Numinus and MAPS Public Benefit Corporation announce collaboration agreement to seek approval of MDMA-assisted psychotherapy for PTSD single-arm, open-label trial
First-of-its-kind trial in Canada will pave the way for expanded MDMA-assisted treatment to support patients with posttraumatic stress disorder
Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies, and the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS PBC) a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) are pleased to announce a collaboration agreement that will seek approval to deliver MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) through a single-arm, open-label, compassionate access 1 trial. This clinical trial will be the first-of-its-kind in Canada and will take a meaningful step in furthering the accessibility of MDMA-assisted treatment options for those experiencing PTSD around the world.
Through the completion of six Phase 2 trials and ongoing Phase 3 trials, MAPS and MAPS PBC have undertaken ground-breaking research demonstrating that MDMA-assisted psychotherapy — which recently received “breakthrough therapy” status from the U.S. Food and Drug Administration (FDA) — may provide sufficient benefit to patients experiencing PTSD to support approval from the FDA.
This compassionate access trial, if approved, will be conducted at Numinus‘ Vancouver clinic, providing MDMA-assisted psychotherapy to an initial 20 individuals experiencing PTSD and collecting outcome and safety data for Health Canada. Numinus‘ physicians, therapists and staff will be trained to deliver the treatment under MAPS’ clinically-tested PTSD treatment protocol prior to approval by Health Canada.
“I am delighted to announce this collaboration agreement which, leveraging MAPS’ evidence-based treatment protocol and Numinus‘ clinical infrastructure, will open the door to MDMA-assisted psychotherapy in Canada ,” said Dr. Devon Christie , Medical Director at Numinus and a MAPS-trained therapist for the delivery of MDMA-assisted psychotherapy.
“Training Numinus therapists in the MDMA-assisted psychotherapy protocol for PTSD will provide a meaningful expansion of access to the ongoing research program for this promising treatment,” said Amy Emerson , CEO of MAPS PBC. “Though this treatment is still investigational, if approval is granted through the regulatory pathway this collaboration will bolster our shared goal of addressing the enormous — and growing — need for improved proven treatments for people suffering from PTSD.”
Dr. Rick Doblin , Founder and Executive Director of MAPS, adds, “Our commitment to open science is rooted in our mission to develop the cadre of qualified practitioners who will provide this world-class therapy. We’re excited to work with Numinus to build the case for regulatory approval through this compassionate access trial and expand best practice clinical infrastructure.”
“We are thrilled to collaborate with MAPS and deliver the meaningful framework that they have spent decades building to better support those experiencing PTSD,” said Payton Nyquvest , CEO of Numinus. “At Numinus, our mandate is to explore and expand patient access to psychedelic-assisted psychotherapies. We are proud to work alongside MAPS in furthering the regulatory landscape for psychedelic-assisted therapies, including MDMA, and setting the stage for the healthcare system of tomorrow.”
The safety and efficacy of MDMA-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
1 Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” ( Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14 ). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation .
ON BEHALF OF THE BOARD OF Numinus Wellness Inc.
President, Chief Executive Officer and Chair
Numinus Wellness Inc. (TSXV: NUMI) is a mental health and wellness company creating an ecosystem of solutions centred around safe, evidence-based, accessible psychedelic-assisted psychotherapy to help people heal and be well.
Numinus Health is dedicated to delivering innovative treatments to address physical, mental, and emotional health, through clinics and virtual services.
Numinus R&D is conducting implementation science and leveraging partnerships to beta-test and refine optimal models of psychedelic-assisted psychotherapy delivery, setting the stage for approved routine use in mental health and wellness care.
Numinus Bioscience is focused on developing testing methods and effective formulas for the evolving psychedelics space. Health Canada licences, scientific expertise, and new technologies facilitate ongoing innovation, and high-throughput contract services generate established revenue.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $100 million for psychedelic therapy and medical marijuana research and education.
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization
Forward Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements 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 statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
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Seth Rogen’s New Cannabis Brand are Now Available at Apothecarium Dispensaries in San Francisco , Berkeley and Capitola
The Apothecarium is offering cannabis from Houseplant, the cannabis lifestyle brand founded by Seth Rogen and Evan Goldberg at its five California dispensaries. The Apothecarium has three San Francisco locations (Castro, SOMA and Marina ) and one each in Berkeley and Capitola (outside of Santa Cruz ).
