Posted on

Understanding neurodiversity

COMPASS Pathways to fund study of COMP360 psilocybin in autistic adults

COMPASS Pathways (CMPS) is funding a psilocybin study to better understand the brain science of neurodiversity.

Using brain imaging and behavioural tasks, researchers will investigate how psilocybin affects the serotonin brain networks in autistic adults compared to non-autistic adults. 

The goal is to understand the unique brain mechanisms associated with autism to provide “better tailored choices” to autistic people.

CMPS shares spiked 11% yesterday after the company announced Q1 financial results, including $21.2M net loss and $243.7M in cash.

PDF of article

Posted on

PsyBio Therapeutics Initiates Blood-Brain Barrier Permeability Testing for Pipeline Compounds to Enhance Portfolio Development

PsyBio Therapeutics Initiates Blood-Brain Barrier Permeability Testing for Pipeline Compounds to Enhance Portfolio Development

PsyBio Therapeutics Further Expands Testing of Portfolio Compounds

OXFORD, Ohio and COCONUT CREEK, Fla., May 6, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), a fully integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today reported that it has expanded its pre-clinical pipeline activities by initiating blood-brain barrier permeability testing. This additional testing procedure is expected to provide a comprehensive, state of the art research methodology with which PsyBio’s ever expanding portfolio of compounds can be more readily and rapidly developed. Favorable results from this type of testing are anticipated to expediate compound selection and progress toward the filing of Investigational New Drug (“IND”) applications with the US Food and Drug Administration (“FDA”).

“Establishing this type of testing is critically important for PsyBio to allow candidate selection to proceed more rapidly,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “We expect that this will allow us to effectively screen and select compounds that are active both in vitro and in vivo to more efficiently produce psycho-targeted therapeutics intended to potentially improve mental and neurological health.”

PsyBio retains the global, exclusive, and perpetual right to license platform technology enabling rapid generation of tryptamines and related compounds through a biosynthetic process using genetically modified bacteria and has demonstrated the ability to manufacture one of its first promising therapeutic candidates at commercial scale. This type of permeability testing is expected to improve the selection ability for compounds able to cross the blood-brain barrier and ultimately produce a brain-based effect.

“We continue to apply and utilize state-of-the-art research methodology to further our ability to produce a variety of psycho-targeted therapeutic candidates as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The initiation of this type of pre-clinical laboratory testing is expected to improve PsyBio’s ability to develop novel therapeutic agents.”

The Company is not proceeding with its previously announced proposed acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as described in the Company’s press release dated March 15, 2022.

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company developing new, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: PsyBio’s plans and ability to conduct successful blood-brain barrier permeability testing; the impact of favorable results from blood-brain barrier permeability testing on compound selection and progress toward the filing of IND applications with the FDA; PsyBio’s plans for filing IND applications with the FDA; PsyBio’s ability to develop novel therapeutic agents; PsyBio’s ability to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; PsyBio’s ability to launch clinical trials; PsyBio’s ability to build its intellectual property portfolio of novel drug candidates; PsyBio’s ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and PsyBio’s ability to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: blood-brain barrier permeability testing will yield favorable results; favorable results from blood-brain barrier permeability testing will have a positive impact on compound selection and progress toward the filing of IND applications with the FDA; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining IND applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The FDA or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSX Venture Exchange (the “TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2022/06/c0968.html

Posted on

Cybin Announces CYB003 Poster to be Presented at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicine

Cybin Announces CYB003 Poster to be Presented at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicine

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that an abstract highlighting preclinical data for its deuterated psilocybin analog CYB003 has been selected for a poster presentation at the ‘From Research to Reality’ Global Summit on Psychedelic-Assisted Therapies and Medicines taking place May 27-29, 2022, in Toronto, Canada. The poster is titled Pharmacological and Pharmacokinetic Profile of CYB003, A Novel, Orally Active Analog of Psilocybin.

