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Is MDMA the Viagra for women?

LOVE PHARMA INC., ANNOUNCES LISTING ON FRANKFURT STOCK EXCHANGE

A Vancouver company called LOVE Pharma (LUV) wants to promote mental and sexual wellness with its growing product line.

The company recently launched two products (a CBD oral strip and a clitoral stimulation gel) and has exclusive rights to a total of seven novel therapeutic products. It’s currently developing a biosynthetic psilocybin strip using the IP from the CBD strip.

On Tuesday, the company was listed on  the Frankfurt Stock Exchange under the symbol “G1Q0”.

In other sexual wellness news, Mindcure (MCUR) recently launched a research program to treat female hypoactive sexual desire disorder (HSDD), a disorder involving low sex drive and emotional distress, with MDMA-assisted therapy.

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Psychedelic research coming to Florida

Florida Would Study Psychedelics’ Medical Benefits Under Top Senate Democrat’s New Bill

“The science regarding psilocybin is real, cannot be ignored, and soon will be a universally-accepted form of treatment in the U.S.,” said Rep. Michael Grieco (D) of Florida.

That’s why he and Senate Minority Leader Lauren Book (D) filed bills that would require the state to study the medical potential of psilocybin and MDMA.

The bills were modeled on the measure enacted in Texas earlier this year to study psychedelic therapy for veterans with PTSD, but with an even broader scope. If enacted, the Department of Health would be directed to research other conditions like depression, anxiety, bipolar disorder, chronic pain and migraines.

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Delic Labs Applies for Dealers License to Commercialize Psychedelics Research, Health Exemption to Test MDMA and LSD

Delic Labs Applies for Dealers License to Commercialize Psychedelics Research, Health Exemption to Test MDMA and LSD

DELIC LABS APPLIES FOR DEALER’S LICENSE TO COMMERCIALIZE PSYCHEDELICS RESEARCH, HEALTH EXEMPTION TO TEST MDMA AND LSD 

License Allows  Authority to Work with Additional Banned Substances and Market the Research for Medical Purposes

Vancouver, British Columbia – October 6, 2021 – Delic Holding Corp Inc. (“DELIC” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), the leading psychedelic wellness platform, today announced Delic Labs has applied for a Health Canada 56 Research Exemption that would allow the scientists to perform research and tests on a host of compounds outside of psychedelic mushrooms, including MDMA and LSD. The lab currently holds a 56 Research Exemption for chemistry analytics on psilocybin mushrooms.

Additionally, the lab has applied for a Dealer’s License and intends to eventually commercialize its psilocybin research and associated intellectual property (IP) for medical and research purposes. Some of the work would include researching extraction of pharmaceutically relevant compounds from  psychedelic mushrooms and turning those extracts into medical products. Additionally, Delic Labs will synthesize non-naturally occurring compounds as part of its ongoing med-chem pipeline..

Delic Labs is a federally-authorized psilocybin and cannabis research laboratory focused on extraction, analytical testing, and chemical process development. Delic Labs serves as the engine for the Delic platform, conducting research and developing innovative product lines and intellectual property, including psilocybin vaporization technology for future distribution across the Company’s physical footprint and licensed psychedelic wellness clinics in the United States.

Matt Stang, co-founder and CEO of Delic Corp, stated, “Never before has a lab been authorized to test psychedelic compounds such as MDMA and LSD with the opportunity to create new medicines for the millions suffering from debilitating conditions like depression, anxiety, PTSD and Parkinson’s disease. Delic Labs is leading the way in psychedelic compound testing and ensuring the safety and effectiveness of any treatments produced using them, while also actively researching potential new medicines for the market.”

Dr. Markus Roggen, co-founder of DELIC Labs stated, “Once we secure this 56 Research Exemption together with the Dealer’s License, Delic Labs will become the leader in safety testing of psychedelic compounds to ensure the highest standards and quality control. We will greatly expand our capabilities to work with other banned substances, such as MDMA and LSD, along with psilocybin to develop new psychedelic drugs for medical and research purposes. We believe we are on the cusp of understanding the breadth of what is possible with psychedelics and medicine.”

