As I delved deeper into my research, I realized that to improve and enhance health, we must turn to nature and medicinal plants like Cannabis.

While Cannabis and medical marijuana can assist with Central Nervous System (CNS) disorders, their effects are often inconsistent and short-lived. The market, valued at around $93 billion, is inadequately served by acute-use cannabis-based drugs. One such example is Epidiolex® recently sold to Jazz Pharmaceuticals for $7.2 billion.

Our approach sets us apart from other cannabis companies by utilizing patented nanotechnologies to sustain the release of cannabinoids in the body, effectively treating chronic pain, anxiety, addiction, and other CNS disorders. 

• Highly competitive, peer reviewed grants (over $10 million) from the National Institutes of Health for manufacturing and nanoencapsulating cannabinoids for cancer pain and addiction
• Strategic collaborations with Rhodes Pharma on THC nanoencapsulation, Alexza Pharma for THCA manufacturing and Prosulus Pharma for transdermal delivery of cannabinoids
• cGMP manufacturing kilogram quantities of highly purified cannabinoids using patented and proprietary SuperFluids carbon dioxide technologies
• Nanoencapsulating cannabinoids using patented SuperFluids polymer and lipid nanoparticle technologies for Marijuana and Opioid Addiction
• Enabling technologies covered by 17 patents including recently granted patent for thermal conversion of CBDA and other carboxylic cannabinoids, US Patent No. 11,981,174

We all have friends and family who suffer from anxiety, pain and addiction. We may also have family and friends who suffer from Multiple Sclerosis and epilepsy. These are the problems that we are addressing.

Addiction: Opioid addiction is a persistent issue, with over 100,000 overdose deaths reported from April 2020 to April 2021. Fentanyl became the leading cause of death for adults aged 18-45 during this time, surpassing car accidents, suicide COVID, and cancer. The FDA has approved only five treatments for opioid use disorder: methadone, buprenorphine, extended-release naltrexone, naloxone, and lofexidine. However, these have limitations, including suboptimal efficacy, low adherence, and serious side effects. Lofexidine is limited to 14 days, unsuitable for long-term use. An urgent need exists for effective, long-term non-opioid treatments for opioid addiction with minimal adverse effects.

Pain is common with age, injuries, and diseases like cancer, which has 2 million U.S. and 20 million global cases annually. About 44% of these cancer patients are treated with chemotherapy and chemotherapy causes peripheral neuropathic pain (CIPNP) in over 80% of patients, with limited treatments beyond opioids, which have significant side effects and addiction risks. CIPNP mechanisms include axonal transport disruption, altered ion channel activity, neuronal injury and inflammation, oxidative stress, and mitochondrial damage. It often limits cancer treatment options. While no clear CIPNP cure exists, approaches like vitamins, pain medicines, and complementary therapies may help. There is an urgent need for effective treatments for CIPNP and other persistent pain conditions.

Anxiety is an evolutionary response tied to our endocannabinoid system, affecting the nervous system. It includes generalized, panic, social, obsessive-compulsive, PTSD, and phobia-related disorders. Generalized Anxiety Disorder (GAD) affects over 38 million Americans, with anxiety rates rising significantly between 2019 and 2021. By 2050, anxiety disorders may impact 87.36 million people. The COVID-19 pandemic has exacerbated this burden, particularly among young individuals. There is an urgent need for targeted global prevention and treatment strategies, especially in the U.S., to address the growing impact of anxiety disorders effectively.

Multiple Sclerosis (MS) is the most common chronic autoimmune disease of the central nervous system (CNS), causing inflammation, demyelination, and axonal degeneration. It affects 2.5 million people globally, including 1 million in the U.S., and is a leading cause of disability in young adults. Women are three times more likely to develop MS, typically diagnosed between ages 20 and 50, though it can occur at any age. Rising prevalence reflects earlier diagnoses, increased survival, and higher incidence. MS also shows social and racial disparities, with U.S. healthcare costs estimated at $85.4 billion annually.

