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Braxia Scientific Achieves Milestone as Landmark Psilocybin Clinical Trial Commences, Participants Receive First Doses of Psilocybin

Braxia Scientific Achieves Milestone as Landmark Psilocybin Clinical Trial Commences, Participants Receive First Doses of Psilocybin

  • Patients receive first dose in first-ever Health Canada-approved, multi-dose psilocybin clinical trial conducted at Braxia Scientific’s subsidiary CRTCE clinic
  • Trial establishes psilocybin treatment framework for patients with TRD and opens new pathway for patients to access psychedelic treatment

TORONTO, ONTARIO December 14th, 2021 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative psychedelic treatments for persons with depression and related disorders, has reached a milestone as the first Health Canada-approved multiple-dose psilocybin clinical trial which commenced with first patients dosed in November 2021. The trial, which is being sponsored by the Brain and Cognition Discovery Foundation, is being conducted at the Canadian Rapid Treatment Center of Excellence (CRTCE), a wholly owned Braxia subsidiary, and includes adults with treatment-resistant depression (TRD) as part of bipolar or unipolar disorder, who have not benefited from multiple conventional treatments. This study is the only Health-Canada approved psilocybin trial in Canada that is actively recruiting participants at this time.

Of the more than 300 million people suffering with depression worldwide, it is estimated that up to two thirds of affected people receiving treatment will inadequately respond to currently approved treatments, making patients with TRD a very large population that disproportionately dominates the majority of mental health services.

“This is a historically significant occasion for our patients, for Braxia, and for other organizations that endeavour to discover and develop innovative rapid-acting psychedelic treatments for the mental health sector,” said Braxia Scientific CEO Dr. Roger McIntyre.

“For patients who have undergone at least two – and possibly dozens of – unsuccessful conventional treatments for their depression, this remedy offers a potential and innovative treatment avenue for adults with TRD.”

“For Braxia Scientific, it marks two very important milestones. First, this trial establishes a proprietary framework and positions our platform among the leading groups that endeavour to research and develop new psychedelic treatments for TRD. Second, our proprietary data from this landmark trial will enable us to continue our work developing potential new chemical entities in the future, while providing patients with TRD immediate access to new treatment.”

Dr. Joshua Rosenblat, Braxia’s Chief Medical and Scientific Officer and the Principal Investigator (PI) of the trial, added, “Outside of rare exemptions for a very small number of patients with terminal medical illnesses, the only way to legally access psilocybin treatment in Canada is through Health Canada-approved clinical trials. As we have the country’s only open trial (e.g., only one actively recruiting, enrolling and treating participants with psilocybin), the CRTCE is currently the only place in Canada that can legally provide psilocybin for depression in the absence of any comorbid medical condition.”

Building on management’s extensive clinical and research expertise, the Company has expanded the necessary infrastructure to provide novel interventions that include ketamine, psilocybin and other potential future psychedelics that become available.

More specifically, the Company infrastructure has:

  • Established access to a high-quality source of psilocybin that meets all regulatory requirements for human use in clinical research
  • Received more than 150 referrals to date for psilocybin-assisted therapy for treatment resistant depression at our clinic in the first six weeks of opening recruitment
  • Received Health Canada and Research Ethics approval for protocols to collect treatment outcome data to allow for further optimization of psilocybin treatment protocols and development of best practice guidelines
  • Trained medical and research staff as part of Braxia Institute to provide psilocybin-assisted therapy with high quality safety monitoring. This program includes twenty (20) therapists licensed to practice in Ontario with specialized training in psilocybin-assisted therapy. All therapists were trained by the Braxia Institute and are serving as study therapists for the active psilocybin clinical trial.
  • Developed physical space to safely provide psilocybin treatment with a comfortable living room-like environment with appropriate medical and psychological monitoring and protocols

“This tremendous infrastructure enables Braxia Scientific to provide psilocybin-assisted therapy today, as part of the current clinical trial, and importantly, if psilocybin is approved in the future for use outside of clinical trials, Braxia Scientific is positioned to immediately provide access to psilocybin-assisted therapy treatment for eligible patients,” commented Dr. Rosenblat.

The trial will also provide Braxia Scientific a chance to evaluate the psilocybin-assisted therapy training program launched earlier this year. Upon completion of the psilocybin study, this program, run by the Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy, is set to graduate its first cohort of medical professionals, a multidisciplinary group of 20 therapists from diverse psychiatry and psychotherapy backgrounds.

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”

Dr. Roger S. McIntyre
Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement


This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements.

Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

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Field Trip Launches Site Management Organization (SMO) Services, Hires Stéphan Côté as Head of Quality

Field Trip Launches Site Management Organization (SMO) Services, Hires Stéphan Côté as Head of Quality

This Expansion of Field Trip Services Will Help The Company Become a Leading Center For Psychedelic Clinical Trials

TORONTO, Dec. 14, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (NASDAQ: FTRP, TSX: FTRP) (“Field Trip”), a global leader in the development and delivery of psychedelic therapies, today announced the launch of its Site Management Organization Services (“SMO Services”). The SMO Services will enable companies and researchers developing psychedelic therapies to use Field Trip’s world class facilities, and expertly trained medical and therapy teams, to conduct clinical trials. The SMO Services will be led by Stéphan Côté, who has joined Field Trip as Head of Quality.

“There are presently over one hundred psychedelic clinical trials in planning or underway, and many more likely, as research into psychedelic therapies continues to accelerate. By adding the SMO Services, we are unlocking additional revenue drivers from our Field Trip Health centers, and playing another key part in the future of the psychedelics industry,” said Joseph del Moral, Field Trip’s Co-Founder and CEO. “Set and setting play an integral role in the positive outcomes that have been demonstrated with psychedelic-assisted psychotherapy. By opening up our locations for clinical research, we are enabling other researchers and organizations to leverage our world class settings and highly trained staff.”

