What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-02-13 compared with 2022-11-10 · 253 added, 158 removed, 133 unchanged (76% of the section changed)

18 unchanged sentences

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 and potential benefits from our products in regenerative medicine, biologics and food tech, as well as potentially in other industries and verticals that have a need for our mass scale and cost-effective cell expansion platform;

the prospects of entering into additional license agreements, or other forms of cooperation with other companies, research organizations and medical institutions, including, without limitation Tnuva (as defined below);

our pre-clinical and clinical study plans, including timing of initiation, expansion, enrollment, results, and conclusion of trials;

the expected development and potential benefits from our products in

regenerative medicine, biologics and food tech, as well as potentially in other industries and verticals that have a need for our

mass scale and cost-effective cell expansion platform;

the prospects of entering into additional license agreements, or other

forms of cooperation with other companies, research organizations and medical institutions, including, without limitation Tnuva (as

defined below);

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, or IIA, the European Union’s Horizon programs, as well as grants from other independent third parties;

the receipt of funds pursuant to our agreement with the European Investment Bank, or the EIB;

developing capabilities for new clinical indications of placenta expanded, or PLX, cells and new products;

the final results of our multinational Phase III trial program for the potential use of PLX cells in the treatment of muscle injury following arthroplasty for hip fracture;

our expectation to 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;

receipt of future funding from the Israel Innovation Authority, or

IIA, the European Union’s Horizon programs, as well as grants from other independent third parties;

developing capabilities for new clinical indications of placenta expanded,

or PLX, cells and new products;

our expectation to 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

our expectations regarding our short- and long-term capital requirements;

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;

our expectations regarding the impact of the COVID-19 pandemic, including on our clinical trials and operations.

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

our expectations regarding the impact of the COVID-19 pandemic, including

on our clinical trials and operations.

Our business and operations are subject to substantial

1 unchanged sentence

In addition, historic results

of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research 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, 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, 2022, or the

2022 Annual Report, as well as 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” mean

of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research 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, 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,

2022, or the 2022 Annual Report, as well as 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”

mean Pluri Inc.

and our wholly owned subsidiaries, Pluri Biotech Ltd.

30 unchanged sentences

In the pharmaceutical area,

we are now completing a Phase III multinational clinical study in muscle recovery following surgery for hip fracture and we have completed

two Phase II clinical studies in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 in the United States, Europe and

In addition, we completed a Phase I clinical study for incomplete recovery following bone marrow transplantation in the United

States and Israel, and our PLX cells are used in an investigator-led Phase I/II Chronic Graft versus Host Disease study in Israel.

R-18 product candidate is also being tested as a potential treatment for Acute Radiation Syndrome under the U.S.

Food and Drug Administration

We believe that each of these indications is a severe unmet medical need.

February 24, 2022, we announced the closing of the joint venture pursuant to joint venture agreement, o r the Joint Venture Agreement,

with Tnuva through the Subsidiary .

Under the Joint Venture Agreement, we established a new

company, Plurinuva, with the purpose of developing cultivated meat products of all types and kinds.

we completed a Phase III multinational clinical study in muscle recovery following surgery for hip fracture and two Phase II clinical

studies in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 in the United States, Europe and Israel.

we completed a Phase I clinical study for incomplete recovery following bone marrow transplantation in the United States and Israel,

and our PLX cells are used in an investigator-led Phase I/II Chronic Graft versus Host Disease study in Israel.

PLX R-18 product candidate

is also being tested as a potential treatment for Acute Radiation Syndrome under the U.S.

Food and Drug Administration animal rule.

believe that each of these indications is a severe unmet medical need.

On February 24, 2022, we announced

the closing of the joint venture pursuant to joint venture agreement, or the Joint Venture Agreement, with Tnuva through the Subsidiary.

Under the Joint Venture Agreement, we established a new company, Plurinuva, with the purpose of developing cultivated meat products of

all types and kinds.

Pursuant to the Joint Venture

Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Plurinuva and the Subsidiary ,

pursuant to which Plurinuva issued on the closing date of the SPA, or the Closing Date, 187,500 ordinary shares, representing 15.79% of

its share capital, to Tnuva, as well as a warrant to purchase additional shares of Plurinuva, in consideration of an aggregate of $7.5

million in cash.

