Good evening and welcome to Dyadic International’s Third Quarter Fiscal 2022 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, November 10, 2022. I'd now like to turn the call over to Ms. Ping Rawson, Dyadic’s Chief Financial Officer. Please go ahead, ma'am.

Thank you. Good evening and welcome everyone to Dyadic International's third quarter fiscal 2022 conference call. I hope you have had opportunity to review Dyadic's press release announcing financial results for the quarter ended September 30, 2022 and the recent company highlights. You may access our release and Form 10-Q under the Investors section of the company's website at dyadic.com. On today's call, our President and CEO, Mark Emalfarb will give a review of our third quarter 2022 business and corporate highlights, including a brief summary of our research and the business development efforts. Our Chief Business Officer, Joe Hazelton will join Mark for the business update. I will follow with a review of our financial results in more detail. We'll 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 involves 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 as a result of new information future events or otherwise. Participants are directed to the risk factors set forth in Dyadic's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emalfarb. Mark?

Thank you, Ping. Hello everyone and thank you for joining Dyadic's third quarter update call. As you will hear on today's call, we are continuing to advance our scientific developments and there is much to be excited about at Dyadic. In Q2, we discussed the company's focus on our core business in achieving commercial agreements in each of its three core verticals, human health, animal health, and alternative proteins. Today, I would like to discuss the progress, we've made an expanding opportunities in these areas and how we believe that the progress will accelerate the future potential for Dyadic. As I stated in our Q2 call, the commitment it takes to build a protein production platform to support life sciences, manufacturing demands, persistence, focus, and the determination to see the process through. It also takes an unwavering belief that the potential monetary and societal impact outweighs the significant investment of not just capital but a yielding dedication to scientific advancement. At Dyadic, our mission is to help make proteins for world health. Our foundation continues to be our science coupled with our highly efficient microbial platforms and commitments to the advancement of that science to create revenue, profits and long-term shareholder value and at the same time, helping to increase access to biologic vaccines and drugs across the globe. To help the Dyadic, achieve this mission, I want to thank the many scientists we continue to work with in academia, industry and government, our collaborators, shareholders, and board members for their support during this crucial journey. As you here today, we have achieved some significant milestones since the second quarter and are even closer to several transformational milestones in life sciences as we close in on our demonstrating that producing proteins using our C1 technology are safe for use in…

Thank you, Mark. The primary purpose of the Phase 1 study is to evaluate the safety of a new drug candidate before it proceeds to further clinical studies. Using the C1 platform to produce biopharmaceuticals, we are starting the biomanufacturing process with what we and a growing number of scientists believe is an extremely safe microorganism. In 2009, Dyadic C1 cells were used to produce an enzyme that received generally recognized as safe or GRAS status from the U.S. FDA, which means safe for use as an additive in food and feed for animals and humans. In addition, Dyadic has generated significant preclinical safety data across several animal species regarding the C1 platform, but unlike E. coli, CHO, which is Chinese hamster ovary cells and insect or baculovirus cells, the C1 cells themselves are free of viruses and endotoxins that must be removed during the downstream processing impacted productivity, cost of purification and delaying product release. Data from vaccines produced from C1 proteins have repeatedly demonstrated safety and efficacy in a range of infectious diseases in animal trials with cattle, lambs, chicken, rabbits, hamsters and mice, again, demonstrating the preliminary safety of proteins produced from the C1 protein production system. Specifically with our DYAI-100 vaccine candidate, we have demonstrated safety in multiple mice studies and most importantly in our successful rabbit toxicology study, which showed safety and persistence of antibodies which were generated from our C1 based DYAI-100 COVID 19 booster vaccine candidate. You may have also seen in today's press release new data presented at the World Vaccine Congress in Europe by Dr. Albert Osterhaus. He's with the University of Veterinary Medicine in Hannover, Germany who has been collaborating with Dyadic for over five years. Dr. Osterhaus presented preclinical safety and efficacy data from animal studies including cancers and…

