Dyadic International, Inc.

Welcome to Dyadic International's fourth quarter and full year 2020 financial results conference call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, there will be a brief question-and-answer session. As a reminder, this conference is being recorded today, March 30, 2021. I'd now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Thank you, Joe. Good evening, everyone, and welcome to Dyadic International's fourth quarter and full year 2020 financial results conference call. Earlier today, Dyadic issued a press release announcing financial results for the full year ended December 31st, 2020, and the recent company highlights. You may access to our press release and form 10K under the investor section of the company website at dyadic.com. On today's call, our president and CEO, Mark Edenfod, will give a review of our business and corporate accomplishments for the full year 2020, including a brief summary of our research and business development efforts. I will follow with a review of our financial results in more detail. We'll then hold a brief Q&A session. Our senior management team, Matthew Jones and Ronan Shillette, will join Mark and I for the Q&A session. At this time, I'd 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 diabetics' actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Diabetic expressly disclaims any duty to provide updates to these formal looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in dyadic reports filed with the ICC. It is now my pleasure to pass the call to our CEO, Mark Unifarb. Mark?

Thank you, Ping, and welcome, everybody. We are very pleased with the substantial progress made thus far in 2021 and in 2020. 2020 was a year of considerable disruption, suffering, and death worldwide as the coronavirus rapidly spread across the globe and the COVID-19 pandemic has and continues to wreak havoc on humankind. Our hearts go out to those who have continued to suffer from this horrible disease. We've been working tirelessly to identify ways in which to apply our C1 technology to help speed the development, increase availability, and lower the cost of COVID-19 vaccines and treatments to make them affordable and available to everyone on the planet. We and our collaborators work to introduce the C1 technology to the world to enable as many COVID-19 programs as possible. and we are continuing to do so as COVID-19 variants continue to emerge. Due to our success in several animal studies where we rapidly engineered C1 cells have achieved high levels of antigen productivity and have shown to be safe, effective, and protective. Our C1 technology has therefore gained the attention of a growing number of infectious disease and other scientists in industry and government. This momentum has begun to accelerate after our announcement that a proprietary COVID-19 vaccine candidate, DYI-100, is advancing into a first in human phase one clinical trial, which is expected to begin in the second half of 2021. As SARS-CoV-2 continues to mutate into different variants, we've already begun the engineering of novel C1 cell lines to enable the development of next-generation multivalent COVID-19 vaccine candidates. The DYA100 Phase I clinical trial's purpose, among others, is to validate that the C1-produced proteins are safe in humans, which we expect will accelerate the C1 technology platform's adoption and commercialization of recombinant protein vaccines and drugs for human use. There are articles almost every day highlighting that the SARS-CoV-2 mutations like the UK, South African, Brazilian, and now New York, Californian, and other emerging COVID-19 variants in Japan, India, and elsewhere are here to stay. And new COVID-19 variants are expected to appear yearly, which, like the seasonal flu, may require annual or even semi-annual booster shots. Just today, CNBC reported COVID-19 variants could render current COVID-19 vaccines ineffective in a year or less, epidemiologists warn. In addition to validating that C1-produced proteins are safe in humans, DIADC's COVID-19 DYAI-100 vaccine candidate clinical trial will help to serve as a proof of concept for the development of potential next-generation multivalent COVID-19 variant vaccine candidates, including the B.1.1.7 UK variant and others. Because of C1's ability to rapidly develop COVID-19 variant vaccine candidates, coupled with its relative advantages of greater productivity and lower cost, the world is waking up to the fact that these variants are here, they're going to keep coming, and more companies recognize we exist and are expressing interest and potentially using C1 to help solve their manufacturing productivity, speed, and cost concerns. All of these attributes give C1 a tremendous advantage over other vaccine and drug manufacturing platforms. Beyond our COVID-19 initiatives in 2020, we commenced 11 new projects and extended two others, including five new funded collaborations with top pharmaceutical companies to produce therapeutics of commercial interest for human health applications. Since the start of this year, we have entered into two new and three extended programs and are in discussions with others in all sectors of our business, including animal health, non-COVID-19 human health, growth factors, and other potential new biologic product markets, where our C1 technology may have the potential to overcome gene expression challenges, improve performance, as well as to increase yield and lower cost. In animal health, we continue to build a strong foothold in the animal health market. As we previously announced, we have entered into