Theratome Bio Completes Manufacturing Technology Transfer

Manufacturing Technology Transfer Marks Major Company Milestone

Gainesville, Florida — (June 24, 2024) — Theratome Bio, Inc. (“Theratome” or the “Company”), a regenerative medicine company enhanced by artificial intelligence focused on developing safer, and more efficacious therapies for patients with limited or poor therapeutic choices, announced today that the Company has successfully completed the technology transfer of its manufacturing process for the production of its proprietary secretome product platform.

The completed technology transfer marks a significant achievement for Theratome. The Company believes its production and process improvements should result in a reliable, scalable, reproducible and stable drug product suitable for storage, shipment and patient use.

“The successful completion of our manufacturing technology transfer represents a major milestone for Theratome,” said Michael T. Redman, President and Chief Executive Officer of the Company. “ As part of this transfer, the manufacturing has been upgraded from the laboratory to a commercial-grade bioreactor, which should result in significantly greater yields and cost savings.“

Dry Eye Disease

Dry eye disease affects more than 16 million Americans and 344 million people worldwide. Dry Eye Disease imposes a substantial economic burden on the healthcare system and society due to both direct and indirect costs. The medical costs associated with DES include diagnostic tests,

ophthalmic appointments, prescription medications (e.g., artificial tears, anti-inflammatory drops), and other treatments. Due to the critical nature of sight to most aspects of daily life, its indirect costs are very significant, with both productivity loss and reduced quality of life. A study published in JAMA Ophthalmology (2020) estimated that the total annual cost of dry eye disease management in the United States exceeds $3.8 billion.

Dry eye disease is also a major eye problem in dogs.

Organ Transplantation

In the case of organ transplantation, the secretome formulation will be added to current approved organ transplantation solutions prior to shipment from the donor to the patient. The solution is washed out prior to placement in the patient. This product will be classified as a device.

Transplanted hearts lose viability faster than any other transplanted organs. At the four-hour mark, heart cell function begins to fail, and the likelihood of organ malfunction or failure rises significantly. Preclinical data show that Theratome secretomes (Thera-103) may double the shelf life of transplanted organs in transit.

More than 10,000 hearts are donated each year in the United States, but approximately 3,000-3,500 are unusable due to a problem with the heart, or another comorbidity that precludes transplantation; and another 3,000-3,500 cannot be used expressly due to the inability to get the heart to the donor in time.

About Theratome Bio

Theratome Bio, Inc., is a biopharmaceutical company focused on regenerative medicine utilizing artificial intelligence. The Company’s technologies are designed to address both causes and symptoms of disease.

Theratome works with world-class institutions and collaborators to develop product candidates to further its pipeline of regenerative medicine products. The treatments have multimodal mechanisms of action that has been shown to aid in the rescue and repair of organs and tissues. The Company has six issued US patents and another two pending.

For more information, please visit the Company’s web site at

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Theratome’s product candidates, alone and in combination with other therapies, on dry eye disease, organ preservation and other diseases, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of our product candidates, including whether we receive fast track or similar regulatory designations; and costs associated with developing our product candidates.

All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Theratome Bio, Inc.

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