Orgenesis

growth-positive

Orgenesis Inc. Announces Acquisition of Certain Neurocords LLC Assets, Strengthening its Regenerative Medicine Portfolio with Spinal Cord Injury Therapies

Orgenesis Inc., a global biotech company, has announced the acquisition of certain assets from Neurocords LLC related to advanced regenerative medicine therapies for spinal cord injuries. This strategic acquisition aims to expand access to cost-effective, scalable regenerative medicine treatments. Neurocords technology, which differentiates induced pluripotent stem cells into spinal cord neurons, will be integrated with Orgenesiss decentralized cell processing approach. This integration is expected to enhance production efficiency, reduce treatment costs, and improve patient outcomes. The acquisition aligns with Orgenesiss goal to accelerate the development of transformative technologies for spinal cord injuries and potentially other indications. Neurocords has developed a large clinical network for spinal cord injury treatment, working with partners like the VA to ensure global access to these therapies.

AcquisitionPartners

Jan 28, 2025 ·

growth-positive

Orgenesis Secures Up to $5 Million Equity Investment from Williamsburg Venture Holdings

Orgenesis Inc., a global biotech company, has secured an equity line of credit up to $5 million from Williamsburg Venture Holdings, LLC. This strategic investment will support Orgenesis in advancing its cell and gene therapy initiatives, leveraging its proprietary POCare platform. The agreement provides Orgenesis with $750,000 upon the effectiveness of a registration statement with the SEC, with the remaining $4.25 million available over 24 months. This funding aims to accelerate the development and commercialization of Orgenesis pipeline, aligning with its mission to democratize access to life-saving therapies. The investment reflects confidence in Orgenesis growth potential and commitment to innovative healthcare solutions.

Investment

Nov 13, 2024 ·

growth-positive

Orgenesis Provides Third Quarter 2024 Business Update

Orgenesis Inc., a global biotech company, provided a business update for Q3 2024, highlighting significant progress in cell and gene therapies. The company is focusing on a decentralized approach to make these therapies more accessible and affordable. A recent study of their CD19 CAR-T therapy, ORG-101, showed promising results, with high response rates and low severe side effects. Orgenesis is initiating a Phase 1/2 clinical study in Greece, supported by a grant from Enterprise Greece. The company is expanding its partnership network, including a strategic joint venture with Harley Street Healthcare Group, to introduce wellness services in the UK, UAE, and Canada. This expansion and partnership strategy aims to enhance healthcare innovations and improve quality of life globally.

PartnersExpand

Oct 21, 2024 ·

growth-negative

Orgenesis Commences Trading on OTCQX® Best Market

Orgenesis Inc., a global biotech company, announced its delisting from the Nasdaq Stock Market due to failing to meet the required stockholders’ equity threshold. The companys stock will now trade on the OTCQX® Best Market under the symbol ORGS. Despite the setback, Orgenesis plans to address the equity deficiency and reapply for a Nasdaq listing. The company is focusing on its Decentralized Cell Processing platform, which aims to make cell and gene therapies more accessible and affordable. Orgenesis has established partnerships with hospitals and research institutions worldwide to support its mission. The company believes its innovative platform can drive industry change and create growth opportunities.

Public TradingPartners

Sep 23, 2024 ·

growth-negative

Orgenesis Announces Reverse Stock Split

Orgenesis Inc. announced a 1-for-10 reverse stock split of its common stock, effective September 24, 2024, to regain compliance with Nasdaqs minimum bid price requirement of $1.00 per share. The reverse split will reduce the number of shares from 47,707,849 to approximately 4,770,785 and proportionally reduce the total authorized shares. No fractional shares will be issued; instead, stockholders will receive cash payments for fractions. The companys transfer agent, Securities Transfer Corporation (STC), will manage the exchange process. The reverse split aims to maintain the companys Nasdaq listing and does not alter stockholders percentage ownership, except for fractional shares.

Public Trading

Aug 29, 2024 ·

growth-positive

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

Orgenesis Inc. announced positive clinical trial results for its CD19 CAR-T therapy, ORG-101, showing high complete response rates and a low incidence of severe Cytokine Release Syndrome in both adult and pediatric patients. Encouraged by these results, Harley Street Healthcare Group plans to set up a Global Cancer Initiative in partnership with Orgenesis to democratize advanced therapies and support further clinical development. Orgenesis is leveraging its decentralized production model to reduce costs and improve access to these therapies. The company is preparing for a Phase 1/2 clinical multicenter study, starting in Greece. The announcement highlights Orgenesis commitment to making advanced therapies more accessible and affordable globally.

PartnersExpand

Aug 14, 2024 ·

growth-positive

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

Orgenesis Inc., a global biotech company, has announced a strategic partnership with Harley Street Healthcare Group (HSHG). The partnership aims to accelerate the clinical development and commercialization of advanced wellness and longevity therapies and products to a global customer base. As part of the agreement, a joint venture will be established, with Orgenesis owning 49% and HSHG owning 51%. The JV will focus on launching innovative health and wellness services, including personalized preventative care and regenerative therapies. HSHG has agreed to invest up to $10 million over three years into Orgenesis and the joint venture.

