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(NEO: CYBN) Cybin Company Update

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Cybin Inc. is a Toronto-based biotechnology company developing novel treatments and therapeutics for psychiatric disorders based on advancing psychedelic compounds. Truffle Report has compiled a roundup of recent company news, making it easier for you to access these insights in one place.

OTCQB Venture Market

On March 3, Cybin announced its successful uplisting from the OTC Pink Sheets to the OTCQB Venture Market (OTCQB). This was followed by the March 8 announcement that its shares had commenced trading on the OTCQB while continuing to trade on the NEO Exchange under the symbol “CYBN.”

“With the commencement of trading on the OTCQB, Cybin has achieved another important milestone on its path to advancing mental health care through evidence-based therapeutics. This additional capital markets exposure offers us greater visibility within the investment community, which should enhance our liquidity and increase our access to institutional and retail investors. This support is extremely valuable to us as we continue to progress our psychedelic drug development programs that target mental health disorders, such as Major Depressive Disorder, and other therapy-resistant psychiatric disorders,” said Doug Drysdale, CEO of Cybin.

Canaccord Targets $8 CAD/Share for Cybin

Global financial services firm Canaccord Genuity published a DCF analysis of Cybin’s share price. The international investment banking and financial services company initiated coverage of Cybin with a price target of $8 CAD, according to the March 15th report.

Factors driving this prediction included: 

  • The advancing progress of Cybin’s drug development program, including sublingual strips for the therapeutic administration of psilocybin
  • The significance of Major Depressive Disorder as the chief indication being pursued, given the unmet demand for effective treatments
  • Cybin’s “relatively broad pipeline, from which at least two other candidates could enter the clinic over the next 24 months or so”

The report fully disclaims that it’s calculations and valuation are based on model assumptions, among these being the crucial calculation on Canaccord’s part of a 50 percent probability of approval for Cybin’s MDD product by U.S. regulators. A change in that probability figure could easily see a corresponding increase or decrease in valuation.

Completion of 20th Pre-Clinical Study and Progressing its Psychedelic IND

On March 17, Cybin announced that it had completed its 20th pre-clinical study, and that was progressing its CYB003 and CYB004 proprietary psychedelic molecules into Investigational New Drug (IND)- enabling studies. Cybin completed key research studies both in vitro and in vivo, which led to the progression of both promising development candidates.

“Excellent team-work and fully supportive partners have greatly facilitated the advancement of these two new therapeutic candidates with enhanced and improved properties. We look forward to rapid progress towards clinical studies,” stated Michael Palfreyman, Chief R&D Officer of Cybin.

Catalent Agreement

On March 22, Cybin announced the signing of a drug development agreement with Catalent Inc., a leading global provider of advanced delivery technologies, development and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. Cybin will be applying Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology for the delivery of a proprietary deuterated tryptamine (CYB003), a potential therapy for treatment-resistant psychiatric disorders. Zydis technology creates a tablet that disperses almost immediately in the mouth without water. Cybin believes that delivering CYB003 in such a dose could have significant benefits. The project is due to commence in April 2021.

Jonathan Arnold, President of Oral and Specialty Delivery at Catalent, commented, “We look forward to working with Cybin to potentially develop a novel and fast-acting therapy for treatment-resistant psychiatric disorders. The Zydis platform is an ideal technology to leverage for this type of drug formulation, as pre-gastric absorption is crucial for efficacy.”

Doug Drysdale added, “We are excited to partner with the team at Catalent with the aim of developing fast-acting, shorter-duration formulations of CYB003, recently acquired as part of our acquisition of Adelia Therapeutics. Our focus on reducing the need for health system resources, such as in-clinic therapist time, is an important part of our goal to create scalable, more accessible treatments for mental health disorders.”

Senior Management Changes in the United States and Europe

On March 30, Cybin announced key senior management changes “to lead the buildout of its development and clinical operations in the United States and Europe.”

