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What changed in Pluri Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Pluri Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+301 added−300 removedSource: 10-K (2024-09-18) vs 10-K (2023-09-12)

Top changes in Pluri Inc.'s 2024 10-K

301 paragraphs added · 300 removed · 177 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

50 edited+61 added−91 removed37 unchanged
Biggest changePending Jurisdictions Granted Jurisdictions Expiry Date METHODS FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED MEDIA PRODUCED THEREBY FOR THERAPY PCT/IL2007/000380 Australia, Canada, China, Hong Kong, Europe, Israel, India, Japan, South Korea, Mexico, Russia, Singapore March 23, 2027 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2008/001185 United States Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Mexico, Russia, United States, South Korea September 2, 2028 METHODS OF TREATING INFLAMMATORY COLON DISEASES PCT/IL2009/000527 United States, Israel, Russia May 26, 2029 METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION PCT/IL2009/000844 Europe, Israel September 1, 2029 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2009/000846 Australia, Canada, China, Europe, Hong Kong, Israel, India, Mexico, Singapore, United States September 1, 2029 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2009/000845 United States, Europe, Israel September 1, 2029 ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE DONORS AND USES THEREOF PCT/IB2011/001413 Israel Israel: April 21, 2031 ADHERENT CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT PCT/IB2010/003219 United States, Israel Australia, Canada, China, Hong Kong, Europe, Israel, Mexico, New Zealand, United States November 29, 2030 7 METHODS AND SYSTEMS FOR HARVESTING ADHERENT STROMAL CELLS PCT/IB2012/000933 China, Israel Australia, Canada, Europe, Israel, India, South Korea, Mexico, Singapore, United States April 15, 2032 METHODS FOR TREATING RADIATION OR CHEMICAL INJURY PCT/IB2012/000664 United States Europe, Hong Kong, Israel, Japan, South Korea, United States March 22, 2032 SKELETAL MUSCLE REGENERATION USING MESENCHYMAL STEM CELLS PCT/EP2011/058730 United States, Europe, Israel May 27, 2031 GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL CELLS CULTURED IN 3D PCT/IB2014/059114 Israel, United States February 20, 2034 METHODS FOR PREVENTION AND TREATMENT OF PREECLAMPSIA PCT/IB2013/058186 China, Hong Kong, Europe, Israel, Japan, South Korea, United States August 31, 2033 METHOD AND DEVICE FOR THAWING BIOLOGICAL MATERIAL PCT/IB2013/059808 Australia, China, Europe, Hong Kong, Israel, India, Japan, South Korea, Russia, Singapore, United States October 31, 2033 SYSTEMS AND METHODS FOR GROWING AND HARVESTING CELLS PCT/IB2015/051559 Israel, United States March 3, 2035 METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING MUSCLE WASTING DISORDERS PCT/IB2015/059763 Israel, United States December 18, 2035 USE OF ADHERENT STROMAL CELLS FOR ENHANCING HEMATOPOIESIS IN A SUBJECT IN NEED THEREOF PCT/IB2016/051585 Israel March 21, 2036 ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND USING SAME PCT/IB2016/053310 Europe, United States, Israel June 6, 2036 METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS PCT/IB2017/050868 Canada Europe, Japan, Israel February 16, 2037 METHODS AND COMPOSITIONS FOR TREATING NEUROLOGICAL DISORDERS PCT/IB2018/052806 Israel, United States April 23, 2038 8 METHODS AND COMPOSITIONS FOR TUMOR ASSESSMENT PCT/IB2018/050984 Israel February 18, 2038 METHODS AND COMPOSITIONS FOR TREATING ADDICTIONS PCT/IB2018/055473 Israel, United States July 23, 2038 METHODS AND COMPOSITIONS FOR DETACHING ADHERENT CELLS Germany 10 2018 115 360.0 Germany June 25-July 3, 2038 METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS PCT/IL2020/050477 Canada, Europe, Hong Kong, Israel, Japan, United States April 28, 2040 METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED THEREBY PCT/IB2019/052569 Israel, Singapore, United States March 28, 2039 METHODS AND COMPOSITIONS FOR TREATING SUBJECTS EXPOSED TO VESICANTS AND OTHER CHEMICAL AGENTS PCT/IB2019/055074 Israel, United States June 18, 2039 METHODS AND COMPOSITIONS FOR FORMULATING AND DISPENSING PHARMACEUTICAL FORMULATIONS PCT/IB2019/053115 United States Israel United States: April 16, 2039 Israel: April 26, 2038 THERAPEUTIC DOSAGE REGIMENS COMPRISING ADHERENT STROMAL CELLS PCT/IB2019/054828 Israel, United States June 10, 2039 MODULAR BIOREACTOR PCT/IB2019/058429 Europe, Israel, Hong Kong, South Korea, Singapore, United States October 3, 2039 THERAPEUTIC METHODS AND COMPOSITIONS PCT/IB2019/059544 Israel, United States November 6, 2039 9 METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND SEQUELAE THEREOF PCT/IL2021/050268 United States, Europe, Israel, Mexico Israel First Israeli application: May 14, 2040 Other applications: March 11, 2041 METHODS AND COMPOSITIONS FOR AESTHETIC AND COSMETIC TREATMENT AND STIMULATING HAIR GROWTH PCT/IL2020/050363 United States, Europe, Canada, China, Israel, Australia March 26, 2040 METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED THEREBY IL277560 Israel September 23, 2040 METHODS AND COMPOSITIONS FOR ENRICHMENT OF TARGET CELLS PCT/IL2021/020514 United States, Israel May 05, 2041 PLACENTAL CELL TREATMENT FOR CRITICAL LIMB ISCHEMIA PATIENT SUBPOPULATIONS PCT/IL2022/050937 Patent Cooperation Treaty, or PCT August 29, 2042 SYSTEM AND METHODS FOR IMMUNE CELLS EXPANSION AND ACTIVATION IN LARGE SCALE PCT/IL2023/050529 PCT, United States May 23, 2043 On January 8, 2022, we entered into a definitive license agreement with Takeda Pharmaceuticals International AG, or Takeda, a company based in Switzerland, which operates in the field of adipose-derived cells, pursuant to which we granted Takeda a global, non-exclusive license to use several of our patents (EP2591789, EP3103463, and 3091071), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing its opposition with regards to said patents and paying us a lump sum of $200,000.
Biggest changePending Jurisdictions Granted Jurisdictions Expiry Date METHODS FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED MEDIA PRODUCED THEREBY FOR THERAPY PCT/IL2007/000380 Australia, Canada, China, Hong Kong, Europe (Spain, Germany, France, Belgium, Switzerland, Czech Republic, Hungary, Ireland, Italy, The Netherlands), Israel, India, Japan, South Korea, Mexico, Russia, Singapore March 23, 2027 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2008/001185 United States Brazil, Canada, China, Europe (Belgium, Austria, Spain, Germany, Switzerland, France, Ireland, Italy, the Netherlands), Hong Kong, Israel, India, Japan, Mexico, Russia, United States, South Korea September 2, 2028 METHODS OF TREATING INFLAMMATORY COLON DISEASES PCT/IL2009/000527 United States, Israel, Russia May 26, 2029 METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION PCT/IL2009/000844 Europe (Switzerland, Germany, France, United Kingdom), Israel September 1, 2029 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2009/000846 Australia, Canada, China, Europe (Switzerland, Germany, France, United Kingdom, Italy), Hong Kong, Israel, India, Mexico, Singapore, United States September 1, 2029 ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY PCT/IL2009/000845 United States, Europe (Switzerland, Germany, France, United Kingdom), Israel September 1, 2029 ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE DONORS AND USES THEREOF PCT/IB2011/001413 Israel April 21, 2031 ADHERENT CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT PCT/IB2010/003219 United States, Israel Australia, Canada, China, Hong Kong, Europe (Switzerland, Germany, Spain, France, United Kingdom, Italy, Belgium, Ireland, The Netherlands), Israel, Mexico, New Zealand, United States November 29, 2030 METHODS AND SYSTEMS FOR HARVESTING ADHERENT STROMAL CELLS PCT/IB2012/000933 China, Israel Australia, Canada, Europe (Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Italy, The Netherlands), Israel, India, South Korea, Mexico, Singapore, United States April 15, 2032 METHODS FOR TREATING RADIATION OR CHEMICAL INJURY PCT/IB2012/000664 United States Europe (Belgium, Switzerland, Germany, France, United Kingdom, Ireland, The Netherlands), Hong Kong, Israel, Japan, South Korea, United States March 22, 2032 SKELETAL MUSCLE REGENERATION USING MESENCHYMAL STEM CELLS PCT/EP2011/058730 United States, Europe (Belgium, Switzerland, Germany, Spain, France, United Kingdom, Ireland, Italy, The Netherlands), Israel May 27, 2031 GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL CELLS CULTURED IN 3D PCT/IB2014/059114 Israel, United States February 20, 2034 METHODS FOR PREVENTION AND TREATMENT OF PREECLAMPSIA PCT/IB2013/058186 Japan, Belgium, France, Italy, Switzerland, United Kingdom, Germany, China, Hong Kong August 31, 2033 METHOD AND DEVICE FOR THAWING BIOLOGICAL MATERIAL PCT/IB2013/059808 Australia, China, Europe (Belgium, Switzerland, Germany, Spain, France, United Kingdom, Italy, The Netherlands), Hong Kong, Israel, India, Japan, South Korea, Russia, Singapore, United States October 31, 2033 7 SYSTEMS AND METHODS FOR GROWING AND HARVESTING CELLS PCT/IB2015/051559 Israel, United States March 3, 2035 METHODS AND COMPOSITIONS FOR TREATING AND PREVENTING MUSCLE WASTING DISORDERS PCT/IB2015/059763 Israel, United States December 18, 2035 USE OF ADHERENT STROMAL CELLS FOR ENHANCING HEMATOPOIESIS IN A SUBJECT IN NEED THEREOF PCT/IB2016/051585 Israel, United States March 21, 2036 ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND USING SAME PCT/IB2016/053310 United States June 6, 2036 METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS PCT/IB2017/050868 Canada Europe (Switzerland, Germany, France, United Kingdom), Japan, Israel February 16, 2037 METHODS AND COMPOSITIONS FOR TREATING NEUROLOGICAL DISORDERS PCT/IB2018/052806 Israel April 23, 2038 METHODS AND COMPOSITIONS FOR TUMOR ASSESSMENT PCT/IB2018/050984 Israel February 18, 2038 METHODS AND COMPOSITIONS FOR TREATING ADDICTIONS PCT/IB2018/055473 Israel July 23, 2038 METHODS AND COMPOSITIONS FOR DETACHING ADHERENT CELLS Germany 10 2018 115 360.0 Germany June 25-July 3, 2038 METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS PCT/IL2020/050477 United States April 28, 2040 METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED THEREBY PCT/IB2019/052569 Israel, Singapore, United States March 28, 2039 METHODS AND COMPOSITIONS FOR TREATING SUBJECTS EXPOSED TO VESICANTS AND OTHER CHEMICAL AGENTS PCT/IB2019/055074 Israel, United States, Singapore June 18, 2039 METHODS AND COMPOSITIONS FOR FORMULATING AND DISPENSING PHARMACEUTICAL FORMULATIONS PCT/IB2019/053115 United States United States: April 16, 2039 Israel: April 26, 2038 THERAPEUTIC DOSAGE REGIMENS COMPRISING ADHERENT STROMAL CELLS PCT/IB2019/054828 Israel, United States June 10, 2039 MODULAR BIOREACTOR PCT/IB2019/058429 Europe, Israel, Hong Kong, South Korea, Singapore, United States October 3, 2039 THERAPEUTIC METHODS AND COMPOSITIONS PCT/IB2019/059544 Israel, United States November 6, 2039 METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND SEQUELAE THEREOF PCT/IL2021/050268 United States, Europe, Mexico March 11, 2040 METHODS AND COMPOSITIONS FOR AESTHETIC AND COSMETIC TREATMENT AND STIMULATING HAIR GROWTH PCT/IL2020/050363 United States March 26, 2040 8 METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED THEREBY IL277560 Israel September 23, 2040 METHODS AND COMPOSITIONS FOR ENRICHMENT OF TARGET CELLS PCT/IL2021/020514 United States, Israel May 5, 2041 PLACENTAL CELL TREATMENT FOR CRITICAL LIMB ISCHEMIA PATIENT SUBPOPULATIONS PCT/IL2022/050937 Patent Cooperation Treaty, or PCT, United States August 29, 2042 SYSTEM AND METHODS FOR IMMUNE CELLS EXPANSION AND ACTIVATION IN LARGE SCALE PCT/IL2023/050529 PCT, Israel, South Korea, United States May 23, 2043 A System For 3D Cultivation of Plant Cells And Methods Of Use 18/207,304 United States April 28, 2040 A SYSTEM FOR 3D CULTIVATION OF PLANT CELLS AND METHODS OF USE PCT/IL2024/050278 PCT, United States, Israel March 18, 2044 June 8, 2043 GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT T (MAIT) CELLS AND USES THEREOF PCT/IL2024/050675 PCT United States July 9, 2044 GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT T (MAIT) CELLS AND USES THEREOF PCT/IL2024/050670 PCT July 9, 2044 On January 8, 2022, we entered into a definitive license agreement with Takeda Pharmaceuticals International AG, or Takeda, a company based in Switzerland, which operates in the field of adipose-derived cells, pursuant to which we granted Takeda a global, non-exclusive license to use several of our patents (EP2591789 and EP3103463,), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing its opposition with regards to said patents and paying us a lump sum of $200,000.