Field Trip currently has locations operating in seven major U.S. cities, making it one of the largest providers of psychedelic-assisted therapies in North America. Since its founding, Field Trip’s focus on pairing set and setting with psychotherapy in connection with its ketamine-assisted therapy offerings has generated improvements for many of its patients as measured by depression and anxiety scales, often superior to the results generated from ketamine IV infusions centers.

Côté, who joins Field Trip as the Head of Quality, brings more than 25 years of experience in the area of Quality and Regulatory Compliance. Prior to joining Field Trip, Côté was Director of Quality Assurance at Impel NeuroPharma where he led and supported the development and optimization of Impel’s quality systems and the buildup of the commercial quality and compliance systems which enabled Impel’s first product launch. Previously, Côté spent 19 years working in a number of Quality Assurance roles with Amgen.

In his role with Field Trip, Côté will focus on development and refinement of the Field Trip’s quality systems to strategically align with rapid advancement of the Field Trip’s drug development pipeline and the creation of a clinical research network and the SMO Services.

“I’m thrilled to join Field Trip at such a pivotal moment in the company’s journey,” said Stéphan Côté, Field Trip’s Head of Quality. “I look forward to building Field Trip into a leading network of clinical research sites and the partner of choice for researchers, CROs and sponsors in the fields of psychedelic-assisted psychotherapy and other mental health therapies. We hope to provide the highest quality of services with a patient-first philosophy. Patient rights, safety, and wellbeing are, and will always be, our first priority. I believe these research services will align with Field Trip’s mission to help bring solutions to this seemingly insurmountable global mental health crisis.”

About Field Trip Health Ltd.

Field Trip is the global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people from those in treatment to those seeking accelerated personal growth, with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.

Cautionary Note Regarding Forward-Looking Information.

This release includes forward-looking information (within the meaning of Canadian securities laws and within the meaning of the United States Private Securities Litigation Reform Act of 1995) regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including commencement, uptake and success of the Site Management Organization (SMO) Services business , the timing and results of SMO activities, if any, the opening of additional clinics that can be used as SMO locations, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.

Neither the Toronto Stock Exchange nor its Regulation Services Provider, have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

Media contacts:
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Investor contacts:
Kathleen Heaney / Tim Regan
KCSA Strategic Communications
fieldtripIR@kcsa.com

SOURCE Field Trip Health Ltd.

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PharmaTher Announces Positive Research Results for LSD Microneedle Patch

PharmaTher Announces Positive Research Results for LSD Microneedle Patch

  • Delivering LSD via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness
  • Pursuing Phase 2 clinical studies in 2022 with LSD and notable psychedelics

TORONTO, December 14, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering lysergic acid diethylamide (“LSD”).  These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with LSD for various indications.

The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver LSD. The research program scope included, full characterization of LSD conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for LSD, and release rate evaluations for the LSD conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA in the future.

The Company’s research program with LSD conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the LSD conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of LSD into microneedles without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022.  Details of the research program will be published in a scientific journal.

The Company believes that its MicroDose-MN™ patch for delivering LSD and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital.  To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”) and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline.  As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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Blackhawk Growth Fully Funds Phase II Clinical Trials in Psychedelics and Begins Development of Digital Mental Health Treatments

Blackhawk Growth Fully Funds Phase II Clinical Trials in Psychedelics and Begins Development of Digital Mental Health Treatments

Vancouver, British Columbia – TheNewswire – December 13, 2021 – Blackhawk Growth Corp. (CSE:BLR); (CNSX:BLR.CN); (OTC:BLRZF); (Frankfurt:0JJ) (“Blackhawk”), is pleased to provide an update on its clinical trials for both of its wholly-owned subsidiaries MindBio Therapeutics PTY Ltd. (“MindBio”) and Digital Mind Technology PTY Ltd. (“Digital Mind”).

MindBio Clinical Trial Update

MindBio is accelerating its clinical trial program and is now fully funded for its Phase II clinical trial for microdosing of psychedelics in late-stage cancer patients. MindBio will be one of only a handful companies that is progressing to a Phase II clinical trial in the psychedelics sector.

The now fully funded Phase II clinical trial will examine the effects of Psychedelic Microdosing Assisted Meaning Centred Psychotherapy (PMA-MCP) in advanced stage cancer patients.

The ground-breaking Phase II trial will examine the feasibility, acceptability and safety of a randomised, double-blind, placebo-controlled trial comparing Psychedelic Microdosing Assisted Meaning Centred Psychotherapy (PMA-MCP) to placebo in advanced stage cancer patients. This trial will help to evaluate whether PMA-MCP provides benefits in advanced stage cancer patients in regard to quality of life, their spiritual well-being, anxiety, depression, hopelessness, and attitudes towards death.

At each quarterly reporting, the intellectual property protection will be discussed and managed between the University of Auckland and MindBio. A qualified medical officer, psychotherapists, and a study nurse will also be appointed for patient therapy and safety.

In addition, MindBio also has the necessary funding to start the development of a second Phase II microdosing depression trial. This will involve the analysis of Phase I trial data, expected to be completed in Q1 2022, which will inform the trial design for Phase II trials for the development of investigator materials and the development of trial protocol documentation.

A pharmacogenomic (liver enzyme genotyping) and pharmacokinetic analyses will also be conducted to help understand the individual variability of response to LSD observed in Phase I study data (see Vizeli et al 2021 Scientific Reports). Furthermore, biomarker analysis will be used to determine potential candidate biomarkers for Phase 2 trials (e.g. mRNA).

MindBio has budgeted to start scientific research to objectively determine the effectiveness of psychedelic microdosing on individuals. This includes developing a platform to ensure time critical requirements of microdosing, personalised algorithms used for optimising microdosing to suit a given individual, artificial intelligent toos for data analytics for studying the impact of therapy on the patient’s mood state, and more.

Digital Mind Technology

Digital Mind has successfully completed a pilot randomized controlled trial with 69 patients of an online mindfulness-based program for people diagnosed with melanoma1. Led by leading scientist Dr. Lahiru Russell, Digital Mind is launching a fully funded Phase I clinical trial of mindfulness-based digital programs for people requiring pain management to avoid or reduce the impact on mental health. The clinical trials will start in Q1, 2022 and will be fully compliant with the Food and Drug Administration’s (FDA) protocols.

