ThermoGenesis Holdings, Inc.

Good day and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the year ended December 31, 2022. As a reminder, all participants will be in the Sonomi 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 now would 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, March 30, 2023. 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 Hsu, Chief Executive Officer, and Jeff Cobble, Chief Financial Officer. I'd now like to turn the call over to Chris. Excuse me. Please go ahead, Chris.

Thank you, Paula, and thank you to everyone for joining the course this afternoon. We appreciate you taking the time to listen in. During 2022 and thus far in 2023, we took important steps towards executing our plans to transform from a medical device company to a contract development and manufacturing organization, or CDMO, for the cell and gene therapy market. In October 2022, we completed an approximately $2.0 million financing and recently completed another $3 million private placement transaction. These financings will support the planned launch of our CDMO business, through which we will leverage our unique and proprietary automated and semi-automated cell processing platforms, including the CAR-T Express platform. Our goal is to help companies and institutions to develop next-generation cancer medicines, such as cell gene therapies, to accelerate drug candidates into clinic as quickly and safely as possible. Our focus will be to establish solutions for customers in order to streamline supply chain, increasing manufacturing predictabilities, and manage overall risks. To that end, we recently announced the rollout of ready-start CGMP suites available for these by early stage life science and cell gene therapy companies expected to be available to customers in the second and third quarter of this year. Before I devolve further into our progress, I want to remind you of where we come from. Thermogenesis has proven its ability to pioneer the development and production of a long list of cutting edge automated technologies and products for the cell banking and cell therapy industry. For many years, Thermogenesis has been the provider of the choice of automated cell processing and automated smart cryogenic storage technologies for some of the world's most important public and private banks. Our bio archive file storage system has warehoused close to 90% of all U.S. FDA VLA-approved pinnacle-grade cold blood units. And our ASP system has been utilized by approximately close to 130 institutes across the world and has processed well over a million samples thus far. The intellectual properties we have accumulated over our history is invaluable and we are excited about the future. Driving our forward-looking strategy in large part is the continued growth and industry focus on the potential for personalized cell and gene therapy. Since 2017, six autologous CAR-T therapies have been approved by the FDA. While CAR-T therapies were initially approved as the last line of defense, more recently there have been CAR-T trials that have shown that these therapies can outperform second-line standard of care options, which could expand its applications in the future. Recent reports show that the industry anticipates additional FDA approvals with as many as 10 to 20 new therapies each year starting in 2025. As the demands for cell gene therapies continue to explode, there are now an estimated over 350 US companies alone working in cell therapy arena and more than 1,000 pipeline assets in clinical development globally, targeting a variety of blood and solid tumors. Unfortunately, the surge in clinical activity has not been matched by an increase in production capacity. Even though over 70% of all cell and gene therapy companies outsource their manufacturing needs, only a fraction of the required capacity exists in the marketplace today, creating a critical 12 to 18 months backlog in commercial manufacturing. This will only be exacerbated by accelerated approvals in the coming days. These dynamics have led to a rise in CDMO partnership activities as more and more biopharmaceutical companies and other industrial participants recognize the urgency of the increased demand for cell therapy and the limited availability of the CGMP facilities. Moving forward from manual process will be a key to facilitating faster timelines and getting these life-saving drops from bench to bedside. At the same time, there are the main critical and growing needs for manufacturing of these compact centerpiece due to continued challenges. created by high production cost, technological inefficiencies, and limited global capacities. Drug manufacturing today is still the largest component of the cost of CAR-T cell therapies. As a result, there is a significant need for high-quality CGMP manufacturing at a reasonable cost. Additionally, There are not a lot of CDMOs that are well equipped to handle the process that is required for cell gene therapy manufacturing. And it takes years for companies to build their own facilities. The need for CDMP manufacturing of these extremely complex personalized and life-saving therapies is as important as ever. Thermogenesis will look to address the growing need for CDMO service by providing high-quality development and manufacturing capacities, cell and tissue processing development, quality systems, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various stage of development. Specifically, we will leverage our unique cell processing technologies, such as Tati Express platform, combined with our existing in-house expertise to provide variable solutions for clients with therapeutic candidates. Taken together, our line of products and services will be specifically designed to provide the flexibility needed to deal with uncertainty at every stage of the process. As recently announced, we are building out our approximately 35,000 square feet of laboratory and office space in Sacramento, California. which includes 12 ReadyStart plus seven CGMP clean room suites to support the industry's manufacturing requirements. These ReadyStart CGMP suite will be available for these by early stage life science and therapy companies. Importantly, the ReadyStart suite will meet the highest scientific quality and regulatory requirements and are ideal for early stage companies looking to jumpstart their development efforts and or to scale up in the same facility with a turnkey solution. Further, the suites will eliminate a tremendous resource burden and greatly accelerate the development cycle by allowing the resident companies to focus on their own core science. Our all-encompassing ReadyStart CGMP Suite will provide a flexible option, enable companies to achieve their anticipated milestones faster and more efficiently. Our team's strong expertise in regulatory affairs and product commercialization will help accelerate the development of our customers' products, allowing them to focus on their own science while Thermogenesis will manage the regulatory and quality compliance associated with running a GMP facility. The ReadyStar CGMP suites are expected to be available for customers in the second and third quarter of this year. And once fully leased, are expected to generate an additional annual revenue in the range of 10 to 16 million. We look forward to reporting more on the progress in the coming months. And with that, Let me turn the call over to Jeff to share some of the key financial results for the year. Jeff?