Nova Mentis Study Confirms Oral Microdose Psilocybin Treatment of Autism

Nova Mentis Study Confirms Oral Microdose Psilocybin Treatment of Autism

Vancouver, British Columbia – February 16, 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 pleased to announce that Nova Mentis successfully completed an oral microdose psilocybin preclinical study, in the laboratory of Dr. Viviana Trezza, Rome Tre University, Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company’s proprietary psilocybin significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of fragile X syndrome (FXS).

“The science team led by Dr. Hausman, together with Dr. Viviana Trezza from Roma Tre University, continues to deliver promising preclinical results. The recent oral microdose data set not only confirms but exceeds our original injectable formulation results,” says Will Rascan, CEO of NOVA. “The clear positive data is critical as we prepare to submit our clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome.”

Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder for which no treatments exist. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent monogenic cause of ASD (1). The aim of the present study was to evaluate various oral doses of the company’s proprietary psilocybin in a rat model of FXS. A major question to be answered in this preclinical study was whether microdose therapy could be the potential treatment of choice in ASD, as compared to single dose macrodose therapy with associated hallucinogenic and other side effects.

Psilocybin efficacy was tested in FXS, in the Fmr1 knock-out (Fmr1 KO) rat (Fmr1-Δexon 8) – an established genetic model of FXS (1). Wild type control and Fmr1 KO animals were treated with 0.1 mg/kg and 0.3 mg/kg oral psilocybin every other day for 6 treatments, over a 2-week period, and on day 18 underwent object recognition testing. We had great results! Both 0.1 and 0.3 mg/kg were effective in reversing the cognitive impairment displayed by Fmr1 KO animals. Moreover, the 0.1 mg/kg worked best, and did not have any apparent side effects. The 0.1 mg/kg dose in the rat translates into approximately 1.5 mg oral dose in a 70 kg person.

“I am elated to be able to report to the medical community that at long last we may have opened the door to treatment of ASD, an unmet medical need, that has a devastating impact on the patient, family and society,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The rat model that we used mimics key autistic-like features in humans and the study results strongly supports an important role for microdose therapy of

FXS. Moreover, this positive response in the rat of every other day oral 0.1 mg/kg psilocybin, equivalent approximately to a 1.5 mg dose in a 70 kg person, may be the treatment of choice to modulate behavioural changes and cognitive defects, and perhaps have a longer term constructive neuroplastic response in the brain without the need for large doses of psychedelic drugs with associated detrimental hallucinogenic side effects.”

Financing

In addition, the Company announces a non-brokered private placement of up to $1,000,000 (the “Placement”).

The Company will issue up to 20,000,000 units at a purchase price of $0.05 per unit.  Each unit will consist of common share of the Company and one transferable share purchase warrant.   Each warrant will entitle the holder to acquire one additional common share at an exercise price of $0.075 for a period of 18 months from the closing date.

The Company will use the proceeds from the Placement towards the launch of its ASD observational study, Health Canada Phase 2A CTA and general working capital  clinical trials.  Finder’s fees may be payable in accordance with the policies of the Canadian Securities Exchange.  All securities issued under the Placement will be subject to a statutory hold period of four months and one day from issuance.

References:

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.

SOURCE: NOVA MENTIS LIFE SCIENCE CORP.

Is microdosing a placebo? 💊

Nova Mentis Study Confirms Oral Microdose Psilocybin Treatment of Autism

This week, Nova Mentis (NOVA) announced that rats with cognitive impairments showed improvements in memory when given a microdose of psilocybin every other day for just two weeks.

However, a new University of Chicago study found no effect on mood or task performance after giving healthy volunteer 4 LSD microdoses 3-4 days apart in a placebo-controlled study.

Could it be that a more frequent dose is needed to see benefits? Or is psilocybin faster acting than LSD? Or maybe microdosing is a placebo after all.

Stay tuned as we follow along with the latest research. 