Results of Digital Mind’s completed pilot randomized controlled trial showed that psycho-educational interventions can decrease anxiety and health-related distress, and prompt positive change in coping with illness. Improving awareness of thoughts may be a therapeutic approach to reduce worrisome and unhelpful thoughts, which underlie fear of disease that can lead to depression and other mental health problems.

This awareness is an essential component of mindfulness-based interventions in which one is aware of any thoughts, feelings, bodily sensations and surrounding environment occurring moment-by-moment. In this state of awareness, thoughts and feelings are experienced as passing events in the mind, instead of a reflection of oneself or reality. This detached self-observation allows individuals to reflect on situations and respond in more adaptive ways, instead of reacting in an automatic, habitual pattern.

Online and digital based interventions are more easily accessible, available at any time to people in their own environment, enable people to work at their own pace and have the option to remain anonymous. Digital Mind’s Phase I clinical trial will build on the results of the pilot trial and protocols to help develop digital platforms (mobile, smart watch, and web) that provides clinically proven mindfulness-based digital programs to help patients deal with pain that ultimately reduces the impact on their mental health conditions. These clinical programs have the potential to be provided to patients via health professionals in a clinical setting.

“MindBio has taken a significant leap forward”, said Frederick Pels, CEO of Blackhawk Growth. “A fully funded Phase II clinical trial puts the research and progress of MindBio in the top echelon of the booming psychedelic sector. Combined with the addition of Digital Mind and its fully funded Phase I clinical trial, it truly displays the strength and growth of our Company’s psychedelic and life science portfolio. I look forward to updating shareholders as these initiatives progress and as we work hard to unlock substantial value for our shareholders.”  

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, MindBio Therapeutics and Digital Mind Technology.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A  

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

  1. https://www.researchgate.net/publication/329333517_A_pilot_randomised_controlled_trial_of_an_online_mindfulness-based_program_for_people_diagnosed_with_melanoma 

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to future operations of Digital Mind Technology Pty Ltd. and MindBio Therapeutics Pyy Ltd The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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atai Life Sciences launches TryptageniX to further expand atai’s robust intellectual property portfolio and strengthen atai’s supply chain

TryptageniX, a majority-owned joint venture with CB Therapeutics, employs bioprospecting to develop new chemical entities with potential applications in mental health.

This new platform company will focus on the generation of intellectual property and further strengthen atai’s drug development pipeline of psychedelic and non-psychedelic compounds.

TryptageniX will also develop scalable and environmentally friendly biosynthetic manufacturing methods for atai’s naturally derived compounds.

NEW YORK, Dec. 09, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the launch of TryptageniX. This new platform company will specialize in both the discovery of new chemical entities (NCEs) for the atai pipeline through bioprospecting and on biosynthesis of atai’s naturally derived development candidates. Both approaches are expected to further strengthen atai’s already robust intellectual property (IP) portfolio spanning psychedelic and non-psychedelic compounds.

Bioprospecting refers to the search for natural products from which medicines can be developed, while biosynthesis is the production of complex molecules within living organisms or cells. Both are central to TryptageniX’s approach to the development of NCEs. In addition, the development of innovative biosynthetic methods will further optimize the scalability of compound manufacturing, allowing atai to address the escalating mental health crisis in an ecologically sustainable manner.1

“We are constantly seeking opportunities to further extend the capabilities of our platform,” said Florian Brand, Chief Executive Officer and Co-Founder of atai Life Sciences. “TryptageniX’s approach to drug discovery is highly complementary to that of EntheogeniX, our existing AI-enabled drug discovery company. The launch of TryptageniX demonstrates our ongoing commitment to harness the most promising scientific advancements of our age for the good of patients.”

“atai is delighted to be collaborating with CB Therapeutics to form TryptageniX,” said Srinivas Rao, Chief Scientific Officer and Co-Founder of atai Life Sciences. “We both share a strong commitment to driving novel approaches in the treatment of mental health disorders. This is yet another important step forward for atai in developing innovative and scalable solutions to serve the ever-growing needs of patients and support our dynamic clinical development strategy.”

“CB Therapeutics is very excited to be joining forces with atai Life Sciences with the launch of TryptageniX,” said Dr. Jacob Vogan, Chief Scientific Officer of CB Therapeutics. “It is our shared ambition that this platform will lead the way in exploring psychedelic-centric biosynthesis solutions and enable the discovery of important new chemical entities. Sensitivity to sustainability and the wider ecosystem is paramount, which we believe can be accomplished through innovative biosynthetic manufacturing methods for naturally derived compounds.”

“Our expertise in synthetic biology, precision fermentation, and downstream processing, along with the opening of our new world-class pilot facility will enable rapid development and deployment of much needed, cutting-edge solutions for mental health and wellness, and we are very excited to be at the forefront of this revolution,” said Sher Ali Butt, Chief Executive Officer of CB Therapeutics.

Naturally derived compounds play an important role across drug development for the central nervous system (CNS). TryptageniX will be a strong complement to atai’s existing drug discovery and development expertise, while also allowing atai to minimize its ecological footprint and ensure a sustainable supply chain for the future.

