Biomind Labs Announces Unprecedented Positive Results of Phase 2 Clinical Trial of BMND08 for Depression & Anxiety in Alzheimer’s Disease

TORONTO--(BUSINESS WIRE)-- Biomind Labs Inc. (“Biomind” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, today announced the successful conclusion of the Phase 2 clinical trial of its proprietary 5-Metoxi-N,N-dimethyltryptamine (“5-MeO-DMT”)-based BMND08, a sublingual formulation designed for the treatment of depression and anxiety in Alzheimer’s disease. Led by Biomind’s Clinical Advisor Neuroscientist Dr. Martín Bruno, the trial showcased remarkable advancements in treatment safety and efficacy.

• Clinical findings support the safety and efficacy of BMND08 at a maximum dosage of 12mg, administered once weekly over four consecutive weeks. These doses, while subpsychedelic, have been shown to significantly enhance mood states, as evidenced in Group 1 (n=4).

• Throughout the trial, 100% of the participants responded to treatment and 100% were in remission from depression, anxiety, and stress by the end of the treatment period (week 5). In Group 2 (n=9), participants received a dose of 9mg of BMND08, while those in Group 3 (n=9) received 6mg, demonstrating a significant enhancement in participants’ overall well-being compared to those who received Placebo (Group P, n=6).

• Preliminary findings have shown encouraging outcomes in the improvement of executive functions and processing speed among individuals in the early stages of mild to moderate Alzheimer’s-related cognitive impairment (“MCI”). This progress was observed with the administration of 6mg of BMND08 to Group 4 (n=9), showcasing notable benefits compared to Placebo (Group P, n=3).

• Building on the compelling data collected during the trial, the Company intends to progress BMND08 to Phase 3 and seek Breakthrough Therapy Designation from the US Food and Drug Administration (“FDA”). Note that on November 14th, 2022, the FDA gave the Company Investigational New Drug (“IND”) clearance related to the Company’s New Chemical Entity (“NCE”) Triptax™.

During the double-blind, randomized, placebo-controlled clinical trial, the maximum safe dose of BMND08 was identified without inducing psychedelic effects. This critical milestone allowed the Company to determine the optimal therapeutic dose for depression and anxiety, ensuring both safety and effectiveness. Patients in various Groups, including those with depression and anxiety, were administered BMND08 to assess its impact on symptom reduction. Notably, the trial demonstrated significant improvements in depression, anxiety and stress, and scores compared to the placebo group, highlighting BMND08’s therapeutic potential. This reduction was statistically significant in the State Anxiety (STAI-S), depression (BDI-II), and stress (DASS STRESS) scales compared to the Placebo Group after the completion of the treatment (week 5).

In addition to addressing mood disorders, BMND08 exhibited promising effects on cognitive function. Participants receiving BMND08 showed notable enhancements in executive functions, particularly in processing speed, suggesting broader implications for cognitive decline associated with MCI.

Alejandro Antalich, CEO of Biomind Labs emphasized: “Finding a dose that doesn’t produce undesirable or harmful side effects is of paramount importance due to the delicate nature of individuals facing Alzheimer’s- related MCI. Patients may be reluctant to continue treatment if they experience adverse reactions, leading to non-adherence and reduced efficacy of the medication; healthcare professionals and regulatory authorities are more likely to approve and endorse treatments that do not produce adverse events, enhancing acceptance and accessibility for patients; clinicians can better assess the true efficacy of the medication in treating the targeted symptoms. Overall, ensuring a dose free from adverse side effects is crucial for optimizing patient safety, treatment adherence, regulatory approval, therapeutic efficacy, and offering cost-effective long-term treatments.”

“These transformative discoveries mark a paradigm shift in Alzheimer’s treatment. This devastating disease significantly impairs cognitive function, memory, and daily functioning, leading to a decline in quality of life for affected individuals. As the disease progresses, individuals may experience difficulty with basic activities of daily living, leading to increased dependency and loss of autonomy. The global costs associated with dementia care, including medical expenses, long-term care, and lost productivity exceed $1 trillion annually. Our upcoming milestones with BMND08 are focused on pursuing a Breakthrough Therapy Designation and halting MCI progression towards Alzheimer’s disease,” concluded Antalich.

Key discoveries of the trial

• The maximum safe, tolerable, and non-psychedelic dose was established at 12mg of BMND08, administered as a repeated single dose on a weekly basis over a 4-week period. All psychological, neurological, biochemical, and clinical parameters showed normal values following BMND08 administration. Pharmacokinetics of BMND08 was determined, reaching a maximum concentration of 1.17 ug/L in plasma with a 12mg dose of 5-MeO-DMT within 20 minutes.

• Patients with depression and anxiety (Group 3, n=9) who received a 6mg dose of BMND08 demonstrated statistically significant improvements in scales assessing depression, anxiety, and stress compared to the Placebo Group (as measured by anxiety STAI-R and STAI-E scales, as well as depression and stress measured by the Beck-BDI II scale). Notably, these improvements were achieved without the necessity of a psychedelic experience, highlighting the impactful therapeutic potential of Biomind’s BMND08 treatment on mood states.

• Patients with early stages of MCI (Group 4, n=9) who received a 6mg dose of BMND08 exhibited improvements in depression and anxiety symptoms, marked by a notable reduction in BDI, STAI-R, and STAI-E scores observed one week after completing Biomind’s dosage regimen. Additionally, patients’ cognitive performance showed progressive enhancements throughout the treatment, as evidenced by statistically significant changes in the PASAT test compared to the Placebo Group. The PASAT test evaluates attentional, working memory, and processing speed strategies.

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge 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 psychedelic molecules, N, N-dimethyltryptamine (“DMT”), 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.

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 psychedelic 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 psychedelic-based therapies; (f) fluctuations in general macroeconomic conditions; (g) expectations regarding the size of the psychedelics 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, 2022 dated March 31, 2023, 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, 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 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.

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