ThermoGenesis Holdings Stock

ThermoGenesis Holdings, Inc. develops and commercializes a range of automated technologies for cell-banking, cell-processing, and cell-based therapeutics.

The company is a leading provider of automated systems that isolate, purify and cryogenically store units of hematopoietic stem and progenitor cells for the cord blood banking industry.

Medical Device Products for Automated Cell Processing

The company provides the AutoXpress and BioArchive platforms for automated clinical bio-banking, PXP platform for point-of-care cell-based therapies and the CAR-TXpress platform for large scale cell manufacturing services.

Clinical Bio-Banking Applications:

AXP Automated Cell Separation System – an automated, fully closed cell separation system for isolating stem and progenitor cells from umbilical cord blood, registered as a U.S. FDA 510(k) medical device.

BioArchive Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications, registered as a U.S. FDA 510(k) medical device.

Point-of-Care Applications:

PXP Point-of-Care System – an automated, fully closed, sterile system allows for the rapid, automated processing of autologous peripheral blood or bone marrow aspirate derived stem cells at the point-of-care, such as surgical centers or clinics, registered as a U.S. FDA 510(k) medical device.

PXP-LAVARE System – an automated, fully closed system that is designed to wash, re-suspend and volume reduce cell suspensions. It allows for volume manipulation, supernatant or media exchange, and cell washing to occur without comprising cell viabilities and maximizing recoveries, registered as a U.S. FDA 510(k) medical device.

PXP-1000 System – an automated, fully closed system that provides fast, reproducible separation of multiple cellular components from blood with minimal red blood cell contamination, registered as a U.S. FDA 510(k) medical device.

Large Scale Cell Processing and Biomanufacturing:

X-Series Products for general laboratory use: X-Lab for cell isolation, X-Wash System for cell washing and reformulation, X-Mini for high efficiency small scale cell purification, and X-BACS System under development for large scale cell purification using the company’s proprietary Buoyancy-Activated Cell Sorting (‘BACS’) technology.

CAR-TXpress Platform for Clinical Manufacturing – a modular designed, functionally closed manufacturing platform that addresses the critical unmet need for large scale cellular processing and chemistry, manufacturing and controls (‘CMC’) needs for manufacturing cellular therapies, including CAR-T cell therapies.

Contract Development and Manufacturing Services for Cell and Cell-Based Gene Therapies

The company plans to expand its business to include contract development and manufacturing services for cell and cell-based gene therapies. The company is in the process building out the capabilities to become a world-class Contract Development and Manufacturing Organization (‘CDMO’) for cell and cell-based gene therapies by partnering with Boyalife Genomics Tianjin Ltd., a China-based CDMO organization (‘Boyalife Genomics’), to in-license certain know-how and other intellectual property from Boyalife Genomics. The company is rolling out a new facility in the Sacramento metro area, containing a total of 12, class-7, ReadyStart cGMP Suites available for lease by early-stage life science and cell gene therapy (‘CGT’) companies. The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The company intends to leverage its existing technology and combine it with the in-licensed technologies to develop a proprietary manufacturing platform for cell manufacturing activities.

The company plans to develop and operate its planned CDMO business through a division named TG Biosynthesis. It is anticipated that TG Biosynthesis will provide high-quality development and manufacturing capabilities, cell and tissue processing development, quality systems, regulatory compliance, and other cell manufacturing solutions for clients with therapeutic candidates in various stages of development.

In furtherance of the company’s planned CDMO business, on March 24, 2022, the company entered into a License and Technology Access Agreement with Boyalife Genomics (the ‘Boyalife License Agreement’). Boyalife Genomics is a Tianjin, China-based cell manufacturing organization that has developed substantial manufacturing technology relating to cell manufacturing services. Under the terms of the Boyalife License Agreement, Boyalife Genomics granted the company and its subsidiaries and affiliates a perpetual exclusive license in the United States to use Boyalife Genomics’ existing and future know-how and the U.S. patents rights (if any) relating to cell manufacturing and related processes, including the right to sublicense such know-how and patent rights to affiliates of the company. Notwithstanding the foregoing exclusivity, Boyalife Genomics retains the right to use (but not license) the licensed intellectual property in the U.S. for its internal use in connection with the provision of products and services to third parties.

The successful development and launch of TG Biosynthesis will require the company to raise additional capital, acquire various equipment for the planned operations, hire certain personnel needed to launch the operation, and timely complete the build-out of the company’s leased Sacramento facility. The company expects the CDMO facility to be completed in 2023.