Thank you, Joe. As Joe mentioned in today's press release, we highlighted several areas of scientific and regulatory advancement. When we undertake a project, it is with a specific objective to either further the scientific advancement or enhance the breadth and scope of where we and our collaborators may be able to apply the technologies being developed such as our C1 protein production platform. These projects and collaborations helps to validate the application of C1 as a differentiated biomanufacturing platform for the prevention and treatment of infectious and other diseases such as rabies, oncology, arthritis and diabetes. For example, data presented recently by Dr. Albert Osterhaus, from the University of Veterinary Medicine in Hannover for C1 produced COVID-19 monoclonal antibody, mAb in a challenge study with the SARS-CoV-2 Delta virus on non-human primates. This demonstrated potential high protection and preventative effects. He also presented preclinical safety and efficacy data from animal studies including hamsters and non-human primates, demonstrating C1 produced antigens and antibodies are as effective as those produced by reference platforms like CHO cells. To further accelerate the adoption of our platform for the prevention and treatment of infectious and other diseases, research and development is ongoing with various collaborators in key therapeutic areas with the strength of our experience and our technologies coincide. In addition to the successful high level expression of ferritin gRBD nanoparticle antigens from C1 cells for use in pan-coronavirus applications. We also have collaborators who are conducting animal trials on mono and multivalent RBD-based blended COVID-19 vaccines for potential next-generation pan-coronavirus vaccine candidates that may provide broader protection and longer lasting prevention against a wide variety of coronaviruses and what is currently available on the market. Beyond our continuing work in COVID vaccines, we believe that our neuraminidase and hemagglutinin influenza antigens will anchor…

Thank you, Mark. As you noted, we are leveraging our science to core verticals and there are many similarities and needs between the human and animal health markets for vaccines and therapeutic proteins, which makes the animal health an attractive segment for Dyadic. The global animal health vaccines market is an estimated $15 billion market, supply of that vaccines making up just another $8 billion. And just the productivity levels that have the potential to increase production at lower costs in a very margin sensitive segment of the animal vaccine market and we’re just beginning to penetrate this segment. These scientific advancements are driving further development of our expanded research projects in animal health for the development of animal vaccines for livestock, a new proof of concept project for a top animal health company for the treatment of a targeted companion animal disease and the initiation of two additional recombinant protein projects to support vaccine research and development. As in the human health market, the increase in the prevalence of diagnosis of chronic and infectious disease has significantly driven demand for therapeutic proteins within the animal health sector, specifically companion animals. The global companion animal antibody market was over $680 million and growing in 2021 and we are currently in discussions with several partners, therapeutic proteins, the livestock and companion animals. Our focus being the acceptance of C1 protein platform, which we believe can serve as an accelerator to drug and vaccine development and commercialization by shortening the time from preclinical to phase trials, increasing productivity and improving cost efficiencies within animal health. Mark, Back to you.

Thank you, Joe. Alternative proteins, this core vertical is home to our nutrition and wellness initiatives in partnerships. Driven by our fully funded joint development agreement with our global food ingredients collaborator, Dyadic is dedicating resources and support for existing projects within this rapidly growing market. Dyadic launched its Dapibus platform at filamentous fungal-based microbial gene expression and protein production platform, which is further designed and customized to enable the rapid development in large scale manufacturer of low cost enzymes, proteins, metabolites and other biological products for use in non-pharmaceutical applications within our alternative protein core vertical. Alternative proteins is another core vertical where we are able to leverage the advancement, innovation and advantages of the Dyadic technologies across a broad and growing market opportunity. As with vaccines and biologics, there is a clear market opportunity in need for alternative proteins in both human and animal health and nutritional segments. The animal alternative protein market that includes livestock and companion animals is a $9 billion market and growing. The human alternative market is a $7 billion market currently driven by plant-based proteins and now further being accelerated by the introduction of cultured or lab grown meats. It is still a smaller scale and yet over $1 billion was invested in this market in 2021. There’s a common shared need across the diverse alternative protein segment for the rapid production of high quality, yet affordable for common in proteins and enzymes. To further accelerate our opportunity within this core vertical, I’m very excited that we have initiated an animal-free recombinant serum albumin and other projects to support the Dapibus platform to meet the growing demand and unmet needs of alternative protein in emerging markets such as cultured meat. These projects can also provide us with additional revenue generating opportunities that serum…