Epilepsy is the fourth most common neurological disorder, affecting 3 million adults and 450,000 children in the U.S., and 51 million worldwide. Despite treatment, 20-30% of patients experience uncontrolled seizures, presenting a market opportunity. Research shows CBD is an effective anti-convulsant, with Epidiolex®, a purified CBD extract, approved for treating Dravet's syndrome. Jazz Pharmaceuticals purchased GW Pharma which obtained FDA approval of Epidiolex® for $7.2 billion. However, Epidiolex® is designed for acute use, not long-term chronic treatment. The global epilepsy drug market was valued at $10.15 billion in 2022 and is projected to grow at a 5.1% CAGR from 2023 to 2030.

• Endocannabinoid System and Health: Our targeted disorders are linked by the fact that we all possess an internal cannabinoid or endocannabinoid system. Imbalances in this system can lead to health issues and impair our ability to respond to negative health influences, both external and internal.
• Challenges with External Cannabinoids: External cannabinoids can help restore balance to our endocannabinoid system. However, cannabis and marijuana, which contain over 60 to 100 unique cannabinoids, interact complexly with our peripheral and central nervous systems. When smoked or vaped, they remain in the body for a brief period. Gummies, which are highly hydrophobic (oil-like), pass through the digestive tract similarly to olive oil, with less than 10% remaining in the body, making them short-lived and non-specific in effect.
• Nanotechnology for Chronic Diseases: Since all our targeted diseases are chronic, we use patented nanoparticles to maintain specific cannabinoids in the body longer and sustain their release over days and weeks. We are transitioning from acute-impact medicines, which can be inconsistent in effectiveness, to extended-release drugs that help rebalance our endocannabinoid system and alleviate suffering from chronic diseases such as pain, anxiety, and addiction.
• Our technology platforms of drug discovery, drug manufacturing and nanotechnology drug delivery are protected by 17 US patents including the recent one, shown on the right-hand side of the slide below, on the thermal conversion of CBDA and other carboxylic cannabinoids.

We have three tiers of competition. Our primary competition in the top left of the cube is Jazz Pharmaceuticals and GW Pharma who developed an immediate release CBD drug called Epidiolex for Dravet’s syndrome that affects a subset of children with epilepsy. As a result of this development, Jazz purchased GW Pharma for $7.2 billion a few years ago.

Other competitors are pharmaceutical companies such as Abbvie producing synthetic immediate release cannabinoids and companies such as Merck, Pfizer and Biogen using synthetic chemicals with huge side effects and addictive potential for similar indications.

We differ from these companies and Jazz by using nanoparticles to sustain cannabinoids in the body longer and extended their release to alleviate suffering from chronic pain, addiction and anxiety.

The total available marketplace (TAM) of this market opportunity at the time of launch of our first product in 2033 is approximately 93 billion dollars. We estimate that the serviceable addressable market (SAM) is about 1/3 or $39 billion and our serviceable obtainable market (SOM) in the United States alone is about $3 billion.

About 35% of the SOM or $1 billion is estimated for opioid use disorder with cancer pain accounting for about 22% followed by anxiety, Multiple Sclerosis and epilepsy, each with about 14 to 15% of the marketplace.

These might seem like varied issues, but they are all connected to our internal or inherent endocannabinoid system that is part of our central and peripheral nervous systems.

Opioid Use Disorder (OUD): The OUD market size was valued at $3.35 billion in 2023 and is projected to grow to $7.48 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9.5%.

Chemotherapy Induced Peripheral Neuropathic Pain (CIPNP): The market size for CIPNP in the seven major markets (US, Germany, Spain, Italy, France, UK and Japan) was around $1.5 billion in 2023.

Anxiety: The global anxiety disorders treatment market size is predicted to increase from $11.5 billion in 2023 growing at a CAGR of 3.6% to approximately $15.9 billion by 2032.

Multiple Sclerosis: The Multiple Sclerosis Drugs market is forecasted to reach $21.52 billion by the year 2024. This projection indicates a steady annual growth rate of 0.98% between 2024 and 2029, leading to a market value of $22.59 billion by 2029.

Epilepsy: The global epilepsy drugs market size was valued at $10.15 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.1% to $15.1 billion in 2030.

Aphios Phama’s pro forma market outcome for our lead opioid use disorder (OUD) product from 2033 to 2043 was determined by independent valuation company Xplico ApS, Denmark. This valuation analysis resulted in a net present value (NPV) for this lead product of $300 million and a risk-adjusted net present value (rNPV) of $69 million.

