Docs on Mushrooms: issue 32

Hello and welcome back.

We’re excited to announce that we’ll be bringing you a FREE virtual event on February 3rd to discuss all things psychedelic and mental health. If your New Year’s resolution is to work on your mental health, you won’t want to miss it! Keep reading for details 😊

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

🍄 The most intense psychedelic?

🍄 Impressive findings from a ketamine study on addiction

🍄 A promising treatment for ALS

🍄 Rescheduling psilocybin GLOBALLY

🍄 And more.

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

What physicians really think about psilocybin

On this episode of the Daily Mushroom Podcast, we have Dr. Lyle Oberg, co-founder, and CEO of MYND life sciences. Dr. Oberg has been had an extensive career across many sectors, including working as a family physician and a Chief Policy and Medical Officer at a cannabis company. He was also part of the Alberta government for 15 years as Minister of Finance, Social Services, Learning, and more. Stick around to hear what Dr. Oberg has to say, we are sure it will give a new insight into the world of psychedelics!

86% abstinent after ketamine therapy

Six months after receiving three ketamine infusions and Awakn Life Sciences’ proprietary therapy, 86% of patients with severe alcohol use disorder remained abstinent from alcohol.

Awakn’s study also showed that:

The treatment was 2.7x more effective than placebo infusions and alcohol education
Risk of mortality within one year dropped from 1 in 8 patients to 1 in 80
Liver function improved (shocker)
Depression scores were significantly reduced
Ability to experience pleasure increased

The downside? There isn’t one. There were no serious adverse reactions either 👏

Slowing the progression of ALS

When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found.

Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.

In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease.

The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.

Psilocybin + CBD 🧠

The majority of patients with traumatic brain injury (TBI) also experience depression, and patients with severe TBI-related depression are 5x more likely to attempt suicide.

Wesana Health (WESA) is planning a study to see if the condition can be treated with one large dose of psilocybin in a clinic, followed by “self-administered maintenance doses” of psilocybin and CBD to sustain the benefits.

Researchers believe the treatment will promote neuroplasticity and neurogenesis while reducing neuroinflammation.

Can ketamine enhance addiction medication?

Novamind (NM) is hosting a first-of-its-kind study to find out.

The trial will see if ketamine-assisted therapy can enhance the effectiveness of buprenorphine, a first-line addiction medication, in treating opioid use disorder.

Will the two drugs finally be able to conquer this treatment-resistant condition?

Join our virtual Mental Health Town Hall

We’re collaborating with experts at Entheon Biomedical (ENBI) to bring you a special virtual event on February 3rd.

Here’s what you can expect to learn:

The latest psychedelic research on mental health and addiction
How psychedelics can be used for personal development
All things microdosing
Where the industry is headed
Answers to all your burning questions

You’ll hear insights and stories from:

Timothy Ko, CEO and Founder of Entheon
Dr. Andrew Greenshaw, Scientific Advisor to Entheon and Professor of Psychiatry and Neuroscience at the University of Alberta
David Mayoh, Communications Manager at Entheon
Thomas Hartle, the first Canadian to receive psilocybin therapy
And more

Now is your chance to get your questions answered by industry experts and connect with fellow members of the Daily Mushroom Community. We can’t wait to see you there. Register now 👇

The most intense psychedelic?

“I truly doubt that there is another psychedelic drug, anywhere, that can match [4-HO-DiPT] for speed, intensity, brevity, and sensitive to dose, at least one that is active orally.”

Field Trip Health’s (FTRP) first novel compound could produce the most intense experience of any oral psychedelic.

It’s a more stable and soluble version of 4-HO-DiPT — a drug that induces an extremely powerful experience lasting 2-3 hours, according to Alexander Shulgin, the chemist who created it.

Considering he’s experimented with 55 different psychedelics, which he reviewed in “Tryptamines I Have Known and Loved,” we’ll take his word for it.

Field Trip expects to receive a patent for the formulation next month.

Mydecine (MYCO) is launching a program to sell MDMA and psilocybin, as well as training and support services, to healthcare practitioners through Health Canada’s amended Special Access Program. The company also completed a model that can rapidly screen billions of compounds using AI to find novel psychedelics that bind to serotonin receptors.

Delic Holdings Corp. (DELC) announced that it plans to more than double its footprint in the next 18 months by opening 15 new ketamine clinics, which will be strategically located in secondary cities to improve patient accessibility.

Ketamine One (MEDI) began trading on the OTCQB marketplace under the symbol ‘KONEF’.

atai Life Sciences (ATAI) received FDA approval for a study to investigate how its R-ketamine compound interacts with other drugs.

Rescheduling psilocybin GLOBALLY 🌍

“Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue,” according to Christopher Koddermann.

That’s why he co-founded The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) – an initiative that’s pushing for psilocybin to be rescheduled on a global scale.

ITPRI aims to reschedule psilocybin through the United Nations’ Convention on Psychotropic Substances, which was enacted over 50 years ago 😮 This would significantly reduce the regulatory barriers that impede psilocybin research and access to treatment.

So yes, rescheduling is long overdue, but better late than never!

Plus, progress in the US & Italy:

A Missouri Rep. filed a bill to expand the state’s right-to-try law to include psilocybin, MDMA, DMT, ibogaine, LSD, mescaline, and peyote. This would grant patients with serious illnesses legal access to the substances. Read more…
Senator Scott Wiener announced that he is once again pushing for a psychedelic decriminalization bill in California after halting it last year, and believes it has a 50/50 chance of being passed. To generate support, veterans are meeting with Assembly members and changes may be made to possession limits and types of psychedelics included. Read more…
Virginia lawmakers introduced a bill to reduce the penalty for possessing peyote, ibogaine, psilocybin, or psilocin from a Class 5 felony to a $100 fine. A separate bill focused on just psilocybin and psilocin was also filed. Read more…
Italian officials verified 630,000 signatures collected in support of a measure to decriminalize cultivation of marijuana and psilocybin mushrooms. If the measure is approved by the Constitutional Court, which will be announced on February 15, it will appear on a ballot this spring. Read more…

Turning mushrooms into mush houses

Architect David Benjamin wants to make the construction industry more sustainable using (you guessed it) mushrooms!

