Dyadic International, Inc.

and most importantly, in our successful rabbit toxicology study, which showed safety and persistence of antibodies, which were generated from our C1-based BYA100 COVID-19 booster vaccine candidate. You may have also seen in today's press release new data presented at the World Vaccine Congress in Europe by Dr. Albert Osterhaus. He's with the University of Veterinary Medicine in Hanover, Germany, who has been collaborating with DIATIC for over five years. Dr. Osterhaus presented preclinical safety and efficacy data from animal studies, including cancers and non-human primates, demonstrating C1-produced antigens and antibodies are as effective as those produced by common cell lines used for biologic vaccine and drug production platforms, like show cells. Mark will speak to this in greater detail a bit later, but in summary, the data supporting the overall safety profile of C1 cells, as well as their ability to produce proteins that prevent and or treat disease equivalent to, if not better than the most commonly used cell lines in production today. You will also hear Mark speak about C1 continues to demonstrate higher productivity and efficiency, potentially increasing global access and lowering overall manufacturing costs. Dr. Osterhaus' video presentation can be found on the addict's website under our media center in the video gallery. Which brings me to the regulatory approval of our clinical trial application. In addition to establishing a track record of safety in humans for antigens produced from our C1 cells, the phase one trial will be a randomized, double-blind, placebo-controlled trial to evaluate the safety, reactogenicity, which is response to vaccination, and immunogenicity, which is the immune response of the BYA100 COVID-19 recombinant protein RBD booster vaccine in 30 healthy adults in South Africa. Trial preparations are actively underway, with site initiation expected later this year. There are eight scheduled patient visits over a six-month period, with safety data being collected throughout the trial, and immunogenicity assessments are scheduled on six of the eight visits. Timing for the results will depend on many factors, including enrollment, and we will share additional data as it becomes available. A successful outcome to the phase one trial for DLA-100 would bring a new weapon against COVID-19 closer to approval and provide additional safety validation for us and our collaborators, reducing developmental risk for other vaccines for infectious disease and other diseases In addition, progress continues to be made by Epigen Biotech, one of Dyadic's non-exclusive licensees, to advance development, manufacture, and conduct phase one and two clinical trials using Dyadic's C1 protein production platform for their COVID-19 vaccine candidate produced from C1 cells. Our C1 protein expression platform is capable of unparalleled scale and productivity in terms of antigen production and the proteins produced from our C1 platform continue to demonstrate comparable safety and efficacy to antigens produced from traditional cell lines used in animal studies. We expect that the Phase I clinical trial in South Africa and later Phase I trial in India with Epigen will be a pivotal point in the many ongoing discussions we're having with top-tier pharma, biotech, and government agencies globally. We have also presented data that demonstrated that our innovative approaches and designs to C1 produced proteins that generated higher neutralizing antibody activity in preclinical animal studies with the potential to improve vaccines for influenza, COVID-19, and other diseases. An example is our successful production of Wuhan and Omicron ferritin RBD nanoparticle antigens, which may have application as a next generation pan-coronavirus vaccine candidate. Similarly, last quarter, we discussed how our efforts in expressing the neuraminidase antigen, which has broad potential use in the development of better seasonal and pandemic flu vaccines, has historically been difficult to produce reliably at high yields and with the right biological activities. The addition of meraminidase to standard flu vaccines can enhance the immune response to provide even greater protection to patients. Our current expression level of 800 milligrams per liter in 168 hours had generated interest with academia, government agencies, and large pharmaceutical and biotech companies within the human vaccine industry. Our high-level expression of ferritin GRBD nail particle antigens from C1 cells for use in developing potentially better performing COVID vaccines, the potential for neuraminidase in combination with previously expressed hemagglutinin or HA, which has a potential to play an important role in providing broader influenza vaccine-induced protection. And the safety data we expect to generate from upcoming DOA100 phase one trial are just a few examples of the many opportunities we believe will accelerate the adoption of the C1 platform. Mark will now discuss our progress in life sciences. Mark?

