MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
+Added: The following discussion
+Added: and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the
+Added: notes thereto contained elsewhere in this Annual Report.
+Added: Certain information contained in the discussion and analysis set forth below
+Added: includes forward-looking statements that involve risks and uncertainties.
+Added: Our actual results may differ materially from those discussed
+Added: in any forward-looking statement because of various factors, including those described in the sections titled “Cautionary Note
+Added: Regarding Forward-Looking Statements” and “Risk Factors” in this Annual Report.
We are a biotechnology company,
−Removed: with an advanced cell-based technology platform.
−Removed: We have developed a unique 3D technology platform for cell expansion with an industrial
−Removed: scale in-house GMP cell manufacturing facility.
−Removed: We are utilizing our technology in the field of regenerative medicine, food tech, CDMO,
−Removed: and agtech and plan to utilize it in industries and verticals that have a need for our mass scale and cost-effective cell expansion platform
−Removed: via partnerships, joint ventures, licensing agreements and other types of collaborations.
−Removed: Our operations are focused
−Removed: on the research, development and manufacturing of cell-based products and the business development of cell therapeutics and cell-based
−Removed: technologies providing potential solutions for various industries.
+Added: leveraging our proprietary cell expansion platform to develop scalable, cell-based solutions across the healthcare, food, and agriculture
+Added: Through a collaborative network of ventures, the Company is advancing a diverse pipeline of products and services, including
+Added: cultivated food, regenerative medicine, and cell-based ingredients.
+Added: We have developed a unique 3D, technology platform for cell expansion
+Added: with an industrial-scale cell manufacturing facility operated in accordance with GMP standards, currently on a self-declared basis.
+Added: are utilizing our technology across the field of regenerative medicine, immunotherapy, food tech, CDMO, and AgTech, and plan to utilize
+Added: it in industries and verticals that have a need for our mass scale and cost-effective cell expansion platform via partnerships, joint
+Added: ventures, licensing agreements and other types of collaborations.
+Added: Our operations are dedicated
+Added: to the research, development, and manufacturing of cell-based products, as well as the commercialization of cell therapeutics and related
+Added: technologies aimed at delivering innovative solutions across a range of industries, as described in detail under Item 1.
+Added: and as set forth below:
We use our advanced cell-based
1 unchanged sentence
of inflammatory, muscle injuries, hematologic conditions and, most recently, we have also launched a novel immunotherapy platform.
−Removed: cells are adherent stromal cells that are expanded using our 3D platform.
−Removed: Our PLX cells can be administered to patients off-the-shelf,
−Removed: without blood or tissue matching or additional manipulation prior to administration.
−Removed: PLX cells are believed to release a range of therapeutic
−Removed: proteins in response to the patient’s condition.
−Removed: In the pharmaceutical area,
−Removed: we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery
−Removed: for hip fracture, incomplete recovery following bone marrow transplantation, CLI, Chronic GvHD and a potential treatment for H-ARS.
−Removed: of these studies have been completed while others are still ongoing.
−Removed: We believe that each of these indications is a severe unmet medical
In July 2023, we announced
−Removed: that we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH.
−Removed: Under such contract, we will collaborate with
−Removed: the AFRRI and the USUHS, to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly
−Removed: disease that can result from nuclear disasters and radiation exposure.
−Removed: 2024, we launched a novel immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors – a critical
−Removed: area in medicine where effective treatments are currently insufficient.
−Removed: We believe that our MAIT cells, isolated from the human placenta ,
−Removed: offer substantial potential benefits compared to conventional T cells.
−Removed: Placental MAIT cells are potent effector cells,
−Removed: potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate
−Removed: their migration directly to tumor sites.
−Removed: Furthermore, unlike conventional autologous T-cells typically collected from peripheral blood,
−Removed: our MAIT cells are designed to be allogenic universal product.
−Removed: Benefiting with very restricted TCR, the MAIT cells minimizes their likelihood
−Removed: of inducing Graft versus Host Disease, or GvHD, a significant advantage over other potential allogeneic products.
−Removed: We are designing the
−Removed: MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
+Added: that we signed a three-year $4.2 million contract with the NIAID, under which we were to collaborate with the AFRRI and the USUHS, in
+Added: 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
+Added: that can result from nuclear disasters and radiation exposure.
+Added: On April 15, 2025, we received formal notice from NIAID that the contract
+Added: was being terminated for the Government’s convenience, effective immediately.
+Added: The termination was not related to any performance
+Added: issues on our part, and we received funding for activities conducted up to the effective date.
+Added: As of the date of this Annual Report,
+Added: we received a total of $2.3 million under the contract.
+Added: In March 2025, we announced
+Added: that we entered into an exclusive collaboration agreement with Hemafund, aiming to establish a strategic initiative for stockpiling,
+Added: local distribution, and potential clinical advancement of our PLX-R18 cell therapy as a countermeasure for H-ARS, in Ukraine.
+Added: The collaboration
+Added: aims to build capacity for up to 12,000 doses of PLX-R18, which will be stored and managed by Hemafund to ensure rapid deployment in
+Added: the event of a radiation-related emergency.
+Added: The parties also intend to pursue external funding to support manufacturing, stockpiling,
+Added: and potential clinical trials of PLX-R18 for regulatory registration in Ukraine.
+Added: If successful, the collaboration could potentially generate
+Added: over $100 million in value for the parties, based on projected demand and dose estimates.
+Added: Immunotherapy MAIT cells:
+Added: In May 2024, we launched a novel immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors.
+Added: In April 2024, we unveiled
+Added: a novel method for expansion of immune cells using proprietary technology and announced we were granted a new U.S.
+Added: patent titled, “System
+Added: and Methods for Immune Cells Expansion and Activation in Large Scale.”
+Added: In October 2024, we announced
+Added: that the IIA approved funding for our collaboration with BIRAD, the commercial arm of Bar-Ilan University, to support the continued development
+Added: of placental-derived MAIT cells for the treatment of solid tumors.
+Added: As part of this collaboration, novel Siglec-based Chimeric Switch
+Added: Receptors (“CCR”), developed by Professor Cyrille Cohen, Head of the laboratory of tumor immunology and immunotherapy at
+Added: Bar-Ilan University, will be integrated into our CAR-MAIT cell therapy platform to enhance tumor specificity and therapeutic efficacy.
+Added: The collaboration leverages our proprietary MAIT cell technology alongside BIRAD’s expertise in engineering clinically optimized
+Added: T-cell modification vectors.
+Added: The IIA has committed to fund the collaboration for an initial term of one year, with an option to extend
+Added: for an additional year, subject to IIA approval.
+Added: The total approved budget for the first year is NIS 549,067 (approximately $163,000).
