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:
−Removed: the expected development and potential benefits from our products in
−Removed: regenerative medicine, biologics and food tech, as well as potentially in other industries and verticals that have a need for our
−Removed: mass scale and cost-effective cell expansion platform;
−Removed: the prospects of entering into additional license agreements, or other
−Removed: forms of cooperation with other companies, research organizations and medical institutions, including, without limitation Tnuva (as
−Removed: defined below);
−Removed: our pre-clinical and clinical study plans, including timing of initiation,
−Removed: expansion, enrollment, results, and conclusion of trials;
+Added: 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;
+Added: 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);
+Added: our pre-clinical and clinical study plans, including timing of initiation, expansion, enrollment, results, and conclusion of trials;
achieving regulatory approvals;
−Removed: receipt of future funding from the Israel Innovation Authority, or
−Removed: IIA, the European Union’s Horizon programs, as well as grants from other independent third parties;
−Removed: developing capabilities for new clinical indications of placenta expanded,
−Removed: or PLX, cells and new products;
−Removed: our expectation to demonstrate a real-world impact and value from our
−Removed: pipeline, technology platform and commercial-scale manufacturing capacity;
−Removed: the possible impacts of cybersecurity incidents on our business and
+Added: 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;
+Added: developing capabilities for new clinical indications of placenta expanded, or PLX, cells and new products;
+Added: our expectation to demonstrate a real-world impact and value from our pipeline, technology platform and commercial-scale manufacturing capacity;
+Added: the possible impacts of cybersecurity incidents on our business and operations;
our expectations regarding our short- and long-term capital requirements;
−Removed: our outlook for the coming months and future periods, including but
−Removed: not limited to our expectations regarding future revenue and expenses;
−Removed: information with respect to any other plans and strategies for our
+Added: our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses;
+Added: 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;
−Removed: Our business and operations are subject to substantial
−Removed: risks, which increase the uncertainty inherent in the forward-looking statements contained in this report.
+Added: the Israeli government is currently pursuing extensive changes to Israel’s judicial system, which may negatively impact the business environment in Israel with reluctance for investments or transactions as well as lead to increased currency fluctuations, downgrades in credit rating and increased interest rates.
+Added: Our business and operations
+Added: are subject to substantial risks, which increase the uncertainty inherent in the forward-looking statements contained in this report.
In addition, historic results
−Removed: of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not
−Removed: suggest different conclusions.
−Removed: Also, historic results referred to in this periodic report would be interpreted differently in light of
−Removed: additional research, clinical and preclinical trials results.
−Removed: Except as required by law, we undertake no obligation to release publicly
−Removed: the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof
−Removed: or to reflect the occurrence of unanticipated events.
−Removed: Further information on potential factors that could affect our business is described
−Removed: 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,
−Removed: 2022, or the 2022 Annual Report, as well as Item 1A of this Quarterly Report.
−Removed: Readers are also urged to carefully review and consider
−Removed: the various disclosures we have made in that report.
−Removed: As used in this Quarterly
−Removed: Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company” and “Pluri”
−Removed: mean Pluri Inc.
−Removed: and our wholly owned subsidiaries, Pluri Biotech Ltd.
−Removed: and Pluristem GmbH, and our subsidiary Plurinuva Ltd., unless otherwise
−Removed: indicated or as otherwise required by the context.
+Added: of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest
+Added: different conclusions.
+Added: Also, historic results referred to in this periodic report would be interpreted differently in light of additional
+Added: research, clinical and preclinical trials results.
+Added: Except as required by law, we undertake no obligation to release publicly the result
+Added: of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect
+Added: the occurrence of unanticipated events.
+Added: Further information on potential factors that could affect our business is described under the
+Added: 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
+Added: 2022 Annual Report, as well as Item 1A of this Quarterly Report.
+Added: Readers are also urged to carefully review and consider the various disclosures
+Added: we have made in that report.
+Added: As used in this Quarterly Report on Form 10-Q, the terms “we”,
+Added: “us”, “our”, the “Company” and “Pluri” mean Pluri Inc.
+Added: and our wholly owned subsidiaries,
+Added: Pluri Biotech Ltd.
+Added: and Pluristem GmbH, and our subsidiary Ever After Foods Ltd., or Ever After, formerly known as Plurinuva Ltd., unless
+Added: otherwise indicated or as otherwise required by the context.
We are a biotechnology company
26 unchanged sentences
to, licensing deals, joint ventures, partnerships, joint development agreements and direct sale of our products.