References:

  1. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: statements regarding TryptageniX and biosynthetic NCE development, the success, cost and timing of development of our product candidates, including the progress of preclinical and clinical trials and related milestones; our business strategy and plans; potential acquisitions; and the plans and objectives of management for future operations and capital expenditures. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond our control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including without limitation: we are a clinical-stage biopharmaceutical company and have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future; we will require substantial additional funding to achieve our business goals, and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our limited operating history may make it difficult to evaluate the success of our business and to assess our future viability; we have never generated revenue and may never be profitable; our product candidates contain controlled substances, the use of which may generate public controversy; clinical and preclinical development is uncertain, and our preclinical programs may experience delays or may never advance to clinical trials; we rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those clinical trials, including progress and related milestones, may be impacted by several factors including the failure by such third parties to meet deadlines for the completion of such trials, research, or testing, changes to trial sites and other circumstances; we currently rely on qualified therapists working at third-party clinical trial sites to administer certain of our product candidates in our clinical trials and we expect this to continue upon approval, if any, of our current or future product candidates; if third-party sites fail to recruit and retain a sufficient number of therapists or effectively manage their therapists, our business, financial condition and results of operations would be materially harmed; we cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized; research and development of drugs targeting the central nervous system, or CNS, is particularly difficult, and it can be difficult to predict and understand why a drug has a positive effect on some patients but not others; we face significant competition in an environment of rapid technological and scientific change; third parties may claim that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent or delay our development and commercialization efforts; a change in our effective place of management may increase our aggregate tax burden; we identified material weaknesses in connection with our internal control over financial reporting; and a pandemic, epidemic, or outbreak of an infectious disease, such as the COVID-19 pandemic, may materially and adversely affect our business, including our preclinical studies, clinical trials, third parties on whom we rely, our supply chain, our ability to raise capital, our ability to conduct regular business and our financial results. Other risk factors include the important factors described in the section titled “Risk Factors” in our final prospectus, dated June 17, 2021, filed with the Securities and Exchange Commission (“SEC”) pursuant to Rule 424(b) under the Securities Act, and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements.

Any forward-looking statements made herein speak only as of the date of this press release, and you should not rely on forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, performance, or achievements reflected in the forward-looking statements will be achieved or will occur. Except as required by applicable law, we undertake no obligation to update any of these forward-looking statements for any reason after the date of this press release or to conform these statements to actual results or revised expectations.

Contact Information

Media Contact:
Camilla Dormer
VP, Communications
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations
Email: chad@atai.life 

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Blackhawk Growth to Complete Strategic Investment of Digital Mind Technology; Fully Funds Phase 1 Clinical Trial for Digital Mind and Phase 2 Clinical Trial for MindBio Therapeutics

Blackhawk Growth to Complete Strategic Investment of Digital Mind Technology; Fully Funds Phase 1 Clinical Trial for Digital Mind and Phase 2 Clinical Trial for MindBio Therapeutics

Highlights:

  • Complementary acquisition of digital wellness company with AUD$2.5M cash on hand 
  • Digital Mind Technology has a fully funded Phase 1 Clinical Trial ongoing 
  • Adds several new high profile and leading institutional psychedelic funds as Blackhawk shareholders 
  • MindBio Therapeutics fully funded Phase 2 Clinical Trials 
  • Blackhawk holding leading assets in legal psychedelic and mental health therapies 

Vancouver, British Columbia – TheNewswire – December 7, 2021 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (Frankfurt:0JJ) ( “Blackhawk”), is pleased to announce that it has entered into a binding share purchase agreement, dated effective December 6, 2021, in which it will acquire 100% of the issued and outstanding share capital of Digital Mind Technology Pty Ltd (“Digital Mind”). In consideration for the acquisition, Blackhawk will issue 8,661,290 common shares to the existing shareholders of Digital Mind.

Blackhawk is also pleased to announce that MindBio Therapeutics is accelerating its clinical trial program and is now fully funded for Phase 2 Clinical Trial for microdosing of psychedelic in late-stage cancer patients. MindBio will be one of a handful of companies that is progressing to a Phase 2 clinical trial in the psychedelics sector.

Digital Mind Technology is an arms-length privately held clinical trial stage company developing digital interventions to treat mental health conditions. It successfully completed a pilot randomized controlled trial with 69 patients of an online mindfulness-based program for people diagnosed with melanoma1. Digital Mind’s clinical trial protocol was developed by leading scientist, Dr Russell, at a major Australian university.

Dr. Russell graduated with a Master in Biochemistry from the University of Geneva, Switzerland. She has worked for a decade in the pharmaceutical industry managing clinical trials. Over the years, Dr. Russell developed an interest in the psychosocial adaptation to illness and strategies to manage stress-related aspects of diseases. Her studies in Epidemiology at the London School of Hygiene and Tropical Medicine (UK) stimulated her desire to undertake research in this field.

Following this, Dr. Russell joined the psycho-oncology research team at the Peter MacCallum Cancer Centre in Melbourne, Australia, evaluating supportive care interventions for people affected by cancer. In 2018, Dr. Russell was awarded her PhD from Deakin University, Australia. Coupling with her personal interest in mindfulness practices and her professional experience in psycho-oncology, Dr. Russell’s PhD research was designed to determine whether a mindfulness program could benefit people with melanoma.

The focus of the program was to empower participants to manage their health by promoting awareness of emotions and teaching skills to manage distressing thoughts. Central to the success of the program was the flexibility offered to participants to access the information at their own convenience. Dr Russell is dedicated to expand from this early research to build an evidence base informing the development of self-guided interventions promoting the mental health of people affected by cancer and other chronic conditions.

Digital Mind has both the intellectual property, with over 5 years of quality research intellectual property and the capital, with approximately AUD$2.5million in working capital to fund its operations. Digital Mind will conduct Phase 1 clinical trials of mindfulness-based digital programs for people requiring pain management to avoid or reduce the impact on mental health. The clinical trials will be fully compliant with the Food and Drug Administration’s (FDA) protocol.

Digital Mind is also working to develop digital platforms (Mobile, Smart Watch, and Web) that provides clinically proven mindfulness-based digital programs to help patients to deal with pain. These clinical programs have the potential to be provided to patients via health professionals in a clinical setting.

Digital intervention technologies are one of the fastest growth areas in the treatment and prevention of mental health conditions. Funding for technology companies that are developing applications to treat behavioural, mental and brain health exceeded
US$5.3 billion to Q3 in 20212.

