Dyadic International, Inc.

Ladies and gentlemen, good evening and welcome to Dyadic International's Q1 2024 conference call. Currently, all participants are in a listen-only mode. Following the management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today, May 14, 2024. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Thank you. Good evening and welcome everyone to Dyadic International's Q1 2024 conference call. I have had the opportunity to review Dyadic's press release announcing financial results for the quarter ended March 31st, 2024. You may access our release and form 10Q in the investor section of the company's website at dyadic.com. On today's call, our President and CEO Mark Emelfarb and our 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 in more detail. We will 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. Dyadic 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 DIAC's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emelfarb. Mark?

Thank you, Ping. Hello, everyone, and thank you for joining DIAC's Q1 2024 conference call. A little over five weeks ago on our 2023 year-end conference call, I highlighted how Dyadic is 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 and the company's pipeline products to enhance shareholder value. We continue building upon the momentum witnessed in 2023, and we have further accelerated our progress. The acclaim and acknowledgement of our C1 technology for its speed, productivity, and low cost persists both domestically and globally, receiving commendations from academia, industry, government bodies, and nonprofit organizations. Additionally, our adaptableness expression platform has exceeded our initial expectations. Despite launching a little over a year ago, we are beginning to gain substantial traction in generating revenue in both the alternative protein and bioindustrial sectors. In the first quarter, we successfully closed a $6 million convertible note financing without issuing any warrants. And I would again like to extend our gratitude to long-term shareholders for their steadfast support as these funds will fuel the acceleration of our goal to introduce revenue-generating products through targeting both pharmaceutical and non-pharmaceutical sectors. To further support our growth imperatives, in March, we announced changes in leadership roles, both at the board level and management team. Patrick Lucey has assumed the role of Chairman of Dyadic's Board of Directors, and Joe Hazelton has expanded his responsibilities as our Chief Operating Officer. With strengthened financial resources, scientific prowess, and bolstered leadership, we are well-positioned to execute our strategic business objectives. We will continue to leverage our microbial protein production platforms, B1 and APOBIS, to craft antigens, antibodies, enzymes, and other recombinant proteins pivotal to each of the sectors we are focused on, human health, animal health, and alternative proteins. These efforts are anticipated to unlock the monetization avenues significantly enhancing shareholder value for dyadic and our partners, spanning both pharmaceutical and non-pharmaceutical domains. With regard to the human health sector, I cannot overstate the significance of the positive outcomes from our phase one human study, which has had an bolstering academia, industry, and government attention towards dyadic NRC1 expression platform. Today we announce that the final clinical study report, CSR, has been issued for a phase one clinical trial demonstrating safety and antibody response for DYE100, a recombinant protein receptor binding domain RVD booster vaccine candidate for protection against COVID-19 infection. This was the final step in the journey for the first in human study for C1-produced protein. It not only achieved its primary endpoint of safety and reactogenicity, but also produced a strong immune response. Since the announcement of these results, heightened interest from industry partners, including two top 10 pharmaceutical firms, has spurred the start of over 12 fully funded vaccine and antibody projects, five of which are fully funded by two of the 10 pharmaceutical companies. These projects span various disease areas, exemplified by our strategic partnership with RabianBV, a Dutch innovative SME founded by seasoned entrepreneurs and vaccine scientists. Rabian secured 1.7 million euros in funding from Eurostars for the Avatar project, aiming to leverage its virology expertise to develop a rabies vaccine utilizing dyadic C1 protein production platform. Additionally, the Israel Institute for Biological Research, IIBR, is harnessing dyadic microbial platform expertise in conjunction with their own capabilities in antibodies and antigen discovery to develop and manufacture treatments and vaccines for emerging diseases and potential bio threats throughout licensing opportunities. In the realm of infectious diseases, our recombinant vaccine capability continues to attract growing interest. We are engaged in expanded research collaborations with a top five pharmaceutical company to develop a number of additional antigens, preventing and treating various infectious diseases. Furthermore, our research collaboration to develop and test vaccine antigens for influenza A and other infectious diseases using the C1 and other platforms with