Core Insights - Pluri Inc. has received a patent from the U.S. Patent and Trademark Office for its immune cell expansion technologies, specifically for MAIT cells, which are important for fighting infections and tissue repair [1][4] - The company has also secured a corresponding patent in Israel, bringing its total intellectual property estate to over 250 patents [1] - Pluri's MAIT cells, derived from the placenta, are positioned as a promising solution for treating solid tumors, addressing a significant unmet medical need in immunotherapy [2][5] Intellectual Property and Technology - The newly granted patents focus on large-scale culturing and activation of immune cells using Pluri's proprietary 3D cell expansion bioreactors [3][7] - Pluri's 3D cell expansion technology mimics the natural environment of lymph nodes, allowing for efficient and high-quality immune cell expansion [8] Market Potential - The global immune cell engineering market is projected to reach approximately $11.7 billion by 2030, while the global cancer immunotherapy market is estimated at $136 billion in 2025 [7] - Pluri's MAIT platform not only supports the expansion of MAIT cells but also Tumor Infiltrating Lymphocytes (TILs), broadening the scope of potential therapies in cancer immunotherapy [7] Strategic Vision - The CEO of Pluri emphasizes the potential of MAIT cells in immunotherapy and the company's capability to scale production, positioning it for collaborations that could deliver immune therapies to patients [4] - Pluri aims to develop its proprietary placental-derived MAIT cell immunotherapy platform to revolutionize solid tumor treatment and support other companies in commercializing their immunotherapy treatments [4][6]

Core Viewpoint - Pluri Inc. has entered into an exclusive collaboration with Hemafund Ltd. to develop and distribute PLX-R18 cell therapy as a countermeasure against Hematopoietic Acute Radiation Syndrome (H-ARS) in Ukraine, in response to recent nuclear threats [1][3][5] Collaboration Agreement - The collaboration will last for an initial three years, with the possibility of a three-year extension, focusing on stockpiling and distribution of PLX-R18 [1][2] - Pluri will produce PLX-R18, while Hemafund will utilize its biostorage and logistics expertise to ensure compliance with local regulations [2][9] Strategic Goals - The collaboration aims to secure external funding to establish an initial capacity of 12,000 doses of PLX-R18, sufficient to treat 6,000 individuals [4][5] - Hemafund will manage the storage and logistics of PLX-R18, ensuring rapid deployment in emergencies [4][9] Financial Implications - If successful, the collaboration could generate over $100 million in value for both parties based on the estimated cost per dose and projected stockpile [5][8] Context and Urgency - The collaboration is a proactive response to recent escalations in nuclear threats, highlighting the urgent need for effective radiation countermeasures in Ukraine [3][10] Company Background - Hemafund specializes in the preservation of umbilical cord blood and operates advanced cryostorage facilities in Ukraine [11] - Pluri is focused on developing cell-based products and solutions across various sectors, including regenerative medicine and food technology [12]

Core Viewpoint - Pluri Inc. has entered into an exclusive collaboration with Hemafund Ltd. to develop and distribute PLX-R18 cell therapy as a countermeasure against Hematopoietic Acute Radiation Syndrome (H-ARS) in Ukraine, in response to recent escalations in regional nuclear threats [1][3]. Group 1: Collaboration Agreement - The collaboration agreement is effective for an initial period of three years, with the possibility of a three-year extension [1]. - Pluri will produce and supply PLX-R18, while Hemafund will utilize its biostorage and logistics expertise to ensure compliance with local regulations [2][9]. - The collaboration aims to secure external funding to build an initial capacity of 12,000 doses of PLX-R18, sufficient to treat 6,000 individuals [4][5]. Group 2: Strategic Goals - The collaboration addresses Ukraine's urgent need for radiation countermeasures and ensures secure storage and rapid deployment of treatments [8]. - It seeks to attract public and private funding to support the development and accessibility of PLX-R18 [9]. - The collaboration may potentially generate over $100 million in value for both parties based on the estimated cost per dose and projected stockpile [5]. Group 3: Context and Need - The collaboration is a response to recent incidents, including a Russian drone strike on the Chernobyl nuclear power plant, highlighting the need for effective radiation countermeasures [3]. - H-ARS is caused by exposure to high levels of ionizing radiation, leading to severe health risks [6].

