Mr. Michal Efraty reports

NEUROTHERA-CLEARMIND COLLABORATION ADVANCES MDMA-N-ACYLETHANOLAMINES IP FOR THE TREATMENT OF PTSD AMID RISING U.S. FEDERAL SUPPORT FOR PSYCHEDELIC INNOVATION

Neurothera Labs Inc.'s continuing collaboration with Clearmind Medicine Inc. has advanced with the publication in the United States of a patent application covering a novel combination of 3,4-methylenedioxymethamphetamine and N-acylethanolamines, such as palmitoylethanolamide, for use in methods of treating posttraumatic stress disorder, anxiety and eating disorders. The U.S. patent application was published by the United States Patent and Trademark Office.

The publication marks a significant intellectual property milestone resulting from the continuing collaboration between Neurothera and Clearmind. Through this collaboration, Neurothera's PEA technology is integrated into Clearmind's psychedelic-derived therapeutic programs, contributing to a joint intellectual property portfolio that includes 13 published patent applications generated through the Neurothera-Clearmind collaboration globally.

The newly published application includes embodiments relating to the potential use of PEA in combination with MDMA, including potential effects on MDMA's therapeutic potency, required dosing, associated side effects and therapeutic window.

Food and Drug Administration finalizes guidance addressing psychedelic drug development, including MDMA

The U.S. patent application publication comes at a time of increasing federal attention to the development of psychedelic medicines and recent U.S. Food and Drug Administration guidance addressing the clinical development of psychedelic drugs, including MDMA.

On July 14, 2026, the FDA finalized its guidance, "Psychedelic Drugs: Considerations for Clinical Investigations." The guidance provides considerations for sponsors developing psychedelic drugs for medical conditions, including psychiatric disorders and substance use disorders.

The FDA's final guidance explicitly includes MDMA within its definition of psychedelic drugs, describing the category as including classic psychedelics, as well as entactogens or empathogens such as 3,4-methylenedioxymethamphetamine. The guidance addresses considerations relating to clinical trial design, conduct, data collection, subject safety and new drug application requirements.

The FDA also notes that psychedelic drugs can present unique challenges in clinical development due to their psychoactive effects and alterations in mood, cognition and perception. The guidance provides sponsors with the FDA's current recommendations for addressing these considerations as part of psychedelic drug development.

For Neurothera and Clearmind, the FDA's explicit inclusion of MDMA in its guidance regarding psychedelic drug development provides regulatory context for the collaboration's MDMA-PEA intellectual property.

About Neurothera Labs Inc.

Neurothera is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations.

We seek Safe Harbor.