plurinuva Ltd.), which is incorporated under the laws of the State of Israel, with the purpose of developing cultivated meat products of all kinds and types.
Current wording
Ever After Foods - In 2022, we announced the establishment of a joint venture with Tnuva Food Industries - Agricultural Cooperative in Israel Ltd. (“Tnuva”), Ever After Foods, incorporated under the laws of the State of Israel. The purpose of the joint venture is to develop and commercialize scalable production technologies for cultivated meat, supporting the development of a wide range of cultivated meat products with industry partners.
Previous wording
In June 2024, we entered into a share purchase agreement by and among Ever After Foods, Tnuva, and certain other international strategic investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private placement offering, for aggregate gross proceeds of $10 million. As part of such private placement offering, we invested $1.25 million. In addition, our wholly owned subsidiary, Pluri Biotech Ltd., and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024 (the “Amended License”). The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the scope of the license to include fish and seafood.
Current wording
In June 2024, we entered into a share purchase agreement by and among Ever After Foods, Tnuva, and certain other international strategic investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private placement offering (the “Offering”), for aggregate gross proceeds of $10 million. As part of the Offering, we invested $1.25 million. In addition, our wholly owned subsidiary, Pluri Biotech, and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024 (the “Amended License”). The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the scope of the license to include fish and seafood.
Previous wording
The $10 million funding round is intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler and will allow it to move to their own facility during March 2025. Following the closing of such private placement offering, the Subsidiary holds approximately 69% of Ever After Foods.
Current wording
The $10 million funding round supports Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler. Following the closing of the Offering, Pluri Biotech holds approximately 69% of Ever After Foods.
Previous wording
RESULTS OF OPERATIONS – THREE AND NINE MONTHS ENDED MARCH 31, 2025 COMPARED TO THREE AND NINE MONTHS ENDED MARCH 31, 2024
Current wording
RESULTS OF OPERATIONS – THREE MONTHS ENDED SEPTEMBER 30, 2025, COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2024.
Previous wording
Cost of revenues for each of the nine-month and three-month periods ended March 31, 2025, were $491,000 and $291,000. Cost of revenues includes (1) manufacturing costs related to our CDMO and agtech fields, which primary consist of materials, personnel-related and overhead costs, and (2) royalties which we are obligated to pay to the EIB, according to the finance agreement (the “EIB Finance Agreement”), executed with the EIB by us, Pluri Biotech Ltd. and Pluristem GmbH in April 2020. We had no cost of revenues for the nine-month and three-month periods ended March 31, 2024.
Current wording
Cost of revenues for the three-month period ended September 30, 2025 was $201,000, as compared to $126,000 for the three-month period ended September 30, 2024. Cost of revenues includes manufacturing costs related to our CDMO and AgTech fields, which primary consist of materials, personnel-related and overhead costs. The increase in cost of revenues is attributed to higher personnel costs associated with a particular project.
Previous wording
R&D expenses, net (costs less participation by the IIA, Horizon Europe and the NIAID) for the three-month period ended March 31, 2025, decreased by 2% from $3,094,000 for the three-month period ended March 31, 2024, to $3,043,000. The decrease is mainly attributed to (1) a decrease in clinical studies expenses following the completion of our clinical studies, partially offset by an increase related to subcontractors activity in our NIAID and immunotherapy projects, (2) a decrease in material purchases and consultants’ activity in line with our manufacturing needs and plans, and (3) a decrease in R&D expenses due to classification of expenses into cost of revenues.
Current wording
R&D expenses, net (costs less participation by the IIA, Horizon Europe and the National Institute of Allergy and Infectious Diseases (“NIAID”)) for the three-month period ended September 30, 2025 increased by 36% from $2,889,000 for the three-month period ended September 30, 2024, to $3,931,000. The increase is mainly attributed to (1) an increase in salaries and a related expenses mainly attributed to exchange rate differences expenses and due to the addition of new employees following the acquisition of our new subsidiary, Kokomodo, and (2) an increase in lease payments on our facilities mainly due to Ever After Foods’ new operating facility, partially offset by (3) a decrease in material purchases in accordance with our manufacturing needs and plans, and (4) a decrease in participation by NIAID.
Previous wording
Other financial income (expenses), net, changed from $362,000 in financial income for the three-month period ended March 31, 2024, to $723,000 in financial expenses for the three-month period ended March 31, 2025. The decrease is mainly attributed to (1) exchange rate differences expenses related to the EIB Loan following fluctuation between the U.S. dollar against the Euro, and (2) a decrease due to exchange rate expenses on a lease liability due to the strength of the NIS against the U.S Dollar.