Core Insights - Ever After Foods (EAF) and Bühler have announced a collaboration to develop a commercial-scale cultivated meat production system that operates at ten-fold lower scale than existing technologies [1][2][5] - The partnership aims to address food system challenges, enhance food security, and reduce environmental impact through sustainable and affordable cellular products [2][3] Company Overview - Ever After Foods is focused on transforming cultivated meat production with its proprietary technology platform, which is designed for scalable and cost-efficient production systems [8] - Bühler is a leader in the global food and feed industry, contributing to feeding over 2 billion people daily and supporting technology developments to reduce the environmental footprint of the food industry [7] Technological Advancements - EAF's patented edible packed-bed (EPB™) technology platform is aimed at accelerating the development and deployment of scalable production solutions for cultivated meat [4][5] - The collaboration allows cultivated meat producers to reduce production costs by over 90% while achieving high production efficiency and enhanced nutritional value [5][6] Market Impact - The partnership is positioned to help the food industry meet the protein demands of a growing global population by transitioning to more sustainable protein production methods [3][5] - EAF has successfully demonstrated its technology for producing muscle and fat tissues for various types of meat, ensuring a replication of conventional meat in taste and texture [6]

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Pluri Inc.'s unaudited interim condensed consolidated financial statements, detailing asset and equity changes [Interim Condensed Consolidated Balance Sheets](index=4&type=section&id=Interim%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of December 31, 2024, shows decreased total assets and an equity deficit due to reduced deposits Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Dec 31, 2024 | June 30, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $22,370 | $31,107 | | **Total Assets** | $30,861 | $39,527 | | **Total Current Liabilities** | $4,440 | $4,454 | | **Total Liabilities** | $33,778 | $34,112 | | **Total Equity (Deficit)** | ($2,917) | $5,415 | [Interim Condensed Consolidated Statements of Operations](index=6&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Operations) For the six months ended December 31, 2024, the company reported revenues of $511 thousand and a net loss of $9.1 million Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended Dec 31, 2024 | Six Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2024 | Three Months Ended Dec 31, 2023 | | :--- | :--- | :--- | :--- | :--- | | **Revenues** | $511 | $159 | $185 | $105 | | **Gross Profit** | $311 | $159 | $111 | $105 | | **Operating Loss** | ($10,155) | ($10,590) | ($4,957) | ($5,213) | | **Net Loss** | ($9,146) | ($10,092) | ($3,110) | ($4,994) | | **Basic and Diluted Net Loss Per Share** | ($1.61) | ($1.92) | ($0.53) | ($0.96) | [Interim Condensed Consolidated Statements of Changes in Shareholders' Equity (Deficit)](index=7&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Deficit)) Shareholders' equity declined from a $5.4 million surplus to a $2.9 million deficit due to a $9.1 million net loss - Total equity shifted from a surplus of **$5,415 thousand** at the beginning of the period to a deficit of **$2,917 thousand** at the end, mainly due to a net loss of **$9,146 thousand**[18](index=18&type=chunk) [Interim Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended December 31, 2024, net cash used in operating activities was $8.7 million, offset by $9.2 million from investing Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended Dec 31, 2024 | Six Months Ended Dec 31, 2023 | | :--- | :--- | :--- | | **Net cash used for operating activities** | ($8,692) | ($9,506) | | **Net cash provided by investing activities** | $9,230 | $9,721 | | **Increase in cash and equivalents** | $619 | $230 | [Notes to Interim Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accumulated deficit, recurring losses, EIB loan, Nasdaq deficiency, and subsequent capital raises - The company has an accumulated deficit of approximately **$429.3 million** and incurred a net loss of **$9.1 million** for the six-month period. Management believes its current resources are sufficient to meet obligations for at least the next twelve months[26](index=26&type=chunk) - The company has a loan from the European Investment Bank (EIB) with a principal and accrued interest balance of **$23.8 million** as of December 31, 2024, which is due on June 1, 2026[26](index=26&type=chunk)[47](index=47&type=chunk) - On November 25, 2024, the company received a deficiency letter from Nasdaq for failing to maintain the minimum shareholders' equity of **$2.5 million**. The company has until May 24, 2025, to regain