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Pure Extracts Provides Q4 Corporate Update

Pure Extracts Provides Q4 Corporate Update

Vancouver, B.C. (November 10, 2021) – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp and the rapidly emerging psychedelic sector, is pleased to provide a brief summary of recent activities.

The fall season has arrived, and with it an ongoing lessening of Covid-19 health measures. This is providing a return to a degree of normalcy here in Canada. Continued optimism is driving business momentum resulting in an increase in activity throughout every aspect of our enterprise operations. Since our last update, the growing wave of nationwide optimism positions the Company to report on several positive activities we can offer our growing base of partners, stakeholders and shareholders alike.

Market Awareness and Product Distribution

Our first and strategically most important update is that Pure Extracts’ products are now listed for sale at licensed outlets throughout British Columbia (BC), Alberta (AB), Saskatchewan (SK), and Ontario (ON).

The product mix encompasses 24 SKUs currently available in each respective provincial recreational cannabis market, and further offers 9 SKUs specifically targeting the medical cannabis supply chain. To-date, Pure Extracts has manufactured approximately 50,000 vape carts and approximately 100,000 gummie packs to support retail sales.

The product lineup has been increased to include a one-gram vape cart which has met with positive consumer uptake. The THC version is in the initial launch phase in BC and AB with the CBD version in ON. Repeat orders of the one-gram product SKU had already been received at the start of the current fiscal quarter.

Pure Extracts’ CBD gummies, offered in their sector-leading unique blister packaging, continue to report uniformly growing market share across all four of the provinces. Medical sales continue to expand through the Abba Medix sales platform, notably in the CBD gummie product lineup. Leading sales figures focus clearly on our ultra-high potency CBD 50, 75 and 100 mg packs.

Our in-house services have also experienced substantial growth in recent months. The two most active services include our white label and tolling business development for industrial-scale customers. We are extremely pleased to have signed three new white label programs for the production of vape cartridges and two of these customers are concurrently tolling their biomass through our services.

New Product Development

Pure Extracts’ development team has identified a new infused-product trend in the cannabis industry and will be executing an unveiling and product launch aimed at new product SKU’s targeting the Canadian marketplace withing the next quarter. Until then, we are keeping details to a minimum as we hope to earn marketing leverage of a very underserved product mix that we believe will position well with our brand identity and distribution ability.

Sales & Marketing

Enhanced social media & sales support strategy:

  • Our dedicated Pure Extracts social strategy (Pure Pulls and Pure Chews) now includes daily posting of a curated feed promoting organic engagement across Instagram, Twitter, Facebook and LinkedIn.
  • Creation of a dedicated Pure Mushrooms social strategy (for Maitake, Reishi, Lion’s Mane) including daily curation of information promoting organic engagement across Instagram, Twitter, Facebook and LinkedIn
  • Ongoing effort and close collaboration with Cannavolve, our national cannabis sales agency and their team on the ground across Canada to promote and secure additional points of purchase for Pure Pulls and Pure Chews
  • A full complement of sales material has been developed to support sales activities in the field.
  • Product knowledge training is actively underway for field sales reps and budtenders (both on-site and virtually).

Michigan Facility Update

In Michigan, the facility build-out continues to progress as the engineers finalize their renovation plans for the existing building. Pure Extracts business development and sales team has toured the Michigan market with our JV partner resulting in meetings with some of their 100+ existing dispensary clients as part of the process to develop specific products tailored to regional consumers. The operations team has identified a head extractor to manage the Michigan facility once in operation. The nominee brings deep cannabis extraction experience especially regarding live rosin and live resin production expertise.

Mushroom Sector Business Development

Our functional mushroom business continues to advance with the development of two new product SKUs including a Lion’s Mane formulation set for launch in December and a Blended product formula scheduled for launch in the first quarter of 2022. Implementation with Amazon Canada experienced some initial issues which have been overcome and we are now on-track to offer cross-border sales with the commencement of a marketing campaign focused on gaining segment visibility and sales penetration of our Pure Mushrooms brand.

Concurrently, our psilocybin enterprise continues to move forward with a joint venture (JV) between Pure Extracts and Psyence Group as Pure Psyence Corp. The JV is structured to formulate a psilocybin extract derived from Psyence Group’s high-potency psychedelic mushroom biomass for 2 clinical trials to be undertaken under the auspices of two prestigious Canadian universities.

Responses from Health Canada regarding our Dealers Licence application are pending, with a successful outcome aimed at allowing us to directly handle controlled substances at our extraction facility in British Columbia.

Near Term Summary

Our near-term goals include product launches in a soon-to-be-named Eastern Canadian province, and the listing of our products through a relationship with a national pharmacy chain. We continue to focus on distribution to medical patients through specific channel partners, with additional medical SKUs planned for 2022.