Management changes effective immediately from that date include:

  • Alexander Belser, PhD, Chief Clinical Officer. Dr. Belser served as an investigator on clinical trials of psilocybin and MDMA to treat depression, anxiety, substance use, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and end-of-life distress at New York University and Yale University. Dr. Belser previously served as Chief Clinical Officer at Adelia Therapeutics, where he directed the clinical program investigating tryptamines and phenethylamines for a variety of treatment indications.
  • Aaron Bartlone, Chief Operating Officer of Cybin U.S. Holdings Inc. Prior to joining Cybin, Bartlone was President & Managing Director at AB Dynamix LLC, where he was responsible for developing customized and innovative quality management systems, regulatory strategies, and supply chains for pharmaceutical, biotechnology, and medical device companies. 
  • Paul Glavine, co-founder and former Chief Operating Officer, will assume the role of Chief Growth Officer of Cybin Inc.
  • John Kanakis, co-founder and former SVP, Business Development, will assume the role of Chief Business Officer.

“We are committed to building our presence both in the United States and in Europe to advance our mission of improving mental healthcare through therapeutic development programs and innovative drug delivery systems. These appointments will serve to strengthen our development and clinical operations globally and solidify Cybin’s position within the industry. Alex and Aaron bring deep clinical, commercial and regulatory expertise that will serve to broaden our management and scientific leadership teams. We look forward to their contributions as we pursue increased visibility across these additional markets,” stated Doug Drysdale.

“Paul and John’s extensive entrepreneurial experience was instrumental in shaping the initial formation of Cybin and the company’s subsequent emergence as a leader within the psychedelics space. Their deep commitment to Cybin’s mission will continue as they assume these new roles and will allow them to further accelerate business development and investor awareness initiatives. We believe these appointments are an important step in taking Cybin to the next level,” Drysdale concluded.

IND-Enabling Studies for CYB003 and CYB004

On April 13, Cybin announced plans to advance the pre-clinical work for its orally dissolving tablet (ODT) formulation of CYB003 and its inhaled formulation of CYB004. The studies are part of the required FDA enabling trials for investigational new drug applications (IND).

“Starting the IND-enabling trials for CYB003 and CYB004 is an exciting and important step forward for Cybin as we progress the study of these molecules. Our scientific team is eager to produce a robust submission to the FDA that will advance our path forward to clinical trials. Once the studies have been completed, we plan to file IND applications, targeting treatment-resistant psychiatric disorders and certain forms of addiction, in 2021,” stated Doug Drysdale.

Upon successful completion, the results in the IND studies will be included in the submissions to the FDA, Health Canada, and European Medical Association (EMA), and then advance into Phase 1 human clinical trials for specified psychiatric conditions. 

Roth Capital Covers Cybin Shares at $10 CAD Price Target

Roth Capital Partners, an investment banking firm headquartered in Newport Beach, California, has initiated price coverage of Cybin Inc., a Toronto, Canada based developer of alternative medicalized psychedelic compounds, with an initial price target of $10 CAD per share. 

The 67-page report from Roth lists factors in its buy rating and 12-month targeted valuation of Cybin as including:

  • Cybin’s “ingenious ways to alter formulations and develop deuterated analogues of psychedelics, creating novel intellectual property”
  • Recently published research materials by Imperial College London indicating that results with psilocybin in the treatment of major depression compare favourably to SSRIs, the current preferred pharmacological option
  • The urgent need and potential revenues associated with the creation of novel and effective therapeutics to address Treatment-Resistant Depression (TRD) 

Truffle Report wishes to disclose that Cybin Inc. is a client of our parent company, Puff Digital.

#Psychedelic use is on the rise among college-age adults in the US. - @lucidnewssite

'Early 2020 saw psychedelic use among college-age young adults reach its highest levels since 1982, the culmination of a five-year upward trend.'

https://www.lucid.news/psychedelic-usage-is-on-the-rise-among-college-age-adults/

Great review on the impact of psychedelics on neuroplasticity from the team at Maastricht!
https://www.frontiersin.org/articles/10.3389/fpsyt.2021.724606/full

Why More Young Women Are Taking Shrooms

"...young women report taking shrooms recreationally and doing it predominantly to aid their mental health."

https://www.refinery29.com/en-gb/2021/10/10709718/mental-health-benefits-mushrooms

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