Item 2. Management’s Discussion and Analysis
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
Forward-Looking Statements
This Quarterly Report on Form
10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other
Federal securities laws, and is subject to the safe-harbor created by such Act and laws. Forward-looking statements may include statements
regarding our goals, beliefs, strategies, objectives, plans, including product and technology developments, future financial conditions,
results or projections or current expectations. In some cases, you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,”
“estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other
variations thereon or comparable terminology. These statements are merely predictions and therefore inherently subject to known and unknown
risks, uncertainties, assumptions, and other factors that may cause actual results, performance levels of activity, or our achievements,
or industry results to be materially different from those contemplated by the forward-looking statements. Such forward-looking statements
appear in Item 2 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and
may appear elsewhere in this Quarterly Report on Form 10-Q and include, but are not limited to, statements regarding the following:
●
the expected development, time-to-market and potential benefits from our products and ventures, based on our cell-based technology platform in regenerative medicine, immunotherapy, food technology (“food tech”), agriculture technology (”AgTech”), wellness and longevity, and our Contract Development and Manufacturing Organization (“CDMO”) business, as well as potentially in other industries and verticals that have a need for our mass-scale and cost-effective cell expansion platform;
●
our expectations of market and industry growth;
●
the prospects of entering into additional license agreements, joint ventures, partnerships or other forms of cooperation with other companies, government institutes, research organizations and medical institutions, and the ability to maintain those agreements, joint ventures, partnerships or other forms of cooperation;
●
our ability to attract clients for our CDMO business;
●
our pre-clinical and clinical study plans, including timing of initiation, expansion, enrollment, results, and conclusion of trials;
●
achieving regulatory approvals;
●
receipt of future funding from the Israel Innovation Authority (“IIA”), the European Union’s Horizon programs, as well as grants from other independent third parties;
●
the capabilities of our placenta expanded (“PLX”) cells, including future collaborations, to further advance the development of our PLX- PAD and PLX-R18 cell therapy as a potential new treatment;
●
the expected clinical development of a new allogeneic placental Mucosal Associated Invariant T (“MAIT”), and the potential benefits it can produce for advanced cell-based therapies for immune disorders and oncology diseases;
●
our expectation to solve medicine’s unmet needs and demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity;
●
the possible impacts of cybersecurity incidents on our business and operations;
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●
our expectations regarding our short and long-term capital requirements, including our discussions with the European Investment Bank (“EIB”) about the restructuring of the EIB Loan (as defined below) and the outcome of such discussions;
●
our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses;
●
information with respect to any other plans and strategies for our business;
●
conditions in the Middle East, including ongoing hostilities involving Israel, Iran and terrorist organizations such as Hamas, Hezbollah, Ansar Allah (Houthis) and other non-state organizations, as well as geopolitical tensions with other regional countries, may affect economic and market conditions where we operate and could directly impact our business, results of operations and financial condition;
●
developments in international trade policy, such as tariffs, sanctions, and other trade barriers imposed by the U.S. or other countries, which could affect our sourcing and distribution channels, increase costs, or otherwise negatively impact our operations and financial results; and
●
our ability to maintain compliance with Nasdaq Listing Rule 5550(b)(2), which requires us to maintain a minimum of $35 million in market value of listed securities (“MVLS”) for continued listing on the Nasdaq Capital Market.
Our business and operations
are subject to substantial risks, which increase the uncertainty inherent in the forward-looking statements contained in this report.
In addition, historical results
of scientific research and development (“R&D”), clinical and preclinical trials, do not guarantee that the conclusions
of future R&D or trials will not suggest different conclusions. Also, historical results referred to in this periodic report may be
interpreted differently in light of additional research, development, clinical and preclinical trials results. Except as required by law,
we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect
events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors
that could affect our business is described under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form
10-K for the fiscal year ended June 30, 2025 (the “2025 Annual Report”), as well as in Part II, Item 1A of this Quarterly
Report. Readers are also urged to carefully review and consider the various disclosures we have made in that report.
As used in this Quarterly
Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company” and “Pluri”
refer to Pluri Inc., together with its wholly owned Israeli subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”) and the subsidiaries
of Pluri Biotech, including its wholly owned Israeli subsidiaries, Coffeesai Ltd. (“Coffeesai”) and Cellav Health and Aesthetics
Ltd. (“Cellav”), its majority-owned Israeli subsidiaries, Kokomodo Ltd. (“Kokomodo”) and Ever After Foods Ltd.
