Tag: fragile x syndrome (FXS)

Nova Mentis Files Patent on Diagnosing, Monitoring and Treating Neurological Diseases with Psychoactive Tryptamine Derivatives

mRNA Diagnostic Index to Measure Drug Treatment Response Vancouver, British Columbia – June 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 it is bolstering its IP with the filing of provisional patent applications to protect data it obtained during its psilocybin preclinical studies and provide protection for the Company’s therapeutic paradigm for treating neuroinflammatory disorders with psilocybin and psilocybin-based tryptamine derivatives. “The filing of these patent applications represent a major milestone in NOVA’s psilocybin research program,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The Company is now in a position to reveal the breakthrough preclinical psilocybin results uncovered in its treatment of fragile X syndrome (FXS). Oral repetitive doses of microdose psilocybin showed a more robust improvement in memory than the same doses given by injection. Metabolic changes of psilocybin within the small intestine and perhaps the microbiome may represent a new paradigm in the application of psilocybin to the treatment of autism spectrum disorder (ASD). The data is scheduled to be published in a peer reviewed journal and presented at the upcoming 18th NFXF International Fragile X Conference in July 2022.” The provisional patent applications filed with the U.S. Patent and Trademark Office relates to diagnosis, monitoring and treating neuroinflammatory diseases and conditions with psychoactive tryptamine derivatives. NOVA’s psilocybin formulation was evaluated in two distinct rat models of autism in the laboratory of Dr. Viviana Trezza, Rome, Italy, and demonstrated psilocybin proof of efficacy and safety. In February 2022, the Company announced it had successfully completed a preclinical study that confirmed oral microdose psilocybin as a potential treatment option for ASD and FXS. The research found that a repeated low dose of NOVA’s proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS. Neuroinflammatory conditions – especially those that have the added complexity of disrupted emotional states and behaviours – are still difficult to diagnose accurately and treat effectively. NOVA’s research program is designed to generate clinical biomarker data that characterize aberrant gene expression and cellular communication in neurological disease or injury and provide insights into possible interventions and disease monitoring. The ability to penetrate the unique genetic language underlying the development of chronic diseases and assess therapeutic responses will assist NOVA in obtaining psychedelic drug approval with the regulatory agencies. In July 2021, NOVA filed a U.S. provisional patent application for a proprietary manufacturing process for the production of psilocybin and tryptamine analogues, baeocystin and aeruginascin. In May and November 2021, the Company filed US provisional patent applications describing a diagnostic/therapeutic combination of mRNA molecules that encode proteins involved in the development of neurogenerative diseases, FXS and ASD.  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 orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and 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 Receives Controlled Substances Export Approval From The U.S DEA For The Company’s Proprietary Psilocybin Drug NM 1001

Vancouver, British Columbia – June 7, 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 it received the required controlled substances export approval from the U.S. Drug Enforcement Administration (DEA). The Company’s proprietary psilocybin drug (NM-1001), has been received at the Toronto Institute of Pharmaceutical Technology (TIPT®) labs in Toronto, Canada to be used to formulate and manufacture psilocybin microdose capsules for a planned Phase 2A fragile X syndrome clinical study.

“NOVA is excited to have completed the successful import of our proprietary psilocybin drug (NM-1001) into Canada. This allows us to move forward with the formulation and final production of microdose capsules in preparation for our clinical trial application submission to Health Canada. Our science team has delivered promising preclinical results and we look forward to continuing to advance our research program to demonstrate the important role that microdose therapy may play in the treatment of autism spectrum disorder and FXS,” stated Will Rascan, President & CEO of Nova Mentis Life Science Corp.

Earlier this year, NOVA announced that a very low microdose formulation of the Company’s proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS.

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 orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and 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 Autism Behaviour Analyst to its Science Team

Vancouver, British Columbia – May 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 is proud to welcome John Molinaro, a Board Certified Behaviour Analyst specializing in autism spectrum disorder therapy, to its Scientific Advisory Board.

“Making advancements in challenging disorders such as autism and fragile x syndrome requires a team of experts who share information and innovative ideas. Mr. Molinaro will further strengthen NOVA’s Scientific Advisory Board and help guide our leading-edge research and clinical endeavors to help find new diagnostic and treatment options for these conditions,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board.

