2 unchanged sentences
Forward-Looking Statements
−Removed: This Quarterly Report on
−Removed: Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and
−Removed: other Federal securities laws, and is subject to the safe-harbor created by such Act and laws.
−Removed: Forward-looking statements may include
−Removed: statements regarding our goals, beliefs, strategies, objectives, plans, including product and technology developments, future financial
−Removed: conditions, results or projections or current expectations.
−Removed: In some cases, you can identify forward-looking statements by terminology
−Removed: such as “may,” “will,” “should,” “expect,” “intend,” “plan,”
−Removed: “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,”
−Removed: the negative of such terms, or other variations thereon or comparable terminology.
−Removed: These statements are merely predictions and therefore
−Removed: inherently subject to known and unknown risks, uncertainties, assumptions , and
−Removed: other factors that may cause actual results, performance levels of activity, or our achievements, or industry results to be materially
−Removed: different from those contemplated by the forward-looking statements.
−Removed: Such forward-looking statements appear in this Item 2 – “Management’s
−Removed: Discussion and Analysis of Financial Condition and Results of Operations,” and may appear elsewhere in this Quarterly Report on
−Removed: Form 10-Q and include, but are not limited to, statements regarding the following:
−Removed: expected development and potential benefits from our products in regenerative medicine, biologics
−Removed: and food technology, or food tech, as well as potentially in other industries and verticals
−Removed: that have a need for our mass scale and cost-effective cell expansion platform;
−Removed: prospects of entering into additional license agreements, or other forms of cooperation with
−Removed: other companies, research organizations and medical institutions, including, without limitation
−Removed: Tnuva (as defined below);
−Removed: pre-clinical and clinical study plans, including timing of initiation, expansion, enrollment,
−Removed: results, and conclusion of trials;
−Removed: regulatory approvals;
−Removed: of future funding from the Israel Innovation Authority, or IIA, the European Union’s
−Removed: Horizon programs, the National Institutes of Health, or NIH, as well as grants from
−Removed: other independent third parties;
−Removed: capabilities for new clinical indications of placenta expanded, or PLX, cells and new products;
−Removed: expectation to demonstrate a real-world impact and value from our pipeline, technology platform
−Removed: and commercial-scale manufacturing capacity;
−Removed: possible impacts of cybersecurity incidents on our business and operations;
−Removed: expectations regarding our short- and long-term capital requirements;
−Removed: outlook for the coming months and future periods, including but not limited to our expectations
−Removed: regarding future revenue and expenses;
−Removed: ● information
−Removed: with respect to any other plans and strategies for our business;
−Removed: Israeli government is pursuing extensive changes to Israel’s judicial system, which
−Removed: may negatively impact the business environment in Israel with reluctance for investments
−Removed: or transactions as well as lead to increased currency fluctuations, downgrades in credit
−Removed: rating and increased interest rates;
−Removed: market, political and economic conditions in the countries in which we operate including
−Removed: those related to recent unrest and actual or potential armed conflict in Israel and other
−Removed: parts of the Middle East, such as the recent attack by Hamas and other terrorist organizations
−Removed: from the Gaza Strip and Israel’s war against them.
+Added: This Quarterly Report on Form
+Added: 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other
+Added: Federal securities laws, and is subject to the safe-harbor created by such Act and laws.
+Added: Forward-looking statements may include statements
+Added: regarding our goals, beliefs, strategies, objectives, plans, including product and technology developments, future financial conditions,
+Added: results or projections or current expectations.
+Added: In some cases, you can identify forward-looking statements by terminology such as “may,”
+Added: “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,”
+Added: “estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other
+Added: variations thereon or comparable terminology.
+Added: These statements are merely predictions and therefore inherently subject to known and unknown
+Added: risks, uncertainties, assumptions, and other factors that may cause actual results, performance levels of activity, or our achievements,
+Added: or industry results to be materially different from those contemplated by the forward-looking statements.