compliance[61](index=61&type=chunk)[62](index=62&type=chunk) - Subsequent to the quarter end, in February 2025, the company closed a private placement for gross proceeds of **$6.5 million** and entered into another agreement for a second offering expected to raise approximately **$3.5 million**[68](index=68&type=chunk)[71](index=71&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business strategy, financial performance, and liquidity, highlighting revenue growth and reduced net loss [Overview](index=23&type=section&id=Overview) Pluri leverages its 3D cell expansion platform across multiple verticals, including cell therapy, CDMO, agtech, and food tech - The company is utilizing its technology platform in regenerative medicine, immunotherapy, food tech, CDMO, and agtech[79](index=79&type=chunk) - Launched PluriCDMO™, a new business division offering cell therapy manufacturing services, in January 2024 and is currently generating revenues[88](index=88&type=chunk) - Entered into a term sheet to acquire approximately **71%** of Kokomodo Ltd., an Israeli agtech company specializing in cultivated cacao production, for **$4.5 million** in Pluri common shares[91](index=91&type=chunk) - Ever After Foods, a subsidiary focused on cultivated meat, raised **$10 million** in a private placement in June 2024 to support its B2B technology platform[94](index=94&type=chunk)[95](index=95&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Revenues increased significantly due to new business verticals, while R&D and G&A expenses decreased, reducing net loss Financial Performance Comparison (in thousands) | Metric | Six Months Ended Dec 31, 2024 | Six Months Ended Dec 31, 2023 | Change | | :--- | :--- | :--- | :--- | | **Revenues** | $511 | $159 | +221% | | **R&D Expenses, Net** | $5,814 | $5,957 | -2% | | **G&A Expenses** | $4,652 | $4,792 | -3% | | **Net Loss** | $9,146 | $10,092 | -9% | - The increase in revenues is mainly attributed to the launch of new business verticals, specifically in the CDMO field and an increase related to a POC collaboration in the agtech field[96](index=96&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2024, the company had a working capital surplus but an equity deficit, with recent capital raises ensuring liquidity - As of December 31, 2024, the company had a working capital surplus of **$17.9 million**, but a total equity deficit of (**$2.9 million**)[107](index=107&type=chunk) - In February 2025, the company closed a private placement raising gross proceeds of **$6.5 million** and entered into an additional agreement to raise approximately **$3.5 million**[118](index=118&type=chunk)[120](index=120&type=chunk)[123](index=123&type=chunk) - The company is in discussions with the EIB regarding a potential restructuring of its **€20 million** loan, which is due for repayment on June 1, 2026[114](index=114&type=chunk) - Management believes that the company has sufficient cash to fund its operations for at least the next twelve months[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls are effective, with no material changes to internal control over financial reporting - Based on an evaluation, the CEO and CFO concluded that the company's disclosure controls and procedures are effective[138](index=138&type=chunk) - There has been no change in internal control over financial reporting during the second quarter of fiscal year 2025 that has materially affected, or is reasonably likely to materially affect, internal controls[139](index=139&type=chunk) [PART II – OTHER INFORMATION](index=33&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks, including potential Nasdaq delisting and operational vulnerabilities from military conflicts - The company received a deficiency letter from Nasdaq on November 25, 2024, for not meeting the minimum **$2.5 million** stockholders' equity requirement. It has been granted an extension until May 24, 2025, to regain compliance[143](index=143&type=chunk)[144](index=144&type=chunk) - The company's principal R&D and manufacturing facilities are located in Haifa, Israel, making its operations vulnerable to interruptions from military conflicts involving Israel, Hamas, and Hezbollah[146](index=146&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 FY2025, the company issued 5,071 restricted common shares to service providers as compensation, claiming registration exemption - In the second quarter of fiscal year 2025, the company issued **5,071** restricted common shares to service providers as compensation, claiming exemption from registration under Section 4(a)(2) of the Securities Act[153](index=153&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including key agreements and the binding term sheet - The exhibits list includes key agreements such as the Securities Purchase Agreements from January and February 2025 and the Binding Term Sheet for the proposed Kokomodo transaction[155](index=155&type=chunk)