“It is an honor to participate in this inaugural conference devoted to psychedelic-assisted therapy and to be part of the rigorous scientific work being done in the field,” said Doug Drysdale, Chief Executive Officer of Cybin. “The findings from our preclinical studies on CYB003 that will be highlighted at the Summit will show that, compared to psilocybin, CYB003 may provide therapeutic benefit across a shorter clinical visit and with improved dosing accuracy resulting in improved tolerability for patients. We look forward to the opportunity to engage with leading scientists and academics in the field with the goal of advancing these treatments and improving the lives of those living with mental illness and substance use disorders.”

Presentation Details:
Abstract Title: Pharmacological and Pharmacokinetic Profile of CYB003, A Novel, Orally Active Analog of Psilocybin
Authors: Geoffrey Varty, Amy Reichelt, Michael Morgan, Joan Krakowsky, Clinton Canal, Tina Mueller, Ken Avery, Pradip Pathare, Joshua Hartsel, Alex Belser, Aaron Bartlone, Doug Drysdale, Alex Nivorozhkin, Michael Palfreyman
Track: The abstract will be part of a dedicated track to examine the use of psychedelics in the treatment and management of substance use disorders, including nicotine, cocaine, alcohol, and opioids.

About CYB003
CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog designed to achieve less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. CYB003 has the potential to effectively treat major depressive disorder (MDD) and alcohol use disorder (AUD).

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

Posted on

How to have a safe solo trip

Psilo Psoirée is an online community that allows psychedelic explorers to connect before and after their journeys.

With a monthly membership, you’ll receive:

  • A super informative guide on how to have a safe solo trip
  • Access to monthly pre-journey “lift-off” and post-journey “landing” calls
  • Support on all things mushroom – from navigating a spiritual awakening to DIY mushroom cultivation

Use code DAILYMUSHROOM22 to get a 2-month membership for FREE!

Posted on

How to avoid adverse reactions to psychedelics

Large survey suggests psilocybin is a “relatively safe” drug, with serious reactions being rare and short-lived

A survey of over 9,200 psilocybin mushroom users found that only 0.2% have sought emergency medical treatment following use.

The most common reported reasons for these adverse experiences were:

  • Mixing substances
  • Poor mindset
  • Poor setting

Additionally, those in the emergency care-seeking group were significantly younger than the group that didn’t seek care, with a median age of 19 compared to 23.

Keep this in mind if you’re considering trying psilocybin!

PDF of article

Posted on

Nova Mentis Psilocybin Manufacturer Receives Approved Health Canada Importation Permit

Nova Mentis Psilocybin Manufacturer Receives Approved Health Canada Importation Permit

Phase 2A Microdose Clinical Study Capsules to be Manufactured  
Vancouver, British Columbia – May 4, 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 the Company continues to advance its psilocybin-based drug development program following the receipt of a Health Canada approved psilocybin import permit.The approval allows NOVA to ship its proprietary psilocybin drug from its manufacturing partner to the labs at Toronto Institute of Pharmaceutical Technology (TIPT®) to be used to formulate and manufacture psilocybin microdose capsules for its’ planned clinical study.Earlier this month, NOVA signed a contract with TIPT, who holds a valid Controlled Drugs and Substances Dealer’s Licence from Health Canada, which allowed the organization to apply for an import permit.“We look forward to building on the promising preclinical results NOVA discovered which showed that repeat low doses of psilocybin has the potential to be an effective therapy to modulate behavioural and cognitive defects in patients with autism and fragile x syndrome (FXS),” stated Dr. Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “We are paving the way to drug approval and commercialization with reliable partners that are facilitating the necessary steps in the regulatory process and allowing us to move forward with our clinical trial application.”NOVA will be submitting a clinical trial application in the coming weeks to Health Canada for a Phase 2A clinical study evaluating psilocybin microdose therapy for 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. About TIPTThe 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 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.
Posted on

Optimi Health Granted Amendment to Controlled Substances Dealer’s Licence

Optimi Health Granted Amendment to Controlled Substances Dealer’s Licence

Request to modify quantities of psilocybin and psilocin receives approval from Health Canada.  