−Removed: In the pharmaceutical area,
−Removed: we completed a Phase III multinational clinical study in muscle recovery following surgery for hip fracture and two Phase II clinical
−Removed: studies in Acute Respiratory Distress Syndrome, or ARDS, associated with COVID-19 in the United States, Europe and Israel.
−Removed: we completed a Phase I clinical study for incomplete recovery following bone marrow transplantation in the United States and Israel,
−Removed: and our PLX cells are used in an investigator-led Phase I/II Chronic Graft versus Host Disease study in Israel.
−Removed: PLX R-18 product candidate
−Removed: is also being tested as a potential treatment for Acute Radiation Syndrome under the U.S.
−Removed: Food and Drug Administration animal rule.
−Removed: believe that each of these indications is a severe unmet medical need.
+Added: In the pharmaceutical area, we
+Added: have focused on a number of indications utilizing our product candidates, including, but not limited to, muscle recovery following surgery
+Added: for hip fracture, incomplete recovery following bone marrow transplantation, critical limb ischemia, or CLI, Chronic Graft versus Host
+Added: Disease and a potential treatment for Acute Radiation Syndrome.
+Added: Some of these studies have been completed while others are still ongoing.
+Added: We believe that each of these indications is a severe unmet medical need.
+Added: In April 2023, we unveiled a breakthrough in cell manufacturing
+Added: that potentially solves one of the biggest hurdles facing cell-based industries:
+Added: cost-effective, industrial scale cell
+Added: manufacturing.
+Added: PluriMatrix, built upon our platform 3D cell expansion technology, significantly scales high-quality cell production,
+Added: potentially having a catalytic impact across numerous industries that require mass-scale cell production including pharma,
+Added: biologics, foodtech and agri-tech.PluriMatrix is also used by our majority-owned subsidiary Ever After, to produce cultivated meat
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.
−Removed: Under the Joint Venture Agreement, we established a new company, Plurinuva, with the purpose of developing cultivated meat products of
+Added: Under the Joint Venture Agreement, we established a new company, Ever After, with the purpose of developing cultivated meat products of
all types and kinds.
Pursuant to the Joint Venture
−Removed: Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Plurinuva and the Subsidiary, pursuant to which Plurinuva
+Added: Agreement, Tnuva entered into a share purchase agreement, or the SPA, with Ever After and the Subsidiary, pursuant to which Ever After
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,
−Removed: as well as a warrant to purchase additional shares of Plurinuva, in consideration of an aggregate of $7.5 million in cash.
−Removed: The first warrant, or the
−Removed: 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
−Removed: 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
−Removed: prior to and subject to the consummation of an initial public offering or acquisition of Plurinuva or (iii) the consummation of a financing
−Removed: round with a non-affiliated investor.
−Removed: In addition, on the six month anniversary of the Closing Date, and provided that the First Warrant
−Removed: has not expired, Plurinuva shall issue to Tnuva a second warrant, or the Second Warrant, which will permit Tnuva to purchase up to a
−Removed: number of ordinary shares of Plurinuva, or the then most senior securities issued by Plurinuva, in consideration for such amount equal
−Removed: to 200% of the remaining balance of the aggregate purchase price of the First Warrant, provided that Tnuva exercises at least 62,500
−Removed: ordinary shares at a price per share of $40.00, or $2,500,000 in the aggregate, of the First Warrant.
−Removed: The Second Warrant’s exercise
−Removed: price per share equals $76.00.
−Removed: The Second Warrant has a term commencing on the six months anniversary of the Closing Date and ending
−Removed: at the earlier of (i) six months from its issuance, (ii) immediately prior to and subject to the consummation of an initial public offering
−Removed: or acquisition of Plurinuva or (iii) the consummation of a financing round with a non-affiliated investor.
−Removed: On August 23, 2022, the First
−Removed: Warrant was extended for an additional 90-day period, so that the exercise period would end on November 22, 2022.
−Removed: On November 22, 2022,
−Removed: the First Warrant expired unexercised.
+Added: as well as a warrant to purchase additional shares of Ever After, in consideration of an aggregate of $7.5 million in cash.
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
−Removed: Technology Collaboration the Biologics
−Removed: In September 2022, we entered
−Removed: into a collaboration agreement with a leading European manufacturer of APIs for liver and gastroenterological diseases.
−Removed: As part of our
−Removed: collaboration, our platform is being utilized to develop and manufacture a unique biologic API used in drugs that treat liver and gastroenterological
+Added: Technology Collaboration the Biologics Field
+Added: In September 2022, we entered into a collaboration agreement with a
+Added: leading European manufacturer of APIs for liver and gastroenterological diseases, or API Collaboration.
