Pharmaceutical

The trial evaluates Numinus' first trademarked product and patent-pending production process  Numinus Wellness Inc.  a leader in psychedelics-focused mental healthcare, is pleased to announce that it has formally submitted the clinical trial application to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies ...

The trial evaluates Numinus' first trademarked product and patent-pending production process

 Numinus Wellness Inc. ("Numinus") (TSX: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has formally submitted the clinical trial application ("CTA") to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies Numinus' long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.

"This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies," says Sharan Sidhu , Science Officer and General Manager, Numinus Bioscience. "The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability."

NBIO-01 is Numinus Bioscience's first proprietary formulation developed from extracts generated using patent-pending technology, for which a patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021 . The formulation has been developed to stably deliver psilocybin and other synergistic compounds and will be studied for safety and bioavailability.

As Numinus' first fully autonomous clinical trial, HOPE is a two-phase study that will take place at a Numinus clinic in Vancouver . Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

"At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained," says Payton Nyquvest , Founder & CEO, Numinus. "I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them."

About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental healthcare and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model - including psychedelic production, research and clinic care - is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinus.com and follow us on LinkedIn , Facebook , Twitter , and Instagram .

Forward-looking statements
This press 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 regarding future performance are "forward-looking statements". Forward-looking statements can be identified by the use of words such as "expects", "does not expect", "is expected", , "intends", "anticipates", "does not anticipate", "believes" or variations of these words, expressions or statements, that certain actions, events or results "may", "could", "would", "might" or "will be" taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company's facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company's limited operating and profitability track record; dependence on management; the Company's need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company's efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially 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 does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

Cision View original content: https://www.prnewswire.com/news-releases/numinus-submits-clinical-trial-application-for-phase-1-trial-on-proprietary-psilocybin-product-301461011.html

SOURCE Numinus Wellness Inc.

Cision View original content: http://www.newswire.ca/en/releases/archive/January2022/14/c3596.html

News Provided by Canada Newswire via QuoteMedia

NUMI:CA
Numinus

Numinus

Overview

Numinus (TSX:NUMI, OTC Pink: NUMIF) is a healthcare company at the forefront of addressing the growing prevalence of mental health issues and desire for greater wellness. The company offers an integrated therapeutic model to create lifelong relationships with people seeking physical, mental and emotional health with a focus on treating mental illness, trauma and substance abuse.

In addition to services including counselling, neurofeedback, physiotherapy and other therapies, Numinus aims to conduct psychedelic-assisted therapies to help people heal, connect and grow — when approved by Health Canada, Colleges and other regulators. Numinus put a value chain in place that will be key to the company's growth and success. Numinus Bioscience is licensed by Health Canada to test, sell and distribute psychedelic substances. Numinus Wellness plans to establish physical locations where psychedelic-assisted therapies can take place once approved by regulators. Lastly, Numinus R&D is where partnerships with leading research groups will take place to advance practice and understanding in the space.

Numinus Bioscience is making a name for itself in analytical testing for psychedelic substances and as a place of excellence for product research and development. Numinus Bioscience's 7,000 square foot analytics and research laboratory handles a range of psychedelic substances and analytical methods and uses for the psychedelics space. In October 2020, Numinus announced it had harvested the first legal flush of Psilocybe mushrooms in Canada by a public company under its Health Canada-issued Controlled Drugs and Substances Dealer's Licence.

Numinus was founded by Payton Nyquvest and Stacey Wallin, who both have a passion for developing holistic therapies that deal with the root causes of mental illness, addictions and trauma. The two founders have a wealth of experience in bringing innovative companies to the capital markets. Nyquvest, for example, has raised over C$100 million for public and private companies alike and has facilitated numerous IPOs, including Numinus' pending RTO with Salvation Botanicals and Rojo Resources Ltd. Joining the team as Chief Operating Officer is Michael Tan, who was the first director for the British Columbia Liquor Distribution Branch's (BCLDB) cannabis division. He also has a track record of driving profitable revenue growth.

