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”), aesthetics and
wellness, and our Contract Development and Manufacturing Organization (“CDMO”) business, as well as potentially in other
industries and verticals that have a need for our mass scale and cost-effective cell expansion platform;
●
our expectations of market
and industry growth;
●
the prospects of entering
into additional license agreements, joint ventures, partnerships or other forms of cooperation with other companies, government institutes,
research organizations and medical institutions, and the ability to maintain those agreements, joint ventures, partnerships or other
forms of cooperation;
●
our ability to attract
clients for our CDMO business;
●
our pre-clinical and clinical
study plans, including timing of initiation, expansion, enrollment, results, and conclusion of trials;
●
achieving regulatory approvals;
●
receipt of future funding
from the Israel Innovation Authority (“IIA”), the European Union’s Horizon programs, as well as grants from other
independent third parties;
●
the capabilities of our
placenta expanded (“PLX”) cells, including future collaborations, to further advance the development of our PLX- PAD
and PLX-R18 cell therapy as a potential 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;
19
●
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 regain 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, historic results of scientific research and development (“R&D”), clinical and preclinical trials do not guarantee
that the conclusions of future R&D or trials would not suggest different conclusions. Also, historic results referred to in this
periodic report would be interpreted differently in light of additional research, development, clinical and preclinical trials results.
Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements
that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further
information on potential factors that could affect our business is described under the heading “Risk Factors” in Part I,
Item 1A of our Annual Report on Form 10-K for the fiscal year ended June 30, 2025 (the “2025 Annual Report”), as well as
in Part II, Item 1A of this Quarterly Report. Readers are also urged to carefully review and consider the various disclosures we have
made in that report.
As
used in this Quarterly Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company”
and “Pluri” refer to Pluri Inc., together with its wholly owned Israeli subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”)
and the subsidiaries of Pluri Biotech, 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 registered as a manufacturer with the U.S. Food and Drug Administration
(“FDA”) 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, aesthetics and wellness, food technology, agricultural technology, and through our CDMO activities.
20
Our
operations pursue a variety of initiatives that leverage the Company’s technology across diverse applications and industries, as
set forth below:
Cell
Therapy
We
use our advanced cell-based technology platform in the field of regenerative medicine to develop placenta-based cell therapy product
candidates for the treatment of inflammatory, muscle injuries and hematologic conditions. Recently, we have also launched a novel immunotherapy
platform.
PLX
Cells - Our PLX cells are adherent stromal cells that are expanded using our 3D platform. Our PLX cells can be administered to patients
off-the-shelf, without blood or tissue matching or additional manipulation prior to administration. PLX cells are believed to release
a range of therapeutic proteins in response to the patient’s condition.
In
the pharmaceutical area, we have focused on several indications utilizing our product candidates, including, but not limited to, muscle
recovery following surgery for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia, Chronic
Graft versus Host Disease (“GvHD”), knee osteoarthritis and a potential treatment for Hematopoietic Acute Radiation Syndrome
(“H-ARS”). Some of these studies have been completed while others are still ongoing. We believe that each of these indications
is a severe unmet medical need.
Immunotherapy
MAIT cells - In May 2024, we launched a novel allogenic immunotherapy platform utilizing MAIT cells specifically designed to address
solid tumors - a critical area in medicine where effective treatments are currently insufficient. We believe that our MAIT cells, isolated
from the human placenta, offer substantial potential benefits compared to conventional T-cells.
Placental MAIT
cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine
receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional autologous T-cells typically collected
from peripheral blood, our MAIT cells are designed to be an allogenic universal product. Benefiting with very restricted T cell receptor,
the MAIT cells minimize their likelihood of inducing GvHD, a significant advantage over other potential allogeneic products. We are aiming
to design the MAIT cells to potentially show better persistence in the body for a longer duration, enhancing their therapeutic efficacy.
PluriCDMO™
- In January 2024, we launched a 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
other services. We have signed several agreements with clients and are currently generating revenues from this activity.
AgTech
We
are involved in several initiatives leveraged by Pluri’s 3D cell expansion in the AgTech field, including:
(a)
an innovative proof-of-concept (“POC”) collaboration with ICL Group Ltd., a leading global specialty minerals company, through
its Open Innovation program, to revolutionize bio stimulant delivery and enhance yield sustainably;
(b)
a strategic POC agreement with a leading international agriculture corporation aimed at boosting the global vegetable product supply,
streamlining supply chains, and promoting a more sustainable future for agriculture; and
21
(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.
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
its proprietary 3D cell expansion technology. Cellav develops cell-derived ingredients, including exosomes and cell extracts, for integration
into partner formulations and for use in professional and consumer skincare and haircare products.
