A photo accompanying this announcement is available at  Mydecine Innovations Group Inc. is pleased to announce that its subsidiary Mindleap Health’s telehealth platform will be officially available for download from the iOS and Android stores on September 30, 2020. Mindleap was founded with the goal of enhancing the wellbeing of millions of people that struggle with mental health problems. By combining ...

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/42c4893d-6232-4d13-9d58-b3098cc222bb

 Mydecine Innovations Group Inc. ( MYCO.CN ) ( MYCOF ) ( 0NF.F ) ("Mydecine" or the "Company"), is pleased to announce that its subsidiary Mindleap Health's ("Mindleap" ) telehealth platform will be officially available for download from the iOS and Android stores on September 30, 2020.

Mindleap was founded with the goal of enhancing the wellbeing of millions of people that struggle with mental health problems. By combining traditional telemedicine with mood and behavior analytics, the Mindleap platform offers a powerful set of tools for managing mental healthcare.

Joshua Bartch, Mydecine Director and CEO commented: "Our team is thoroughly impressed by the user experience and capabilities of Mindleap and we are excited to be able to support such an innovative and mission-driven company. The adoption of telemedicine has significantly increased in 2020 and virtual health-care interactions are on pace to top 1 billion , providing a big opportunity that I'm confident Mindleap can capitalize on."

Platform Overview
Through Mindleap, users can browse vetted and experienced specialists and easily schedule appointments and purchase mental health services. Specialists on Mindleap benefit from the platform's full freedom to manage their virtual practice on their terms; setting their own prices and choosing the hours they work each week (with no minimums or maximums).

Mindleap has established a model that creates value by facilitating exchanges between mental health specialists and people needing mental health services. The company is focused on creating a community with network effects that allows users to interact and transact with specialists in order to improve their mental health. Mindleap is free to use for end users and for specialists who want to build a profile. It is only when an end user purchases services on the platform that Mindleap charges a 9% fee as a percentage of each session.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8bb9a452-1cba-4e72-ad78-14a6226dfc30

Mindleap Founder and CEO, Nikolai Vassev commented: "The world is seeing a crisis that is having unprecedented effects on the wellbeing of millions of people. Mental health is hands down one of today's most important problems and our team is thrilled to officially announce the launch of our platform."

Effective Solutions for Psychedelic Integration

Mindleap is the world's first telemedicine platform uniquely designed to offer psychedelic integration services and currently has over 30 professionals available to offer mental health support to clients. Psychedelics offer a window into the mind, and integration specialists help clients through a systematic process that can turn their psychedelic experience into something practical. This can include helping make sense of unique images or ideas that came to mind during a psychedelic experience, as well as setting new goals, habits and behaviours that can help to improve a person's life.

Over the past decade, a growing body of research published by leading academic institutions such as Imperial College of London, Yale University, and Johns Hopkins University has demonstrated that psychedelic medicines like psilocybin (the active compound found in magic mushrooms), MDMA, and ketamine can be used as effective and safe treatments for a variety of mental health conditions, which often significantly outperform today's standard pharmacological treatments and therapies.

While Mindleap does not encourage people to spend time on their phones while taking psychedelic substances, and does not facilitate psychedelic use via the platform, the company recognizes a deep need for people to connect with trained professionals who can help them discuss and understand their individual psychedelic experiences.

Dr. Danielle Wise, Director of Product Development commented: "When designing Mindleap, we focused on combining the real need for integration after a psychedelic experience with modern and innovative technologies that can help improve the overall therapeutic experience along with outcomes. As the decriminalization and legalization movement progresses we aim to be at the forefront in supporting the psychedelic community and people that are searching for real solutions that are effective but also safe and properly informed."

Later this year, Mindleap will be expanding by adding mental health specialists with different aptitudes as well as a digital therapeutics marketplace that will allow users to access comprehensive mental health programs. These additional offerings will focus on various topics such as meditation, addiction, psychedelic integration, drug harm reduction and holistic wellness.

Mindleap Puts User Privacy and Security First

Mindleap recognizes the immense responsibility in handling people's mental health data, and is setting a new standard for both user privacy and data integrity. Foremost, Mindleap will never sell or license user data, including electronic Personal Health Information (ePHI) to anyone. Mindleap also has strict policies around how data is handled and stored; all data is encrypted in-transit and at-rest, and specialists are not permitted to save their clients' data – they can only view it temporarily while the user chooses to share it during a video call.