+Added: As of the date of this Annual Report, we have received approximately $29,000 from the IIA for this project.
+Added: In April 2025, we announced
+Added: that the USPTO has issued a patent covering our immune cell expansion technologies.
+Added: Additionally, we announced that we were issued a
+Added: patent in Israel, which mirrors a previously granted U.S.
+Added: Following these recent patent grants, our intellectual property
+Added: estate includes over 250 patents pending, allowed, and granted.
In January 2024, we
announced that we are launching a new business division offering cell therapy manufacturing services as a CDMO:
−Removed: offers CDMO services to companies from early preclinical development, through late-stage clinical trials and commercialization, with a
−Removed: mission to deliver high-quality, essential therapies to patients.
−Removed: We have signed several agreements with clients and generating revenues
−Removed: from PluriCDMO™.
−Removed: are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the agtech field, such as:
−Removed: (a) cell-based
−Removed: coffee business activity through PluriAgtech business vertical, which we announced in January 2024, (b) an innovative POC collaboration
−Removed: with ICL Group, a leading global specialty minerals company, to revolutionize bio stimulant delivery and enhance yield sustainably, and
−Removed: (c) a strategic POC agreement with a leading international agriculture corporation which is intended to boost the global vegetable product
−Removed: supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture.
+Added: PluriCDMO™, as
+Added: well as other services.
+Added: We have signed several agreements with clients and generating revenues from PluriCDMO™.
+Added: We are actively involved
+Added: in several initiatives leveraged by Pluri’s 3D cell expansion in the AgTech field, which include:
+Added: (a) an innovative POC collaboration
+Added: with ICL, a leading global specialty minerals company, through its Open Innovation program, to revolutionize bio stimulant delivery and
+Added: enhance yield sustainably;
+Added: (b) a strategic POC agreement
+Added: with a leading international agriculture corporation aimed at boosting the global vegetable product supply, streamlining supply chains,
+Added: and promoting a more sustainable future for agriculture.
+Added: (c) the development of cell-cultured
+Added: coffee and cacao through business activities operated via our subsidiaries, Coffeesai and Kokomodo, respectively:
+Added: In 2024, we established Coffeesai
+Added: Ltd., an Israeli company focused on developing cultivated, cell-cultured coffee.
+Added: Coffeesai has successfully
+Added: demonstrated a proof-of-concept coffee beverage, validating the potential of its technology.
+Added: Ongoing efforts are focused on enhancing
+Added: flavor and aroma profiles through bioprocess optimization and downstream refinement.
+Added: In parallel, Coffeesai is exploring research and
+Added: development collaborations aimed at accelerating development and commercialization with leading global coffee suppliers.
+Added: A third-party
+Added: techno-economic assessment has confirmed the cost-competitiveness of the platform at scale, supporting its commercial viability.
+Added: On January 23, 2025, the
+Added: Company entered into a binding term sheet (“Term Sheet”) for the purchase of certain shares representing approximately 79%
+Added: of the equity of Kokomodo, for an aggregate purchase price of $4.5 million, payable in common shares of the Company.
+Added: Following the execution
+Added: of the Term Sheet, on March 13, 2025, the Company and our wholly owned subsidiary, Pluri Biotech, (collectively, the “Purchaser”),
+Added: entered into a Share Purchase Agreement (the “Share Purchase Agreement”), effective as of March 12, 2025, with Chutzpah Holdings
+Added: Limited (“Chutzpah”), a company wholly owned by Mr.
+Added: Alejandro Weinstein, and Plantae Bioscience Ltd.
+Added: a corporation controlled by Mr.
+Added: Weinstein (collectively, the “Seller”), pursuant to which, on April 28, 2025, the Seller
+Added: sold to the Purchaser 400,000 ordinary shares and 175,000 preferred seed-1 shares (the “Purchased Shares”), representing
+Added: approximately 79% of the equity of Kokomodo, for an aggregate purchase price of $4.5 million, payable in 976,139 of our common shares
+Added: (the “Consideration Shares”).
+Added: Pursuant to the Share Purchase Agreement, the Seller also transferred, assigned and conveyed
+Added: in favor of the Purchaser a convertible loan, pursuant to an assignment and assumption agreement (the “Assignment Agreement”),
+Added: reflecting a principal aggregate amount of $0.5 million (together with the Purchased Shares, the “Purchased Interests” and
+Added: such transactions are referred to as the “Kokomodo Transaction”).
+Added: Kokomodo is an innovative
+Added: startup, pioneering the sustainable production of cacao using cellular agriculture technology.
+Added: Instead of relying on traditional tropical
+Added: farming, Kokomodo cultivates real cacao directly from plant cells in controlled environments, such as bioreactors, making climate-resilient
+Added: cacao accessible year-round on a global scale.
+Added: Founded in 2024, Kokomodo aims to transform the cacao industry, reducing environmental
+Added: impact while ensuring a steady, high-quality supply for chocolate and related products.
+Added: In March 2024, we announced
+Added: an important expansion to our IP portfolio with a new patent approval from the IPO, that is designed to reshape the agricultural technology
+Added: landscape and represents a major breakthrough in our proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells
+Added: across various applications, from sustainable agriculture to critical healthcare solutions.
In 2022, we announced the
−Removed: establishment of a joint venture with Tnuva, Ever After Foods, which is incorporated under the laws of the State of Israel, with the purpose
−Removed: of developing cultivated meat product of all kinds and types.
−Removed: Leveraging Pluri’s innovative
−Removed: technology, Ever After Foods has rapidly advanced its scalable production platform, developing a B2B version of its proprietary technology
−Removed: system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for various animal cells, ensuring taste, feel,
−Removed: and texture akin to conventional animal-derived meat.
−Removed: June 12, 2024, we entered into a share purchase agreement, or the Agreement, by and among Ever After Foods, Tnuva, and certain other international
−Removed: investors, or, collectively, the Investors, pursuant to which Ever After Foods issued and sold ordinary shares in a private placement
−Removed: offering, or the Offering, for aggregate gross proceeds of $10 million.
−Removed: As part of the Offering, we invested $1.25 million.
−Removed: the Subsidiary and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024, or the Amended
−Removed: The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the scope
−Removed: of the license to include fish and seafood.
−Removed: $10 million funding round was intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology
−Removed: Following the closing of the Offering, the Subsidiary holds approximately 69% of Ever After Foods.
+Added: establishment of a joint venture with Tnuva - Ever After Foods, with a purpose to develop and commercialize scalable production technologies
+Added: for cultivated meat, supporting the development of a wide range of cultivated meat products by industry partners.
+Added: In June 2024, we entered
+Added: into the Agreement, by and among Ever After Foods, Tnuva, and certain other international investors, pursuant to which Ever After Foods
+Added: issued and sold ordinary shares in a private placement offering, or the Offering, for aggregate gross proceeds of $10 million.
