Good evening, and welcome to Dyadic International First 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 call is being recorded today, May 12, 2022. I would now like to turn the conference over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Thank you. Good evening and welcome everyone to Dyadic International's first quarter 2022 conference call. I hope you have had the chance to review Dyadic's press release announcing financial results for the quarter ended March 31 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 first quarter's business and corporate highlights, including a brief summary of our research and 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. Our senior management team will join for the 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 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 once again for joining Dyadic for our first update call of the new fiscal year. 2022 will be important for the development of Dyadic's business and our technologies. The foundation of Dyadic is our science and advancement of that science has yield a broad spectrum of business segments we can apply our technologies and experience to create revenue, profits and long-term shareholder value. Net value will be realized through the ability of Dyadic to help our customers develop more robust and efficient biomanufacturing processes. Dyadic remains laser-focused on our core life science business where we are starting with infectious diseases. We continually to globally leverage the adoption of our C1 protein production platform, tell the speed of development and lower the cost of vaccines and antibodies. In our efforts to enhance our capability to drive shareholder value, we are also pursuing potential applications for our technologies in adjacent markets where we have a competitive differentiation. This effort is demonstrated by yesterday's announcement of our new collaboration agreement with a global food ingredients company for the manufacture of animal-free protein products. Over the past five years, we have successfully engineered our C1 cells to where they are now being used to develop potential vaccines and treatments for growing number of diseases to advance our life sciences applications. The adoption of C1 in infectious disease is growing. And Dyadic has multiple global research projects which continue to generate positive, pre-clinical animal data and several C1 produced antigens and antibodies for host of infectious diseases including Influenza, Rabies, SARS-CoV-2, Zika and others. The primary objective of these projects is to validate the application of C1 as a differentiated biomanufacturing platform for developing and producing vaccines, antibodies and other therapeutics more rapidly at higher yields and lower costs for the prevention and treatment of infectious and other diseases, such as oncology, arthritis and diabetes. Earlier this week we announced successful toxicology data published in Toxicologic Pathology, which demonstrates excellent safety profile and lasting immunogenic response from Dyadic's DYAI-100 recombinant protein receptor binding domain, RBD, COVID-19 vaccine candidate. Since the beginning of this year three manuscripts have been published in leading peer-reviewed scientific journals, which included scientists and authors for the EU, Israel and the United States. These publications support that the scientific community is also recognizing the important role our C1 protein production platform may play in preventing and treating animal and human diseases. And furthering the validation efforts for our C1 platform, we intend to file our first in-human clinical trial application CTA with the South African Health Products Regulatory Authority, SAHPRA, to support the clinical safety of C1 produced proteins, including our DYAI-100 COVID-19 vaccine candidate. I will now turn the call over to our Chief Business Officer, Joe Hazelton, to provide a brief update on the progress of our Phase 1 program.

Thank you, Mark. I'm pleased with the progress that has been achieved this quarter in the Phase 1 clinical program for our DYAI-100 COVID-19 vaccine candidate. cGMP production and the fill and finish activities of DYAI-100 have been completed. This allows us to prepare the final documentation for the regulatory submission of the CTA, which we're targeting for late June. Pending a favorable regulatory review, we anticipate first dosing of patients in the fall of this year. We are hopeful for a successful outcome to the Phase 1 trial for DYAI-100 in terms of bringing another weapon closer to approval in the battle against COVID-19, while also demonstrating first-in-human safety for a C1 cGMP manufactured product. As with any new technology for human use, safety is the first hurdle to commercialization. The demonstration of safety in humans for a C1 produced therapeutic will accelerate Dyadic's business development efforts in vaccines, obviously, but also other therapeutic proteins, as the results are the platform validation that increases value for our partners and reduces their developmental risk analysis. I'll now turn the discussion back to you Mark.