Current wording
Other financial income (expenses), net, increased from $621,000 in financial expenses for the three-month period ended September 30, 2024 to $439,000 in financial income for the three-month period ended September 30, 2025. This increase is mainly attributed to exchange rate differences expenses related to the EIB Loan due to fluctuations between the U.S. dollar against the Euro, and from an increase in income from hedging transactions, partially offset by a decrease in interest income from deposits, caused by reduced deposit balances following withdrawals.
Previous wording
Interest expenses related to our outstanding EIB Loan and all changes during the nine-month and three-month periods ended March 31, 2025, compared to the nine-month and three-month periods ended March 31, 2024, are attributable solely to currency rate differences of the Euro compared to the U.S. dollar.
Current wording
Interest expenses related to our outstanding balance of the EIB Loan and all changes during the three-month period ended September 30, 2025 compared to the three-month period ended September 30, 2024, are attributable solely to currency rate differences of the Euro compared to the U.S. dollar.
Previous wording
Net loss for the nine-month and three-month periods ended March 31, 2025, were $15,481,000 and $6,335,000, respectively, as compared to net loss of $15,482,000 and $5,390,000 for the nine-month and three-month periods ended March 31, 2024, respectively. The increase in net loss was mainly due to exchange rate differences expenses as mentioned above. Net loss per share attributed to shareholders for the nine-month and three-month periods ended March 31, 2025, were $2.56 and $0.94, respectively, as compared to $2.92 and $1.01 for the nine-month and three-month periods ended March 31, 2024, respectively. We had a net loss attributed to our non-controlling interest in Ever After Foods for the nine-month and three-month periods ended March 31, 2025, of $496,000 and $188,000, respectively.
Current wording
Net loss for the three-month period ended September 30, 2025, was $6,132,000, compared to net loss of $6,036,000 for the three-month period ended September 30, 2024. The increase is mainly due to the increase in R&D expenses, net and general and administrative expenses, partially offset by an increase in financial income, net, for the reasons mentioned above. We had a net loss attributed to our non-controlling interest in Ever After Foods for the three-month period ended September 30, 2024 of $154,000, and $282,000 for the three-month period ended September 30, 2025 with respect to Ever After Foods and Kokomodo.
Previous wording
For the nine-month and three-month periods ended March 31, 2025, and 2024, we had weighted average common shares outstanding of 5,857,743, 6,563,555 and 5,193,808, 5,221,162, respectively, which were used in the computations of net loss per share for the nine-month and three-month periods.
Current wording
For the three-month periods ended September 30, 2025 and 2024, we had weighted average common shares outstanding of 8,995,635 and 5,459,236, respectively, which were used in the computations of net loss per share for the three-month period.
Previous wording
As of March 31, 2025, our total current assets were $27,455,000 and total current liabilities were $5,705,000. On March 31, 2025, we had a working capital surplus of $21,750,000, total equity of $483,000, after deduction of $4,957,000 which is attributed to the non-controlling interest in Ever After Foods, and an accumulated deficit of $(435,457,000).
Current wording
As of September 30, 2025, our total current assets were $16,921,000 and total current liabilities were $32,160,000. On September 30, 2025, we had a working capital deficit of $15,239,000, total deficit of $5,647,000, out of which $5,713,000 is attributed to the non-controlling interest in Ever After Foods and Kokomodo, and an accumulated deficit of $448,905,000.
Previous wording
Our cash and cash equivalents and restricted cash as of March 31, 2025, amounted to $8,906,000, compared to $7,354,000 as of March 31, 2024, and compared to $7,037,000 as of June 30, 2024. Cash balances changed in the nine months ended March 31, 2025, compared to the nine months ended March 31, 2024, for the reasons presented below.
Current wording
Our cash and cash equivalents and restricted cash as of September 30, 2025 amounted to $4,687,000, compared to $3,563,000 as of September 30, 2024, and compared to $6,317,000 as of June 30, 2025. Cash balances changed in the three months ended September 30, 2025 compared to the three months ended September 30, 2024 for the reasons presented below.
Previous wording
Financing activities provided cash of $9,968,000 in the nine months ended March 31, 2025, which were related to net proceeds received from the of issuances of common shares, pre-funded warrants and warrants, net of issuance cost related to the Offering and the Second Offering. We had no financing activities in the nine months ended March 31, 2024.
Current wording
We had no financing activities in the three months ended September 30, 2025, and 2024.
