A lawsuit filed by a physician and his cancer patients against the DEA for denying access to psilocybin therapy was rejected by the Court of Appeals.
The panel of judges determined that the agency is not at fault because it does not have the authority to waive the Controlled Substances Act.
TORONTO, ONTARIO January 31, 2022 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, today provided an update on the Company’s leading research role within the psychedelics industry. As the Company continues to focus on developing innovative treatments for depression, including potential ketamine derivatives, Braxia Scientific’s team of researchers also continue to carry out multiple psychedelic-based clinical research trials, adding to the Company’s large and growing proprietary dataset critical to informing future drug development.
To date, Braxia Scientific has compiled comprehensive health data from administering more than 5,200 ketamine treatments at its network of clinics. Additionally, Braxia Scientific’s researchers have published 43 ketamine-related manuscripts in peer-reviewed biomedical journals, and the Canadian Rapid Treatment Centre of Excellence (CRTCE), a wholly owned Braxia subsidiary, has established a growing database with key clinical outcomes for an ongoing clinical trial evaluating psilocybin-assisted therapy.
“We are tremendously proud of our research team, which includes three individuals ranked among the world’s top 20 experts in depression, mood disorders and ketamine research,” said Dr. Roger McIntyre, CEO of Braxia Scientific. “With our unmatched human capital, well-established clinical infrastructure and large proprietary health database we believe Braxia Scientific has a distinct competitive advantage among the leading groups endeavouring to develop new psychedelic treatments.
“With this expertise and data, we are well-positioned to enhance our intellectual property, including our work to identify and develop new chemical entities, while providing patients with access to new pathways to treat their mental health disorders.”
Building on management’s extensive clinical expertise, the Company has expanded the necessary infrastructure to provide innovative interventions that include ketamine, psilocybin and other potential future psychedelics that become available.
The Company also continues to exhibit itself as a leader in the psychedelics industry, establishing treatment protocols and best practice guidelines, including for innovative potential therapies, such as psilocybin. The Company’s leadership is illustrated by the publication by the American Journal of Psychiatry of the International Expert Opinion and Implementation Guidance, led by Braxia Scientific’s leaders, which outlines Ketamine and Esketamine treatment parameters and sets the standard for the clinical implementation of rapid-acting treatments in persons with treatment-resistant depression.
About Braxia Scientific Corp.
Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly
owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.
ON BEHALF OF THE BOARD
“Dr. Roger S. McIntyre”
Dr. Roger S. McIntyre
Chairman & CEO
– 30 –
FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com
The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.
Forward-looking Information Cautionary Statement
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”
Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. 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, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.
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. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. 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.
Vancouver, British Columbia, January 31, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced Health Canada approval for a phase 2 clinical trial using PEX010, the Company’s botanical psilocybin drug candidate. Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols, has licensed PEX010 (25 mg) from Filament for use in the trial. The trial is expected to begin in Q3’22 and will include individuals with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as those who are SSRI-naive.
“Health Canada’s approval is a testament to both the validity of this trial as well as Filament’s ability to produce and license pharmaceutical-grade botanical drug candidates,” said Filament Chief Executive Officer, Benjamin Lightburn. “The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research.”
“Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic assisted psychotherapy (PAP) clinical trials,” said Josh Taylor, Founder of Cybin Therapeutics. “If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols.”
Filament has also licensed PEX010 (25 mg) to CT for additional phase 2 clinical trials, which are expected to begin in the fourth quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.
MEDIA CONTACT
Anna Cordon, Director of Communications
778.245.9067
anna@filament.health
Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com
INVESTOR RELATIONS CONTACT
KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health
FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.
Lexston Life Sciences (LEXT) received a Section 56 exemption to research psilocybin. It is developing a tool that can rapidly identify and quantify different mushroom compounds such as psilocin, psilocybin, baeocystin, norbaeocystin and aeruginascin.
A meta-analysis of 7 clinical trials (5 psilocybin + 2 ayahuasca) found that psychedelic therapy significantly reduced suicidality in as little as 80 minutes.
The significant reductions were sustained for 3-4 months, and patients still had a moderate reduction in suicidality after 6 months.
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.
Vancouver, British Columbia – January 27, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is proud to announce that the Company has formed a tactical partnership with KGK Science Inc. (“KGK”), which is a wholly owned subsidiary of Wellbeing Digital Sciences Inc. (NEO: MEDI), to develop its psychedelic psilocybin drug portfolio in Canada. KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. Both Companies plan to jointly submit a clinical trial application (“CTA”) to Health Canada for a Phase 2A clinical study evaluating psilocybin microdose therapy for fragile X syndrome.
“NOVA and KGK have synergistic capabilities that will facilitate submission of the CTA to Health Canada and achieve, in my opinion, no objection to this unprecedented clinical study,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “In our discussions with KGK, we realized early on that our two teams had the ability to navigate the entire lifecycle journey of our novel psilocybin microdose treatment of fragile X syndrome from a Phase 2A clinical study to drug approval and commercialization.”
“I am delighted to work with NOVA’s team to advance this novel initiative. NOVA’s microdose approach aims to address an unmet need that promises to have a significant impact on the lives of families impacted by fragile X syndrome. KGK is proud to be able to contribute and is confident our expertise will guide NOVA to success through the orphan drug pathway,” said Najla Guthrie, President and CEO of KGK.