Thank you, Joe. As Joe mentioned, in today's press release, we highlighted several areas of scientific and regulatory advancement. When we undertake a project, it is with a specific objective to either further the scientific advancement or enhance the breadth and scope of where we and our collaborators may be able to apply the technologies being developed, such as our C1 protein production platform. These projects and collaborations helps to validate the application of C1 as a differentiated biomanufacturing platform for the prevention and treatment of infectious and other diseases such as rabies, oncology, arthritis, and diabetes. For example, data presented recently by Dr. Albert Osterhaus from the University of Veterinary Medicine in Hanover for a C1 produced COVID-19 monoclonal antibody, MAB, in a challenge study with the SARS-CoV-2 Delta virus on nonhuman primates. This demonstrated potential high protection and preventative effects. He also presented preclinical safety and efficacy data from animal studies, including hamsters and non-human primates, demonstrating C1-produced antigens and antibodies are as effective as those produced by reference platforms like ChoCells. To further accelerate the adoption of our platform for the prevention and treatment of infectious and other diseases, Research and development is ongoing with various collaborators in key therapeutic areas, where the strength of our experience and our technologies coincide. In addition to the successful high-level expression of ferritin-GRBD nanoparticle antigens from C1 cells for use in pan-coronavirus applications, we also have collaborators who are conducting animal trials on mono- and multivalent RBD-based blended COVID-19 vaccines for potential next-generation pan-coronavirus vaccine candidates that may provide broader protection and longer-lasting prevention against a wide variety of coronaviruses and what is currently available on the market. Beyond our continuing work in COVID vaccines, we believe that our neuraminidase and hemagglutinin influenza antigens will anchor and further support our business development opportunities in infectious disease. In collaboration with Oswald University, we have additional animal trials that are ongoing with C1-produced HA and COVID-19 antigens for potential more effective influenza and or combined influenza coronavirus vaccine. There are other preclinical animal studies that are also ongoing, including C1-produced antigens being evaluated for intranasal and oral applications. Now just a few words on the key life science growth market in therapeutic proteins. Therapeutic protein drugs in the market was valued at over $280 billion in 2020 and is estimated to reach over $560 billion by 2030. These drugs have already shown to have the potential to significantly improve human health and are used to treat a variety of diseases such as cancer, immunological, hormonal, genetic, infectious diseases, and others. Global demand for therapeutic proteins is growing at unprecedented levels due to the rising prevalence and diagnosis of chronic and infectious diseases, and that demand has been further accelerated by the COVID-19 pandemic and rising concerns for twin or even triple concurrent pandemics with other infectious diseases such as influenza. As we saw with COVID, the supply of therapeutic proteins during heightened demand was hampered due to the high cost and timelines required for developing and manufacturing protein-based therapeutics like monoclonal antibodies. Beyond cost and timing, there is also a clear need for more productive manufacturing platforms that will be able to meet this growing demand in the timeframe needed by patients all over the world. As Joe discussed, our progress on vaccines combined with the various preclinical animal models tested and impending Phase I trial that we expect will allow us to demonstrate to big pharma, biotech companies, government, and academia globally the safety profile for recombinant antigens produced using our C1 platform for the commercial production of recombinant vaccines and antibodies. We are now generating data to support our science regarding the therapeutic proteins. While we're excited about the rapid advancements in our technologies to improve the productivity for our therapeutic proteins, we're equally focused on the quality aspects of our monoclonal antibodies. In the second quarter, we announced the dosing and completed for a fully funded non-human primate study of a C1-produced COVID-19 monoclonal antibody. This monoclonal antibody, 87G7, which is developed by the EU's EpiScientists, already demonstrated broad neutralization protection against Omicron BA1 and BA2 and all other earlier variants of concern in hamsters. In today's release, we highlighted Dr. Osterhaus's recent presentation at the World Vaccine Congress Europe in Barcelona, where he presented some preliminary results from the non-human primate challenge study with the SARS-CoV-2 Delta virus that demonstrated protection equally as important is that the C1 produced COVID-19 monopole antibody was as effective as a comparator antibody produced in the mammalian cells reference platform. The importance of this data as they were obtaining safety and efficacy of the C1 produced therapeutic protein in a non-human primate study that demonstrates C1 produced proteins are safe and just as effective as those produced in today's commonly used platforms. This provides further validation of the C1 platform beyond high productivity and efficiency. This is a fully funded initiative with one of our third party collaborators, and this non-human primate study is anticipated to lead to a funded GLP toxicology study and potentially CGMP manufacturing of drug substance in a phase one clinical trial, this time demonstrating safety for therapeutic protein from a C1 manufactured cell. Establishing safety and efficacy through these phase one trials for vaccines and potentially monoclonal antibodies is a key gating item for big pharma, biotech, and government agencies. And we expect this to accelerate the use of our C1 platform to produce safe and effective vaccines and therapeutic proteins. While we still have work to do, the interest we are generating in therapeutic proteins, the knowledge we are gaining, as well as our collaborators are gaining such knowledge, are rapidly expanding interest, not only in the Villamab, but also many areas which our C1 platform can be applied for rapid development and production of large quantities of antibodies across large and mid-sized pharmaceutical companies in both human and animal health. Our collaboration with Janssen to develop C1 cell lines to produce targeted therapeutic protein candidates demonstrates our ability to attract the attention of large pharmaceutical partners. Progress is ongoing and on time, and we anticipate it will lead to development milestones and eventually commercial revenues generated from one or more of the chance and targeted proteins. With regard to animal health and the expanding opportunity for business development that exists within this core vertical, we are leveraging our scientific innovation and new designs in animal health to enhance the potential for monetization with this core vertical. You may have noted in today's press release that we successfully expressed a recombinant livestock antigen at titers up to 10 grams per liter in seven days, which is significantly higher than has traditionally been produced with the reference platforms. Gel will provide more color on dietics efforts in this market.

Thank you, Mark.