Biomind Labs to Advance a Phase II Clinical Trial on DMT for Treatment-Resistant Depression

TORONTO–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND), a leading biotech company in fast-acting psychedelics is pleased to announce that its Phase II clinical trial on N, N-dimethyltryptamine (“DMT”) for treatment-resistant depression has been approved by the Brazilian Institutional Review Board.

“A paramount step in our rapid evolution that positions us at the forefront of clinical research on the DMT molecule. DMT is an indole alkaloid found endogenously in various plant species and in humans, it is found primarily in the lungs, thyroid, adrenal gland, and in lower concentration in the brain. DMT provides the principal psychedelic in the Amazonian decoction, ayahuasca. According to a recent randomized placebo-controlled trial in patients with treatment-resistant depression conducted by our Neuroscientist Dr. Draulio Barros de Araujo, published in Psychological Medicine, ayahuasca is safe and presented a rapid antidepressant effect. This clinical trial is the first and the only completed randomized placebo-controlled trial to test a psychedelic substance in treatment-resistant depression. The results of this trial were crucial for Biomind Labs to be able to advance with an isolated form of DMT”, said Alejandro Antalich, CEO of Biomind Labs.

The Phase II clinical trial will be conducted by Dr. Draulio Barros de Araujo, will include 40 individuals and will be conducted in Brazil. Given the safety profile, the absence of overdose, tolerance and previous results with ayahuasca, Biomind Labs continues to reinforce the Molecule Clinical Development Dossier of its novel pharmaceutical BMND01, enabling a potentially successful molecule-to-market lifecycle.

“Approximately 20-30% of people with depression have inadequate responses to antidepressants and psychotherapies, even after multiple interventions. Treatment-resistant depression places great demands on healthcare resources and on patients, many of whom attempt and die by suicide. This scenario makes the search for new treatments a necessity. Clinical trials carried out in recent years have shown rapid antidepressant responses to psychedelic substances. Our scientific team is a pioneer in conducting clinical trials, using open and randomized designs with psychedelic substances in patients with treatment-resistant depression”, commented Dr. Draulio Barros de Araujo.

“We believe that DMT possesses a number of benefits in comparison to other tryptamine compounds such as psilocybin. This includes a short psychedelic experience with a duration of less than 30 minutes compared to other psychedelic compounds, including psilocybin, whose duration of experience typically lasts six hours, LSD typically lasts ten hours and ayahuasca four hours. The significant reduction in experience duration provides greater practical applicability to potentially deliver the psychedelic treatment in a supervised real-world clinical setting. This is also highly relevant to affordability, one of our core objectives. While establishing a close relationship with the psychiatry community, government authorities and health agencies, we are working towards a potentially massive and affordable solution for millions of patients suffering from depression, anxiety and eating disorders, among others”, concluded Antalich.

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge from natural psychotropic plants into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main natural psychedelic molecules, DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to guarantee patients access to affordable and modern-day treatments and use cases. Biomind Labs understands that long-lasting psychedelic effects make it difficult to create adequate clinical protocols to serve a larger number of patients, and this is the reason why Biomind Labs specializes in fast-acting psychedelics.

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 expectations regarding the results and timelines of the Company’s Phase II clinical trial, the molecule-to-market lifecycle of BMND01, the potential health benefits of DMT, building strong relationships with the psychiatric community, government authorities and health agencies, the business plans and growth plans of the Company and other statements that are not historical facts. 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) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) general business, economic, competitive, political and social uncertainties. 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 U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed 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 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 Neo 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.

Contacts

Biomind Labs Inc.

Alejandro Antalich

Chief Executive Officer

Email: [email protected]