+Added: Such forward-looking statements
+Added: appear in this Item 2 – “Management’s Discussion and Analysis of Financial Condition and Results of Operations,”
+Added: and may appear elsewhere in this Quarterly Report on Form 10-Q and include, but are not limited to, statements regarding the following:
+Added: the expected development, time-to-market and potential benefits from our products in regenerative medicine, biologics and food technology, or 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: our expectations of market and industry growth;
+Added: the prospects of entering into additional license agreements, or other forms of cooperation or strategic partnerships 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, scale, expansion, enrollment, results, and conclusion of trials;
+Added: achieving regulatory approvals;
+Added: receipt of future funding from the Israel Innovation Authority, or IIA, the European Union’s Horizon programs, the National Institutes of Health, or NIH, 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 solve medicine’s unmet needs and 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;
+Added: our expectations regarding our short- and long-term capital requirements;
+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;
+Added: changes to the Israel’s judicial system, which if pursued by the Israeli government, 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: general market, political and economic conditions in the countries in which we operate including those related to recent unrest in the Middle East and armed conflict between Israel and Hamas, Hezbollah and other terrorist organizations from the Gaza Strip and Lebanon.
Our business and operations
1 unchanged sentence
In addition, historic results
−Removed: of scientific research and development, clinical and preclinical trials do not guarantee that the conclusions of future research and
−Removed: development or trials would not suggest different conclusions.
−Removed: Also, historic results referred to in this periodic report would be interpreted
−Removed: differently in light of additional research, development, clinical and preclinical trials results.
−Removed: Except as required by law, we undertake
−Removed: no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or
−Removed: circumstances after the date hereof or to reflect the occurrence of unanticipated events.
−Removed: Further information on potential factors that
−Removed: could affect our business is described under the heading “Risk Factors” in Part I, Item 1A, of our Annual Report on Form
−Removed: 10-K for the fiscal year ended June 30, 2023, or the 2023 Annual Report, as well as Item 1A of this Quarterly Report.
−Removed: Readers are also
−Removed: urged to carefully review and consider the various disclosures we have made in that report.
+Added: of scientific research and development, clinical and preclinical trials do not guarantee that the conclusions of future research and development
+Added: or trials would not suggest different conclusions.
+Added: Also, historic results referred to in this periodic report would be interpreted differently
+Added: in light of additional research, development, clinical and preclinical trials results.
+Added: Except as required by law, we undertake no obligation
+Added: to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances
+Added: after the date hereof or to reflect the occurrence of unanticipated events.
+Added: Further information on potential factors that could affect
+Added: 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
+Added: year ended June 30, 2023, or the 2023 Annual Report, as well as Item 1A of this Quarterly Report.
+Added: Readers are also urged to carefully
+Added: review and consider the various disclosures we have made in that report.
As used in this Quarterly
9 unchanged sentences
We are utilizing our technology in
−Removed: the field of regenerative medicine and food tech and plan to utilize it in other industries and verticals that have a need for our mass
−Removed: scale and cost-effective cell expansion platform.
+Added: the field of regenerative medicine,food tech, Contract Development and Manufacturing Organization, or CDMO, and agtech and plan to utilize
+Added: it in industries and verticals that have a need for our mass scale and cost-effective cell expansion platform.
+Added: Our operations are focused
+Added: on the research, development and manufacturing of cells and cell-based products, and business development of cell therapeutics and cell-based
+Added: technologies and cell-based products.
We use our advanced cell-based
1 unchanged sentence
of inflammatory, muscle injuries and hematologic conditions.
−Removed: Our PLX cells are adherent stromal cells that are expanded using our 3D
−Removed: Our PLX cells can be administered to patients off-the-shelf, without blood or tissue matching or additional manipulation
−Removed: prior to administration.
+Added: Our PLX cells are adherent stromal cells that are expanded using our 3D platform.
+Added: 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.
−Removed: Our operations are focused
−Removed: on the research, development and manufacturing of cells and cell-based products, conducting clinical studies and the business development
−Removed: of cell therapeutics and cell-based technologies, such as our collaboration with Tnuva Food Industries – Agricultural Cooperative
−Removed: in Israel Ltd., through its fully owned subsidiary, Tnuva Food-Tech Incubator (2019), Limited Partnership, or Tnuva, to use our technology
−Removed: to establish a cultivated food platform, as well as a collaboration agreement we signed in 2022 with a leading European manufacturer
−Removed: of active pharmaceutical ingredients, or APIs, to use our expansion technology, which aims to revolutionize the production of biologics
−Removed: by enabling a cost-effective, sustainable and cruelty-free ingredient.
