NASDAQ: PLUR
Pluri Inc.CIK 0001158780 · Biological Products
We are a biotechnology company, leveraging our proprietary cell expansion platform to develop scalable, cell-based solutions across the healthcare, food, and agriculture sectors. Through a collaborative network of ventures, we are advancing a diverse pipeline of products and services, including… About this business →
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About Pluri Inc.
Source: Item 1 (Business) from the 10-K filed September 17, 2025. Description as filed by the company with the SEC.
ITEM 1.
BUSINESS.
Overview
We are a biotechnology company,
leveraging our proprietary cell expansion platform to develop scalable, cell-based solutions across the healthcare, food, and agriculture
sectors. Through a collaborative network of ventures, we are advancing a diverse pipeline of products and services, including cultivated
food, regenerative medicine, and cell-based ingredients. We have developed a unique three-dimensional (“3D”) technology platform
for cell expansion with an industrial-scale cell manufacturing facility operated in accordance with Good Manufacturing Practice (“GMP”)
standards, currently on a self-declared basis. We are utilizing our technology across the fields of regenerative medicine, immunotherapy,
food tech, CDMO, and AgTech and plan to utilize it in industries and verticals that have a need for our mass scale and cost-effective
cell expansion platform via partnerships, joint ventures, licensing agreements and other types of collaborations.
We were incorporated in Nevada
on May 11, 2001. Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”), which is incorporated under
the laws of the State of Israel. In January 2020, Pluri Biotech established a wholly owned subsidiary, Pluristem GmbH, which is incorporated
under the laws of Germany.
In November 2021, Pluri Biotech
established a new subsidiary, Ever After Foods, which is incorporated under the laws of the State of Israel. Pluri Biotech holds approximately
69% of Ever After Foods’ issued and outstanding shares.
Read full description ↓
In March 2024 Pluri Biotech
established a wholly owned subsidiary, Coffeesai, which is incorporated under the laws of the State of Israel.
On April 28, 2025, the Company
completed an acquisition of approximately 79% of the equity in Kokomodo, which is currently held as majority owned Israeli subsidiary
of Pluri Biotech.
Our operations are dedicated
to the research, development and manufacturing of cell-based products, as well as the commercialization of cell therapeutics and related
technologies aimed at delivering innovative solutions across a range of industries, as set forth below:
Cell Therapy
We use our advanced cell-based
technology platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates for the treatment
of inflammatory, muscle injuries, hematologic conditions and, most recently, we have also launched a novel immunotherapy platform.
1
PLX cells: Our PLX
cells are adherent stromal cells that are expanded using our 3D platform. Our PLX cells can be administered to patients off-the-shelf,
without blood or tissue matching or additional manipulation prior to administration. PLX cells are believed to release a range of therapeutic
proteins in response to the patient’s condition.
In the pharmaceutical area,
we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery
for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia (“CLI”), chronic Graft
versus Host Disease (“GvHD”), knee osteoarthritis and a potential treatment for Hematopoietic Acute Radiation Syndrome (“H-ARS”).
Some of these studies have been completed while others are still ongoing. We believe that each of these indications is a severe unmet
medical need.
Immunotherapy MAIT cells:
In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors
– a critical area in medicine where effective treatments are currently insufficient. We believe that our MAIT cells, isolated from
the human placenta, offer substantial potential benefits compared to conventional T cells.
Placental MAIT cells are
potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors,
which facilitate their migration directly to tumor sites. Furthermore, unlike conventional autologous T cells typically collected from
peripheral blood, our MAIT cells are designed to be allogenic universal product. Benefiting with very restricted T-cell receptor (“TCR”),
the MAIT cells minimize their likelihood of inducing GvHD, a significant advantage over other potential allogeneic products. We are aiming
to design the MAIT to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
PluriCDMO™
In January 2024, we
launched a new business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers CDMO
for cell therapy manufacturing expertise to companies from early preclinical development, through late-stage clinical trials and commercialization,
with a mission to deliver high-quality, essential therapies to patients, as well as other services. We have signed several agreements
with clients and are currently generating revenues from PluriCDMO™.
2
AgTech
We are actively involved
in several initiatives leveraging Pluri’s 3D cell expansion technology in the AgTech field, including:
(a) an innovative proof-of-concept
(“POC”) collaboration with ICL Group Ltd. (“ICL”), a leading global specialty minerals company, through its Open
Innovation program, to revolutionize bio stimulant delivery and enhance yield sustainably;
(b) a strategic POC agreement
with a leading international agriculture corporation aimed at boosting the global vegetable product supply, streamlining supply chains,
and promoting a more sustainable future for agriculture; and
(c) the development of cell-cultured
coffee and cacao through business activities operated via our subsidiaries in the plant-based vertical, Coffeesai and Kokomodo, respectively.
Coffeesai
In 2024, we established Coffeesai
Ltd., an Israeli subsidiary focused on developing cultivated, cell-cultured coffee. This initiative addresses key challenges facing the
traditional coffee industry, such as climate-related crop instability, supply chain disruptions, and environmental impact. By leveraging
controlled, scalable bioprocess, Coffeesai aims to deliver consistent product quality, reduced resource consumption, and long-term cost
efficiency.
