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Disrupting a $180B Market

Osteoarthritis is the most common form of arthritis, affecting millions worldwide with over $180B spent globally on treatments each year. Cytonics’ mission is to develop first-in-class therapies for treating osteoarthritis.

25% Of adults by year 2030

Over 27M Americans currently suffer from Osteoarthritis, and with the aging population incidence of Osteoarthritis is projected to reach 25% of the adult population in the US by 2030.

Over 27 Million Americans

Current Therapies Only Address Symptoms

Limited treatment options for Osteoarthritis exist, and the current therapies are all palliative. They only address the symptoms but fail to address the root cause: cartilage damage from the activity of degradative enzymes (proteases) that destroy the arthritic joint.

That’s why Cytonics developed a novel treatment to operate at the molecular level. A successful treatment must combat the degradative enzymes at a molecular level.

Treatment Options

  • Non-steroidal Anti-inflammatory
    Drugs (e.g., Advil)
  • Hyaluronic Acid (Essential component of cartilage)
  • Corticosteroids (e.g., Prednisone)

Poor Outcomes

  • Temporary symptomatic relief
  • Treats the symptoms, not the cause
  • Many side effects

The Path to an Innovative Discovery

1

Key Insight

Cytonics discovered alpha-2-macroglobulin (A2M) as a potent inhibitor of the cartilage-destroying proteases that cause Osteoarthritis. A2M is found naturally in the blood. Cytonics theorized that delivering high concentrations of A2M directly into the joint could bind to and inhibit the enzymes that cause arthritis, in order to slow and eventually halt the progression of Osteoarthritis.

2

Validation and Traction

Cytonics developed the Autologous Platelet Integrated Concentration (APIC) system to selectively enrich A2M from a patient’s blood and deliver high concentrations of the therapeutic A2M to the joint, which eliminates all of the damaging molecules that cause Osteoarthritis. The APIC system successfully treated over 7,000 patients nationwide. Read the patient and physician testimonials here.

3

Seeking FDA Approval

The clinical success of the APIC system led Cytonics to the development of CYT-108, a synthetic variant of the naturally occurring protein, A2M. Test data for CYT-108 show a substantial improvement in cartilage protection. See the results here.

The Patented Science behind Cytonics

An effective treatment for Osteoarthritis would have a tremendous impact on both human well-being and the economic burden of the disease, as over $180B is spent treating Osteoarthritis per year.

Cytonics discovered alpha-2-macroglobulin (A2M) as a potent inhibitor of the cartilage-destroying proteases. A2M is found naturally in the blood. While the natural levels of A2M are too low to lend any therapeutic benefit to damaged joints, Cytonics theorized that delivering high concentrations of A2M directly into the joint space could bind to and inhibit the proteases, slowing and eventually halting the progression of Osteoarthritis.

Our Autologous Platelet Integrated Concentration (APIC) system selectively enriches for A2M from a patient’s own blood, delivering high concentrations of the therapeutic A2M to the joint and eliminating all of the damaging molecules.

This is achieved by drawing and centrifuging the patient’s blood, then filtering out all of the proteins that could cause damage to the joint (such as proteases and inflammatory cytokines) and selectively concentrating A2M.

APIC’s successful treatment of over 7,000 patients nationwide led to the development of CYT-108, the synthetic A2M variant with test data showing a substantial improvement in cartilage protection. See the results here.

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Pre-clinical research on CYT-108: the Data is in, and CYT-108 Works

Preliminary preclinical data demonstrate CYT-108’s efficacy in preserving the cartilage and surrounding tissues (e.g., synovial membrane) in a large animal model of post-traumatic osteoarthritis. Regular treatments of CYT-108 (or placebo saline solution) were injected into the damaged joints along a 12-week treatment window. Pieces of the cartilage and surrounding tissues were examined to measure the cartilage-protective effects of CYT-108 and its ability to encourage joint remodeling/healing. In summary, administration of CYT-108 into the joint restored the damage caused by osteoarthritis to the cartilage and synovial membranes by ~60%.” Read more here.

The results of our study look very promising,” said Joey Bose, President of Cytonics. “The purpose of this pilot preclinical study was to examine whether CYT-108 is a feasible drug candidate for treating osteoarthritis and safe to administer to patients. Importantly, CYT-108 was well-tolerated when injected into the joints of animals and no adverse effects were observed when administered at a 10-fold higher dose under the skin (subcutaneous injection). Moreover, we observed cartilage-protective effects of CYT-108 when administered into arthritic joints.

