After several unsuccessful depression treatments, a patient in Quebec will finally get to try psilocybin therapy through the Special Access Program (SAP), marking the first legal psilocybin treatment in the province.
Numinus Wellness (NUMI) received Health Canada approval to administer the treatment at its Montreal clinic. It will be the company’s first treatment outside of a clinical trial setting.
Hopefully we’ll start seeing more wins like this thanks to TheraPsil, a non-profit that launched an initiative to make it easier for patients to access psilocybin through the SAP.
The initiative, called Project Solace, will secure a safe supply of psilocybin from HAVN Life (HAVN) and other licensed dealers and collect data on treatment outcomes to support policy change.
VANCOUVER, BC (GLOBE NEWSWIRE – February 16, 2022) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, is pleased to report that Health Canada has added the Company’s wholly-owned subsidiary Optimi Labs Inc. to a list of approved suppliers under the Special Access Program (SAP). With a mission to provide compassionate, frontline solutions to Canada’s growing mental health crisis, the Company plans to supply psychedelics like psilocybin to those truly in need.
Announced on January 5, 2022, the SAP allows qualified medical practitioners to request access to Schedule 3 controlled substances such as psilocybin on a case-by-case emergency basis. Prior to the new regulatory amendments, medical practitioners were prohibited from requesting access to psilocybin and MDMA for individual psychedelic-assisted psychotherapy. The amendments have the potential to positively affect the lives of people experiencing serious mental health conditions and end-of-life distress when other therapies have failed, are unsuitable or are unavailable in Canada.
Optimi’s CEO, Bill Ciprick, says the SAP is already having a positive impact on patients in need and will provide the Company with the right avenue to develop and supply the demand for natural psilocybin.
“Optimi is committed to bringing transformative change to those suffering from debilitating palliative and non-palliative mental health trauma,” said Ciprick. “We will leave no stone unturned in our effort to provide the safest and most efficacious natural psilocybin product in the world, because frankly we need to get this right for those depending on us for support and healing.”
“Between the science, research, and good manufacturing practices, the SAP is an excellent opportunity for all of us to learn, grow and expand our knowledge capacity and improve treatment outcomes for many people in the years to come,” added Ciprick.
With the Company’s Dealer’s License approved by Health Canada earlier this month, Optimi has received requests for supply agreements from potential partners interested in the Company’s new EU-GMP compliant 10,000 sq. ft. facility located in Princeton, British Columbia. Once fully commercialized, the production facility will position Optimi as a global frontrunner in the cultivation, extraction, and vertical integration of high-grade all-natural psilocybin.
“Establishing Optimi’s presence in the psychedelic market begins with trust, which we believe we have earned through our in-house expert research and world-class advisory team, and by setting the gold standard in GMP compliance,” added JJ Wilson, Optimi’s Chairman of the Board.
Optimi plans to host a grand opening of its new facility this May and is committed to building awareness and education about the benefits of the SAP to physicians qualified to recommend the program to patients.
Bill Ciprick Chief Executive Officer Optimi Health Corp.
ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.
FORWARD‐LOOKING STATEMENTS This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
The CSE does not accept responsibility for the adequacy or accuracy of this release.
Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program
VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific drugs for approved patients who have not responded to other available treatment options.
The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psilocybin and MDMA that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psilocybin and MDMA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.
“While we will continue to advance the research of psychedelic-assisted psychotherapy through our clinical trials and drug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psilocybin and MDMA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.
Following the addition of psilocybin and MDMA to Health Canada’s SAP in January, Mydecine launched its Special Access Support and Supply Program for physicians, clinics and hospitals throughout Canada, providing access to cGMP products, protocol training, therapy manuals, and technology to ensure safe and effective therapy outcomes for patients.
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
For more information, please contact: Media Contact Morgan Kervitsky, Director of Marketing pr@mydecineinc.com
Investor Relations Morgan Kervitsky, Director of Marketing contact@mydecineinc.com
On behalf of the Board of Directors: Joshua Bartch, Chief Executive Officer contact@mydecineinc.com
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
CCrest Laboratories is donating psilocybin truffles so patients in need can access the medicine for free through Canada’s Special Access Program (SAP).
The company was just approved as a licensed psilocybin producer by Health Canada, along with Numinus Wellness (NUMI) and Filament Health’s (FH) Psilo Scientific, allowing them to supply psilocybin for clinical trials and emergency treatments through the SAP.
The truffles will be grown by Red Light Holland (TRUFF) and tested at CCrest Labs before being donated as part of their “compassionate need and free supply” approach.