(“Ever After Foods”) and its wholly owned German subsidiary, Pluristem GmbH (collectively, the “Subsidiaries”),
unless otherwise indicated or as otherwise required by the context.
Overview
We are a biotechnology company
leveraging our proprietary three-dimensional (“3D”) cell expansion platform, which is supported by an in-house, industrial-scale
cell manufacturing facility and operated in accordance with Good Manufacturing Practice (“GMP”) standards on a self-declared
basis. We utilize our technology platform to enable scalable and cost-efficient cell expansion and to support a range of cell-based products,
services, therapeutics and related technologies. The platform is currently applied in practice across multiple business areas, including
regenerative medicine, wellness and longevity, food technology, agricultural technology, and through our CDMO activities.
Our operations pursue a variety
of initiatives that leverage the Company’s technology across diverse applications and industries, as set forth below:
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Cell Therapy
We use our advanced cell-based
technology platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates for the treatment
of inflammatory, muscle injuries and hematologic conditions. In addition, we are advancing a proprietary immunotherapy platform based
on novel technology.
PLX Cells - Our PLX
cells are adherent stromal cells that are expanded using our 3D platform. Our PLX cells can be administered to patients off-the-shelf,
without blood or tissue matching or additional manipulation prior to administration. PLX cells are believed to release a range of therapeutic
proteins in response to the patient’s condition.
In the pharmaceutical area,
we have focused on several indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery
for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia, Chronic Graft versus Host Disease
(“GvHD”), knee osteoarthritis and a potential treatment for Hematopoietic Acute Radiation Syndrome (“H-ARS”).
Some of these studies have been completed while others are still ongoing. We believe that each of these indications is a severe unmet
medical need.
Immunotherapy MAIT cells
- In May 2024, we launched a novel allogeneic immunotherapy platform utilizing MAIT cells specifically designed to address solid tumors
- a critical area in medicine where effective treatments are currently insufficient. We believe that our MAIT cells, isolated from the
human placenta, offer substantial potential benefits compared to conventional T-cells.
Placental MAIT cells
are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine
receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional autologous T-cells typically collected
from peripheral blood, our MAIT cells are designed to be an allogenic universal product. Given their highly restricted T-cell receptor
profile, the MAIT cells minimize their likelihood of inducing GvHD, a significant advantage over other potential allogeneic products.
We are aiming to design the MAIT cells to potentially show better persistence in the body for a longer duration, enhancing their therapeutic
efficacy.
PluriCDMO™ -
In January 2024, we launched a business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™
offers cell therapy development and 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 related services. We
have entered into several agreements with clients through PluriCDMO™ and are actively generating revenues as a result of such agreements.
AgTech
We are involved in several
initiatives leveraged by Pluri’s 3D cell expansion in the AgTech field, including:
(a) a proof-of-concept (“POC”)
collaboration with ICL Group Ltd., a global specialty minerals company, through its Open Innovation program, to improve bio stimulant
delivery and enhance yield sustainably;
(b) a strategic POC agreement
with an 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.
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Kokomodo - On
April 28, 2025, we completed the acquisition of approximately 79% of the equity in Kokomodo (held as a majority owned subsidiary of our
wholly owned subsidiary, Pluri Biotech). Kokomodo, an Israeli company, is an innovative agfood startup pioneering the sustainable production
of cacao using cellular agriculture technology. Instead of relying on traditional tropical farming, Kokomodo cultivates real cacao directly
from plant cells in controlled environments, such as bioreactors, making climate-resilient cacao accessible year-round on a global scale.
Founded in 2024, Kokomodo aims to transform the cacao industry, reducing environmental impact while ensuring a steady, high-quality supply
for chocolate and related products.
Food Tech
Ever After Foods
- In 2022, we announced the establishment of a joint venture with Tnuva Food Industries - Agricultural Cooperative in Israel Ltd. (“Tnuva”),
Ever After Foods, incorporated under the laws of the State of Israel. The purpose of the joint venture is to develop and commercialize
scalable production technologies for cultivated meat, supporting the development of a wide range of cultivated meat products with industry
partners.