Founded by Dr. Roggen, an award-winning chemist, and UBC Professor, Dr. Glenn Sammis, Delic Labs supports the psychedelic industry with high precision chemical analytics,  metabolomic identification and process optimization. Delic Labs is one of a handful of licensed psilocybin research labs in Canada and has an aggressive plan to build out a suite of novel compounds and delivery methods for the industry. Delic Labs is also a leading cannabis analytical and research company boasting clients that include some of the largest brands in the world.

About Delic Labs (formerly Complex Biotech Discovery Ventures Ltd.)

Delic Labs is a federally licensed cannabis and psilocybin research laboratory focused on extraction optimization, analytical testing, and process development. Based at the University of British Columbia in Vancouver, Canada and founded by award-winning chemists Dr. Markus Roggen and UBC Professor Dr. Glenn Sammis, Delic Labs uses precision chemical analytics and metabolomics identification to develop IP, produce novel products for patients, and advance the cannabis and psychedelic wellness industries. Part of the Delic Corp family, the leading psychedelic wellness platform, Delic Labs powers innovation and treatment options with an ever-expanding line of unique and high-quality products for markets that allow legal cannabis and psychedelic-based care. 

About DELIC Corp.

Delic is the leading psychedelic wellness platform, committed to bringing science-backed benefits to all and reframing the psychedelic conversation. The company owns and operates an umbrella of related businesses, including trusted media and e-commerce platforms like Reality Sandwich and Delic Radio, Delic Labs, the only licensed [6] entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Meet Delic the premiere psychedelic wellness event, and Ketamine Infusion Centers one of the largest ketamine clinics in the country. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and treatment options to the masses.

Media and Investor Relations Contact

Rich Rodriguez

rich@deliccorp.com

The Canadian Securities Exchange ‎has neither approved nor disapproved the contents of this news release and does not accept responsibility ‎for the adequacy or accuracy of this release.‎

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of Delic’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to: information regarding the timing or terms upon which the Transaction will be completed; potential benefits of the Transaction;  anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, Delic is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of Delic to be ‎materially different from those ‎expressed or implied by such information and statements. Such risks and other factors may include, but are not limited to: risks and uncertainties relating to the Transaction not closing as planned or at all or on terms and conditions set forth in the Merger Agreement; incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.

In addition, in ‎connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to:

assumptions as to the time required to negotiate a definite agreement and complete matters related to the Transaction; the ability to consummate the Transaction; ‎the ability of the parties to ‎obtain, in a timely manner, the requisite regulatory, corporate and other third party approvals and the satisfaction of ‎other conditions to the ‎consummation of the Transaction on the proposed terms; the potential impact of the announcement or consummation of the Transaction on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion ‎of management time on the Transaction.‎

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although Delic believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and Delic does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to Delic or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

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Progress down under

The TGA could reschedule MDMA and psilocybin — what that means for ASX-listers

Australia’s Therapeutic Goods Administration (TGA) may reschedule psilocybin and MDMA to increase access to psychedelic medicine.

After assessing several studies, the TGA recognized that the two drugs have promising therapeutic potential for treating anxiety and depression.

The substances are currently classified as Schedule 9, or “prohibited substances”, creating a barriers for conducting clinical research. The TGA is considering changing the classification to Schedule 8, or “controlled substances” (the same as THC) to allow controlled use in clinical settings. The verdict will be announced in the first week of December after an advisory committee meeting!

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MINDCURE Launches “Desire Project” To Treat Female Hypoactive Sexual Desire Disorder With MDMA-Assisted Psychotherapy

MINDCURE Launches “Desire Project” To Treat Female Hypoactive Sexual Desire Disorder With MDMA-Assisted Psychotherapy

VANCOUVER, BC, Sept. 27, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research in psychedelics, introduces its “Desire Project,” a clinical research program focused on the treatment of female hypoactive sexual desire disorder with MDMA-assisted psychotherapy.

