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What changed in Pluri Inc.'s 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of Pluri Inc.'s 2022 and 2023 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 2023 report.

+307 added−280 removedSource: 10-K (2023-09-12) vs 10-K (2022-09-21)

Top changes in Pluri Inc.'s 2023 10-K

307 paragraphs added · 280 removed · 185 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

82 edited+44 added−39 removed52 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 China, Hong Kong 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, Israel Australia, 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, Russia, 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 United States Israel Israel: April 21, 2031 U.S: March 22, 2027 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 DEVICES AND METHODS FOR CULTURE OF CELLS PCT/IB2013/058184 United States, Israel August 31, 2033 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 China 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 United States, Israel March 21, 2036 ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND USING SAME PCT/IB2016/053310 Europe, China, Israel Europe, United States June 6, 2036 METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS PCT/IB2017/050868 United States, Japan, Canada, Israel Europe, Japan February 16, 2037 METHODS AND COMPOSITIONS FOR TREATING NEUROLOGICAL DISORDERS PCT/IB2018/052806 Israel, United States April 23, 2038 METHODS AND COMPOSITIONS FOR TUMOR ASSESSMENT PCT/IB2018/050984 United States Israel February 18, 2038 METHODS AND COMPOSITIONS FOR TREATING ADDICTIONS PCT/IB2018/055473 Israel, United States July 23, 2038 8 METHODS AND COMPOSITIONS FOR DETACHING ADHERENT CELLS Germany 10 2018 115 360.0 Germany June 25-July 3, 2038 DRUG CONTAINING HUMAN PLACENTA-ORIGIN MESENCHYMAL CELLS AND PROCESS FOR PRODUCING VEGF USING THE CELLS JP20030579842 Japan March 28, 2023 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 METHODS AND COMPOSITIONS FOR TREATING VIRAL INFECTIONS AND SEQUELAE THEREOF PCT/IL2021/050268 PCT, 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, Japan, Israel, Australia March 26, 2040 METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED THEREBY IL277560 Israel September 23, 2040 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, 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.
The regenerative medicine field is characterized by intense competition, as global and local pharma players are becoming more engaged in the cell therapy field based on the advancements made in clinical studies and due to the favorable regenerative medicine legislation in certain regions.
Competition Regenerative medicine: The regenerative medicine field is characterized by intense competition, as global and local pharma players are becoming more engaged in the cell therapy field based on the advancements made in clinical studies and due to the favorable regenerative medicine legislation in certain regions.
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. 9 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. 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.
This European Union regulation requires: ● Filing a Central Clinical Trial Application utilizing the Clinical Trials Information System (CTIS) and obtaining an assessment and approval; ● Obtaining approval of local and central ethics committees as required to test the investigational product into humans in clinical studies; ● Conducting adequate and well-controlled clinical studies to establish the safety and efficacy of the investigational product for its intended use; and ● Since our investigational cellular products are regulated under the Advanced Therapy Medicinal Product regulation, the application for marketing authorization to the EMA is mandatory within the 28 member states of the European Union.
This European Union regulation requires: ● Filing a Central Clinical Trial Application utilizing the Clinical Trials Information System, and obtaining an assessment and approval; ● Obtaining approval of local and central ethics committees as required to test the investigational product into humans in clinical studies; ● Conducting adequate and well-controlled clinical studies to establish the safety and efficacy of the investigational product for its intended use; and ● Since our investigational cellular products are regulated under the Advanced Therapy Medicinal Product regulation, the application for marketing authorization to the EMA is mandatory within the 28 member states of the European Union.
CRISPR-IL brings together the leading experts in life science and computer science from academia, medicine, and industry, to develop Artificial Intelligence, or AI, based end-to-end genome-editing solutions. These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharma, agriculture, and aquaculture industries.
CRISPR-IL brings together the leading experts in life science and computer science from academia, medicine, and industry, to develop Artificial Intelligence, or AI, based on end-to-end genome-editing solutions. These next-generation, multi-species genome editing products for human, plant, and animal DNA, have applications in the pharma, agriculture, and aquaculture industries.
Upon termination of the CHA Agreement, the license granted thereunder will terminate, and all rights included therein will revert to us, whereupon we will be free to enter into agreements with any other third parties for the granting of a license in or outside South Korea or to deal in any other manner with such rights as it shall see fit in our sole discretion. 10 Horizon 2020 The Phase III study of PLX-PAD in CLI was conducted as a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies, together with the Company and with the participation of additional third parties.
Upon termination of the CHA Agreement, the license granted thereunder will terminate, and all rights included therein will revert to us, whereupon we will be free to enter into agreements with any other third parties for the granting of a license in or outside South Korea or to deal in any other manner with such rights as it shall see fit in our sole discretion. 12 Horizon 2020 The Phase III study of PLX-PAD in CLI was conducted as a collaborative project carried out by an international consortium led by the Berlin-Brandenburg Center for Regenerative Therapies, together with the Company and with the participation of additional third parties.
The site was also inspected and approved by the MOH and we received a cGMP Certification and manufacturer-importer authorization. 12 We obtain the human placentas used for our research and manufacturing activities from various hospitals in Israel after receiving a written informed consent by the mother and pathogen clearance.
The site was also inspected and approved by the MOH and we received a cGMP Certification and manufacturer-importer authorization. We obtain the human placentas used for our research and manufacturing activities from various hospitals in Israel after receiving a written informed consent by the mother and pathogen clearance.
CHA Agreement On June 26, 2013, we entered into an exclusive out-licensing and commercialization agreement, or the CHA Agreement, with CHA for conducting clinical studies and commercialization of our PLX-PAD product candidate in South Korea in connection with two indications: the treatment of CLI and IC.
CHA Agreement On June 26, 2013, we entered into an exclusive out-licensing and commercialization agreement, or the CHA Agreement, with CHA Biotech for conducting clinical studies and commercialization of our PLX-PAD product candidate in South Korea in connection with two indications: the treatment of CLI and IC.
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.
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 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. 16
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.
Any medical waste related to the use of placentas is treated in compliance with local environmental laws and standards. We have developed a serum-free formulation to support the manufacturing of cell therapy products.
Any medical waste related to the use of placentas is treated in compliance with local environmental laws and standards. We have developed a serum-free formulation to support the manufacturing of our cell therapy products.
As such, Tel Aviv Sourasky Medical Center supports the study and is responsible for its design and implementation. 13 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.
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.
Among other things, we expect to compete based upon our intellectual property portfolio, our in-house manufacturing efficiencies and capabilities, and the efficacy of our products.
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.
The human placenta from which our PLX cells are derived provides an uncontroversial 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.
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.
In October 2017, we entered into a collaborative project, the nTRACK, carried out by an international consortium led by Leitat. The aim of this project is to examine gold nano particles labeling of stem cells to enable assessment of cells’ in vivo persistence and distribution in correlation to biological efficacy.
In October 2017, we entered into a collaborative project, the nTRACK, carried out by an international consortium led by Leitat Technological Center. The aim of this project is to examine gold nano particles labeling of stem cells to enable assessment of cells’ in vivo persistence and distribution in correlation to biological efficacy.
Patients treated with PLX-R18 showed a mean increase in all three blood cell types compared to baseline with platelets (p Peripheral and Cardiovascular Diseases . We investigated the use of PLX-PAD cells for the treatment of peripheral arterial disease, or PAD, including IC and CLI.
