MindBio Therapeutics

MindBio Therapeutics is a clinical stage drug development company pioneering microdosing of psychedelic medicines.

MindBio Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for mental health conditions using microdoses of psychedelic medicines. The company's lead candidate, MB22001, is a proprietary titratable form of lysergic acid Diethylamide (LSD) designed for self-administered take-home use. MindBio's approach centers on using small, sub-hallucinogenic doses of psychedelics that patients can take at home, contrasting with other companies' focus on large doses administered in clinical settings.&nbsp;

Enveric Biosciences Signs $66.5 Million Non-Binding Term Sheet with MindBio Therapeutics to Out-License Novel Psilocin Prodrug Candidate for Mental Health Disorders

MINDBIO THERAPEUTICS CORP. ANNOUNCING LISTING DATE ON CSE AND CLOSING OF NON-BROKERED PRIVATE PLACEMENT

MindBio nears completion of MB22001 trial for depression

Mindbio Therapeutics First Batch of MB22001 has Been Manufactured and is Ready for Use in World First Phase 2 Take at Home Psychedelic Clinical Trials

MindBio Therapeutics Completes World's First Microdosing Trial

MindBio Therapeutics Reports Sustained Antidepressant Response from MB22001 in Depression Clinical Trials

BLACKHAWK AND MINDBIO THERAPEUTICS CORP. (formerly, 1286409 B.C. LTD.) ANNOUNCE COMPLETION OF PLAN OF ARRANGEMENT

MindBio Therapeutics receives approval for LSD study for major depression

Blackhawk's MindBio Therapeutics Announces Completion of World First Phase 1 Microdosing Clinical Trial - Blackhawk Gwth (OTC:BLRZF)

MindBio Therapeutics Scientists Present Landmark Women’s Health Trials. Company To Release Phase 2A Depression Trial Secondary Data This Month

Blackhawk's Shareholders Vote in Favour of Plan of Arrangement to Spin-out its Subsidiary, 1286409 B.C. Ltd. (Mindbio Therapeutics Corp.) to Form an Independent Listed Company

MindBio Therapeutics Nears Completion of Landmark Phase 2a LSD Microdosing (MB22001) Clinical Trial in Depressed Patients

MindBio Therapeutics Announces Landmark Women’s Health CNS Drug Trials

MindBio Therapeutics Receives Final Regulatory Approval to Conduct Phase 2B Randomised Controlled Trial Microdosing Mb22001 in Patients Diagnosed with Major Depressive Disorder

MindBio Therapeutics World First Phase 2 Take-Home LSD-Microdosing Clinical Trial in Patients with Major Depressive Disorder Begins Pre-Screening Participants

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

Psychedelic Medicine

MindBio Therapeutics Appoints Haywood Securities to Conduct Strategic Investment Advisory

Outrigger Hotels and Resorts

Signed a non-binding agreement to out-license its class of novel psilocin prodrugs (NPP) to Vancouver-based biotechnology company MindBio Therapeutics.Under the terms of the partnership, MindBio will leverage Enveric's NPP molecules, which are designed to release therapeutic levels of systemic psilocin, to advance the treatment of neuropsychiatric conditions like depression.

Companies conducting research on psychedelic compounds and developing novel therapeutics.

MindBio Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for mental health conditions using microdoses of psychedelic medicines. The company's lead candidate, MB22001, is a proprietary titratable form of Lysergic Acid Diethylamide (LSD) designed for self-administered take-home use. MindBio has completed Phase 1 clinical trials microdosing LSD in 80 healthy participants and a Phase 2a trial in patients with Major Depressive Disorder. The company is currently conducting multiple Phase 2B clinical trials, including studies on depression and existential distress in late-stage cancer patients. MindBio's approach centers on using small, sub-hallucinogenic doses of psychedelics that patients can take at home, contrasting with other companies' focus on large doses administered in clinical settings. In its completed Phase 2a trial for depression, MindBio reported that 53% of patients were in remission from their depression at week 8, with a mean 14.1 point drop in the Montgomery-Asberg Depression Rating Scale score. The company is also developing intellectual property in drug formulation and design for practical and safe take-home use of MB22001, as well as building a repository of data to inform personalized treatment regimens.

MindBio Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel treatments for mental health conditions using microdoses of psychedelic medicines. The company's lead candidate, MB22001, is a proprietary titratable form of lysergic acid Diethylamide (LSD) designed for self-administered take-home use. MindBio's approach centers on using small, sub-hallucinogenic doses of psychedelics that patients can take at home, contrasting with other companies' focus on large doses administered in clinical settings.&nbsp;MindBio has completed Phase 1 clinical trials microdosing LSD in 80 healthy participants and a Phase 2a trial in patients with major depressive disorder. Further in&nbsp;<a href="https://sp-edge.com/updates/34550">October 2024</a>, it announced that its MB22001 has achieved 12-month shelf stability at room temperature. As of October 2024, the company is conducting multiple Phase 2B clinical trials, including studies on depression and existential distress in late-stage cancer patients.&nbsp;The company is also developing intellectual property in drug formulation and design for practical and safe take-home use of MB22001, as well as building a repository of data to inform personalized treatment regimens.The company is listed in the Canadian Securities Exchange under ticker symbol “MBIO”.&nbsp;Key customers and partnershipsIn&nbsp;<a href="https://sp-edge.com/updates/29421">May 2024</a>, MindBio entered into a non-binding agreement with Enveric Biosciences to out-license Enveric’s class of novel psilocin prodrugs.&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 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. 

PROMINENT_CATEGORY

<div>
 MindBio Therapeutics, a company specializing in the development of microdoses of psychedelic medicines for psychiatric treatments, has confirmed that its microdosing compound MB22001 has accomplished 12-month shelf stability at ambient temperature.
 The compound MB22001 is a distinctive, self-adjustable form of Lysergic Acid Diethylamide (LSD) primarily devised for home consumption by patients suffering from depression. As of October 2024, MB22001 is subjected to several Phase IIB clinical tests.
 This 12-month shelf stability confirms the safety and efficacy of the product throughout this period, thus satisfying essential regulatory standards related to product quality and patient safety.
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MindBio Therapeutics

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