Open-label clinical trial will evaluate and refine best practices for the delivery of psilocybin-assisted psychotherapy for participants with tobacco, stimulant, alcohol, and/or opioid disorders

 Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI ), a company creating an ecosystem of solutions centred on the research, development, and delivery of safe, evidence-based, accessible psychedelic-assisted psychotherapies, has announced it will undertake a compassionate access clinical trial of psilocybin-assisted psychotherapy for substance use disorders. This study will enable the company to implement, test, and refine optimal protocols for the use of psilocybin-assisted psychotherapy for participants with a range of substance use disorders and will be conducted in collaboration with Syreon Corporation a global contract research organization with expertise in conducting clinical trials across a broad range of chronic and complex diseases. The study will involve an initial 30 participants who will take part in a motivational enhancement psychedelic psychotherapy intervention with psilocybin.


According to Health Canada’s Special Access Programme , compassionate access single-arm open-label clinical trials can be incorporated into drug development planning to “meet the needs of patients who are not eligible for enrollment in other pivotal trials” and is one of Health Canada’s preferred means for patients to access drugs that are not yet available on the market.

“Research has already demonstrated great promise for psilocybin-assisted psychotherapy as a treatment for certain substance use disorders,” said Chief Medical Officer, Dr. Evan Wood . “But, psilocybin is still illegal in Canada . This compassionate access trial will begin to address the hurdle of public accessibility, while allowing us to evaluate service delivery models and study the impacts of psilocybin-assisted psychotherapy as an adjunct to standard of care treatments for substance use disorders.”

The study builds upon a growing body of research demonstrating psilocybin-assisted psychotherapy’s efficacy as a novel treatment for specific substance use disorders. A pilot study focusing on tobacco addiction at Johns Hopkins University found that 12 months after psilocybin therapy sessions, approximately 70 percent of participants remained completely abstinent from smoking and approximately 90 percent rated their psilocybin experience as among the most personally meaningful experiences of their lives. A study of psilocybin-assisted psychotherapy for alcohol use disorder at New York University has also demonstrated major reductions in alcohol use.

The evolving international regulatory landscape has opened the door to accessibility of psilocybin-assisted psychotherapy, and Numinus‘s compassionate access trial is expected to contribute to continued interest in expanding access.

“The tides are turning for the regulated use of psilocybin, as witnessed earlier this month in the United States . A yes vote for Measure 109 in Oregon permits licensed service providers to provide psilocybin-assisted psychotherapy, and Health Canada has an ongoing provision of exemptions for psilocybin for medical use,” said Founder, CEO, and Chair, Payton Nyqvest . “By increasing access through a compassionate access trial, we hope to help lead the way to regulation in Canada through our implementation science approach which will provide critical outcome and safety data to health regulators.”

Numinus‘ compassionate access trial is the first in a series of planned projects and partnerships aimed at expanding access to MDMA for treatment of PTSD and psilocybin for treatment of substance use disorders. These implementation science initiatives will allow the company to refine clinical protocols and strategies for when these medications are approved for widespread use by regulating bodies.

ON BEHALF OF THE BOARD OF Numinus Wellness Inc.
Payton Nyquvest
President, Chief Executive Officer and Chair

About Numinus
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.

Learn more at numinus.ca , and follow us on Facebook , Twitter , and Instagram .

About Syreon
Syreon provides a full suite of adaptive clinical trials, health economics and outcomes research ensuring safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.

Syreon partners with an elite portfolio of global pharmaceutical corporations and early-stage biotech companies to speed the evaluation of new therapies and improve health outcomes. Its expert research services identify precise therapeutic needs, rapidly evaluate new health interventions, monitor clinical use and define optimal economic value in today’s competitive health environment.

Syreon scientists have contributed to many groundbreaking innovations, from the first blockbuster signal inhibitors, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, stem cell therapeutics and other recent initiatives in precision medicine.

Syreon’s head offices in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, providers, purchasers and payers. Our services through all phases of study planning, operation, analysis and reporting ensure safe, effective and value-driven clinical use.

www.syreon.com

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.

SOURCE Numinus Wellness Inc.

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Cannabis Market Update: Q3 2020 in Review

Click here to read the previous cannabis market update.

During the first few months of investment time in 2021, cannabis faced some volatility alongside optimism about federal changes in the most important market for the drug.

The cannabis business found its stride during Q1 thanks to policy change signals and consolidation.

To find out more, the Investing News Network (INN) asked experts about progress in the market during the first major period of the new year, and which developments investors should watch out for.

 

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Cannabis market update: New York and US potential boost operations

New York state’s legalization of recreational cannabis was a huge Q1 announcement that added pressure to the US federal government when it comes to cannabis policy, said George Mancheril, co-founder and CEO of Bespoke Financial, a debt financing business with a particular focus on servicing cannabis businesses.

“It’s going to add to the chorus of voices in the federal scene to basically move sooner rather than later,” he explained to INN.

Following the US election in 2020, the momentum for cannabis businesses went on the upswing, as did company valuations, with the idea of expansion at the heart of it all, according to Mancheril.

Before starting Bespoke Financial, Mancheril learned from traditional investment banks, working in the lending, fixed income and debt markets with Goldman Sachs (NYSE:GS) and Guggenheim Partners.

Nawan Butt, portfolio manager with Purpose Investments, agrees with Mancheril. The financial expert told INN the ongoing legalization process seen in the US market is leading to expansion.

“It’s becoming more of a national move, then small pockets of proliferation. That’s very exciting about cannabis right now,” said Butt, who co-manages the Purpose Marijuana Opportunities Fund (NEO:MJJ).

