Psyence

Psyence is a life science biotechnology company that has pioneered the use of natural psilocybin to heal psychological trauma and the diagnosable disorders that can result from it, including anxiety, depression, PTSD, stress, grief, and bereavement. It focuses on these diseases in the context of palliative care. The company conducts scientific research and development of psilocybin medical products for research institutions, clinics, and psilocybin-containing products that are regulatory-compliant. It is also working on functional mushroom nutraceutical products to treat depression, anxiety, and sleep disorders.

Psyence is a life science biotechnology company that specializes in natural psychedelics, particularly in palliative care and the treatment of psychological trauma. The company's Psyence Biomed Division works with natural psilocybin products for this purpose. Psyence has established one of the world's first commercial psilocybin mushroom cultivation and production facilities at its federally licensed ISO22000 facility&nbsp;in South Africa. The company is conducting clinical trials in the field of palliative care to assess the safety and efficacy of psilocybin-assisted therapy for the treatment of adjustment disorder in people with terminal diagnoses. In&nbsp;<a href="https://sp-edge.com/updates/35265">October 2024</a>, the company added a second clinical trial site for psilocybin treatment study in Perth, Australia.&nbsp;

Promising research and receding stigma are giving investors cannabis-boom flashbacks.

Psychedelic Medicine

Psyence pays $500k to acquire fellow psilocybin biotech Clairvoyant and phase 2 AUD asset

Psyence is a life science biotechnology company that specializes in natural psychedelics, particularly in palliative care and the treatment of psychological trauma. The company's Psyence Biomed Division works with natural psilocybin products for this purpose. Psyence has established one of the world's first commercial psilocybin mushroom cultivation and production facilities at its federally licensed ISO22000 facility&nbsp;in South Africa. The company is conducting clinical trials in the field of palliative care to assess the safety and efficacy of psilocybin-assisted therapy for the treatment of adjustment disorder in people with terminal diagnoses. In&nbsp;<a href="https://sp-edge.com/updates/35265">October 2024</a>, the company added a second clinical trial site for psilocybin treatment study in Perth, Australia.&nbsp;The company is focused on various fields such as mycology, neurology, palliative care, and drug development, and operates internationally with divisions including Psyence Production, Psyence Therapeutics, and Psyence Function.&nbsp; The company has a presence in several countries including Canada, UK, US, and Australia.In&nbsp;<a href="https://sp-edge.com/updates/33340">September 2024</a>, entered a conditional binding term sheet to acquire Clairvoyant Therapeutics to expand its pipeline for up to USD 2.8 million in cash and shares, and subsequently in&nbsp;<a href="https://sp-edge.com/updates/34456">October 2024</a>, it decided not to proceed with the acquisition. Further September 2024, the company announced its intention to&nbsp;<a href="https://sp-edge.com/updates/33848">acquire</a> 11.1% stake in PsyLabs.&nbsp;Key customers and partnershipsThe company has partnered with many companies such as&nbsp;<a href="https://psychedelicalpha.com/news/psyence-group-signs-collaboration-agreement-with-leading-jamaican-psilocybin-retreat-provider-to-conduct-observational-study">MycoMeditations</a>,&nbsp;<a href="https://psychedelicalpha.com/news/psyence-group-announces-collaboration-with-the-scientific-research-council-src-of-jamaica-for-psilocybin-product-development">Jamaican Government’s Scientific Research Council</a>,&nbsp;<a href="https://psychedelicalpha.com/news/filament-health-and-psyence-enter-into-exclusive-licensing-agreement-for-natural-psilocybin-products">Filament Health</a>,&nbsp;<a href="https://psychedelicalpha.com/news/psyence-and-eden-labs-announce-extraction-and-product-development-collaboration">Eden Labs</a>,&nbsp;<a href="https://sp-edge.com/updates/17235">iNGENū</a>,&nbsp;<a href="https://sp-edge.com/updates/28294">Fluence</a> and other organizations. However in&nbsp;<a href="https://sp-edge.com/updates/31936">July 2024</a>, Psyence Biomed terminated its licensing agreement with Filament Health, which covered the supply and commercialization of PEX010. Further in&nbsp;<a href="https://sp-edge.com/updates/33276">September 2024</a>, the company entered a worldwide exclusive licensing agreement with PsyLabs for nature-derived psilocybin supply.&nbsp;