Novamentis
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Nova Mentis and KGK Science Form Tactical Partnership

Nova Mentis and KGK Science Form Tactical Partnership

The Companies Plan to Jointly Submit a Psilocybin Clinical Trial Application to Health Canada

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:

  • 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 (ASD) and fragile X syndrome (FXS); 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 (“IND”) enabling activities;
  • Clinical trial design and trial execution;
  • Established clinical sites; and
  • In-house virtual behavioural testing models.

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.

Wellbeing Digital Sciences’ Subsidiary KGK Science Forms Tactical Partnership with Nova Mentis

Wellbeing Digital Sciences’ Subsidiary KGK Science Forms Tactical Partnership with Nova Mentis

The Companies Plan to Jointly Submit a Psilocybin Clinical Trial Application  to Health Canada  

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.  

Nova Mentis Provides Corporate Update – 2022 Planned Catalysts

Nova Mentis Provides Corporate Update – 2022 Planned Catalysts

Vancouver, British Columbia – January 12, 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 reviews its 2021 drug development accomplishments and its planned 2022 steps towards drug approval and commercialization.

“As we enter 2022, I want to thank NOVA’s shareholders for their continued support and investment in our company. We, despite being a small drug biotech company, have achieved tremendous progress last year in our psilocybin research and drug development program, as well as established new partnerships that will help accelerate our efforts and guide us on the pathway to drug approval and commercialization,” says Will Rascan, NOVA’s CEO & President. “NOVA has laid the necessary groundwork to quickly move in 2022 to submit applications to the regulatory agencies in the U.S., Canada, and Europe for phase 2A clinical studies of psilocybin in fragile X syndrome (FXS), a rare disease with unmet medical needs. I personally look forward to reporting to our shareholders this year that our clinical studies have achieved positive clinical results and that NOVA is on its way to potential drug approval and commercial sales.”


The Nova 2021 Story – Accomplishments:

  • Development of manufacturing process for non-GMP >98% purity psilocybin under proprietary manufacturing agreement (PDMO); NOVA ownership of Drug Master File (DMF) to be used in drug regulatory submissions.
  • Psilocybin export/import application approved by the U.S. DEA and Italian Ministry of Health; Proof of efficacy and safety established by Dr. Viviana Trezza, Roma Tre University, Rome, Italy.
  • NOVA proprietary synthetic non-GMP psilocybin proof of efficacy and safety established in 4 preclinical autism spectrum disorder (ASD) models. Significant modulation of anxiety symptoms and improvement of cognition.
  • Microdose psilocybin therapeutic levels established in preclinical fragile X syndrome (FXS) model.
  • Approval granted of Orphan Drug Status from U.S. FDA and European Medicines Agency (EMA) for psilocybin treatment of FXS. This status will provide the Company market exclusivity and significant financial benefits in both regions, including the potential to rapidly advance our clinical program toward regulatory approval and commercialization.
  • Patent filings:
    1. manufacturing process for psilocybin and tryptamine derivatives; July 2021.
    2. Worldwide diagnostic mRNA neuroinflammatory PCT application; November 2021.
  • Completed manufacturing supply of cGMP (>98% purity) psilocybin for U.S., Canada and Europe phase 2 clinical studies.
  • Developed novel mRNA technology to monitor pre- and post- neuroinflammatory drug treatment response. Acquire FDA Real World Evidence (RWE) to prove drug efficacy.

The Nova 2022 Story – Future Catalysts:

  • Finalize human dose delivery formulation for phase 2A human IND regulatory submissions.
  • Joint venture with Mycrodose Therapeutics to develop transdermal psilocybin patch; Schedule 1 license completed and drug shipped to R&D facility in San Diego, CA.
  • Strategic relationship with a major university regarding serotonin research. Cooperative clinical setting for enrolling ASD patients in Observational Study and future FDA phase 2A study.
  • Design and submit Phase 2A psilocybin fragile X syndrome INDs to the U.S. FDA, Health Canada and European Medicines Agency (EMA).
  • Preparation of psilocybin manufacturing process file in support of Phase 2A IND filings with U.S. FDA, Health Canada and EMA.
  • Consummate ongoing pharmaceutical industry partnerships to promote psychedelic drug development and commercialization in the U.S., Canada and Europe.
  • Potential sales of NOVA cGMP manufactured drug to doctors and clinics exploring use of psilocybin under Health Canada’s recently enacted Special Access Programme (SAP) to restricted drugs for psychedelic therapy.
  • Recruitment of patients for NOVA’s North American autism clinical study, which was listed on ClinicalTrials.gov (NCT04869930), a database of privately and publicly funded clinical studies conducted around the world. This Observational Study based in the US and Canada [NM101: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS)] is a large-scale effort to measure genetic neuroinflammatory biomarkers and the neurotransmitter serotonin in an attempt to further understand the development and progression of behavioural symptoms observed in ASD and FXS.

