UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________ to __________ Commission file number 001-31392 PLURI INC. (Exact name of registrant as specified in its charter) | Nevada | 98-0351734 | | --- | --- | | (State or other jurisdic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from [ ] to [ ] Commission file number 001-31392 PLURI INC. (Exact name of registrant as specified in its charter) Nevada 98-0351734 (State or other jurisdiction of incorporat ...

Form 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________ to __________ Commission file number 001-31392 PLURI INC. (Exact name of registrant as specified in its charter) | Nevada | 98-0351734 | | --- | --- | | (State or other jurisdiction ...

[Form 10-Q Filing Information](index=1&type=section&id=Form%2010-Q%20Filing%20Information) This section details the company's Form 10-Q filing as a non-accelerated, smaller reporting company for the period ended December 31, 2022, including its incorporation and outstanding shares - The document is a Quarterly Report (Form 10-Q) for the period ended December 31, 2022[1](index=1&type=chunk) - The registrant, PLURI INC., is incorporated in Nevada with a Nasdaq Global Market trading symbol 'PLUR'[2](index=2&type=chunk) Registrant Status | Status | Checkmark | | :-------------------- | :-------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | | Shell company | No ☒ | - As of February 13, 2023, there were **39,807,172 common shares** issued and outstanding[4](index=4&type=chunk) [Interim Condensed Consolidated Financial Statements](index=3&type=section&id=Interim%20Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited interim financial statements, including balance sheets, statements of operations, changes in equity, cash flows, and detailed notes [Interim Condensed Consolidated Balance Sheets](index=5&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) The company's balance sheet as of December 31, 2022, shows a decrease in total assets and shareholders' equity compared to June 30, 2022, primarily driven by a reduction in current assets and an accumulated deficit Key Balance Sheet Data (USD in thousands) | Item | Dec 31, 2022 | Jun 30, 2022 | Change (Dec 22 vs Jun 22) | | :-------------------------- | :----------- | :----------- | :------------------------ | | Total current assets | $50,140 | $57,747 | $(7,607) | | Total long-term assets | $9,787 | $10,318 | $(531) | | Total assets | $59,927 | $68,065 | $(8,138) | | Total current liabilities | $5,284 | $6,829 | $(1,545) | | Total long-term liabilities | $29,677 | $29,050 | $627 | | Total shareholders' equity | $23,191 | $30,039 | $(6,848) | | Accumulated deficit | $(385,501) | $(371,263) | $(14,238) | [Interim Condensed Consolidated Statements of Operations](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a significant reduction in net loss for both the three-month and six-month periods ended December 31, 2022, primarily due to decreased operating expenses, particularly in R&D and G&A, and the generation of initial revenues Key Statements of Operations Data (USD in thousands) | Item | 6 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2021 | Change (YoY) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | Change (YoY) | | :---------------------------------- | :-------------------------- | :-------------------------- | :----------- | :-------------------------- | :-------------------------- | :----------- | | Revenues | $89 | $- | N/A | $2 | $- | N/A | | Research and development expenses, net | $(8,056) | $(12,860) | 37.39% | $(3,785) | $(6,507) | 41.83% | | General and administrative expenses | $(5,635) | $(9,376) | 39.89% | $(2,896) | $(4,288) | 32.46% | | Operating loss | $(13,602) | $(22,236) | 38.74% | $(6,679) | $(10,795) | 38.13% | | Net loss | $(14,523) | $(22,372) | 35.08% | $(8,254) | $(10,940) | 24.55% | | Basic and diluted net loss per share | $(0.44) | $(0.70) | 37.00% | $(0.24) | $(0.34) | 29.41% | - Revenues for the six-month and three-month periods ended December 31, 2022, were primarily related to collaboration in the biologic field[90](index=90&type=chunk) - The decrease in R&D expenses was mainly due to the completion of clinical studies, reduced material purchases, a reduction of **29 R&D employees**, decreased share-based compensation, and higher participation from Horizon 2020 grants[91](index=91&type=chunk)[92](index=92&type=chunk) - The decrease in G&A expenses was mainly due to a decrease in share-based compensation expenses related to market-based vesting RSUs granted to the CEO and Chairman, employee terminations, and RSU expense amortization[93](index=93&type=chunk)[94](index=94&type=chunk) - Other financial income (expenses), net, shifted from income to expenses, primarily due to exchange rate differences related to the EIB loan following the Euro's strength against the U.S. dollar[95](index=95&type=chunk)[96](index=96&type=chunk) [Interim Condensed Statements of Changes in Shareholders' Equity](index=8&type=section&id=Interim%20Condensed%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Shareholders' equity decreased from **$30,039 thousand** as of July 1, 2022, to **$23,191 thousand** as of December 31, 2022, primarily due to a net loss of **$14,238 thousand**, partially offset by share-based compensation and the issuance of common stock and warrants from a private placement Changes in Shareholders' Equity (USD in thousands) | Item | July 1, 2022 | Dec 31, 2022 | Change | | :---------------------------------------------------------------- | :----------- | :----------- | :------- | | Additional Paid-in Capital | $401,302 | $408,692 | $7,390 | | Accumulated Deficit | $(371,263) | $(385,501) | $(14,238) | | Total Shareholders' Equity | $30,039 | $23,191 | $(6,848) | | Non-controlling interests | $2,147 | $1,775 | $(372) | | Total Equity | $32,186 | $24,966 | $(7,220) | - Share-based compensation to employees, directors, and non-employee consultants contributed **$1,355 thousand** to additional paid-in capital for the six months ended December 31, 2022[17](index=17&type=chunk) - Issuance of common stock and warrants related to the December 2022 Private Placement, net of issuance costs, added **$5,406 thousand** to additional paid-in capital[17](index=17&type=chunk) - The expiration of warrants in Plurinuva resulted in a reclassification of **$1,014 thousand** from non-controlling interests to additional paid-in capital[17](index=17&type=chunk) [Interim Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company experienced a decrease in cash, cash equivalents, and restricted cash by **$1,245 thousand** for the six months ended December 31, 2022, driven by operating activities, partially offset by investing and financing activities Key Cash Flow Data (USD in thousands) | Cash Flow Activity | 6 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2021 | | :------------------------------------ | :-------------------------- | :-------------------------- | | Net cash used for operating activities | $(13,889) | $(18,652) | | Net cash provided by investing activities | $7,062 | $7,075 | | Net cash provided by financing activities | $5,693 | $- | | Decrease in cash, cash equivalents and restricted cash | $(1,245) | $(12,616) | | Cash, cash equivalents and restricted cash at end of period | $10,168 | $19,222 | - The decrease in net cash used for operating activities (from **$18,652 thousand** to **$13,889 thousand**) was mainly due to a reduced net loss following clinical trial completions and cost reduction efforts[104](index=104&type=chunk) - Investing activities provided **$7,062 thousand** in cash, primarily from the withdrawal of short-term deposits, a shift from cash used in the prior year[105](index=105&type=chunk) - Financing activities provided **$5,693 thousand**, mainly from the issuance of common stock and warrants in the December 2022 Private Placement[106](index=106&type=chunk) [Notes to Interim Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) The notes provide detailed information on the company's general operations, significant accounting policies, commitments, contingencies, loan agreements, and changes in shareholders' equity, offering crucial context to the unaudited interim financial statements [Note 1: General Information](index=12&type=section&id=NOTE%201:%20-%20GENERAL) This note covers the company's name change to Pluri Inc., its business focus on 3D cell expansion technology, financial position including accumulated deficit and cash, and details regarding the Plurinuva joint venture and warrant expiration - Effective July 26, 2022, Pluristem Therapeutics Inc. changed its name to Pluri Inc. and its Nasdaq symbol from 'PSTI' to 'PLUR'[24](index=24&type=chunk) - The company operates in one business segment, focusing on a 3D cell expansion technology platform for regenerative medicine, food tech, agri-tech, and biologics[24](index=24&type=chunk) - As of December 31, 2022, the company had an accumulated deficit of **$385,501 thousand** and incurred a net loss of **$14,523 thousand** with negative cash flows from operating activities of **$13,889 thousand** for the six-month period[24](index=24&type=chunk) - The company's cash position (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled **$48,596 thousand** as of December 31, 2022, deemed sufficient for at least twelve months of operations[25](index=25&type=chunk) - The joint venture Plurinuva Ltd. was established with Tnuva in January 2022 to develop cultured meat products, granting Plurinuva exclusive licensing rights to Pluri's technology in this field[27](index=27&type=chunk) - Warrants issued to Tnuva for additional investment in Plurinuva expired unexercised on November 22, 2022, resulting in a reclassification of **$1,014 thousand** from non-controlling interest to additional paid-in capital[34](index=34&type=chunk) [Note 2: Significant Accounting Policies](index=14&type=section&id=NOTE%202:%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the basis of preparation for the interim unaudited financial statements, adherence to U.S. GAAP and SEC regulations, and the adoption of recent accounting standards updates, including ASU 2021-04, 2021-10, and 2016-13 - The interim unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC Regulation S-X, and do not include all disclosures required for complete annual financial statements[35](index=35&type=chunk) - Operating results for the six-month period ended December 31, 2022, are not necessarily indicative of the results expected for the full year ending June 30, 2023[36](index=36&type=chunk) - The company adopted ASU 2021-04 (Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options), which impacted the modification of warrants to non-controlling interest in Plurinuva[45](index=45&type=chunk) - The company adopted ASU 2021-10 (Government Assistance Disclosures), which did not have a material impact on its consolidated financial statements[46](index=46&type=chunk)[47](index=47&type=chunk) - The company, as a smaller reporting company (SRC), is adopting the deferral period for ASU 2016-13 (Credit Losses) and does not expect a material impact on its consolidated financial statements[49](index=49&type=chunk)[50](index=50&type=chunk) [Note 3: Commitments and Contingencies](index=17&type=section&id=NOTE%203:%20-%20COMMITMENTS%20AND%20CONTINGENCIES) This note details the company's contingent liabilities, including royalties owed to the Israeli Innovation Authority and Tel-Aviv Sourasky Medical Center, as well as pledged cash for bank guarantees and commitments under the 'Shalav' program - As of December 31, 2022, the company's contingent liability for royalties to the Israeli Innovation Authority (IIA) amounted to **$27,574 thousand**, excluding LIBOR interest[52](index=52&type=chunk) - The company has pledged **$1,350 thousand** in cash and deposits for bank guarantees related to its facility operating lease and credit line for hedging transactions[53](index=53&type=chunk) - Royalties to the IIA are **3%** on sales of products derived from IIA-funded technology until **100%** of the dollar-linked grant is repaid, contingent on actual sales[53](index=53&type=chunk) - The company will pay **1%** royalties from net sales of PLX-PAD cell therapy for cGVHD to Tel-Aviv Sourasky Medical Center, with a maximum aggregate royalty of approximately **$250 thousand**[59](index=59&type=chunk) - Contingent liability for royalties under the 'Shalav' program (Israeli Ministry of Economy and Industry) was **$52 thousand** as of December 31, 2022, with no royalties paid or accrued[59](index=59&type=chunk) [Note 4: Loan from the European Investment Bank (EIB)](index=18&type=section&id=NOTE%204:%20-%20LOAN%20FROM%20THE%20EIB) This note details the EIB loan agreement, including the €50 million facility, the €20 million first tranche received, its interest rate and principal balance, associated royalty obligations, and the expectation of no further disbursements - The German Subsidiary entered into a finance contract with the EIB in April 2020 for a loan of up to **€50 million**, payable in three tranches, to support R&D in the EU[55](index=55&type=chunk)[114](index=114&type=chunk) - The first tranche of **€20 million** was received in June 2021, due June 1, 2026, bearing an annual interest rate of **4%**[58](index=58&type=chunk)[115](index=115&type=chunk) - As of December 31, 2022, the linked principal balance was **$21,330 thousand** and accrued interest was **$1,345 thousand**, presented as long-term liabilities[58](index=58&type=chunk) - The EIB is entitled to royalties from future revenues (**0.2% to 2.3%** of consolidated revenues) for seven years starting fiscal year 2024, pro-rated to the disbursed loan amount[57](index=57&type=chunk)[115](index=115&type=chunk) - The company does not expect to receive additional funds from the EIB Finance Contract as the project term ended on December 31, 2022[58](index=58&type=chunk)[115](index=115&type=chunk) [Note 5: Shareholders' Equity](index=19&type=section&id=NOTE%205:%20-%20SHAREHOLDERS'%20EQUITY) This note details changes in shareholders' equity, including the ATM agreement, a private placement of common shares and warrants, the CEO's equity compensation agreement, and activity related to options and restricted stock units for employees and directors - The company reduced the amount available to be sold under its ATM Agreement with Jefferies LLC to a maximum aggregate offering price of **$11,800 thousand** as of September 21, 2022, and no common shares were sold under this agreement during the six-month period ended December 31, 