+Added: of the Offering, we invested $1.25 million.
+Added: In addition, our wholly owned subsidiary, Pluri Biotech, and Ever After Foods executed the Amended
+Added: and Restated Technology License Agreement, expanding the scope of the license to include fish and seafood.
+Added: The $10 million funding round
+Added: was intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler.
+Added: the closing of the Offering, our wholly owned subsidiary, Pluri Biotech, holds approximately 69% of Ever After Foods.
+Added: In February 2025, Ever After
+Added: Foods announced a strategic collaboration with Bühler, to jointly advance scalable cultivated meat production systems specifically
+Added: designed for the food industry.
+Added: The parties intend to develop and deploy manufacturing equipment that enables food producers to efficiently
+Added: produce cultivated meat at significantly reduced costs and at volumes suitable for market entry.
RESULTS OF OPERATIONS – YEAR ENDED JUNE 30, 2025 COMPARED
2 unchanged sentences
June 30, 2025 were $1,336,000, compared to $326,000 for the year ended June 30, 2024.
−Removed: The revenues in the year ended June 30, 2024 were
−Removed: mainly related to fees derived from services provided to CDMO clients and to a POC collaboration with ICL Group in the agtech field.
−Removed: revenues in the year ended June 30, 2023 were mainly related to our collaboration in the biologic field.
−Removed: The increase in revenues is mainly
−Removed: attributed to the launch of new business verticals, specifically in the CDMO and agtech fields.
+Added: The revenues for the years ended June 30, 2025
+Added: and 2024, were primarily generated from services provided to CDMO clients for process and product development, as well as income from
+Added: fees in the AgTech sector.
+Added: The increase in revenues is mainly attributed to higher services provided to CDMO clients and additional revenues
+Added: from POC collaboration in the AgTech field.
+Added: Cost of Revenues
+Added: of revenues for the year ended June 30, 2025 were $682,000, compared to $4,000 for the year ended June 30, 2024.
+Added: Cost of revenues for
+Added: the year ended June 30, 2025 includes manufacturing costs related to our CDMO and AgTech fields, which primary consist of materials,
+Added: personnel-related and overhead costs.
+Added: Cost of revenues for the year ended June 30, 2024, includes royalties which we are obligated to
+Added: pay to the IIA.
Research and Development, Net
Research and development,
−Removed: net (costs less participation by the IIA, Horizon Europe and the NIAID) decreased by 21% from $15,745,000 for the year ended June 30,
+Added: net (costs less participation by the IIA, Horizon Europe and the NIAID) increased by 3% from $12,446,000 for the year ended June 30,
2024, to $12,851,000 for the year ended June 30, 2025.
−Removed: The decrease is mainly attributed to:
−Removed: (1) a decrease in clinical studies expenses
−Removed: following the completion of our CLI, COVID-19 and muscle regeneration following hip fracture clinical studies, (2) a decrease in material
−Removed: purchases in accordance with our manufacturing needs and plans, (3) a decrease in salaries and related expenses as part of a efficiency
−Removed: cost-reduction plan, specifically a reduction of 16 research and development, or R&D, employees in the Subsidiary (92 employees on
−Removed: June 30, 2024, compared to 108 employees on June 30, 2023) and due to the exchange rate differences related to the strength of the U.S.
−Removed: dollar against the NIS, and (4) participation grants from the NIAID contract, offset by a decrease in other participation grants, specifically
−Removed: the completion of the CLI and muscle regeneration following hip fracture clinical studies which were supported by the EU Horizon 2020
+Added: The increase is mainly attributed to (1) an increase related to subcontractors
+Added: in immunotherapy and AgTech projects and an increase due to write off provisions in clinical studies following its completion, partially
+Added: offset by (2) a decrease in materials costs related to a supplier credit and a decrease due to material purchases in line with our manufacturing
+Added: needs and plans, (3) a decrease in participation by NIAID, and (4) a decrease in R&D expenses due to classification of expenses into
+Added: cost of revenues.
General and Administrative
−Removed: administrative expenses decreased by 15% from $11,779,000 for the year ended June 30, 2023, to $10,034,000 for the year ended June
−Removed: The decrease is mainly attributed to:
−Removed: (1) a decrease in share-based compensation expenses related to employee terminations
−Removed: and RSU expense amortization over time (see also notes 9c to the consolidated financial statements included elsewhere in this Annual
−Removed: Report) and a decrease due to the amount of RSUs and options granted to our CEO in 2023, partially offset by an increase in
−Removed: share-based compensation expenses related to the amount of RSUs and options granted in 2024, and (2) a decrease in salaries and related
−Removed: expenses due to the exchange rate differences relates to the strength of the U.S.
−Removed: dollar against the NIS and as a result of our cost
−Removed: reduction and efficiency plan, including a temporary reduction in the salaries of our executive officers.
−Removed: Total Financial Income (Expense), Net
−Removed: financial income (expenses), net increased from $1,641,000 in financial expenses for the year ended 2023 to $814,000 in financial
−Removed: income for the year ended June 30, 2024.
−Removed: This increase is mainly attributable to (1) income relating to exchange rate differences
−Removed: related to the EIB loan provided to us in June 2021 pursuant to the EIB Finance Agreement (as a result of the strength of the U.S.
−Removed: dollar against the Euro, which increased by 3% in 2024 compared to 2023 where it decreased by 5%), (2) an increase related to
−Removed: interest income from bank deposits, and (3) an increase in gain from hedging transactions compared to a loss from hedging
−Removed: transactions in the previous period.
+Added: General and administrative
+Added: expenses decreased by 0.5% from $10,034,000 for the year ended June 30, 2024, to $9,979,000 for the year ended June 30, 2025.
+Added: This decrease
+Added: was primarily driven by a reduction in share-based compensation expenses, mainly attributed to employee terminations and amortization
+Added: of restricted stock units (“RSUs”) expenses over time.
+Added: This reduction was partially offset by:
+Added: (1) an increase in salaries
+Added: and related expenses due to the reinstatement of the salary of Mr.
+Added: Yaky Yanay, our CEO (following his salary reduction from January 2023
+Added: through December 2023, whereby he waived 75% of his salary and converted it to RSUs, and options), (2) an increase in salaries and related
+Added: expenses due to reinstatement of temporary reduction in employees’ regular working hours for a limited period in December 2023,
+Added: (3) an increase in bonus expenses for certain employees, including our CEO and Mrs.
+Added: Chen Franco-Yehuda, our former Chief Financial Officer
+Added: (“CFO”), related to performance-based bonuses pursuant to their respective employment agreements, and (4) increased share-based
+Added: compensation expenses related to RSUs and options granted during the prior year to employees, officers, directors and consultants.