“With the vast number of dispensaries in California , we put a lot of effort into identifying the right ones that align with Houseplant’s values,” said Seth Rogen , Co-Founder of Houseplant. “The Apothecarium shares the same commitment to creating a strong consumer experience that we pride ourselves on and we are thrilled to bring our three initial strains to their stores in the Bay Area.”
Houseplant is launching with three flower strains, all of which will be available at The Apothecarium, including: Diablo Wind (sativa), Pancake Ice (sativa) and Pink Moon (indica). Like their founder’s groundbreaking film “Pineapple Express”, Houseplant strains are named after weather phenomena. Each strain will be sold in a custom tin.
“We are so proud to be one of the very first dispensaries in California to offer Houseplant to our customers,” said Ryan Hudson , CEO and co-founder of The Apothecarium. “Seth, Evan and everyone at Houseplant love and respect cannabis as much as we do. We simply cannot wait to share their beautiful and delicious flowers with our guests.”
“We’ve been working with the Houseplant team for more than a year and are grateful to have a partner that shares so many of our values, including an emphasis on cannabis education, quality, reform of cannabis laws and beautifully designed, recyclable packaging.”
“Seth has been hands-on during the process, spending time with our store managers to make sure they know the products and how much care has gone into vetting and selecting the best strains. We think our guests are going to love Houseplant.”
About The Apothecarium
The Apothecarium is recognized as one of the nation’s premier cannabis dispensaries, with an emphasis on education via in-depth one-on-one consultations from highly trained cannabis consultants. The company was founded by three first cousins and two family friends in 2011. Our dispensaries are known for providing educational events that are open to the public at no cost — and for welcoming seniors, first-time dispensary visitors, and people with serious medical conditions. The Apothecarium’s flagship San Francisco dispensary was named the best-designed dispensary in the country by Architectural Digest . Patients and customers may order at our dispensaries or online for pickup or delivery at apothecarium.com [apothecarium.com] .
The Apothecarium is committed to giving back to the communities we serve. We have donated more than $400,000 in cash to community groups and nonprofits — plus more than $300,000 worth of in-kind donations.
All Apothecarium dispensaries continue to implement safety measures to protect guests and team members. Protocols include strict social distancing inside and outside the dispensaries, a mask requirement for everyone inside the dispensaries, no contact check-in procedures and ongoing sanitizing throughout the day.
CA Licenses: C10-0000523-LIC; C10-0000522-LIC; C10-0000515-LIC, C10-0000738-LIC, C10-0000706-LIC
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Love Hemp Group PLC (AQSE:LIFE)(OTCQB:WRHLF), one of the UK’s leading CBD and hemp product suppliers, announces that Charles Lamb will be stepping down as a Non-Executive Independent Director of the Company, with effect from April 16, 2021, to focus on his other business interests
Charles has been an integral part of the Board’s efforts to grow the Company since its inception and has played a key role in the Company’s shift in strategy to focus on growing the Love Hemp brand globally.
Love Hemp will continue to develop the team over the coming months, focussing on maximising the significant business opportunities available to the Company as well as preparing it for its upcoming move to the London Stock Exchange’s Main List as announced on 8 April 2021.
Andrew Male, Chairman of Love Hemp Group, commented: “Charles has made a significant contribution to the Company over a period of successful growth and refocussing. On behalf of the Board, I would like to thank him for all his efforts and support and wish him the best with future endeavours.
“As we move towards a listing on the Main Market, we will be looking to strengthen our Board with those who are able to provide experience and guidance to support our future growth.”
For further information please contact:
AQSE Corporate Adviser
H&P Advisory Limited
+44 (0) 20 7907 8500
About Love Hemp Group
The Company, previously World High Life Plc, was incorporated on 30 January 2019 as an Investment Vehicle. Originally intended to identify opportunities in the CBD and Medicinal Cannabis space, it quickly acquired Love Hemp Ltd., the UK’s most recognisable CBD brand. The listed company recently changed its name to Love Hemp Group PLC as part of its evolving strategy to purely focus on supporting the “best in class” CBD brand as it embarks on a wider expansion of its core business and offering.