2022[62](index=62&type=chunk)[112](index=112&type=chunk) - Between December 13 and December 27, 2022, the company entered into a private placement, issuing **5,550,121 common shares** and warrants as of December 31, 2022, for **$5.8 million** in proceeds, with total gross proceeds of **$7.3 million** from **7,015,900 common shares** and warrants issued as of February 13, 2023[63](index=63&type=chunk)[108](index=108&type=chunk) - CEO Yaky Yanay agreed to forgo **$375 thousand** of his annual cash salary for 12 months starting January 1, 2023, in return for equity grants, including **334,821 RSUs** and options to purchase **334,821 common shares**, plus additional options to purchase **1,500,000 common shares**[67](index=67&type=chunk)[110](index=110&type=chunk) Options Outstanding to Consultants (6 Months Ended Dec 31, 2022) | Item | Number | Weighted Average Exercise Price | | :-------------------------------- | :----- | :------------------------------ | | Options outstanding at beginning | 91,045 | $1.32 | | Options forfeited | (15,000) | $2.65 | | Options outstanding at end | 76,045 | $1.06 | | Options exercisable at end | 54,795 | $0.73 | RSU Activity for Employees and Directors (6 Months Ended Dec 31) | Item | 2022 (Number) | 2021 (Number) | | :-------------------------- | :------------ | :------------ | | Unvested at beginning | 1,935,014 | 2,404,415 | | Granted | 334,821 | 75,000 | | Forfeited | (39,138) | (32,480) | | Vested | (212,287) | (233,570) | | Unvested at end | 2,018,410 | 2,213,365 | Compensation Expenses for RSUs to Employees and Directors (USD in thousands) | Expense Category | 6 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2021 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Research and development expenses | $117 | $418 | | General and administrative expenses | $1,139 | $4,494 | | Total | $1,256 | $4,912 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's discussion and analysis of the company's financial condition and results of operations, including forward-looking statements, a business overview, and detailed insights into financial performance and liquidity [Forward-Looking Statements](index=23&type=section&id=Forward-Looking%20Statements) This section highlights that the report contains forward-looking statements subject to inherent risks and uncertainties, and actual results may differ materially from those contemplated. The company does not undertake to publicly release revisions to these statements - Forward-looking statements include expectations regarding product development, licensing agreements, clinical study plans, regulatory approvals, future funding, and financial outlook[73](index=73&type=chunk) - The business and operations are subject to substantial risks, and historic results of scientific research or trials do not guarantee future conclusions[74](index=74&type=chunk)[75](index=75&type=chunk) [Business Overview](index=24&type=section&id=Overview) Pluri Inc. is a biotechnology company leveraging its 3D cell expansion technology platform across regenerative medicine, food tech, and biologics. The company focuses on R&D, manufacturing, clinical studies, and business development, aiming for commercialization through various strategic partnerships - Pluri utilizes a unique 3D technology platform for cell expansion with an industrial-scale in-house GMP cell manufacturing facility[77](index=77&type=chunk) - Current applications include regenerative medicine (placenta-based cell therapy candidates for inflammatory, muscle injuries, and hematologic conditions) and food tech (cultivated meat via Plurinuva joint venture)[78](index=78&type=chunk)[79](index=79&type=chunk)[83](index=83&type=chunk) - The company is also expanding into biologics, with a collaboration to develop a unique biologic API using its 3D cell expansion bioreactor systems[79](index=79&type=chunk)[87](index=87&type=chunk) - Clinical studies include Phase III in muscle recovery (hip fracture), Phase II in ARDS (COVID-19), Phase I in incomplete bone marrow transplantation recovery, and an investigator-led Phase I/II in Chronic Graft versus Host Disease[81](index=81&type=chunk) - Plurinuva, the joint venture with Tnuva, successfully completed proof of concept in cultivated meat development in December 2022[86](index=86&type=chunk) [Results of Operations](index=26&type=section&id=RESULTS%20OF%20OPERATIONS%20%E2%80%93%20THREE%20AND%20SIX%20MONTHS%20ENDED%20DECEMBER%2031,%202022%20COMPARED%20TO%20THREE%20AND%20SIX%20MONTHS%20ENDED%20DECEMBER%2031,%202021.) The company significantly reduced its net loss for both the three-month and six-month periods ended December 31, 2022, compared to the prior year, driven by substantial decreases in R&D and G&A expenses due to cost reduction plans and the completion of clinical studies. Initial revenues were also generated from biologic collaborations Comparative Financial Performance (USD in thousands) | Metric | 6 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2021 | YoY Change (%) | 3 Months Ended Dec 31, 2022 | 3 Months Ended Dec 31, 2021 | YoY Change (%) | | :---------------------------------- | :-------------------------- | :-------------------------- | :------------- | :-------------------------- | :-------------------------- | :------------- | | Revenues | $89 | $- | N/A | $2 | $- | N/A | | R&D Expenses, Net | $(8,056) | $(12,860) | (37.39%) | $(3,785) | $(6,507) | (41.83%) | | G&A Expenses | $(5,635) | $(9,376) | (39.89%) | $(2,896) | $(4,288) | (32.46%) | | Operating Loss | $(13,602) | $(22,236) | (38.74%) | $(6,679) | $(10,795) | (38.13%) | | Other Financial Income (Expenses), net | $(515) | $317 | (262.46%) | $(1,363) | $80 | (1803.75%) | | Interest Expenses | $(406) | $(453) | 10.38% | $(212) | $(225) | 5.80% | | Net Loss | $(14,523) | $(22,372) | (35.08%) | $(8,254) | $(10,940) | (24.55%) | | Basic and Diluted Net Loss Per Share | $(0.44) | $(0.70) | (37.14%) | $(0.24) | $(0.34) | (29.41%) | - The decrease in R&D and G&A expenses was attributed to the completion of clinical trials, a cost reduction plan, and reduced share-based compensation[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[99](index=99&type=chunk) - Other financial income (expenses), net, shifted to a significant expense due to exchange rate differences related to the EIB loan, following the Euro's strength against the U.S. dollar[95](index=95&type=chunk)[96](index=96&type=chunk) - Weighted average common shares outstanding increased due to the December 2022 Private Placement and vesting of RSUs[100](index=100&type=chunk)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2022, the company maintained a working capital surplus of **$44,856 thousand** and a cash position of **$48,596 thousand**, which management believes is sufficient for at least the next twelve months. Cash flows from operations improved, and financing activities provided significant cash through a private placement Liquidity Position (USD in thousands) | Metric | Dec 31, 2022 | Jun 30, 2022 | Dec 31, 2021 | | :-------------------------- | :----------- | :----------- | :----------- | | Total current assets | $50,140 | $57,747 | N/A | | Total current liabilities | $5,284 | $6,829 | N/A | | Working capital surplus | $44,856 | N/A | N/A | | Total equity | $24,966 | $32,186 | N/A | | Accumulated deficit | $385,501 | $371,263 | N/A | | Cash