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Aphios Pharma LLC

Developing Nanotechnology Solutions for Human Health and Well Being

Pitch Video
Investor Panel

Highlights

1
Green biotech developing sustained release nanoencapsulated cannabinoids for highly unmet chronic medical needs ✨
2
ESG opportunity addressing a $10B market for cancer pain, $5B for opioid use disorder, $20B for anxiety etc. ✨
3
Aphios has spent $47 million to date on developing enabling drug manufacturing and drug delivery technologies ✨
4
Established supercritical fluid manufacturing facility for 1,000 kg pharma-grade cannabinoids per yr under cGMP✨
5
Our proprietary manufacturing and nanoencapsulation technologies are protected by 16 issued and 4 pending patents ✨

Our Team

Medical marijuana has proven to be partially effective for cancer pain, opioid addiction and Multiple Sclerosis. These effects are acute and not effective for the treatment for chronic diseases such as pain and opioid addiction. With nanoencapsulation, we can improve the delivery and efficacy of cannabinoids.

Inspired by Nature, Enabled by Science®

About Aphios Pharma

We are dedicated to the discovery, delivery, development and commercialization of cannabis and hemp-based drugs for Central and Peripheral Nervous System disorders. 

Our initial product targets are pain, including cancer-induced peripheral neuropathic pain (CIPNP), opioid use disorder (OUD), anxiety and Multiple Sclerosis (MS).


What are Internal Cannabinoids?

We, as humans, have an inherent endocannabinoid or internal cannabinoid system – anandamide (AEA) is stimulated by fatty acid hydrolase (FAAH) enzyme. 

Unbalances in our internal endocannabinoid system can create unbalances in our health and our abilities to respond to negative health intrusions. 

Cannabis and hemp can help. Cannabis consists of 60 - 100 bioactive compounds including Δ9-THC and CBD. Hemp primarily contains CBD. 

Cannabis/Hemp have complicated interactions with the Peripheral and Central Nervous Systems and can help rebalance our endocannabinoid system.

The Problem: Pain, Anxiety, Opioids, MS

Millions suffer from pain and anxiety -

  • 50% of cancer patients experience untreated pain
  • Pain from diseases such as MS, age, and injuries

Opioids can be an effective treatment, yet Opioid Use Disorder is a massive problem -

  • Common treatments for Opioid Use Disorder are ineffective

Cannabis can be an effective treatment, but. . . . . .there are problems -

The Problem with External Cannabinoids

When Cannabis is smoked or inhaled, cannabinoids are rapidly absorbed. Cannabinoid composition is not consistent, making it difficult to dose. The impact is very short-lived or acute and not adequate for chronic use. 

When cannabinoids are taken orally, they are rapidly degraded and excreted from our bodies. They are difficult to administer orally because they are hydrophobic with poor bioavailability (~ 6%) which results in over 90 percent loss from the body. 

Cannabinoids can help but we need to keep them in the body longer and protect them from degradation. We can do so by encapsulating cannabinoids in nanoparticles. 

Cancer pain and opioid addiction are primarily treated with synthetic drugs, such as opioids, that have significant adverse side-effects such as addiction.

Our Solution: Sustained Release Nanoparticles

Keep specific, bioactive cannabinoids in the body longer.

Improve stability from oxygen degradation, and protect from enzymes in digestive tract and stomach acids.

Prevent first-pass metabolism by liver enzymes, and keep nanoparticles in circulation longer using pegylation.

Sustained release from breakdown of biodegradable polymers increases bioavailability from ~6%, reduces dosing, improves compliance and efficacy.

Transition acute impact drugs into a sustained release drugs for chronic indications. 

The Market: Opportunity

The Market: Competition 

Traction: Research & Collaborations 

  • Development of Δ9-THC, A Natural Cannabinoid Product, NCI, NIH and Nanoencapsulated Δ9-THC for Marijuana Addiction, NIDA, NIH 
  • Development of cGMP Manufacturing Process for CBD from Cannabis sativa, NIDA, NIH
  • Collaboration with Rhodes Pharma to nanoencapsulate Δ9-THC in biodegradable polymer nanospheres & phospholipid nanosomes
  • Collaboration with Alexza Pharmaceuticals to manufacture Δ9-THC and Δ9 THCA 
  • Collaboration with Prosulus Pharma to manufacture transdermal patches of Δ9-THC and CBD

Traction: Manufacturing & Agreements

  • Developed proprietary technologies for manufacturing and nanoencapsulation of pharmaceutical-grade cannabinoids 
  • Established supercritical fluid manufacturing facility for 1,000 kg/yr pharma-grade cannabinoids under cGMP and fully equipped Schedule I BSL-2 labs 
  • Inventory of 1.8 kilograms of cannabinoids (CBD, CBDA, Δ9-THC, Δ 9-THCA, CBG, CBC, CBN) 
  • Sixteen (16) patents on drug discovery, manufacturing and nanotechnology drug delivery and four (4) pending 
  • Mutual Nondisclosure Agreements (mNDAs) with GW Pharma, Erie Management Group, Fujimoto Pharmaceuticals, Royal Emerald Pharmaceuticals

Traction: Intellectual Property

Our Team: Management 

    Our Team: Scientific Advisors

    Our Team: Key Opinion Leader

    Our Plan: Research & Clinical Strategy

    Isolate and manufacture specific cannabis drugs using patented environmental-friendly supercritical carbon dioxide extraction and chromatographic purification technologies.

    Nanoencapsulate these drugs in biodegradable polymer nanospheres utilizing patented supercritical fluid technologies to significantly improve oral bioavailability and sustain release over 8-24 hours. 

    Conduct rigorous Phase 2 clinical trials to demonstrate safety and efficacy.

    Our Plan: Product Development Schedule

    Our Plan: Funding History, Ask and Exit 

    Our Plan: Business Development Strategy

    Aphios® Pharma LLC strategic commercialization and exit plans will follow one or more of three strategic options: 

    (1) Establish a strategic corporate partnership or M&A with a multinational pharmaceutical company such as Jazz Pharma, Merck, Biogen, AbbVie or Pfizer to develop and commercialize nanocannabinoids on a worldwide basis 

    (2) In this option, we will seek to out-license nanocannabinoids as early as possible in the development cycle, on a regional basis 

    (3) In this option, we will raise $100M in an IPO to continue clinical development and commercialization of nanocannabinoids for CIPNP, anxiety, opioid use disorder, and/or Multiple Sclerosis 

    Investors in the A round can exit on the execution of an M&A in Option 1 or IPO in Option 3

    Exit Strategy: Multiple Opportunities

    Overview