Patients treated with PLX-R18 showed a mean increase in all three blood cell types compared to baseline with platelets (p Peripheral and Cardiovascular Diseases . We investigated the use of PLX-PAD cells for the treatment of peripheral arterial disease, or PAD, including intermittent claudication, or IC, and CLI.
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 placental expanded, or PLX, cells are adherent stromal cells that are expanded using our 3D platform.
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.
We utilize this strategy in working with the FDA, the EMA, Germany’s PEI as well as other European national competent authorities, the MOH, Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, and also the Ministry of Food and Drug Safety, or MFDS, of South Korea.
We utilize this strategy in working with the FDA, the EMA, Germany’s PEI as well as other European national competent authorities, the Minister of Health, or MOH, Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, and also the Ministry of Food and Drug Safety, or MFDS, of South Korea.
According to the agreement, we will be the exclusive owner of the technology and any products produced as a result of the collaboration. Charité will receive between 1% to 2% royalties from net sales of new developments that have been achieved during the joint development.
According to the agreement, we will be the exclusive owner of the technology and any products produced as a result of the collaboration. Charité will receive between 1% to 2% royalties from net sales of new developments that have been achieved during the joint development. U.S.
The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages which will be determined by the consortium. The Phase I/IIa study will be carried out by Charité.
The funds from the grant are expected to be allocated between us and other members of the consortium in accordance with budget and work packages which will be determined by the consortium. The Phase I/IIa study will be carried out by Charité.
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 .
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.
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 PEI.
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.
Collaborations and Ongoing Research and Development Plans Charité Agreement In July 2007, we entered into a five-year collaborative research agreement with the Berlin-Brandenburg Center for Regenerative Therapies at Charité – University Medicine Berlin, or Charité, which was extended from time to time through June 2027. We and Charité are collaborating on a variety of indications utilizing PLX cells.
Charité Agreement In July 2007, we entered into a five-year collaborative research agreement with the Berlin-Brandenburg Center for Regenerative Therapies at Charité – University Medicine Berlin, or Charité, which was extended from time to time through June 2027. We and Charité are collaborating on a variety of indications utilizing PLX cells.
Horizon Europe On September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies.
Horizon Europe - PROTO On September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union, or EU’s, Horizon program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies.
We are the sole owner of 137 issued patents and approximately 64 pending patent applications in the United States, Europe, China, Japan and Israel, as well as in additional countries worldwide, including countries in the Far East and South America (in calculating the number of issued patents, each European patent validated in multiple jurisdictions was counted as a single patent).
We are the sole owner of 142 issued patents and approximately 55 pending patent applications in the United States, Europe, China, Japan and Israel, as well as in additional countries worldwide, including countries in the Far East and South America (in calculating the number of issued patents, each European patent validated in multiple jurisdictions was counted as a single patent).
In October 2017, we announced that the FDA granted us an orphan drug designation for our PLX-R18 cell therapy for the prevention and treatment of ARS. In April 2018, we announced that the FDA approved our IND application for PLX-R18 cell therapy in the treatment of ARS.
In October 2017, we announced that the FDA granted us an orphan drug designation for our PLX-R18 cell therapy for the prevention and treatment of ARS. In April 2018, we announced that the FDA approved our Investigational New Drug, or IND, application for PLX-R18 cell therapy in the treatment of ARS.
Our Activities in the Food Tech Sector On January 5, 2022, we signed definitive collaboration agreements with Tnuva through the Subsidiary . Under the definitive collaboration agreements, or the Joint Venture Agreement, we established a new company, Plurinuva, with the purpose of developing cultivated meat products of all types and kinds.
Our Activities in the Food Tech Sector - Ever After Foods On January 5, 2022, we signed definitive collaboration agreements with Tnuva through the Subsidiary. Under the definitive collaboration agreements, or the Joint Venture Agreement, we established a new company, Ever After Foods, with the purpose of developing cultivated meat products of all types and kinds.
The IND allows us to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD Armed Forces Radiobiology Research Institute, part of the Uniformed Services University of Health Sciences.
The IND allows us to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident. In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD Armed Forces Radiobiology Research Institute, part of the USUHS.
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 ARDS .
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 .
Through our experience with adherent stromal cell-based product development, we have developed 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. Certain aspects of our manufacturing process are covered by patents and patent applications.
Pursuant to the Joint Venture Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Plurinuva and the Subsidiary , pursuant to which Plurinuva issued on the closing date of the SPA, or the Closing Date, 187,500 ordinary shares, representing 15.79% of its share capital, to Tnuva, as well as a warrant to purchase additional shares of Plurinuva, in consideration of an aggregate of $7.5 million in cash.
Pursuant to the Joint Venture Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Ever After Foods and the Subsidiary, pursuant to which Ever After Foods issued on the closing date of the SPA, or the Closing Date, 187,500 ordinary shares, representing 15.79% of its share capital, to Tnuva, as well as a warrant to purchase additional shares of Ever After Foods, in consideration of an aggregate of $7.5 million in cash, which expired unexercised.
Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, ICU free-days, and hospitalization free-days. Safety and survival follow-up will be conducted until week 52.
Secondary efficacy endpoints include all-cause mortality, duration of mechanical ventilation, intensive care unit, or ICU, free-days, and hospitalization free-days. Safety and survival follow-up will be conducted until week 52.
Under the “SEC Filings” and “Financial Information” sections, under the “Investors & Media” section 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”, 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.
Fukushima Medical University We signed an MOU for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center. The purpose of the collaboration is to develop our PLX-R18 cells for the treatment of ARS, and for morbidities following radiotherapy in cancer patients.
Fukushima Medical University We signed a memorandum of understanding for a collaboration with Fukushima Medical University, Fukushima Global Medical Science Center, or Fukushima. The purpose of the collaboration is to develop our PLX-R18 cells for the treatment of ARS, and for morbidities following radiotherapy in cancer patients.
Our multi-national portfolio of patent and patent applications includes the following claims: ● our proprietary expansion methods for 3D stromal cells and plant 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.
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.
In October 2021, we received 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. The CRISPR-IL consortium program does not require us to pay royalties to the IIA.
In October 2021, we received 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. The CRISPR-IL consortium program which ended on June 30, 2023 does not require us to pay royalties to the IIA.
Plurinuva is intended to be engaged in the development, manufacturing and commercialization of technology, know-how and products that will be based on licensed products, or the Licensed Products, relating to the field of cultivated meat, or the Field.
Ever After Foods is engaged in the development, manufacturing and commercialization of technology, know-how and products that will be based on licensed products, or the Licensed Products, relating to the field of cultivated meat, or the Field.
The goal of this project is to extend the PLX-R18 ARS studies to include examination of survival in pediatric and geriatric populations as well as the ability of PLX-R18 to alleviate delayed effects of radiation in survivors.
The goal of this project is to extend the PLX-R18 ARS studies to include examination of survival in pediatric and geriatric populations as well as the ability of PLX-R18 to alleviate delayed effects of radiation in survivors. The grant period ended during fiscal year 2023.
Following FDA and European Medicine Agency, or EMA, clearance, a multinational Phase III study is currently being conducted in the United States, Europe and Israel. The primary endpoint of this study is the Short Physical Performance Battery, or SPPB, a test for lower limb performance and functional status.
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.
This license is in addition to the grant of 13 patents to us by the Japanese Patent Office, which address three dimensional methods for expanding placental and adipose cells, and specified cell therapies produced from placental tissue using these methods and bedside thawing devices.