Previous wording
We have an effective Form S-3 registration statement (File No. 333-273347), filed under the Securities Act with the U.S. Securities and Exchange Commission (the “SEC”), using a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell our common shares, preferred stock and warrants to purchase common shares, and of two or more such securities, in one or more offerings, for an aggregate initial offering price of $200 million (including amounts sold under the Sales Agreement).
Current wording
We have an effective Form S-3 registration statement (File No. 333-273347), filed under the Securities Act of 1933, as amended, with the SEC using a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell our common shares, preferred stock and warrants to purchase common shares, and of two or more of such securities, in one or more offerings for an aggregate initial offering price of $200 million (including amounts sold under the Sales Agreement).
Previous wording
In April 2020, we and our subsidiaries, Pluri Biotech Ltd. and Pluristem GmbH, executed the EIB Finance Agreement for non-dilutive funding of up to €50 million in the aggregate, payable in three tranches. The proceeds from the EIB Finance Agreement were intended to support our R&D in the European Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market. The term of the project was three years commencing on January 1, 2020.
Current wording
In April 2020, we and our subsidiaries, Pluri Biotech and Pluristem GmbH, executed the EIB Finance Agreement for non-dilutive funding of up to €50 million in the aggregate, payable in three tranches. The proceeds from the EIB Finance Agreement were intended to support our R&D in the European Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market. The initial funding period under the EIB Finance Agreement was three years commencing on January 1, 2020.
Previous wording
During June 2021, we received the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement. The amount received is due to be repaid on June 1, 2026, and bears annual interest of 4% to be paid together with the principal of the loan. We are currently in discussions with the EIB regarding a potential restructuring of the terms of the EIB Loan. Such discussions are currently focused on the new terms of the EIB Loan, including an extension of the current maturity date of the EIB Loan. The Company is expecting to finalize such discussions by the end of June 2025; however, there is no certainty that such restructuring will be achieved on the expected timeline or at all. As of March 31, 2025, the interest accrued was in the amount of approximately €3.06 million. In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million. As of March 31, 2025, we had an accrued royalty in the amount of $8 thousand. As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
Current wording
During June 2021, we received the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement. The amount received is due to be repaid on June 1, 2026, and bears annual interest of 4% to be paid together with the principal of the loan. Discussions with the EIB regarding a potential restructuring of the EIB Loan, including a possible extension of its maturity date are in progress. However, there is no certainty as to the outcome of these discussions. As of September 30, 2025, the interest accrued was in the amount of approximately €3.5 million. In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million, and 0.2% of our consolidated revenues exceeding $500 million. As of September 30, 2025, we had an accrued royalty in the amount of $15 thousand. Since the initial funding period under the EIB Finance Agreement ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
Previous wording
In July 2023, we announced that we signed a three-year $4.2 million contract with the U.S. National Institute of Allergy and Infectious Diseases (“NIAID”), which is part of the NIH. Under such contract, we were to collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute (“AFRRI”), and the Uniformed Services University of Health Sciences (“USUHS”), in Maryland, U.S.A., to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation exposure. On April 15, 2025, Pluri Biotech Ltd. received a formal notice of termination from the NIAID, according to which, the contract was terminated for the Government’s convenience and such termination was effective as of April 15, 2025. As of March 31, 2025, prior to receiving the notice of termination, we received approximately $2.16 million in funding under the contract, and we expect to receive an additional amount of approximately $75 thousand for activities conducted by that date. We believe that the termination of the contract may reflect broader federal budgetary and administrative adjustments that have recently affected multiple health-related agencies, including the NIH, and are monitoring these developments closely to assess any potential implications on our ongoing programs.
Current wording
On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the National Institute of Health (“NIH”). We will collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute and the Uniformed Services University of Health Sciences to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS. H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure. The term of this contract was from July 1, 2023 through June 30, 2024, with an optional extension for an additional two-year period.
Previous wording
On June 6, 2024, the NIAID exercised its option for year two of the three-year $4.2 million contract. During the 12 months period from July 1, 2024, through June 30, 2025, the NIAID was planned to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS. On April 15, 2025, we received formal notice of termination from the NIAID. According to the notice of termination, the contract was terminated for the Government’s convenience and such termination was effective as of April 15, 2025. As of March 31, 2025, we have received from the NIAID approximately $2.16 million and as of March 31, 2025, we expect to receive an additional amount of approximately $75 thousand for activities conducted by that date. We believe that the termination of the contract may reflect broader federal budgetary and administrative adjustments that have recently affected multiple health-related agencies, including the NIH.