If at any time during performance of this contract, the contracting officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), NIH, that we are not in compliance with any of the requirements and standards stated in the agreement, the contracting officer may immediately suspend, in whole or in part, work and further payments under this contract until we correct the noncompliance.
If at any time during performance of this contract, the contracting officer determines, in consultation with the Office of Laboratory Animal Welfare, or OLAW, NIH, that we are not in compliance with any of the requirements and standards stated in the agreement, the contracting officer may immediately suspend, in whole or in part, work and further payments under this contract until we correct the noncompliance.
The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale: ● Submission of an IND Application, which must become effective before clinical testing in humans can begin; ● Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce the drug candidate into humans in clinical studies; ● FDA may grant approval for EAP prior to the completion of clinical studies, in order to allow access for the investigational drug, for patients that are excluded from the study; ● FDA may grant priority review status to expedite the BLA review process.
The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale: ● Submission of an IND Application, which must become effective before clinical testing in humans can begin; ● Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce the drug candidate into humans in clinical studies; 13 ● FDA may grant approval for EAP prior to the completion of clinical studies, in order to allow access for the investigational drug, for patients that are excluded from the study; ● FDA may grant priority review status to expedite the BLA review process.
In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD. 11 NIAID Agreement On July 11, 2023 we signed a three year $4.2 million contract with the NIAID, which is part of the NIH. Pluri will collaborate with the U.S.
In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD. NIAID Agreement On July 11, 2023 we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH. We will collaborate with the U.S.
CRISPR-IL is funded by the IIA with a total budget of approximately $10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for an initial period of 18 months, with a potential for extension of an additional 18 months, or the Second Period, with additional budget from the IIA.
CRISPR-IL was funded by the IIA with a total budget of approximately $10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for an initial period of 18 months, with a potential for extension of an additional 18 months, or the Second Period, with additional budget from the IIA.
In accordance with regulatory requirements, nonclinical safety and toxicity studies are conducted under Good Laboratory Practice, requirements to ensure their quality and reliability; ● The manufacture of the product according to cGMP regulations and standards; ● Conducting adequate and well-controlled human clinical studies in compliance with Good Clinical Practice, or GCP, to establish the safety and efficacy of the product for its intended indication; and ● Potential post-marketing clinical testing and surveillance of the product after marketing approval, which can result in additional conditions on the approvals or suspension of clinical use.
In accordance with regulatory requirements, nonclinical safety and toxicity studies are conducted under Good Laboratory Practice, requirements to ensure their quality and reliability; ● The manufacture of the product according to GMP regulations and standards; ● Conducting adequate and well-controlled human clinical studies in compliance with Good Clinical Practice, or GCP, to establish the safety and efficacy of the product for its intended indication; and ● Potential post-marketing clinical testing and surveillance of the product after marketing approval, which can result in additional conditions on the approvals or suspension of clinical use.
The proceeds from the EIB Finance Agreement were intended to support our research and development in the EU to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market. The term of the project was three years commencing on January 1, 2020.
The proceeds from the EIB Finance Agreement were intended to support our research and development in Europe to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market. The term of the project was three years commencing on January 1, 2020.
Under the “Investors & ESG”, under the “Investors” and “Media” sections of our website, we make available free of charge our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
Under the “Investors & ESG”- “Financial Reports” and “SEC Filings” sections of our website, we make available free of charge our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.
Pluri will collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation exposure.
Department of Defense’s Armed Forces Radiobiology Research Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation exposure.
The following table sets forth our key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope. In some cases, a jurisdiction is listed as both pending and granted for a single patent family.
The following table sets forth our key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope. In some cases, a jurisdiction is listed as both pending and granted for a single patent family. This is due to pending continuation or divisional applications of the granted case.
See “Risk Factors – The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved” Our Patent Portfolio Patent Name/ Int. App. No.
See “Risk Factors – The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.” 6 Our Patent Portfolio Patent Name/ Int. App. No.
The following Corporate Governance documents are also posted on our website: Code of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist Financing Compliance Policy, Trading Policy and the Charters for each of the Committees of our Board of Directors, or the Board.
The following Corporate Governance documents are also posted on our website under the Investors & ESG” - Governance” section: Code of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist Financing Compliance Policy, Trading Policy, Clawback Policy and the Charters for each of the Committees of our Board of Directors, or the Board.
We, together with an international consortium under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery will be carrying out the study.
We, together with an international consortium under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery will be carrying out the study. The initiation of the study is still pending regulatory approvals.
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. Our PLX cells are adherent stromal cells that are expanded using our 3D platform.
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, hematologic conditions and, most 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 multi-national portfolio of patent and patent applications includes the following claims: ● our proprietary 3D expansion methods for adherent cells including placental stromal cells plant cells; ● composition of matter claims covering the cells; ● our proprietary 3D expansion methods for cells in suspension including immune cells; ● the therapeutic and cosmetic use of PLX cells for the treatment of a variety of conditions; and ● cell-culture, harvest, thawing and formulation devices.
Our multi-national portfolio of patent and patent applications includes the following claims: ● our proprietary 3D cell expansion methods for adherent cells including placental stromal cells plant cells, and plant cells; ● our proprietary 3D cell expansion methods for cells in suspension including immune cells; ● composition of matter claims covering the cells; ● the therapeutic and cosmetic use of PLX cells for the treatment of a variety of conditions; and ● cell-culture, harvest, thawing and formulation devices, cell therapy for a diverse array of diseases utilizing engineered MAIT cells derived from the placenta.
In addition, the manufacturing conditions are specifically inspected by the MOH. In the U.S. and European Union, the FDA and the European Medicines Agency, or EMA, respectively, must approve products prior to marketing. Furthermore, various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products and their marketing.
In addition, our manufacturing facility was inspected by the MOH. In the United States and the European Union, the FDA and the European Medicines Agency, or EMA, respectively, must approve products prior to marketing. Furthermore, various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products and their marketing.
PLX-R18 is the first product candidate manufactured using the serum-free media. 14 Government Regulation – Pharma The development, manufacturing, and future marketing of our cell therapy product candidates are subject to the laws and regulations of governmental authorities in the United States, Europe and Israel, as well as other countries in which our products may be marketed in the future like Japan, and South Korea.
Government Regulation – Pharma The development, manufacturing, and future marketing of our cell therapy product candidates are subject to the laws and regulations of governmental authorities in the United States, Europe and Israel, as well as other countries in which our products may be marketed in the future like Japan, and South Korea.
Through our experience with the development of adherent stromal cell-based products, we have gained expertise and know-how in this field and have established procedures for manufacturing clinical-grade PLX cells in our facilities. Certain aspects of our manufacturing process are covered by patents and patent applications.
Through our experience with the development of adherent stromal cell-based products, we have gained expertise and know-how in this field and have established procedures for manufacturing clinical-grade PLX cells in our facilities.
Our second product, PLX-R18, was cleared by the FDA and the MOH for clinical use. Furthermore, the site was inspected and approved by a European Union qualified person (European accreditation body), approving that the site and production processes meet the current GMP for the purpose of manufacturing clinical grade products.
Furthermore, the site was inspected and approved by a European Union qualified person (European accreditation body), approving that the site and production processes meet the current GMP for the purpose of manufacturing clinical grade products.
We are utilizing our technology in the field of regenerative medicine and food tech and plan to utilize it in other industries and verticals that have a need for our mass scale and cost-effective cell expansion platform.
We are utilizing our technology in the field of regenerative medicine, immunotherapy, food tech, CDMO, 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 via partnerships, joint ventures, licensing agreements and other types of collaborations.
Although some companies have recently brought their cultivated meat products to market in the United States, cultivated meat is not yet generally commercially available, but technologies like the one being developed by Ever After Foods are anticipated to facilitate the imminent scaling up of cultivated meat production.
Although some companies have recently received regulatory approval for their cultivated meat products in the United States, Israel and Singapore cultivated meat is not yet generally commercially available. However, technologies like the one being developed by Ever After Foods are anticipated to facilitate the scaling up of cultivated meat production.
On January 10, 2022, we entered into a definitive license agreement with Novadip Biosciences, or Novadip, a company based in Belgium, which operates in the field of adipose-derived stem cells for cell therapy and cell-free therapy in respect of medical or cosmetic conditions, under which we granted Novadip a global, non-exclusive, royalty free license to use two of our patents (EP2591789, EP3103463), limited to non-placental cells and cell-derived therapies, sub-licensable only to Novadip’s customers. 10 In April 2016, the Subsidiary entered into a licensing agreement with TES Holdings Co., Ltd., a venture company derived from the University of Tokyo, to obtain a key patent in Japan to cover the treatment of ischemic diseases with placental cell therapy.
On January 10, 2022, we entered into a definitive license agreement with Novadip Biosciences, or Novadip, a company based in Belgium, which operates in the field of adipose-derived stem cells for cell therapy and cell-free therapy in respect of medical or cosmetic conditions, under which we granted Novadip a global, non-exclusive, royalty free license to use two of our patents (EP2591789, EP3103463), limited to non-placental cells and cell-derived therapies, sub-licensable only to Novadip’s customers.
Employees As of June 30, 2023, we employed a total of 123 full-time employees and 11 part-time employees, of whom, 97 full-time employees and 9 part-time employees are engaged in cell research, development, and manufacturing including clinical and regulation affairs, excluding Ever After Foods.
Employees As of June 30, 2024, we employed a total of 106 full-time employees and 12 part-time employees, of whom, 82 full-time employees and 9 part-time employees are engaged in cell research, development, and manufacturing including clinical and regulation affairs, excluding Ever After Foods’ employees.
Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, which is incorporated under the laws of the State of Israel.
Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, which is incorporated under the laws of the State of Israel. In January 2020, the Subsidiary established a wholly owned subsidiary, Pluristem GmbH, which is incorporated under the laws of Germany, or the German Subsidiary.
As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
As of June 30, 2024, the royalty accrued was in the amount of €2,800. As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.
An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patient. Government Regulations - Food Tech Regulators around the world are in the process of developing or implementing a regulatory approval process for cultivated meat.
We monitor changes in these laws and believe that we are in material compliance with applicable laws. 17 Clinical Studies Typically, in the United States, as well as in the European Union, clinical development involves a series of clinical studies from early, small scale, Phase 1 studies to late-stage large, Phase 3 studies, although the phases may overlap.
The EMA is expected to review and approve the MAA. Clinical Studies Typically, in the United States, as well as in the European Union, clinical development involves a series of clinical studies from early, small scale, Phase 1 studies to late-stage large, Phase 3 studies, although the phases may overlap.
In general, cultivated meat production is subject to extensive regulatory laws and regulations in the United States and in other jurisdictions such as Canada, Japan, the European Union and the United Kingdom. The FDA and the U.S. Department of Agriculture, or USDA, will be issuing additional guidance and regulations applicable to cultivated meat.
In general, cultivated meat production is subject to extensive regulatory laws and regulations. In the United States, the FDA and the U.S. Department of Agriculture, or USDA, are in the process of developing guidance and regulations applicable to cultivated meat.
Approval of a drug for clinical studies in humans and approval of marketing are sovereign decisions of states, made by national, or, in case of the European Union, international regulatory competent authorities. 15 The Regulatory Process in the United States In the United States, our product candidates are subject to regulation as a biological product under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act.
Approval of a drug for clinical studies in humans and approval of marketing are sovereign decisions of states, made by national, or, in case of the European Union, international regulatory competent authorities.
This is due to pending continuation or divisional applications of the granted case. 6 The expiration dates of these patents, based on filing dates, range from 2027 to 2043.
The expiration dates of these patents, based on filing dates, range from 2027 to 2043.
Pluri will collaborate with the U.S. Department of Defense’s, or DoD’s, AFRRI and USUHS to further advance the development of its 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.
ARS On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH. Pluri will collaborate with the U.S. Department of Defense’s, or DoD’s, AFRRI, and the USUHS, to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS.
As of June 30, 2023, the interest accrued was in the amount of €1,665,000.
As of June 30, 2024, the interest accrued was in the amount of €2.465 million.
We aim to establish partnerships that leverage our 3D cell-based technology to additional industries that require effective, mass cell production and will enable us to accelerate the time to market.