In Conclusion

As anyone following the Pure Extracts story since our inception in the Fall of 2020 can readily attest to, an incredible effort has propelled the Company forward across multiple fronts. We are very grateful to have the opportunity to work with such a dedicated and committed team who really pulled together as our entire society has had to struggle against unprecedented conditions. It’s a real joy for us all to know we have earned the trust and loyalty of so many consumers, partners and shareholders who share our vision for success. As we head towards a new year, we remain focused on growth, innovation, and value generation. We invite everyone to stay engaged with us, either through social media or by signing up on our website for regular news alerts, because we will have much more to talk about in the months ahead.

ON BEHALF OF THE BOARD

“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director

About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)

Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.

Find out more at https://pureextractscorp.com/

Or contact:
Pure Extracts Investor Relations
Tel: +1 604 493 2052
info@pureextractscorp.com    

This news release contains forward-looking statements relating to the future operations of Pure Extracts,

and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.

This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company, and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.

The CSE has neither approved nor disapproved the contents of this press release.

SAFE HARBOR STATEMENT

This press release may contain forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Companies, its directors or its officers with respect to, among other things: (i) the Company’s financing plans; (ii) trends affecting the Companies’ financial condition or results of operations; (iii) the Companies’ growth strategy and operating strategy; and (iv) the declaration and payment of dividends. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companies’ ability to control, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors including the risk disclosed in Grown Rogue’s Form 20-F and 6-K filings with the Securities and Exchange Commission.

STATEMENT REGARDING UNITED STATES REGULATORY FRAMEWORK FOR CANNABIS

Pursuant to Pure Extracts’ joint venture with Golden Harvests, LLC, Pure Extracts expects to derive revenues from the cannabis industry in the State of Michigan in the United States, which industry is illegal under United States federal law. The joint venture is expected to be directly or indirectly engaged in the manufacture, possession, use, sale and distribution of cannabis in the medical and/or adult-use cannabis marketplace in the State of Michigan.

The United States federal government regulates drugs through the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”), which places controlled substances, including cannabis, in a schedule. Cannabis is classified as a Schedule I drug. Under United States federal law, a Schedule I drug or substance has a high potential for abuse, no accepted medical use in the United States, and a lack of accepted safety for the use of the drug under medical supervision. The United States Food and Drug Administration has not approved cannabis as a safe and effective drug for any indication.

In the United States, cannabis is largely regulated at the state level. State laws regulating cannabis are in direct conflict with the federal Controlled Substances Act, which makes cannabis use and possession federally illegal. Although certain states authorize medical and/or adult-use cannabis production and distribution by licensed or registered entities, under United States federal law, the possession, use, cultivation, and transfer of cannabis and any cannabis-related drug paraphernalia is illegal and any such acts are criminal acts under federal law. The Supremacy Clause of the United States Constitution establishes that the United States Constitution and federal laws made pursuant to it are paramount and in case of conflict between federal and state law, the federal law shall apply.

There is no guarantee that state laws legalizing and regulating the sale and use of cannabis will not be repealed or overturned, or that local governmental authorities will not limit the applicability of state laws within their respective jurisdictions. Unless and until the United States Congress amends the CSA with respect to medical and/or adult-use cannabis (and as to the timing or scope of any such potential amendments there can be no assurance), there is a risk that U.S. federal authorities may enforce current U.S. federal law. If the U.S. federal government begins to enforce U.S. federal laws relating to cannabis in states where the sale and use of cannabis is currently legal, or if existing applicable state laws are repealed or curtailed, Pure Extracts’ business, results of operations, financial condition and prospects would be materially adversely affected. For these reasons, Pure Extracts’ operations in the United States cannabis market (through the joint venture) may subject Pure Extracts to heightened scrutiny by regulators, stock exchanges, clearing agencies and other Canadian and U.S. authorities and is subject to a number of risks, including those risks that are described in the Companies’ public filings profile on SEDAR at www.sedar.com .

To Pure Extracts’ knowledge, no statement has been made by federal authorities or prosecutors regarding the risk of enforcement action with respect to state-sanctioned marijuana activities in the state of Michigan.

No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

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Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

Goodness Growth Holdings Announces Third Quarter 2021 Financial Results

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Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon ID(TM) Clinical Study to Assess the Effect of Ketamine on Neurological Activity as Measured by EEG

Vancouver, British Columbia–(Newsfile Corp. – November 10, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced today that recruitment has begun for the clinical research study with Heading Health LLC (“Heading Health”) as institution and Dr. Steve Levine, MD, as principal investigator to determine the electro-neurophysiologic effects of ketamine.

Entheon recently announced its sponsorship of the study, which will gather electroencephalogram (EEG) biomarker data and patient experience insight from individuals receiving ketamine therapy, and now confirms that enrolment has begun. The study population will be composed of participants who have been diagnosed with treatment-resistant Major Depressive Disorder and have been determined to have a medically appropriate indication for intramuscular ketamine treatment. The participants are also willing to wear an EEG headset which will measure brainwave patterns.