Health Canada list identifies select companies that can supply psilocybin to approved applicants through the Special Access Program for patient treatment
VANCOUVER, BC, Jan. 27, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI), a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that its research facility, Numinus Bioscience, has been included on Health Canada’s list of federally licensed psilocybin producers.
This list is available by request to those seeking access to psilocybin through the Special Access Program (SAP), and clinical researchers. The SAP is a federal program that allows healthcare professionals to apply for access to non-marketed medications that have not yet been approved for sale, when such medications show clinical evidence of safety and efficacy and are intended to treat patients with severe or life-threatening illness. Earlier this month, Health Canada added certain psychedelic compounds to the SAP that were previously available only through clinical trials.
“Through our inclusion, we look forward to collaborating with healthcare providers and other groups to ensure people in need receive efficacious treatments,” said Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience.
At this time, Numinus Bioscience is prepared to supply psilocybin in whole mushroom form, through three packaged doses equivalent to 10, 15 and 25mg of psilocybin. These doses are produced under Good Agricultural and Collection Practices and tested for potency and impurities to support patient safety and practitioner confidence. With sufficient clinical data, Numinus may also make available other products that are currently being developed in its IP pipeline, should those meet the standards identified by Health Canada. With its Dealer’s License and research facility, Numinus Bioscience is permitted to conduct several activities in addition to the production of psilocybin, including assembly, sale, export, analytical testing and R&D of ketamine, LSD and MDMA.
“Numinus is glad to see Health Canada committing to broadened mental healthcare access, starting with those in most need,” said Payton Nyquvest, CEO and Founder, Numinus. “As clinical evidence grows, we look forward to making more treatments available and further advancing the development of psychedelic therapies and mental health innovations.”
About Numinus Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care 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 numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
Forward-Looking Statements Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect” and “intend” and statements that an event “may”, “will”, “should”, “could” or “might” occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management’s estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com; Media Contact: May Lee, Communications Manager, may.lee@numinus.com
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.
VANCOUVER, BC, Jan. 20, 2022 /CNW/ – 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.
“We have made significant advancements in all areas of our business over the last several months, with many exciting opportunities on the horizon,” said Payton Nyquvest, Founder and CEO. “Of note, the partnership across our lab and clinical teams has been instrumental in passing key milestones on two major clinical trials: one for a proprietary Psilocybe formulation and the other a MAPS-sponsored MDMA study. In addition, we’re continuing to make discoveries in our Bioscience lab and recently begun genetic testing on several newly-acquired psychedelic mushroom species.”
Mr. Nyquvest continued, “The recent amendments by Health Canada to the Special Access Programme further underscore the importance and growth potential of Numinus’ wellness clinic network. With facilities purpose-designed for a wide range of psychedelic-assisted psychotherapies, therapists already trained on providing Psilocybin-assisted and MDMA-assisted therapies, and a Health Canada distribution license that allows us to import, possess, produce, and distribute psychedelic compounds – Numinus is well positioned as a national leader to provide these important treatments to those who qualify. I’m encouraged by the recent changes by Health Canada and proud of everyone at Numinus for the ongoing leadership, drive and commitment to our mission over the past quarter.”
First Quarter Financial Highlights:
Cash balance of $53.9 million as of November 30, 2021
Revenues grew 244.5% year-over-year to $0.8 million in Q1 2021, due primarily to the acquisition of Mindspace. Sequentially, revenues grew 60.9% compared to Q4 2021.
Gross profit of $50,965 in Q1 2022, compared to gross loss of $38,135 in Q1 2021
Gross margin was 6.5%, compared to -16.6% in Q1 2021
Loss was $5.4 million for Q1 2022, compared to a loss of $1.9 million in Q1 2021
Operational Highlights During and Subsequent to Fiscal First Quarter 2022:
Numinus Bioscience – Laboratory Operations
Q1 2022 revenue of $141,702, a 56.4% sequential increase from Q4 2021, but a 27.7% decrease from $196,090 in Q1 2021. This year-over-year decline is primarily due to the Company ceasing cannabis related activities during 2021 to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company’s strategy and overall objectives.
On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus’ research and development capabilities and generate new revenue streams through third-party client product testing.
Phase 1 clinical trial on NBIO-01:
On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract (“NBIO-01”), advancing Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
On January 14, 2022, the Company submitted its clinical trial application to Health Canada for its Phase 1 trial of NBIO-01. The clinical trial, named HOPE, is a two-phase study that will take place at a Vancouver based clinic. 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.
MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial study (“MAPPUSX”):
On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to evaluate the safety of MDMA in treating severe PTSD, titled “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD.”