He constructed a 40-foot-tall structure using bricks grown from mushroom mycelium.

The bricks are lightweight yet durable and can be grown in five days without emitting carbon or producing waste.

Video of the Week

Playlist of the Week

January 13, 2022March 10, 2022

Mydecine to Launch Special Access Support and Supply Program in Canada Expanding Access to Psychedelic-Assisted Psychotherapy For Patients

With the addition of psilocybin and MDMA to Health Canada’s Special Access Program, Mydecine looks to offer a package of cGMP products and support services promoting responsible administration to patients and creating near-term revenue potential

VANCOUVER, British Columbia, Jan. 13, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they would be launching The Special Access Support and Supply Program (SASSP) to provide products and services to physicians, clinics, and hospitals in Canada who are looking to treat patients through psychedelic-assisted psychotherapy. With the new addition of psilocybin and MDMA to the approved list of substances under Health Canada’s Special Access Program (SAP), the company aims to fill a critical gap in the market by allowing thousands of healthcare professionals and clinics the resources needed to bring these treatments to patients in need.

Last week, Health Canada announced an amendment to federal regulations, granting practitioners and pharmacists the ability to request and prescribe psilocybin and MDMA for treatment-resistant patients. This means patients who have not seen success from other treatments can now access additional treatment options. To re-enforce safe and effective integrations of these treatments, Mydecine’s SASSP will offer A-Z support to medical practices across Canada.

Through the Company’s SASSP, healthcare practitioners can purchase a package including cGMP psilocybin and MDMA, investigative brochures, therapy manuals, protocol training, advisory services, and post-therapy support for patients through Mydecine’s wholly-owned subsidiary Mindleap Health. Mindleap is a digital health platform that combines therapeutic and educational content with virtual 1-on-1 professional support for psychedelic integration.

Mydecine is currently producing cGMP certified pharmaceutical grade psilocybin and MDMA with coverage under a Health Canada Schedule 1 Drugs and Substances Dealer’s License in Alberta. With multiple clinical trials launching this year utilizing psychedelic compounds, as well as their partnership with Johns Hopkins University, the Company is well-positioned to help physicians, clinics, and hospitals use Canada’s new regulations.

Mydecine’s Chief Medical Officer, Dr. Rakesh Jetly, stated, “While we are committed to demonstrating the safety and efficacy of these medicines for specific indications through our clinical trials, we do recognize that in the meantime, there are people that are suffering from mental illnesses that haven’t responded to the evidence-based treatments that are currently accessible to them. I believe through our program, we can help treat a significant patient population who are in need of alternative options. Our global team of scientists, doctors, and advisors have extensive experience in administering these types of treatments, and we look forward to sharing that knowledge and expertise to promote responsible and successful use of psilocybin and MDMA.”

CEO Josh Bartch added, “The goal of our Special Access Support and Supply Program, is to help physicians who want to prescribe these treatments to their patients but might not have access to the drug product in Canada or experience implementing psychedelic-assisted psychotherapy. It’s extremely encouraging to see these much-needed treatments gaining government acceptance, and now we need to enable successful therapy outcomes. Outside of safe drug products, practitioners need access to the resources and the proper training to provide these treatments to their patients. By launching this program, we are providing the resources the thousands of non-psychedelic clinics and hospitals will need in order to safely and effectively integrate these therapies into existing medical practices.”

If you are interested in more information on Mydecine’s program, please complete this form or send an email to contact@mydecineinc.com.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

About Mindleap Health
Mindleap Health Inc. is a wholly-owned subsidiary of Mydecine. Mindleap’s virtual healthcare platform offers technology solutions to allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments, and can lead to more personal breakthroughs. In addition, Mindleap’s proprietary platform is designed to provide professional support and personalized medicine for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people worldwide.

Download for Android

Download for IOS

Learn more at: mindleap.com.

For more information, please contact:

Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 specific actions, events or results “may,” “could,” “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected, including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to protect and enforce its intellectual property adequately, the Company’s ability to bring its products to commercial production, the continued growth of the global adaptive pathway medicine, natural health products, and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, other factors may cause effects 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 information. These forward-looking statements are made as of the date hereof. The Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

January 10, 2022March 10, 2022

Mydecine Achieves Innovative Supercomputing Artificial Intelligence Modeling in Psychedelic Drug Development Enabling Quick Screening of Billions of Compounds

The new serotonin receptor model (5-HT_2A) will allow the Company to rapidly increase drug analysis promoting near-term patent filings for novel psychedelic molecules.

DENVER, Jan. 10, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today they have completed a target-based model of the classic psychedelic serotonin receptor 5-HT_2A for use in their AI-driven drug discovery program. The new model will allow them to expeditiously screen billions of structures to determine which novel compounds are most likely to increase binding affinity, enabling them to continue creating improved second and third generation psychedelic molecules for medical use.

By centering their drug discovery efforts around artificial intelligence (AI) and machine learning (ML), Mydecine is positioned to discover drug enhancements more cost effectively and more efficiently than their competitors. Using AI technology is relatively new in the drug development space and its applications are continuously expanding. The goal of this technology is to eliminate, or drastically reduce, the manual efforts companies typically undergo to identify possible drug improvements. By filtering the drug candidates with AI, the Company is inherently making their investments in later stage drug development more valuable by eliminating potential candidates that are likely to fail early on in the process.

Without AI and ML, based on their hypotheses, companies have to manually synthesize each molecule and individually test the likelihood of a successful binding agent. This process can consume enormous amounts of time and money; therefore, efficiently eliminating candidates likely to fail in preference for candidates that are more promising is extremely valuable.