the Vaccine and Immunotherapy Center, at Massachusetts General Hospital, which received over $5 million in funding from the DOD or the Department of Defense, is ongoing, showing strong initial yield results with the C1 platform. Turning our focus to therapeutic proteins, particularly monoclonal antibodies, or MABs, we see significant potential in utilizing the C1 production system for the production of antibodies targeting infectious and other diseases. In the first quarter, we announced the publication of a manuscript in the esteemed peer-reviewed journal Nature Communications detailing 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 possess broad neutralization and protection against various variants, including Omicron, BA1, and BA2, as well as the earlier variants of concern in hamsters, underwent dosing. Findings 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 the non-human primate study, affirming both the safety and efficacy of C1-produced antibodies for addressing infectious diseases. These recent findings regarding safety and efficacy of monoclonal antibodies produced using C1 technology are significant in accelerating research and development efforts in the field of infectious disease. This is particularly noteworthy, taking with previous reported data that C1-produced MABs are comparable in efficacy and safety that was produced using traditional CHO cells or Chinese hamster ovary cells. In the first quarter, Dyadic entered into a collaboration with another top 10 pharmaceutical company to develop an infectious disease monoclonal antibody and vaccine antigen using our C1 technology. This marks a significant step forward in this area. The fact that this collaboration is fully funded underscores the confidence and the potential of the C1 technology reducing effective treatments and vaccines against infectious and other diseases. Overall, these developments suggest a promising future for the C1 technology in the field of infectious disease research and development, potentially leading to more effective treatments and vaccines and antibodies against a variety of pathogens. In the animal health sector, we continue to extend and expand our presence in vaccines and therapeutic proteins with a focus on zoonotic infection diseases with the potential for spillover, which refers to the transmission of a pathogen that typically infects one species and is transferred to another, to other animals and humans. One example is the H5N1 pathogen or bird flu spillover threat, which continues to escalate. H5N1 is now being found in multiple animal species, including dairy cows, companion animals, and has surfaced in a few occasions in humans. We are experiencing the worst outbreak of H5N1 since 2015, where over 50 million chickens died, and in 2022, over 90 million chickens have died in 48 states, with over an estimated 50 million dead this year, mostly from being slaughtered to control the spread, but some from the deadly virus itself. This kind of transmission can pose significant health risk especially if the new host species has little to no immunity against the pathogen. Diatics reports that Verovax has completed initial preclinical testing of the potential H5N1 bird flu ferritin nanoparticle vaccine candidate, showing promising results in producing a strong immune response in animal models. The company has also estimated the potential production of up to 300 million doses that can be manufactured and purified in as little as two weeks using one 15,000-liter microbial bioreactor using dose levels based on the preclinical dosing of 25 to 50 micrograms. Dyadic has taken a proactive approach to tackle the threat of a bird flu outbreak in collaboration with Verovax. We are combining the strengths of our C1 platform to rapidly produce large amounts of low-cost H5N1 vaccine antigens with Verovax's highly efficient and effective adjuvant to develop an efficacious bird flu vaccine candidate that may offer significant advantages in terms of scalability, speed, and efficacy. The C1-produced adjuvanted recombinant ferritin nanoparticle H5N1 bird flu human vaccine candidate demonstrated a strong immune response in animal studies. Recently, Verovax generated additional data that indicates that the C1 produced adjuvanted recombinant ferritin nanoparticle H5N1 bird flu human vaccine candidate also has a potential to induce a strong immune response against all three of the circulating H5N1 viruses, including Texas, to provide protection for humans and cattle. We are pleased with the progress of the C1 platform in both the human and animal health sectors. As part of that effort, it's important to continue for us to invest in our platforms to meet regulatory expectations. As part of those efforts, we previously engaged Cygnus Technologies to co-develop a CM1 host cell protein HCP ELISA kit. These kits are essential for detecting and quantifying contaminating proteins derived from the host strain during manufacturing to ensure product purity and quality is achieved. This is a standard test required for all protein production platforms. We are pleased that the C1 HCP ELISA kits are now available to Dyadic and Cygnus customers through Cygnus' online ordering system. I will now turn the call over to our Chief Operating Officer, Joe Hazelson, to provide an update on the alternative protein sector. Joe?