We developed a new cell manufacturing process for industrial scale cell manufacturing called PluriMatrix, which is built upon our 3D cell expansion technology platform, scaling high-quality cell production. We aim to establish partnerships that leverage our 3D cell-based technology to additional industries that require effective, mass cell production and will enable us to accelerate the time-to-market of our products.
During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study sites investigators to minimize risks and ensure high quality and integrity of the collected data.
In some circumstances, a regulatory agency may require Phase IV, or post-marketing studies in case additional information needs to be collected after the drug is on the market. 14 During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study sites investigators to minimize risks and ensure high quality and integrity of the collected data.
PLX-PAD Our first product candidate, PLX-PAD, is composed of maternal mesenchymal stromal cell, or MSC, like cells originating from the placenta. PLX-R18 Our second product candidate, PLX-R18, is composed of fetal MSC like cells originating from the placenta.
Product Candidates - Pluri Health PLX-PAD PLX-PAD is composed of maternal mesenchymal stromal cell, or MSC, like cells originating from the placenta. PLX-R18 PLX-R18 is composed of fetal MSC like cells originating from the placenta. Allogeneic MAIT Cell Therapy Platform MAIT cells are a distinct type of unconventional immune T cells.
Our state-of-the-art Good GMP grade manufacturing facility in Haifa has been in use since February 2013 for the main purpose of clinical grade, large-scale manufacturing. The facility’s new automated manufacturing process and products were approved for production of PLX-PAD for clinical use by the FDA, EMA, MFDS, PMDA and the MOH.
The facility’s new automated manufacturing process and products were approved for production of PLX-PAD for clinical use by the FDA, EMA, MFDS, PMDA and the MOH. Our second product, PLX-R18, was cleared by the FDA and the MOH for clinical use.
Our ability to compete successfully will depend on our continued ability to attract and retain experienced and skilled executives, scientific and clinical development personnel, to identify and develop viable cellular therapeutic candidates and exploit these products commercially, and keep expanding and improving our unique technological capabilities.
Our ability to compete successfully will depend on our continued ability to attract and retain experienced and skilled executives, scientific and clinical development personnel, to identify and develop viable cellular therapeutic candidates and exploit these products commercially and keep expanding and improving our unique technological capabilities. 15 Food Tech: Ever After Foods operates in a competitive landscape that includes both consumer-facing companies like Upside Foods, Believer Meats, and GOOD Meat, as well as B2B players like Gelatex, Esco Aster, Ark Biotech, GEA and more.
Among other things, we expect to compete based upon our intellectual property portfolio, our in-house manufacturing efficiencies and capabilities, and the potential efficacy of our products.
While there are hundreds of companies in the regenerative medicine space globally, there are multiple participants in the cell therapy field based in the United States, Europe, Japan, Korea, and Australia. Among other things, we expect to compete based upon our IP portfolio, our in-house manufacturing efficiencies and capabilities, and the potential efficacy of our products.
Additionally, our current manufacturing process, which has scaled up during the years, has demonstrated batch-to-batch consistency, an important manufacturing challenge for biological products. We developed a new cell manufacturing process for industrial scale cell manufacturing called PluriMatrix, which we announced in April 2023, and which is built upon our platform 3D cell expansion technology, scaling high-quality cell production.
Our automated proprietary 3D, GMP, approved process enables the large-scale monitored and controlled production of reproducible, high quality cell products and in mass quantities. Additionally, our current manufacturing process, which has scaled up over the years, has demonstrated batch-to-batch consistency, an important manufacturing challenge for biological products.
In the food tech field, we established a new venture with Tnuva, Ever After Foods Ltd., or Ever After Foods, (previously Plurinuva Ltd.), which is incorporated under the laws of the State of Israel. Ever After Foods is developing cultivated meat products based on Pluri’s platform 3D cell expansion technology. We were incorporated in Nevada on May 11, 2001.
Food Tech In 2022, we announced the establishment of a joint venture with Tnuva, Ever After Foods, (previously Plurinuva Ltd.), which is incorporated under the laws of the State of Israel, with the purpose of developing cultivated meat product of all kinds and types.
Our Technology Our technology platform, a patented and validated state-of-the-art 3D cell expansion system, aims to advance novel cell-based solutions for a range of industries, including, but not limited to pharmaceuticals, food, agricultural, and biologics. Our method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch.
We are designing the MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy. Our Technology Our technology platform, a patented and validated state-of-the-art 3D cell expansion system, aims to advance novel cell-based solutions for a range of industries, including, but not limited to pharmaceuticals, foodtech, agtech, and CDMO.
We believe that using the placenta as a unique cell source, combined with our innovative research, development and high-quality manufacturing capabilities, will be the “engine” that drives this platform technology towards the successful development of additional PLX cell therapy products and indications. 2 Our Clinical Development Product Candidates Orthopedic Indications . Following U.S.
We believe that leveraging the placenta as a unique source of cells, combined with our cutting-edge research, development and established high-quality manufacturing capabilities, will serve as the driving force towards the successful development of a broader range of cell therapy products and applications. 3 Our Clinical Development Product Candidates Both PLX-PAD and PLX-R18 products were tested in clinical studies.
The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIA study for the treatment of mild to moderate knee osteoarthritis. Final approval of the grant is subject to completion of the consortium and Horizon Europe grant agreements, or Horizon Europe.
The goal of the PROTO project is to utilize our PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis. The clinical study will be carried out by Charité.
We believe that proof of concept with API derived from animals will open opportunities for us to serve additional API manufacturers in the rapidly growing biologics markets. 5 Intellectual Property We understand that our success will depend, in part, on maintaining our intellectual property, and therefore we are committed to protecting our technology and product candidates with patents and other methods described below.
The agreement is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture. 5 Intellectual Property We understand that our success will depend, in part, on maintaining our IP, and therefore we are committed to protecting our technology and product candidates with patents and other methods described below.
The period of performance of this contract will be from July 1, 2023 through June 30, 2024, which may be extended for additional two years period.
The period of performance of this contract was from July 1, 2023 through June 30, 2024, with an optional extension for an additional two year period. 10 On June 6, 2024 the NIAID exercised its option for year two of the three-year $4.2 million contract.
The Phase III studies are considered confirmatory for establishing the efficacy and safety profile of the drug and are critical for approval. In some circumstances, a regulatory agency may require Phase IV, or post-marketing studies in case additional information needs to be collected after the drug is on the market.
The Phase III studies are considered confirmatory for establishing the efficacy and safety profile of the drug and are critical for approval.
Ongoing Collaborations EIB Agreement In April 2020, we and our subsidiaries, Pluri Biotech Ltd. and Pluristem GmbH, executed a finance agreement executed with the EIB, or the EIB Finance Agreement, for non–dilutive funding of up to €50 million in the aggregate, payable in three tranches.
Under the agreement, Bar-Ilan University via Birad will receive the right to further develop and commercialize PLX cells as a cocaine anti-addiction product, and Pluri is entitled to 20% revenue sharing from future sales of the product for anti-addiction. 9 Ongoing Collaborations EIB Agreement In April 2020, we, the Subsidiary, and the German Subsidiary, together with the European Investment Bank, or EIB, executed a finance agreement, or the EIB Finance Agreement, for non–dilutive funding of up to €50 million in the aggregate, payable in three tranches.
Our technology is currently implemented in the fields of regenerative medicine and food tech. Our system utilizes a synthetic scaffold to create an artificial 3D environment where cells can grow. Our automated proprietary 3D, Current Good Manufacturing Practice, or cGMP, approved process enables the large-scale monitored and controlled production of reproducible, high quality cell products and in mass quantities.
Our method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Our technology is currently being implemented in the fields of regenerative medicine, food tech, agtech and CDMO. Our system utilizes a synthetic scaffold to create a 3D environment where adherent or non-adherent cells can grow in a tissue like environment.
As such, Tel Aviv Sourasky Medical Center supports the study and is responsible for its design and implementation. 17 patients have been treated in this study to date. Regulatory and Clinical Affairs Strategy Our cell therapy development strategy is to hold open and frequent discussions with regulators at all stages of development from preclinical studies to more advanced regulatory stages.
Prior to signing the contract with NIAID, we conducted several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with NIAID and DoD Armed Forces Radiobiology Research Institute, part of the USUHS. 4 Regulatory and Clinical Affairs Strategy Our cell therapy development strategy is to hold open and frequent discussions with regulators at all stages of development from preclinical studies to more advanced regulatory stages.
As of the date of this annual report, we have not received any royalties from Chart that relate to the sale of the thawing device. 13 CRISPR-IL In June 2020, we announced that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA.
The POC Party may terminate upon 14 days’ written notice following the end of either of the two phases of the POC. CRISPR-IL In June 2020, we announced that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA.
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Our operations are focused on the research, development and manufacturing of cells and cell-based products, conducting clinical studies and the business development of cell therapeutics and cell-based technologies, such as our collaboration with Tnuva Food Industries – Agricultural Cooperative in Israel Ltd., through its fully owned subsidiary, Tnuva Food-Tech Incubator (2019), Limited Partnership, or Tnuva, to use our technology to establish a cultivated food platform, as well as the collaboration agreement we signed in 2022 with a leading European manufacturer of active pharmaceutical ingredients, or APIs, to use our expansion technology, which aims to revolutionize the production of biologics by enabling a cost-effective, sustainable and cruelty-free ingredient.
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Our operations are focused on the research, development and manufacturing of cell-based products and the business development of cell therapeutics and cell-based technologies providing potential solutions for various industries. We were incorporated in Nevada on May 11, 2001.
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In January 2020, the Subsidiary established a wholly owned subsidiary, Pluristem GmbH, which is incorporated under the laws of Germany. 1 Scientific Background – Cell Therapy Cell therapy is an established field within the regenerative medicine area. The characteristics and properties of cells vary as a function of tissue source and growth conditions.
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In November 2021, the Subsidiary established a new subsidiary, Ever After Foods Ltd., or Ever After Foods, which is incorporated under the laws of the State of Israel. The Subsidiary holds approximately 69% of Ever After Foods issued and outstanding shares on a fully diluted basis.
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The human placenta from which our PLX cells are derived provides a unique source of non-embryonic, adult cells and represents an innovative approach in the cell therapy field. The different factors that PLX cells release suggest that the cells can be used therapeutically for a variety of ischemic, inflammatory, autoimmune and hematological deficiencies.
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In March 2024 the Subsidiary established a wholly owned subsidiary, Coffeesai Ltd., or Coffeesai, which is incorporated under the laws of the State of Israel.
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PluriMatrix is also used by Ever After Foods, for producing cultivated meat. Product Candidates We believe that our technology will continue to fuel medical research and develop pharmaceuticals, while also being used to potentially create novel cell-based solutions for other innovative initiatives—such as food tech, cellular agriculture and biologics.
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Under such contract, we will collaborate with the U.S.
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Pluri Health Our primary objective is to be the leading provider of allogeneic placenta-based cell therapy products that are true off-the-shelf products that do not require any matching or additional manipulation prior to administration. Currently, our PLX products are administered intramuscular, or IM, using a standard needle and syringe.
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Immunotherapy MAIT cells: In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors – a critical area in medicine where effective treatments are currently insufficient.
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Modified PLX cells As a platform technology company, we are also developing additional product candidates, which are modified or induced PLX cells: Induced PLX cells: we are using cells from the placenta, induced with cytokines, to transiently alter their secretion profile.
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We believe that our MAIT cells, isolated from the human placenta, offer substantial potential benefits compared to conventional T cells. 1 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.
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Modified PLX cells using CRISPR, or other gene editing technology: CRISPR is a unique technology which allows precise gene editing of cells. Using this technology, we can initiate the next evolution in cell therapy by allowing the reprograming of cells for specific needs.
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Furthermore, unlike conventional autologous T cells typically collected from peripheral blood, our MAIT cells are designed to be allogenic universal product. Benefiting with very restricted T-cell receptor, or TCR, the MAIT cells minimize their likelihood of inducing Graft versus Host Disease, or GvHD, a significant advantage over other potential allogeneic products.
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Our aim is to incorporate the genetic engineering techniques into our cell manufacturing platform in order to develop large scale allogenic engineered PLX products designed for specific indications.
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We are aiming to design the MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
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Food and Drug Administration, or FDA, and European Medicine Agency, or EMA, clearance, a multinational Phase III study was conducted and completed in the United States, Europe and Israel. The primary endpoint of this study was the Short Physical Performance Battery, or SPPB, a test for lower limb performance and functional status.
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In April 2024, we unveiled a novel method for expansion of immune cells using proprietary technology and announced we were granted a new U.S. patent titled, “System and Methods for Immune Cells Expansion and Activation in Large Scale.” This innovative approach ensures that the produced immune cells retain their integrity, functionality, and therapeutic efficacy, thus offering a promising solution to meet the escalating demand for advanced cell-based therapies for immune disorders and neurodegenerative diseases.
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We completed enrollment of 240 patients and the study was designed to assess the efficacy at six months and a year, as well as safety for up to two years. On July 13, 2022, we announced topline results from our Phase III study of muscle regeneration following hip fracture surgery.
