Dyadic International, Inc.

Good evening, and welcome to the Dyadic International's third quarter 2021 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 call is being recorded today, November 10, 2021. I'd now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead, Ping.

Thank you. Good evening and welcome everyone to Dyadic International's third quarter 2021 financial results conference call. I hope you've had the opportunity to review Dyadic's press release announcing financial results for the third quarter ended September 30, 2021 and the recent company highlights. You may access our press release and form 10Q under the investor section of the company's website at dyadic.com. On today's call, our president and CEO, Mark Imelfarb, will give a review of our third quarter business and corporate highlights, 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 will then hold a brief 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 BADIC's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. BADIC expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in dietics reports filed with SCC. It is now my pleasure to pass the call to our CEO, Mark Emelfarb. Mark?

Thank you, Ping. Good afternoon, and thank you for joining us today. Our mission is to transform biomanufacturing to improve how we feed, fuel, and heal the world by utilizing modern biotechnology to revolutionize science, medicine, agriculture, and engineering. We are addressing the animal and human health markets by working together with the global scientific community in academia, industry, and government to provide a cost-effective solution to increase biomanufacturing outputs and satisfy the growing demands for protein production and unmet needs for affordable biologic drugs, vaccines, and other biologic products and processes that can help address health inequity in middle and lower income countries. We are continuing to advance our science and business development efforts towards the commercialization of our C1 protein production platform for use in the human and animal pharmaceutical industries. 2020 was a very productive year, which we announced many new developments and commercial partnerships in addition to publishing critical proof-of-concept scientific and animal data, further advancing the attributes of our C1 technology. 2021 has been a continuation of those efforts as we continue to advance towards our first in-human clinical trial of our COVID-19 vaccine candidate, DYAI-100, to validate C1 produced proteins are safe in humans and further accelerate global C1 platform adoption. The efforts to launch the C1 protein production platform has been a global effort, which includes important collaboration relationships in Africa, Asia, Europe, and the Americas. It is important to understand that while many people believe COVID will soon be in the rear view mirror, it is still a real problem that will likely require annual vaccinations or periodic boosters to maintain antibody effectiveness. Many underdeveloped countries are still struggling to produce sufficient quantities at affordable prices to protect their citizens. A key takeaway from my comments today is that our phase one trial is not just about COVID. It's a means to an end. Our main objective is to demonstrate safety and efficacy in humans so we can pursue all the other indications that our C1 platform can be used for. COVID just happens to be the current focus. There are many countries interested in the C1 platform for numerous other applications in vaccines and drugs. Demonstrating safety in phase one is an important gating event. I would like to give you some brief updates on several ongoing collaborations. the Rubik Consortium, our C1 technology transfer has commenced, and the DYA-100 and other COVID-19 variant RBDs have been delivered. In addition, genetic tools, C1 strains and protocols for engineering C1 cells and producing proteins from subcells has also been transferred. We are in discussion with Rubik regarding where, in addition to COVID-19, they can successfully apply the C1 technology for the development and commercialization of several other vaccine candidates. Syngene International. Accelerated tech transfer of the DYAI-100 cell line has been completed. The manufacturing part of technology training on the C1 production platform has shown initial success, and a number of the SARS-CoV-2 RBD variant concern antigens, including the Delta RBD, has been delivered. MediTox. C1 platform tech transfer has been completed, and they are developing nanoparticle vaccine candidates for COVID-19 variants. Sorrento Therapeutics. We're continuing to negotiate the license agreement in the terms, which may be materially different than the terms set forth in the binding term sheet announced on August 11, 2021. We can give no guidance if or when the license agreement will be executed, but in the interim, technology transfer to Sorrento for DYAI-100 and the C1 platform has been initiated. This week in Israel, Biotechnology General Israel a fairing pharmaceutical company, is carrying out what we anticipate will be a successful purification of the DYAI-100 drug substance, which will, after being converted into a drug product and after regulatory acceptance, may be used in one or more DYAI-100 Phase I clinical trials. A GLP animal toxicology study has demonstrated preliminary safety profile of our C1-produced SARS-CoV-2 RBD vaccine candidate, DYAI-100. SARS-CoV-2 virus-specific immunoglobulin IgG antibodies have been detected in those animals. We