Duyuru • Jun 24
Pluri Inc. Announces Board and Board Committee Changes On June 15, 2026, Pluri Inc. held its 2026 Annual Meeting of Shareholders. As a result of the voting outcome at the 2026 Annual Meeting, Mr. Eitan Ajchenbaum was not re-elected to the Board and therefore ceased to serve as a director and as a member of the respective committees on which he served, effective from the close of day of the 2026 Annual Meeting. Prior to his departure, Mr. Ajchenbaum was classified as an independent director, and served as Chairman of the Audit Committee, and the sole member of the Investment Committee. On June 19, 2026, the Board elected Mr. Doron Shorrer to serve as a member of the Board, effective immediately on June 19, 2026, to fill an existing vacancy on the Board created by the end of the service of Mr. Ajchenbaum following the results of the 2026 Annual Meeting, to hold office until the next general meeting of shareholders of the Company at which directors are being elected or as set forth in the Company’s bylaws. Mr. Shorrer, age 73, is an experienced executive and financial professional with extensive expertise in insurance, capital markets and financial services. Mr. Shorrer was one of the Company’s founders. He became a director of the Company on October 2, 2003, served as the Board’s first Chairman until 2006, and thereafter as a director and member of the Audit Committee and the Compensation Committees until his departure in June 2022. Since 1998, Mr. Shorrer has served as Chairman and Chief Executive Officer of Shorrer International Ltd., an investment and financial consulting firm. Mr. Shorrer also previously served as Director General of Israel’s Ministry of Transportation, Commissioner of Insurance, Capital Markets and Savings at Israel’s Ministry of Finance, Chairman of Mivtachim Pension Fund, and Chairman of The Phoenix Insurance Company. Mr. Shorrer holds a B.A. in Economics and Accounting and an M.B.A. in Finance and Banking from the Hebrew University of Jerusalem and is a Certified Public Accountant in Israel. Duyuru • Jun 02
Cellav Health and Aesthetics Ltd Completes Development and U.S. Cosmetic Product Listings of Regenativo+ and Placento+ Cellav Health and Aesthetics Ltd. had completed the development and U.S. cosmetic product listings of two flagship regenerative aesthetic products - Regenativo+ and Placento+, clearing the path for commercial launch in the United States. With the U.S. commercial launch and its professional portfolio now listed under the U.S. cosmetic framework and pursuant to U.S. Food and Drug Administration regulation, Cellav is in active discussions with U.S. distributors, clinic networks and advancing commercial discussions with strategic partners across the United States, United Kingdom and additional international markets. The Company is focused on securing initial commercial orders, expanding adoption among licensed aesthetic professionals and building a scalable commercial platform for future growth. The products, Regenativo+, a plant-derived treatment, and Placento+, a placenta-derived formulation, are supplied in Cellav’s signature DUO format: a vial of lyophilized powder paired with a booster vial, designed for topical, professional use following aesthetic procedures. Clinical validation of Cellav’s ingredients underscores commercial readiness: statistically significant improvements (p<0.05) in skin distensibility, elasticity, firmness and the skin-fatigue index, using plant-based extra cellular vesicles ingredients. Another study using placenta-based secretome and exosomes, demonstrated significant improvements (p<0.05) in vascular tone (redness) and brown discoloration, with additional improvements in pigmented spots observed in subjects with higher baseline values, and favorable trend observed in skin texture. The tested ingredients were well tolerated, with no clinically meaningful adverse events reported, supporting Cellav’s premium positioning in the professional regenerative and longevity channel. Duyuru • Apr 24
Pluri Inc., Annual General Meeting, Jun 15, 2026 Pluri Inc., Annual General Meeting, Jun 15, 2026. Location: at matam advanced technology park building no. 5, haifa, Israel Duyuru • Mar 27
Pluri Inc. announced that it expects to receive $2.5 million in funding Pluri Inc. announced that it has Securities Purchase Agreement relates to a private placement offering consisting of: 625,000 common shares, par value $0.00001 per share of the Company, and warrants to purchase up to 625,000 common shares of the Company at an issue price of $4 per share for gross proceeds of 2,500,000 on March 26, 2026. The warrants are exercisable immediately upon closing of the transaction at an exercise price of $4.25 per share and will be exercisable until the expiration of the eighteen-month anniversary of the closing of the transaction. The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, or applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The warrants are exercisable immediately upon closing of the transaction at an exercise price of $4.25 per share and will be exercisable until the expiration of the eighteen-month anniversary of the closing of the transaction. Duyuru • Jan 23
Pluri Inc. Receives Notice of Non-Compliance with Nasdaq Listing Standards On January 20, 2026, Pluri Inc. (the Company") received a written notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") indicating that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires the Company to maintain a minimum of $35 million in market value of listed securities (MVLS") for continued listing on The Nasdaq Capital Market (the MVLS Requirement"), nor is it in compliance with either of the alternative listing standards, including having stockholders' equity of at least $2.5 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. The Notice has no immediate effect on the listing or trading of the Company's common shares, which will continue to trade on The Nasdaq Capital Market under the symbol PLUR". Pursuant to the Notice, and in accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has been provided with an initial period of 180 calendar days, until July 20, 2026, to regain compliance with the MVLS Requirement (the Compliance Period"). Nasdaq indicated that if, at any time during the Compliance Period, the Company's MVLS closes at $35 million or more for a minimum of 10 consecutive business days (unless Nasdaq, in its discretion, requires a longer period, but generally no more than 20 consecutive business days), Nasdaq will provide a written confirmation that the Company has regained compliance and the matter will be closed. In the event the Company does not regain compliance within the Compliance Period, the Company expects that Nasdaq will provide written notification that the Company's securities are subject to delisting. At that time, the Company may be eligible to appeal any delisting determination to a Nasdaq Hearings Panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. The Company is evaluating options to regain compliance with the MVLS Requirement and intends to take appropriate actions to regain compliance; however, there can be no assurance that the Company will be able to regain compliance with all applicable requirements or maintain compliance thereafter. Duyuru • Jan 22