PartnersInvestmentExpand

Aug 8, 2024 ·

growth-positive

Orgenesis Provides Second Quarter 2024 Business Update

Orgenesis Inc., a global biotech company, has announced the acquisition of GMP-validated platforms for launching proprietary CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes. The acquisition is part of the companys efforts to improve access and outcomes in healthcare through cell and gene therapies. The company also provided a business update for Q2 2024, highlighting its efforts to integrate its capabilities into a decentralized platform and form partnerships to develop a wide range of therapies. The financial results for Q2 2024 are available in the companys Form 10-Q.

AcquisitionExpand

May 21, 2024 ·

growth-positive

Orgenesis Provides Business Update for the First Quarter of 2024

Orgenesis Inc. has announced a partnership with Germfree and the acquisition of full ownership of Octomera. The partnership with Germfree will allow Orgenesis to access Germfrees global network and customer base, accelerating the rollout of its POCare platform. The acquisition of Octomera gives Orgenesis full control over its strategic CGT processing subsidiary. The company also received investments of approximately $2.5 million from a group of accredited investors. Additionally, shareholders agreed to exchange approximately $16 million of debt for 15.8 million shares of common stock.

PartnersAcquisitionInvestment

Apr 15, 2024 ·

growth-positive

Orgenesis Provides Year End Business Update

Orgenesis Inc., a global biotech company, has announced a business update for the year ended December 31, 2023. The company has recently reasserted full ownership and control over Octomera and secured a $2.3 million investment from a group of healthcare professionals. Orgenesis has also entered into an asset purchase and strategic collaboration agreement which will provide Octomera with over $8 million of initial collaboration payments. The company is focusing on advancing its cell and gene therapies (CGTs) towards commercialisation.

InvestmentAcquisitionPartners

Apr 10, 2024 ·

growth-positive

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

Orgenesis Inc. and Germfree have 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 seeks to significantly reduce the production costs of cell and gene therapy products, making these treatments more affordable and accessible to patients worldwide. Germfree will be marketing, manufacturing, and servicing Orgenesis’ decentralized Octomera service platform and its Octomera Mobile Processing Units and Labs (OMPULs) globally.

Partners

Mar 18, 2024 ·

Growth-Positive

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

Orgenesis Inc., a global leader in decentralizing cell and gene therapies (CGTs), announced that its CEO, Vered Caplan, will be presenting at the Bioprocessing Summit Europe. The conference is known for gathering leading professionals to advance the manufacturing and quality control of biological and genetic therapies. Caplan will discuss how the Company’s POCare solutions can overcome conventional CGT processing challenges and enable standardization. The focus will be on closed, automated, and reproducible processes to bring treatments closer to patients, making these innovative therapies more affordable and accessible worldwide.

Management Changes

Mar 13, 2024 ·

growth-positive

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

Orgenesis Inc. has been awarded a €1.5 million grant from the Walloon government in Belgium for its EXOFASTTRACK project, which focuses on the manufacturing and quality control of therapeutic exosomes. The project is a collaboration with several consortium members including Cilyx, CMMI, convExYO, EXO Biologics, ExoXpert, Genflow Biosciences, LiveDrop, ULB, UMONS and Xomexbio. Orgenesis role in the consortium is to develop a therapeutic candidate composed of exosomes derived from adipose tissue MSC loaded with an active compound and/or fused with Bioxomes™ to treat skin ulcers.

InvestmentPartners

Mar 4, 2024 ·

growth-positive

Orgenesis Inc. Announces $2.3 Million Private Placement

Orgenesis Inc., a global leader in decentralized cell and gene therapies, has announced a securities purchase agreement with certain accredited investors. The agreement involves the sale of over 2 million shares of the companys common stock and warrants, with an expected gross proceed of approximately $2.3 million. The offering is expected to close on March 5, 2024. The financing includes participation from healthcare industry executives and physicians. The securities to be sold in this private placement will not be registered under the Securities Act of 1933.

Investment

Feb 29, 2024 ·

growth-positive

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

Orgenesis Inc., a global leader in decentralized cell and gene therapies, has been awarded a €2.0 million grant from the Walloon Government in Belgium. The grant is for the project Monitoring with AI of Decentralized ATMP Manufacturing (MAIDAM), which aims to develop AI-based approaches for monitoring and improving decentralized manufacturing processes for Advanced Therapy Medicinal Products (ATMPs). The project is a part of the ATMP-Partenariat d’Innovation Technologique (ATMP-PIT) initiative, which has a budget of €81 million over three years and aims to stimulate Wallonia’s advanced therapy medicines sector.

InvestmentPartnersExpand

Jan 31, 2024 ·

growth-positive

EXCLUSIVE: Orgenesis Acquires Control of Octomera, Takes One Step Closer To Progressing Its Decentralized Immuno-Oncology Portfolio To Clinic

Orgenesis Inc has acquired a 25% stake in its subsidiary, Octomera, from MM OS Holdings, an affiliate of Metalmark Capital Partners. This acquisition gives Orgenesis full ownership of Octomera, a cell processing services unit. In return, Metalmark will receive a 5% royalty on Octomeras net revenue from 2025 to 2027 and a portion of proceeds if theres a change of control within ten years. The acquisition aligns with Orgenesiss strategy to advance its decentralized immuno-oncology portfolio, supported by regulatory initiatives from FDA and EMEA. The move is seen as a step towards addressing cost pressures and capacity constraints in healthcare.