+Added: As part of our collaboration,
+Added: our platform is being utilized to develop and manufacture a unique biologic API used in drugs that treat liver and gastroenterological
The current source of this API is derived from animals that are sacrificed during the extraction process.
2 unchanged sentences
molecule without harming animals.
+Added: As of March 31, 2023 we recorded revenues of $160,000 relates to API Collaboration.
We believe that proof of concept
with this agreement and APIs will open opportunities for us to serve additional API manufacturers in the rapidly growing biologics market.
−Removed: RESULTS OF OPERATIONS – THREE AND SIX
−Removed: MONTHS ENDED DECEMBER 31, 2022 COMPARED TO THREE AND SIX MONTHS ENDED DECEMBER 31, 2021.
−Removed: Revenues for each of the six-month
−Removed: and three-month periods ended December 31, 2022 were $89,000 and $2,000, respectively, as compared to no revenues during the six-month
−Removed: and three-month periods ended December 31, 2021.
−Removed: Revenues for the six-month and three-month periods ended December 31, 2022 were mainly
−Removed: related to our collaboration in the biologic field.
+Added: RESULTS OF OPERATIONS – THREE AND NINE
+Added: MONTHS ENDED MARCH 31, 2023 COMPARED TO THREE AND NINE MONTHS ENDED MARCH 31, 2022.
+Added: Revenues for each of the nine-month and three-month periods ended March
+Added: 31, 2023 were $176,000 and $87,000, respectively, as compared to $234,000 in revenues during the nine-month and three-month periods ended
+Added: March 31, 2022.
+Added: Revenues for the nine-month and three-month periods ended March 31, 2023 were mainly related to our API Collaboration.
Research and Development Expenses, Net
−Removed: Research and development,
−Removed: or R&D, expense, net (costs less participation and grants by the Horizon 2020 program, the IIA and other parties) for the six-month
−Removed: 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.
−Removed: decrease is mainly attributed to:
−Removed: (1) a decrease in clinical studies subcontractor expenses following the completion of our critical
−Removed: limb ischemia and ARDS associated with COVID-19 studies and the end of enrollment of our muscle regeneration following hip fracture study
−Removed: in November 2021, (2) a decrease in materials purchases in accordance with our manufacturing needs and plan, (3) a decrease in salaries
−Removed: and related expenses as part of our cost reduction, specifically a reduction of 29 R&D employees (108 on December 31, 2022, compared
−Removed: to 137 on December 31, 2021), (4) a decrease in share-based compensation expenses and (5) higher participation by the European Union
−Removed: with respect to the Horizon 2020 grants, which relate to our critical limb ischemia and muscle regeneration following hip fracture studies.
−Removed: R&D expense, net (costs
−Removed: less participation and grants by the Horizon 2020 program, the IIA and other parties) for the three-month period ended December 31, 2022
−Removed: decreased by 42% from $6,507,000 for the three-month period ended December 31, 2021 to $3,785,000.
−Removed: The decrease is mainly attributed
−Removed: (1) a decrease in clinical studies subcontractor expenses following the completion of our critical limb ischemia and ARDS associated
−Removed: with COVID-19 studies and the end of enrollment of our muscle regeneration following hip fracture study in November 2021, (2) a decrease
−Removed: in salaries and related expenses as part of our cost reduction, specifically a reduction of 29 R&D employees (108 on December 31,
−Removed: 2022, compared to 137 on December 31, 2021), (3) a decrease in share-based compensation expenses and (4) higher participation by the
−Removed: European Union with respect to the Horizon 2020 grants which relates to muscle regeneration following hip fracture program that commenced
−Removed: during the 2018 calendar year.
+Added: Research and development, or R&D, expense, net (costs less participation
+Added: by the IIA, Horizon 2020, Horizon Europe and other parties) for the nine-month period ended March 31, 2023 decreased by 36% from $19,016,000
+Added: for the nine-month period ended March 31, 2022 to $12,223,000.
+Added: The decrease is mainly attributed to:
+Added: (1) a decrease in clinical studies
+Added: subcontractor expenses following the completion of our critical limb ischemia and ARDS associated with COVID-19 studies and the end of
+Added: enrollment of our muscle regeneration following hip fracture study in November 2021, (2) a decrease in materials purchases in accordance
+Added: with our manufacturing needs and plan, (3) a decrease in salaries and related expenses as part of our efficiency cost-reduction plan,
+Added: specifically a reduction of 29 R&D employees (107 on March 31, 2023, compared to 136 on March 31, 2022), (4) a decrease in share-based
+Added: compensation expenses and (5) higher participation by the European Union with respect to the Horizon 2020 grants, which relate to our
+Added: critical limb ischemia and muscle regeneration following hip fracture studies.