Thanks, Joe. To expand on Joe's point regarding business development in our vaccine segment, last month we announced Epygen Biotech Dyadic's nonexclusive licensee receive funding from the Indian government to further the development, manufacturing, conduct Phase 1 and 2 clinical trials of their COVID-19 vaccine candidate produced from C1 cells. In South Africa our collaboration with the Rubic Consortium is intended to develop end-to-end solutions for vaccine discovery, development and manufacture for the African market. Tech transfer of the C1 protein production platform is advancing on target and has been substantially completed and Rubic has already begun engineering and growing C1 cells. Dyadic was a recipient of one of 32 project grants awarded by NIMBLE, the National Institute for Manufacturing and Biologics funded through the White House's American Rescue plan. Under the NIMBLE grant, Dyadic will receive and has already started to receive up to $690,000 in funding to engineer a C1 protein production platform to produce two different antibodies, one being a COVID-19 antibody. We have successfully completed the expression phase or the first phase of the project and are currently moving into the second phase to further increase productivity. Dyadic and our C1 protein platform is gaining exposure, credibility and traction globally within animal and human biopharmaceutical industry. In addition to our anticipated Phase 1 human clinical trial with our DYAI-100-COVID-19 vaccine candidate, our further efforts are starting to pay off, resulting in several global preclinical and animal trials for vaccines and therapeutic proteins. Of note is the C1 produced COVID-19 monoclonal antibody, which has demonstrated broad neutralization and protection against Omicron, BA.1 and BA.2 and other variants of concern. Based on recent HAMSTER trial conducted by one of our European collaborators. Since 2016, we have been focusing our research and development efforts to reengineer our industrially proven…

Thank you Mark. Having spent my entire career in pharmaceutical development and commercialization, I'm honestly amazed at the relatively brief period of time, over which Dyadic has built its biopharmaceutical value proposition of accelerated and adaptable development, higher yields and cost-efficient biomanufacturing. We have the potential to help our human and animal health partners develop vaccines and therapeutics faster, rapidly adapt to market events and improve the efficiency of their portfolio capabilities in terms of yield and cost. In addition to the further validation of the C1 platform, we're currently undertaking an internal management project to further refine our corporate strategy, business development targets, licensing and other monetization opportunities within our core verticals. This will enable us to better focus our efforts and resources on both internal and external business development and licensing opportunities with the highest potential to drive value for Dyadic, our partners and our shareholders. An example of this revised strategy is our intent to run process for our biobetter candidate, nivolumab, Bristol Myers $8 billion oncology drug Opdivo. Nivolumab was Dyadic’s strategic monoclonal antibody product target as the model protein for manufacturing proteins with human glycosylation from C1-cells. Through our developmental efforts for nivolumab, we've established the foundation of the potential for developing and manufacturing monoclonal and other antibodies with mammalian glycosylation. With nivolumab we've demonstrated and optimized our ability to create stable human-like and functional biobetters and new biotherapeutics with improved yields and cost efficiencies from our C1 protein production platform. The preliminary data we've obtained so far supports further clinical development of nivolumab, which we anticipate by running a process that may lead into a Phase 1 human trial together with a partner. As we complete our internal management review, you will hear more about our refocused corporate strategy and associated reorganization plans in the second half of this year. Mark I turn the floor back to you.

As Joe alluded to in these five short years of developing C1 for the life sciences we can say that through leveraging learnings of the prior use cases for C1 in commercial scale industrial manufacturing, C1 is much further along in its life cycle development for life sciences and where industrial cell mines development was within the same time frame. Based on the continued advances in our science and the corresponding data, we believe that there is significantly more room to optimize the C1 platform. As seen in 2021, our results to date have really stood out as we've been highly effective in gaining industry adoption to further develop the platform for human and animal health with organizations not just in the US but worldwide. We've also focused our efforts in messaging around our core verticals in response to outside inquiries. To further refine and focus our resources and efforts to share the internal reorganization planning underway, which we expect will in a streamlined strategic approach improve value through enhanced efforts in business development, licensing and corporate organization. At the same time as a result of the increase in adoption of C1, we are evaluating new opportunities aligned with our verticals in targeted markets of high potential return. We announced earlier in the week, the initiation of a partnership to develop C1 for use in industrial food manufacturing with one of the largest dairy, product manufacturers in the world. This is with the aim to exploit C1 for the manufacturing of animal-free products. These opportunities underscore the diverse nature of our platform technologies and the potential benefits and commercial opportunities that we look to exploit through 2022 fiscal year and beyond. I want to summarize, the opportunity before Dyadic and our shareholders. What we have now is an elegant, refined…