continue to focus on the glycoengineering of C1 cells for their use in producing monoclonal antibodies, which continues to show progress towards both a proof-of-concept biomolecule, nivolumab, to demonstrate that C1 can be used to manufacture monoclonal and other antibodies, multispecifics, and other glycosylated proteins faster, at higher yields, and at lower cost. Now I'd like to provide a brief update on our ongoing efforts using C1 for manufacturing vaccines and drugs for use in animal health. The Zoonotic Anticipation Preparative Initiative, ZAPI, was successfully concluded in July of 2021. The ZAPI program validated C1 as the most effective production platform to express SPV and RVFV antigens. C1 cell express antigens were successfully used to develop recombinant protein particle display vaccines. The C1 produced SPV antigen showed safety, efficacy, and protection in cattle, sheep, and mice. In June, the ZAPI study was published in Vaccines. a leading peer-reviewed scientific journal. We are continuing to work with a global animal health company that is conducting poultry animal trials using C1-produced antigens. The C1 antigens are demonstrating promising efficacy in those studies. We began a fully funded phase two portion of this project to work on further increasing productivity of one or more of these antigens. Based on the encouraging results to date, we are in discussions to determine how to expand our collaboration for additional potential commercial antigens for farm animals. We are also working with another global animal health company to develop a companion animal antibody. The inbound interest that we are experiencing in applying our two-plus decades of industrial biotech experience and expertise, knowledge, and technology in non-pharmaceutical markets is accelerating. These potential markets, in conjunction with our current focus of applying C1 in the animal and human health markets, underscores the broad potential applications we are exploring in agriculture, cosmetics, food, nutraceuticals, as well as other markets. Our growth has been an iterative process, as often is the case. The company has not been able to make an announcement or name a collaborating partner. However, we have made every effort to do so where possible. Based on the collaborations we have announced and the level of new activity we are working on, we are clearly executing on our mission in gaining commercial traction across life science industries, especially in geographical regions where vaccine and drug distribution and production are lacking, and where flexible, easy to use to set up tooling and manufacturing facilities with smaller physical footprints are necessary. We are uniquely positioned to deal with these situations. We are at a critical point in the company's corporate and operational development lifecycle, as our efforts across many initiatives are starting to bear fruit or otherwise nearing to a head regarding outcomes. As much of the attention around dietics operating activity has been COVID-19 related as a result of the clear need for the production capabilities of the C1 platform, our journey to create a better production technology for vaccines, biologics, human and animal health started well before the pandemic. And our story is not just a play on COVID, but once in a generation technology shifts whose benefits could transform global biomanufacturing for decades to come. We have a clear and strategic operating plan, as well as the resources and appropriate capital allocation strategy. Our focus has been and continues to be to expand commercial opportunities of where to apply our C1 technology for human and animal health applications. Getting the company's proprietary COVID-19 vaccine candidate DYAI-100 into a first in human phase one clinical trial is a key next step. I am pleased to welcome Joe Hazelton to our executive leadership team. Joe joins us as a chief business officer. He comes to Dyadic with over 20 years of portfolio management, regulatory oversight, and global commercialization experience, including 15 years with Novartis. Joe joins at a critical point and our commercial development, supporting the global commercialization of the company's new and existing business initiatives, including closing on opportunities, business development, licensing, and regulatory matters. Joe's experience is critically important as we continue to pursue cutting-edge science in order to further the application of our C1 protein expression and manufacturing platform. I previously mentioned that our non-compete agreement with DuPont outside of licensed sciences has expired, allowing DIATIC to explore additional new business development activity going forward. Our C1 production platform is a culmination of more than 20 years of ongoing research, development, evolution, and ultimately cross-application of proven industrial-scale enzyme and protein production in broad-ranging industries such as biofuels. Diatics development advances have transformed the scalability, production, efficiency, as well as the manufacturing footprint needed for those industries to reliably produce enzymes, and proteins at industrial scale. We have an enormous number of opportunities to monetize our C1 platform technology for the benefits of shareholders. Management is committed to focusing on those that present the best opportunity to maximize our limited resources. We have done it before, and we are working toward doing it again. I will now turn the call over to Ping for a financial update.