The first warrant, or the First

Warrant, issued to Tnuva permits Tnuva to purchase up to 125,000 ordinary shares of Plurinuva at an exercise price of $40.00 per share

and has a term commencing on the Closing Date and ending at the earlier of (i) six months from the Closing Date, (ii) immediately prior

to and subject to the consummation of an initial public offering or acquisition of Plurinuva or (iii) the consummation of a financing

Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Plurinuva and the Subsidiary, pursuant to which Plurinuva

issued on the closing date of the SPA, or the Closing Date, 187,500 ordinary shares, representing 15.79% of its share capital, to Tnuva,

as well as a warrant to purchase additional shares of Plurinuva, in consideration of an aggregate of $7.5 million in cash.

The first warrant, or the

First Warrant, issued to Tnuva permits Tnuva to purchase up to 125,000 ordinary shares of Plurinuva at an exercise price of $40.00 per

share and has a term commencing on the Closing Date and ending at the earlier of (i) six months from the Closing Date, (ii) immediately

prior to and subject to the consummation of an initial public offering or acquisition of Plurinuva or (iii) the consummation of a financing

round with a non-affiliated investor.

In addition, on the six month anniversary of the Closing Date, and provided that the First Warrant

has not expired, Plurinuva shall issue to Tnuva a second warrant, or the Second Warrant, which will permit Tnuva to purchase up to a number

of ordinary shares of Plurinuva, or the then most senior securities issued by Plurinuva, in consideration for such amount equal to 200%

of the remaining balance of the aggregate purchase price of the First Warrant, provided that Tnuva exercises at least 62,500 ordinary

shares at a price per share of $40.00, or $2,500,000 in the aggregate, of the First Warrant.

The Second Warrant’s exercise price

per share equals $76.00.

The Second Warrant has a term commencing on the six months anniversary of the Closing Date and ending at the

earlier of (i) six months from its issuance, (ii) immediately prior to and subject to the consummation of an initial public offering or

acquisition of Plurinuva or (iii) the consummation of a financing round with a non-affiliated investor.

has not expired, Plurinuva shall issue to Tnuva a second warrant, or the Second Warrant, which will permit Tnuva to purchase up to a

number of ordinary shares of Plurinuva, or the then most senior securities issued by Plurinuva, in consideration for such amount equal

to 200% of the remaining balance of the aggregate purchase price of the First Warrant, provided that Tnuva exercises at least 62,500

ordinary shares at a price per share of $40.00, or $2,500,000 in the aggregate, of the First Warrant.

The Second Warrant’s exercise

price per share equals $76.00.

The Second Warrant has a term commencing on the six months anniversary of the Closing Date and ending

at the earlier of (i) six months from its issuance, (ii) immediately prior to and subject to the consummation of an initial public offering

or acquisition of Plurinuva or (iii) the consummation of a financing round with a non-affiliated investor.

On August 23, 2022, the First

Warrant was extended for an additional 90-day period, so that the exercise period will end on November 22, 2022.

Technology Collaboration the Biologics Field

Warrant was extended for an additional 90-day period, so that the exercise period would end on November 22, 2022.

On November 22, 2022,

the First Warrant expired unexercised.

In December 2022, we reported

that our joint venture successfully completed proof of concept in its development of cultivated meat based on our cell-based technology

Technology Collaboration the Biologics

In September 2022, we entered

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with this agreement and APIs will open opportunities for us to serve additional API manufacturers in the rapidly growing biologics market.

RESULTS OF OPERATIONS – THREE MONTHS

ENDED SEPTEMBER 30, 2022 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2021.

Revenues for the three-month

period ended September 30, 2022 were $87,000, as compared to no revenues, during the three-month period ended September 30, 2021.

for the three-month period ended September 30, 2022 were mainly related to our collaboration in the biologic field.

RESULTS OF OPERATIONS – THREE AND SIX

MONTHS ENDED DECEMBER 31, 2022 COMPARED TO THREE AND SIX MONTHS ENDED DECEMBER 31, 2021.

Revenues for each of the six-month

and three-month periods ended December 31, 2022 were $89,000 and $2,000, respectively, as compared to no revenues during the six-month

and three-month periods ended December 31, 2021.

Revenues for the six-month and three-month periods ended December 31, 2022 were mainly

related to our collaboration in the biologic field.