Pluri Successfully Completes First Phase of Resbiomed Program for Placenta-Derived Collagen-Rich Biomaterials Pluri Inc. announced the completion of the first phase of its program with Resbiomed Technologies OOD ("Resbiomed"), a European biotechnology company developing extracellular-matrix-based biomaterials and biologics for regenerative medicine. The program is being executed through Pluri's contract development and manufacturing division, PluriCDMO. In June 2025, Pluri Biotech Ltd., a wholly owned subsidiary of the Company, and a provider of Contract Development and Manufacturing ("CDMO") services under its PluriCDMO business line, entered into an agreement with Resbiomed to apply Pluri's proprietary placenta-derived processing and bioprocessing capabilities to enhance, standardize and enable scalable production of placenta-derived biomaterials containing naturally occurring human collagen. Pluri believes scalable, standardized manufacturing of placenta-derived collagen-rich materials can expand access across regenerative medicine, advanced wound care, medical devices, 3D cell culture and bioprinting, and selected aesthetics. For Pluri, it views the agreement as underscoring growing demand for PluriCDMO services among companies developing next-generation, cell- and tissue-based technologies, and further strengthens PluriCDMO's position as a partner for biologics and advanced biomaterials programs requiring reproducibility, scale, and robust manufacturing controls. Duyuru • Dec 10
Pluri Inc. announced that it expects to receive $2.5 million in funding from Chutzpah Holdings Limited Pluri Inc. announced that it has entered into a Securities Purchase Agreement for a private placement offering of 625,000 common shares, par value $0.00001 per share at a price of $4.00 for gross proceeds of $2,500,000 and will issue Common Warrants to purchase up to 625,000 Common Shares on December 8, 2025. The transaction includes participation from Chutzpah Holdings LP a limited partnership beneficially owned by Mr. Alexandre Weinstein, a non-U.S. investor and an existing shareholder and director of the Company. The Common Warrants will be exercisable immediately at an exercise price of $4.25 per share and will be exercisable until June 30, 2026. The Common Warrants contain customary anti-dilution provisions and are subject to a 35% beneficial ownership limitation. The Securities Purchase Agreement contains customary representations, warranties and indemnification obligations of the parties. The Offering is expected to close on or about December 15, 2025, subject to the satisfaction of customary closing conditions. The securities issued with respect to the Offering are exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities Act and/or Rule 903 of Regulation S promulgated thereunder. The securities have not been registered under the Securities Act and may not be sold in the United States absent registration or an exemption from registration. The offer and sale of the foregoing securities is being made in a private placement in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, or applicable state securities laws. Accordingly, the securities offered in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Duyuru • Dec 09
Pluri Inc. Announces Chairman of the Board of Directors Changes Pluri Inc. announced that Mr. Alejandro Weinstein, one of the Company’s largest shareholders, has been appointed Chairman of the Board of Directors. The appointment reflects the Board’s view that Mr. Weinstein brings a decisive, business driven perspective that aligns with Pluri’s objectives of strengthening market positioning and accelerating the recognition and realization of the significant value embedded in the Company’s underlying assets. Mr. Weinstein, a prominent investor, has built and scaled global companies across healthcare, biotechnology, and wellness, including transforming CFR Pharmaceuticals into a multinational group later acquired by Abbott for $2.9 billion, and founding leading investment platforms such as WM Partners, Olive Tree Ventures, and Vanterra Ventures, which is active in functional food and nutrition innovation. His proven ability to grow companies, execute strategic transactions, and lead value driven organizations makes him a strong candidate to serve as Chairman. As part of this leadership evolution, Mr. Zami Aberman, who has served as Pluri’s Chairman for two decades, will transition into the role of Vice Chairman and continue to support the Company’s strategic direction. Duyuru • Apr 10
Pluri Inc. Announces Expansion of Intellectual Property Portfolio with Two Granted Patents for 3D Expansion of Immune Cells in the United States and Israel Pluri Inc. announced that the U.S. Patent and Trademark Office has issued a patent covering the Company's immune cell expansion technologies. This patent specifically includes MAIT cells, a unique subset of T cells that are crucial in helping the body fight infection and repair tissue. The granted patents titled "System and Methods For Immune Cells Expansion and Activation In Large Scale" focus on a system and method for culturing and/or activating immune cells in a large scale, within Pluri's proprietary 3D cell expansion bioreactors. Offering substantial potential benefits compared to conventional T cells, Pluri's MAIT cells are isolated from the human placenta, a source rich in highly potent allogeneic immune cells. These cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites. The tightly controlled and fully automated bioreactor system provides cells with the conditions they need in order to expand, enabling efficient expansion of immune cells at scale and quality. The company believe that this innovative approach ensures that the produced immune cells retain their integrity, functionality, and therapeutic efficacy, thus offering a potentially promising solution to meet the escalating demand for advanced cell-based therapies for immune disorders and neurodegenerative diseases. Duyuru • Mar 20
Pluri Inc. announced that it has received $3.5 million in funding from Merchant Adventure Investment Advisors, LLC On March 19, 2025 Pluri Inc. closed the transaction. The company received the proceeds from a single investor pursuant to Regulation D. Duyuru • Mar 17
Pluri Inc., Annual General Meeting, May 14, 2025 Pluri Inc., Annual General Meeting, May 14, 2025. Location: matam advanced technology park building no. 5, 3508409., haifa Israel Duyuru • Nov 28
Pluri Receives Nasdaq Notification of Non-Compliance with Listing Rule 5550(B)(1) On November 25, 2024, Pluri Inc., received a deficiency letter, or the Nasdaq Letter, from the Listing Qualifications Department of The Nasdaq Stock Market LLC, or Nasdaq, notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires the Company to maintain a minimum of $2,500,000 in stockholders' equity for continued listing on The Nasdaq Capital Market, or the Stockholders' Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. Pursuant to the Nasdaq Letter, the Company has 45 calendar days from the date of the Nasdaq Letter to submit a plan to regain compliance and the Company intends to submit such a plan during this period. If it accepts the plan, Nasdaq can grant an extension of up to 180 calendar days from the date of the Nasdaq Letter to evidence compliance. In the event the plan is not accepted by Nasdaq, or in the event the plan is accepted and the 180-day extension period granted but the Company fails to regain compliance within such plan period, the Company would have the right to a hearing before an independent panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance that Nasdaq will grant the Company's request for an extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing. Neither the Nasdaq Letter nor the Company's noncompliance have an immediate effect on the listing or trading of the Company's common shares, which will continue to trade on The Nasdaq Capital Market under the symbol PLUR". Duyuru • Jul 24