This study serves as the research foundation for two divisions of the company, Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data.

EBIQ-101, an Open Label Observational Study, will observe the EEG pattern of participants being treated with intramuscular ketamine. The data collected will be used to inform the understanding of brain activity changes in response to ketamine. In addition, genetic markers across participants will be compared, with data on impact of genetic markers and response to ketamine also being analyzed.

Based on the two hypotheses being tested, that the clinical response to drug treatment can be accurately assessed during ketamine administration, and EEG changes can predict long term response to drug treatment Entheon intends to develop a framework of understanding for characterizing the psychedelic drug state of patients and to research phenotypes associated with particular addictions and mental health disorders.

“The initiation of EBIQ-101 study is a landmark occasion for Entheon’s ID™ and Entheon IQ™ programs,” said Timothy Ko, Chief Executive Officer of Entheon. “We believe that personalized medicine is the future of psychedelic psychiatry, and that EEG and genetic-based biomarkers will add much needed layers of data insight which can be used to improve patient care.”

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Heading Health LLC

Founded in Austin, Texas, Heading Health delivers mental healthcare which is high quality, affordable and accessible. A comprehensive set of evidence-based, insurance covered therapeutics and technologies are available through Heading, including Spravato (esketamine), Transcranial magnetic stimulation (TMS), telepsychiatry and Intramuscular (IM) ketamine.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
eglassen@blueskycommunications.com

Cautionary Note on Forward-Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to a strategic investment, the performance of such investment and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the design and commencement of the study of the electroneurophysiologic effects of ketamine, the effects of ketamine, obtaining regulatory approvals, subject enrollment, obtaining meaningful data, if at all, and the outcome of the study. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.

Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release

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Better Plant Congratulates Affiliate Neonmind On Recent Achievements

Better Plant Congratulates Affiliate Neonmind On Recent Achievements

Vancouver, B.C. – November 10, 2021: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FRA: YG3) (“Better Plant” or the “Company”), a wellness company, congratulated its affiliate NeonMind Biosciences Inc. (“NeonMind”) on its recent achievements and advancements toward its drug development program and planned specialty clinics launch.

On November 8, 2021, NeonMind formed an alliance with SRx Health Solutions (“SRx”). SRx is a leading Canadian specialty healthcare services and medical treatment provider, to establish and operate a network of NeonMind-branded specialty clinics to deliver evidence-backed innovative treatments for a variety of mental health needs. NeonMind will leverage SRx’s nationwide network of over 70 clinics, as well as its operational capabilities, to bring NeonMind’s unique treatment protocols to underserved populations in Canada.

Prior to its alliance with SRx, NeonMind was ranked third in Psychedelia Magazine’s “8 Industry Innovators” segment within the magazine’s inaugural Winter 2022 issue. NeonMind was recognized for its dual approach in bringing psychedelic treatments to patients in need through its anticipated specialty mental health clinic launch and its drug development program for novel obesity treatments.

Better Plant congratulates NeonMind for these advancements toward providing integrated mental health services and delivering evidence-backed, innovative treatments tailored to local market needs. NeonMind is a Better Plant portfolio company with an ownership of 26 percent. NeonMind is listed on the CSE under the ticker symbol “NEON”, and on the OTCQB under the ticker symbol “NMDBF”.

 

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind established a medical services division with the goal of launching NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs.

For more information on NeonMind, go to  www.NeonMindBiosciences.com.

 

About Better Plant Sciences Inc.

Better Plant harnesses plant intelligence and leverages modern science to offer sustainable, plant-based products that are better for health and better for the earth. It makes and sells over 75 proprietary products, all made with 100% natural ingredients, under the brands Jusu, Urban Juve and Wright & Well.  Better Plant operates Jusu Bar, a quick serve restaurant alternative in Victoria, BC, which serves up fresh, healthy, and nutritious options with a focus on Jusu cold-pressed juices. Jusubar.com offers home delivery of refrigerated plant-based beverages consisting of cold-pressed juices and packaged juice cleanses. Through its Shopify enabled eCommerce sites getjusu.com and urbanjuve.com, Better Plant sells plant-based personal care products and cleaning products. Better Plant products are sold through a network of online and brick and mortar retail locations including Whole Foods Market, Pharmasave, Healthy Planet and Vitasave. Better Plant also offers operational, financial, and other services to companies with businesses that align with Better Plant’s mission to help create a better world.

For more information on Better Plant, visit betterplantsciences.com or follow on Instagram, Twitter or LinkedIn.

 

Penny White, President & CEO

penny@betterplantsciences.com

1-833-515-2677

 

Investor Relations:

Alexandra Dumanski

invest@betterplantsciences.com

1-833-515-2677

 

Sales Inquiries:

Amber Allen, Head of Sales

amber@betterplantsciences.com

604-808-8118

 

The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.