Research and Development Expenses, Net

Research and development, or R&D, expense, net

(costs less participation and grants by the Horizon 2020 program, the IIA and other parties) for the three-month period ended September

30, 2022 decreased by 33% from $6,353,000 for the three-month period ended September 30, 2021 to $4,270,000.

Research and development,

or R&D, expense, net (costs less participation and grants by the Horizon 2020 program, the IIA and other parties) for the six-month

period ended December 31, 2022 decreased by 37% from $12,860,000 for the six-month period ended December 31, 2021 to $8,056,000.

decrease is mainly attributed to:

(1) a decrease in clinical studies subcontractor expenses following the completion of our critical

limb ischemia and ARDS associated with COVID-19 studies and the end of enrollment of our muscle regeneration following hip fracture study

in November 2021, (2) a decrease in materials purchases in accordance with our manufacturing needs and plan, (3) a decrease in salaries

and related expenses as part of our cost reduction, specifically a reduction of 29 R&D employees (108 on December 31, 2022, compared

to 137 on December 31, 2021), (4) a decrease in share-based compensation expenses and (5) higher participation by the European Union

with respect to the Horizon 2020 grants, which relate to our critical limb ischemia and muscle regeneration following hip fracture studies.

R&D expense, net (costs

less participation and grants by the Horizon 2020 program, the IIA and other parties) for the three-month period ended December 31, 2022

decreased by 42% from $6,507,000 for the three-month period ended December 31, 2021 to $3,785,000.

The decrease is mainly attributed

1 unchanged sentence

with COVID-19 studies and the end of enrollment of our muscle regeneration following hip fracture study in November 2021, (2) a decrease

in materials purchases in accordance with our manufacturing needs and plan, (3) a decrease in salaries and related expenses as part of

our cost reduction, specifically a reduction of 26 R&D employees (110 on September 30, 2022, compared to 136 on September 30, 2021)

and (4) a decrease in share-based compensation expenses.

in salaries and related expenses as part of our cost reduction, specifically a reduction of 29 R&D employees (108 on December 31,

2022, compared to 137 on December 31, 2021), (3) a decrease in share-based compensation expenses and (4) higher participation by the

European Union with respect to the Horizon 2020 grants which relates to muscle regeneration following hip fracture program that commenced

during the 2018 calendar year.

General and Administrative Expenses

General and administrative

expenses for the three-month period ended September 30, 2022 decreased by 46% from $5,088,000 for the three-month period ended September

expenses for the six-month period ended December 31, 2022 decreased by 40% from $9,376,000 for the six-month period ended December 31,

2021 to $5,635,000.

The decrease is mainly attributed to a decrease in share-based compensation expenses related to market based vesting

conditioned restricted stock units, or RSUs, granted to our CEO and Chairman, employee terminations and RSU expenses amortization

Other Financial Income, net

Other financial income increased

from $237,000 for the three-month period ended September 30, 2021 to $848,000 for the three-month period ended September 30, 2022.

increase is mainly attributable to income from exchange rate differences related to the EIB loan provided to us in June 2021 pursuant

to the finance agreement executed with the EIB, or the EIB Finance Agreement, following the strength of the U.S.

dollar against the Euro.

This increase was partially offset by losses from hedging transactions linked to the Euro as a result of the strength of the U.S.

against the Euro and exchange rate expenses related to deposits linked to the NIS following the strength of the U.S.

dollar against the

conditioned restricted stock units, or RSUs, granted to our Chief Executive Officer and Chairman which was recorded as an expense

of $7,283,000 between September 11, 2020 and October 30, 2021, employee terminations and RSU expenses amortization over time.

General and administrative

expenses for the three-month period ended December 31, 2022 decreased by 32% from $4,288,000 for the three-month period ended December

31, 2021 to $2,896,000.

The decrease is mainly attributed to a decrease in share-based compensation expenses related to market based

vesting conditioned restricted stock units, or RSUs, granted to our Chief Executive Officer and Chairman which was recorded as an

expense of $7,283,000 between September 11, 2020 and October 30, 2021, employee terminations and RSU expenses amortization over time.