In the pharmaceutical area,
11 unchanged sentences
Department of Defense’s Armed Forces Radiobiology Research
−Removed: Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the
−Removed: development of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters
−Removed: and radiation exposure.
+Added: Institute, or AFRRI, and the Uniformed Services University of Health Sciences, or USUHS, in Maryland, U.S.A., to further advance the development
+Added: of our PLX-R18 cell therapy as a potential novel treatment for H-ARS, a deadly disease that can result from nuclear disasters and radiation
+Added: On January 8, 2024, we
+Added: announced that we are launching a new business division offering cell therapy manufacturing services as a CDMO:
+Added: offers services relating to early preclinical development, through late-stage clinical trials and commercialization, with a mission to
+Added: deliver high-quality, essential therapies to patients.
+Added: January 23, 2024, we announced that we are launching cell-based coffee business activity through a new business vertical, PluriAgtech.
+Added: PluriAgtech’s new cell-based coffee business activity is leveraged by Pluri’s 3D cell expansion and has been developed to
+Added: address the growing global demand for sustainable, high-quality coffee at mass scale production.
On January 5, 2022, we signed
−Removed: definitive collaboration agreements with Tnuva through the Subsidiary.
−Removed: Under the definitive collaboration agreements, or the Joint Venture
−Removed: Agreement, we established a new company, Ever After, with the purpose of developing cultivated meat products of all types and kinds.
−Removed: Ever After is engaged in the development, manufacturing and commercialization of technology, know-how and products that will be based
−Removed: on licensed products relating to the field of cultivated meat.
+Added: definitive collaboration agreements with Tnuva Food Industries – Agricultural Cooperative in Israel Ltd., through its fully owned
+Added: subsidiary, Tnuva Food-Tech Incubator (2019), Limited Partnership, or Tnuva.
+Added: Under the definitive collaboration agreements, or the Joint
+Added: Venture Agreement, we established a new company, Ever After, with the purpose of developing cultivated meat products of all types and
+Added: Ever After is engaged in the development, manufacturing and commercialization of technology, know-how and products that will be
+Added: based on licensed products relating to the field of cultivated meat.
Our joint venture successfully
2 unchanged sentences
PluriMatrix for producing cultivated meat.
−Removed: RESULTS OF OPERATIONS – THREE MONTHS
−Removed: ENDED SEPTEMBER 30, 2023 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2022.
−Removed: Revenues for the three-month
−Removed: period ended September 30, 2023 were $54,000 as compared to $87,000 in revenues during the three-month period ended September 30, 2022.
−Removed: Revenues for the three-month period ended September 30, 2023 were mainly related to services provided in the field of process and product
−Removed: Revenues for the three-month period ended September 30, 2022 were mainly related to our collaboration in the biologic field.
+Added: RESULTS OF OPERATIONS – THREE AND SIX
+Added: MONTHS ENDED DECEMBER 31, 2023 COMPARED TO THREE AND SIX MONTHS ENDED DECEMBER 31, 2022.
+Added: Revenues for each of the six-month
+Added: and three-month periods ended December 31, 2023 were $159,000 and $105,000, respectively, as compared to $89,000 and $2,000, respectively,
+Added: during the six-month and three-month periods ended December 31, 2022.
+Added: Revenues for the six-month and three-month periods ended December
+Added: 31, 2023 were mainly related to services provided in the field of process and product development in the CDMO and agtech field.
+Added: for the six-month and three-month periods ended December 31, 2022 were mainly related to our collaboration in the biologic field.
+Added: increase in revenues is mainly attributed to implementation of our new business strategy and collaboration in various industries, specifically
+Added: in the CDMO and agtech field.
Research and Development Expenses, Net
−Removed: Research and development, or R&D, expenses, net (costs less participation
−Removed: by the IIA, Horizon 2020, Horizon Europe and the NIAID) for the three-month period ended September 30, 2023 decreased by 30% from $4,270,000
−Removed: for the three-month period ended September 30, 2022 to $2,993,000.
