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If you invest, you're betting Psycheceutical Bioscience, Inc. will be worth more than $115.389M in the future.
It seems like everyone these days knows a friend or family member who is struggling with their mental health, or is personally facing such issues themselves–whether it's depression, anxiety, PTSD, or addiction. 90% of adults say the U.S. is experiencing a mental health crisis, and the problem continues to worsen since the COVID-19 pandemic. These serious disorders need a better approach to treatment.
Current treatments for mental health are still based on 1980s technology, using SSRIs and SNRIs to change levels of serotonin in the brain. However, new research has shown no evidence linking serotonin levels to depression or anxiety. Additionally, these medicines are not designed for long-term use, come with numerous side effects, and have shown severe withdrawal symptoms. Neuroscientists are now calling for a fundamental reassessment of how mental illness is treated.
Decades of research have shown that psychedelic medicines have powerful potential for lifesaving mental health treatment by promoting neuroplasticity in the brain. However, for widespread adoption, psychedelics need to be delivered in the same way that pharmaceuticals are – with safe and controlled dosing.
Psycheceutical Inc. is a bioscience company bringing this much-needed innovation for precision psychedelic dosing to the mental health industry. Our mission is to develop cutting-edge delivery technologies to provide the safe and effective delivery of psychedelic medicines. We're combining the brain-enhancing aspects of psychedelics with the controlled dosing of pharmaceuticals –creating “psycheceuticals” that can be used across the mental health treatment spectrum.
The therapeutic use of psychedelics for depression, anxiety, PTSD and more is a booming industry, with billions of dollars being poured into psychedelic drug research and development. Many neuroscientists and physicians believe that psychedelic medicine will become the next major breakthrough in mental health treatment, representing an approximate $400 billion global market size that is expected to reach $540 billion by 2030 (Yahoo Finance, Feb. 2022).
Until now, there have been significant medical and technological limitations keeping psychedelic medicines from being safe, effective, and widely accessible:
Psycheceutical is seeking to remove these barriers by developing two next-generation patented delivery technologies designed to increase the safety and efficacy of psychedelic compounds. Our goal is to provide direct and profound benefits to those suffering from mental health disorders.
This novel precision dosing technology is being developed to:
We believe that our two patented delivery technologies are poised to become the foundation for how psychedelic medicines will be delivered to treat mental health disorders.
NeuroDirect™ Non-Systemic Delivery Technology
(Currently in Phase 1 Clinical Trials)
Psycheceutical’s patented NeuroDirect™ non-systemic delivery technology is being developed to deliver neuroaffective compounds directly into the nervous system through topical application at the back of the neck. This delivery method is expected to act within minutes to enable immediate and sustained delivery, safe dosage control, and consistent results–while avoiding the systemic side effects of psychedelic compounds such as hallucinations, nausea, dizziness, as well as toxicity to the liver and kidneys.
NeuroDirect is intended to be administered at home or on-the-go instead of a clinical setting, which could greatly lower the cost of care for both insurance companies and patients. By making psychedelic medicines safer and cheaper, those suffering from mental health disorders or central nervous system diseases would potentially have greater access to these life-saving treatments.
Janus Particle Systemic Delivery Technology
(Currently in the Pre-clinical Phase)
Psycheceutical’s patented Janus particle systemic delivery system is designed to use nano-sized multi-layered compounds (called Janus particles) to deliver targeted doses of any psychedelic compound directly through the blood-brain barrier.
Our patented manufacturing process can make Janus particles in virtually any size or shape, as some shapes have shown better absorption by certain types of cells. Our Janus particles are intended for lower dosages, which would minimize unwelcome side effects and toxicity by avoiding the stomach, digestive tract, and liver. This delivery method is designed to improve the effectiveness of the active components, target specific cells, and deliver multiple medicines at the same time or in time-release.
Drug Pipeline
Our initial focus for our drug pipeline is using the FDA 505(b)(2) regulatory pathway for new drug applications (NDAs), which have full safety and effectiveness reports but can reference some of the information required for approval from other data and study results. Our 505(b)(2) drugs use established, unmodified psychedelic molecules with decades of supporting clinical data, which can result in a much less expensive and much faster route to approval while creating new products with tremendous commercial value.
Other psychedelic companies in the industry are typically following the traditional 505(b)(1) development pathway by attempting to modify the molecular structure of psychedelic compounds to remove the psychedelic effects. This requires extensive FDA approvals and preclinical studies, leading to higher expenses and longer timelines.
Treatment of PTSD
The first drug in our development pipeline is our NeuroDirect ketamine topical cream for the treatment of PTSD. We’ve selected ketamine because it’s currently the only legal psychedelic compound. The market size for PTSD treatment is over $16 billion per year, and there are no known effective therapeutic solutions currently available.
Our novel NeuroDirect ketamine topical has already shown positive preclinical results in a recently published study in Drug Development & Delivery. In 100 patients with intractable depression, anxiety, and other symptoms commonly associated with PTSD who had failed numerous other treatments, more than 80% experienced symptom relief from the NeuroDirect ketamine cream.
“Discernible improvement[s] in anxiety, depression, paranoia and unrealistic fear, focusing issues, cloudy thinking, neuropathic pain, and other such symptoms were noted within 8-10 minutes of topical drug application. No psychogenic effects, such as hallucinations or dissociative phenomena, were experienced by any patient. To the contrary, patients indicated their thought processes were clearer, more focused, and that they were more keenly aware of surroundings.”