“AI gives us an incredibly robust tool for screening potential novel psychedelic compounds. This screening gives us increased confidence in investing in the later stages of our drug development and enables rapid development in our pipeline,” said Chief Science Officer Rob Roscow.

“Our 5-HT_2A AI models construct billions of new drug candidates and filter them for their ability to modulate the 2A receptor activity. These AI models also predict the interactions and affinity of each drug candidate to the level of a single atom. By considering the unique structural and dynamical fingerprint of the 2A receptor, our AI drug discovery program paves the road towards designing selective 5-HT_2A modulators which reduces any potential side effects that may emerge in the future,” said Khaled Barakat, Principal Investigator with Applied Pharmaceutical Innovation.

Mydecine has mainly focused on psilocybin, and its active metabolite psilocin, in their drug development efforts. When ingested, psilocin interacts with the human body’s serotonin receptor 5-HT_2A triggering a “psychedelic experience” but perhaps more importantly, neuroplasticity. Neuroplasticity, the brain’s ability to reorganize its neural pathways to accomplish the needed outcome, is a critical component for successful psychedelic-assisted-psychotherapy.

Psilocybin/psilocin, as it stands in nature, poses a few challenges for successful integration for medical use such as its weak shelf stability and its wide variety of onset time between patients. Both of these characteristics must be improved upon in order to create medication-based treatments that are safe, effective and repeatable. Mydecine will use their AI 5-HT_2A model to identify which molecules are most likely to bind to this receptor, enabling them to improve the undesirable characteristics of naturally produced psilocybin/psilocin.

This 5-HT_2A receptor model is just the beginning of Mydecine’s planned modeling in production that will continue to enhance their AI-driven drug discovery program. The Company’s AI program has already led to identifying promising enhancements to psilocybin and psilocin which they have included in their recent patent application around MYCO-004, which directly addresses further precision in delivery control and shelf stabilization through a dermal route of administration. To learn more about the benefits of this second-generation psychedelic compound, read the Company’s recent press release here.

Read: 3 Things Investors Should Know About Mydecine’s Artificial Intelligence & Machine Learning Drug Discovery Program

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

For more information, please contact:

Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause 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 information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

December 31, 2021March 10, 2022

2021 Psychedelics Unwrapped // 2022 Year of the 🍄: issue 30

Hello and welcome back for the final issue of the year.

2021 proved to be a monumental year for the psychedelic sector. We saw more psychedelic research than ever before, and the medicines became widely accepted by the public and mainstream media (we like to think that we helped with that 😉).

In this special issue, we’ll review this year’s top advancements, scientific breakthroughs, and legislation changes that have moved the psychedelic revolution forward.

Whether you’ve been following along since Issue 1 or you’re brand new to the Daily Mushroom Community – thank you for joining us 🧡 We are so grateful that we can use this platform to give psychedelic medicine the attention it deserves.

We’ll see you in the New Year with an exciting announcement!

Don’t miss a Daily Mushroom Podcast!

In 2021, we heard stories from:

The first Canadian to receive legal psilocybin therapy
CEOs of major psychedelic companies
The founder of a ketamine-assisted group therapy workshop
A veteran who cured his pain and PTSD with a (wild) DMT trip
And many more amazing guests

Listen now on YouTube, Spotify, or Apple ⬇️

MDMA was found to be an extremely promising PTSD treatment

The Multidisciplinary Association for Psychedelic Studies (MAPS) conducted the first-ever Phase 3 trial for psychedelic-assisted therapy – and the results were incredible.

Patients with chronic PTSD (many battling the condition for over 20 years) finally found relief after three sessions of MDMA-assisted therapy.

Of the 46 patients, two-thirds no longer qualified for a PTSD diagnosis and 88% experienced a clinically significant reduction in symptoms after the sessions 👏

Researchers explain that MDMA reduces activity in the amygdala, a part of the brain associated with fear response, allowing patients to process trauma in therapy without becoming overwhelmed.

MAPS expects that MDMA therapy will become FDA-approved in 2023. The non-profit has begun patient enrollment for a second study of similar nature, so stay tuned for the results.

Psilocybin out-performed a leading antidepressant…

A study conducted by Dr. Robin Carhart-Harris at Imperial College London suggests that psilocybin is more effective than antidepressants – and with fewer side effects.

Patients with mild-to-severe depression were given either a daily dose of escitalopram (aka Lexapro) or two doses of psilocybin.

In the psilocybin group:

70% saw at least a 50% reduction in depression scores, with an average decrease of 8.0 points
57% were in remission at week 6, meaning they no longer qualified for a depression diagnosis
Patients were more likely to report improvements in the ability to feel compassion, pleasure, and intense emotion
No patient requested to stop dosing
The most common adverse event was headache

In the escitalopram group:

48% saw at least a 50% reduction in depression scores, with an average decrease of 6.0 points
28% were in remission from depression at week 6
Patients were more likely to experience anxiety, dry mouth, sexual dysfunction, drowsiness, and reduced emotional responsiveness
4 patients stopped dosing and 1 halved their dose due to adverse side effects

…and became widely accepted as viable treatment

These magazine covers say it all – just look how far we’ve come!

Research revealed that psychedelics help the brain grow

Yale researchers discovered that psilocybin regrows and strengthens neuronal connections that can be lost due to depression or chronic stress.

Two months later, Algernon Pharmaceuticals (AGN) found that DMT was even more effective at growing neuronal connections, even at sub-hallucinogenic doses 🤯

The formation of new connections could explain why psychedelics are so effective at altering negative thought patterns and fostering positive behaviour change!

Psychedelic research received gov’t funding for first time in 50 years

When the War on Drugs was declared in the 70s, the US federal government stopped funding psychedelic research.