fully funded agreements with all four leading animal health companies, as well as the fifth global animal health company to evaluate C1 for the expression and production of vaccines and therapeutic proteins for animal diseases. We expect candidates expressed using C11 to enter animal trials this year. We are particularly proud of the progress made in our long-standing successful partnership with the European Zoonosis Anticipation Preparative Initiative, SAPI. SAPI is a five-year, 20 million euro initiative that has brought together experts in human and animal health to create new platforms and technologies that will facilitate a fast coordinated and practical response to new infectious diseases as soon as they emerge. ZAPI selected our C1 technology platform to boost antigens more efficiently that are safe, effective, and protective for both the Schmalenberg and Red Valley fever viruses. Notably, the C1 gene expression platform demonstrated greater productivity and stability than the baculovirus insect cells for both the SPV and RVFV antigens, enabling the ZAPI project to meet its objectives of producing enough low-cause doses with reduced fermentation volume capacity. Additionally, the seawood-produced antigen demonstrated full protection for cattle, sheep, and mice from the SPV virus. We are very pleased with the growing volume of scientific data and the results we achieved in our own internal and externally funded programs last year and in the first quarter of 2021. Based on the growing amount of productivity, safety, and efficacy data generated in our own internal and third-party R&D activities, we are being approached by many companies related to the growing number and type of infectious disease opportunities, both COVID-19 and others. In the non-COVID human health, we're constantly looking for ways to improve our shots on goal for building shareholder value. Beyond our COVID-19 collaborations, an increasing number of global pharmaceutical and biotech companies are selecting our C1 technology for diverse applications in human health. Last month, we established a fully funded collaboration with TurtleTree Scientific to to develop several recombinant protein growth factors which play a critical role in tissue development and healing, including regenerative therapies. Manufacturing human growth factors at large scale and affordable cost has been a major industry challenge. We're excited to apply our C1 technology to overcome this hurdle and a significant new commercial opportunity. We've also expanded our presence in Europe Asia, and India. In addition to our partnership with Meditox in South Korea, we've established a fully funded collaboration with Hangzhou Hangaroo Medicine Company Limited, the largest pharmaceutical company in China by market capitalization. For the development of selected Hangaroo biologic drugs, as well as a non-exclusive research collaboration with Wuxi Biologics, a leading contract development manufacturing organization headquartered in China. From a strategic point of view, we believe these global co-development partnerships have been cornerstone of the company's success to date. The goal is to access commercial opportunities in large and growing human and animal health markets. Importantly, these partnerships also enable us to continually improve and accelerate development of our C1 platform technology. Now that our non-compete with DuPont has expired, we also remain open to exploring new potential commercial opportunities in the industrial biotech markets. In regard to some of our scientific achievements, as for internal development, the company continues to make progress in terms of the stability and productivity of the C1 technology, including through glycoengineering, C1 cells to impart human-like glycan structures and reducing the extracellular protease background by 50-fold. Strives in glycoengineering and non-glycoengineering cell lines should broaden the potential applications of the C1 expression platform for its use in developing and manufacturing vaccines, monoclonal antibodies, and a variety of other therapeutic proteins. In closing, 2020 was marked by many new partnerships and significant progress towards clinical development. We look forward to building on the momentum achieved in 2020 as we work towards advancing our COVID-19 vaccine candidate, DYAI-100, into a phase one clinical trial later this year. We expect our extensive number of collaborations will continue to generate robust scientific data that highlights the broad potential impact of our C1 platform and diverse animal and human health applications. And as always, we will continue to work tirelessly to advance our C1 platform while evaluating other opportunities to maximize its value to meet the global need for rapid, safe, and scalable therapeutics. As recently announced, Patrick Lucey has joined our board of directors. I have known Patrick for over two decades. His extensive experience in the development, adoption, and commercialization of cell lines used in the biopharmaceutical industry will be extremely helpful in guiding our strategic, scientific, and commercialization efforts. We're very excited to have Patrick join DIADC's Board of Directors. Lastly, I want to give special thanks to our employees and partners for their commitment and dedication during these challenging times. I also would like to thank our shareholders and our board members for their continued confidence and support as we work towards bringing more affordable healthcare solutions to a global population. With that, I will turn the call over to Ping for a financial update.