Love Hemp produces and supplies more than 40 product lines, comprising of oils, sprays and tinctures and a variety of edible and water-based CBD products. Love Hemp has established relationships with over 2,000 stores in the UK, including leading retailers such as Sainsbury’s, Boots, Ocado and Holland & Barrett.
Market Abuse Regulation (MAR) Disclosure
The information contained within this announcement is deemed by the Company to constitute inside information. Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
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SOURCE: Love Hemp Group PLC
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Love Hemp Group PLC
Expects to file its 2020 Annual Financial Statements on or before May 31, 2021
Matica Enterprises Inc. (CSE: MMJ) (FSE: 39N) (OTCQB: MMJFF) (“Matica” or the “Company”) today announced that, as a result of the COVID-19 Pandemic measures, it will not be in a position to file its audited annual financial statements, the related management’s discussion and analysis and related CEO and CFO certificates (the “Annual Filings”) before the required deadline of April 30, 2021 (the “Specified Requirements”).
The Company is working closely with its auditor and expects to file the Annual Filings on or before May 31, 2021. The Company does not anticipate any delay in filing its interim financial statements, management’s discussion and analysis, and the related officer certifications for the financial period ended March 31, 2021.
Matica has applied to the OSC, as principal regulator for the Company, for the imposition of a management cease trade order under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”) over the duration of the default. If a management cease trade order is issued, it will generally not affect the ability of persons who have not been directors, officers or insiders of Matica to trade in their securities.
The Company is providing this press release in accordance with National Policy 12-203 Management Cease Trade Orders (“NP 12-203”). The Company intends to follow the provisions of the Alternative Information Guidelines set out in NP 12-203, including the issuance of bi-weekly default status reports in the form of news releases, for as long as the Company remains in default. The Company confirms as of the date of this news release that there is no other material information concerning the affairs of the Company that has not been generally disclosed.
Matica is a multi-faceted, innovative company in the Quebec cannabis space. Its subsidiary, RoyalMax Biotechnology Canada Inc. is a Dorval, Quebec based Health Canada Licence Holder. RoyalMax has been granted a standard cultivation licence, standard processing and medical sales licences by Health Canada.
On behalf of the Board of Directors
Matica Enterprises INC.
Boris Ziger, CEO & Chairman
Disclaimer for Forward-Looking Information
Certain information in this press release may constitute forward-looking information. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results might differ materially from results suggested in any forward-looking statements. The Corporation assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Corporation. Additional information identifying risks and uncertainties is contained in the Corporation’s filings with the Canadian securities regulators, which filings are available at www.sedar.com.
This news release contains statements about the Company’s information that may be made available on the S&P Capital IQ Corporation Records Listing Program and the business of Matica that are forward-looking in nature and as a result, are subject to certain risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, undue reliance should not be placed on them as actual results may differ materially from the forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof, and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, except as required by law.
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. We seek Safe Harbor.
This news release is not for distribution or dissemination in the United States of America
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So far there are no clear indicators as to when or if Australia could legalise recreational cannabis, but attitudes seem to be changing. Public support is growing, and there’s even some political acceptance.
Read on to learn more about when Australia may legalise recreational cannabis.
Public support for legalisation growing
Australians are no strangers to cannabis — a recently updated report from the Australian Institute of Health and Welfare shows that marijuana is the most extensively used illicit substance in the country.
With that in mind, it’s perhaps unsurprising that views on cannabis are changing in the country. In 2019, Australia’s National Drug Strategy Household Survey found that 41 percent of Australians are in favour of legalising cannabis — that’s close to double the support seen when the survey was done in 2007.
Aside from that, legalisation has been recommended by a number of government inquiries, including a 2019 Queensland Productivity Commission report on imprisonment and recidivism.
Several states have decriminalised personal use of cannabis on private property, including the ACT, the Northern Territory (NT) and South Australia. Most other states have a discretionary almost de facto decriminalisation in place through police diversion programs.
Those arrested for small amounts of under 50 grams of cannabis can be diverted to drug counselling or education, or issued a fine rather than a criminal conviction.
Economic opportunities lie in legalisation
Although Australia’s economy ended 2020 on a high note after facing COVID-19-related setbacks, some experts believe cannabis legalisation could assist even further with economic growth.