Leveraging Pluri’s innovative
technology, Ever After Foods has rapidly advanced its scalable production platform, developing a business-to-business (“B2B”),
version of its proprietary technology system, Ever After Foods has demonstrated the natural production of muscle and fat tissues for various
animal cells, ensuring taste, feel, and texture akin to conventional animal-derived meat.
In June 2024, we entered into
a share purchase agreement by and among Ever After Foods, Tnuva, and certain other international strategic investors, pursuant to which
Ever After Foods issued and sold, ordinary shares in a private placement offering (the “Ever After Foods Offering”), for aggregate
gross proceeds of $10 million. As part of the Ever After Foods Offering, we invested $1.25 million. In addition, our wholly owned subsidiary,
Pluri Biotech, and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024 (the “Amended
License”). The Amended License amended the parties’ existing license agreement dated as of February 23, 2022, to expand the
scope of the license to include fish and seafood.
The $10 million funding round
supports Ever After Foods’ B2B technology platform, positioning it as a sustainable technology enabler. Following the closing of
the Ever After Foods Offering, Pluri Biotech holds approximately 69% of Ever After Foods.
In February 2025, Ever After
Foods announced a strategic collaboration with Bühler, to jointly advance scalable 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 costs and at volumes suitable for market entry.
Aesthetics and Wellness
Cellav - In
November 2025, we established Cellav, a wholly owned subsidiary focused on developing regenerative skin and hair solutions using our proprietary
3D cell expansion technology. Cellav develops, manufactures and markets skin care and cosmetic products and cell-derived ingredients,
including exosomes and cell ingredients (human or plant-derived), conditioned media for integration into third-party formulations and
for use in professional and consumer skincare and haircare products. These products and ingredients may also be offered as finished, ready-to-sell
products, professional kits or consumable products.
During the nine-months period
ended March 31, 2026, and through the date of this report, we continued to advance our activities across our foodtech, AgTech and cell-based
aesthetics and wellness subsidiaries. Each of Ever After Foods, Kokomodo, Coffeesai and Cellav entered into collaboration agreements with
leading collaboration partners in Asia, Europe, and the United States to evaluate and potentially further develop applications of our
proprietary technologies in their respective fields. These collaborations are structured around initial, partner-funded POCs or pilot
programs, designed to assess the application of our technologies in cultivated meat, cacao, coffee, and cell-based skincare, and may,
subject to positive outcomes, be expanded into subsequent development or commercialization activities. Collectively, we believe that these
collaborations underscore the growing commercial and technological validation of our platform and enhance our strategic positioning across
multiple industries.
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RESULTS OF OPERATIONS – THREE AND NINE
MONTHS ENDED MARCH 31, 2026 COMPARED TO THREE AND NINE MONTHS ENDED MARCH 31, 2025
Revenues
Revenues for the nine-month
and three-month periods ended March 31, 2026, were $681,000 and $167,000, respectively, as compared to $938,000 and $427,000 during the
nine-month and three-month periods ended March 31, 2025, respectively. Revenues for the nine-month and three-month periods ended March
31, 2026, and 2025 were primarily generated from services provided to CDMO clients for process and product development and additional
revenues from POC collaborations in the AgTech field. The decrease in revenues for each of the nine-month and three-month periods ended
March 31, 2026, was primarily driven by a lower volume of project activity as compared to the corresponding periods in fiscal year 2025.
Cost of Revenues
Cost of revenues for each
of the nine-month and three-month periods ended March 31, 2026, were $424,000 and $111,000, respectively, as compared to $491,000 and
$291,000 during the nine-month and three-month periods ended March 31, 2025, respectively. Cost of revenues includes manufacturing costs
related to our CDMO and AgTech fields, which primarily consist of materials, personnel-related and overhead costs. The decrease in cost
of revenues for each of the nine-month and three-month periods ended March 31, 2026, was primarily driven by a lower volume of project
activity as compared to the corresponding periods in fiscal year 2025, resulting in reduced materials usage, personnel costs and allocated
overhead.
