Dyadic International Inc (DYAI) 2021 Q4 法說會逐字稿

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  • Operator

  • Good evening, and welcome to the Dyadic International's 2021 Year-End Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded today, March 29, 2022.

  • I'd now like to turn the conference over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

  • Ping Wang Rawson - CFO

  • Thank you. Good evening, and welcome, everyone, to Dyadic International's 2021 Year-End Conference Call. I hope you've had the opportunity to review Dyadic's press release announcing the financial results for the year ended December 31, 2021, and the recent company highlights. You may access our press release and Form 10-K 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 year-end 2021 business and recent corporate highlights, 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 will then hold a brief Q&A session. Our senior management team, Joe Hazelton, Matthew Jones and Ronen Tchelet, will join Mark and I for the Q&A.

  • At this time, I'd 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?

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Thank you, Ping. Good evening, and thank you for joining us today. Before we begin, I just wanted to share the team's optimism for what is in store for Dyadic in the year ahead and just how proud we are of Dyadic's scientific and business accomplishments in 2021.

  • While we're still early in the days, we're seeing what the full potential of synthetic biology holds for the world. We are excited to be part of this future as we look forward to leveraging our proprietary and patented C1 protein production platform and our other technologies to become one of the leading platforms for synthetic biology production.

  • The synthetic biology market is categorized into the following segments: medical applications, industrial applications, food and agriculture, and environmental applications.

  • In 2020, the medical application segments accounted for the largest share of the synthetic biology market, which remains our primary focus for C1 commercial goals into protein manufacturing platform. To this end, we are proud to share not on the year's progress for you, but also our 2022 development goals on this first investor update call of the new calendar year.

  • As you know, we have made clear that it is the company's mission to improve the way we feed, fuel and heal the world. This year sets new operating milestones for us to hit while staying true to that mission. What I hope you take away from today's call is renewed focus Dyadic has to our mission and the ability to take it to the next level.

  • We expanded and enhanced our leadership team with the appointment of Joe Hazelton as Chief Business Officer, whose role supports the global commercialization of the company's new and existing business initiatives, including corporate strategy, business and corporate development, and licensing.

  • We have put ourselves in a better position to tackle the influx of global partnering requests and interests related to the company's experience and knowledge, coupled with the advancement of our C1 platform and other technologies.

  • Additionally, after several years of internal research and development, published preclinical proof-of-concept papers across the industries we are targeting today, we believe we are entering a new period of potential growth, highlighted by advanced testing and development of our C1 protein production platform and our other technologies in the industries that we are using to penetrate some of the largest commercial enterprises in these industries, be it human or animal health, food manufacturing, or industrial endeavors.

  • As we focus our commercialization and development efforts on these core verticals of human health, animal health and other biomolecules, examples of major accomplishments in advancing the commercial viability of our C1 protein production platform and other technologies have included partnerships with Phibro Animal Health, Janssen and a multitude of organizations around the world that have been instrumental in fully funding a number of our non-COVID-19 biopharmaceutical programs as well as helping us to advance our proprietary DYAI-100 COVID-19 vaccine candidate.

  • We are pleased to note that manuscripts relating to antigens produced from C1 cells showing safety and efficacy in animal models against influenza and SARS-CoV-2 are published in 3 peer-reviewed scientific journals, including Vaccines.

  • We have successfully completed the toxicology study of our DYAI-100 COVID-19 vaccine candidate. A manuscript showing safety and persistence has been peer reviewed and is awaiting publication in a scientific journal, Toxicologic Pathology. These are exciting preclinical study for us and, among other benefits, demonstrate the safety, efficacy and the number of other biochemical structures and properties of the SARS-CoV-2 RBD antigen produced from C1 cells.

  • In addition, these publications also demonstrated a novel method to deliver the C1 SARS-CoV-2 RBD antigen subcutaneously and intranasally, and separately, the utility of the C1 cell protein platform in expediting production of seasonal and pandemic influenza vaccines.

  • We have refocused and improved our active outbound awareness regarding the steady advancement of our knowledge for the [ubiquitous] uses of C1 across 20-plus years of proven industrial manufacturing, which we have begun to leverage as we continue to pivot into biopharmaceutical manufacturing of vaccines, antibodies and other therapeutic proteins. We firmly believe that these efforts have the potential to revolutionize medicinal biomanufacturing. We've already begun to conduct funded research in areas of agriculture, food production and metabolic engineering.