John Molinaro is a Board Certified Behaviour Analyst (BCBA) with a Master’s degree in Applied Behaviour Analysis, as well as a Bachelor’s degree in Psychology. For more than 13 years, Mr. Molinaro has dedicated his life to supporting children, youth and adults challenged with physical and cognitive disabilities. Since 2015, Mr. Molinaro shifted his efforts primarily towards the autism community and started the Colours of the Spectrum ABA autism spectrum disorder (ASD) clinic in 2018. Mr. Molinaro and his team have supported hundreds of children and families with varying severities of ASD through one-on-one behaviour therapy and parent coaching.

NOVA is currently enrolling participants into its North American observational study that will examine the neuroinflammatory mRNA genetic profile contained within cheek cells and measure serotonin levels in patient saliva. The research objective is to develop a genetic neuroinflammatory and serotonin data bank that will help establish a “Diagnostic Index” – an objective set of tools that helps to differentiate subtypes of ASD and FXS, and to develop more accurate methods of diagnosis and treatment.

Collected data will be analyzed using customized machine learning algorithms and used to guide design of upcoming clinical trials that will test the efficacy of psilocybin-based therapeutics in ASD and FXS. Patients enrolled in this observational study will have a high priority position to be enrolled in NOVA’s planned psilocybin microdose clinical trials in Canada and the United States.

For more information on this research, visit: novamentis.ca/autismstudy. To express your interest in participating in this study, please complete our enrollment form. 


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 orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and 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 Sees Rapid Enrollment in Autism Study

Databank to focus on mRNA neuroinflammatory markers and serotonin neuro-transmitters

Vancouver, British Columbia – April 28, 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 excited to announce that enrollment in its North American autism study has been progressing swiftly, with 70 participants enrolled in the first month. “We’re very pleased that enrollment into our autism spectrum disorder (ASD) and fragile X syndrome (FXS) observational study is progressing faster than planned, which I think speaks to the need that exists to find more precise ways to diagnose and treat these disorders. The first batch of specimen collection kits were mailed last week to participants and we look forward to sharing the results we uncover,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. The Company is aiming to recruit at least 300 qualifying participants; 200+ ASD/FXS patients and 100+ neurotypical controls. NOVA’s observational study will study the neuroinflammatory mRNA genetic profile contained within cheek cells and measure serotonin levels in patient saliva. The research objective is to develop a genetic neuroinflammatory and serotonin data bank that will help establish a “Diagnostic Index” – an objective set of tools that helps to differentiate subtypes of ASD and FXS, and to develop more accurate methods of diagnosis and treatment. Collected data will be analyzed using customized machine learning algorithms and used to guide design of upcoming clinical trials that will test the efficacy of psilocybin-based therapeutics in ASD and FXS. Patients enrolled in this observational study will have a high priority position to be enrolled in NOVA’s planned psilocybin microdose clinical trials in Canada and the United States. For more information on this research, visit: novamentis.ca/autismstudy. To express your interest in participating in this study, please complete our enrollment form.If you have any questions, email us at clinicaltrials@novamentis.ca or call us at 1-888-505-NOVA (6682).  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 orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.  On Behalf of the BoardWill Rascan, President & CEO Nova Mentis Life Science Corp.Phone: 778-819-0244 Toll Free: 1-833-542-5323Twitter: @novamentislscInstagram: @novamentislscFacebook: @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 to Produce Psilocybin Capsules for Phase 2A Clinical Study

Manufacturing Contract with the Toronto Institute of Pharmaceutical Technology

Vancouver, British Columbia – April 07, 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 it has consummated a contract with the Toronto Institute of Pharmaceutical Technology (TIPT®) to formulate and manufacture psilocybin microdose capsules for its upcoming Canadian Phase 2A fragile X syndrome (“FXS”) clinical study.

“Autism spectrum disorder (“ASD”) and especially FXS, the largest genetic cause of ASD, continue to have unmet medical needs. Scientists at NOVA, over the past two years, have laid the groundwork for development of potential novel psilocybin-based microdose treatment of ASD,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The recently completed preclinical study of repeat low doses of our psilocybin drug – every other day for 2 weeks, showed clinical responses that greatly exceeded our expectations. We significantly modulated behavioural and cognitive defects, such as recognition memory, in FXS.”