Thank you, Mark. In addition to the financial results I’ll be discussing now, you can find additional information in our Form 10-Q, which we filed earlier today. Research and development revenue and license revenue for the third quarter of 2022 increased to approximately $880,000 compared to $693,000 for the same period a year ago. Research and development revenue and license revenue for the nine months ended September 30, 2022 increased to approximately $2,187,000 comparing to $2,091,000 for the same period a year ago. Cost of research and development revenue for the third quarter increased to approximately $603,000 comparing to $393,000 for the same period a year ago. Cost of research and development revenue for the nine months ended September 30, 2022 decreased to approximately $1,419,000 compared to $1,613,000 for the same period a year ago. Research and development expenses for the third quarter decreased to approximately $744,000 compared to $1,902,000 for the same period a year ago. Research and development expenses for the nine months ended September 30, 2022 decreased to approximately $3,917,000 compared to $5,919,000 for the same period a year ago. The decrease in research and development expenses was due to the winding down of activities of contract research organization and pharmaceutical quality and the regulatory consultants to manage and support the preclinical and clinical development as well as a decrease in CGMP manufacturing costs as the company moves toward its anticipated Phase 1 clinical trial of it’s DYAI-100 RBD COVID-19 booster vaccine candidates. G&A expenses for the third quarter decreased to approximately $1,383,000 compared to $1,693,000 for the same period a year ago. G&A expenses for the nine months ended September 30, 2022 decreased to approximately $4,753,000 compared to $4,994,000 for the same period a year ago. Net loss for the third quarter was approximately $1,809,000 or $0.06 per share compared to $1,715,000 or $0.06 per share for the same period a year ago. Net loss for the nine months ended September 30, 2022 was approximately $7,589,000 or $0.27 per share compared to $8,856,000 or $0.32 per share for the same period a year ago. Our cash, cash equivalents and a tearing value of investment grade securities as of September 30, 2022, including accrued interest were approximately $14.2 million U.S. dollars comparing to $20.4 million U.S. dollars on December 31, 2021. Based on our current plans, the company’s cash burn for 2022 will be much lower than the original estimated range of $10 million to $11 million that was announced in March this year. We reiterate our expectations that our existing cash, cash equivalent and investment grade securities will be sufficient to fund our Phase 1 clinical trials of DYAI-100 and our operating expenses into 2024. With that, I will now ask the operator to begin our Q&A session. Each caller will be allowed one question and one follow-up question to provide all callers an opportunity to participate. If time permits, the operator will allow additional questions from those who have already spoken.

Thank you. [Operator Instructions] The first question comes from John Vandermosten from Zacks SCR. Please proceed with your question, John.

Hello, Ping, Mark, Joe. How are you guys doing? Let me start out with a question on the scientific conferences that have recently happened. Mark, I think you attended several of those. When you’re going to those, what are some of the trends that you’ve heard in the industry that might be favorable or maybe even unfavorable? And then also does it give you a chance when you’re there to talk with potential companies or individuals who might be interested in C1?

Yes, so to the second half your question, which is the easiest one to answer is obviously I’ve met with numerous big pharma scientists, business development people that are key to big pharma and getting doors open to further collaborations and license agreements. And I would say that the level of interest in C1 on the recombinant vaccine platform has been elevated to I think significant levels and many of the fronts between several of the top 10 pharmaceutical companies, including different divisions in companies we work with like Janssen. We’re working with currently the therapeutic side, but also the vaccine side has expressed extreme interest. I’m going to get into more details for that because the confidentiality, but I can go on and on. At least five out of top 10 pharmaceutical companies have had recent discussions at some of those conferences. In terms of the trends, it’s crystal clear that the world isn’t been in turmoil in terms of having access and affordability in health equity. Now, whether that actually plays out in the real world over time, but I can tell you that people are starting to recognize and realize that there’s a need outside of the west and in more affluent countries for not only vaccines, but treatments not just for COVID-19, but for cancer, rheumatoid arthritis, for diabetes, all kinds of other diseases. So I think quite frankly that these conferences are much more important to us for the long-term in developing strategic relationships, scientific collaborations, and putting us on higher and higher levels in within these companies to getting deals done and going to investor conferences.

Right, okay. And that kind of leads me to my next question, which is one of the areas that might be of interest to yours. I think the NIH did some work on this monoclonal antibody that would treat malaria fairly successfully. I don’t know if you’ve seen that or not. But is that something that you might pursue? I’m not sure who owns the mab, but I mean it seems like with your relationships in Africa and just the prevalence of malaria in Africa, that might be something that we’d be interested in. Does that sound like something similar to that or that in particular came up? Would you jump on that to try to see if you could work something out?

Well, we certainly would jump on it. The question is who’s going to fund it? And so the issue there is, I’ve already reached out to that individual scientist, I think his name was Bob Seder from that paper you’re talking about. But the RUBIC Consortium is not just interested in COVID-19. In fact, their main interest is in other varieties in types of antibodies, vaccines for both animal and humans, including HIV and malaria as well as others. And they’re not alone.