Research and Development Expenses (“R&D”),
Net
R&D expenses, net
(costs less participation by the IIA, Horizon Europe and the National Institute of Allergy and Infectious Diseases
(“NIAID”)) for the nine-month period ended March 31, 2026, increased by 32% from $8,857,000 for the nine-month
period ended March 31, 2025, to $11,719,000. The increase was mainly attributable to (1) an increase in salaries and related
expenses due to foreign exchange differences and the addition of new employees following the acquisition of our subsidiary,
Kokomodo, partially offset by headcount reductions and the implementation of a cost-reduction plan, (2) an increase in lease
expenses on our facilities mainly due to Ever After Foods’ new operating facility, and (3) an increase in share-based
compensation expenses related to Ever After Foods’s options granted to an Ever After Foods’s employee, partially offset
by (4) a decrease in participation by NIAID and (5) a decrease in R&D expenses following POC activities in our subsidiaries.
R&D expenses, net (costs
less participation by the IIA, Horizon Europe and the NIAID) for the three-month period ended March 31, 2026, increased by 30% from
$3,043,000 for the three-month period ended March 31, 2025, to $3,962,000. The increase was mainly attributable to the same reasons described
in the preceding paragraph.
General and Administrative Expenses
General and
administrative expenses for the nine-month period ended March 31, 2026, increased by 11% from $7,145,000 for the nine-month
period ended March 31, 2025, to $7,930,000. The increase was mainly attributable to (1) an increase in share-based compensation
expenses related to restricted shares (“RS”), which were granted during the reporting period to consultants, as well as
restricted stock units (“RSUs”) and options granted to our Chief Executive Officer (“CEO”) in recognition of
the achievement of certain performance objectives and other accomplishments during fiscal year 2025, and to Ever After Foods’s
options granted to an Ever After Foods’s employee; and (2) an increase in salaries and related expenses primarily due to
foreign exchange differences, the addition of new employees following the acquisition of our subsidiary, Kokomodo, partially offset
by (3) a reduction in our CEO’s salary, whereby he waived 25% of his salary from July through December 2025, and 30% of his
salary between January and February 2026, as well as the implementation of a cost-reduction plan, which included a reduction in
headcount, and (4) a decrease in expenses related to corporate activities, such as professional services expenses.
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General and
administrative expenses for the three-month period ended March 31, 2026, increased by 6% from $2,493,000 for the three-month period
ended March 31, 2025, to $2,630,000. The increase was mainly attributed to an increase in share-based compensation expenses related
to RS which were granted during the current period to consultants, as well as Ever After Foods’s options granted to an Ever
After Foods’s employee, partially offset by a decrease in expenses related to corporate activities, such as professional
services expenses.
Other Financial Income (expenses), net
Other financial income (expenses),
net, increased from $714,000 in financial income for the nine-month period ended March 31, 2025, to $889,000 in financial income for the
nine-month period ended March 31, 2026. The increase was mainly attributable to (1) exchange rate differences expenses related to the
EIB Loan (as defined below) following fluctuation between the U.S. dollar against the Euro, and (2) an increase in income derived from
hedging transactions, partially offset by (3) a decrease in interest income from deposits, due to lower deposit balances following withdrawals,
and (4) a decrease due to exchange rate expenses on a lease liability and on deposits due to the strength of the New Israeli Shekel (“NIS”),
against the U.S. Dollar.
Other financial income (expenses),
net, increased from $723,000 in financial expenses for the three-month period ended March 31, 2025, to $593,000 in financial income for
the three-month period ended March 31, 2026. The increase was mainly attributable to (1) exchange rate differences expenses related to
the EIB Loan (as defined below) following fluctuation between the U.S. dollar against the Euro, and (2) an increase in income derived
from hedging transactions, partially offset by (3) a decrease in interest income from deposits, due to lower deposit balances following
withdrawals, and (4) a decrease due to exchange rate expenses on a lease liability and due to the strength of NIS, against the U.S. Dollar.
Interest Expenses
Interest expenses related
to our outstanding loan from the EIB and all changes during the nine-month and three-month periods ended March 31, 2026, compared to the
nine-month and three-month periods ended March 31, 2025, were attributable solely to currency rate differences of the Euro compared to
the U.S. dollar.