+Added: R&D expense, net (costs less participation by the IIA, Horizon
+Added: 2020, Horizon Europe and other parties) for the three-month period ended March 31, 2023 decreased by 32% from $6,156,000 for the three-month
+Added: period ended March 31, 2022 to $4,167,000.
+Added: The decrease is mainly attributed to:
+Added: (1) a decrease in clinical studies subcontractor expenses
+Added: following the completion of our critical limb ischemia and ARDS associated with COVID-19 studies and the end of enrollment of our muscle
+Added: regeneration following hip fracture study in November 2021, (2) a decrease in salaries and related expenses as part of our efficiency
+Added: cost reduction plan, specifically a reduction of 29 R&D employees (107 on March 31, 2023, compared to 136 on March 31, 2022) and (3)
+Added: a decrease in share-based compensation expenses.
General and Administrative Expenses
−Removed: General and administrative
−Removed: 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,
−Removed: 2021 to $5,635,000.
−Removed: The decrease is mainly attributed to a decrease in share-based compensation expenses related to market based vesting
−Removed: conditioned restricted stock units, or RSUs, granted to our Chief Executive Officer and Chairman which was recorded as an expense
−Removed: of $7,283,000 between September 11, 2020 and October 30, 2021, employee terminations and RSU expenses amortization over time.
−Removed: General and administrative
−Removed: expenses for the three-month period ended December 31, 2022 decreased by 32% from $4,288,000 for the three-month period ended December
−Removed: 31, 2021 to $2,896,000.
−Removed: The decrease is mainly attributed to a decrease in share-based compensation expenses related to market based
−Removed: vesting conditioned restricted stock units, or RSUs, granted to our Chief Executive Officer and Chairman which was recorded as an
−Removed: expense of $7,283,000 between September 11, 2020 and October 30, 2021, employee terminations and RSU expenses amortization over time.
+Added: General and administrative expenses for the nine-month period ended
+Added: March 31, 2023 decreased by 38% from $13,929,000 for the nine-month period ended March 31, 2022 to $8,655,000.
+Added: The decrease is mainly
+Added: attributed to a decrease in share-based compensation expenses related to market based vesting conditioned restricted stock units, or RSUs,
+Added: granted to our Chief Executive Officer and Chairman which was recorded as an expense of $7,283,000 between September 11, 2020 and
+Added: October 30, 2021, decrease in share-based compensation expenses related to allocation of shares of Ever After to our Chief Executive Officer,
+Added: Chief Financial Officer and Chairman of our board of directors pursuant to their employment or consulting agreement, employee terminations
+Added: and RSU expenses amortization over time.
+Added: Offset by an increase in share-based compensation expenses related to the amount of RSUs granted
+Added: to employees.
+Added: General and administrative expenses for the three-month period ended
+Added: March 31, 2023 decreased by 34% from $4,553,000 for the three-month period ended March 31, 2022 to $3,020,000.
+Added: The decrease is mainly
+Added: attributed to a decrease in share-based compensation expenses related to allocation of shares of Ever After to our Chief Executive Officer,
+Added: Chief Financial Officer and chairman of our board of directors pursuant to their employment or consulting agreement, offset by an increase
+Added: in share-based compensation expenses related to the amount of RSUs granted to employees.
Other Financial Income (Expenses), net
−Removed: Other financial income (expenses)
−Removed: decreased from $317,000 in financial income for the six-month period ended December 31, 2021 to $515,000 in financial expenses for the
−Removed: six-month period ended December 31, 2022.
−Removed: This decrease is mainly attributable to expenses relating to exchange rate differences related
−Removed: 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
+Added: Other financial income (expenses) decreased from $1,097,000 in financial
+Added: income for the nine-month period ended March 31, 2022 to $956,000 in financial expenses for the nine-month period ended March 31, 2023.
+Added: This decrease is mainly attributable to expenses relating to exchange rate differences related to the EIB loan provided to us in June
+Added: 2021 pursuant to the finance agreement executed with the EIB, or the EIB Finance Agreement.
+Added: During the nine-month period ended March 31,
2023, the strength of the Euro against the U.S.
−Removed: Other financial income (expenses)
−Removed: decreased from $80,000 in financial income for the three-month period ended December 31, 2021 to $1,363,000 in financial expenses for
−Removed: the three-month period ended December 31, 2022.
−Removed: This decrease is mainly attributable to expenses from exchange rate differences, related
−Removed: 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.
+Added: dollar, increased by 4% compared to a decrease of 6% during the nine-month period ended
+Added: March 31, 2022.
