Hope on the Horizon: Psychedelics Offer Potential for Transforming Mental Health Treatments

NEW YORK, Dec. 16, 2020 /PRNewswire/ -- More than 700 million people worldwide are affected with some form of mental illness, addiction or eating disorder, representing about 13% of total disease burden. In reality, the worldwide picture is a bit murky, considering the high frequency of nondiagnosis as well as lack of treatment, even in the most developed countries. Advances in medicine to treat these conditions of the brain have been elusive, as conventional drugs that treat symptoms and not underlying causes remain the most popular. There are reasons to be optimistic about the future, though, underscored by increased research activity surrounding psychedelics. This is the area of focus for Cybin Inc. (NEO: CYBN) (Profile), which this week acquired Adelia Therapeutics, a transformational move that broadened addressable indications in its pipeline and strengthened its scientific team. Cybin has a three-pillar approach,  its initial sights set on treating major depression disorder (MDD) now expanded to address additional indication as well through innovative psychedelic therapeutics development and unique delivery technologies. Cybin stands shoulder-to-shoulder with peers striving for a world of better mental well-being such as COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine Inc (OTC: MMEDF) (NEO: MMED), Numinus Wellness Inc. (OTC: LKYSF) (NEO: NUMI) (TSX.V: NUMI) and HAVN Life Sciences (OTC: HAVLF), all of which are developing innovative approaches to bring new psychedelic-based therapies to patients in need.

• Mental health disorders forecast to cost $16 trillion by 2030.
• Cybin's acquisition of Adelia Therapeutics accelerates growth strategy, bolsters world-class scientific team, increases IP portfolio to seven patent filings.
• The company executes on three-pillar growth plan focused on developing psychedelic-based drug discovery platform, efficient drug-delivery methods and novel treatment regimens.

Click here to view the custom infographic of the Cybin editorial.

Time for Effective Options to Alleviate the Pain, Financial Strain

More than 700 million people dealing with illnesses takes a toll on health-care systems. By 2030, it is estimated that the aggregate cost of mental health maladies to the global economy could reach a stunning $16 trillion. The problem is not that there aren't options to treat a disease such as depression; there are many, including selective serotonin reuptake inhibitors (SSRI) such as Prozac (fluoxetine), and serotonin and norepinephrine reuptake inhibitors (SNRI) such as Effexor XR (venlafaxine).

In fact, more than 40 million Americans take antidepressants or some other type of psychiatric drug. No, the problem is not availability. The problem lies more in conventional drugs often being accompanied by negative side effects and doing more to mask the disease rather than get to the root of the condition.

Meeting Promises

Toronto-based Cybin Inc. (NEO: CYBN) is developing technologies and delivery systems, aiming to improve bioavailability to potentially achieve the desired medicinal effects of psychedelics at low-dosage levels. In its latest move, the company acquired Adelia Therapeutics. The acquisition combines two talented management and scientific teams while also bringing an attractive intellectual property portfolio of seven patent filings with further IP development and expanding Cybin's focus beyond treatment of MDD to include multiple indications.

"We are thrilled to join forces with Adelia, as we see this transaction as potentially advancing Cybin's ability to innovate our psychedelic drug development program and diversify beyond major depressive disorder," said Cybin CEO Doug Drysdale. "Adelia's focus on creating novel therapeutics, including novel delivery methods and innovative therapeutic regimens can support our goal of creating therapies that result in faster onset of action, smoother pharmacokinetic profiles, shorter treatment durations, and reduced side effects. Leveraging Adelia's expertise across multiple molecules and multiple indications could potentially allow Cybin to extend its reach and capability to address gaps across a larger domain."

"Cybin is committed to expansion through strategic M&A opportunities," he continued. "Today we deliver on that commitment and we will continue to pursue such opportunities to drive growth in the future."

The acquisition dovetails perfectly with Cybin's already stated drug-delivery goals, bringing onboard a proprietary drug-delivery platform developed by Adelia for the controlled administration of psychedelic therapies that bypass the problems with conventional administration and liver metabolism.

This move reinforces Cybin's focus on R&D of next-generation medications based on psilocybin, a nonhabit forming, naturally occurring psychedelic compound found in certain species of so-called "magic" mushrooms, for the treatment of MDD. Clinical studies at Johns Hopkins revealed that psilocybin, given with supportive psychotherapy, produced rapid and large reductions in depressive symptoms, with most participants showing improvement and half of study participants actually achieving remission through a four-week follow-up.

Impressive Team Additions

Cybin intends to be a leader in this exciting breakthrough for mental health. In its efforts, the company has assembled an experienced team with a combined 80-plus years in the pharmaceutical industry that recently raised C$45 million in the largest go-public capital raise in the Canadian psychedelic sector and total of C$55 million raised across Seed, Series-A and Series-B financing rounds. Part of that capital is now being deployed in a powerful move to acquire Adelia Therapeutics Inc., further bolstering the fundamental strengths of Cybin.

While raising capital, Cybin shared it three-pillar plan of building a novel drug-discovery platform, developing optimal technology and novel treatment regimens. The IP model is multipronged, covering chemically synthesized molecules, delivery mechanisms, screeners, protocols and new drug formulations alongside a merger and acquisition strategy to acquire proprietary technologies and novel compounds and molecules. Cybin also holds worldwide exclusive rights to sublingual film delivery technology from Intelgenx for the delivery of psilocybin and other psychedelic molecules.