Current wording
On June 6, 2024, the NIAID exercised its option for year two of the three-year contract. During the 12 months period from July 1, 2024 through June 30, 2025, the NIAID was to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.
Previous wording
According to the IIA grant terms, we are required to pay royalties at a rate of 3% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required. Through March 31, 2025, total grants obtained from the IIA, which are bearing royalties, aggregated to approximately $27.7 million and total royalties paid and accrued amounted to $179 thousand.
Current wording
According to the IIA grant terms, we are required to pay royalties at a rate of 3% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required. Through September 30, 2025, total grants obtained from the IIA aggregated to approximately $28.2 million and total royalties paid and accrued amounted to $179 thousand.
Previous wording
On September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded to Advanced Personalized Therapies for Osteoarthritis (“PROTO”), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies. The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/II study for the treatment of mild to moderate knee osteoarthritis.
Current wording
On September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded to Advanced PeRsOnalized Therapies for Osteoarthritis (“PROTO”), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies (“Charité”). The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/II study for the treatment of mild to moderate knee osteoarthritis.
Previous wording
An amount of approximately €500,000 (approximately $540,000) is a direct grant that will be allocated to us. As of March 31, 2025, we received a payment of approximately $330,000 in cash as part of the PROTO program.
Current wording
An amount of approximately €500,000 (approximately $540,000) is a direct grant that will be allocated to us. Through September 30, 2025, we received a payment of approximately $330,000 in cash as part of the PROTO program.
Previous wording
The clinical study, once approved by the regulatory agencies, will be carried out by Charité, together with us and other members of the international consortium, under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery.
Current wording
In June 2025, the clinical study was approved by the Paul-Ehrlich-Institut. The study is conducted at Charité, together with an international consortium and under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery.
Previous wording
The currency of our financial portfolio is mainly in U.S. dollars, and we use options contracts and other financial instruments in order to hedge our exposures to currencies other than the U.S. dollar. For more information, please see Item 7A. - “Quantitative and Qualitative Disclosures about Market Risk” in the 2024 Annual Report.
Current wording
The currency of our financial portfolio is mainly in U.S. dollars and we use options contracts and other financial instruments in order to hedge our exposures to currencies other than the U.S. dollar.
Previous wording
Since our inception in May 2001, we have accumulated a deficit of approximately $435,457,000. We do not anticipate generating significant revenue from product sales over the next twelve months. However, we expect to generate revenue from CDMO services, collaborations related to our cell-based products, and licensing of our technologies and products. While we have made meaningful progress in reducing our burn rate in recent years, it is unlikely that near-term revenues will exceed our operating costs.
Current wording
We have accumulated a deficit of $448,905,000 since our inception in May 2001. We do not anticipate generating any significant revenues from sales of products in the next twelve months. While we have made meaningful progress in reducing our burn rate in recent years, it is unlikely that near-term revenues will exceed our operating costs. We may need to secure additional sources of liquidity to support the commercialization of our products and technologies, as well as to sustain our ongoing R&D activities.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
(a) an innovative proof-of-concept (“POC”) collaboration with ICL Group Ltd., a leading global specialty minerals company, through its Open Innovation program, to revolutionize bio stimulant delivery and enhance yield sustainably;
Current report — wording carried from elsewhere
(b) a strategic POC agreement with a leading international agriculture corporation aimed at boosting the global vegetable product supply, streamlining supply chains, and promoting a more sustainable future for agriculture; and
Current report — wording carried from elsewhere
On April 15, 2025, Pluri Biotech received a formal notice of termination from the NIAID, according to which, the contract was terminated for the Government’s convenience, and such termination was effective as of April 15, 2025. We believe that the termination of the contract may reflect broader federal budgetary and administrative adjustments that have affected multiple health-related agencies, including the NIH. As of the date of this Quarterly Report, we received a total of $2.3 million in funding under the contract.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Our operations are dedicated to the research, development, and manufacturing of cell-based products, as well as the commercialization of cell therapeutics and related technologies aimed at delivering innovative solutions across a range of industries.
Previous report — wording carried elsewhere
On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, to support the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS. The program included collaboration with the U.S. Department of Defense (AFRRI and the USUHS) and was funded by NIAID as part of the NIH.
Previous report — wording carried elsewhere
We may need to secure additional sources of liquidity to support the commercialization of our products and technologies, as well as to sustain our ongoing R&D activities.