Acquisition

Jan 31, 2024 ·

Growth-Positive

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

Orgenesis Inc. has announced a definitive agreement with MM OS Holdings L.P., an affiliate of Metalmark Capital Partners, for the acquisition of its approximate 25% stake in Octomera LLC, the cell processing services subsidiary of the company. This will allow Orgenesis to have 100% ownership of this core strategic business unit. In exchange, Metalmark will 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.

AcquisitionManagement Changes

Jan 31, 2024 ·

growth-positive

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

Orgenesis Inc. has acquired a 25% stake in its subsidiary, Octomera LLC, from Metalmark Capital Partners, gaining full ownership of this strategic business unit. In return, Metalmark will receive a 5% royalty on Octomeras net revenue from 2025 to 2027 and a share of proceeds if theres a change of control within the next decade. The acquisition aligns with Orgenesiss strategy to advance its decentralized cell therapy approach, which is gaining traction due to cost pressures and regulatory support. The company is also progressing in developing its oncology therapeutics, emphasizing decentralized GMP production and proof of concept.

Acquisition

Jan 31, 2024 ·

growth-positive

EXCLUSIVE: Orgenesis Acquires Control of Octomera, Takes One Step Closer To Progressing Its Decentralized Immuno-Oncology Portfolio To Clinic

Orgenesis Inc has entered into an agreement with MM OS Holdings, an affiliate of Metalmark Capital Partners, to acquire its approximate 25% stake in Octomera, Orgenesiss cell processing services subsidiary. This transaction will give Orgenesis 100% ownership of Octomera. In return, Metalmark will receive a royalty of 5% of the net revenue of Octomeras cell processing services for the years 2025-2027, along with a portion of the proceeds should there be a change of control in the next ten years.

Acquisition

Nov 22, 2023 ·

Growth-Negative

Analysts Expect Orgenesis Inc. (NASDAQ:ORGS) To Breakeven Soon

Orgenesis Inc., a biotech company, has recently announced a loss of US$15m in the full financial year, with the latest trailing-twelve-month loss of US$25m. This has moved the company further away from breakeven. However, analysts predict that the company will incur a final loss in 2022, before generating positive profits of US$5.5m in 2023. The company is expected to breakeven within a year. However, the companys debt-to-equity ratio of 172% is a concern, as it significantly overshoots the typical 40% limit.

Investment

Nov 14, 2023 ·

growth-positive

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

Orgenesis Inc., a global biotech company specializing in cell and gene therapies, has been ranked 171 on the Deloitte Technology Fast 500, a list of the fastest-growing technology companies in North America. The companys CEO, Vered Caplan, expressed pride in the recognition and highlighted the companys efforts to decentralize the manufacturing of advanced cell and gene therapies. The companys approach has reportedly led to lower costs, streamlined logistics, and expanded capacity, gaining traction in the market. Orgenesis continues to focus on making cell and gene therapies more accessible and cost-effective for patients.

CustomersPartners

Nov 13, 2023 ·

growth-positive

Orgenesis Provides Business Update for the Third Quarter of 2023

Orgenesis Inc., a global biotech company, provided a business update for Q3 2023, highlighting the advancement of its POCare Platform and POCare Therapies. The company is expanding its network of hospitals and healthcare providers across the U.S., Europe, the Middle East, and other regions. It also expanded its partnership with California Davis (UC Davis) through California Institute of Regenerative Medicine (CIRM) grant funding. The companys financial results for Q3 2023 are available on its website. The company deconsolidated Octomera on June 30, 2023, but still holds a 75% stake in the business.

PartnersExpand

Nov 13, 2023 ·

growth-positive

Orgenesis Provides Business Update for the Third Quarter of 2023

Orgenesis Inc., a global biotech company, is advancing the rollout of its POCare Platform and therapies, focusing on a decentralized network to deliver cell and gene therapies. The company has expanded its partnership with UC Davis through CIRM grant funding to streamline CGT product production in California. Orgenesis aims to deploy Octomera Mobile Processing Units & Labs in California and has entered an agreement with CGT Global to accelerate CGT research and clinical trials in the U.S. The company is also advancing its therapeutic pipeline across various medical fields. Despite deconsolidating Octomera, Orgenesis still holds a 75% stake, with Octomera recognizing $2.7 million in revenue. The companys strategy includes leveraging government grants and regional partnerships to support its scalable business model.

Partners

Nov 8, 2023 ·

growth-positive

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

Orgenesis Inc., a global biotech company, has announced a securities purchase agreement with an institutional investor to purchase approximately $1.1 million of its common stock and warrants. The company will issue 1,410,256 shares of common stock and warrants to purchase up to an aggregate of 1,410,256 shares of common stock. The offering is expected to close on November 9, 2023. Titan Partners Group, a division of American Capital Partners, is acting as the sole placement agent for the offering.

Investment

Nov 2, 2023 ·

growth-positive

Orgenesis Announces Expanded Partnership Between Octomera and UC Davis Through CIRM Grant Funding

Orgenesis Inc., a global biotech company, has announced the progression of its Point of Care (POCare) network and infrastructure for advanced therapeutic services and facilities through its subsidiary Octomera. The company has partnered with the University of California Davis, following a $1.7 million grant from the California Institute of Regenerative Medicine. The partnership aims to standardize Good Manufacturing Practice (GMP) manufacturing capabilities across California and create a network to harmonize operations. The collaboration between UC Davis and Orgenesis began in 2020 and has continued to evolve into 2023.