As part of MINDCURE’s research and development, this research program will mark the first psychedelic-based treatment program targeted at addressing what is clinically known as Hypoactive Sexual Desire Disorder (“HSDD”), a common sexual disorder characterized by persistent low sexual desire and emotional distress not attributable to an existing medical condition or relationship issue. According to current estimates, HSDD affects 10% of adult women1 and 14% of premenopausal adult women,2 all reporting that their low desire results in a state of distress. In the U.S. alone, HSDD affects an estimated 9.5 million premenopausal women.3 HSDD is also present in men.

“We know that sexual health contributes to overall wellbeing and that studies relating to HSDD suggest that female desire has deep roots in the mind. Women’s desire issues have not been adequately addressed to date, and we believe that treatment incorporating MDMA and psychotherapy has real promise as it may target those roots of desire in the mind and unlock healing for women lacking desire,” said Kelsey Ramsden, President & CEO, MINDCURE. “MINDCURE has identified a gap in the market, and I think that with the team we have built to execute this project, we can help those seeking improved desire in a new way.”

In clinical trials, MDMA therapy has shown success in helping people heal from Post-Traumatic Stress Disorder (“PTSD”) by working on brain pathways related to fear; it can enhance fear memory extinction, modulate fear memory reconsolidation, and bolster social behavior in animal models. MINDCURE has spent six months designing its forthcoming clinical research program, much of it spent in looking at how MDMA may ease some of these fear factors for women, which play a large role in causing female-related sexual disorders that are not treated by current medications on the market.

“I’m very excited to lead our team and launch a clinical study for the treatment of female Hypoactive Sexual Desire Disorder,” said Dr. Joel Raskin, Chief Medical Officer, MINDCURE. “During my decades as a psychiatrist clinician and researcher, I’ve seen first-hand the limitations of existing treatments. This is an exciting opportunity to find a potentially more effective and better tolerated treatment for women affected by this disorder.”

MINDCURE’s “Desire Project” team is comprised of some of the world’s leading researchers in female sexual desire research and psychedelics, including Dr. Jennifer Mitchell, the lead author of the recently published MAPS MDMA-assisted therapy for PTSD study. Dr. Anita Clayton is the Professor and Chair of the Department of Psychiatry and Neurobehavioral Sciences and a Professor of Clinical Obstetrics and Gynecology at the University of Virginia.  Dr. Cindy Meston directs the Female Sexual Psychophysiology Laboratory at the University of Texas in Austin, one of the few laboratories in the world devoted exclusively to the study of women’s sexual health. Dr. Robert Pyke led the Addyi® project, a drug used in treating the symptoms of HSDD through Phases II and III, and has over 100 peer-reviewed publications in the last 18 years. Dr. Sherry Walling is a practicing licensed clinical psychologist with a master’s degree in theology and an emphasis in trauma.

About Mind Cure Health Inc.
MINDCURE is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The Company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally. Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995

Forward-Looking Information
Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases. Some of the specific forward-looking information in this news release includes, but is not limited to, statements with respect to: the treatment of HSDD with MDMA-assisted psychotherapy; potential effects of MDMA on certain fear factors for women; and the execution and potential outcome of the Desire Project.

Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that MINDCURE will advance wellness worldwide; and the Desire Project will show a successful treatment for HSDD.

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results, and involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: the Desire Project may not be completed as anticipated or at all; MDMA-assisted psychotherapy may not treat HSDD as expected; and results from the Desire Project may not be able to be incorporated into MINDCURE’s products or business as expected. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

1.

https://pubmed.ncbi.nlm.nih.gov/27916394/

2.

https://journals.lww.com/greenjournal/Abstract/2018/05001/Incidence_and_Knowledge_of_Hypoactive_Sexual.649.aspx

3.

Based on an estimate of the number of premenopausal women in the U.S. and the expected number of women affected by HSDD (see footnote 2 above)

SOURCE Mind Cure Health Inc.