NOVA’s research and clinical team initially identified unique opportunities in psychedelic drug development and chose a classic drug development pathway involving careful planning and execution of chemistry, manufacturing and preclinical proof of efficacy studies. The Company’s successes to date include but are not limited to:
KGK’s expertise includes:
About KGK Science
Founded in 1997, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. The business has successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. On an approximate basis, the business to date has produced 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points.
About Wellbeing Digital Sciences
Wellbeing Digital Sciences Inc. (formerly KetamineOne Capital Limited) is an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research. Its mission is supported by a network of North American clinics that provide ketamine-assisted therapies and other types of treatment to patients as well as through a contract research organization that offer clinical trials services to clients pursuing drug development. In essence, the company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.
About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union.
The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).
For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.
On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.
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
Vancouver, British Columbia, January 27, 2022 / Globe Newswire / – KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research, is pleased to announce that its wholly owned subsidiary, KGK Science Inc., (“KGK”), has formed a tactical partnership with Nova Mentis Life Science Corp. (“Nova”) (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) to help develop Nova’s psychedelic psilocybin drug portfolio in Canada. Nova is a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders. Both Companies plan to jointly submit a clinical trial application (“CTA”) to Health Canada for a Phase 2A clinical study evaluating psilocybin microdose therapy for fragile X syndrome.
“I am delighted to work with Nova’s team to advance this novel initiative. Nova’s microdose approach aims to address an unmet need that promises to have a significant impact on the lives of families impacted by Fragile X Syndrome. KGK is proud to be able to contribute and is confident our expertise will guide Nova to success through the Orphan drug pathway,” said Najla Guthrie, President and CEO of KGK.
“Nova and KGK have synergistic capabilities that will facilitate submission of the CTA to Health Canada and achieve, in my opinion, no objection to this unprecedented clinical study,” stated Marvin S. Hausman MD, Nova SAB Chairman. “In our discussions with KGK, we realized early on that our two teams had the ability to navigate the entire lifecycle journey of our novel psilocybin microdose treatment of Fragile X Syndrome from a Phase 2A clinical study to drug approval and commercialization.”
Nova’s research and clinical team initially identified unique opportunities in psychedelic drug development and chose a classic drug development pathway involving careful planning and execution of chemistry, manufacturing and preclinical proof of efficacy studies. The Company’s successes to date include but are not limited to:
Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union;
Manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization after drug approval;
Proof of efficacy and safety in preclinical rat models of Autism Spectrum Disorder and FXS with 4 studies completed;
Established psilocybin microdose levels to treat FXS; and
Preparing Phase 2 chemistry and manufacturing file for regulatory submission.
KGK’s expertise includes:
Regulatory submission expertise;
Manage Investigational New Drug enabling activities;
Clinical trial design and trial execution;
Established clinical sites; and
In-house virtual behavioral testing models.
ABOUT NOVA MENTIS LIFE SCIENCE CORP.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS). For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.
ABOUT KGK SCIENCE
Founded in 1997, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. The business has successfully helped hundreds of companies with custom-designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. On an approximate basis, the business to date has produced 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. (formerly KetamineOne Capital Limited) is an evidence-based healthcare company focused on innovative clinical solutions, artificial intelligence-powered digital therapeutics and contract research. Its mission is supported by a network of North American clinics that provide ketamine-assisted therapies and other types of treatment to patients as well as through a contract research organization that offer clinical trials services to clients pursuing drug
development. In essence, the company exists to make breakthrough treatments more accessible and to offer patients transformational experiences.
On behalf of:
WELLBEING DIGITAL SCIENCES INC.
“Adam Deffett”
Adam Deffett, Interim CEO
For further information, please contact:
Nick Kuzyk, Investor Relations
Tel: 1-844-746-6351
Email: ir@wellbeingdigital.co
Web: www.wellbeingdigital.co
Twitter: @Wellbeing_IR
Notice Regarding Forward-Looking Information:
This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.
The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.
TORONTO, Jan. 25, 2022 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that it has entered into a pharmaceutical manufacturing agreement with a leading contract development and manufacturing organization (CDMO), for the production of pharmaceutical grade batches of Mindset’s next-generation psilocybin drug candidate, MSP-1014.
“Following our co-development announcement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for our short-duration compounds (Mindset Families 2 & 4), we continue to receive interest from potential partners for our wider portfolio of differentiated next-generation drug candidates. As such, our manufacturing agreement with a leading CDMO positions MSP-1014 well for partnership opportunities to advance this optimized compound to human clinical trials,” said James Lanthier, Chief Executive Officer of Mindset. “In preclinical trials, MSP-1014 has shown improved efficacy and safety compared to first-generation psilocybin. Also, it has demonstrated pharmacological diversity making it potentially suitable for both in clinic treatment approaches and as a take-home medicine.”
“Notably, MSP-1014 is not a scheduled substance based on current guidance from regulators in Canada and the USA. With MSP-1014’s unique structure and Mindset’s innovative synthesis process, we anticipate a lower cost and more simple manufacturing process than psilocybin that well positions MSP-1014 for rapid commercialization,” concluded Mr. Lanthier.
About Mindset Pharma
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.
For further information on Mindset, please visit our website at www.mindsetpharma.com.
For more information, please contact:
Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788
Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585
Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com
Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094
Forward-Looking Information
This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized bywords such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
