TORONTO, Dec. 15, 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 its wholly-owned subsidiary, PharmAla Biotech Australia, has contracted with a UK-based CDMO to execute manufacture of its ALA-002 drug substance. “PharmAla Australia worked diligently, executing a global RFP search ...

Core Viewpoint - PharmAla Biotech Holdings Inc. has filed a final short form base shelf prospectus to provide flexibility for financing opportunities over a 25-month effective period, allowing the company to issue various securities as needed [1][2][4] Group 1: Prospectus Details - The prospectus has been filed in all provinces and territories in Canada, enabling the company to offer common shares, warrants, units, subscription receipts, debt securities, or any combination of these securities [2] - The company may utilize the prospectus for "at-the-market distribution," allowing securities to be sold through the Canadian Securities Exchange or other trading markets [3] - Currently, there are no immediate plans to issue any securities under the prospectus, and specific terms will be outlined in a prospectus supplement if the company decides to proceed [4] Group 2: Loan Facility with Radium Capital - PharmAla's subsidiary, PharmAla Biotech Australia, has signed a term sheet with Radium Capital for a loan facility based on expected Research and Development Tax Incentive refunds [5] - The loan facility allows for up to 80% of the expected RDTI refund to be advanced once qualifying expenses are incurred, with each tranche secured by the related RDTI refund [5] - The CEO emphasized that this loan facility presents an opportunity to develop intellectual property without exposing it to securitization risk, aligning with the company's clinical trial strategy in Australia [6] Group 3: Strategic Goals - The CFO highlighted that securing efficient, low-risk debt funding will help optimize future tax incentives and drive cost efficiency in planned clinical trials [7] - PharmAla aims to alleviate the global backlog of generic, clinical-grade MDMA for clinical trials and commercial sales while developing novel drugs in the same class [7]

Core Insights - PharmAla Biotech Holdings Inc. has launched NEXUS, a new tool aimed at connecting prescribers, therapists, and clinic managers involved in MDMA-assisted therapy, enhancing the care delivery process [1][2][3] Group 1: NEXUS Tool - NEXUS is designed to facilitate communication and data sharing among the entire MDMA-assisted therapy team, including prescribers, therapists, and clinic managers [2][3] - The tool aims to address the challenges faced by prescribers and other stakeholders in navigating regulatory pathways and improving patient care [2][3] Group 2: Leadership Changes - Farnoud Kazemzadeh has been appointed as the Chief Operating Officer of PharmAla, bringing extensive experience in scaling businesses [3] - Dr. Harriet De Wit has resigned from PharmAla's Board of Directors, with the company expressing gratitude for her contributions [4] Group 3: Company Overview - PharmAla focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA, and is the only company providing clinical-grade MDMA for patient treatments outside of clinical trials [5] - The company aims to alleviate the backlog of clinical-grade MDMA for trials and commercial sales while developing novel drugs in the same class [5]

Core Insights - PharmAla Biotech Holdings Inc. has successfully shipped its LaNeo™ MDMA to Johns Hopkins University, marking a significant advancement in MDMA research in the United States [1][2] - The CEO of PharmAla emphasizes the importance of this delivery for clinical trials, which have faced challenges in sourcing investigational medical products [2] - LaNeo™ MDMA is now approved for use in the continental US and is already utilized in clinical trials globally [2] Company Overview - PharmAla Biotech is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, with a dual aim of alleviating the backlog of clinical-grade MDMA and developing novel drugs [4] - The company is currently the only provider of clinical-grade MDMA for patient treatments outside of clinical trials [4] - PharmAla's research unit has completed proof-of-concept research for several drug candidates, including ALA-002, its lead candidate [4] Financial Activities - The company has settled $150,000 in debt by issuing 1,666,667 common shares at a deemed price of $0.09 per share [3]

Core Insights - PharmAla Biotech Holdings Inc. has signed a distribution agreement with Veridion Group to act as the exclusive distributor for its LaNeo MDMA in the Netherlands market [1] - The partnership aims to ensure safe and controlled access to MDMA treatments for New Zealand clinicians [2][3] - Dr. Kiyan Afzali has been appointed as a director for PharmAla Australia, bringing nearly a decade of experience in translational research and drug discovery [4][5] Company Overview - PharmAla is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and aims to alleviate the backlog of clinical-grade MDMA for trials and commercial sales [6] - The company is the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research into several drug candidates [6] Strategic Developments - The distribution agreement with Veridion includes an annual purchase minimum, waived for the first year, and restrictions on re-export [2] - Dr. Afzali's appointment is effective October 1, 2025, and is expected to enhance PharmAla's research and development efforts in Australia [5]

Core Viewpoint - PharmAla Biotech Holdings Inc. has filed an amended and restated preliminary short form base shelf prospectus to enhance its financing flexibility over a 25-month effective period, allowing the company to capitalize on favorable market conditions as needed [1][2] Group 1: Prospectus Details - The prospectus enables the company to offer, issue, and sell various securities, including common shares, warrants, and debt securities, with an aggregate offering price of up to C$30,000,000 during the effective period [2][3] - The prospectus has been filed in all provinces and territories in Canada, and it may be used for "at-the-market distribution" through the Canadian Securities Exchange [2][3] Group 2: Current Plans and Debt Settlement - The company currently has no immediate plans to issue any securities under the prospectus and may not proceed with any issuance [4] - The board of directors has approved the settlement of $150,000 owed to arm's length creditors through the issuance of common shares at a price to be determined at the time of settlement [5] Group 3: Company Overview - PharmAla is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, and aims to alleviate the global backlog of clinical-grade MDMA for trials and commercial sales [6] - The company is the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research for several drug candidates [6]