Things changed this September, when Johns Hopkins researcher Dr. Matthew W. Johnson received a grant from the National Institute on Drug Abuse (NIDA) to conduct a psilocybin study on tobacco addiction.

So far, his research has suggested that psilocybin is more than twice as effective at treating addiction than nicotine patches.

The Canadian government also began funding psilocybin research, with a grant given to MYND Life Sciences (MYND) to study depression and neuroinflammation.

Canada expanded access to psilocybin therapy 🇨🇦

Earlier this month, three Canadians gained legal exemptions to access psilocybin therapy to treat mental health conditions. This marked an exciting turning point by expanding access to the treatment beyond end-of-life care.

DMT was fast-tracked in the UK 🇬🇧

In October, Small Pharma’s DMT program for depression was found to be so promising that it was granted an Innovation Passport Designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The designation will give Small Pharma access to specialist advice to expedite the drug development process and facilitate patient access to the treatment.

Once approved, DMT could make psychedelic therapy more accessible and affordable because the trip takes just 20 minutes, yet produces long lasting effects!

Microdosing took the world by storm 💊

We saw an explosion of microdosing research this year, including the largest psychedelic study to date, which revealed that microdosers exhibit lower levels of depression, anxiety, and stress than non-microdosers. Many other intriguing studies have been initiated such as:

Diamond Therapeutics’ study on psilocybin microdoses for healthy volunteers
MindMed’s studies on LSD microdoses for sleep and cognitive function and for ADHD
MindBio Therapeutics’ study on LSD microdoses for cancer-related pain management
Nova Mentis and Mycrodose Therapeutics’ study on psilocybin microdoses for children with autism – the first-ever study investigating psilocybin’s impact on children 😮

Companies around the world jumped on the psychedelic bandwagon

With more and more research confirming the incredible healing power of psychedelics, it’s no surprise that we’ve seen a tremendous amount of capital invested in the sector this year.

At the beginning of the year, there were just a handful of publicly-traded psychedelic companies. Now, there are over 70 public companies working to bring psychedelic medicines to market – some valued at over $1 billion! 🚀

The first-ever psychedelic indexes were launched

In 2021, it became easier than ever to diversify your psychedelic portfolio 🤑

In January, Horizons ETFs Management debuted PSYK on Toronto’s NEO exchange, becoming the first exchange traded fund for psychedelic stocks.

Later in the year, two more ETFs were introduced on US exchanges – Definace ETFs’ PSY, a passive fund, and AdvisorShares’ PSIL, an actively managed fund.

Private investments reached record highs

Private investments in psychedelic companies reached $595M across 45 deals this November — that’s an increase of 66% from last year and 625% higher than in 2019 📈

We saw widespread drug reform across both red and blue states…

Some or all psychedelics were decriminalized in:

More big wins:

Texas and Connecticut passed bills to study the therapeutic potential of psilocybin.
New Jersey successfully reduced the criminal penalties for possession of psilocybin.
The DEA increased production quotas for psilocybin, psilocin, MDMA, and DMT for both 2021 and 2022, allowing more research to be conducted.

We saw widespread drug reform across both red and blue states…

Legislation was filed to decriminalize psychedelics in:

Legislation was filed to promote psychedelic research or legalize therapeutic use in:

December 22, 2021March 10, 2022

Mydecine Signs LOI with Maya to Co-Develop a Novel Prescription Digital Therapeutic Platform Aiming to Further Increase Safety, Efficacy, and Accessibility of Psychedelic-Assisted Treatments

DENVER, Dec. 22, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NF.F) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today that the Company has signed an LOI (letter of intent) with Maya. Together, the two companies plan to co-develop a novel digital therapeutics (DTx) platform. This platform would allow Mydecine to enhance treatment effectiveness by pairing the DTx with the Company’s existing digital health platform, Mindleap Health (“Mindleap”), alongside the Company’s medication-based treatments to create a trifecta approach.

This collaborative partnership aims to enhance Mindleap’s digital platform by collecting and computing unique data to create more personalized treatments for patients. Once the new DTx platform is complete, physicians could prescribe the new digital therapeutic in addition to Mydecine’s drug and therapy protocols or as a standalone option. The Company believes this will improve the efficacy of current treatment options by personalizing them to the patient and making them more accessible.

Maya is a purpose-built platform enabling real-world data and research to optimize outcomes and industry standards by enhancing safety, reducing the cost of care, increasing IP equity, and informing regulation of psychedelic-based therapy. Maya’s clinically validated surveys, biometric tracking, and protocol customization combined with Mindleap’s telemedicine, exclusive digital content, and community features will allow both companies to accelerate the development and commercialization of a novel DTx platform.

Both companies will pursue rigorous studies to achieve FDA Section 510(k) clearance upon software integration and a comprehensive regulatory assessment. This clearance will allow the DTx platform to be registered and used as a medical device to allow patients to receive insurance reimbursement coverage for treatments on the platform. This developing partnership with Maya will enable both companies to create standalone evidence-based software as a medical device DTx platform. In addition, the current smoking cessation clinical trial Mydecine is conducting in partnership with Johns Hopkins University, and Mindleap’s current consumer-facing offerings, will not be altered or affected.

“The technology integration of the two software platforms is aimed at enhancing Mindleap’s medical capabilities to more quickly and efficiently develop a personalized prescription-based digital therapeutic that will not only complement Mydecine’s smoking cessation treatment but eventually for all primary and ancillary indications the Company is targeting. We believe Digital Therapeutics is the next big wave in healthcare. We feel confident that once our DTx platform is complete, Mydecine will be on the cutting-edge and well-ahead of the competition. Creating and integrating a DTx will be equally as valuable as the drug discovery and therapeutic protocols that the Company currently has under development. The new platform will provide improved adherence to treatment protocols, patient experience, biometric insights, and post-approval insurance reimbursements,” commented Damon Michaels, Mydecine Co-Founder, Director, and COO.