and cash equivalents | $8,818 | $9,772 | $18,715 | | Total cash position (incl. deposits) | $48,596 | N/A | N/A | Cash Flow Summary (USD in thousands) | Cash Flow Activity | 6 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2021 | | :------------------------------------ | :-------------------------- | :-------------------------- | | Net cash used for operating activities | $(13,889) | $(18,652) | | Net cash provided by investing activities | $7,062 | $7,075 | | Net cash provided by financing activities | $5,693 | $- | - The December 2022 Private Placement generated aggregate gross proceeds of **$7.3 million** from the issuance of **7,015,900 common shares** and warrants as of February 13, 2023[108](index=108&type=chunk) - The CEO's agreement to forgo **$375 thousand** of annual cash salary for equity grants (RSUs and options) is part of the company's capital management[110](index=110&type=chunk) - The company received grants from the IIA (total **$757 thousand** from CRISPR-IL program, **$62 thousand** in current period) and the European Union's Horizon 2020 program (total **$6,614 thousand**, with an additional **$735 thousand** approved for PLX-PAD program)[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - A **€7.5 million** non-dilutive grant from the EU's Horizon program was awarded to the PROTO consortium for a Phase I/IIa study for knee osteoarthritis, with approximately **€500 thousand** allocated directly to Pluri[120](index=120&type=chunk) - The company does not expect significant revenues from product sales in the next twelve months but anticipates revenues from licensing technology or products, which are unlikely to exceed operating costs in the short to medium term[124](index=124&type=chunk) [Part II—Other Information](index=33&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers other important information, including risk factors, details on unregistered equity sales, internal controls and procedures, other significant events, and a list of all exhibits filed with the report [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors.) This section refers readers to the comprehensive discussion of risk factors detailed in the company's 2022 Annual Report on Form 10-K, as well as other disclosures in this Quarterly Report - Readers should carefully consider the factors discussed in Part I, Item 1A, 'Risk Factors' in the 2022 Annual Report on Form 10-K, which could materially affect the business, financial condition, or future results[131](index=131&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported an unregistered sale of equity securities on December 27, 2022, involving common shares and warrants, which was exempt from SEC registration requirements - On December 27, 2022, the company sold **135,000 common shares** and warrants to purchase **135,000 common shares** to a single investor at **$1.12 per share**, with a three-year term[132](index=132&type=chunk) - The warrants are exercisable upon the later of six months from issuance or until the company increases its authorized shares[132](index=132&type=chunk) - The securities were issued under exemptions from registration requirements of the Securities Act of 1933, specifically Section 4(a)(2) and/or Rule 506(b) of Regulation D and Regulation S[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures.) The company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective as of December 31, 2022, and reported no material changes in internal control over financial reporting during the quarter - The CEO and CFO evaluated the effectiveness of disclosure controls and procedures and concluded they were effective as of the end of the reporting period[128](index=128&type=chunk)[129](index=129&type=chunk) - There were no changes in internal control over financial reporting during the second quarter of fiscal year 2023 that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[130](index=130&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information.) This section discloses a significant recent event regarding a consulting agreement for the appointment of a new Chairman of the Board of Directors - On February 13, 2023, Pluri Biotech Ltd. entered into a consulting agreement with Mr. Zami Aberman for him to serve as the Company's Chairman of the Board of Directors[134](index=134&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including forms of agreements, certifications, and XBRL data - Key exhibits include the Form of Warrant, Form of Securities Purchase Agreement, Amended and Restated Consulting Agreement, Rule 13a-14(a) Certifications of CEO and CFO, and XBRL formatted financial statements[137](index=137&type=chunk) [Signatures](index=34&type=section&id=SIGNATURES) This section confirms the official signing of the report on February 13, 2023, by the Chief Executive Officer and President, and the Chief Financial Officer - The report was signed on February 13, 2023, by Yaky Yanay, Chief Executive Officer and President (Principal Executive Officer), and Chen Franco-Yehuda, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)[141](index=141&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________ to __________ Commission file number 001-31392 PLURI INC. (Exact name of registrant as specified in its charter) | Nevada | 98-0351734 | | --- | --- | | (State or other jurisdic ...

PART I [Item 1. Business](index=6&type=section&id=Item%201.%20Business) Pluri Inc. is a biotechnology company utilizing a 3D cell expansion technology platform for regenerative medicine and food tech. The company develops placenta-based cell therapy candidates (PLX cells) and operates a GMP manufacturing facility. It recently changed its name from Pluristem Therapeutics Inc. to reflect a broader strategy beyond medicine - Company Name Change: **Pluristem Therapeutics Inc. to Pluri Inc.** (effective July 26, 2022), Nasdaq ticker changed to "PLUR"[23](index=23&type=chunk) - Core Business: Biotechnology company with an advanced 3D cell expansion technology platform for regenerative medicine and food tech, with plans for other industries[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) - Business Model: Includes licensing deals, joint ventures, partnerships, joint development agreements, and direct sales of products[20](index=20&type=chunk) [Overview](index=6&type=section&id=Overview) [Scientific Background](index=6&type=section&id=Scientific%20Background) [Our Technology](index=7&type=section&id=Our%20Technology) [Product Candidates](index=7&type=section&id=Product%20Candidates) [Pluri Health](index=7&type=section&id=Pluri%20Health) [PLX-PAD](index=7&type=section&id=PLX-PAD) [PLX-R18](index=7&type=section&id=PLX-R18) [Modified PLX cells](index=7&type=section&id=Modified%20PLX%20cells) [Our Clinical Development Product Candidates](index=8&type=section&id=Our%20Clinical%20Development%20Product%20Candidates) [Orthopedic Indications](index=8&type=section&id=Orthopedic%20Indications) [COVID-19 Complicated by ARDS](index=8&type=section&id=COVID-19%20Complicated%20by%20ARDS) [Recovery Following HCT](index=9&type=section&id=Recovery%20Following%20HCT) [Peripheral and Cardiovascular Diseases](index=9&type=section&id=Peripheral%20and%20Cardiovascular%20Diseases) [ARS](index=9&type=section&id=ARS) [Steroid-Refractory cGVHD](index=10&type=section&id=Steroid-Refractory%20cGVHD) [Regulatory