
Form 10-Q Filing Information 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, 20221 - The registrant, PLURI INC., is incorporated in Nevada with a Nasdaq Global Market trading symbol 'PLUR'2 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 outstanding4 Interim Condensed Consolidated Financial Statements 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 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 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 field90 - 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 grants9192 - 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 amortization9394 - 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. dollar9596 Interim Condensed Statements of Changes in Shareholders' Equity 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, 202217 - 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 capital17 - The expiration of warrants in Plurinuva resulted in a reclassification of $1,014 thousand from non-controlling interests to additional paid-in capital17 Interim Condensed Consolidated Statements of Cash Flows 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 efforts104 - Investing activities provided $7,062 thousand in cash, primarily from the withdrawal of short-term deposits, a shift from cash used in the prior year105 - Financing activities provided $5,693 thousand, mainly from the issuance of common stock and warrants in the December 2022 Private Placement106 Notes to Interim Condensed Consolidated Financial Statements 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 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 - The company operates in one business segment, focusing on a 3D cell expansion technology platform for regenerative medicine, food tech, agri-tech, and biologics24 - 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 period24 - 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 operations25 - 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 field27 - 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 capital34 Note 2: Significant Accounting Policies 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 statements35 - 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, 202336 - 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 Plurinuva45 - The company adopted ASU 2021-10 (Government Assistance Disclosures), which did not have a material impact on its consolidated financial statements4647 - 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 statements4950 Note 3: Commitments and Contingencies 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 interest52 - 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 transactions53 - 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 sales53 - 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 thousand59 - 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 accrued59 Note 4: Loan from the European Investment Bank (EIB) 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 EU55114 - The first tranche of €20 million was received in June 2021, due June 1, 2026, bearing an annual interest rate of 4%58115 - As of December 31, 2022, the linked principal balance was $21,330 thousand and accrued interest was $1,345 thousand, presented as long-term liabilities58 - 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 amount57115 - The company does not expect to receive additional funds from the EIB Finance Contract as the project term ended on December 31, 202258115 Note 5: Shareholders' Equity 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, 202262112 - 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, 202363108 - 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 shares67110 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 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 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 outlook73 - The business and operations are subject to substantial risks, and historic results of scientific research or trials do not guarantee future conclusions7475 Business 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 facility77 - 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)787983 - The company is also expanding into biologics, with a collaboration to develop a unique biologic API using its 3D cell expansion bioreactor systems7987 - 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 Disease81 - Plurinuva, the joint venture with Tnuva, successfully completed proof of concept in cultivated meat development in December 202286 Results of Operations 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 compensation9192939499 - 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. dollar9596 - Weighted average common shares outstanding increased due to the December 2022 Private Placement and vesting of RSUs100101 Liquidity and Capital Resources 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, 2023108 - 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 management110 - 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)117118119 - 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 Pluri120 - 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 term124 Part II—Other Information 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 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 results131 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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 term132 - The warrants are exercisable upon the later of six months from issuance or until the company increases its authorized shares132 - 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 S133 Item 4. Controls and Procedures 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 period128129 - 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 reporting130 Item 5. Other Information 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 Directors134 Item 6. Exhibits 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 statements137 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