Numinus' Company Highlights

  • RTO with Salvation Botanicals and Rojo Resources Ltd. completed in Q2 2020.
  • When approved by Health Canada and Colleges, Numinus aims to conduct psychedelics-assisted therapies to help people heal, connect and grow. These therapies will be conducted in safe, controlled therapeutic environments when approved by regulators.
  • Has a 7,000 square foot laboratory that is licensed by Health Canada to test, possess, buy and sell various controlled substances.
  • In October 2020, the company harvested the first legal flush of Psilocybe mushrooms in Canada by a public company under its Health Canada-issued Controlled Drugs and Substances Dealer's Licence.
  • Revenue from the company's existing cannabis testing operations provides a foundation for growth, differentiating Numinus from others in the psychedelics space.
  • The cannabis portion of the business has the potential to bring in C$25 million, dependent on timing of receiving Health Canada processing licence and production facility operating at capacity.
  • The company's long-term plans are to build a network of healing centres across North America, staffed with professional therapists and integrative health professionals.
  • Research partnerships in place with MAPS and Together We Can and Memorandum of Understanding signed with the BC Centre on Substance Use (BCCSU).
  • Numinus has closed its acquisition of the Neurology Centre of Toronto (NCT), a leading Canadian provider of clinical neurologic care.

Regulators Turning to Psychedelic Therapies to Treat Mental Illness and Addiction

In 2017, psychedelic therapies were designated as a breakthrough therapy by the FDA due to the growing need for solutions for mental health-related issues across the globe. According to the World Health Organization, mental health disorders affect one in four people at some point in their lives, and approximately 450 million people currently suffer from mental health issues, making it a leading cause of ill-health and disability worldwide.

If left untreated, mental health disorders can cost Canadians C$51 billion per year in health care costs, lost productivity and reductions in health-related quality of life, according to the Centre for Addiction and Mental Health (CAMH).

Leading organizations such as the FDA and Johns Hopkins are helping to position the use of psychedelic assisted therapies in regulated, safe, controlled therapeutic environments as accepted therapeutic options. Many research organizations, such as BCCSU, have been testing the efficacy of treating mental health disorders with various psychedelics.

Numinus' Management Team

Payton Nyquvest – Founder, Chairman and CEO

Payton Nyquvest founded Numinus out of a lifelong interest in health, wellness and personal development, triggered by mental health and chronic autoimmune problems in his earlier years. Transformational therapies helped to save his life, and he is driven to provide public access to these therapies.

He is a former Director, VP and Head of Sales at Mackie Research Capital, with 15 years of experience focusing on early-stage companies in multiple industries including technology, healthcare, biotech, cleantech and cannabis. He has raised over $100 million for more than 100 public and private companies and facilitated numerous IPOs.

Dr. Evan Wood – Chief Medical Officer

Dr. Evan Wood is a recognized researcher with 20+ years of experience in addiction research, most recently as Executive Director of the British Columbia Centre on Substance Use (BCCSU). A professor of medicine at the University of British Columbia. Work on psychedelic-assisted psychotherapy, his work includes involvement with the Multidisciplinary Association for Psychedelics Studies (MAPS) trial of MDMA-assisted psychotherapy and examining the potential of psilocybin-assisted psychotherapy for a range of mental health disorders.

Dr. Devon Christie – Medical Director

Dr. Christie, a clinical instructor with the UBC Department of Medicine, is also a family physician with a focused practice in Multidisciplinary Pain Management. She is a Registered Therapeutic Counsellor emphasizing Relational Somatic Therapy for trauma resolution and she is also trained to deliver both MDMA-assisted psychotherapy for PTSD (MAPS USA) and ketamine-assisted psychotherapy, in a research setting. She is a recognized speaker and expert on the potential for incorporating psychedelic assisted therapies in an improved health care model for the future.

Michael Tan – Chief Operating Officer

Michael Tan is the former and first executive director of the BCLDB's Cannabis Division, where he successfully launched cannabis operations in British Columbia. Michael has 20 years of strategic planning and execution with national and multinational corporations. He is a high-impact product development, marketing and operations executive with a track record of driving profitable revenue growth.

Kraig Docherty – Chief People Officer

Kraig Docherty has over 20 years of experience growing and scaling tech and creative companies such as EA, Activision Blizzard, Indochino, Invoke and Eventbase.

John Fong – Chief Financial Officer

John Fong is a professional accountant with over two decades of experience in financial and operational management. He provides stability and growth solutions to public natural resource companies and technology start-ups.