and Clinical Affairs Strategy](index=10&type=section&id=Regulatory%20and%20Clinical%20Affairs%20Strategy) [Our Activities in the Food Tech Sector](index=10&type=section&id=Our%20Activities%20in%20the%20Food%20Tech%20Sector) [Intellectual Property](index=11&type=section&id=Intellectual%20Property) [Research and Development](index=15&type=section&id=Research%20and%20Development) [Foundational Research](index=15&type=section&id=Foundational%20Research) [Collaborations and Ongoing Research and Development Plans](index=15&type=section&id=Collaborations%20and%20Ongoing%20Research%20and%20Development%20Plans) [In-House Clinical Manufacturing](index=17&type=section&id=In-House%20Clinical%20Manufacturing) [Government Regulation](index=18&type=section&id=Government%20Regulation) [The Regulatory Process in the United States](index=19&type=section&id=The%20Regulatory%20Process%20in%20the%20United%20States) [The Regulatory Process in Europe](index=19&type=section&id=The%20Regulatory%20Process%20in%20Europe) [Other Regulations](index=20&type=section&id=Other%20Regulations) [Clinical Studies](index=20&type=section&id=Clinical%20Studies) [Employees](index=20&type=section&id=Employees) [Competition](index=21&type=section&id=Competition) [Impact of COVID-19](index=21&type=section&id=Impact%20of%20COVID-19) [Available Information](index=21&type=section&id=Available%20Information) [Item 1A. Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors) An investment in Pluri Inc. carries a high degree of risk, including potential adverse effects from the COVID-19 pandemic, a history of financial losses, and the ongoing need for significant capital. The company faces risks related to intellectual property, manufacturing, international operations, stock price volatility, and the unproven nature of its food-tech business. Regulatory hurdles, dependence on third parties, and cybersecurity threats also pose substantial challenges - Key Risks: COVID-19 impact, history of losses, need for additional capital (dilution risk), intellectual property disputes, manufacturing risks, international business exposure (currency fluctuations, Israeli political conditions), stock price volatility, EIB Finance Agreement restrictions, IIA grant limitations, cybersecurity incidents, global inflation, and unproven food-tech business[120](index=120&type=chunk)[121](index=121&type=chunk) - Financial Risks: Company has a history of losses and limited revenue, requiring significant future capital. Inability to secure financing or successfully commercialize products/obtain regulatory approvals could severely limit profitability[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk)[131](index=131&type=chunk) - Operational Risks: Clinical trial delays/terminations, inherent risks in novel technology development, uncertain market acceptance for cell therapies, and potential changes in interim data[136](index=136&type=chunk)[137](index=137&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk)[146](index=146&type=chunk) [Summary of Risk Factors](index=22&type=section&id=Summary%20of%20Risk%20Factors) [Risk Related to Our Business](index=24&type=section&id=Risk%20Related%20to%20Our%20Business) [Risks Related to Development, Clinical studies, and Regulatory Approval of Our Product Candidates](index=25&type=section&id=Risks%20Related%20to%20Development%2C%20Clinical%20studies%2C%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) [Risks Related to Our Food-Tech Business](index=29&type=section&id=Risks%20Related%20to%20Our%20Food-Tech%20Business) [Risk Related to Commercialization of Our Product Candidates](index=30&type=section&id=Risk%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) [Risk Related to Intellectual Property](index=31&type=section&id=Risk%20Related%20to%20Intellectual%20Property) [Risk Related to Our Common Shares](index=32&type=section&id=Risk%20Related%20to%20Our%20Common%20Shares) [Risks Related to Foreign Exchange Rates](index=34&type=section&id=Risks%20Related%20to%20Foreign%20Exchange%20Rates) [Other Risks](index=35&type=section&id=Other%20Risks) [Risk Related to Our Industry](index=36&type=section&id=Risk%20Related%20to%20Our%20Industry) [Risk Related to Our Dependence on Third Parties](index=37&type=section&id=Risk%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) [Cybersecurity and Data Privacy Risks](index=38&type=section&id=Cybersecurity%20and%20Data%20Privacy%20Risks) [Foreign Corrupt Practices Act](index=40&type=section&id=Foreign%20Corrupt%20Practices%20Act) [Item 1B. Unresolved Staff Comments](index=40&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) This section indicates that there are no unresolved staff comments from the SEC [Item 2. Properties](index=40&type=section&id=Item%202.%20Properties) Pluri's principal executive, manufacturing, and research and development offices are located in Haifa, Israel, occupying approximately 4,389 square meters. The monthly rent as of July 2022 was approximately $89,000, with a net expense of $921,000 for Fiscal Year 2022. The company believes its current space is adequate for present and foreseeable future needs - Principal Facilities: Located at MATAM Advanced Technology Park, Building No. 5, Haifa, Israel, occupying approximately **4,389 square meters**[215](index=215&type=chunk) Property Expenses (FY2022) | Metric | Amount | | :------------------ | :------- | | Monthly Rent (July 2022) | ~$89,000 | | Net Expense (FY2022) | $921,000 | [Item 3. Legal Proceedings](index=40&type=section&id=Item%203.%20Legal%20Proceedings) The company reported no legal proceedings [Item 4. Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Pluri Inc PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=41&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Pluri Inc.'s common shares are traded on the Nasdaq Global Market and the Tel Aviv Stock Exchange under the symbol "PLUR". As of September 15, 2022, there were 32,620,343 common shares issued and outstanding, held by 50 record holders - Trading Information: Common shares traded on Nasdaq Global Market and Tel Aviv Stock Exchange under symbol "**PLUR**"[220](index=220&type=chunk) Common Shares Outstanding (as of Sept 15, 2022) | Metric | Value | | :--------------------- | :------------ | | Shares Outstanding | 32,620,343 | | Holders of Record | 50 | [Item 6. [Reserved]](index=41&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=41&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Pluri's business, a detailed comparison of financial results for fiscal years 2022 and 2021, and an analysis of the company's liquidity and capital resources. It highlights a decrease in net loss driven by reduced R&D and G&A expenses, despite minimal revenue. The company continues to rely on grants and financing to support its operations and R&D activities - Business Overview: Reiterates focus on 3D cell expansion technology for regenerative medicine and food tech, with ongoing clinical studies and a commercialization model including licensing and partnerships[222](index=222&type=chunk)[223](index=223&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - Financial Outlook: Accumulated deficit of **$371,263,000** as of June 30, 2022. No significant product sales revenue expected in the next twelve months, with licensing revenues