22
During
the first and second quarters of fiscal year 2026, and through the date of this report, we continued to advance our activities across
our foodtech, AgTech and cell-based aesthetics and wellness subsidiaries. Each of Ever After Foods, Kokomodo, Coffeesai and Cellav entered
into collaboration agreements with leading counterparties in Asia, Europe, and the United States to evaluate and potentially further
develop applications of our proprietary technologies in their respective fields. These collaborations are structured around initial,
partner-funded POC or pilot programs, designed to assess the application of our technologies in cultivated meat, cacao, coffee, and cell-based
skincare, and may, subject to positive outcomes, be expanded into subsequent development or commercialization activities. Collectively,
we believe that these collaborations underscore the growing commercial and technological validation of our platform and enhance our strategic
positioning across multiple industries.
RESULTS
OF OPERATIONS – THREE AND SIX MONTHS ENDED DECEMBER 31, 2025 COMPARED TO THREE AND SIX MONTHS ENDED DECEMBER 31, 2024
Revenues
Revenues
for the six-month and three-month periods ended December 31, 2025 were $514,000 and $198,000, respectively, as compared to $511,000 and
$185,000 during the six-month and three-month periods ended December 31, 2024, respectively. Revenues for the six-month and three-month
periods ended December 31, 2025 and 2024, were primarily generated from services provided to CDMO clients for process and product development
and additional revenues from POC collaborations in the AgTech field.
Cost
of Revenues
Cost
of revenues for each of the six-month and three-month periods ended December 31, 2025 were $313,000 and $112,000, respectively, as compared
to $200,000 and $74,000 during the six-month and three-month periods ended December 31, 2024, 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 increase in cost of revenues for each of the six-month and three-month periods ended December 31, 2025 is attributed to higher personnel
costs associated with projects during the current period.
Research
and Development Expenses, Net
R&D
expenses, net (costs less participation by the IIA, Horizon Europe and the National Institute of Allergy and Infectious Diseases (“NIAID”))
for the six-month period ended December 31, 2025 increased by 33% from $5,814,000 for the six-month period ended December 31, 2024,
to $7,757,000. The increase is mainly attributed to (1) an increase in salaries and a related expenses mainly attributed to exchange
rate differences expenses and the addition of new employees following the acquisition of our subsidiary, Kokomodo, and (2) an increase
in lease payments on our facilities mainly due to Ever After Foods’ new operating facility, partially offset by (3) a decrease
in participation by NIAID.
R&D
expenses, net (costs less participation by the IIA, Horizon Europe and the NIAID) for the three-month period ended December 31, 2025
increased by 31% from $2,925,000 for the three-month period ended December 31, 2024 to $3,826,000. The increase is mainly attributed
to the same reasons described in the preceding paragraph.
General
and Administrative Expenses
General
and administrative expenses for the six-month period ended December 31, 2025 increased by 14% from $4,652,000 for the six-month
period ended December 31, 2024 to $5,300,000. The increase is mainly attributed to (1) an increase in share-based compensation expenses
related to restricted shares (“RS”), restricted stock units (“RSUs”), and options which were granted during the
first half of fiscal year 2026 to consultants, and a grant of equity awards to our Chief Executive Officer (“CEO”), in recognition
of the achievement of certain performance objectives and other accomplishments during fiscal year 2025, (2) an increase in salaries and
a related expenses mainly attributed to exchange rate differences expenses and due to the addition of new employees following the acquisition
of our 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, employee terminations and the execution of a cost-reduction plan, and (4) a decrease in expenses related
to corporate activities, such as professional services expenses and public relations.
23
General
and administrative expenses for the three-month period ended December 31, 2025 increased by 29% from $2,143,000 for the three-month period
ended December 31, 2024 to $2,766,000. The increase is mainly attributed to an increase in share-based compensation expenses related
to RS, RSUs, and options which were granted during the first half of fiscal year 2026 to consultants, and a grant of equity awards to
our CEO, in recognition of the achievement of certain performance objectives and other accomplishments during fiscal year 2025, partially
offset by a decrease in expenses related to corporate activities, such as professional services expenses and public relations.
Other
Financial Income (expenses), net
Other
financial income (expenses), net, decreased from $1,437,000 in financial income for the six-month period ended December 31, 2024 to $296,000
in financial income for the six-month period ended December 31, 2025. The decrease is mainly attributed to (1) exchange rate differences
expenses related to the EIB Loan (as defined below) following fluctuation between the U.S. dollar against the Euro, (2) a decrease in
interest income from deposits, resulting from reduced deposit levels due to withdrawals, (3) a decrease due to exchange rate expenses
on a lease liability due to the strength of the New Israeli Shekel (“NIS”), against the U.S. Dollar, partially offset by
(4) an increase in income from hedging transactions.