Other Financial Income (Expenses), net

Other financial income (expenses)

decreased from $317,000 in financial income for the six-month period ended December 31, 2021 to $515,000 in financial expenses for the

six-month period ended December 31, 2022.

This decrease is mainly attributable to expenses relating to exchange rate differences related

to the EIB loan provided to us in June 2021 pursuant to the finance agreement executed with the EIB, or the EIB Finance Agreement, following

the strength of the Euro against the U.S.

Other financial income (expenses)

decreased from $80,000 in financial income for the three-month period ended December 31, 2021 to $1,363,000 in financial expenses for

the three-month period ended December 31, 2022.

This decrease is mainly attributable to expenses from exchange rate differences, related

to the EIB loan provided to us in June 2021 pursuant to the EIB Finance Agreement, following the strength of the Euro against the U.S.

Interest Expenses

Interest expenses decreased

from $228,000 for the three-month period ended September 30, 2021 to interest expenses of $194,000 for the three-month period ended September

This decrease is attributable only to exchange rate differences due to the strength of the U.S.

dollar against the Euro.

Net loss for the three-month

period ended September 30, 2022 was $6,269,000, as compared to net loss of $11,432,000 for the three-month periods ended September 30,

The decrease was due to a decrease in general and administrative expenses and research and development expenses, as a result of

our cost reduction plan and the implementation of our new business strategy.

Net loss per share attributed

to shareholders for the three-month period ended September 30, 2022 was $0.19, as compared to $0.36 for the three-month period

ended September 30, 2021.

We had net loss attributed to our non-controlling interest in Plurinuva for the three-month period ended September

30, 2022 of $148,000.

For the three-month periods

ended September 30, 2022 and 2021, we had weighted average common shares outstanding of 32,562,596, and 32,000,789 ,

respectively, which were used in the computations of net loss per share for the three-month periods.

from $453,000 for the six-month period ended December 31, 2021 to interest expenses of $406,000 for the six-month period ended December

This decrease is attributable solely to exchange rate differences due to the Euro against the U.S.

Interest expenses decreased

from $225,000 for the three-month period ended December 31, 2021 to interest expenses of $212,000 for the three-month period ended December

This decrease is attributable solely to exchange rate differences due to the strength of the Euro against the U.S.

Net loss for six-month and

three-month periods ended December 31, 2022 was $14,523,000 and $8,254,000, respectively, as compared to net loss of $22,372,000 and

$10,940,000 for the six-month and three-month periods ended December 31, 2021.

The decrease was due to a decrease in general and administrative

expenses and research and development expenses, as a result of our cost reduction plan and the implementation of our new business strategy,

alongside the completion or termination of several clinical studies (in critical limb ischemia, ARDS associated with COVID 19, incomplete

recovery following bone marrow transplantation and completion of enrollment of muscle regeneration following hip fracture).

per share attributed to shareholders for the six-month and three-month periods ended December 31, 2022 was $0.44 and $0.24, respectively,

as compared to $0.70 and $0.34 for the six-month and three-month periods ended December 31, 2021.

We had net loss attributed to our non-controlling

interest in Plurinuva for the six-month and three-month periods ended December 31, 2022 of $285,000 and $137,000, respectively.

For the six-month and three-month

periods ended December 31, 2022 and 2021, we had weighted average common shares outstanding of 32,878,434, 33,194,622, and 32,068,271,

32,136,352, respectively, which were used in the computations of net loss per share for the six and three-month periods.

The increase in weighted average

common shares outstanding reflects the issuances of additional shares upon the vesting of RSUs issued to directors, employees and consultants .

common shares outstanding reflects the issuance of additional shares pursuant to a private placement offering we conducted in December

2022, or the December 2022 Private Placement, and the issuance of additional shares upon the vesting of RSUs issued to directors, employees

and consultants.

Liquidity and Capital Resources

As of September 30, 2022, our

As of December 31, 2022, our

total current assets were $50,140,000 and total current liabilities were $5,284,000.

On September 30, 2022, we had a working capital

surplus of $44,705,000, total equity of $26 , 901 , 000, out of which $2,709,000 is attributed to the non-controlling interest

in Plurinuva, and an accumulated deficit of $377,384,000.

On December 31, 2022, we had a working capital surplus

of $44,856,000, total equity of $24,966,000, out of which $1,775,000 is attributed to the non-controlling interest in Plurinuva, and

an accumulated deficit of $385,501,000.