Net Loss
Net losses for the nine-month
and three-month periods ended March 31, 2026, were $19,176,000 and $6,172,000, respectively, as compared to net losses of $15,481,000
and $6,335,000 for the nine-month and three-month periods ended March 31, 2025, respectively. The changes were mainly due to the change
in R&D expenses, net, general and administrative expenses and financial income, net, for the reasons mentioned above.
We had a net loss attributed
to our non-controlling interest with respect to Ever After Foods and Kokomodo of $1,235,000 and $624,000 for the nine-month and three-month
periods ended March 31, 2026, respectively, as compared to $496,000 and $188,000, for the nine-month and three-month periods ended March
31, 2025, respectively, with respect to Ever After Foods.
Net loss per share attributed
to shareholders for the nine-month and three-month periods ended March 31, 2026, were $1.90 and $0.55, respectively, as compared to $2.56
and $0.94 for the nine-month and three-month periods ended March 31, 2025, respectively. The decrease in the loss per share was due primarily
to an increase in our weighted average number of shares outstanding which reflects the issuance of additional shares in the First Offering
and the Second Offering (as defined below), (see “Liquidity and Capital Resources” Section below), the issuance of additional
shares upon the vesting of RSUs and RS issued to directors, employees and consultants and exercise of pre-funded warrants, partially offset
by an increase in the loss for the year.
For the nine-month and three-month
periods ended March 31, 2026, and 2025, we had weighted average common shares outstanding of 9,431,741, 10,054,803 and 5,857,743, 6,563,555,
respectively, which were used in the computations of net loss per share for such nine-month and three-month periods.
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Liquidity and Capital Resources
As of March 31, 2026, our
total current assets were $10,463,000 and total current liabilities were $32,006,000. On March 31, 2026, we had a working capital deficit
of $21,543,000, total deficit of $12,999,000, out of which $5,604,000 was attributed to the non-controlling interest in Ever After Foods
and Kokomodo, and an accumulated deficit of $460,996,000.
Our cash and cash equivalents,
restricted cash and short-term bank deposits as of March 31, 2026 amounted to $9,548,000, compared to $26,680,000 as of March 31, 2025,
and compared to $21,035,000 as of June 30, 2025. Cash balances changed in the nine-month period ended March 31, 2026, compared to the
nine-month period ended March 31, 2025, for the reasons presented below.
Net cash used for operating
activities increased to $15,145,000 during the nine-month period ended March 31, 2026, compared to $12,995,000 during the nine-month period
ended March 31, 2025, primarily due to an increase in exchange rate, an increase in salaries following the acquisition of our subsidiary,
Kokomodo, and a decrease in grants received from the IIA and NIAID contract funding, partially offset by an increase in cash generated
from services provided to CDMO clients for process and product development, income from fees in the AgTech sector, and a reduction in
payments to suppliers, subcontractors, professional service providers, and consultants.
Investing activities provided
cash in the amount of $8,294,000 in the nine-month period ended March 31, 2026, compared to cash provided in the amount of $4,998,000
for the nine-month period ended March 31, 2025. Cash provided by investing activities for the nine-month period ended March 31, 2026,
consisted primarily of proceeds from short-term deposits, net of $8,901,000, partially offset by payments of $607,000 related to investments
in property and equipment. Cash provided by investing activities for the nine-month period ended March 31, 2025, consisted primarily
of proceeds from short-term deposits, net of $5,895,000, partially offset by payments of $897,000 related to investments in property
and equipment.
Financing activities provided cash in the amount of $4,221,000 in the nine months ended March 31, 2026, compared
to financing activities which provided cash in the amount of $9,968,000 in the nine months ended March 31, 2025. Cash provided by financing
activities for the nine-month period ended March 31, 2026, was related to net proceeds received from the issuances of common shares and
warrants, net of issuance costs related to the First Offering (as defined below), the Second Offering (as defined below) and the Sales
Agreement with A.G.P (as defined below), as well as, proceeds related to the SAFE Agreements (as defined below). Cash provided by financing
activities for the nine-month period ended March 31, 2025, consisted primarily of proceeds received from issuances of common shares,
pre-funded warrants and warrants, net of issuance costs.
In July 2025, our CEO agreed
to forgo 25% of his gross monthly salary, in the aggregate amount of NIS 148,500 for a period of six months commencing July 2025.