Dennis McKenna – Advisor

McKenna brings over 40 years of experience conducting research in ethnopharmacology. He is a Founding Board Member of the Heffter Research Institute and a former key investigator on the Hoasca Project, the first biomedical investigation of ayahuasca. McKenna has taught courses on Ethnopharmacology and Plants in Human Affairs for 17 years as an adjunct Assistant Professor in the Center for Spirituality and Healing at the University of Minnesota . In collaboration with colleagues in Canada and the US, he incorporated a new non-profit, the McKenna Academy of Natural Philosophy.

Jamie Wheal – Advisor

Wheal is a bestselling author, Pulitzer Prize nominee and founder of the Flow Genome Project, an international organization dedicated to research and training of ultimate human performance. Since its inception in 2011, the organization has become the leading voice of evidence-based peak performance. Wheal is an expert on peak performance and leadership, specializing in the neuroscience and application of Flow states.

Ben Nemtin – Advisor

Nemtin is the #1 New York Times bestselling author of What Do you Want to Do Before You Die?, co-founder of the Buried Life movement and a mental health advocate. Nemtin was forced to drop out of university due to depression and in an effort to feel more alive, he and his three friends made a list of “100 things to do before you die" and for every list item they accomplished, they helped a complete stranger cross something off their bucket list. Oprah Winfrey declared their mission “truly inspiring." Nemtin is recognized as one of the “World's Best Motivational Speakers" as well as “World's Top Organizational Culture Thought Leaders" by Global Gurus and regularly speaks to Fortune 100 leadership teams and business conferences around the world.

Pamela Hadfield – Advisor

Hadfield is an entrepreneur and thought leader in the cannabis space. She became a cannabis advocate after finding relief from debilitating migraines using medical cannabis. After cannabis transformed her health, she dedicated her time and efforts to helping others with alternative healthcare approaches, including cannabis. Hadfield is the co-founder of HelloMD, a digital telehealth and educational platform for cannabis consumers and people seeking complementary care.

Nichol Bradford – Advisor

Bradford is CEO of the Willow Group and Executive Director of the Transformative Technology Lab. She is a former senior executive in the video game industry responsible for strategy, operations and marketing for major brands, including Disney, Vivideni and Activision Blizzard. Bradford is also a fellow of the British American Project, a former term member of the Council on Foreign Relations and served on the board of the Brandon Marshall Foundation for Mental Health.

Keep reading... Show less

Numinus to expand state-of-the-art psychedelics research laboratory

Numinus Bioscience adds research space, enhances contract services,
accelerates IP development and increases psychedelic supply capacity

Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI ), a global leader in supporting and expanding the safe, accessible and evidence-based use of psychedelic-assisted psychotherapies (PAP), is pleased to announce plans to significantly expand its psychedelics research laboratory by late 2021.

Keep reading... Show less

Regulatory approvals place Numinus lab at the forefront of global psychedelics research

Numinus Bioscience adds Ketamine and LSD to licence to produce, assemble and sell a wide variety of psychedelic compounds

Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI ), a global leader in supporting and expanding the safe, accessible and evidence-based use of psychedelic-assisted psychotherapies (PAP), has received new amendments under Canada's Controlled Drugs and Substances Act that enhance the Company's ability to lead psychedelics research and support the global psychedelics sector.

Keep reading... Show less

Numinus and Syreon Provide Psilocybin Compassionate Access Trial Update

Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage

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 (PAP), and Syreon Corporation (Syreon), a global contract research organization with expertise in conducting clinical trials across a broad range of diseases, are pleased to share that significant progress has been made in the single-arm, open-label compassionate access 1 trial of Psilocybin-Research Intervention with Motivational Enhancement (PRIME) for substance use disorders. Currently in the development stage, the PRIME study will assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy.

Keep reading... Show less

Numinus announces milestones in compassionate access trial for MDMA-assisted therapy in collaboration with MAPS Public Benefit Corporation

Trial enters pre-implementation stage having met several key milestones towards expanding access to patients with PTSD

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, is pleased to share that the single-arm, open-label, compassionate access 1 trial for MDMA-assisted therapy has made significant progress towards treating patients with posttraumatic stress disorder (PTSD). This trial is being pursued in collaboration with MAPS Public Benefit Corporation (MAPS PBC) a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) the leading developer of the treatment protocols, research, and MDMA-assisted therapy training programs.