Team

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Gaetano Scuderi, MD is the Founder of Cytonics Corporation. Dr. Scuderi is a fellowship-trained (UCSD, San Diego, CA) spine surgeon who has practiced medicine since 1993. He was also appointed to Clinical Assistant Professor in the Department of Orthopedic Surgery of Stanford University. He graduated medical school from State University of New York (Buffalo, NY) and completed his Residency at University of Miami School of Medicine (Miami, FL). Dr. Scuderi has published over 45 scientific articles and has lectured world-wide. Dr. Scuderi currently practices orthopedic surgery in Jupiter, FL.

In addition to his clinical practice and his role with Cytonics, Dr. Scuderi is a 4th degree black-belt in Jiu Jitsu and the founder/principle instructor of Scuderi Self Defense (Jupiter, FL). Dr. Scuderi’s love for this martial art is only surpassed by his passion for helping the sick and elderly reclaim their mobility and quality of life.

Gaetano Scuderi, MD

Founder and Chairman of the Board

Mr. Carvalho has more than 25 years’ experience developing, manufacturing, and commercializing innovative products in the pharmaceutical and consumer product industries. He served as Vice President of Finance for the Global Oncology business unit of Novartis Pharmaceuticals, where he had financial oversight for the unit’s 20 product launches in a 5 year span. Prior to this role, Mr. Carvalho was the General Manager for Novartis’ US Pharmaceutical manufacturing unit. His other roles at Novartis included CFO Latin America, CFO US Ophthalmics, and Vice President and Controller for Novartis’ US Pharmaceutical Division. Mr. Carvalho has a BBA in Accounting from Iona College (New Rochelle, NY) and is a Certified Public Accountant.

Antonio Carvalho, CPA

CEO and CFO

Mr. Bose has over 10 years’ experience in biotechnology research development and healthcare investment banking. He began his career as a systems biology researcher at the University of Virginia and Johns Hopkins University, advancing the field of proteomics and elucidating the molecular drivers of cancers. Mr. Bose worked for two boutique healthcare investment banks/consultancies in the south Florida region, bringing his expertise in translational medicine to the deal diligencing team. As President of Cytonics, his primary responsibilities include coordinating capital raising efforts, initiating clinical trials for the company’s lead drug candidate (CYT-108), filing and maintaining patent protection of intellectual property, and identifying strategic buyers and out-licensing opportunities for the company. He holds a BS in Biomedical Engineering from the University of Virginia (Charlottesville, VA) and an MS in Biomedical Engineering from Johns Hopkins University (Baltimore, MD).

Joey Bose, MS

President

Dr. Hanna has served as Chief Scientific Officer of Cytonics since February 2008. Dr. Hanna has over 28 years’ experience in pharmaceutical research and development, specializing in the development of recombinant protein therapies. He has extensive knowledge of protein folding, purification, formulation, large-scale production, quality, and the regulatory requirements to obtain FDA new drug approval. Until 2004, Dr. Hanna was the Director of Process Development at Alexion Pharmaceutical, and prior to that he was a Group Leader at Bristol-Myers Squibb Pharmaceutical Research Institute. He also served a Principal Research Scientist at R.W. Johnson Pharmaceutical Research Institute (Raritan, NJ) for 7 years. Dr. Hanna received his BS degree from Cairo University (Giza, Egypt), received his PhD from City University of New York (New York City, NY), and completed a postdoctoral fellowship at Cornell University (Ithaca, NY).

Lewis Hanna, PhD

Chief Scientific Officer

The clinical success of the APIC treatment is a testament to the effectiveness of A2M in treating cartilage damage. This significantly “de-risks” CYT-108 drug development because CYT-108 is a genetically modified variant of the naturally occurring A2M protein. 

Testimonials from Physicians and Patients

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“I was an early investor in Cytonics as the technology is timely in unraveling the etiology of Low back pain. The future will be assaying for specific biomarkers to determine not only the cause of pain but the potential for improvement with certain interventions. As a busy spine surgeon for the last 25 years the direction that Cytonics is proceeding in attempting to minimize clinical failures through their Autologous Platelet Integrated Concentration (APIC) System is breathtaking and timely.”