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PluriCDMO™ In January 2024, we launched a new business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers CDMO services to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. We have signed several agreements with clients and are currently generating revenues from PluriCDMO™.
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PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration. A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120).
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AgTech We are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the agtech field, such as: (a) cell-based coffee business activity through our PluriAgtech business vertical, which is incorporated into our wholly owned subsidiary, Coffeesai (b) an innovative proof-of-concept, or POC, collaboration with ICL Group Ltd., or ICL Group, a leading global specialty minerals company, to revolutionize bio stimulant delivery and enhance yield sustainably, and (c) a strategic POC agreement with a leading international agriculture corporation which is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture.
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The study did not meet the primary endpoint, which was the SPPB test at week 26. On October 26, 2022, a 52-week follow up of all patients was completed.
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In March 2024, we announced an important expansion to our intellectual property, or IP portfolio with a new patent approval from the Israel Patent Office, that is designed to reshape the agricultural technology landscape.
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Our Phase III study protocol and design was based on our phase I/II, randomized, double-blind, placebo-controlled study (n=20) to assess the safety and efficacy of IM injections of allogeneic PLX-PAD cells for the regeneration of injured gluteal musculature after total hip replacement had been conducted in Germany under the approval of Paul Ehrlich Institute, or PEI.
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The patent represents a major breakthrough in our proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various applications, from sustainable agriculture to critical healthcare solutions.
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In this study, PLX-PAD cells or placebo were administered into the traumatized gluteal muscle during total hip replacement surgery. The study results met its primary efficacy endpoint, change in maximal voluntary isometric contraction force of the gluteal muscle at six months after total hip replacement.
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Leveraging Pluri’s innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business, or 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.
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Patients treated with PLX-PAD had a significantly greater improvement of maximal voluntary muscle contraction force than the placebo group (p=0.0067). In addition, the study demonstrated that PLX-PAD was safe and well tolerated by patients. COVID-19 Complicated by Acute Respiratory Distress Syndrome, or ARDS .
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In June 2024, we entered into a share purchase agreement, or the Agreement, by and among Ever After Foods, Tnuva, and certain other international strategic investors, or, collectively, the Investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private placement offering, or the Offering, for aggregate gross proceeds of $10 million.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

67 edited+40 added−17 removed137 unchanged
Biggest changeWe expect to experience future losses and do not foresee generating significant or steady revenues in the immediate future; ● we may need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and could dilute our shareholders’ ownership interests, and such offers or availability for sale of a substantial number of our common shares may cause the price of our publicly traded shares to decline; ● we may become subject to claims by much larger and better funded competitors enforcing their intellectual property rights against us or seeking to invalidate our intellectual property or our rights thereto; ● there are inherent risks in the manufacturing of our product candidates, including meeting relevant high regulatory standards, the failure of which could materially and adversely affect our results of operations and the value of our business; ● if we are unable to obtain and maintain intellectual property protection covering our products and technology, others may be able to utilize our intellectual property, which would adversely affect our business; 19 ● we are an international business, and we are exposed to various global and local risks that could have a material adverse effect on our financial condition and results of operations; ● the market prices of our common shares are subject to fluctuation and have been and may continue to be volatile, which could result in substantial losses for investors; ● we anticipate being subject to fluctuations in currency exchange rates because a significant portion of our business is conducted outside the United States and we are exposed to currency exchange fluctuations in other currencies such as the New Israeli Shekel, or NIS, and the Euro; ● restrictions and covenants contained in the EIB Finance Agreement may restrict our ability to conduct certain strategic initiatives; ● limitations we may face relating to the grants we have received from the IIA may impact our plans and future decisions; ● if there are significant shifts in the political, economic and military conditions in Israel and its neighboring countries, it could have a material adverse effect on our business relationships and profitability; ● it may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers; ● cybersecurity incidents may have an adverse impact on our business and operations; ● recent increasing global inflation could affect our ability to purchase materials needed for manufacturing and could increase the costs of our future product; ● we have a limited operating history in the field of food tech to date and our prospects will be dependent on our ability to meet a number of challenges; ● there are risks relating to our food-tech endeavors, including changes in consumer preferences and governmental regulations relating to cultivated meat; ● our business and market potential in the field of cultivated food are unproven, and we have limited insight into trends that may emerge and affect our business; ● the research and development associated with technologies for cultivated meat manufacturing is a lengthy and complex process; and ● we could fail to maintain the listing of our common shares on Nasdaq, which could harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction. 20 Risk Related to Our Business We may need to raise additional financing to support the research, development and manufacturing of our cell based products in the future, but we cannot be sure we will be able to obtain additional financing on terms favorable to us when needed.
Biggest changeWe expect to experience future losses and do not foresee generating significant or steady revenues in the immediate future; ● we may need to raise additional capital to meet our business requirements in the future, and such capital raising may be costly or difficult to obtain and could dilute our shareholders’ ownership interests, and such offers or availability for sale of a substantial number of our common shares may cause the price of our publicly traded shares to decline; 16 ● we may become subject to claims by much larger and better funded competitors enforcing their IP rights against us or seeking to invalidate our IP or our rights thereto; ● there are inherent risks in the manufacturing of our product candidates, including meeting relevant high regulatory standards, the failure of which could materially and adversely affect our results of operations and the value of our business; ● if we are unable to obtain and maintain IP protection covering our products and technology, others may be able to utilize our IP, which would adversely affect our business; ● we are an international business, and we are exposed to various global and local risks that could have a material adverse effect on our financial condition and results of operations; ● the market prices of our common shares are subject to fluctuation and have been and may continue to be volatile, which could result in substantial losses for investors; ● we anticipate being subject to fluctuations in currency exchange rates because a significant portion of our business is conducted outside the United States and we are exposed to currency exchange fluctuations in other currencies such as the New Israeli Shekel, or NIS, and the Euro; ● restrictions contained in the EIB Finance Agreement may restrict our ability to conduct certain strategic initiatives; ● limitations we may face relating to the grants we have received from the IIA may impact our plans and future decisions; ● if there are significant shifts in the political, economic and military conditions in Israel and its neighboring countries, it could have a material adverse effect on our business relationships and profitability; ● it may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers; ● cybersecurity incidents may have an adverse impact on our business and operations; ● recent increasing global inflation could affect our ability to purchase materials needed for manufacturing and could increase the costs of our future product; ● we have a limited operating history in the field of food tech agtech and CDMO to date and our prospects will be dependent on our ability to meet a number of challenges; ● there are risks relating to our CDMO business, including financial risks associated with contracts that could be terminated, changed or delayed, risk related to products that might not gain market approval and risk related to providing timely services to customers in a highly competitive industry in which we operate. ● there are risks relating to our food-tech endeavors, including changes in consumer preferences and governmental regulations relating to cultivated meat; ● our business and market potential in the field of cultivated food and cell-based coffee technology are unproven, and we have limited insight into trends that may emerge and affect our business; ● the research and development associated with technologies for cultivated meat manufacturing is a lengthy and complex process; and ● we could fail to maintain the listing of our common shares on Nasdaq, which could harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction. 17 Risk Related to Our Business We may need to raise additional financing to support the research, development and manufacturing of our cell-based products in the future, but we cannot be sure we will be able to obtain additional financing on terms favorable to us when needed.
A number of events and factors may have an adverse impact on the market price of our common shares, such as: ● results of our clinical trials or adverse events associated with our products; ● the amount of our cash resources and our ability to obtain additional funding; ● changes in our revenues, expense levels or operating results; ● entering into or terminating strategic relationships; ● announcements of technical or product developments by us or our competitors; ● market conditions for pharmaceutical and biotechnology shares in particular; ● changes in laws and governmental regulations, including changes in tax, healthcare, competition and patent laws; ● disputes concerning patents or proprietary rights; ● new accounting pronouncements or regulatory rulings; ● public announcements regarding medical advances in the treatment of the disease states that we are targeting; ● patent or proprietary rights developments; ● regulatory actions that may impact our products; 28 ● future sales of our common shares, or the perception of such sales; ● disruptions in our manufacturing processes; and ● competition.
A number of events and factors may have an adverse impact on the market price of our common shares, such as: ● results of our clinical trials or adverse events associated with our products; ● the amount of our cash resources and our ability to obtain additional funding; ● changes in our revenues, expense levels or operating results; ● entering into or terminating strategic relationships; ● announcements of technical or product developments by us or our competitors; 26 ● market conditions for pharmaceutical and biotechnology shares in particular; ● changes in laws and governmental regulations, including changes in tax, healthcare, competition and patent laws; ● disputes concerning patents or proprietary rights; ● new accounting pronouncements or regulatory rulings; ● public announcements regarding medical advances in the treatment of the disease states that we are targeting; ● patent or proprietary rights developments; ● regulatory actions that may impact our products; ● future sales of our common shares, or the perception of such sales; ● disruptions in our manufacturing processes; and ● competition.
In addition, increasing ESG-related regulation, such as the SEC’s climate disclosure proposal, may also result in increased compliance costs or scrutiny. 30 Expectations around a company’s management of ESG matters continues to evolve rapidly, in many instances due to factors that are out of our control.
In addition, increasing ESG-related regulation, such as the SEC’s climate disclosure proposal, may also result in increased compliance costs or scrutiny. Expectations around a company’s management of ESG matters continues to evolve rapidly, in many instances due to factors that are out of our control.
There can be no assurance that we will be successful in finding the relevant partners to fund and market our cell-based products. 21 Risks Related to Development, Clinical studies, and Regulatory Approval of Our Product Candidates If we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA, EMA, MOH and other regulatory authorities may be delayed or denied.
There can be no assurance that we will be successful in finding the relevant partners to fund and market our cell-based products. 18 Risks Related to Development, Clinical studies, and Regulatory Approval of Our Product Candidates If we are not able to conduct our clinical trials properly and on schedule, marketing approval by FDA, EMA, MOH and other regulatory authorities may be delayed or denied.
The manufacture and marketing of food products is highly regulated. Ever After Foods, its suppliers and licensees, may be subject to a variety of laws and regulations.
The manufacture, distribution and marketing of food products is highly regulated. Ever After Foods and its suppliers and licensees, may be subject to a variety of laws and regulations.
If consumer demand for such products decreases, Ever After Food’s business and financial condition would suffer. Consumer trends that we believe favor sales of products manufactured using our licensed technologies could change based on a number of possible factors, including a shift in preference from animal-based protein products, economic factors and social trends.
If consumer demand for such products decreases, Ever After Foods’ business and financial condition would suffer. Consumer trends that we believe favor sales of products manufactured using our licensed technologies could change based on a number of possible factors, including a shift in preference from animal-based protein products, economic factors and social trends.
Given our need for cash and that equity raising is the most common type of fundraising for companies like ours, the risk of dilution is particularly significant for shareholders of our company. 29 Risks Related to Foreign Exchange Rates We are exposed to fluctuations in currency exchange rates. A significant portion of our business is conducted outside the United States.
Given our need for cash and that equity raising is the most common type of fundraising for companies like ours, the risk of dilution is particularly significant for shareholders of our company. 27 Risks Related to Foreign Exchange Rates We are exposed to fluctuations in currency exchange rates. A significant portion of our business is conducted outside the United States.
Cost control initiatives could decrease the price for products that we may develop, which would result in lower product revenues to us. 26 Risk Related to Intellectual Property Our success depends in large part on our ability to develop and protect our technology and our cell therapy products.
Cost control initiatives could decrease the price for products that we may develop, which would result in lower product revenues to us. 24 Risk Related to Intellectual Property Our success depends in large part on our ability to develop and protect our technology and our cell therapy products.
Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs. 31 Some of our competitors have greater resources, more product candidates and have developed product candidates and processes that directly compete with our products.
Some of these competitors are pursuing the development of cellular therapeutics, drugs and other therapies that target the same diseases and conditions that we target in our clinical and pre-clinical programs. 28 Some of our competitors have greater resources, more product candidates and have developed product candidates and processes that directly compete with our products.
To date, we have focused our efforts primarily in the regenerative medicine field and in the Food Tech field, but we may seek partners for licensing deals, joint ventures, partnerships, and direct sale of our products or use of our technology in various industries.
To date, we have focused our efforts primarily in the regenerative medicine field, in the food tech field, in the CDMO field, and in the agriculture field, but we may seek partners for licensing deals, joint ventures, partnerships, and direct sale of our products or use of our technology in various industries.
We believe that our cash is held in institutions whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected in our consolidated financial statements as of June 30, 2023. Currently, we hold most of our cash assets in bank deposits in Israel.
We believe that our cash is held in institutions whose credit risk is minimal and that the value and liquidity of our deposits are accurately reflected in our consolidated financial statements as of June 30, 2024. Currently, we hold most of our cash assets in bank deposits in Israel.
To succeed, Ever After Food’s cultured meat products must excel in costs, taste, ingredients, marketing and branding. Generally, the food industry is dominated by multinational corporations with substantially greater resources and operations than Ever After Foods.