Debt Settlement and RSU Grant
 
The Company has entered into a debt settlement agreement pursuant to which the Company has agreed to issue 1,056,583 common shares (each, a “Share”), at a deemed price of $0.06 per Share, to settle indebtedness of $63,395 (the “Transaction”). All Shares issued pursuant to the Transaction are subject to a statutory four-month and one-day hold period. 
 
In addition, the Company has granted 2,350,000 restricted share units (the “RSUs”) to directors, officers and consultants of the Company. The RSUs are valid for a two-year term and are governed by the Company’s RSU Plan, approved by the Company’s shareholders on December 22, 2020.
 
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.

Nova Mentis Welcomes New CFO Rebecca Hudson

Nova Mentis Welcomes New CFO Rebecca Hudson

Vancouver, British Columbia – December 31, 2021 –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 pleased to announce Rebecca Hudson has joined NOVA as its Chief Financial Officer, adding corporate finance, accounting and risk management experience to the Company’s management team.

“Ms. Hudson has a demonstrated track record of financial management and is known for being a strategic leader who has the necessary expertise to build operations and cultivate partnerships to deliver financial results. We are delighted she has joined our team and look forward to the guidance and leadership she will provide,” says Will Rascan, NOVA’s CEO & President.

Ms. Hudson is a Chartered Professional Accountant (CPA, CA) with over 23 years of experience in accounting and financial reporting, corporate finance, risk management, financial audit and corporate governance, serving a range of industries, including mining and exploration, oil and gas, cannabis, manufacturing and retail, and not-for-profit.

“I’m excited to take on this new role and use my experience to help drive corporate strategy and the Company’s growth. I share NOVA’s commitment to financial discipline and their passion for researching novel approaches to help treat neuroinflammatory disorders such as autism spectrum disorder, diabetes and obesity. I look forward to being part of the team and contributing to its success,” says Rebecca Hudson, CPA, CA.

Ms. Hudson holds a Bachelor’s Degree and a Masters of Accounting from the University of Waterloo and has served as CFO, and consulted for, a number of publicly-listed resource companies with projects in North and South America and across Europe.

NOVA would like to thank outgoing CFO Jamie Robinson for his 4+ years of service with the Company and wishes him great success moving forward.

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 receive psilocybin orphan drug designation from both the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA).

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 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.

🍄 Adderall, Autism & Access: issue 28

Here’s what’s in store for you in today’s issue:

🍄 How psychedelics change your social life

🍄 Is LSD the new Adderall?

🍄 Microdosing patch for autism

🍄 Changes to who can access psilocybin therapy in Canada

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

A special episode : Our host Brett recounts a recent psilocybin therapy session with his guide Adrian as the guest.

 
This episode has been published and can be heard everywhere your podcast is available.
In this very special episode, our host Brett, recounts his first hand experience of a recent psilocybin assisted psychotherapy session. His guest Adrian ,was his guide through the whole process !

Adrian Oberg started the organization VAPS ( Victoria Association of Psychedelic Study ) He has a background working in harm reduction and has been guiding people through psychedelic therapy sessions for the last 5 years.

Therapeutic banner

Is LSD the new Adderall?

MindMed (MNMD) is collaborating with universities in Switzerland and the Netherlands to study the effects of microdosing LSD on adults with ADHD. Patients will be assessed on symptoms of inattention, impulsivity, and hyperactivity after microdosing twice a week for six weeks. 