Nasdaq Grants Extension Till Nov. 24 to Pluri Inc. to Regain Compliance with Stockholder Equity Requirement As previously reported, on May 28, 2024, Pluri Inc., or Pluri or the Company, received a deficiency letter, or the Nasdaq Letter, from the Listing Qualifications Department of The Nasdaq Stock Market LLC, or Nasdaq, notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires the Company to maintain a minimum of $2,500,000 in stockholders' equity for continued listing on The Nasdaq Capital Market, or the Stockholders' Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. On July 11, 2024, the Company submitted a plan to regain compliance, or the Compliance Plan. Based on the Compliance Plan, Nasdaq has determined to grant the Company an extension of time to regain compliance with the Stockholders' Equity Requirement until November 24, 2024. If the Company fails to evidence compliance by the required deadline, the Company may be subject to delisting. At that time, the Company may appeal Staff's determination to a Hearings Panel. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance the Company will ultimately regain compliance with all applicable requirements for continued listing. Neither the Nasdaq Letter nor the Company's noncompliance have an immediate effect on the listing or trading of the Company's common shares, which will continue to trade on The Nasdaq Capital Market under the symbol PLUR". Duyuru • Jun 08
U.S. National Institutes of Health Exercises Option to Fund $1.4 Million 2nd Year Budget for Pluri Inc.’s PLX-R18 Acute Radiation Syndrome Contract Pluri Inc. announced the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has exercised its option for year two of the three-year $4.2 million contract it entered into with Pluri in July 2023. During the 12 months from July 1, 2024 through June 30, 2025, the NIAID will provide $1.4 million for the Company to manufacture the PLX-R18 cell therapy and to conduct both in vitro and in vivo studies to develop PLX-R18 as a potential novel treatment for hematopoietic complications of the acute radiation syndrome (H-ARS). H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as that which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, and anemia, and possibly death. The U.S. Food and Drug Administration (FDA) previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation. Over the past year, Pluri has collaborated with the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of Health Sciences in Bethesda, Maryland, resulting in significant advancements in the development of PLX-R18 as a potential treatment for H-ARS. PLX-R18 has been safely tested in both humans and animals. Prior studies funded by the NIH/NIAID and conducted in accordance with the FDA’s Animal Rule pathway demonstrated that PLX-R18 administered to animals after radiation exposure for H-ARS significantly increased survival rates from 29% in the control group to 97% in the treated group (p<0.001). Studies conducted by the DoD have shown that PLX- R18, administered as a prophylactic measure 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival in the placebo group to 74% in the treated group (log-rank test p< 0.0001). In addition, the data show a significant increase in recovery of white blood cell (p = 0.0047), platelet (p = 0.0070), neutrophil (p = 0.0003) and lymphocyte (p = 0.0025) counts compared to administration of vehicle, and also demonstrate a favorable safety profile. PLX-R18 was tested in humans with incomplete hematopoietic recovery following hematopoietic cell transplantation and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types compared to the baseline with platelet (p<0.001), hemoglobin (p=0.02) and neutrophil (p=0.15) levels increasing as early as 1 month following PLX-R18 administration and enduring up to 12 months following treatment, while experiencing a significant reduction in mean number of transfused units from a monthly 5.09 to 0.55 for platelets (p=0.045) and 2.91 to 0 for red blood cells (p=0.0005) over 12 months of follow-up. Duyuru • Jun 01
Pluri Receives Deficiency Letter from Nasdaq Regarding Non-Compliance with Minimum of $2.5 Million in Stockholders’ Equity Requirement for Continued Listing on the Nasdaq Capital Market On May 28, 2024, Pluri Inc. (Pluri or the Company) received a deficiency letter, or the Nasdaq Letter, from the Listing Qualifications Department of The Nasdaq Stock Market LLC, or Nasdaq, notifying the Company that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires the Company to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing on The Nasdaq Capital Market, or the Stockholders’ Equity Requirement, nor is it in compliance with either of the alternative listing standards, market value of listed securities of at least $35 million or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years. Pursuant to the Nasdaq Letter, the Company has 45 calendar days from the date of the Nasdaq Letter to submit a plan to regain compliance and the Company intends to submit such a plan during this period. If it accepts the plan, Nasdaq can grant an extension of up to 180 calendar days from the date of the Nasdaq Letter to evidence compliance. In the event the plan is not accepted by Nasdaq, or in the event the plan is accepted and the 180-day extension period granted but the Company fails to regain compliance within such plan period, the Company would have the right to a hearing before an independent panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. However, there can be no assurance that Nasdaq will grant the Company’s request for an extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing. Neither the Nasdaq Letter nor the Company’s noncompliance have an immediate effect on the listing or trading of the Company’s common shares, which will continue to trade on The Nasdaq Capital Market under the symbol ‘PLUR’. New Risk • Apr 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m (US$357k revenue). Minor Risks Shareholders have been diluted in the past year (2.0% increase in shares outstanding). Market cap is less than US$100m (€28.9m market cap, or US$31.0m). Duyuru • Mar 11
Pluri Inc. Receives First-Ever Patent Approval for 3D Bioreactor Technology in Plant Cell Cultivation Pluri Inc. announced an important expansion to its intellectual property portfolio with a new patent approval, that is designed to reshape the agricultural technology landscape. The patent titled "A System for 3D Cultivation of Plant Cells and Methods of Use" represents a major breakthrough in Pluri's proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various applications, from sustainable agriculture to critical healthcare solutions. An immediate application for the patent is PluriAgtech’s sustainable cell-based coffee. The 3D cell expansion technology can produce high-quality coffee with 98% less water and 95% less growing area. Pluri’s patent and 3D cell expansion technology can also potentially address an emerging gap in agricultural healthcare, as approximately one-fifth of the 50,000 medical plants used on a list of threatened species. Duyuru • Mar 06