 

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation.  Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements.  Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of COVID-19, the potential for not acquiring any rights as a result of the patent  application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen.  Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets.  Better Plant cautions readers not to place undue reliance on forward-looking statements provided by Better Plant, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better Plant expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

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Cannabis Global in Distribution and Purchase Option Agreement for Cannabis Transport System Comply Bag(R)

Cannabis Global in Distribution and Purchase Option Agreement for Cannabis Transport System Comply Bag(R)

LOS ANGELES, CA / ACCESSWIRE / November 10, 2021 / Cannabis Global, Inc. (OTC PINK:CBGL), an innovation-oriented company investing in disruptive cannabis technologies, today announces it has entered into a distribution agreement with Humboldt Bliss to distribute the Company’s Comply Bag®, cannabis transport system with integrated smartphone track and trace app. As part of the agreement, the Company also also granted Humboldt Bliss an option to purchase a controlling interest in Ethos Technology LLC, dba Comply Bag®, a wholly-owned subsidiary of Cannabis Global, for $4 million, which controls the products and the associated intellectual property.

David Welch, the managing partner at DRWelch, a Los Angeles-based law firm specializing in regulatory compliance and intellectual property issues with a strong specialization in the cannabis industry, who serves as general counsel of Humboldt Bliss, commented, “We see strong possibilities relative to Comply Bag® especially relating to what most people in the cannabis industry believe will be an upcoming national market for cannabis. Comply Bag® is the best way to stop diversion of cannabis from the legal market into the illicit market and we believe likely to become a standard requirement for Government approved cannabis facilities. As more licensed and legal cannabis commerce occurs, the secure tracking and tracing of cannabis shipments will become a vital interest of both corporations and regulatory agencies.”

Comply Bag® utilizes proven security, tamper resistance, and tracking features that will allow cannabis companies to transport products as safely as large financial institutions transport cash and marketable securities. The product includes the ??integration of the METRC applications programming interface (API) into a custom smartphone app that will allow cannabis shippers and receivers to scan shipments with the information being integrated directly into the leading cannabis track and trace system. At least 15 states, including California, mandate the use of METRC.

Arman Tabatabaei, CEO of Cannabis Global commented, “With our first shipments of Comply Bag® already in our Los Angeles warehouse, we believe the distribution of this innovative product line can begin immediately. Over the coming weeks, we will be working with the Humboldt Bliss team to add more features and functions to the smartphone app, which is at the heart of the Comply Bag® transport system.”

The Agreement grants Humboldt Bliss as the exclusive distributor for North and Central America, the Caribbean, and Europe, based on specific first rights of refusal outlined in the Agreement. In addition, the Purchase Option allows Humboldt Bliss to acquire a 51% controlling interest in Ethos Technologies and contains specific anti-dilution and first rights of refusal provisions. The Company will file the complete agreement on Form 8-K with the Securities and Exchange Commission, to be accessed at www.sec.gov.

About Comply Bag

Comply Bag® features a multi-layer, low-density polyethylene outer shell that protects valuable shipments and allows manufacturers, buyers, and processors full view of contents to assess quality. Each Comply Bag™ contains financial institution-grade tamper-evident seams, self-sealing closures, and sequential numbering to ensure what is sent is what is received. In addition, because all U.S. states have implemented specific regulations for the tracking and tracing of cannabis shipments from seed to sale, Comply Bags® features regulator demanded tracking features, such as those required in the California Cannabis Track-and-Trace (CCTT) system, including Unique Identifier Tags (UID) mandated by California via its contracted service provider, METRC, Inc.

About Cannabis Global, Inc.

Cannabis Global, Inc. is a Los Angeles-based, fully audited and reporting Company with the U.S. Securities & Exchange Commission, trading under the stock symbol CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio. We are marketing and producing Comply Bag®, an innovative solution for cannabis storage, transport and tracking and Natural Plant Extract (NPE), which is a Southern California licensed cannabis manufacturer and distributor which licenses our technologies to produce edibles for the cannabis marketplace. Cannabis Global has filed three non-provisional and multiple provisional patents for cannabis infusion and nanoparticle technologies and continues an active research & development program.

Forward-looking Statements

This news release contains “forward-looking statements” which are not purely historical and may include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities and words such as “anticipate,” “seek,” intend,” “believe,” “estimate,” “expect,” “project,” “plan,” or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects, the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission. For more information, please visit www.sec.gov.

