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Orgenesis Inc. (NASDAQ: ORGS) is a pioneering biotech company focused on unlocking the potential of cell and gene therapies (CGTs). Headquartered in White Plains, New York, Orgenesis specializes in autologous therapies, employing a closed and automated processing system designed for compliant production close to the patient, enhancing the efficiency of treatments at the point of care (POCare).
The company operates through two main segments: Octomera and Therapies. Octomera is the company's decentralized cell therapy platform, which has been fundamental in their approach to CGT production. Their decentralized model allows for the integration of academia, hospitals, and industry partners to expedite the commercialization of these therapies. This approach not only reduces costs but also improves patient outcomes by bringing processing services closer to the patient.
Despite industry challenges in 2023, Orgenesis remains steadfast in its mission. CEO Vered Caplan highlighted the growing demand for decentralized cell therapy solutions due to cost pressures and patient demand. Orgenesis has seen support from regulators like the FDA and EMEA, who are progressing guidelines for decentralized production. These advancements have solidified the company’s strategic advantage in handling the development and regulatory processes of their products.
On the financial front, Orgenesis has made significant strides. The recent appointment of Victor Miller as CFO has brought renewed focus on their financial strategy, leveraging their robust cell processing expertise to secure their position in the life sciences sector. Their collaboration with Metalmark has provided critical support, aiding in navigating the biotech industry's fluctuations.
Orgenesis is also at the forefront of developing therapeutic exosomes through their EXOFASTTRACK project. This project aims to accelerate the clinical evaluation of therapeutic exosomes, providing a scalable and cost-effective production process that can revolutionize the field of advanced therapy medicinal products (ATMPs).
Furthermore, Orgenesis has strengthened its infrastructure through a strategic partnership with Germfree. This collaboration focuses on advancing Orgenesis’ therapeutic programs and cell processing services, aiming to make CGTs more accessible and affordable globally. The partnership also includes marketing Orgenesis' decentralized Octomera service platform and its Mobile Processing Units and Labs (OMPULs™).
Orgenesis continues to innovate and expand its global footprint, committed to bringing life-saving therapies to market faster and more efficiently. Their decentralized approach and strategic collaborations position them as leaders in transforming how cell and gene therapies are developed and delivered.
For more information, please visit www.orgenesis.com.
Orgenesis (NASDAQ: ORGS) announced it completed a pre-IND consultation with the FDA for its phase 2 trial of Ranpirnase for anogenital warts. The company confirmed it is on schedule for the submission. Additionally, its partner Okogen reported positive interim results from a phase 2 trial of OKG-0301 (Ranpirnase) in acute adenoviral conjunctivitis. Orgenesis is also collaborating with Leidos for a clinical trial of Ranpirnase against SARS-CoV-2. The company is exploring reformulating Ranpirnase with Bioxome technology, enhancing its delivery and manufacturing scalability.
Orgenesis (NASDAQ: ORGS) has started enrollment for a phase 2, randomized, placebo-controlled trial evaluating the safety and efficacy of autologous stromal and vascular fraction (SVF) injections after rotator cuff surgery. The trial is being conducted at the Hospital for Special Surgery in New York, using the Tissue Genesis Icellator, with 56 patients expected to be enrolled. Early evidence suggests SVF may enhance tissue regeneration and mitigate inflammation. The investigator Dr. Scott Rodeo expresses optimism about the trial's potential to improve patient outcomes.
Orgenesis, a global biotech company focused on cell and gene therapies, announced its participation in the Summer Solstice Conference hosted by The MicroCap Rodeo, from June 1-4, 2021. CEO Vered Caplan will present on June 2 at 2:30 PM Eastern Time and engage in one-on-one meetings with investors. The conference showcases the top 25 companies recommended as best ideas by qualified institutional investors. Interested parties can access the presentation live or on replay through the provided link.
Orgenesis Inc. (NASDAQ: ORGS) reported a more than four-fold revenue increase for Q1 2021, attributed to long-term contracts with regional partners under its new POCare strategy. The company achieved positive operating income and maintained a robust cash position of $41.8 million as of March 31, 2021. Orgenesis is advancing therapeutic pipelines with over 30 advanced cell and gene therapies, focusing on autologous immunotherapies and metabolic diseases. The company continues to expand its POCare Network globally, collaborating with hospitals and investing in new point-of-care technologies.
Orgenesis (NASDAQ: ORGS) has received Investigational Device Exemption (IDE) approval from the FDA for a first-in-human feasibility study of the Tissue Genesis Icellator2® to treat Acute Respiratory Distress Syndrome (ARDS) related to COVID-19. The trial will involve 21 patients at one site in the U.S. and aims to evaluate the therapeutic efficacy of stromal and vascular cells (SVF) derived from adipose tissue. The company may also amend its development plan to address non-COVID-19 related ARDS. This milestone reflects significant progress in Orgenesis's clinical development strategy.
Orgenesis (NASDAQ: ORGS) announced a conference call to discuss corporate progress on May 7, 2021, at 8:30 AM ET. Analysts and investors can join the call via telephone or webcast. The call will be accessible again as a replay on the Investor Events section of their website. Orgenesis aims to enhance cell and gene therapies through its POCare Platform, which promotes affordable and accessible treatments. This platform includes licensed therapeutics and focuses on decentralized production at the point of care, collaborating with various stakeholders worldwide.
Orgenesis (NASDAQ: ORGS) has announced its collaboration with Bambino Gesù Children's Hospital in Rome to establish a Point of Care Cell Therapy center. This center will support clinical trials and the development of advanced cell and gene therapies, aiming to streamline manufacturing processes and reduce costs. The partnership also allows for the deployment of Orgenesis' Mobile Processing Units (OMPULs) on-site, enhancing decentralized production capabilities. This collaboration marks a significant step for Orgenesis in expanding its POCare Network globally.
Orgenesis has announced a strategic collaboration with MIDA Biotech to establish point-of-care centers across Italy, Germany, Spain, and Benelux. This partnership aims to deploy Orgenesis Mobile Processing Units and Labs (OMPULs) for the onsite development of cell and gene therapies. The collaboration highlights Orgenesis' commitment to expanding its POCare Network and providing scalable, affordable access to therapies. The agreements signify crucial steps towards commercialization, as hospitals have conducted thorough due diligence before engaging.
Orgenesis Inc (NASDAQ: ORGS) has entered the second phase of collaboration with Hospital Infantil Universitario Niño Jesús in Madrid to develop and commercialize the proprietary Celyvir therapy for solid tumors. The therapy uses oncolytic virotherapy combined with autologous Mesenchymal Stem Cells (MSCs) to enhance cancer treatment. Initial trial data indicates a favorable safety profile and potential for disease stabilization. This partnership aims to leverage Orgenesis's POCare Platform to facilitate the development of innovative cell therapies.
Orgenesis reported a 96% increase in revenue for 2020, totaling $7.7 million. The company anticipates it will more than double its revenue in 2021 based on existing contracts. Following the strategic sale of its Masthercell division for $315 million, Orgenesis is focused on expanding its POCare platform, aimed at reducing costs and improving access to cell and gene therapies. The company has developed over 30 therapies and established partnerships in 14 countries to provide decentralized treatment solutions. A conference call to discuss these results is scheduled for March 9, 2021.
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