This license is in addition to the grant of 13 patents to us by the Japanese Patent Office, which address 3D methods for expanding placental and adipose cells, and specified cell therapies produced from placental tissue using these methods and bedside thawing devices. The patent in Japan expired in March 2023; and therefore, the licensing agreement expired.
Achieving this significant technological challenge is expected to provide us with large-scale, highly consistent production capacity with operational independency from third party suppliers for standard serum, an expensive and quantity limited product. PLX-R18 is the first product candidate manufactured using the serum-free media.
Achieving this significant technological challenge is expected to provide us with large-scale, highly consistent production capacity with operational independency from third party suppliers for standard serum, an expensive and quantity limited product.
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. 13 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.
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.
Government Regulation 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.
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.
Phase III clinical studies are generally large-scale, multi-center, controlled studies conducted with a heterogeneous group of patients afflicted with the target disease, aiming to provide statistically significant support of efficacy, as well as safety and potency. The Phase III studies are considered confirmatory for establishing the efficacy and safety profile of the drug and are critical for approval.
Phase III clinical studies, sometimes known as pivotal studies, are generally large-scale, multi-center, controlled studies conducted with a heterogeneous group of patients afflicted with the target disease, aiming to provide statistically significant support of efficacy, as well as safety and potency.
There are several stages every drug undergoes during its development process. Among these are: ● Performance of nonclinical laboratory and animal studies to assess a drug’s biological activity and to identify potential safety concerns, and to characterize and document the product’s chemistry, manufacturing controls, formulation, and stability.
Among these are: ● Performance of nonclinical laboratory and animal studies to assess a drug’s biological activity and to identify potential safety concerns, and to characterize and document the product’s chemistry, manufacturing controls, formulation, and stability.
In addition, the manufacturing conditions are specifically inspected by the MOH. The FDA and the EMA 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. Governments in other countries have similar requirements for testing and marketing.
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.
As a platform technology company, we are currently 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. Modified PLX cells using CRISPR, or other gene editing technology: CRISPR is a unique technology which allows precise gene editing of cells.
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.
The Regulatory Process in Europe In the European Union, our investigational cellular products are regulated under the Advanced Therapy Medicinal Product regulation, a regulation specific to cell and tissue products. Additionally, as of January 31, 2022, conducting clinical studies within EMA countries is subject to clinical trials regulation.
The Regulatory Process in Europe In the European Union, our investigational cellular products are regulated under the Advanced Therapy Medicinal Products regulation, a regulation specific to cell and tissue products. Additionally, as of January 31, 2022, the Clinical Trials Regulation harmonizes the submission, assessment and supervision processes of clinical trials in the European Union.
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. 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.
We believe that our ability to compete in the food tech field will derive from our experienced team, our unique 3D technology platform, and our industrial scale in-house GMP, cell manufacturing facility, together with our partner, Tnuva, which has vast experience in the food business.
We believe that our ability to compete in the cultivated food field will derive from our experienced team, our unique 3D technology platform, and our industrial scale in-house GMP, cell manufacturing facility, together with our partner, Tnuva, which has vast experience in the food industry. Available Information Additional information about us is contained on our Internet website at www.pluri-biotech.com.
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 recent 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.
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.
Plurinuva competes with companies that include Upside Foods, Future Meat, GOOD Meat, Mosa Meat, Aleph Farms, and Gourmey.
Ever After Foods competes with companies that include Upside Foods, Believer Meats, GOOD Meat, Mosa Meat, Aleph Farms, Stakeholder 3D and Gourmey.
Using this technology, we can initiate the next evolution in cell therapy by allowing the reprograming of cells for specific needs. 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.
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.
We have conducted several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with the National Institute of Allergy and Infectious Diseases, or the NIAID. The NIH funded and conducted a pilot study in non-human primates, or NHPs, to evaluate the therapeutic effect of PLX-R18 on hematological aspects of ARS.
The NIH funded and conducted a pilot study in non-human primates, or NHPs, to evaluate the therapeutic effect of PLX-R18 on hematological aspects of ARS. In 2017, we announced results of the NHPs pilot study for PLX-R18 as a treatment for ARS.
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. 6 The expiration dates of these patents, based on filing dates, range from 2027 to 2041.
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.
Based on the review, the DMC concluded that the CLI study was unlikely to meet the primary endpoint by the time of the final analysis. Following the DMC’s recommendation, we decided to terminate the CLI study. ARS .
Based on the review, the DMC concluded that the CLI study was unlikely to meet the primary endpoint by the time of the final analysis. Following the DMC’s recommendation, we decided to terminate the CLI study. ARS . On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH.
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, agri-tech, and biologics. We aim to establish partnerships that leverage our 3D cell-based technology to additional industries that require effective, mass cell production.
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.
Obtaining a Fast Track designation allows access for the request of priority review; ● Submission of a BLA for marketing authorization of the product, which must include adequate results of pre-clinical testing and clinical studies; ● Submission of BLA with a proof of efficacy that is based only on animal studies is feasible in instances where human efficacy studies cannot be conducted because the conduct of such studies is unethical and field studies after an accidental or deliberate exposure are not feasible; ● FDA review of the BLA in order to determine, among other things, whether the product is safe and effective for its intended uses; and ● FDA inspection and approval of the product manufacturing facility at which the product will be manufactured.
Obtaining a Fast Track designation allows access for the request of priority review; ● Submission of a BLA for marketing authorization of the product, which must include adequate results of pre-clinical testing and clinical studies; ● Submission of BLA with a proof of efficacy that is based only on animal studies is feasible in instances where human efficacy studies cannot be conducted because the conduct of such studies would not be ethical or feasible (such as H-ARS).
This system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. Our automated proprietary 3D, cGMP approved, process enables the large-scale monitored and controlled production of reproducible, high quality cell products and can manufacture a large number of PLX doses.
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.
Under the project, PLX cells, labeled and non-labeled will be characterized and examined in animal models for muscle injury.
Under the project, PLX cells, labeled and non-labeled will be characterized and examined in animal models for muscle injury. All of our collaborative projects under the Horizon 2020 program ended as of June 30, 2023.
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. Given the magnitude of the potential opportunity for cell therapy, we expect competition in this area to intensify.
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.
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. 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.
Employees As of June 30, 2022, we employed a total of 154 full-time employees and 5 part-time employees, of whom, 128 full-time employees and 5 part-time employees are engaged in research and development, manufacturing and clinical development.
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.
We were incorporated in Nevada on May 11, 2001. Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, previously named Pluristem Ltd., 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.
Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, which is incorporated under the laws of the State of Israel.
These data will help the design of a pivotal study to fulfill the requirements for a Biologics License Application, or BLA, submission under the FDA’s Animal Rule regulatory pathway.
Efficacy measures included survival as well as hematological parameters which are affected by exposure to high levels of radiation as may occur in a nuclear accident or attack. These data will help the design of a pivotal study to fulfill the requirements for a Biologics License Application, or BLA, submission under the FDA’s Animal Rule regulatory pathway.
In addition, specific aspects of our technology are retained as know-how and trade secrets that are protected by our confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors.
In addition, specific aspects of our technology are retained as know-how and trade secrets that are protected by our confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors. These agreements generally provide for protection of confidential information, restrictions on the use of materials, and obligations to assign to us inventions created during the course of performing services for us.
