UPDATE -- Dyadic Advancing Proprietary Owned COVID-19 vaccine candidate, DYAI-100, Towards Human Clinical Trial - Seite 2

“The ongoing devastating COVID-19 pandemic requires a new variant of concern vaccine approaches that are not only safe, effective and protective but can also be scaled up to meet the global need for billions of doses of vaccines at an affordable price. We are honored to partner with Dyadic and its strategic partners in developing an affordable, scalable, protective and safe vaccine to combat this disease that continues to impact our everyday life,” added Hadil Es-Sbai, CR2O’s Chief Executive Officer.

Dyadic’s Chief Scientific Officer, Dr. Ronen Tchelet, added, “Moving DYAI-100 into a first in human Phase 1 clinical trial is a major milestone for the program and our C1 protein production platform. We believe that demonstrating the safety of a C1 expressed antigen in humans will open the door for many opportunities for us and our collaborators to apply our proprietary and patented C1-cells to produce biologic drugs and vaccines for human use. With our collaboration with CR2O, we continue to build momentum in our efforts to develop a safe and effective C1 COVID-19 vaccine candidate that can be rapidly and efficiently mass produced and we believe is better suited for global distribution, than mRNA-based vaccines. Interim results for DYAI-100 continue to be very promising, and animal studies conducted by the Israel Institute for Biological Research (“IIBR”) and other collaborators demonstrated its potential to drive substantial immunogenicity responses with very high titers and neutralizing antibodies against SARS-CoV-2. Recently, the IIBR reported they carried out successful challenge studies using human ACE2 transgenic mice vaccinated with DYAI-100. Further, as SARS-CoV-2 continues to mutate into different variants, we began engineering new C1 cell lines, including the UK variant that could enable multivalent COVID-19 vaccine candidates, consisting of COVID-19 variants, with the potential for broader efficacy against new SARS-CoV-2 strains that may emerge as possible immune escape virus variants. Additionally, we recently announced an expanded fully funded vaccine development partnership with Medytox to accelerate the development of multivalent COVID-19 vaccine candidates and/or boosters to immunize people against multiple existing or future SARS-CoV-2 variants. As Dr. Gi-Hyeok Yang, Sr, Executive Vice President and Head of Research and Development at Medytox, recently stated, ‘Based on our experience and comparing the C1 technology platform against several other expression platforms, such as CHO and insect cells, we believe that the fungi-derived C1 expression system is the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses, without the need for a large-scale bioreactor facility. Medytox has confidence that the C1 technology platform can play a critical role in helping combat COVID-19, which may continue to persist as a seasonal influenza and necessitate COVID-19 variant vaccine shots every year. We look forward to gaining additional experience with the C1 technology as it has potential for use in developing and producing a growing number of vaccines, drugs, and other biological products in addition to COVID-19’.”