+Added: Financial Income (expenses), Net
+Added: Financial income (expenses),
+Added: net, decreased from $1,680,000 in financial income for the year ended 2024 to $206,000 in financial expenses for the year ended June
+Added: This decrease is mainly attributed to (1) exchange rate differences expenses related to the EIB Loan pursuant to the EIB Finance
+Added: Agreement, following fluctuation between the U.S.
+Added: dollar against the Euro, (2) a decrease in interest income from deposits, resulting
+Added: from lower interest rates and reduced deposit levels due to withdrawals, and (3) a decrease due to exchange rate expenses on a lease
+Added: liability due to the strength of the NIS against the U.S Dollar, partially offset by (4) an increase in income from hedging transactions,
+Added: and (5) an increase in income from change in fair value of warrant and pre-funded warrant liabilities.
+Added: Our primary expenses paid in NIS
+Added: are employee salaries, and lease payments on our facilities.
+Added: From time to time, we may apply a hedging strategy by using options and
+Added: forward contracts to protect ourselves against some of the risks of currency exchange fluctuations and we are actively monitoring the
+Added: exchange rate differences of the NIS, Euro and U.S.
+Added: Interest Expenses
+Added: expenses related to our outstanding balance of the EIB Loan and all changes during the year ended June 30, 2025, compared to the year
+Added: ended June 30, 2024, are attributable solely to currency rate differences of the Euro compared to the U.S.
Net Loss for the Year
−Removed: Net loss decreased from $28,887,000
+Added: Net loss increased from $21,344,000
for the year ended June 30, 2024, to $23,250,000 for the year ended June 30, 2025.
−Removed: The decrease was mainly due to a decrease in R&D
−Removed: expenses, net, a decrease in general and administrative expenses and an increase in financial income (expense), net for the reasons mentioned
−Removed: We had a net loss attributed to our non-controlling interest in Ever After Foods for the year ended June 30, 2024 and June 30,
−Removed: 2023 of $456,000 and $566,000, respectively.
+Added: The increase in net loss was mainly due to exchange
+Added: rate differences expenses as mentioned above.
+Added: We had a net loss attributed to our non-controlling interest in Ever After Foods for the
+Added: year ended June 30, 2024 of $456,000, and $667,000 for the year ended June 30, 2025 with respect to Ever After Foods and Kokomodo.
Loss per share for the year
−Removed: ended June 30, 2024, was $3.99, as compared to $6.24 loss per share for the year ended June 30, 2023.
−Removed: The change in the loss per share
−Removed: was mainly as a result of a decrease in the loss for the year, and by an increase in our weighted average number of shares due to the
−Removed: issuance of additional shares during fiscal year 2024.
+Added: ended June 30, 2025, was $3.56, compared to $3.99 loss per share for the year ended June 30, 2024.
+Added: The change in the loss per share was
+Added: primarily due to an increase in the loss for the year, as well as an increase in our weighted average number of shares outstanding resulting
+Added: from the issuance of additional shares due to the Offering (as defined below), the Second Offering (as defined below) and the investment
+Added: in Kokomodo during fiscal year 2025.
Liquidity and Capital Resources
−Removed: As of June 30, 2024, our total
−Removed: current assets were $31,107,000 and our total current liabilities were $4,454,000.
−Removed: On June 30, 2024, we had a working capital surplus
−Removed: of $26,653,000 and an accumulated deficit of $420,472,000.
−Removed: As of June 30, 2023, our total
−Removed: current assets were $41,409,000 and our total current liabilities were $5,621,000.
+Added: As of June 30, 2025, our
+Added: total current assets were $22,095,000 and our total current liabilities were $32,328,000.
+Added: On June 30, 2025, we had a working capital
+Added: deficit of $10,233,000 and an accumulated deficit of $443,055,000.
+Added: As of June 30, 2024, our
+Added: total current assets were $31,107,000 and our total current liabilities were $4,454,000.
On June 30, 2024, we had a working capital surplus
of $26,653,000 and an accumulated deficit of $420,472,000.
−Removed: Our cash, cash
−Removed: equivalents and restricted cash as of June 30, 2024, amounted to $7,037,000, which reflects an increase of $1,408,000 from the
−Removed: $5,629,000 reported as of June 30, 2023.
−Removed: Our cash equivalents and restricted cash increased in the year ended June 30, 2024, for the
−Removed: reasons presented below.
−Removed: Our bank deposits and restricted bank deposits as of June 30, 2024, amounted to $23,836,000 compared to
−Removed: $35,438,000 as of June 30, 2023.
−Removed: Our bank deposits and restricted bank deposits as of June 30, 2024, decreased in the year ended
−Removed: June 30, 2024, for the reasons presented below.
−Removed: Our cash used in operating
−Removed: activities was $18,021,000 during the year ended June 30, 2024, and $22,857,000 during the year ended June 30, 2023.
−Removed: The decrease in cash
−Removed: used in operating activities is mainly attributed to a decrease in net loss following the completion of certain clinical trials and the
−Removed: implementation of a cost reduction and efficiency plan including a temporary reduction in the salaries of our executive officers, directors,
−Removed: management team and other employees.
−Removed: Cash used in operating activities in year ended June 30, 2024 and June 30, 2023 consisted primarily
−Removed: of payments of fees to our suppliers, subcontractors, professional services providers and consultants, and payments of salaries to our
−Removed: employees, partially offset by grants from the IIA, the Horizon Europe program, and funds received from the NIAID contract.
+Added: Our cash, cash equivalents
+Added: and restricted cash as of June 30, 2025, amounted to $6,317,000, which reflects a decrease of $720,000 from the $7,037,000 reported as
+Added: of June 30, 2024.
+Added: Our cash equivalents and restricted cash decreased in the year ended June 30, 2025.
+Added: Our bank deposits and restricted
+Added: bank deposits as of June 30, 2025, amounted to $15,597,000 compared to $23,836,000 as of June 30, 2024.
+Added: Our bank deposits and restricted
+Added: bank deposits as of June 30, 2025 decreased for the year ended June 30, 2025.
+Added: The cash, cash equivalents, restricted cash, bank deposits
+Added: and restricted bank deposits decreased for the reasons presented below.
+Added: Cash used in operating activities
+Added: increased to $18,211,000 for the year ended June 30, 2025, from $18,021,000 in the prior year, primarily due to a reduction in grants
+Added: received from the IIA, Horizon Europe, and NIAID contract funding, effect of exchange rate, continued payments to suppliers, subcontractors,
+Added: professional service providers, and employees, partially offset by an increase in customer receivable and in income from hedging transactions.
