Welcome to our dedicated page for Orgenesis news (Ticker: ORGS), a resource for investors and traders seeking the latest updates and insights on Orgenesis stock.
Overview of Orgenesis Inc.
Orgenesis Inc. (Nasdaq: ORGS) is a global biotechnology company dedicated to advancing the field of cell and gene therapies (CGTs) through innovative technologies and a decentralized processing model. Established in 2012, the company has pioneered solutions to address the high costs, logistical challenges, and scalability issues associated with traditional centralized CGT manufacturing. By integrating cutting-edge science with a collaborative approach, Orgenesis aims to democratize access to life-saving therapies, making them more affordable and accessible to patients worldwide.
Core Business Areas
Orgenesis operates at the intersection of therapeutic development and enabling infrastructure. Its business model encompasses two primary areas:
- Therapeutic Development: The company focuses on developing advanced CGTs, including CAR-T therapies, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic viruses, and therapeutic exosomes. These therapies target a range of conditions, from cancer to chronic wounds, leveraging the regenerative and anti-inflammatory properties of cell-based treatments.
- Decentralized Processing: Through its proprietary POCare (Point-of-Care) platform and Octomera Mobile Processing Units and Labs (OMPULs™), Orgenesis enables the localized production of CGTs. This decentralized approach reduces costs, shortens production timelines, and ensures therapies can be delivered closer to patients, addressing critical bottlenecks in traditional manufacturing models.
Innovative Technologies
Orgenesis is at the forefront of technological innovation in the biotech industry. Key advancements include:
- Bioxomes™: Liposome-like nanostructures used as delivery vehicles for therapeutic agents. The company has developed a scalable, cost-effective manufacturing process for Bioxomes™, ensuring consistent and repeatable results.
- Exosome Production: In collaboration with partners, Orgenesis is advancing the large-scale production and therapeutic application of exosomes derived from mesenchymal stem cells. These extracellular vesicles serve as intercellular messengers and have potential applications in regenerative medicine and advanced therapy medicinal products (ATMPs).
- Automated Manufacturing: Orgenesis employs automated, low-footprint technologies to streamline CGT production, reducing environmental impact and enhancing efficiency.
Collaborative Ecosystem
Orgenesis’ decentralized model is underpinned by strategic partnerships with academia, hospitals, and industry stakeholders. This collaborative ecosystem facilitates the rapid translation of scientific discoveries into clinical applications. Recent alliances, such as the partnership with Germfree, highlight the company’s commitment to advancing modular cleanroom infrastructure and expanding its global footprint.
Market Impact and Differentiation
Orgenesis stands out in the competitive biotech landscape due to its dual focus on therapeutic innovation and enabling infrastructure. By addressing the logistical and economic barriers of CGT manufacturing, the company is poised to transform the delivery of advanced therapies. Its decentralized processing model not only reduces costs but also enhances accessibility, ensuring that cutting-edge treatments reach underserved populations.
Commitment to Quality and Compliance
Operating within a highly regulated industry, Orgenesis adheres to stringent quality standards and Good Manufacturing Practices (GMP). Its automated and controlled production modules ensure consistency and compliance, fostering trust among stakeholders and regulatory authorities.
Conclusion
Orgenesis Inc. exemplifies innovation and collaboration in the biotech industry. By combining therapeutic development with decentralized processing, the company is redefining how cell and gene therapies are developed, manufactured, and delivered. Through its commitment to reducing costs, improving outcomes, and enhancing accessibility, Orgenesis is making significant strides toward its mission of democratizing advanced healthcare solutions.
Orgenesis (OTCQX:ORGS) has acquired key assets from Neurocords focused on advanced regenerative medicine therapies for spinal cord injuries (SCI). The acquisition includes technology that differentiates induced pluripotent stem cells (iPSC) into spinal cord neurons using Orgenesis's decentralized cell processing approach.
The transaction involves Orgenesis issuing 1,200,000 shares of common stock to Neurocords. The global SCI treatment market, valued at $7.5 billion in 2023, is projected to reach $11.2 billion by 2031.
The integration combines Neurocords' technology with Orgenesis's MIDA Technology of AI-based generation of autologous stem cells, aiming to create an autologous neural cell production platform. This approach is designed to expedite capacity setup, enhance production efficiency, and reduce treatment costs, potentially making therapies more accessible to patients.
Orgenesis (OTCQX:ORGS) has secured an equity line of credit of up to $5 million from Williamsburg Venture Holdings, a Nevada-based family office. The agreement includes an initial $750,000 payment upon registration statement effectiveness, with the remaining $4.25 million available over 24 months.
The purchase price for shares will be 90% of the market price, calculated as the average of the two lowest Volume-Weighted Average Prices (VWAP) over five consecutive trading days. The company can also opt for an accelerated purchase notice by 11:00 AM on any day, with the price set at that day's lowest traded price.
The funding aims to accelerate the rollout of Orgenesis's decentralized Cell and Gene Therapy (CGT) platform and support the development and commercialization of their therapeutic pipeline through their POCare platform.
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.
FAQ
What is the current stock price of Orgenesis (ORGS)?
What is the market cap of Orgenesis (ORGS)?
What does Orgenesis Inc. specialize in?
What is the POCare platform?
What are Bioxomes™?
How does Orgenesis differentiate itself from competitors?
What industries does Orgenesis collaborate with?
What are therapeutic exosomes?
What challenges does Orgenesis address in the CGT industry?
What role does automation play in Orgenesis’ processes?
What are OMPULs™?
How does Orgenesis ensure compliance with regulatory standards?
