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New York, NY – April 21, 2022 – Investment banks are continuing to release positive coverage for psychedelic stocks and the latest report from Roth Capital is no exception. On April 19, Roth Capital analyst Elemer Piros issued an industry note outlining the significant upside potential of six psychedelic drug companies. Piros cited the positive results of psychedelic-assisted psychotherapy for the treatment of mental health, which “isn’t a perfect solution, but for many the response rate is remarkable.” The analyst believes the psychedelic medicine market could exceed $500 billion, which is more than the annual US prescription drug spend, creating an extraordinary opportunity for companies like Cybin Inc. (NEO:CYBN) (NYSE:CYBN), which was among the six companies included in the Roth Capital report, as well as Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF), Ehave Inc (OTC:EHVVF), Atai Life Sciences N.V. (NASDAQ:ATAI), and Enveric Biosciences Inc (NASDAQ:ENVB).
Cybin Inc. (NEO:CYBN) (NYSEAmerican:CYBN) is transforming the landscape of mental health treatment by combining novel psychedelic molecules with controllable drug delivery systems through its proprietary deuterated process, creating patent-protected, commercially scalable drug candidates.
Cybin recently announced that it has selected Clinilabs Drug Development Corporation, a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out its Phase 1/2a clinical trial of Cybin’s CYB003, a proprietary deuterated psilocybin analog. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (MDD). Through multi-species preclinical studies, CYB003 demonstrated significant advantages over classic psilocybin including, faster onset of action, shorter duration of effect, less variability in plasma levels, and potentially better tolerability for an overall better outcome for patients.
“We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders,” said Cybin CEO Doug Drysdale. “Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD.”
Cybin recently completed its IND-enabling in vivo preclinical studies of CYB003 to support the advancement toward an investigational new drug (IND) filing with the U.S. Food and Drug Administration (FDA) for the Phase 1/2a clinical trial. The company intends to submit an IND to the FDA in Q2 2022 and expects to initiate the Phase 1/2a trial in mid-2022.
Cybin is also currently developing CYB004 to treat anxiety. On April 13, the company released encouraging CYB004 preclinical data, which may support the use of inhalation as a viable and well-controlled delivery system for therapeutic psychedelics. The pharmacokinetic study evaluates its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, which is administered by inhalation. Inhaled CYB004 showed significant advantages over intravenous and inhaled DMT, such as longer duration of action and improved bioavailability. The pilot study is expected to launch in the third quarter of this year.
For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.
Biopharma Companies Have Cash to Develop New Treatments
Atai Life Sciences (NASDAQ: ATAI), a clinical-stage biopharmaceutical company focused on transforming the treatment of mental health disorders, announced on March 30 its financial results for the fourth quarter and full year 2021. Highlights included positive Phase 2b data with COMP360 from a breakthrough trial in treatment-resistant depression (TRD). Eight new programs had been added to the company’s platform since January 2021, bringing a total of 13 drug discovery and development programs and four enabling technologies to date. atai ended 2021 with a strong cash position of $362 million. At least 14 drug and enabling technology development catalysts are planned over the next two years, including PCN-101 Phase 2a proof-of-concept data in TRD.
Ehave Inc (OTC:EHVVF), a leading healthcare services and technology company, announced on April 19 that its mobile application platform MetaHealthU will enter the market with a focus on determining the cause and finding a possible cure for hallucinogen-persisting perception disorder (HPPD). Ehave pioneered HPPD research efforts by initiating a series of studies through its partnership with the University of Melbourne to gather data and biomarkers to target the disease. As psychedelics become more widely accepted, Ehave‘s MetaHealthU data and biomarkers will help medical and mental health professionals diagnose whether an individual is genetically predisposed to suffer from HPPD. One of the components of MetaHealthU is its digital wallet connectivity with the blockchain, which allows users to aggregate and share their health records securely and seamlessly. The pilot study will begin at the end of the second trimester or the beginning of the third trimester.
Enveric Biosciences Inc (NASDAQ:ENVB), a neuroscience company developing next-generation psychedelic-inspired mental health drugs, has filed a provisional patent application based on new findings by the company. The patent application and claimed drug candidates fall under Enveric‘s EVM201 second-generation psychedelic-derived drug development program, with an initial target indication of Cancer-Related Distress (CRD) and the possibility of being expanded to other mental health indications. Enveric reported a comprehensive net loss of $48.8 million for the year ended December 31, 2021, compared to a net loss of $7 million a year ago. The company had cash and cash equivalents of $17.4 million and working capital of $15.3 million at the end of 2021. After December 31, 2021, the company has raised an additional $10 million and plans to use the funds to advance its novel drug discovery platform, strong intellectual property portfolio, and growing portfolio of promising drug candidates.
On April 12, Numinus Wellness (TSX:NUMI) (OTCQX:NUMIF) announced it will acquire Novamind in an all-share transaction for total consideration of approximately C$26.2 million. Following the transaction, the combined company will operate 13 wellness clinics. Numinus will become one of North America’s leading providers of psychedelic therapies, leading its peer group in revenue with approximately C$10 million in annual pro-forma revenue based on the past four quarters. For the second quarter, Numinus’s revenue grew 240% year-over-year to $800,000. The company achieved a gross margin of 29.1% in the quarter, compared to 6.5% in the prior-year quarter, due to a greater proportion of higher-margin services provided in wellness clinics. Gross profit amounted to $228,759 during Q2 2022, an increase of 349% year-over-year. Numinus ended the quarter with a strong cash position of $48.3 million.
Cybin recently published an international patent application covering inhalation delivery methods for multiple psychedelic molecules. The PCT application will allow Cybin to apply for IP protection for multiple inhaled forms of psychedelic molecules that the company is currently researching and developing.
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