Orgenesis

Orgenesis, Inc. is a biotechnology company, which engages in the development, manufacturing and provision of technologies and services in the cell and gene therapy industry. It operates through the Contract Development and Manufacturing Organization (CDMO) and Point-Of-Care Cell Therapy (POC) segments. The CDMO segment, through MaSTherCell, consists of services from cell therapy development through cell therapy manufacturing and companies that provide an end-to-end solution. The POC segment provides a multitude of cell therapies including, but not limited to, cell-based immunotherapies, therapeutics for metabolic diseases, neurodegenerative diseases and tissue regeneration. The company was founded by Sarah Ferber on June 5, 2008 and is headquartered in Germantown, MD.

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Orgenesis, Inc. is a biotechnology company, which engages in the development, manufacturing, and provision of technologies, and services in the cell and gene therapy industry. It operates through the Morgenesis and Therapies segments. The Morgenesis segment refers to the POCare services. The Therapies segment is involved in therapeutic development operations. The company was founded by Sarah Ferber on June 5, 2008 and is headquartered in Germantown, MD.

Orgenesis' CD19 CAR-T therapy, ORG-101, had a complete  response (CR) of 82% in adults and 93% in pediatric patients with the incidence of severe Cytokine Release Syndrome (CRS) of 2% in adult patients and 6% in pediatric patients in a real-world study

Orgenesis Announces Positive Results From a Real-World Study of ORG-101 CAR-T Therapy in Patients with CD19+ Acute Lymphoblastic Leukemia

The strategic alliance aims to drive new-age innovation in wellness & longevity, backed by an investment commitment of up to $10 million over 3 years into both Orgenesis and the newly formed joint venture The strategic alliance aims to drive new-age innovation in wellness & longevity, backed by an investment commitment of up to $10 million over 3 years into both Orgenesis and the newly formed joint venture

Orgenesis Announces Strategic Partnership with Harley Street Healthcare Group to Launch a State-of-the-Art Longevity & Wellness Initiative Globally

Accelerates rollout of POCare platform following partnership agreement with Germfree and acquisition regaining full ownership and control over Octomera Accelerates rollout of POCare platform following partnership agreement with Germfree and acquisition regaining full ownership and control over Octomera

Orgenesis Provides Business Update for the First Quarter of 2024

M ajor transformation underway commencing with recent acquisition reasserting full ownership and control over Octomera

Orgenesis Provides Year End Business Update

ORMOND BEACH, Fla. and GERMANTOWN, Md., April 10, 2024 (GLOBE NEWSWIRE) -- Germfree, a leading innovator in modular cleanroom infrastructure and services, and Orgenesis Inc. (Nasdaq: ORGS), a global leader in decentralizing cell and gene therapies (CGTs), today announced an asset purchase and strategic partnership aimed at advancing Orgenesis' therapeutic programs and its suite of product development and GMP cell processing services. The collaboration's goal is to transform the production of cell and gene therapies, making these vital treatments more affordable and accessible to patients worldwide.

Germfree and Orgenesis Announce Asset Purchase and Strategic Partnership Intended to Revolutionize Cell and Gene Therapy Through Decentralized Production and Global Accessibility

GERMANTOWN, Md., March 18, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralizing cell and gene therapies (CGTs), today announced that its CEO, Vered Caplan, will be presenting at the upcoming Bioprocessing Summit Europe. The conference, renowned for gathering leading professionals to advance the manufacturing and quality control of biological and genetic therapies, will take place in Barcelona from March 19th to 21st, 2024.

Vered Caplan, CEO of Orgenesis, to Present at the Bioprocessing Summit Europe Conference

GERMANTOWN, Md., March 13, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralizing cell and gene therapies (CGTs), today announced that the Company has been awarded a €1.5 million grant from the Walloon government in Belgium for its EXOFASTTRACK project focused on manufacturing, loading, analytical methods and quality control of therapeutic exosomes. Consortium members include: Orgenesis, Cilyx, CMMI, convExYO, EXO Biologics, ExoXpert, Genflow Biosciences, LiveDrop, ULB, UMONS and Xomexbio. This grant is the second such project awarded to an Orgenesis consortium by the Walloon Government partnership, ATMP-Partenariat d'Innovation Technologique (ATMP-PIT), in collaboration with BioWin, the health cluster of Wallonia, and the Public service of Wallonia.

