Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company's robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases.

Seelos Therapeutics is a pharmaceutical company focused on developing therapies for central nervous system disorders and rare diseases. Along with&nbsp;three non-psychedelic drug programs targeted at various diseases, the company is also developing a ketamine therapy.&nbsp;

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

Psychedelic Medicine

Seelos Therapeutics, Inc.(OTCPK:SEEL) dropped from S&P TMI Index

Seelos Therapeutics is a pharmaceutical company focused on developing therapies for central nervous system disorders and rare diseases. Along with&nbsp;three non-psychedelic drug programs targeted at various diseases, the company is also developing a ketamine therapy.&nbsp;The company’s lead product candidate, SLS-002, is an intranasal racemic ketamine to treate acute suicidal ideation and behavior (ASIB) in patients with major depressive disorders (MDD).&nbsp;As of August 2023, the company’s ketamine therapy (SLS-002) was at Phase 2 stage, undergoing its Part 2 study which is a directed, double-blind, placebo-controlled study for ASIB in adults with MDD. The company completed the first part related to the dosing and Proof of Concept (PoC) study for ASIB in patients with depression.Founded in 2016, Seelos Therapeutics is listed on the Nasdaq exchange under the ticker symbol “SEEL.”

Core One Labs is a biotechnology company focused on the development and production of psychedelic compounds for mental health treatment. Through its subsidiary, Vocan Biotechnologies, it developed a proprietary biosynthesis platform that uses engineered bacteria to produce API-grade psilocybin via fermentation, which the company claims was more cost-effective and scalable than traditional extraction or chemical synthesis methods. The company filed patents for this production system and additional synthetic technologies for psilocybin and psilocin production methods.&nbsp;Another subsidiary, Akome Biotech, was researching psychedelic-based pharmaceutical formulations targeting neurological conditions like Alzheimer's, Parkinson's, stroke, and depression (November 2024). In January 2023, Core One began commercial production trials of API-grade psilocybin at a GMP facility in Ontario after it acquired GMP Drug. The company also developed proprietary sublingual strips for administering microdoses of its biosynthetic psilocybin.Through its subsidiaries, Core One holds four provisional patents for psychedelic-based pharmaceutical formulations and three provisional patents for synthetic production methods. Additionally, the company has four psychedelic clinics that support clinical trials and maintain a database of more than 275,000 patients.&nbsp;Core One Labs is listed on the Canadian Securities Exchange (CSE) market under the ticker symbol “COOL” and in the OTC market under the ticker symbol “CLABF”.

Core One Labs

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’s main focus is the treatment of mild traumatic brain injury and post-traumatic stress disorder (PTSD).&nbsp;The company's lead product candidate is L-130, a proprietary stabilized psilocin compound designed to deliver psilocin directly, eliminating the need for first-pass metabolism required with psilocybin. In December 2023, Lobe completed a Phase I study of L-130, which demonstrated superior bioavailability and faster onset compared to psilocybin, with no significant adverse events reported. L-130 is being developed as a potential treatment for chronic cluster headache, a rare neurological condition.As of October 2024, Lobe Sciences held one issued patent related to conjugated psilocin. Additionally, the company filed several patent applications to expand its intellectual property portfolio, including three focused on novel drug compounds and two on unique delivery devices.&nbsp;After its restructuring and name change, the company started trading on the Canadian Securities Exchange (CSE) in November 2020. The company also established a wholly owned subsidiary, Alera Pharma, to focus on clinical development of its drugs.&nbsp;Key customers and partnershipsLobe had collaborated with the University of Miami’s Miller School of Medicine to conduct preclinical studies. In&nbsp;<a href="https://sp-edge.com/updates/12322">August 2022</a>, Lobe had partnered with an Australia-based contract research organization, iNGENU Pty Ltd, to design and conduct the clinical trials.&nbsp;

Lobe Sciences

Cybin is a psychedelic biotechnology company developing treatments for psychiatric and neurological conditions. The company's lead program, CYB003, is a proprietary deuterated psilocybin analog being developed for major depressive disorder (MDD). In Phase 2 trials completed in 2023, CYB003 demonstrated significant efficacy with 75% of patients achieving remission from depression four months after receiving two 16mg doses. The company's second key program, CYB004, is a deuterated dimethyltryptamine (DMT) molecule being developed for generalized anxiety disorder. Cybin utilizes proprietary drug discovery platforms to engineer novel drug delivery systems and treatment approaches.&nbsp;In July 2023, the company announced&nbsp;<a href="https://sp-edge.com/updates/20076">EMBARKCT,&nbsp;</a>a streamlined version of its EMBARK training program for pivotal studies of lead candidates, CYB003 and CYB004. In&nbsp;<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.The company is actively building a patent portfolio, including chemically-synthesized compounds, delivery mechanisms, protocols, and new drug formulations.&nbsp;It possesses an intellectual property portfolio with 70 granted patents and 220 patent applications pending as of October 2024.&nbsp;Founded in 2019, Cybin is listed on the NEO exchange under the ticker symbol “CYBN” and was uplisted to the NYSE American Stock Exchange in July 2021 under the same symbol.&nbsp;For FY2023, the company reported a decrease in net loss by 29.7% YoY to CAD 47.5 million (USD 35 million). Further in&nbsp;<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.&nbsp;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&nbsp;<a href="https://sp-edge.com/updates/21335">August 2023&nbsp;</a>it acquired&nbsp;<a href="https://sp-edge.com/companies/470858">Small Pharma&nbsp;</a>in an all-share transaction to strengthen its psychedelic portfolio.&nbsp;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&nbsp;<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&nbsp;<a href="https://sp-edge.com/updates/22180">Fluence</a> to support Cybin's EMBARK facilitator training program.

Cybin

Canadian 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. The company, via XPhyto Labs, develops psychedelic medicine programs centered on GMP drug synthesis, proprietary drug delivery systems, and novel psychedelic analogue engineering to treat conditions such as depression, anxiety, addiction, and trauma-related stress disorder.The company is publicly traded on the Canadian Securities Exchange under the ticker symbol "BNXT".Key customers and partnershipsThe company established a research and development collaboration with Applied Pharmaceutical Innovation in February 2021 to advance their psychedelic compound applications. In November 2020, the company formed a partnership with a German university for the exclusive development of a proprietary biotechnology process for industrial-scale pharmaceutical grade psilocybin manufacturing.

BioNxt Solutions

Gilgamesh Pharmaceuticals is a biotechnology company developing psychedelic-inspired medicines for neuropsychiatric conditions such as depression, anxiety, addiction, and cognitive deficits. The company’s research programs include: 1) Serotonergic Micro-Dose–a non psychedelic therapeutic treatment for attention deficit hyperactivity disorder (ADHD) and mood/anxiety disorders, 2) Arylcyclohexylamine–an improved molecule of ketamine for treatment-resistant depression and opiate use disorder, and 3) Novel Ibogaine Analogue–for the treatment of substance use disorders.&nbsp;As of May 2024, Gilgamesh had two lead clinical programs, GM-1020 and GM-2505, which had both entered Phase II studies for major depressive disorder.Gilgamesh is one of the few psychedelic companies launched by the startup accelerator Y Combinator, and as such enjoys the accelerator’s world-famous business expertise and network.Key customers and partnershipsIn&nbsp;<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 "neuroplastogens."&nbsp;

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. 

Seelos Therapeutics

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