Dry Eye Study Marks Major Company Milestone and Paves Way to Human Trials

Gainesville, Florida — (August 1, 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 commenced a study using its proprietary secretome formulation to treat dry eye disease, also known as keratoconjunctivitis sicca (KCS).

Theratome announced it has received Institutional Animal Care and Use Committee (IACUC) clearance to conduct this study. Local IACUC committees review research protocols and conducts evaluations of each institution’s animal care and use. The drug substance has been manufactured and vialed into eye droppers suitable for the study. The study will be conducted at a leading U.S. veterinary school in 10 to 15 dogs over a 13-week period.

“The dog dry eye study has substantial significance,” said Michael T. Redman, President and Chief Executive Officer of the Company. “The data from this study may support the use for human clinical trials and provide a means to outlicense this technology to veterinarian companies for use in dogs. Like humans, dogs commonly suffer from dry eye disease.”

Dry Eye Disease
KCS affects more than 16 million Americans and 344 million people worldwide. Furthermore, this disease imposes a substantial economic burden on the healthcare system and society due to both direct and indirect costs. The medical costs include diagnostic tests, ophthalmic appointments, prescription medications (e.g., artificial tears, anti-inflammatory drops), and other treatments, which are frequently ineffective. 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 KCS management in the United States exceeds $3.8 billion.

Certain dog breeds are more likely to develop KCS, including Spaniels, Terriers, English Bulldog, Lhasa Apso, Miniature Schnauzer, Pekinese, Pug and Shih Tzu.

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, repair and preservation 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 www.theratomebio.com.

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.
mredman@theratomebio.com