The global digital therapeutics market size is estimated to be $4.20 billion in 2021 and expects to reach $10.62 billion in 2025 at a CAGR of 26.1%. Digital therapeutics, particularly those that a physician prescribes instead of releasing directly to consumers, allow biotech companies to enhance treatments using modern technology. This partnership will enable Mydecine to accelerate the launching of new features using a market-leading technology partner.

David Champion, Founder, and CEO of Maya, commented, “Digital therapeutics are starting to transform how biotech companies approach clinical development and healthcare delivery. Our team is excited to develop a prescription DTx tool to initially aid in smoking cessation along with Mydecine’s researchers and Mindleap’s technology team.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO: MYCO) (OTC: MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise, focusing on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

About Mindleap Health
Mindleap Health Inc. is a wholly-owned subsidiary of Mydecine. Mindleap’s virtual healthcare platform offers technology solutions to allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments, and can lead to more personal breakthroughs. In addition, Mindleap’s proprietary platform is designed to provide professional support and personalized treatment for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people worldwide.

Download for Android

Download for IOS

Learn more at: https://www.mindleap.com.

About Maya
The Maya platform empowers psychedelic practitioners to map care journeys and improve health outcomes comprehensively. Maya’s global community of providers, participants, and researchers chart a knowledge base to advance safe and accessible psychedelic practices. Maya is a Colorado Public Benefit Corporation (PBC), which means its team members, advisors, investors, and supporters are aligned to prioritize purpose over profit. In addition, Maya is laying the foundations of a global environment for psychedelic healthcare to scale safely and effectively with specialized therapy software solutions.

Learn more at: https://www.mayahealth.com.

For more information, please contact:

Media Contact:
Morgan Kervitsky, Director of Marketing
+1 (720) 277-9879
pr@mydecineinc.com

Investor Relations:
+1 (720) 277-9879
corp@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 specific actions, events or results “may,” “could,” “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected, including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to protect and enforce its intellectual property adequately, the Company’s ability to bring its products to commercial production, the continued growth of the global adaptive pathway medicine, natural health products, and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, other factors may cause effects 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 information. These forward-looking statements are made as of the date hereof. The company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

December 10, 2021March 10, 2022

Your relatives 🤬 Christmas 🎄 and Psychedelics 🍄: issue 27

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

🍄 First psychedelic studies program in Canada

🍄 How to cure depression in two hours 🤯

🍄 Psilocybin works twice as well as nicotine patches!

🍄 Two stock that could quadruple in price 📈

🍄 And more.

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

Can DMT really help cure addiction?

In this episode of the Daily Mushroom Podcast, we have David Mayoh, communication manager for Entheon Biomedical. David talks about how psychedelic therapy changed his life and how DMT can help those who are suffering from addiction.

How to cure depression in two hours

GH Research (GHRS) discovered that the most powerful psychedelic, 5-MeO-DMT (aka toad venom), is highly effective at curing treatment-resistant depression.

Out of eight patients, seven were in remission from depression just one day after receiving the company’s proprietary formulation, and five of those were in remission in as little as two hours.

All eight patients showed improved depression scores, with an average reduction of 76%.

Psilocybin works twice as well as nicotine patches!

Dr. Matthew Johnson’s research found that 59% of nicotine-addicted patients remained abstinent from smoking for 12 months after receiving a single macrodose of psilocybin. Only 28% of patients on a nicotine patch remained abstinent for the same time period.

His other research shows that multiple psilocybin doses can have an 80% success rate!

Psychedelics → spirituality → emotional regulation → happiness

A recent survey shows that spirituality increases with psychedelic use, and that increased spirituality is linked to improved emotional regulation. The findings suggest that better emotional regulation is associated with decreased scores for depression, anxiety, and disordered eating.

Reboot your brain

Marcus Capone, a former Navy SEAL who was battling PTSD, finally got his life back after travelling to Mexico for an ibogaine treatment.

He instantly felt like a huge weight had been lifted, as if his brain “was rebooted like a new operating system.”

“You can’t hide from the medicine. It’s going to reach down and it’s going to pull out everything that is affecting you,” he explains.

Ibogaine is a psychedelic substance found in the root bark of the iboga tree! Learn more here.

The first psychedelic studies program in Canada

This semester, the University of Ottawa launched a three-course “microprogram” on Psychedelics and Spirituality. The school will offer a master’s program in psychedelics in the fall of 2022 and aims to develop a Ph.D. program after that!

Why?

“I was getting emails almost on a daily basis from people who wanted to know how they could become psychedelic therapists,” said Dr. Monica Williams, who created the program.

US government studies ibogaine

Delix Therapeutics, a private Boston-based company, is partnering with The National Institute on Drug Abuse (NIDA) to develop a treatment for substance abuse. The partnership will evaluate Delix’s non-hallucinogenic formulation of ibogaine, which has already shown promise of reducing alcohol- and heroin-seeking behavior.

BetterLife Pharma (BETR) found that its LSD formulation successfully increased exploratory and grooming behaviours in rats, two indicators of an antidepressant effect.

atai Life Sciences (ATAI) launched TryptageniX, a majority-owned joint venture with CB Therapeutics that will focus on discovering new compounds, both psychedelic and non-psychedelic.

Mycotopia Therapies (TPIA) is planning a $360M merger with Ei.Ventures to form PSLY.COM and intends to list on the NASDAQ. The new company would focus on Ei.Ventures’ flagship product Psilly, which combines psilocybin with other plant and fungi extracts for a synergistic effect.

Vine Ventures and MAPS formed a $70M special purpose vehicle called the Regenerative Financing Vine to fund MDMA research for PTSD and promote patient access.