Right, right. Exactly. All right, well, thank you, Mark. Appreciate that.

Thank you.

[Operator Instructions] The next question comes from Lewis Titterton from who is a Private Investor. Please proceed with your question, Lewis.

Thank you. Hi, Mark. Congratulations on a number of things, number one, getting your burn down and getting your revenues up that’s absolutely terrific. It gives you a much longer runway. Congratulations on all the good scientific work you’re doing. I have a pretty simple question. You’ve talked about Janssen and J&J and what’s going on there? It’s been about a year, I think, roughly a year since you announced that collaboration. Can you give us a little more color on the timing of this stuff so we can see when we could expect some results that we can look at?

Yes, so I think it's been about nine months since we've started the actual project with Janssen and we're talking about Janssen on the therapeutic side, not the vaccine side, which I intimate it as something else that we're working on as well. So we've improved the yield of all the proteins in this project purely, significantly so from the science perspective, the R&D teams of Janssen and Dyadic are working well together and the progress made so far in these projects is advancing towards reaching the milestones outlined in our agreement with Janssen, including the multiple seven figure potential milestones, eventual payments of the nine figures per each product if the volumes of these product projections are reached. So I think what's going very well and it's very difficult with these big pharmaceutical companies because of the difference between what's going on with the science and the business development and those timelines sort of have to come together, but it's first reaching these scientific milestones and achievements that we're hitting that leads to those milestones and the bigger payments that we're all looking for. So Janssen, we have a very strong relationship with them on the scientific side. We certainly met with them at BPI East as John Vandermosten was talking about these conferences, we met with their business development guide, we actually made the deal with, so they're all over it. They're watching and hopefully they're expanding to actually do more things in different sides of their business that may surprise all of us is becoming even faster.

Thank you, that's very useful. I appreciate it. Do you think that within the next 12 months we'll start seeing them, if I remember correctly, they're going to pay us $5 million for each one. There were two things we're working on, they’re going to pay us $5 million upfront on each one. Where would that sit?

Well, I'm not quite sure what you mean, but where would it sit? But if you remember…

That’s what I'm getting at it, the point I'm getting at is when would we expect to see the 5 million on each of these products?

Yes, I mean honestly we can't give you a projected timeline or timeline, but if you remember, they gave us 500,000 cash upfront. They're funding up to $1.6 million in R&D revenue. And then let's talk about, to your point on exercise of an option, we'd receive a mid seven figure for an additional non-exclusive target and then another mid seven figure for the bringing the technology in for a technology transfer. And then single-digit seven figures for doing technology transfer, the first project going in, then of course up to nine figure payments over time on the backend, they achieve certain productivity goals and sales on the products produced. But we don't expect that the technology is going to end with a few different proteins. We expect that they – hopefully they'll adopt it and bring it in, in addition to the incredible opportunity we're talking about here, that this can just be leveraged into more and more opportunities within both sides of their hands and business both on the recombinant protein side and potentially even on the, let's say the recombinant protein vaccine side.

Okay. Thank you very much. I appreciate it.

No problem. Thank you.

Thank you. There are no further questions. I'll now turn the call over to Dyadic’s CEO, Mr. Emalfarb for closing remarks. Thank you, sir.

We are proud of our scientific advancements and achievements in 2022. Most significantly, the Dyadic has received regulatory approval to initiate a Phase 1 clinical trial to demonstrate clinical safety and antibody response in humans for the DYAI-100 COVID-19 recombinant protein RBD booster vaccine candidate. We believe this first-in-human safety data for C1 produced protein from the C1 platform, in addition to the continued advances in productivity, quality and efficiency will help to accelerate the adoption use of the C1 protein production platform within the human pharmaceutical industry to the benefit of patients across the globe. We're not only focused on improving the value of Dyadic, for the life science industry, which will in turn improve value for shareholders, but will also improve access to affordable vaccines and therapeutics for populations in developed and emerging nations. Our reorganization of our infrastructure and focus strategy has prepared Dyadic for exploiting existing and new commercialization opportunities to enable us to fulfill our mission as a global biotechnology company in order to improve the way we feed, fuel and heal the world. Thank you once again for joining us on today's Q3 2022 conference call. And we look forward to keeping you updated as we advance our commercial and scientific initiatives across the companies and our collaborators programs. We also look forward to seeing you on the next call and I hope you keep an eye out for our periodic updates.

Thank you very much, sir. This conference has now concluded. Thank you for attending today's presentation and you may now disconnect your lines at this time.