TORONTO, November 04, 2022–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” 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 and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce positive initial results from part I of its Phase II trial on its BMND01 candidate, a novel liquid inhaled formulation of N,N-Dimethyltryptamine (“DMT“) for Treatment-Resistant Depression (“TRD“).

“With the conclusion of the dosing sessions, 30 volunteers went through the activities of the proprietary clinical-experimental protocol developed by our scientific team, to verify the safety and tolerability of our novel DMT-based candidate BMND01 and protocol in healthy individuals. This is the world’s first in-lab study using an inhaled formulation of DMT, and the largest completed trial with this molecule. We are seeking to tackle one of the most concerning factors related to psychedelics as a potential novel treatment for mental health disorders, the long duration of the sessions. This trial aims to go through the full psychedelic experience in just 10 minutes. These successful first results bring strong potential for the next phase of the trial, which will address patients suffering from TRD”, commented Alejandro Antalich, CEO of Biomind Labs.

The trial, led by Professor Dráulio Araújo, Ph.D., has involved a dose exploration schedule ranging from 5 to 100 mg. No volunteer presented serious adverse events or clinical risk to the 11 different doses tested. “During the trial, we observed only a mild, transient and self-limited increase in blood pressure and heart rate of up to 30% compared to baseline values, with no clinical repercussions. This is a physiological increase comparable to moderate physical activity in healthy individuals”, commented Marcelo Falchi, M.D., Biomind Labs’ Head of the Psychiatric Research Unit, who sees excellent clinical potential and safety in DMT, “the only endogenous psychedelic molecule, which is already present in low concentrations in different organs of the human body”, said Marcelo Falchi, M.D.

The experimental design of this open-label ascending dose trial involved developing and implementing a proprietary clinical-experimental protocol based on the fundamentals of interventional psychiatry. This multidisciplinary approach combines a psychiatric procedure for dosing DMT associated with psychological support under strict clinical standards. “The model is intended to integrate into existing health systems globally, quickly and easily, positioning Biomind Labs’ BMND01 candidate at the frontier of accessible psychedelic medicine. By allowing the creation of specialized centers for the administration of DMT, it is possible to scale-up treatments without the need to train a whole new generation of mental health professionals”, concluded Alejandro Antalich, CEO of Biomind Labs.

The trial is registered at www.clinicaltrials.gov (NCT05573568).

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 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, any timeframes and possible results associated with the Company’s Phase II trial of the novel drug candidate BMND01; any statement regarding the creation of specialized centers for the administration of DMT; the Company’s ability to provide patients access to affordable and modern-day treatments; 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 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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221104005328/en/

Contacts

Biomind Labs Inc.
Alejandro Antalich
Chief Executive Officer
Email: [email protected]
Tel: + 598 97 702500

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

MYND Diagnostics was formed to commercialize proprietary biomarker diagnostic tests for patients suffering from MDD, TRD and other psychiatric disorders.

VANCOUVER, BC, Oct. 7, 2021 /CNW/ – MYND Life Sciences Inc. (CSE: MYND) (OTC: MYNDF) (“MYND” or the “Company“) is pleased to announce the formation of its diagnostic biomarker division with the incorporation of a wholly-owned subsidiary, MYND Diagnostics Ltd. (“MYND Diagnostics” or the “Subsidiary”).

MYND Diagnostics’ robust investigational pipeline of diagnostics, novel small molecules, and biologics, is focused on improving disease outcomes, monitoring and improving the treatment experience for patients suffering from Major Depressive Disorder (“MDD”), Treatment Resistant Depression (“TRD”) and other inflammatory afflictions of the Central Nervous System. The Subsidiary’s innovation, enabled by proprietary technology, allows for the quantitative and qualitative measurement of the MYND Anti-inflammatory Peptide (“MAP”) biomarker. The subsidiary forecasts revenue by Q2 of 2022.

“We are focused on supporting our drug development pipeline with the formation of MYND Diagnostics Ltd., our diagnostic biomarker division which will generate near term revenue through the commercialization of our MAP biomarker”, stated Dr. Lyle Oberg MD, MYND. Life Sciences CEO. “For decades, the diagnosis of psychiatric illness relied almost exclusively on self-reporting and physician observation of symptoms to make a diagnosis. The MAP Biomarker will give healthcare providers an objective monitoring tool that will detect and diagnose mental illness earlier, thereby enabling quicker, more targeted treatments. We will deliver an accurate indicator of depression, therefore allowing for better monitoring of improving or relapsing disease.”

