U.S. FDA Approves Nova Mentis Orphan Drug Application

Psilocybin Fragile X Syndrome Treatment

Vancouver, British Columbia – November 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 the U.S. FDA has approved the Company’s proprietary psilocybin drug Orphan Drug Application to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

“NOVA has established a unique position in the field of psychedelic therapy by having its FXS program achieve orphan drug status in both the United States and European Union,”says Will Rascan, NOVA’s CEO & President. “I am pleased to announce that we are the first biotech company to have psilocybin registered for treatment of FXS in the drug regulatory logs of both the FDA and EMA.”

Medicines that have been granted an orphan designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) receive  benefits, including but not limited to:

• Seven-Ten years of market exclusivity: FDA and EMA cannot approve the same drug for the same indication.
• 25% federal tax credit for expenses incurred in conducting clinical research within the United States.
• Waiver of Prescription Drug User Fee Act (PDUFA) fees: a value of approximately $2.9 million.
• Ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies.
• Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.

“The attainment of Orphan Drug status in both the U.S. and Europe is a significant milestone towards launch of psilocybin FXS phase 2 clinical studies,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The U.S. FDA has issued guidance concerning the usage of observational clinical study Real-World Evidence (RWE) to support the potential benefits of a medical product (1).  NOVA intends to immediately launch an IRB approved ASD observational study to provide baseline clinical biomarker RWE data in support of its psilocybin IND to treat FXS.”

1. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

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 https://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 Earns Psilocybin Orphan Drug Designation in Europe for Fragile X Syndrome

Vancouver, British Columbia – October 26, 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 it has received orphan drug designation from the European Medicines Agency (EMA) for its propriety psilocybin drug for the treatment of fragile X syndrome (FXS), the leading genetic cause of symptoms related to autism spectrum disorder (ASD).

“Orphan Drug designation of our proprietary psilocybin formulation in Europe is a significant milestone on the pathway to drug approval,” says Will Rascan, NOVA’s CEO & President. “This achievement has the potential to rapidly advance our company’s clinical program in Europe with the goal of approval of psilocybin in the treatment of FXS, a major unmet medical need. Nova intends to move expeditiously to begin a phase 2 study with psilocybin in FXS.” Medicines that have been granted an orphan designation receive the following benefits:

• Ten years of market exclusivity: once approved, NOVA’s proprietary formulation is protected from competition with similar medicines in similar indications.
• Reduced fees for protocol assistance and other regulatory activities.
• Access to grants from the European Commission and other sources.
• Scientific advice and administrative and procedural assistance.
• Access to a centralized marketing authorization with a single application.

There are currently no approved prevention or treatment methods for FXS. Current therapies, including pharmaceutical and behavioural interventions, offer a patchwork of solutions that have limited efficacy and high toxicity. Psilocybin has the capacity to influence cognition and behaviour as well as modulate the immune system and neural signaling pathways. Likewise, psilocybin is non-toxic and is not expected to have adverse side effects in humans.

“Our proprietary psilocybin drug is being proposed as a novel, first-in-class treatment for fragile X,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. We have achieved several drug development breakthroughs this year, including a significant therapeutic effect in validated preclinical models of ASD and FXS, identification of an effective dose and no observed psilocybin toxicity. We look forward to working closely with EMA to advance our efforts to receive European regulatory marketing approval for our leading psilocybin drug candidate.”

EMA is a decentralised agency of the EU responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Orphan designation is a status assigned to a medicine intended for use against a rare condition.

 

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 https://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.

Mycrodose Therapeutics and Nova Mentis Announce LOI to Co-Develop Advanced Drug Delivery System

Partnership will Create Patented Products for the Treatment of Neuroinflammatory Disorders

October 19, 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, and Mycrodose Therapeutics (“Mycrodose”), a US pharmaceutical company focused on developing advanced drug delivery systems for use with psychedelic compounds, announce that they have entered into a letter of intent (“LOI”) to develop patented products to treat neuroinflammatory disorders, such as fragile X syndrome (“FXS”) and autism spectrum disorder (“ASD”).

The Joint Venture (“NewCo”) will accelerate the research and development of psilocybin-based therapeutics by utilizing Mycrodose Therapeutics’ patented advanced drug delivery systems with Nova’s proprietary psilocybin drug to treat patients with neuroinflammatory conditions, including FXS, the most common inherited cause of ASD.

“NOVA’s lead drug candidate, psilocybin, has revealed significant promising results in preclinical models of fragile X syndrome and autism spectrum disorder. The results are exciting and have shown that psilocybin corrects the cognitive deficits displayed by a rat model of FXS and mitigates the anxiety-like traits observed in an environmental model of autism based on prenatal exposure to valproic acid,” stated Marvin S. Hausman MD,  Chairman of NOVA’s Scientific Advisory Board. “We have established a microdose therapeutic level for psilocybin in our most recent study that can be used in a planned upcoming human clinical study. This collaboration with Mycrodose Therapeutics is a ‘hand and glove fit’ with our breakthrough psilocybin microdose discovery, as their advanced drug delivery technologies offer many advantages for microdosing drug delivery, including providing a non-invasive, sustained and controlled dose of medicine that can be self-administered.”

NOVA has already successfully completed four preclinical studies confirming the therapeutic efficacy of the company’s proprietary psilocybin drug. The ability of the drug to modulate levels of neuroinflammatory molecules (cytokines) measured pre- and post-treatment is an important catalyst driving the fragile X clinical program.