Contact:
Arman Tabatabaei
IR@CannabisGlobalInc.com
+1 (310)-986-4929

IR Contact:
John Grosso
http://www.iconiconsulting.com/
+1 (424) 239-9521

References:

https://www.hempgrower.com/article/ab-45-passes-california-legislature-draws-opposition-smokable-hemp-legalize-cbd/

https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202120220AB45

https://www.jdsupra.com/legalnews/california-finally-breaks-from-fda-on-8133219/

SOURCE: Cannabis Global, Inc.
View source version on accesswire.com:
https://www.accesswire.com/672055/Cannabis-Global-in-Distribution-and-Purchase-Option-Agreement-for-Cannabis-Transport-System-Comply-BagR

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Nova Mentis Files Genetic Neuroinflammatory Disease Patent

Nova Mentis Files Genetic Neuroinflammatory Disease Patent

Vancouver, British Columbia – November 9, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, is pleased to announce that it has filed a genetic neuroinflammatory disease patent which describes a  diagnostic/therapeutic combination of mRNA molecules that encode proteins involved in the development of neurogenerative diseases, including fragile X syndrome (FXS) and autism spectrum disorders (ASD).

“The ability to penetrate the unique genetic language underlying the development of neurodegenerative chronic diseases and assess therapeutic responses opens the door for the development of breakthrough products in the field of psychedelic medicine,” states Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The clinical biomarker data generated with this genetic paradigm can be used to support the potential benefits of a psychedelic drug product IND application with U.S. FDA (1).”

  1. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union.

The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca.

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.

Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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MYND Executes LOI to Enter into a Clinical Research Collaboration with Revitalist

MYND Executes LOI to Enter into a Clinical Research Collaboration with Revitalist

Focused on generating data through proprietary biomarkers and diagnostic testing of inflammation

VANCOUVER, BC, Nov. 9, 2021 /CNW/ – MYND LIFE SCIENCES INC. (“MYND” or the “Company”) (CSE: MYND) (OTC: MYNDF) is pleased to announce its wholly-owned subsidiary MYND DIAGNOSTICS INC. (“MYND Diagnostics“) has executed a binding letter of intent (“LOI“) with REVITALIST LIFESTYLE AND WELLNESS LTD. (“Revitalist“) (CSE:CALM) (OTC:RVLWF) (FSE: 4DO) to enter into a clinical research collaboration studying a link between diagnostic results and improved patient outcomes using MYND Diagnostics’ proprietary anti-inflammatory peptide (“MAP“) biomarker. The MAP diagnostic is intended to give health care providers an objective monitoring tool to detect and diagnose mental illness more accurately than the current diagnostic methodology, which can be very subjective. If successful, this biomarker test has the potential to lead to earlier diagnosis of mental illness and ongoing treatment decisions with the goal of improving patient outcomes by providing more tailored and efficacious treatments.

The goal of the collaboration with Revitalist is to utilize their broad network of clinics with patients suffering from mental illness to commence clinical trials to demonstrate MAP’s ability to diagnose and monitor mental health in order to gain approval by the U.S. Food and Drug Administration (“FDA“). The parties anticipate that initial clinical trial will be focused on patients with mental health issues who had previously been infected with COVID-19 and are seeking medical help for post COVID-19 mental health symptoms (“Brain Fog“). The World Health Organization reports that COVID-19 has affected more than 249 million individuals1. Research indicates that approximately 50% on average of those with COVID-19 have reported having lasting effects2. Revitalist has a network of over 2,300 patients through its multiple clinics in the United States, with many of those patients having been previously infected with COVID-19 and seeking specialized treatments to deal with Brain Fog and other lasting effects.

Dr. Lyle Oberg, MD, CEO of MYND stated “A critical step in diagnostics development is demonstrating that an investigational tool produces consistent results. With the new collaboration we intend to design next phase clinical validation studies and take blood samples from existing patients at Revitalist with an expectation that we will submit the MYND biomarker (MAP) data to the FDA for approval in Q2 of 2022. The Company anticipates generating near-term revenue through research and development projects related to MAP. Ultimately, MYND intends to work with physicians to adopt MAP in their practices and provide access to patients and insurance providers for reimbursement when utilizing our proprietary diagnostic. We anticipate that working with Revitalist will be our first of many mental health studies. Their comprehensive network of patients and expert providers will provide the MYND Diagnostics team with optimal research conditions to study MAP in patients so dearly needing better diagnostic and treatment options.”

Kathryn Walker, CEO of Revitalist stated “We are excited to be working with MYND Diagnostics to potentially diagnose and monitor mental health using MAP. Prior to MAP the only diagnostic for mental health was an interview with the patient regarding their history of symptoms, which of course can be very subjective. A diagnostic tool such as MAP would allow for a more objective diagnosis and monitoring, hopefully resulting in a higher level of care and treatments for our patients. One size doesn’t fit all with mental health and treatments that work for some may not work for others. Utilizing MAP would allow us to quickly adjust treatments to better address patient specific mental health issues.”

ABOUT MYND LIFE SCIENCES INC.