To succeed, Ever After Foods’ cultured meat products must excel in costs, taste, ingredients, marketing and branding. Generally, the food industry is dominated by multinational corporations with substantially greater resources and operations than Ever After Foods.
Any such delay or failure could materially and adversely affect Ever After Foods’ financial condition, results of operations and prospects. Consumer preferences for alternative proteins in general, and more specifically cultured meats, are difficult to predict and may change, and, if we are unable to respond quickly to new trends, Ever After Food’s business may be adversely affected.
Any such delay or failure could materially and adversely affect Ever After Foods’ financial condition, results of operations and prospects. Consumer preferences for alternative proteins in general, and more specifically cultivated meats, are difficult to predict and may change, and, if we are unable to respond quickly to new trends, Ever After Foods’ business may be adversely affected.
The manufacturing of cultured meat is expected to be subject to extensive regulations internationally, with products subject to numerous food safety and other laws and regulations relating to the sourcing, manufacturing, composition and ingredients, storing, labeling, marketing, advertising and distribution of these products.
The manufacturing of cultivated meat is expected to be subject to extensive regulations internationally, with products subject to numerous food safety and other laws and regulations relating to the sourcing, manufacturing, composition and ingredients, storing, labeling, marketing, advertising and distribution of these products.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our products and technology, including interference proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.
We may become party to, or threatened with, future adversarial proceedings or litigation regarding IP rights with respect to our products and technology, including interference proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.
In the case that the IIA-supported company retains its research and development center in Israel for at least three consecutive years, following the year of transferring the IIA-supported know-how outside of Israel, while maintaining at least 75% of its research and development employees in Israel – the payment will be limited to three times the total sum of grants received plus interest.
In the case that the IIA-supported company sells the IP but retains its research and development center in Israel for at least three consecutive years, following the year of transferring the IIA-supported know-how outside of Israel, while maintaining at least 75% of its research and development employees in Israel – the payment will be limited to three times the total sum of grants received plus interest.
Nonetheless, despite the implementation of security measures, including the steps we have taken following the November 2021 cybersecurity incident, our internal computer systems and those of our current and future CROs and other contractors and consultants may not prevent future incidents of a similar nature or other cyber-attacks.
Nonetheless, despite the implementation of security measures, including the steps we have taken following the November 2021 cybersecurity incident, our internal computer systems and those of our current and future clinical research organization or CROs and other contractors and consultants may not prevent future incidents of a similar nature or other cyber-attacks.
If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all.
If we are found to infringe a third party’s IP rights, we could be required to obtain a license from such third party to continue developing and marketing our products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all.
Ever After Food’s business is focused on the development and marketing of licensable cultured meat manufacturing technologies. Consumer demand for the cultured meats manufactured using these technologies could change based on a number of possible factors, including dietary habits and nutritional values, concerns regarding the health effects of ingredients and shifts in preference for various product attributes.
Ever After Foods’ business is focused on the development and marketing of licensable cultivated meat manufacturing technologies. Consumer demand for the cultivated meats manufactured using these technologies could change based on a number of possible factors, including dietary habits and nutritional values, concerns regarding the health effects of ingredients and shifts in preference for various product attributes.
Ever After Foods’ current technologies are, in large part, based on our technologies and intellectual property. It may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups and future growth, or at all.
Ever After Foods’ current technologies are, in large part, based on our technologies and IP. It may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups and future growth, or at all.
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
Third parties may initiate legal proceedings alleging that we are infringing their IP rights, the outcome of which would be uncertain and could have a material adverse effect on our business.
Moreover, disagreements could arise with our collaborators over rights to intellectual property or our rights to share in any of the future revenues of products developed by our collaborators. These kinds of disagreements could result in costly and time-consuming litigation.
Moreover, disagreements could arise with our collaborators over rights to IP or our rights to share in any of the future revenues of products developed by our collaborators. These kinds of disagreements could result in costly and time-consuming litigation.
In addition, as we do not have experience in areas outside of the regenerative medicine field and limited experience in Food Tech field, we may lack the personnel to properly lead such initiatives.
In addition, as we do not have experience in areas outside of the regenerative medicine field and limited experience in the food tech, CDMO and agriculture fields, we may lack the personnel to properly lead such initiatives.
A significant shift in consumer demand away from products manufactured using our technologies could reduce our sales or our market share and the prestige of our brand, which would harm our business and financial condition. 24 We expect that products utilizing Ever After Food’s technologies will be subject to regulations that could adversely affect its business and results of operations.
A significant shift in consumer demand away from products manufactured using our technologies could reduce our sales or our market share and the prestige of our brand, which would harm our business and financial condition. We expect that products utilizing Ever After Foods’ technologies will be subject to regulations that could adversely affect Ever After Foods’ business and operations.
We rely on and utilize services provided by third parties in connection with our clinical trials, which services involve the collection, use, storage and analysis of personal health information.
We have relied on and utilize services provided by third parties in connection with our clinical trials, which services involve the collection, use, storage and analysis of personal health information.
Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects. 23 Risks Related to Our Cultivated Food Business Ever After Foods has a limited operating history in the field of cultivated meat to date and its prospects will be dependent on its ability to meet a number of challenges.
Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects. 20 Risks Related to Our Cultivated Food Business Ever After Foods has a limited operating history in the field of cultivated or cultured meat (hereinafter, “cultivated meat”) to date and its prospects will be dependent on its ability to meet a number of challenges.
In addition, a food may be deemed misbranded if its labeling is false or misleading in any particular way, and the USDA, CFIA, EFSA or other regulators could interpret the use of the term “meat” or any similar phrase(s) to describe our cultured meat products as false or misleading or likely to create an erroneous impression regarding their composition.
In addition, a food may be deemed misbranded if its labeling is false or misleading in any particular way, and the USDA, CFIA, EFSA or other regulators could interpret the use of the terms “meat” or “poultry” or any similar phrase(s) to describe our customers’ cultivated meat products as false or misleading or likely to create an erroneous impression regarding their composition.
Even if early-stage clinical trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for longer periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities outside the United States.
Results of further clinical trials may be disappointing. 19 Even if early-stage clinical trials are successful, we may need to conduct additional clinical trials for product candidates with patients receiving the drug for longer periods before we are able to seek approvals to market and sell these product candidates from the FDA and regulatory authorities outside the United States.
Any changes in, or changes in the interpretation of, applicable laws, regulations or policies of the USDA, state regulators or similar foreign regulatory authorities that relate to the use of the word “meat” or other similar words in connection with cultured meat products could adversely affect our business, prospects, results of operations or financial condition.
Any changes in, or changes in the interpretation of, applicable laws, regulations or policies of the USDA, state regulators or similar foreign regulatory authorities that relate to the use of the terms “meat” or “poultry” or other similar terms in connection with cultivated meat products could adversely affect our business, prospects, results of operations or financial condition.
To the extent a company wishes to transfer its IIA-supported know-how outside of Israel - the IIA acts under the Law for the Encouragement of Research, Development and Technological Innovation in the Industry 1984 and the related IIA rules and regulations, it must be preapproved by the IIA and the company may be required to pay an additional payment to the IIA.
To the extent a company wishes to transfer its IIA-supported know-how outside of Israel (by way of sale and/or granting a license to use the IP) – the IIA acts under the Law for the Encouragement of research, Development and Technological Innovation in the Industry 1984 and the related IIA rules and regulations, it must be preapproved by the IIA and the company may be required to pay an additional payment to the IIA.
While results from treating patients through compassionate use have in certain cases been successful, we cannot be assured that further trials will ultimately be successful. Results of further clinical trials may be disappointing.
While results from treating patients through compassionate use have in certain cases been successful, we cannot be assured that further trials will ultimately be successful.
These laws and regulations apply to many aspects of Ever After Food’s business, including the manufacture, composition and ingredients, packaging, labeling, distribution, advertising, sale, quality and safety of food products, as well as the health and safety of our employees and the protection of the environment.
These laws and regulations apply to many aspects of Ever After Foods’ business, including the manufacture, composition and ingredients, packaging, labeling, distribution, advertising, sale, quality and safety of food products and food contact substances (including some manufacturing equipment), as well as the health and safety of our employees and the protection of the environment.
We are constantly exploring new and advanced security protection measures to prevent future cybersecurity incidents. Future security breaches or any material system failure events could result in a material disruption of our development programs and our business operations.
We are constantly exploring new and advanced security protection measures to prevent future cybersecurity incidents. See Item 1C. “Cybersecurity”, for additional information. Future security breaches or any material system failure events could result in a material disruption of our development programs and our business operations.
From a regulatory perspective, in the United States, we expect companies manufacturing finished cultured meat products to be subject to regulation by various government agencies, including the FDA, the USDA, the FTC, Occupational Safety and Health Administration and the Environmental Protection Agency, as well as the requirements of various state and local agencies and laws, such as the California Safe Drinking Water and Toxic Enforcement Act of 1986.
From a regulatory perspective, in the United States, we expect companies manufacturing finished cultivated meat products ( i.e., the companies that will license Ever After Foods’ manufacturing technologies) to be subject to regulation by various government agencies, including the FDA, the USDA, the FTC, the Occupational Safety and Health Administration and the Environmental Protection Agency, as well as the requirements of various state and local agencies and laws, such as the California Safe Drinking Water and Toxic Enforcement Act of 1986.
The USDA, state regulators or similar foreign regulatory authorities, such as Health Canada or the Canadian Food Inspection Agency, or CFIA, or authorities of the EU or the EU member states ( e.g., European Food Safety Authority, or EFSA), could take action to impact our ability to use the term “meat” or similar words, such as “beef”, to describe the product.
The USDA, state regulators or similar foreign regulatory authorities, such as Health Canada or the Canadian Food Inspection Agency, or CFIA, or authorities of the EU or the EU member states ( e.g., European Food Safety Authority, or EFSA), could take action that impacts our customers’ ability to use the term “meat” or “poultry” or similar words, such as “beef” or “chicken” , to describe their finished products.
The terms of the IIA’s grants limit our ability to transfer know-how developed under an approved research and development program, and/or the manufacturing of products developed under an approved research and development program, outside of Israel, regardless of whether the royalties are fully paid.
The terms of the IIA’s grants limit our ability to transfer know-how developed under an approved research and development program (by way of sale and/or granting a license to use the IP), and/or the manufacturing of products developed under an approved research and development program, outside of Israel, regardless of whether the royalties are fully paid.
One of the elements of our business strategy is to license our technology to other companies.
One of the elements of our business strategy is to collaborate with partners and to license our technology to other companies.
We cannot assure that we will be able to maintain a competitive position or compete successfully against such sources of competition. Potential product liability claims could adversely affect our future earnings and financial condition. We face an inherent business risk of exposure to product liability claims in the event that the use of our products results in adverse effects.
We cannot assure that we will be able to maintain a competitive position or compete successfully against such sources of competition. Potential product liability claims could adversely affect our future earnings and financial condition.
Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment. The Israeli government is currently pursuing extensive changes to Israel’s judicial system.
Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our product candidates could be delayed. 30 In addition, we are subject to laws, rules and regulations in the Israeli, United States, the EU and other jurisdictions relating to the collection, use and security of personal information and data.
Other Risks Since we received grants from the IIA, we are subject to on-going restrictions. We have received royalty-bearing grants from the IIA, for research and development programs that meet specified criteria.
We have received royalty-bearing grants from the IIA, for research and development programs that meet specified criteria.
We may need to seek a license for one or more of these patents. No assurances can be given that such a license will be available on commercially reasonable terms, if at all. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.
We may need to seek a license for one or more of these patents. No assurances can be given that such a license will be available on commercially reasonable terms, if at all.
Violations of the FCPA may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business, operating results, and financial condition. In addition, the U.S. government may seek to hold our Company liable for successor liability FCPA violations committed by companies in which we invest or that we acquire.
Violations of the FCPA may result in severe criminal or civil sanctions, and we may be subject to other liabilities, which could negatively affect our business, operating results, and financial condition.
Since we have signed the EIB Finance Agreement, we agreed to guaranty the loan as well as agreed to limitations that require us to notify the European Investment Bank, or EIB, and in some cases obtain their approval, before we engage with other banks for additional sources of funding or with potential partners for certain strategic activities.
To the extent ESG matters negatively impact our reputation, it may also impede our ability to compete as effectively to attract and retain employees or customers, which may adversely impact our operations. 32 Since we have signed the EIB Finance Agreement, we agreed to guaranty the loan as well as agreed to limitations that require us to notify the EIB, and in some cases obtain their approval, before we engage with other banks for additional sources of funding or with potential partners for certain strategic activities.
Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation. This trend may adversely affect our ability to enter into license agreements or agreements for the development and commercialization of our product candidates, and as a result may materially harm our business.
This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates. Also, if a consolidating company is already doing business with our competitors, we may lose existing licensees or collaborators as a result of such consolidation.
Foreign Corrupt Practices Act, or FCPA, and similar worldwide anti-bribery laws, which generally prohibit companies and their intermediaries from making improper payments to officials or other third parties for the purpose of obtaining or retaining business.