On October 15, 2025, the Company’s
Board of Directors (the “Board”) approved a grant of equity awards to our CEO, in recognition of the achievement of certain
performance objectives and other accomplishments during fiscal year 2025. The approved equity awards consisted of (i) 39,050 RSUs which
were fully vested at the time of grant, and (ii) options to purchase 39,050 common shares of the Company which were fully vested at the
time of grant and exercisable for a period of three years at an exercise price of $5.00 per share. As the performance objectives for fiscal
year 2025 were satisfied through share-based awards rather than cash compensation, the provision previously recorded in the amount of
approximately $41,000, was reversed.
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On November 13, 2025, Kokomodo
entered into a Simple Agreement for Future Equity agreement with an investor for an aggregate amount of $300,000 and on March 17, 2026,
with another investor for an aggregate amount of $129 (the “SAFE Agreements”). Pursuant to the terms of the SAFE agreements,
in the event of an Equity Financing, which is defined in the SAFE Agreements as a capital raising transaction or series of transactions,
pursuant to which (i) Kokomodo issues and sells a new series of preferred shares of Kokomodo at a fixed pre-money valuation; and (ii)
at least 25% of the amount of the capital raised is not attributed to the SAFE Investors (as defined in the SAFE Agreements), the investment
will be automatically converted into the number of most senior preferred shares of Kokomodo, equal to the purchase amount divided by either:
(1) the price per share equal to a Valuation Cap (as defined in the SAFE Agreements) divided by Kokomodo Capitalization (as defined in
the SAFE Agreements), or (2) the price per preferred share sold in the Equity Financing discounted by 20%. The SAFE Agreements were classified
as a long-term liability, accounted at fair value, with remeasurement at each reporting period.
On December 4, 2025, in order
to ensure the Company’s financial stability, the Board approved, at the recommendation of the Company’s management, (i) a
30% gross monthly salary reduction in the aggregate amount of NIS 59,400 to Mr. Yanay, our CEO, applicable to the months of January 2026
and February 2026, (ii) a 20% gross monthly salary reduction in the aggregate amount of NIS 33,000 to Mrs. Zalts, our Chief Financial
Officer (“CFO”), applicable to the months of December 2025, January 2026 and February 2026, and (iii) a 20% monthly fee
reduction to the fees that are paid to the Company’s directors applicable to the months of December 2025 through February 2026.
On December 4, 2025, the Board
approved a grant of 10,248 RSUs, in aggregate, to the CEO and CFO and an aggregate of 2,885 RSUs to Board members in lieu of cash compensation
under the Company’s 2019 Equity Compensation Plan, with all RSUs vesting in equal monthly installments over three months. These
grants were made to support the Company’s cost-management initiatives and to align leadership incentives with long-term performance
objectives.
Effective December 4, 2025,
Mr. Alexandre Weinstein, an existing shareholder and a director of the Company, was appointed by the Board as Chairman of the Board, and
Mr. Zami Aberman, who had held the position as Chairman of the Board since January 2022, was appointed by the Board as Vice Chairman of
the Board. In connection therewith, Mr. Aberman’s consultancy agreement with the Company terminated effective January 4, 2026. Following
the termination of the consultancy agreement, Mr. Aberman is entitled to receive compensation in accordance with the Company’s Directors
Compensation policy.
On December 8, 2025, we entered
into a Securities Purchase Agreement (the “First Securities Purchase Agreement”) with Chutzpah Holdings LP (the “Purchaser”),
a limited partnership beneficially owned by Mr. Weinstein, relating to a private placement offering (the “First Offering”)
of: (i) 625,000 common shares of the Company, and (ii) warrants (the “First Common Warrants”) to purchase up to 625,000 common
shares. The combined purchase price for each common share and accompanying First Common Warrant was $4.00. The First Common Warrants were
exercisable immediately at an exercise price of $4.25 per share and are exercisable until June 30, 2026. The First Common Warrants contain
customary anti-dilution provisions and are subject to a 35% beneficial ownership limitation.
On December 30, 2025, the
First Offering closed and the Company received gross proceeds in the amount of $2.5 million, which it is using for working capital and
general corporate purposes.