−Removed: The decrease is mainly attributed to:
−Removed: (1) a decrease in clinical studies
−Removed: expenses following the completion of our CLI, COVID-19 and muscle regeneration following hip fracture studies, and (2) a decrease in salaries
−Removed: and related expenses due to the exchange rate differences related to the strength of the U.S.
−Removed: dollar against the NIS and a reduction in
−Removed: head count of 10 R&D employees (99 on September 30, 2023, compared to 109 on September 30, 2022), partially offset by (3) increased
−Removed: participation of the NIAID related to the H-ARS contract which commenced in fiscal year 2024.
+Added: Research and development,
+Added: or R&D, expenses, net (costs less participation by the IIA, Horizon Europe and the NIAID) for the six-month period ended December
+Added: 31, 2023 decreased by 26% from $8,056,000 for the six-month period ended December 31, 2022 to $5,957,000.
+Added: The decrease is mainly attributed
+Added: (1) a decrease in clinical studies expenses following the completion of our CLI, COVID-19 and muscle regeneration following hip fracture
+Added: studies, and (2) a decrease in salaries and related expenses due to the exchange rate differences related to the strength of the U.S.
+Added: dollar against the NIS , reduction in head count of 8 R&D employees (100 R&D employees on December 31, 2023, compared to 108 R&D
+Added: employees on December 31, 2022) and as a result of our cost reduction and efficiency plans partially offset by (3) a decrease in grants
+Added: participation, specifically the completion of the Horizon 2020 program.
+Added: R&D expenses, net (costs
+Added: less participation by the IIA, Horizon Europe and the NIAID) for the three-month period ended December 31, 2023 decreased by 22% from
+Added: $3,785,000 for the three-month period ended December 31, 2022 to $2,964,000.
+Added: The decrease is mainly attributed to the same reasons described
+Added: in the precedent paragraph.
General and Administrative Expenses
−Removed: General and administrative expenses for the three-month period ended
−Removed: September 30, 2023 decreased by 11% from $2,740,000 for the three-month period ended September 30, 2022 to $2,438,000 mainly due to:
−Removed: a decrease in salaries and related expenses due to the exchange rate differences relates to the strength of the U.S.
−Removed: dollar against the
−Removed: NIS (2) the reduction of our CEO’s salary, whereby he waived 50% of his salary and converted it to restricted stock units, or RSUs,
−Removed: and options, and (3) a decrease in costs relates to our directors and officers insurance policy.
−Removed: Other Financial Income, net
−Removed: Other financial income, net, decreased by 42% from $848,000 in financial
−Removed: income for the three-month period ended September 30, 2022 to $493,000 in financial income for the three-month period ended September
−Removed: This decrease is mainly attributable to a reduction in income from exchange rate differences related to the EIB loan.
−Removed: This decrease
−Removed: was partially offset by expenses from exchange rate related to NIS deposits following the strength of the U.S.
−Removed: dollar against the NIS
−Removed: and from increased income related to interest on deposits, due to an increase in interest rates.
+Added: General and administrative
+Added: expenses for the six-month period ended December 31, 2023 decreased by 15% from $5,635,000 for the six-month period ended December 31,
+Added: 2022 to $4,792,000 mainly due to:
+Added: (1) a decrease in salaries and related expenses due to the exchange rate differences relates to the
+Added: strength of the U.S.
+Added: dollar against the NIS and as a result of our cost reduction and efficiency plan, (2) the reduction of our CEO’s
+Added: salary, whereby he waived 75% of his salary and converted it to restricted stock units, or RSUs, and options, (3) a decrease in costs
+Added: relates to our directors and officers insurance policy, and (4) a decrease in share-based compensation expenses related RSU expenses amortization
+Added: General and administrative
+Added: expenses for the three-month period ended December 31, 2023 decreased by 19% from $2,896,000 for the three-month period ended December
+Added: 31, 2022 to $2,354,000 mainly due to:
+Added: (1) a decrease in salaries and related expenses due to the exchange rate differences relates to
+Added: the strength of the U.S.
+Added: dollar against the NIS and due to temporary reduction in employees’ regular working hours for a limited
+Added: period, (2) the reduction of our CEO’s salary, whereby he waived 75% of his salary and converted it to RSUs and options, and (3)
+Added: a decrease in share-based compensation expenses related to employee terminations and RSU expenses amortization over time.
