Dyadic International, Inc.

Good evening, and thank you for holding. Welcome to Dyadic International's first quarter 2021 financial results conference call. Currently, all participants are in listen-only mode. Following management's prepared marks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today, May 13, 2021. 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 first quarter 2021 financial results conference call. Earlier today, Dyadic issued a press release announcing financial results for the first quarter ended March 31st, 2021, and the recent company highlights. You may access our press release and form 10-Q and the investor section of the company's website at dyadic.com. On today's call, our president and CEO, Mark Emmefarb, will give a review of our business and corporate accomplishments for the first quarter of 2021, 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 Shalett, will join Mark and I for the Q&A session. At this time, I'd like to inform you that certain commentary made on this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause the addict's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. DIATIC expressly disclaims any duty to provide updates to these forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factor set forth in DIATIC's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Imhofar. Mark?

Thank you, Ping. Welcome, everyone, and thank you for joining us. We have ushered in a new year with substantial progress on our R&D initiatives. I would like to highlight first some of the exciting progress we've made on developing new COVID-19 vaccine candidates. We enter into nearly a year and a half since the start of the COVID-19 pandemic. Yet, the coronavirus continues to cause worldwide disruptions and suffering. Although many countries, including the U.S., have been able to ramp up its vaccination efforts, it is clear that there's still significant global vaccine inequality. It's becoming increasingly apparent that there are critical bottlenecks in the manufacturing and supply chains of these vaccine products that are hindering the efforts to get the populations vaccinated and save lives. If global efforts to stop the spread of COVID-19 are to be successful, it is clear that there needs to be more efficient affordable and flexible ways to develop and manufacture vaccines and drugs globally. We believe, as do a growing number of scientists, our hyperproductive C1 protein production platform technology is ideally suited to help meet this global demand for health equity. As such, we've been working tirelessly on applying our C1 technology to speed up the development of new COVID-19 vaccines that have the potential be more affordable and accessible. We are pleased to partner with leading scientists, government agencies, and pharma companies worldwide to expedite the application of our C1 technology in multiple COVID-19 programs. We believe our COVID-19 partnerships stem from our success in several animal studies that demonstrated C1 cells to be engineered to efficiently and rapidly produce large quantities of safe and effective protein-based products. Our SARS-CoV-2 SRBD vaccine candidate, DYAI-100, has been evaluated in 10 animal studies by academic, industrial, and governmental R&D groups globally, including the Israel Institute for Biological Research and scientists from ZAPI. Based on compelling preclinical data, we are now moving towards an anticipated first-in-human phase one clinical trial to evaluate its safety and preliminary efficacy. We've engaged the Contract Research Organization, CR2O, to manage and support its preclinical and clinical development. Moving DYAI-100 into the clinical stage marks a major milestone for the program. First, it's critical to emphasize that the fight against COVID-19 is not over, but the risk that COVID-19 may become an endemic disease and issues with vaccine distribution and potency, there's still a significant need for next-generation vaccines that can bridge this gap for protecting the global population. Our clinical trial with DYA100 may serve as an important proof of concept for the next generation of COVID-19 vaccine candidates for emerging variants. And furthermore, we believe DYA100 has the potential to be a more affordable and highly potent solution to serve this global need. Second, although this will be a clinical trial for our COVID-19 vaccine candidate, its value goes well beyond that. Demonstrating that DYA-100 can be produced under CGMP conditions and is safe and well-tolerated in humans serves as a proof of principle for the C1 platform itself. We anticipate that by de-risking our C1 technology and demonstrating that the C1 platform has strong potential to safely produce proteins for use in humans that we can accelerate its adoption, use, and commercialization by the biotech and pharmaceutical industry globally for a number of biologic drug and vaccine opportunities. As such, we look forward to bringing DYAI-100 into phase one by the end of the year, following the completion of our ongoing animal GLP toxicology study. As SARS-CoV-2 continues to mutate into different variants, we are engineering additional C1 cell lines to produce SARS-CoV-2 variant antigens for monovalent and multivalent vaccine candidates. We have already successfully expressed the South African, Brazilian, and UK variant antigens at highly productivity levels and stability. And we will continue to work towards developing both RBD antigen and potentially full spike protein for additional variants. Importantly, it is becoming increasingly clear that emerging variants are here to stay. And it is expected that new variants may appear annually, similar to a seasonal flu, and consequentially potentially require annual or even semiannual booster shots. Multivalent vaccines will have the potential to confer broader efficacy against SARS-CoV-2 variants may be an important approach for future efforts in managing COVID-19 and future pandemics. Towards this end, we have expanded our fully funded vaccine development partnership with Meditox to accelerate the development of multivalent COVID-19 