Dyadic International, Inc. (DYAI) on Q1 2021 Results - Earnings Call Transcript
Operator: Good evening and thank you for holding. Welcome to Dyadic International’s First Quarter 2021 Financial Results Conference Call. Currently, all participants are in a listen-only mode. As a reminder, this conference call is being recorded today, May 13, 2021. I’d now like to turn the call over to Ms. Ping Rawson, Dyadic’s Chief Financial Officer. Please go ahead.
Ping Rawson: Thank you, Operator. Good evening, and welcome 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 31, 2021 and the recent company highlights. You may access our press release and Form 10-Q under the Investors section of the company’s website at dyadic.com.
Mark Emalfarb: Thank you, Ping. Welcome, everyone, and thank you for joining us. We have ushered in a New Year with substantial progress on R&D initiatives. I’d like to highlight first some of the exciting progress we’ve made on developing new COVID-19 vaccine candidates. We’re entering into nearly a year and a half since the start of the COVID-19 pandemic, yet to 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 populations vaccinated and save lives. If global efforts to stop this 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 hyper-productive 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 to be more affordable and accessible.
Ping Rawson: Thank you, Mark. In addition to the financial results, I will discuss 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 security, including accrued interest were approximately $27.4 million at March 31, 2021, compared to $29.2 million at December 31, 2020. Research and development revenue for the quarter ended March 31, 2021 increased to approximately $461,000 compared to $315,000 for the same period a year ago. Cost of the research and development revenue for the quarter ended March 31, 2021 increased to approximately $391,000 compared to $278,000 for the same period a year ago. The increase in revenue and costs of research and development revenue for the three months ended March 31, 2021 reflected that the increase the number of ongoing research collaborations to eight compared to five collaborations for the same period a year ago. R&D expenses for the three months ended March 31, 2021, increased to approximately $1,808,000 compared to $755,000 for the same period a year ago. The increase primarily reflected Phase 1 clinical trial costs of DYAI-100 or COVID-19 vaccine in the amount of $882,000 and the additional cost of $159,000 related to our other internal research projects. G&A expenses for the three months ended March 31, 2021, decreased 6% to approximately $1,554,000 compared to $1,653,000 for the same period a year ago. The decrease principally reflected reductions in travel and rent expenses of $65,000. Insurance and other outside services of $47,000, other decrease of $30,000 offset by increase in legal expenses of $43,000. Interest income for the three months ended March 31, 2021 was approximately $26,000 compared to $168,000 for the same period a year ago. The decrease was primarily due to the lower balance of held-to-maturity, investment securities and the less reinvestment as a result of the decrease of interest rates. Net loss for the three months ended March 31, 2021 was approximately $3.3 million or $0.12 per share, compared to $2.2 million or $0.08 per share for the same period a year ago.
Operator: Thank you. Your first question comes from John Vandermosten with Zacks Investment Research. Please go ahead.
John Vandermosten: All right. Good evening. And let me just start off with a question about vaccines. Serum Institute is one of the organizations you’re working with. And I’m wondering, with the crisis in India has there been any further discussions with them to perhaps work on something to help out with that? I mean, I know there’s a very long timeline. But given the severity of the crisis and the need for a lot of vaccine, perhaps that’s a way to advance the conversation.
Mark Emalfarb: Yes, thanks, John. Serum, I think is a handful, I’m just trying to make the AstraZeneca vaccine, but we are in discussions with other parties in India and other parts of the world to help out and we’re having those discussions, and we hope one or more of those were turned into something, to turn into fruition of moving the C1 vaccine into humans to help this horrific situation that we’re all facing in a global basis.
John Vandermosten: Okay. And I noticed that you guys had expanded the agreement with IDBiologics. Well, that include more equity as part of that and maybe you can provide a little more detail on how that will expand as well, from what was?
Mark Emalfarb: That’s a great idea. And I’m a great example of how we take initial proof of concept collaborations and turn them into money and into opportunity, because, that’s not a fee for stock. That’s a fully funded program. It is a antibody. It has a potential for infectious disease and different diseases in COVID-19. I think people are starting to recognize that this C1 technology platform, in addition to obviously, potentially helping on COVID can help prepare for a variety of almost unlimited number of infectious disease and treatment. So hopefully, that answers your question is a fully funded project, and one that we’re excited to expand the breadth and scope of applying C1 for these infectious disease, treatments that are going to be needed.
Operator: Your next question comes from David Snyder with Private Investor.
David Snyder: Hi, thanks for taking my question. I have two, the vaccine for birds is for some disease that affects some pet that people have like parrots or is it for some birds in the wild?
Mark Emalfarb: Hi, David, no, it’s for animal health. It’s for a huge unmet need. And it’s a vaccine that people have tried to make in the past. Couldn’t make it an affordable price for chickens – there’s a lot of these things out there in the world . Yes, sorry.
David Snyder: Yes, I think there’s lot more chickens around and pet parrots? So that’s very encouraged.
