Orgenesis Inc.

Good day, ladies and gentlemen, and welcome to the Orogenesis Business Update Call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, David Waldman from Investor Relations. Sir, the floor is yours.

Thank you and good morning everyone and welcome to our genesis second quarter 2022 business update conference call on the call with us this morning are very Kaplan chief executive officer and Neil Reitinger chief financial officer. If you have any questions after the call would like any additional information about the company, please contact crescendo communications at 212-671-1020. This conference call contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 as amended and Section 21E of the Securities and Exchange Act of 1934 as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon current expectations, estimates, and projections and reflect our beliefs and assumptions based upon information available to us at the date of this conference call. We caution listeners that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance that are subject to risks, uncertainties, and assumptions that are difficult to predict. Their actual performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including but not limited to the risk factors and uncertainties discussed under the heading Risk Factors in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 2021. And in our other filings with the Securities and Exchange Commission, we undertake no obligation to revise or update any forward-looking statement for any reason. And now I turn the call over to our Genesis CEO, Ms. Verit Kaplan. Please go ahead, Verit.

Thank you, David. And thanks to everyone for joining us on our call today. I'm always glad to have a chance to speak directly to shareholders. And as many of you know, I'm really glad to be responsive and available to other people wish to speak to this. I also appreciate the support we have received from some of you lately. The last several months have been ones of much turmoil, political issues, economic instability, and many are still suffering from the latest pandemic, while new biological threats appear around the corner. These issues have not had a direct influence on our activities. but they have affected investors and shareholders throughout the biotech industry. And many companies have not survived these events. Funds that have been frozen, shareholders that have had to liquidate their assets quickly, and the general mood of the biotech investment world. We are extremely fortunate that we have support of some of our shareholders and investors, and that our suppliers and customers have gone out of the world to make sure we maintain our stability. We appreciate this very much and think this is part of the strength of a network, the point-of-care network that we have woven together in the last few years. We are also not a typical biotech company, far from it. As Uber is not a typical taxi company, as Amazon is not a typical bookstore chain, if you remember when Amazon sold books, and Airbnb is not a hotel chain, we are a new breed of biotech. Just as the developments in software, hardware, and communication technologies enable the capability to share resources, products, and services to many more people around the globe more efficiently and enable new sources of employment and deployment of goods, so are we building a new accessibility to cell and gene innovations and therapies. Our point-of-care network enables clinicians and patients to access access to life-saving therapies, and pave the pathway for new, innovative treatments to reach clinical use in a decentralized manner. A therapy licensed from one hospital may be made available to any hospital in the network. Our network allows clinical and scientific data to be shared, so instead of each hospital trying to face the challenges of supplying these therapies to patients, and overcoming the pitfalls that others have faced, we provide a well-collaborated approach. Our point-of-care services, now regrouped under More Genesis, have the know-how and infrastructure to provide such therapies across the network, with quick and efficient capability to expand such services to new hospitals and clinical sites. Biotech companies wish to access this network and develop and supply their products, utilizing our point-of-care network to benefit from such services, enabling them to have a robust supply chain, not limiting access to their products by complex supply issues that arise from a centralized processing facility. The biotech industry in general speaks of cell and gene therapy manufacturing. But no biotech company as far as I know has ever manufactured a cell. Cells are expanded, engineered, processed, or reprogrammed. Cells may be used to manufacture proteins or other materials, and by doing so may be utilized in a manufacturing process such as is done in traditional biotech industries. But no cell and gene therapy is based on someone actually manufacturing and making a cell. The source material is always taken from biological tissues. This is a subtle difference, but a crucial one. Cell therapies are based on the know-how and research of scientists around the world that have studied their behavior and have established scientific methods that enable reprogramming the function of various cells, as well as the capability of selecting and growing these cells. These technologies are the pinnacle of human achievement. allowing us in some cases to cut free from the restriction that evolution has imposed on ourselves, and in other cases, providing us the insight to utilize the intelligence that resides in ourselves based on such evolution. Cell and gene therapies are about utilizing scientific knowledge, sophisticated biological algorithms, and tools to reprogram cells for our own benefits and health. Their success depends on the processing systems, the hardware, the biological techniques, and the software that enables user-friendly, low-cost, and high-quality replication of these algorithms. Our approach to this industry is based on these fundamentals. We work closely with many cellular processing system developers to optimize these devices, and in some cases, have even developed our own, which are integrated into our onboard. We work closely with the suppliers and developers of different technologies, which enable processing and reprogramming themselves. We utilize these technologies to optimize the quality and the safety of various therapies. We have set up our network in Europe, Asia, the Middle East, and the U.S. We now have our arm pools deployed in Europe and the Middle East and have set up point-of-care centers and strategic hubs in the U.S. We have managed to generate revenues that cover the activity in Europe and Asia, and