The climate of the NT and its accessibility to Asia makes the likelihood of legalised marijuana a possible gold mine for the NT, according to economist Rolf Gerritsen.
“The Government, if it licensed the system and appointed official sales points, could actually set up a nice little industry with the possibility of future exports,” Gerritsen told ABC News.
In 2020, Australia’s economy plunged into its first recession in three decades due to fallout from the coronavirus, which came mere months after devastating bushfires that ravaged over 12 million hectares.
A Twitter campaign from the Australian Greens political party is pushing for legalisation to help pull the nation out of recession, declaring cannabis a “multi-billion dollar industry.”
Federal cannabis legalisation unlikely
Although exciting, it seems unlikely that the Australian government will legalise marijuana at this stage.
Outside the Twitter campaign mentioned above, legalisation of cannabis has been a big part of the platform for the Greens, which are seeking the establishment of a controlled market for the sale of cannabis and would allow members of the public to grow up to six plants.
But the Greens are currently the only political party pushing for legalisation of recreational cannabis.
Both the Liberal National Party and Australian Labor Party have only shown support for medicinal cannabis at a federal level. In fact, Australian Attorney-General Christian Porter has been vocally opposed to the legalisation in Canberra, declaring the laws “terrible” and saying state- and territory-level laws conflict with federal laws on possession.
Many were looking towards the outcome of a New Zealand referendum on legalisation that failed as 50.7 percent voted “no” to the 48.4 percent “yes” votes.
What could legalisation do to the market?
A report from cannabis researcher Prohibition Partners hypothesizes great potential for Australia to significantly increase value through cannabis exports, while a focus on buying local could see more domestic cannabis revenue than ever before.
Success could encourage more regions to look closely at their own reform measures, particularly after watching the ACT’s adoption of restricted cannabis legalisation, the study argues.
“Both Victoria and Tasmania are also making moves towards more lenient cannabis laws and could be following in the ACT’s footsteps,” said the report’s authors.
“The Victorian government invested in R&D of the local industry, and is said to have ambitions to be the ‘cannabis bowl of Australia’ with a target of 500 local jobs.
The report predicts the Australian cannabis market will break a total market value of US$1.5 billion by the year 2025, which would make it the largest legal cannabis market in Oceania. Eagle-eyed investors will be watching the market closely.
Don’t forget to follow @INN_Australia for real-time updates!
Securities Disclosure: I, Ronelle Richards, hold no direct investment interest in any company mentioned in this article.
Kelowna, British Columbia TheNewswire – April 15, 2021 Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (CSE:LXX) (CNSX:LXX.CN) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, announces the appointment of a new Chief Financial Officer and the issuance of share purchase warrants to third party consultants.
Lexaria is pleased to announce that effective April 15, 2021, Gregory Downey will be assuming the role of Chief Financial Officer of the Company. During the past two years, Mr. Downey has been engaged by the Company as its Controller and has intimate knowledge regarding the Company’s business and finances. Mr. Downey brings a wealth of experience to Lexaria, having served as the Chief Financial Officer of several public companies during the past ten years. Mr. Downey holds a Certified Management Accountant designation and is a member of the Chartered Professional Accountants of British Columbia.
In the position as Chief Financial Officer, Mr. Downey will be compensated with a base annual salary of CDN$144,000, with an annual increase of 10%, an option grant for the issuance of up to 12,000 common shares, and other customary incentives.
The Company is grateful to outgoing CFO, Mr. Allan Spissinger, for his many contributions and wishes him continued success in his future endeavours.
The Company also announces that effective on April 16, 2021, it will be issuing share purchase warrants (the “ Warrants ”) for the issuance of up to an aggregate 300,000 common shares to three unrelated third party consultants. The Warrants will be exercisable for a period of three years ending on April 16, 2024 at an exercise price of US$9.00 per share. The shares issuable upon exercise of the Warrants will be restricted securities pursuant to US securities laws.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s proprietary drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company’s technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. DehydraTECH has repeatedly demonstrated since 2016 with cannabinoids and nicotine the ability to increase bio-absorption by up to 5-10x, reduce time of onset from 1 – 2 hours to minutes, and mask unwanted tastes; and is planned to be further evaluated for orally administered bioactive molecules, including anti-virals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 18 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com .
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company’s ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company’s best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company’s ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company’s public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria’s postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
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