Mark Emalfarb: Well, I think there’s a lot more chickens, a lot more cows and a lot more other animals in our people, so…
David Snyder: That’s true. In regarding the COVID vaccine, the U.S. taxpayer has paid for, how I view it most of the fixed costs of Moderna's COVID vaccine, we should have all been given shares of Moderna stock, because we basically, it came out of our checking accounts. But because this is a little bit sarcastic, as you can tell, but because their fixed costs have already been paid by the U.S. taxpayer. The economic argument for using C1, as the platform for COVID vaccines is a little bit hurt by that, because, we already paid for the fixed costs so they can crank up billions of doses as well as the other players that are already out there. So can you just maybe talk about that?
Mark Emalfarb: Yes, first of all, that pandemic hopefully will be the last one we ever see. But it’s not likely. And some experts think in the next – are going to be even, let’s say, even worse shape. I think there was an article out or comment made by Scott Caudalie that mRNA vaccines work this time around, but they’re not going to work for all these different types of infectious disease. So, second of all, as a booster shot one of the theories that people are working on now, you’ve been watching the news and the research is what’s called a hydrologist boost, a DNA prime and a protein boost, where you take somebody’s initial vaccine and booster with a different vaccine. I think that plays into our hands because we have a recombinant protein vaccine that can be either a subunit vaccine or a nanoparticle potential vaccine. It’s more, I would say concentrated for the receptor binding domain or neutralizing antibody. So yes, of course, subsidized they got a lot of money in the bank. In the end, I believe we can produce far more far less, for much lower cost. But we’re really not aiming at the moment for the U.S. as in potential boosters on an annual basis. But also the rest of the world has a crying need for not paying $20 to $30 a dose I can’t afford it. Not sustainable in America, let alone in Africa or Bangladesh or India, or no variety of other countries in South America.
Operator: Your next question comes from John Vandermosten with Zacks Investment Research. Please go ahead.
John Vandermosten: All right, thank you again. So in the press release, you mentioned the University of Oslo Influenza study, and I was looking at that comparison that was in the slide deck. And what was behind I guess the, better performance of C1 versus baculovirus? I mean, is it better purity? Is it more consistent output? Is it maybe glycosylation or some other characteristic what’s the driver there for the better efficacy?
Mark Emalfarb: Well, we don’t know exactly what the driver is, we think it might be the glycosylation, unique advantages the more human like structure of the glyco can produce from C1. However, it’s not exactly human, but close enough to giving you the immunogenicity benefit. But we don’t know that we just know this is the second time around. As we already proved once we can make hemagglutinin at very, very low cost that was even more effective. That actually in that case, with Sanofi we use 1/3 the amount and had a better result in their mice trials. So it looks like a potential producer of a flu vaccine. Again, like all other vaccines that we’ve seen, so far, safe, protective, effective, low cost. So again, you can maybe even combine the COVID-19 vaccines with the flu vaccine is one of the approaches people are discussing doing. So the good news is it works. And we can make a lot of it.
John Vandermosten: Yes, I mean, it’s in that test that it did better, obviously. Another question on kind of a bigger picture question on vaccine production, I mean, I think I’ve heard anecdotally, I can’t find any sources, but that it’s kind of squeezed out other production of other things, although, we have enough vaccine here in the U.S. any evidence of that you’ve seen where, production of COVID vaccine has, taken up so much resources that we’re not getting other things that we need?
Mark Emalfarb: Yes, I think during the KOL, one of the scientists had mentioned that’s one of the problems. People are focusing on producing COVID-19 vaccines, in lieu of potentially other vaccines that could actually impact human health for decades to come. So again, in the end, what we really need is a more efficient way to produce proteins, whether that’s a recombinant vaccine for infectious disease, or other treatments. And we believe that C1 is more horsepower, it’s more productive, it grows fast, it can be scaled quickly, it could be grown using single use, or stainless steel bio reactors, the raw materials to use this are not bottleneck because they’re available locally. They’re cheap, they’re abundant. And the one thing that you’re going to remember when we designed to DYAI-100 vaccine, we had a goal in mind, the goal in mind there was to have safety, efficacy and protection, but also to be able to produce billions of doses of vaccines. So we chose the raw materials very carefully. We could have chose other adjutants, but we chose because it’s been around for decades, it’s proven, it’s safe. And the first time we go into human beings, we wanted to make sure that we got safety and preliminary efficacy, because that’s the goal of that Phase 1 trial was always the goal. It was the first thing we wanted. And obviously we can launch and help and we should be able to do and we hope to be able to as an opportunity is COVID vaccines that are enlarge more affordably for other populations that have that critical need, and of course, for the booster shots. But the primary goal here is to prove safety and efficacy of this platform, which we believe is going to open up the doors, even wider. And we’re currently inundated with opportunity. And it’s going to open to – open the floodgates even further and wider and deeper once we show safety and efficacy in this first Phase 1 clinical trial or even potentially, in the middle of it when we start getting the preliminary data.
John Vandermosten: Okay, great. That’s all for me. Thanks.
Operator: Your next question comes from Lee Alper with Hammock Investors. Please go ahead.
Lee Alper: Yes, Mark, what happened to the program with Frederick Lab? Then I have a follow up.
