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U.S. publication of a patent application covering the MDMA-N-acylethanolamines combination expands intellectual property generated through the collaboration, and provides guidance addressing clinical development considerations for psychedelic drugs, including MDMA

Toronto, Ontario – TheNewswire - August 24, 2026 – NeuroThera Labs Inc. (TSXV: NTLX) (the " Company " or " NeuroThera "), a clinical-stage pharmaceutical company, today announced that its ongoing collaboration with Clearmind Medicine Inc. (Nasdaq: CMND) (“ Clearmind ”) has advanced with the publication in the United States of a patent application covering a novel combination of 3,4-methylenedioxymethamphetamine (“ MDMA ”) and N-acylethanolamines, such as palmitoylethanolamide (“ PEA ”), for use in methods of treating post-traumatic stress disorder (PTSD), 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 ongoing 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 thirteen 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.

FDA 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 (“FDA”) 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 (MDMA).” 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 Labs Inc. (TSXV: NTLX) 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.

For further information, please contact:

Michal Efraty

IR Manager

NeuroThera Labs Inc.

Telephone: +972-3-7617108

Email: michal@efraty.com

Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Notice on Forward-Looking Statements

This news release contains statements that constitute "forward-looking information" within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Forward-looking information can often be identified by words such as "may," "potential," "could," "expects," "anticipates," "intends," "believes" and similar expressions.

Forward-looking information in this news release includes, without limitation, statements regarding: the potential therapeutic benefits, safety, efficacy, advantages and commercial potential of the combination of MDMA and N-acylethanolamines, including PEA; the potential of PEA to enhance MDMA's therapeutic effects, reduce dosing requirements, mitigate side effects and broaden MDMA's therapeutic window; the potential application of such combination in the treatment of PTSD, anxiety and eating disorders; the development, scope, value and potential benefits of the Company's intellectual property portfolio and its collaboration with Clearmind; and the potential impact of the FDA's final guidance on the development and regulatory pathway of MDMA-based therapies.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Such factors include, without limitation, the risk that the published U.S. patent application, or any other pending application in the joint portfolio, will not issue as a patent, will issue with claims that are narrower than those sought, or will be challenged, invalidated or circumvented; the fact that publication of a patent application does not confer any enforceable rights and is not an indication of patentability; the risk that the MDMA-PEA combination will not demonstrate the enhanced potency, reduced dosing, improved tolerability or broadened therapeutic window described in the patent application, which are based on embodiments and hypotheses that have not been confirmed in clinical trials; the risk that preclinical or early-stage results, if any, will not be predictive of results in later-stage clinical trials; the risk that the FDA's final guidance, which is non-binding and does not alter the standards for drug approval, will not result in a faster, clearer or more favorable regulatory pathway for MDMA-based therapies, and the FDA's previous decision not to approve an MDMA-assisted therapy for PTSD; the classification of MDMA as a Schedule I controlled substance in the United States and as a controlled substance in Canada and other jurisdictions, and the resulting restrictions on research, manufacturing, distribution and commercialization; the risk that regulatory requirements applicable to psychedelic drug development, including those relating to functional unblinding, abuse potential, monitoring during dosing sessions and risk evaluation and mitigation strategies, will increase the cost, duration or complexity of any clinical program;         the Company's dependence on its collaboration with Clearmind, including the risk that the collaboration may be amended, suspended or terminated, that the parties may disagree regarding the ownership, prosecution or commercialization of jointly developed intellectual property, or that Clearmind's priorities, resources or financial condition may change; the Company's need for additional financing to advance its programs and the risk that such financing will not be available on acceptable terms, or at all; competition from other companies developing psychedelic, MDMA-based or PTSD therapies, some of which have substantially greater resources or are at more advanced stages of development; the Company's reliance on third parties for research, manufacturing and clinical activities; changes in government policy, public perception or the legal status of psychedelic substances, including the possibility that current federal support in the United States may not continue; the Company's status as a majority-owned subsidiary of SciSparc Ltd. and the potential for conflicts of interest or changes in SciSparc's strategy or ownership; and general economic, market and business conditions, and the risks described in the Company's continuous disclosure documents filed on SEDAR+ ( www.sedarplus.ca ).

Clearmind and NeuroThera cannot assure that any patent will issue as a result of a pending patent application or, if issued, that it will issue in a form that will be advantageous to them. Readers are cautioned that the foregoing list of factors is not exhaustive. These statements are not guarantees of future performance and undue reliance should not be placed on them. The Company does not undertake any obligation to update or revise any forward-looking information, except as required by applicable securities laws.

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