- U.S. Patent 12,679,817, covering novel processes for preparing the (R)- and (S)-enantiomers of MDMA and MBDB, granted to PharmAla by the US Patent and Trademark Office (USPTO)
- PharmAla has exercised its option to cancel the proposed licensing of APA-01 to Restora Neurosciences, and will evaluate in-house and co-development pathways
- Canaccord Genuity LLC has been engaged as exclusive financial advisor and placement agent
TORONTO, Aug. 21, 2026 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTCQB: MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), today announced three corporate updates.
1. U.S. Patent Granted for Novel Enantioselective Manufacturing Processes
PharmAla has been granted United States Patent No. 12,679,817, covering novel processes for preparing the (R)- or (S)-enantiomers of 3,4-methylenedioxymethamphetamine (“MDMA”) and the (R)- or (S)-enantiomers of N-methyl-1,3-benzodioxolylbutanamine (“MBDB”).
MDMA and MBDB are chiral molecules, meaning each exists as two mirror-image forms, or enantiomers, with distinct pharmacological properties. Conventional manufacturing produces a racemic mixture — an equal blend of both enantiomers — and isolating a single enantiomer at commercial scale has historically been costly and low-yielding. The processes covered by the newly granted patent are directed at preparing individual enantiomers directly.
PharmAla believes these processes will have significant value in the future economical production of R-MDMA, as well as of the Company’s own ALA-002 formulations. ALA-002, PharmAla’s lead drug candidate, is a patented, non-racemic MDMA formulation. The grant adds a manufacturing-process layer to PharmAla’s existing composition-of-matter and formulation intellectual property in the MDXX class.
“Everyone in this sector talks about molecules. Far fewer talk about how you actually make them at scale, at cost, and to GMP standard — and that is usually what decides whether a drug is commercially viable. Single-enantiomer MDXX compounds have been chemically achievable for years, but not necessarily economically achievable. This patent protects processes we developed specifically to close that gap, for R-MDMA and for our own ALA-002. As a manufacturer as well as a developer, that is a defensible position we intend to build on.”
— Nicholas Kadysh, Founding Chief Executive Officer, PharmAla Biotech
2. PharmAla Exercises Option to Cancel Proposed Licensing of APA-01 to Restora Neurosciences
On May 13, 2026, PharmAla announced the execution of a definitive SPV Formation, Shareholder and License Agreement (the “SPV Agreement”) with Aluvaris Inc. (“Aluvaris”) and Diteba Inc. (“Diteba”), establishing a jointly-owned special purpose vehicle, Restora Neurosciences, intended to lead clinical and regulatory development of APA-01, PharmAla’s patented novel MDXX molecule.
Two developments have since materially changed the context for that structure. First, on July 20, 2026, PharmAla executed a definitive license agreement granting Jupiter Neurosciences, Inc. (NASDAQ: JUNS) exclusive U.S. rights to ALA-002, demonstrating that PharmAla is able to monetize its assets directly on attractive terms while retaining meaningful downstream economics. Second, it has been publicly reported that Resilient Pharmaceuticals (formerly Lykos Therapeutics and MAPS Public Benefit Corporation) has resubmitted a New Drug Application for MDMA-assisted therapy for PTSD to the FDA. PharmAla is not a party to that application and cannot verify its status; however, if accurate, such a filing would represent a constructive development for the regulatory pathway applicable to MDXX-class therapeutics generally.
In light of these developments, PharmAla has made the decision to exercise its option to cancel the proposed licensing of APA-01 to Restora Neurosciences, in accordance with the terms of the SPV Agreement. PharmAla retains full ownership of APA-01 and all associated intellectual property.
The process undertaken with Aluvaris, Diteba and prospective partners demonstrated significant interest in APA-01 as a molecule for use in a diverse array of clinical disorders. PharmAla will continue to examine potential opportunities to develop APA-01 both in-house and by way of co-development. The Company thanks Aluvaris and Diteba for their work over the course of the engagement.
3. Engagement of Canaccord Genuity LLC as Exclusive Investment Banking Partner
PharmAla has signed a letter of engagement, dated August 10, 2026, with Canaccord Genuity LLC (“Canaccord Genuity”), the U.S. investment banking arm of Canaccord Genuity Group Inc., appointing Canaccord Genuity as the Company’s exclusive investment banking partner.
Under the engagement, Canaccord Genuity has been retained as PharmAla’s exclusive financial advisor with respect to financial and strategic matters, including:
- acting as exclusive placement agent, lead agent or lead left bookrunner in connection with one or more private placements or public offerings of the Company’s securities during the agreed financing exclusivity period; and
- acting as exclusive financial advisor in connection with one or more possible business combinations, including mergers, joint ventures, strategic alliances, and purchases or sales of equity, debt or assets.
Canaccord Genuity may also be asked to deliver a fairness opinion to PharmAla’s Board of Directors in connection with any such transaction. The engagement does not constitute a commitment by Canaccord Genuity to underwrite, place or purchase any securities, or to arrange any financing, and there can be no assurance that any financing or transaction will result from the engagement. The commercial terms of the engagement are confidential.
Canaccord Genuity LLC is a member of FINRA/SIPC and operates from New York, New York.
“Bringing on a banking partner of Canaccord’s calibre is the logical next step after the Jupiter transaction. We now have a validated out-licensing model, a growing patent estate, and a manufacturing platform that very few companies in this sector can match. Canaccord knows the life sciences market and knows the Canadian and U.S. capital markets, and having a single exclusive partner across both financing and strategic alternatives lets us evaluate our options in a disciplined way.”
— Nicholas Kadysh, Founding Chief Executive Officer, PharmAla Biotech
About APA-01
APA-01 is a patented, novel MDXX-class molecule owned by PharmAla, under evaluation for potential application in psychological trauma and neurological conditions including post-stroke neurorehabilitation and traumatic brain injury. APA-01 is an investigational compound. It has not been approved by the FDA or any other regulatory authority, is not the subject of an active Investigational New Drug application, and its safety and efficacy have not been established.
About ALA-002
ALA-002 is PharmAla’s lead drug candidate: a patented, non-racemic MDMA formulation that has received New Chemical Entity (NCE) designation from the FDA. ALA-002 has been designed with the goal of delivering an improved cardiovascular safety profile and reduced abuse liability relative to racemic MDMA, while preserving the therapeutic properties associated with MDMA-assisted therapy. ALA-002 is an investigational product that has not been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established.
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.