Pluri Inc. Announces Appointment of Jim Roosevelt, Jr. to its Advisory Board Pluri Inc. announced the appointment of attorney James Roosevelt, Jr. to the Company’s Advisory Board. Having served in public-service positions in Washington, D.C., followed by a successful decade in the private sector as CEO of Tufts Health Plan, Mr. Roosevelt is a trusted and sought-after advisor on business matters, legislative and regulatory issues, governance, and personnel matters. The intersection of public policy and health is a passion for him. As CEO of Tufts Health Plan, his leadership achieved consistent profitability while attaining the #1 ranking from the National Committee for Quality Assurance. Bringing his expertise to Pluri'sAdvisory Board, Mr. Roosevelt will contribute to the Company's strategic growth plans, particularly in the area of regenerative medicine, by advising on longevity opportunities, best practices for securing and maintaining ongoing grants and contracts with U.S. government agencies, and facilitating relationships with investors and partners. Before joining Tufts Health Plan, Mr. Roosevelt served as associate commissioner of the U.S. Social Security Administration and is a national speaker and published author writing about the Affordable Care Act, Medicare and Medicaid policy, and Social Security. He has also been a visiting fellow at the Institute of Politics of the Harvard Kennedy School of Government and continues as a clinical instructor in the Public Health and Community Medicine Department of Tufts University School of Medicine. In the tradition of his grandfather and other members of the Roosevelt family, Mr. Roosevelt co-chairs the Rules and Bylaws Committee of the Democratic National Committee and serves as volunteer legal counsel for the Massachusetts Democratic Party. Mr. Roosevelt is also a trustee of the Cambridge Public Library, the Cambridge Community Foundation, and the Atrius Health Equity Foundation. In the past, he has co-chaired Rhode Island Governor Gina Raimondo'sHealth-Care Leaders Task Force on Health-Care Cost Growth and the Massachusetts Hospital Association's work group on access to behavioral health care. Duyuru • Feb 14
Pluri Inc. has filed a Follow-on Equity Offering in the amount of $10 million. Pluri Inc. has filed a Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Reported Earnings • Feb 13
Second quarter 2024 earnings released: US$0.12 loss per share (vs US$0.24 loss in 2Q 2023) Second quarter 2024 results: US$0.12 loss per share (improved from US$0.24 loss in 2Q 2023). Net loss: US$4.91m (loss narrowed 40% from 2Q 2023). Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. Duyuru • Jan 23
Pluri Inc. Launches Sustainable Cell-Based Coffee as Countermeasure for Global Coffee Crisis Pluri Inc. announced that it has launched its cell-based coffee business activity, an innovative product that will potentially revolutionize the traditional coffee industry. Pluri’s cell-based coffee product is designed to address the growing global demand for sustainable, high-quality coffee at mass scale production. Pluri is pioneering plant cell-based, industrial scale manufacturing solutions for the coffee industry, leveraging its 3D cell expansion technology to create high quality coffee under the Company’s new business vertical, PluriAgtech. PluriAgtech aims to forge a brighter, greener future for agriculture by using breakthrough cell technology to create more eco-friendly alternatives to traditional farming methods. PluriAgtech’s cell-based coffee has been developed to deliver authentic coffee while solving key challenges faced by the industry. Compared to traditional methods of coffee production, Pluri’s cell-based coffee is estimated to slash water usage by 98%. This innovation promises to confront the reduction of suitable growing areas that are expected to decline by up to 50% by 2050; reduce price instability in a traditional commodity market; and minimize the environmental impact of coffee production, as current production methods have a high carbon footprint and upcoming regulations are expected to further strain producers. While coffee production challenges persist, world demand for coffee is expected to triple by 2050. Duyuru • Jan 08
Pluri Inc. Appoints Andy Lewin to Lead Business of its Contract Development and Manufacturing Organization: PluriCDMO Division Pluri Inc. announced that it has appointed industry expert, Andy Lewin, to lead the business of its Contract Development and Manufacturing Organization (CDMO): PluriCDMO division. Mr. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies including Ascend Gene and Cell Therapies Ltd., Oxford Biomedica, and AGC Biologics Inc. Reported Earnings • Nov 15
First quarter 2024 earnings released: US$0.12 loss per share (vs US$0.19 loss in 1Q 2023) First quarter 2024 results: US$0.12 loss per share (improved from US$0.19 loss in 1Q 2023). Net loss: US$4.96m (loss narrowed 19% from 1Q 2023). Over the last 3 years on average, earnings per share has increased by 26% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Duyuru • Oct 20
Pluri Receives an Extension of an Additional 180 Calendar Days from The Nasdaq Stock Market LLC to Regain Compliance with the Minimum Bid Price Requirement On October 17, 2023, Pluri Inc. (the ‘Company’) received a letter (the ‘Letter’), from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) approving an extension of an additional 180 calendar days from the date of the Letter, or until April 15, 2024 (the ‘Additional Compliance Period’) to regain compliance with the Minimum Bid Price Requirement as well as approving the Company’s application to transfer its securities from the Nasdaq Global Market to The Nasdaq Capital Market starting at the opening of business on October 19, 2023. The Company’s Common Shares will continue to trade under the symbol ‘PLUR.’ The Nasdaq Capital Market is a continuous trading market that operates in substantially the same manner as The Nasdaq Global Market and listed companies must meet certain financial requirements and comply with Nasdaq’s corporate governance requirements. As previously disclosed, on April 19, 2023, the company received a written notification (the ‘Notice’) from the Staff of The Nasdaq Stock Market LLC, notifying the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company’s common shares, par value $0.00001 per share (the ‘Common Shares’), had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the ‘Minimum Bid Price Requirement’). Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was granted 180 calendar days, or until October 16, 2023, to regain compliance with the Minimum Bid Price Requirement. If at any time during the Additional Compliance Period, the bid price of the Common Shares closes at or above $1.00 per share for a minimum of ten (10) consecutive trading days, Nasdaq will provide the Company with written confirmation of compliance with the Minimum Bid Price Requirement and the matter will be closed. If the Company does not regain compliance within the Additional Compliance Period or does not comply with the terms of the extension, Nasdaq will provide notice that the Company’s securities will be delisted from The Nasdaq Capital Market. The Company intends to continuously monitor the closing bid price for its Common shares and is in the process of considering various measures to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement, even if it maintains compliance with the other Nasdaq listing requirements. Reported Earnings • Sep 13