“The acquisition of Digital Mind will help scale our life science and psychedelic portfolio tremendously” said Frederick Pels, CEO of Blackhawk Growth. “It will allow our psychedelic microdosing company, MindBio Therapeutics, to have close collaboration ties with Digital Mind for both product development and commercialization activities. A robust digital mental health platform will form the 3rd pillar of our multi-disciplinary mental health solution combining with our existing tier 1 university grade clinical research and established mental health clinics. We look forward to updating our shareholders with our progress over the coming weeks and months as well as details of our clinical trials shortly.”

Dr. Zena Burgess has also been appointed to Digital Mind advisory board. Dr. Burgess serves as Director of MindBio Therapeutics and is also a member of the international advisory board of Connext2MyDoctor and the telehealth influencers alliance. Dr. Burgess is currently the Chief Executive Officer of the Australian Psychologists Society. Formerly, Dr. Burgess was Chief Executive of the Royal Australian College of General Practitioners. Dr. Burgess has substantial experience serving on boards of government entities.

She holds a PhD in psychology and a Master of Business Administration and a Master of Education. She has a wealth of experience in health changes and strategic advocacy to governments.

Digital Mind also has several high-profile shareholders including some of the largest psychedelic funds who will now become shareholders of Blackhawk through this acquisition. They include for instance:

Iter Investments
Iter Investments is a venture capital firm based in the USA focused on supporting emerging companies within the psychedelic ecosystem of behavioral and mental health.

https://www.iterinvestments.com/

The Conscious Fund 
The Conscious Fund is an early-stage venture capital firm headquartered in London, United Kingdom. The firm seeks to invest in psychedelics medicine.

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Transaction Structure

In connection with the acquisition, Blackhawk will acquire all of the outstanding share capital of Digital Mind Technology Pty Ltd. in consideration for the completion of the transaction, Blackhawk is required to issue 8,661,290 common shares to the existing shareholders of Digital Mind. One-half of these shares will be subject to restrictions on resale for a period of four months and one day following issuance. No finders’ fees or commissions are payable by Blackhawk in connection with the acquisition.

Blackhawk is at arm’s length from Digital Mind and its shareholders. The transaction neither constitutes a fundamental change nor a change of business for Blackhawk, nor is it expected to result in a change of control of Blackhawk within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange. Completion of the acquisition remains subject to the satisfaction of customary closing conditions. Following completion of the acquisition, Digital Mind will expand Blackhawk’s existing portfolio of investments in the health care sector.

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics.

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A  

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Publications By Dr Russell

  • Russell, L., Whiffen, R., Chapman, L., Just, J., Dean, E., Ugalde, A. and White, S., 2021. Hospital staff perspectives on the provision of smoking cessation care: a qualitative description study. BMJ open, 11(5), p.e044489. DOI: 10.1136/bmjopen-2020-044489 
  • Lynch, F.A.; Katona, L.; Jefford, M.; Smith, A.B.; Shaw, J.; Dhillon, H.M.; Ellen, S.; Phipps-Nelson, J.; Lai-Kwon, J.; Milne, D.; Russell, L.; Dax, V.; Diggens, J.; Kent, H.; Button-Sloan, A.; Elliott, J.; Shackleton, M.; Burridge, H.; Ftanou, M. Feasibility and Acceptability of Fear-Less: A Stepped-Care Program to Manage Fear of Cancer Recurrence in People with Metastatic Melanoma. J. Clin. Med. 2020, 9, 2969. DOI: 10.3390/jcm9092969 
  • Russell, L., McIntosh, R., Martin, C., Scott J., Kheng Soo W., Zappa B., Haynes K., Livingston PM. Ugalde, A. A model of cancer survivorship care within a community health setting: the Good Life Cancer Survivorship program. Journal of Cancer Survivorship. 2019 DOI: 10.1007/s11764-019-00821-6 
  • Russell, L., Ugalde, A., White, V., Pitcher, M., Jorgensen, S., Whitfield, K., … Livingston, P. Relevance of mindfulness practices for Culturally And Linguistically Diverse cancer populations. PsychoOncology, 2019 DOI: 10.1002/pon.5221 
  • Ugalde A, Haynes K, White V, Russell L, Livingston PM. “An Ambition to Make People Feel at Home” or “The Emperor’s New Clothes”? Professional Stakeholder Views of Wellness Centres in Cancer Care. European Journal of Cancer Care. 2019 DOI: 10.1111/ecc.13096 
  • Russell L, Pascoe MC, Seymour JF, Aranda S, Butow P, Gough K, Schofield P. The trials and tribulations of conducting an m-health pilot randomized controlled trial to improve oral cancer therapy adherence: recommendations for future multisite, non-drug clinical trials. BMC research notes. 2019 Dec;12(1):226. 
  • Russell L, Ugalde A, Orellana L, Milne D, Krishnasamy M, Chambers C, Austin D and Livingston P M, A pilot randomised controlled trial of an online mindfulness-based program for people diagnosed with melanoma, Journal of Supportive Care in Cancer. 2018 DOI: 10.1007/s00520-018-4574-6  
  • Russell L, Ugalde A, Milne D, Austin D and Livingston P M, Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review, JMIR Mental Health. 2018 DOI: 10.2196/mental.9645  
  • Russell L, Ugalde A, Milne D, Krishnasamy M, Chung Seul O E, Austin D, Chambers R, Orellana L, and Livingston PM, Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial, Trials. 2018 Dec; 19(1):223 
  • Pereira-Salgado A, Westwood JA, Russell L, Ugalde A, Ortlepp B, Seymour JF, Butow P, Cavedon L, Ong K, Aranda S, Breen S.,… Schofield P, Mobile Health Intervention to Increase Oral Cancer Therapy Adherence in Patients With Chronic Myeloid Leukemia (The REMIND System): Clinical Feasibility and Acceptability Assessment, JMIR mHealth and uHealth. 2017. DOI: 10.2196/mhealth.8349 
  • Russell L, Orellana L, Ugalde A, Milne D, Krishnasamy M, Chambers R, Livingston PM., Exploring Knowledge, Attitudes, and Practice Associated With Meditation Among Patients With Melanoma, Integrative Cancer Therapies, 2017. DOI: 10.1177/1534735417699514 
  • Jefford M, Gough K, Drosdowsky A, Russell L, Aranda S, Butow P, Phipps-Nelson J, Young J, Krishnasamy M, Ugalde A, King D., … and Schofield P, A Randomized Controlled Trial of a Nurse-Led Supportive Care Package (SurvivorCare) for Survivors of Colorectal Cancer, Oncologist, 2016. DOI: 10.1634/theoncologist.2015-0533 
  • Russell L, Gough K, Drosdowsky A, Schofield P, Aranda S, Butow PN, Westwood JA, Krishnasamy M, Young JM, Phipps-Nelson J, King D. Jefford M, , Psychological distress, quality of life, symptoms and unmet needs of colorectal cancer survivors near the end of treatment, Journal of Cancer Survivorship, 2015. DOI: 10.1007/s11764-014-0422-y  
  • Jefford M, Mann GB, Nolte L, Russell L, Brennan M., Follow-up of Women with Early Stage Breast Cancer. Current Breast Cancer Reports, 2014. DOI:10.1007/s12609-014-0150-3 
  • Jefford M, Aranda S, Gough K, Lotfi-Jam K, Butow P, Krishnasamy M, Young J, Phipps-Nelson J, Russell L, King D, Schofield P., Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial, Trials 2013. DOI: 10.1186/1745-6215-14-260 