Cash provided by investing
−Removed: activities was $10,584,000 during the year ended June 30, 2024, and cash provided by investing activities of $9,698,000 during the year
−Removed: ended June 30, 2023.
+Added: activities was $8,026,000 during the year ended June 30, 2025, and cash provided by investing activities during the year ended June 30,
+Added: 2024 was $10,584,000.
Cash provided by investing activities in the year ended June 30, 2025 consisted primarily of the withdrawal of
−Removed: of short-term deposits, partially offset by payments of $323,000 related to investments in property and equipment.
−Removed: Cash provided by investing
−Removed: activities in the year ended June 30, 2023 consisted primarily of the withdrawal of $9,960,000 of short-term deposits, partially offset
−Removed: by payments of $262,000 related to investments in property and equipment.
+Added: $9,271,000 of short-term deposits, net and cash related to the Kokomodo Transaction of $373, partially offset by payments of $1,618,000
+Added: related to investments in property and equipment.
+Added: Cash provided by investing activities in the year ended June 30, 2024 consisted primarily
+Added: of the withdrawal of $10,907,000 of short-term deposits, partially offset by payments of $323,000 related to investments in property
+Added: and equipment.
Financing activities provided
1 unchanged sentence
The financing
−Removed: activities during the year ended June 30, 2024 related primarily to the investment in Ever After Foods by external investors.
−Removed: The financing
−Removed: activities during the year ended June 30, 2023 related to issuances of common shares and warrants, net of issuance costs, in the December
−Removed: 2022 Private Placement (as defined below).
−Removed: December 13, 2022 and December 27, 2022, the Company entered into a series of securities purchase agreements with several purchasers for
−Removed: an aggregate of 1,019,488 common shares and warrants, or the Warrants, to purchase up to 1,019,488 common shares, or the December 2022
−Removed: Private Placement.
−Removed: On December 13, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.24 per
−Removed: share, up to 697,486 common shares and warrants to purchase up to 697,486 common shares, with an exercise price of $8.24 per share and
−Removed: a term of three years.
−Removed: On December 14, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.4 per
−Removed: share, up to 258,565 common shares and warrants to purchase up to 258,565 common shares, with an exercise price of $8.4 per share and
−Removed: a term of three years.
−Removed: On December 15, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.48
−Removed: per share, up to 29,688 common shares and warrants to purchase up to 29,688 common shares, with an exercise price of $8.48 per share and
−Removed: a term of three years.
−Removed: On December 19, 2022, the Company executed a securities purchase agreement to sell at a purchase price of $8.72
−Removed: per share, up to 16,875 common shares and warrants to purchase up to 16,875 common shares, with an exercise price of $8.72 per share and
−Removed: a term of three years.
−Removed: On December 27, 2022, the Company executed a securities purchase agreement to sell at a purchase price of $8.96
−Removed: per share, up to 16,875 common shares and warrants to purchase up to 16,875 common shares, with an exercise price of $8.96 per share and
−Removed: a term of three years.
−Removed: The Warrants sold in the December 2022 Private Placement are exercisable upon the later of six months from their
−Removed: issuance date, or from the date the Company increased its authorized shares.
−Removed: The Company issued 1,019,488 common shares and Warrants that
−Removed: relate to the December 2022 Private Placement and received $8 million as of that date net of $445,000 from issuance expenses.
−Removed: The Warrants sold in the December
−Removed: 2022 Private Placement were exercisable upon the later of six months from their issuance date, or from the date we increased our authorized
−Removed: On April 27, 2023, our shareholders approved an amendment to our articles of incorporation to increase the number of authorized
−Removed: common shares from 7,500,000 shares to 37,500,000 shares and such increase was effectuated on May 1, 2023 when the Company filed its amendment
−Removed: to its articles of incorporation reflecting such increase.
−Removed: As such, the Warrants became exercisable on May 1, 2023.
+Added: activities during the year ended June 30, 2025 related primarily to net proceeds received from the Offering (as defined below) and
+Added: the Second Offering (as defined below).
+Added: The financing activities during the year ended June 30, 2024 related primarily to the investment
+Added: in Ever After Foods by external investors.
On December 14, 2022,
−Removed: Yaky Yanay, our CEO, agreed to forgo, starting January 1, 2023, $375,000 of his annual cash salary for the next twelve months in return
+Added: Yanay, 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.
3 unchanged sentences
price of $8.96 per share.
−Removed: In addition, the Boards also agreed to grant Mr.
−Removed: Yanay options to purchase 187,500 common shares, with a term
−Removed: of 3 years, with the following terms:
+Added: In addition, the Board agreed to grant Mr.
+Added: Yanay options to purchase 187,500 common shares, with a term of
+Added: 3 years, with the following terms:
(i) options to purchase 62,500 common shares at an exercise price of $12.48 per share, 50% vested
4 unchanged sentences
will expire on April 27, 2026.
−Removed: December 2023, in light of the ongoing conflict in Israel and challenges in predicting its resolution and the subsequent impact on the
−Removed: Company’s operations, and in order to ensure the Company’s financial stability, the Board approved, at the recommendation
−Removed: of the Company’s management, (i) a 20% monthly cash salary reduction in the amount of 39,600 NIS to Mr.
−Removed: Yanay, our CEO, for the
−Removed: months of January 2024 and February 2024, (ii) a 20% cash salary reduction in the amount of 39,000 NIS to Mrs.
−Removed: Franco – Yehuda,
−Removed: our Chief Financial Officer, or CFO, for the months of December 2023, January 2024 and February 2024, and (iii) a 20% monthly fee
−Removed: reduction to the fees that are paid to each of the Company’s directors for the months of December 2023 through February 2024.
−Removed: July 16, 2020, we entered into an at-the market agreement, or the ATM Agreement, with Jefferies LLC, or Jefferies, pursuant to which we
−Removed: may issue and sell shares of our common shares having an aggregate offering price of up to $75,000,000 from time to time through Jefferies.
−Removed: Upon entering into the ATM Agreement, we filed a new shelf registration statement on Form S-3, which was declared effective by the SEC
−Removed: on July 23, 2020.
−Removed: On September 21, 2022, as a result of General Instruction I.B.6 of Form S-3, and in accordance with the terms of the
−Removed: Sales Agreement, we reduced the amount available to be sold under the ATM Agreement to a maximum aggregate offering price of up to $11,800,000
−Removed: of our common shares from time to time through Jefferies.
−Removed: During the year ended June 30, 2023, we did not sell of our any common shares
−Removed: under the ATM Agreement.
−Removed: On September 7, 2023, we provided
−Removed: a formal notice of termination of the ATM Agreement with Jefferies, which took effect on September 8, 2023.