vaccine candidates and or boosters to immunize people against multiple existing or future SARS-CoV-2 variants. We are pleased to partner with Meditox who understands firsthand that C1 may be the most realistic technology to develop and manufacture affordable multivalent vaccines rapidly and at lower cost in larger volumes. The transformative potential of C1 to solve key challenges related to manufacturing productivity, speed, and cost was highlighted in our recent KOL Fireside Chat. We are grateful to have the support of such esteemed thought leaders who can attest the remarkable potential of C1 to provide a game-changing advance in global access to vaccine and drugs for major health challenges such as COVID-19 and beyond. I strongly encourage you all to listen in on this panel discussion by watching the replay webinar, which is available on our website. In parallel to our COVID-19 initiatives, we remain focused on advancing C1 for a number of other human and animal health applications. During the first quarter, we were pleased to enter into a fully funded collaboration with Turtle Tree Scientific to develop a number of recombinant protein growth factors, which may play a critical role in tissue development and healing, including regenerative therapies. Manufacturing human growth factors at large scale at an affordable cost has been an industry challenge. As such, we are excited to apply our C1 technology to help overcome this hurdle and a significant new commercial opportunity. Our C1 technology continues to be sought out by many other pharma and biotech companies looking for a better manufacturing solution. These ongoing collaborations, such as with Hangzhou Hangzhou Medicine, the largest pharmaceutical company in China by market cap, we continue to report promising results for biologic drugs of commercial interest. We are particularly excited about the promising potential of several candidates for bispecific antibodies that offer significant benefits over conventional monoclonal antibody therapeutics. For these bispecific antibodies and other biologic drugs, C1 has consistently achieved high productivity levels that support advancing several of these programs towards clinical development. As for our efforts in animal health, we are pleased at the positive results from animal studies evaluating The safety, efficacy, and protection of C1-produced antigens were highlighted in ZAPI's final stakeholders meeting in February. The C1 platform was selected by ZAPI to produce recombinant antigens after demonstrating far greater antigen productivity from C1 cells than insect cells and other cell lines. The next leading expression platform for both Schmeilenberg virus, SPV, and Rift Valley fever virus, RVFE. Notably, C1-produced SPV antigen has demonstrated not only hyperproductivity, but strong protection of cattle, sheep, and mice from the SPV virus. During the first quarter, ZAPI expanded its program with Dyadic by providing additional funding to C1 research and development efforts, as well as to conduct potential additional animal studies using SPV and RVFE antigens produced from C1. These ongoing animal studies are intended to demonstrate further commercial scale viability of C1 produced SPV and RVFV antigens. As part of the expanded program, ZAPI is conducting additional studies to further optimize the use of C1 to produce recombinant protein subunit nanoparticle vaccines by producing larger quantities at lower cost. Preliminary results have been very encouraging and support C1 potential to improve productivity of nanoparticle vaccines. An additional collaboration with a top animal health company has demonstrated successful production of two different antigens produced from C1 for a potential vaccine for an acute respiratory disease in birds. We expect that an animal challenge study to evaluate protection provided by these vaccine candidates will initiate in June of 2021. Our global co-development partnerships such as with ZAPI, TotalTree, MediTox, and others highlighted today, drive access to broad commercial opportunities in large and growing human and animal health markets. Further, these partnerships provide robust scientific data that complements our internal development efforts. As our current R&D efforts continue to demonstrate that C1 has the versatility to efficiently and rapidly produce large quantities of more affordable protein-based products. We expect a growing number of companies will seek our C1 platform to address manufacturing challenges for cost-effective and flexible-scale commercial production. We believe these clear advantages, coupled with the support of a growing number of partners, key opinion leaders, and subject matter experts, will position our C1 protein production platform as a leading solution for more affordable and accessible therapeutics and vaccines worldwide. Lastly, during the first quarter, we added Patrick Lucey to our board of directors. We look forward to benefiting from his wealth of experience in development, adoption, and commercialization of cell lines in the biopharmaceutical industry as we work towards commercializing our C1 technology. Looking ahead to the remainder of 2021, we expect to achieve a number of milestones, notably our first vaccine candidate, DYAI-100. We have initiated our animal GOP toxicology study already last month, and we look forward to progressing to a first in human phase one trial by the end of this year. After generating a phase one data, we expect to submit an IND. We also expect that our extensive number of collaborations will continue to generate robust scientific data that highlights the broad potential impact of our C1 platform in diverse animal and human health applications. We look forward to updating you on these accomplishments as we continue to work tirelessly to advance our C1 platform to meet the global need for rapid, safe, effective, and scalable therapeutics and vaccines. As always, I want to extend my thanks to our employees, our partners for their commitment and dedication during these challenging times. I would also 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.