Thank you, Mark. In addition to the financial results, I will be discussing now, you can find additional information in our Form 10-Q, which we filed earlier today. Our cash, cash equivalents and the carrying value of investment-grade securities as of March 31, 2022 including accrued interest were approximately US$17.5 million, compared to $20.4 million on December 31, 2021. R&D revenue for the quarter increased to approximately $534,000 comparing to $461,000 for the same period a year ago. The license revenue recorded in the first quarter of 2022 of $115,000 was in connection with the Phibro/Abic and Janssen agreements. Cost of the R&D revenue for the quarter increased to approximately $405,000 comparing to $391,000 for the same period a year ago. The increase in revenue and the cost of R&D revenue for the quarter was due to higher amounts for individual projects, comparing to the same period a year ago. R&D expenses for the quarter decreased to approximately $1,343,000 comparing to $1,808,000 for the same period a year ago. The decrease primarily reflected the winding down of activities of CRO and pharmaceutical quality, and regulatory consultants to manage and support the pre-clinical and clinical development, as well as a decrease in cGMP manufacturing costs, as the company moves towards its anticipated Phase 1 clinical trial of our DYAI-100 COVID-19 vaccine candidate in the amount of approximately $165,000 and our other internal research projects of $300,000. G&A expenses for the quarter increased by 6.6% to approximately $1,656,000 compared to $1,554,000 for the same period a year ago. The increase principally reflected increases in insurance expenses and business development and investor relations expenses. Other income for the quarter was $250,000 comparing to zero for the same period a year ago. The other income recognized in the first quarter of 2022, was related to a settlement payment we received from the termination of our proposed license and collaboration. Net loss for the three months ended March 31, 2022 was approximately $2,492,000 or $0.09 per share comparing to $3,295,000 or $0.12 per share for the same period a year ago. With that, I will now ask the operator to begin our Q&A session. Dr. Ronen Tchelet and Joe Hazelton will join Mark and I to answer the questions. Each caller will be allowed one 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. Operator?

Thank you. [Operator Instructions] We'll take our first question from the line of John Vandermosten with Zacks. Please go ahead. Your line is now open.

Thank you very much and good evening, Mark and Ping how are you guys doing?

Good. How are you John?

I'm doing good.

Hey, John we also have Joe here with us too and Ronen.

Great. Yes, that's right Joe. I'm sorry I forget you.

No worries.

So on Epygen have they received the grant funds yet for that trial from the Indian government. And are they enrolling patients? I wasn't quite sure kind of where they are in that? Any update?

Yes, they've received the first tranche of the money and they're starting to move things forward.

Okay. And will you let us know when they enroll those patients? And I mean that's a pretty big achievement. I think having..

Yes.

Pretty long.

Yes. Once they get to that point we'll be happy to do that.

Okay. And then when you look at your portfolio and I think I've got about 30 different active collaborations in there. And you -- I guess multiply I guess the probability of their success and the size that they could be. What are the top three in your mind when you think of it that way that investors should be thinking about?

Well I think number one, of course, we're in the life science industry for vaccines and antibodies other therapeutic proteins. So Janssen, J&J is obviously a key player one of the top five companies in the world in that space. So we're just starting the, let's say, the second go around with Janssen, but to first go around with this new project in a collaboration and license agreement. So, so far so good. It's on time. So that would be one certainly that's very important for us because it comes along with it potential milestones of significant numbers seven figures. And ultimately in the end you're looking at potentially nine figure payments up to nine figure payments per product. So it can bring us a lot of cash a, lot of recognition, a lot of science. It's not just the money they're putting in which is this funding project is up to €1.6 million to putting in resources on their own internally refining the product, technologies, purification, potentially trials and then obviously in the clinical human trials. So that's a major opportunity for us. And by the way that's opened up the doors and open up the eyes of a variety of other big players who now recognize that this technology may be here today, but it might not be here tomorrow. Then on the animal health we've got Phibro. Phibro was one of the top 10 animal health companies. So they've already run two chicken trials successfully with the product that we developed with them for poultry and they're working on other products in the pipeline as well. And of course, if you talk about the most recent deal you're talking about a company that's involved in animal ingredient products it's one of the largest in their space. So, we think that the technology of those three and many others that are going on that we haven't shared because of their names and confidentiality, I think are going to lead us along a golden path to not only providing the world with a better solution to speed the development all the cause of drugs, because it creates value for our shareholders and increase our shareholder value, and bring cash upfront, and milestone payments and also on new discussions we're having with other companies.