Mindleap's software development team has built the platform to meet all HIPAA guidelines by implementing secure electronic access to health data and remains in compliance with privacy regulations and best practices.

Mindleap's Chief Technology Officer Simon Abou-Antoun commented: "Mindleap was designed to improve upon existing software solutions our development team is already working on enhancing our capabilities so Mindleap can capture market share in the fast growing digital health market that is estimated to reach USD 510.4 billion by 2025 ."

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e4a5730-fd8c-43fc-84aa-492111e6061e

Official Launch Date
Mindleap will be available for iOS and Android on Wednesday, September 30th, 2020. Register to be the first to download and get $25 of free credits on Mindleap.

About Mindleap Health
Mindleap is a telehealth solution that helps people connect with mental health specialists that can empower them to thrive and develop habits for a healthy mind. The Mindleap platform brings convenience, improves access to treatments and can lead to more personal breakthroughs. Mindleap's proprietary platform is designed by clinical psychologists and neuroscientists to provide professional support and personalized treatment for every user. Our vision is for a world where people can make lasting life changes by having advanced tools and access to expert mental health professionals right from the palm of their hand.

Learn about Mindleap Health

Learn about The Past and Future of Psychedelics as a Medicine

Apply to become a Specialist on Mindleap

Watch the Mindleap Platform Overview Video

About Mydecine Innovations Group

Mydecine Innovations Group™ is a publicly traded life sciences parent company dedicated to the development and production of adaptive pathway medicine, natural health products and digital health solutions stemming from fungi. Mydecine's experienced cross functional teams have the dynamic capabilities to oversee all areas of medicine development including synthesis, genetic research, import/export, delivery system development, clinical trial execution, through to product commercialization and distribution. By leveraging strategic partnerships with scientific, medical, military, and clinical organizations, Mydecine is positioned at the forefront of psychedelic medicine naturally derived from fungi, therapeutic solutions, and fungtional™ mushroom vitality products. Our portfolio of unified companies, including Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ focus on providing innovative and effective options that can provide millions of people with a healthier quality of life.

For further information about Mydecine Innovations Group Inc., please visit the Company's profile on SEDAR at www.sedar.com or visit the Company's website at www.mydecine.com .

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer

Corp Communication:
Charles Lee, Investor Relations

Public Relations:
Cynthia Salarizadeh, Public Relations

*Mindleap Health Platform Services Disclaimer: Mindleap Services are designed to connect users of our Services with mental health specialists so as to receive assistance and guidance with integrating their prior psychedelic or consciousness-expanding experiences and translating them into positive changes. Our Services are not designed or intended for the integration or translation of a presently occurring psychedelic experience and must not be used for that purpose. Psychedelic substances are legally controlled or prohibited in many jurisdictions, but there are legal means to have a psychedelic or conscious-expanding experience in certain circumstances. You are solely responsible and liable for adequately informing yourself of the Laws of your jurisdiction before using our Services and determining if use of our Services and the receipt of Specialist Services (defined below) is lawful in your jurisdiction. Our Services are meant to be used exclusively in connection with lawful activities and must not be used in connection with illegal substances or illegal activities. Without limiting the previous sentence, you are not permitted to promote, procure, consume, or sell illegal substances through the Services. Do not use psychedelic substances if doing so is unlawful in your jurisdiction. Possession of psychedelic substances in violation of applicable laws can carry significant penalties, including years of incarceration.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management's current expectations and assumptions. Such forward-looking statements reflect management's current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company's ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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COMPASS Pathways announces further positive results from groundbreaking phase IIb trial of investigational COMP360 psilocybin therapy for treatment-resistant depression

- Positive topline results validated by additional analyses

- Patient improvements beyond reduction of depression symptoms

- Further insights into timing and circumstance of adverse events demonstrate COMP360 psilocybin therapy was generally well-tolerated

