🎄 Family Christmas dinner discussion ideas 🍄: issue 29

Merry Christmas Eve everyone!

Did you know that many popular Christmas traditions likely originated from psychedelic mushroom rituals? Be sure to check out the Video of the Week to learn more!  

If you need something to discuss over Christmas dinner, keep reading to learn how psychedelics allegedly ended the Cold War 😮 

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

🍄 Why psychedelics could be the key to world peace 🔑

🍄 The common flower that can make you trip?!

🍄 Fixing brain damage at home

🍄 Another city decriminalizes psychedelics 🎉

🍄 And more.

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

A special episode : Our host Brett recounts a recent psilocybin therapy session with his guide Adrian as the guest.

 
This episode has been published and can be heard everywhere your podcast is available.
In this very special episode, our host Brett, recounts his first hand experience of a recent psilocybin assisted psychotherapy session. His guest Adrian ,was his guide through the whole process !

Adrian Oberg started the organization VAPS ( Victoria Association of Psychedelic Study ) He has a background working in harm reduction and has been guiding people through psychedelic therapy sessions for the last 5 years.

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Fixing brain damage at home

Evidence suggests that microdosing improves cognitive function and memory. This kit could take the benefits up a notch.👇🏽

Ixtlan Bioscience, a private Israeli company, filed a US patent for a microdosing kit that can be used at home to treat Alzheimer’s, brain damage, and neuronal disorders.

The kit includes:

  • Psilocybin capsules
  • Games and exercises to enhance the benefits of microdosing
  • A web application that patients can use to track their progress.

Who knows, maybe this time next year, it’ll be the trending gift to put under the tree. 🎄

Take this test before your first ayahuasca retreat

HaluGen Life Sciences expanded its psychedelic DNA test – it can now assess how your body metabolizes LSD, MDMA and ayahuasca. 

The kit tests for a CYP2D6 gene mutation, which can cause metabolism of the drugs to take up to twice as long. This could lead to longer, more intense trips and adverse reactions. 

Thankfully, the mutation is only present in 5-10% of people!

The findings from COMPASS’s depression study keep coming!

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

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Why psychedelics could be the key to world peace

This scientist claims she helped end the Cold War with MDMA.

Carol Rosin—a space and missile defense consultant for the US—said she gave MDMA to Soviet scientists and military personnel prior to nuclear negotiations in 1985 (before the drug was illegal).

The plan was created with help from Rick Doblin, the founder of MAPS. 

“The thought was that if they can work through their fears and traumas and feel their connection to humanity, then that might be helpful,” Doblin explains.

While some are skeptical if this actually happened, MDMA releases oxytocin (aka the hormone of love and empathy), which could certainly help the opposing sides see eye to eye!  

Most addiction specialists see promise in psychedelic treatments!

A recent survey revealed how psychedelic therapy is viewed by medical professionals in the American Academy of Addiction Psychiatry.

Of the 145 respondents:

  • 64% believe that psychedelics show promise in treating substance use disorders
  • 82% agree that the drugs show promise in treating psychiatric disorders like depression
  • 75% were in favour of legalizing psychedelics for therapeutic uses

Interest is growing among patients too – the vast majority of specialist said they had discussed psychedelic experiences with at least one patient.

Nature’s acid ✿

This common flower can make you trip?! 

The seeds of Morning Glory flowers contain a hallucinogenic compound that’s similar to LSD. It’s said to induce a dreamlike state and was even used in Mayan rituals to communicate with spirits.

(However, it can also cause nausea, vomiting, and cramping, so do with that information what you will 😉)

Research on the plant is gaining traction, so we may see it in clinical trials in the near future.

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Pasithea Therapeutics (KTTA) opened its second ketamine clinic in London to treat PTSD and treatment-resistant depression.

Maya Health raised $4.3M to decentralize psychedelic research. The company is developing a blockchain-based platform that allows the psychedelic community to collaborate, share best practices, and gather real-world data to accelerate pre-clinical research.

HAVN Life (HAVN) entered into an agreement to acquire Spore Life Sciences, a subscription-based functional mushroom company with current sales exceeding $1M per month.

Novamind (NM) is planning to acquire two Arizona-based ketamine clinics from Foundations for Change. The founder of Foundations for Change, who specializes in treating veterans and first responders, will be the Medical Director of both clinics. 