Full year 2023 earnings released: US$0.77 loss per share (vs US$1.28 loss in FY 2022) Full year 2023 results: US$0.77 loss per share (improved from US$1.28 loss in FY 2022). Net loss: US$28.3m (loss narrowed 31% from FY 2022). Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Duyuru • Aug 17
Pluri Inc. Announces PLX-R18 Increases Blood Cell Counts and Reduces Need for Transfusions in Phase I Study: Results Published in Nature Bone Marrow Transplantation Pluri Inc. announced the publication of an article titled Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phaseI study in the peer reviewed journal Nature Bone Marrow Transplantation. As described in the article, in a successful Phase I first-in-human study which achieved its primary endpoint, patients with incomplete hematopoietic recovery post-hematopoietic cell transplantation (HCT) were treated with escalating doses of Pluri’s cell therapy, PLX-R18. While patients received only two administrations of PLX-R18 during the first week, as compared to the standard of care which requires frequent and ongoing dosing, treated patients showed increased blood cell counts for as long as 12 months from administration, and a reduction in the need for blood transfusions. PLX-R18 was well tolerated with a favorable safety profile. PLX-R18, a placental-derived cell therapy, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of graft failure, incomplete hematopoietic recovery following HCT, and the treatment of ARS. Low levels of blood cells (cytopenia) post-HCT can persist despite adequate engraftment of donor cells. Pluri’s PLX-R18 cells secrete a large array of hematopoietic factors which promote regeneration, maturation, and differentiation of hematopoietic cells and stimulate their migration to peripheral blood. Duyuru • Jul 13
Pluri Inc. Announces Appointment of Lorne Abony to Board of Directors Pluri Inc. announced the appointment of Lorne Abony to the Company’s Board of Directors, effective as of July 11, 2023. Abony is a successful entrepreneur who has decades of experience building and scaling multi-billion-dollar global businesses – both public and private companies – across multiple industries. He is a globally recognized leader who has invested, directly or indirectly, in more than 20 cellular agriculture and cultivated food companies. Bringing his expertise to Pluri's board, he will contribute to the Company's strategic growth plans by utilizing its cell-expansion technology platform across various sectors, such as cultivated food and cellular agriculture. As a founder and executive, Mr. Abony has scaled major ventures including FUN Technology Ltd, Emmac Life Sciences Limited and NuuVera Inc. He has raised over $1.7 billion through public and private debt and equity markets. In 2011, Mr. Abony received Canada’s Ernst & Young Entrepreneur of the Year Award for his founding and leadership of Mood Media Corporation (Mood). Mr. Abony scaled Mood from a pre-revenue startup to the world’s largest in-store media company with more than 3,300 employees, offices in 47 countries and over $750 million in annual revenue, before selling the company to a private equity firm. He was also featured on the hit network T.V. series, “Undercover Boss.” Mr. Abony is currently chair and board member of several companies in the field of cultivated food, AI, and technology such as VitroLabs Inc., AmyInsights, and Einride A.B. Duyuru • Dec 31
Pluri Inc. announced that it has received $8.469323 million in funding On December 30, 2022, Pluristem Therapeutics, Inc closed the transaction. The company amended the terms of the transaction. The company has received $8,469,323 pursuant to exemption provided under Regulation D form 14 investors. Duyuru • Dec 16
Pluri Inc. announced that it expects to receive $8.170972 million in funding Pluri Inc. announced that it has entered into a security purchase agreement for the issuance of up to 5,579,883 common shares at a price of $1.03 per common share for gross proceeds of $5,747,279.49, up to 2,068,517 common shares at a price of $1.05 per shar for the gross proceeds of $2,171,942.85 and 237,500 common shares at a price of $1.06 per share for gross proceeds of $251,750; for aggregate proceeds of $8,170,972.34 on December 15, 2022. The company will also issue warrant in the transaction to purchase 7,885,900 common shares, exercisable upon the later of six months from their issuance date, or until the company increases its authorized shares. The transaction is expected to close by January 31, 2023. The transaction is being made in the United States pursuant to the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 1 experienced director. 1 highly experienced director. Chairman Zami Aberman is the most experienced director on the board, commencing their role in 2005. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Duyuru • Oct 14
Pluri Receives Non-Compliance Letter from Nasdaq October 12, 2022, Pluri Inc. (the Company") received a letter (the Notice") from The Nasdaq Stock Market (Nasdaq") advising the Company that for 30 consecutive trading days preceding the date of the Notice, the bid price of the Company's common shares had closed below the $1.00 per share minimum required for continued listing on the Nasdaq Global Market pursuant to Nasdaq Listing Rule 5450(a)(1) (the Minimum Bid Price Requirement"). The Notice has no effect on the listing of the Company's common shares at this time, and the Company's common shares continue to trade on the Nasdaq Global Market under the symbol PLUR." Under Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar day period following the date of the Notice the closing bid price of the Company's common shares is at or above $1.00 for a minimum of 10 consecutive business days, the Company will regain compliance with the Minimum Bid Price Requirement and its common shares will continue to be eligible for listing on the Nasdaq Global Market, absent noncompliance with any other requirement for continued listing. The compliance period for the Company to comply with the Minimum Bid Price Requirement will expire on April 10, 2023 (the Compliance Period"). If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, then under Nasdaq Listing Rule 5810(c)(3)(A)(i) the Company may transfer to The Nasdaq Capital Market, provided that it meets the applicable market value of publicly held shares requirement for continued listing as well as all other standards for initial listing of its common shares on the Nasdaq Capital Market (other than the Minimum Bid Price Requirement) and notifies Nasdaq of its intention to cure the deficiency. Following a transfer to The Nasdaq Capital Market, under Nasdaq Listing Rule 5810(c)(3)(A)(ii), the Company may be afforded an additional 180-days to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period (or the Compliance Period as may be extended) the Company's common shares will be subject to delisting. The Company intends to monitor the closing bid price of its common shares and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement under the Nasdaq Listing Rules, including initiating a reverse stock split. Duyuru • Sep 07