  • We remain focused on the application of our C1 protein production platform to address health and equity in middle- and lower-income countries who are reliant on outside sources of vaccine and drug production or which lack the infrastructure and resources to store and distribute vaccines which require advanced cold storage techniques.

  • While we continue to move our DYAI-100 COVID-19 vaccine candidate into the clinic, we want to emphasize that interest in the C1 platform is happening across numerous other applications in addition to vaccines and therapeutics. And we believe that we will continue to deliver in this arena for years, not only in the U.S., but through our collaboration relationships in Africa, India, Asia, Europe and the Americas.

  • As we move these efforts forward, I want to reiterate that Dyadic, through these partnerships, continues to maintain our own IP as we structured our partnerships to include upfront payments, development milestones and future commercial-based royalty or other forms of earn-outs.

  • With this said, let's move ahead in the call to quickly cover some of our recent company highlights, which we have announced in recent press releases. A major win was the announcement of Dyadic's agreement with Janssen Biotech, facilitated by J&J innovation. We already received Janssen's upfront payment of $500,000 for the nonexclusive rights to utilize the C1 cell protein production platform to develop C1 production cell lines for the manufacturing of Janssen therapeutic protein candidates against several biologic targets.

  • As awareness continues to expand around C1's ability to revolutionize commercial protein expression, we believe we'll continue to see similar agreements to come as we ramp up our team's efforts in new business development, which we expect would in turn trigger future upfront payments, milestones, royalties or other forms of payments.

  • Additionally, for this particular agreement with Janssen, we will be provided R&D funding for up to EUR 1.6 million to develop and assess Q1 production cell lines for its product candidates.

  • We recently announced a broadening of our relationship with Phibro Animal Health, a leading global diversified animal health and mineral nutrition company. We've entered into an exclusive license agreement to produce a single specific targeted antigen for development and commercialization of a poultry vaccine. The agreement followed a successful proof-of-concept development work, including animal trials previously completed by the 2 companies. The parties expect to continue working on developing additional animal vaccine candidates to be produced from Dyadic C1 cells.

  • In December, we announced that we received a national institute of manufacturing of biologics, NIIMBL, coronavirus grant under the White House American Rescue Plan of up to $690,000 in order to engineer 2 C1-derived antibodies. The NIIMBL project is off to a good start. This grant is intended to benchmark the speed at C1 manufacturing platform and the advantage we will have compared to current state-of-the-art methods, which could lead to a rapid ability to produce medical countermeasures and vaccines in response to future pandemics.

  • Earlier this month, the company announced that due to a disagreement between the parties concerned on timing and terms and conditions of the previously announced term sheet with Sorrento Therapeutics [entering] the license agreement that the parties have mutually agreed to terminate the term sheet effective March 17, 2022.

  • We also set Luina Bio a termination notice that are related to our license agreement with Luina Bio Novovet in February 22 as they not have been able to raise capital to continue the program.

  • As our partners' needs and business focus has changed over time, we view these terminations as an ongoing part of our business. However, both Janssen and Phibro are great examples of how our years of hard work in the research and development of C1 as well as renewed business development efforts on multiple fronts are bearing fruit.

  • For those who have followed the company over the last several years, all indications have marked a certain maturity in our development life cycle as we move towards the company's technology from proof of concept to partnering and collaboration, towards commercialization and feasibility studies to first-in-human trials.

  • Moving on to certain of Dyadic's ongoing global collaborations. We entered into a technology transfer and license agreement with South Africa's Rubic Consortium, who have already begun working to develop end-to-end solutions for vaccine discovery, development and manufacturing for the African market. This arrangement includes C1 COVID-19 vaccine technology transfer and licensing agreement, a potential funding pathway for C1-manufactured COVID-19 vaccine to progress to Phase II and III clinical trials, established in a co-development basis for research, developing and manufacturing multiple other products, vaccines in addition to DYAI-100, an intention to reduce staffing and dependence on foreign vaccine suppliers.