+Added: Other Financial Income (expenses), net
+Added: Other financial income (expenses),
+Added: net, changed from $515,000 in financial expenses for the six-month period ended December 31, 2022 to $928,000 in financial income for
+Added: the six-month period ended December 31, 2023.
+Added: This change is mainly attributed to exchange rate related to NIS deposits following the
+Added: strength of the U.S.
+Added: dollar against the NIS, from increased income related to interest on deposits, due to an increase in interest rates
+Added: and income from hedging transactions.
+Added: Other financial income (expenses),
+Added: net, changed from $1,363,000 in financial expenses for the three-month period ended December 31, 2022 to $435,000 in financial income
+Added: for the three-month period ended December 31, 2023.
+Added: This change is mainly attributable to a reduction in exchange rate differences expenses
+Added: related to the European Investment Bank (“EIB”) loan, a reduction in exchange rate differences expenses related to NIS deposits
+Added: following the strength of the U.S.
+Added: dollar against the NIS and from increased income related to interest on deposits, due to an increase
+Added: in interest rates.
Interest Expenses
Interest expenses increased
−Removed: by 10% from $194,000 for the three-month period ended September 30, 2022 to interest expenses of $214,000 for the three-month period
−Removed: ended September 30, 2023.
+Added: by 6% from $406,000 for the six-month period ended December 31, 2022 to interest expenses of $430,000 for the six-month period ended December
This increase is attributable solely to exchange rate differences of Euro versus the U.S.
−Removed: Net loss for the three-month period ended September 30, 2023 was $5,098,000,
−Removed: as compared to net loss of $6,269,000 for the three-month period ended September 30, 2022.
−Removed: The decrease was due to a decrease in general
−Removed: and administrative expenses and research and development expenses, as part of our efforts to reduce costs pursuant to an efficiency plan,
−Removed: in addition to the completion or termination of several clinical studies.
−Removed: Net loss per share attributed to shareholders for the three-month
−Removed: period ended September 30, 2023 was $0.12, as compared to $0.19 for the three-month period ended September 30, 2022.
−Removed: We had net loss attributed
−Removed: to our non-controlling interest in Ever After for the three-month period ended September 30, 2023 of $137,000.
−Removed: For the three-month periods
−Removed: ended September 30, 2023 and 2022, we had weighted average common shares outstanding of 41,331,764 and 32,562,596, respectively which
−Removed: were used in the computations of net loss per share for the three-month periods.
−Removed: The increase in weighted
−Removed: average common shares outstanding reflects the issuance of additional shares pursuant to a private placement offering we conducted in
−Removed: December 2022, or the December 2022 Private Placement, and the issuance of additional shares upon the vesting of RSUs issued to directors,
+Added: dollar, which relates to the EIB loan
+Added: Interest expenses increased
+Added: by 2% from $212,000 for the three-month period ended December 31, 2022 to interest expenses of $216,000 for the three-month period ended
+Added: December 31, 2023.
+Added: This increase is attributable solely to exchange rate differences of Euro versus the U.S.
+Added: dollar, which relates to
+Added: the EIB loan interest.
+Added: Net loss for the six-month
+Added: and three-month periods ended December 31, 2023 were $10,092,000 and $4,994,000, respectively, as compared to net loss of $14,523,000
+Added: and $8,254,000 for the six-month and three-month periods ended December 31, 2022.
+Added: The decrease was due to a decrease in general and administrative
+Added: expenses and research and development expenses, as part of our efforts to reduce costs pursuant to an efficiency plan, and due to an increase
+Added: in income due to additional collaborations signed.
+Added: Net loss per share attributed to shareholders for the six-month and three-month periods
+Added: ended December 31, 2023 were $0.24 and $0.12, respectively, as compared to $0.44 and $0.24 for the six-month and three-month periods ended
+Added: December 31, 2022.
+Added: We had net loss attributed to our non-controlling interest in Ever After for the six-month and three-month periods
+Added: ended December 31, 2023 of $226,000 and $89,000, respectively.
+Added: For the six-month and three-month
+Added: periods ended December 31, 2023 and 2022, we had weighted average common shares outstanding of 41,526,817, 41,428,439 and 32,878,434,
+Added: 33,194,622, respectively, which were used in the computations of net loss per share for the six-month and three-month periods.