Sales and Distribution Channels

The company markets and sells its medical device products through independent distributors, except in North America and India, where the company sells direct to end-user customers.

Research and Development

The company’s research and development expenses related to the company’s medical device products were $1,659,000 for the year ended December 31, 2022.

Quality System

The company’s quality system for its medical device products business is compliant with domestic and international standards and is appropriate for the specific devices the company manufactures. The company’s corporate quality policies govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. Such policies are intended to ensure that the products the company markets are safe, effective, and otherwise in compliance with the FDA Quality System Regulation (‘QSR’) (21 C.F.R. Part 820), EN ISO 13485: 2016 standard, the European Union Medical Device Regulations (EU MDR 2017/745), the Canadian Medical Device Regulations (SOR 98-282), the Brazil ANVISA RDC 16/2013, UK MDR and/or other applicable local, state, national and international regulations.

The company and its contract manufacturers are subject to inspections by the FDA and other regulatory agencies to ensure compliance with the FDA’s QSRs. Compliance requirements relate to manufacturing processes, product testing, documentation control and other quality assurance procedures. The company’s facilities have undergone International Organization of Standards (‘ISO’) 13485:2016 and EU Medical Device Directive (‘MDD’) (93/42/EEC) inspections and the company has obtained approval to CE-Mark the company’s products. The company has received its updated certificate demonstrating compliance to this standard under the Medical Device Single Audit Program (‘MDSAP’).

Regulatory Scheme and Strategy

The development, manufacture and marketing of the company’s medical device products are subject to regulation by the FDA, as well as the equivalent agencies of other countries, including the countries of the European Union and India.

The company has a quality and regulatory compliance management system that meets the requirements of the ISO 13485: 2003 standard, the FDA’s QSRs, the EU MDD, Canadian Medical Device Regulations (SOR 98-282), and all other applicable local, state, national and international regulations.

Several of the company’s products, including the BioArchive and the AXP II are categorized as U.S. Class II medical devices and require premarket notification, also known as a section 510(k) clearance, prior to commercialization.

The company’s marketing and facilities licenses are subject to revocation by the applicable state Drug Controller in Haryana or DCGI.

Patents and Proprietary Rights

The company has over 28 issued patents globally relating to the company’s medical devices that will expire at various times between March 2031 and May 2040.

Material Agreements

Corning Incorporated

On August 30, 2019, the company entered into a Supply Agreement with Corning (the ‘Supply Agreement’). The Supply Agreement has an initial term of five years with automatic two-year renewal terms, unless terminated by either party in accordance with the terms of the Supply Agreement (collectively, the ‘Term’). Pursuant to the Supply Agreement, the company has granted to Corning exclusive worldwide distribution rights for substantially all X-Series products under the CAR-TXpress platform (the ‘Products’) manufactured by its subsidiary, ThermoGenesis Corp., for the duration of the Term, subject to certain geographical and other exceptions. In addition, the company has granted Corning rights of first refusal for the exclusive worldwide distribution of certain future products developed or introduced by the company relating to cell isolation or cell selection, including any such products substantially related or similar to the Products (the ‘ROFR Products’).

CBR Systems, Inc. (‘CBR’)

Manufacturing and Supply Agreement

Effective July 13, 2020, the company entered a Manufacturing and Supply Amending Agreement #2 (the ‘Amendment’) with CBR Systems, Inc. (‘CBR’), an amendment to the Manufacturing Supply Amending Agreement #1 effective March 16, 2020 and the Manufacturing and Supply Agreement effective May 15, 2017 (the ‘CBR Agreement’), in which the company agreed to supply CBR with AXP cord blood processing system and disposables.

Technology License and Escrow Agreement

As part of the Amendment, the company updated the compliance conditions in the Technology License and Escrow Agreement (the ‘Escrow Agreement’), which was originally signed by the company and CBR in June 2010. Under the Escrow Agreement, the company granted CBR a perpetual, royalty-free license to certain intellectual property necessary for the manufacture of AXP devices and disposables. The license is for the sole and limited purpose of ensuring continued supply of AXP devices and disposables for use by CBR. The licensed intellectual property is held in escrow and available to CBR only in the event of a default under the Escrow Agreement. The company was in compliance with the License and Escrow Agreement at December 31, 2022.

History

The company was founded in 1986. It was incorporated in the state of Delaware in 1986. The company was formerly known as Cesca Therapeutics Inc. and changed its name to ThermoGenesis Holdings, Inc. in 2019.