On January 19, 2022, Numinus announced that it had received approvals from Health Canada and the Institutional Review Board to proceed with its clinical trial study for MAPPUSX. Enrollment for the trial is expected to begin shortly and will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (“MAPP1”) or who were not able to receive treatment due to COVID-19 restrictions.
Subsequent to the quarter:
Numinus Bioscience secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes.
Numinus Health – Numinus Wellness Clinic Network
Q1 2022 revenue of $647,915, a 61.9% sequential increase from Q4 2021, and a 1,857.6% increase compared to $33,098 during the same period last year when Numinus had only one clinic, which was impacted by COVID-19 during the quarter.
On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto (“NCT”) for less than $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
During Q1 2022, clients received a total of 6,217 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments and Ketamine-assisted psychotherapy), representing a 91.9% increase in clinic appointments compared to the prior quarter (Q4 2021), due in part to the acquisition of NCT. On a same-store basis, excluding NCT, client appointments increased 42.0% compared to the prior quarter.
On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term.
Subsequent to the quarter:
Numinus has finalized a formal Ketamine-Assisted Psychotherapy (“KAP”) training program for therapists, with virtual training sessions occurring over the next two months. This training program will expand the number of Numinus therapists qualified to provide KAP sessions to clients.
As of January 20, 2022, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the Company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).
Corporate Updates
On November 22, 2021, the Company changed its OTC ticker symbol to “NUMIF” (from “LKYSF”) to better align with its Canadian ticker symbol.
Subsequent to the quarter:
On December 16, 2021, Numinus graduated to the TSX (from the TSX-Venture), trading under the symbol “NUMI”.
Industry Updates
On January 5, 2022, Health Canada implemented amendments to the Special Access Programme (“SAP”). These amendments now enable:
Doctors and practitioners to apply for psychedelic medicines that have shown promise through Phase 2 or Phase 3 trials, on behalf of their patients, when other traditional medicines and therapies have not proven effective.
Doctors and patients to hear, within 48 hours of the application being submitted, if access to psychedelic medicines are approved for their case. If approved, doctors can refer patients to clinics – such as Numinus’ wellness clinics, to receive psychedelic-assisted psychotherapy.
Companies holding a Health Canada dealers license, including Numinus Bioscience, to act as a licensed distributor of certain psychedelic medicines for SAP approved cases.
Q1 2022 Key Performance Metrics:
For the quarter ended November 30:
2022
2021
% change
Numinus Bioscience¹ revenue
141,702
196,090
-27.7%
Numinus Health2 revenue
647,915
33,098
1,857.6%
Total Revenue
$789,617
$229,188
244.5%
Cost of revenue
(738,652)
(267,323)
176.3%
Gross Profit (Loss)
$50,965
$(38,135)
n.m.
Gross profit margin
6.5%
-16.6%
n.m.
General and administrative expenses
(3,736,890)
(1,285,448)
190.7%
Share-based compensation
(400,568)
(174,250)
129.9%
Sales and marketing expenses
(760,519)
(269,243)
182.5%
Depreciation
(51,829)
(91,261)
-43.2%
Research and development expenses
(330,626)
(89,727)
268.5%
Transaction costs
(45,092)
—
100.0%
Loss before other items
$(5,274,559)
$(1,948,064)
170.8%
Other items
(79,530)
19,327
n.m.
Loss and comprehensive loss
$(5,354,089)
$(1,928,737)
177.6%
Loss per share, basic and diluted
$(0.03)
$(0.02)
50.0%
Average number of shares outstanding, basic and diluted
203,409,202
112,364,998
81.0%
1 Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations.
2 Numinus Health consists of revenues generated through Numinus’ clinic network.
Numinus’ condensed consolidated financial statements for the three months ended November 30, 2021 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com. These documents were prepared in accordance with IFRS and with TSX-Venture disclosure timeline requirements, as the company was listed on the TSX-Venture at quarter end.
Conference Call and Webcast Details
Interested parties are invited to participate in the Company’s Q1 2022 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.
Date:
Thursday, January 20, 2022
Time:
5:30 p.m. (EST)
Dial-In:
1 (833) 989-2968 (Toll-free North America), 1 (236) 714-4028 (International)
About Numinus Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care 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.
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”, “believes”, “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.
SOURCE Numinus Wellness Inc.
For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, May Lee, Communications Manager, may.lee@numinus.com
Under Mydecine’s recently announced Special Access Support and Supply Program, the Company will supply cGMP Psilocybin and MDMA to The Newly. The companies will partner to co-develop protocols, therapy manuals, and training needed to treat patients who need specific care.