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of Digital Mind Technology Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

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Optimi Health Requests Final Inspection for Dealer’s License

Optimi Health Requests Final Inspection for Dealer’s License

VANCOUVER, BC (December 7, 2021) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional as well as novel psychedelic compounds focused on the health and wellness sector, is pleased to announce it has substantially completed construction on its proposed Dealer’s License facility in Princeton, British Columbia and called for final site inspection.

The Optimi team has relentlessly endeavored to build world-class GMP capable facilities from the ground up. Since December of 2020, the Company has been heavily invested in completing its state-of-the-art facilities in full compliance with Health Canada’s Directive on Physical Security Requirements for Controlled Substances. As noted in the recently filed annual financials, as of September 30, 2021, $8,586,465 CAD of expenditures was incurred in connection with the construction of these facilities. Following on the Company’s facility update September 14, 2021, the schedule 8 security protocol is commissioned, Argus environmental control system is being installed, curbs and blacktop poured, interior clean walls are erect, HVAC units are mounted, and ancillary cultivation equipment has arrived on site.

Concurrent to the finalization of the dealer’s license submission the Company has now presented its analytical laboratory license for consideration and review. Optimi believes a healthy domestic regulatory environment is a critical and necessary driver of the rigorous safety and security regulations for licensed producers and builds confidence in local production quality and capacity. By adhering to Health Canada guidelines in the development of facilities and practices, Optimi believes it is positioned to exceed initial internal expectations for product excellence and delivery.

“Regulations are critical and necessary for building product safety and efficacy,” notes Company CSO Justin Kirkland. “With the tools we now have available, we are highly confident in our ability to isolate high purity natural psilocybin from our own mushroom harvest. We are looking forward to working with Health Canada, and other global regulatory agencies in order to deliver the finest all-natural products wherever possible.”

The Company has recently completed the purchase of research and development as well as analytical instrumentation which is poised to dramatically ramp up in-house productivity. Upon final approval by the onsite quality assurance team, Optimi will be able to provide assays to include potency testing by high-performance liquid chromatography including a diode array detector that allows for measuring multiple substance at multiple wavelengths (or components) simultaneously. Additional study capability includes potency, stability and identity testing utilizing thin layer chromatography, ultraviolet-visible spectroscopy, and mass spectrometry. The laboratory now provides an advanced ability to test for heavy metals and elemental impurities in compliance with guidelines put forth by the FDA, USP and ICH organizations to protect patients from the risks associated with heavy metal contaminants.

Michael Kydd, regulatory consultant to Optimi states, “The Company is clearly focused on respecting the regulatory process and by so doing, is positioning itself as an undisputed global supply leader through the development of one of Canada’s highest-quality GMP-capable facilities. The entire team looks forward to building strong relationships within national and international governments as the industry matures. In my opinion collaboration and communication define excellence, and the work we undertake today with Health Canada positions us to propel Optimi as an industry leader in standards and excellence around the world.”

Optimi Health CEO Bill Ciprick concludes, “I’m extremely proud of our recent and ongoing achievements. The senior leadership team has a strong history of operational and facility management in the cultivation of GMP-certified health products. That experience took time to build, and it now places Optimi Health in contention as a potential North American leader in the production of functional and medicinal mushrooms. Our common outlook is predicated on working together to optimize human development and fundamentally improve the physical, spiritual, and mental well-being of those impacted by serious mental health problems. It is potentially a massive sector, and with all that is going on around the world today, the need for improved health and wellness solutions has never been greater. Once again, our heartfelt thanks for the continued assistance of all our supporters as we grow this exciting and timely enterprise.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

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

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion 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 applied for 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. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
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 the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption 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 Final Prospectus dated February 12, 2021. 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.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

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PsyBio Therapeutics Successfully Completes First Pre-IND Meeting with the United States Food and Drug Administration

PsyBio Therapeutics Successfully Completes First Pre-IND Meeting with the United States Food and Drug Administration

PsyBio is committed to innovate, develop, and optimize technology related to its ever growing psycho-targeted portfolio through formal regulatory pathways

Based on feedback received, PsyBio intends to request its initial compound-specific pre-IND meeting

OXFORD, Ohio and COCONUT CREEK, Fla. , Dec. 7, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (” PsyBio ” or the ” Company “), an intellectual property driven biotechnology company focused upon discovery and development of new, bespoke,  psycho-targeted therapeutics to potentially improve mental and neurological health, today announced the successful completion of its initial pre-Investigational New Drug (” IND “) application meeting with the United States Food and Drug Administration (” FDA “) as part of the regulatory submission process.