In 2017, we announced results of the NHPs pilot study for PLX-R18 as a treatment for ARS. Although study size was not designed to show significance, results showed a trend toward improved survival of PLX-R18 treated animals compared to control, placebo treated animals.
Although study size was not designed to show significance, results showed a trend toward improved survival of PLX-R18 treated animals compared to control, placebo treated animals. The study, conducted and funded by the NIAID, was designed to assess the safety and efficacy of PLX-R18 following IM injection into irradiated and non-irradiated NHPs.
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 Indiana University In April 2018, NIAID awarded a $2.5 million grant to Indiana University to conduct, together with us, studies of our PLX-R18 cell therapy in the treatment of ARS.
Indiana University In April 2018, NIAID awarded a $2.5 million grant to Indiana University to conduct, together with us, studies of our PLX-R18 cell therapy in the treatment of ARS.
Phase I, clinical studies are conducted in a small number of healthy volunteers, or patients in cases of ethical issues with using healthy volunteers and are designed to provide information about product safety and to evaluate the pattern of drug distribution and metabolism within the body.
Phase I, clinical studies are conducted in a small number of healthy volunteers, or patients with the disease or condition. These studies are designed to provide information about product safety and dosage by gathering information on the drug interaction with the human body, its side effects as well as early preliminary information on effectiveness.
The EMA is expected to review and approve the MAA. In May 2015, we were selected by the EMA for development of PLX-PAD cells via the EMA Adaptive Pathways Project. 14 Other Regulations In general, the approval procedure varies among countries, and may involve additional preclinical testing and clinical studies.
The EMA is expected to review and approve the MAA. In May 2015, we were selected by the EMA for development of PLX-PAD cells via the EMA Adaptive Pathways Project. 16 Government Regulations - Food Tech Regulators around the world are in the process of developing a regulatory approval process for cultivated meat.
The study did not meet the primary endpoint, which was the SPPB test at week 26. The study will continue to follow up with patients for up to 52 weeks for safety and other efficacy measures.
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.
Plurinuva shall retain exclusive worldwide marketing, distribution, and sale rights for the Licensed Products worldwide, except in Israel. 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.
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.
In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD.
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.
Available Information Additional information about us is contained on our Internet website at www.pluri-biotech.com. Information on our website is not incorporated by reference into this report.
Information on our website is not incorporated by reference into this Annual Report.
Effective July 26, 2022, our Nasdaq ticker symbol was changed to “PLUR.” Scientific Background 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.
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.
The process of obtaining these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time, resources and money. There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved, will be reimbursed by public and private health insurance.
There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved, will be reimbursed by public and private health insurance. There are several stages every drug undergoes during its development process.
More recently, through our collaboration with Tnuva and the establishment of Plurinuva, we have begun to utilize our technology in the food tech field. Competitors in the cultivated meat domain include both producers of consumer-end-products, as well as those developing inputs for the production process.
Given the magnitude of the potential opportunity for cell therapy, we expect competition in this area to intensify. 18 Food Tech: Competitors in the cultivated meat domain include both producers of consumer-end-products, as well as those developing inputs for the production process.
The U.S. study was recently completed, and the second study conducted in Europe and Israel is planned for completion during the third calendar quarter of 2022. 3 Recovery Following HCT . This Phase I study of PLX-R18 in HCT was completed in the United States and Israel.
The U.S., Europe, and Israel studies are complete and the clinical study reports have been submitted to the relevant regulatory agencies. 3 Recovery Following HCT . This Phase I study of PLX-R18 in HCT was completed in the United States and Israel.
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. 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 initiatives, including, but not limited to, pharmaceuticals, climate change, food security and animal welfare.
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.
These agreements generally provide for protection of confidential information, restrictions on the use of materials, and an obligation to assign to us inventions conceived during the course of performing services for us. The following table sets forth our key patents and patent applications and is not intended to represent an assessment of claims, limitations or scope.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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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; 17 ● 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; ● our business and market potential in the field of food-tech are unproven, and we have limited insight into trends that may emerge and affect our business; and ● the research and development associated with technologies for cultivated meat manufacturing, is a lengthy and complex process. 18 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; ● 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.
If our patents and proprietary rights agreements do not provide sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer. Our success will also depend in part on our ability to develop our technology and commercialize cell therapy products without infringing the proprietary rights of others.
If our patents and proprietary rights agreements do not provide sufficient protection for our technology and our cell therapy products, our business and competitive position will suffer. Our success will also depend in part on our ability to develop our technology and commercialize our products without infringing the proprietary rights of others.
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; ● future sales of our common shares, or the perception of such sales; 27 ● 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; ● 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.
In addition, as we proceed with our clinical trial efforts, we must be able to continuously demonstrate to the FDA, EMA and other regulatory authorities that we can manufacture our cell therapy product candidates with consistent characteristics. Accordingly, we are materially dependent on these suppliers for supply of current GMP-grade materials of consistent quality.
In addition, as we proceed with our trial efforts, we must be able to continuously demonstrate to the FDA, EMA and other regulatory authorities that we can manufacture our cell therapy product candidates with consistent characteristics. Accordingly, we are materially dependent on these suppliers for supply of current GMP-grade materials of consistent quality.
Any profitability in the future from our business will be dependent upon successful commercialization of our cell-based products and/or licensing of our products, which will require additional research and development. 19 If our cell therapy product candidates do not prove to be safe and effective in clinical trials, we will not obtain the required regulatory approvals.
Any profitability in the future from our business will be dependent upon successful commercialization of our cell-based products and/or licensing of our products, which will require additional research and development. If our cell therapy product candidates do not prove to be safe and effective in clinical trials, we will not obtain the required regulatory approvals.
We are constantly exploring new and advanced security protection measures to prevent future cybersecurity incidents. 33 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. Future security breaches or any material system failure events could result in a material disruption of our development programs and our business operations.
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 Korea and with Chart for the thawing device.
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.
For more information, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources.” Recent increasing global inflation may adversely affect our business results.
For more information, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources.” Recent global inflation may adversely affect our business results.
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. 21 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.
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.
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. 28 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. 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.
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. 34 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.
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.
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. 26 The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.
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.
Cost control initiatives could decrease the price for products that we may develop, which would result in lower product revenues to us. 25 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. 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.
To date, we have focused our efforts primarily in the regenerative medicine 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 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.
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, 2022. Currently, we hold most of our cash assets in bank deposits.
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.
The terms of the IIA’s grants limit our ability to transfer know-how 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, 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.
Plurinuva cannot guarantee that it will be successful in developing these technologies, based on its current roadmap , or at all. If Plurinuva is able to successfully develop its cultivated meat technologies, it cannot ensure that it will obtain regulatory approval or that, following approval, upon commercialization its technologies will achieve market acceptance.
Ever After Foods cannot guarantee that it will be successful in developing these technologies, based on its current roadmap, or at all. If Ever After Foods is able to successfully develop its cultivated meat technologies, it cannot ensure that it will obtain regulatory approval or that, following approval, upon commercialization its technologies will achieve market acceptance.
The GPDR also extends the geographical scope of European Union data protection law to non-European Union entities under certain conditions, tightens existing European Union data protection principles and creates new obligations for companies and new rights for individuals.
The GPDR also extends the geographical scope of EU data protection law to non-EU entities under certain conditions, tightens existing EU data protection principles and creates new obligations for companies and new rights for individuals.
The increasing inflation could affect our ability to purchase materials needed to support our research and operational activities, which in turn could result in higher burn rate and a higher end price of our future products. As a result, we may not be able to effectively develop our product candidates or cultivated meat products.