Coffeesai has successfully
demonstrated a POC coffee beverage, validating the potential of its technology. Ongoing efforts are focused on enhancing flavor and aroma
profiles through bioprocess optimization and downstream refinement. In parallel, Coffeesai is exploring research and development collaborations
aimed at accelerating development and commercialization with leading global coffee suppliers. A third-party techno-economic assessment
has confirmed the cost-competitiveness of the platform at scale, supporting its commercial viability.
Kokomodo
On April 28, 2025, we completed
the acquisition of approximately 79% of the equity in Kokomodo (held as a majority owned subsidiary of our wholly owned subsidiary, Pluri
Biotech). Kokomodo, an Israeli company, is an innovative agfood startup pioneering the sustainable production of cacao using cellular
agriculture technology. Instead of relying on traditional tropical farming, Kokomodo cultivates real cacao directly from plant cells
in controlled environments, such as bioreactors, making climate-resilient cacao accessible year-round on a global scale. Founded in 2024,
Kokomodo aims to transform the cacao industry, reducing environmental impact while ensuring a steady, high-quality supply for chocolate
and related products.
3
Food Tech
In 2022, we announced the
establishment of a joint venture with Tnuva - Ever After Foods, incorporated under the laws of the State of Israel. The purpose of the
venture is to develop and commercialize scalable production technologies for cultivated meat, supporting the development of a wide range
of cultivated meat products by industry partners.
Leveraging Pluri’s
innovative technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business (“B2B”)
version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for
various animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat.
In June 2024, we entered
into a share purchase agreement (the “Agreement”) by and among Ever After Foods, Tnuva, and certain other international strategic
investors, pursuant to which Ever After Foods issued and sold, ordinary shares in a private placement offering (the “Offering”),
for aggregate gross proceeds of $10 million. As part of the Offering, we invested $1.25 million. In addition, Pluri Biotech and Ever
After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024 (the “Amended License”).
The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the scope of
the license to include fish and seafood.
The $10 million funding round
is intended to support Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler. Following
the closing of the Offering, our wholly owned subsidiary, Pluri Biotech, holds approximately 69% of Ever After Foods.
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 human placenta, the source of our PLX and MAIT cells, provides a unique reservoir of stromal and immune cells representing
a groundbreaking approach in the field of cell therapy.
PLX, cells are placenta-derived,
mesenchymal-like adherent stromal cells that are expanded ex vivo. The diverse factors released by PLX cells indicate their potential
therapeutic use across a range of ischemic, inflammatory, autoimmune and hematological conditions. Placental MAIT cells are potent effector
cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate
their migration directly to tumor sites. Furthermore, unlike conventional autologous T cells typically collected from peripheral blood,
our MAIT cells are designed to be allogenic universal product. Benefiting with very restricted TCR, the MAIT cells minimize their likelihood
of inducing GvHD, a significant advantage over other potential allogeneic products.
4
Our Technology
Our patented and validated
3D cell expansion platform is a state-of-the-art system designed to enable novel cell-based solutions. It delivers high accuracy, scalability,
cost-efficiency, and consistent batch-to-batch performance. The platform is currently being applied in regenerative medicine, FoodTech,
AgTech, and CDMO.
Our system utilizes a synthetic
scaffold to create a 3D environment where adherent or non-adherent cells can grow in a tissue like environment. Our automated proprietary
3D, GMP, approved process enables the large-scale monitored and controlled production of reproducible, high quality cell products and
in mass quantities. Additionally, our current manufacturing process, which has scaled up over the years, has demonstrated batch-to-batch
consistency, an important manufacturing challenge for biological products.
We developed PluriMatrix,
an industrial-scale cell manufacturing system built on our 3D cell expansion platform, designed to enable high-quality cell production
at commercially relevant volumes.
We aim to establish partnerships
that leverage our 3D cell-based technology to additional industries that require effective, mass cell production and will enable us to
accelerate the time-to-market of our products.
Cell Therapy Product Candidates - Pluri
Health
PLX-PAD
PLX-PAD is composed of maternal
mesenchymal stromal cell (“MSC”) like cells originating from the placenta.
PLX-R18
PLX-R18 is composed of fetal
MSC like cells originating from the placenta.
Allogeneic MAIT Cell Therapy Platform
MAIT cells are a distinct
type of unconventional immune T cells. Their unique characteristics, including robust cytotoxic activity and low alloreactivity profile,
make them promising candidates for engineering and subsequent use in the treatment of solid tumors in the setting of allogeneic adoptive
cell therapy.
We believe that leveraging
the placenta as a unique source of cells, combined with our cutting-edge research, development and established high-quality manufacturing
capabilities, will serve as the driving force towards the successful development of a broader range of cell therapy products and applications.
Our Clinical Development Product Candidates
Both PLX-PAD and PLX-R18
products were tested in clinical studies. Studies were conducted in the United States, Europe and Israel.
PLX-PAD was tested
as a treatment for several indications: acute muscle injuries following hip fracture, acute respiratory distress syndrome, due to Coronavirus
Disease (“COVID-19”), GvHD, and peripheral artery disease, including intermittent claudication, and critical limb ischemia
(“CLI)”. All clinical studies were completed.
In addition, PLX-PAD is being
developed for the treatment of mild to moderate knee osteoarthritis as part of the Advanced PeRsOnalized Therapies for Osteoarthritis
(“PROTO”) program, an international collaboration led by Charité Berlin Institute of Health Center for Regenerative
Therapies (“Charité”). In June 2025, the clinical study was approved by the Paul-Ehrlich-Institut (“PEI”)
and the clinical study will be carried out by the Charité.