VANCOUVER, British Columbia, Jan. 18, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has signed a Letter of Intent (LOI) with The Newly Institute Inc. (“The Newly”), a Calgary, Alberta based company opening private inter-disciplinary mental health clinics across Canada, to collaborate on expanding psychedelic-assisted psychotherapy to patients.
The Newly offers rapid access outpatient programs providing innovative mental health, addiction and trauma therapies. The Newly opened its first location last year in Calgary and intends to open additional clinics in cities across Canada beginning in 2022. Mydecine and The Newly have world-class teams of medical and scientific experts positioning their companies to provide the highest quality and most responsible care to patients. Together, the companies will create the package of resources needed for patients and practitioners to successfully gain acceptance into Health Canada’s Special Access Program (SAP).
The Newly is the first partner under Mydecine’s recently announced Special Access Support and Supply Program (SASSP). The companies will develop protocols and therapy manuals for a variety of indications. Mydecine will provide cGMP psilocybin and MDMA alongside the safety and efficacy data needed to gain acceptance into Health Canada’s SAP. The Newly will provide the clinic locations and experienced therapists needed to perform the treatments. The companies intend to enter into a revenue sharing agreement.
The Newly’s Chief Scientific Officer Dr. Marshall Ross said, “We believe this partnership with Mydecine brings many positives to The Newly, and more importantly, to Canadians in need. Research supports that psychedelic-assisted psychotherapy can break down deeply rooted psychological defenses, facilitate therapeutic breakthroughs and effect substantial improvements in long-term mental health. We will promote and exemplify safe and effective treatment techniques by implementing and studying our evidence-based protocols for the use of psychedelics in our practice.”
Mydecine Chief Medical Officer Dr. Rakesh Jetly said, “The recent changes to Canada’s SAP program are encouraging, but in order to make a significant positive impact on patients, we need to ensure these therapies are carried out safely and effectively. We are excited to work hand-in-hand with The Newly team to develop the evidence-based protocols, therapy manuals, training and other resources physicians need in order to promote the successful integration of these treatments into their existing infrastructure.”
The Newly’s President & CEO Arthur H. Kwan said, “Our goal at The Newly is to build a network of clinics across Canada that deliver innovative and leading-edge mental health treatments to individuals in need. The platform we’re developing can be very effective in enabling us to deploy new and innovative best-practice treatments and therapies. We are pleased to partner with a company like Mydecine to enhance the mental health care being provided to Canadians.”
Mydecine CEO Josh Bartch said, “We couldn’t think of a better partner than The Newly to act as the model site for our SASSP. Both companies come with incredibly talented and experienced medical and scientific teams who value treatments based on evidence and data. Collaboration is the foundation of all work processes and essential to our overall success. I believe this partnership will set the gold standard for these psychedelic-assisted therapies while making them more accessible to patients.”
Working collaboratively will allow the companies’ experts to share common ideas and goals surrounding proper therapy protocols. The different perspectives and expertise across the teams will enable the most effective, innovative, and scalable treatment solutions. Mydecine will also support The Newly’s patients with post-therapy needs through their digital health platform called Mindleap. Additionally, both companies plan to create an exclusive research database to aid in future developments.
About Mydecine Innovations Group Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
Investor & Media Contact: Morgan Kervitsky, Director of Marketing (720) 689-4638 contact@mydecineinc.com
On behalf of the Board of Directors: Joshua Bartch, Chief Executive Officer contact@mydecineinc.com
About The Newly Institute
The Newly Institute Inc., a Calgary, Alberta based private company, believes mental health treatment is in drastic need of a paradigm shift. Our vision is to provide long-lasting change within the industry, our community and with our patients. We have pioneered an intensive bio-psycho-social-spiritual treatment model that can be supplemented by medically managed psychedelic-assisted therapies when appropriate. Our medical professionals help patients overcome deeply embedded traumas, addiction and pain that are preventing them from living fully in their everyday lives. While our programs are based on evidence and data, our approach is personal as we know it is vital that people feel safe as together we do the difficult work necessary to achieve wellness.
The Newly is on track to becoming Canada’s largest and premier operator of inter-disciplinary mental health clinics. We currently operate an 11,000 square foot clinic in Calgary with additional locations planned for Fredericton, New Brunswick, Edmonton, Alberta and St. John’s, Newfoundland and Labrador, as well as in several more Canadian cities. Learn more at www.thenewly.ca.