This proliferation effect is causing a change in valuations and enthusiasm for US-based operations. Mancheril told INN that by the end of Q1, multi-state operators (MSOs) had raised approximately US$3.3 billion.

The cannabis lender said he sees the industry as having grown from the woes of 2019; it is now undergoing a return to form as excitement about the US opening up increases.

The expert explained that there is likely to be a windfall of capital in the wake of major federal changes in US cannabis policy, although the timeline for these changes is becoming increasingly hard to predict.

Leading up to that capital influx, Mancheril said he wants to see operators really drill down on the value of desired assets and whether they make sense.

“What I’d hope is that we continue to see bullish sentiment, but with some measure of responsibility, and let’s not just get over ahead of ourselves,” Mancheril told INN. “The idea is let’s minimize the volatility and continue growing responsibly.”

 

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As far as struggles go, Butt explained that the cannabis industry has cemented itself as a growth-type sector, and as such there are macro pressures affecting the way these assets operate.

“We’ve seen this preference for cash flows at growth in the current or in the near future, rather than in the far future, and that’s what we’re seeing as far as valuations go in the broad market,” Butt said.

Cannabis market update: Volatility continues to rule as industry foundations build

Despite the industry’s potential and the growing pains it has gone through as a whole in both the US and Canada, volatility remains a key factor in the cannabis investment scene.

Butt explained that the current shareholder base, which is dominated by hedge funds and retail investors, still lacks enough institutional support to avoid the day-to-day volatility cannabis has come to be known for.

These two investor groups, Butt said, can be easily spooked and excited by the news of the day when it comes to their investments.

“A lot of these institutions’ strategies are not about short-term profits, but they’re about long-term sustainability of the businesses themselves,” Butt said.

“That’s why you see a lot of volatility in the space, and that’s essentially what we’ve seen over the past, I’d say, three to two months as well,” he added.

That means investors shouldn’t expect an end to volatility anytime soon.

“It’s not about whether we continue to expect volatility, because we do,” Butt said. “We really think that the volatility will be taken out when the shareholder base becomes more institutional, but it’s really about understanding why there is volatility in the first place.”

Cannabis market update: Canadians talk up US business, but questions remain

A surge of mergers and acquisitions has taken over the Canadian cannabis sector recently as more producers see potential in America.

One of the biggest announcements in this regard came when Organigram Holdings (NASDAQ:OGI,TSX:OGI) secured a C$221 million investment deal from British American Tobacco (NYSE:BTI,LSE:BATS).

Using the funds, the two will work in tandem to develop new branded products designed for the international stage, including in the US. Organigram CEO Greg Engel previously told INN that the US represents a critical opportunity for Canadian companies, but the entry point isn’t as clean as it could be.

 

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While the long-term potential may be exciting for investors, Butt told INN he’s still unsure how the approach will work for Canadian companies.

The Purpose Investments expert said there will be plenty of space for the biggest Canadian names to pursue US market entries, beyond the initial hemp-derived CBD moves some operators have mde, since the US represents the biggest market in the world.

“But there’s just way too many unknowns right now to say exactly what that participation is going to look like, or when that participation will happen,” he said.

“What we do know is that currently the US MSOs are in a wonderful sort of position to expand on their market leadership that they have. And it will be tough for Canadians to come in and compete with them,” Butt said.

Canadian players still retain the upper hand at times in terms of valuation, which is confusing for both Butt and Dan Ahrens, chief operating officer and portfolio manager at AdvisorShares.

“The performance in quarterly earnings of US companies has been rather spectacular. They’ve knocked it out of the park in most instances,” Ahrens told INN.

Butt praised the recent performance reports from MSOs across the board, pointing to year-over-year growth lines and projections for continued positive performance. In his view, share prices still don’t reflect company value. “Those are really being discounted at this point,” Butt told INN.

“We’ve seen the Canadian licensed producers be really hot stock performance-wise, outpacing the US (MSOs), and I’ll say it’s rather nonsensical to me,” said Ahrens, who oversees the AdvisorShares Pure Cannabis ETF (ARCA:YOLO) and the recently launched AdvisorShares Pure US Cannabis ETF (ARCA:MSOS).

Cannabis market update: Investor takeaway

The cannabis investment proposition finds itself at an interesting moment in time, as the entire sector eagerly awaits confirmation in the US at the federal level.

While for the Canadian companies waiting on the sidelines, this development may feel like a major necessity to address current financial struggles, for US-based operators, the heat around the corner could represent future positivity for already thriving operations.

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All interested parties can join the conference call by dialing 1-888-231-8191 or 1-647-427-7450, conference ID: 4880609. Please dial in 15 minutes prior to the call to secure a line. The conference call will be archived for replay until May 20, 2021 . To access the archived conference call, please dial 1-855-859-2056 and enter the encore code 4880609.

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Appointment of Dr. Kelmendi, Assistant Professor of Psychiatry at Yale University and co-founder of the Yale Psychedelic Science Group, brings another experienced medical professional to Lobe’s advisory team.

 Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company”) is pleased to announce the appointment of Benjamin Kelmendi, MD, Assistant Professor of Psychiatry at Yale University School of Medicine, to its Scientific Advisory Board.

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Ayurcann Holdings Corp. ( CSE: AYUR ) (the “ Company ” or ” Ayurcann “), a Canadian extraction company specializing in the processing of cannabis and hemp for the production of oils and various derivative products, is pleased to unveil further details of its Phase 2 expansion plans.

Ayurcann has commenced trading on the Canadian Securities Exchange (” CSE “) on April 8, 2021 and subsequently announced a private placement of up to $500,000 (” Financing “), as per the Company’s press release dated April 12, 2021. The proceeds of the Financing are intended to be used to further pursue Phase 2 of the expansion of the production capacity of the Company’s Pickering facility.

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