5/15/2023

speaker
Operator
Conference Operator

Good day, and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the first quarter ended March 31st, 2023. 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'd 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'd now like to turn the conference over to our host, Paula Schwartz of RX Communications. Please go ahead.

speaker
Paula Schwartz
Host, RX Communications

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, May 15th, 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 Xu, Chief Executive Officer, and Jeff Cobble, Chief Financial Officer. I'd now like to turn the call over to Chris. Please go ahead, Chris.

speaker
Dr. Chris Xu
Chief Executive Officer

Thank you, Paula, and thank you to everyone for joining the call this afternoon. We appreciate you to take the time to listen in. During the first quarter, we are making progress towards executing our plans to transform the from a medical device company to an integrated contract development and manufacturing organization, or CDMO, for the cell and gene therapy market. In March 2023, we closed a $3 million private placement, which will help support the planned launch of our CDMO business. The goal is to leverage our unique and proprietary automated and semi-automated cell processing technologies, including the Kachi Express platform, to manufacture future cell gene therapies cheaper and more efficiently. To that end, we have made significant headway building out a 12-unit ready-to-start CGMP suite at our 35,500 square foot facility in Sacramento. These class seven clean rooms are designed to meet the highest scientific quality and regulatory requirements that would be ideal for the early stage companies and institutions developing next generation of cancer medicines such as CAR-C cell therapies. and to accelerate direct candidates into connect quicker and safer. Our goal is to establish solutions for customers in order to streamline the supply chain, increase manufacturing predictability, and manage overall risk. We have begun to market this turnkey solution to early stage life science cell gene therapy companies who are looking to jumpstart their development efforts and scale up in the same facility. We expect the ReadyStop CGMP suite to be available for these two customers in the second or third quarter of this year. As you may know, for over 35 years, Thermogenesis has pioneered the development and manufacturing of a series of innovative automated technologies and products specifically for the cell banking and cell therapy industry. In fact, Thermogenesis has been the leading provider of choice for automated cell processing and automated smart cloud storage technologies for some of the world's most important public and private cell banks. Our bioarchive smart file storage systems has warehoused close to 90% of all U.S. FDA VLA-approved clinical-grade cobalt units, or CBUs, and our AXP system has been used to process well over a million samples from well over 100 institutes globally. In addition to our manufacturing know-how in cell gene therapies, the intellectual properties that we have amassed over the years are invaluable. Driving our shift to a CDMO in large part is the continued growth of the industry, focusing on the potentials for personalized cell and gene therapies. Since 2017, six autologous CAR-G cell therapies have been approved by the FDA. CAR-G therapies were approved as the last line of defense for those patients who did not respond to other therapeutic options. More recently, there have been several CAR-G trials that have shown that such therapies can outperform second-line or standard of care options, indicating that the applications for CAR-T cell therapy may expand in the future. Recent reports show that the industry anticipates additional FDA approvals with as many as 10 to 20 new cell therapies potentially being approved for commercialization annually starting in 2025. With more cell therapies, such as CAR-T cell therapies, receive FDA approval, the demand for manufacturing of these lifesaving 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 in clinical development globally, targeting a range of blood and solid tumors. While a majority of this innovative research was driven by small to medium-sized biotech companies and medical research centers, the demand for third-party manufacturers continued to grow. Each of our well-encompassing ReadyStart CGMP suites will provide a flexible option, enabling small to medium-sized companies to achieve their anticipated milestones faster and more efficiently. Additionally, 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 science while Thermogenesis will manage the regulatory and quality compliance associated with running a GMP facility. With Thermogenesis strong intellectual property position, cutting-edge technology and manufacturing service expertise, our new facility will have the ability to address the increased demand for cell gene therapy manufacturer capabilities. We will remain focused on launching the CDMO service and Ready Start CGMP unit to customers in the cell gene therapy field in the next few months. And with that, let me turn the call over to Jeff to share the key financial results for the first quarter. Jeff?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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