+Added: The increase in weighted average
+Added: common shares outstanding reflects the issuance of additional shares pursuant to a private placement offering we conducted in December
+Added: 2022, or the December 2022 Private Placement, and the issuance of additional shares upon the vesting of RSUs and RS issued to directors,
employees and consultants.
Liquidity and Capital Resources
−Removed: As of September 30, 2023,
−Removed: our total current assets were $35,258,000 and total current liabilities were $4,322,000.
−Removed: On September 30, 2023, we had a working capital
−Removed: surplus of $30,936,000, total equity of $11,038,000, out of which $2,137,000 is attributed to the non-controlling interest in Ever After,
−Removed: and an accumulated deficit of $404,545,000.
+Added: As of December 31, 2023, our
+Added: total current assets were $32,252,000 and total current liabilities were $4,530,000.
+Added: On December 31, 2023, we had a working capital surplus
+Added: of $27,722,000, total equity of $6,617,000, out of which $2,218,000 is attributed to the non-controlling interest in Ever After, and an
+Added: accumulated deficit of $409,450,000.
Our cash and cash equivalents
−Removed: as of September 30, 2023 amounted to $5,253,000, compared to $8,744,000 as of September 30, 2022, and compared to $5,360,000 as of June
−Removed: Cash balances changed in the three months ended September 30, 2023 compared to the three months ended September 2022 for the
−Removed: reasons presented below.
+Added: as of December 31, 2023 amounted to $5,468,000, compared to $8,818,000 as of December 31, 2022, and compared to $5,360,000 as of June
+Added: Cash balances changed in the six months ended December 31, 2023 compared to the six months ended December 2022 for the reasons
+Added: presented below.
Net cash used for operating
−Removed: activities was $5,857,000 in the three months ended September 30, 2023, compared to $7,609,000 in the three months ended September 30,
−Removed: The decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation
−Removed: of our cost reduction and efficiency plan.
−Removed: Cash used in operating activities in the three months ended September 30, 2023 and 2022 consisted
−Removed: primarily of payments to suppliers, subcontractors, professional services providers and consultants, and payments of salaries to our
−Removed: employees, partially offset by grants from the IIA, the EU’s Horizon 2020 and Horizon Europe programs, and funds received from
−Removed: the NIAID contract.
+Added: activities was $9,506,000 in the six months ended December 31, 2023, compared to $13,889,000 in the six months ended December 31, 2022.
+Added: The decrease is mainly attributed to a decrease in net loss following the completion of clinical trials and the implementation of our
+Added: cost reduction and efficiency plan, including a temporary reduction in the scope of roles and salaries of executive officers.
+Added: in operating activities in the six months ended December 31, 2023 and 2022 consisted primarily of payments to suppliers, subcontractors,
+Added: professional services providers and consultants, and payments of salaries to our employees, partially offset by grants from the IIA, the
+Added: Horizon Europe program, and funds received from the NIAID contract.
Investing activities provided
−Removed: cash of $5,802,000 in the three months ended September 30, 2023, compared to cash provided of $6,393,000 for the three months ended September
−Removed: The investing activities in the three-month period ended September 30, 2023 and September 30, 2022 consisted primarily of the
−Removed: withdrawal of short-term deposits, net of $5,905,000 and $6,466,000, respectively.
+Added: cash of $9,721,000 in the six months ended December 31, 2023, compared to cash provided of $7,062,000 for the six months ended December
+Added: The investing activities in the six-month period ended December 31, 2023 and December 31, 2022 consisted primarily of the withdrawal
+Added: of short-term deposits, net of $10,013,000 and $7,203,000, respectively.
We had no financing activities
−Removed: in the three months ended September 30, 2023 or 2022.
+Added: in the six months ended December 31, 2023.
+Added: The cash provided in the six months ended December 31, 2022 by financing activities was related
+Added: 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
+Added: December 2022 Private Placement.
Between December 13, 2022
1 unchanged sentence
common shares and warrants, or the Warrants, to purchase up to 8,155,900 common shares.
−Removed: On December 13, 2022, we executed securities
−Removed: 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
−Removed: common shares, with an exercise price of $1.03 per share and a term of three years.