PartnersInvestmentExpand

Oct 31, 2023 ·

growth-negative

Orgenesis Announces Withdrawal of Proposed Public Offering

Orgenesis Inc., a global biotech company, has withdrawn its previously announced proposed underwritten public offering of securities due to market conditions. The company, which is working to unlock the full potential of cell and gene therapies, made the announcement on October 30, 2023. The press release also included information about the companys history and its forward-looking statements.

Public Trading

Oct 30, 2023 ·

Growth-Positive

Orgenesis Announces Proposed Underwritten Public Offering

On October 30, 2023, Orgenesis Inc., a global biotech company, announced the commencement of an underwritten public offering. The company plans to use the net proceeds from the offering for working capital and general corporate purposes. EF Hutton, a division of Benchmark Investments, LLC, is acting as the sole book-running manager for the offering. The offering consists of units of common stock and warrants to purchase common stock. The offering is being made pursuant to a shelf registration statement on Form S-3, which was filed with the U.S. Securities and Exchange Commission (SEC) and declared effective by the SEC on April 7, 2021.

Public TradingInvestment

Sep 21, 2023 ·

growth-positive

CGT Global and Octomera Enter Agreement to Expand Cell & Gene Therapy Development and Patient Access Across the United States

Orgenesis Inc., a global biotech company, is expanding its Point of Care (POCare) network and infrastructure through its subsidiary Octomera by partnering with CGT Global. The partnership aims to leverage CGT Global’s network of CGT Clinics and Healthcare partnerships to expand the commercialization of cell and gene therapies (CGTs) in California and other US locations. The collaboration will also involve the placement of Octomera Mobile Processing Units & Labs (OMPULs) for leukapheresis and the production of CAR-T and TILS products. The company expects to grow its footprint as CGT Global partners with more hospitals.

PartnersExpand

Sep 6, 2023 ·

growth-positive

Cell and Gene Therapy Industry Pioneer & GMP Expert, Gerhard Bauer, Joins Orgenesis Business, Octomera, to Drive Continued Expansion of POCare Facilities and Service Support

Orgenesis, a global biotech company, has appointed Gerhard Bauer as the Vice President of Global Product Implementation at Octomera, its advanced therapeutic POCare services and facilities supply business. Bauers role will be to enhance the process development, regulatory, engineering, equipment, and data/technical service offering and POCare Center hubs. He will also contribute to the evolution of the flexible facilities format, Octomera Mobile Process Labs & Units (OMPULs) and network. The move is part of Orgenesis mission to decentralize access to advanced medicines and streamline cell and gene therapy production.

Management ChangesExpand

Aug 28, 2023 ·

growth-negative

Is Orgenesis (ORGS) Too Good to Be True? A Comprehensive Analysis of a Potential Value Trap

Orgenesis Inc, a biotech company focused on cell and gene therapies, has caught the attention of value-focused investors. The stock has recently experienced a single-day gain of 14.61% but has seen a 3-month decrease of 60.35%. The stocks fair valuation, as indicated by its GF Value, is $3.83. However, investors should consider the risk factors associated with Orgenesis, such as its low Altman Z-score and Beneish M-Score, which suggest potential financial distress and earnings manipulation. Despite its apparent undervaluation, Orgenesis may be a potential value trap. Thorough due diligence is important before making an investment decision. Orgenesis operates in the biotech industry, focusing on autologous therapies and utilizing closed and automated processing systems for compliant production near the patient. The article warns investors to be cautious about the stocks true value.

Investment

Aug 28, 2023 ·

growth-negative

Orgenesis Inc (ORGS): A Deep Dive into Its Performance Potential

Orgenesis Inc, a biotech company, is facing potential headwinds according to the GuruFocus Score Rating. The companys rankings in financial strength, growth, and valuation have diminished, suggesting it may not live up to its historical performance. The GF Score, a stock performance ranking system, assigned Orgenesis Inc a score of 55 out of 100, indicating poor future outperformance potential. The companys financial strength indicators, such as interest coverage ratio and Altman Z-Score, raise concerns about its balance sheet health and potential financial distress. Additionally, Orgenesis Incs profitability has been low, with a declining gross margin over the past five years. Investors are advised to exercise caution and conduct further research before making investment decisions.

Financial StrengthProfitability

Aug 23, 2023 ·

growth-negative

Orgenesis (ORGS): A Value Trap in Disguise?

The article discusses Orgenesis Inc (NASDAQ:ORGS) as a potential value trap due to its low stock price compared to its intrinsic value and various financial risk factors. The companys Altman Z-score and Beneish M-Score suggest potential financial distress. Key drivers such as declining liquidity, diminishing ability to reinvest profits, rising days sales outstanding, contracting gross margin, and asset quality issues raise concerns about the companys true value and risk profile. Investors are advised to exercise caution and conduct thorough due diligence before investing in Orgenesis.

Investment

Aug 12, 2023 ·

growth-positive

Q2 2023 Orgenesis Inc Earnings Call

Orgenesis Inc., a biotech company, has reported revenue of approximately $7 million in the second quarter of 2023. The companys point-of-care services business has been rebranded to Okta mail, reflecting its focus on providing standardized decentralized, cost-effective development and production of advanced cell and gene therapies. The expansion of the point-of-care strategy has been enabled by recent investments from Metalmark Capital. The company is also expanding to new customers and moving to more advanced clinical stages among existing ones. Orgenesis has also developed additional assets that are positioned to be integrated into a decentralized model.

