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.

A full discussion of our financials is available in the earnings release in 10Q, so I'll just take a moment to review the key financial information for the quarter ended September 30, 2023. Net revenues were $2.2 million for the quarter. up approximately $100,000 from the same period as last year. Current revenues continue to be driven by AXP disposable sales, which were up approximately $400,000 from the third quarter of last year. With the completion of our ready start clean rooms in October, we will begin recording revenues from CDMO services in the fourth quarter. Gross profit for the third quarter was $400,000, or 18% of net revenue, in line with our gross profit from the same period in 2022. We expect to see increases in our gross margin in 2024 as a higher percentage of our revenue is derived from CDMO services. Selling general and administrative expenses were $1.7 million for the third quarter as compared to $2 million for the same period last year. The decrease was driven by lower employee benefit and corporate expenses. Interest expense was $2.1 million for the third quarter as compared to $1.4 million for the same period in 2022. The increase was driven primarily by non-cash amortization expense in the current year. For the quarter ended September 30, 2023, the company reported a comprehensive loss attributable to common stockholders of $3.6 million or $1.44 per share based on approximately 2.5 million shares outstanding. This compares to a comprehensive net loss of $3.2 million or $4.66 per share based on approximately 700,000 shares outstanding for the quarter ended September 30th, 2022. At September 30th, 2023, the company had cash and cash equivalents totaling 4 million compared with cash and cash equivalents totaling 4.2 million at December 31st, 2022. This concludes our prepared remarks. So now we'd like to open the call for your questions. Operator?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. And if for any reason you would like to withdraw a question, please press star, then 2. At this time, we will take our first question, which will come from Sean Lee with HC Wainwright. Please go ahead.

Good afternoon, everyone, and thanks for taking my questions. My first question is on the... uh response so far to the launch so i was wondering how have you been marketing your cdmo services since its launch and what how would you gauge the response so far from the market hi sean thanks uh for for following up on our company so uh we officially launched and had a written rebel ribbon cut event

in October, and we have since had the clients start to move in in this. And there are certainly, as you may aware, a nationwide shortage on CDMO facilities and services across the entire country. So there are an increasing number of biotech and pharmaceutical companies looking for not only just the CDMO service, but also facilities that have the full CGMP capability to help them develop and manufacture product candidates for clinical trials. So we certainly, with regards to how we market this, And the long-term goal is to use some of the suites by ourselves by launching the service. But in the short term, we are actually engaging a few different agents and brokers in the laboratory space in the life science area. where they see a clear shortage of such CGMP labs. And they are really helping marketing our newly opened facility nationwide. And on a financial end, we will probably, I will leave that to Jeff, but we will probably start to recording the revenue in in the fourth quarter.

Yep, that's correct. I mean, we do have several, we're actively engaged with several customers right now on contracts that are in process. We have a couple that are finalized right now. So we do anticipate seeing some revenues this quarter, but as a lot of the companies are just be moving in, I think we'll see the larger revenues begin to hit in 2024.

That's great to hear. Thank you for that. My next question is on the future direction. So you mentioned you have the suites ready. Would you be able to expand additional suites if there is enough demand for it? And would these suites be able to be upgraded with the Cartier Express system? Okay.

So currently we have 12 CGMP suites, and just putting that into perspective, and I mean, for instance, UC Davis as a major research-oriented university has six GMT suites, and many of the academic center has single-digit manufacturer suites. So that put us in pretty good shape, satisfying the need of the market. We do have extra space that we can expand to building more of such GMP suites, if needed. With regards to whether we can upgrade this to CAR T, currently, we design our CDMP in the highest quality and standards, these suites are ready to take on car key manufacturing as yet. So in that regard, we really don't have to upgrade them. With regard to future, to lease out some of the GMP suites, It's really just so that we can use this extra space for the time being. The long-term goal is actually we leverage our proprietary manufacturing platform, as you know, the Kachi Express platform, which significantly reduced the manufacture cost by 50%. By providing a CDMO service ourselves, we can save our clients a lot more in terms of the cell manufacturing needs. So that's the long-term goal. It's not just to lease out cells, but actually providing the drug manufacturing service for the cell gene therapy field.

Thank you for the additional color. That's all the questions I have.

Thanks, Sean.

And this concludes our question and answer session. I'd like to turn the conference back over to Dr. Hsu for any closing remarks.

Thank you, operator. We look forward to updating you on our progress during our year-end 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 your lines.