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

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.

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Nova Mentis Applies to US FDA for Psilocybin Orphan Drug Designation Fragile X Syndrome Treatment

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.

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

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.

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Nova Mentis Expands Psilocybin Research Program Targets Obesity and Diabetes

Nova Mentis Expands Psilocybin Research Program Targets Obesity and Diabetes

Vancouver, British Columbia – September 7, 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 is expanding its psilocybin research and development program to target obesity and diabetes.

NOVA recently finished three successful preclinical psilocybin treatments of rats with symptoms of autism spectrum disorder (ASD). Besides amelioration of anxiety and cognition issues in the ASD rats, as compared to controls, without significant psychedelic side effects, NOVA’s collaborative partners uncovered additional significant findings regarding inflammatory cytokines and chemokines, including their response to certain psilocybin dosing. These exciting unsuspected findings strongly suggest that NOVA’s proprietary psilocybin formulation has potential application to treatment of obesity, as well as diabetes related to obesity – “diabesity.”

Scientific studies have shown that there is a role for serotonin receptors such as 5-HT2C in the regulation of body weight and food intake. Mice without this receptor displayed an obese phenotype and epilepsy. 5HT2C receptors, regulate nerve excitability, are also implicated in ASD and react to psilocybin (1). Significantly, the US Food and Drug Administration (FDA) has approved the serotonin (5-hydroxytryptamine, 5-HT) 5-HT2C receptor agonist lorcaserin for the treatment of obesity which represents a new therapeutic drug class available to the clinic. Targeting serotonin receptors with agonists such as psilocybin opens the door for a new class of therapy for diabesity.

“I am particularly excited that the ASD rat model that NOVA has tested in the laboratory of Dr. Viviana Trezza in Rome, Italy, has revealed inflammatory receptor technology that can be utilized in studying the potential role of psilocybin in control of obesity and diabetes,” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “NOVA’s technology has shown that its proprietary compound, psilocybin, can influence levels of inflammatory chemokines/cytokines that transmit physiologic messages with the potential to influence responses within the serotonergic system. A diagnostic mRNA genetic inflammatory panel is being developed with the assistance of Thermo Fisher Scientific and this panel will be studied in ASD individuals in an upcoming IRB approved observational clinical study.”

There is a global presence of diabesity in almost epidemic proportions (2,3). Current options include bariatric surgery and medical management including pharmacologic agents, but there remains no consensus approach as to how to control diabesity. Long term management appears to require varying combinations of anti-diabetic and anti-obesity medications. Current majority opinions of companies in the psychedelic field are to focus on use of a psychedelic compound as part of psychotherapy, so-called drug-enhanced psychotherapy. NOVA’s recent finding of psilocybin’s effect on specific inflammatory cytokine clinical biomarkers opens the door to a potentially novel approach to control diabesity.

“These exciting findings may be extremely promising in the treatment of diabesity. Because inflammation plays an important role within the adipocyte and other organs, attenuating the inflammatory response, leading to decreased dysfunction, may significantly impact the short and long-term complications seen in those living with obesity and diabetes,” stated Dr. Stephen A. Glazer MD, NOVA’s Chief Science Officer.

References:

  1. Fletcher PJ et al. Characterizing the effects of 5-HT2C receptor ligands on motor activity and feeding behaviour in 5-HT2C receptor knockout mice. Neuropharm. 2009; 57: 259-267.
  2. World Health Organization. 2015 Obesity and overweight. Geneva: World Health Organization. http://www.who.int/mediacentre/factsheets/fs311/en/.
  3. Ogden CL et al. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014; 311:806–14.

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.