InvestmentExpand

Aug 11, 2023 ·

growth-positive

Orgenesis Provides Business Update for Second Quarter of 2023

Orgenesis Inc., a global biotech company, has reported a revenue of approximately $7.0 million for Q2 2023, reflecting the ongoing rollout of their POCare platform. The company recently rebranded the POC Services business from Morgenesis to Octomera, following an additional investment from MM OS Holdings, an affiliate of Metalmark Capital Partners. Orgenesis also announced a partnership with the University of California, UC Davis, to deploy Octomera Mobile Processing Units and Labs. The company is also advancing its POCare therapeutic pipeline by leveraging grants and partnerships.

InvestmentPartners

Aug 10, 2023 ·

Neutral

Orgenesis Schedules Second Quarter 2023 Business Update Conference Call

Orgenesis Inc., a global biotech company specializing in cell and gene therapies, has announced a conference call to discuss the companys corporate progress and other developments. The call will take place at 8:00 AM Eastern Time on Friday, August 11, 2023. Orgenesis has been committed to unlocking the potential of decentralized cell and gene therapies since 2012 and established the POCare Network in 2020 to make these innovations more affordable and accessible to patients.

Management Changes

Jul 13, 2023 ·

growth-positive

Orgenesis Appoints Finance Veteran Elliot Maltz as its Chief Financial Officer

Orgenesis Inc., a global biotech company, has announced the appointment of Elliot Maltz as Chief Financial Officer, effective from September 1, 2023. Maltz, who has 16 years of experience in accounting and corporate finance, will succeed Neil Reithinger. Reithinger is resigning after years of service but will remain with the company until he completes his transition of duties. Maltz previously served as the CFO of Gelesis, Inc., a commercial stage biotherapeutics company.

Management Changes

Jul 11, 2023 ·

growth-positive

Orgenesis Announces Name Change of Morgenesis Business Unit to Octomera

Orgenesis Inc. has announced the rebranding of its POC Services business, Morgenesis, to Octomera. The name change reflects the companys growth and focus on advanced cell and gene therapy (CGT) services, facilities, and technologies. Additionally, MM OS Holdings, an affiliate of Metalmark Capital Partners, has invested additional funds into Octomera for the continued development of POCare Centers with a focus on expanding in the US market. Octomera aims to change the paradigm of centralized CGT production to produce treatments in a decentralized manner.

InvestmentPartners

Jun 15, 2023 ·

growth-positive

Orgenesis Inc. (NASDAQ:ORGS) On The Verge Of Breaking Even

Orgenesis Inc., a biotech company, is expected to reach breakeven in 2023 according to industry analyst expectations. The company posted a loss in its most recent financial year and has a low debt obligation. Analysts anticipate a growth rate of 142% year-on-year for Orgenesis to achieve profitability. The article advises readers to conduct a deeper analysis of the companys historical track record and management team. It also mentions that the article is not intended to be financial advice.

Investment

Jun 7, 2023 ·

growth-positive

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

Orgenesis Inc. has announced a partnership with the University of California, Davis to roll out its proprietary Orgenesis Mobile Processing Units and Labs (OMPULs) at medical or academic institutions within the University of California system. This partnership will enable the development and manufacture of cell and gene therapies at hospitals throughout California, with the goal of decentralizing the process and making therapies more accessible. The first OMPUL will be established at UC Davis, followed by placement at other healthcare sites in California. The agreement was signed by Orgenesis POC CA Inc. and The Regents of the University of California. This partnership is expected to have a positive impact on Orgenesis growth.

PartnersCustomers

May 30, 2023 ·

growth-positive

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

Orgenesis Inc. has appointed Claudia Zylberberg as an independent board member and senior advisor of its Morgenesis LLC subsidiary. Zylberberg, a cell and gene therapy pioneer, will guide Morgenesis in delivering point-of-care therapies. The company aims to bring novel technologies and a range of point-of-care services to patients globally. Earlier this month, Morgenesis secured additional funding of $35 million from Metalmark Capital Partners. Orgenesis is a global biotech company focused on unlocking the full potential of cell and gene therapies.

Partners

May 22, 2023 ·

growth-positive

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

Orgenesis Inc. has announced the first graduating class from its Master of Science degree program in Cell and Gene Therapies. The program, sponsored by the companys joint venture theraCell Laboratories, aims to develop scientists with the knowledge and skills to meet the increasing demand in the field of cell and gene therapies. The majority of the graduates have already received job offers and progressed their careers in the field. The program is part of The Orgenesis Academy, which is a global initiative to train experts in the field. The company is proud of the graduates and sees this as an opportunity to improve access to advanced therapies and meet the high unmet medical needs of patients.

Expand

May 19, 2023 ·

growth-positive

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

Orgenesis Inc. announced that its CEO will be participating in the Benchmark Companys 3rd Annual Healthcare House Call Virtual 1x1 Conference. The conference offers one-on-one and small-group virtual meetings with the management of over 40 small and mid-sized healthcare companies. Orgenesis is a global biotech company focused on unlocking the full potential of cell and gene therapies in an affordable and accessible format at the point of care. The companys POCare Platform consists of licensed POCare Therapeutics processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. The POCare Network brings together patients, doctors, industry partners, research institutes, and hospitals to achieve harmonized, regulated clinical development and production of therapies.