PLX-R18 was tested
in a Phase I trial for treatment of patients with incomplete recovery following hematopoietic cell transplantation, in the United States
and Israel.
5
In addition, PLX-R18 is being
developed under the FDA’s Animal Rule regulatory pathway for Acute Radiation Syndrome (“ARS”), and in November 2024,
we announced that we are evaluating our readiness to initiate mass production of PLX-R18 in light of heightened global nuclear threats.
Acute Radiation Syndrome:
On July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the NIH. Pluri will collaborate with
the U.S. Department of Defense’s (“DoD’s”), AFRRI, and the USUHS, to further advance the development of its PLX-R18
cell therapy as a potential novel treatment for H-ARS. H-ARS is a deadly disease that can result from nuclear disasters and radiation
exposure. On June 6, 2024, NIAID exercised its option for year two of the three-year $4.2 million contract.
Prior to signing the contract
with NIAID, we conducted several animal studies for the evaluation of PLX-R18 for the treatment of ARS, in collaboration with NIAID and
DoD Armed Forces Radiobiology Research Institute, part of the USUHS. On April 15, 2025, we received formal notice from NIAID that the
contract was being terminated for Government’s convenience, effective from the date of the notice. We believe that the termination
reflects broader federal budgetary and administrative adjustments that have affected various health-related agencies, including the NIH.
The termination was not related to any performance issues on our part, and we received the funding for activities conducted up to the
effective date.
On January 8, 2022, we entered
into a definitive license agreement with Takeda Pharmaceuticals International AG (“Takeda”), a company based in Switzerland,
which operates in the field of adipose-derived cells, pursuant to which we granted Takeda a global, non-exclusive license to use several
of our patents (EP2591789 and EP3103463,), limited to adipose fat cells only, in the field of therapeutics, in exchange for Takeda ceasing
its opposition with regards to said patents and paying us a lump sum of $200,000. The license covers methods for expanding adherent stromal
cells and specified second medical uses.
On January 10, 2022, we entered
into a definitive license agreement with Novadip Biosciences (“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.
On December 20, 2023, we
entered into an agreement assigning the joint patent rights to develop Pluri’s PLX cells in the treatment of cocaine addiction,
to Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), the commercial arm of Bar-Ilan University.
Under the agreement, Bar-Ilan University via BIRAD will receive the right to further develop and commercialize PLX cells as a cocaine
anti-addiction product, and Pluri is entitled to 20% revenue sharing from future sales of the product for anti-addiction.
In March 2025, we entered
into an exclusive collaboration agreement with Hemafund, a Ukrainian umbilical cord blood bank with clinical and research laboratories
and facilities specializing in cell preservation and cryostorage. The collaboration aims to establish a strategic initiative for e stockpiling,
local distribution, and potential clinical advancement of our PLX-R18 cell therapy as a countermeasure for Hematopoietic Acute Radiation
Syndrome, or H-ARS, in Ukraine.
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. We utilize this strategy in working with the FDA, the European Medicines Agency (“EMA”), Germany’s
PEI as well as other European national competent authorities, the Israeli Minister of Health (“MOH”), Japan’s Pharmaceuticals
and Medical Devices Agency (“PMDA”) and also the Ministry of Food and Drug Safety (“MFDS”) of South Korea.
Our Activities in the Food Tech Sector - Ever
After Foods
Ever After Foods is engaged
in the development and commercialization of innovative cultivated meat products, leveraging proprietary technology and expertise to create
sustainable, high-quality meat alternatives and to facilitate the production of cultivated meat and fish products by providing the necessary
technological infrastructure and support.
Ever After Foods’ key
operations are:
■
Research and Development: Ever After Foods is committed to advancing
cultivated meat technology. Its R&D efforts focus on:
-
Optimizing bioreactor processes for efficient production.
-
Enhancing the taste, texture, and nutritional value of cultivated meat
products.
■
Product Development: It is dedicated to creating a diverse range of
bioreactors with specialized scaffolds for cultivated meat production, emphasizing efficient and sustainable production processes.
■
Partnerships and Collaborations: It collaborates with industry leaders,
gaining access to valuable expertise, resources, and market channels through these strategic partnerships.
6
By combining cutting-edge
technology, a talented team, and strategic partnerships, we believe that Ever After Foods is poised to revolutionize the food industry
and offer consumers a sustainable and delicious alternative to traditional meat.
In February 2025, Ever After
Foods announced entering into a strategic collaboration with Bühler Group (“Bühler”), a leading global provider
of food processing technologies, to jointly advance scalable cultivated meat production systems. The collaboration aims to combine Bühler’s
engineering and market access capabilities with Ever After Foods’ proprietary edible packed-bed (EPB™) bioreactor platform
to deliver commercial-scale cultivated meat production systems specifically designed for the food industry. The parties intend to develop
and deploy manufacturing equipment that enables food producers to efficiently produce cultivated meat at significantly reduced cost and
at volumes suitable for market entry. The joint effort reflects a shared focus on addressing global food security challenges and supporting
the sustainable transition of protein systems. Under the collaboration, Ever After Foods and Bühler plan to accelerate commercial
availability of tailored production systems that can support industry-wide adoption of cultivated meat technologies.