Other
financial income (expenses), net, decreased from $2,058,000 in financial income for the three-month period ended December 31, 2024 to
$143,000 in financial expenses for the three-month period ended December 31, 2025. The decrease is mainly attributed to (1) exchange
rate differences expenses related to the EIB Loan (as defined below) following fluctuation between the U.S. dollar against the Euro,
(2) a decrease in interest income from deposits, resulting from reduced deposit levels due to withdrawals, and (3) a decrease due to
exchange rate expenses on a lease liability due to the strength of the NIS, against the U.S. Dollar.
Interest
Expenses
Interest
expenses related to our outstanding loan received from the EIB and all changes during the six-month and three-month periods ended December
31, 2025 compared to the six-month and three-month periods ended December 31, 2024 are attributable solely to currency rate differences
of the Euro compared to the U.S. dollar.
Net Loss
Net
loss for the six-month and three-month periods ended December 31, 2025 were $13,004,000 and $6,872,000, respectively, as compared to
net loss of $9,146,000 and $3,110,000 for the six-month and three-month periods ended December 31, 2024, respectively. The increase is
mainly due to the increase 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 $611,000 and $329,000 for
the six-month and three-month periods ended December 31, 2025, respectively, as compared to $308,000 and $154,000, for the six-month
and three-month periods ended December 31, 2024, respectively, with respect to Ever After Foods.
Net
loss per share attributed to shareholders for the six-month and three-month periods ended December 31, 2025 were $1.36 and $0.71, respectively,
as compared to $1.61 and $0.53 for the six-month and three-month periods ended December 31, 2024, 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 upon the vesting of RSUs and RS issued to directors, employees and consultants and pre-funded warrants, partially offset by an
increase in the loss for the year.
24
For
the six-month and three-month periods ended December 31, 2025 and 2024, we had weighted average common shares outstanding of 9,127,616,
9,260,439 and 5,505,915, 5,552,931, respectively, which were used in the computations of net loss per share for the six-month and three-month
periods.
Liquidity
and Capital Resources
As
of December 31, 2025, our total current assets were $13,804,000 and total current liabilities were $32,346,000. On December 31, 2025,
we had a working capital deficit of $18,542,000, total deficit of $9,213,000, out of which $5,395,000 is attributed to the non-controlling
interest in Ever After Foods and Kokomodo, and an accumulated deficit of $455,448,000.
Our
cash and cash equivalents and restricted cash as of December 31, 2025 amounted to $4,914,000, compared to $7,490,000 as of December 31,
2024 and compared to $6,317,000 as of June 30, 2025. Cash balances changed in the six-month period ended December 31, 2025 compared to
the six-month period ended December 31, 2024 for the reasons presented below.
Net
cash used for operating activities increased to $10,633,000 during the six-month period ended December 31, 2025, compared to $8,692,000
during the six-month period ended December 31, 2024, primarily due to increase in exchange rate, 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, as well as income from fees in the AgTech
sector.
Investing
activities provided cash of $6,508,000 in the six-month period ended December 31, 2025, compared to cash provided of $9,230,000 for the
six-month period ended December 31, 2024. Cash provided by investing activities for the six-month period ended December 31, 2025, consisted
primarily of proceeds from short-term deposits, net of $7,071,000, partially offset by payments of $563,000 related to investments in
property and equipment. Cash provided by investing activities for the six-month period ended December 31, 2024, consisted primarily of
proceeds from short-term deposits, net of $9,550,000, partially offset by payments of $320,000 related to investments in property and
equipment.
Financing
activities provided cash of $2,843,000 in the six months ended December 31, 2025, which were related to net proceeds received from
the issuances of common shares and warrants, net of issuance cost related to the Offering (as defined below) and the Sales Agreement
with A.G.P (as defined below), as well as, proceeds related to the SAFE Agreement (as defined below). We had no financing activities
in the six-month period ended December 31, 2024.
In
July 2025, our CEO agreed to forgo 25% percent of his monthly salary, in the 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 consist
of (i) 39,050 RSUs which are fully vested, and (ii) stock options to purchase 39,050 common shares of the Company which are fully vested
and exercisable for a period of three years at an exercise price of $5.00 per share. 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.
The
Board further approved, contingent upon the achievement of certain objectives and accomplishments by December 31, 2025, the future grant
to the CEO of (i) 9,266 RSUs, and (ii) stock options to purchase 9,266 common shares of the Company. As of December 31, 2025, the applicable
objectives had not been achieved, and therefore no grant was made.
