Protagenic Therapeutics Announces Completion of Enrollment and Dosing in Phase 1 MAD Study

NEW YORK CITY, NY / ACCESS Newswire / November 13, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel therapeutics for stress-related neuropsychiatric and neurodegenerative disorders, today announced the successful completion of enrollment and dosing in its Multiple Ascending Dose (MAD) Phase 1 study evaluating its lead compound, known as PT00114. The study, conducted in healthy volunteers, was designed to assess the safety and tolerability profile of PT00114 following multiple doses over time. With all healthy volunteers now dosed, the company has achieved a milestone in the clinical development of its proprietary peptide-based therapeutic.

“We’ve completed all dosing for all healthy volunteers in the Phase 1 Study,” said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics. “We plan to deliver a full summation of our analysis of the safety results within by the end of the month.”

The company expects to finalize and release top-line results from the MAD study by November 30^th.

“This milestone underscores our commitment to advancing PT00114 as a novel, first-in-class therapeutic aimed at restoring resilience and balance in individuals suffering from chronic stress and its neurological consequences,” added Dr. Armen. “The company had previously completed a single ascending dose study in early 2025. We are encouraged by the progress to date and are excited to move toward the next phase of development.”

About Protagenic Therapeutics, Inc.

Protagenic Therapeutics, Inc. (NASDAQ:PTIX) is a biopharmaceutical company focused on developing innovative peptide-based therapeutics targeting the biological pathways underlying stress-related neurological and mood disorders. The company’s lead compound, PT00114, is a synthetic analog of a naturally occurring brain peptide that helps regulate the body’s stress response and emotional equilibrium. For more information, visit www.protagenic.com.

Forward-Looking Statements

Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to the Company’s product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Company Contact:

Alexander K. Arrow, MD, CFA
Chief Financial Officer
Protagenic Therapeutics, Inc.
149 Fifth Ave, Suite 500, New York, NY 10010
Tel: 213-260-4342
Email: alex.arrow@protagenic.com

SOURCE: Protagenic Therapeutics, Inc.

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