Keep reading... Show less

Numinus Wellness Closes Q1 2021 with Strong Cash Position and Industry Firsts

Key milestones met in ongoing trials, expanding national footprint, and enhanced research
capabilities ensure Numinus' continued growth

Numinus Wellness Inc. ("Numinus" or the "Company") (TSXV: NUMI), a health care and research company developing and delivering psychedelic-centred solutions to treat mental illness, substance abuse and trauma, today announced its financial results for the first quarter for the three months ended November 20, 2020 ("Q1 2021"). After achieving two industry firsts, launching new compassionate access trials, and augmenting its clinical and research activity, Numinus meaningfully expanded its industry presence in Q1 2021. All financial results are reported in Canadian dollars unless otherwise stated.

Keep reading... Show less

Trulieve Announces Resale Registration Statement Filings

Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) ("Trulieve" or "the Company"), a leading and top-performing cannabis company in the United States today announced that it publicly filed a resale registration on Form S-1 (the "Registration Statement") with the United States Securities and Exchange Commission ("SEC") on January 21, 2022 to register for resale Subordinate Voting Shares of the Company issued as consideration for previously announced 2021 acquisitions.

Keep reading... Show less
business person cutting a cost sign

Cannabis Weekly Round-Up: HEXO Plans Cost Savings to Improve Cash Generation

This week, a Canadian licensed cannabis producer shared its plan to cut on costs as it aims to reach a better cash flow line over the next two fiscal years.

Meanwhile, a planned acquisition from a US-based multi-state operator (MSO) has now been dismantled.

Keep reading to find out more cannabis highlights from the past five days.

Keep reading... Show less

Harvest and Trulieve Celebrate One Year Anniversary of Recreational Cannabis Sales in Arizona

Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) ("Trulieve" or "the Company"), a leading and top-performing cannabis company in the United States today announced plans to celebrate the one year anniversary of recreational cannabis sales in Arizona through a series of in-store activations, product specials and celebrations. All Trulieve-affiliated Harvest locations will have doorbuster deals on January 21 - 22 and the company will host a rooftop event at The Clarendon Hotel on Saturday, January 22 .

Keep reading... Show less
Little Green Pharma logo

LGP Signs Exclusive Distribution Agreement With Pharmaserve Hellas

Greece added to rapidly expanding EU distribution portfolio. LGP now has distribution agreements in 5 EU territories including France, Denmark, Germany, Poland and Greece.

Little Green Pharma Ltd (ASX: LGP, “LGP” or the “Company”) is pleased to announce its entry into an exclusive agreement with PharmaServe Hellas SMSACI (“PharmaServe”) for the distribution of LGP-branded oil medicines and cannabis flower in Greece (“Agreement”).

Keep reading... Show less
Numinus Wellness Inc. Reports Q1 2022 Results

Numinus Wellness Inc. Reports Q1 2022 Results

  • Ended quarter with strong cash position of $53.9 million
  • Revenues grew 245% year-over-year to $0.8 million for the quarter
  • Generated gross profit of $50,965 during the quarter, representing a 6.5% gross margin
  • Well-positioned to offer psychedelic-assisted psychotherapy services through Canada's newly expanded Special Access Program
  • Clinical trial application made to Health Canada to begin Phase 1 study for proprietary psilocybe extract
  • MAPS-sponsored MDMA-Assisted Therapy for PTSD study to begin shortly; approvals received from Health Canada and the Institutional Review Board

All financial results are reported in Canadian dollars unless otherwise stated.

Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal first quarter results for the three months ended November 30, 2021 .

Keep reading... Show less
AYURCANN HOLDINGS CORP. UPDATE FOR 2022

AYURCANN HOLDINGS CORP. UPDATE FOR 2022

Ayurcann Holdings Corp. ( CSE: AYUR OTCQB: CDCLF FSE: 3ZQ0 ) (the " Company "), a leading Canadian cannabis extraction company specializing in the processing and co-manufacturing of pharma grade cannabis and hemp to produce various derivative cannabis 2.0 products in the medical and recreational market, is pleased to provide an update to its exponential growth throughout Canada.

Ayurcann Market segments

Keep reading... Show less

Latest Press Releases

Related News

×