For further information: MINDCURE Investor Relations: investors@mindcure.com, 1-888-593-8995; Media Inquiries: Annie Graf / Kristin Cwalinski, KCSA Strategic Communications, mindcure@kcsa.com

‍

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Healing the Armed Forces

Congress to Vote on Psychedelics Research Amendments for Active Military Members

The US government is funding psychedelic research to get military members the relief they deserve!

A new measure, filed by Rep. Dan Crenshaw of Texas, would allow the Secretary of Defense to award research grants to study psychedelic therapy as a PTSD treatment for active military members.

The measure would allow any State or Federal agency, academic institution, or nonprofit to study the therapeutic effects of psilocybin, ibogaine, MDMA, or 5-MeO-DMT. If passed, funds could be used for Phase 2 clinical studies involving members of the Armed Forces or to train practitioners to offer the treatment.

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Awakn Life Sciences acquires Exclusive Rights To MDMA Research From Imperial College London

Awakn Life Sciences acquires Exclusive Rights To MDMA Research From Imperial College London

This was the world’s first published study assessing MDMA-assisted psychotherapy as a treatment for addiction

TORONTO, September 23, 2021 – Awakn Life Sciences Corp. (Awakn), (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) a biotechnology company developing and delivering psychedelic therapeutics to treat addiction, announced today that it has acquired the exclusive rights to the data from the phase IIa Bristol Imperial MDMA in Alcoholism Study (BIMA) from Imperial College London, which has one of the world’s leading psychedelics research centers.

BIMA was an Open-label safety, tolerability and proof-of-concept study to investigate the role of MDMA-Assisted Psychotherapy in treating patients with alcohol use disorder (AUD). It was the first published study assessing MDMA-Assisted Psychotherapy as a treatment for addiction. The results which were published in February 2021, indicated that MDMA has the potential to be more effective at treating AUD. With a 20% relapse rate within the first nine months, compared to 75% relapse rate with traditional treatments.

This data will assist Awakn’s progress by enabling a better design and more efficient execution of its clinical program. Awakn will now be able to accelerate its clinical research into a phase IIb randomized controlled trial (RCT) in the U.K. This is part of its strategy to secure marketing authorization for MDMA to treat AUD in both the U.K. and the European Union, a 400 million person territory.

“Drinking behavior outcomes from the BIMA phase IIa study that Awakn just acquired indicates that MDMA has the potential to be more effective at treating AUD, with only a 20% relapse rate within the first nine months. This compares very favourably with the current best available traditional treatments for patients’ post-detox with AUD” said Dr. Ben Sessa, Chief Medical Officer of Awakn and the principal investigator of the BIMA study.

He continued, “This data acquisition is an important step along Awakn’s path to providing lifesaving MDMA treatment to the millions of people currently suffering with AUD, offering better outcomes without the exorbitant rates of relapse.”

AUD is a serious and currently poorly treated disorder, affecting 5% of the global adult population. Treatment of AUD rates are low at 16%.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (drugs and therapies to be used in combination) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will also deliver evidence backed psychedelic therapies for addiction in clinics in the U.K. and Europe and through licensing partnerships globally.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

About Imperial College London

Imperial College London is one of the world’s leading universities. The College’s 20,000 students and 8,000 staff are working to solve to the biggest challenges in science, medicine, engineering, and business.

Imperial is the world’s fifth most international university, according to Times Higher Education, with academic ties to more than 150 countries. Reuters named the College as the UK’s most innovative university because of its exceptional entrepreneurial culture and ties to industry.

Imperial staff, students and alumni are working round-the-clock to combat COVID-19. Imperial has nearly two thousand key workers, and is at the forefront of coronavirus epidemiology, virology, vaccine development and diagnostics. More than one thousand Imperial staff and students are volunteering to support the NHS.

http://www.imperial.ac.uk/

Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:

KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

 

Media Enquiries:

America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk

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Wesana Health Commits Funding of $1.5 Million To Support MAPS’ Research Pipeline

Wesana Health Commits Funding of $1.5 Million To Support MAPS’ Research Pipeline

MAPS to Investigate Viability of Research Pathway for MDMA-Assisted Therapy to Treat Traumatic Brain Injury

Effort Positions MAPS, Sponsor of the Only Completed Phase 3 Trial for Psychedelic-Assisted Therapy, to Serve New Unique Role Within 

CHICAGO, Sept. 14, 2021 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.  (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), an emerging data-driven life sciences company focused on developing innovative approaches for better understanding, protecting and improving neurological health and performance, including through the advancement of psychedelic medicines, announced its commitment to fund an initial US $1.5 million to assess the viability of Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted therapy to treat traumatic brain injury (TBI).