Cybin (CYBN) and Tryp Therapeutics (TRYP) announced end-of-year business highlights.

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Here’s what you missed in the legal world:

  • Port Townsend became the second city in Washington to decriminalize psychedelics after a unanimous council vote! Read more…
  • Activists in Colorado submitted an initiative for statewide decriminalization of psychedelics, which will likely appear on the 2022 ballot. Read more…
  • The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) changed its guidelines to allow the use of “real-world data” collected from the healthcare system to aid in regulatory approval of new medicines. This will expedite clinical trials and get treatments to patients sooner! Read more…
  • The FDA put a clinical hold on MindMed’s study on LSD for anxiety. The reason for doing so is unclear, but more details are expected within 30 days. Read more…

Turning oil into soil

Millions of liters of oil are spilled into the ocean every year. Mushrooms (once again) come to the rescue!

Mats made of human hair have been used to effectively clean up oil spills – they soak up over 15 times their weight in oil.

Oyster mushrooms thrive in oily environments and can easily be grown on the mats. In just 12 weeks, they can transform the black gunk into nontoxic soil!

Video of the Week

Playlist of the Week

MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder

MindMed Provides Status Update on IND for Phase 2b Trial of LSD for the Treatment of Generalized Anxiety Disorder

FDA has issued a clinical hold on initial IND submission required to initiate Phase 2b trial of LSD for the treatment of generalized anxiety disorder

NEW YORK, Dec. 21, 2021 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its IND submission intended to support the initiation of a Phase 2b trial of lysergic acid diethylamide (LSD) for the treatment of generalized anxiety disorder (GAD). Additional detail regarding the FDA’s decision is expected within 30 days.

“Our team has a tremendous sense of urgency to bring new treatments, such as LSD, to the many patients in need, particularly given the growing mental health epidemic,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We remain highly confident in the therapeutic potential of LSD to usher in a new treatment paradigm for these disorders and we look forward to working closely with FDA to satisfy all outstanding concerns as rapidly as possible.”

About GAD
GAD is a chronic, often debilitating mental health disorder that affects approximately 6% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there is substantial diagnostic overlap between GAD, Major Depressive Disorder and other major mental health disorders, there has been very little innovation focused on the treatment of GAD in the past several decades.

About MindMed
MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address mental health and addiction. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the therapeutic potential of LSD and the ability to initiate a Phase 2b trial of LSD for the treatment of GAD, the expected timing of additional information regarding the FDA’s decision and working closely with the FDA to satisfy all outstanding concerns as rapidly as possible. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

For Media: media@mindmed.co

For Investors: ir@mindmed.co

Is LSD the new Adderall?

MindMed Initiates Phase 2a LSD Trial for the Treatment of Adult ADHD

MindMed (MNMD) is collaborating with universities in Switzerland and the Netherlands to study the effects of microdosing LSD on adults with ADHD. Patients will be assessed on symptoms of inattention, impulsivity, and hyperactivity after microdosing twice a week for six weeks. 

“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes,” says the company’s new CEO, Robert Barrow, who was appointed this week.

PDF of article

🍄 Adderall, Autism & Access: issue 28

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

🍄 How psychedelics change your social life

🍄 Is LSD the new Adderall?

🍄 Microdosing patch for autism

🍄 Changes to who can access psilocybin therapy in Canada

🍄 And more.

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

A special episode : Our host Brett recounts a recent psilocybin therapy session with his guide Adrian as the guest.

 
This episode has been published and can be heard everywhere your podcast is available.
In this very special episode, our host Brett, recounts his first hand experience of a recent psilocybin assisted psychotherapy session. His guest Adrian ,was his guide through the whole process !

Adrian Oberg started the organization VAPS ( Victoria Association of Psychedelic Study ) He has a background working in harm reduction and has been guiding people through psychedelic therapy sessions for the last 5 years.

Therapeutic banner

Is LSD the new Adderall?

MindMed (MNMD) is collaborating with universities in Switzerland and the Netherlands to study the effects of microdosing LSD on adults with ADHD. Patients will be assessed on symptoms of inattention, impulsivity, and hyperactivity after microdosing twice a week for six weeks. 

“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes,” says the company’s new CEO, Robert Barrow, who was appointed this week.

A better solution for cancer patients

Antidepressants are often ineffective and can even interfere with cancer treatment drugs.

“Psychedelics are proving to not conflict with the cancer drug and are more effective than normal antidepressants generally,” according Frank Lane, director of Albert Labs. 