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 Canadian biotech firm Core One Labs maintains three primary business operations: 1) developing novel delivery systems for psychedelic medicines, 2) psilocybin manufacturing, and 3) medical clinics to provide psychedelic-assisted psychotherapy. The company has developed proprietary technology with infused strips that dissolve immediately when placed in the patient&rsquo;s mouth to deliver molecules with a higher level of bioavailability. The company plans to advance this technology to incorporate psychedelic molecules, particularly psilocybin.&nbsp;
 
 
 Core One Labs also claims it has discovered a patentable method of producing high-quality psilocybin, which it may license to pharmaceutical companies. Additionally, the company has two psychedelic clinics in Vancouver that currently support clinical trials and maintain a database of more than 275,000 patients. The company acquired Vocan Biotechnologies and Akome Biotech in May 2021 for undisclosed amounts. Akome is developing a patent-pending psychedelic drug formulation for the treatment of Alzheimer&rsquo;s Disease.&nbsp;
 
 
 Core One Labs is listed on the Canadian Securities Exchange (CSE) and OTC markets.
 
 
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Core One Labs

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 Vancouver-based Lobe Sciences (formerly GreenStar Biosciences) is a biotechnology company developing psychedelic medicines (microdose applications) and medical devices for efficient drug delivery. The company&rsquo;s main focus is the treatment of mild traumatic brain injury and post-traumatic stress disorder (PTSD). It is also conducting early studies on psilocybin combined with N-acetylcysteine (NAC), and MDMA combined with NAC as a treatment. Lobe is also developing a patent pending nasal mist transducer device for the delivery of medicines directly to the brain&rsquo;s olfactory bulb.&nbsp;
 
 
 In June 2020, Lobe acquired Eleusian Biosciences, a company focused on the development of psychedelic medicine which expanded its intellectual property portfolio with three US patent applications for psychedelic therapeutics. Lobe is also collaborating with the University of Miami&rsquo;s Miller School of Medicine to conduct preclinical studies. After its restructuring and name change, the company started trading on the Canadian Securities Exchange (CSE) in November 2020.
 
 
 
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Lobe Sciences

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 Cybin is a psychedelic biotechnology company developing treatments for psychiatric and neurological conditions. Through its Serenity Life Science division, Cybin conducted Phase II of clinical trials on using psilocybin to treat major depressive disorder. Additionally, the company's Nature's Journey division focuses on creating non-psychedelic medicinal and nutraceutical mental health products.
 
 
 Cybin is actively building a patent portfolio, including chemically-synthesized compounds, delivery mechanisms, protocols, and new drug formulations. It has also filed an International Patent Application through the Patent Cooperation Treaty, potentially covering 153 countries.&nbsp;
 
 
 In July 2023, the company announced 
 <a href="https://sp-edge.com/updates/20076">
 EMBARKCT, 
 </a>
 a streamlined version of its EMBARK training program for pivotal studies of lead candidates, CYB003 for major depressive disorder and CYB004 for generalized anxiety disorder, respectively. In 
 <a href="https://sp-edge.com/updates/27577">
 March 2024
 </a>
 , the company received a breakthrough designation from the FDA for CYB003, and expects to initiate Phase III clinical trials for the program by mid-2024.
 
 
 Cybin implements an M&amp;A strategy to grow in the psychedelic industry. It did a reverse takeover of Charmin in June 2020, raising CAD 45 million (USD 35.5 million) for clinical studies. It acquired Adelia Therapeutics in December 2020, adding novel treatments and patent applications. Also in 
 <a href="https://sp-edge.com/updates/21335">
 August 2023 
 </a>
 it acquired 
 <a href="https://sp-edge.com/companies/470858">
 Small Pharma 
 </a>
 in an all-share transaction to strengthen its psychedelic portfolio.&nbsp;
 
 
 Founded in 2019, Cybin is listed on the NEO exchange under the ticker symbol &ldquo;CYBN&rdquo; and was uplisted to the NYSE American Stock Exchange in July 2021 under the same symbol. For FY2023, the company reported a decrease in net loss by 29.7% YoY to CAD 47.5 million (USD 35 million).&nbsp;
 Further in 
 <a href="https://sp-edge.com/updates/33849">
 September 2024
 </a>
 , it completed a 38-to-1 share consolidation of its common stock which reduced the number of outstanding common shares to ~20 million. 
 