25
On
November 13, 2025, Kokomodo entered into a Simple Agreement for Future Equity agreement (the “SAFE Agreement”) with an investor
for an aggregate amount of $300,000. In the event of an Equity Financing, which is defined in the SAFE Agreement 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 Agreement), 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 Agreement) divided
by Kokomodo Capitalization (as defined in the SAFE Agreement), or (2) the price per preferred share sold in the Equity Financing discounted
by 20%. The SAFE was 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% monthly cash salary reduction in the amount of NIS 59,400 to Mr. Yanay, our CEO, applicable to months of January
2026 and February 2026, (ii) a 20% cash salary reduction in the amount of NIS 33,000 to Mrs. Zalts, our Chief Financial Officer (“CFO”),
applicable to 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 director of the Company was appointed by the Board as Chairman
of the Board, and Mr. Zami Aberman 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.
On
December 8, 2025, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with Chutzpah Holdings
LP (the “Purchaser”), a limited partnership beneficially owned by Mr. Weinstein, relating to a private placement offering
(the “Offering”) of: (i) 625,000 common shares of the Company, and (ii) common warrants (the “Common Warrants”)
to purchase up to 625,000 common shares. The combined purchase price for each common share and Common Warrant is $4.00. The Common Warrants
were exercisable immediately at an exercise price of $4.25 per share and are exercisable until June 30, 2026. The common warrants contain
customary anti-dilution provisions and are subject to a 35% beneficial ownership limitation.
On
December 30, 2025, the 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
February 13, 2024, we entered into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”),
as agent, pursuant to which we may issue and sell our common shares having an aggregate offering price of up to $10 million, from time
to time through A.G.P. During the second quarter of fiscal year 2026, the Company sold 22,800 common shares under the Sales Agreement
at an average price of $3.90 per share, with issuance expenses of $43,000. As of February 12, 2026, the Company had sold a
total of 65,529 common shares under the Sales Agreement at an average price of $5.23 per share.
26
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 of 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 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 December 31, 2025, accrued interest amounted to approximately €3.6 million. Discussions are still being held with
the EIB regarding a potential restructuring of the EIB Loan, including a possible extension of its maturity date; however, there is no
certainty as to the outcome of these discussions. 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 December 31, 2025, accrued royalties amounted to $5 thousand.
On
July 11, 2023, we signed a three-year $4.2 million contract with the NIAID, which is part of the National Institute of Health (“NIH”).
We will collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute and the Uniformed Services
University of Health Sciences to further advance the development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS.
H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure. The term of this contract was from July
1, 2023 through June 30, 2024, with an optional extension for an additional two-year period.
On
June 6, 2024, the NIAID exercised its option for year two of the three-year contract. During the 12 months period from July 1, 2024 through
June 30, 2025, the NIAID was to provide us with $1.4 million to manufacture the PLX-R18 cell therapy and to conduct both in vitro and
in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the H-ARS.
On
April 15, 2025, Pluri Biotech received a formal notice of termination from the NIAID, according to which, the contract was terminated
for the Government’s convenience, and such termination was effective as of April 15, 2025. We believe that the termination of the
contract may reflect broader federal budgetary and administrative adjustments that have affected multiple health-related agencies, including
the NIH. As of the date of this 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 December 31, 2025, total grants obtained from the IIA aggregated to approximately $28.2 million and total
royalties paid and accrued amounted to $179 thousand.
27
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 fund the collaboration for an initial term of one year, with an option to extend it for an additional year,
subject to the IIA’s approval. During October 2025, we received approval for an additional month to finish the program until November
30, 2025. The total approved budget for the first year is NIS 549,067 (approximately $172,000).
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 December 31, 2025,
we received a payment of approximately $330,000 in cash as part of the PROTO program.
In
June 2025, the clinical study was approved by the Paul-Ehrlich-Institut. The study is conducted at Charité, together with an international
consortium and under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of
Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. 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.
Outlook
We
have accumulated a deficit of $455,448,000 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 December 31, 2025, our cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits)
totaled $13,645,000. We are addressing our liquidity issues by implementing initiatives to allow the continuation of our activities.
Our current operating plan includes various assumptions concerning the level and timing of cash outflows for operating activities and
capital expenditures, which include a cost-reduction plan.
28
Our
ability to successfully carry out our business plan, is primarily dependent upon our ability to (1) obtain sufficient additional capital,
(2) enter licensing or other commercial, partnerships and collaboration agreements, (3) provide CDMO services to clients, (4) enter into
agreement with the EIB regarding the EIB Loan restructuring and (5) receive other sources of funding, including non-diluting sources
such as grants. There are no assurances, however, that we will be successful in obtaining an adequate level of financing needed for the
long-term development and commercialization of our products, or any financing at all. In the event that we are unable to obtain the required
level of financing, our operations may need to be scaled down or discontinued.
According
to our management’s estimates, we have sufficient resources to meet our operating obligations for a period of less than six months
from the issuance date of our interim unaudited condensed consolidated financial statements, which was February 12, 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.