3/28/2022

speaker
Operator
Conference Operator

Good day and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the year ended December 31st of 2021. As a reminder, all participants are in a 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 telephone keypad. And if you wish to withdraw your question, please press star then 2. If you should need assistance during the conference call, please signal our operator by pressing the start key, then zero. As a reminder, this conference is being recorded. I would now like to turn the conference over to our host today, Ms. 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, March 28, 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 Hsu, Chief Executive Officer and Jeff Cobble, Chief Financial Officer. I'd like to now turn the call over to Chris. Please go ahead.

speaker
Dr. Chris Hsu
Chief Executive Officer

Thank you, Paula. And thank you for everyone to join us for our fiscal year 2021's earning call this afternoon. We appreciate you taking the time to listen in. For the past two years, our industry and the entire world have been affected by the COVID-19 global pandemics. we are happy to see that we are now getting close to the end of that. And our customers and our clients are rebounding in many aspects. As for thermogenesis, we are not only taking this opportunity to grow our existing business, but also to get ready to transform the company into a new direction for its future growth. Ever since we established in 1986, For more than 30 years, thermogenesis has always been focused on the development and production of cutting-edge automated cell processing medical devices for the cell banking and cell therapy industry. For example, we have supplied many automated cell processing and cryogenic storage technologies towards major public and private cord blood banks. Our bio-archive smart cryo-storage system warehoused close to 90% of all U.S. FDA biological license application or BLA-approved clinical grade core blood units. Our AXP system has processed more than 1.2 million samples worldwide since its launch in nearly 40 countries and 140 institutes. In the past two years, we continued to develop more FDA-approved medical devices for point-of-care clinical applications and for large-scale cell therapy manufacturing. These intellectual properties, proprietary technologies, and know-hows are invaluable assets to the company. In the past five years, cell therapies have become the next pillar of medicine. In 2017, the U.S. FDA approved the first CAR-T cell therapy, ChemRyder, which uses cancer patients' own immune cells and turned that into a cell therapy for the treatment of acute lymphoblastic leukemia. The CAR-T cell therapy demonstrated close to 90% response rate in the relapsed and refractory cancer patient group. Or in other words, patients who have failed chemotherapy, radiation, and all other therapeutic options. By the end of 2021, FDA has approved five CAR-T therapies for various forms of blood cancers. And globally, there were over 1,200 CAR-T cells-related clinical trials registered on the National Institute of Health website, targeting a variety of blood and solid tumors. One of the major issues with moving cell therapy products from bench to bedside has been the manufacturing bottleneck. The heterogeneous and personalized nature of the cell therapy product has introduced manufacturing and scaling up complexities that are not seen with the traditional pharmaceutical products. A significant number of cell therapy-based companies are seeking external service providers for their cell manufacturing needs. We believe that we can leverage our extensive IP and proprietary cell processing technologies to more effectively address cell manufacturing needs. With that said, Thermogenesis plans to launch its own contract manufacturing service for cell therapy products, leveraging our significant amount of IP and proprietary technologies in the cell processing and cell manufacturing field. By doing so, we are transforming thermogenesis from a traditional medical device company to a contract development and manufacturing organization, or CDMO, for cell therapy manufacturing. The company plans to develop and operate the CDMO business through a newly formed division named TG Biosynthesis. TG Biosynthesis intends to provide high-quality development and manufacturing capacities, cell and tissue processing development, quality system, regulatory compliances, and other cell manufacturing solutions for clients with therapeutic candidates in various stages of preclinical or clinical development. As you may have seen in our press announcement in 10K files today, which is March 28, 2022, Thermogenesis entered into a licensing and technology access agreement with Boyle Life Genomics for a license in the U.S. to use Boyle Life Genomics patents and know-hows related to cell processing and manufacturing. where Life Genomics is an affiliate of our Chairman and CEO, Dr. Chris Hsu, and is a China-based cell manufacturing organization that has developed substantial manufacturing technologies related to cell manufacturing services. Also, on March 24, 2022, Thermogenesis entered into a long-term lease agreement with Z3 Investment another affiliate of our chairman and CEO, to lease approximately 35,500 square feet of space in Sacramento, California, to build out a current good manufacturing practice or GMP-compliant cell manufacturing facility with 12 CGMP clean room suites. The planned build-out is expected to complete in six to nine months. We are targeting to launch our CDMO service to customers by the end of 2022. We look forward to reporting more of this exciting transformation in the coming months. And with that, let me turn the call over to Jeff to share the key financial results for the year 2021. Jeff?

Disclaimer

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