Core Insights - PharmAla Biotech Holdings Inc. has established a wholly-owned subsidiary, PharmAla Biotech Australia Pty Ltd., to conduct research and development activities in Australia [1][2] - The Australian market is recognized for its strong biotech development environment, which the company aims to leverage through existing relationships and expertise [2] - PharmAla Australia will hold a full and perpetual license to the ALA-002 asset and associated patents, enabling it to engage in manufacturing development and clinical research [2][3] Company Developments - The company appointed Dr. Evan Lewis to its Scientific Advisory Board, effective September 1, 2025, enhancing its expertise in clinical research and drug discovery [3][4] - Dr. Lewis has a background in neurology, particularly in epilepsy and pediatric neurology, and has previously led initiatives in psychedelic neurology and medical cannabis [4][5] - PharmAla is focused on alleviating the backlog of clinical-grade MDMA and developing novel drugs within the MDXX class, positioning itself as a leader in the psychedelics industry [6] Industry Context - Australia is highlighted as having a favorable regulatory environment for launching clinical trials, which is expected to benefit PharmAla's operations [3] - The company aims to capitalize on the growing ecosystem of biotech financiers and government incentives in Australia [3] - PharmAla is currently the only company providing clinical-grade MDMA for patient treatments outside of clinical trials, indicating a unique market position [6]

Company Overview - PharmAla Biotech Holdings Inc. is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA [4] - The company aims to alleviate the global backlog of generic, clinical-grade MDMA for clinical trials and commercial sales, while also developing novel drugs in the same class [4] - PharmAla is currently the only company provisioning clinical-grade MDMA for patient treatments outside of clinical trials [4] Recent Developments - PharmAla has completed customs clearance and delivered over 500 capsules of LaNeo 40mg MDMA to Merhavim Mental Health Centre in Israel [1] - The delivery is seen as a precedent for innovative terms that reduce financial risk for researchers while allowing PharmAla to develop intellectual property cost-effectively [2] - The clinical trial associated with this delivery focuses on "MDMA Assisted Psychotherapy for PTSD of Early Sexual Trauma Compared to All Trauma in Adulthood" [2] Research and Support - Researchers can access a tool for drug product quality information on PharmAla's website, facilitating the examination of the LaNeo MDMA Chemistry, Manufacturing, and Control package [3] - PharmAla is open to offering discounts for data sharing where appropriate, encouraging collaboration with qualified researchers [3] Strategic Partnerships - MAPS Israel, a non-profit organization focused on psychedelic research and public health education, is a partner in the clinical trial [2] - The collaboration aims to explore new mental health indications while navigating complexities in cross-border trade and regional conflicts [2] Future Outlook - PharmAla's research and development unit has completed proof-of-concept research into several intellectual property families, including its lead drug candidate ALA-002 [4] - The company emphasizes the importance of maintaining excellent relationships with regulators to achieve success in the psychedelics industry [4]

Core Insights - PharmAla Biotech Holdings Inc. has reported significant operational progress, including a large shipment of LaNeo MDMA to a U.S. distribution partner for clinical trials, and the completion of a manufacturing run for LaNeo Capsules in Australia [2][4] Financial Highlights - Customer deposits increased by $150,463 through Q3, with recognized revenue of $79,558, indicating a strong demand for clinical trial products [6] - Total expenses for the nine months ended May 31, 2025, were $2,117,495, compared to $1,085,458 for the same period in 2024, reflecting increased operational costs due to new hires and the cessation of capitalizing R&D costs [6] Company Overview - PharmAla focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA, and aims to alleviate the backlog of clinical-grade MDMA for trials and commercial sales [5] - The company is recognized as the only provider of clinical-grade MDMA for patient treatments outside of clinical trials, emphasizing its regulatory relationships as a key to success in the psychedelics industry [5]

Core Insights - PharmAla Biotech Holdings Inc. has successfully completed an international shipment of LaNeo™ MDMA to Yale University for a clinical trial focused on Borderline Personality Disorder [1][2] - This shipment follows a previous successful delivery to the University of Washington, indicating PharmAla's growing role in clinical research involving MDMA [2] - The company aims to expand its market presence through these clinical trials, which could lead to new therapeutic applications for its products [2] Company Developments - PharmAla has granted MAPS authorization to publicly post its Investigator's Brochure, enhancing access to research on MDMA for global researchers [3][4] - The company has issued options totaling 1,500,000 shares to various board members and officers, with a fixed exercise price of $0.105, vesting over a 12-month period [5][6][7] - PharmAla's CEO, Nicholas Kadysh, will participate in the Canadian Security Exchange's Summit on Responsible Investment, highlighting the company's commitment to responsible practices in the biotech sector [8] Company Overview - PharmAla Biotech focuses on the research, development, and manufacturing of MDXX class molecules, including MDMA, and is the only company providing clinical-grade MDMA for patient treatments outside of clinical trials [9] - The company aims to alleviate the backlog of generic, clinical-grade MDMA and develop novel drugs, positioning itself as a regulatory-first organization in the psychedelics industry [9]