+Added: Other financial income (expenses) decreased from $780,000 in financial
+Added: income for the three-month period ended March 31, 2022 to $441,000 in financial expenses for the three-month period ended March 31, 2023.
+Added: This decrease is mainly attributable to expenses from exchange rate differences related to the EIB loan provided to us in June 2021 pursuant
+Added: to the EIB Finance Agreement.
+Added: During the three-month period ended March 31, 2023, the strength of the Euro against the U.S.
+Added: dollar, increased
+Added: by 2% compared to a decrease of 2% during the three-month period ended March 31, 2022.
Interest Expenses
−Removed: Interest expenses decreased
−Removed: 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
−Removed: This decrease is attributable solely to exchange rate differences due to the Euro against the U.S.
+Added: Interest expenses decreased from $676,000 for the nine-month period
+Added: ended March 31, 2022 to interest expenses of $623,000 for the nine-month period ended March 31, 2023.
+Added: This decrease is attributable solely
+Added: to exchange rate differences due to the strength of the Euro against the U.S.
Interest expenses decreased
−Removed: 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
+Added: from $223,000 for the three-month period ended March 31, 2022 to interest expenses of $217,000 for the three-month period ended March
This decrease is attributable solely to exchange rate differences due to the strength of the Euro against the U.S.
−Removed: Net loss for six-month and
−Removed: 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
−Removed: $10,940,000 for the six-month and three-month periods ended December 31, 2021.
−Removed: The decrease was due to a decrease in general and administrative
−Removed: expenses and research and development expenses, as a result of our cost reduction plan and the implementation of our new business strategy,
−Removed: alongside the completion or termination of several clinical studies (in critical limb ischemia, ARDS associated with COVID 19, incomplete
−Removed: recovery following bone marrow transplantation and completion of enrollment of muscle regeneration following hip fracture).
−Removed: per share attributed to shareholders for the six-month and three-month periods ended December 31, 2022 was $0.44 and $0.24, respectively,
−Removed: as compared to $0.70 and $0.34 for the six-month and three-month periods ended December 31, 2021.
−Removed: We had net loss attributed to our non-controlling
−Removed: interest in Plurinuva for the six-month and three-month periods ended December 31, 2022 of $285,000 and $137,000, respectively.
−Removed: For the six-month and three-month
−Removed: 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,
−Removed: 32,136,352, respectively, which were used in the computations of net loss per share for the six and three-month periods.
+Added: Net loss for nine-month and three-month periods ended March 31, 2023
+Added: was $22,281,000 and $7,759,000, respectively, as compared to net loss of $32,290,000 and $9,918,000 for the nine-month and three-month
+Added: periods ended March 31, 2022.
+Added: The decrease was due to a decrease in general and administrative expenses and research and development expenses,
+Added: as a result of our efficiency cost reduction plan and the implementation of our new business strategy, alongside the completion or termination
+Added: of several clinical studies (in critical limb ischemia, ARDS associated with COVID 19, incomplete recovery following bone marrow transplantation
+Added: and completion of enrollment of muscle regeneration following hip fracture).
+Added: Net loss per share attributed to shareholders for the nine-month
+Added: and three-month periods ended March 31, 2023 was $0.63 and $0.19, respectively, as compared to $1.00 and $0.31 for the nine-month and
+Added: three-month periods ended March 31, 2022.
+Added: We had net loss attributed to our non-controlling interest in Ever After for the nine-month
+Added: and three-month periods ended March 31, 2023 of $419,000 and $135,000, respectively.
+Added: For the nine-month and three-month
+Added: periods ended March 31, 2023 and 2022, we had weighted average common shares outstanding of 35,217,037, 39,947,602, and 32,131,503, 32,261,628,
+Added: respectively, which were used in the computations of net loss per share for the nine and three-month periods.
The increase in weighted average
3 unchanged sentences
Liquidity and Capital Resources
−Removed: As of December 31, 2022, our
−Removed: total current assets were $50,140,000 and total current liabilities were $5,284,000.
−Removed: On December 31, 2022, we had a working capital surplus
−Removed: 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
−Removed: an accumulated deficit of $385,501,000.
+Added: As of March 31, 2023, our total current assets were $46,687,000 and
+Added: total current liabilities were $5,377,000.
+Added: On March 31, 2023, we had a working capital surplus of $41,310,000, total equity of $20,881,000,
+Added: out of which $1,817,000 is attributed to the non-controlling interest in Ever After, and an accumulated deficit of $393,125,000.
Our cash and cash equivalents
−Removed: 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
−Removed: Cash balances changed in the six months ended December 31, 2022 and 2021 for the reasons presented below.
