Silo Pharma

Silo Pharma Inc. is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research. It was founded in 2010 and is headquartered in Englewood Cliffs, New Jersey.

Silo Pharma is a developmental-stage biopharmaceutical company that develops novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments. The company's pipeline focuses on addressing underserved conditions, including psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases.&nbsp;

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

Psychedelic Medicine

Silo Pharma Initiates Pharmacokinetic and Tolerability Study for SP-26 Targeting Chronic Pain and Fibromyalgia

Kymanox

To develop a subcutaneous insertion device for SP-26, a ketamine-loaded implant therapeutic, aimed at treating chronic pain and fibromyalgia.

Companies conducting research on psychedelic compounds and developing novel therapeutics.

Silo Pharma is a developmental-stage biopharmaceutical company that develops novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments. The company's pipeline focuses on addressing underserved conditions, including psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases.&nbsp;Its lead program, SPC-15, is an intranasal prophylactic treatment for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorders that utilizes biomarkers as a serotonin four receptor agonist. The drug employs a patented nasal spray system using nose-to-brain drug dispersion that bypasses the blood-brain barrier for enhanced therapeutic delivery. As of November 2024, the company was developing SPC-14, an intranasal compound targeting glutamate receptor NDMAR and serotonin type four receptor 5HT4 for treating cognitive and neuropsychiatric symptoms in Alzheimer's disease. Another product in development is SP-26, a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Additionally, Silo was advancing SPU-16, a CNS-homing peptide targeting multiple sclerosis that aims to enhance therapeutic effects while decreasing drug toxicity.Silo Pharma is traded on the OTC market under the ticker symbol “SILO.”Key customers and partnershipsIn&nbsp;<a href="https://sp-edge.com/updates/36737">December 2024</a>, Silo Pharma partnered with Kymanox to develop a subcutaneous insertion device for SP-26, a ketamine-loaded implant therapeutic. In August 2024, the company collaborated with WuXi AppTec for a preclinical small animal study of its CNS homing peptide, SPU-16, and secured exclusive worldwide rights from Columbia University to develop and commercialize its PTSD drug, SPC-15. In July 2024, Silo partnered with Resyca BV for the device and CMC development of SPC-15 and continued collaborations with Columbia University and the University of Maryland, Baltimore, for R&amp;D. Earlier, in November 2023, it entered an exclusive license agreement with Medspray Pharma BV for soft mist nasal spray technology targeting PTSD, anxiety, Alzheimer’s, and anorexia.

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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 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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 Silo Pharma, a biopharmaceutical company based in New Jersey, has entered into a partnership with Kymanox, which is based in North Carolina. The purpose of this partnership is to develop a device for subcutaneous insertion of SP-26, an implant therapeutic loaded with ketamine.
 The responsibilities of Kymanox in this partnership include conducting the initial proof-of-concept design, the development of the prototype, and feasibility testing for optimal tissue insertion. The purpose of SP-26 is to treat chronic pain and fibromyalgia. It is being developed to be the first ketamine-based therapeutic that can be injected at home with controlled dosage and time of release.
 
</div> Analyst QuickTake: 
 This partnership builds upon the company's <a href="https: 
//sp-edge.com/updates/19451"> June 2023 </a> preclinical research agreement to study and develop the ketamine implant. If successful, SP-26 could qualify for the FDA's regulatory pathway, potentially enabling faster approval with lower risks and costs.

Silo Pharma

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