PsyBio Therapeutics Corp. logo (CNW Group/PsyBio Therapeutics Corp.)

“PsyBio was created to develop novel therapeutic candidates with the goal to help improve human health,” stated Michael Spigarelli , MD, PhD, MBA, PsyBio’s Chief Medical Officer. “To achieve this goal, regulatory approval for any potential therapeutic candidate is absolutely necessary to bring that product to the patients who may benefit. As such, it is critically important to have open discussions, such as this meeting, with regulatory officials to most efficiently and effectively follow all requirements and guidance to facilitate future approvals.”

The focus of this pre-IND meeting was to discuss potential indications, manufacturing strategy, and obtain regulatory guidance as PsyBio guides its technology forward towards regulatory approval. The responses received from the FDA to these initial set of questions were constructive and no changes were proposed with respect to PsyBio’s approach.  Based upon this initial discussion, PsyBio intends to submit compound specific pre-IND meeting requests to define manufacturing and clinical trial parameters.

“This initial pre-IND meeting marks our formal entry into the regulatory process, which is paramount and of foremost importance to PsyBio as part of our commitment to being a leader in developing psycho-targeted therapeutic candidates,” stated Evan Levine , PsyBio’s Chief Executive Officer. “The FDA has provided invaluable guidance which the Company plans to heed and implement during the development period.  We look forward to collaborating with the FDA and other regulatory agencies to demonstrate our potential therapeutic candidates are safe and effective for their proposed indications.”

About PsyBio Therapeutics Corp.

PsyBio is an intellectual property driven biotechnology company focusing on discovering and developing new, bespoke, 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.

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 to submit compound specific pre-IND meeting requests to the FDA to define manufacturing and clinical trial parameters; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build and protect its intellectual property portfolio of novel drug candidates; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio 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: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file one or more IND Applications with the FDA; PsyBio will be successful in obtaining all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favourable; 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.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/December2021/07/c5455.html

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Optimi Health Engages Expert Management Consultancy to Drive Corporate Visibility

Optimi Health Engages Expert Management Consultancy to Drive Corporate Visibility

VANCOUVER, BC  (November 3, 2021) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional as well as novel psychedelic compounds focused on the health and wellness sector, is pleased to announce the engagement of management and communications consultants Kydder Management Group Inc. (“Kydder Group”) to assist with governmental, regulatory, corporate, and policy matters.

Driven by the desire to support change in Canada’s mental health regime, Kydder Group is a regulatory communication firm led by Principal & Founder, Michael Kydd, that provides regulatory and political communication advice to some of the most prominent psychedelic therapy, research and biotech companies and associations across the world.

Kydder Group is currently spearheading Canada’s first Memorandum of Regulatory Approval (MORA) to amend current Health Canada regulations, hopefully resulting in controlled legal access to psilocybin therapy for palliative and end-of-life Canadians. The firm is also leading a national coalition through the Canadian Psychedelic Association focused on Medical Assistance in Dying (MAID) and psychedelic therapy as a dignified, quality-of-life option for Canadians at end-of-life.

“There is an incredible responsibility on industry to communicate the safety and efficacy of controlled substances through the highest and most stringent scientific and clinical standards,” says Kydd. “Bill Ciprick and the Optimi Health team have a remarkable history of exceeding those standards and they appreciate the importance of building trust and operational excellence with Health Canada and consumers. Their growing presence as a global leader in functional mushroom growth and research into psychoactive formulations is something I am very excited to be part of.”

Kydder Group has been engaged to consult upon and oversee many key activities including management of the ongoing relationship with Health Canada, completion of the facility inspection process, future amendments to the dealer’s license, reporting on Health Canada policy changes and trends, identification of future distribution and export opportunities, and entry into future licensing applications (e.g., drug establishment license).

Additional services encompass intra-industry partnerships and connectivity, along with regulatory environment development including participation with other major industry players in the development of regulations for approval, participation in industry calls/meetings with Health Canada on regulatory issues, future appearances before Parliamentary Committees, meetings with provincial governments to study the socio-economic benefits of psychedelic therapies and products, and the drafting of SOPs (as needed).

Lastly, Kydder Group will manage political advocacy including meetings and arranging facility tours with political officials, staff, and other influencers. Overall, consumer and regulatory-facing efforts will be coordinated with Optimi Health’s communications providers to assist in the management of messaging strategy and tactics.

Optimi Health CEO Bill Ciprick notes, “We are delighted to welcome Michael and his team as they join us at this critical juncture in the growth of our venture, and of the industry. Optimi is a group of passionate advocates for the innovation of mushroom-based formulations. Given that we are pioneering an industry, we have to ensure our path is aligned to meet the least resistance, which is accomplished through communication and regulatory excellence. Today’s announcement is another positive step towards unlocking the value of the psychedelic marketplace.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion 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 applied for 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. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
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 the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption 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 Final Prospectus dated February 12, 2021. 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.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

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Want a life-changing psychedelic trip but don’t know where to start?: issue 26

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

🍄 The cure for the worst pain known to humans

🍄 Combining antidepressants and psilocybin

🍄 More positive findings from biggest psilocybin trial

🍄 Psychedelic cream?

🍄 And more.

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

Why a psychedelic retreat might be the best vacation you’ve ever been on

In this episode of the Daily Mushroom Podcast, we have the CEO of Silo Wellness, Douglas Gordon. Silo Wellness offers legal, psychedelic retreats in Jamaica and Oregon. Their mission is heavily rooted in the education around the physical and mental benefits of mushrooms. We hope you enjoy this one!

Antidepressants + psilocybin

Do patients need to come off of antidepressants before trying psilocybin therapy?

New research from MindMed (MNMD) and Liechti Labs suggests that it’s not necessary – and there are actually benefits of combining the two.

Escitalopram (aka Lexapro) did not affect the way psilocybin was processed and helped reduce negative side effects like anxiety and high blood pressure.

More positive findings from biggest psilocybin trial

COMPASS Pathways (CMPS) announced additional findings from the world’s largest psilocybin trial for depression. 

