Filament Health and Cybin Therapeutics Announce Approval for Phase II Clinical Trial for Depression

Filament Health and Cybin Therapeutics Announce Approval for Phase II Clinical Trial for Depression

Trial to investigate the effects of Filament’s botanical psilocybin drug candidate and Cybin Therapeutics’ protocols in treating major depressive disorder in patients taking SSRIs.
Patient enrollment is expected to commence in Q3’22

Vancouver, British Columbia, January 31, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced Health Canada approval for a phase 2 clinical trial using PEX010, the Company’s botanical psilocybin drug candidate. Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols, has licensed PEX010 (25 mg) from Filament for use in the trial. The trial is expected to begin in Q3’22 and will include individuals with major depressive disorder who are undergoing selective serotonin reuptake inhibitor (SSRI) therapy, commonly used to treat depression, as well as those who are SSRI-naive.

“Health Canada’s approval is a testament to both the validity of this trial as well as Filament’s ability to produce and license pharmaceutical-grade botanical drug candidates,” said Filament Chief Executive Officer, Benjamin Lightburn. “The effect of psilocybin therapy in patients taking traditional SSRI antidepressant medication is an extremely important investigation and we are thrilled to participate in this important research.”

“Many Canadians who battle depression undergo SSRI therapy, and until now, this has generally meant exclusion from psychedelic assisted psychotherapy (PAP) clinical trials,” said Josh Taylor, Founder of Cybin Therapeutics. “If it can be demonstrated that PAP can be safely and effectively given to patients on SSRIs, many will stand to benefit. We feel this is an outstanding opportunity to show Health Canada that Cybin Therapeutics can improve patient outcomes with our team and developed protocols.”

Filament has also licensed PEX010 (25 mg) to CT for additional phase 2 clinical trials, which are expected to begin in the fourth quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on TwitterInstagram and LinkedIn.

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

MDMA Passport + Commercial LSD Study: issue 34

Hello and welcome back.

Who else is counting down the days til the Daily Mushroom + Entheon Biomedical Mental Health Town Hall?? If you haven’t registered yet, you can do so here. What are you waiting for? It’s totally free and virtual so anyone can attend.

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

🍄 The psychedelic that’s already in our brains

🍄 MAPS receives Innovation Passport for MDMA therapy 🎉

🍄 First commercial study of LSD in 40 years

🍄 Will Oregon legalize microdosing?

🍄 And more.

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

7 days of tripping to heal mentally, physically and radically change a career path

In this episode of The Daily Mushroom Podcast, we have Cory Firth, Executive Director of The Canadian Psychedelic Association and founder of DoseDay! Cory opens about his battle with mental health and shares his experience with psychedelics in his quest to find meaning in his life. He also talks about how he got himself into a 7 ayahuasca retreat and what that journey gave him.

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First commercial study of LSD in 40 years

MindMed’s LSD-based compound received FDA clearance, allowing the company to proceed with a trial that will be the first commercial study of LSD in over 40 years.

The study will assess 200 patients with generalized anxiety disorder to find the optimal dose of the formulation. 

Shares of MNMD spiked 30% following the announcement 💰

Goodbye Blue Mondays

A recent study found pure MDMA administered in a clinic does not have the “come down” effect that recreational users often report the day after dosing. 

Participants maintained a positive mood during the week following the dose. Plus, no participant had used or desired to use illegal MDMA at the 3 month and 6 month follow ups.

Mario’s secret revealed 🍄

The iconic red and white spotted mushroom (officially called Amanita Muscaria and unofficially called the Super Mario mushroom) is showing potential to treat arthritis.

Psyched Wellness (PSYC) is working with the National Research Council of Canada (NRC) to study the mushroom’s properties. It doesn’t contain psilocybin, but has a different psychoactive component called muscimol.

Preliminary data suggests that Amantia Muscaria could reduce inflammation in the skin, gut, brain, and lungs. The company believes it has potential to treat chronic inflammatory conditions like arthritis.

Maybe that’s why Mario can jump so high without destroying his joints 😉

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MAPS receives Innovation Passport for MDMA therapy 🎉

The Innovation Passport will make MDMA therapy for PTSD widely available in the UK, as rapidly as possible!

The Multidisciplinary Association for Psychedelic Studies (MAPS) found that 88% of patients had a reduction in PTSD symptoms after three MDMA sessions in conjunction with trauma-focused therapy. 

The organization was granted an Innovation Passport for the treatment – a UK designation that speeds up the timeline for approval of innovative medicines for life-threatening conditions (similar to Breakthrough Therapy Designations in the US, which the treatment received in 2017).

The psychedelic that’s already in our brains

Did you know that one of the most promising addiction treatments is a psychedelic compound that’s found throughout nature and is present within the human body?

It’s called DMT (N,N-Dimethyltryptamine) and is thought to be produced in the brain’s pineal gland. DMT is released in large amounts when we dream and when we die.  

Learn what leading DMT experts have discovered at the Daily Mushroom + Entheon Biomedical Mental Health Town Hall on Thursday, Feb. 3rd. Register now for free to get the inside scoop 👇

Donating psilocybin to patients in need

CCrest Laboratories is donating psilocybin truffles so patients in need can access the medicine for free through Canada’s Special Access Program (SAP).

The company was just approved as a licensed psilocybin producer by Health Canada, along with Numinus Wellness (NUMI) and Filament Health’s (FH) Psilo Scientific, allowing them to supply psilocybin for clinical trials and emergency treatments through the SAP. 

The truffles will be grown by Red Light Holland (TRUFF) and tested at CCrest Labs before being donated as part of their “compassionate need and free supply” approach.

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Beckley Psytech began training psychotherapists for a phase II study on 5-MeO-DMT for treatment-resistant depression through Fluence’s interactive training program. Within the next year, Beckley aims to train 80 psychotherapists on how to administer psychedelic therapy.

Mydecine (MYCO) is partnering with a UK-based charity called Combat Stress and the King’s College London to study psilocybin therapy as a treatment for veterans with severe, treatment-resistant PTSD. 

Psygen Labs entered into an agreement to supply Universal Ibogaine (IBO) with ibogaine for an upcoming clinical trial on opioid addiction.

atai Life Sciences (ATAI) launched a wholly owned platform company called Invyxis, which will focus on developing novel compounds that target serotonin 5-HT2A receptors.

Akome Biotech, a subsidiary of Core One Labs’ (COOL), signed a consulting agreement with the University of Barcelona to develop psychedelic treatments for depression, stroke, Parkinson’s, and Alzheimer’s.

Ketamine One (MEDI) changed its name to Wellbeing Digital Sciences and partnered with Nova Mentis (NM) to study psilocybin microdosing for fragile x syndrome.

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Oregon is on track to provide legal psilocybin services in 2023

But one question remains unanswered: will the new program include microdosing?

For the past year, the Oregon Health Authority has been planning the regulatory framework to implement Measure 109, which legalized psilocybin sessions under the care of licensed facilitators. The program is on schedule to roll out at the beginning of 2023.

At the latest public Zoom meeting, a push to include microdosing in the program received backlash from some advisory board members, but others thought it was worth considering. Members have until the end of June to reach a consensus.

 

Two psilocybin bills filed in Oklahoma

The first bill would promote research focused on treating depression and anxiety in veterans. The second would promote research into 10 different conditions and reduce the penalty for psilocybin possession to a fine.

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Donating psilocybin to patients in need

Red Light Holland’s Partner CCrest Laboratories Approved By Health Canada to Supply Psilocybin to the Special Access Program

CCrest Laboratories is donating psilocybin truffles so patients in need can access the medicine for free through Canada’s Special Access Program (SAP).

The company was just approved as a licensed psilocybin producer by Health Canada, along with Numinus Wellness (NUMI) and Filament Health’s (FH) Psilo Scientific, allowing them to supply psilocybin for clinical trials and emergency treatments through the SAP. 

The truffles will be grown by Red Light Holland (TRUFF) and tested at CCrest Labs before being donated as part of their “compassionate need and free supply” approach.

Red Light Holland Corp.

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Filament Health and Cybin Therapeutics Announce Licensing Agreement

Filament Health and Cybin Therapeutics Announce Licensing Agreement

Filament will license PEX010, its proprietary botanical psilocybin drug candidate, to Cybin Therapeutics for use in two upcoming Phase II clinical trials awaiting Health Canada approval

Vancouver, British Columbia, January 14, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it has entered into a licensing agreement with Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols to treat mild mood disorders and addictions. Under the agreement, Filament will license PEX010, its botanical psilocybin drug candidate, to CT for two upcoming Phase II clinical trials addressing depression and alcohol use disorder with an additional two planned for 2022. The financial terms were not disclosed.

CT filed a Clinical Trial Application (CTA) to Health Canada for the first trial in 2021, and anticipates its depression study to begin in the second quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips. Dr. Reg Peters has been involved in advocacy for compassionate use of psilocybin for palliative patients, including as a medical advisor to Therapsil. Mr. Dave Phillips, Training Advisor to Therapsil and a highly experienced psilocybin-assisted therapist, will lead the therapy component of the trials along with an experienced clinical team at Cybin Therapeutics’ purpose-built clinic.

“This agreement with Cybin Therapeutics demonstrates Filament’s ability to license our technology and facilitate our partners’ trials,” said Filament Chief Executive Officer, Benjamin Lightburn. “Our mission is to support the treatment of mental health conditions through the discovery and delivery of exclusively-natural psychedelic medicines, and we are proud to aid CT’s efforts. We view this as the first of many agreements in a long partnership.”

Josh Taylor, Cybin Therapeutics Founder, said “We are excited to advance our mission of creating psilocybin-based therapies for a number of treatment areas. Filament’s unique, all-natural drug candidates combined with our experienced team, we believe, create an ideal environment for creating research-based protocols, formulations, and outcomes for healing.”

BUSINESS DEVELOPMENT

Due to strong commercial demand for Filament’s unique proprietary drug candidates, the Company has engaged business development professionals to meet inbound requests and begin commercial outreach. Andry Tjahyana joins as Vice President, Business Development, bringing more than 25 years’ relevant experience. Filament has also engaged Thomas Ryan, Rob Grundy, and Christine Verstraate from NavigatorBIO, who bring a combined 65 years of pharmaceutical industry sales experience. 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on TwitterInstagram and LinkedIn

ABOUT CYBIN THERAPEUTICS

Cybin Therapeutics (“CT”), is a private therapeutic bioscience company established in 2019, on a mission to develop psilocybin-assisted therapeutic protocols and natural formulations to treat mild mood disorders and addictions. Cybin Therapeutics works with healthcare specialists who together form a dynamic clinical team with the ability to carry out studies and clinical trials for Cybin Therapeutics and it’s future partners looking to conduct psilocybin based studies and trials. 

Learn more at www.cybintherapeutics.com.

MEDIA RELATIONS

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including results of the clinical trial. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

Finally, a way to have less sex in 2022: issue 31

Hello and welcome back.

We hope you’ve had a great start to 2022. 

In 2021, we read thousands of articles so you didn’t have to. (You’re welcome 😉)

We curated the best content and summarized over 300 articles so you could be the smartest mushroom in the room, covering over 45 conditions and disorders that could potentially be treated with psychedelics 🤯 

This is just the beginning… Get ready for another year of groundbreaking research, inspiring stories, and major business deals. 

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

🍄 Take a psychedelic retreat from your bed

🍄 The African shrub that could solve the opioid crisis

🍄 How to make your NY’s resolutions stick

🍄 How psychedelic therapy just got A LOT more accessible for Canadians

🍄 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!

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Microdoses for the whole family

Here’s a fun way to bond with grandma…

Mindset Pharma (MSET) filed a patent for psilocybin microdoses that have potential to treat Alzheimer’s disease and ADHD. 

The compounds may promote cognitive benefits without the liability of a psychedelic experience, making them suitable for “fragile population groups” like children and the elderly, according to the company’s Chief Scientific Officer.

Could this African shrub solve the opioid crisis?

MindMed (MNMD) developed a non-hallucinogenic molecule based on ibogaine, the psychoactive compound in the African iboga plant, and it’s showing potential to treat opioid addiction.

How? 🤔

The compound has demonstrated the ability to reduce opioid use and ease withdrawal symptoms by regulating excessive dopamine fluctuations.

An upcoming Phase 2a trial will put the compound to the test.

Make your New Year’s resolutions stick

Spent too much time gaming or had too much sex in 2021? 

We’re guessing you didn’t answer yes to both, but if you struggle with one of these things, ketamine therapy could help you make changes this year 😉

Awakn Life Sciences (AWKN) received ethics approval to expand its ketamine study. In addition to investigating Gambling Disorder, it will now cover three more behavioral addictions: Internet Gaming Disorder, Compulsive Sexual Behaviour, and Binge Eating Disorder.

The goal is to “harness a window in which the brain is able to make new connections” to create lasting behaviour changes. 

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The quest to treat addiction

After his brother overdosed in 2019, Timothy Ko founded Entheon Biomedical (ENBI) on his quest to find a better treatment for addiction through psychedelic therapy.

The company is focused on advancing the DMT molecule to treat substance use disorders. It just submitted a regulatory package to an ethics committee for a human clinical trial on healthy smokers, which will be one of the most comprehensive studies of DMT ever.

Entheon has also begun recruiting patients with treatment-resistant depression for a ketamine therapy study, which will be conducted with Heading Health LLC. The study will use an electroencephalography (EEG) headset and genetic screening to:

  • Understand how ketamine influences brainwave patterns
  • Investigate how genetic markers influence ketamine response
  • Explore the effects of music on therapeutic outcomes
  • Develop a framework for characterizing the psychedelic drug state

Take a psychedelic retreat from your bed

Psychedelic retreats are inaccessible to most due to high costs, length of treatments, and travel restrictions. Who has ten thousand dollars to drop on a week in Jamaica?

That’s why Ei.Ventures is investing (heavily) in the Metaverse.

The company purchased a $2.2M estate in The Sandbox virtual world – the third largest land sale in the Metaverse ever. 

The goal? 

To provide “wondrous” psychedelic journeys through the Hawaiian islands, or outer space, using VR technology.

Sound like the ideal setting for your next trip?

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Filament Health (FH) received Health Canada approval for a psilocybin microdosing study on 100 patients with persistent depression, which will be funded by the Nikean Foundation.

The McQuade Centre for Strategic Research and Development (MSRD), a subsidiary of Otsuka Pharmaceutical (one of Japan’s biggest pharma companies), invested $5M in Mindset Pharma to support its drug development.

MindBio Therapeutics is aiming to develop a “smart drug delivery technology” that can use patient data to determine an optimal microdose for each individual.

Compass Pathways’ (CMPS) early psilocybin research was published in The Journal of Psychopharmacology this week. The study suggests that both low and high doses of psilocybin are safe to administer in group settings and do not have negative impacts on thought patterns or processing of emotions. 

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Psychedelic therapy just got A LOT more accessible for Canadians

Until now, the only way for patients to access psychedelic therapy outside a clinical trial was to apply for a Section 56 exemption and wait months on end to (possibly) receive approval from Health Canada.

Despite six more patients receiving the exemption over the holidays, the system remains flawed.

Thankfully, this Wednesday, Health Canada made an amendment to this thing called the Special Access Program (SAP), which enables healthcare practitioners to request access to drugs that are not yet approved, but have shown promise in clinical trials.

The amendment allows practitioners to request access to psilocybin and MDMA for their patients with serious, life-threatening, or treatment-adverse conditions. And the best part: requests are typically processed in just 1 day! 🎉

While this does not guarantee access for patients, it certainly feels like a big step in the right direction.

To learn more about the amendment, check out TheraPsil’s free webinar on Jan. 19th.

WA pushes for psilocybin sessions for all

Washington State legislators introduced a bill that would legalize supported psilocybin sessions for “nearly any purpose” – no medical diagnosis required.

The experiences would be administered by state-licensed facilitators at licensed service centers or, in some cases, remotely.

Goodbye styrofoam 👋

M2Bio Sciences developed a sustainable alternative to styrofoam out of mushroom mycelium and hemp. 

The foamy material, appropriately named Hempcelium, is fully biodegradable and can even remove industrial toxins from groundwater and soil.

Plus, it takes less energy to produce than styrofoam and can be grown into any shape.

Video of the Week

Playlist of the Week

Filament Health to Participate in Key Psychedelics Conferences in December 2021

Filament Health to Participate in Key Psychedelics Conferences in December 2021

Vancouver, British Columbia, December 1, 2021  –  Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it will participate in the following upcoming events in December 2021:

  • Horizons: Perspectives on Psychedelics Conference to be held virtually and live in New York City from December 1-5, 2021. Filament CEO, Benjamin Lightburn, will be attending the conference in New York City on Thursday, December 2, 2021.
  • H.C. Wainwright 2nd Annual Psychedelics Conference to be held virtually on December 6, 2021. An on-demand presentation featuring Mr. Lightburn will be available beginning at 7:00 am EST on Monday, December 6, 2021. 
  • GCI Summit Psychedelics Conference to be held virtually on December 7-9, 2021. Mr. Lightburn will be presenting alongside Ryan Moss, Filament’s Director of Research, and Dr. Joshua Woolley, Director, Translational Psychedelic Research Program (TrPR) at University of California San Francisco on Wednesday, December 8, 2021 at 1:00 pm EST, with the session available on-demand post-broadcast.

To schedule a one-on-one meeting with Filament’s management at the H.C. Wainwright Conference, please contact KCSA Strategic Communications at KCSA-investor-relations@filament.health or an H.C. Wainwright representative directly, or book meeting times through the H.C. Wainwright event platform. 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

FFilament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on TwitterInstagram and LinkedIn.

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

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.

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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.

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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. 

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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.

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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…

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Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

Filament Health Reports Third Quarter 2021 Financial Results and Operational Highlights

FDA Authorization of Historic Phase I Clinical Trial Using All-Natural Psychedelic Compounds and Direct Psilocin Administration for the First Time

Granted First and Only Patent for Extraction and Standardization of Natural Psilocybin

Health Canada Dealer’s License Enables Production and Distribution of All Natural cGMP-Grade Psychedelic Supply from its Facilities

Vancouver, British Columbia, November 15, 2021  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, released its third quarter financial results and operational highlights for the period ended September 30, 2021.

 

Third Quarter and Post Period Operational Highlights:

FDA authorization of phase I clinical trial using naturally-sourced psychedelic substances and direct administration of psilocin (both orally and sublingually) for the first time in FDA history;

  • First and only patent granted for the extraction and standardization of natural psilocybin;
  • Over 20 patent applications to-date, including three international Patent Cooperation Treaty (PCT) applications covering extraction, standardization, purification and delivery of botanical drug candidates;
  • Completed industry-first export of current good manufacturing practices (“cGMP”)-quality natural psychedelic substances to the United States;
  • Psilo Scientific Ltd., Filament’s wholly-owned subsidiary received an amendment to Health Canada Dealer’s License for its facility, allowing the possession, production, and delivery of all controlled natural psychedelic substances;
  • Produced pharmaceutical-grade batches of natural psilocybin extracts including leading drug candidates which will be entered into upcoming FDA clinical trials.

Third Quarter and Post Period Financial and Capital Markets Highlights

  • Uplisted to the OTCQB Market under the symbol FLHLF on October 12, 2021;
  • Received Depository Trust Company (“DTC”) eligibility on October 12, 2021;
  • Listed on the Frankfurt Stock Exchange (“FSE”) under the symbol FSE:7QS on October 15, 2021;
  • Cash and cash equivalents of $6.4 million as of September 30, 2021.

Commentary and Outlook

“To-date, we have distinguished ourselves as a leader in the extraction and drug development of all-natural psychedelic compounds through our patent-protected botanical extraction process and recent FDA approval of the first-ever clinical trial using all-natural psychedelics to treat a variety of mental health disorders,” said Benjamin Lightburn, Chief Executive Officer. “Our team continues to quickly execute on Filament’s operational milestones, supported by our industry partnerships, extraction expertise and long-term IP strategy. Our goal is to continue our momentum by advancing our novel psilocybin and psilocin compounds through clinical trials, further building out our IP protection, and establishing ourselves as a unique provider of all-natural pharmaceutical-grade psychedelics to the industry. We are committed to maintaining this pace of innovation in order to support the treatment of mental health conditions with safe, natural psychedelics as soon as possible.”

 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary technology platform enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on TwitterInstagram and LinkedIn.

 

MEDIA CONTACT

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

 

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

 

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning Filament’s upcoming clinical trials; strategic and growth plans of the Company including intellectual property; and the impact, timing and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.15