Pluri Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations. Forward-Looking Statements This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws, and is subject to the safe-harbor created by such Act and laws. Forward-looking statements may include statements regarding our goals, beliefs, strategies, objectives, plans, including product and technology developments, future financial conditions, results or projections or current expectations. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other variations thereon or comparable terminology. These statements are merely predictions and therefore inherently subject to known and unknown risks, uncertainties, assumptions, and other factors that may cause actual results, performance levels of activity, or our achievements, or industry results to be materially different from those contemplated by the forward-looking statements. Such forward-looking statements appear in Item 2 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and may appear elsewhere in this Quarterly Report on Form 10-Q and include, but are not limited to, statements regarding the following: ● the expected development, time-to-market and potential benefits from our products and ventures, based on our cell-based technology platform in regenerative medicine, immunotherapy, food technology (“food tech”), agriculture technology (”AgTech”), aesthetics and wellness, and our Contract Development and Manufacturing Organization (“CDMO”) business, as well as potentially in other industries and verticals that have a need for our mass scale and cost-effective cell expansion platform; ● our expectations of market and industry growth; ● the prospects of entering into additional license agreements, joint ventures, partnerships or other forms of cooperation with other companies, government institutes, research organizations and medical institutions, and the ability to maintain those agreements, joint ventures, partnerships or other forms of cooperation; ● our ability to attract clients for our CDMO business; ● our pre-clinical and clinical study plans, including timing of initiation, expansion, enrollment, results, and conclusion of trials; ● achieving regulatory approvals; ● receipt of future funding from the Israel Innovation Authority (“IIA”), the European Union’s Horizon programs, as well as grants from other independent third parties; ● the capabilities of our placenta expanded (“PLX”), cells, including future collaborations to further advance the development of our PLX- PAD and PLX-R18 cell therapy as a potential novel treatment; ● the expected clinical development of a new allogeneic placental Mucosal Associated Invariant T (“MAIT”), and the potential benefits it can produce for advanced cell-based therapies for immune disorders and oncology diseases; ● our expectation to solve medicine’s unmet needs and demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity; ● the possible impacts of cybersecurity incidents on our business and operations; ● our expectations regarding our short and long-term capital requirements, including our discussions with the European Investment Bank (“EIB”) about the restructuring of the EIB Loan (as defined below); ● our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; 18 ● information with respect to any other plans and strategies for our business; ● general market, political and economic conditions in the countries in which we operate, including those affected by ongoing instability in the Middle East and the armed conflict involving Israel and terrorist organizations such as Hamas, Hezbollah, Ansar Allah (Houthis) and other terrorist organizations, as well as tensions with other regional countries hostile to Israel, may directly affect our business; ● developments in international trade policy, such as tariffs, sanctions, and other trade barriers imposed by the U.S. or other countries, which could affect our sourcing and distribution channels, increase costs, or otherwise negatively impact our operations and financial results; and ● our ability to continue to comply with the rules for continued listing on the Nasdaq Capital Market. Our business and operations are subject to substantial risks, which increase the uncertainty inherent in the forward-looking statements contained in this report. 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. 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. Overview 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. 19 Our operations pursue a variety of initiatives that leverage the Company’s technology across diverse applications and industries, as set forth below: Cell Therapy We use our advanced cell-based technology platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates for the treatment of inflammatory, muscle injuries and hematologic conditions. Recently, we have also launched a novel immunotherapy platform. PLX Cells - Our PLX cells are adherent stromal cells that are expanded using our 3D platform. Our PLX cells can be administered to patients off-the-shelf, without blood or tissue matching or additional manipulation prior to administration. PLX cells are believed to release a range of therapeutic proteins in response to the patient’s condition. 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. 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. 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. 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™. AgTech We are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the AgTech field, including: (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; (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 (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: 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. 20 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. 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. Food Tech 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. Leveraging Pluri’s innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business (“B2B”), version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for various animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat. 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. 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. Aesthetics and Wellness 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. 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. RESULTS OF OPERATIONS – THREE MONTHS ENDED SEPTEMBER 30, 2025, COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2024. Revenues 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. 21 Cost of Revenues 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. Research and Development Expenses, Net 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. General and Administrative Expenses 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. Other Financial Income (expenses), net 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. Interest Expenses 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. Net Loss 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. 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. 22 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. Liquidity and Capital Resources 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. 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. Cash used in operating activities increased to $5,428,000 during the three months ended September 30, 2025, 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. 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. We had no financing activities in the three months ended September 30, 2025, and 2024. 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. 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. 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. On February 13, 2024, we entered into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”), as agent, 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 through A.G.P. As of November 12, 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. 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). 23 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. 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. 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. 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. 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. Non-dilutive grants Israel Innovation Authority (IIA) 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. 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. 24 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). EU grants - Horizon 2020 and Horizon Europe 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. 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. 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. 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. Outlook 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. 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. 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. 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.