The Breakthrough Therapy Aiming To Solve The World's Mental Health Crisis

FN Media Group Presents GlobalInvestmentDaily.com Market Commentary

LONDON, Sept. 19, 2023 /PRNewswire/ -- Depression is costing the economy $1 trillion in lost production every single year. Yet, a classical compound that even the FDA has twice designated a "breakthrough therapy" is shaping up to potentially be the revolutionary treatment that big pharma has been waiting for. Mentioned in today's commentary includes:  Johnson & Johnson (NYSE: JNJ), AbbVie Inc. (NYSE: ABBV), Atai Life Sciences NV (NASDAQ: ATAI), Compass Pathways PLC (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD).

Scientists say this "miracle compound" can help reset the brain and has huge implications for the treatment of people with...

• Depression and anxiety
• PTSD
• Addiction
• And many other disabling diseases…

But this is a game of patents, and with multi-billion-dollar IP at stake, Big Pharma certainly isn't wasting any time…In fact, Johnson and Johnson (NYSE: JNJ) recently reported massive sales growth for its up-in-coming blockbuster drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market.

As reported on JNJ's most recent earnings call, US & worldwide sales for SPRAVATO were up 93.2% & 98.6% y/y respectively, making it the fastest growing drug in its neuroscience portfolio (by far); and with US $170 million in Q2 2023 sales, J&J CEO, Joaquin Duato, went out of his way on the earnings call to dub SPRAVATO its next $1 billion-plus product…

Some of the core  team behind the SPRAVATO IP recently joined a small but emerging NYSE American listed company on the leading edge of the next biotech breakthrough…

That company  expects to report  Phase 2 clinical data in just a few months, and it recently announced a game-changing agreement to acquire a key strategic asset . The company? Cybin

Cybin (NYSE:CYBN) (NEO:CYBN) is on the leading edge of transformational psychedelic therapeutics , developing novel and proprietary therapeutics to improve clinical outcomes and the mental health and wellbeing of patients. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile, but at a low dose.

Cybin's intellectual property portfolio encompasses several granted U.S. patents in support of its lead candidates – CYB003 and CYB004 - and over 50 pending patent applications across 6 patent families.

Two of the biggest drivers of value for Cybin in the near-term include Phase 2 topline efficacy data for CYB003, expected to be released in the fourth-quarter of this year, and the Phase 1 data for CYB004, also expected before the end of this year.

On August 28, Cybin announced an agreement to acquire  Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies' combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy.

De-Risking Safety and Efficacy: Near-Term Catalysts

Oppenheimer, which has initiated coverage on CYBN, is encouraged by the results so far, and believes the stock will have room to run further with new results expected before the end of the year.

The analysts expect the DMT acquisition to provide Cybin with "key synergies" as it "deepens focus on short treatment duration, expecting late 2023 readouts".

Likewise, in an August 28, 2023 company update, H.C.Wainwright & Co. reiterated its "buy" rating on CYBN, with a price target of US $10.00 per share, after the recent Small Pharma acquisition, which it sees as strengthening Cybin's position in short-acting psychedelics.

The acquisition also gives Cybin access to Small Pharma's SPL026, "which has already demonstrated potential in MDD including rapid antidepressant effects that appear durable for six months based on datasets reported in January and April 2023, H.C.Wainwright noted.

The Proprietary Molecules That Are Changing Mental Health

"The molecular structure of psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms,' allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses," according to Johns Hopkins Center for Psychedelic and Consciousness Research.

What makes Cybin's pipeline so important to the new world of mental health is that from the start, it has set out to create novel and improved psilocybin molecules, while others in the space have been relying on generic materials that are not proprietary. This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending. That makes it the leader of intellectual property in this space.

Cybin has taken two molecules—DMT and psilocybin—and focused on the deuteration, which improves the molecules' efficiency. In other words, it eases the path of the molecule into the brain, making it much faster and much more potent with a lower dose.