Pluri Inc. Announces €7.5 Million Non-Dilutive Grant from the European Union’s Horizon Europe Program to Study PLX-PAD Cells for Osteoarthritis Treatment Pluri Inc. announced that a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité, Berlin Institute of Health Center for Regenerative Therapies. The goal of the PROTO project is to utilize Pluri’s PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA). The project is currently under grant agreement preparation number 101095635. Final approval of the grant is subject to completion of the consortium and Horizon Europe grant agreements. The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages which will be determined by the consortium. The Phase I/IIa study will be carried out by Charité, Pluri and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator (PI) at the Berlin Institute of Health Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Professor Winkler was also the lead PI in the Phase II and Phase III muscle regeneration studies using Pluri’s PLX-PAD cells. OA is one of the most common chronic articular diseases, with a global prevalence of 16% in the adult population. OA is the third most rapidly growing disease associated with disability2, showing an increase of 30% over the past decade, currently affecting more than 500 million people worldwide and about 50 million in Europe3. Globally, symptomatic OA affects 10% of men and 18% of women over 60 years of age, with knee being most the commonly affected joint4. OA also represents a huge healthcare burden with U.S. indirect costs amounting to 1% of the gross national product. There is currently no effective disease-modifying treatment for OA, only symptomatic treatment at a late stage. OA increases the risks of joint inflammation, pain, stiffness, swelling, disability, morbidity and mortality, and it reduces quality of life and work performance. OA might lead to reduced mobility and chronic disability and is associated with cardiovascular and metabolic co-morbidities. PLX-PAD is an innovative anti-inflammatory allogeneic placental cell therapy product candidate to treat patients with mild to moderate knee OA as a direct approach to reduce inflammation and cartilage degeneration. Duyuru • Jul 14
Pluristem Reports Topline Results from its Phase III Study of Muscle Regeneration Following Hip Fracture Surgery Pluristem Therapeutics Inc. announced topline results from its multinational double-blind, placebo-controlled phase III study. The Company designed the study to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture. The study enrolled 240 patients in the United States, Europe, and Israel. PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration. A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120). This new data confirms the results demonstrated in Pluristem’s phase I/II study. The study did not meet the primary endpoint, which was the Short Physical Performance Battery (SPPB) test at week 26. The SPPB is a series of physical performance tests used in older persons to assess lower extremity function and mobility. PLX-PAD was well tolerated and demonstrated a significant increase in HAS: In the injured leg: Patients treated with PLX-PAD cells showed an increase of 3.2kg from reference (week 6) to week 26 compared to 1.3kg in the placebo group, a 2kg difference (p=0.047). Patients treated with PLX-PAD cells showed an increase of 5.01kg from reference (week 6) to week 52 compared to 0.86kg in the placebo group, a 4kg difference (p=0.0022). In the uninjured leg: Patients treated with PLX-PAD cells showed an increase of 2.3kg from reference (week 6) to week 26 compared to 0.51kg in the placebo group, a 1.8kg difference (p=0.073). Patients treated with PLX-PAD cells showed an increase of 3.3kg from reference (week 6) to week 52 compared to a decrease of 0.7kg in the placebo group, a 4kg difference, (p=0.0046). When comparing the absolute HAS between study groups (treated versus placebo) at week 52, patients treated with PLX-PAD showed a 2.6kg higher score than placebo treated patients in the injured leg (p=0.0511). A similar benefit was seen in the uninjured leg, with a 2.2kg difference (p=0.113). The increase in HAS was further supported by a positive trend in a 6-minute walk test at week 52, showing an increase in walking distance: PLX-PAD treated patients (N=36) were able to walk 296 meters versus only 266 meters in placebo treated patients (N=45). The 6-minute walk test evaluates the global and integrated responses of all the systems involved in walking (pulmonary, cardiovascular, systemic and peripheral circulation, musculoskeletal function, neuromuscular units, and muscle metabolism), and is an acceptable functional endpoint. Duyuru • Jun 25
Pluristem Therapeutics Inc. Announces Board Changes On June 21, 2022, Pluristem Therapeutics Inc., or the Company, held its 2022 Annual Meeting of Stockholders, or the 2022 Annual Meeting. As a result of the voting outcome from the 2022 Annual Meeting, on June 21, 2022, each of Mark Germain, Moria Kwiat, and Doron Shorrer were not re-elected to the Company’s Board of Directors, or the Board, and vacated their seats on the Board, and their respective committees, effective immediately. Prior to vacating their seats on the Board, Mr. Germain was an independent director and Chairman of the Nominating Committee; Ms. Kwiat was an independent director and member of the Compensation Committee; and Mr. Shorrer was an independent director and a member of the Nominating Committee and served as Chairman of the Compensation Committee and the Audit Committee. As a result of vacating their seats on the Board, Ms. Kwiat and Messers. Germain and Shorrer were also deemed to vacate their membership on the aforementioned Board committees. On June 23, 2022, the Board (i) appointed Ms. Varda Shalev to serve on the Audit Committee in place of Mr. Shorrer and appointed Mr. Doron Birger to serve as the Chairman of the Audit Committee; (ii) appointed Ms. Maital Shemesh-Rasmussen and Ms. Shalev to serve on the Compensation Committee, in place of Mr. Shorrer and Ms. Kwiat, with Ms. Shemesh-Rasmussen to serve as the Chairperson of the Compensation Committee; and (iii) appointed Mr. Rami Levi and Ms. Shemesh-Rasmussen to the Nominating Committee, in place of Mr. Germain and Mr. Shorrer, with Mr. Levi to serve as the Chairman. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Yoram Palti was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Board Change • Apr 01
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Yoram Palti was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Duyuru • Mar 10