Partners

May 18, 2023 ·

growth-positive

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

Orgenesis has signed a collaboration agreement with SCTbio to open new point-of-care (POCare) sites in the Czech Republic and utilize SCTbios GMP facility for the production of lentivirus vectors. The collaboration aims to support Orgenesis POCare worldwide customers, particularly in CAR-T cell and gene therapies. SCTbio brings expertise in retroviral vector GMP production. The partnership reflects Orgenesis commitment to bringing breakthrough cell therapies to market in a cost-effective and scalable manner. The collaboration is expected to have a positive impact on Orgenesis growth.

Partners

May 10, 2023 ·

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

May 10, 2023 ·

Orgenesis Secures an Additional $5 Million Investment from Metalmark Capital to Accelerate Growth of Point-of-Care Service Subsidiary

Apr 25, 2023 ·

Orgenesis CEO Vered Caplan Featured in Keynote Series at INTERPHEX Conference to Discuss Innovations in Cell & Gene Therapy Manufacturing

Apr 19, 2023 ·

Orgenesis Inc.'s (NASDAQ:ORGS) Share Price Is Matching Sentiment Around Its Revenues

Mar 24, 2023 ·

Orgenesis Inc. (NASDAQ:ORGS) Q4 2022 Earnings Call Transcript

Mar 22, 2023 ·

Q4 2022 Orgenesis Inc Earnings Call

Mar 21, 2023 ·

Orgenesis Reports 98% Year-Over-Year Increase in Revenue to $13.6 Million for the Fourth Quarter of 2022

Mar 19, 2023 ·

www.biopharma-reporter.com

growth-positive

Orgenesis and UC Davis partner on decentralized development and manufacturing of CGTs

Orgenesis has signed a memorandum of understanding with UC Davis to establish and validate mobile processing units and labs (OMPULs) for the development and manufacture of cell and gene therapies. The partnership aims to decentralize manufacturing and reduce the costs of developing these therapies. The first stage involves establishing an OMPUL at UC Davis, followed by the development of a decentralized model for OMPUL placement at other healthcare sites in California. The collaboration builds on UC Davis previous agreement to join Orgenesis POCare Network and utilize its POCare Platform for the development and supply of cell and gene products and therapies. The partnership could enable the development of CGTs for patients across a range of conditions at a cost supported by payers and society.

PartnersExpand

Mar 17, 2023 ·

Orgenesis Schedules Fourth Quarter 2022 Business Update Conference Call

Mar 16, 2023 ·

Orgenesis Signs MOU with University of California, Davis to Develop a Collaboration Agreement to Deploy Cell and Gene Therapy Mobile Processing Units and Labs Across California

Feb 27, 2023 ·

Orgenesis Inc. Announces Closing of $3.7 Million Registered Direct Offering

Feb 23, 2023 ·

Orgenesis Inc. Announces Pricing of $3.7 Million Registered Direct Offering

Jan 4, 2023 ·

Investors in Orgenesis (NASDAQ:ORGS) have unfortunately lost 73% over the last five years

Dec 20, 2022 ·

Orgenesis and Kurve Therapeutics Announce Pre-Clinical Study Results for a Cell-Based Oncolytic Virus Bearing Product Demonstrating Over 50% Reduction in a Murine Glioblastoma Model

Nov 16, 2022 ·

Orgenesis Third Quarter 2022 Earnings: Revenues Beat Expectations, EPS Lags

Nov 12, 2022 ·

Loss-Making Orgenesis Inc. (NASDAQ:ORGS) Expected To Breakeven In The Medium-Term

Dec 3, 2020 ·

https://www.proactiveinvestors.com/companies/news/935582/orgenesis-leads-the-charge-at-an-exciting-time-for-cell-and-gene-therapy-935582.html

Nov 17, 2020 ·

www.biopharma-reporter.com

growth-positive

Orgenesis CEO talks disruption: 'We are the Uber of the cell and gene therapy space'

Orgenesis, a Maryland-based company, is championing a decentralized model for the development and commercialization of cell and gene therapies. The company works with partner hospitals to prepare precision medicines on-site, aiming to make these therapies accessible to large populations. Orgenesis has created an international network of point-of-care (POCare) centers in the US, Europe, Israel, South Korea, and India. The companys goal is to provide a solution for hospitals to offer gene and cell therapies, reducing costs and increasing efficiency. Orgenesis has developed a customized, automated processing system that simplifies facility management, reduces technical staffing, and eliminates logistical difficulties. The company has also signed contracts with partners, which are expected to generate over $40 million in revenue over the next three years. Orgenesis is focused on immuno-oncology, anti-viral, and metabolic/auto-immune diseases.

CustomersPartnersInvestment

Feb 19, 2020 ·

Orgenesis teams up with Johns Hopkins University to develop gene therapies with its POCare platform

Jun 17, 2019 ·

growth-positive

Orgenesis Granted FDA Orphan Drug Designation for Autologous Insulin Producing Cells in the Treatment of Severe Hypoglycemia-Prone Diabetes Resulting from Total Pancreatectomy

Orgenesis Inc. has received Orphan Drug designation from the FDA for its Autologous Insulin Producing (AIP) cells as a cell replacement therapy for severe hypoglycemia-prone diabetes resulting from total pancreatectomy (TP) due to chronic pancreatitis (CP). The designation is expected to reduce the time and costs required to bring the therapy to market. Orgenesis has developed a transdifferentiation process and Point of Care (POCare) liver expansion technology to transform liver cells into AIP cells. The cells are derived from the patients liver cells and expanded in a liver cell bank. They can be converted into functional glucose-regulated AIP cells and returned to the patients liver via a transfusion. The goal is to provide a long-term insulin independence without the need for immunosuppressive therapy. Orgenesis operates in the biotechnology industry and has two platforms: POCare cell therapy and Contract Development and Manufacturing Organization (CDMO).