On December 13, 2022, we executed securities purchase
2 unchanged sentences
On December 14, 2022, we executed securities purchase agreements
+Added: 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,
+Added: with an exercise price of $1.05 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 $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.
−Removed: On December 19, 2022, we executed a securities purchase agreement to
−Removed: 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
−Removed: an exercise price of $1.09 per share and a term of three years.
−Removed: On December 27, 2022, we executed a securities purchase agreement to
−Removed: 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
−Removed: an exercise price of $1.12 per share and a term of three years.
−Removed: The Warrants sold in the December 2022 Private Placement will be exercisable
−Removed: upon the later of six months from their issuance date, or from the date the authorized shares increased.
−Removed: The Company issued 8,155,900
−Removed: common shares and warrants that relate to the December 2022 Private Placement and received $8,024,000 as of that date net of $445 from
−Removed: issuance expenses.
+Added: On December 19, 2022, we executed a securities purchase agreement to sell,
+Added: 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
+Added: price of $1.09 per share and a term of three years.
+Added: On December 27, 2022, we executed a securities purchase agreement to sell, at a purchase
+Added: 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: $1.12 per share and a term of three years.
+Added: The Warrants sold in the December 2022 Private Placement will be exercisable upon the later
+Added: of six months from their issuance date, or from the date the authorized shares increased.
+Added: The Company issued 8,155,900 common shares and
+Added: warrants that relate to the December 2022 Private Placement and received $8,024,000 as of that date net of $445,000 from issuance expenses.
On April 27, 2023, our shareholders
19 unchanged sentences
its authorized share capital.
−Removed: July 16, 2020, we entered into an at-the market agreement, or the ATM Agreement, with Jefferies LLC, or Jefferies, pursuant to which
−Removed: we may issue and sell shares of our common shares having an aggregate offering price of up to $75,000,000 from time to time through Jefferies.
−Removed: Upon entering into the ATM Agreement, we filed a new shelf registration statement on Form S-3, which was declared effective by the SEC
−Removed: on July 23, 2020.
−Removed: 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
−Removed: 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
−Removed: of our common shares from time to time through Jefferies.
−Removed: On September 7, 2023, we provided a formal notice of termination of the ATM
−Removed: Agreement with Jefferies, which took effect on September 8, 2023.
−Removed: the three months ended September 30, 2022, and 2023, we did not sell of our any common shares under the ATM Agreement.
−Removed: Pursuant to a shelf registration on Form S-3 filed on September 12,
−Removed: 2023, which became effective on September 21, 2023, the Company may elect, from time to time, to offer and sell common shares, preferred
−Removed: stock, warrants and units having an aggregate offering price of up to $200,000,000.
+Added: December 25, 2023, Yaky Yanay, our Chief Executive Officer, agreed to a reduction in the scope of his role and to a 20% reduction of his
+Added: salary in the amount of 39,600 NIS for the months of January 2024 and February 2024.
+Added: January 12, 2024, Chen Franco-Yehuda, our Chief Financial Officer, agreed to a reduction in the scope of her role and to a 20% reduction
+Added: of her salary in the amount of 39,000 NIS for the months of December 2023, January 2024 and February 2024.
In April 2020, we and
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June 1, 2026 and bears annual interest of 4% to be paid together with the principal of the loan.
−Removed: As of September 30, 2023, the interest
+Added: As of December 31, 2023, the interest
accrued was in the amount of €2,062,000.
8 unchanged sentences
In the absence of such sales, no payment
−Removed: Through September 30, 2023, total grants obtained from the IIA aggregated to approximately $27,743,000 and total royalties
+Added: Through December 31, 2023, total grants obtained from the IIA aggregated to approximately $27,848,000 and total royalties
paid and accrued amounted to $179,000.
5 unchanged sentences
DNA, have applications in the pharma, agriculture, and aquaculture industries.
−Removed: CRISPR-IL is funded by the IIA with a total budget of
−Removed: approximately $10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for the initial period of
−Removed: During October 2021, we received an approval for an additional grant of approximately $583,000 from the IIA pursuant to the
−Removed: CRISPR-IL consortium program, for an additional period of eighteen months.
−Removed: During January 2023, we received approval for an extension
−Removed: of an additional 2 months to finish the program until June 30, 2023.