Our cash and cash equivalents

as of September 30, 2022 amounted to $8,744,000, compared to $14,611,000 as of September 30, 2021, and compared to $9,772,000 as of June

Cash balances changed in the three months ended September 30, 2022 and 2021 for the reasons presented below.

as of December 31, 2022 amounted to $8,818,000, compared to $18,715,000 as of December 31, 2021, and compared to $9,772,000 as of June

Cash balances changed in the six months ended December 31, 2022 and 2021 for the reasons presented below.

Net cash used for operating

activities was $7,609,000 in the three months ended September 30, 2022, compared to $8,789,000 in the three months ended September 30,

The decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation of

our cost reduction and efficiency plan that we initiated in order to align with the change in our business strategy.

activities was $13,889,000 in the six months ended December 31, 2022, compared to $18,652,000 in the six months ended December 31, 2021.

The decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation of our

cost reduction and efficiency plan that we initiated in order to align with the change in our business strategy.

Cash used in operating

activities in the three months ended September 30, 2022 and 2021 consisted primarily of payments of fees to our suppliers, subcontractors,

professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA, the

EU’s Horizon 2020 program, Israel’s Ministry of Economy and other research grants.

activities in the six months ended December 31, 2022 and 2021 consisted primarily of payments of fees to our suppliers, subcontractors,

professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA,

the EU’s Horizon 2020 program, Israel’s Ministry of Economy and other research grants.

Investing activities provided

cash of $6,393,000 in the three months ended September 30, 2022, compared to cash used of $7,240,000 for the three months ended September

The investing activities in the three-month period ended September 30, 2022 consisted primarily of the withdrawal of $6,466,000

of short-term deposits.

The investing activities in the three-month period ended September 30, 2021, consisted primarily of the investment

of $12,084,000 in short-term deposits and proceeds of $4,859,000 from withdrawal of long-term deposits.

No cash was used or provided

from financing activities during the three months ended September 30, 2022, and 2021.

July 16, 2020, we entered into an Open Market Sale Agreement SM , or the ATM Agreement with Jefferies LLC, or Jefferies, pursuant

to which we were able to issue and sell our common shares having an aggregate offering price of up to $75,000,000 from time to time through

Upon entering into the ATM Agreement, we filed a new shelf registration statement on Form S-3, which was declared effective

by the SEC on July 23, 2020.

During the year ended June 30, 2021, we sold 1,045,097 of our common shares under the ATM Agreement at an

average price of $8.50 per share for aggregate net proceeds of approximately $8,506,000, net of issuance expenses of $380,000.

September 21, 2022, as a result of General Instruction I.B.6 of Form S-3, and in accordance with the terms of the Sales Agreement, we

reduced the amount available to be sold under the ATM Agreement to a maximum aggregate offering price of up to $11,800,000 of our common

shares from time to time through Jefferies.

the three month period ended September 30, 2022 we did not sell of our any common

shares under the ATM Agreement.

In April 2020, we and our subsidiaries,

and Pluristem GmbH, executed the EIB Finance Agreement for non–dilutive funding of up to €50 million in the aggregate,

payable in three tranches.

The proceeds from the EIB Finance Agreement are intended to support our research and development in the European

Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline to market.

We do not expect

to receive additional funds pursuant to the EIB Finance Agreement.

cash of $7,062,000 in the six months ended December 31, 2022, compared to cash used of $7,075,000 for the six months ended December 31,

The investing activities in the six-month period ended December 31, 2022 consisted primarily of the withdrawal of $7,203,000 of

short-term deposits.

The investing activities in the six-month period ended December 31, 2021 consisted primarily of the investment of

$5,539,000 in short-term deposits and proceeds of $12,658,000 from withdrawal of long-term deposits.

The cash provided in the six

months ended December 31, 2022 by financing activities was related to net proceeds of $5,693,000 related to issuances of common shares

and warrants, net of issuance cost that were paid in cash, in the December 2022 Private Placement.

No cash was used or provided from

financing activities during the six months ended December 31, 2021.

Between December 13, 2022

and December 27, 2022, we entered into a series of securities purchase agreements with several purchasers for an aggregate of 8,155,900

common shares and warrants, or the Warrants, to purchase up to 8,155,900 common shares.

