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PharmAla Completes Shipment of LaNeo™ MDMA to Yale University, Provides Investor Update

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PharmAla Biotech (MDXXF) has successfully delivered LaNeo™ MDMA to Yale University for a clinical trial investigating its effects on Borderline Personality Disorder. This marks their second university trial delivery, following a March shipment to the University of Washington for Narcissistic Personality research. The company has also granted MAPS permission to publicly post PharmAla's LaNeo MDMA Investigator's Brochure, aiming to promote broader research access. Additionally, PharmAla issued 1.5 million stock options to directors and officers, with CEO Nicholas Kadysh receiving 500,000 options at $0.105 per share, vesting over 12 months and expiring in 2030.
PharmAla Biotech (MDXXF) ha consegnato con successo LaNeo™ MDMA all'Università di Yale per uno studio clinico che indaga i suoi effetti sul Disturbo Borderline di Personalità. Si tratta della loro seconda consegna per una sperimentazione universitaria, dopo una spedizione a marzo all'Università di Washington per la ricerca sul Disturbo Narcisistico di Personalità. L'azienda ha inoltre concesso a MAPS il permesso di pubblicare pubblicamente il Fascicolo Informativo per Investigatori di LaNeo MDMA di PharmAla, con l'obiettivo di favorire un accesso più ampio alla ricerca. Inoltre, PharmAla ha emesso 1,5 milioni di stock option per direttori e dirigenti, con il CEO Nicholas Kadysh che ha ricevuto 500.000 opzioni a $0,105 per azione, con maturazione in 12 mesi e scadenza nel 2030.
PharmAla Biotech (MDXXF) ha entregado con éxito LaNeo™ MDMA a la Universidad de Yale para un ensayo clínico que investiga sus efectos en el Trastorno Límite de la Personalidad. Esta es su segunda entrega para ensayos universitarios, tras un envío en marzo a la Universidad de Washington para investigación sobre Trastorno Narcisista de la Personalidad. La compañía también ha autorizado a MAPS para publicar públicamente el Folleto para Investigadores de LaNeo MDMA de PharmAla, con el objetivo de promover un acceso más amplio a la investigación. Además, PharmAla emitió 1.5 millones de opciones sobre acciones para directores y ejecutivos, con el CEO Nicholas Kadysh recibiendo 500,000 opciones a $0.105 por acción, con un periodo de adquisición de 12 meses y vencimiento en 2030.
PharmAla Biotech(MDXXF)는 경계성 인격장애에 대한 효과를 조사하는 임상시험을 위해 LaNeo™ MDMA를 예일 대학교에 성공적으로 전달했습니다. 이는 3월에 워싱턴 대학교에 나르시시스트 인격장애 연구를 위해 배송한 두 번째 대학 임상시험 배송입니다. 또한 회사는 MAPS에 PharmAla의 LaNeo MDMA 연구자 안내서를 공개 게시할 수 있는 권한을 부여하여 연구 접근성을 확대하고자 합니다. 아울러 PharmAla는 임원 및 이사들에게 150만 주의 스톡옵션을 발행했으며, CEO Nicholas Kadysh는 주당 $0.105에 50만 주를 부여받아 12개월에 걸쳐 권리가 확정되고 2030년에 만료됩니다.
PharmAla Biotech (MDXXF) a livré avec succès LaNeo™ MDMA à l'Université de Yale pour un essai clinique étudiant ses effets sur le trouble de la personnalité borderline. Il s'agit de leur deuxième livraison pour un essai universitaire, après un envoi en mars à l'Université de Washington pour la recherche sur le trouble de la personnalité narcissique. La société a également autorisé MAPS à publier publiquement la brochure de l'investigateur de LaNeo MDMA de PharmAla, dans le but de promouvoir un accès plus large à la recherche. De plus, PharmAla a émis 1,5 million d'options d'achat d'actions pour les administrateurs et dirigeants, le PDG Nicholas Kadysh recevant 500 000 options à 0,105 $ par action, avec une période d'acquisition de 12 mois et une expiration en 2030.
PharmAla Biotech (MDXXF) hat erfolgreich LaNeo™ MDMA an die Yale University für eine klinische Studie zu den Auswirkungen auf die Borderline-Persönlichkeitsstörung geliefert. Dies ist ihre zweite Lieferung für universitäre Studien, nach einer Lieferung im März an die University of Washington für die Forschung zur narzisstischen Persönlichkeitsstörung. Das Unternehmen hat MAPS zudem die Erlaubnis erteilt, PharmAlas LaNeo MDMA Investigator's Brochure öffentlich zu veröffentlichen, um einen breiteren Forschungszugang zu fördern. Außerdem hat PharmAla 1,5 Millionen Aktienoptionen an Direktoren und Führungskräfte ausgegeben, wobei CEO Nicholas Kadysh 500.000 Optionen zu je 0,105 $ pro Aktie erhielt, mit einer Vesting-Periode von 12 Monaten und Ablauf im Jahr 2030.
Positive
  • Successfully completed international MDMA shipment to Yale University for clinical trials
  • Expanding research applications for MDMA into new therapeutic areas (Borderline Personality Disorder and Narcissistic Personality)
  • Strategic partnership with MAPS through public sharing of Investigator's Brochure, potentially increasing LaNeo MDMA adoption
  • Management alignment with shareholders through issuance of stock options
Negative
  • Facing significant cross-border friction for US exports
  • Stock options issued at $0.105 represent potential future dilution

TORONTO, June 03, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has successfully completed an international shipment of LaNeo™ MDMA to Yale University.