Inflation could affect our ability to purchase materials needed to support our research, development and operational activities, which in turn could result in higher burn rate and a higher end price of our future products. As a result, we may not be able to effectively develop our cell-based product candidates or cultivated meat products.
In addition, we are subject to laws, rules and regulations in the Israeli, United States, the European Union and other jurisdictions relating to the collection, use and security of personal information and data.
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.
Failure to comply with the requirements of the GDPR and the related national data protection laws of the European Union Member States may result in fines and other administrative penalties.
Failure to comply with the requirements of the GDPR and the related national data protection laws of the EU Member States may result in fines and other administrative penalties.
Plurinuva’s business prospects are difficult to predict due to its lack of operational history in the new and emerging food tech field, and its success will be dependent on its ability to meet a number of challenges.
Ever After Foods’ business prospects are difficult to predict due to its lack of operational history in the new and emerging food tech field, and its success 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. Risks Related to Our Food-Tech Business Plurinuva 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. 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.
Our cash may be subject to a risk of loss, and we may be exposed to fluctuations in interest rates. Our assets include a significant component of cash and cash equivalents and bank deposits. We adhere to an investment policy set by our investment committee which aims to preserve our financial assets, maintain adequate liquidity and maximize returns.
Our cash may be subject to a risk of loss. Our assets include a significant component of cash and cash equivalents and bank deposits. We adhere to an investment policy set by our investment committee which aims to preserve our financial assets, maintain adequate liquidity and maximize returns.
The collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation, or GDPR.
The collection and use of personal health data in the EU is governed by the provisions of the General Data Protection Regulation, or GDPR.
We have a limited operating history in our business of commercializing cell production technology and we have not generate any material revenues to date. It is not clear when we will generate revenues or whether we will generate revenues in the future.
We have a limited operating history in our business of commercializing cell-based products and cell technology and we have not generated material revenues to date. It is not clear when we will generate material revenues or whether we will generate material revenues in the future.
Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthier.
For example, the FDA, the EMA and other countries’ regulatory authorities have relatively limited experience with cell therapies. Very few cell therapy products have been approved by regulatory authorities to date for commercial sale, and the pathway to regulatory approval for our cell therapy product candidates may accordingly be more complex and lengthier.
Therefore, our cash and any bank deposits that we now hold or may acquire in the future may be subject to risks, including the risk of loss or of reduced value or liquidity, particularly in light of the increased volatility and worldwide pressures in the financial and banking sectors. 29 Other Risks The ongoing COVID-19 pandemic, or any other pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business and operations.
Therefore, our cash and any bank deposits that we now hold or may acquire in the future may be subject to risks, including the risk of loss or of reduced value or liquidity, particularly in light of the increased volatility and worldwide pressures in the financial and banking sectors.
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.
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.
Risks Related to Development, Clinical studies, and Regulatory Approval of Our Product Candidates 20 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. 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.
If we are not able to successfully manage any increases in inflation, our prospects, business, financial condition, and results of operations could be adversely impacted. 30 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.
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.
Plurinuva is primarily focused on utilizing its technology for the development of cultivated meat , and it has limited data on the performance of our and its technologies in the field of cultivated meat to date. Plurinuva does not currently have any products or technologies approved for sale and it is still in the early stages of development.
Ever After Foods does not currently have any products or technologies approved for sale and it is still in the early stages of development. To date, Ever After Foods has limited data on the ability of our and its technologies to successfully manufacture cultivated meat, towards which they have devoted substantial resources to date.
Even if we are able to obtain approval for our product candidates through an accelerated approval review program, we may still be required to conduct clinical trials after such an approval.
Even if we are able to obtain approval for our product candidates through an accelerated approval review program, we may still be required to conduct clinical trials after such an approval. If we are not successful in commercializing any of our lead product candidates, or are significantly delayed in doing so, our business will be materially harmed.
Our development costs may increase if we have material delays in a clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial. If we are unable to conduct our clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA, EMA, MOH and other regulatory authorities.
If we will be unable to conduct clinical trials properly and on schedule, marketing approval may be delayed or denied by the FDA, EMA, MOH and other regulatory authorities.
We may not be successful in developing its technologies in a manner sufficient to support its expected scale-ups and future growth, or at all. Plurinuva expects that a substantial portion of its efforts and expenditures over the next few years will be devoted to the development of technologies designed to enable Plurinuva to market industrial-scale cultivated meat manufacturing processes.
Ever After Foods expects that a substantial portion of its efforts and expenditures over the next few years will be devoted to the development of technologies designed to enable Ever After Foods to market industrial scale cultivated meat manufacturing processes.
We could fail to maintain the listing of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction. The Nasdaq Stock Market has established continued listing requirements, including a requirement to maintain a minimum closing bid price of at least $1.00 per share.
We could fail to maintain the listing of our common shares on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction.
Because it has a limited operating history in the field of cultivated meat and it is in the early stages of development, Plurinuva may not be able to evaluate its future prospects accurately. Plurinuva's prospects will be primarily dependent on its ability to successfully develop industrial scale cultivated meat technologies and processes, and market these to its potential customers.
Because it has a limited operating history in the field of cultivated meat and it is in the early stages of development, Ever After Foods may not be able to evaluate its future prospects accurately.
If the health care community does not accept our potential products for any of the foregoing reasons, or for any other reason, it could affect our sales, having a material adverse effect on our business, financial condition, and results of operations. 23 Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures, which could result in material changes in the final data.
Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures, which could result in material changes in the final data.
In addition, as we do not have experience in areas outside of the regenerative medicine field, we may lack the personnel to properly lead such initiatives. There can be no assurance that we will be successful in finding the relevant partners to fund and market the cell based products.
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.
If we raise additional capital by issuing equity securities, the percentage ownership of our existing shareholders may be reduced, and accordingly these shareholders may experience substantial dilution. We may also issue equity securities that provide for rights, preferences and privileges senior to those of our common shares.
Future sales of our common shares, or the perception that such sales may occur, could cause immediate dilution and adversely affect the market price of our common shares. If we raise additional capital by issuing equity securities, the percentage ownership of our existing shareholders may be reduced, and accordingly these shareholders may experience substantial dilution.
If we are not able to regain compliance, there is a risk that our common shares may be delisted from Nasdaq. As of the date of this filing, our common shares are trading below $1.00 per share.
Following a transfer to The Nasdaq Capital Market, we may be afforded an additional 180-days to regain compliance with the MBPR. As of the date of this filing, our common shares are trading below $1.00 per share.
However, these effects could have a material impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely. 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.
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.
Summary of Risk Factors Our business is subject to a number of risks, including risks that may adversely affect our business, financial condition and results of operations.
Summary of Risk Factors Our business is subject to a number of risks, including risks that may adversely affect our business, financial condition and results of operations. These risks are discussed more fully below and include, but are not limited to, risks related to: ● we have a history of losses and have not generated significant revenues to date.
Excessive insurance costs or uninsured claims would add to our future operating expenses and adversely affect our financial condition.
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.
If Plurinuva is not able to successfully meet these challenges, its prospects, business, financial condition, and results of operations could be adversely impacted. In addition, Plurinuva will be subject to changing laws, rules and regulations in the Israeli, United States, Asia Pacific, the European Union and other jurisdictions relating to the food tech industry.