Our Activities in the AgTech Sector
In October 2023, we
entered into a POC collaboration with ICL, a global specialty minerals company, through its Open Innovation program, to evaluate the
potential of our technology for enhancing the delivery of biostimulants in agriculture. The initial phase of the collaboration focused
on exploring the use of plant-derived bioactive compounds in combination with our proprietary platform to improve crop resilience and
yield under abiotic stress conditions. In December 2024, we signed an agreement to extend the collaboration with ICL, which reflects
a continued mutual interest in further developing and validating the underlying technology for agricultural applications.
In January 2024, we announced
the launch of our cell-based coffee business activity through a new business vertical, PluriAgTech, leveraging Pluri’s 3D cell
expansion and addressing the ongoing global demand for sustainable, high-quality coffee at mass scale production.
In March 2024, we
announced an important expansion to our intellectual property (“IP”) portfolio with a new patent approval from the
Israel Patent Office (“IPO”) that is designed to reshape the agricultural technology landscape. The patent represents a
major breakthrough in our proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various
applications, from sustainable agriculture to critical healthcare solutions.
In July 2024, we announced
the signing of a €1 million POC agreement with a leading international agriculture corporation. The collaboration, which remains
ongoing, is focused on enhancing global sustainable vegetable production, improving supply chain efficiency, and addressing climate-related
challenges. This initiative aims to support a more resilient and environmentally sustainable agricultural system through natural, innovation-driven
solutions.
Intellectual Property
We recognize that our success
depends, in part, on securing our intellectual property, and therefore we are committed to protecting our technology and product
candidates through patents and other means, as outlined below.
We are the sole owner of
193 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).
Based on the well-established
understanding that the characteristics and therapeutic potential of a cell product are largely determined by their source, the methods,
and conditions used during their culture, our patent portfolio includes various types of claims that protect the unique aspects of our
technology.
Our multi-national patent portfolio and pending
applications include claims directed at:
●
our proprietary 3D cell expansion methods for adherent cells,
including placental stromal cells and plant cells;
●
our proprietary 3D cell expansion methods for suspension cells, including
immune cells;
●
composition of matter claims covering the expanded cells;
●
therapeutic and cosmetic use of PLX cells for a broad range of indications;
and
●
devices and methods related to cell-culture, harvesting, thawing and
formulation, as well as cell therapies employing unmodified and engineered placenta-derived MAIT cells for the treatment of various
diseases.
7
Through our development of
adherent stromal cell-based products, we have built expertise and proprietary know-how, establishing robust procedures for the manufacturing
of clinical-grade PLX cells in our facilities. Leveraging this foundation, we have expanded our capabilities to include the handling
and expansion of suspension cells including immune cells, thereby broadening our platform in cellular therapies. Certain elements of
our manufacturing process are protected by issued patents and pending applications. In parallel, we safeguard proprietary aspects of
our technology, trade secrets and know-how, maintained through confidentiality agreements with our employees, consultants, contractors,
manufacturers and advisors. These agreements typically include provisions to protect confidential information, restrict material use
and require the assignment of inventions developed in the course of such engagement.
The following table outlines
our key patents and patent applications. It is not intended to represent a legal assessment of claims, scope, enforceability or limitations.
In certain instances, a jurisdiction may appear under both “pending” and “granted” status within a single patent
family, reflecting the existence of continuation or divisional applications filed in parallel with a granted patent.
The expiration dates of these
patents, based on filing dates, range from 2027 to 2044. Actual expiration dates will be determined according to extensions received
based on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), commonly known as the “Hatch-Waxman”
Act, which permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining FDA market approval. The
Hatch-Waxman Act is based on a U.S. federal law and therefore only relevant to U.S. patents.
There is a risk that our
patents will be invalidated, and that our pending patent applications will not result in issued patents. We also cannot be certain that
we will not infringe on any patents that may be issued to others. See “Risk Factors – The patent approval process is complex,
and we cannot be sure that our pending patent applications or future patent applications will be approved.”
Our Patent Portfolio
Patent Name/ Int. App. No.