That’s why the BC-based company wants to bring a psilocybin treatment for cancer patients to European markets.

Albert Labs is expected to begin trading on the CSE early next year under the ticker ’ABRT’.

New microdosing patch for autistic patients

Nova Mentis (NOVA) and Mycrodose Therapeutics successfully created a transdermal patch that delivers Nova’s psilocybin formulation through the skin. The companies aim to use the patch to administer microdoses to autistic patients to treat cognitive impairments.

This method could be administered at home to reduce medical costs for families and save time for overworked medical professionals.

The findings from COMPASS’s depression study keep coming!

COMPASS Pathways’ (CMPS) announced that patients taking SSRI antidepressants in conjunction with psilocybin therapy had similar outcomes and fewer side effects compared to those who withdrew from SSRIs before the study.

Five patients who withdrew from SSRIs had serious adverse effects, such as suicidal ideation, when given the largest dose. None of the patients on SSRIs had this experience. 

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How psychedelics change your social life

Researchers developed a personality model to test how psychedelics affect the qualities that help us build and maintain healthy relationships.

They discovered that after taking psychedelics, users were less critical in their interactions with others, less anxious, and less likely to get upset easily. They also reported greater feelings of social connectedness.

Advancing careers in psychedelics

atai Life Science’s (ATAI) philantropic program created its first initiative – the atai Fellowship Fund in Psychedelic Neuroscience. The $2M fund will support recent graduate students in furthering their careers in the psychedelics sector.

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Doseology Sciences Inc. (MOOD), a functional mushroom company, is preparing to expand into the psilocybin market with a recent application for a controlled substance Dealer’s License and a new addition to its research team. The company aims to develop and sell novel strains of psychedelic mushrooms once granted the license. 

atai Life Sciences (ATAI) and COMPASS Pathways (CMPS) were added to the NASDAQ Biotechnology Index (NBI), an index fund of biotech and pharmaceutical companies with a market cap of at least $200M and an average daily trading volume of at least 100,000 shares.

MINDCURE’s (MCUR) digital therapeutics platform was certified as HIPAA compliant, meaning that it effectively protects sensitive patient data. The certification gets the company one step closer to commercially deploying the platform in Q2 of 2022.

COMPASS Pathways’ (CMPS) patent for crystalline psilocybin is being challenged by the non-profit Freedom to Operate. After conducting advanced analysis, the organization is confident that the formulation isn’t novel and has been known for decades. 

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You no longer have to be on your deathbed to eat mushrooms!

Up until this week, the only people in Canada that could legally access psilocybin therapy were patients with terminal illnesses. 

Things changed on Monday, when the non-profit organization TheraPsil helped three Canadians with mental health issues get Section 56 exemptions, granting them access to psilocybin therapy.

“This is a very clear indication that exemptions are now available for people who have anxiety, depression, addiction, and chronic pain,” says TheraPsil’s CEO. “It opens it up to everyone.”

New York could be the next state to legalize psilocybin therapy

New York assemblyman Pat Burke (D) filed a bill that would legalize psilocybin therapy and create a $2M grant program to ensure veterans and first responders can access the treatment.

If passed, therapists would be able to certify patients for psilocybin therapy after completing a two-hour training course through the Department of Health.

Australia refuses to reschedule psychedelics

In some un-inspirational news, Australia’s Therapeutic Goods Administration rejected an application to reschedule MDMA and psilocybin for therapeutic research, noting that the drugs pose acute and long-term risks if used outside a clinical setting 🙄

Mushrooms go high fashion

According to the Higg Materials Sustainability Index, leather causes more environmental damage than any other fabric. Mushrooms are now being used as a sustainable alternative!

In a matter of weeks, mushroom mycelium can be grown into a material that looks and feels just like leather. It’s actually stronger and more durable than real leather 🤯

Even high fashion brands like Hermès are using the material!

Video of the Week

Playlist of the Week

MindMed Appoints Robert Barrow as Chief Executive Officer and Director

MindMed Appoints Robert Barrow as Chief Executive Officer and Director

-Mr. Barrow previously served as interim Chief Executive Officer and Chief Development Officer of MindMed

–Carol Vallone appointed as Chair of the Board of Directors, Andreas Krebs appointed as Vice Chair and Perry Dellelce transitions from his role as Chairman-

NEW YORK, Dec. 14, 2021 /PRNewswire/ — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that Robert Barrow was appointed as Chief Executive Officer and as a member of the Board of Directors, effective immediately. Mr. Barrow previously served as interim Chief Executive Officer and Chief Development Officer of MindMed and brings strategic expertise and deep industry insight to his role.

