Mark Emalfarb
Analyst · NOBLE Capital
Thank you, Ping. Welcome, everyone, and thank you for joining us today. Before we begin tonight's conference call, I hope you and your families are safe and staying as best you can out of harm's way as the world continues to struggle with the coronavirus outbreak. We here at Dyadic are committed to help combat this terrible virus whenever we can by offering access to our C1 technology to industry and governmental agencies globally to try and help speed the development and commercialization of potential SARS-CoV-2 vaccines and antibodies to help combat the coronavirus. Later on in the call, I will get into more details about some of the things we have going on. I am pleased to report that 2019 was another successful year for Dyadic, as we achieved several important scientific and business milestones and expanded our global presence. While still early in 2020, we are seeing continued momentum with our existing collaborations as well as potential new collaborations. During 2019, we entered into 6 new proof-of-concept research collaborations to express different types of biologic vaccines and drugs for both human and animal health and entered into 2 research licenses. As a result, Dyadic's pipeline of opportunity is gaining more depth and diversity of projects that we anticipate will bring significant future value to the company. Last week, we entered into a nonexclusive research license with WuXi Biologics, one of the world's most prestigious global contract development and manufacturing organizations, or CDMO as they are most commonly referred to, and entered into another fully funded feasibility study with another leading animal health company. We are now working with 3 of the top 4 animal health companies, which we believe give us a strong foothold in this market. To assist in the global fight against the COVID-19 pandemic, we are working with The Israel Institute for Biological Research, IIBR; Ufovax, a spin-off vaccine company of Scripps Research; a group of coronavirus experts from Erasmus Medical Center; University of Utrecht; and the University of Veterinary Medicine Hannover, TiHo. We have already started to express a growing number of potential coronavirus vaccine and antibody candidates using our C1 gene expression platform for a number of different parties. Supporting our growth strategy is our robust scientific data, solid financial position and ongoing collaborations funded by our partners. In 2019, our shares were uplisted to the NASDAQ Capital Markets, and we joined the Russell Microcap Index, further reinforcing the continued growth of our company. We look forward to sharing additional new developments as the year progresses, as we remain confident in our vision of creating more efficient and commercially cost-effective health care solutions. We continue to make excellent progress in our internal and externally funded research programs, which continue to generate important and improved data that we expect will continue to drive our science and business development efforts. An example of this has been our involvement in the Zoonoses Anticipation and Preparedness Initiative, ZAPI, which 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. In the ZAPI project, C1 produced a ZAPI antigen against the Schmallenberg virus, SBV, at 17x the initial targeted expression level and more than 35x baculovirus, the next closest expression platform and 100x more than E. coli. I am pleased to report that in December, Dyadic received positive preliminary results for the ZAPI animal studies and expanded the funded research collaboration by ZAPI by 2 additional funded proteins. Recent results shared with us from the ZAPI consortium indicate that Dyadic C1 antigen demonstrated very strong performance in protecting both cattle and mice from the SBV. A publication reporting these results is expected to be available in Q2 2020. This data is helping us accelerate our entry into animal health in that industry. We are now carrying out fully funded proof-of-concept research collaborations, as I mentioned earlier, with 3 of the top 4 animal health companies. Through our involvement in the ZAPI consortium, we developed relationships with 3 of the top 20 global coronavirus experts. In conjunction with these experts and a clinical contract research organization, CR2O, we have formed a consortium, which generated a proposal for advanced vaccine candidates against SARS-CoV-2. We believe that combining their SARS-CoV-2 vaccine candidates with the unprecedented yield and efficient flexible commercial-scale production of vaccine components, along with the safety and efficacy data seen in the ZAPI project, will result in a SARS-CoV-2 vaccine antigen that is not only effective at low dosages, but one that could be produced in sufficient dosages faster and at lower cost with potentially better potency. The ZAPI data and the novel glycan structures human imparts on the expressed proteins, combined with a previous promising Sanofi Pasteur hemagglutinin, HA, in influenza data led to a second proposal with Ufovax, a spin-off vaccine company of Scripps Research. This SARS-CoV-2 vaccine was developed by Jiang Zhu, Ph.D., a Scripps Research Associate Professor in the Department of Integrative Structural and Computational Biology. Dr. Zhu has already delivered promising vaccine candidates to address global health challenges such as HIV, HCV, Ebola and RSV. Over the past two years, Dr. Zhu co-led 2 NIH-supported projects focusing on coronavirus, SARS-CoV and MERS-CoV, vaccine development using the nanoparticle system. With the COVID-19 outbreak, Zhu and his team worked to create a 1c-SApNP vaccine against SARS-CoV-2 in less than 60 days. We're also working with Ufovax on 2 HIV vaccines. In response to COVID-19, the company submitted the above proposals to various funding agencies to develop SARS-CoV-two vaccine candidates up to and through a Phase I trial. In February, we expanded our existing agreement with The Israel Institute for Biological Research, IIBR, which was entered into originally in January 2018. Like ZAPI, based on their experience with C1, the IIBR expanded its collaboration with Dyadic to explore the potential of Dyadic C1 expression platform to express gene sequences and targets developed by IIBR into both a recombinant vaccine candidate and monoclonal antibodies, mAbs, that may help combat the outbreak of the COVID-19 virus. We are hopeful that 1 or more of our existing or future partners who are working on combating the COVID-19 virus may run a Phase I clinical trial with SARS-CoV-2 vaccine or antibodies produced from C1, and we want to support them. We are also in discussion with another potential collaborator who has indicated they may even take a SARS-CoV-2 vaccine expression from C1 into a Phase II clinical trial if their vaccine expressed on C1 is effective at low dosages and can be produced in sufficient dosages faster at a lower cost using C1. The industry appears to be somewhat