- Alexander R Vaccaro, MD, PhD, MBA

I have been using Cytonics’ alpha2- macroglobulin kits to treat various joint pains mostly in the knee. This is part of my regenerative medicine practice. I’ve seen remarkable results such that I have suggested that my wife and my son undergo treatments as well as patients. The treatments were remarkably successful in both of them. I am very pleased and I’m looking forward to having this product available more easily off-the-shelf and approved by insurance. I expect a huge demand for it. Thank you.

- Laurence  Rosenfield, MD

Cytonics’ recombinant drug development program is anchored in robust preclinical data indicating that the proteinase inhibitor alpha-2-macroglobulin critically inhibits cartilage breakdown in models of osteoarthritis. Cytonics has developed a lead recombinant drug candidate, a variant of human alpha-2-macroglobulin that possesses a unique and improved bioactivity profile. Cytonics’ strategic efforts are exciting as they target the development of a first biologic therapy for patients suffering from osteoarthritis.”

- Martin Angst, MD

[Dr. Scuderi] took out some of my blood and he put it into the centrifuge and they did what they had to do and then he reinjected the A2M protein back into my knee. Before he did the procedure, I could not bend my knee, I could not walk upstairs. I really couldn't do anything. In fact, I was using a brace on my knee just to give me some support because the whole knee felt like it was going to cave in. A few days after the procedure I was walking and we were walking the dogs and the swelling seemed to have been going down.

- Gail Lynn

I came with Gail when she discovered Dr. Scuderi and what he can do for arthritis. I went for an x-ray. Very simply, he did the same procedure. He took blood from my arm and put it in a centrifuge and got the protein out and injected it in my shoulder. And I’ve been great. We had nothing but success with this protein shot.

- Robert Lynn

- Gail Lynn & Robert Lynn

I partially tore my ACL in a skiing accident in Switzerland. After an unnecessary arthroscopy revealed I was not a candidate for ACL reconstruction, my knee was swollen and stiff for 6 weeks. Then I had a single treatment of Cytonics A2M therapy, APIC. Within 2 days the swelling and stiffness was gone and hasn’t returned 6 months later. I was so impressed with these results that I have been evangelizing for APIC treatment to my doctors and friends ever since.

Even if I need another treatment soon, a couple APIC injections per year with no noticeable side effects and no drugs is closer to a miracle-treatment than I imagined possible before my experience with Cytonics’ product. Joint injuries can be physically and emotionally debilitating, but medical advancements like this make now the best time in history to tear one’s ACL.

- Gabe

“I suffered prolonged pain from a partial tear in my right Achilles tendon. I am very familiar with this pain as I ruptured and had my left Achilles surgically repaired. After almost eight months of therapy and various treatments, Richard Grossman, MD told me about Cytonics and the available A2M treatment. I received my first injection in April of 2018 and within weeks the large nodule in my Achilles had shrunk significantly. While I was feeling much better and able to start playing basketball and tennis again for the first time in ten months, I still felt a little pain. I went back for a 2nd injection in November of 2018 and the pain has been reduced to only minor pain with NO LIMITATIONS. The A2M therapy has given me my sports and mobility life back and I have recommended this treatment to all of my friends.”

- Daryle Bobb

Investment Opportunity in Early-Stage Regenerative Medicine.

Cytonics Corporation – Developing First-in-Class Therapies for Osteoarthritis.

We have been receiving a great deal of interest from potential investors such as yourself, and some very insightful questions have been asked during our investor webinars.
I would like to share some of that insight below:

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.

Return on Investment

Advancement of FDA clinical trials for CYT-108 increases Cytonics’ valuation and shareholder ROI

Estimating the future cash flows of CYT-108 as an approved therapy for osteoarthritis yields a conservative valuation of over $1B, representing a 26x return on investment for early investors.

  • Discount rate of 30% (this is appropriate for pre-clinical stage biotech)*
  • 2% market capture (very conservative) in the US human orthopedic market only (does not include expansion into other markets)
  • $1,000 per treatment, avg. 2 treatments per year (based on APIC treatment schedule)
  • Cytonics assumes full development cost of bringing CYT-108 to market and producing and selling the drug upon FDA approval
    • COGS = 15% of revenue (According to a meta-analysis compiled in Biotech Forecasting & Valuation (2016)**. Data was retrieved from company 10-k filings.)
    • SG&A = 34% (According to an analysis of 35 small and mid-cap drug companies in the NASDAQ Biotechnology Index in 2015, reported in Biotech Forecasting & Valuation (2016)**
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Investment Highlights

Massive Market Potential

Osteoarthritis is the most common form of arthritis, affecting millions worldwide with over $180B spent globally on treatments each year.