An analyst at H.C. Wainwright predicted that Field Trip Health’s (FTRP) and COMPASS Pathways’ (CMPS) stocks could quadruple in value in the next 12 months! 🤑

GH Research (GHRS) and Numinus Wellness (NUMI) announced their financial highlights.

Here’s what you missed in the legal world:

The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) showed support for Biden’s plan to accelerate research on cannabis and certain psychedelics. The plan would reduce the requirements to research Schedule I substances, making them more similar to the Schedule II requirements. Read more…

4,000% of your daily vitamin D

The majority of people are deficient in vitamin D. Mushrooms could provide a solution!

Wild mushrooms are rich in the vitamin, but commercial production (which is often done in the dark) reduces concentration levels.

Scientists discovered that exposing mushrooms to UV radiation can increase vitamin D levels to over 4,000% of your daily value per serving! The exposure also causes mushrooms to produce more antioxidants and anti-inflammatory molecules.

Industry Quick Hits

Dec 6 – Novamind (NM) Opens New Salt Lake City Clinic with Specialized Focus on Substance Use Disorders Read more…

Dec 6 – Mydecine (MYCO) Files Full Patent Application Covering Multiple Families of Psilocin Analogs Read more…

Dec 8 – Ketamine One (MEDI) Adds Seattle Location To US Clinical Network Read more…

Dec 8 – Silo Wellness (SILO) Announces U.S. DTC Eligibility Read more…

Dec 8 – Nue Life announces donations to MAPS and Ketamine Research Foundation Read more…

Dec 9 – Cannabis company Nextleaf Solutions (OILFF) Receives a Controlled Substance Dealers License Read more…

Video of the Week

Playlist of the Week

December 9, 2021March 10, 2022

Psilocybin works twice as well as nicotine patches!

Mydecine Secures Financing and Provides Company Update on Clinical Trials, Drug Development and Technology Initiatives

His other research shows that multiple psilocybin doses can have an 80% success rate!

PDF of article

December 6, 2021March 10, 2022

Mydecine Files Full Patent Application Covering Multiple Families of Psilocin Analogs

Dr. Saeid Babaei Appointed Independent Board Member as Mydecine Moves Closer to NASDAQ Listing in Q1 2022

DENVER, Dec. 06, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has filed a full patent application covering multiple families of psilocin analogs. The application includes solutions to directly address further precision in delivery control and shelf stabilization of psilocin, psilocybin’s active metabolite, both of which are critical for use in the medical setting.

When psilocybin is administered orally, there is wide variability in onset time for each patient, making it more difficult to standardize protocols and scale treatments. The purpose of Mydecine’s dermal route for the administration of psilocin is to directly address such controllability concerns. The Company’s patent pending permeation enhanced prodrug provides more control over the drug while also possibly eliminating undesirable properties like nausea by bypassing the digestive system.

Another concern of naturally produced psilocybin is its poor shelf stability. Mydecine’s recent filing includes a family of stabilized psilocin analogs, moving the Company closer to a drug that will meet regulatory requirements and address concerns for medical use; specifically providing access to a reliable potency psilocin source for physicians.

“The goal of creating these improved second-generation compounds is to enable safer, more effective treatments for patients along with improved management of dosage and drug behavior for clinicians. We believe these improvements are necessary for psychedelic medicines to become an accepted and adopted form of treatment,” said Chief Science Officer, Rob Roscow.

Mydecine also announced today that it has appointed Dr. Saeid Babaei, PhD, to its Board of Directors. Dr. Babaei is an experienced leader in bringing drug products from early development to commercialization. Dr. Babaei’s track record includes over 20 years of academic and corporate experience, during which he has led a number of novel and first-in-class product opportunities to either commercialization or to late-stage development. He brings tremendous business foresight having closed over 25 licensing and strategic alliance transactions, as well as raising over $50 million in equity and debt financing.

“We are pleased to welcome Dr. Babaei to the team as he brings decades of experience in biotechnology development, award-winning discoveries in gene therapy, and licensing and strategic advancements for the companies he has founded and accelerated. As Mydecine continues to move our lead candidates down the pipeline, Dr. Babaei will play an integral role in advancing our novel psychedelic-based therapeutic candidates as well as meeting NASDAQ listing requirements,” said Josh Bartch, Chairman & CEO of Mydecine.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, Instagram and LinkedIn.

For more information, please contact:

Media Contact
Morgan Kervitsky, Director of Marketing
(720) 689-4638
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
(720) 689-4638
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause 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 information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Source: Mydecine Innovations Group Inc.

Released December 6, 2021

November 19, 2021March 10, 2022

Kids try ketamine in the metaverse: issue 24

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

🍄 Psychedelic therapy enters the Metaverse?!

🍄 Kids try ketamine

🍄 How psychedelics help you manage stress

🍄 Microdosing for a better sleep

🍄 And more.

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

Functional Mushrooms for Health & Nutrition with FreshCap CEO Tony Shields

In the episode of the Daily Mushroom Podcast, we have Tony Shields, CEO of FreshCap. Tony’s knowledge on mushrooms is deep and expansive and stems from a childhood fascination with these magnificent fungi. If you want to learn more about the benefits of functional mushrooms, this podcast is for you.

How psychedelics help you manage stress

Psychedelic drug users had less psychological distress and more social support during pandemic lockdowns, according to a recent Tilburg University survey.

Users were more likely to spend time outdoors, maintain healthy diets, meditate, play music, and do yoga. Non-users spent more time watching TV and following COVID news.

Ditch your opioid addiction

A new study found that people who used psychedelics within the past six months were 55% less likely to use opioids daily.

Can microdosing before bed help you sleep better?

MindMed (MNMD) launched a study to investigate the effects of microdosing LSD in the morning versus the evening.

Researchers will use digital devices and software to track:

Various sleep measures
Neuroplasticity
Mood
Cognitive function
Regulation of emotions
Quality of life &
Immune function

Too much screen time, shopping, or sex?