On December 13, 2022, we executed securities purchase

agreements to sell, at a purchase price of $1.03 per share, up to 5,579,883 common shares and Warrants to purchase up to 5,579,833 common

shares, with an exercise price of $1.03 per share and a term of three years.

On December 14, 2022, we executed securities purchase agreements

to sell, at a purchase price of $1.05 per share, up to 2,068,517 common shares and Warrants to purchase up to 2,068,517 common shares,

with an exercise price of $1.05 per share and a term of three years.

On December 15, 2022, we executed securities purchase agreements

to sell, at a purchase price of $1.06 per share, up to 237,500 common shares and Warrants to purchase up to 237,500 common shares, with

an exercise price of $1.06 per share and a term of three years.

On December 19, 2022, we executed a securities purchase agreement to sell,

at a purchase price of $1.09 per share, up to 135,000 common shares and Warrants to purchase up to 135,000 common shares, with an exercise

price of $1.09 per share and a term of three years.

On December 27, 2022, we executed a securities purchase agreement to sell, at a purchase

price of $1.12 per share, up to 135,000 common shares and Warrants to purchase up to 135,000 common shares, with an exercise price of

$1.12 per share and a term of three years.

The Warrants sold in the December 2022 Private Placement will be exercisable upon the later

of six months from their issuance date, or until we increase our authorized shares.

As of December 31, 2022, we issued 5,550,121 common

shares and warrants that relates to the December 2022 Private Placement and received $5.8 million as of that date.

As of December 2022,

$361,000 were recorded as issuance expenses that relates to the December 2022 Private Placement.

As of February 13, 2023, 7,015,900 common

shares and warrants sold in the December 2022 Private Placement were issued for aggregate gross proceeds of $7.3 million.

In addition, the purchasers

in the December 2022 Private Placement agreed to execute proxies permitting our Chief Executive Officer and Chief Financial Officer to

vote the securities purchased in the December 2022 Private Placement in favor of any shareholder vote relating to a future increase of

our authorized shares.

Pursuant to the securities purchase agreements executed with the purchasers, we agreed to hold a meeting of shareholders

within 200 days of the execution of the securities purchase agreements for the purpose of increasing our authorized shares.

On December 14, 2022, Yaky

Yanay, our Chief Executive Officer, agreed to forgo, starting January 1, 2023, $375,000 of his annual cash salary for the next twelve

months in return for equity grants, issuable under the our existing equity compensation plans.

In that regard, we granted Mr.

334,821 RSUs, vesting ratably each month, and (ii) options to purchase 334,821 common shares, vesting ratably each month, with a term

of 3 years, at an exercise price of $1.12 per share.

In addition, the Board of Directors also agreed to grant Mr.

Yanay options to purchase

1,500,000 common shares, with a term of 3 years, with the following terms:

(i) options to purchase 500,000 common shares at an exercise

price of $1.56 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, (ii) options to purchase 500,000 common shares

at an exercise price of $2.08 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023, and (iii) options to purchase

500,000 common shares at an exercise price of $2.60 per share, 50% vesting on June 30, 2023 and 50% vesting on December 31, 2023.

options were granted in January 2023 and will expire three years from the later of the vesting date or the date upon which the Company

increases its authorized share capital.

On July 16, 2020, we entered

into an Open Market Sale Agreement SM , or the ATM Agreement, with Jefferies LLC, or Jefferies, pursuant to which we were able

to issue and sell our common shares having an aggregate offering price of up to $75,000,000 from time to time through Jefferies.

entering into the ATM Agreement, we filed a new shelf registration statement on Form S-3, which was declared effective by the SEC on July

On September 21, 2022, as a

result of General Instruction I.B.6 of Form S-3, and in accordance with the terms of the Sales Agreement, we reduced the amount available

to be sold under the ATM Agreement to a maximum aggregate offering price of up to $11,800,000 of our common shares from time to time through

During the six-month period

ended December 31, 2022, we did not sell of our any common shares under the ATM Agreement.

In April 2020, we and our

subsidiaries, Pluri Biotech Ltd.

and Pluristem GmbH, executed the EIB Finance Agreement for non–dilutive funding of up to €50

million in the aggregate, payable in three tranches.