Orgenesis Consortium Awarded €1.5M EUR Grant from the Walloon Government in Belgium for EXOFASTTRACK Project Dedicated to Accelerated Development of Multiple Therapeutic Exosomes

GERMANTOWN, Md., March 04, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global leader in decentralized cell and gene therapies (CGTs), announced today that it has entered into a definitive securities purchase agreement with certain accredited investors for the sale of 2,272,719 shares of the Company's common stock, warrants to purchase up to 2,272,719 shares of common stock at an exercise price of $1.50 per share and warrants to purchase up to 2,272,719 shares of common stock at an exercise price of $2.00 per share in a private placement at a purchase price of $1.03 per share and associated warrants. The warrants are exercisable immediately and expire five years from the date of issuance. The Company expects to receive gross proceeds of approximately $2.3 million before deducting related offering expenses. The offering is expected to close on or about March 5, 2024, subject to customary closing conditions.

Orgenesis Inc. Announces $2.3 Million Private Placement

GERMANTOWN, Md., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralized cell and gene therapies (CGTs), today announced that the Company's consortium was awarded a €2.0 million grant from the Walloon Government in Belgium, titled: “Monitoring with AI of Decentralized ATMP Manufacturing” (MAIDAM). The consortium members include: Orgenesis Services Belgium, Université catholique de Louvain (UCLouvain) / TRusted AI Labs (TRAIL) and DNAlytics. Advanced Therapy Medicinal Products (ATMPs) are among the most innovative and promising biomedicines designed to address unmet medical needs, including cell, gene, exosome and phage therapies.

Orgenesis Consortium Awarded €2.0M EUR Grant from Walloon Government in Belgium for MAIDAM AI Project for Monitoring Decentralized ATMP Manufacturing

GERMANTOWN, Md., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (Nasdaq:ORGS) (“Orgenesis” or the “Company”), a global leader in decentralizing cell and gene therapies (CGTs), today announced it has entered into a definitive agreement with MM OS Holdings L.P., an affiliate of Metalmark Capital Partners (“Metalmark”), for the acquisition of its approximate 25% stake in Octomera LLC (“Octomera”), the cell processing services subsidiary of the Company, thereby allowing the Company to have 100% ownership of this core strategic business unit. In exchange, Metalmark shall receive a royalty of 5% of the net revenue of Octomera's cell processing services, for the three calendar years 2025-2027, along with a portion of the proceeds attributable to Octomera's cell processing services should there be a change of control in the next 10 years.

Orgenesis Acquires Control of Octomera with the Goal of Progressing its Decentralized Immuno-Oncology Portfolio to Clinic

GERMANTOWN, Md., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today announced it ranked 171 on the Deloitte Technology Fast 500™, a ranking of the fastest-growing technology, media, telecommunications, life sciences, fintech, and energy tech companies in North America, now in its 29th year.

Orgenesis Ranked No. 171st Fastest-Growing Company in North America on the 2023 Deloitte Technology Fast 500 TM

GERMANTOWN, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc.

Orgenesis Provides Business Update for the Third Quarter of 2023

GERMANTOWN, Md., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc. (“Orgenesis”) (Nasdaq: ORGS), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), announced today that it has entered into a securities purchase agreement with a single institutional investor to purchase approximately $1.1 million of its common stock and warrants to purchase common stock in a registered direct offering. The combined effective purchase price for each share of common stock and associated warrant to purchase one share of common stock will be $0.78.

Orgenesis Inc. Announces Pricing of $1.1 Million Registered Direct Offering

GERMANTOWN, Md., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today announced that it has withdrawn its previously announced proposed underwritten public offering of securities due to market conditions.

Orgenesis Announces Withdrawal of Proposed Public Offering

GERMANTOWN, Md., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today announced it has commenced an underwritten public offering. Orgenesis intends to use the net proceeds from the offering for working capital and general corporate purposes.

Orgenesis Announces Proposed Underwritten Public Offering

Reports Progress in Advancing the Rollout of the POCare Platform  and POCare Therapeutic Pipeline Orgenesis to Host Conference Call Today at 8:00 AM ET GERMANTOWN, Md., Aug. 11, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc.

Orgenesis Provides Business Update for Second Quarter of 2023

GERMANTOWN, Md., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today announced that it will host a conference call at 8:00 AM Eastern Time on Friday, August 11, 2023, to discuss the company's corporate progress and other developments.