Under the terms of the recently signed memorandum of understanding, Wesana’s financial commitment will enable MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), to activate a team to evaluate the scope of unmet need for TBI treatment and help to define terms of a desired joint venture between MAPS and Wesana. Use of funds will include, in part, legal support in drafting and finalizing a partnership agreement, business development and executive staff costs in evaluating viability of the treatment, and other research-related expenses including establishing ethical guidelines governing the desired agreement.

MAPS’ research has primarily focused on MDMA-assisted therapy for PTSD, with the first of two Phase 3 trials demonstrating a clinically significant reduction in PTSD symptoms for 88% of participants. Similar to PTSD, TBI can have profound, diverse, and life-long impacts on a person’s physical and mental health. Lingering visible and invisible challenges interfere with work, education, and relationships, with disproportionate impacts for people of color. While leading front-line treatments are considered effective for some individuals or types of injury, more than 6.2 million Americans are estimated to have chronic TBI-related disabilities and millions more live with milder, yet disruptive, symptoms. Nearly 414,000 Iraq and Afghanistan Veterans had a TBI and for many, long-term negative health outcomes are poorly understood.

“Wesana is a serious, thoughtful and ethical company engaged in the development of psychedelic-assisted therapy. What Daniel and his team are doing is in line with MAPS’ ethics, mission, values and scientific rigor, and we believe together, MAPS and Wesana can bring much needed help to the massively underserved TBI population. Data collected from MAPS-sponsored Phase 3 clinical trials suggests that MDMA-assisted therapy appears promising in the treatment of TBI. Consistent with our mission, we seek to investigate treatments for affected patients who can be helped by MDMA – this is an important step in that direction” said MAPS Executive Director Rick Doblin, Ph.D.

Daniel Carcillo, CEO of Wesana Health added “The work MAPS has done for more than 35 years with regulators and clinical researchers to navigate the rigorous and necessary FDA approval process for MDMA therapeutic use has positioned psychedelic-assisted therapy on the precipice of national – and global – acceptance. The millions of people afflicted with PTSD may soon have access to MDMA therapy, and we believe the millions suffering from TBI may experience similar relief in the future.”

This first-of-its-kind research collaboration between MAPS and Wesana will accelerate MAPS PBC’s research timelines and provide additional support for further research, advocacy, education, and equitable access to MDMA-assisted therapy treatments. Under the terms of the relationship, Wesana is expected to:

  • Gain expertise and information to design psychedelic-assisted therapy programs for TBI and improve the Wesana timeline and path to market for its treatments
  • Explore obtaining an exclusive commercial license to use MDMA for the treatment of TBI
  • Evaluate the viability of revenue share agreements between the organizations
  • Adapt MAPS’ equitable access research projects to develop a meaningful patient access program
  • Fund associated research, administered by MAPS PBC, with additional capital

Carcillo continued, “Success in forming a research collaboration with MAPS is expected to shrink Wesana Health’s time to market for MDMA therapy for TBI to a handful of years. With millions of people around the world experiencing injuries impacting their brain health, our hope is that through this partnership we will soon deliver meaningful help to the victims, families, friends and communities affected by TBI.”

Note
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from our projections.

The formation of a long-term partnership between Wesana and MAPs remains subject to, among other things, negotiation and execution of definitive documentation and satisfaction of the conditions precedent negotiated therein. There is no assurance that any such definitive documentation will be settled and entered into by the parties nor that any such conditions precedent will be met.

