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New York, NY – March 29, 2022 – Mental health cases are continuing to rise and are taking a serious toll on the healthcare system. Luckily, psychedelics like DMT, psilocybin, MDMA, and LSD are being developed to treat various psychiatric disorders such as depression, anxiety, and PTSD. One study by researchers at Johns Hopkins Medicine shows that psychedelic treatment with psilocybin relieved symptoms of major depressive disorder for at least a year for some patients. Another study from scientists at McGill University demonstrated that regular low doses of LSD reduces anxiety symptoms through neurobiological mechanisms similar to commonly prescribed antidepressants. Positive results have led to increased investors interest, with funding for psychedelic medicine companies exceeding $700 million in 2021. This influx of capital catalyzes the growth of biotech companies developing psychedelic drugs like Cybin Inc (NYSE:CYBN) (NEO:CYBN), ATAI Life Sciences (NASDAQ:ATAI), Johnson & Johnson (NYSE:JNJ), Enveric Biosciences Inc (NASDAQ:ENVB), and Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP).
Cybin Inc (NYSEAmerican:CYBN) (NEO:CYBN) has established a leadership position in the psychedelic therapeutic space based on its proprietary scientific approach and drug development ecosystem.
On March 29, Cybin announced that it has successfully completed in vivo preclinical studies evaluating its deuterated psilocybin analog CYB003 for the potential treatment of major depressive disorder (MDD). Data from in vivo preclinical studies show that CYB003 is well tolerated after multiple doses in multiple species. Cybin plans to submit an Investigational New Drug (IND) filing with the US Food and Drug Administration (FDA) in the second quarter of 2022 and to initiate the Phase 1/2a clinical trial in mid-2022.
“The completion of these in vivo preclinical studies for CYB003 represents a significant milestone toward advancing this program into first-in-human clinical development and brings us one step closer to progressing CYB003 as a best-in-class treatment candidate for mental illness and addiction,” said Cybin CEO Doug Drysdale. “We plan to focus the Phase 1/2a trial in the United States. We believe this will allow us to escalate the study through early-stage clinical development and into a potential broader Phase 2b trial, while concurrently collecting a large amount of data to support late-stage studies.”
Cybin also recently announced that it has partnered with the Chopra Foundation to increase education and awareness of the potential use of psychedelics to support wellness and mental health. Recent research shows that psychedelic-assisted therapy can potentially improve the quality of life for people with mental illnesses.
In addition to its ongoing preclinical, clinical and investigational drug development programs, Cybin shares The Chopra Foundation’s commitment to ensuring access to wellness resources for all, including those in underserved communities.
“We are honored to partner with The Chopra Foundation, and specifically, to be part of the NeverAlone Initiative. Much is understood about psychedelics, as they have been studied in academia for decades, but there is still much investigative work to be done,” said Cybin CEO Doug Drysdale. “At Cybin, we are using medicinal chemistry and drug delivery technologies to build on existing clinical data and improve the patient experience by overcoming the limitations of current treatments for mental illness.”
Last month, Cybin posted Q3 results with cash and cash equivalents totaling C$63.6 million as of December 31, 2021. Cash operating expenses totaled C$12 million for the quarter ended December 31, 2021, of which C$2.5 million were one-time, non-recurring costs. Non-cash expenses totaled C$5.2 million for a net loss of C$17.2 million.
Cybin also reported several other notable milestones, including completing over 140 pre-clinical studies supporting the advancement of CYB003, CYB004, and other proprietary psychedelic molecules toward regulatory filings, marking 50+ new preclinical studies completed in January 2022 alone, and receiving a US patent for CYB004 further strengthening its IP portfolio.
CEO Doug Drysdale said that the company continued to make tremendous progress during the quarter in advancing their proprietary psychedelic-based molecules into clinical development, reaching regulatory milestones, completing numerous preclinical studies and establishing reliable supply chains in the US and the UK.
For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.
Biotech Companies Make Progress on Psychedelic Drugs
On February 16, Atai Impact, the philanthropic program of Atai Life Sciences (NASDAQ:ATAI) announced it has donated $500,000 to the Multidisciplinary Association for Psychedelic Studies (MAPS). atai Impact’s donation is for multi-year support of MAPS’ ongoing initiatives, including its health equity program. The program aims to optimize access and healing through the development of a diverse network of therapy providers reflecting the diverse experiences of those who suffer from trauma and mental health issues. Atai Impact’s donation to MAPS was issued through Vanguard Charitable’s Atai Impact fund.
Johnson & Johnson (NYSE:JNJ) is the developer of SPRAVATO® (esketamine nasal spray), the first prescription nasal spray, taken with an oral antidepressant for adults with treatment-resistant depression and major depressive disorder (MDD) and the first FDA-approved psychedelic treatment. Last February, the company announced that the European Union authorized the expanded use of SPRAVATO, co-administered with oral antidepressant therapy for adults experiencing a moderate to severe episode of MDD, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency.
Enveric Biosciences Inc (NASDAQ:ENVB) a neuroscience-focused biotechnology company developing next-generation psychedelic-inspired mental health drugs, recently announced that the company’s first four Patent Cooperation Treaty (PCT) applications for the tryptamine family of new molecules have been published by the World Intellectual Property Organization (WIPO). Further PCT patent applications are expected to be published in the coming months. Based on recent and emerging data, Enveric Biosciences believes that tryptamine molecules may have the potential to produce rapid, profound and long-lasting benefits for a wide range of indications.
Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. On March 21, Tonix announced the Phase 3 RALLY study results for TNX-102 SL for the management of Fibromyalgia. As expected based on interim analysis results that were reported in jJuly 2021, TNX-102 SL didn’t achieve statistical significance over placebo on the primary endpoint of reduction in daily pain.
Cybin Inc (NYSE:CYBN)(NEO:CYBN) CEO Doug Drysdale will participate in the 2022 Maxim Group Virtual Growth Conference on March 28-30.
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