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

ABOUT REVITALIST LIFESTYLE AND WELLNESS

Revitalist Lifestyle and Wellness Ltd. is a publicly traded company, headquartered in Knoxville, Tennessee, with five clinics operating across the United States and expanding. Revitalist is dedicated to empowering individuals toward an improved quality of well-being through a combination of comprehensive care and future-centric treatments provided by medical professionals, mental health experts, and chronic pain specialists. Since opening their first clinic in 2018, Revitalist has provided thousands of infusions for patients suffering from treatment-resistant conditions. Additionally, Revitalist offers a number of lifestyle optimization services and vitamin infusions that can bring anyone closer to total wellness.

CONTACT INFORMATION

MYND Life Sciences Inc.
Dr. Lyle Oberg, MD, CEO
Email: ir@myndsciences.com 
Web: www.myndsciences.com

Forward-Looking Statements

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

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

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

https://covid19.who.int
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003773#sec016

SOURCE MYND Life Sciences Inc.

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Cybin to Announce Second Quarter FY2021 Financial Results and Business Update on November 15, 2021

Cybin to Announce Second Quarter FY2021 Financial Results and Business Update on November 15, 2021

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM” today announced that it will report financial results for its second quarter of fiscal 2021 ended September 30, 2021 on Monday, November 15, 2021.

A conference call will be held on the same day at 4:30 p.m. (EST) to discuss the results and recent business updates. The call will be hosted by Doug Drysdale, Cybin’s Chief Executive Officer. Mr. Drysdale and other members of the management team will be available to answer questions from participants following the prepared remarks.

CONFERENCE CALL DETAILS:

DATE:

Monday, November 15, 2021

TIME:

4:30 p.m. (EST)

DIAL-IN

1-844-200-6205 (U.S. toll free) or 1-833-950-0062 (Canada toll free)

CODE

727873

WEBCAST

https://events.q4inc.com/attendee/747515026

An archived webcast will also be available on the Company’s Investor Relations site under the Events & Presentations page.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Investor & Media Contacts:

Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com

Tim Regan/Scott Eckstein
KCSA Strategic Communications
cybin@kcsa.com

Lisa M. Wilson
In-Site Communications, Inc.
lwilson@insitecony.com

Source: Cybin Inc.

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

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

Largest randomised, controlled, double-blind psilocybin therapy study ever completed shows rapid and sustained response for patients receiving a single dose of COMP360 psilocybin with psychological support

COMPASS management team to host an investor conference call today at 1.00pm UK (8.00am ET)

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 that its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression has achieved its primary endpoint for the highest dose, with a 25mg dose of COMP360 demonstrating a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response*.

In the randomised, controlled, double-blind trial, a single dose of investigational COMP360 psilocybin was given to 233 patients in conjunction with psychological support from specially trained therapists. All patients discontinued antidepressants prior to participation. The trial was powered to compare two active doses of COMP360, 25mg and 10mg, against a comparator 1mg dose. The 25mg group vs the 1mg group showed a -6.6 difference on the MADRS* depression scale at week 3 (p<0.001). The 25mg group demonstrated statistical significance on the MADRS efficacy endpoint on the day after the COMP360 psilocybin administration (p=0.002). The 10mg vs 1mg dose did not show a statistically significant difference at week 3. The MADRS was assessed by independent raters who were remote from the trial site, and blind to intervention and study design, effectively creating a triple blind. At least twice the number of patients in the 25mg group showed response and remission* at week 3 and week 12, compared with the 1mg group. The protocol-defined sustained response* up to week 12 was double, with 20.3% of patients in the 25mg group vs 10.1% in the 1mg group. Using a definition of sustained response* that is consistent with other TRD studies, the difference was more than double, with 24.1% of patients in the 25mg group vs 10.1% in the 1mg group. COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) being mild or moderate in severity. 179 patients reported at least one TEAE; the most common TEAEs across treatment groups (>10% overall incidence) were headache, nausea, fatigue and insomnia. There were 12 patients who reported treatment-emergent serious adverse events (TESAEs). These TESAEs included suicidal behaviour, intentional self-injury, and suicidal ideation, which are regularly observed in a treatment-resistant depression patient population, and which occurred more frequently in the 25mg group than in the 10mg or 1 mg groups. Overall, 209 patients completed the study; there were five withdrawals from the 25mg group, nine from the 10mg, and 10 from the 1mg.

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.

Depression that isn’t helped after two or more adequate antidepressive treatments is referred to as treatment-resistant depression (TRD)1,2. More than 100 million people worldwide are affected by TRD1,2, and as many as 30% of these attempt suicide at least once during their lifetime3,4. 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 designation for its COMP360 psilocybin therapy for TRD.