Clearmind Medicine’s (CMND) proprietary compound could treat alcohol addiction, but that’s not all. It is now being evaluated to treat other addictive behaviours such as compulsive consumption of food, television, technology, shopping, gambling, and even sex.

Reducing alcohol cravings

A study discovered that psilocybin can reduce the odds of alcohol relapse!

How does it work? Alcohol reduces a protein in the brain called mGluR2. In a rat model, researchers found that the more protein lost, the more alcohol the rats craved, creating an addictive cycle.

Psilocybin was able to restore protein levels, thus decreasing relapses.

Psychedelic therapy enters the Metaverse?!

Tennessee-based ketamine company Revitalist (CALM) announced that it’s developing a mental health clinic in the Metaverse 🤯

Patients will be able to attend VR therapy sessions, pay with cryptocurrency, and earn NFTs as part of a rewards program.

Should kids try ketamine?

Most parents think they should!

A survey shows that parents, especially those who have experienced mental illness, are very open to ketamine therapy for children. The average acceptance score was 7/10 and over 60% said they would allow their child to try ketamine therapy to treat depression.

Allied Corp. (ALID) sourced the active ingredients to produce Psilonex™, its formulation of psilocybin, functional mushrooms, and vitamins. It will be used in conjunction with a daily dose of CBD in an upcoming clinical trial on depression, anxiety, and PTSD.

Way2Grow Biopharma, a private BC company, received a license from Health Canada to create a psychedelic production campus. The company can produce up to $30 worth of compounds to sell to pharmacies and clinics.

Delic (DELC) launched a free, virtual education program to teach the families of ketamine therapy patients how they can best support their loved ones through the healing journey.

These companies announced their quarterly highlights:

Suing for access to MDMA

A psychiatrist is suing the Australian state of Victoria for denying a patient access to MDMA-assisted therapy. The case has been adjourned until early next year, as the government may decide to reschedule MDMA from a Schedule 9 to a Schedule 8 substance.

Tackling one of the biggest litter problems in the world!

Researchers in Australia are training oyster mushrooms to digest cigarette butts, including their microplastics. The goal is to turn some of the 4.5 trillion cigarette butts that are littered annually into a reusable material!

Need a brain-boost?

Try FreshCap’s Mushroom Coffee to have the most productive day ever!

Made with organic Lion’s Mane mushrooms to support cognition, immune-boosting Chaga, and stress-relieving Ashwagandha, it’s everything you love about coffee – made even better.

Use promo code DAILY for 10% off your order at FreshCaps.com!

You’re welcome in advance 😉

Industry Quick Hits

Nov 15 – Lobe Sciences Announces Common Stock to Trade Under the Symbol “LOBEF” in US Markets Read more…

Nov 16 – Michael J. Fox Foundation Donates $2M to Fund Ketamine Trial to Treat Depression in Patients with Parkinson’s Disease Read more…

Nov 16 – Ketamine One (MEDI) Subsidiary IRP Health Opens Two New Veteran-Focused Clinics in Comox Valley and Ottawa Read more…

Nov 17 – Pasithea Therapeutics (KTTA) Expands At-Home Ketamine Therapy to New York City, Los Angeles, San Diego, and San Francisco Read more…

Nov 19 – Numinus to Begin Trading on the OTC Under Symbol “NUMIF” Read more…

Nov 19 – PsyBio Therapeutics Furthers Intellectual Property Portfolio with Six New Manufacturing Patent Applications Read more…

Video of the Week

Playlist of the Week

November 16, 2021March 10, 2022

Mydecine Reports Third Quarter 2021 Financial Results and Provides Business Update

To Launch Phase 2/3 Smoking Cessation Clinical Trial with Johns Hopkins University (JHU)

Signed 5-Year Research Agreement with JHU to Further Mydecine’s Research of Multiple Molecules for a Variety of Indications
—

DENVER, Nov. 16, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today reported its financial results for the third quarter ended September 30, 2021 and provided a business update.

“During the third quarter of 2021, we entered into a 5-year research agreement with Johns Hopkins University School of Medicine, one of the most experienced university departments in conducting clinical research related to the therapeutic use of psychedelics. In collaboration with JHU, we are rapidly progressing one of our lead candidates, MYCO-001, through clinical trials with the upcoming seamless Phase 2/3 smoking cessation clinical trial, and their NIDA grant-funded smoking cessation study which will use MYCO-001. This marks the first time in over 50 years that the U.S government has funded a study of a psychedelic compound for therapeutics,” stated Joshua Bartch, CEO of Mydecine. “As we prepare for the launch of these trials, we expect to meet with the FDA for Pre-Investigational New Drug Application (Pre-IND) meetings in early 2022, another step closer to bringing to market more effective treatments for today’s unmet needs in mental health and addiction.”

Business Highlights During and Subsequent to the Third Quarter 2021

Clinical Trials

Prepared to supply its lead drug candidate, MYCO-001, for a JHU multi-site NIDA grant-funded smoking cessation study led by Dr. Matthew Johnson.
Announced upcoming launch of seamless Phase 2/3 smoking cessation clinical trial studying the science and efficacy of MYCO-001.
Signed a five-year research agreement with JHU School of Medicine to advance clinical trials and explore multiple molecules and medicines for a variety of indications.

IP Portfolio

Filed final patent application for MYCO-003 with the United States Patent and Trademark Office and the World Intellectual Property Organization, which is being developed to offer enhanced treatment of anxiety and PTSD.
Filed new patent for MDMA-like compounds further expanding its robust portfolio of novel compounds after MDMA-assisted psychotherapy received Breakthrough Therapy Designation from the Food and Drug Administration (FDA).
Filed a technology patent that allows for the creation of formulations that utilize nanoemulsion technology to enhance, stabilize and make repeatable properties of ingredients from traditional medicine. The patent will cover formulations that are generally recognized as safe by FDA (GRAS-certified).
Successfully synthesized a novel psilocin analogue with improved pharmaceutical properties to further expand its library of patent-pending tryptamines.

