Investment Opportunity in Early-Stage Regenerative Medicine

Cytonics Corporation – Developing First-in-Class Therapies for Osteoarthritis
June 27, 2020

Through conversations with potential investors, Cytonics has received a number of insightful questions - below you will find answers to recurring questions. If you have a question not answered here, please reach out or join the discussion on our SeedInvest profile page.

What is the key innovation of Cytonics’ technology?

Alpha-2-Macroglobulin (A2M) is a naturally-occurring blood serum protein that has been shown to protect against cartilage breakdown by inhibiting a class of deleterious enzymes (called “proteases”) which degrade the cartilage cushion and cause joint pain/inflammation. A2M inhibits all the inflammatory mediators of the process, eliminating the burden on the immune system and allowing the body to heal itself efficiently. Unfortunately, the levels of naturally occurring A2M are insufficient to completely halt the progression of OA and can only delay the onset of symptoms at best. Cytonics has demonstrated that hyper-concentrating A2M within the joint cavity can halt the progression of OA, allowing the body to heal itself and bring about significant relief to the suffering patient. Cytonics’ Autologous Platelet Integrated Concentration (APIC™) System was developed with the intent of delivering high concentrations of A2M into damaged joints. The APIC™ system utilizes a proprietary filtration process to selectively concentrate A2M and remove inflammatory proteins from a patient’s own blood. Over 7,000 patients have been treated to-date!

How does your drug development pipeline align with your commercialized technologies?

Our First-in-Class drug development pipeline is predicated on the activity of Alpha-2-Macrglobulin and the success of the APIC treatment. We have engineered a synthetic variant of the A2M molecule (“CYT-108”) which we have shown to be more effective than the naturally occurring A2M found in your bloodstream. We are also able to deliver CYT-108 in high concentrations without the need for the patient’s own blood. If successful, CYT-108 will be the only approved therapy to treat the root cause of osteoarthritis.

Why seek funding via the Regulation A+ route instead of Venture Capital?

Regulation A+ is a unique capital raising method because it allows the public to participate in early-stage companies that have the potential to be disruptive. Venture Capital is more inclined to invest in later-stage companies that are less risky, but at a higher price. The beauty of the Reg A+ is that we can offer the public the ability to get in on the ground floor at a low valuation, grow with the company, and participate in the development of a technology that could truly revolutionize regenerative medicine!

What are the risks involved in this investment?

Early-stage biotech investing is not for everyone. The risk is high. The reward is higher. Seasoned investors know the game, but with the abundance of opportunities to invest in early-stage biotech R&D, the attractiveness of the investment must be based on key selection criteria: strong management backed by key opinion leaders in the field, a track record of accomplishing research and clinical milestones, cap table backed by sophisticated and institutional investors, and a patented technology that can disrupt a sufficiently large market. The largest barrier to success is the FDA regulatory approval pathway. Clinical trials are very risky, but this risk can be mitigated. Cytonics’ risk mitigation strategy includes: engaging strategic advisors to lead us through the clinical trial and regulatory process, relying on our previous experience bringing a healthcare technology (the APIC system) to market, seeking continued support from Johnson and Johnson (who owns ~14% of the company), and the prosecution of an airtight IP portfolio that will be attractive to a potential buyer (8 international patents granted, 9 more pending). Importantly, the development of CYT-108 is significantly de-risked compared to other drug development projects because it is based upon the action of the naturally occurring Alpha-2-Macroglobulin (A2M) molecule, which we have already demonstrated to be an effective treatment for osteoarthritis with our commercially and clinically successful APIC system. CYT-108 is a synthetic version of A2M and was developed much like insulin was by Eli Lilly when they engineered a version of the naturally occurring insulin molecule.

When do you see Cytonics being profitable for investors?

Our exit strategy is either acquisition of the company's entire IP portfolio or licensing of the technology to Big Pharma for further development. This typically happens when an experimental drug has Phase 2 results, which we expect by 2025. The value of the company increases incrementally at each successive Phase of the clinical trial process, and our goal is to maximize shareholder value by demonstrating the clinical success of CYT-108 to Big Pharma. We may also provide liquidity to early investors by uplisting to a major exchange (such as the NASDAQ).

How will your patent portfolio prevent duplication of your technologies?

The key innovation of Cytonics' technology is the blocking of certain enzymes from degrading the cartilage in arthritic joints. This is accomplished by CYT-108 binding to these enzymes (proteases) and inhibiting their activity at specific binding sites. We have identified the binding sites to all 3 major classes of proteases that CYT-108 interacts with and inhibits. It would be extremely difficult to replicate this strategy without interacting with some, if not all, of our protected binding sites. This was a very clever way of patenting CYT-108 because it does not just protect a synthetic A2M therapy, it protects the mechanism of action of the drug. Additionally, there is a large R&D barrier to entry - Producing and purifying CYT-108 is an extremely difficult process that took us 2 years to optimize (due to the size and physiochemical properties of the molecule). It is possible that another group could create a competing technology, but it is unlikely that they will be able to do so in a profitable way.

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see slides 16 and 17 for preclinical study results