MYND Diagnostics Clinical Trials

The Subsidiary’s focus will be to conduct clinical trials to identify a marker for quantitatively diagnosing and monitoring depression in response to treatment. MYND’s Chief Clinical Officer, Iryna Saranchova, MD, Ph.D. will oversee the Subsidiary’s diagnostic trials.

MYND Diagnostics Biomarker Tests

The target market for MYND Diagnostics’ proprietary tests includes hospitals, clinics, healthcare facilities and other corporate and pharmaceutical companies, during clinical trials, and once efficacy and safety is demonstrated on humans, direct to consumer and physician.

The Global Biomarkers Market

According to Reports and Data, the global biomarkers market is forecasted to grow at a rate of 13.6%, from USD 41.47 billion in 2019 to USD 115.45 billion in 2027. The biomarker market is experiencing rapid growth attributed to its increasing application in drug discovery and development, diagnostic, risk assessment of target conditions, and benefits in personalized medication. MYND Diagnostics’ competitive advantage is that its process is cost-effective, time-efficient and can produce test results directly from a dried blood sample rather than the often cumbersome logistics of using vials of whole blood.

ABOUT MYND LIFE SCIENCES

MYND Life Sciences is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to the Company’s mailing list, please visit https://myndsciences.com/contact/

CONTACT INFORMATION
Dr. Lyle Oberg, MD, CEO
Email: [email protected]
Web: www.myndsciences.com

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release.

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the “1933 Act”), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

BERLIN and SAN DIEGO, Sept. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its digital therapeutic platform Introspect Digital Therapeutics, Inc. (“Introspect”), today announced a usability study of Introspect’s digital therapeutic (DTx) app technology in support of standard of care ketamine therapy for patients with treatment resistant depression (TRD) in collaboration with Kadima Neuropsychiatry. TRD impacts 100 million people globally, close to a third of the 300 million diagnosed with depression, many of whom are geographically restricted in their ability to access in-person psychological care.

Introspect’s DTx app approach to supported treatment in mental health will be integrated across 3 cohorts, with Cohort 1 focusing on user acceptability, Cohort 2 examining the introduction of therapeutic content via the app, and Cohort 3 assessing set and setting of treatment.

“We’re thrilled to be working with Kadima to test our digital therapeutic approach in a clinical setting with patients receiving with standard of care ketamine therapy,” said David Keene, CEO of Introspect. “Our goal is to show that our novel DTx app can be used alongside a drug; that it is useful, usable and intuitive to patients and providers.”

“The integration of Introspect’s digital therapeutic in a clinical environment is a pivotal step towards developing potentially scalable care,” said Florian Brand, Co-Founder and CEO of atai. “In our mission to improve the lives of millions living with mental health disorders, technology will be instrumental, ensuring that our pipeline of novel compounds can benefit patients everywhere.”

Introspect believes that high-quality digital combination therapies have the potential to improve the safety and effectiveness of many mental health treatments. In addition, Introspect considers DTx to be vital to the mission of providing personalized and scalable treatment to those who might not otherwise be able to access high-quality psychological care.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London and Berlin. For more information, please visit www.atai.life.

About Introspect Digital Therapeutics

Introspect is a wholly-owned enabling platform company providing tightly integrated DTx on a shared architecture across all of atai’s platform companies. Incorporating a DTx strategy from the very beginning of drug development, Introspect is dedicated to providing more comprehensive, personalized care management with potential to secure stronger IP protection. Introspect aims to develop digital biomarkers, which clinicians will be able monitor to predict patients’ recovery pathways, limiting trial and error while simultaneously streamlining therapeutic impact. A key goal for Introspect is to provide great precision psychiatry and personalization to assist therapists in making the best decisions for their patients.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including without limitation statements regarding the support of clinical trials by Introspect Digital Therapeutics and future activities thereunder, the potential Introspect’s digital therapeutics technology, and similar statements of a future or forward-looking nature. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, other than to the extent required by applicable law.

Investor Contact:

Greg Weaver

Chief Financial Officer

Email: [email protected]

Media Contact:

Anne Donohoe

KCSA Strategic Communications

Phone: +1 (212) 896-1265

Email: [email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.