“We’re very pleased to have delivered this shipment to Yale, achieved despite significant cross-border friction. We are continuing to obtain permits to export to US, with more to come,” said Nick Kadysh, Founding CEO, PharmAla Biotech. “Following our news from March of our successful delivery of LaNeo™ MDMA for a trial at the University of Washington, this is the second new pilot study with a novel indication for MDMA enabled by PharmAla: first Narcistic Personality, and now Borderline Personality Disorder. Ultimately, this work is not only important for advancing science, but for potentially opening new markets for PharmAla’s products.”

The shipment will be used for an open-label trial which will investigate the effects of a dose of MDMA on social cognition in adults with Borderline Personality Disorder.

“We are grateful to the PharmAla Team for their hard work in making this delivery happen,” said Dr. Sarah Fineberg, Principal Investigator for the trial. “We’re thrilled to begin our trial, and look forward to future developments.”

Authorization to MAPS to post PharmAla Investigator’s Brochure

PharmAla has granted the Multidisciplinary Association for Psychedelic Studies (MAPS) authorization to post the PharmAla LaNeo MDMA Investigator’s Brochure (IB) publicly on the MAPS website. Access to the PharmAla Investigator’s Brochure has thus far been solely reserved for researchers working with PharmAla Biotech.

“Pharmala's willingness to post its Investigators Brochure summarizing the scientific research on the risks and benefits of MDMA on the MAPS website is a major contribution to researchers all over the world considering whether to study MDMA,” said Rick Doblin, Founder of MAPS. “Pharmala being open to providing researchers both GMP MDMA, and knowledge about MDMA research in its Investigator's Brochure, is a model for the industry.”

PharmAla hopes that greater access to the PharmAla IB will encourage continued adoption of PharmAla’s LaNeo™ MDMA for clinical trial and patient use. The PharmAla IB remains the sole copyrighted work of PharmAla Biotech, all rights reserved.

Issuance of Options

PharmAla has issued options to the following Board Members and Officers. The options are issued subject to a vesting period, such that every 3 months 25% of the allotment will be vested, such that the options shall be fully vested on the 12 month anniversary of the date of grant, which is May 29th. The options have a fixed exercise price per share of $0.105 (subject to adjustment in accordance with the terms of the Plan and/or stock option agreement). All vested but unexercised options shall expire and cease to be of effect on May 29, 2030.

Name of OptioneePositionNumber of Options
Jodi ButtsDirector100,000
Kevin RoyDirector100,000
Fraser MacdonaldDirector100,000
Perry TsergasDirector100,000
Harriet De WitDirector100,000
Abdelmalik SlassiDirector100,000
Will AveryChief Financial Officer100,000
Shane MorrisChief Operating Officer100,000
Ali TaghvaChief Commercial Officer100,000
Harpreet KuarEmployee100,000
Nicholas KadyshChief Executive Officer500,000
Total  1,500,000


PharmAla to appear at the Canadian Security Exchange’s Summit on Responsible Investment

PharmAla’s CEO, Nicholas Kadysh, will appear at the CSE’s Summit on Responsible Investing in Kelowna, BC, this Thursday, June 5, 2025.

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular news updates.

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: www.PharmAla.ca

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.


FAQ

What is the purpose of PharmAla's (MDXXF) MDMA shipment to Yale University?

The shipment will be used for an open-label trial investigating the effects of MDMA on social cognition in adults with Borderline Personality Disorder

How many stock options did PharmAla issue and at what price?

PharmAla issued 1.5 million stock options to directors and officers at $0.105 per share, vesting over 12 months and expiring in May 2030

What is the significance of PharmAla sharing its Investigator's Brochure with MAPS?

Making the Investigator's Brochure publicly available on MAPS' website will help researchers worldwide access information about MDMA research and potentially increase adoption of PharmAla's LaNeo MDMA

What are the new therapeutic applications being explored for PharmAla's LaNeo MDMA?

PharmAla's LaNeo MDMA is being studied for Borderline Personality Disorder at Yale University and Narcissistic Personality at the University of Washington

How many options did PharmAla's CEO Nicholas Kadysh receive?

CEO Nicholas Kadysh received 500,000 stock options, the largest allocation among all recipients
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