For further information, please contact:
Media Contact: Stephen Lewis, VP, Public Relations (403) 472-6574 info@thenewly.ca
On behalf of the Board of Directors: Arthur H. Kwan, President & CEO info@thenewly.ca
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
With the addition of psilocybin and MDMA to Health Canada’s Special Access Program, Mydecine looks to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential
VANCOUVER, British Columbia, Jan. 13, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they would be launching The Special Access Support and Supply Program (SASSP) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy. With the new addition of psilocybin and MDMA to the approved list of substances under Health Canada’s Special Access Program (SAP), the company aims to fill a critical gap in the market by allowing thousands of healthcare professionals and clinics the resources needed to bring these treatments to patients in need.
Last week, Health Canada announced an amendment to federal regulations, granting practitioners and pharmacists the ability to request and prescribe psilocybin and MDMA for treatment-resistant patients. This means patients who have not seen success from other treatments can now access additional treatment options. To re-enforce safe and effective integrations of these treatments, Mydecine’s SASSP will offer A-Z support to medical practices across Canada.
Through the Company’s SASSP, healthcare practitioners can purchase a package including cGMP psilocybin and MDMA, investigative brochures, therapy manuals, protocol training, advisory services, and post-therapy support for patients through Mydecine’s wholly-owned subsidiary Mindleap Health. Mindleap is a digital health platform that combines therapeutic and educational content with virtual 1-on-1 professional support for psychedelic integration.
Mydecine is currently producing cGMP certified pharmaceutical grade psilocybin and MDMA with coverage under a Health Canada Schedule 1 Drugs and Substances Dealer’s License in Alberta. With multiple clinical trials launching this year utilizing psychedelic compounds, as well as their partnership with Johns Hopkins University, the Company is well-positioned to help physicians, clinics, and hospitals use Canada’s new regulations.
Mydecine’s Chief Medical Officer, Dr. Rakesh Jetly, stated, “While we are committed to demonstrating the safety and efficacy of these medicines for specific indications through our clinical trials, we do recognize that in the meantime, there are people that are suffering from mental illnesses that haven’t responded to the evidence-based treatments that are currently accessible to them. I believe through our program, we can help treat a significant patient population who are in need of alternative options. Our global team of scientists, doctors, and advisors have extensive experience in administering these types of treatments, and we look forward to sharing that knowledge and expertise to promote responsible and successful use of psilocybin and MDMA.”
CEO Josh Bartch added, “The goal of our Special Access Support and Supply Program, is to help physicians who want to prescribe these treatments to their patients but might not have access to the drug product in Canada or experience implementing psychedelic-assisted psychotherapy. It’s extremely encouraging to see these much-needed treatments gaining government acceptance, and now we need to enable successful therapy outcomes. Outside of safe drug products, practitioners need access to the resources and the proper training to provide these treatments to their patients. By launching this program, we are providing the resources the thousands of non-psychedelic clinics and hospitals will need in order to safely and effectively integrate these therapies into existing medical practices.”
If you are interested in more information on Mydecine’s program, please complete this form or send an email to contact@mydecineinc.com.
About Mydecine Innovations Group Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
About Mindleap Health Mindleap Health Inc. is a wholly-owned subsidiary of Mydecine. Mindleap’s virtual healthcare platform offers technology solutions to allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments, and can lead to more personal breakthroughs. In addition, Mindleap’s proprietary platform is designed to provide professional support and personalized medicine for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people worldwide.
On behalf of the Board of Directors: Joshua Bartch, Chief Executive Officer contact@mydecineinc.com
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect,” “intends,” “anticipated,” “believes,” or variations (including negative variations) of such words and phrases, or state that specific actions, events or results “may,” “could,” “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected, including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to protect and enforce its intellectual property adequately, the Company’s ability to bring its products to commercial production, the continued growth of the global adaptive pathway medicine, natural health products, and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, other factors may cause effects not to be as anticipated, estimated, or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof. The Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.
Until now, the only way for patients to access psychedelic therapy outside a clinical trial was to apply for a Section 56 exemption and wait months on end to (possibly) receive approval from Health Canada.
Despite six more patients receiving the exemption over the holidays, the system remains flawed.
Thankfully, this Wednesday, Health Canada made an amendment to this thing called the Special Access Program (SAP), which enables healthcare practitioners to request access to drugs that are not yet approved, but have shown promise in clinical trials.
The amendment allows practitioners to request access to psilocybin and MDMA for their patients with serious, life-threatening, or treatment-adverse conditions. And the best part: requests are typically processed in just 1 day! 🎉
While this does not guarantee access for patients, it certainly feels like a big step in the right direction.
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