ThermoGenesis Holdings, Inc.

Good day and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the third quarter ended September 30, 2022. As a reminder, all participants will be in listen-only mode. There will be an opportunity to ask questions at the end of today's presentation. If you would like to ask a question, please press star then 1 on your phone. If you wish to withdraw your question, please press star then 2. If you should need assistance during the conference call, please signal an operator by pressing star then zero. As a reminder, this conference call is being recorded. I would now like to turn the conference over to our host, Paula Schwartz of RX Communications. Please go ahead.

Thank you, Operator. This conference call contains forward-looking statements within the meaning of the federal securities laws. The company's actual results may differ materially from those projected in the forward-looking statements. Additional information concerning factors that might cause actual results to differ materially from those in the forward-looking statements is contained in the company's periodic reports filed with the Securities and Exchange Commission. The information presented today is time-sensitive and is accurate only as of the date of this call, November 10, 2022. If any portion of this call is being rebroadcast, retransmitted, or redistributed at a later date, Thermogenesis will not be reviewing or updating this material. Participating on today's call are Dr. Chris Schuch, Executive Officer, and Jeff Cobble, Chief Financial Officer. I'd now like to turn the call over to Chris. Please go ahead, Chris.

Thank you, Paula, and thank you to everyone for joining the call this afternoon. We appreciate you taking the time to listen in. During the third quarter of 2022, we continue to progress our transition to become a high-performance integrated CDMO for the cell gene therapy market. As announced in October, we completed a financing raising aggregate gross proceeds of approximately $2.05 million, which will help to support the planned launch of our TG viral synthesis division. As most of you know, for over 35 years, Thermogenesis has pioneered the development and manufacture series of innovative automated technologies and products, especially for the cell banking and cell therapy industry. Thermogenesis has been the provider of choice for automated cell processing and automated smart cryogenic storage technologies for some of the world's most important public and private cell banks. Our bioarchive quire storage system has warehoused close to 90% of all U.S. FDA BLA-approved clinical-grade cold blood units, or CBUs. And our AXP system has been used to process well over a million samples from many institutes globally. In addition to our manufacturing know-how in cell and gene therapy, the intellectual properties we have amassed over the years is invaluable. As more cell-based therapeutics such as CAR-T cell therapies received FDA approval, the demands for manufacturing of these life-saving therapies continues to grow. As we speak, there are more than 350 U.S. companies alone working in the cell therapy arena. and more than 1,000 pipeline assets are in clinical development globally, targeting a range of blood and solid tumors. The continued explosion in research and development is made possible by the incredible potential inherited in current commercialized therapies and the future possibilities provided by additional personalized cell gene therapies. Since 2017, six autologous CAR T therapy has been approved by the FDA. Recent reports show that the industry anticipates additional FDA approvals with as many as 10 to 20 new therapeutics each year starting in 2025. At the same time, there remains a critical and growing unmet needs for manufacturing of these compact therapies due to the continued challenges created by the high production cost, technological inefficiencies, and limited global capacity. Drug manufacturing today is still the largest component of the cost of CAR T-cell therapy, with listing price ranging as I mentioned many times, from 373,000 to 475,000, depending on the specific drugs and indications. Thus, there is a significant need for high-quality CGMP manufacturing at a reasonable cost. These dynamics have led to a rise in CDMO partnership activities, as more and more biopharmaceutical companies and other industrial participants recognized the urgency of the increased demand for cell therapies and the limited available of good manufacturing practices facilities. Moving away from manual process will be the key to facilitating fast timelines and getting these lifesaving drugs from bench to bedside. Therein lies the opportunity for thermogenesis to play a crucial role in the availability and use of these emerging cell gene therapies in both the research and real-world clinical settings. In response to this tremendous backlog for those products at the research, clinical, and commercialization stage as outlined earlier, Thermogenesis is working to contribute by adding needed CGMP manufacturing space, promoting cost efficiency through automated and fast processing time, and providing comprehensive manufacturing services. That said, we continue to make significant progress towards launching our TG biosynthesis CDMO division. and building out our approximately 35,000 square feet of laboratory and office space in Sacramento, California to create a state-of-art CGMP-compliant facility with 12 CGMP clean room suites to support the industry's manufacturing requirements. As an integral part of this plan, we will leverage our proprietary, high-efficiency, semi-automated CAR-T express platform, which has shown the ability to tangibly reduce processing time, improve cell recovery, and potentially cut manufacturing costs associated with CAR-T and other cell gene therapy by up to 50%. of the new division is to address the growing needs for broad and integrated CDMO services by providing high-quality development and manufacturing capacity, cell and tissue processing development, quality system, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various different stages of development. In summary, thermogenesis has strong intellectual property, cutting-edge technology, and manufacturing service expertise, and when built out, the ability to address scalable demands for access to state-of-the-art manufacturing capacity. We remain laser-focused on launching the TG Biosynthesis Division and our CDMO services to customers in the cell and gene therapy field in the coming months. And with that, let me turn the call over to Jeff to share the key financial results for the third quarter. Jeff? Thank you, Chris.