FDA ProgRobust Patent Portfolio

World-renowned Wilson Sonsini Patent Attorneys

8 issued international patents, 9 pending.

Traction

The clinical success of the APIC treatment is a testament to the effectiveness of A2M in treating cartilage damage. This significantly “de-risks” CYT-108 drug development because CYT-108 is a genetically modified variant of the naturally occurring A2M protein.

FDA Progress

Cytonics' preclinical results indicate signs of safety & efficacy. Read the results here.

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Disruptive Product Line

BIOPHARMACEUTICALS

IND (Drug) Pathway to FDA Approval

MEDICAL DEVICES

510(K) Pathway to FDA Approval

DIAGNOSTICS

Clinical Laboratory Test

APIC

Our APIC system for concentrating the naturally occurring A2M in the patient’s blood has been approved by the FDA and used to treat over 7,000 patients.

APIC Mini

We have developed a smaller, less expensive APIC system dubbed “APIC Mini” to provide physicians with a solution for treating small joints (such as fingers) that do not require as much volume. The APIC Mini also has the potential for veterinary applications.

CYT-108

We are currently pursuing pre-clinical studies for our recombinant A2M, CYT-108. We have contracted a research organization, Goodwin Biotechnology, to purify GMP/GLP quantities of CYT-108 for pre-clinical experiments and FDA clinical trials.

FDA pre-IND Submission for Osteoarthritis

Pre-IND application provides opportunity for dialogue with FDA prior to conducting Phase 1 clinical study for Osteoarthritis. This is critical to designing an effective, efficient human clinical trial

FDA pre-IND
Meeting for Osteoarthritis

FDA will provide feedback on preclinical data and guidance on GLP preclinical and Phase 1 human clinical trials for Osteoarthritis

FDA pre-IND Submission for COVID

Submission of COVID-19 preclinical study proposal and Phase 1 human trial protocol for review and feedback prior to conducting any studies

FDA pre-IND
Meeting for COVID

FDA will provide feedback on proposed preclinical and Phase 1 human trials for CYT-108 as a treatment for COVID. FDA will also discuss Emergency Use Authorization to expedite the drug approval process for COVID drugs

GLP Preclinical Study for Osteoarthritis

Repeat the large animal preclinical study under GLP conditions, as per the FDA’s recommendation in the pre-IND meeting (4) for Osteoarthritis held on September 25 (Q3 2020)

Preclinical COVID-19 Study

Preclinical study to assess the safety and efficacy of CYT-108 as a therapeutic for COVID-19. Levels of SARS-CoV-2  virus and inflammatory cytokines in the blood and lungs will be measured

Reg A Capital Raise Complete

Reg A+ issuance of preferred equity complete. Potential NASDAQ listing following close. Funds will be used to complete drug development, pursue Phase 1 human clinical trials for CYT-108 as a treatment for osteoarthritis, and preclinical studies to assess the safety and efficacy of CYT-108 as a treatment for COVID-19

IND Filing for Osteoarthritis Phase 1 Clinical Study

FDA will provide feedback on proposed preclinical and Phase 1 human trials for CYT-108 as a treatment for COVID. FDA will also discuss Emergency Use Authorization to expedite the drug approval process for COVID drugs

Phase 1 Trial Begins

Phase 1 human clinical study commences upon FDA acceptance of IND filing. Establishing safety is the primary goal. Efficacy will be scored by measuring a reduction in patient-reported pain

Join Joey Bose, President of Cytonics in an exclusive investor webinar to learn more about Cytonics' first-in-class drug development program for inflammatory diseases (osteoarthritis, COVID-19) and investment in the company!

Register Here
Joey Bose, President of Cytonics

Topics covered:

  • Cytonics' APIC therapy for osteoarthritis and the future of regenerative medicine
  • The development of a first-in-class biologic therapeutic, "CYT-108", for osteoarthritis
  • Preclinical trial results and roadmap to FDA approval for CYT-108
  • CYT-108 as a treatment for COVID-19
  • Investment opportunity in Cytonics
Register Here
Invest In The Future of Pain Relief
INVEST IN CYTONICS