+Added: as of March 31, 2023 amounted to $3,677,000, compared to $23,791,000 as of March 31, 2022, and compared to $9,772,000 as of June 30, 2022.
+Added: Cash balances changed in the nine months ended March 31, 2023 and 2022 for the reasons presented below.
Net cash used for operating
−Removed: 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.
−Removed: The decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation of our
−Removed: cost reduction and efficiency plan that we initiated in order to align with the change in our business strategy.
−Removed: Cash used in operating
−Removed: activities in the six months ended December 31, 2022 and 2021 consisted primarily of payments of fees to our suppliers, subcontractors,
−Removed: professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA,
−Removed: the EU’s Horizon 2020 program, Israel’s Ministry of Economy and other research grants.
+Added: activities was $19,960,000 in the nine months ended March 31, 2023, compared to $28,074,000 in the nine months ended March 31, 2022.
+Added: decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation of our cost
+Added: reduction and efficiency plan that we initiated in order to align with the change in our business strategy.
+Added: Cash used in operating activities
+Added: in the nine months ended March 31, 2023 and 2022 consisted primarily of payments of fees to our suppliers, subcontractors, professional
+Added: services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA, the EU’s
+Added: Horizon 2020 and 2022 programs, Israel’s Ministry of Economy and other research grants.
Investing activities provided
−Removed: 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,
−Removed: The investing activities in the six-month period ended December 31, 2022 consisted primarily of the withdrawal of $7,203,000 of
−Removed: short-term deposits.
−Removed: The investing activities in the six-month period ended December 31, 2021 consisted primarily of the investment of
+Added: cash of $5,374,000 in the nine months ended March 31, 2023, compared to cash used of $14,738,000 for the nine months ended March 31,
+Added: The investing activities in the nine-month period ended March 31, 2023 consisted primarily of the withdrawal of $5,539,000 of short-term
+Added: The investing activities in the nine-month period ended March 31, 2022 consisted primarily of the investment of $4,233,000
in short-term deposits and proceeds of $19,052,000 from withdrawal of long-term deposits.
−Removed: The cash provided in the six
−Removed: months ended December 31, 2022 by financing activities was related to net proceeds of $5,693,000 related to issuances of common shares
−Removed: and warrants, net of issuance cost that were paid in cash, in the December 2022 Private Placement.
−Removed: No cash was used or provided from
−Removed: financing activities during the six months ended December 31, 2021.
−Removed: Between December 13, 2022
−Removed: and December 27, 2022, we entered into a series of securities purchase agreements with several purchasers for an aggregate of 8,155,900
−Removed: common shares and warrants, or the Warrants, to purchase up to 8,155,900 common shares.
−Removed: On December 13, 2022, we executed securities purchase
−Removed: 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
−Removed: shares, with an exercise price of $1.03 per share and a term of three years.
−Removed: On December 14, 2022, we executed securities purchase agreements
−Removed: 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,
−Removed: with an exercise price of $1.05 per share and a term of three years.
−Removed: On December 15, 2022, we executed securities purchase agreements
−Removed: 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
−Removed: an exercise price of $1.06 per share and a term of three years.
−Removed: On December 19, 2022, we executed a securities purchase agreement to sell,
−Removed: 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
−Removed: price of $1.09 per share and a term of three years.
−Removed: On December 27, 2022, we executed a securities purchase agreement to sell, at a purchase
−Removed: 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
+Added: Financing activities provided cash of $8,034,000 in the nine months
+Added: ended March 31, 2023, compared to $7,500,000 for the nine months ended March 31, 2022.
+Added: The financing activities in the nine-month period
+Added: ended March 31, 2023 related to issuances of common shares and warrants, net of issuance cost, that were paid in cash, in the December
+Added: 2022 Private Placement.
+Added: The financing activities in the nine-month period ended March 31, 2022 were related to proceeds of $7,500,000
+Added: we received from Tnuva as an investment in Ever After.
+Added: Between December 13, 2022 and December 27, 2022, we entered into a
+Added: series of securities purchase agreements with several purchasers for an aggregate of 8,155,900 common shares and warrants, or the Warrants,
+Added: to purchase up to 8,155,900 common shares.
+Added: On December 13, 2022, we executed securities purchase agreements to sell, at a purchase price
+Added: of $1.03 per share, up to 5,579,883 common shares and Warrants to purchase up to 5,579,833 common shares, with an exercise price of $1.03
per share and a term of three years.
−Removed: The Warrants sold in the December 2022 Private Placement will be exercisable upon the later
−Removed: of six months from their issuance date, or until we increase our authorized shares.
