Hollister Biosciences Inc. today announced results of its 2021 Annual General and Special Shareholder Meeting held on November 22, 2021 . All of the matters put forward before the Company's shareholders for consideration and approval, as listed in the management information circular of the Company dated October 18, 2021 were approved by the requisite majority of votes cast at the Meeting. This includes the election ...

Hollister Biosciences Inc. (CSE: HOLL) (OTC: HSTRF) (FRANKFURT: HOB) (the " Company " or " Hollister Biosciences ") today announced results of its 2021 Annual General and Special Shareholder Meeting (the " Meeting ") held on November 22, 2021 .

All of the matters put forward before the Company's shareholders for consideration and approval, as listed in the management information circular of the Company dated October 18, 2021 (the " Circular "), were approved by the requisite majority of votes cast at the Meeting. This includes the election of all six (6) Board of Director nominees listed in the Circular: Jakob Ripshtein, Jacob Cohen , Eula Adams , Lily Dash , Kevin Harrington , and Brett Mecum .

Shareholders approved the creation of a new class of shares designated as proportionate voting shares (" PVS "). As previously announced , holders of PVS will be entitled to 1,000 votes in respect of each PVS held. No dividend will be declared or paid on the PVS unless the Company simultaneously declares or pays, as applicable, equivalent dividends (on an as converted to common share basis) on the common shares in the capital of the Company (the " Common Shares "). In addition, each PVS will be convertible into 1,000 Common Shares.

Promptly following the filing of a notice of alteration to its articles by the Company, Carl Saling has agreed to convert 26,814,400 Common Shares into PVS and Jake Cohen has agreed to convert 48,762,400 Common Shares into PVS. Mr. Saling and Mr. Cohen have also each agreed not to convert the PVS back into Common Shares until July 2, 2022 .

The PVS are being created in order to minimize the proportion of the outstanding voting securities of the Company that are held by "U.S. persons" for purposes of determining whether the Company is a "foreign private issuer" for purposes of United States securities laws.

Board of Director Biographies

Mr. Jakob Ripshtein, CPA – Mr. Ripshtein served as the President of Aphria Inc. (" Aphria "), which was acquired by Tilray, Inc. (NASDAQ: TLRY), one of the largest cannabis companies in the world, and played an instrumental role in its growth throughout Canada , global product innovation and the integration of global supply networks. He joined Aphria after spending years as the Chief Financial Officer of Diageo North America Inc. (" Diageo ") (NYSE: DEO) and President of Diageo Canada, the multinational beverage giant behind such global brands as Johnnie Walker , Don Julio , Guinness, Baileys, Smirnoff and Captain Morgan. Prior to Diageo, Mr. Ripshtein held a variety of roles in finance, sales and strategy in various global companies and has been based in Canada , the U.S. and the U.K. Earlier in his career, Mr. Ripshtein oversaw business, sales and tax functions in the Canadian spirits, pharmaceutical and financial sectors. Mr. Ripshtein holds a Bachelor of Business Administration from York University , as well as a CPA and International Tax designation. Mr. Ripshtein is currently CEO of Perennial Brands Inc., a full life-cycle brand strategy organization.

Mr. Jacob Cohen - Mr. Cohen is the founder of Venom Extracts, one of the industry's premier award- winning cannabis concentrate brands. Commencing in March 2020 , Venom Extracts sales were consolidated with the Company's sales and contributed approximately 95% of the Company's overall sales. Venom Extracts' product suite is a category leader in Arizona with over 4 million grams of cannabis sold in 2020, accounting for up to 30% of category sales state-wide (per BDS Analytics). Venom Extracts has strong brand recognition and distribution, with products in the vast majority of dispensaries in Arizona .

Mr. Eula Adams - Mr. Adams has had a highly accomplished career spanning five decades across a variety of industries serving public, private, government and philanthropic causes. He has an extensive history in executive leadership and governance roles of large, diverse organizations. Most recently, Mr. Adams served as a member of the board of directors and Chairman of the Audit Committee for Harvest Health & Recreation Inc. from December of 2019 through the recent completion of its acquisition by Trulieve Cannabis Corp. (CSE: TRUL), which formed the world's largest legal seller of cannabis by revenue.

Mr. Adams is a graduate of Morris Brown College with a Bachelor of Science degree in accounting, a Master of Business Administration from Harvard Business School , and is a Certified Public Accountant. He spent 20 years with Deloitte (Public Accounting, Taxation and Management Consulting), was the former Executive Vice President of First Data Corporation (Payments and Money Transfer); the former Senior Vice President of Sun Microsystems (Computer Servers, Storage Devices, Software and Services); and a former member of the Board of Directors of MasterCard (U.S. Region). His corporate rise led him to be named one of the 50 most powerful black executives by Fortune in July of 2002.