Pluristem Therapeutics Inc. and Tnuva Group Appoint Eyal Rosenthal as Chief Executive Officer of Their New Joint Venture Pluristem Therapeutics Inc. and Tnuva Group jointly announced the appointment of Eyal Rosenthal as Chief Executive Officer of their joint venture to develop, manufacture and commercialize cultured meat. Mr. Rosenthal is a seasoned entrepreneur and visionary leader in the agritech and food tech industries, serving until recently as venture partner and head of Israeli operations at Finistere Ventures, a pioneering global venture fund dedicated to identifying and nurturing promising agribusiness and food tech companies. He brings to his role over two decades of leadership within business, food tech, agriculture investment and sustainability, and will oversee the newventure’s growth into a scaled company. Mr. Rosenthal also served as Executive Chairman of Fresh Start, a leading global food tech incubator backed by the Israel Innovation Authority, as well as top strategic and financial players. He was previously Managing Director at Infinity Group, a $600 million growth fund, and advised the International Finance Corporation, a World Bank Group member, on global food security issues. The joint venture, which was incorporated through an agreement between Pluristem and Tnuva, has exclusive licensing rights to use Pluristem’s proprietary technology and intellectual property to develop, manufacture and commercialize cultured meat. It combines Pluristem’s technological advantage in mass-scale, cost-effective cell production with Tnuva’s expertise in food sector research and development (R&D), consumer marketing, and distribution. Board Change • Mar 02
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Member of Strategic Advisory Board Yoram Palti was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Feb 18
Chairman recently bought €126k worth of stock On the 10th of February, Zami Aberman bought around 81k shares on-market at roughly €1.57 per share. This was the largest purchase by an insider in the last 3 months. This was Zami's only on-market trade for the last 12 months. Duyuru • Dec 28
Pluristem Therapeutics Inc. Reports Topline Results from its Phase II Studies of Acute Respiratory Distress Syndrome Associated with COVID-19 Pluristem Therapeutics Inc. announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the “U.S. study”) and in Europe and Israel (collectively, the “EU study” and together with the U.S. study, the “Studies”). The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo. In July 2021, Pluristem announced its decision to bring the Studies to early clinical readout based on 89 patients enrolled, instead of the originally planned 180 patients (140 in the U.S. study and 40 in the EU study). The decision came in response to COVID-19’s evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients. These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient population in the Studies. The early termination of recruitment led to a significant reduction in the statistical power of the Studies. Efficacy trends from the Studies included: A single administration of 300 million PLX-PAD cells demonstrated overall better results, compared to other treatment groups. Patients in the U.S. study treated with a single dose of 300 million PLX-PAD cells (n=14) showed an increased survival rate by 40% at day 60 compared to placebo group (n=14) (50% vs. 35%). Patients in the EU Study treated with a single dose of 300 million PLX-PAD cells (n=11) showed an increased survival rate by 27% at day 60 compared to control group (n=12) (64% vs. 50%). In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 28 by 3.6 days, from 0.2 days in the control group (n=12) to 3.8 days in the treated group (n=11). In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 60 by 112% or 6.6 days, from 5.9 days in the control group (n=12) to 12.5 days in the treated group (n=11). About the Studies: The U.S. Study included 66 patients enrolled to a randomized, double-blind, placebo-controlled, multicenter, parallel-group study, with three treatment groups of PLX-PAD cells - single administration of 300 million cells, single administration of 600 million cells, or 300 million cells administered twice in a one-week interval; and two placebo control groups single administration, and two administrations in a one-week interval. All groups received a study treatment in addition to the best standard medical care according to local practices. The EU Study enrolled 23 patients in Germany, Bulgaria, and Israel to a randomized, controlled, multicenter, parallel-group study with a single treatment group (single dose of 300 million PLX-PAD cells) in addition to best standard medical care according to local practices, and a control group received the best standard medical care according to local practices. Executive Departure • Jun 09
Independent Director Isaac Braun has left the company On the 1st of June, Isaac Braun's tenure as Independent Director ended after 15.9 years in the role. As of March 2021, Isaac still personally held 61.48k shares (€235k worth at the time). A total of 4 executives have left over the last 12 months. The current median tenure of the management team is 1.92 years, which is considered inexperienced in the Simply Wall St Risk Model. Recent Insider Transactions • May 28
Insider recently sold €1.3m worth of stock On the 25th of May, Adi Wolf sold around 410k shares on-market at roughly €3.16 per share. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought €9.9m more than they sold in the last 12 months. Recent Insider Transactions • May 05
Insider recently sold €84k worth of stock On the 3rd of May, Adi Wolf sold around 24k shares on-market at roughly €3.55 per share. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought €11m more than they sold in the last 12 months. Duyuru • Apr 30
Pluristem Reports Positive Topline Phase I Results in Innovative Hematology Program, Which Is First to Study PLX-R18 in humans Pluristem Therapeutics Inc. reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans. The company’s Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). Poor graft function is a life-threatening complication for patients undergoing HCT. Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages. Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect. Pluristem's PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow. This potentially enhances the production of all three blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages. Is New 90 Day High Low • Mar 05
New 90-day low: €4.30 The company is down 51% from its price of €8.75 on 04 December 2020. The German market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €61.39 per share. Analyst Estimate Surprise Post Earnings • Feb 10
Revenue in line with expectations Revenue was in line with analyst estimates. Duyuru • Jan 08
Pluristem Therapeutics Inc. Announces Board Appointments Pluristem Therapeutics Inc. announced the appointment of Ms. Maital Shemesh-Rasmussen and Mr. Rami Levi to its Board of Directors. Ms. Maital Shemesh-Rasmussen brings over 20 years of diverse commercialization experience across various industries. From 2018 to 2020, she served as Global Head of Solution Marketing at Roche Diagnostics Information Solutions, where she defined Roche's new health-tech strategy, bringing to market advanced digital solutions and commercial models that positioned Roche as a world leader in health technology. Mr. Rami Levi, Founder and President of Catalyst Group International, brings over 30 years of experience in managing successful international projects on five continents, partnering with world leaders, and connecting nations and industry on a global scale. Duyuru • Dec 30