In addition to reduced depression scores, patients showed improvements in anxiety, daily functioning, cognition, and quality of life. Just one day after the treatment, patients had increased positive feelings such as “interested, excited, strong” and decreased negative feelings like “distressed, upset, afraid.” 

Psychedelic cream

Psycheceutical Inc., a private Florida company, is developing a unique way to deliver psychedelics – through a cream or patch applied to the back of the neck. This method allows psychedelics to enter the brain in just 5-10 minutes without entering the bloodstream, which reduces negative side effects.

Participate in psychedelic research from your phone!

Quantified Citizen is a platform made in collaboration with Paul Stamets to accelerate health research. It allows anyone to participate in studies anonymously from their phone.

The platform was used to conduct the world’s largest mobile microdosing study, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress.

It’s not too late to participate – download the app here to join the study!

Curing the worst pain known to humans

For years, Brad Badelt suffered from debilitating cluster headaches (which are often called “suicide headaches” and described as the worst pain known to humans.

After seeing countless neurologists, chiropractors, acupuncturists, and naturopaths, he would still experience the horrible headaches several times a day for weeks on end.

After taking one dose of shrooms, things finally changed. 

“When I woke the next morning, I felt different: the mental fog brought on by my cluster headaches was gone. For the next twelve months, I remained headache free. Every year since, I’ve downed a dose of shrooms, and every year my cluster headaches have remained in remission.”

Want a life-changing psychedelic trip but don’t know where to start?

The Wakeful Integration Journal is your guide to transformation. 

It’s the ultimate tool to help you prepare for, navigate, and deeply integrate your psychedelic experiences. The journal features:

  • Prompts to discover your intentions and reflect on your trip
  • Dose tracking
  • Tips to support you along the journey
  • Colouring pages to unlock your creativity

If you want to start with microdosing rather than a full-on trip, the Wakeful Intention Journal is for you! It guides you through a 6-week microdosing protocol and helps you set intentions, notice patterns, and integrate your insights.

Support the Kickstarter here to receive a journal and begin your transformation journey!

The Canadian government is funding psychedelic research!

MYND Life Sciences (MYND) received $45,600 in government funding to support a psilocybin research project on treatment resistant depression and neuroinflammation. The project will run now until March 2022.

Novamind (NM) partnered with Bienstar Wellness to develop the first network of integrative mental health clinics in Latin America. The companies plan to bring psychedelic medicine to Uruguay, Brazil, Mexico, Peru, and Panama.

PharmaTher (PHRM) was granted a Japanese patent for KETBET, a combination of ketamine and betaine anhydrous that can be used for various mental health and pain disorders. Betaine anhydrous enhances the antidepressant effect of ketamine while reducing the side effects.

Telescope Innovations (TELI) acquired the rights to the University of British Columbia’s research on synthetic psilocybin in exchange for 1M common shares at $0.99 each.

Bright Minds Biosciences (DRUG) announced that its drug discovery program has synthesized hundreds of patentable psychedelic compounds. Researchers are optimizing the most encouraging molecules and aim to announce the lead molecule early next year.

Shanti Therapeutics, a subsidiary of Global Wellness (GWS), is awaiting ethics committee approval to conduct one of the first studies on MDMA for pain management. 

These companies announced their financial highlights:

legal banner

Here’s what you missed in the legal world:

  • New Zealand is legalizing drug testing so users can check the purity of illegal substances. The services will be available at events like concerts and festivals. Read more…
  • The DEA is once again increasing the production quotas of these psychedelic drugs for 2022: 
    • Psilocybin increased from 3,000 to 8,000 grams
    • Psilocin increased from 2,000 to 3,000 grams
    • MDMA increased from 3,200 to 8,200 grams
    • DMT increased from just 250 to 3,000 grams

          The new limits will allow more researchers to study the drugs! Read more…

  • A Florida Rep. filed a bill to decriminalize all illegal substances and implement rehabilitative health intervention or civil fines instead. Read more…

Eco-friendly funerals

A startup in the Netherlands is making biodegradable “living coffins” out of mushroom mycelium!

Not only do the coffins enrich the soil, but they allow “people to become one with nature again.” 

After months of testing, the first funeral using a mushroom coffin was a success.

Bob Marley mushrooms 🇯🇲

Silo Wellness (SILO) launched a line of functional mushroom products in collaboration with Bob Marley’s family!

The Marley One line features:

  • One Mind: A coffee-flavored blend of lion’s mane and gingko biloba designed to improve focus and cognitive function.
  • One Flow: A peppermint-flavored blend of cordyceps and ginseng designed to enhance physical endurance and mental function.
  • One Harmony: A mango-flavored blend of chaga and ginger designed to stimulate gut health and improve digestion.
  • One Body: A berry-flavored blend of turkey tail and astragalus designed to support immune health.
  • One Rest: A vanilla-flavored blend of reishi and GABA designed to help reduce tension and stress and improve quality of sleep. 

Use promo code DAILYMUSHROOM20 to get 20% off! 

Shop Marley One

Industry Quick Hits

Nov 29 – Numinus (NUMI) Develops Proprietary Psychedelic Tests with New Toxicity and Potency Scans Read more…

Nov 29 – atai Life Sciences (ATAI) Increases its Ownership Position in COMPASS Pathways (CMPS) Read more…

Nov 30 – Cybin (CYBN) Announces FDA IND and IRB Approvals for Clinical Trial to Treat Frontline Clinicians with COVID-Related Distress Read more…

Dec 2 – Ketamine One (MEDI) Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD Read more…

Dec 2 – Tryp Therapeutics (TRYP) Receives Confirmation from FDA to Proceed with Phase 2a Study in Fibromyalgia  Read more…

Nov 26 – Delic Corp’s (DELC) Ketamine Wellness Centers Opening Salt Lake City & Reno Locations Read more…

Video of the Week

How LSD Triggered a Psychedelic Revolution

Playlist of the Week

Psychedelic Chill