Pending
Jurisdictions
Granted
Jurisdictions
Expiry Date
METHODS FOR CELL EXPANSION AND USES OF CELLS AND CONDITIONED
MEDIA PRODUCED THEREBY FOR THERAPY
PCT/IL2007/000380
Australia, Canada, China, Hong Kong, Europe (Spain, Germany, France, Belgium, Switzerland, Czech
Republic, Hungary, Ireland, Italy, The Netherlands, United Kingdom, Poland, Portugal, Denmark, Sweden, Slovakia), 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 (Germany, Switzerland, France, Ireland, Italy, the Netherlands),
Hong Kong, Israel, India, Japan, Mexico, Russia, United States, South Korea
September 2, 2028
METHODS OF TREATING INFLAMMATORY COLON DISEASES
PCT/IL2009/000527
United States, Israel
May 26, 2029
METHODS OF SELECTION OF CELLS FOR TRANSPLANTATION
PCT/IL2009/000844
Israel
September 1, 2029
ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY
PCT/IL2009/000846
Australia, Canada, China, Europe (Switzerland, Germany, France, United Kingdom, Italy), Hong Kong,
Israel, India, Mexico, Singapore, United States
September 1, 2029
8
ADHERENT CELLS FROM PLACENTA TISSUE AND USE THEREOF IN THERAPY
PCT/IL2009/000845
United States, Israel
September 1, 2029
ADHERENT STROMAL CELLS DERIVED FROM PLANCENTAS OF MULTIPLE
DONORS AND USES THEREOF
PCT/IB2011/001413
Israel
April 21, 2031
ADHERENT CELLS FROM PLACENTA AND USE OF SAME IN DISEASE TREATMENT
PCT/IB2010/003219
Australia, Canada, China, Europe (Switzerland, Germany, France, United Kingdom, Italy), Israel,
Mexico, United States
November 29, 2030
METHODS AND SYSTEMS FOR HARVESTING ADHERENT STROMAL CELLS
PCT/IB2012/000933
China
Australia, Canada, Europe (Belgium, Switzerland, Germany, France, United Kingdom, Ireland, Italy,
The Netherlands), Israel, India, South Korea, Mexico, Singapore, United States
April 15, 2032
METHODS FOR TREATING RADIATION OR CHEMICAL INJURY
PCT/IB2012/000664
United States
Europe (Belgium, Switzerland, Germany, France, United Kingdom, Ireland, The Netherlands), Hong
Kong, Israel, Japan, South Korea, United States
March 22, 2032
SKELETAL MUSCLE REGENERATION USING MESENCHYMAL STEM CELLS
PCT/EP2011/058730
United States
May 27, 2031
GENE AND PROTEIN EXPRESSION PROPERTIES OF ADHERENT STROMAL
CELLS CULTURED IN 3D
PCT/IB2014/059114
Israel, United States
February 20, 2034
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
ALTERED ADHERENT STROMAL CELLS AND METHODS OF PRODUCING AND
USING SAME
PCT/IB2016/053310
United States
June 6, 2036
METHODS AND COMPOSITIONS FOR TREATING CANCERS AND NEOPLASMS
PCT/IB2017/050868
Canada
Europe (Switzerland, Germany, France, United Kingdom), Israel
February 16, 2037
METHODS AND COMPOSITIONS FOR TREATING NEUROLOGICAL DISORDERS
PCT/IB2018/052806
Israel
April 23, 2038
METHODS AND COMPOSITIONS FOR PRODUCING CANNABINOIDS
PCT/IL2020/050477
United States
April 28, 2040
9
METHODS FOR EXPANDING ADHERENT STROMAL CELLS AND CELLS OBTAINED
THEREBY
PCT/IB2019/052569
Singapore, United States
March 28, 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
MODULAR BIOREACTOR
PCT/IB2019/058429
Europe, Israel, Hong Kong, South Korea, Singapore, United States
Israel, South Korea
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
Israel
March 11, 2040
METHODS AND COMPOSITIONS FOR AESTHETIC AND COSMETIC TREATMENT
AND STIMULATING HAIR GROWTH
PCT/IL2020/050363
United States
March 26, 2040
METHODS AND COMPOSITIONS FOR
ENRICHMENT OF TARGET CELLS
PCT/IL2021/020514
United States, Israel
May 5, 2041
PLACENTAL CELL TREATMENT FOR CRITICAL LIMB ISCHEMIA PATIENT
SUBPOPULATIONS
PCT/IL2022/050937
United States
August 29, 2042
SYSTEM AND METHODS FOR IMMUNE CELLS EXPANSION AND ACTIVATION
IN LARGE SCALE
PCT/IL2023/050529
Israel, South Korea, Europe, China, India, Japan, Singapore, Hong
Kong, Australia
Israel, South Korea, Australia, United States
May 23, 2043
A SYSTEM FOR 3D CULTIVATION OF PLANT CELLS AND METHODS OF USE
PCT/IL2024/050278
PCT, United States, Australia, China, Hong Kong, Europe, India,
Japan, South Korea, Singapore
Israel
March 18, 2044
GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT
T (MAIT) CELLS AND USES THEREOF
PCT/IL2024/050675
PCT
United States, China, Europe, Australia, Israel, India, Japan,
South Korea, Hong Kong
July 9, 2044
GENETICALLY ENGINEERED PLACENTAL MUCOSAL-ASSOCIATED INVARIANT
T (MAIT) CELLS AND USES THEREOF
PCT/IL2024/050670
PCT, United States
July 9, 2044
10
Ongoing Collaborations
EIB Finance Agreement
In April 2020, we and our
subsidiaries, Pluri Biotech and Pluristem GmbH, executed a finance agreement with EIB (the “EIB Finance Agreement”) for non-dilutive
funding of up to €50 million in the aggregate, payable in three tranches (the “EIB Loan”). The proceeds from the EIB
Finance Agreement were intended to support our R&D in the European Union to further advance our regenerative cell therapy platform,
and to bring the products in our pipeline to market. The initial funding period under the agreement was three years commencing on January
1, 2020.