Lower doses mean more potency, and proprietary materials will have to lead this charge, giving the company with the most IP a huge advantage.

"Getting it out of the periphery and into the brain is now becoming much faster, without causing side effects," says Drysdale. "If you get the molecules out of the blood stream and into the brain, you're making it more efficient".

There is an enormous need to address Major Depressive Disorder (MDD), the leading cause of disability due to mental illness.

Between 2010 and 2018, the cost of this illness in the U.S. alone soared 38%, affecting 17.5 million adults at a cost of a devastating $326 billion. That bill includes the direct medical costs of treating MDD, treating comorbidities, suicide-related costs and workplace productivity impacts. And that was five years ago. The costs continue to mount.

Another major unmet need in the mental health space is an effective treatment for anxiety disorders, which affect an estimated 18% of the U.S. population alone, or more than 300 million people around the world. Anxiety disorders are the sixth leading cause of disability in adolescents and young adults. Cybin's CYB004 is hoping to address this need.

With the combined power of Cybin and Small Pharma and all the complex and proprietary IP that this merger brings together under a single umbrella, CYBN is positioned for big things in a space that desperately needs to cross the finish line on a new way to treat mental health.

With its IP catalogue, acquisition agreement, and near-term catalysts, Cybin's (CYBN) small $75-million market cap appears to be far below its potential for the coming months and years. with its expected  stage 2 clinical data reveal, this may set up Cybin for an exciting 2024.

A New Era of Healthcare Backed by Big Medicine

Johnson & Johnson (JNJ) is a multinational healthcare behemoth, with its fingers in a myriad of sectors ranging from pharmaceuticals to medical devices and consumer health products. Within the vast expanse of J&J's portfolio, its pharmaceutical subsidiary, Janssen, ventured into the realm of mental health with the development of esketamine, marketed under the brand name Spravato. This nasal spray, which is a close relative of the anesthetic ketamine, received FDA approval for its use in treating treatment-resistant depression.

AbbVie (ABBV), a global powerhouse in the biopharmaceutical world, came into existence after its split from Abbott Laboratories in 2013. Since its inception, AbbVie has been laser-focused on developing treatments for a range of conditions, from rheumatoid arthritis to various forms of cancer.

The acquisition of Allergan by AbbVie brought with it a subtle yet significant pivot towards the psychedelic sector. Allergan, before its acquisition, had shown a keen interest in the potential of psychedelics, investing in research related to their use for mental health conditions.

Atai Life Sciences (ATAI), a clinical-stage biopharmaceutical company, emerged with a clear mission: to revolutionize the treatment of mental health disorders.  Atai's approach to mental health is both comprehensive and innovative. The company boasts a diverse pipeline of compounds, including a range of psychedelics, and has fostered collaborations with various companies to develop groundbreaking therapies.

Compass Pathways (CMPS) stands as a beacon in the realm of mental health care, with its pioneering research in the therapeutic use of psilocybin. Psilocybin, a psychedelic compound found in certain mushrooms, has been the focal point of Compass's research endeavors.

The primary thrust of Compass's research has been the potential application of psilocybin therapy for treatment-resistant depression. Through rigorous clinical trials and research initiatives, Compass Pathways seeks to legitimize and standardize the use of this compound in a therapeutic context

MindMed (MNMD) is a beacon of innovation in the neuro-pharmaceutical landscape. With its roots firmly planted in the exploration of psychedelic substances, the company seeks to unlock new treatment modalities for a range of mental health conditions. MindMed's research portfolio is as diverse as it is promising. The company is actively exploring the therapeutic applications of substances like LSD, MDMA, DMT, and psilocybin. Each compound, with its unique properties, offers a potential avenue for addressing conditions like anxiety, depression, and addiction.