Mr. Barrow commented, “I am delighted to join MindMed’s Board of Directors and look forward to building on the progress to date alongside our outstanding executive leadership team, all while advancing the Company into the future. This is an exciting time for MindMed, and my immediate priority will be to leverage the necessary resources to advance our clinical development programs. In parallel, our team will continue to explore new opportunities that expand MindMed’s pipeline—bringing forward novel therapies and executing on our mission to deliver on the therapeutic potential of psychedelics for the many patients in need.”

Mr. Perry Dellelce has stepped down from his role as Director and Chairman of the Company’s Board of Directors, effective immediately. With the departure of Mr. Dellelce, the Board has appointed Ms. Carol Vallone to serve as Chair of the Board of Directors and Mr. Andreas Krebs to serve as Vice Chair.

Mr. Dellelce added, “It has been a tremendous honor to serve on MindMed’s Board of Directors, and I am incredibly proud of everything our team has accomplished. Rob, Carol and Andreas’ diverse backgrounds across the biotech and healthcare industries will be invaluable as MindMed continues its efforts to transform mental health treatment. I have the greatest confidence in the leadership team’s ability to maximize the value of our platform and successfully lead MindMed through this next phase of continued growth.”

Ms. Vallone added, “Since MindMed’s inception, Perry has played a pivotal role in the Company’s evolution to become a leader in the psychedelic sector. I, along with the entire Board and executive team, wish to formally acknowledge and thank him for his guidance, vision and significant contributions. As we enter this inflection point and execute on our path forward, we are thrilled to name Rob as our permanent CEO, whose strategic agility, strong leadership and impressive track record makes him exceptionally well qualified.”

Robert Barrow is an accomplished pharmaceutical executive with over a decade of experience leading organizations and drug development programs in a variety of disease areas. Mr. Barrow is a recognized leader in the psychedelic industry, in which he has played a central role in the design and execution of several successful regulatory and drug development strategies.  Mr. Barrow previously served as the head of drug development & discovery at Usona Institute, where he led research and development efforts for Usona’s psychedelic drug candidates and was responsible for obtaining Breakthrough Therapy Designation for psilocybin in the treatment of Major Depressive Disorder. Prior to his tenure at Usona, Mr. Barrow served as Chief Operating Officer and a Director of Olatec Therapeutics, where he oversaw the execution of numerous early and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease. Mr. Barrow has also served as a technical and strategic advisor to numerous large and small pharmaceutical companies developing novel central nervous system therapeutics and has been an invited speaker at multiple industry and scientific presentations. Mr. Barrow holds a M.S. in Pharmacology from The Ohio State University and a B.S. from Wake Forest University, where he graduated summa cum laude.

Carol Vallone is an esteemed executive and corporate board director, with a strong track record in launching, scaling and selling global companies. Currently, she serves as Board Director, Chair of Compensation Committee, and Member of Audit/Finance Committee at MindMed. She also serves as Chair of the Board of Trustees at McLean Hospital, the #1 ranked freestanding psychiatric hospital and largest psychiatric affiliate of Harvard Medical School, as well as the board of trustees at MGH Institute of Health Professions and on the finance committee at Mass General Brigham. Additionally, Ms. Vallone serves as a board member for the publicly traded Cresco Labs, and for a Bain Capital Double Impact portfolio company, Arosa. She is also an Advisory Director for the investment firm, Berkshire Partners, and an Advisory Board Member of the healthcare-focused venture growth firm, Longitude Capital. In addition, Ms. Vallone has served as founder & CEO of global e-learning companies, held management positions in leading corporate technology companies and served on the boards of a public financial services and private e-commerce organization.

Andreas Krebs is an internationally experienced executive, entrepreneur and best-selling author (“The Illusion of Invincibility”). He heads the family-owned investment company Longfield Invest (Langenfeld/Germany), which focuses on growth companies in various industries as well as in the new economy. He has worked in seven countries, in Latin America, Asia and Canada and as President and Executive Board Member of Wyeth Corporation in the United States. Andreas Krebs was Chairman of the Supervisory Board and Shareholder Council of Merz Pharma, Frankfurt am Main, Germany from 2010 to 2019, is currently a member of the Supervisory Board of the European eye clinic group Veonet (Nordic Capital Group) and holds other board positions across various sectors. Furthermore, he serves as Chairman of the private non-governmental organization, Förderverein Girassol eV, which supports children and young people from socially difficult backgrounds in São Paulo, Brazil.

About MindMed
MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the ability to execute on our business strategy, expand our pipeline and achieve growth.  Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of the MindMed Session Monitoring System

MindMed Engages in Productive Pre-Submission Meeting with FDA for Development of the MindMed Session Monitoring System

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies recently met with the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) with consultation from the Center for Drug Evaluation and Research (CDER) concerning several key points for ongoing development of the MindMed Session Monitoring System (MSMS) in a device pre-submission meeting that took place on October 25, 2021.

MindMed presented FDA with a working Indications for Use statement (IFU), and a development roadmap. These describe technology and infrastructure for the collection of precise, multimodal, multivalent data that can be processed via machine learning, artificial intelligence, signal processes, and other statistical methods to yield clinically meaningful output to satisfy the requirements of the IFU. FDA provided key feedback regarding the draft IFU and the research methods that will lay the  foundation for regulatory submissions. 

“We regard our regulators as key stakeholders throughout the device development process and seek meetings with FDA as early and often as feasible. These regulatory engagements provide the opportunity to thoroughly and continually discuss and assess alignment around the various considerations, which are essential to the success and adoption of MindMed’s Session Monitoring System’s regulated components” said Daniel R Karlin, MD MA, Chief Medical Officer of MindMed. “The FDA is supportive of our plans to develop regulated devices that would allow the use of novel analyses of multimodal data to capture, model, and map outputs that, if cleared, could be useful to clinicians and patients in the delivery of psychedelic and other perception-altering substances.”

“We found the feedback from both CDRH and CDER to be invaluable as we look to bring our innovative products toward regulatory approval,” said Todd M. Solomon, PhD, Head of Digital Psychiatry at MindMed. “We look forward to continued engagement across both CDRH and CDER and believe this  opportunity to collaborate across centers will benefit MindMed as we continue to refine our development plans.”  

About MindMed

MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the development of the MindMed session monitoring system and bringing our innovative products toward regulatory approval. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are  available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

Media Contact: media@mindmed.co

Investor Contact: ir@mindmed.co

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. 

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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! 

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…

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MindMed to Participate at the Benzinga Global Small Cap Conference

MindMed to Participate at the Benzinga Global Small Cap Conference

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that MindMed’s Chief Executive Officer, Robert Barrow, will provide a corporate update and the Company’s management will participate in one-on-one investor meetings at the Benzinga Global Small Cap Conference to be held virtually on December 8-9, 2021.

Details on the conference can be found below.

Format: Corporate update and one-on-one investor meetings 

Date: Thursday, December 9, 2021

Time: 4:00 p.m. ET

Webcast: Click Here

The webcast will also be accessible in the “Investors” section of MindMed’s website. MindMed will maintain an archived replay of the webcast on its website for 30 days after the conference. 

About MindMed

MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Media Contact: media@mindmed.co

Investor Contact: ir@mindmed.co

MindMed to Present at H.C. Wainwright 2nd Annual Psychedelics Conference

MindMed to Present at H.C. Wainwright 2nd Annual Psychedelics Conference

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (DE: MMQ) (the “Company”), a leading biotech company developing psychedelic-inspired therapies, today announced that MindMed’s Chief Executive Officer, Robert Barrow, will participate in a panel and Company’s management will participate in one-on-one investor meetings at the virtual H.C. Wainwright 2nd Annual Psychedelics Conference to be held on Monday, December 6, 2021.

Details on the panel discussion can be found below.

Topic: The Future of Mental Healthcare

Date: Monday, December 6, 2021

Time: 2:30 p.m. ET

 

A webcast of the company presentation will be available on-demand through the H.C. Wainwright conference portal beginning Monday, December 6, 2021 at 7:00 a.m. ET for those registered for the event.

About MindMed

MindMed is a clinical-stage psychedelic medicine biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic-inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Investor Contact: bmackle@lifesciadvisors.com

Antidepressants + psilocybin

MindMed and Liechti Lab publish first human data on the interacting effects of an SSRI and 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.

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