George Goldsmith, CEO and Co-founder, COMPASS Pathways, said: “No one is untouched by the mental health crisis – everyone has a story. We urgently need options for people who are not helped by existing therapies. We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage. I am delighted that we have succeeded in doing this. We have demonstrated our ability to execute an innovative, multicentre, multinational clinical trial programme – and in the midst of a global pandemic. Our work follows the efforts and achievements of so many researchers before us, and we are grateful to all of them and for the opportunity to work with the mental health care community to transform patient experience and patient outcomes. With our world-leading psychedelic research over the last few years, we have now created a unique and extensive data lake; this provides an unprecedented opportunity to further evaluate and optimise psilocybin therapy for patients suffering with serious mental health illness. With these compelling data, we will urgently progress our clinical development programme and move closer to making this therapy accessible to patients in need, if approved.”

Key findings:

  • COMP360 25mg vs 1mg: a difference of -6.6 points in change from baseline in MADRS total scores at week 3 (p<0.001), with a statistically significant difference seen from day 2 up to week 6
  • COMP360 10mg vs 1mg: a non-statistically significant numerical treatment difference of -2.5 points at week 3 (p=0.184)
  • At least double the number of MADRS responders, remitters, and sustained responders with 25mg vs 1mg; rapid response and remission from day 2 to week 3
    • 36.7% (29 patients) in 25mg group showed response at week 3, compared with 17.7% (14 patients) in 1mg group
    • 29.1% (23 patients) in 25mg group were in remission at week 3, compared with 7.6% (6 patients) in 1mg group
    • 24.1% (19 patients) in 25mg group were sustained responders at week 12, compared with 10.1% (8 patients) in 1mg group
  • COMP360 was generally well tolerated, with more than 90% of treatment-emergent adverse events (TEAEs) mild or moderate in severity
  • Treatment-emergent adverse event (TEAE) incidence
    • 5% (66 patients) in 25mg group
    • 7% (56 patients) in 10 mg group
    • 2% (57 patients) in 1 mg group
  • Treatment-emergency serious adverse event (TESAE) incidence
    • 3% (5 patients) in 25mg group
    • 0% (6 patients) in 10 mg group
    • 3% (1 patient) in 1mg group

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is a common and devastating condition, affecting tens of millions of people, with few effective treatments. This is the largest modern study of a psychedelic drug, combined with psychological support, enrolling over 200 people with TRD. In this groundbreaking study, a single dose of psilocybin, given in conjunction with psychological support, generated a rapid response that lasted up to 12 weeks. Remission rates appear to be higher than seen in traditional medication studies. We now have evidence from a large well-designed trial that psilocybin may be effective for people with treatment-resistant major depressive disorder. These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

Michael Pollock, CEO at the Depression and Bipolar Support Alliance (DBSA), said: “Many people suffering with severe forms of depression find that existing treatments don’t work for them. We support any attempt to investigate alternative therapies. The approach of cycling through drugs that aren’t working is inadequate for anyone who is living with a mental health condition and disheartening for the family members and healthcare professionals who care for them. The results seen from this study are an early indicator of hope for those who are desperately in need of help.”

Robin Carhart-Harris PhD, Director of the Psychedelics Division at the Weill Institute for Neurosciences at the University of California San Francisco, and Ralph Metzner Distinguished Professor of Neurology, Psychiatry and Behavioral Sciences, said: “This is an important and exciting moment for the mental health care community. It builds upon more than two decades of research into the viability of psychedelic compounds to treat mental health conditions and demonstrates the potential it has in helping people living with treatment-resistant depression. It’s encouraging to see how far this field has progressed in the last 20 years and I look forward to further research.”

In addition to this topline data, COMPASS is conducting comprehensive secondary analyses which are expected to further inform the clinical development programme for COMP360 psilocybin therapy. In the meantime, this promising topline data will be shared in an expeditious manner with regulators as part of an ongoing dialogue.

Conference call

The COMPASS management team will host a conference call at 1:00pm UK (8.00am ET) on 9 November. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054.

The call will also be webcast on the Investors section of the COMPASS Pathways website. The webcast will be archived for 30 days.

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)5, the leading cause of disability worldwide and one of the fastest growing mental health illnesses6. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)7. 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 patients8.

About the COMP360 psilocybin therapy phase IIb study

The phase IIb study was a dose-finding study, assessing 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 is 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. We are headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. 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

 

 

 

*Notes: MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; protocol-defined sustained response = patients meeting the MADRS response criteria from week 3 until week 12; sustained response = patients meeting the MADRS response criteria at week 3 and at week 12, and at least at one visit out of week 6 and week 9

  1. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf
  2. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388
  3. Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
  4. Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
  5. WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
  6. WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
  7. Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
  8. Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23
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COMPASS Pathways plc announces financial results and business highlights for the third quarter 2021

COMPASS Pathways plc announces financial results and business highlights for the third quarter 2021

Highlights:

  • Positive topline results from phase IIb COMP360 psilocybin therapy trial for treatment-resistant depression; rapid and sustained response for patients receiving a single 25 mg dose of COMP360 psilocybin with psychological support
  • Launch of phase II study of COMP360 psilocybin therapy for PTSD
  • Positive signals from Maryland Oncology Hematology open-label investigator initiated study of COMP360 psilocybin therapy for depression in cancer
  • Acquisition of IP portfolio of novel psychedelic compounds and prodrugs
  • Hamilton Morris appointed full-time consultant
  • New US composition patent granted for crystalline psilocybin
  • Conference call today at 1:00pm UK (8:00am ET)

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2021 and gave an update on recent progress across its business.