During June 2021, we received
the first tranche in the amount of €20 million pursuant to the EIB Finance Agreement. The amount received is due to be repaid on
June 1, 2026, and bears annual interest of 4% to be paid together with the principal of the loan. We are currently in advanced discussions
with the EIB regarding a potential restructuring of the terms of the EIB Loan, which are currently focused on the new terms of the EIB
Loan, including an extension of the current maturity date of the EIB Loan. However, there is no certainty as to the outcome of these
discussions. As of June 30, 2025, the interest accrued was in the amount of approximately €3.27 million. In addition to the interest
payable, the EIB is also entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues
beginning in the fiscal year 2024 up to and including its fiscal year 2030, in an amount equal to up to 2.3% of our consolidated revenues
below $350 million, 1.2% of our consolidated revenues between $350 million and $500 million and 0.2% of our consolidated revenues exceeding
$500 million. As of June 30, 2025, we had an accrued royalty in the amount of $12 thousand. Since the initial funding period under the
EIB Finance Agreement ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.
Charité Agreement
In July 2007, we entered
into a five-year collaborative research agreement with the Charité, which was extended from time to time through June 2027. We
and Charité are collaborating on a variety of indications utilizing PLX cells. 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. Department of Defense
In August 2017, we announced
that a pilot study of our PLX-R18 cell therapy was initiated by the DoD. The study examined the effectiveness of PLX-R18 as a treatment
for ARS prior to, and within the first 24 hours of exposure to radiation. In July 2019, we presented positive results from a series of
studies of our PLX-R18 cell therapy product conducted by the DoD.
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NIAID Agreement
On July 11, 2023, we signed
a three-year $4.2 million contract with the NIAID, which is part of the NIH. We agreed to collaborate with the U.S. DoD’s AFRRI
and USUHS to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for H-ARS. H-ARS is a deadly
disease that can result from nuclear disasters and radiation exposure. The term of this contract was from July 1, 2023, through June
30, 2024, with an optional extension for an additional two-year period.
On June 6, 2024, the NIAID
exercised its option for year two of the three-year contract. During the 12 months period from July 1, 2024, through June 30, 2025, the
NIAID was to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to
develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.
On April 15, 2025, Pluri
Biotech received a formal notice of termination from the NIAID, according to which, the contract was terminated for the Government’s
convenience, and such termination was effective as of April 15, 2025. We believe that the termination of the contract may reflect broader
federal budgetary and administrative adjustments that have affected multiple health-related agencies, including the NIH. As of the date
of this Annual Report, we received a total of $2.3 million in funding under the contract.
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,
an international collaboration led by Charité. The goal of the PROTO project is to utilize our PLX-PAD cells for the treatment
of mild to moderate knee osteoarthritis.
In June 2025, the clinical
study was approved by the PEI. The study is being conducted at Charité together with an international consortium and under the
leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius
Wolff Institute and Center for Musculoskeletal Surgery.
ICL
In October 2023, we
signed a POC collaboration with ICL, through its Open Innovation program, to pioneer advanced bioactive carriers and bio stimulants.
This partnership aims to leverage natural delivery mechanisms within plants, boosting crop yields and fostering sustainability in agriculture.
In December 2024, we signed an agreement to extend this collaboration, reflecting continued mutual interest in further developing and
validating the underlying technology for agricultural applications.
Undisclosed - Leading international agriculture
corporation
In July 2024, we announced
the signing of a €1 million POC agreement with a leading international agriculture corporation (the “POC Party”) to
enhance the global sustainable vegetable supply. This strategic POC agreement is intended to boost the global vegetable product supply,
streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture. The
result of the planned collaboration has the potential to minimize environmental impact and foster greater food security, as well as to
build a better agronomic and environmentally friendly infrastructure, bringing sustainable, high-quality solutions to the market. Pursuant
to this POC agreement, the POC Party will provide its know-how and other IP rights related to vegetable products while the Company will
provide its know-how and other IP rights related to its proprietary 3D cell expansion technology to develop a solution aimed at increasing
the global vegetable products supply.
The POC Party is paying us
in three installments: the first installment was made upon the effective date of the POC agreement; the second installment was paid following
completion of Phase I of the POC and the POC Party’s written decision to proceed to the next phase; and the final installment will
be payable upon completion of Phase II. The POC Party may terminate the agreement with 14 days’ prior written notice following
the conclusion of either Phase I or Phase II.
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CRISPR-IL
In June 2020, we announced
that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA. CRISPR-IL brings together the leading experts
in life science and computer science from academia, medicine, and industry, to develop Artificial Intelligence (“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. CRISPR-IL was funded by the IIA with a total budget of approximately
$10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for an initial period of 18 months, with
a potential for extension of an additional 18 months, with additional budget from 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.
In-House Clinical Manufacturing
We maintain an in-house capability
for clinical cell manufacturing at our GMP-grade facility in Haifa, Israel, operational since February 2013 and previously approved for
the production of PLX-PAD and PLX-R18 for clinical use by multiple regulatory authorities, including the FDA, EMA, MFDS, PMDA, and the
MOH. The facility was approved by the MOH for a Phase III PLX-PAD trial and received GMP certification and manufacturer-importer
authorization, which remained valid through March 2023. In addition, the facility was inspected by a European Union Qualified Person
in December 2024, confirming compliance with current GMP requirements for the purposes of the PROTO clinical trial.
The facility continues to
operate in alignment with current GMP standards and principles under a self-declared compliance framework. We remain committed to maintaining
rigorous quality and regulatory practices consistent with applicable GMP principles.