On March 25, 2026, we entered
into an additional Securities Purchase Agreement (the “Second Securities Purchase Agreement”), effective as of March 24, 2026,
with Chutzpah Holdings LP (the “Second Offering”), of: (i) 625,000 common shares of the Company, and (ii) warrants (the “Second
Common Warrants”), to purchase up to 625,000 common shares. The Second Offering price per share and accompanying Second Common Warrant
was $4.00. The Second Common Warrants have an exercise price of $4.25 per share and are exercisable commencing on their issuance date
and until the expiration of the eighteen-month anniversary following the closing of the Second Offering. The Second Common Warrants contain
customary anti-dilution provisions and are subject to a 35% beneficial ownership limitation.
27
The Second Offering closed
in two installments: 50% closed on March 31, 2026, and the remaining 50% closed on April 21, 2026, each generating gross proceeds of $1.25
million. The Second Common Warrants were issued in two installments in connection with the two closings of the Second Offering, with 50%
of the Second Common Warrants issued on March 31, 2026, and the remaining 50% issued on April 21, 2026, and each installment is exercisable
from its respective issuance date until the eighteen-month anniversary of such issuance date. The proceeds are intended for working capital
and general corporate purposes.
On February 13, 2024, we entered
into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”), as sales agent,
pursuant to which we may issue and sell our common shares having an aggregate offering price of up to $10 million, from time to time through
A.G.P. During the nine-month period ended March 31, 2026, the Company sold 23,300 common shares under the Sales Agreement at an average
price of $3.89 per share, with issuance expenses of $43,000. As of May 14, 2026, the Company had sold a total of 79,029 common
shares under the Sales Agreement at an average price of $4.97 per share.
We have an effective Form
S-3 registration statement (File No. 333-273347), filed under the Securities Act of 1933, as amended (the “Securities Act”),
with the SEC using a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell
our common shares, preferred stock and warrants to purchase common shares, and of two or more such securities, in one or more offerings
for an aggregate initial offering price of $200 million (including amounts sold under the Sales Agreement).
In April 2020, we and our
subsidiaries, Pluri Biotech and Pluristem GmbH, entered into a finance agreement with the EIB, providing for non-dilutive funding of up
to €50 million, payable in three tranches (the “EIB Loan”). In June 2021, the Company received the first tranche
in the amount of €20 million, which represents the only amount disbursed under the EIB finance agreement, as the initial funding
period expired on December 31, 2022 and no additional funds are made available thereunder.
The €20 million loan
bears annual interest at a rate of 4% and is repayable on June 1, 2026, with interest payable together with the principal. As of March
31, 2026, accrued interest amounted to approximately €3.9 million. In addition to the interest, the EIB is entitled to royalty payments,
pro-rated to the amount disbursed from the EIB Loan, on the Company’s consolidated revenues from fiscal year 2024 through fiscal
year 2030, at rates of up to 2.3% on consolidated revenues below $350 million, 1.2% on consolidated revenues between $350 million and
$500 million, and 0.2% on consolidated revenues exceeding $500 million. As of March 31, 2026, accrued royalties amounted to $6 thousand.
On April 21, 2026, we received a notice from the EIB reserving its rights under the finance agreement; however, discussions with the EIB
regarding potential alternatives with respect to the EIB Loan, including a possible extension of its maturity date, remain ongoing. There
can be no assurance as to the outcome of these discussions or the timing or terms of any resolution.
On July 11, 2023, we signed
a three-year $4.2 million contract with the NIAID, which is part of the National Institute of Health (“NIH”). We will collaborate
with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute and the Uniformed Services University of Health
Sciences to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS. H-ARS is a deadly disease
that can result from nuclear disasters and radiation exposure. The term of this contract was from July 1, 2023, through June 30,
2024, with an optional extension for an additional two-year period.
On June 6, 2024, the NIAID
exercised its option for year two of the three-year contract. During the 12 months period from July 1, 2024, through June 30, 2025, the
NIAID was to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to
develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.
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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 report,
we received a total of $2.3 million in funding under the contract.
Non-dilutive grants
Israel Innovation Authority (IIA)
According to the IIA grant
terms, we are required to pay royalties at a rate of 3% on sales of products and services derived from technology developed using this
and other IIA grants until 100% of the dollar-linked grants amount plus interest are repaid. In the absence of such sales, no payment
is required. Through March 31, 2026, total grants obtained from the IIA aggregated to approximately $28.2 million and total royalties
paid and accrued amounted to $179 thousand.
