ThermoGenesis Holdings, Inc.

Good day and welcome to the Thermogenesis Holdings conference call and webcast to review financial and operating results for the second quarter ended June 30th, 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 would like to ask a question, please press star then one on your phone. If you wish to withdraw from the question queue, please press star then two. 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 law. 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 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, August 10, 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 this afternoon. We appreciate you taking the time to listen in. During the second quarter, we continued to make progress to transform from a medical device company to a CDMO cell manufacturer for the cell and gene therapy market, through which we will leverage our unique and proprietary automated and semi-automated cell processing technologies, including the CAR-T Express platform. We are getting close to completion of the 12 Ready-Start Current Good Manufacture Practice Suites, or GMP Suites, at our 35,000 square feet GMP facility in Sacramento. These Class VII clean rooms are designed for early-stage businesses and organizations striving to speed up the process to bring in novel cell gene therapies to clinical trials. Our priority is to provide customers with solutions that optimize the supply chain increasing manufacturer predictability, and manage overall risk. We have started advertising this turnkey solution to early stage life science cell gene therapy companies whose team want and need to expedite their development efforts from early non-GMP grade research. We have continued to draw interest from potential customers for the state of art Ready Start CGMP unit, which remain on target for availability, which is later this year. As most of you know, for over 35 years, Thermogenesis has spearheaded the advancement and production of a variety of revolutionary automated technologies and products tailored for the cell banking and cell therapy sector. Indeed, thermogenesis has been the top choice for automated cell processing and state-of-art smart cryogenic storage technology for numerous renowned public and private cell banks globally. Our bio-archive cryo storage system has safeguarded nearly 90% of all US FDA BLA-approved clinical-grade core blood units, or CBUs, while our AXP system has been utilized to handle well over a million samples for approximately 130 institutes globally. In addition to our expertise in manufacturing cell gene therapies, the intellectual properties we have acquired over the years is extremely valuable. The driving force behind our transition to a CDMO is the ongoing growth and the industry emphasis on the potential of personalized cell gene therapies. Since 2017, FDA has approved six autologous CAR-T therapeutics which have demonstrated unprecedented efficacy in patients with B-cell malignancy and multiple myeloma. Although CAR-Ts were initially authorized as a final resort for patients who did not respond to alternative treatments, recent trials have demonstrated their ability to outperform second-line standard of care options. This suggests that the scope of applications for CAR T therapies may expand in the future. Recent reports indicate that the industry expects additional FDA approvals with potential 10 to 20 new CAR T therapies approved for commercialization each year starting in 2025. As I have noted previously, with the rise in FDA-approved regenerative medicine treatments and CAR T therapies, there is an increasing need for the production of these life-saving therapies. Presently, there are over 350 U.S. companies exclusively focused on cell therapy research and development. And there are more than 1,000 pipeline assets in clinical trials worldwide, specifically targeting a wide range of blood and solid tumors. This exponential growth in R&D is enabled by the remarkable potential inherited in already available therapies, alongside the promising prospect provided by personalized cell and gene therapies. With thousands of preclinical and clinical trials currently being conducted, there is an unprecedented demand for high-quality and reliable CDMO services. Moreover, as I have noted many times, approved CAR T cell therapies in the U.S. tends to cost between approximately $373,000 to $475,000 per dose, making them one of the most expensive drug classes on the market. Significantly, the manufacturing cost for just one dose of some CAR T therapeutics exceeds $100,000. with 79% of which attributed to labor and GMP facility expenses. Given these dynamics, developers need to tackle the issue of producing high-quality, clinical-grade cell therapies at a commercial scale, which will enable more patients to benefit from these revolutionary treatments. We strongly believe that the CAR-T express platform we have holds the potential to considerably reduce processing time, enhancing cell recovery rates, and effectively lowering the manufacturing cost for CAR-T and other cell gene therapies. Through our CDMO services, we offer high-quality development and manufacturing capacities as well as cell and tissue processing development, quality system, regulatory compliance, and other cell manufacturer solutions for clients with therapeutic candidates in different stage of development. As mentioned, An integral aspect of this plan is leveraging our proprietary high-efficient CAR-Chi Express platform, which has demonstrated its ability to significantly reduce processing time, enhancing cell recovery rate, and potentially cut manufacturing costs associated with CAR-Chi and other cell gene therapies by up to 50%. Additionally, by utilizing our comprehensive cell therapy portfolio, we intend to provide clients with the benefit of our extensive expertise in a variety of cell types such as chimeric antigen receptor T cells, TCRT, and tumor infiltrating lymphocytes, natural killer cells, and including other cells such as inducible pluripotent stem cells and mesenchymal stem cells. Our all-encompassing ReadyStart CGMP suite provides a versatile solution, allowing companies to reach their projected milestones faster and more efficiently. Our team's expertise in regulatory affair and product commercialization should accelerate the development of our customers' products, allowing them to focus on their research while we manage the regulatory and quality compliance aspects associated with operating CGMP units. In the second quarter, we invited two additional members to our board of directors, Dr. Biao Xiyi and Dr. James Xu. Biao is a highly regarded life science executive with extensive expertise in biopharmaceutical research and drug development. And James brings strong legal, IP, and business acumen. including more than 25 years in the field of patent, corporate law, and tax law. Their contributions are highly valuable to the company. And with that, let me turn the call over to Jeff to share the key financial results for the second quarter. Jeff?