 
 Key customers and partnerships&nbsp;
 
 
 In July 2020, Cybin expanded its operations and research activities in the European region via research partnerships and transferred its intellectual property assets to its fully-owned Irish subsidiary (formed in May 2021). In July 2023, the company partnered with 
 <a href="https://sp-edge.com/updates/20455">
 Worldwide Clinical Trials
 </a>
 to develop new psychedelic-based treatment options for mental health conditions, including major depressive disorder. Further, in September 2023, the company partnered with 
 <a href="https://sp-edge.com/updates/22180">
 Fluence
 </a>
 to support Cybin's EMBARK facilitator training program.
 
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Cybin

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 Canadian cannabinoid-based therapeutics company BioNxt Solutions
 (formerly Xphyto Therapeutics) announced in November 2020 that it has expanded its drug development program to incorporate a number of psychedelic compounds. This includes substances such as psilocybin, mescaline, LSD, MDMA, and DMT. Xphyto&rsquo;s initial focus is on developing standardized drug formulations with efficient delivery mechanisms for therapeutic use.
 
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BioNxt Solutions

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 New York-based Gilgamesh Pharmaceuticals is a biotechnology company developing psychedelic-inspired medicines for neuropsychiatric conditions such as depression, anxiety, addiction, and cognitive deficits. The company has three research programs in its pipeline: 1) Serotonergic Micro-Dose&ndash;a non psychedelic therapeutic treatment for attention deficit hyperactivity disorder (ADHD) and mood/anxiety disorders, 2) Arylcyclohexylamine&ndash;an improved molecule of ketamine for treatment-resistant depression and opiate use disorder, and 3) Novel Ibogaine Analogue&ndash;for the treatment of substance use disorders.&nbsp;
 
 
 Gilgamesh is one of the few psychedelic companies launched by the startup accelerator Y Combinator, and as such enjoys the accelerator&rsquo;s world-famous business expertise and network.
 
 
 Key customers and partnerships
 
 
 In 
 <a href="https://sp-edge.com/updates/29382">
 May 2024
 </a>
 , the company partnered with AbbVie to leverage AbbVie's psychiatric expertise and Gilgamesh's research platform to create novel &quot;neuroplastogens.&quot; 
 
 
 Funding and Financials
 
 
 In 
 <a href="https://sp-edge.com/updates/27575">
 March 2024
 </a>
 , the company received a grant of&nbsp; USD 14 million from the National Institute on Drug Abuse to develop the GM-3009 compound. Prior to this, it raised USD 39 million in a 
 <a href="https://sp-edge.com/updates/15359">
 Series B 
 </a>
 funding round led by Prime Movers Lab in December 2022. 
 
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Gilgamesh Pharmaceuticals

Companies conducting research on psychedelic compounds and developing novel therapeutics.

Companies operating digital platforms to deliver psychedelic therapies including psychedelic integration, virtual experiences, and mental coaching and tracking. AI drug discovery companies specializing in psychedelic therapeutics are also included.

Companies operating clinics and treatment centers to deliver psychedelic therapies.

Companies supplying psychedelic compounds through cultivation, chemical synthesis and biosynthesis for medical research and drug development.

Companies building a patent portfolio of novel analogs and derivatives of first-generation psychedelics and new drug delivery mechanisms. 

ANALYST_QUICK_TAKE

PROMINENT_CATEGORY

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Psyence Biomed, part of Psyence specialising in natural psilocybin products, has added Empax Center in Perth, Australia, as a second site for its Phase IIb trial studying psilocybin treatment for adjustment disorder in palliative care. Patient recruitment is set to start in December 2024.
The trial will be held at Empax Center, focused on mental health treatments and psychedelic-assisted therapies. It will test PEX010, Psyence’s naturally derived psilocybin drug, successfully exported to Australia. The study is backed by partnerships with Fluence for professional training and iNGENū CRO for clinical research.

</div> Analyst QuickTake: 
 Psyence Biomed is steadily progressing in its development programs. In <a href="https: 
//www.globenewswire.com/en/news-release/2024/09/09/2942714/0/en/Psyence-Biomed-Announces-Initiation-of-First-Trial-Site-in-Australia-for-its-Phase-IIb-Study-of-Nature-Derived-Psilocybin-as-a-Potential-Treatment-for-Adjustment-Disorder-in-Pallia.html"> September 2024 </a> , the company launched its first clinical trial in Australia, with the first participant expected to be enrolled in October 2024.

Psyence

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