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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) and Kurve Therapeutics have announced promising results from a preclinical study demonstrating over 50% tumor reduction in a glioblastoma mouse model using intranasal delivery of a cell-based oncolytic virus. This breakthrough utilizes Kurve's Controlled Particle Dispersion® technology, overcoming the blood-brain barrier, a common challenge in CNS therapies. The study was conducted independently, and Orgenesis is equipped with clinical-grade manufacturing capabilities in partnership with Hospital Infantil Universitario Niño Jesús in Madrid, aiming for future clinical applications.
Orgenesis Inc. (NASDAQ: ORGS) announced securing up to $50 million from Metalmark Capital Partners to enhance its POCare platform. The funding, valuing the subsidiary Morgenesis LLC at $125 million, allows Orgenesis to minimize dilution. The company achieved approximately $8 million in revenue for Q3 2022 while significantly reducing operating expenses by 49%, nearing breakeven income. Orgenesis emphasizes the scalability and cost-effectiveness of its cell and gene therapy services, addressing production capacity challenges in the industry.
Orgenesis Inc (NASDAQ: ORGS) is set to host a conference call on November 11, 2022, at 8:00 AM ET to discuss its corporate progress and developments. Interested participants can join via phone or through a live webcast. The company is focused on advancing cell and gene therapies through its innovative POCare Platform, which facilitates effective and affordable treatment access. A replay of the call will be available on their Investor Events webpage after the session.
Orgenesis Inc (NASDAQ: ORGS) announced a partnership with Metalmark Capital Partners for a growth investment of up to $50 million in its US-based subsidiary, Morgenesis LLC. This investment includes an upfront $30 million, with a pre-money valuation of $125 million. The funds will be utilized to enhance Morgenesis' point-of-care services, expanding its capabilities in cell and gene therapies. Orgenesis aims to streamline POCare Services, enhancing access to innovative treatments globally.
Orgenesis Inc. (NASDAQ: ORGS) announced a $10 million loan from Metalmark Capital Partners to advance its POCare platform and point of care services. The company is transitioning to phase two of its business model, targeting revenue from process development and supply of cell and gene therapies. With over 16 clinical programs in immuno-oncology and regenerative medicine, Orgenesis aims to benefit from high-margin, recurring revenue streams. They also secured a €4M grant for personalized stem cell technologies, demonstrating significant advancements in their therapeutic pipeline.
Orgenesis Inc. (NASDAQ: ORGS) announced a conference call scheduled for August 16, 2022, at 11:00 AM ET to discuss corporate progress and developments. U.S. callers can dial 888-506-0062, while international participants can reach out at +1 973-528-0011 using entry code 223911. A webcast will also be available. Orgenesis focuses on advancing cell and gene therapies through its POCare Platform, aiming for affordable access at the point of care. A replay of the call will be accessible via the company's Investor Events section until August 16, 2023.
Orgenesis Inc. (NASDAQ: ORGS) reported a business update for Q1 2022, highlighting significant advancements in its POCare Platform. Key developments include the expansion of POCare partnerships with Johns Hopkins University and Hospital Infantil Universitario Niño Jesús, alongside securing a €4M grant from the European Innovation Council. CEO Vered Caplan emphasized the company's ongoing rollout and its potential for significant revenue from long-term contracts for clinical trials. The existing contract pipeline suggests a potential revenue exceeding $75 million in two years, indicating promising growth.
Orgenesis Inc. (NASDAQ: ORGS) has received a €4 million grant from the European Innovation Council Pathfinder Challenge Program. This funding will support the development of cost-effective production technologies for autologous induced pluripotent stem cells (iPSCs) using microfluidic technologies and AI. The initiative, led by MIDA Biotech, aims to enhance the speed and affordability of producing personalized iPSCs, addressing current manufacturing challenges. The project is expected to speed iPSC production while significantly reducing costs, potentially unlocking new therapies in regenerative medicine.
Orgenesis Inc. (NASDAQ: ORGS) has entered into a definitive agreement for a private placement of 4,933,333 shares at $3.00 each, alongside warrants for 1,000,000 shares at $4.50. Gross proceeds are expected to be approximately $14.8 million, with closing anticipated around April 30, 2022. The securities will be sold under Regulation D and are not registered under the Securities Act. The company aims to file a registration statement for the resale of the shares and warrants. Orgenesis focuses on cell and gene therapies through its POCare Platform.
Orgenesis reports a substantial revenue increase in 2021, reaching $35.5 million, up from $7.7 million in 2020. The company has secured over $30 million in future commitments for 2022 and $55 million for 2023. Their POCare Platform aims to provide cost-effective cell and gene therapies at the point-of-care, addressing high costs and availability issues.
Recent developments include operational centers in multiple countries and a €32 million government grant in Greece, enhancing their capacity and market presence.
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