Thank you, Chris. A full discussion of our financials is available in the press release in 10Q. So I'll just take a moment to review key financials for the quarter ended June 30th, 2023. Net revenues were 2.3 million for the quarter as compared to 3 million in the second quarter of last year. The decrease was driven by a large AXP purchase, AXP disposables purchase from our distributor in China last year. which was offset by increased domestic ASV disposable and bioarchive device revenue in the second quarter of this year. Selling general and administrative expenses were $1.8 million for the quarter ended June 30, 2023, as compared to $2 million for the same period last year. The decrease was driven by lower employee benefit and decreased legal expenses in the second quarter of this year. For the quarter ended June 30, 2023, the company reported a comprehensive loss of $2.3 million, or $0.91 per share, based on approximately 2.5 million shares outstanding. This compares to a comprehensive loss of $2.7 million, or $8.98 per share, based on approximately 300,000 shares outstanding for the quarter ended June 30, 2022. At June 30, 2023, the company had cash at cash equivalents totaling $4.5 million, and paired with cash and cash equivalents of $4.2 million at December 31st, 2022. This concludes our prepared remarks. Now we'd like to open the call to your questions. Operator?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press star, then 2. The first question is from Sean Lee of HC Wainwright. Please go ahead.

Good afternoon, Chris and Jeff, and thank you for taking my questions. My first question is on the GMP facility. So what remains to be done before they would be open for business, should we say, and be ready to have the first customers?

Hi Sean, thanks for the question. So we have completed majority of the infrastructure build out and what's remaining is just to have the facilities certified for ISO and we are really in the last step, last few steps. So we are actually very actively having customers touring the facilities and having ongoing discussions with customers.

It's at the pre-opening stage. Okay. So do you have any potential leads on customers so far? And when do you estimate we can see the first one move in?

Yeah, we are actively discussing with various different customers in the cell gene therapy and also in other life science fields that require GMP facility. So we may have customers moving as early as towards the end of the third quarter or very early fourth quarter. So we definitely see the growth of interest.

Great. For these facilities, you mentioned they're used for cell therapies. In particular, are there specific types of cell therapies they would be well-suited for?

Yes. This entire facility is highly specific and very specifically designed for cell and gene therapies. Because traditionally for pharmaceutical industry and the clean rooms tend to be large and that allows big equipment to be put in to produce batches of drug. And each batch can be thousands of patients. Actually, each batch could be millions of patients. And that's the historic way of producing drugs. With cell and gene therapy, and that changed the practice entirely because cell and gene therapy are very personalized and very individual. So each drug is specifically produced for that purpose. that particular patient. So you can see this as one drug, one patient. So the facility is designed into small GMP unit, almost like a beehive, and so that allow individual drugs, individual personalized cell gene therapy can be produced in each unit. And you can produce as many batch as it allows and allow the quick turnover for each individualized medicine. So this facility is particularly designed for that purpose. And there are such a shortage of facility designed for cell gene therapy at this moment.

Thanks for that. That's very helpful. My last question is on the potential revenues we can see from this facility. What's the average revenue we can expect to see from each one of these suites, and what are your key costs for maintaining this?

Currently, we run 12 GMP units, and each unit average 500 square feet size. For the 500 square feet, the average market cost, if it's available, mostly are not available because of the big demand. The average cost per 500 square feet GMP suite is about $75,000 to $150,000. per month. So basically, we have 12 GMP units on hand.

John, I mean, on an annualized basis, I mean, we're looking at roughly $1 million per suite. And the costs per suite are fairly minimal to us because most of the expenses the companies are coming in and renting the room i mean so so realistically we're looking at a pretty small number probably 50 to 100 000 per room on an annualized basis and expenses for us yep and that's very helpful thanks chris and thanks jeff that's all i have thanks john this concludes our question and answer session i would like to turn the conference back over to management for closing remarks

Thank you, operator. We look forward to updating you on our progress during our third quarter 2023 call. And thank you to everyone who participated today and for your interest in thermogenesis holdings.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.