Thank you. We'll take our next question from the line of Robert Smith with the Center for Performance Investing. Please go ahead, your line is now open.

Hi, good afternoon everyone. thanks for taking my questions. So, the Janssen collaboration, the recent setback in to them in the marketplace on limitations of their vaccine. Does that do anything to the movement of your work with them as far as timeline?

No, we're not doing anything with them in the vaccine space anyway. It's about antibodies and therapeutic proteins. But I will tell you I was just at the vaccine research conference in Washington D.C. a couple of weeks ago. And if anything they're set back is our fortune because we have a platform technology that can help them not saying that they'll expand what we're doing but possibly that is greater now than it was before for two weeks

That was my point that I was trying to look at. That's a possibility

Yes Robert it's not just a setback that they might have had. It's also the understanding of the power of our platform and the data of the platform and DYAI-100 vaccine candidate. The fact that we can rapidly produce which we've showed not in Wuhan but alphabetic anecdote on Omicron. We have -- I think we've noticed in today's press release we've done a trivalent in a multivalent animal study with one of our collaborators already. So we're on the path to really make a difference. So, we're just hoping that one of the big pharma companies steps up to the plate after our Phase I clinical trial and we finally demonstrated human beings what we all know is likely that the product produced in C1 and the proteins are going to be safe and effective.

Yes. Mark I'm thinking along the lines also as my follow-up that the variance as they come with such speed and that would be a positive for you and the way I'm thinking because you also have a more rapid profitability of development. So, is that accurate as well?

Yes. So, I think that actually -- if you take politics out of the equation, we're in the driver's seat to do a lot of wonderful things to help combat the pandemic today and future vaccines and drugs tomorrow and possibly in future pandemics. But yes we can reprogram the cell lines very quickly. But more importantly than that not only do we reprogram them quickly we do it in a way that's regulatory friendly and then we can pump out a lot of product very quickly at flexible commercial scale. So, to give you an example and I think if you look at my World Vaccine Conference presentation, I don't know the slide number, but at two grams per liter of this -- for example the Wuhan, this is where we're at in terms of our R&D. We can produce two billion doses of that in a 60,000 liter from 105 days. So that covers all of North America very quickly. If you're in Australia and New Zealand, you've got 30 million people of Canada, you can do it in a 600 liter from -- in a few weeks or a month. So depending on where you are in the country, we can send you a FedEx two-day delivery and we've done this for our -- with Syngene with Rubic with Epygen. We just said actually a frozen vial and you can then start running it and you're from enters. So if you have a cGMP microbial standard from enter we fit in that environment. So that's what makes Epygen very interesting. They've got a very modern plant that I think they finished in 2019. Unlike a lot of the plants in India, this plant is very modern was just built. So they can pump out a lot of products very quickly. But just FedEx and the cell line that we stabilize and produce in VTT in Finland, and in a couple of days you've got it and you offset races.

Thank you. We'll take our next question from the line of Tony Bauer [ph] with [indiscernible]. Please go ahead. Your line is now open.

Hey, Mark congratulations on the progress. And Joe welcome to the team. I'm thinking that disrupting markets is always a tough thing to do. And I'm imagining that you're going to find a greater open-mindedness perhaps overseas. As you broadened your collaborations into India, South Africa, are you finding that that is indeed the case that you can in those places short circuit regulations and avoid the not-invented-here mentality of a U.S. industry that has kind of enjoyed the way they've done things for many years.