The leadership team joining Cybin is impressive, including co-founder and CEO Alex Nivorozhkin, PhD and co-founder, and president and chief strategy officer Brett J. Greene, both of whom bring decades of experience in psychedelics and drug development and are affiliated with Northeastern University's world-renowned Center for Drug Discovery in Boston. COO Michael Palfreyman, PhD, DSc., is an accomplished pharmaceutical industry veteran responsible for more than 30 successful clinical programs.

Members of the Adelia team have CV's steeped in success, such as 35 successful exits, work developing proprietary ketamine analogs, experience with major pharmas (e.g., Johnson&Johnson, Pfizer, Roche), a wealth of highly cited peer-reviewed publications, and oversight in the R&D and commercialization of drugs such as Allegra (fexofenadine), Sabril (vigabatrin), Anzemet (dolasetron), and Vaniqa (eflornithine). The team further brings a Rolodex of major network affiliations, including the likes of Massachusetts Institute of Technology, Harvard, Stanford, Yale and Northeastern University.

An Operating Facility Too

With the acquisition, Cybin is significantly broadening its footprint in the United States. In addition to the reach and esteemed networks of Adelia's leadership team, the company is also gaining an operating development facility in the epicenter of Boston biotech, a heartbeat of innovation in the country.

"Cybin brings complementary resources to the table, and together we can advance our shared goal of bringing psychedelic therapies across a broad spectrum of indications," commented Nivorozhkin, who will assume the role of Cybin chief scientific officer upon completion of the acquisition. "[We] look forward to the opportunity to transform the psychedelic therapeutics industry together," he said.

A Movement Underway

The world is seeing a resurgence in interest in psychedelics after a relative standstill that lasted several decades. Only older generations recall a growing body of evidence supporting the therapeutic advantages of psychedelics before 1970. To the demise of the emerging health-care segment, President Richard Nixon signed the Controlled Substances Act into law that year, outlawing psychedelics as Schedule I drugs with no medicinal benefits.

Small amounts of research in specific academic pockets have been completed over the years, but the acceleration in lab and clinical work has been tied to the legalization of cannabis amid public outcries for new medical options in recent years. Finally, the negative stigma is abating and lawmakers at state and local levels are taking the initiative to open the door to developing new therapies. Following the pioneering lead of Denver, Colorado, three other major U.S. cities have legalized psychedelics in the last year, along with the state of Oregon.

COMPASS Pathways Plc (NASDAQ: CMPS) has effectively served as a tide that has elevated the entire psychedelics space, earning attention from institutions and retail traders alike with a high-profile initial public offering in September and spectacular ascension in value since. From its headquarters in the United Kingdom, COMPASS is regarded by most as the gold standard in psychedelics because it is in mid-stage clinical trials evaluating its synthetic version of psilocybin for use in treatment-resistant depression. The company is developing its psilocybin program for the indication under a Breakthrough Therapy designation from the FDA.

Much like COMPASS, Mind Medicine Inc (OTC: MMEDF) (NEO: MMED) embodies the attention psychedelics are getting, enabling the raising of capital to support large leadership and advisory teams, which includes Bruce Linton, a co-founder and former CEO of Canopy Growth Corp., the largest cannabis company in the world. MindMed is developing several experimental therapies in its pipeline derived from psychedelics without the hallucination effect. The flagship product in 18-MC, which the company is developing to treat the cause of the brain disease that is addiction rather than merely substituting one addictive substance for another less harmful one.

Numinus Wellness Inc. (OTC: LKYSF) (NEO: NUMI) (TSX.V: NUMI) is bringing a diversified approach to the industry to create a mental health company with a complete ecosystem for making psychedelic-assisted psychotherapy available to people in need. Numinus is integrated, with a Health Canada-licensed laboratory for research and analytics services (Numinus Bioscience), a unit (Numinus R&D) for developing new psychedelic-assisted therapeutic protocols and a third division (Numiness Health) that provides treatments to patients through clinical and virtual services. The company can trumpet many first-mover advantages, including being the first company in Canada to receive a license to grow and extract psilocybin from mushrooms, for which the first harvest was recently completed.

HAVN Life Sciences (OTC: HAVLF) is an active part of the Canadian biotech community, researching the benefits of microdosing a variety of psychedelics for hard-to-treat conditions while pursuing standardized extraction of psychoactive compounds under a research license from Health Canada. There is a feel-good component to the HAVN mission in that it works with veterans and military thought leaders in its quest to initiate clinical trials addressing post-traumatic stress disorder (PTSD) and other trauma related ailments. A Memorandum of Understanding was inked this month for the purpose of HAVN supplying the international veterans organization Heroic Hearts Project for collaboration on future clinical studies planned to evaluate low doses of ayahuasca, psilocybin and ketamine in mental trauma patients.

The world is witnessing a genuine progression into the opportunity psychedelics present to make a meaningful impact on an area of health care that is ripe for innovation. This movement is quietly being spearheaded by seasoned and successful drug-development veterans and supported by the investment community, providing some real reason for optimism about potential breakthroughs to bridge some large unattended gaps in mental health.

For more information about Cybin Inc., please visit Cybin Inc. (NEO: CYBN)

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