Since 2024, our CDMO has
been working with pharmaceutical and biotech companies to offer manufacturing, development and other services. Based on over 15 years
of experience in GMP manufacturing, our highly skilled team and utilizing our proprietary technologies and flexible 4400 square meter
purpose-built facilities, PluriCDMO™ can offer comprehensive manufacturing support from preclinical development, through clinical
trials to commercial supply.
In January 2024, we
announced that we are offering cell therapy manufacturing services as a CDMO with the following key elements and services:
●
Process development and optimization;
●
Manufacturing from preclinical stages to commercial stages; and
●
Analytical development and testing: We offer a comprehensive range
of on-site analytical capabilities, including methods development to meet characterization requirements, gap assessment, method transfer,
and validation. Additionally, we maintain well-established relationships with relevant audited vendors to further support our clients’
needs.
Government Regulation – Pharma
The development, manufacturing,
and future commercialization of our cell therapy product candidates are subject to the laws and regulations of governmental authorities
in the United States, the European Union, Israel, and other potential markets, including Japan and South Korea.
13
In the United States and
the European Union, the FDA and the 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. Governments in other countries may have similar requirements for testing and marketing.
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 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. 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 (“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.
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.
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. The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires
the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale:
●
Submission
of an Investigational New Drug (“IND”) Application, which must become effective before clinical testing in humans can
begin;
●
Obtaining approval of Institutional Review Boards (“IRBs”)
of research institutions or other clinical sites to introduce the drug candidate into humans in clinical studies;
●
FDA may grant approval for EAP prior to the completion of clinical
studies, in order to allow access for the investigational drug, for patients that are excluded from the study;
●
FDA may grant priority review status to expedite the BLA review
process. Obtaining a Fast Track designation allows access to 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). In these cases, approval can be based on well controlled animal studies conducted under the
FDA Animal Rule;
●
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.
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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. 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. The EMA is expected to review and approve the Marketing Authorization Application (“MAA”).
Clinical Studies
Typically, in the United
States, as well as in the European Union, clinical development involves a series of clinical studies from early, small scale, Phase I
studies to late-stage large, Phase III studies, although the phases may overlap. 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 interaction of the drug with the human body, its side effects as well as early preliminary
information on effectiveness.
Phase II clinical studies
are conducted in a homogenous group of patients afflicted with the specific target disease, to explore preliminary efficacy, optimal
dosages and confirm the safety profile. In some cases, an initial study is conducted in patients to assess both preliminary efficacy
and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II study.
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 for efficacy,
as well as safety and potency. The Phase III studies are considered confirmatory for establishing the efficacy and safety 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.
During all phases of clinical
development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study
sites investigators to minimize risks and ensure high quality and integrity of the collected data. The sponsor of a clinical study is
required to submit an annual safety report to the relevant regulatory agencies, in which serious adverse events are reported, and to
submit in an expedited manner any individual serious adverse events that are suspected of being related to the tested drug and are unexpected
with its use. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that
have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.
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Government Regulations - Food Tech
Regulators around the world
are in the process of developing or implementing a regulatory approval process for cultivated meat. Although some companies have recently
received regulatory approval for their cultivated meat products in the United States, Israel and Singapore cultivated meat is not yet
generally commercially available. However, technologies like the one being developed by Ever After Foods are anticipated to facilitate
the scaling up of cultivated meat production. In general, cultivated meat production is subject to extensive regulatory laws and regulations.
In the United States, the FDA and the U.S. Department of Agriculture, or USDA, are in the process of developing guidance and regulations
applicable to cultivated meat.
In the cultivated plant-based
initiatives (e.g., coffee, cacao), we are working with an external regulatory consultant to evaluate the technical and scientific requirements
for determining whether our cultured coffee product is Generally Recognized as Safe, or GRAS, under section 201(s) of the Federal Food,
Drug, and Cosmetic Act, or FDCA, and FDA’s implementing regulations (21 C.F.R. § 170.30). If the plant-based cultivated products
(including all components) are determined to be GRAS in accordance with U.S. FDA requirements, it will be exempt from the definition
of “food additive” in section 201(s) of the FDCA and can therefore be lawfully marketed as a food in the United States without
the need to obtain a premarket authorization from the FDA.
Government Regulations- CDMO
Our CDMO business may be
subject to additional regulations, depending on the services we provide to companies under such business division.
Employees
As of June 30, 2025, we employed
a total of 127 full-time employees and 15 part-time employees, of whom 100 full-time employees and 11 part-time employees are engaged
in cell research, development, and manufacturing including clinical and regulation affairs.
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. We
face competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical
companies, biopharmaceutical companies, and governmental agencies. Some of the clinical indications we currently have under development
are also being investigated in preclinical and clinical programs by others.
According
to the Alliance for Regenerative Medicine’s July 2025 Report, there were a total of 2,096 cell-based therapies in development,
including 820 gene-modified and cellular immunotherapies, with 1,483 ongoing clinical trials registered globally, of which, 403 trials
were in solid tumors (Source: ARM Report H1 2025).
In the global market (excluding
China), while most allogeneic cell therapies remain in the preclinical stage, approximately 20 allogeneic Chimeric Antigen Receptor (“CAR”)-T
therapy products being studied for solid tumors have advanced into clinical stages. Notable examples include Adicet Bio’s allogeneic
CD70-CAR gamma-delta T cells, Poseida’s Allogenic MUC1-CAR Tscm cells, Fate’s allogeneic MICA/B-CAR T cells, and MD Anderson’s
TROP2-CAR NK cells (Source: GlobalData; Clinicaltrial.gov).