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “With the positive topline results from our COMP360 psilocybin therapy phase IIb trial, we are one step closer to potentially providing a much-needed therapeutic option to patients suffering with treatment-resistant depression. At the same time, we are making great progress in broadening our pipeline – we are beginning a phase II COMP360 psilocybin therapy trial for PTSD, and we have acquired a large portfolio of new compounds and IP, working with Matthias Grill PhD. Our goal remains the same – to transform mental health care and bring options to the millions of patients who currently don’t have many.”

 

Business highlights

  • Positive topline results from groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD); data shared in separate press release published today
  • Continued investment in the expansion of COMPASS portfolio with addition of phase II trial of COMP360 psilocybin therapy in post-traumatic stress disorder (PTSD)
    • 20 patient, fixed dose, open-label trial to begin at The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London
  • Promising data from open-label investigator-initiated study of COMP360 psilocybin therapy for depression in cancer, conducted and reported by Maryland Oncology Hematology at the Aquilino Cancer Center (Rockville, MD)
    • Showed feasibility of simultaneous psilocybin administration in small groups, with 1:1 support
    • Remission in major depression symptoms for 15 of the 30 patients, sustained for eight-week follow-up
    • COMP360 psilocybin found to be generally well-tolerated with no treatment-related serious adverse events
  • Acquisition of intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances
    • IP developed with Dr Matthias Grill, founder and CEO of MiHKAL GmbH in Basel, Switzerland
    • Working with Dr Grill on exclusive research project to develop new product candidates
  • Hamilton Morris, research scientist and filmmaker, appointed full-time consultant
    • Researching new psychedelic compounds that could be developed into therapies in areas of unmet mental health need
  • New US patent granted
    • Claims covering alternative crystalline psilocybin not used in COMP360
    • Portfolio of nine granted patents, including four in the US, two in the UK, one in Germany, two in Hong Kong

 

Financial highlights

  • Net loss for the three months ended 30 September 2021 was $15.8 million or $0.38 loss per share (after including non-cash share-based compensation expense of $2.3 million), compared with $16.7 million or $1.30 loss per share during the same period in 2020 (after including non-cash-share-based compensation expense of $5.2 million).
  • Net loss for the nine months ended 30 September 2021 was $46.1 million, or $1.17 loss per share (after including non-cash share-based compensation expense of $5.9 million), compared with $41.5 million, or $3.90 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $16.6 million).
  • Research & development (R&D) expenses were $12.2 million for the three months ended 30 September 2021, compared with $6.9 million during the same period in 2020. Of this increase, $6.2 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $0.9 million in non-cash share-based compensation expense compared with the same period in the prior year.
  • R&D expenses were $30.4 million for the nine months ended 30 September 2021, compared with $18.8 million during the same period in 2020. Of this increase, $14.3 million reflected increased development activities, including hiring additional staff, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. There was a reduction of $2.7 million in non-cash share-based compensation expense compared with the same period in the prior year.
  • G&A expenses were $9.6 million for the three months ended 30 September 2021, compared with $6.6 million during the same period in 2020. The increase was attributable to a reduction of $2.0 million in non-cash share-based compensation, offset against an increase of $2.5 million, $0.7 million and $1.8 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.
  • G&A expenses were $24.5 million for the nine months ended 30 September 2021, compared with $21.1 million during the same period in 2020. The increase was attributable to a reduction of $8.0 million in non-cash share-based compensation, offset against an increase of $5.8 million, $0.8 million and $4.9 million, respectively, in personnel expenses, legal and professional fees, and facilities and other expenses.
  • Cash and cash equivalents were $294.0 million as of 30 September 2021, compared with $196.5 million at 30 September 2020.

 

Conference call

The COMPASS Pathways management team will host a conference call at 1.00pm UK (8.00am ET) on 9 November 2021. The call can be accessed by dialing (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 34908054. The call will be accompanied by a presentation which will be available on the COMPASS Pathways website (ir.compasspathways.com). The call will also be webcast on the website and archived for 30 days.

 

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 is investigational and 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. We are headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. 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”, “plan”, “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, COMPASS’s business strategy and goals, 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, 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 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 7423