Mark Emalfarb: Yes, again, which we’ve mentioned in the past, and we made a product. We were successful expressing with C1. We sample them, and they put it in a freezer and are concentrating and other things. And what happened to it? We don’t know. It’s like a black box. So, unfortunately, we have no idea what they’ve done with it. And we’re actually trying to find out what they’ve done with it. But I think they’re more focused on getting out more vaccines of the ones that exist today, then, tomorrow, but I think the good news is, they’ve seen the power of C1 firsthand.
Lee Alper: Okay, and also, have you applied the BARDA or Warp Speed for any money?
Mark Emalfarb: We have obviously spoken to BARDA and Warp Speed. And, I can’t – we get into those intimate discussions. But, of course, they’re fully aware, in fact, we’ve actually been told by them in the past, they understand the power, the speed, and the cost advantages. But we’re a small biotech company versus politically, the big boys. And I think they chose to give the money to the big boys and think about what we’re going to do in the future. But one of those programs that we talked about the one with IDBiologics is actually being sponsored by the U.S. government. So, we’re seeing more and more interest from the U.S. government, whether it be the NIH, or DoD or DARPA, or HHS, and potentially even BARDA. Hopefully, they’ll be more funding coming. But we don’t know.
Operator: Your next question comes from Dick Williams with Williams Resource Group. Please go ahead.
Dick Williams: Hi, Mark.
Mark Emalfarb: Hey, Dick.
Dick Williams: Obviously, looking at the landscape of all the things that you’re doing and everything connected to C1, and then there’s a myriad of opportunities, obviously, significant opportunities, assuming efficacy, and safety. And again, you have a pretty good inkling of that, at some point through maybe into the middle of the Phase 1 trial or even sooner. Can we be unrealistic and thinking that we could have a license agreement with a big pharma or a biotech by the end of this year?
Mark Emalfarb: The answer to that is yes. And the answer is, whether it be COVID-19 related, animal health related, pharmaceutical related, growth factor related or all of the above. Any of those things could happen by the end of the year, whether they will, we’ll find out and see, but they’re all possibilities, of course. And the one thing you got to realize is, if this disease sticks around, and people need boost, we’re there. So, once we prove safety and efficacy, and you got to realize we ran over a dozen animal studies, cattle, sheep, mice, and then of course, all the animals studies last year, in the – with the COVID RBD, C1 produced vaccine candidate. So, we’re in the middle of our toxicology study today, it was reported that three of the three shots for the male have already been given, two shots for the female. So in the next two to three weeks, we should have a good indication, but so far, it looks as expected safe. So, we don’t expect any issue with safety. And in all the animal studies we did, or the majority of them, we elicited significant neutralizing anybody. So, we expect to see high levels of neutralizing antibodies, and we expect to see safety. But fingers crossed that what we saw in the animals will be that way in humans.
Dick Williams: Okay, that’s all I had. Thank you.
Operator: Your next question comes from with Cluny Road LP. Please go ahead.
Unidentified Analyst: Hey Mark, this question is for you. So the stock is down 60% in the last year. You haven’t really made any significant money since 2016 on your sale. The street is betting that you’re going to run out of money you have roughly two and a half years at the rate your burn rate. So tell me if I said to you okay, you got two and a half years. Where’s your money coming from? When are you going to start making some money? We talked about all these collaboration. And nobody’s paying for anything. They’re paying for the collaboration, but they’re not giving you upfront fees, or obviously, you haven’t gotten any royalties, because you haven’t created anything. So, how are you going to make money?
Mark Emalfarb: Yes, thanks, Kip . So first of all, we’ve given guidance of between $10 million and $12 million burn for 2021. So, we still have at least two years cash runway as of today, a significant portion of our R&D is covered by third party collaborations. And we’re very prudent with the amount of internal R&D programs we approve. Based on the scientific progress to demonstrate and results, increasing the acceptability of our C1 program and platforms, and a large number of ongoing collaboration we currently have in progress, let alone the ones that were on the drawing board. We expect to begin successfully licensing C1 during this two year timeframe for potentially upfront cash, milestones and royalties. And if you remember from our industrial biotech business, DuPont – not DuPont , Shell, Abengoa, BASF, and others, we received over $30 million or $32 million or $33 million in upfront cash for non-exclusive license agreements and then we of course, milestone funding, for example, in the case of BASF $2 million. And then of course, when the products were going to come to virtualization, then we would get royalties. So, we expect something similar here, with higher magnitudes. So we expect to get upfront cash payments, milestones, and royalties. And that’s how we expect to generate cash flow and income during these two year timeframe and obviously, hopefully, sometime before the end of this year.
Operator: There are no further questions. I will now turn the call over to Dyadic CEO, Mr. Emalfarb.
Mark Emalfarb: Let’s see there are no further questions. So, I want to thank everybody again, to joining us on the call. We are pleased you could join us to hear our progress over the first quarter. We’re excited about where we are. We’re excited even more where we’re going. And we look forward to keeping you updated on our progress along the way.
Operator: This conference has now concluded. Thank you for attending today’s presentation. You may disconnect your lines at this time.