In addition, Ever After Foods will be subject to changing laws, rules and regulations in the United States, Israeli, Asia Pacific, the European Union and other jurisdictions relating to the food tech industry. Such laws and regulations may negatively impact its ability to expand its business and pursue business opportunities.
Wars and acts of terrorism have resulted in significant damage to the Israeli economy, including reducing the level of foreign and local investment. Risk Related to Our Industry 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.
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.
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 may not be able to maintain adequate levels of insurance for these liabilities at reasonable cost and/or reasonable terms.
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.
The novel nature of our therapeutics creates significant challenges in regard to product development and optimization, manufacturing, government regulation, third party reimbursement and market acceptance. For example, the FDA, the EMA and other countries’ regulatory authorities have relatively limited experience with cell therapies.
Our product development programs are based on novel technologies and are inherently risky. We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our therapeutics creates significant challenges in regard to product development and optimization, manufacturing, government regulation, third party reimbursement and market acceptance.
Our competitors may have developed, or could develop in the future, new products that compete with our products or even render our products obsolete. Potential product liability claims could adversely affect our future earnings and financial condition.
Our competitors may have developed, or could develop in the future, new products that compete with our products or even render our products obsolete. Moreover, the alternative protein market is highly competitive, with numerous brands vying for limited space in retail, foodservice, and consumer preference.
Any such delay or failure could materially and adversely affect Plurinuva's financial condition, results of operations and prospects. 24 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.
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.
If the closing bid price of our common shares continues trading below $1.00 per share for an aggregate of 30 consecutive business days, we will receive a deficiency notice from Nasdaq.
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.
If, in such circumstance, we are not able to regain compliance with the minimum bid price requirement within 180 days, our common shares will be subject to a delisting action by Nasdaq.
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.
Assuming it is in compliance with the other continued listing requirements, Nasdaq would provide such company a period of 180 calendar days in which to regain compliance by maintaining a closing bid price at least $1.00 per share for a minimum of ten consecutive business days.
Under Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar days period following the date of the Notice the closing bid price of our common shares is at or above $1.00 for a minimum of 10 consecutive business days, we will regain compliance with the MBPR and our common shares will continue to be eligible for listing on Nasdaq, absent noncompliance with any other requirement for continued listing.
Such laws and regulations may negatively impact its ability to expand its business and pursue business opportunities. Plurinuva may also incur significant expenses to comply with the laws, regulations and other obligations that will apply to it.
Ever After Foods may also incur significant expenses to comply with the laws, regulations and other obligations that will apply to it. Ever After Foods is primarily focused on utilizing its technology for the development of cultivated meat, and it has limited data on the performance of our and its technologies in the field of cultivated meat to date.
Removed
These risks are discussed more fully below and include, but are not limited to, risks related to: ● the COVID-19 pandemic has caused interruptions and delays of our business plan and may have a adverse effect on our business; ● we have a history of losses and have not generated significant revenues to date.
Added
If the health care community does not accept our potential products for any of the foregoing reasons, or for any other reason, it could affect our sales, having a material adverse effect on our business, financial condition, and results of operations.
Removed
If we are not successful in commercializing any of our lead product candidates, or are significantly delayed in doing so, our business will be materially harmed. 22 Our product development programs are based on novel technologies and are inherently risky. We are subject to the risks of failure inherent in the development of products based on new technologies.
Added
Ever After Foods’ prospects will be primarily dependent on its ability to successfully develop industrial scale cultivated meat technologies and processes, and market these to its potential customers. If Ever After Foods is not able to successfully meet these challenges, its prospects, business, financial condition, and results of operations could be adversely impacted.
Removed
To date, Plurinuva has limited data on the ability of our and its technologies to successfully manufacture cultivated meat, towards which they have devoted substantial resources to date. Plurinuva’s current technologies are, in large part, based on our technologies and intellectual property.
Added
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.
Removed
If a company trades for 30 consecutive business days below such minimum closing bid price, it will receive a deficiency notice from Nasdaq.
Added
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.
Removed
Future sales of our common shares may cause dilution. Future sales of our common shares, or the perception that such sales may occur, could cause immediate dilution and adversely affect the market price of our common shares.
Added
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.
Removed
COVID-19 has had and continues to have a significant impact, both direct and indirect, on businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services, such as medical services and supplies, has spiked, while demand for other goods and services, such as travel, has fallen.
Added
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.
Removed
We are actively monitoring any developments regarding the pandemic, and we are taking any necessary measures to respond to the situation in cooperation with the various stakeholders. COVID-19 infection of our workforce could result in a temporary disruption in our business activities, including manufacturing and other functions.
Added
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.
Removed
Based on guidelines provided by the Israeli Government, we have increased as much as possible the capacity and arrangement for employees to work remotely, and although the vast majority of our employees have been vaccinated and we have adopted hybrid working models to minimize exposure, we cannot guaranty that there will be no infection and spread of the virus among our employees and staff.
Added
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.
Removed
The COVID-19 pandemic is also affecting the United States, Israel and global economies and has affected, and may continue to affect, the conduct of our clinical trials and may in the future affect our operations and those of third parties on which we rely, including by causing disruptions in our raw material supply.
Added
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.
Removed
In that regard, to date we have experienced delays in enrolling patients in our various studies due to the COVID-19 pandemic.
Added
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.
Removed
In addition, the COVID-19 pandemic may affect the operations of the FDA and other health authorities, which could result in delays of reviews and approvals, including with respect to our Phase III clinical trial related to muscle recovery following surgery for hip fracture.
Added
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.
Removed
The evolving COVID-19 pandemic has already impacted, and may continue to, directly or indirectly impact the pace of enrollment in our clinical trials as patients may avoid or may not be able to travel to healthcare facilities and physicians’ offices unless due to a health emergency and clinical trial staff may not be able to physically arrive to the clinical sites.
Added
We likewise expect these products to be regulated by equivalent agencies outside the United States by various international regulatory bodies.
Removed
Additionally, such facilities and offices have been and may continue to be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, thereby decreasing availability, in whole or in part, for clinical trial services. Additionally, the stock market has been unusually volatile during the COVID-19 outbreak and such volatility may continue.
Added
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.

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Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−1 removed0 unchanged
Biggest changeFor Fiscal Year 2022, we recognized a net expense (rent expenses after deducting deferred participation payments from MATAM) in the amount of $921,000, 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.
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.
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 July 2022 was 291,000 NIS (approximately $89,000).
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, 2023 was 292,000 NIS (approximately $83,000).
Removed
Mine Safety Disclosures. Not applicable. 35 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed0 unchanged
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Our common shares are traded on the Nasdaq Global Market and the Tel Aviv Stock Exchange under the symbol “PLUR”. As of September 15, 2022, there were 50 holders of record, and 32,620,343 of our common shares were issued and outstanding.
Biggest changeITEM 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.
American Stock Transfer and 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]
Equiniti 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]

Item 7. Management's Discussion & Analysis

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

45 edited+32 added−26 removed10 unchanged
Biggest changeThe decrease is mainly attributed to a decrease in clinical study expenses following the termination of our CLI study, end of enrollment of our Phase II studies of ARDS associated with COVID-19, and end of enrollment in our Phase III hip study , as well as a decrease in share-based compensation expenses related to restricted share units, or RSUs, granted to employees and consultants.
Biggest changeThe 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.
In addition to the interest payable to the EIB, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million.
In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB loan, on our consolidated revenues beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding $500 million.