“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes,” says the company’s new CEO, Robert Barrow, who was appointed this week.

A better solution for cancer patients

Antidepressants are often ineffective and can even interfere with cancer treatment drugs.

“Psychedelics are proving to not conflict with the cancer drug and are more effective than normal antidepressants generally,” according Frank Lane, director of Albert Labs. 

That’s why the BC-based company wants to bring a psilocybin treatment for cancer patients to European markets.

Albert Labs is expected to begin trading on the CSE early next year under the ticker ’ABRT’.

New microdosing patch for autistic patients

Nova Mentis (NOVA) and Mycrodose Therapeutics successfully created a transdermal patch that delivers Nova’s psilocybin formulation through the skin. The companies aim to use the patch to administer microdoses to autistic patients to treat cognitive impairments.

This method could be administered at home to reduce medical costs for families and save time for overworked medical professionals.

The findings from COMPASS’s depression study keep coming!

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

inspirational banner

How psychedelics change your social life

Researchers developed a personality model to test how psychedelics affect the qualities that help us build and maintain healthy relationships.

They discovered that after taking psychedelics, users were less critical in their interactions with others, less anxious, and less likely to get upset easily. They also reported greater feelings of social connectedness.

Advancing careers in psychedelics

atai Life Science’s (ATAI) philantropic program created its first initiative – the atai Fellowship Fund in Psychedelic Neuroscience. The $2M fund will support recent graduate students in furthering their careers in the psychedelics sector.

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Doseology Sciences Inc. (MOOD), a functional mushroom company, is preparing to expand into the psilocybin market with a recent application for a controlled substance Dealer’s License and a new addition to its research team. The company aims to develop and sell novel strains of psychedelic mushrooms once granted the license. 

atai Life Sciences (ATAI) and COMPASS Pathways (CMPS) were added to the NASDAQ Biotechnology Index (NBI), an index fund of biotech and pharmaceutical companies with a market cap of at least $200M and an average daily trading volume of at least 100,000 shares.

MINDCURE’s (MCUR) digital therapeutics platform was certified as HIPAA compliant, meaning that it effectively protects sensitive patient data. The certification gets the company one step closer to commercially deploying the platform in Q2 of 2022.

COMPASS Pathways’ (CMPS) patent for crystalline psilocybin is being challenged by the non-profit Freedom to Operate. After conducting advanced analysis, the organization is confident that the formulation isn’t novel and has been known for decades. 

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You no longer have to be on your deathbed to eat mushrooms!

Up until this week, the only people in Canada that could legally access psilocybin therapy were patients with terminal illnesses. 

Things changed on Monday, when the non-profit organization TheraPsil helped three Canadians with mental health issues get Section 56 exemptions, granting them access to psilocybin therapy.

“This is a very clear indication that exemptions are now available for people who have anxiety, depression, addiction, and chronic pain,” says TheraPsil’s CEO. “It opens it up to everyone.”

New York could be the next state to legalize psilocybin therapy

New York assemblyman Pat Burke (D) filed a bill that would legalize psilocybin therapy and create a $2M grant program to ensure veterans and first responders can access the treatment.

If passed, therapists would be able to certify patients for psilocybin therapy after completing a two-hour training course through the Department of Health.

Australia refuses to reschedule psychedelics

In some un-inspirational news, Australia’s Therapeutic Goods Administration rejected an application to reschedule MDMA and psilocybin for therapeutic research, noting that the drugs pose acute and long-term risks if used outside a clinical setting 🙄

Mushrooms go high fashion

According to the Higg Materials Sustainability Index, leather causes more environmental damage than any other fabric. Mushrooms are now being used as a sustainable alternative!

In a matter of weeks, mushroom mycelium can be grown into a material that looks and feels just like leather. It’s actually stronger and more durable than real leather 🤯

Even high fashion brands like Hermès are using the material!

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New microdosing patch for autistic patients

Nova Mentis and Mycrodose Therapeutics Announce Major Milestone with Transdermal Technology for Fragile X Syndrome Clinical Program

Nova Mentis (NOVA) and Mycrodose Therapeutics successfully created a transdermal patch that delivers Nova’s psilocybin formulation through the skin. The companies aim to use the patch to administer microdoses to autistic patients to treat cognitive impairments.