Technology

Launched Mindleap 2.0, an updated version of its virtual health platform, providing improved infrastructure, better user experience, and expanded content. The 2.0 version also adds focus on the conscious and trustworthy adoption of psychedelics into the broader categories of mental health.
Continued development of AI-driven drug discovery program, screening billions of new drug candidates and filtering them for their ability to modulate the activity of the psychedelic-related targets.

Corporate

Completed its spin-out transaction of ALT House Cannabis Inc., which now holds the Company’s U.S. cannabis assets in order for the Mydecine Innovations Group’s team to focus on the company’s core drug development business.

Financial Results for the Third Quarter 2021

Net Loss: Net loss attributable to common stockholders was $4.5 million for the third quarter 2021, or a basic and diluted loss per share attributable to common stockholders of $0.02, as compared to a net loss attributable to common stockholders of $17.4 million for the third quarter 2020, or a basic and diluted loss per share attributable to common stockholders of $0.11.

Cash Position: As of September 30, 2021, the Company had cash and cash equivalents of $1.6 million.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and therapeutic treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we view mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the mental healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, and LinkedIn.

For more information, please contact:

Media Contacts
Anne Donohoe / Nick Opich
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1265 / 1-212-896-1206

Investor Contacts
Charles Lee, Investor Relations
corp@mydecineinc.com
1-720-277-9879

Allison Soss / Erika Kay
KCSA Strategic Communications
myco@kcsa.com
1-212-896-1267

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. 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 forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause 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 information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

As at,	September 30, 2021 $		December 31, 2020 (audited) $
Current assets
Cash	1,593,516		2,190,702
Rent and other receivable	135,674		27,746
Inventory	41,268		47,262
Sales tax receivable	73,632		13,734
Prepaids and deposits	3,782,180		216,003
Total current assets	5,626,270		2,495,447
Non-current assets
Prepaids and deposits	1,922,559		–
Investment in joint venture	158,432		303,982
Note receivable	327,536		316,110
Investment in associate	233,579		4,481,988
Right-of-use asset	154,347		223,645
Investment properties	1,419,347		1,418,345
Property and equipment	521,867		291,614
Total assets	10,363,937		9,531,131
Current liabilities
Accounts payable and accrued liabilities	1,315,927		1,187,486
Convertible debentures	272,740		2,959,755
Derivative liabilities	837,207		1,586,744
Lease liability – current portion	76,969		69,329
Total current liabilities	2,502,843		5,803,314
Non-current liabilities
Long-term portion of lease liability	94,515		167,118
Total liabilities	2,597,358		5,970,432
Shareholders’ equity
Share capital	105,648,795		85,298,435
Contributed surplus	14,848,383		12,734,636
Equity portion of convertible debentures	17,190		254,690
Accumulated other comprehensive loss	(449,317	)	(444,803	)
Deficit	(112,298,472	)	(94,282,259	)
Total shareholders’ equity	7,766,579		3,560,699
Total liabilities and shareholders’ equity	10,363,937		9,531,131

MYDECINE INNOVATIONS GROUP INC.
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
UNAUDITED
(EXPRESSED IN CANADIAN DOLLARS)

	For the three-month period ended,				For the nine-month period ended,
	For the three-month period ended,				For the nine-month period ended,
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020

Sales	73		17,158		21,278		43,391
Cost of goods sold	(35	)	(21,153	)	(10,032	)	(31,829	)
Gross margin	38		(3,995	)	11,246		11,562

Expenses
Finance cost	22,995		19,151		146,692		19,151
Corporate development	410,424		325,038		2,838,317		1,099,728
Amortization	47,572		61,886		126,767		128,926
Consulting fees	1,617,184		461,623		3,835,207		1,744,009
Director and management fees	454,215		186,520		1,286,723		367,622
Foreign exchange loss (gain)	(65,862	)	(21,233	)	249,746		(158,014	)
Insurance	171,704		–		324,927		–
Office and miscellaneous	427,486		113,441		648,961		170,235
Share of losses (income) from investment in Joint Venture	28,503		–		136,604		–
Share of (income) from investment in Associate	45,056		(7,470	)	86,808		(15,411	)
Professional fees	179,130		43,255		1,529,599		143,088
Regulatory and filing fees	7,879		12,644		185,791		27,091
Research and development	1,265,610		433,408		2,587,740		434,791
Salaries	311,355		–		545,686		–
Share-based payments	–		3,715,421		–		4,725,174
Total expenses	(4,923,251	)	(5,343,684	)	(14,529,568	)	(8,686,360	)

Other income (expenses)
Change in fair value of derivative liabilities	353,612		(740,434	)	575,505		(740,434	)
Impairment of investment in associate	–		–		(4,169,616	)	–
Consideration paid in excess of net assets acquired from acquisition	–		(10,645,239	)	–		(10,645,239	)
Write-off of inventory	–		(458,921	)	–		(458,921	)
Other income	–		35		–		35
Rental income	33,073		45,293		98,539		141,715
Gain (loss) on settlement of debt	–		21,879		(2,319	)	33,304
Total other income (expenses)	386,685		(11,777,387	)	(3,497,891	)	(11,669,540	)

Net loss for the period	(4,536,528	)	(17,125,066	)	(18,016,213	)	(20,344,338	)

Foreign currency translation adjustment	44,114		(279,811	)	(4,514	)	(152,659	)

Net loss and comprehensive loss for the period	(4,492,414	)	(17,404,877	)	(18,020,727	)	(20,496,997	)

Net loss per share – Basic and diluted	(0.02	)	(0.11	)	(0.08	)	(0.22	)
Weighted average number of shares outstanding – Basic and diluted	240,222,065		152,596,239		228,662,632		95,039,381

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