Foreign Corrupt Practices Act, or FCPA, and similar worldwide anti-bribery laws, which generally prohibit companies and their intermediaries from making payments to foreign government officials for the purpose of obtaining or retaining business, and require companies both to keep accurate books and records and to devise and maintain an adequate system of internal accounting controls.
Furthermore, certain of our employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time.
In addition, to the extent the IIA no longer makes grants similar to those we have received in the past, it could adversely affect our financial results. Furthermore, certain of our employees may be obligated to perform annual reserve duty in the Israel Defense Forces and are subject to being called up for active military duty at any time.
Our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products.
As a result, the issuance, scope, validity, enforceability and commercial value of our and any future licensors’ patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued which protect our technology or products or which effectively prevent others from commercializing competitive technologies and products.
The GDPR regulations impose additional responsibility and liability in relation to personal data that we process, and we intend to put in place additional mechanisms ensuring compliance with these and/or new data protection rules.
The GDPR regulations impose additional responsibility and liability in relation to personal data that we process, and we intend to put in place additional mechanisms ensuring compliance with these and/or new data protection rules. Changes to these European privacy regulations and unsuccessful compliance may be onerous and adversely affect our business, financial condition, prospects, results of operations and reputation.
Changes to these European privacy regulations and unsuccessful compliance may be onerous and adversely affect our business, financial condition, prospects, results of operations and reputation. 33 We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business.
We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business.
If we do not keep pace with our competitors and with technological and market changes, our technology and products may become obsolete, and our business may suffer. The cellular therapeutics industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid and intense.
The cellular therapeutics industry, of which we are a part, is very competitive and is subject to technological changes that can be rapid and intense.
It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile. 22 Favorable results from compassionate use treatment or initial interim results from a clinical trial do not ensure that later clinical trials will be successful and success in early-stage clinical trials does not ensure success in later-stage clinical trials.
Favorable results from compassionate use treatment or initial interim results from a clinical trial do not ensure that later clinical trials will be successful and success in early-stage clinical trials does not ensure success in later-stage clinical trials.
While our policies mandate compliance with anti-bribery laws, our internal control policies and procedures may not protect us from reckless or criminal acts committed by our employees, contractors or agents. Violations of these laws, or allegations of such violations, could disrupt our business and adversely impact our results of operations, cash flows and financial condition.
While our policies mandate compliance with anti-bribery laws, including the FCPA, our internal control policies and procedures may not protect us from reckless or criminal acts committed by our employees, contractors or agents.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 25 Even if resolved in our favor, litigation or other legal proceedings relating to IP claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities.
Some of our competitors are able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.
Some of our competitors are able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize a product candidate.
Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize a product candidate. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.
All Israeli male citizens who have served in the army are required to perform reserve duty until they are between 40 and 49 years old, depending upon the nature of their military service.
Many Israeli citizens who have served in the army are required to perform reserve duty until they reach the age of 40 or older, depending upon the nature of their military service. Currently, none of our employees have been called up for active military duty.
We may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms. Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.
Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our and any future licensors’ patent rights are highly uncertain.
The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation.
Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors.
Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors. On October 7, 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets.
This consolidation trend may result in the remaining companies having greater financial resources and technical discovery capabilities, thus intensifying competition in these industries. This trend may also result in fewer potential collaborators or licensees for our therapeutic product candidates.
Risk Related to Our Industries The trend towards consolidation in the pharmaceutical and biotechnology industries may adversely affect us. There is a trend towards consolidation in the pharmaceutical and biotechnology industries. This consolidation trend may result in the remaining companies having greater financial resources and technical discovery capabilities, thus intensifying competition in these industries.
There can be no guarantee that we will successfully implement the use of our serum-free formulation to support the manufacturing of cell therapy products or any other future product candidates, if any, that we seek to produce using such formulation, or that such implementation of the serum-free formulation will decrease our dependency on third party suppliers for raw materials. 32 A cybersecurity incident, other technology disruptions or failure to comply with laws and regulations relating to privacy and the protection of data relating to individuals could negatively impact our business and our reputation.
There can be no guarantee that we will successfully implement the use of our serum-free formulation to support the manufacturing of cell therapy products or any other future product candidates, if any, that we seek to produce using such formulation, or that such implementation of the serum-free formulation will decrease our dependency on third party suppliers for raw materials. 29 With respect to CAR/TCR-MAIT products for immune-oncology, we are dependent upon third party suppliers for the construct of Chimeric Antigen Receptor, or CAR, or TCR, needed to manufacture the final product; if these third parties fail or are unable to perform in a timely manner, our ability to manufacture and deliver the final product will be compromised.
In the U.S., the USDA will develop new labeling requirements for foods under its jurisdiction produced through cell culture technology as noted in an ANPR published in September 2021. 25 Risk Related to Commercialization of Our Product Candidates We may not successfully establish new collaborations, joint ventures or licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates.
Part 1, Subpart L) as applicable. 23 Risk Related to Commercialization of Our Product Candidates We may not successfully establish new collaborations, joint ventures or licensing arrangements, which could adversely affect our ability to develop and commercialize our product candidates.
If we do not regain compliance with the MBPR by the end of the Compliance Period (or the Compliance Period as may be extended), our common shares will be subject to delisting.
If we fail to evidence compliance by the required deadline, we may be subject to delisting. At that time, we may appeal Staff’s determination to a Hearings Panel. If we do not regain compliance with the Stockholders’ Equity Requirement, our common shares will be subject to delisting.
Rather, we believe the regulatory obligation falls on our customers — cultured meat producers — to ensure that all food produced using our technology is wholesome and not adulterated. Consistent with food industry norms, we expect that our customers will therefore request assurances from us that our products are suitable for their intended use from an FDA regulatory perspective.
Consistent with food industry norms, we expect that our customers will therefore request assurances from us that our products are suitable for their intended use under applicable U.S. legal requirements.
Through our experience with adherent stromal cell-based product development, we have developed expertise and know-how in this field. To protect these expertise and know-how, our policies require confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors.
Additionally, we have built the ability to grow on a large scale plant cells for various agtech uses. To protect these expertise and know-how, our policies require confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors.
We intend to monitor the closing bid price of our common shares and may, if appropriate, consider implementing available options to regain compliance with the MBPR under the Nasdaq Listing Rules, including initiating a reverse stock split. Future sales of our common shares may cause dilution.
We intend to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance we will ultimately regain compliance with all applicable requirements for continued listing. Future sales of our common shares may cause dilution.
Removed
For the reasons discussed below, we ourselves do not expect to be directly regulated by the FDA for United States compliance purposes but will apply the FDA’s food contact substance standards or analogous foreign regulations.
Added
As applicable, the manufacturing equipment that will be manufactured by Ever After Foods will comply with the FDA’s regulatory requirements for food contact substances and analogous foreign regulations. Ever After Foods will also ensure that the edible scaffolds and any other production materials it sells to its customers comply with applicable FDA standards.
Removed
We likewise expect these products to be regulated by equivalent agencies outside the United States by various international regulatory bodies.
Added
We likewise expect these products to be regulated by equivalent agencies outside the United States by various international regulatory bodies. 21 While, as noted above, Ever After Foods will ensure that the products it sells to its customers (including manufacturing equipment and scaffolds) comply with applicable FDA and USDA standards, we believe that our customers, as entities engaged in the manufacture, distribution, and sale of cultivated meat products, will bear primary legal responsibility for ensuring that all finished foods produced using our technology is wholesome and not adulterated and otherwise in compliance with applicable laws and regulations.
Removed
As the manufacturer of technology used to produce cultured meat, and consistent with the Federal Food, Drug and Cosmetic Act, Federal Meat Inspection Act, and Poultry Products Inspection Act, we believe we will not be directly regulated by the FDA or USDA.
Added
Violations of these laws, or allegations of such violations, could result in government investigations, the assessment of fines and penalties, reputational damage, disruption to our business, and adverse impacts on our results of operations, cash flows and financial condition.
Removed
To date, we have a strategic partnership with Tnuva to use our technology to establish a cultivated food platform, with CHA for both the IC and CLI indications in South Korea and with Chart for the thawing device.
Added
In the U.S., the USDA intends to issue new labeling requirements for foods under its jurisdiction produced through cell culture technology as noted in an ANPR published in September 2021.
Removed
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 27 The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.
Added
Our various new lines of business, including our cell-based coffee business vertical, PluriAgtech, and Ever After Foods, are new businesses with limited operating activity to date, and their success is dependent on the ability to deliver a high-quality product while overcoming multiple challenges.
Removed
On April 19, 2023, we received a letter, or Notice, from Nasdaq, advising us that for 30 consecutive trading days preceding the date of the Notice, the bid price of our common shares had closed below the $1.00 per share minimum required for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5450(a)(1), or MBPR.
Added
The success of our various new lines of business is difficult to predict due to our lack of operational history in these industries, and we will be dependent on our ability to meet a number of challenges.
Removed
The Notice had no effect on the listing of our common shares , and our common shares continue to trade on Nasdaq under the symbol “PLUR”.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeFor fiscal year 2023, we recognized expense in the amount of $1,052,000, according to the implementation of Accounting Standards Update No. 2016-02, “Leases.” We believe that the current space we have is adequate to meet our current and foreseeable future needs. ITEM 3. LEGAL PROCEEDINGS. None.
Biggest changeFor fiscal year 2024, we recognized expense in the amount of $1,024,000, according to the implementation of Accounting Standards Update No. 2016-02, “Leases.” We believe that the current space we have is adequate to meet our current and foreseeable future needs. ITEM 3. LEGAL PROCEEDINGS. None. ITEM 4. MINE SAFETY DISCLOSURES. Not applicable. 35 PART II
ITEM 2. PROPERTIES. Our principal executive, manufacturing and research and development offices are located at MATAM Advanced Technology Park, Building No. 5, Haifa, Israel, where we occupy approximately 4,389 square meters. Our gross monthly rent payment for these leased facilities as of June 30, 2023 was 292,000 NIS (approximately $83,000).
ITEM 2. PROPERTIES. Our principal executive, manufacturing and research and development offices are located at MATAM Advanced Technology Park, Building No. 5, Haifa, Israel, where we occupy approximately 4,389 square meters. Our gross monthly rent payment for these leased facilities as of June 30, 2024 was 292,000 NIS (approximately $78,000).

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeEquiniti Trust Company, LLC is the registrar and transfer agent for our common shares. Their address is 6201 15th Avenue, 2nd Floor, Brooklyn, NY 11219, telephone: (718) 921-8300, (800) 937-5449. ITEM 6. [RESERVED]
Biggest changeWe claimed exemption from registration under the Securities Act of 1933, as amended, or the Securities Act, for the foregoing transactions under Section 4(a)(2) of the Securities Act. Equiniti Trust Company, LLC is the registrar and transfer agent for our common shares. Their address is 55 Challenger Road, Floor 2, Ridgefield Park, NJ 07660. Telephone: (718) 921-8124, (800) 937-5449.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our common shares are traded on Nasdaq and the Tel Aviv Stock Exchange under the symbol “PLUR”. As of September 8, 2023, there were 52 holders of record, and 41,351,870 of our common shares were issued and outstanding.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our common shares are traded on Nasdaq Capital Market and the Tel Aviv Stock Exchange under the symbol “PLUR”. As of September 13, 2024, there were 57 holders of record, and 5,470,163 of our common shares were issued and outstanding.
Added
During the fiscal year 2024, we issued an aggregate of 25,395 restricted common shares to certain of our service providers as compensation in lieu of cash compensation owed to them for services rendered.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThe decrease is mainly attributed to a decrease in share-based compensation expenses related to market based vesting conditioned restricted stock units, or RSUs, granted to our CEO and Chairman, a decrease in share-based compensation expenses related to the allocation of shares of Ever After Foods to our CEO, Chief Financial Officer, or CFO, and Chairman of our Board pursuant to their employment or consulting agreements, employee terminations and RSU expense amortization over time (see also notes 1e and 9c to the consolidated financial statements included elsewhere in this Annual Report).
Biggest changeThe decrease is mainly attributed to: (1) a decrease in share-based compensation expenses related to employee terminations and RSU expense amortization over time (see also notes 9c to the consolidated financial statements included elsewhere in this Annual Report) and a decrease due to the amount of RSUs and options granted to our CEO in 2023, partially offset by an increase in share-based compensation expenses related to the amount of RSUs and options granted in 2024, and (2) a decrease in salaries and related expenses due to the exchange rate differences relates to the strength of the U.S. dollar against the NIS and as a result of our cost reduction and efficiency plan, including a temporary reduction in the salaries of our executive officers.
We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Share-Based Compensation Share-based compensation is considered a critical accounting policy due to the significant expenses of RSUs which were granted to our employees, directors and consultants.
We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. 42 Share-Based Compensation Share-based compensation is considered a critical accounting policy due to the significant expenses of RSUs which were granted to our employees, directors and consultants.
