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| Additionally, our team’s strong expertise in regulatory affair and product commercialization will help accelerate the development of our customer’s products, allowing them to focus on their science, while ThermoGenesis will manage the regulatory and quality compliance associated with running a cGMP facility |
| So that puts us in pretty good shape, satisfying the need of the market |
| The ongoing surge in research and development is enabled by the remarkable potential that exists in the current commercialized therapies |
| A crucial aspect of our plan is to leverage our proprietary, highly efficient, semi-automated CAR-T 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% |
| During the third quarter and subsequent period, we continued 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 |
| 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 |
| Our CDMO services will provide clients with high quality development and manufacturing capabilities, along with cell tissue -- cell and tissue processing development, quality systems, regulatory compliance and other cell manufacturing solutions for the therapeutic candidates at different stages of development |
| The long-term goal is actually we leverage our proprietary manufacturing platform, as you know, the CAR-T Express platform, which significantly reduces the manufacturing cost by 50% |
| Our 12 ReadyStart cGMP clean room suites are designed to meet the highest scientific, quality and regulatory requirements for the 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 |
| The expectancy increases in our gross margin in 2024, as a higher percentage of our revenue is derived from CDMO services |
| 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 |
| As most of you know, for over 35 years, ThermoGenesis has pioneered the development and manufacturing of a series of innovative automated technologies and products, especially for the cell-banking and cell therapy industry |
| 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 |
| According to recent reports, the industry anticipates further FDA approvals, potentially of 10 to 20 new cell gene therapies per year starting in 2025 |
| With regards to whether we can upgrade this to CAR-T, currently we design our cGMP in the highest quality and standards |
| And thank you to everyone who participated today and for your interest in ThermoGenesis holdings |
| 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 result 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 |
| By providing a CDMO service ourselves, we can save our clients a lot more in terms of the manufacturing needs |
| Thank you for that |
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| And there are certainly, as you may be aware, a nationwide shortage of CDMO facilities and services across the entire country |
| 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 30, 2022 |
| 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 |
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