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), is pleased to announce that a requested Amendment to its Controlled Substances Dealer’s Licence has been granted by Health Canada, enabling it to further expand the capacity to produce natural, GMP psilocybin at its Princeton, British Columbia facility, as well as introducing a provision allowing the Company to extract psilocin for use in clinical trials.

Optimi’s operational footprint now includes 20,000 square feet of state-of-the-art, technologically advanced aeroponics facilities dedicated to the cultivation of safe, high-quality psychedelic and functional mushrooms. Under the terms of the amendment, the Company is now permitted to possess a quota of up to 5000kg of dried psilocybin mushrooms – the equivalent of 10kg of psilocybin – and 100g of psilocin.

Optimi Labs Inc., a wholly owned subsidiary of Optimi Health, filed the amendment in March 2022 in order to ensure adequate supply for licensed companies undertaking molecular development research and Phase 2a and 2b clinical trials investigating the treatment of addictions and mental health conditions. The strategy is part of the Company’s goal to commercialize operations in 2022.

“This approval from federal health authorities for an effective doubling of our growing potential is an important milestone in Optimi’s planned year of commercialization,” said Optimi Health CEO Bill Ciprick. “Optimi prides itself on the efficacy of our ongoing dialogue with regulators working towards the mutual goal of ensuring the highest operational standards and the safety and quality of our various strains of GMP mushrooms for use by approved entities.”

Through its scalable production methods, Optimi Health is working to position itself as the sector’s leading supplier of vertically farmed, naturally sourced psilocybin mushrooms and extracts for use both by authorized private and public sector researchers and patients granted access by Health Canada via legal mechanisms such the Special Access Program and Section 56 exemptions to the Controlled Drugs and Substances Act (CDSA).

Unique Security and Advanced Cultivation Technology: 

Optimi’s unique laboratory extraction methods for natural formulations are supported by advanced cultivation systems custom designed for biological efficiency and high-yield optimization, utilizing pure air exchange, compost, and high humidity controls to produce bio-sustainable fungi.

Further, the facility is classified as a Level 8 Security Environ with an allowance of $50 million CAD worth of product to be stored on site, making it fully compliant with any requirements under GACP, GMP, and as defined in the CDSA.

Optimi Health’s Grand Opening: 

On Friday, May 27th, the Optimi Health executive team and advisory board will be welcoming guests and dignitaries from the psychedelic business space, the medical and public health fields, local and national politics, and the Indigenous community for a grand opening event and reception to inaugurate its Princeton, BC facility.

Members of the media, investors and other stakeholders relevant to the Company’s developing position as a leading supplier in the field of psychedelic and functional mushrooms will be in attendance, with renowned psychedelics industry journalist and author Amanda Siebert acting as Master of Ceremonies.

In recognition of the importance of community to the success of its facility and all future endeavors, Optimi Founders JJ Wilson, Dane Stevens, and Bryan & Jacob Safarik are inviting the residents of Princeton and the surrounding area to attend alongside Optimi guests and investors.

A livestream of the proceedings will be made available for members of the public and those interested parties unable to attend in person.

Those interested in attending this unique event either in-person or virtually are invited to contact the event organizer, Michael Kydd at:

info@kyddergroup.com
(902) 880 6121

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)  

Optimi Health is a homegrown, Canadian success story producing and supplying natural, GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose to produce scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural GMP grade psilocybin across the world. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:  

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

FORWARD‐LOOKING STATEMENTS  

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

Optimi Health 10-Foot Mushroom Shelving Racks

Optimi’s 10-foot mushroom shelving units have been installed in the fruiting chamber.

Posted on

Tryp Therapeutics Doses First Patient in Phase II Psilocybin-assisted Therapy Clinical Trial

Tryp Therapeutics Doses First Patient in Phase II Psilocybin-assisted Therapy Clinical Trial

Phase II trial to determine efficacy of psilocybin in combination with psychotherapy for potential treatment of Binge Eating Disorder

San Diego, California — (April 27, 2022) – Tryp Therapeutics, Inc. (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company”), a clinical-stage biotechnology company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that the first patient has been dosed in the Company’s Phase II clinical trial for its lead candidate, TRP-8802. In combination with psychotherapy, TRP-8802 is intended to serve as a potential treatment of Binge Eating Disorder (“BED”).