All RSUs granted in fiscal years 2022 and 2021 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 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.
The RSUs granted in Fiscal Year 2022 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 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”.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. We are a biotechnology company with an advanced cell-based technology platform. We have developed a unique three-dimensional, or 3D, technology platform for cell expansion with an industrial scale in-house GMP cell manufacturing facility.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. We are a biotechnology company with an advanced cell-based technology platform. We have developed a unique 3D technology platform for cell expansion with an industrial scale in-house GMP cell manufacturing facility.
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 and clinical study activities.
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.
According to the IIA grant terms, we are required to pay royalties at a rate of 3% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.
Non-dilutive grants Israel Innovation Authority (IIA) According to the IIA grant terms, we are required to pay royalties at a rate of 3% on sales of products and services derived from technology developed using this and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment is required.
On July 16, 2020, we entered into the ATM Agreement with Jefferies, pursuant to which we may issue and sell shares of our common shares having an aggregate offering price of up to $75,000,000 from time to time through Jefferies.
On July 16, 2020, we entered into an at-the market agreement, or the ATM Agreement, with Jefferies LLC, or Jefferies, pursuant to which we may issue and sell shares of our common shares having an aggregate offering price of up to $75,000,000 from time to time through Jefferies.
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, 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 change in the loss per share was mainly as a result of a decrease in the loss for the year, partially offset by an increase in our weighted average number of shares due to the issuance of additional shares during Fiscal Year 2022.
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 fair value of shares of Plurinuva granted to CEO, CFO and Chairman (see details in Item 11 below) was calculated using the Monte Carlo model, and fair value of the options of Plurinuva granted to employees and officers were calculated using the Black Scholes model.
The fair value of shares of Ever After Foods granted to our CEO, CFO and Chairman (see details in Item 11 below) was calculated using the Monte Carlo model, and the fair value of the options of Ever After Foods granted to employees and officers were calculated using the Black Scholes model.
Our cash equivalents and restricted cash decreased in the year ended June 30, 2022 for the reasons presented below. Our cash used in operating activities was $36,501,000 during the year ended June 30, 2022, and $30,910,000 during the year ended June 30, 2021.
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.
The Phase III study of PLX-PAD in CLI will be 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.
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.
In August 2016, our CLI program in the European Union was awarded a €7,600,000 non-royalty bearing grant. The grant is part of the European Union’s Horizon 2020 program.
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.
Research and Development, Net Research and development, net (costs less participation and grants by the IIA, Horizon 2020 and other parties) decreased by 19% from $30,066,000 for the year ended June 30, 2021, to $24,377,000 for the year ended June 30, 2022.
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.
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 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.
Cash provided by investing activities was $11,783,000 during the year ended June 30, 2022, as opposed to cash used for investing activities of $7,265,000 during the year ended June 30, 2021.
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 in the year ended June 30, 2022 consisted primarily of the withdrawal of $23,269,000 of long-term deposits, partially offset by cash investment in short-term deposits of $11,206,000 and payments of $280,000 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.
General and Administrative General and administrative expenses decreased by 15% from $20,557,000 for the year ended June 30, 2021, to $17,450,000 for the year ended June 30, 2022.
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.
As of June 30, 2022, the interest accrued was in the amount of €865,000.
As of June 30, 2023, the interest accrued was in the amount of €1,665,000.
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 European Union’s Horizon 2020 program.
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.
This Phase III study was a collaborative project carried out by an international consortium led by Charité, together with us, and with participation of additional third parties. The grant covered a significant portion of the project costs.
This Phase III study was a collaborative project carried out by an international consortium led by Charité, together with us, and with participation of additional third parties. The grant covered a significant portion of the project costs and the program was ended during fiscal year 2023. Through June 30, 2023, we received a total of €3,228,000 (approximately $3,699,000).
Application of Critical Accounting Policies and Estimates Our significant accounting policies are more fully described in Note 2 to our consolidated financial statements appearing in this Annual Report. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
We believe that we have sufficient cash to fund our operations for at least the next twelve months. Application of Critical Accounting Policies and Estimates Our accounting policies are more fully described in Note 2 to our consolidated financial statements appearing in this Annual Report.
The proceeds from the EIB Finance Agreement are intended to support our research and development in the European Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market.
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.
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.
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.
Actual results may differ from these estimates under different assumptions or conditions. 40 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. In Fiscal Year 2022, we recorded share-based compensation expenses related to options, restricted shares and RSUs in the amount of $8,909,000.
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.
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 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.
We are continually looking for sources of funding, including non-diluting sources such as collaboration with other companies via licensing agreements, the IIA grants, the European Union grant and other research grants, and sales of our common shares. We believe that we have sufficient cash to fund our operations for at least the next twelve months.
We are continually looking for sources of funding, including collaboration with other companies via licensing agreements, joint ventures and partnerships, and other non-dilutive sources such as our contract with NIAID and DoD, research grants such as the IIA grants and the European Union grants, and sales of our common shares.
Cash used in operating activities in the year ended June 30, 2022, and in the year ended on June 30, 2021 primarily consisted of payments to subcontractors, suppliers, and professional services providers related to our ongoing clinical studies and payments of salaries to our employees, offset by participation of the IIA, Horizon 2020 or other third parties.
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.
The decrease is mainly attributed to a decrease in share-based compensation expenses related to market based vesting conditioned RSUs granted to our CEO and Chairman, partially offset by an increase in share-based compensation expenses related to the allocation of shares of Plurinuva to our CEO, CFO and Chairman pursuant to their employment or consulting agreement (see also notes 1e and 9b1 to the consolidated financial statements included elsewhere in this Annual Report) and increased payroll expenses related to new employees, payroll adjustments and exchange rate fluctuations.
The 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).
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, 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.
This decrease is mainly attributable to an increase in interest expenses related to the EIB loan provided to us in June 2021 pursuant to the EIB Finance Agreement and losses from hedging transactions due to strength of the U.S Dollar against the Euro, partially offset by exchange rate income on lease liability due to the strength of the U.S Dollar against the NIS and exchange rates adjustments relating to the EIB loan.
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.
Cash used for investing activities in the year ended June 30, 2021, consisted primarily of cash used for investment in long-term deposits of $10,953,000 and payments of $373,000 related to investments in property and equipment, partially offset by the withdrawal of $4,061,000 of short-term deposits.
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.
The CRISPR-IL consortium program does not include any obligation to pay royalties. 39 As of June 30, 2022 and 2021, we received total grants of approximately $694,000 and $401,000 in cash from the IIA pursuant to the CRISPR-IL consortium program, respectively. In July 2017, we were awarded the Smart Money grant of approximately $229,000 from Israel’s Ministry of Economy.
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 discussion and analysis of our financial condition and results of operations is based on our financial statements, which we prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as the reported revenues and expenses during the reporting periods.
The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as the reported revenues and expenses during the reporting periods. We evaluate such estimates and judgments on an ongoing basis, including those described in greater detail below.
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 recent collaboration with Tnuva Food Industries – Agricultural Cooperative in Israel Ltd., through its fully owned subsidiary, Tnuva, to use our technology to establish a cultivated food platform.
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.
Financing activities provided cash in the amount of $7,500,000 during the year ended June 30, 2022, and $61,402,000 during the year ended June 30, 2021. The cash provided in the year ended June 30, 2022, from financing activities is related to net proceeds of $7,500,000 received from an investment by Tnuva in Plurinuva .
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.
