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 30th, 2023. As a reminder, this call is being recorded today. I would now like to turn the conference call 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 13, 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 would now like to turn the call over to Chris. Please go ahead.

Thank you, Paula. And thank you to everyone for joining the call today. We appreciate you taking the time to listen in. During the third quarter and subsequent period, we continue to make significant progress in executing our plan to transform from a medical device company to an integrated contract development and manufacturing organization, or CDMO, for the cell gene therapy market. To that end, we completed and officially launched our 35,500 square feet CGMP clean room suite in Sacramento. CGMP stands for Current Good Manufacturing Practices. Our 12 Ready Start CGMP clean room suites are designed to meet the highest scientific, quality, and regulatory requirement for cell gene therapy field, and will be ideal for early and mid-stage companies and institutions that are currently developing cell and gene therapies and advanced therapy medicinal products, or ATMPs. We provide this turnkey solution to early and mid-stage life science and biopharmaceutical companies who look to jumpstart their R&D efforts and to scale up for clinical development quickly. Our goal is to establish solutions for customers in order to streamline the supply chain, increase manufacturing predictability, and manage overall risk while reducing overall costs. As most of you know, for over 35 years, Thermogenesis has pioneered the development and manufacturing of a series of innovative or automated technologies and products, especially for the cell banking and cell therapy industry. The driving force for us to transition into a CDMO is largely due to the continuous growth on personalized cell and gene therapies. Since 2017, the FDA has approved six autologous CAR-T therapeutics. While CAR-Ts were initially authorized as the last resort for patients who did not respond to other therapeutic treatments, recent CAR-T trials have demonstrated that these treatments can surpass second-line standard of care options, suggesting that the scope of the application for CAR-Ts may expand in the future. According to recent reports, the industry anticipates further FDA approvals, potentially of 10 to 20 new cell gene therapies per year starting in 2025. At this very moment, there are over 350 US companies operating in the field of cell therapy alone. with over 1,000 pipeline assets worldwide. The ongoing search in research and development is enabled by the remarkable potential that exists in the current commercialized therapies. As thousands of preclinical and clinical trials are currently underway for innovative cell therapies, there is increasing needs for dependable and quality CDMO cell manufacturing services. Our CDMO services will provide clients with high-quality development and manufacturing capabilities, along with cell and tissue processing development, quality systems, regulatory compliance, and other cell manufacturing solutions for the therapeutic candidates. at different stages of development. A crucial aspect of our plan is to leverage our proprietary, highly efficient, semi-automated Kachi Express platform, which has already demonstrated the ability to significantly reduce processing time, improve cell recovery rates, and potentially lower the manufacturing cost associated with the cell gene therapies by up to 50%. Additionally, our team's strong expertise in regulatory affair and product commercialization will help accelerate the development of our customers' products, allowing them to focus on their science while thermogenesis will manage the regulatory and quality compliance associated with running a CGMP facility. Utilizing our extensive and comprehensive knowledge and experiences in the cell therapy field, we aim to offer clients the advantage of our broad expertise across the manufacturing of many different cell types. 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.