NOVA plans to submit a clinical trial application to Health Canada in the coming weeks for a Phase 2A study evaluating psilocybin microdose therapy for FXS.

NOVA is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of FXS. Furthermore, NOVA has manufactured a large supply of >98% pure psilocybin for clinical studies and commercialization following 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. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.

About TIPT

The Toronto Institute of Pharmaceutical Technology (TIPT®) is North America’s premier pharmaceutical institute of education, technology and research. We operate a fully compliant Health Canada-licensed GMP manufacturing and testing facility for solid dosage forms and liquid preparations.

Since our inception in 1992, we have successfully established corporate partnerships with leading pharmaceutical companies worldwide and have provided innovative product development solutions uniquely supported by pragmatic institutional experts.

For more information, please visit: www.tipt.com.

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 Begins Enrollment in North American Autism Study

Vancouver, British Columbia – March 23, 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 it has begun the patient enrollment process for its North American Observational study: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome (FXS).

“Families caring for patients with autism spectrum disorder (ASD) and fragile X syndrome (FXS) deserve new scientific and therapeutic options to improve diagnosis, quality of care and treatment outcomes. The goal of our North American ASD and FXS Observational Study is to uncover novel and meaningful ways to diagnose and treat ASD and FXS, which is particularly relevant for statistical separation between the multitude of ASD subtypes, currently differentiated rather crudely, based on behavioural analysis,” says Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board.

NOVA’s Observational Study will study the neuroinflammatory mRNA genetic profile contained within cheek cells from ASD and FXS patients, as well as measure serotonin levels in patient saliva. The research objective is to develop a genetic neuroinflammatory and serotonin data bank that will help establish a “Diagnostic Index” – an objective set of tools that helps to differentiate subtypes of ASD, as well as FXS, and to develop more accurate methods of diagnosis and treatment.

Collected data will be analyzed using customized machine learning algorithms and used to guide design of upcoming clinical trials that will test the efficacy of psilocybin-based therapeutics in ASD and FXS. Patients enrolled in this Observational Study will have a high priority position to be enrolled in planned psilocybin microdose clinical trials in Canada and the United States.

NOVA is aiming to recruit at least 300 qualifying participants; 200+ ASD/FSX patients and 100+ neurotypical controls.

For more information on this research, visit: novamentis.ca/autismstudy. To express your interest in participating in this study, please complete our enrollment form.

If you have any questions, email us at clinicaltrials@novamentis.ca or call us at 1-888-505-NOVA (6682).

The Company further announces the engagement of the following marketing consultants:

• The Company has engaged Even Keel Capital Ltd. to provide social media and public relations campaign services in Europe, specifically the German speaking market, to the Company commencing on March 18, 2022 for a three-month term, in consideration of a total fee of CAD $60,000.
• Additionally, the Company has engaged Maricom to provide bilingual marketing and social media services to the Company commencing on March 23, 2022 for a four-month term in consideration of a total fee of CAD $20,000.
• Lastly, the Company engaged Octagon Media Corp. to provide marketing services to the Company commencing on March 18, 2022 for a three-month term, in consideration of a total fee of US $100,000. Octagon Media Corp.’s services consist of the Wall Street Reporter and Next Super Stock platforms.

The Company has granted an aggregate of 1,250,000 incentive stock options (“the Options”) to its marketing consultants.  The Options are exercisable at a price $0.08 per share and valid for a period of 1 year.  The Options have been granted under and are governed by the terms of the Company’s incentive stock option plan.

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 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:

• Schiavi S, Carbone E, Melancia F, Buzzelli V, Manduca A, Campolongo P, Pallottini V, Trezza V. Perinatal supplementation with omega-3 fatty acids corrects the aberrant social and cognitive traits observed in a genetic model of autism based on FMR1 deletion in rats. Nutr Neurosci. 2020 Sep 11:1-14. doi: 10.1080/1028415X.2020.1819107. 

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.

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

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 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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