−Removed: As of December 31, 2022, we issued 5,550,121 common
−Removed: shares and warrants that relates to the December 2022 Private Placement and received $5.8 million as of that date.
−Removed: As of December 2022,
−Removed: $361,000 were recorded as issuance expenses that relates to the December 2022 Private Placement.
−Removed: As of February 13, 2023, 7,015,900 common
−Removed: shares and warrants sold in the December 2022 Private Placement were issued for aggregate gross proceeds of $7.3 million.
+Added: On December 14, 2022, we executed securities purchase agreements to sell, at a purchase price of
+Added: $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
+Added: per share and a term of three years.
+Added: On December 15, 2022, we executed securities purchase agreements to sell, at a purchase price of
+Added: $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
+Added: share and a term of three years.
+Added: On December 19, 2022, we executed a securities purchase agreement to sell, at a purchase price of $1.09
+Added: 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
+Added: and a term of three years.
+Added: On December 27, 2022, we executed a securities purchase agreement to sell, at a purchase price of $1.12 per
+Added: 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
+Added: a term of three years.
+Added: The Warrants sold in the December 2022 Private Placement will be exercisable upon the later of six months from
+Added: their issuance date, or from the date the authorized shares increased.
+Added: As March 31, 2023, the Company issued 8,155,900 common shares and
+Added: warrants that relate to the December 2022 Private Placement and received $8,034,000 as of that date net of $435 from issuance expenses.
In addition, the purchasers
4 unchanged sentences
within 200 days of the execution of the securities purchase agreements for the purpose of increasing our authorized shares.
+Added: On April 27, 2023, our shareholders approved an amendment to our articles
+Added: of incorporation of to increase the number of authorized common shares from 60,000,000 shares to 300,000,000 shares and such increase
+Added: was effectuated on May 1, 2023 when the Company filed its amendment to its articles of incorporation reflecting such increase.
+Added: the Warrants became exercisable on May 1, 2023.
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
−Removed: months in return for equity grants, issuable under the our existing equity compensation plans.
+Added: months in return for equity grants, issuable under our existing equity compensation plans.
In that regard, we granted Mr.
−Removed: 334,821 RSUs, vesting ratably each month, and (ii) options to purchase 334,821 common shares, vesting ratably each month, with a term
−Removed: of 3 years, at an exercise price of $1.12 per share.
+Added: Yanay (i) 334,821
+Added: RSUs, vesting ratably each month, and (ii) options to purchase 334,821 common shares, vesting ratably each month, with a term of 3 years,
+Added: at an exercise price of $1.12 per share.
In addition, the Board of Directors also agreed to grant Mr.
1 unchanged sentence
common shares, with a term of 3 years, with the following terms:
−Removed: (i) options to purchase 500,000 common shares at an exercise
−Removed: 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
−Removed: 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
+Added: (i) options to purchase 500,000 common shares at an exercise price of
+Added: $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
+Added: 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.
−Removed: 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
−Removed: increases its authorized share capital.
+Added: options were granted in January 2023 and will expire three years from the later of the vesting date or the date which the Company increased
+Added: its authorized share capital.
On July 16, 2020, we entered
2 unchanged sentences
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
−Removed: On September 21, 2022, as a
−Removed: 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
+Added: On September 21, 2022, as
+Added: 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
−Removed: During the six-month period
−Removed: ended December 31, 2022, we did not sell of our any common shares under the ATM Agreement.
+Added: During the nine-month period
+Added: ended March 31, 2023, we did not sell of our any common shares under the ATM Agreement.
In April 2020, we and our
9 unchanged sentences
June 1, 2026 and bears annual interest of 4% to be paid together with the principal of the loan.
−Removed: As of December 31, 2022, the interest
−Removed: accrued was in the amount of €1,262,000.
−Removed: In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated
−Removed: to the amount disbursed from the EIB loan, on the Company’s consolidated revenues beginning in the fiscal year 2024 up to and including
+Added: As of March 31, 2023, the interest accrued
+Added: was in the amount of €1,463,000.
+Added: In addition to the interest payable, the EIB is also entitled to royalty payments, pro-rated to
+Added: the amount disbursed from the EIB loan, on the Company’s consolidated revenues beginning in the fiscal year 2024 up to and including
its fiscal year 2030, in an amount equal to up to 2.3% of the Company’s consolidated revenues below $350 million, 1.2% of the Company’s
5 unchanged sentences
In the absence of such sales, no payment
−Removed: Through December 31, 2022, total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties
−Removed: paid and accrued amounted to $169,000.
+Added: Through March 31, 2023, total grants obtained from the IIA aggregated to approximately $27,760,000 and total royalties paid
+Added: 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.