“The world’s first FDA regulated clinical trial for psilocybin-assisted therapy targeting BED is underway, further advancing our clinical milestones,” said Dr. Jim Gilligan, Chief Scientific Officer, and interim CEO of Tryp Therapeutics. “This is a key study for our psilocybin-assisted therapy portfolio as we assess the effectiveness of TRP-8802 (oral psilocybin) to treat patients with BED. There has been strong interest in trial recruitment to date. We believe that psilocybin-assisted therapy has the potential to offer a new therapeutic treatment for BED, a disorder that devastates the lives of over 250,000 people each year.”

The first of up to 10 patients with BED, has now been dosed in this open-label, exploratory Phase II study of TRP-8802 in combination with psychotherapy. The study will investigate the safety and preliminary efficacy of psilocybin-assisted therapy among patients with BED in collaboration with the University of Florida. The open-label study affords Tryp the ability to monitor results on an ongoing basis.

Tryp’s BED trial will utilize psychotherapy protocols developed in conjunction with Fluence and their dedicated team of well-respected researchers and clinicians who possess extensive psychedelic trials experience and psychotherapeutic training expertise to support healthcare professionals.

“We are thrilled to support Tryp’s BED program and be part of this historical event,” said Ingmar Gorman, Ph.D., Co-Founder of Fluence. He added, “Fluence is excited to assist Tryp in bringing innovative, psychedelic-based treatments to people struggling with overeating that will have a positive and lasting patient impact.”

About Binge Eating Disorder (BED)

  • BED is characterized by recurring episodes of eating large quantities of food and feeling unable to stop.
  • Nearly 30% of people seeking weight loss treatments show signs of BED.
  • Up to 3.5% of females and 2.0% of males will develop BED at some point in their lives; current drug treatments to date have demonstrated limited effectiveness.

About TRP-8802

  • TRP-8802 is a non-proprietary 25 mg oral capsule of synthetic psilocybin.
  • Using TRP-8802 for Phase 2a studies allows Tryp to quickly initiate clinical trials to generate initial data while they concurrently develop an improved, proprietary formulation and delivery system (TRP-8803) for psilocybin-related molecules for target indications like BED.


About Tryp Therapeutics
Tryp Therapeutics is a clinical-stage biotechnology company focused on developing psilocybin-related molecules, including TRP-8803, for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin-related molecules as a new class of drug for the treatment of binge eating, chronic pain, and other indications. The Company has begun enrolling patients in its Phase II trial for the treatment of binge eating disorder at the University of Florida and recently announced an upcoming Phase IIa clinical trial with the University of Michigan to evaluate TRP-8802 for fibromyalgia. TRP-8803 is a proprietary psilocybin-based product that uses a novel formulation and route of administration to potentially improve efficacy, safety and the patient experience. For more information, please visit www.tryptherapeutics.com.

About Fluence
Fluence is an expertise-driven educational platform that provides professional training in psychedelic therapy and psychedelic integration for psychiatrists, psychotherapists, social workers, and other healthcare practitioners. Fluence’s mission is to give healthcare providers the clinical skills and knowledge to provide effective, compassionate, evidence-based psychedelic therapy and integration services to patients through dynamic, interactive online and in-person trainings. www.fluencetraining.com


Investor Relations:
Jim Gilligan, Interim CEO
Tryp Therapeutics
jgilligan@tryptherapeutics.com

Media Relations:
Francesca DeMauro
KCSA Strategic Communications
TRYP@KCSA.com


Forward-Looking Information

Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “anticipates” or “does not anticipate” or “believes,” or variations of such words and phrases or state that certain actions, events or results “may,” “could,” “would,” “might,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.