This method could be administered at home to reduce medical costs for families and save time for overworked medical professionals.

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Novamentis

Nova Mentis to Present at the H.C. Wainwright Psychedelics Conference

Nova Mentis to Present at the H.C. Wainwright Psychedelics Conference

Vancouver, British Columbia – December 2, 2021 – 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 pleased to announce that it will present at the H.C. Wainwright Psychedelics Conference on December 6, 2021.

“The psychedelic industry is still in its infancy and what is required to bring needed medical therapy in this restricted, regulated market is to develop drugs in a classic pharmaceutical approach. This approach is based upon strict quality controls of the produced therapeutic agent, behavioural results confirmed with known biologic markers, and minimal side effects,” says Dr. Marvin S. Hausman, Chairman of NOVA’s Scientific Advisory Board.

In his presentation, Dr. Hausman will reveal significant new findings and technology to show the physiologic application of microdose psychedelic therapy and positive genetic confirmatory response.

His presentation will be available on-demand starting at 7:00 a.m. EST on December 6, 2021. Click here to register for the conference and schedule a one-on-one meeting with Dr. Hausman.

NOVA is leading a psilocybin-based therapeutics and diagnostics program for neuroinflammatory disorders and is the first biotech company to receive psilocybin orphan drug designation in both the U.S. and European Union, which will greatly assist the company on the pathway to drug approval.

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.

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 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.

Smoke weed with a veteran on DMT: issue 23

Here’s what’s in store for you in today’s issue:

🍄 How weed influences your trip

🍄 Healing veterans with DMT

🍄 The results from the biggest psilocybin study ever!

🍄 At-home ketamine therapy

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.

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The results from the world’s biggest psilocybin trial are in!

COMPASS Pathways’ (CMPS) stock dropped nearly 30% after announcing mixed study findings and Q3 financial results on Monday.

The company conducted a trial on 233 patients to determine the best psilocybin dose for treatment-resistant depression (TRD).

All three groups showed improvements the day after receiving the dose. The group with the largest dose had the best results, with 36.7% of patients showing at least a 50% decrease in depression scores and 29.1% in remission at week 3. A quarter of the patients showed sustained improvements until week 12.

Unfortunately, 12 patients experienced serious adverse events such as suicidal ideation or self harm, but these behaviours are common in patients with TRD.

The company is preparing for a larger trial beginning next year.

COMPASS also announced that it lost $15.8 million or $0.38 per share in Q3, an improvement compared to its $1.30 loss per share in Q3 of last year.

Here’s a graph that shows the impact on levels of depression reported by trial patients: 👇🏽

Why ketamine is so effective at preventing suicide

Researchers have known for years that ketamine can reduce depression symptoms and suicidal ideation in as little as 24 hours, but a recent study helps us understand why it’s so beneficial.

The study showed that a single dose of ketamine rapidly improved cognitive function, problem-solving abilities, and distorted thinking in suicidal patients.

“Being able to think more clearly can make someone feel less suicidal,” explains Ravi. N. Shah, MD, one of the researchers.

Ketamine was more effective than Midazolam, a benzodiazepine used as a sedative for surgeries. After the dose, suicidal ideation was diminished for up to 6 weeks.

Treating alcoholism and depression with half the dose

Cybin (CYBN) announced that its psilocybin formulation for depression and alcoholism, CYB003, could be more effective than oral psilocybin.

The company conducted preclinical testing on multiple species of animals. Researchers found that CYB003 has nearly double the brain penetration compared to oral psilocybin, resulting in a 50% reduction in dosage, variability, and onset time.

A smaller dosage has potential to reduce negative side effects such as nausea. The formulation could lead to shorter sessions which would make treatment more affordable!

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Can weed make your trip better?

A bit of weed could make your trip more spiritual and less scary.

A survey of 321 people suggests that using cannabis while on psychedelics increases the odds of mystical experiences, ego deaths, and intense visuals. 