Orgenesis Schedules Second Quarter 2023 Business Update Conference Call

GERMANTOWN, Md., July 13, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, today announced the appointment of Elliot Maltz as Chief Financial Officer, effective September 1, 2023. Mr. Maltz succeeds Mr. Neil Reithinger, who is resigning following years of dedicated service and will remain with the Company until he completes his transition of duties, through September 1, 2023.

Orgenesis Appoints Finance Veteran Elliot Maltz as its Chief Financial Officer

GERMANTOWN, Md. and DAVIS, Calif., June 07, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, and University of California, Davis (UC Davis) , today announce an agreement to roll out proprietary Orgenesis Mobile Processing Units and Labs™ (“OMPULs™”) at medical or academic institutions within the University of California system. The partnership agreement sets out a staged approach through which Orgenesis will install and operate OMPULs™, enabling their proprietary point-of-care (“POCare”) Service Platform to manufacture therapeutics at hospitals throughout California, empowering onsite production for clinical trials like the cell and gene therapies in development at UC Davis Health's Alpha Stem Cell Clinic.

Orgenesis and University of California, Davis Sign Partnership Agreement for Rollout of Cell and Gene Therapy Mobile Processing Units and Labs Throughout California

GERMANTOWN, Md., May 30, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), today announced that cell and gene therapy pioneer Claudia Zylberberg, PhD has been appointed as an independent board member and senior advisor of its Morgenesis LLC (“Morgenesis”) point-of-care (POCare) subsidiary. As founder, board member and former CEO of Akron Bio, Dr. Zylberberg has led Akron Bio to its leadership position among makers of cGMP-compliant ancillary materials, novel products, and tools for advanced and regenerative medicines. She is also a member of the Strategic Advisory Council for the International Society for Cell & Gene Therapy, sits on the boards for Canada's CCRM and the Standards Coordinating Body (SCB) for Regenerative Medicine, and is co-founder and board chair of ARScience Biotherapeutics, a clinical developer of immunomodulators.

Claudia Zylberberg Appointed as Independent Board Member of POCare Business Subsidiary of Orgenesis

Program prepares scientists to meet the accelerating demand for cell and gene therapy expertise across an industry already delivering cures for dangerous diseases Program prepares scientists to meet the accelerating demand for cell and gene therapy expertise across an industry already delivering cures for dangerous diseases

Orgenesis Academy Graduates First Class of Cell and Gene Therapy Experts from theraCell Laboratories-backed Master's Program

GERMANTOWN, Md., May 19, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, today announced that Vered Caplan, CEO of Orgenesis, will be participating in the Benchmark Company's 3rd Annual Healthcare House Call Virtual 1x1 Conference, which will be held on Tuesday, May 23, 2023.

Orgenesis to Participate in Benchmark's 3rd Annual Healthcare House Call Virtual 1x1 Investor Conference on May 23, 2023

GERMANTOWN, Md. and PRAGUE, Czech Republic, May 18, 2023 (GLOBE NEWSWIRE) -- (NASDAQ: ORGS) (“Orgenesis”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) through its US-based point-of-care (POCare) services subsidiary, Morgenesis LLC (“Morgenesis”), has signed a collaboration agreement with SCTbio, a full-service contract development and manufacturing organization (CDMO) specializing in cell-based therapy and viral vectors. The goal of the collaboration is to open new point-of-care (POCare) sites within the Czech Republic and leverage SCTbio's GMP facility for the production of lentivirus vectors to support Morgenesis' POCare worldwide customers, including use in CAR-T cell and gene therapies (CGTs).

Orgenesis Announces Collaboration Agreement with SCTbio to Expand POCare Sites in the Czech Republic and Enhance Capabilities for the Production of Lentivirus Vectors

GERMANTOWN, Md., May 10, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT), today provided a business update for the first quarter ended March 31, 2023.

Orgenesis Provides Business Update for the First Quarter of 2023 and Reports Continued Progress on its POCare Strategy

GERMANTOWN, Md., May 10, 2023 (GLOBE NEWSWIRE) -- Orgenesis Inc . (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) at the point of care, and Metalmark Capital Partners (“Metalmark”), a leading private equity firm with extensive expertise in the healthcare sector, today announced that Metalmark has agreed to make an additional growth investment of $5 million into Orgenesis' US-based point-of-care (POCare) services subsidiary, Morgenesis LLC (“Morgenesis”). This investment follows the previously announced investment of $30 million in November 2022. In addition, Metalmark has committed to investing up to an additional $15 million, subject to the achievement of certain milestones.

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