About Wesana
Wesana is an emerging life sciences company championing the development and delivery of psychedelic and naturally-sourced therapies to treat traumatic brain injury (TBI) and other neurological conditions. Through extensive clinical research and academic partnerships, Wesana is developing evidence-based formulations and protocols that empower patients to overcome neurological, psychological and mental health ailments caused by trauma.

Learn more at www.wesanahealth.com

Forward-Looking Information and Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company and MAPs, including, but not limited to: information concerning the completion and timing of completion of the initial US$1.5 million funding to MAPs, information concerning the completion and timing of entering into a partnership with MAPs, expectations regarding whether the contemplated partnership will be consummated, including whether conditions to the consummation of the partnership will be satisfied, expectations for the effects of the contemplated partnership on the business of the Company, expectations regarding the markets to be entered into by the Company as a result of the contemplated partnership, the ability of the Company to successfully achieve its business objectives as a result of entering into the contemplated partnership, expectations regarding the method by which future revenue is generated, expectations regarding the safety and efficacy of MDMA-assisted therapy, including therapies that are being developed by MAPs, and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information.

Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made including among other things assumptions about the ability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the ability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; development costs remaining consistent with budgets; favorable equity and debt capital markets; favorable operating conditions; obtaining and maintaining all required licenses and permits; receipt of governmental approvals and permits; political and regulatory stability; the level of demand for the Company’s proposed products and services; the ability of the Company to be successful in its research and development initiatives; and the availability of third party service providers and other inputs for the Company’s operations. While the Company considers these assumptions to be reasonable, the assumptions are inherently subject to significant business, social, economic, political, regulatory, competitive and other risks and uncertainties, contingencies and other factors that could cause actual performance, achievements, actions, events, results or conditions to be materially different from those projected in the forward-looking information. Many assumptions are based on factors and events that are not within the control of the Company and there is no assurance they will prove to be correct.

Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, financial position, performance or achievements of the Company to be materially different from any future plans, intentions, activities, results, financial position, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others: the inability of the Company to successfully negotiate and enter into definitive documentation in respect of the contemplated partnership with MAPs and satisfy any related conditions precedent; the inability of the Company to raise sufficient capital to advance the business of the Company, including to be able to fund such partnership with MAPs; and such other risks factors discussed in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and in the Company’s other public filings available on SEDAR. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

For more information, please contact:

Media Contact:
Nick Opich / Annie Graf
KCSA Strategic Communications
Email: Wesana@kcsa.com
Phone: 212-896-1206 / 786-390-2644

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: (773) 236-7972

Source: Wesana Health

Released September 14, 2021

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Revolutionizing all of healthcare?

This West Philly Doctor Says Psychedelic-Assisted Therapy Could Change Your Life

Psychedelic therapy clinics continue to pop up across North America.

Last week, a nonprofit organization called SoundMind Center officially opened in West Philadelphia, which will be dedicated to psychedelic research, treatment, and therapist training.

On Tuesday, another clinic called Innerbloom Healing Arts opened in Charleston, South Carolina. Both clinics currently offer ketamine-assisted therapy with plans to offer MDMA and psilocybin therapy as soon as possible.

“Psychedelics are not only going to revolutionize mental health. They have the ability to revolutionize all of healthcare. Changing the way we think about the relationship between mind and body. And health and disease”, said Dr. Hannah McLane, SoundMind’s founder.

 

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How to bond with strangers

Minnesota Psychedelic Therapy Clinic, Institute for Integrative Therapies, Begins Offering Psychedelic Therapy in a Group Setting

“We have a crisis of loneliness and isolation.” Is group psychedelic therapy the solution?

This week, the Institute for Integrative Therapies (IIT) in Minnesota began offering ketamine-assisted therapy in group settings, and will soon offer group therapy with psilocybin and MDMA too.

Group sessions can provide a powerful healing experience and a sense of connection, plus they’re much cheaper than one-on-one sessions at just $500 per person for a 3-hour experience.

Participants work with a therapist both individually and in group settings to prepare for the experience before laying on a floor mat and tripping in a room full of strangers. Each group has a focus such as depression, anxiety, PTSD, existential crises, grief, end of life distress, and LGBTQ experiences.

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