All RSUs granted in fiscal years 2023 and 2022 were granted for no consideration; therefore, their fair value was equal 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 of grant was calculated using the Monte Carlo model.
All RSUs granted in fiscal years 2024 and 2023 were granted for no consideration; therefore, their fair value was equal 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 of grant was calculated using the Monte Carlo model.
During October 2021, we received an approval for an additional grant of approximately $583,000 from the IIA pursuant to the CRISPR-IL consortium program, for an additional period of eighteen months. During January 2023, we received approval for an extension of an additional 2 months to finish the program until June 30, 2023.
During October 2021, we received an approval for an additional grant of approximately $583 thousand from the IIA pursuant to the CRISPR-IL consortium program, for an additional period of eighteen months. During January 2023, we received approval for an extension of an additional 2 months to finish the program until June 30, 2023.
These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharmaceutical, agriculture, and aquaculture industries. CRISPR-IL is funded by the IIA with a total budget of approximately $10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for the initial period of 18 months.
These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharmaceutical, agriculture, and aquaculture industries. CRISPR-IL is funded by the IIA with a total budget of approximately $10 million of which, an amount of approximately $480 thousand was a direct grant allocated to us, for the initial period of 18 months.
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 CLI Chronic Graft versus Host Disease and a potential treatment for H-ARS. Some of these studies have been completed while others are still ongoing.
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, CLI, Chronic GvHD and a potential treatment for H-ARS. Some of these studies have been completed while others are still ongoing.
Through June 30, 2023, we received a payment of approximately $185,000 in cash, which relates to the PROTO program.
Through June 30, 2024, we received a payment of approximately $185,000 in cash, which relates to the PROTO program.
The CRISPR-IL consortium program does not include any obligation to pay royalties. Through June 30, 2023, we received total grants of approximately $774,000 in cash from the IIA pursuant to the CRISPR-IL consortium program, and we expect to receive an additional $253,000.
The CRISPR-IL consortium program does not include any obligation to pay royalties. Through June 30, 2024, we received total grants of approximately $774 thousand in cash from the IIA pursuant to the CRISPR-IL consortium program, and we expect to receive an additional $253 thousand.
During the years ended June 30, 2022, and 2023, we did not sell of our any common shares under the ATM Agreement. On September 7, 2023, we provided a formal notice of termination of the ATM Agreement with Jefferies, which took effect on September 8, 2023.
During the year ended June 30, 2023, we did not sell of our any common shares under the ATM Agreement. On September 7, 2023, we provided a formal notice of termination of the ATM Agreement with Jefferies, which took effect on September 8, 2023.
As such, the Warrants became exercisable 6 months from the date of their issuance. On December 14, 2022, 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 for equity grants, issuable under our existing equity compensation plans. In that regard, we granted Mr.
As such, the Warrants became exercisable on May 1, 2023. On December 14, 2022, 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 for equity grants, issuable under our existing equity compensation plans. In that regard, we granted Mr.
In fiscal year 2023, we recorded share-based compensation expenses related to options, restricted shares and RSUs in the amount of $3,977,000. In accordance with ASC 718, “Compensation-Stock Compensation”, or ASC 718, RSUs granted to employees and directors are measured at their fair value on the grant date.
In fiscal year 2024, we recorded share-based compensation expenses related to options, restricted shares and RSUs in the amount of $2,618,000. In accordance with ASC 718, “Compensation-Stock Compensation”, or ASC 718, RSUs granted to employees and directors are measured at their fair value on the grant date.
On April 27, 2023, our shareholders approved an amendment to our articles of incorporation to increase the number of authorized common shares from 60,000,000 shares to 300,000,000 shares and such increase was effectuated on May 1, 2023, when the Company filed its amendment to its articles of incorporation reflecting such increase.
On April 27, 2023, our shareholders approved an amendment to our articles of incorporation to increase the number of authorized 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 to its articles of incorporation reflecting such increase.
We believe that each of these indications is a severe unmet medical need. In July 2023, we announced that we signed a three year $4.2 million contract with the NIAID, which is part of the NIH. Pluri will collaborate with the U.S.
We believe that each of these indications is a severe unmet medical need. In July 2023, we announced that we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH.
Through June 30, 2023, total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties paid and accrued amounted to $179,000. 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.
Through June 30, 2024, total grants obtained from the IIA aggregated to approximately $27.7 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.
The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIA study for the treatment of mild to moderate knee osteoarthritis. Final approval of the grant is subject to completion of the consortium agreement. An amount of approximately Euro 500,000 (approximately $545,000) will be a direct grant that will be allocated to us.
The goal of the PROTO project is to utilize our PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis. Final approval of the grant is subject to completion of the consortium agreement. An amount of approximately Euro 500 thousand (approximately $520,000) will be a direct grant that will be allocated to us.
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. Our PLX cells are adherent stromal cells that are expanded using our 3D platform.
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, hematologic conditions and, most 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.
Cash provided by investing activities in the year ended June 30, 2023 consisted primarily of the withdrawal of $9,960,000 of short-term deposits, partially offset by payments of $262,000 related to investments in property and equipment.
Cash provided by investing activities in the year ended June 30, 2023 consisted primarily of the withdrawal of $9,960,000 of short-term deposits, partially offset by payments of $262,000 related to investments in property and equipment. Financing activities provided cash in the amount of $8,841,000 during the year ended June 30, 2024, and $8,024,000 during the year ended June 30, 2023.
We are utilizing our technology in the field of regenerative medicine and food tech and plan to utilize it in other industries and verticals that have a need for our mass scale and cost-effective cell expansion platform.
We are utilizing our technology in the field of regenerative medicine, food tech, CDMO, 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 via partnerships, joint ventures, licensing agreements and other types of collaborations.
Between December 13, 2022, and December 27, 2022, we entered into a series of securities purchase agreements with several purchasers for an aggregate of 8,155,900 common shares and warrants, or the Warrants, to purchase up to 8,155,900 common shares.
Between December 13, 2022 and December 27, 2022, the Company entered into a series of securities purchase agreements with several purchasers for 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 Private Placement.
Yanay (i) 334,821 RSUs, vesting ratably each month, and (ii) options to purchase 334,821 common shares, vesting ratably each month, with a term of three years, at an exercise price of $1.12 per share. In addition, the Board also agreed to grant Mr.
Yanay (i) 41,853 RSUs, vesting ratably each month, and (ii) options to purchase 41,853 common shares, vesting ratably each month, with a term of 3 years, at an exercise price of $8.96 per share. In addition, the Boards also agreed to grant Mr.
Liquidity and Capital Resources As of June 30, 2023, our total current assets were $41,409,000 and our total current liabilities were $5,621,000. On June 30, 2023, we had a working capital surplus of $35,788,000 and an accumulated deficit of $399,584,000. As of June 30, 2022, our total current assets were $57,747,000 and our total current liabilities were $6,829,000.
On June 30, 2024, we had a working capital surplus of $26,653,000 and an accumulated deficit of $420,472,000. As of June 30, 2023, our total current assets were $41,409,000 and our total current liabilities were $5,621,000. On June 30, 2023, we had a working capital surplus of $35,788,000 and an accumulated deficit of $399,584,000.
On December 15, 2022, we executed securities purchase agreements to sell, at a purchase price of $1.06 per share, up to 237,500 common shares and Warrants to purchase up to 237,500 common shares, with an exercise price of $1.06 per share and a term of three years.
On December 15, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.48 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 a term of three years.
On December 19, 2022, we executed a securities purchase agreement to sell, at a purchase price of $1.09 per share, up to 135,000 common shares and Warrants to purchase up to 135,000 common shares, with an exercise price of $1.09 per share and a term of three years.
On December 19, 2022, the Company executed a securities purchase agreement to sell at a purchase price of $8.72 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 a term of three years.
On December 27, 2022, we executed a securities purchase agreement to sell, at a purchase price of $1.12 per share, up to 135,000 common shares and Warrants to purchase up to 135,000 common shares, with an exercise price of $1.12 per share and a term of three years.
On December 27, 2022, the Company executed a securities purchase agreement to sell at a purchase price of $8.96 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 a term of three years.
The proceeds from the EIB Finance Agreement were intended to support our research and development in the EU to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market. The term of the project was three years commencing on January 1, 2020.
The proceeds from the EIB Finance Agreement were intended to support our research and development in the EU to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market.
Cash used in operating activities in year ended June 30, 2023 and June 30, 2022 consisted primarily of payments of fees to our suppliers, subcontractors, professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA, the EU’s Horizon 2020, Horizon Europe and 2022 programs, Israel’s Ministry of Economy and other research grants.
Cash used in operating activities in year ended June 30, 2024 and June 30, 2023 consisted primarily of payments of fees to our suppliers, subcontractors, professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA, the Horizon Europe program, and funds received from the NIAID contract.
General and Administrative General and administrative expenses decreased by 32% from $17,450,000 for the year ended June 30, 2022, to $11,779,000 for the year ended June 30, 2023.
General and Administrative General and 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 30, 2024.
On December 14, 2022, we executed securities purchase agreements to sell, at a purchase price of $1.05 per share, up to 2,068,517 common shares and Warrants to purchase up to 2,068,517 common shares, with an exercise price of $1.05 per share and a term of three years.
On December 14, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.4 per 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 a term of three years.
On December 13, 2022, we executed securities purchase agreements to sell, at a purchase price of $1.03 per share, up to 5,579,883 common shares and Warrants to purchase up to 5,579,833 common shares, with an exercise price of $1.03 per share and a term of three years.
On December 13, 2022, the Company executed securities purchase agreements to sell at a purchase price of $8.24 per 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 a term of three years.
Research and Development, Net Research and development, net (costs less participation and grants by the IIA, Horizon 2020, Horizon Europe and other parties) decreased by 35% from $24,377,000 for the year ended June 30, 2022, to $15,745,000 for the year ended June 30, 2023.
Research and Development, Net Research and development, 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, 2023, to $12,446,000 for the year ended June 30, 2024.
EU grants – Horizon 2020 and Horizon Europe Through June 30, 2023, we received total grants of approximately $8,621,000 in cash from the EU R&D consortiums pursuant to the Horizon programs.
EU grants – Horizon 2020 and Horizon Europe Through June 30, 2024, we received total grants of approximately $8.4 million in cash from the EU Horizon programs.
Yanay options to purchase 1,500,000 common shares, with a term of three years, with the following terms: (i) options to purchase 500,000 common shares at an exercise price of $1.56 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, (ii) options to purchase 500,000 common shares at an exercise price of $2.08 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, and (iii) options to purchase 500,000 common shares at an exercise price of $2.60 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023.
Yanay options to purchase 187,500 common shares, with a term of 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 on June 30, 2023 and 50% vested on December 31, 2023, (ii) options to purchase 62,500 common shares at an exercise price of $16.64 per share, 50% vested on June 30, 2023 and 50% vested on December 31, 2023, and (iii) options to purchase 62,500 common shares at an exercise price of $20.8 per share, 50% vested on June 30, 2023 and 50% vested on December 31, 2023.
The financing activities during the year ended June 30, 2023 related to issuances of common shares and warrants, net of issuance costs, in the December 2022 Private Placement. The financing activities during year ended June 30, 2022 were related to proceeds of $7,500,000 we received from Tnuva as an investment in Ever After Foods.
The financing activities during the year ended June 30, 2024 related primarily to the investment in Ever After Foods by external investors. The financing activities during the year ended June 30, 2023 related to issuances of common shares and warrants, net of issuance costs, in the December 2022 Private Placement (as defined below).
The change in the loss per share 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 issuance of additional shares during fiscal year 2023.
The change in the loss per share 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 issuance of additional shares during fiscal year 2024. 38 Liquidity and Capital Resources As of June 30, 2024, our total current assets were $31,107,000 and our total current liabilities were $4,454,000.
Cash provided by investing activities in the year ended June 30, 2022, consisted primarily of a withdrawal of $12,063,000 of short-term deposits partially offset by payments of $280,000 related to investments in property and equipment. Financing activities provided cash in the amount of $8,024,000 during the year ended June 30, 2023, and $7,500,000 during the year ended June 30, 2022.
Cash provided by investing activities in the year ended June 30, 2024 consisted primarily of the withdrawal of $10,907,000 of short-term deposits, partially offset by payments of $323,000 related to investments in property and equipment.
This decrease is mainly attributable to (1) expenses relating to exchange rate differences related to the EIB loan provided to us in June 2021 pursuant to EIB Finance Agreement (as a result of the strength of the Euro against the U.S. dollar, which increased by 5% in 2023 compared to 2022 where it decreased by 7%), and (2) a decrease due to exchange rate expenses on a lease liability due to the strength of the U.S Dollar against the NIS which resulted in an expense of $690,000.
This increase is mainly attributable to (1) income relating to exchange rate differences 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. dollar against the Euro, which increased by 3% in 2024 compared to 2023 where it decreased by 5%), (2) an increase related to interest income from bank deposits, and (3) an increase in gain from hedging transactions compared to a loss from hedging transactions in the previous period.
