Star Metro - Biomind Labs Accelerates FDA Pathway for 5-MEO-DMT Candidate BMND08 with Proprietary Nano-Formulation as Patent Observations Are Successfully Withstood

TORONTO, ON / ACCESS Newswire / December 3, 2025 / Biomind Labs Inc. ("Biomind" or the "Company") (CBOE:BMND)(OTC PINK:BMNDF)(FRA:3XI), a clinical-stage biopharmaceutical company focused on transforming breakthroughs in neuroscience and biomedical research into novel pharmaceutical drugs, today announced a major strategic advancement in the development of BMND08, transitioning the program into FDA-directed activities using the Company's newly engineered nano-formulation drug-delivery platform, designed to support commercial-stage clinical trials in neuropsychiatric and neurodegenerative disorders.

Following a Phase 2 trial that established a new benchmark in neurology with a 100% response rate in Alzheimer's-related mood disorders, Biomind is now introducing a proprietary nano-delivery technology for BMND08, engineered to deliver superior dosing precision, safety, absorption, and commercial-grade manufacturing scalability.

Strengthened Biomind's Intellectual Property Position:

• Several third-party patent observations were filed with the patent office.

• All third-party patent observations were successfully resolved.

• The patent application continues to progress in good standing.

Biomind believes this outcome:

• Reinforces the novelty, inventiveness, and strategic importance of the proprietary nano-formulation.

• Demonstrates external recognition of the relevance of the technology within the pharmaceutical and Central Nervous System ("CNS") therapeutics landscape.

• Supports the competitive defensibility of BMND08 as it moves toward commercial-stage development.

While the Company does not speculate on the identity or motives of the parties who submitted the observations, management views the outcome as an affirmation of the strength and unique nature of the underlying invention.

"Biomind is entering a new phase of execution," said Alejandro Antalich, CEO of Biomind Labs. "Advancing BMND08 into the FDA's commercial pathway using our proprietary nano-formulation is a transformative moment for the Company. We are developing a commercial-ready CNS therapeutic, supported by strong intellectual property and the progress of a patent application that has successfully withstood third-party observations. Our objective is to bring to market a next-generation pharmaceutical product with regulatory, clinical and competitive durability. This is not a minor reformulation; it is a new pharmaceutical asset."

The Company is now preparing the regulatory and technical prerequisites for the FDA to present the nano-formulation package, discuss pivotal trial design, define commercial-stage development requirements, and evaluate eligibility for expedited programs such as Breakthrough Therapy.

The Company also announces that it has granted an aggregate of 6,200,000 incentive stock options to certain directors, officers, and consultants to the Company. The options are exercisable at $0.35 per share and expire on November 3, 2030.

About Biomind Labs Inc.

Biomind Labs Inc. is a clinical-stage biopharmaceutical company focused on transforming breakthroughs in neuroscience and biomedical research into novel pharmaceutical drugs and proprietary nanotechnology-based delivery systems for psychiatric and neurological conditions that affect the Central Nervous System. Leveraging translational neuroscience and formulation science, Biomind aims to optimize the pharmacological profile of key endogenous and naturally derived molecules to address unmet needs in the CNS therapeutics. The Company is committed to rigorous clinical validation and patient-centric innovation.

For more information, please contact:

Biomind Labs Inc.
Alejandro Antalich
Chief Executive Officer
Email: [email protected]
Tel: + 598 98 663166

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of the 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. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this document include, among others, statements relating to the Company's ability to scientifically harness the medicinal power of certain molecules to treat patients suffering from neurological and psychiatric disorders, future research and development in various therapeutic areas, the anticipated results and potential of the Company's future trials, the ability to obtain regulatory approvals, the marketability of the Company's products, ability to source raw materials in the formulation of products, ability to raise capital, and the Company's plan to engineer proprietary drug development platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company's business and results of operations; (d) fluctuations in securities markets; (e) adverse changes in the public perception of tryptamine-based treatments and phenethylamine-based therapies; (f) fluctuations in general macroeconomic conditions; (g) expectations regarding the size of the targeted market; (h) the ability of the Company to successfully achieve its business objectives; (i) plans for growth; (j) political, social and environmental uncertainties; (k) employee relations; (l) the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and (m) the risk factors set out in the Company's annual information form for the year ended December 31, 2024, which is available under the Company's Issuer profile on SEDAR+ at www.sedarplus.ca. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.

The Company makes no medical, treatment or health benefit claims about the Company's proposed products. The United States Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments or phenethylamine-based therapies. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of tryptamines, tryptamine derivatives or phenethylamines, phenethylamine derivatives can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company's performance and operations.

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.

The CBOE Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

SOURCE: Biomind Labs Inc.

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A.Desjardins--SMC