Our go-to-market (GTM) strategy is product licensing to strategic corporate partners after completing Phase IIb clinical trials with milestone payments and royalties. As a Plan B, we plan to continue development through Phase III clinical trials and filing of an NDA with the FDA. This plan to either be followed by licensing to strategic corporate partners with milestone payment and royalties or direct product sales to consumers. Strategic corporate relationships include competitors.

In parallel, we may GTM with direct to consumer sales for dietary supplement products. This strategy is still being evaluated based on market conditions.

Our potential exit strategy in three to five years is planned to be one or more of three options - strategic corporate partnership or Merger and Acquisition, licensing or IPO.

• “Aphios Granted US Patent for Thermal Conversion of CBDA and Other Carboxylic Acid Cannabinoids” January 15, 2025
• “Aphios Awarded NIH Grant for Combination Therapeutic for Chronic Opioid Use Disorder Relapse” September 06, 2023.
• “Aphios Pharma LLC – Opioid Use Disorder.”
• “Aphios Pharma LLC – Chemotherapy Induced Peripheral Neuropathic Pain (CIPNP).”
• “Aphios Pharma LLC – Anxiety.”
• “Aphios Pharma LLC – Multiple Sclerosis.”
• “Aphios® Pharma LLC to Host Webinar on the Business of Cannabis as a Medicine” July 14, 2022.
• “Aphios Pharma LLC to Host Webinar on the Science and Technology of Cannabis as a Medicine” June 23, 2022.
• “Aphios Pharma LLC to Host Webinar on the Minds, Technology and Science Behind Aphios Pharma” April 21, 2022.
• “Why the US decision to expand marijuana supply for research matters.” Nature. 21 Aug 2016.
• “Cannabis-Based Pharmaceuticals: The Next Frontier?” Life Science Leader. November 2014.

We are a unique scientific and management team with a diversity of backgrounds and experiences in startups to multinationals such as Pfizer and research institutions such as the NIH and MIT.

Our experiences range from natural products drug discovery and nanotechnology to manufacturing and regulatory and clinical affairs as well as financial and accounting management.

We collaborate with highly qualified clinical trial CROs and research institutions such Harvard Medical School, McLean Hospital, Belmont, MA. We operate in a DEA Schedule I facility following cGMP of the US FDA and other federal guidelines.

Our management team consists of Dr. Trevor P. Castor, President & CEO, with over 30 years of biotech experience, Dr. Judith Palmer Castor, Director of Regulatory and clinical affairs with over 20 years of academic and industrial experience, advisor Dr. Val Livada, ex-MIT with over 30 years of startup and multinational business experience and Ms. Catherine Prillo, financial controller with more than 30 years of financial and actuarial experience.

Advisors include Dr. Stacy Gruber, Associate Professor, Harvard Medical School on anxiety, Dr. Brent Boyer, Chief Medical Officer, Drug & Alcohol Treatment Centers on drug addiction, Dr. J Stephen Alexander, Professor of Neurology, Louisiana State University on Multiple Sclerosis and epilepsy, and Dr. Todd Vanderah, Professor of Pharmacology, University of Arizona on pharmacology and cancer pain.

Here are some reasons why you should capture this opportunity and invest now.

• We are addressing highly unmet medical needs of addiction, pain, anxiety and other nervous system disorders.
• We believe these are huge markets with significant investment opportunity.
• We have significant traction from highly competitive NIH grants and collaborations with biopharmaceutical companies.
• We are protected by several (17) patented drug discovery, drug manufacturing and drug delivery nanotechnologies with several more patents pending

Join us in our journey to develop natural therapeutics for chronic disorders and diseases that affect us all. We are endowed with a natural endocannabinoid system, when unbalanced by internal or external forces, can cause or exacerbate these conditions. External cannabinoids can help restore balance to our internal endocannabinoid systems. By leveraging our unique and patented nanotechnology platform, Aphios Pharma’s innovative approach can sustain cannabinoids in the body longer and enhance their therapeutic effects. With your financial support ( or investment), we aim to get these pioneering therapies approved by the FDA. We are inspired by nature and enabled by science.

Sign up and join us to seize this tremendous opportunity offering significant societal benefits. Let me know if you have any questions or you could follow up with me at tcastor@aphios.com, thank you for your interest!