“With the high safety profile of Mycrodose’s technologies and NOVA’s FDA/EU FXS orphan drug indication for its proprietary psilocybin, this partnership opens microdosing psilocybin-based drugs to a broader patient base, including pediatric applications. To our knowledge, the planned therapeutic study for autism and fragile X will be the first to research the potential for psilocybin to help treat pediatric patients,” says Chad Conner, Chief Executive Officer, Mycrodose Therapeutics. “The complementary relationship between NOVA and Mycrodose definitely helps everyone get into clinical trials faster with fewer hurdles. The sum of this partnership with NOVA is much greater together than each individual company alone, and allows our combined team to deepen its research on our kids and young people, a segment of the population that truly touches all of our hearts.”

NOVA has applied to the US FDA and European Union for psilocybin Orphan Drug designation for fragile X syndrome treatment, which would provide a wide range of financial and regulatory benefits.

The US Orphan Drug Act grants very attractive financial incentives to companies through a seven-year period of market exclusivity for the drug approved, even if the product is not under a provisional or granted patent. In addition, the US Orphan Drug Act provides tax credits of up to 50% of the qualified clinical testing expenses, provides grants for clinical testing, additional assistance in framing protocols for investigations, and the FDA waives the $2.4 million New Drug Application filing fee.

Summary Terms of the LOI include:

• The Parties will incorporate a company (“NewCo“) whereby both Nova Mentis and Mycrodose Therapeutics will subscribe for shares to become equal 50% shareholders of NewCo and nominate an equal number of individuals to the Board of Directors of NewCo.
• NewCo will be the owner of the Product(s), technologies, R&D protocols, and data gathered.
• The Parties will mutually develop a R&D and Clinical Plan.
• Mycrodose Therapeutics will give an exclusive license of its patented technologies to the collaboration for agreed upon indications.
• A Scientific Advisory Board (“SAB”) will be created by the Parties to decide priorities based on rationales (financial, medical, clinical, scientific, delivery, etc.) that ranks the importance of specific product development and applicable clinical programs. The formalization of a definitive agreement is subject to satisfactory due diligence from both parties as well as other conditions customary for such a transaction.

About Mycrodose Therapeutics

Mycrodose Therapeutics is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License and been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds: psilocybin, LSD, MDMA, and DMT. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom

Chief Operating Officer

Mycrodose Therapeutics

Email: Patrick@MycrodoseThera.com

Phone: 1-619-494-1367

Website: www.MycrodoseThera.com

 

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 https://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 Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

Vancouver, British Columbia – September 14, 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 it has filed an application with the U.S. Food and Drug Administration (FDA) to receive orphan drug designation for its proprietary psilocybin drug to  treat patients with fragile X syndrome (FXS), the most common inherited cause of autism spectrum disorder (ASD).

The U.S. Orphan Drug Act (ODA) grants special status to a drug for the treatment, diagnosis or prevention of a rare disease or condition. In the United States, a rare disease is defined as a condition that affects fewer than 200,000 people. Developmental delays affect ~13% of all American children ages 3-10 and FXS is the most common inherited cause of intellectual disability. The Centers for Disease Control and Prevention estimates FXS prevalence as 1 in 4,000 for males and 1 in 8,000 for females.

“NOVA is committed to accelerating the research and development of psilocybin-based therapeutics to help treat fragile X syndrome,” says Will Rascan, NOVA’s CEO & President. “With FDA orphan drug designation, our Company would qualify for benefits and incentives such as seven years of market exclusivity after drug approval, tax credits for clinical testing, eligibility for orphan drug grants and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.” He adds the Company filed for orphan drug designation with the European Medicines Agency (EMA) on August 12, 2021.

“New clinical treatments for FXS are needed and we believe serotonergic agonists like psilocybin represent  a promising option,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “Psilocybin and other tryptamine derivatives are expected to modulate the molecular and behavioural underpinnings of the disorder, improve brain plasticity, improve cognition, reduce anxiety and behavioural rigidity. NOVA has successfully completed three preclinical studies confirming therapeutic efficacy, without apparent side effects, of Nova’s proprietary psilocybin drug. Moreover, an important catalyst driving the fragile X clinical program is the ability of our drug to modulate levels of neuroinflammatory molecules (cytokines) measured pre- and post-treatment.”

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 https://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 Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

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Nova Mentis to Present at the H.C. Wainwright Global Investment Conference

Vancouver, British Columbia – September 9, 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 chronic inflammatory disorders, is pleased to announce that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, from September 13-15, 2021.

Dr. Marvin S. Hausman, MD, Chairman of NOVA’s Scientific Advisory Board, will present recent positive preclinical therapeutic results in the treatment of autism spectrum disorder (ASD) with psilocybin. Discussion will also include NOVA’s planned steps toward initiating approved regulatory clinical studies in autism, as well as application of newly discovered psilocybin biomarker data that targets obesity and diabetes.

The presentation will be available on-demand starting at 7:00 a.m. EST on September 13, 2021, and continuing through September 15th. Click here to register for the conference and schedule a one-on-one meeting with Dr. Hausman.

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 https://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 Files Fragile X Orphan Drug Designation with European Medicines Agency

Fragile x syndrome (FXS) is the leading genetic cause of autism spectrum disorder (ASD) symptoms, yet there is currently no approved prevention or treatment options. Nova Mentis (NOVA) is working to fill this gap with a non-psychedelic psilocybin-based drug.

The company announced that its proprietary psilocybin drug, NM1010, was able to improve cognition without a creating psychedelic effect in a preclinical model of FXS. In tests on animals, the drug showed improvements in inflammatory biomarkers that may be linked to the ASD disease process.

The company has filed for orphan drug designation with the European Medicines Agency (EMA), a status that gives companies exclusive rights and tax credits to incentive the development of treatments for diseases affecting ≤ 5 in 10,000 people.