Yes. And by the way, I think, those are Tony very good comments. The answer is yes. We're finding obviously an abundance of people overseas that are interested in. We have a lot of people we can provide the technology to for example in India. There's a lot more people than just Epygen and Syngene. I don't know if you know Syngene is owned by Biocon, the largest biopharmaceutical company in India. And Syngene themselves is a multi-billion dollar company. So these guys are very large, very big on their own right. But yes, overseas, we're doing that. But I'll tell you big pharma is waking up to some degree. I think not only for Janssen. I think they recognize that there's a new share of coming in town and it's going to take some time, but it may not be here long enough. If you think about our industrial biotech space we had Abengoa Bioenergy non-exclusive license; Shell Oil non-exclusive license; BASF non-exclusive license; combined over $30 million in upfront fees and then potential milestones and royalties down the road. And then DuPont recognized we were going to enable the world with a platform technology that they didn't want to happen and they came up with $75 million in cash. So the pharmaceutical industry hopefully a little wiser and a little quicker to the game, but as you know they're more conservative, but yes, we're finding more interest overseas, but we are finding interest domestically not just from big pharma, but from governmental agencies from the NIH, NIAID, from BARDA. So there's a possibility to expand this even in America in ways that big pharma may not like, but may have to deal with.

Yes. Terrific. Look forward to hearing more about your strategic kind of re-prioritization with Joe.

Great. Thanks.

Good luck.

Take our next question from the line of Louis Peterson [ph] Private Investor. Please go ahead. Your line is now open.

Hi, Mark congratulations on all the good work you're doing. My question is obviously about cash. We've talked about that before. You indicated it will be at the low end of the range, which I guess would be around $10 million. But of course, if that happens at the end of the year you only have about $10 million left a little over $10 million left. So I guess the question is your front-loading cost at this point in time. By the end of the year, do you expect that you will probably close some of these things? I know, you're going to get two $5 million payments from Janssen if they accept your protein. You think by the end of the year you'll be positive cash flow on an operating ongoing basis.

That's the goal and the objective. So we're in discussions with a variety of people and have other discussions on how to get upfront cash to do exactly to your point. So, that at the end of the year, we're not having to slow things down. But as I mentioned, we have this flexible burn rate, because we don't have our own infrastructure of research and development people. We used to have 40, what I call gene jockeys in our own lab in Holland, which we sold off with DuPont. We work with VTT in a flexible way, where we can turn on and off those researchers, and all the projects that we have other than our own internal are all fully funded. And part of the fully funding actually has some revenue to us. So we can reduce the things we are doing, if we need to but our goal and expectations that we won't have to.

Okay. But let me follow-up, I got one follow-up. I guess, the question is about Janssen itself. You say, we're on track with the work we're doing on Janssen. Do you think that will be during the next, what eight months will be in a situation where they will they like what they say they'll have accepted the proteins and made the first two $5 million payments?

Honestly, Louis, I can't really tell you – we cannot do at this point. But that's the goal and objective. And if Janssen doesn't do it, we're working on other people that hopefully will that may force Janssen to decide that they want to do it or that may go away.

Okay. Thank you very much for commenting on this.

Thank you.

[Operator Instructions] There are no further questions. I'll now turn the call back over to Dyadic's CEO, Mr. Emalfarb for closing remarks.

We have exciting prospects for 2022 and beyond as we continue advancing our first in-human clinical trial application CTA to South African Health Products Regulatory Authority or SAHPRA, to support clinical safety of C1 produced proteins. The areas in which we can apply our platform technologies has accelerated even in the past 12 months. We've brought in Joe Hazelton as Chief Business Officer, who has experience in leadership capability to manage and advance the inventory of existing potential deals and collaborations, to develop and execute, internal pipeline opportunities, and to further our expansion of life science partnerships. As such, our optimism at Dyadic remains high, as we're now seeing the fruits of our labor payoffs. We continue to draw interest from large industry players, within biopharmaceuticals, and otherwise, as well as from a growing number of other markets. Thank you once again for joining us on today's Q1 2022 conference call, and we look forward to keeping you updated as we advance our commercial and scientific initiatives across the companies and our collaborator programs. We also look forward to seeing you on the next call, and I hope you keep an eye out for our periodic updates.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.