We recently announced the completion of dosing of the first cohort of subjects in a Phase I clinical trial of our NeuroDirect topical ketamine formulation for the treatment of PTSD. Key results from the cohort confirmed the topical administration of NeuroDirect ketamine to be successful, safe and well-tolerated. Psycheceutical’s clinical trial program is the first ever to test the topical application of ketamine for use in treating a mental health disorder (source: ClinicalTrials.gov). Phase II clinical trials for NeuroDirect ketamine topical are planned for the beginning of 2024.
Treatment of Addiction
The next compound in our development pipeline will focus on the treatment of substance abuse disorders. The current market for treatment of substance abuse in the U.S. is more than $35 billion annually, with patient relapse rates estimated at 40-60%. There are currently no therapeutics on the market that have shown the ability to consistently and effectively treat cravings, withdrawal, and other symptoms that are experienced by those battling with substance abuse.
We have received positive initial feedback from the National Institute of Drug Abuse and the FDA about our development strategy to seek fast-track approval of our substance abuse product to combat the current addiction crisis.
During the next few years, a higher frequency of mental health illnesses combined with a greater awareness of mental health is expected to fuel a global market expansion for psychedelic medications. Mental health disorders result in large economic costs to those afflicted, their families, and society as a whole. The United States alone already spends nearly over $280 billion on mental health treatments annually, with current therapies only showing marginal efficacy. Psychedelic medicines have the potential to capture a huge share of this market, while having greater effectiveness, reduced risk, and the potential for a dramatic improvement in quality of life for up to one billion people.
Leadership
Members of the Psycheceutical team
We’ve assembled an incredibly talented and diverse team, consisting of medical doctors and specialists, biotechnology scientists, FDA regulatory advisors, psychedelic industry insiders, and business development experts.
We’re honored to have famed entrepreneur and “Original Shark” from Shark Tank, Kevin Harrington, as an investor and Strategic Advisor to provide expertise on the company’s growth and development. Kevin is an advocate of mental health, and sees psychedelic medicines as the future of mental health treatment. He believes the psychedelic medicine industry will be worth over $1 trillion dollars in the next few decades, and chose to invest in Psycheceutical because our patented delivery technologies could benefit the entire industry.
Medical Team
Our Medical Advisory Board is led by our Chief Medical Officer, Dr. Julian Bailes, a world-renowned leader in the field of neurosurgery. Bailes was played by Alec Baldwin in the movie Concussion with Will Smith, detailing his discovery of CTE brain injury in athletes. His leadership and expertise have been invaluable, particularly for our strategy to deliver drugs to specific receptor sites in the brain. The Board also includes cardiologist Dr. Thomas Cabell and neuropsychologist Dr. Tony Strickland, who work in tandem with the company’s scientific team in identifying and reviewing outstanding molecules to bring through the drug discovery and development process to clinical application.
Science Team
Our science team includes the inventors of our two patents: our Chief Science Officer Dr. Anish Tuteja, and our Clinical Advisor Dr. Ronald Aung-Din. The work of Dr. Tuteja at the University of Michigan has led to over 20 patents and patent disclosures including our Janus Particle manufacturing technology, while Dr. Aung-Din has been granted 13 patents related to his NeuroDirect technology. Our regulatory and research advisors are guiding our clinical trial processes as we continue to add new intellectual property to our portfolio to further shareholder value.
Psycheceutical has been honored to be featured extensively in the media, as excitement builds about our breakthrough biotechnology. Check out our Press Room to see press features, our press releases, and podcasts our team members have been featured on.
Here are some notable articles written about us:
Our growth strategy is to continue development efforts for our delivery technologies and our planned drug development programs. We then plan to focus on revenue opportunities through the licensing of our proprietary assets and the commercialization of the drugs that come out of our drug development efforts.
Licensing
It is our expectation to be able to generate revenues through the licensing of our drug delivery technologies to pharmaceutical and psychedelic drug development companies in exchange for customary upfront cash payments, milestone payments, and royalty payments.
In-house IP and Drug Development
We intend to develop and then commercialize our own unique drugs as well as intellectual property surrounding drug delivery technologies and formulations in the psychedelic and neurological spaces.
Psycheceutical finds itself in a mode of “coopetition,” since we believe existing companies who are developing pharmaceutical approaches will require our novel delivery systems to more effectively deliver their products.
Strategic Partnership with Vici Health Sciences
Members of the Psycheceutical team meeting with the founders of Vici Health Sciences at their formulation lab in Maryland
Psycheceutical has entered into an exclusive option to acquire a majority equity ownership stake in Vici Health Sciences, a state-of-the-art formulation and testing lab in Maryland. Vici is a DEA Schedule 1-5 licensed facility, meaning they can legally synthesize and formulate all psychedelic compounds. This opportunity would allow us to establish vertical integration, allowing our drug development pipeline to move quickly and without interruption.
Summary
Unfortunately, mental health conditions are on the rise worldwide. In the U.S. alone, more than 50% of Americans will be diagnosed with a mental illness or disorder at some point in their life. Effective mental health treatments have been sorely lacking for decades, and millions of people continue to suffer. While psychedelic medicines have shown incredible promise, they need to be safe, effective, and delivered in controlled dosages to be approved for use by the general public.
Psycheceutical has the team and the technology to take on the mental illness crisis. Our patented delivery technologies can potentially benefit the entire emerging psychedelic medicine industry, projected to be worth more than $1 trillion dollars in the coming decades. By becoming a shareholder today, you can join us in our mission to be part of the solution for mental health care and to truly make a difference in the world.
