21:36:12 EST Wed 03 Dec 2025
Enter Symbol
or Name
USA
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Biomind Labs Inc
Symbol BMND
Shares Issued 77,571,773
Close 2025-12-03 C$ 0.35
Market Cap C$ 27,150,121
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Biomind Labs moves BMND08 into FDA pathway

2025-12-03 18:07 ET - News Release

Mr. Alejandro Antalich reports

BIOMIND LABS ACCELERATES FDA PATHWAY FOR 5-MEO-DMT CANDIDATE BMND08 AND GRANTS STOCK OPTIONS

Biomind Labs Inc. has made a major strategic advancement in the development of BMND08, transitioning the program into Food and Drug Administration-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-per-cent 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, chief executive officer 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 6.2 million incentive stock options to certain directors, officers and consultants to the company. The options are exercisable at 35 cents per share and expire on Nov. 3, 2030.

About Biomind Labs Inc.

Biomind Labs 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.

We seek Safe Harbor.

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