The data also showed that low doses of cannabis reduced the chances of bad trip, whereas high doses increased feelings of fear and insanity.

Healing veterans with DMT

In honour of Veteran’s Day, we’re sharing how a Special Ops veteran cured his chronic pain and PTSD with DMT.

Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.

After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.

“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”

After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.

“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.

To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.

Insurance coverage for ketamine therapy

A major hurdle of making psychedelic therapy accessible to all will be getting the treatment covered by insurance.

That’s why we’re excited to share that Novamind (NM) has secured coverage for ketamine treatments from four major health insurance providers: Blue Cross Blue Shield, the University of Utah, PEHP Health & Benefits and MBA Benefit Administrators!

The company’s Chief Medical Officer says that this a promising signal that insurance providers are interested in more effective mental health treatments as research emerges.

Novamind has also opened a call center dedicated to insurance verification to ensure that patients are approved and reimbursed as quickly as possible.

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Congrats to the top psychedelic companies of 2021!

These leading psychedelic companies were recognized for their accomplishments at Microdose Psychedelic Insights’ Wonderland: Miami – the world’s largest psychedelic business event, ever.

Company of the Year: Cybin Inc. (CYBN)

Psilocybin Company of the Year: MycroDose Therapeutics (private)

Ketamine Company of the Year: Field Trip Health (FTRP)

Ibogaine Company of the Year: MindMed (MNMD)

DMT Company of the Year: Psilera Bioscience (private)

LSD Company of the Year: MindMed (MNMD)

MDMA Company of the Year: MAPS (non-profit)

Platform Company of the Year: MindMed (MNMD)

Drug Development Company of the Year: Awakn Life Sciences (AWKN)

Retreat of the Year: Synthesis

Clinic of the Year: Awakn Life Sciences (AWKN)

B2C Tech Company of the Year: Fireside Project (non-profit)

B2B Tech Company of the Year: MycroDose Therapeutics (private)

Try psychedelic therapy at home in these states

TripSitter Clinic Corp. now offers at-home ketamine therapy in 10 states! 

The company, which is part of Origin Therapeutics’ portfolio, expanded its services to eight new states: Arizona, Colorado, Michigan, Washington, Florida, New York, Ohio, and Virginia, in addition to California and Illinois.

Patients can receive a prescription for oral ketamine after a virtual consultation with a physician. They then take the medication at home with virtual guidance, followed by therapy sessions.

This is a promising step toward greater ketamine accessibility. 💪🏼

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Psilocybin production increases 11,900% in 2021

To keep up with the growing demand for psychedelic research, the DEA is yet again increasing the legal production quotas for certain Schedule I substances.

The original proposal for psilocybin was just 50 grams, which increased to 1,500 grams in September. The final quota is now 6,000 grams – a total increase of 11,900%!

Production of both MDMA and DMT increased 6,300% from 50 grams to 3,200 grams.

Industry Quick Hits

Nov 5 – Fluence Raises $1.6M for Psychedelic Therapy Training Read more…

Nov 5 – MAPS and Momentum Events Announce Collaboration on Psychedelic Science 2023 Read more…

Nov 8 – Blackhawk Growth’s (BLR) MindBio Therapeutics Completes Safety Milestone in its Phase 1 Clinical Trials Read more…

Nov 8 – Delic Corp (DELC) Acquisition Of Ketamine Wellness Centers Is Complete Read more…

Nov 8 – NeonMind (NEON) And SRx Health Solutions Announce Strategic Alliance To Establish Specialty Mental Health Clinics For Interventional Psychiatry Treatments Read more…

Nov 9 – MYND Life Sciences (MYND) Executes LOI to Enter into a Clinical Research Collaboration with Revitalist Read more…

Nov 9 – Nova Mentis (NOVA) Files Genetic Neuroinflammatory Disease Patent Read more…

Nov 9 – Herbal Supplement Giant, Irwin Naturals (IWINF), To Enter THC & Psychedelics Industries Read more…

Nov 11 – PharmaTher (PHRM) Announces Positive Research Results for Psilocybin Microneedle Patch Read more…

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