will now use the additional funds we have received from Metalmark, which we announced this morning, to deploy additional arm fuels to provide services to our customers in Europe and in the U.S. Our focus this year has been, and will continue to be, to establish our point-of-care development and processing services with a strong focus on expanding capacity in the U.S. One excellent example is our partnership with Johns Hopkins, where we have established a point-of-care center supported by a generous Maryland grant that will be utilized for the construction of the Cell and Gene Therapy Processing Facility. Our process development services are already active on site. We have managed to provide our customers with all the services we committed to in a timely manner and believe that they continue to see the value of our decentralized approach. We are also expanding our marketing effort, as we believe we have now the resources to expand our capacity. Turning in more detail to our funding announcement this morning, I'm pleased to report we secured a $10 million loan for Metalmark Capital Partners, a premier investment firm with deep expertise in the healthcare sector. For those of you unfamiliar with Metalmark, they target investments in middle market companies seeking to build long-term value through active and collaborative partnerships. Metalmark is managed in excess of $8 billion in both recurrence and predecessor funds. They are committed partners, and we look forward to working closely with them to help us accelerate the rollout of our point-of-care platform and these critical services. Equally important is the fact that we secure this investment at the subsidiary level. For those of you who have known us over the years, we have two major priorities. Number one is delivering life-saving cell and gene therapies to patients around the world. At cost, it will allow widespread adoption and, no less important, protecting and preserving our shareholder values by avoiding the usual toxic funding that often destroys the capital structure and, in turn, value for small biotech companies. I strongly believe that the underlying value of what we are building is not reflected in the public market. partner at Metalmark, who has deep expertise in the healthcare sector and understands the valuation biotech services companies are getting in the private sector, will help establish that value. Additionally, they understand, I believe, the gross potential of our business, and we could not be more excited to have them as a partner while preserving our capital structure and minimizing equity dilution. The reason our point-of-care business is resonating well in the industry is that we are able to lower the cost, streamline logistics, expand capacity, enhance distribution through processing of therapies close to the hospital setting, which we hope will support payer uptake and make these therapies more broadly available to patients. We believe this is a crucial step that is necessary for cell therapies to become widely available. Utilizing our ample-based approach, we believe we are uniquely positioned to address the challenges of current centralized production. OMPL shortened the implementation time of building out new capacity 18, 24 months this week. In terms of expenses, our goal over time is to reduce the cost of these services, tens of thousands versus hundreds of thousands of dollars. Importantly, we believe we have built a highly scalable business model and expect to benefit from growth no margin, reoccurring revenue stream, and based on future royalties and long-term contracts from industrial line and supplying these 7G therapies. At the same time, we've already started generating revenue in our therapy outlicing. And though not at the same level as the services, still we believe this will provide a longer-term source of future income and additional value for shareholders. Our point-of-care therapeutic pipeline now spans over 16 distinct clinical programs across immune oncology, antiviral, metabolic, and autoimmune disease, as well as tissue regeneration. Our strategy involves leveraging government grants and other sources of non-dilutive funding from regional partners in order to advance life-saving therapy. And by designing these therapies from the ground up, using our on-pull-based model, we believe these therapies can be advanced through clinical trials at a fraction of the cost of traditional clinicals by leveraging our network of academic institutes and healthcare systems around the world. We are also taking advantage of non-diluted funding, such as our recent award in May 2022, totaling €4 million from the European Innovation Council, past finder grants, to advance technologies for the production of personalized autologous induced pluripotent stem cells. The grant is aimed at the development of technologies to speed production of personalized iPSCs, but significantly reducing manufacturing. In turn, these products can be utilized for a wide array of indications, including autologous, adoptive cancer immunotherapy, hematopoietic stem cell transplantation, and regenerative medicine. We believe our therapeutic pipelines hold tremendous and large potential, and we and our partners advance each of these assets through clinical and preclinical milestones. And when you compare our therapeutic pipeline against other biopharmaceutical companies of our market cap, as well as many of those much larger than us, most of us have only a small hand full of related programs. In contrast, we have access to many therapies across various indications, at all stages of development through our growing partnerships. So to wrap up, we are executing on everything we said we are going to do. And now with Metalmark's support, we look forward to accelerating the rollout of our point-of-care services and the deployment of our own tools. Our partners and customers are committed to support the validation, development, and clinical trials of advanced therapies utilizing the point-of-care platform within the respective markets. and we continue generating revenue while transitioning from the first to second stages of our business model. Our agreements with our customers are long-term contacts, and as we advance the respective pipelines, we expect to benefit from growth and high-margin, reoccurring revenue streams. Overall, we are more enthusiastic than ever about the outlook of the business and believe that we are well-positioned to expand our market position, not only as a leader, but as a disruptor in the selling gene therapy market. We have built a highly scalable business and we believe we'll drive value for shareholders for years to come. On that note, I'll now turn the call over to Neil Eichinger, our Chief Financial Officer.