−Removed: On February 13, 2024, we entered
−Removed: into a sales agreement, or the Sales Agreement, with A.G.P./Alliance Global Partners, or A.G.P., as agent, pursuant to which we may issue
−Removed: and sell our common shares having an aggregate offering price of up to $10 million, from time to time through A.G.P.
−Removed: As of September 17,
−Removed: 2024, we have sold an aggregate of 42,729 common shares pursuant to the Sales Agreement at an average price of $5.93 per share.
−Removed: have an effective Form S-3 registration statement (File No.
−Removed: 333-273347), filed under the Securities Act of 1933, as amended, with the
−Removed: SEC using a “shelf” registration process.
−Removed: Under this shelf registration process, we may, from time to time, sell our common
−Removed: shares, preferred stock and warrants to purchase common shares, and of two or more of such securities, in one or more offerings for an
−Removed: aggregate initial offering price of $200 million (including amounts sold under the Sales Agreement).
−Removed: April 2020, we and the Subsidiary and the German Subsidiary, executed the EIB Finance Agreement for non–dilutive funding of up to
−Removed: €50 million in the aggregate, payable in three tranches.
−Removed: The proceeds from the EIB Finance Agreement were intended to support our
−Removed: research and development in the EU to further advance our regenerative cell therapy platform, and to bring the products in our pipeline
−Removed: The term of the project was three years commencing on January 1, 2020.
−Removed: June 2021, we received the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement.
−Removed: The amount received
−Removed: 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.
−Removed: As of June 30,
−Removed: 2024, the interest accrued was in the amount of approximately €2.5 million.
−Removed: In addition to the interest payable, the EIB is also
−Removed: entitled to royalty payments, pro-rated to the amount disbursed from the EIB loan, on our consolidated revenues beginning in the fiscal
−Removed: 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,
−Removed: 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million.
−Removed: As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
+Added: In July 2025, Mr.
+Added: to forgo 25% percent of his monthly cash salary for a period of six months commencing July 2025.
+Added: On February 13, 2024, we
+Added: entered into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P”), as agent,
+Added: pursuant to which we may issue and sell our common shares having an aggregate offering price of up to $10 million, from time to time
+Added: through A.G.P.
+Added: As of September 17, 2025, we have sold an aggregate of 42,729 common shares pursuant to the Sales Agreement at an average
+Added: price of $5.93 per share.
+Added: We have an effective Form
+Added: S-3 registration statement (File No.
+Added: 333-273347), filed under the Securities Act of 1933, as amended, with the SEC using a “shelf”
+Added: registration process.
+Added: Under this shelf registration process, we may, from time to time, sell our common shares, preferred stock and warrants
+Added: to purchase common shares, and of two or more of such securities, in one or more offerings for an aggregate initial offering price of
+Added: $200 million (including amounts sold under the Sales Agreement).
+Added: In April 2020, we and our
+Added: subsidiaries, Pluri Biotech and Pluristem GmbH, executed the EIB Finance Agreement for non-dilutive funding of up to €50 million
+Added: in the aggregate, payable in three tranches.
+Added: The proceeds from the EIB Finance Agreement were intended to support our R&D in the
+Added: European Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market.
+Added: funding period under the EIB Finance Agreement was three years commencing on January 1, 2020.
+Added: During June 2021, we received
+Added: the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement.
+Added: The amount received is due to be repaid on
+Added: June 1, 2026, and bears annual interest of 4% to be paid together with the principal of the loan.
+Added: We are currently in advanced discussions
+Added: with the EIB regarding a potential restructuring of the EIB Loan terms, which are currently focused on the new terms of the EIB Loan,
+Added: including an extension of the current maturity date of the EIB Loan.
+Added: However, there is no certainty as to the outcome of these discussions.
+Added: As of June 30, 2025, the interest accrued was in the amount of approximately €3.27 million.
+Added: In addition to the interest payable,
+Added: the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues beginning
+Added: 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
+Added: $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding
+Added: $500 million.
+Added: As of June 30, 2025, we had an accrued royalty in the amount of $12 thousand.
+Added: Since the initial funding period under the
+Added: EIB Finance Agreement ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
+Added: January 23, 2025, we entered into the Securities Purchase Agreement with a company wholly owned by Mr.
+Added: Alexandre Weinstein (the “Investor”)
+Added: relating to a private placement offering (the “Offering”) of:
+Added: (i) 1,383,948 of our common shares, par value $0.00001 per
+Added: share, (ii) pre-funded warrants (the “Pre-Funded Warrants”), to purchase up to 26,030 common shares, and (iii) warrants (the
+Added: “Common Warrants”), to purchase up to 84,599 common shares.
+Added: On April 25, 2025, we entered into an amendment to the Securities
+Added: Purchase Agreement, pursuant to which we and the Investor agreed to exchange 976,139 of the common shares for additional Pre-Funded Warrants
+Added: to purchase up to 976,139 common shares.
+Added: The Offering price per share and accompanying warrant was $4.61.
+Added: The Pre-Funded Warrants have
+Added: an exercise price of $0.0001 per share, are exercisable at any time following the receipt of certain approvals from our shareholders,
+Added: which is required by the applicable rules of the Nasdaq Capital Market, and until exercised in full.
+Added: The Common Warrants have an exercise
+Added: price of $5.568 per share, are exercisable following the receipt of approval from our shareholders, and will be exercisable for three
+Added: years following the date of receipt of such approval.
+Added: Such approval for the exercise of Pre-Funded Warrants and Common Warrants was sought
+Added: and obtained at our 2025 Annual Meeting on June 30, 2025.
+Added: The Pre-Funded Warrants and Common Warrants contain customary anti-dilution
+Added: provisions and were subject to a 19.99% beneficial ownership limitation until the approval from our shareholders was obtained.
+Added: The Securities
+Added: Purchase Agreement contains customary representations and warranties and agreements of the Company and the Investor and customary indemnification
+Added: rights and obligations of the parties.
+Added: to the terms of the Securities Purchase Agreement, we appointed Mr.
+Added: Weinstein to our Board, effective February 5, 2025, and agreed to
+Added: recommend his election to our shareholders provided that he continues to hold at least 10% of our issued and outstanding common shares.
+Added: gross proceeds from the Offering were $6.5 million and we intend to use the proceeds from the Offering for working capital and general
+Added: corporate purposes.
+Added: The Offering closed on February 5, 2025, following the satisfaction of customary closing conditions.
+Added: March 13, 2025, we entered into a Share Purchase Agreement effective as of March 12, 2025 (the “Share Purchase Agreement”),
+Added: with Chutzpah, a company wholly owned by Mr.
+Added: Alexandre Weinstein, and Plantae, a corporation controlled by Mr.