London, UK 1 December 2021 COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced further results from its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD). Additional analyses of primary and secondary endpoints validated topline findings and provided more insights into safety data. Analyses of exploratory measures including anxiety, self-reported depression, positive and negative affect, and functioning, showed greater improvements for patients receiving a 25mg dose of COMP360 psilocybin compared with those receiving a 1mg dose after three weeks, both with psychological support. Further analysis is ongoing and full trial results will be submitted for publication in a peer-reviewed journal. The data will be reviewed with regulators early next year. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "Our additional analyses underline the robustness of our findings that a single high dose of COMP360 psilocybin, given in conjunction with psychological support, led to a rapid and sustained response for many patients. This phase IIb study was designed to determine the optimal COMP360 dose for our phase III programme, evaluating safety and efficacy at the primary endpoint at week 3. Additionally, we observed consistent improvement in measures of anxiety, positive and negative affect, quality of life, daily functioning, cognition, and self-reported depression. We believe this could make a tremendous difference to patients suffering with treatment-resistant depression, who have few options available to them. Remember, a quarter of the 25mg group maintained response, as measured by the MADRS, at 12 weeks after a single administration with no other antidepressant medication. This finding in itself is unprecedented."

COMPASS reported topline data from this trial last month, which investigated three doses of COMP360 psilocybin (1mg, 10mg, 25mg) in 233 patients with TRD. The results showed that a single 25mg dose of COMP360 demonstrated a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p

As well as looking at clinician-rated depression severity on the MADRS, the trial explored other aspects which are recognised as being important for patients with TRD - and essential to recovery - including positive and negative affect, anxiety, self-rated depression severity, quality of life, functioning and cognition. These exploratory measures also showed that patients in the 25mg dose group of COMP360 psilocybin therapy reported benefits on those measures over those in the 1mg group. On the PANAS* scale measuring positive and negative affect, patients in the 25mg group had a higher increase in positive affect (eg including feeling interested, excited, strong) and a greater decrease in negative affect (eg including feeling distressed, upset, afraid) on the day after COMP360 administration and at the questionnaire's final administration at week 3. On scales measuring anxiety (GAD-7*), self-rated depression (QIDS-SR-16*) and functioning (SDS* and WSAS*), a greater improvement was also shown at week 3, by patients in the 25mg group compared with the 1mg group.

A post-hoc analysis of the 19 sustained responders in the 25mg group found that changes in quality of life, self-reported depression severity, and functioning, were clinically meaningful, with mean scores for these patients returning to "normal" levels and maintained to 12 weeks, the end of the trial. Durability is being studied in a one-year follow-up study which is currently underway.

As noted in the topline data reported last month, COMP360 psilocybin was generally well-tolerated. Further analysis showed that there were no concerns with vital signs, ECG or clinical laboratory data in any of the treatment groups. The majority of treatment-emergent adverse events (TEAEs) occurring on the day of COMP360 administration resolved on the same day or the day after (77.4%); most of these events were mild or moderate in nature, eg headache, nausea, fatigue. All TEAEs involving hallucination (which only occurred in the 25mg and 10mg groups) and illusion (which occurred in all groups) started on the day of administration and resolved on the same day. No events of this nature continued past the administration day.

TEAEs of suicidal ideation, suicidal behaviour and intentional self-injury were seen in all groups, as is regularly observed in a TRD population. Two thirds of the patients had previous thoughts of wishing to be dead, as assessed by a suicidality scale completed during patient screening; this included all patients reporting one of these adverse events, so all patients who experienced these events during the trial had said in patient screening that they had had suicidal thoughts prior to the trial. Further detailed case-by-case analysis of safety data found no evidence to suggest, at this time, a causal relationship between these reported adverse events and administration of COMP360. The events occurred in all treatment groups and at a range of onset times and durations; the majority occurred more than a week after the psilocybin session.

  • There was no difference between the three groups post-administration in scores from item 10 on the MADRS, which measures suicidality and was assessed by a blinded remote rater; mean scores across treatment groups were lower than baseline at all subsequent time points
  • 27 of the TEAEs of suicidal ideation, suicidal behaviour and intentional self-injury occurred across 17 patients, with seven patients in the 25mg group, six in the 10mg group, and four in the 1mg group
  • 14 of these events were reported as treatment-emergent serious adverse events (TESAEs); these occurred across nine patients, with four patients in the 25mg group, four patients in the 10mg group, and one in the 1mg group
  • The majority of these TESAEs (10 events out of 14) occurred at least one week after the COMP360 psilocybin session
  • All suicidal behaviours occurred at least one month after the psilocybin therapy session and all patients reporting these events were non responders at their last assessment prior to the event or at the time of the event

Professor Goodwin said: "Further understanding of the timing and circumstance of adverse events in the trial demonstrates that COMP360 psilocybin therapy was generally well-tolerated. More detailed analysis of the safety data supports our conclusion that there is no evidence to date to suggest a causal relationship between the serious adverse events of suicidal ideation, suicidal behaviour and self-injury, and administration of COMP360 psilocybin therapy. Unfortunately, these events occur unpredictably and are to be expected in this patient population."