8 unchanged sentences
program, for an additional period of eighteen months.
+Added: During January 2023, we received approval for an extension of an additional 2 months
+Added: to finish the program until June 30, 2023.
The CRISPR-IL consortium program does not include any obligation to pay royalties.
−Removed: December 31, 2022, we received total grants of approximately $757,000 in cash from the IIA pursuant to the CRISPR-IL consortium program,
−Removed: out of which an amount of $62,429 was received during the six-months ended December 31, 2022.
−Removed: of December 31, 2022, we received total grants of approximately $6,614,000 in cash from the European Union research and development consortiums
−Removed: pursuant to the Horizon 2020 program.
−Removed: During December 2022, we received an approval for an additional grant of approximately $735,000
−Removed: to be used towards our PLX-PAD cell program in muscle recovery following surgery for hip fracture.
−Removed: September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded
−Removed: to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité Berlin Institute
−Removed: of Health Center for Regenerative Therapies.
−Removed: The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIa study for
−Removed: the treatment of mild to moderate knee osteoarthritis.
−Removed: Final approval of the grant is subject to completion of the consortium agreement.
−Removed: The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and
−Removed: work packages which will be determined by the consortium.
−Removed: An amount of approximately Euro 500,000 (approximately $533,745) is a direct
+Added: March 31, 2023, we received total grants of approximately $775,000 in cash from the IIA pursuant to the CRISPR-IL consortium program,
+Added: out of which an amount of $80,000 was received during the nine-months ended March 31, 2023.
+Added: of March 31, 2023, we received total grants of approximately $6,614,000 in cash from the European Union research and development
+Added: consortiums pursuant to the Horizon programs.
+Added: During December 2022, we received an approval for an additional budget allocation of
+Added: approximately $735,000 to us, relates to PLX-PAD program for muscle recovery following surgery for hip fracture.
+Added: The full amount was
+Added: received by us in April 2023.
+Added: On September 6, 2022, we announced that a €7.5 million non-dilutive
+Added: grant from the European Union’s Horizon program was awarded to Advanced PeRsOnalized Therapies for Osteoarthritis (PROTO), an international
+Added: collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies.
+Added: The goal of the PROTO project is to
+Added: utilize our PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis.
+Added: Final approval of the grant
+Added: is subject to completion of the consortium agreement.
+Added: An amount of approximately Euro 500,000 (approximately $533,745) will be a direct
grant that will be allocated to us.
−Removed: Phase I/II study will be carried out by Charité, together with us and other members of the international consortium under the
−Removed: leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius
−Removed: Wolff Institute and Center for Musculoskeletal Surgery.
+Added: Through March 31, 2023, we received a payment of approximately $185,000 in cash, which relates to
+Added: the PROTO program.
+Added: Phase I/II study will be carried out by Charité, together with us and other members of the international consortium under the leadership
+Added: of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, Julius Wolff
+Added: Institute and Center for Musculoskeletal Surgery.
The currency of our financial
3 unchanged sentences
For more information, please see Item 7A.
−Removed: - “Quantitative and Qualitative Disclosures about Market
−Removed: Risk” in the 2022 Annual Report.
+Added: - “Quantitative and Qualitative Disclosures about Market Risk”
+Added: in the 2022 Annual Report.
We have an effective Form
2 unchanged sentences
registration process.
−Removed: Under this shelf registration process, we may, from time to time, sell our common shares, preferred shares and
−Removed: 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
−Removed: of $250,000,000.
−Removed: As of February 13, 2022, other than the $11,800,000 of common shares we are eligible to sell pursuant to the ATM Agreement,
−Removed: and the $30,000,000 of common shares we sold in a registered direct offering in February 2021, no securities have been sold pursuant
−Removed: to our effective Form S-3 registration statement.
+Added: Under this shelf registration process, we may, from time to time, sell our common shares, preferred shares and warrants
+Added: 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.
+Added: 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
+Added: of common shares we sold in a registered direct offering in February 2021, no securities have been sold pursuant to our effective Form
+Added: S-3 registration statement.
We have accumulated a deficit
7 unchanged sentences
development and clinical study activities.
−Removed: We are continually looking
−Removed: for sources of funding, including non-diluting sources such as collaboration with other companies via licensing agreements, the IIA grants,
−Removed: the European Union grant and other research grants, and sales of our common shares.
+Added: We are continually looking for sources of funding, including non-diluting
+Added: sources such as collaboration with other companies via licensing agreements, joint venture and partnerships, research grants such as the
+Added: IIA grants and the European Union grant, and sales of our common shares.
We believe that we have sufficient
1 unchanged sentence
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.