Mr. Adams serves a number of public sector and non-profit positions and his memberships include: American Institute of CPAs; White House Historical Association National Council; Colorado Society of CPAs; United Way of Colorado ; Board of Directors Grow Generation; Congressional Black Caucus Foundation; Sigma Pi Phi Fraternity; Kappa Alpha Psi Fraternity; CareerWise Colorado Board; Volunteers of America Board ; Denver International Airport Advisory Board; Colorado Department of Transportation; and New Hope Baptist Church Board of Trustees.

Lily Dash, ESQ Ms. Dash's background includes extensive governance, legal, transactional and emerging markets experience. Ms. Dash is a practicing lawyer, a dynamic entrepreneur with global experience, and a visionary technology and ESG founder. Ms. Dash's vast experience and perspective will support the Company's growth and expansion. Ms. Dash is a Chairwoman of the Board of Directors of Polymath Inc, Member of the Board of Directors of Earth Wallet, and Founder of Villabound Inc., Rexy Inc., and Co-Founder of WiFetch Inc.

Mr. Kevin Harrington – Mr. Harrington is a veteran CEO, bestselling author and platform-building entrepreneur known to millions as one of the original "sharks" on the 4x Emmy- winning ABC series Shark Tank . His many landmark achievements include inventing the infomercial, pioneering the As Seen on TV brand, co-founding the Electronic Retailers Association (ERA), serving as a co-founding board member of the Entrepreneurs' Organization (EO) and creating HSN Direct as a joint venture with the Home Shopping Network. Twenty of his companies have each topped $100 million in revenue, and his behind-the-scenes work has helped produce billions more in global sales. He's launched massively successful products like The Food Saver, Ginsu Knives, The Great Wok of China , The Flying Lure, and many more. He has worked with amazing celebrities like Billie Mays , Tony Little , Jack Lalanne , and George Foreman to name a few. Mr. Harrington then built on that success to help pioneer the As Seen on TV brand.

In 2013 after divesting of the As Seen on TV brand, Mr. Harrington joined the Board of Directors of an emerging start-up in the functional beverage space; Celsius Holdings Inc. (NASDAQ: CELH) (" Celsius "), which at the time had a share value of $0.22 and a total market cap of less than $10 million . Since then, Celsius has grown into a leading brand in the functional and energy beverage categories. Mr. Harrington served on the Board of Directors of Celsius until August 19th, 2021 . Today, Celsius is valued at greater than $7.2 billion , and the share price is greater than $94 per share.

Brett Mecum Mr. Mecum is an innovative and seasoned government relations professional with a record of success at the federal, state, and local level throughout the country. He is known for an ability to build long term relationships, collaborate with stakeholders, and engage organizational grassroots to ensure legislative policy goals are met. He is an expert at understanding legislative processes, bill drafting, and budget appropriations at all levels of government, and is an experienced political operative and fundraiser with expertise running high energy and high- profile political campaigns, political action committees, and independent expenditure committees.

Mr. Mecum is the Chief Executive Officer of a full-service government relations firm representing corporate, association, and non-profit sector clients in 12 state legislatures through policy development of short and long-term legislative objectives. He has managed 20+ programs that provide meaningful engagement for association members with lawmakers, successfully ended increased taxation schemes on Premium Cigars in Minnesota , Nebraska and New York ; curbed new over-regulation of the premium cigar industry in Oklahoma and was the only lobbyist to successfully amend the Arizona Medical Marijuana Act with implementation of testing protocols and new regulatory enforcement of the industry by the Arizona Department of Health Services. Mr. Mecum is also regarded as a policy expert in the Blockchain and Cryptocurrency space and was the catalyst behind the state of Arizona creating its first Blockchain and Cryptocurrency task force.

About Hollister Biosciences

Hollister Biosciences is a multi-state company with a portfolio of innovative, high-quality cannabis & hemp branded consumer products and white-labeling manufacturing. The Company's products are sold in 370 dispensaries across Arizona and California . Hollister Biosciences wholly-owned brand, Venom Extracts, is a category-leading brand that sold more than 4 million grams in 2020, accounting for up to 30% of category sales in Arizona .

Products from Hollister Biosciences include HashBone, the brand's premier artisanal hash-infused pre-roll, along with concentrates (shatter, budder, crumble), distillates, solvent-free bubble hash, pre-packaged flower, pre-rolls, tinctures, vape products and full-spectrum high CBD pet tinctures. The Company's wholly-owned California subsidiary Hollister Cannabis Co is the 1st state and locally licensed cannabis company in the city of Hollister, CA , birthplace of the "American Biker".

Website: www.hollisterbiosciences.co

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SOURCE Hollister Biosciences Inc.

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- 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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