Dyadic International, Inc.

Good evening and welcome to the Dyadic International's fiscal year 2023 year end conference call. Currently, all participants are on a listen only mode. Following management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today, March 28th, 2024. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's chief financial officer. Please go ahead.

Thank you, operator. Good evening and welcome everyone to Dyadic International's fiscal year 2023 year end conference call. I hope you have had a chance to an opportunity to review Dyadic's press releases announcing financial results for a year ended December 31st, 2023 and a separate press release on changes in board and management leadership roles. You may access our release and Form 10-K under the Investors section of the company's website at addicts.com. On today's call, our President and CEO, Mark Imhofar, and our new Chief Operating Officer, Joe Hazleton, will give a review of our 2024 business and corporate highlights, including a brief summary of our recent research and business development efforts. I will follow with a review of our financial results of 2023 in more detail. We'll then hold a brief Q&A session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements which involve risks and uncertainties and other factors that could cause dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. DIADX expressly disclaims any duty to provide updates to its forward-looking statements, whether because of new information, future events, or otherwise. Participants are directed to the risk factors set forth in DIADX reports filed with the ICC. It is now my pleasure to pass the call to our CEO, Mark Imhoff. Mark?

thank you ping hello everyone and thank you for joining dyadic school year 2023 conference call i cannot overstate how exciting this time is in dyadic's history we are uniquely positioned to rapidly capitalize on the present opportunities and those on the horizon over the next two years we anticipate reaching multiple revenue streams and other inflection points through fully funded collaborations in the company's pipeline products to enhance shareholder value. We are building upon the momentum witnessed in 2023, and we have further accelerated our progress. The acclaim and acknowledgments of our C1 technology for its speed, productivity, and effectiveness persist both domestically and globally, receiving recommendations recommendations from academia, industry, and government bodies. The C1 platform's distinction is further bolstered by clinical validation to our successful phase one human trial. It's not only demonstrated that the proteins produced from our human cells are safe to use in humans. Additionally, the DYA-100 vaccine has been shown to induce immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus. We believe that our successful person-human clinical trial of a C1-produced protein redefines the benchmarks for recombinant protein antigen production levels. C1's productivity is up to 300 times that of baculovirus cells. coupled with its abbreviated fermentation times and lack of need for viruses or endotoxins needing removal and downstream processing, builds the future with a rapid, large-scale and cost-efficient production of recombinant vaccine becomes the norm rather than the exception. Speaking to our pharmaceutical initiatives, I cannot overstate the significance of the positive outcomes for our phase one human study that has bolstered industry attention toward dyadic and our C1 expression platform. Since the announcement of these top results, heightened interest from industry partners, including two top 10 pharmaceutical firms, has spurred the commencement of over 12 fully funded vaccine and antibody projects. These projects span various disease areas, exemplify our strategic partnership with RabianBV, a Dutch innovative SME founded by seasoned entrepreneurs and vaccine scientists. Rabian secured 1.7Million dollars in euros or 1.7Million euros. In funding from your stars for the avatar project, aiming to leverage virology expertise. To develop a rabies vaccine, utilizing dyadic protein production platform. Additionally, the Israeli Institute for Biological Research, the IIBR, is harnessing dyadic's microbial platform expertise in conjunction with their own capabilities in antibodies and antigens discovery to develop and manufacture treatments and vaccines for emerging diseases and potential bio threats for licensing opportunities. In the realm of infectious diseases, our recombinant vaccine capability continues to attract growing interest. We are engaged in an expanded research collaboration with a top five pharmaceutical company to develop a number of antigens preventing and treating various infectious disease. Furthermore, we have initiated a new research collaboration with the Vaccine and Immunotherapy Center, VIC, and Massachusetts General Hospital, which received over $5 million in funding from the Department of Defense, DOD, to develop and test vaccine antigens for influenza A and other infectious diseases, including antigens produced using our C1 platform. Additionally, our DAPAVIS expression platform has exceeded our initial expectations despite launching a little over a year ago, gaining substantial traction, generating revenue in both their alternative protein and bio-industrial sectors. During today's call, Joe and I will review our strategic blueprint for enhancing revenue growth, highlighting significant technological strides and recent achievements in business development across our primary markets. We will elaborate on our near- and longer-term strategies aimed at bolstering our revenue outlook and enhancing shareholder value. I would like to extend our gratitude to long-term shareholders for their steadfast support as we successfully close a $6 million convertible note financing. These funds will fuel the acceleration of our goal to introduce revenue-generating products targeting both pharmaceutical and non-pharmaceutical sectors. Our recent announcements of both business and scientific achievements demonstrate that the success of our corporate strategy is beginning to be realized and that Dyadoc is strongly positioned for new area of revenue growth. To further support our growth imperatives, we have announced changes in leadership roles at the board level and management team. We expanded the responsibilities of our Chief Business Officer, Joe Hazleton, appointing him as Chief Operating Officer. His demonstrated pivotal role in advancing our strategic objectives is undeniable. With strength in financial resources and scientific prowess, we are well positioned to execute our strategic business objectives. Michael tarnock is stepping down as chairman of the export director in making room for Patrick Lucy we've been appointed to succeed him effective immediately. Mister Connor will continue the director to the end of his current term which ends in June 2025 at the time which he expects to retire. Dr. Barry Buckland is retiring from the board at the end of his term in June 2024, which will result in reduction of the size of the board to six members. I would like to thank Mike Tarnock for his leadership as chairman over the past 10 years and for agreeing to serve out his remaining one-year term, enabling a smooth transition of board leadership. I'm excited that Mr. Lucy, who has been an