  • In coordination with CR2O, Parexel and Rubic, we are preparing for a submission of a clinical trial application, CTA, of our DYAI-100 vaccine candid to the South African Health Products Regulatory Authority, or SAHPRA. We have identified Wits Clinical Research, a division of the Wits Health Consortium PTY Limited, as a potential site for carrying out the DYAI-100 Phase I clinical trial to validate C1-produced proteins are safe in humans and further accelerate the global C1 platform adoption. This clinical trial will also serve as a proof-of-concept for other next-generation variant COVID-19 vaccine candidates.

  • It's important to note that Wits has experienced carrying out COVID-19 vaccine clinical trials in South Africa for big pharma. While many on the call may be familiar with the FDA's clinical testing phases and drug approval process, we wanted to take some time to discuss the process for South Africa.

  • It's important to note the importance of partnering with the consortium in South Africa, Rubic and Wits, not only from a regulatory partnering perspective, but also from a trial design perspective, especially amidst the evolving landscape of COVID-19, including the disease, infection and transmission rates. The shift now has been away from treating COVID-19 as a pandemic, but rather controlling and managing infection and transmission rates as well as symptom severity in the absence of the ability to control how COVID-19 variants evolve. This is the primary reason why global regulatory guidelines on COVID-19 vaccine development is still evolving. That said, our partnership with Wits and the consortium in South Africa give us unprecedented access to leading institutions and R&D scientists who have been at the very front lines of testing and developing current COVID-19 treatments, including Pfizer's current COVID vaccine, AstraZeneca and others that is in the marketplace in South Africa today.

  • Current data suggests that many of the so-called first-generation vaccines remain highly effective against existing several variants of concern, However, the Omicron variant and sub-variants being potential exceptions, particularly against severe disease. However, it's possible a new variant will emerge and may overcome the current vaccine-induced protection to some degree, with the emergence of the Omicron variant only highlighting this risk.

  • The C1 cell protein production platform can effectively support the global immunization strategies that are needed against emerging SARS-CoV-2 variants of concern. The company can rapidly insert receptive binding to main variant genes into the same C1 cell line, same genotype in approximately 60 days. Thus far, in addition to the original Wuhan SARS-CoV-2, the following variants have been successfully produced from C1 cells. The Alpha U.K., Beta in South Africa, Gamma Brazil, Delta India, and already we have the Omicron B11.529.

  • One of the commercial goals of Dyadic is to demonstrate effective capability to rapidly produce different combinations of multivalent COVID-19 vaccines, which could protect against several variants of concern at once.

  • We continue to work with Syngene in India, a major global contract development and manufacturing organization with a headcount of over 5,000 employees. Syngene International is an integrated research, development and manufacturing company providing scientific services, conducts early-stage research, preclinical and clinical trials, drug substance and drug product manufacturing and development, biologics manufacturing and other services. The company serves not only the pharmaceutical industry, but the biotechnology industry, nutrition, animal health and consumer goods and special chemical industries.

  • Our discussions with Syngene have centered on advancing a commercial framework and planning around the use of C1 cell protein production platform and our other technologies as an in-house option to traditional [chilled] and other cell line manufacturing offerings for manufacturing vaccines, antibodies and other therapeutic proteins.

  • In 2020, the company entered into a nonexclusive technology usage agreement with Epygen Biotech of India, who plans to conduct clinical trials in India using Dyadic's C1 cell protein production platform to produce a COVID-19 vaccine. Epygen recently procured the approval for funding from the government of India to move forward towards vaccine production technology across early-stage Phase I and Phase II human clinical trials. In order for Epygen to receive the government funding, it must contribute approximately 25% of the funding from those sources.

  • During 2021, the company also expanded its influenza vaccine collaboration with the University of Oslo. Scientific results included having mice vaccinated with C1-produced [AMHC2] hemagglutinin/California/7/2009 combined with an adjuvant ASO3 challenged with a lethal dose of 5 LD50 of the homologous influenza A, H1N1. Showed no clinical signs, no weight loss, and the mice were fully protected. All the mice trials are ongoing as we speak, and others are scheduled with C1-produced antigens, flu and influenza, and SARS-CoV-2 with Oslo University.