−Removed: The CRISPR-IL consortium program does not include any obligation
−Removed: to pay royalties.
−Removed: September 30, 2023, we received total grants of approximately $774,000 in cash from the IIA pursuant to the CRISPR-IL consortium program;
−Removed: no amount was received during the three months ended September 30, 2023.
+Added: CRISPR-IL is funded by the IIA with a total budget of approximately
+Added: $10,000,000 of which, an amount of approximately $480,000 was a direct grant allocated to us, for the initial period of 18 months.
+Added: October 2021, we received an approval for an additional grant of approximately $583,000 from the IIA pursuant to the CRISPR-IL consortium
+Added: 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.
+Added: The CRISPR-IL consortium program does not include any obligation to pay royalties.
+Added: December 31, 2023, we received total grants of approximately $774,000 in cash from the IIA pursuant to the CRISPR-IL consortium program;
+Added: no amount was received during the three months ended December 31, 2023.
September 6, 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon program was awarded
−Removed: to Advanced PeRsOnalized Therapies for Osteoarthritis (PROTO), 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.
+Added: to Advanced PeRsOnalized Therapies for Osteoarthritis (PROTO), an international collaboration led by Charité Berlin Institute of
+Added: Health Center for Regenerative Therapies.
+Added: The goal of the PROTO project is to utilize our PLX-PAD cells in a Phase I/IIa study for the
+Added: treatment of mild to moderate knee osteoarthritis.
Final approval of the grant is subject to completion of the consortium agreement.
−Removed: An amount of approximately Euro 500,000 (approximately $533,745) will be a direct grant that will be allocated to us.
−Removed: Through September
+Added: amount of approximately Euro 500,000 (approximately $533,745) will be a direct grant that will be allocated to us.
+Added: Through December 31,
2023, we received a payment of approximately $185,000 in cash, which relates to the PROTO program.
−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: 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.
July 11, 2023, we signed a three-year $4,200,000 contract with the NIAID, which is part of the NIH.
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of this contract will be from July 1, 2023 through June 30, 2024, which may be extended for an additional two-year period.
−Removed: As of September
−Removed: 30, 2023, we expect to receive from the NIAID grant approximately $382,000.
+Added: As of December
+Added: 31, 2023, we have received from the NIAID approximately $382,000 and we expect to receive an additional amount of approximately $343,000.
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 2023 Annual Report.
+Added: - “Quantitative and Qualitative Disclosures about Market Risk”
+Added: in the 2023 Annual Report.
We have an effective Form
5 unchanged sentences
$200,000,000.
−Removed: As of November 13, 2023 , no securities have been sold pursuant to
−Removed: our effective Form S-3 registration statement.
−Removed: We have accumulated a deficit of $404,545,000 since our inception in
−Removed: We do not expect to generate any significant revenues from sales of products in the next twelve months.
−Removed: We expect to generate
−Removed: revenues, from collaborations and sales of licenses to use our technology or products, but in the short and medium terms these will unlikely
−Removed: exceed our costs of operations.
+Added: As of February 12, 2024, no securities have been sold pursuant to our effective Form S-3 registration statement.
+Added: We have accumulated a deficit
+Added: of $409,450,000 since our inception in May 2001.
+Added: We do not expect to generate any significant revenues from sales of products in the next
+Added: twelve months.
+Added: We expect to generate revenues, from collaborations and sales of licenses to use our technology or products, but in the
+Added: short and medium terms these will unlikely exceed our costs of operations.
We may be required to obtain
additional liquidity resources in order to support the commercialization of our products and technology and maintain our research and
−Removed: development and clinical study activities.
+Added: development activities.
We are continually looking
−Removed: for sources of funding, including non-diluting sources such as collaboration with other companies via licensing agreements, joint venture
−Removed: and partnerships, R&D contracts such as our agreement with the NIAID, research grants such as the IIA grants and the European Union
−Removed: grant, and sales of our common shares.
+Added: for sources of funding, including non-diluting sources such as collaboration with other companies via licensing agreements, service agreements
+Added: under our CDMO business, joint venture and partnerships, R&D contracts such as our agreement with the NIAID, research grants such
+Added: as the 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.