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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 (OTCQX: ORGS) provided its Q3 2024 business update, highlighting progress in decentralized cell and gene therapies. Their CD19 CAR-T therapy, ORG-101, showed impressive results with 82% complete response rate in adults and 93% in pediatric patients with CD19+ Acute Lymphoblastic Leukemia. The therapy demonstrated lower severe Cytokine Release Syndrome incidence (2% adults, 6% pediatric) compared to conventional treatments. The company is initiating a Phase 1/2 multicenter clinical study in Greece and announced a strategic joint venture with Harley Street Healthcare Group focusing on wellness and longevity services in the UK, UAE, and Canada.
Orgenesis Inc. (NASDAQ: ORGS) announced that its common stock will begin trading on the OTCQX® Best Market under the ticker symbol "ORGS" following its delisting from the Nasdaq Stock Market. The delisting resulted from the Company's failure to meet the required stockholders' equity threshold. Orgenesis plans to reapply for a Nasdaq listing as soon as practical.
The Company remains committed to maintaining high levels of corporate governance and transparency while addressing the equity shortfall. Orgenesis continues to focus on advancing its Decentralized Cell Processing (DCP) platform, which offers a cost-effective, scalable solution for producing advanced therapies at or near the point of care. The Company's partnerships with hospitals and research institutions worldwide support its mission of making cell and gene therapies more affordable and accessible.
Orgenesis Inc. (Nasdaq:ORGS) has announced a 1-for-10 reverse stock split of its common stock, effective September 24, 2024. The split aims to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share. Trading on a split-adjusted basis will begin on September 25, 2024, under the existing symbol "ORGS".
Key points:
- The number of issued and outstanding shares will reduce from 47,707,849 to approximately 4,770,785
- Total authorized shares will decrease from 145,833,334 to 14,583,333
- No fractional shares will be issued; affected stockholders will receive cash payments
- The split will proportionately affect equity incentive plans, stock options, warrants, and convertible notes
Securities Transfer will manage the exchange process for stockholders with physical certificates.
Orgenesis (NASDAQ: ORGS) announced positive results from a real-world study of its CD19 CAR-T therapy, ORG-101, in patients with CD19+ Acute Lymphoblastic Leukemia. The study showed complete response rates of 82% in adults and 93% in pediatric patients, with low incidence of severe Cytokine Release Syndrome (2% in adults, 6% in pediatrics).
ORG-101 utilizes a third-generation lentiviral vector with a proprietary CAR construct and decentralized onsite production, offering a potentially more affordable solution compared to traditional CAR-T therapies. Orgenesis is preparing to initiate a Phase 1/2 clinical multicenter study, starting in Greece.
Harley Street Healthcare Group plans to set up a Global Cancer Initiative through its joint venture with Orgenesis, aiming to democratize Advanced Therapies and support further clinical development.
Orgenesis (NASDAQ: ORGS) has formed a strategic partnership with Harley Street Healthcare Group (HSHG) to launch a global Longevity & Wellness Initiative. This alliance aims to drive innovation in wellness and longevity, supported by an investment commitment of up to $10 million over 3 years into both Orgenesis and a newly formed joint venture.
The partnership combines Orgenesis' expertise in cell and gene therapies with HSHG's innovative healthcare approach. This collaboration is expected to accelerate the development and accessibility of advanced therapies in the wellness and longevity sectors, potentially opening new markets and revenue streams for Orgenesis.
Orgenesis Inc. (NASDAQ: ORGS), a global biotech company focused on cell and gene therapies (CGT), provided a business update for Q2 2024. The company has acquired GMP-validated platforms for producing CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes. CEO Vered Caplan highlighted the integration of their robust cell therapy production capabilities with their wide range of therapies developed through partnerships. Orgenesis now offers hospitals and partners both services for their own development and products, as well as the opportunity to benefit from Orgenesis' proprietary therapies. The company plans to use the newly acquired platform to supply its own CAR-T cell products, aiming to provide a comprehensive solution for the industry, including hospitals and researchers worldwide.
Orgenesis (NASDAQ: ORGS), a biotech company focused on cell and gene therapies (CGT), provided a business update for Q1 2024. The company accelerated the rollout of its decentralized POCare platform following a partnership with Germfree and reacquisition of full ownership of Octomera. This enhances their Orgenesis Mobile Processing Units and Labs (OMPULs) offering, aimed at delivering cost-effective, rapidly deployable CGT solutions. A strategic partnership with Germfree grants access to a global network, bolstering the company's go-to-market strategy. Orgenesis has secured over $50 million in potential future grant funding, and additional investments of $2.5 million were received. Furthermore, shareholders agreed to exchange $16 million of debt for 15.8 million shares of common stock, demonstrating strong support. Financial details are available on Orgenesis' website.
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