outstanding board member over the past three years, has agreed to take on the role of board chairman at an important time for DIAC. In our ongoing efforts to make clear our strategy and business perspectives, we will spotlight our focus on our three primary sectors, human health, animal health, and alternative proteins. Joe and I will outline our achievements and strategic outlook spanning both pharmaceutical and non-pharmaceutical domains, along with providing a look into our roadmap for 2024 and beyond. We are poised at the edge of leveraging our microbial protein production platforms, C1 and Daprovis, to create antigens, antibodies, enzymes, and other recombinant proteins pivotal to each of our core sectors. These efforts are anticipated to unlock the monetization avenues, significantly enhancing shareholder value for dyadic and our partners. In defining dyadic value proposition against conventional platforms for the manufacture of vaccines and therapeutics, it's pivotal to grasp the foundation of C1's uniqueness, which is in our industrial heritage. This heritage isn't just a backdrop. It's the bedrock of our approach to biologic pharmaceutical production. traditional cell lines typically evolve from research skills, struggling to balance increasing scale and yield against cost constraints. In stark contrast to that, Dyadic harnesses microbial platforms and seasoned veterans in the economical production of large-scale bio-industrial proteins and enzymes at large scales. This deep-rooted experience is being repurposed to navigate the complex landscape of biologic pharmaceutical development and production, marrying it with industrial-scale efficiencies with pharmaceutical precision. As I highlighted earlier, the C1 platform distinction is further bolstered by its clinical validation through our successful Phase I human trial, which not only demonstrated that proteins produced from our C1 cells are safe for use in humans, and that the DY vaccine has been shown to induce immune responses at both those levels, suggesting its potential efficacy in generating protective immunity against the target virus. We believe we are redefining the benchmark for recombinant protein antigen production levels. We are pleased with the progress of the C1 platform, but it's crucial to keep investing in validating and advancing our technology to match emerging science and support our partners' development efforts. To this end, more than a year ago, we engaged Cygnus Technologies to co-develop a C1 host cell protein, HCP, ELISA kit. This step is vital for regulatory reviews and manufacturing, as HCP residues can cause toxicity and affect biologic stability. These kits are essential for detecting and quantifying HCPs during manufacturing to ensure product purity and quality necessary for marketing approval, and we are excited that C1 HCP ELISA kits are now available to Dyadic and Cygnus customers. Expanding our portfolio with potential new commercial products produced by the C1 platform is equally important. Diatics has entered into a development and commercialization agreement with EU-based Bjorna to explore the development of messenger RNA using our C1 technology. This collaboration combines Bjorna's innovative eukaryotic bioRNA platform with Diatics' proven C1 protein production platform. This aim is to offer the pharmaceutical industry a potentially more cost-efficient method for manufacturing large quantities of lower cost messenger RNAs facilitating broader global access to mRNA vaccines and drugs. Turning our focus to our therapeutic proteins, particularly monoclonal antibodies, we see significant potential in utilizing the C1 production system for the production of antibodies targeting infectious and other diseases such as arthritis, oncology, and neurological diseases. Therapeutic proteins aimed at combating infectious disease often require shorter-term treatment durations, yet they may necessitate larger quantities and shorter manufacturing times to effectively and efficiently address pandemics or outbreaks. Earlier this week, we announced the publication of a manuscript in the esteemed peer-reviewed journal Nature Communications. detailing the preclinical studies conducted on a monoclonal antibody produced using the C1 system, utilizing non-human primates and hamsters as models. In the non-human primate challenge study, a C1-produced COVID-19 monoclonal antibody previously shown to present broad neutralization protection against various variants, including all the way from Wuhan to BA.1 and BA.2 Omicron, as well as the earlier variants, concerning enhancers and underwent dosing. Finding from the challenge study involving the SARS-CoV-2 Delta variant in non-human primates indicated promisingly high levels of protection. This marks the first instance of a C1-produced monoclonal antibody being employed in a non-human primate study, affirming both the safety and efficacy of C1-produced antibodies for addressing infectious diseases. These recent findings regarding the safety and efficacy of monoclonal antibodies produced using C1 technology are significant in accelerating the research and development efforts in the field of infections and other diseases. This is particularly noteworthy, taken with the previously reported data that C1-produced MAVs are comparable in efficacy and safety to those produced using traditional CHO, Chinese hamster ovary cell lines. Just this week, Dyadic entered into a collaboration with another top 10 pharmaceutical company to develop an infectious disease monoclonal antibody and a vaccine antigen using C1 technology, which marks a significant step forward in this area. The fact that this collaboration is fully funded by a top 10 pharmaceutical company underscores the confidence and the potential of C1 technology for producing effective treatments and vaccines against infectious and other diseases. Moreover, Diatics' existing collaborations with industry partners for producing monoclonal antibodies targeting diseases like Ebola and Marburg highlight the versatility and applicability of C1 technology across a range of infectious diseases. Overall, these developments suggest a promising future for C1 technology in the field of infectious and other disease research and development. potentially leading to more effective treatments and vaccines against a variety of pathogens for a global population. We are continuing our efforts to forge and sustain long-term strategic partnerships in the pharmaceutical sector for both humans and animals. This is evidenced as well as we enter the fourth year of our expanded collaboration with Rubicon Health to advance commercial products and clinical development of vaccines for human and animal health in Africa. Our collaboration with Fibro Agic to develop seawood-produced poultry vaccine is entering its fifth year and has expanded to additional infectious diseases and disease areas over that time. Animal health remains a targeted segment for dyadic due to the higher margin sensitivity of pharmaceutical biologics and the significant impact of outbreaks on the global supply chain and potentially human health. We continue to expand our presence in the animal health market for vaccines and therapeutic proteins. I will now turn the call over to our Chief Operating Officer, Joe Hazleton, to provide an update on our non-pharmaceutical license and product opportunities. Joe?