Core Viewpoint - Pluri Inc. has successfully secured a total of $10 million in strategic investments over the past two weeks, including a recent $3.5 million private placement from Merchant Adventure Fund, reinforcing confidence in the company's growth strategy and technology [3][4][9]. Investment Details - The company has agreed to issue 759,219 shares at a price of $4.61 per share, along with warrants for 45,553 shares at an exercise price of $5.568, resulting in gross proceeds of $3.5 million [2]. - The closing of this offering is expected around February 20, 2025, pending customary closing conditions [2]. Strategic Implications - The recent investments are intended to support Pluri's growth as a global leader in cell-based technology, with applications across various industries such as pharmaceuticals, food technology, and agriculture technology [4][5]. - The company is also pursuing an agreement to acquire Kokomodo Ltd., which may allow entry into the cacao market, subject to shareholder approval [3]. Company Overview - Pluri Inc. is focused on creating cell-based products for commercial use, utilizing a patented 3D cell expansion system to address challenges in medicine, climate change, food scarcity, and animal welfare [8]. - The company operates in regenerative medicine, food technology, and agriculture technology, and offers Contract Development and Manufacturing Organization services [8].

Core Viewpoint - Pluri Inc. has announced a $6.5 million strategic private investment led by Alejandro Weinstein and is acquiring a 71% stake in Kokomodo Ltd. for $4.5 million, positioning itself to expand in sustainable food technologies and strengthen its operational capabilities [1][4]. Investment Details - The investment includes the issuance of 1,383,948 shares at $4.61 per share, warrants for 84,599 shares at $5.568, and pre-funded warrants for 26,030 shares at $0.0001, totaling $6.5 million [2][7]. - The net proceeds from the investment will be used for working capital and general corporate purposes, with the closing expected around January 31, 2025, pending customary closing conditions [2][8]. Acquisition of Kokomodo - Pluri will acquire approximately 71% of Kokomodo for $4.5 million, payable in 976,139 newly issued Common Shares, aimed at enhancing its presence in the cultivated cacao market [3][6]. - The global cacao market was valued at $13.5 billion in 2023 and is projected to grow at a CAGR of 8.2% to $23.5 billion by 2030, indicating significant market potential for Pluri's expansion [4]. Strategic Implications - The transactions are designed to strengthen Pluri's financial position and accelerate its entry into the cultivated cacao market, leveraging Kokomodo's climate-resilient cacao production technology [4][8]. - Mr. Weinstein's appointment to Pluri's Board of Directors is expected to provide strategic guidance and enhance the company's growth trajectory in sustainable food production [7][8]. Regulatory and Approval Process - Both transactions are subject to customary regulatory and corporate approvals, including those from the European Investment Bank, Nasdaq, and the Tel Aviv Stock Exchange, as well as shareholder approval [8][10].

Core Viewpoint - The FDA's approval of the first MSC-based therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) represents a significant advancement in regenerative medicine and highlights the potential of MSC therapies [1][2] Company Overview - Pluri Inc. is focused on developing innovative cell-based technologies and has a proprietary 3D cell-expansion platform that enables scalable and robust cell-based therapies [2][4] - The company aims to address critical unmet medical needs through its advanced cell therapy product candidates, including PLacental eXpanded cells for various indications [3][4] Industry Impact - The FDA approval is seen as a milestone not only for Mesoblast but for the entire field of cellular medicine, emphasizing the transformative potential of MSC therapies in healthcare [2][3] - Regenerative medicine is positioned to shift the healthcare paradigm from managing chronic conditions to enabling true healing and regeneration, potentially improving patient outcomes and creating more sustainable healthcare systems [2][3] Future Aspirations - Pluri is committed to expanding the therapeutic boundaries of cell-based solutions and accelerating the development of MSC-based therapies globally [3][4] - The company envisions a future where cell-based technologies can transform lives across a spectrum of diseases, leveraging its expertise to pioneer new treatments [3]

Memorandum of Understanding has been signedNEW YORK, Nov. 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it has entered into a Memorandum of Understanding (MOU) with Pluri Inc. (NASDAQ: PLUR) through its wholly owned subsidiary ("Pluri"), an established global leader in the development and manufacturing of cell-based therapeutics, to manufacture NurOwn® for use in BrainStorm's planned P ...

Core Insights - Plurilock Security Inc. is positioned for growth in the cybersecurity sector, focusing on expanding its service offerings and client base while enhancing operational efficiency [4][11][12]. Group 1: Corporate Developments - The company received a three-year contract worth US$814,000 to provide cloud security services to a major laboratory data and advisory firm [3]. - Plurilock has announced over US$20 million in new sales orders since the beginning of 2024, indicating strong demand for its services [11][12]. - The company has streamlined operations and integrated its four key acquisitions, achieving annual savings of US$2 million, which are being reinvested into higher-margin services [5][6]. Group 2: Strategic Focus - Plurilock's strategic plan emphasizes converting one-time engagements into recurring managed services, thereby enhancing client retention and profitability [6][28]. - The launch of the Critical Services division in February 2024 aims to address urgent cybersecurity challenges and improve organizational efficiency [13][14]. - The company is actively recruiting new sales staff to bolster its sales efforts, particularly in high-margin Critical Services and SaaS offerings [26]. Group 3: Financial Position - Plurilock completed a financing round that raised US$5.5 million, which will support the growth of its Critical Services division and expand its sales team [24][27]. - The company achieved revenue of US$70.4 million in 2023, reinforcing its status as a trusted cybersecurity provider in North America and NATO countries [23]. - Plurilock is focused on achieving breakeven and converting existing client relationships into long-term managed services contracts, which will generate stable revenue streams [28].