CustomersPartners

Apr 30, 2019 ·

growth-positive

Orgenesis Announces Planned Study to Confirm Suitability of Liver Cells as a Source for Personalized Cell Replacement Therapy for Insulin-Dependent Diabetic Patients

Orgenesis Inc. has received Institutional Review Board (IRB) approval to collect liver biopsies from patients at Rambam Medical Center in Israel for a study on personalized cell replacement therapy for patients with insulin-dependent diabetes. The goal of the study is to confirm the suitability of liver cells for this therapy and evaluate patients immune response. The study will enroll 20 patients and is expected to commence in May 2019. If successful, this study could represent a major milestone for Orgenesis and transformative for patients worldwide.

Customers

Apr 22, 2019 ·

growth-positive

Orgenesis Announces Collaboration Agreement with Columbia University to Develop Cellular Vaccination Product Platform for Pancreatic, Hepatic and Cholangiocarcinoma Cancers

Orgenesis Inc. has entered into an agreement with Columbia University to fund research for the development of a cellular vaccination product platform for pancreatic, hepatic, and cholangiocarcinoma cancers. The company will receive an exclusive license on the technology developed at Columbia University. The patented dual-vaccine design uses whole cancer cells as a source of antigens and the patients immune cells to present the cancer antigens to the immune system. This approach aims to boost the immune system and direct it against cancer cells. The vaccine has the potential to treat various types of solid tumors and offers a promising approach with ease of administration and minimal side effects. The partnership with Columbia University is a growth-positive move for Orgenesis Inc.

Partners

Apr 11, 2019 ·

growth-positive

Orgenesis Announces Collaboration and License Agreement for Exosome-Related Technologies with ExcellaBio

Orgenesis Inc. has entered into a Collaboration and Licensing Agreement with ExcellaBio Ltd. for certain technologies developed by Sabina Glozman, Ph.D. The agreement grants Orgenesis exclusive, worldwide rights to certain commercial applications of the technology. The technology includes an exosome-like membrane nanostructure (Bioxome™) and related processes for the production of exosomes/extracellular vesicles (EVs). The collaboration aims to enhance the development of exosome/EV technology for various indications, such as liver fibrosis, aesthetic indications, CNS disorders, and other medical conditions. Orgenesis operates through two platforms: a point-of-care cell therapy platform and a Contract Development and Manufacturing Organization platform. The companys goal is to bring Advanced Therapy Medicinal Products (ATMPs) to patients through collaborations, in-licensing, and out-licensing with regional partners. The collaboration with ExcellaBio has the potential to significantly impact Orgenesis growth in the cell therapy industry.

Partners

Apr 4, 2019 ·

growth-positive

Orgenesis Announces Collaboration with Digilab to Develop Industrial 3D Printing Capability for Cellular Structures and Tissues for Clinical Use

Orgenesis Inc. has entered into a collaboration agreement with Digilab Inc. to develop a live cell printing process and systems for the production of three-dimensional live cellular structures and tissues. Orgenesis will co-develop the process and systems and have exclusive rights to utilize, market, and distribute the new cell printer systems and related products. The collaboration aims to automate the production of complex cell structures and full organs, with an initial focus on liver and liver-derived cells. The technology being developed by Orgenesis and Digilab has the potential to transform the cell therapeutics service industry. The collaboration further demonstrates Orgenesis commitment to developing cutting-edge technologies for cell and gene therapy applications.

Partners

Apr 3, 2019 ·

growth-positive

Orgenesis Announces Publication of an Independent Study "The Role of The Vasculature Niche on Insulin Producing Cells Generated by Transdifferentiation of Adult Human Liver Cells" in the Stem Cell Research and Therapy Journal

Orgenesis Inc., a developer of advanced cell therapies, announced the publication of an independent study on the role of the vasculature niche on insulin producing cells. The study demonstrated that co-implantation of mesenchymal stem cells and endothelial colony forming cells with autologous insulin producing cells led to increased survival rates and insulin production. The study validates the transdifferentiation process and highlights the importance of vasculature in generating regenerative properties for the treatment of diabetes. Orgenesis specializes in the development, manufacturing, and provision of technologies and services in the cell and gene therapy industry. They operate through a point-of-care cell therapy platform and a Contract Development and Manufacturing Organization platform. The company aims to bring Advanced Therapy Medicinal Products to patients through collaborations and in-licensing with other biopharmaceutical companies.

Customers

Mar 28, 2019 ·

growth-positive

Orgenesis Signs Master Service and Joint Venture Agreement with TheraCell Advanced Biotechnology for the Development of Cell and Gene Therapies

Orgenesis Inc. has entered into a Master Service and Joint Venture Agreement with TheraCell Advanced Biotechnology for the clinical development and commercialization of cell and gene therapies. The agreement aims to bring Advanced Therapy Medicinal Products (ATMPs) to patients in Greece, Cyprus, Balkan region, and Turkey. Orgenesis will provide regulatory consultancy services, pre-clinical studies, intellectual property services, and point-of-care services. TheraCell specializes in autologous cell therapy and regenerative medicine, with a focus on chronic kidney disease. The partnership aims to advance kidney regeneration technology through clinical trials and commercialization. Orgenesis is a biotechnology company specializing in the development, manufacturing, and provision of technologies and services in the cell and gene therapy industry.