** IMPORTANT NOTICE AND DISCLAIMER -- PLEASE READ CAREFULLY **

PAID ADVERTISEMENT. This article is a paid advertisement.  FTB Capital and its owners, managers, employees, and assigns (collectively "the Publisher") is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. (CYBN) to conduct investor awareness advertising and marketing. CYBN paid the Publisher to produce and disseminate this article and related banner ads for one hundred fifty thousand dollars. This compensation should be viewed as a major conflict with our ability to be unbiased. 

Readers should beware that third parties, profiled companies, and/or their affiliates may liquidate shares of the profiled companies at any time, including at or near the time you receive this communication, which has the potential to hurt share prices. Frequently companies profiled in our articles experience a large increase in volume and share price during the course of investor awareness marketing, which often ends as soon as the investor awareness marketing ceases. The investor awareness marketing may be as brief as one day, after which a large decrease in volume and share price may likely occur.

This communication is not, and should not be construed to be, an offer to sell or a solicitation of an offer to buy any security. Neither this communication nor the Publisher purport to provide a complete analysis of any company or its financial position. The Publisher is not, and does not purport to be, a broker-dealer or registered investment adviser. This communication is not, and should not be construed to be, personalized investment advice directed to or appropriate for any particular investor. Any investment should be made only after consulting a professional investment advisor and only after reviewing the financial statements and other pertinent corporate information about the company. Further, readers are advised to read and carefully consider the Risk Factors identified and discussed in the advertised company's SEC, SEDAR and/or other government filings. Investing in securities, particularly microcap securities, is speculative and carries a high degree of risk. Past performance does not guarantee future results. This communication is based on information generally available to the public, and does not (to the Publisher's knowledge, as confirmed by CYBN) contain any material, non-public information. The information on which it is based is believed to be reliable. Nevertheless, the Publisher cannot guarantee the accuracy or completeness of the information.

FORWARD LOOKING STATEMENTS. This publication contains forward-looking statements, including statements regarding expected continual growth of the featured companies and/or industry. The Publisher notes that statements contained herein that look forward in time, which include everything other than historical information, involve risks and uncertainties that may affect the companies' actual results of operations. Factors that could cause actual results to differ include, but are not limited to, government regulations concerning the products being developed by the company, the size and growth of the market for the companies' products and services, the companies' ability to fund its capital requirements in the near term and long term, pricing pressures, etc. 

INDEMNIFICATION/RELEASE OF LIABILITY. By reading this communication, you acknowledge that you have read and understand this disclaimer, and further that to the greatest extent permitted under law, you release the Publisher, its affiliates, assigns and successors from any and all liability, damages, and injury from this communication. You further warrant that you are solely responsible for any financial outcome that may come from your investment decisions.

TERMS OF USE. By reading this communication you agree that you have reviewed and fully agree to the Terms of Use found here http://GlobalInvestmentDaily.com/Terms-of-Use. If you do not agree to the Terms of Use http://GlobalInvestmentDaily.com/Terms-of-Use, please contact GlobalInvestmentDaily.com to discontinue receiving future communications.

INTELLECTUAL PROPERTY. GlobalInvestmentDaily.com is the Publisher's trademark. All other trademarks used in this communication are the property of their respective trademark holders. The Publisher is not affiliated, connected, or associated with, and is not sponsored, approved, or originated by, the trademark holders unless otherwise stated. No claim is made by the Publisher to any rights in any third-party trademarks.

DISCLAIMER:  GlobalInvestmentDaily.com is Source of all content listed above.  FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with GlobalInvestmentDaily.com or any company mentioned herein.  The commentary, views and opinions expressed in this release by GlobalInvestmentDaily.com are solely those of GlobalInvestmentDaily.com and are not shared by and do not reflect in any manner the views or opinions of FNM.  FNM is not liable for any investment decisions by its readers or subscribers.  FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM was not compensated by any public company mentioned herein to disseminate this press release.  FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

Contact Information:
Media Contact e-mail:  editor@financialnewsmedia.com  U.S. Phone: +1(954)345-0611