Net Loss for the Year Net loss decreased from $49,865,000 for the year ended June 30, 2021 to $41,374,000 for the year ended June 30, 2022. The decrease was mainly due to a decrease in research and development expenses , net, and a decrease in general and administrative expenses for the reasons mentioned above.
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.
As of June 30, 2022, we received a total of €2,166,000 (approximately $2,540,000) and we expect to receive an additional €382,000 (approximately $397,000). In October 2017, the nTRACK, a collaborative project carried out by an international consortium led by Leitat was awarded a €6,800,000 non-royalty bearing grant. An amount of €500,000 is a direct grant allocated to us.
In October 2017, the nTRACK, a collaborative project carried out by an international consortium led by Leitat was awarded a €6,800,000 non-royalty bearing grant. As of June 30, 2023, we received a total of €764,000 (approximately $859,000). The nTRACK program ended during fiscal year 2023. 38 Outlook We have accumulated a deficit of $399,584,000 since our inception in May 2001.
On June 30, 2022, we had a working capital surplus of $50,918,000 and an accumulated deficit of $371,263,000. As of June 30, 2021, our total current assets were $67,371,000 and our total current liabilities were $11,517,000. On June 30, 2021, we had a working capital surplus of $55,854,000 and an accumulated deficit of $330,021,000.
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.
We had a net loss attributed to our non-controlling interest in Plurinuva for the year ended June 30, 2022 of $132,000. 37 Loss per share for the year ended June 30, 2022 was $1.28, as compared to $1.77 loss per share for the year ended June 30, 2021.
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.
Our cash and cash equivalents and restricted cash as of June 30, 2022, amounted to $10,779,000, which reflects a decrease of $21,059,000 from the $31,838,000 reported as of June 30, 2021. Our bank deposits as of June 30, 2022, amounted to $45,244,000 compared to $56,978,000 as of June 30, 2021.
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.
The increase in weighted average common shares outstanding reflects the issuance of additional shares upon settlement of RSUs issued to directors, employees and consultants. Liquidity and Capital Resources As of June 30, 2022, our total current assets were $57,747,000 and our total current liabilities were $6,829,000.
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.
Effective July 26, 2022, our Nasdaq ticker symbol was changed to “PLUR.” 36 RESULTS OF OPERATIONS – YEAR ENDED JUNE 30, 2022 COMPARED TO YEAR ENDED JUNE 30, 2021. Revenues Revenues for the year ended June 30, 2022 were $234,000, compared to no revenues for the year ended June 30, 2021.
Revenues Revenues for the year ended June 30, 2023 were $287,000, compared to $234,000 for the year ended June 30, 2022.
Total Financial Income, Net Financial income, net decreased from $758,000 for the year ended June 30, 2021 to $219,000 for the year ended June 30, 2022.
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.
Removed
We expect to demonstrate a real-world impact and value from our cell-based technology platform, our current PLX pipeline and from other cell-based product candidates that may be developed based on our platform. Our business model for commercialization and revenue generation includes, but is not limited to, licensing deals, joint ventures, partnerships, joint development agreements and direct sale of our products.
Added
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.
Removed
We are now completing a multinational Phase III clinical study in muscle recovery following surgery for hip fracture, with sites in the United States, Europe and Israel.
Added
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.
Removed
In the last year, we have completed a Phase II clinical study in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 and a Phase I clinical study for incomplete recovery following bone marrow transplantation.
Added
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.
Removed
Additional areas of focus for clinical development include an investigator-led Phase I/II Chronic Graft versus Host Disease, or cGVHD, study in Israel, and an Acute Radiation Syndrome, or ARS, program under the U.S. Food and Drug Administration, or FDA, animal rule. We believe that each of these indications represents a severe unmet medical need.
Added
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.
Removed
We were incorporated in Nevada on May 11, 2001. Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd., or the Subsidiary, previously named Pluristem Ltd., 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.
Added
(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.
Removed
In January 2022, the Subsidiary established an additional subsidiary, Plurinuva Ltd., or Plurinuva, which is incorporated under the laws of Israel, which followed the execution of the collaboration agreement with Tnuva .
Added
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.
Removed
On July 26, 2022, we completed our legal entity name change from Pluristem Therapeutics Inc. to Pluri Inc., by merging a wholly-owned subsidiary with and into the Company, with us being the surviving corporation.
Added
Our bank deposits as of June 30, 2023, amounted to $34,811,000 compared to $45,244,000 as of June 30, 2022.
Removed
The name change reflects a broader strategy of leveraging our 3D cell expansion technology to develop innovative cell-based products that can be harnessed for a range of fields beyond medicine, providing solutions for various areas of life.
Added
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.
Removed
The decrease was partially offset by an increase in materials purchased to support our manufacturing plans, increased payroll expenses related to payroll adjustments and exchange rate fluctuations, and an increase in building lease costs following the extension of our lease contract.
Added
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.
Removed
The cash provided in the year ended June 30, 2021 from financing activities is related to: (1) net proceeds of $36,589,000 from our registered direct offering which closed in February 2021 and common share issuances made under the Open Market Sale Agreement SM , or the ATM Agreement, that we entered into with Jefferies LLC, or Jefferies, on July 16, 2020, (2) proceeds of $24,449,000 received from the EIB pursuant to the EIB Finance Agreement, and (3) net proceeds of $364,000 from the exercise of outstanding warrants.
Added
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.
Removed
During the year ended June 30, 2021, we sold 1,045,097 of our common shares under the ATM Agreement at an average price of $8.50 per share for aggregate net proceeds of approximately $8,506,000, net of issuance expenses of $380,000.
Added
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.
Removed
During the year ended June 30, 2022, we did not sell of our any common shares under the ATM Agreement. 38 In the year ended June 30, 2021, warrants to purchase up to 51,999 shares from our April 2019 firm commitment public offering were exercised by investors at an exercise price of $7.00 per share, resulting in the issuance of 51,999 common shares for net proceeds of approximately $364,000.
Added
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.
Removed
During the year ended June 30, 2022, no warrants to purchase shares were exercised. On February 2, 2021, we entered into a securities purchase agreement with several institutional investors, or the Investors, pursuant to which we sold, in a registered direct offering, directly to the Investors, 4,761,905 common shares, for gross proceeds of $30,000,000.
Added
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.
Removed
The aggregate net proceeds were approximately $28,077,000, net of issuance expenses of approximately $1,923,000. In April 2020, we and our subsidiaries, Pluristem Ltd. and Pluristem GmbH, executed the EIB Finance Agreement for funding of up to €50 million in the aggregate, payable in three tranches.
Added
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.
Removed
The proceeds from the EIB Finance Agreement are expected to be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones. We do not expect to receive additional funds pursuant to the EIB Finance Agreement.
Added
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.
Removed
Non-dilutive grants During the year ended June 30, 2022, we did not receive any cash grants from the European Union research and development consortiums relating to the Horizon 2020 program, as opposed to approximately $239,000 received in cash during the year ended June 30, 2021.
Added
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.
Removed
During the year ended June 30, 2022, no royalties were paid to the IIA. Through June 30, 2022 , total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties paid and accrued amounted to $169,000.
Added
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.
Removed
The Israeli government granted us budget resources to advance our product candidate towards marketing in China-Hong Kong markets. The Smart Money program ended on April 2022. As of June 30, 2022, we received total grants of approximately $179,000 in cash from Israel’s Ministry of Economy for the Smart Money program.

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