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.
Introduction
Orgenesis Inc (ORGS) is a global biotech company that specializes in unlocking the potential of cell and gene therapies (CGTs) through a groundbreaking decentralized manufacturing approach. Leveraging advanced innovations in automation and GMP-compliant technologies, Orgenesis is transforming the production of therapeutic products, including therapeutic exosomes and other cell-based modalities. With a focus on high-quality, scalable, and cost-effective solutions, the company is addressing major challenges in regenerative medicine and immuno-oncology.
Business Focus and Core Competencies
At its core, Orgenesis is dedicated to developing and commercializing transformative cell therapies. The company employs a decentralized production model that brings together academia, hospital networks, and industry partners to accelerate the manufacturing and eventual commercialization of vital therapies. This approach is supported by a suite of innovative platforms that facilitate rapid, large-scale production and ensure consistent product quality. Orgenesis addresses complex technological challenges inherent in the production of advanced therapeutic products by integrating state-of-the-art automated systems and low-footprint processes that optimize both production efficiency and environmental sustainability.
Innovative Manufacturing and Technological Excellence
Orgenesis has developed pioneering processes within the field of regenerative medicine, most notably in therapeutic exosome production. Exosomes, isolated primarily from stem cells, are employed by the company as intercellular messengers capable of delivering specific therapeutic agents. The proprietary manufacturing techniques not only enable the reliable production of billions of exosomes but also ensure consistent particle sizes and uniformity without the complexities associated with using whole cells. By refining a unique process known as the production of Bioxomes™, Orgenesis has positioned itself at the forefront of optimizing scale-up while simultaneously reducing manufacturing costs and energy consumption.
Collaborative Ecosystem and Strategic Partnerships
The success of Orgenesis is significantly bolstered by strategic alliances and collaborative projects within the biotechnology sector. The company has engaged in multiple partnerships that enhance its production capabilities. Collaborations with experts in modular cleanroom infrastructure and automated quality management systems have allowed Orgenesis to integrate advanced digital workflows into its production lines. These partnerships, which include joint ventures with third-party manufacturers and quality control specialists, are instrumental in reinforcing the company’s standing as an innovator in decentralizing cell and gene therapy processes.
Product Development and Applications
Orgenesis’s technological platforms are versatile and cater to a broad range of therapeutic applications. By focusing on areas such as immuno-oncology, regenerative medicine for dermatological conditions, and potential applications in treating spinal cord injuries, the company is building a robust portfolio. Through projects like EXOFASTTRACK and strategic acquisitions targeting advanced regenerative therapies, Orgenesis continues to expand its pipeline and demonstrates its commitment to making vital therapies more accessible and affordable. The development process emphasizes rigorous quality control and functional characterization, conducted in partnership with specialized laboratories and research institutions.
Decentralized Manufacturing and Clinical Relevance
The company’s decentralized approach is a significant differentiator in the biotech industry. By employing modular manufacturing units and mobile processing units, Orgenesis ensures that its therapeutic platforms can be rapidly deployed and scaled across global markets. This flexible model not only facilitates collaborations with regional partners but also helps streamline regulatory compliance on a worldwide scale. The decentralization model is particularly beneficial in optimizing clinical workflows, reducing production turnaround times, and enhancing patient access to life-saving cell therapies.
Competitive Positioning and Market Significance
In the competitive landscape of cell and gene therapies, Orgenesis stands out through its commitment to technological innovation and collaborative synergies. The company’s emphasis on reducing production costs while maintaining GMP standards resonates with broader trends in the healthcare sector, where efficiency and quality are paramount. By integrating automated processes and partnerships with key industry innovators, Orgenesis bolsters its ability to navigate the complexities of therapeutic production and reinforces a market position that leverages comprehensive R&D and operational excellence.
Commitment to Quality and Regulatory Excellence
Ensuring consistent quality in biotech production is crucial. Orgenesis has implemented stringent quality control measures, including advanced microfluidic droplet analysis and cryo-electron microscopy evaluations, to ensure that every batch of therapeutic material meets rigorous standards. This meticulous attention to quality not only underpins its operational integrity but also facilitates compliance with global regulatory frameworks, thereby building trust with healthcare providers and regulatory authorities worldwide.
Conclusion
With a robust foundation built on technological innovation, strategic partnerships, and a commitment to decentralized manufacturing, Orgenesis Inc is redefining the pathways to effective and accessible cell and gene therapies. The company’s comprehensive approach—spanning advanced exosome production, automated GMP processes, and scalable manufacturing—positions it as a key player in the global biotech arena focused on transformative regenerative medicine solutions. Investors and industry observers can appreciate the company’s methodical approach to addressing industry challenges through cutting-edge science and agile operational strategies.
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.
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