#20 ?? Success Begets Success

by Joey Bose and Gaetano Scuderi, MD

?? CYT-108 is our novel biopharmaceutical for osteoarthritis that is based on the therapeutic action of a natural protein called Alpha-2-Macroglobulin.

?? CYT-108 and the Legacy of APIC’s Success

Just as the introduction of synthetic (recombinant) insulin revolutionized the treatment of diabetes by providing an improved and scalable source of insulin,?Cytonics is poised to transform the field of osteoarthritis (OA)?therapy with CYT-108.?Building upon the clinical and commercial triumphs of our Autologous Platelet Integrated Concentrate (APIC) therapy, CYT-108 embodies the next evolution in targeted treatment for osteoarthritis. Harnessing the insights from protease inhibition and tissue regeneration mechanisms garnered through APIC’s success, CYT-108 aims to offer enhanced efficacy and precision in managing joint health. If approved by the FDA, CYT-108 may be the first and only?disease-modifying pharmaceutical for OA, a remarkable leap forward in the field of regenerative medicine.

Just like the development of synthetic insulin was de-risked by the clinical efficacy of the natural, purified insulin peptide, Cytonics’ CYT-108 development is de-risked by the clinical and commercial success of our first-generation?APIC therapy.

?? The APIC Therapy: A Natural Solution To OA

The Autologous Protease Inhibitor Concentrate (APIC) therapy harnesses the body’s natural healing processes by selectively concentrating the therapeutic Alpha-2-Macroglobulin (A2M) protein?patient’s own blood and introducing it into affected joints. This method has proven highly effective in treating the root cause of osteoarthritis by blocking the enzymes that degrade cartilage?in arthritic joints, promoting cartilage repair and reducing inflammation. To date, over 8,000 patients?have been successfully treated with APIC. The widespread adoption and positive patient outcomes have not only solidified APIC’s reputation in therapeutic circles but also demonstrated its commercial viability across diverse markets, setting a robust foundation for further innovation.

?? Bridging Success: How APIC Paves the Way for CYT-108

The clinical success of APIC significantly de-risks the development of our latest innovation, CYT-108. This synthetic variant of the natural A2M protein was engineered for increased efficacy, and CYT-108 is over 200% more effective than the natural A2M in inhibiting the destructive enzymes that degrade cartilage. CYT-108 draws from APIC’s established base of knowledge about the efficacy of A2M as disease-modifying?therapy for osteoarthritis, and patient confidence cultivated by APIC’s success may ensure a smoother regulatory journey and heightened market anticipation. CYT-108 is poised to build on the legacy of APIC, offering a refined and more effective approach to joint health with enhanced specificity and efficacy for OA.

?? Unleashing Potential: Promising Preclinical Results for CYT-108

In our preclinical studies, CYT-108 showcased promising results that emphasize its potential efficacy and safety. CYT-108 demonstrated up to?60% reduction in cartilage degradation?and joint membrane inflammation?compared to controls, and it was well-tolerated by the study subjects. Notably, no?deleterious immune response was observed nor?damage to organs. The safety of CYT-108 is supported by the route of administration, which is directly into the joint, limiting the drug’s exposure to the bloodstream. This substantially decreases the chances of “off target” adverse effects. APIC’s success further de-risks the safety aspect because we know that we can deliver high concentrations of A2M directly into patients’ joints without significant side effects.

??? From Lab to Life: Charting CYT-108’s Journey to Clinical Application

The outcomes from preclinical study ?are not just a milestone for CYT-108 but also a beacon for future clinical applications in human medicine. These results validate the continued exploration of CYT-108 in human trials, where we expect to see similar efficacy and safety profiles. As we move forward, the insights gained from this preclinical phase will guide the optimization of dosing regimens and treatment protocols, ensuring that CYT-108 can offer a significant improvement in the quality of life for patients suffering from osteoarthritis.

We recently received ?? ethics approval to begin our?first-in-human ?? Phase 1 clinical trial, a ?? monumental milestone?and?significant ?? valuation inflection point!

Ready to become a shareholder? Visit?invest.cytonics.com.

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