unlikely to exceed operational costs in the short to medium term. Company believes current cash is sufficient for at least the next twelve months[258](index=258&type=chunk)[260](index=260&type=chunk) [Overview](index=41&type=section&id=Overview) [Results of Operations – Year Ended June 30, 2022 Compared to Year Ended June 30, 2021](index=42&type=section&id=Results%20of%20Operations%20%E2%80%93%20Year%20Ended%20June%2030%2C%202022%20Compared%20to%20Year%20Ended%20June%2030%2C%202021) [Revenues](index=42&type=section&id=Revenues) Revenues (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :------- | :----- | :----- | :--------- | :--------- | | Revenues | 234 | 0 | 234 | N/A | - The revenues in FY2022 were primarily from a license agreement with Takeda and sales of PLX cells for research use[229](index=229&type=chunk) [Research and Development, Net](index=42&type=section&id=Research%20and%20Development%2C%20Net) Research and Development, Net (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :-------------------- | :------- | :------- | :--------- | :--------- | | R&D Expenses, Net | 24,377 | 30,066 | (5,689) | (19%) | - The decrease was mainly due to reduced clinical study expenses (following CLI study termination, end of enrollment for ARDS and hip studies) and lower share-based compensation expenses. This was partially offset by increased materials, payroll, and building lease costs[230](index=230&type=chunk) [General and Administrative](index=42&type=section&id=General%20and%20Administrative) General and Administrative Expenses (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :-------------------- | :------- | :------- | :--------- | :--------- | | G&A Expenses | 17,450 | 20,557 | (3,107) | (15%) | - The decrease was primarily attributed to lower share-based compensation expenses for the CEO and Chairman, partially offset by increased share-based compensation related to Plurinuva shares and higher payroll expenses[231](index=231&type=chunk) [Total Financial Income, Net](index=42&type=section&id=Total%20Financial%20Income%2C%20Net) Total Financial Income, Net (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :-------------------- | :----- | :----- | :--------- | :--------- | | Financial Income, Net | 219 | 758 | (539) | (71%) | - The decrease was mainly due to increased interest expenses from the EIB loan and losses from hedging transactions, partially offset by exchange rate income on lease liability and EIB loan adjustments[232](index=232&type=chunk) [Net Loss for the Year](index=42&type=section&id=Net%20Loss%20for%20the%20Year) Net Loss (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :------- | :------- | :------- | :--------- | :--------- | | Net Loss | (41,374) | (49,865) | 8,491 | (17%) | - The decrease in net loss was primarily due to lower research and development expenses, net, and reduced general and administrative expenses[233](index=233&type=chunk) - Net loss attributed to non-controlling interest in Plurinuva for FY2022 was **$132,000**[233](index=233&type=chunk) [Loss per share](index=43&type=section&id=Loss%20per%20share) Loss per Share | Metric | FY2022 | FY2021 | Change ($) | Change (%) | | :-------------------------- | :----- | :----- | :--------- | :--------- | | Basic and Diluted Loss per Share | (1.28) | (1.77) | 0.49 | (28%) | | Weighted Average Shares Outstanding | 32,192,074 | 28,113,636 | 4,078,438 | 14.5% | - The change in loss per share was mainly a result of the decrease in net loss, partially offset by an increase in the weighted average number of shares outstanding due to additional share issuances[235](index=235&type=chunk)[236](index=236&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) [Cash Flow Activities](index=43&type=section&id=Cash%20Flow%20Activities) Cash Flow Summary (USD thousands) | Activity | FY2022 | FY2021 | Change ($) | | :------------------------------------ | :------- | :------- | :--------- | | Net cash used in operating activities | (36,501) | (30,910) | (5,591) | | Net cash provided by (used for) investing activities | 11,783 | (7,265) | 19,048 | | Net cash provided by financing activities | 7,500 | 61,402 | (53,902) | | Cash, cash equivalents, and restricted cash (end of period) | 11,413 | 31,838 | (20,425) | - As of June 30, 2022, the company had a working capital surplus of **$50,918,000** and an accumulated deficit of **$371,263,000**[237](index=237&type=chunk) [Equity Offerings and Warrants](index=43&type=section&id=Equity%20Offerings%20and%20Warrants) - No common shares were sold under the ATM Agreement in FY2022, compared to **$8,506,000** net proceeds in FY2021[242](index=242&type=chunk) - No warrants were exercised in FY2022, compared to **$364,000** net proceeds from warrant exercises in FY2021[244](index=244&type=chunk) - A registered direct offering in February 2021 generated approximately **$28,077,000** in net proceeds from the sale of 4,761,905 common shares[245](index=245&type=chunk) [EIB Finance Agreement](index=44&type=section&id=EIB%20Finance%20Agreement) - Received the first tranche of **€20 million** from the European Investment Bank (EIB) in June 2021, part of a larger **€50 million** facility[246](index=246&type=chunk)[247](index=247&type=chunk) - The loan is due on June 1, 2026, and bears an annual interest rate of **4%**. The EIB is also entitled to royalty payments (**0.2% to 2.3%**) on consolidated revenues from FY2024 to FY2030[247](index=247&type=chunk) [Non-dilutive grants](index=44&type=section&id=Non-dilutive%20grants) - No cash grants were received from European Union Horizon 2020 programs in FY2022, compared to approximately **$239,000** in FY2021[248](index=248&type=chunk) - IIA grants require **3% royalties** on sales of products derived from funded technology until **100% repayment**; no royalties were paid in FY2022[249](index=249&type=chunk) - Received an additional grant of approximately **$583,000** from the IIA for the CRISPR-IL consortium program in October 2021, which does not include any royalty obligations[251](index=251&type=chunk) [Outlook](index=45&type=section&id=Outlook) [Application of Critical Accounting Policies and Estimates](index=45&type=section&id=Application%20of%20Critical%20Accounting%20Policies%20and%20Estimates) [Share-Based Compensation](index=46&type=section&id=Share-Based%20Compensation) [Research and Development Expenses, Net](index=46&type=section&id=Research%20and%20Development%20Expenses%2C%20Net) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=46&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is marked as not applicable, indicating no quantitative or qualitative disclosures about market risk are provided [Item 8. Financial Statements and Supplementary Data](index=47&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements of Pluri Inc. and its subsidiaries for the fiscal years ended June 30, 2022, and 2021, prepared in accordance with U.S. GAAP. It includes the Report of Independent Registered Public Accounting Firm, Consolidated Balance Sheets, Statements of Operations, Statements of Changes in Shareholders' Equity, Statements of Cash Flows, and comprehensive Notes to Consolidated Financial Statements - Financial statements are prepared in accordance with U.S. GAAP and stated in **thousands of United States Dollars**[269](index=269&type=chunk) - Kesselman & Kesselman (PwC) provided an **unqualified opinion** on the consolidated financial statements for FY2022 and FY2021[276](index=276&type=chunk) - The establishment of Plurinuva was identified as a critical audit matter due to the complexity of accounting for the transaction and the involvement of specialized valuation professionals[282](index=282&type=chunk)[283](index=283&type=chunk) [Report of Independent Registered Public Accounting Firm](index=49&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) [Consolidated Balance Sheets](index=51&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (USD thousands) | Metric | June 30, 2022 | June 30, 2021 | Change ($) | | :-------------------------- | :------------ | :------------ | :--------- | | Total current assets | 57,747 | 67,371 | (9,624) | | Total current liabilities | 6,829 | 11,517 | (4,688) | | Working capital surplus | 50,918 | 55,854 | (4,936) | | Total assets | 68,065 | 93,538 | (25,473) | | Total liabilities | 29,050 | 24,870 | 4,180 | | Total shareholders' equity | 30,039 | 57,151 | (27,112) | | Non-controlling interests | 2,147 | - | 2,147 | | Accumulated deficit | (371,263) | (330,021) | (41,242) | [Consolidated Statements of Operations](index=53&type=section&id=Consolidated%20Statements%20of%20Operations) Consolidated Statements of Operations Highlights (USD thousands) | Metric | FY2022 | FY2021 | Change ($) | | :------------------------------------ | :----- | :----- | :--------- | | Revenues | 234 | 0 | 234 | | Research and development expenses, net | (24,377) | (30,066) | 5,689 | | General and administrative expenses | (17,450) | (20,557) | 3,107 | | Operating loss | (41,593) | (50,623) | 9,030 | | Total financial income, net | 219 | 758 | (539) | | Net loss | (41,374) | (49,865) | 8,491 | | Net loss attributed to non-controlling interests | (132) | - | (132) | | Net loss attributed to shareholders | (41,242) | (49,865) | 8,623 | | Basic and diluted loss per share | (1.28) | (1.77) | 0.49 | | Weighted average number of shares | 32,192,074 | 28,113,636 | 4,078,438 | [Statements of Changes in Shareholders' Equity](index=54&type=section&id=Statements%20of%20Changes%20in%20Shareholders%27%20Equity) - Total Shareholders' Equity decreased from **$57,151,000** as of July 1, 2021, to **$30,039,000** as of June 30, 2022[293](index=293&type=chunk) - Share-based compensation to employees, directors, and non-employee consultants amounted to **$8,909,000** in FY2022[293](index=293&type=chunk) - The establishment of Plurinuva resulted in a **$7,500,000** investment, allocated between additional paid-in capital (**$5,657,000**) and non-controlling interests (**$1,843,000**)[293](index=293&type=chunk) [Consolidated Statements of Cash Flows](index=56&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights (USD thousands) | Activity | FY2022 | FY2021 | Change ($) | | :------------------------------------ | :------- | :------- | :--------- | | Net cash used for operating activities | (36,501) | (30,910) | (5,591) | | Net cash provided by (used for) investing activities | 11,783 | (7,265) | 19,048 | | Net cash provided by financing activities | 7,500 | 61,402 | (53,902) | | Increase (decrease) in cash, cash equivalents and restricted cash | (20,425) | 22,609 | (43,034) | | Cash, cash equivalents and restricted cash at end of period | 11,413 | 31,838 | (20,425) | [Notes to Consolidated Financial Statements](index=57&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [NOTE 1: - GENERAL](index=57&type=section&id=NOTE%201%3A%20-%20GENERAL) [NOTE 2: - SIGNIFICANT ACCOUNTING POLICIES](index=58&type=section&id=NOTE%202%3A%20-%20SIGNIFICANT%20ACCOUNTING%20POLICIES) [NOTE 3: - PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=69&type=section&id=NOTE%203%3A%20-%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) [NOTE 4: - PROPERTY AND EQUIPMENT, NET](index=69&type=section&id=NOTE%204%3A%20-%20PROPERTY%20AND%20EQUIPMENT%2C%20NET) [NOTE 5: - OTHER ACCOUNTS PAYABLE](index=70&type=section&id=NOTE%205%3A%20-%20OTHER%20ACCOUNTS%20PAYABLE) [NOTE 6: - LEASES](index=70&type=section&id=NOTE%206%3A%20-%20LEASES) [NOTE 7: - LOAN FROM THE EIB](index=71&type=section&id=NOTE%207%3A%20-%20LOAN%20FROM%20THE%20EIB) [NOTE 8: - COMMITMENTS AND CONTINGENCIES](index=72&type=section&id=NOTE%208%3A%20-%20COMMITMENTS%20AND%20CONTINGENCIES) [NOTE 9: - SHAREHOLDERS' EQUITY](index=73&type=section&id=NOTE%209%3A%20-%20SHAREHOLDERS%27%20EQUITY) [NOTE 10: - FINANCIAL INCOME (EXPENSES), NET](index=78&type=section&id=NOTE%2010%3A%20-%20FINANCIAL%20INCOME%20%28EXPENSES%29%2C%20NET) [NOTE 11: - TAXES ON INCOME](index=78&type=section&id=NOTE%2011%3A%20-%20TAXES%20ON%20INCOME) [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=83&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with accountants on accounting and financial disclosure [Item 9A. Controls and Procedures](index=83&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, under the supervision of the CEO and CFO, concluded that Pluri's disclosure controls and procedures were effective as of June 30, 2022. The internal control over financial reporting was also deemed effective, with no material changes during the fourth quarter of Fiscal Year 2022 - Disclosure Controls and Procedures: Management concluded that disclosure controls and procedures were **effective** as of June 30, 2022[438](index=438&type=chunk) - Internal Control over Financial Reporting: Management assessed and determined that internal control over financial reporting was **effective** as of June 30, 2022[442](index=442&type=chunk) - Changes in Internal Control: No material changes in internal control over financial reporting occurred during the fourth quarter of Fiscal Year 2022[443](index=443&type=chunk) [Item 9B. Other Information](index=83&type=section&id=Item%209B.%20Other%20Information) The company reported no other information [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=83&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to Pluri Inc PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=84&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section provides information on Pluri's directors and executive officers, including their business experience, and details the structure and responsibilities of the Audit, Compensation, and Nominating Committees. It also outlines the company's director nomination process and Code of Ethics, noting a minor delinquency in Section 16(a) reports - Key Personnel: **Zami Aberman** (Chairman), **Yaky Yanay** (CEO, President, Director), **Chen Franco-Yehuda** (CFO, Treasurer, Secretary)[448](index=448&type=chunk) - Board Committees: Audit Committee (Chairman: **Doron Birger**), Compensation Committee (Chairman: **Maital Shemesh-Rasmussen**), and Nominating Committee (Chairman: **Rami Levi**). All committee members are independent[467](index=467&type=chunk)[469](index=469&type=chunk)[471](index=471&type=chunk) - Code of Ethics: The Board adopted a Code of Business Conduct and Ethics applicable to directors, officers, and employees, available on the company website[477](index=477&type=chunk)[478](index=478&type=chunk) [Business Experience](index=84&type=section&id=Business%20Experience) [Audit Committee and Audit Committee Financial Expert](index=86&type=section&id=Audit%20Committee%20and%20Audit%20Committee%20Financial%20Expert) [Compensation Committee](index=87&type=section&id=Compensation%20Committee) [Nominating Committee](index=87&type=section&id=Nominating%20Committee) [Director Nominations](index=87&type=section&id=Director%20Nominations) [Code of Ethics](index=88&type=section&id=Code%20of%20Ethics) [Delinquent Section 16(a) Reports](index=88&type=section&id=Delinquent%20Section%2016%28a%29%20Reports) [Item 11. Executive Compensation](index=88&type=section&id=Item%2011.