Mr. Nicholas Kadysh reports

PHARMALA BIOTECH SIGNS SUPPLY AND DATA AGREEMENT WITH AALBORG UNIVERSITY HOSPITAL FOR DANISH RANDOMIZED TRIAL OF MDMA-ASSISTED TREATMENT FOR SERVICE-RELATED PTSD

Pharmala Biotech Holdings Inc. has signed a project supply agreement with the North Denmark Region, acting through the unit for psychiatric research at Aalborg University Hospital.

Under the agreement, Pharmala will be the sole supplier of MDMA for the Mirror study: "a randomized, open-label, rater-blinded, controlled trial of psychotherapy versus music-assisted relaxation in MDMA-facilitated treatment for service-related PTSD." Aalborg University Hospital is the study sponsor. The study will compare two forms of support given with MDMA: psychotherapy and music-assisted relaxation.

Key terms:

• Supply: Pharmala will supply LaNeo (MDMA HCl) 40-milligram (mg) and 20 mg capsules, manufactured under good manufacturing practice and released Pharmala's European Union qualified person. Aalborg will pay a cash sum in addition to providing a licence to its data.
• Data licence: Aalborg University Hospital will deliver an anonymized data package to Pharmala after database lock. This includes dosing and safety data, the final clinical study report, and the hospital's safety and efficacy analyses. Pharmala receives a non-exclusive, perpetual, irrevocable, worldwide, royalty-free licence to use this data, including for regulatory submissions and commercial purposes, with the right to sublicense to partners.
• Regulatory support: Pharmala will provide chemistry, manufacturing and controls information to support the hospital's regulatory submissions for the study.
• Independence: Aalborg University Hospital will publish the study results, whether positive, negative or inconclusive. Pharmala has no influence on the study data or results.

"Most MDMA trials ask whether the drug works. Mirror asks a different question: what kind of support works best with it. That question matters to every health system that wants to deliver MDMA-assisted treatment at scale," said Nicholas Kadysh, founding chief executive officer, Pharmala Biotech. "We are proud that Aalborg University Hospital chose LaNeo MDMA for this work. This agreement also follows our supply-and-data model: We supply GMP drug, and we receive rights to high-quality clinical data that adds value to our regulatory and commercial programs in Europe and elsewhere in exchange for a discount."

MDMA-assisted treatment for PTSD has shown promising results, but an important unanswered question is how much of the therapeutic effect depends on the accompanying psychotherapy. The Mirror trial is designed to address this directly by comparing MDMA combined with psychotherapy with MDMA combined with a much less intensive therapeutic approach. Understanding the contribution of psychotherapy is important both scientifically and for determining how MDMA-based treatments might eventually be implemented in clinical practice," said Prof. Rene Ernst Nielsen, Aalborg University Hospital.

The agreement adds to Pharmala's growing base of clinical trial supply relationships with academic and government institutions, and extends the company's clinical supply footprint in the European Union.

Restora Neuroscience to present at BIO-Europe

Mr. Kadysh will be presenting data pertaining to the company's APA-01 novel molecular entity, as well as its wholly owned special-purpose vehicle (SPV), Restora Neuroscience, at the BIO-Europe Conference on Monday, Nov. 9.

Restora's participation in the conference is made possible with support from the Ministry of Economic Development, Job Creation and Trade of the Ontario government. Restora was selected as a featured company by the Canadian Trade Commissioner Service.

Restora will also be participating in London Life Sciences Week, Nov. 16 to Nov. 18.

About Pharmala Biotech Holdings Inc.

Pharmala 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.

We seek Safe Harbor.