The IIA may impose certain
conditions on any arrangement under which the IIA permits the Company to transfer technology or development out of Israel or outsource
manufacturing out of Israel. While the grant is given to the Company over a certain period of time (usually a year), the requirements
and restrictions under the Israeli Law for the Encouragement of Industrial Research and Development, 1984, continue and do not have a
set expiration period, except for the royalties, which requirement to pay them expires after payment in full.
On October 28, 2024, we announced
that the IIA will fund our collaboration with Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), to support
the continued development of MAIT cells for the treatment of solid tumors. As part of this collaboration, novel Chimeric Switch Receptors,
developed by Prof. Cohen, head of laboratory of tumor immunology and immunotherapy at Bar-Ilan University, will be integrated into our
CAR-MAIT cell therapy platform to enhance tumor specificity and therapeutic efficacy. The collaboration leverages our proprietary MAIT
cell technology alongside BIRAD’s expertise in engineering clinically optimized T-cell modification vectors. The IIA has committed
to funding the collaboration for an initial term of one year, with an option to extend it for an additional year. During October 2025,
we received approval for an additional month to finish the program by November 30, 2025. The total approved budget for the first year
was NIS 549,067 (approximately $174,000). On March 4, 2026, we received approval from the IIA for the second year of funding for the collaboration.
The total approved budget for the second year amounts to NIS 597,572 (approximately $189,000).
EU grants - Horizon 2020 and Horizon Europe
On September 6, 2022, we announced
that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded to Advanced PeRsOnalized Therapies
for Osteoarthritis (“PROTO”), an international collaboration led by Charité Berlin Institute of Health Center for Regenerative
Therapies (“Charité”). The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/II study for the
treatment of mild to moderate knee osteoarthritis.
An amount of approximately
€500,000 (approximately $540,000) is a direct grant that will be allocated to us. Through March 31, 2026, we received a payment of
approximately $330,000 in cash as part of the PROTO program.
In June 2025, the clinical
study was approved by the Paul-Ehrlich-Institut. The study is conducted at Charité, together with an international consortium and
under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies,
Julius Wolff Institute and Center for Musculoskeletal Surgery. In November 2025, the Company entered into an agreement with Charité
governing the execution of the Phase I study of PLX-PAD for the treatment of mild to moderate knee osteoarthritis, including provisions
relating to the allocation of rights in potential joint inventions arising from the study and the licensing of study results not subject
to industrial property rights, if any.
The currency of our financial
portfolio is mainly in U.S. dollars and we use options contracts and other financial instruments in order to hedge our exposures to currencies
other than the U.S. dollar.
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Outlook
We have accumulated a deficit
of $460,996,000 since our inception in May 2001. We do not anticipate generating any significant revenues from sales of products in the
next twelve months. While we have made meaningful progress in reducing our burn rate in recent years, it is unlikely that near-term revenues
will exceed our operating costs. We may need to secure additional sources of liquidity to support the commercialization of our products
and technologies, as well as to sustain our ongoing R&D activities.
As of March 31, 2026, our
cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled $10,495,000.
We are addressing our liquidity issues by implementing cost-saving initiatives to allow the continuation of our activities. Our current
operating plan includes various assumptions concerning the level and timing of cash outflows for operating activities and capital expenditures,
which include a cost-reduction plan.
Our ability to successfully
carry out our business plan, is primarily dependent upon our ability to (1) obtain sufficient additional capital, (2) enter licensing
or other commercial partnerships and collaboration agreements, (3) provide CDMO services to clients, (4) enter into an agreement with
the EIB regarding the EIB Loan restructuring and (5) receive other sources of funding, including non-dilutive sources such as grants.
There are no assurances, however, that we will be successful in obtaining an adequate level of financing needed for the long-term development
and commercialization of our products, or any financing at all. If we are unable to obtain the required level of financing, our operations
may need to be scaled down or discontinued.
According to our management’s
estimates, we have sufficient resources to meet our operating obligations for a period of less than three months from the issuance date
of our interim unaudited condensed consolidated financial statements, which was May 14, 2026. These conditions raise substantial doubt
about our ability to continue as a going concern.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.