more receptive now than ever before in exploring innovative expression platforms as alternatives to existing less efficient expression systems to deal with the current global pandemic situation. And C1 is definitely one of those on the list to be considered. Our thoughts and prayers are with those people and families who are suffering from this invisible enemy, and we're honored to join this global fight and, hopefully, our efforts will save lives and not be in vain. I will now provide a brief update on our new as well as existing collaborations in our animal and human health business. In animal health, last week, as I mentioned earlier, we just signed another collaboration with a leading animal health company. This is important to Dyadic, as a number of these potential biologics may come to market sooner than our human health collaborations. Under the terms of these agreements, Dyadic and the animal health companies are engaged in a number of different feasibility studies regarding the production of various types of proteins in C1. Our growing footprint in animal health positions us well in large and growing addressable market, with a regulatory pathway that is much shorter compared to human trials for biologics and cost of goods is a much more critical issue. WuXi Biologics. We entered into a nonexclusive research agreement with WuXi Biologics, one of the leading global CDMOs with significant presence in China, Europe and the U.S. WuXi Biologics provides development and manufacturing services to pharma and biotech companies globally. This nonexclusive research license is similar to the one we announced in January, which we entered into with an affiliate of a top 25 pharmaceutical company that supplies tools for life science research. WuXi will invest its own resources to evaluate the C1 technology for research for their customers globally. Even though these nonexclusive research licenses don't necessarily bring in immediate revenue, we see them as stepping stones to potentially larger license deals, other types of collaborations in the future that we anticipate will bring in revenue and create shareholder value. Being able to establish relationships with cGMP manufacturers is important, as they would likely be the ones producing biologic vaccines and drugs produced for -- from C1 for the biotech and pharmaceutical companies. We also recently announced that we are also working with and entered into a research collaboration with the University of Oslo consortium to perform a feasibility study evaluating the potential of C1 to express targeted influenza virus antigen proteins. Just like the coronavirus, the flu kills thousands of people every year in the United States and tens of thousands of people, if not more, globally. Sanofi-Aventis. In our previously completed Sanofi feasibility study, we demonstrated that C1 could express all 7 of the therapeutic and vaccine proteins. We were able to express more than half of the proteins at or exceeding the production levels initially set by Sanofi. Together with the Sanofi scientists, we've been preparing the final presentation materials to share the data with our colleagues. We expect to have further discussions regarding possible next steps, which we would anticipate will occur sometime midyear. In 2019, we signed a research and commercialization collaboration with the Serum Institute of India, one of the largest global vaccine producers. Under this agreement, Serum has the right to apply our C1 technology to express up to 12 proteins, 8 mAbs and 4 vaccines provided by Serum. Serum has the option to obtain an exclusive commercial sublicense for each of the 12 proteins in exchange for research funding, milestone payments and royalties for 15 years from the date of first commercial sale. Currently, we are working on re-expressing the antibody genes provided by Serum that have already been expressed in earlier generations of C1 cells by using 1 or more of the recently generated glyco-engineered C1 cell lines in order for Serum to carry out further purification and analytical tests to see if 1 or more of these antibodies will have the quality attributes that will be necessary for Serum to move into clinical trials and commercial manufacturing. Finally, we are making significant progress on our own internally funded C1 glyco-engineering program. In November, we announced that our C1 strain have been successfully glyco-engineered to impart the core human-like G0 glycan structure and G0 glycan levels of up to 95%, exceeding our internal objective of 90%. Our CRO, VTT, also presented data at the 15th European Conference on Fungal Genetics in late February that our C1 strain had now also been engineered or glyco-engineered to achieve a core-like human G2 glycan level of 76% on Host Cell Proteins. Currently, we have 4 novel C1 cell lines with different glycan patterns: Man3 to Man9, which is ideal for vaccines; Man3; G0; and G2, which are useful for the monoclonal antibody and other antibodies. We are continuing to work on generating two additional C1 cell lines, G0F and G2F, and hope to be able to report that progress as the year continues. It's been a very successful year in the last few months. We have been extremely busy for Dyadic, as our pipeline of opportunities gets larger and more diverse to address the emerging markets, especially the COVID-19. So let me summarize some of the key takeaways. First, our vision of creating more efficient and commercially cost-effective health care solution for society globally through our C1 technology continues to resonate with the scientific community. Over the past 2 years, we've entered into more than 10 proof-of-concept research collaborations to produce different types of biologic vaccines and drugs for both human and animal health, two sublicense agreements and a handful of not-for-profit research licenses. In regard to the novel coronavirus, the strength of our C1 platform and scientific data reported from prior efforts facilitated furthering our partnerships with existing collaborators such as the IIBR and our colleagues in the ZAPI project as well as expanding our portfolio of collaborations. Our approach is targeting the high-value markets, and we are opportunistic as to the opportunities that are available. The scientific data being generated from our efforts is robust and its visibility becoming more broad-based. Our expanding presence in animal health is a good example of a large and growing addressable market with attractive regulatory pathways, but cost of goods sold is a critical issue. In pursuing these opportunities, we maintain an asset-light infrastructure by using third-party CROs, flexibility to scale our operations up and down as needed. And finally, we fund a large portion of R&D efforts through partner funding, limiting our cash investment, but leaving us significant upside potential as we attempt to commercialize our solutions. With that, I will now turn the call over to Ping for the financial review.