+Added: Weinstein (collectively,
+Added: the “Seller”), pursuant to the terms of a term sheet entered into on January 23, 2025.Pursuant to the Share Purchase Agreement,
+Added: on April 28, 2025, the Seller (i) sold to us 400,000 ordinary shares and 175,000 preferred seed-1 shares, representing approximately
+Added: 79% of the equity of Kokomodo.
+Added: (the “Purchased Interest”), and (ii) transferred, assigned and conveyed in favor of the Purchaser
+Added: a convertible loan, pursuant to the Assignment Agreement, reflecting a principal aggregate amount of $0.5 million.
+Added: consideration of the sale, transfer and conveyance of the Purchased Interest, we paid the Seller an aggregate purchase price of $4.5
+Added: million, which was paid in 976,139 of our common shares.
+Added: April 28, 2025, we completed the Kokomodo Transaction.
+Added: Kokomodo continues to operate as an independent company and is majority-owned
+Added: by our wholly owned subsidiary, Pluri Biotech.
+Added: February 3, 2025, we entered into an additional Securities Purchase Agreement, with Merchant Adventure Fund L.P., an existing investor
+Added: of the Company, relating to a private placement offering, (the “Second Offering”), of:
+Added: (i) 759,219 of our common shares,
+Added: par value $0.00001 per share, and (ii) warrants, to purchase up to 45,553 common shares.
+Added: The Second Offering price per share and accompanying
+Added: warrant is $4.61.
+Added: The Second Offering warrants have an exercise price of $5.568 per share and a term of three years commencing on the
+Added: date of issuance.
+Added: On March 19, 2025, the Second Offering closed, and the Company received gross proceeds in the amount of $3.5 million,
+Added: which it intends to use for working capital and general corporate purposes.
Non-dilutive grants
4 unchanged sentences
In the absence of such sales, no payment
−Removed: Through June 30, 2024, total grants obtained from the IIA aggregated to approximately $27.7 million and total royalties paid
−Removed: and accrued amounted to $179 thousand.
−Removed: The IIA may impose certain
−Removed: conditions on any arrangement under which the IIA permits the Company to transfer technology or development out of Israel or outsource
−Removed: manufacturing out of Israel.
−Removed: While the grant is given to the Company over a certain period of time (usually a year), the requirements
−Removed: and restrictions under the Israeli Law for the Encouragement of Industrial Research and Development, 1984 continue and do not have a set
−Removed: expiration period, except for the royalties, which requirement to pay them expires after payment in full.
+Added: Through June 30, 2025, total grants obtained from the IIA aggregated to approximately $28.2 million and total royalties
+Added: paid and accrued amounted to $179 thousand.
+Added: The IIA may impose certain conditions on any
+Added: arrangement under which the IIA permits the Company to transfer technology or development out of Israel or outsource manufacturing out
+Added: While the grant is given to the Company over a certain period of time (usually a year), the requirements and restrictions
+Added: under the Israeli Law for the Encouragement of Industrial Research and Development, 1984 continue and do not have a set expiration period,
+Added: except for the royalties, which requirement to pay them expires after payment in full
In June 2020, we announced
2 unchanged sentences
in life science and computer science from academia, medicine, and industry, to develop AI based end-to-end genome-editing solutions.
−Removed: next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharmaceutical, agriculture,
−Removed: and aquaculture industries.
−Removed: CRISPR-IL is funded by the IIA with a total budget of approximately $10 million of which, an amount of approximately
−Removed: $480 thousand was a direct grant allocated to us, for the initial period of 18 months.
−Removed: During October 2021, we received an approval for
−Removed: an additional grant of approximately $583 thousand from the IIA pursuant to the CRISPR-IL consortium program, for an additional period
−Removed: of eighteen months.
−Removed: During January 2023, we received approval for an extension of an additional 2 months to finish the program until June
+Added: These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharmaceutical,
+Added: agriculture, and aquaculture industries.
+Added: CRISPR-IL is funded by the IIA with a total budget of approximately $10 million of which, an
+Added: amount of approximately $480 thousand was a direct grant allocated to us, for the initial period of 18 months.
+Added: During October 2021, we
+Added: received approval for an additional grant of approximately $583 thousand from the IIA pursuant to the CRISPR-IL consortium program, for
+Added: an additional period of eighteen months.
+Added: During January 2023, we received approval for an extension of an additional 2 months to finish
+Added: the program until June 30, 2023.
The CRISPR-IL consortium program does not include any obligation to pay royalties.
−Removed: Through June 30, 2024, we received total
−Removed: grants of approximately $774 thousand in cash from the IIA pursuant to the CRISPR-IL consortium program, and we expect to receive an additional
−Removed: $253 thousand.
−Removed: EU grants – Horizon
−Removed: 2020 and Horizon Europe
−Removed: Through June 30, 2024, we
−Removed: received total grants of approximately $8.4 million in cash from the EU Horizon programs.
−Removed: On September 6, 2022, we announced
−Removed: that a €7.5 million non-dilutive grant from the EU’s Horizon program was awarded to Advanced Personalized Therapies for Osteoarthritis
−Removed: (PROTO), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies.
−Removed: the PROTO project is to utilize our PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis.
−Removed: Final approval of the grant
−Removed: is subject to completion of the consortium agreement.
−Removed: An amount of approximately Euro 500 thousand (approximately $520,000) will be a
−Removed: direct grant that will be allocated to us.
−Removed: Through June 30, 2024, we received a payment of approximately $185,000 in cash, which relates
−Removed: to the PROTO program.
−Removed: The clinical study, once approved by the regulatory agencies, will be carried out by Charité, together
−Removed: with us and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator, at
−Removed: the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery.
+Added: Through June 30, 2025, we received total grants
+Added: 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
+Added: On October 28, 2024, we announced
+Added: that the IIA will fund our collaboration with the BIRAD, to support the continued development of MAIT cells for the treatment of solid
+Added: As part of this collaboration, novel CCR, developed by Prof.
+Added: Cohen, will be integrated into our CAR-MAIT cell therapy platform
+Added: to enhance tumor specificity and therapeutic efficacy.
+Added: The collaboration leverages our proprietary MAIT cell technology alongside BIRAD’s
+Added: expertise in engineering clinically optimized T-cell modification vectors.
+Added: The IIA has committed to fund the collaboration for an initial
+Added: term of one year, with an option to extend for an additional year, subject to IIA approval.
+Added: The total approved budget for the first year
+Added: is NIS 549,067 (approximately $163,000).
+Added: EU grants – Horizon 2020 and Horizon
+Added: September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded
+Added: to the PROTO, an international collaboration led by Charité.
+Added: The goal of the PROTO project is to utilize our PLX-PAD cells in
+Added: a Phase I/II study for the treatment of mild to moderate knee osteoarthritis.
+Added: amount of approximately €500,000 (approximately $540,000) is a direct grant that will be allocated to us.