Cash provided by investing activities was $9,698,000 during the year ended June 30, 2023, as opposed to cash provided for investing activities of $11,783,000 during the year ended June 30, 2022.
Cash provided by investing 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 ended June 30, 2023.
The decrease in cash used in operating activities is mainly attributed to a decrease in net loss following the completion of certain clinical trials and the implementation of our cost reduction and efficiency plan that we initiated to align with the change in our business strategy.
The decrease in cash used in operating activities is mainly attributed to a decrease in net loss following the completion of certain clinical trials and the implementation of a cost reduction and efficiency plan including a temporary reduction in the salaries of our executive officers, directors, management team and other employees.
The Phase I/II study will be carried out by Charité, together with us and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery.
The clinical study, once approved by the regulatory agencies, will be carried out by Charité, together with us and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. 41 Outlook We have accumulated a deficit of $420,472,000 since our inception in May 2001.
We do not expect to generate any significant revenues from sales of products in the next twelve months. We expect to generate revenues, from the sale of licenses to use our technology or products, but in the short and medium terms will unlikely exceed our costs of operations.
We do not expect to generate any significant revenues from sales of products in the next twelve months. We expect to generate revenues from the sale of services in our CDMO activity, from collaboration based on our cell-based products, and from licenses to use our technology and products.
The Warrants sold in the December 2022 Private Placement will be exercisable within six months from their issuance date. As of June 30, 2023, the Company issued 8,155,900 common shares and Warrants that relate to the December 2022 Private Placement and received $8,024,000 as of that date net of $445 from issuance expenses.
The Company issued 1,019,488 common shares and Warrants that relate to the December 2022 Private Placement and received $8 million as of that date net of $445,000 from issuance expenses. 39 The Warrants sold in the December 2022 Private Placement were exercisable upon the later of six months from their issuance date, or from the date we increased our authorized shares.
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.
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. As of June 30, 2024, the interest accrued was in the amount of approximately €2.5 million.
Our cash equivalents and restricted cash decreased in the year ended June 30, 2023, for the reasons presented below. 36 Our cash used in operating activities was $22,857,000 during the year ended June 30, 2023, and $36,501,000 during the year ended June 30, 2022.
Our cash used in operating activities was $18,021,000 during the year ended June 30, 2024, and $22,857,000 during the year ended June 30, 2023.
The value of the portion 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. We have graded vesting based on the accelerated method over the requisite service period of each of the awards. The expected pre-vesting forfeiture rate affects the number of the shares.
We have graded vesting based on the accelerated method over the requisite service period of each of the awards. The expected pre-vesting forfeiture rate affects the number of the shares.
The RSUs granted in fiscal year 2023 to non-employee consultants were measured at their fair value on the grant date in accordance with ASU No. 2018-07 - “Compensation—Share Compensation”.
The RSUs granted in fiscal year 2024 to non-employee consultants were measured at their fair value on the grant date in accordance with ASU No. 2018-07 - “Compensation—Share Compensation”. The value of the portion 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.
The decrease was mainly due to a decrease in R&D expenses, net, and a decrease in general and administrative expenses for the reasons mentioned above. We had a net loss attributed to our non-controlling interest in Ever After Foods for the year ended June 30, 2023 of $566,000.
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, 2023 of $456,000 and $566,000, respectively. Loss per share for the year ended June 30, 2024, was $3.99, as compared to $6.24 loss per share for the year ended June 30, 2023.
Department of Defense’s Armed Forces Radiobiology Research Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation exposure.
Under such contract, we will collaborate with 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 disease that can result from nuclear disasters and radiation exposure.
We may be required to obtain additional liquidity resources in order to support the commercialization of our products and technology and maintain our research and development activities.
Although we were able to reduce the burn rate significantly in the last few years, it is unlikely that in the short term revenues will exceed our costs of operations. We may be required to obtain additional liquidity resources in order to support the commercialization of our products and technology and maintain our research and development activities.
The decrease is mainly attributed to: (1) a decrease in clinical studies expenses following the completion of our CLI and ARDS associated with COVID-19 studies and the end of enrollment of our muscle regeneration following hip fracture study in November 2021, (2) a decrease in material purchases in accordance with our manufacturing needs and plans, (3) a decrease in salaries and related expenses as part of our efficiency cost-reduction plan , specifically a reduction of 22 research and development, or R&D, employees in Pluri Biotech Ltd.
The decrease is mainly attributed to: (1) a decrease in clinical studies expenses following the completion of our CLI, COVID-19 and muscle regeneration following hip fracture clinical studies, (2) a decrease in material purchases in accordance with our manufacturing needs and plans, (3) a decrease in salaries and related expenses as part of a efficiency cost-reduction plan, specifically a reduction of 16 research and development, or R&D, employees in the Subsidiary (92 employees on 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. dollar against the NIS, and (4) participation grants from the NIAID contract, offset by a decrease in other participation grants, specifically the completion of the CLI and muscle regeneration following hip fracture clinical studies which were supported by the EU Horizon 2020 grants.
The decrease in financial income (expense) was partially offset by an increase related to interest income from bank deposits. Net Loss for the Year Net loss decreased from $41,374,000 for the year ended June 30, 2022 to $28,887,000 for the year ended June 30, 2023.
Net Loss for the Year Net loss decreased from $28,887,000 for the year ended June 30, 2023 to $21,344,000 for the year ended June 30, 2024. The decrease was mainly due to a decrease in R&D expenses, net, a decrease in general and administrative expenses and an increase in financial income (expense), net for the reasons mentioned above.
These decreases were partially offset by an increase in share-based compensation expenses related to the amount of RSUs and options granted to our CEO. Total Financial Income (Expense), Net Total financial income (expenses), net decreased from $219,000 in financial income for the year ended 2022 to $1,641,000 in financial expenses for the year ended June 30, 2023.
Total Financial Income (Expense), Net Total financial income (expenses), net increased from $1,641,000 in financial expenses for the year ended 2023 to $814,000 in financial income for the year ended June 30, 2024.
Revenues Revenues for the year ended June 30, 2023 were $287,000, compared to $234,000 for the year ended June 30, 2022.
Following the closing of the Offering, the Subsidiary holds approximately 69% of Ever After Foods. 37 RESULTS OF OPERATIONS – YEAR ENDED JUNE 30, 2024 COMPARED TO YEAR ENDED JUNE 30, 2023 Revenues Revenues for the year ended June 30, 2024 were $326,000, compared to $287,000 for the year ended June 30, 2023.
The revenues in the year ended June 30, 2023 were mainly related to our API Collaboration and the revenues in the year ended June 30, 2022 were related to the revenue derived from our license agreement with Takeda and the sale of our PLX cells for research use.
The revenues in the year ended June 30, 2024 were mainly related to fees derived from services provided to CDMO clients and to a POC collaboration with ICL Group in the agtech field. The revenues in the year ended June 30, 2023 were mainly related to our collaboration in the biologic field.
On June 30, 2022, we had a working capital surplus of $50,918,000 and an accumulated deficit of $371,263,000. Our cash, cash equivalents and restricted cash as of June 30, 2023, amounted to $5,629,000, which reflects a decrease of $5,150,000 from the $10,779,000 reported as of June 30, 2022.
Our cash, cash equivalents and restricted cash as of June 30, 2024, amounted to $7,037,000, which reflects an increase of $1,408,000 from the $5,629,000 reported as of June 30, 2023. Our cash equivalents and restricted cash increased in the year ended June 30, 2024, for the reasons presented below.
All options were granted in January 2023 and will expire three years from the later of the vesting date.
All options that were granted in January 2023 will expire on April 27, 2026.
Our bank deposits as of June 30, 2023, amounted to $34,811,000 compared to $45,244,000 as of June 30, 2022.
Our bank deposits and restricted bank deposits as of June 30, 2024, amounted to $23,836,000 compared to $35,438,000 as of June 30, 2023. Our bank deposits and restricted bank deposits as of June 30, 2024, decreased in the year ended June 30, 2024, for the reasons presented below.
Removed
Our operations are focused on the research, development and manufacturing of cells and cell-based products, conducting clinical studies and the business development of cell therapeutics and cell-based technologies, such as our collaboration with Tnuva to use our technology to establish a cultivated food platform, as well as the collaboration agreement we signed in 2022 with a leading European manufacturer of APIs to use our expansion technology, which aims to revolutionize the production of biologics by enabling a cost-effective, sustainable and cruelty-free ingredient.
Added
Our operations are focused on the research, development and manufacturing of cell-based products and the business development of cell therapeutics and cell-based technologies providing potential solutions for various industries.
Removed
In the food tech field, we established a new venture with Tnuva, Ever After Foods . Ever After Foods is developing cultivated meat products based on Pluri’s platform 3D cell expansion technology. 35 RESULTS OF OPERATIONS – YEAR ENDED JUNE 30, 2023 COMPARED TO YEAR ENDED JUNE 30, 2022.
Added
MAIT cells: In May 2024, we launched a novel immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors – a critical area in medicine where effective treatments are currently insufficient.
Removed
(108 on June 30, 2023, compared to 130 on June 30, 2022), (4) a decrease in share-based compensation expenses and (5) higher participation by the European Union with respect to the Horizon 2020 grants, which relate to our CLI and muscle regeneration following hip fracture studies.
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We believe that our MAIT cells, isolated from the human placenta , offer substantial potential benefits compared to conventional T cells. 36 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.
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Loss per share for the year ended June 30, 2023, was $0.78, as compared to $1.28 loss per share for the year ended June 30, 2022.
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Furthermore, unlike conventional autologous T-cells typically collected from peripheral blood, our MAIT cells are designed to be allogenic universal product. Benefiting with very restricted TCR, the MAIT cells minimizes their likelihood of inducing Graft versus Host Disease, or GvHD, a significant advantage over other potential allogeneic products.
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The increase in weighted average common shares outstanding reflects the issuance of additional shares pursuant to a private placement offering we conducted in December 2022, or the December 2022 Private Placement, and the issuance of additional shares upon the vesting of RSUs issued to directors, employees and consultants.
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We are designing the MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy. PluriCDMO™ In January 2024, we announced that we are launching a new business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™.
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In addition, the purchasers in the December 2022 Private Placement agreed to execute proxies permitting our CEO and CFO to vote the securities purchased in the December 2022 Private Placement in favor of any shareholder vote relating to a future increase of our authorized shares.
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PluriCDMO™ offers CDMO services to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. We have signed several agreements with clients and generating revenues from PluriCDMO™.
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Pursuant to the securities purchase agreements executed with the purchasers, we agreed to hold a meeting of shareholders within 200 days of the execution of the securities purchase agreements for the purpose of increasing our authorized shares.
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AgTech We are actively involved in several initiatives leveraged by Pluri’s 3D cell expansion in the agtech field, such as: (a) cell-based coffee business activity through PluriAgtech business vertical, which we announced in January 2024, (b) an innovative POC collaboration with ICL Group, a leading global specialty minerals company, to revolutionize bio stimulant delivery and enhance yield sustainably, and (c) a strategic POC agreement with a leading international agriculture corporation which is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture.
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Pursuant to a shelf registration on Form S-3 filed on July 20, 2023, which we intend to obtain the effectiveness of in the near term, the Company may elect, from time to time, to offer and sell shares of common stock, preferred stock, warrants and units having an aggregate offering price of up to $200,000,000. 37 In April 2020, we and our subsidiaries, Pluri Biotech Ltd. and Pluristem GmbH, executed the EIB Finance Agreement for non–dilutive funding of up to €50 million in the aggregate, payable in three tranches.
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Food Tech In 2022, we announced the establishment of a joint venture with Tnuva, Ever After Foods, which is incorporated under the laws of the State of Israel, with the purpose of developing cultivated meat product of all kinds and types.
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As of June 30, 2023, the interest accrued was in the amount of €1,665,000.
Added
Leveraging Pluri’s innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a 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.
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In August 2016, our CLI program in the EU was awarded a €7,600,000 non-royalty bearing grant. The grant was part of the EU’s Horizon 2020 program.
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On June 12, 2024, we entered into a share purchase agreement, or the Agreement, by and among Ever After Foods, Tnuva, and certain other international investors, or, collectively, the Investors, pursuant to which Ever After Foods issued and sold ordinary shares in a private placement offering, or the Offering, for aggregate gross proceeds of $10 million.
Removed
The Phase III study of PLX-PAD in CLI was a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies together with the Company and with participation of additional third parties. The grant covered a significant portion of the CLI program costs, and the program was ended during fiscal year 2023.
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As part of the Offering, we invested $1.25 million. In addition, the Subsidiary and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024, or 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.
Removed
Through June 30, 2023, we received a total of €3,235,000 relating to the CLI program in the EU (approximately $3,563,000). In September 2017, our Phase III study of PLX-PAD cell therapy in the treatment of muscle injury following surgery for hip fracture was awarded a €7,400,000 grant, as part of the EU’s Horizon 2020 program.
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The $10 million funding round was intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler.

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