ThermoGenesis Announces Roll Out of ReadyStart cGMP Suites for Early-Stage Cell and Gene Therapy Companies

Rhea-AI Summary

ThermoGenesis Holdings, Inc. (THMO) announced the launch of a new facility in Sacramento, featuring 12 ReadyStart cGMP Suites for early-stage life science and cell gene therapy companies. This initiative aligns with ThermoGenesis' strategy to transition into a contract development and manufacturing organization (CDMO). The facility, which will be operational in Q2 or Q3 2023, could generate $10-16 million in annual revenue if fully leased. The ReadyStart Suites aim to provide flexible solutions that accelerate product development while alleviating resource burdens for startups.

Positive

• Launch of 12 ReadyStart cGMP Suites to support early-stage companies.
• Potential annual revenue generation of $10-16 million if fully occupied.
• Facility expected to enhance development speed and efficiency for clients.

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• None.

RANCHO CORDOVA, Calif., March 15, 2023 /PRNewswire/ -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, today announced that 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 roll-out of the ReadyStart Suites is part of ThermoGenesis' previously announced plan to transform from a medical device company to a contract development and manufacturing organization ("CDMO") in the cell gene therapy field. The facility is expected to be available for customers in the second or third quarter of this year. If fully occupied, the facility is anticipated to generate an estimated $10-16 million in annual revenue.

"We launched the flexible ReadyStart cGMP Suites to better support the research and clinical development of cell gene therapy products. Early-stage life science and cell gene therapy companies face a long and complex path to product commercialization often while being constrained by limited budgets," stated Chris Xu, Ph.D, Chairman and Chief Executive Officer of ThermoGenesis. "Our all-encompassing ReadyStart cGMP Suites, will provide a flexible option, enabling companies to achieve their anticipated milestones faster and more efficiently. Additionally, our team's strong expertise in regulatory affairs 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 compliances associated with running a cGMP facility."

The ReadyStart Suites are located in a 35,500+ square foot cGMP facility that will meet the highest scientific, quality, and regulatory requirements. The designing, building and managing of a cleanroom requires a significant capital investment is extremely time consuming and can be draining on a company's resources. ThermoGenesis' ReadyStart cGMP cleanrooms are ideal for early-stage companies looking to jump-start their development efforts and/or scale up in the same facility, providing a turnkey solution. Further, the suites will eliminate a tremendous resource burden and greatly accelerate the development cycle by allowing the resident companies to focus on their core science.

About ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc. develops, commercializes, and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect the current expectations of ThermoGenesis concerning future events and results. Forward-looking statements based on ThermoGenesis' current assumptions, expectations and beliefs are generally identifiable by use of words "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue," or similar expressions and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. Such forward-looking statements involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, market and other conditions, as well as those risk factors discussed in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") as well as other documents that may be filed by ThermoGenesis from time to time with the SEC, which are available at www.sec.gov. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Company Contact:
Wendy Samford
916-858-5191
ir@thermogenesis.com

Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com

 

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SOURCE ThermoGenesis Holdings, Inc.

FAQ

What is the significance of ThermoGenesis' rollout of the ReadyStart cGMP Suites?

The rollout provides early-stage life science companies with flexible, compliant spaces that enhance product development.

When will the ReadyStart cGMP Suites be available for lease?

The suites are expected to be available for customers in the second or third quarter of 2023.

What revenue could ThermoGenesis generate from the new facility?

If fully occupied, the new facility could generate an estimated $10-16 million in annual revenue.

How does ThermoGenesis plan to support cell gene therapy companies?

ThermoGenesis aims to manage regulatory and quality compliance to help clients focus on their scientific research.

What strategic shift is ThermoGenesis making with its new facility?

ThermoGenesis is transitioning from a medical device company to a contract development and manufacturing organization (CDMO).