  • A part of inbound inquiries, we have highlighted the launch of our biomolecule development in order to demonstrate that our industrially proven C1 cells can be engineered to manufacture therapeutically viable and commercially useful cannabis compounds, including cannabidiol, or CBD, and its precursors using synthetic biology.

  • As acceptance for therapeutic uses for cannabinoids continue, we are demonstrating C1's potential to manufacture purer synthetic cannabinoids for commercial use, potentially cheaper and more effectively as compared to conventional methods using hemp and the marijuana plant, cannabis sativa. This is just another example how we are starting to apply synthetic biology to engineer human cells to help improve, develop more efficient bioprocesses for a number of potential applications.

  • And with this, I'll turn the call over to our CFO to run through our financials, Ping Rawson.

  • Ping Wang Rawson - CFO

  • Thank you, Mark. In addition to the financial results I'll be discussing now, you can find additional information in our Form 10-K, which we filed earlier today.

  • Our cash, cash equivalents and the carrying value of investment-grade securities as of December 31, 2021, including accrued interest, were approximately $20.4 million compared to $29.2 million last year.

  • Research and development revenue for the year ended December 31, 2021 increased to approximately $2.4 million compared to $1.6 million last year.

  • At December 31, 2021, the company recorded the $500,000 upfront payments received from the collaboration and license agreement with Janssen as deferred license revenue.

  • Cost of R&D revenue for the year ended December 31, 2021 increased to approximately $1.9 million compared to $1.4 million last year. The increase in revenue and cost of the R&D revenue was due to a number of larger research collaborations conducted in 2021.

  • R&D expenses for the year ended December 31, 2021 increased to approximately $8.4 million compared to $3.9 million last year. The increase primarily reflected the cost to manage and support preclinical and clinical development as well as cGMP manufacturing costs as the company moves towards its anticipated Phase I clinical trial of DYAI-100 COVID-19 vaccine candidate in the amount of approximately $5.1 million, offset by a decrease of $621,000 in other internal R&D costs.

  • G&A expenses for the year ended December 31, 2021 increased to approximately $6.7 million compared to $6 million last year. The increase principally reflected increases in legal expenses, insurance premiums and other outside services, offset by reductions in business development and investor relations costs.

  • Interest income for the year ended December 31, 2021 decreased to approximately $52,000 compared to $447,000 last year. The decrease was primarily due to a decrease in interest rates and yield of the company's investment-grade securities, which are classified as held to maturity.

  • For the year ended December 31, 2021, the company also recorded a gain from the sale of investment in DDI in the amount of $1.6 million.

  • Net loss for the year ended December 31, 2021 was approximately $13.1 million or $0.47 per share compared to a net loss of $9.3 million or $0.34 per share last year.

  • Our cash position remains strong for 2022. We expect our cash burn for 2022 will be in the range of $10 million to $11 million.

  • With that, I will now ask the operator to begin our Q&A session. Dr. Ronen Tchelet, Joe Hazelton and Matthew Jones will be joining Mark and I to answer your questions.

  • (Operator Instructions) Operator?

  • Operator

  • (Operator Instructions) Our first question today is coming from John Vandermosten from Zacks.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • First question is on the animal health side of things. I know -- we all know that that's a faster route to get things approved. And I was wondering if you could remind us, Mark, just what is required to get something approved once the companies decide that they want to take it forward.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Well, I think what -- every company is different, of course, but they would run the animal studies. In the case of the Phibro poultry study, they've already run 2 out of the maybe 3 animal studies that they would run. And obviously, they saw the excellent results, which is why they entered into the license agreement. So then they went -- from there, they would then have to go and file for regulatory approval. And depending on the different countries, there's different time lines for that. And then through the regulatory approval process, then they would have an approval. Hopefully, they would come up. And then they would be launching their product. Case of Phibro, it's a global animal health company so it would be have to register it in a variety of countries all over the world. So depending on where they would first apply for that, and we can leverage that application and regulatory filings in the other countries. So it's kind of rolled out country by country, all over the globe in their case as a global company.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • Okay. And looking at the DYAI-100 Phase I trial, what's left there to get done before it can get started? And I know you have it potentially going on in a number of different countries which may have different time lines there. But what do you see on that, that needs to get done, I guess for the U.S. specifically?