The proceeds from the EIB Finance Agreement were intended to support our research

and development in the European Union to further advance our regenerative cell therapy platform, and to bring the products in our pipeline

The term of the project was three years commencing on January 1, 2020.

During June 2021, we received

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June 1, 2026 and bears annual interest of 4% to be paid together with the principal of the loan.

As of September 30, 2022, the interest

As of December 31, 2022, the interest

accrued was in the amount of €1,262,000.

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consolidated revenues between $350 million and $500 million and 0.2% of the Company’s consolidated revenues exceeding $500 million.

As the project term ended on December 31, 2022, we do not expect to receive additional funds pursuant to the EIB Finance Agreement.

According to the IIA grant

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In the absence of such sales, no payment

Through September, 2022, total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties paid

and accrued amounted to $169,000.

Through December 31, 2022, total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties

paid and accrued amounted to $169,000.

June 2020, we announced that we were selected as a member of the CRISPR-IL consortium, a group funded by the IIA.

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The CRISPR-IL consortium program does not include any obligation to pay royalties.

September 30, 2022, we received total grants of approximately $701,000 in cash from the IIA pursuant to the CRISPR-IL consortium program,

out of which an amount of $7,000 was received during the three-months ended September 30, 2022.

the three-month period ended September 30, 2022, we received the final payment pursuant to the EU’s Horizon 2020 PACE grant program

in the amount of $617,000.

December 31, 2022, we received total grants of approximately $757,000 in cash from the IIA pursuant to the CRISPR-IL consortium program,

out of which an amount of $62,429 was received during the six-months ended December 31, 2022.

of December 31, 2022, we received total grants of approximately $6,614,000 in cash from the European Union research and development consortiums

pursuant to the Horizon 2020 program.

During December 2022, we received an approval for an additional grant of approximately $735,000

to be used towards our PLX-PAD cell program in muscle recovery following surgery for hip fracture.

September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded

to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute of

Health Center for Regenerative Therapies.

The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIa study for the

treatment of mild to moderate knee osteoarthritis.

Final approval of the grant is subject to completion of the consortium and Horizon

Europe grant agreements.

The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance

with budget and work packages which will be determined by the consortium.

Phase I/II study will be carried out by Charité, together with us and other members of the international consortium under the leadership

of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff

Institute and Center for Musculoskeletal Surgery.

to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute

of Health Center for Regenerative Therapies.

The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIa study for

the treatment of mild to moderate knee osteoarthritis.

Final approval of the grant is subject to completion of the consortium agreement.

The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and

work packages which will be determined by the consortium.

An amount of approximately Euro 500,000 (approximately $533,745) is a direct

grant that will be allocated to us.

Phase I/II study will be carried out by Charité, together with us and other members of the international consortium under the

leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius

Wolff Institute and Center for Musculoskeletal Surgery.

The currency of our financial

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For more information, please see Item 7A.

- “Quantitative and Qualitative Disclosures about Market Risk”

in the 2021 Annual Report.

We have an effective Form S-3

registration statement (File No.

- “Quantitative and Qualitative Disclosures about Market

Risk” in the 2022 Annual Report.

We have an effective Form

S-3 registration statement (File No.

333-239890), filed under the Securities Act of 1933, as amended, with the SEC using a “shelf”

registration process.

Under this shelf registration process, we may, from time to time, sell our common shares, preferred shares and warrants

to purchase common shares, and units of two or more of such securities in one or more offerings up to a total dollar amount of $250,000,000.

As of November 8, 2022, other than the $11,800,000 of common shares we are eligible to sell pursuant to the ATM Agreement, and the $30,000,000

of common shares we sold in a registered direct offering in February 2021, no securities have been sold pursuant to our effective Form

S-3 registration statement.

Under this shelf registration process, we may, from time to time, sell our common shares, preferred shares and

warrants to purchase common shares, and units of two or more of such securities in one or more offerings up to a total dollar amount

of $250,000,000.

As of February 13, 2022, other than the $11,800,000 of common shares we are eligible to sell pursuant to the ATM Agreement,

and the $30,000,000 of common shares we sold in a registered direct offering in February 2021, no securities have been sold pursuant

to our effective Form S-3 registration statement.

We have accumulated a deficit

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis