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Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Vancouver, British Columbia, Canada – March 4, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”), has entered into an agreement with the Universidad Complutense de Madrid (“Universidad Complutense”), officially commencing neurogenesis stimulation and modelling studies research, to advance the development of the Company’s patent pending psychedelic bioactive compounds that target Alzheimer’s Disease, Parkinson’s Disease, Major Depressive Disorder and Ischemic Stroke.

Neurogenesis is the ability of the brain to grow new neurons. Until recently, neuroscientists believed that the central nervous system, including the brain, was incapable of neurogenesis and unable to regenerate. However, research conducted over the last two decades confirms, not only that adult neurogenesis is a normal process that occurs in the healthy brain, but also that it can be enhanced by psychedelics among other potent stimulants. Neurogenesis is considered important in neuroplasticity, the ability of the brain to form new connections and pathways and change how its circuits are wired. Through Akome’s initial data mapping of how psychedelic substances and selected bioactive substances cooperate, there is potential for significant stimulus in adult neurogenesis in the brains of individuals that are afflicted with certain neurological disorders, and Akome’s research with Universidad Complutense seeks to prove that its chosen bioactive-compounds can enhance such processes.

The research, which is currently underway, is being led by Dr. Jose A. Morales-Garcia, PhD, of the Universidad Complutense de Madrid, a leading institution with extensive experience in psychedelics research, and neurodegenerative processes responsible for conditions such as Alzheimer’s disease, Major Depressive disorder, Parkinson’s disease and ischemic stroke. The scope of research is designed to advance the Company’s hypothesis that the selected candidate bioactive compounds included in its patent submissions, are viable candidates and will react positively upon targets in the Central Nervous System, and have the potential to stimulate neurogenesis in the brain of individuals afflicted with neurological disorders, and subsequently result in groundbreaking clinical implications for the indications of Ischemic stroke, Alzheimer’s disease, Major Depressive disorder and Parkinson’s disease.

Dr. Morales is an Assistant Professor and Honorary fellow in the Cellular Biology Department at the Complutense University of Madrid, Medical School, a scientist at the Center for Networked Biomedical Research on Neurodegenerative Diseases, as well as a professor in the Master of Pharmacological Research at the Autonoma University of Madrid. Dr. Morales has over 40 scientific publications in peer-reviewed journals.

Dr. Morales’ has vast research background in the identification and analysis of new cellular targets implicated in neurogenesis and neurodegeneration as well as focused work in the study in vitro and in vivo of the mechanism underlying neurodegenerative disease, mainly Alzheimer´s and Parkinsonism in order to develop new neuroprotective, anti-inflammatory and neurogenic compounds for the treatment of these disorders.

“I believe that the treatment of individuals with neurological disorders through the use of psychedelic based pharmaceuticals, will become a major focus of mental healthcare in the near future. The groundbreaking work that Universidad Complutense is doing for Akome, will contribute significantly to the advancement of our drug formulations as we work to commercialize our patents. By developing unique psychedelic based pharmaceutical formulations that can be used for the treatment of Alzheimer’s, Parkinson’s, Depression and Ischemic Stroke, the Company is positioning itself to serve a larger and more diverse patient base,” stated Joel Shacker, the Company’s CEO.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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World’s first DMT trial for depression

World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

Small Pharma (DMT) successfully completed a phase I trial on the safety of DMT in preparation for a phase II trial on depression. Researchers discovered that:

  • Most of the 24 patients described the experience as pleasurable and not too challenging (even though no one had tried psychedelics before)
  • Although there were 20 adverse events (85% mild, 15% moderate, and 0% severe), no patient regretted participating
  • The trip lasted 20 minutes, and DMT was nearly undetectable in the blood after 60 minutes
  • For three months following the dose, there were no significant negative effects on anxiety or well-being

Phase II results are expected in the first half of this year, which will reveal how one dose compares to two doses in treating depression.

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World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

In the Phase I clinical trial, participants were administered SPL026 and underwent a 20-minute psychedelic experience

Phase I full dataset demonstrates consistent dose related effects on the intensity and quality of the psychedelic experience

February 22, 2022 – London, United Kingdom – Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (“DMT”) therapies for mental health, is pleased to share the analysis of Phase I data from the combined Phase I/IIa clinical trial of SPL026 with psychotherapy for the treatment of Major Depressive Disorder (“MDD”).

In the dose-escalating, placebo-controlled Phase I study, 32 healthy psychedelic naïve volunteers across four dose cohorts received either SPL026 in combination with psychotherapy (n=24) or placebo (n=8). This analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures, including the treatment experience and subject well-being.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma said:

The analysis of the unblinded data set supports our choice to explore the antidepressant potential of our selected dose of SPL026 in the Phase IIa trial. Given the subjectivity of the psychedelic experience, it was exciting to see a close correlation between levels of drug in the body and pharmacodynamic endpoints. As for the subjects’ experience, most reported that it was pleasurable, not too challenging, and most importantly, nobody expressed any regrets. Additionally, the strong safety profile and rapid clearance of SPL026 from the body provides the potential for a scalable treatment with limited monitoring needs post dosing.”

Key Results

  • No drug-related serious adverse events and minimal short-lived adverse events reported on dosing day.
  • Of 20 drug-related adverse events, all were mild (85%) or moderate (15%) and resolved rapidly and independently.
  • No statistically significant negative effects on anxiety and well-being identified at any point during the three-month follow-up.
  • Data show a clear correlation between quality of psychedelic experience and dosing levels, starting at 9mg and up to 21.5mg, across all four cohorts.
    • Participant-reported scores, using a 0 to 100 scale, on the richness of the psychedelic experience demonstrated increasing values of 48 (9mg), 79, 79, 88 (21.5mg) across the four increasing doses. A dose correlation was seen across most patient-reported scores.
    •  Therapist assessment of the predicted therapeutic benefit of SPL026 demonstrated a positive relationship with dose.
  • In the majority of participants, there was a strong correlation between levels of N,N-dimethyltryptamine (“DMT”) in the body and the quality and intensity of the psychedelic experience.
  • IV administration of SPL026 offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session to last only ~30 minutes.
  • Pharmacokinetic sampling supported rapid clearance out of the body, showing near undetectable DMT levels in the blood by 60 minutes at all investigated doses.

The data confirms the selected dose of SPL026 taken forward into Phase IIa most consistently delivers the target treatment profile across subjects through a multi-dimensional assessment including safety, tolerability, pharmacokinetic and pharmacodynamic parameters. The full dataset is anticipated to be published in a peer reviewed journal.

David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said:

Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development. The dosing time of 30 minutes, in comparison with up to 6 hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers.”

The blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD remains on track to deliver topline results in the first half of 2022. This study will assess the efficacy of one dose of SPL026 versus a placebo, and one versus two doses of SPL026 in combination with psychotherapy in patients with MDD while bolstering existing safety and tolerability data. About Small Pharma

Small Pharma is a neuropharmaceutical company specialized in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate, SPL026, alongside development of a robust pipeline of proprietary preclinical assets.

About DMT 

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (<30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.

For further information contact: Small Pharma

Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)20 7112 9118

Investor Relations Contacts:

Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
Tel: +1 (646)-889-1200

Tim Regan
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6788

Media Relations Contacts:

USA
McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585

Rest of World
Donna Curran
Hanover Communications
Email: dcurran@hanovercomms.com
Tel: +44 (0)20 7400 4480

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s continued progress in Phase I/IIa clinical trial of SPL026, the anticipated timing for the readout of topline data for the Company’s Phase IIa trial, the Company’s advancement of pre-clinical trials into new clinical trials, including the anticipated commencement and timing of the Company’s Phase IIb trial of SPL026, the Company’s success in launching a clinical program into DMT-assisted therapy, the Company’s ability to develop solutions to effectively address depression through DMT-based therapies, the potential of DMT-assisted therapies to transform the lives of patients suffering with MDD, the ILAP providing potential access to speedier time to market and facilitation of patient access to emerging and novel treatments, and the Company’s development of a robust pipeline of proprietary preclinical assets. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The U.K. Medicines and Healthcare products Regulatory Agency (“MHRA”)or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.

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

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XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

Vancouver, Canada, and Uttenweiler, Germany (February 22, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide an update on its wholly owned subsidiary XPhyto Laboratories Inc. (“XPhyto Labs”). XPhyto Labs’ psychedelic medicine programs based in Edmonton, Canada, are focused on a multi-pronged approach to psychedelic medicine including GMP drug synthesis, proprietary drug delivery systems, novel psychedelic analogue engineering, and clinical validation.

Psychedelic Medicine – Canada

Through its exclusive contract R&D collaboration with Applied Pharmaceutical Innovation (“Applied”), first announced on February 3, 2021, XPhyto Labs is pursuing the application of psychedelic compounds as impactful solutions to mental health-related conditions.

Based on a systematic literature review, the Company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a broad range of mental disease states such as depression, anxiety, PTSD, and addiction, as well as cluster headaches. XPhyto and Applied developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and to date approximately 60 g of GMP grade mescaline has been manufactured for clinical trial evaluation.

With respect to mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side-effects and provide precise and predictable dosage forms for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed via ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability. The Company is pursuing a novel drug delivery system designed to prevent these common negative side-effects and complications; however, due to sensitivity related to intellectual property, further details cannot be disclosed at this time. The Company will announce further details in due course.

In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel “2nd generation” psychedelic analogues. The Company has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability. Intellectual property related information will be disclosed in due course.

XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a robust Phase I clinical trial to commence in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system. Details will be provided as decisions are finalized over the coming months.

“We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization,” said Prof. Dr. Löbenberg, XPhyto director and founder and director of the Drug Development and Innovation Centre, University of Alberta. “Our focus is to develop production methodology for GMP manufacturing, proprietary drug formulations with precise, predictable and efficient API delivery for clinical investigation and therapeutic use of novel next-generation psychedelic compounds.”

Psychedelic Medicine – Germany

In addition to operations in Canada and in collaboration with a major German university, the Company is pursuing the development of industrial scale production methodology for GMP psilocybin through an advanced biosynthesis process focused on the insertion of genes from the psilocybin mushroom into certain bio-organisms. Gene insertion is complete and the micro-organisms are now producing psilocybin. The Company will announce further details in due course.

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PharmaTher Announces Grant of U.S. Patent on Ketamine Formulation

PharmaTher Announces Grant of U.S. Patent on Ketamine Formulation

PharmaTher (PHRM) was granted a US patent for its formulation of ketamine and betaine anhydrous, a chemical that occurs naturally in the human body and may increase ketamine’s antidepressant effect. The formulation is already patented in Japan and Taiwan, and the company expects to receive patents in Europe, Canada, Israel and China in the near future.

PharmaTher Holdings Ltd. Ketamine

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Discovering self-worth with ketamine

Healing my worth: Sarah’s story

Despite having a supportive family and a healthy lifestyle, Sarah had crippling self doubt and suicidal ideation. It wasn’t until she tried ketamine therapy that she realized why she felt these emotions.

The experience revealed that she never healed the scars of feeling unloved during her parents’ divorce. Her dream-like visions on ketamine showed her that separation is a natural part of life, and that she doesn’t need to be perfect to deserve love.

Sarah finally believes “I’m worth being here,’ she says. 

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Depression free for 1 year

Psychedelic therapy for depression still effective one year later

Johns Hopkins researchers followed up with patients one year after receiving psilocybin therapy. They found that 75% of patients sustained significant reductions in depression scores and 58% no longer qualified for a diagnosis. 

However, about a third of patients also used traditional antidepressants and 42% received additional psychotherapy at some point during the year.

So although psilocybin therapy can have rapid results, multiple treatment options can help sustain the benefits.

New Atlas logo

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A better way to measure depression

MYND Diagnostics Inc. Announces Participation in Approved Monash University (Australia) Government Funded $3 Million Clinical Trial

Diagnosing and measuring depression is usually very subjective, relying on data from patient questionnaires. This leaves room for bias and makes it difficult to know if a treatment is actually working.

MYND Diagnostics of MYND Life Sciences (MYND) developed a biomarker test that provides objective data to solve this problem. It measures inflammation in the brain, which may be what causes depression.

Seeing evidence of improvement gives patients hope in the treatment process, like showing them the “light at the end of the tunnel” as MYND’s CEO explained on a recent Daily Mushroom Podcast.  

The company announced that Monash University will use the biomarker test in a psilocybin study on treatment-resistant depression, which has received $3M in funding from the Australian government. 

Mynd

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Novamind Hosts Clinical Trial to Advance Ketamine Therapy for End-of-Life Patients

Novamind Hosts Clinical Trial to Advance Ketamine Therapy for End-of-Life Patients

TORONTO, ON / February 3, 2022 / Novamind Inc. (CSE: NM | OTCQB: NVMDF | FSE: HN2) (“Novamind” or the “Company”), a leading mental health company specialized in psychedelic medicine, today announced it has been selected by the Ketamine Research Foundation (KRF) to host a phase II clinical trial investigating ketamine-assisted psychotherapy (KAP) for adults with life-threatening illness (the “Conscious Dying/Conscious Living Trial”).

The FDA approval of the study’s KAP protocol marks a first in the investigation of KAP for end-of-life patients and its potential to serve as a model of care for this difficult-to-treat population. The mental health toll of a terminal illness is well-documented; between 24% to 70% of patients experience depression with significant negative impacts on quality of life.1 For patients with shortened life expectancy, ketamine may reduce symptoms of depression, anxiety and existential distress, and improve quality of life. Over the course of six weeks, study participants will undergo two KAP sessions at Novamind’s Murray, Utah research site under the supervision of clinical experts.

“This study is an important addition to the clinical care and research opportunities for patients within the Psychedelic Palliative Care program that we are building at Novamind,” said Dr. Paul Thielking, Chief Scientific Officer and Principal Investigator at Novamind’s Murray research site. “I’ve worked with this population for most of my career and, unfortunately, I’ve sometimes felt limited in what I can offer my patients to ease their emotional distress. The findings will contribute to the evidence for using KAP with patients who have a life-threatening illness and offer new insights into alternative treatments.”

The Conscious Dying/Conscious Living Trial is sponsored by the KRF, a non-profit leader in ketamine research, advocacy and clinical training. Phil Wolfson, MD is the Founder and CEO of KRF and a pioneering practitioner and instructor of KAP. He is also a Principal Investigator for the Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored phase II study of MDMA-assisted psychotherapy for individuals with significant anxiety due to life-threatening illnesses.

Dr. Wolfson commented, “Ketamine is still considered a novel treatment option for psychiatric illness and can sometimes be seen as controversial. Now with FDA approval, we’re hopeful that this ground-breaking study will demonstrate KAP’s potential to relieve distress and serve as a model for practitioners of palliative care, hospice and mental health professionals engaged with those who are facing death, to assist in their attitudes and choices for their remaining time.”

To learn more about the Conscious Dying/Conscious Living Trial, please visit this link.

About Novamind
Novamind is a leading mental health company enabling safe access to psychedelic medicine through a network of clinics and clinical research sites. Novamind provides ketamine-assisted psychotherapy and other novel treatments through its network of integrative mental health clinics and operates a full-service contract research organization specialized in clinical trials and evidence-based research for psychedelic medicine. For more information on how Novamind is enhancing mental wellness and guiding people through their entire healing journey, visit novamind.ca.

Contact Information
Yaron Conforti, CEO and Director
Telephone: +1 (647) 953 9512

Samantha DeLenardo, VP, Communications
Email: media@novamind.ca

Investor Relations
Email: ir@novamind.ca

Forward-Looking Statements
This news release contains forward-looking statements. All statements other than statements of historical fact included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations including the risks detailed from time to time in the Company’s public disclosure. The reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable laws.

1: J Palliat Med . 2021 May;24(5):767-781. doi: 10.1089/jpm.2020.0659. Epub 2021 Mar 15.

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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 Twitter, Instagram 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.