He continued: "We are now taking all the data we have generated and using it to inform our clinical development programme so we can understand which patients we might be able to help and how we might help more of them. We will be discussing this with regulators early next year as part of our ongoing dialogue with them."

Sidney Zisook MD, Director of the University of California San Diego Residency Training Program, a Distinguished Professor of Psychiatry at UCSD, and a Principal Investigator on the trial, said: "Many of the participants in this study had suffered for years with severe and crippling depressive disorders despite multiple treatment trials with traditional antidepressant medications and therapies. To see so many experience a robust and sometimes persisting response - and a new, brighter, more positive attitude - during the course of the study, was immensely gratifying and hopeful."

Further detail on additional findings from exploratory measures

  • Affect : results from the PANAS (Positive Affect and Negative Affect Schedule) showed higher positive affect and lower negative affect changes from baseline in the 25mg vs 1mg groups at day 2 and week 3. For positive affect and negative affect, there was a least squares mean (95% confidence intervals) treatment difference favouring the 25mg vs 1mg group at week 3: 6.17 (3.53, 8.82) and -3.18 (-5.59, -0.77), respectively
  • Anxiety: changes from baseline in the GAD-7 (Generalised Anxiety Disorder-7 item scale) total score were greater in the 25mg group vs the 1mg group at week 3. For GAD-7, a least squares mean (95% confidence intervals) treatment difference favouring the 25mg vs 1mg group was found at week 3:  -1.79 (-3.35, -0.23)
  • Self-reported depression: changes from baseline in the QIDS-SR-16 (Quick Inventory of Depressive Symptomatology - Self Rated - 16 item scale) total score were greater in the 25 mg group at weeks 1, 2 and 3, compared with the 1mg group. The least squares mean treatment difference (95% confidence intervals) at week 3 was -2.78 (-4.62, -0.95)
  • Functioning: changes from baseline in the SDS (Sheehan Disability Scale) and the WSAS (Work and Social Adjustment Scale) were greater in the 25mg group vs the 1mg group at week 3. There was a treatment difference of -6.49 (95% confidence interval = -9.52, -3.46) on the SDS 25mg vs 1mg at week 3 and a treatment difference of -5.11 (95% confidence interval = -8.39, -1.82) on the WSAS between the 25mg vs 1mg at week 3
  • Quality of life: no differences were seen between the groups on the EQ-5D-3L (EuroQol-5-Dimension-3-Level Scale) total score and EuroQoL-Visual Analogue Scale – all groups showed an improvement over time. On the EQ-5D-3L total score, the 25mg vs 1mg least squares mean treatment differences at week 3 was 0.06 (95% confidence intervals = -0.03, 0.15). On the EuroQoL Visual Analogue Scale, the 25mg vs 1mg treatment difference at week 3 was 6.77 (95% confidence interval = -0.37, 13.90). A post-hoc analysis of sustained responders in the 25mg group found that changes in quality of life were clinically meaningful, with mean scores in these patients returning to "normal" levels and maintained to 12 weeks
  • Cognition: no differences were seen between the groups on the DSST (Digit Symbol Substitution Test) – all groups showed an improvement over time. The least squares mean treatment difference between the 25mg vs 1mg groups at week 3 was 1.32 (95% confidence intervals = -1.00, 3.64)


Notes to editors:

About treatment-resistant depression (TRD)
More than 320 million people globally suffer with major depressive disorder (MDD) 1 , the leading cause of disability worldwide and one of the fastest growing mental health illnesses 2 . About a third of these patients - 100 million people - aren't helped by existing therapies and suffer with treatment-resistant depression (TRD) 3 . As many as 30% of these attempt suicide at least once during their lifetime 4 , 5 . TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients 6 . The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designati on for its COMP360 psilocybin therapy for TRD.

About the COMP360 psilocybin therapy phase IIb study
This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.

 About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p www.compasspathways.com

Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's business strategy and goals, the future accessibility of COMP360 psilocybin therapy, COMPASS's ability to continue to advance its research, including COMP360, COMPASS's expectations regarding the benefits of its psilocybin therapy, including COMP360 and COMPASS's ability to advance new psychedelic compounds in other areas of unmet mental health need. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

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