Partners

Mar 25, 2019 ·

growth-positive

Orgenesis Subsidiary Masthercell Global Announces Plans to Establish New Facility for Cell and Gene Therapy Commercial Manufacturing

Orgenesis Inc. plans to establish a new production site for its Masthercell Global subsidiary in Belgium. The new facility is expected to triple Masthercell Globals current capacity and will focus on manufacturing late-stage and commercially-approved cell and gene therapy products. The facility will incorporate industry 4.0 precepts to provide efficient and cost-effective manufacturing solutions. The current facility will shift its focus to industrial manufacturing process development and early to mid-stage cell and gene therapy products. The new facility is expected to be operational in early 2021. The expansion aims to address the lack of commercial manufacturing capacity in Europe and create several hundred jobs.

Expand

Feb 5, 2019 ·

growth-positive

Orgenesis Announces the Opening of New Offices and Laboratories at Accessia Pharma in Liège, Belgium to Support its Point of Care Cellular Therapy Platform

Orgenesis Inc. has announced the opening of new offices and laboratories in Belgium to support its Point of Care Cellular Therapy platform. The company aims to advance new autologous cell therapies and enable POCare cell therapy development and services. Orgenesis is strategically positioned in the Walloon Region of Belgium and is supported by partners such as Theracell, Hemogenyx, and Serpin. The opening of the new center in Belgium is seen as a significant starting location for Orgenesis global POCare network. The company plans to reduce development costs through joint ventures with local partners and engage in continuous in-licensing of autologous therapies from academia and research institutes. Orgenesis operates through two platforms: an autologous POCare cellular therapy development platform and a Contract Development and Manufacturing Organization (CDMO) platform.

PartnersExpand

Jan 25, 2019 ·

growth-positive

Orgenesis Announces U.S. Expansion of Masthercell Global Subsidiary

Orgenesis Inc. announced that its subsidiary, Masthercell Global, is expanding into the United States and has received a milestone payment of $6.6 million from Great Point Partners. Masthercell Global will build a new manufacturing facility in Houston, Texas, to expand its world presence and capacities. The expansion is funded by Great Point Partners, with a total planned investment of $25 million. The funding will also be used to launch the new U.S. facility, expand facilities in Europe, Israel, and Korea, and enhance services for Masthercell Globals customer base. The expansion is expected to allow Orgenesis to expand its presence in North America and capitalize on the growing global market demand for cell and gene therapies.

Expand

Jan 22, 2019 ·

growth-positive

Orgenesis Subsidiary Atvio Biotech to Present at Phacilitate Leaders World 2019 Conference

Orgenesis Inc. announced that Dr. Ohad Karnieli will be presenting at the Phacilitate Leaders World 2019 Conference. The presentation will focus on bringing cell therapy to the point of care, automation, analytics, and everything in between. The company will also have a booth at the event. The conference is expected to attract 2,000 attendees, 150 exhibitors, and 300 speakers. Orgenesis is a vertically-integrated biopharmaceutical company specializing in cell therapy development and support services. Through its subsidiaries, the company is developing technology to reprogram human liver cells into insulin-producing cells and offers contract development and manufacturing services to cell therapy organizations.

Partners

Jan 3, 2019 ·

growth-positive

Orgenesis CEO Selected to Participate in Cell and Gene Therapy Workshop at Biotech Showcase 2019 in California

Orgenesis Inc. announced that its CEO, Vered Caplan, has been selected to participate in a workshop on cell and gene therapy financing at the 2019 Biotech Showcase. The workshop will discuss how disruptive therapeutic products have affected the investment and financial landscape in the sector. Orgenesis is a developer, manufacturer, and service provider in the cell and gene therapy industry, operating through a Cell Therapy development platform and a Contract Development and Manufacturing Organization platform. The company aims to bring Advanced Therapy Medicinal Products to patients through its expertise in decentralized point-of-care cell therapy manufacturing.

Investment

Dec 18, 2018 ·

globenewswire.com

growth-positive

Orgenesis Announces Collaboration with MangoGen Pharma for Advanced Gene Delivery Platform

Orgenesis Inc. has announced a collaboration with MangoGen Pharma Inc. to develop insulin producing cells (IPC) using MangoGens gene delivery platform. The collaboration aims to develop a complete solution for the delivery of IPC cells to animal models. Orgenesis has also received a grant from the Canada-Israel Industrial R&D Foundation to fund the project. The CEO of Orgenesis believes that MangoGens baculoviral delivery system has the potential to enhance the performance and reduce the cost of goods for Orgenesis cell therapies. MangoGen sees broad potential for its platform technology in the cell therapy and regenerative medicine markets. Orgenesis is a vertically integrated service and research company in the regenerative medicine industry.

Investment

Dec 12, 2018 ·

https://www.proactiveinvestors.com/companies/news/211072/orgenesis-seals-pact-with-ben-gurion-university-to-develop-dissolvable-carriers-for-cell-culturing-211072.html

Nov 2, 2018 ·