+Added: As of the date of this
+Added: Annual Report, we have received a payment of approximately $330,000 in cash as part of the PROTO program.
+Added: In June 2025, the clinical
+Added: study was approved by the PEI.
+Added: The study is conducted at Charité together with an international consortium and under the leadership
+Added: of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff
+Added: Institute and Center for Musculoskeletal Surgery.
We have accumulated a deficit
of $443,055,000 since our inception in May 2001.
−Removed: We do not expect to generate any significant revenues from sales of products in the next
+Added: We do not anticipate generating significant revenues from sales of products in the next
twelve months.
−Removed: We expect to generate revenues from the sale of services in our CDMO activity, from collaboration based on our cell-based products, and
−Removed: from licenses to use our technology and products.
−Removed: Although we were able to reduce the burn rate significantly in the last few years, it
−Removed: is unlikely that in the short term revenues will exceed our costs of operations.
−Removed: We may be required to obtain
−Removed: additional liquidity resources in order to support the commercialization of our products and technology and maintain our research and
−Removed: development activities.
−Removed: are continually looking for sources of funding, including collaboration with other companies via licensing agreements, joint ventures
−Removed: and partnerships, and other non-dilutive sources such as our contract with NIAID and DoD, research grants such as the IIA grants and the
−Removed: European Union grants, and sales of our common shares.
−Removed: We believe that we have sufficient
−Removed: cash to fund our operations for at least the next twelve months.
+Added: While we have made meaningful progress in reducing our burn rate in recent years, it is unlikely that near-term revenues
+Added: will exceed our operating costs.
+Added: We may need to secure additional sources of liquidity to support the commercialization of our products
+Added: and technologies, as well as to sustain our ongoing R&D activities.
+Added: As of June 30, 2025, our
+Added: cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled to $21,914,000.
+Added: We are addressing our liquidity issues by implementing initiatives to allow the continuation of our activities.
+Added: Our current operating
+Added: plan includes various assumptions concerning the level and timing of cash outflows for operating activities and capital expenditures,
+Added: which includes a cost-reduction plan should it be unable to raise sufficient additional capital.
+Added: Our ability to successfully
+Added: carry out our business plan, is primarily dependent upon our ability to (1) obtain sufficient additional capital, (2) enter licensing
+Added: or other commercial, partnerships and collaboration agreements, (3) provide CDMO services to clients, (4) finalize discussions with the
+Added: EIB regarding loan restructuring and (5) receive other sources of funding, including non-diluting sources such as grants.
+Added: assurances, however, that we will be successful in obtaining an adequate level of financing needed for the long-term development and
+Added: commercialization of our products, or any financing at all.
+Added: In the event that we unable to obtain the required level of financing, our
+Added: operations may need to be scaled down or discontinued.
+Added: According to management estimates,
+Added: we do not have sufficient resources to meet our operating obligations for at least twelve months from the issuance date of our consolidated
+Added: financial statements, which was September 17, 2025.
+Added: These conditions raise substantial doubt about our ability to continue as a going
Application of Critical Accounting Policies and Estimates
5 unchanged sentences
of our financial condition and results of operations is based on our financial statements, which we prepared in accordance with U.S.
−Removed: The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets
−Removed: and liabilities, as well as the reported revenues and expenses during the reporting periods.
+Added: The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of
+Added: assets and liabilities, as well as the reported revenues and expenses during the reporting periods.
We evaluate such estimates and judgments
2 unchanged sentences
other factors that we believe are reasonable under the circumstances.
−Removed: Actual results may differ from these estimates under different assumptions
−Removed: or conditions.
+Added: Actual results may differ from these estimates under different
+Added: assumptions or conditions.
Share-Based Compensation
−Removed: Share-based compensation is
−Removed: considered a critical accounting policy due to the significant expenses of RSUs which were granted to our employees, directors and consultants.
−Removed: In fiscal year 2024, we recorded share-based compensation expenses related to options, restricted shares and RSUs in the amount of $2,618,000.
+Added: Share-based compensation
+Added: is considered a critical accounting policy because of the significant expenses of RSUs which were granted to our employees,
+Added: directors and consultants.
+Added: In fiscal year 2025, we recorded share-based compensation expenses related to options, restricted shares
+Added: (“RS”) and RSUs in the amount of $2,143,000.
In accordance with ASC 718,
−Removed: “Compensation-Stock Compensation”, or ASC 718, RSUs granted to employees and directors are measured at their fair value on
−Removed: the grant date.
−Removed: All RSUs granted in fiscal years 2024 and 2023 were granted for no consideration;
−Removed: therefore, their fair value was equal
−Removed: to the share price at the date of grant unless the RSUs include a market-based condition in which case the fair value RSUs at the date
−Removed: of grant was calculated using the Monte Carlo model.
−Removed: The RSUs granted in fiscal year 2024 to non-employee consultants were measured at
−Removed: their fair value on the grant date in accordance with ASU No.
+Added: RSUs granted to employees and directors are measured at their fair value on the grant date.
+Added: All RSUs granted in fiscal years 2025 and
+Added: 2024 were granted for no consideration.
+Added: Therefore, their fair value was equal to the share price at the date of grant.
+Added: The RSUs and RS
+Added: granted in fiscal year 2025 to non-employee consultants were measured at their fair value on the grant date in accordance with ASU No.
2018-07 - “Compensation Share Compensation”.
−Removed: The value of the portion of
−Removed: the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in our consolidated statements
+Added: The value of the portion
+Added: of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in our consolidated statements
of operations.
3 unchanged sentences
grant is 16% for the shares granted to employees and 0% for the shares granted to our directors and officers and non-employee consultants.
−Removed: QUANTITATIVE AND
−Removed: QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
+Added: Business Combination
+Added: We allocate the fair value
+Added: of purchase consideration to the tangible assets acquired, liabilities assumed and intangible assets acquired based on their estimated
+Added: The excess of the fair value of purchase consideration over the fair values of these identifiable assets and liabilities
+Added: is recorded as goodwill.
+Added: Such valuations require our management to make significant estimates and assumptions, especially with respect
+Added: to intangible assets.
+Added: Significant estimates in valuing certain intangible assets include, but are not limited to, future expected cash
+Added: flows from acquired technology and other intangible assets, their useful lives and discount rates.
+Added: Our management’s estimates of
+Added: fair value are based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable and, as a result,
+Added: actual results may differ from estimates.
+Added: During the measurement period, which should not exceed one year from the acquisition date, we
+Added: may record adjustments to the assets acquired and liabilities assumed, with the corresponding offset to goodwill.
+Added: Upon the conclusion
+Added: of the measurement period, any subsequent adjustments are recorded to earnings.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not applicable.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.