Dr. Robert C. Malenka is the Pritzker Professor of Psychiatry and Behavioral Sciences, Director of the Nancy Pritzker Laboratory and Deputy Director of the Wu Tsai Neurosciences Institute at Stanford University - Mind Medicine Inc. a leading psychedelic medicine biotech company, has announced the addition of Dr. Robert C. Malenka an accomplished neuroscientist and psychiatry professor from Stanford University to ...

Dr. Robert C. Malenka is the Pritzker Professor of Psychiatry and Behavioral Sciences, Director of the Nancy Pritzker Laboratory and Deputy Director of the Wu Tsai Neurosciences Institute at Stanford University

- Mind Medicine (MindMed) Inc. ("MindMed" or the "Company") (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, has announced the addition of Dr. Robert C. Malenka an accomplished neuroscientist and psychiatry professor from Stanford University to Chair the Company's Scientific Advisory Board.

Dr. Malenka is an elected member of the National Academy of Sciences and the National Academy of Medicine as well as an elected fellow of the American Academy of Arts and Sciences, the American Association for the Advancement of Science, and the American College of Neuropsychopharmacology. He has served on the National Advisory Council on Drug Abuse and as a Counselor for the Society for Neuroscience and the American College of Neuropsychopharmacology. He is well known for his landmark contributions to understanding of brain plasticity mechanisms, and has extensive experience as an advisor to various pharmaceutical and biotechnology companies.

MindMed CEO J.R. Rahn said: "Dr. Malenka has tremendous knowledge and wisdom across several critical fields in which MindMed operates. We are honored to have him join MindMed as Chair of the Scientific Advisory Board. The entire MindMed team is elated to learn and receive guidance from an industry veteran who has guided several pharmaceutical and biotechnology companies throughout their growth and development. As the MindMed team progresses toward achieving MindMed's goal of providing innovative new potential treatments to the mental health and addiction patient populations, we look forward to Dr. Malenka's input and guidance."

Dr. Robert Malenka added: "I am very excited to join the MindMed team and to help bring creative, sophisticated and rigorous scientific approaches to advancing MindMed's mission of developing new, more efficacious treatments to potentially improve the mental health of the large segments of the population in need. There are incredible opportunities to leverage the use of previously demonized drugs as therapies and combine them with other treatment modalities to potentially achieve more rapid, more effective and longer-lasting reductions in symptoms that often destroy lives and families. New approaches for improving mental health are desperately needed, and I look forward to working with MindMed on such approaches."

MindMed's Scientific Advisory Board is composed of a diverse group of members with expertise in psychiatry, neuroscience, and clinical development. Such Board leverages decades of deep knowledge in biotechnology and psychiatry to help guide MindMe d's development programs. Members represent institutions such as Johns Hopkins , NYU Langone Health, Duke University , NIH, Stanford University , and Albany Medical College.

Dr. Robert C. Malenka Bio :

Dr. Robert C. Malenka is the Pritzker Professor of Psychiatry and Behavioral Sciences, Director of the Nancy Pritzker Laboratory and Deputy Director of the Wu Tsai Neurosciences Institute. After graduating from Harvard College he received an M.D. and a Ph.D. in neuroscience in 1983 from Stanford University School of Medicine. Over the ensuing 6 years, he completed residency training in psychiatry at Stanford and 4 years of postdoctoral research at the University of California, San Francisco (UCSF). In 1989, he was appointed Assistant Professor of Psychiatry and Physiology at UCSF, at which he reached the rank of Full Professor in 1996. In addition to running an active research program at UCSF he was the Director of the Center for the Neurobiology of Addiction and Associate Director of the Center for Neurobiology and Psychiatry. He returned to the Stanford University School of Medicine in 1999. He is an elected member of the National Academy of Sciences and the National Academy of Medicine as well as an elected fellow of the American Academy of Arts and Sciences, the American Association for the Advancement of Science, and the American College of Neuropsychopharmacology. He has served on the National Advisory Council on Drug Abuse and as a Counselor for the Society for Neuroscience and the American College of Neuropsychopharmacology. He is on the scientific advisory boards of numerous non-profit foundations and biotechnology companies. He has been the recipient of numerous awards including: the Society for Neuroscience Young Investigator Award (1993); the Daniel Efron Award from the American College of Neuropsychopharmacolgoy (1998); the Kemali Foundation International Prize in Neuroscience (2000); the CINP-Lilly Neuroscience Basic Research Award (2002), the Perl/UNC Neuroscience Prize (2006), the NARSAD Goldman-Rakic Prize for Outstanding Neuroscience Research (2010), the Pasarow Foundation Award for Extraordinary Accomplishment in Neuropsychiatry Research (2011), and the Society for Neuroscience Julius Axelrod Prize (2016). His laboratory continues to conduct research on the molecular mechanisms of neural plasticity as well as the role of circuit dysfunction in brain disorders including addiction, autism, obsessive compulsive disorder and depression.

About MindMed

MindMed is a psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company's groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED . MindMed is also traded in the United States on the OTCQB under the symbol MMEDF , and in Germany under the symbol MMQ . For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements under applicable securities laws.  Such forward-looking statements involve risks and uncertainties relating to future events, results and the performance of MindMed, and actual events, results and the performance of MindMed may differ materially from these forward-looking statements. Words such as "will," "may," "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," "potential" and variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include, but are not limited to, statements related to the potential for psychedelic inspired medicines and therapies to achieve more rapid, more effective and longer-lasting reductions in symptoms in the mental health and addiction patient populations. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, among others, MindMed's and its collaborators' ability to continue to conduct research and progress their preclinical, study and clinical trial programs; the nature, enrollment, timing, results and possible success and therapeutic applications of its products and product candidates and research and preclinical, study and clinical trial programs now underway or planned; and the likelihood, timing, and scope of possible regulatory approval and commercial launch of any product candidates and new indications for any products. Any forward-looking statements are made based on management's current beliefs and judgment, and MindMed does not undertake any obligation to update publicly any forward-looking statement.s  Investors are cautioned not to rely on these forward-looking statements and are encouraged to read MindMed's continuous disclosure documents, including, but not limited to, its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at www.sedar.com .

Media Contact: mindmed@150bond.com

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SOURCE Mind Medicine (MindMed) Inc.

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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)

-Ends-

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.

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

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COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in three investor conferences as follows:

  • Evercore ISI 4 th Annual HEALTHCONx Virtual Conference: fireside chat at 9:40am ET on 1 December 2021. The fireside chat will feature Augustus John Rush MD, Adjunct Professor in the Department of Psychiatry and Behavioral Sciences at Duke University School of Medicine

  • H.C. Wainwright 2nd Annual Psychedelics Conference: panel "Three Forms of Psilocybin" at 10:00am ET on 6 December 2021 and presentation available on demand

  • Berenberg European Conference 2021: virtual one-on-one meetings on 8 December 2021

A live audio webcast of the Evercore fireside chat and the H.C. Wainwright presentation will be available on the "Events" page of the Investors section of the COMPASS website. A replay of the webcast will be available for 30 days following each event. For more information, please visit ir.compasspathways.com.

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