%20Executive%20Compensation) This section details the compensation for Pluri's named executive officers and directors for fiscal years 2022 and 2021, including salaries, bonuses, and share-based awards. It also outlines employment agreements, potential payments upon termination or change-in-control, and outstanding equity awards Summary Compensation Table (USD) | Name and Principal Position | Fiscal Year | Salary | Non-Equity Plan Compensation | Share-based Awards | All Other Compensation | Total | | :-------------------------- | :---------- | :------- | :--------------------------- | :----------------- | :--------------------- | :-------- | | Zami Aberman (Chairman) | 2022 | 432,043 | - | - | 751,472 | 1,183,515 | | | 2021 | 556,475 | - | 8,741,402 | 508,074 | 9,805,951 | | Yaky Yanay (CEO) | 2022 | 488,569 | 64,000 | - | 745,610 | 1,297,726 | | | 2021 | 459,016 | 126,000 | 8,741,402 | 27,588 | 9,354,006 | | Chen Franco-Yehuda (CFO) | 2022 | 310,253 | 44,000 | - | 253,953 | 607,915 | | | 2021 | 251,642 | 64,000 | 1,020,000 | 14,653 | 1,350,295 | - All Other Compensation in FY2022 for executive officers includes significant allocations of Plurinuva shares (e.g., **$705,000** for Mr. Aberman and Mr. Yanay, **$235,000** for Ms. Franco-Yehuda)[486](index=486&type=chunk)[487](index=487&type=chunk) - Equity awards for executive officers and directors include acceleration of vesting (**100%** for involuntary termination/change-in-control, up to **50%** for voluntary resignation) under specific conditions, excluding certain market-based RSUs[491](index=491&type=chunk)[494](index=494&type=chunk)[504](index=504&type=chunk) [Employment and Consulting Agreements](index=90&type=section&id=Employment%20and%20Consulting%20Agreements) [Potential Payments Upon Termination or Change-in-Control](index=91&type=section&id=Potential%20Payments%20Upon%20Termination%20or%20Change-in-Control) [Pension, Retirement or Similar Benefit Plans](index=93&type=section&id=Pension%2C%20Retirement%20or%20Similar%20Benefit%20Plans) [Outstanding Equity Awards at the End of Fiscal Year 2022](index=93&type=section&id=Outstanding%20Equity%20Awards%20at%20the%20End%20of%20Fiscal%20Year%202022) [Long-Term Incentive Plans-Awards in Last Fiscal Year](index=94&type=section&id=Long-Term%20Incentive%20Plans-Awards%20in%20Last%20Fiscal%20Year) [Director Compensation](index=94&type=section&id=Director%20Compensation) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=96&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section details the beneficial ownership of Pluri's common shares as of September 15, 2022, for major shareholders, directors, and executive officers. It also provides information on the company's equity compensation plans, including outstanding options and shares available for future grants Beneficial Ownership of Common Shares (as of Sept 15, 2022) | Name | Number of Shares Beneficially Owned | Percentage of Shares Beneficially Owned | | :------------------------------------ | :---------------------------------- | :-------------------------------------- | | David M. Slager | 1,685,038 | 5.2% | | Zami Aberman (Chairman) | 839,747 | 2.6% | | Yaky Yanay (CEO, President and Director) | 685,973 | 2.1% | | Directors and Executive Officers as a group (7 persons) | 1,875,547 | 5.0% | - As of June 30, 2022, under the 2016 and 2019 Equity Compensation Plans, there were **91,045 options outstanding** and **4,765,113 securities remaining available** for future issuance[516](index=516&type=chunk) [Equity Compensation Plan Information](index=98&type=section&id=Equity%20Compensation%20Plan%20Information) [Item 13. Certain Relationships and Related Transactions and Director Independence](index=98&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%20and%20Director%20Independence) The company reported no material related party transactions beyond executive compensation arrangements. The Board determined that Doron Birger, Rami Levi, Varda Shalev, and Maital Shemesh-Rasmussen are independent directors as per SEC and Nasdaq rules - No material related party transactions were reported, other than executive compensation arrangements[517](index=517&type=chunk) - Independent Directors: **Doron Birger, Rami Levi, Varda Shalev, and Maital Shemesh-Rasmussen** were determined to be independent directors[518](index=518&type=chunk) [Item 14. Principal Accounting Fees and Services](index=98&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) This section details the fees paid to Pluri's independent registered public accounting firm, Kesselman & Kesselman (PwC), for audit, audit-related, tax, and other services for fiscal years 2022 and 2021. All services were pre-approved by the Audit Committee Principal Accounting Fees and Services (USD) | Fee Type | FY2022 | FY2021 | | :----------------- | :------- | :------- | | Audit Fees | 114,532 | 105,000 | | Audit-Related Fees | 6,214 | None | | Tax Fees | 14,624 | 28,507 | | All Other Fees | 36,975 | None | | Total Fees | 172,345 | 133,507 | - All services provided by the independent registered public accounting firm were **pre-approved** by the Audit Committee[523](index=523&type=chunk) PART IV [Item 15. Exhibits](index=100&type=section&id=Item%2015.%20Exhibits) This section lists all documents filed as exhibits to the 10-K report, including corporate governance documents, equity compensation plans, and various agreements such as license agreements and financial contracts - Exhibits include corporate governance documents (Articles of Incorporation, By-laws), equity compensation plans (2016 and 2019 Plans), and various agreements (License, Employment, Finance Contract with EIB, Share Purchase Agreement for Plurinuva)[527](index=527&type=chunk)[528](index=528&type=chunk) [Item 16. Form 10-K Summary](index=102&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company did not provide a Form 10-K Summary

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________ to __________ Commission file number 001-31392 PLURISTEM THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or or ...

For the quarterly period ended December 31, 2021 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT For the transition period from __________ to __________ Commission file number 001-31392 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 PLURISTEM THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

For the transition period from __________ to __________ Commission file number 001-31392 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT PLURISTEM THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the fiscal year ended June 30, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from [ ] to [ ] Commission file number 001-31392 PLURISTEM THERAPEUTICS INC. FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Nevada 98-0351734 (State or other jurisdict ...