Pluristem Therapeutics Inc. Enters Collaboration With Innovare R&D to Expand Its ARDS Associated With COVID-19 Program to Mexico Pluristem Therapeutics Inc. announced it has entered into a collaboration agreement with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico. The Phase II study in Mexico is subject to the approval of local authorities, with the goal of being conducted under the U.S. Food and Drug Administration (FDA) cleared protocol. In accordance with the agreement, Innovare will open clinical sites and enroll patients for the proposed clinical study in Mexico. Innovare will fund the study in Mexico and will purchase PLX cells for the study from Pluristem. Subject to potential positive clinical study results and Mexican regulatory approval for commercialization, the agreement grants Innovare exclusive distribution rights in Mexico to supply PLX cells for treating severe COVID-19 cases complicated by ARDS. All intellectual property and manufacturing rights remain with Pluristem. With 1,389,430 cases and 122,855 deaths as of December 29, 2020, Mexico’s COVID-19 infection and mortality rates have been increasing. Duyuru • Dec 11
Pluristem Therapeutics Inc. Announces DMC Recommendation Following Interim Analysis of its Phase III CLI Study PluristemTherapeutics Inc. announced that the independent Data Monitoring Committee (DMC) of its global pivotal Phase III study for the treatment of critical limb ischemia (CLI) issued its recommendation letter following the interim analysis. The clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death. Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis. The DMC advised the Company that the CLI study population has experienced a substantial low number of events (major amputation of the index leg or death), different from what is known in clinical medicine for the rate of these events in this patient population. The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint. DMC noted that PLX-PAD was well tolerated, and no significant safety concerns were raised during the study. Is New 90 Day High Low • Dec 09
New 90-day high: €9.75 The company is up 16% from its price of €8.40 on 10 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €61.85 per share. Recent Insider Transactions • Dec 02
Insider recently bought €162k worth of stock On the 30th of November, Adi Wolf bought around 20k shares on-market at roughly €8.12 per share. In the last 3 months, they made an even bigger purchase worth €1.7m. Insiders have collectively bought €11m more in shares than they have sold in the last 12 months. Duyuru • Nov 19
Pluristem Therapeutics Inc. to Present Initial Results from its Phase I HCT Study Pluristem Therapeutics Inc. announced the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up. The initial data from the Phase I trial demonstrated: The treatment with PLX-R18 was found to be safe and well-tolerated. An overall improvement was observed in most patients, with the high-dose cohort showing clinically meaningful improvements from baseline to 9-month in hemoglobin (Hb); absolute neutrophil count (ANC) a measure of white blood cells; and platelet count (PLT). In this cohort, Hb levels increased from 9.29±0.5 to 13.19±1.2 (p=0.0019), ANC increased from 1.09±0.6 to 5.13±1.7 (p=0.018) and PLT increased from 45.7±10 to 175.9±28 (p=0.000012). Incomplete hematopoietic recovery poses a significant life-threatening condition to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication. A presentation titled “Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX-R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study” will be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine, Case Western Reserve University, and Member of the study's Steering Committee at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020. Is New 90 Day High Low • Nov 11
New 90-day low: €7.20 The company is down 3.0% from its price of €7.45 on 12 August 2020. The German market is flat over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €58.72 per share. Analyst Estimate Surprise Post Earnings • Nov 07
Revenue in line with expectations Revenue was in line with analyst estimates. Over the next year, revenue is forecast to grow 45,517%, compared to a 321% growth forecast for the Biotechs industry in Germany. Recent Insider Transactions • Oct 30
Insider recently bought €158k worth of stock On the 29th of October, Adi Wolf bought around 20k shares on-market at roughly €7.89 per share. In the last 3 months, they made an even bigger purchase worth €1.7m. Insiders have collectively bought €11m more in shares than they have sold in the last 12 months. Duyuru • Oct 14
Pluristem Announces Clearance to Move Forward with Enrollment for Cohort II in an Investigator-Led Phase I/II Chronic Graft vs Host Disease Study Pluristem Therapeutics Inc. announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center. Is New 90 Day High Low • Oct 07
New 90-day high: €9.40 The company is up 21% from its price of €7.80 on 09 July 2020. The German market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €66.22 per share. Duyuru • Oct 07
Pluristem Expands its Phase II COVID-19 European Clinical Trial to Israel Pluristem Therapeutics Inc. announced that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency. A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany. The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem’s other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration’s (FDA) approved protocol, and a per-patient compassionate use program in Israel. The primary efficacy endpoint of the Phase II European study titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLXPAD for the Treatment of severe COVID-19” is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52. Duyuru • Oct 03
Abu Dhabi Stem Cells Center and Pluristem Unveil Joint Projects At Malta Conferences Foundation Online Event On September 30, 2020, Pluristem Therapeutics Inc. and the Abu Dhabi Stem Cells Center (ADSCC) unveiled their first joint projects in a presentation at the Malta Conferences Foundation. The first joint project brings together the expertise of Pluristem and ADSCC to advance a potential COVID-19 treatment. The project will involve the first-time administration of Pluristem’s PLX cells via a nebulizer, a drug delivery device that helps a patient inhale medication through a mask or mouthpiece, to COVID-19 patients. The collaboration allows ADSCC to expand their stem cell therapy options using Pluristem’s PLX cells, while enabling Pluristem to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells. ADSCC has reported effectively using nebulizers to treat COVID-19 patients with stem cells sourced from the patient’s own blood. Further discussions for additional projects are underway, including for potential collaboration in chronic Graft Versus Host Disease (cGvHD), a life-threatening immune response of the donor’s stem cells against the host (patient). The parties presented the joint projects to a distinguished audience at the MCF, including Nobel Laureates, scientists, and diplomats. The foundation’s mission is to address the shared desire to improve quality of life and political stability in the Middle East by identifying opportunities for collaboration to meet the scientific and technological challenges of the region. Recent Insider Transactions • Sep 27
Insider recently bought €269k worth of stock On the 24th of September, Adi Wolf bought around 35k shares on-market at roughly €7.74 per share. In the last 3 months, they made an even bigger purchase worth €1.4m. Insiders have collectively bought €8.8m more in shares than they have sold in the last 12 months.