While there are hundreds
of companies in the regenerative medicine space globally, there are multiple participants in the cell therapy field based in the United
States, Europe, Japan, Korea, and Australia. Among other things, we expect to compete based upon our IP portfolio, our in-house manufacturing
efficiencies and capabilities, and the potential efficacy of our products. 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.
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Food Tech:
Ever After Foods operates
in a competitive landscape that includes both consumer-facing companies like Upside Foods, Believer Meats, and GOOD Meat, as well as
B2B players like Gelatex, Esco Aster, Ark Biotech, GEA and more. Unlike traditional technological production approaches that rely on
adapting cells to grow in stirred tank bioreactors, Ever After Foods has a unique proprietary technology that is optimized for natural
cell growth. This allows Ever After Foods to produce cultivated meat at a significantly lower cost and on a larger scale. Ever After
Foods’ unique technology, combined with an experienced team and strategic partnerships with industry leaders, provides us with
a strong competitive advantage in the cultivated food market.
AgTech:
The AgTech industry continues
to evolve, driven by advancements in biotechnology, sustainability initiatives, and the transformation of traditional farming practices
into more efficient and environmentally responsible approaches. Competitors in this domain include companies focused on plant cell culture
for specialty ingredients, such as California Cultured, Inc. and Ayana Bio LLC, as well as established producers of plant-derived compounds
and flavors, including DSM Firmenich AG and Givaudan International SA. We believe that our competitive positioning is derived from our
technology platform capabilities and our innovative developments. We also believe that our ability to compete successfully will depend
on our continued innovation, the scalability of our production systems, and the consistent improvement of our unique technological capabilities.
As part of our AgTech operations,
we are currently advancing two principle product streams (which are also referred herein collectively as our plant-based vertical) -
cell-cultured coffee through Coffeesai, and cell-cultured cacao via Kokomodo, both leveraging our shared technological foundation and
competing in distinct markets with different dynamics. Our proprietary 3D cell expansion platform, originally developed by our biotechnology
subsidiary, Pluri Biotech, enables efficient, high-volume, and consistent cultivation of plant cells in controlled environments. We believe
that this platform provides meaningful advantages in scalability, cost-efficiency and product quality, positioning us to address critical
challenges in cellular agriculture that competitors often face in achieving industrial-scale production.
Coffeesai operates in the
emerging field of cell-cultured coffee, which currently includes a limited number of participants, such as California Cultured, Inc.,
Food Brewer AG, Another Food Pte. Ltd., and Atomo Foods, Inc. - each pursuing innovative approaches to sustainable coffee production.
Within this early-stage competitive landscape, we believe that Coffeesai differentiates itself through its integration of advanced scale-up
technology, proprietary bioprocessing expertise and deep scientific know-how, all of which contribute to an efficient, cost effective
and sustainable production model. These capabilities, combined with potential partnerships across the coffee value chain, may offer Coffeesai
a strategic advantage in shaping the future of sustainable coffee.
Our cacao business, Kokomodo,
operates in a similarly dynamic and environment focused on cellular agriculture for cacao and cocoa-derived ingredients. Current participants
in this space include Celleste Bio Ltd., California Cultured, Inc., and Food Brewer AG, all of which aim to develop alternatives to conventional
cacao cultivation in response to growing concerns about climate impact, supply volatility, and ethical sourcing. Kokomodo seeks to differentiate
itself by leveraging the same advanced 3D cell expansion platform and bioprocess optimization strategies that underpin Coffeesai, enabling
the potential for consistent, large-scale production of high-quality cacao ingredients. We believe that this combination of technological
innovation, process efficiency, and industrial scalability positions Kokomodo to play a significant role in the development of sustainable
solutions for the global chocolate industry.
17
CDMO:
We compete in the cell therapy
CDMO services with several companies like Lonza Group AG, AGC Biologics A/S and Charles River Laboratories International, Inc. for outsourced
services from development to manufacturing in biotechnology and pharmaceutical cell-based products. The majority of our competitors are
large service providers with multiple offerings for different technologies, range of dosage form capabilities and medicine products.
The competition is driven
by geographic location, technological capabilities, operational capacity, manufacturing expertise, and price.
While there are multiple
competitors that compete in the CDMO services, we have a few competitors that compete in advanced stages of cell therapy clinical trials
and can provide access to state-of-the-art manufacturing efficiency and capabilities.
Our ability to compete successfully
will depend on our continued ability to attract and retain customers, support clinical development, identify new opportunities and keep
expanding our unique know-how, technology and manufacturing capabilities.
Available Information
Additional information about
us is available on our website at www.pluri-biotech.com. Information contained on, or accessible through, our website is not incorporated
by reference into, and should not be considered part of this Annual Report. Under the “Financial Reports” and “SEC
Filings” subsections of the “Investors” section on our website, 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, are available as soon as reasonably practicable after we electronically file such
material with, or furnish it to, the SEC. Our reports filed with the SEC are also made available on the SEC’s website at www.sec.gov.
The following Corporate Governance documents are also posted on our website under the “Governance” subsection of the “Investors”
section: Trading Policy, Code of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist Financing
Compliance Policy, Clawback Policy and the Charters for each of the Committees of our Board of Directors (the “Board”).