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Well, let me turn you over to Joe Hazelton, who is our Chief Business Officer, who's handling the regulatory process on that. So Joe, please.

  • Joseph P. Hazelton - Chief Business Officer

  • So as you're aware, we're -- our initial CTA application is in South Africa. So pending approval and data from the Phase I study in South Africa, we would then turn to file an IND in the United States with that data. And then again, that would take potentially anywhere from 6 months to a year to get that filed and pushed through and move on to our end of Phase II meeting, pending a successful meeting or a successful resolution with the FDA regarding our IND status. So that would be the option for us as we move from South Africa to the United States.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • But we would also have the ability to go to different countries, which we probably would be doing even in advance of that in addition to South Africa and potential other countries.

  • Our partners in South Africa, Rubic, which would be handling the regulatory filings on the Phase II/Phase III in their own countries, on their own continent. And then, of course, in India, Epygen if they move forward with this new grant they got from the Indian government, would obviously handle all the regulatory filings and approvals for the country of India, which you know is over 1 billion people alone.

  • I think there's 1.3 billion people in Africa and 1-point-some billion people in India. So probably, between the 2 of those continents, I'm not quite sure, but my guess is that's somewhere around 20% to 30% of the world population.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • Okay. Great. And Joe, welcome aboard. Good to hear your voice.

  • Operator

  • Your next question today is coming from Paul Rosenbaum from SWR Corporation.

  • Paul Rosenbaum;SWR Corporation

  • For the size of your company, you - and I applaud you for this, you've taken a very aggressive stand on many issues. And so my question to you is merely an observation, no criticism intended. It just seems to me from everything I've read and everything I've heard, you're probably 18 months away at best from commercialization. So please correct me if I'm wrong, but I'm just asking that question. I'm just curious.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Yes. So most of the commercialization is not coming from Dyadic. It's coming from potentially Janssen, Phibro or other collaborators. It's their products and we're getting paid fully funded R&D with the margin on top of that to develop those products and the candidates for them, and then they'll be picking up the cost and expense of moving those forward.

  • The goal here and the key here is to do what we did in the industrial biotech sector, where we raised over $30-some million in upfront access fees before milestones and commercialization. So in that particular case, we had Abengoa Bioenergy, where we had $15.5 million in income from just biofuels in the industrial space there, $6 million upfront from BASF, $2 million in R&D research development funding and $1 million milestone. So I think it was somewhere between $8 million to $9 million that came in from that. And then we had Codexis and Shell put in $10 million for the biofuel for nonexclusive rights to limited markets.

  • So we expect this year to be able to start bringing in some of those upfront access fees where we bring in the money and the cash to reduce or eliminate the burn. In the case of the industrial side, some of those years, we had no burn at all when we got a big payment in. So that's the way we're moving forward to try to monetize.

  • The businesses have them prove out the technology in certain cases. Other than the DYAI-100. We also have the nivolumab, which you know, which is a bio better of OPDIVO which we've been developing. And the cannabinoid technology, another primary metabolite technology that we're looking to out-license to bring in revenue as well. But I appreciate you asking that question.

  • Paul Rosenbaum;SWR Corporation

  • No. And I do. And as a shareholder, I'm particularly interested when I talk about commercialization as a shareholder as to the bottom line of the company and when do you expect to find those revenues in the future. Again, it was an observation, no criticism intended.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • No, no, I don't take it as criticism. As I mentioned, we've already gone down this path on the industrial side. In that case, we also made enzymes and built them in 35 countries around the world. And as we mentioned, we are now getting approached and starting to work towards our noncompete with DuPont ended on 12/31, 2020. So we're working now towards leveraging this technology back into the industrial world as well because people are reaching out to us, and I'd say stay tuned for some of those potential opportunities to start being moving towards commercialization and announcements.

  • Operator

  • Our next question today is a follow-up from John Vandermosten from Zacks.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • I had a question on the NIIMBL grant. Does that $690,000 there fully cover all related work that you're going to do for the project? Or does Dyadic have to contribute some to that as well?

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • No, it's fully funded with a little margin for us.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • Great. And then has that work started yet? Or what is the time line on that?

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Yes. I think I mentioned in my -- today, on today's call that it's already moving forward. It's actually very, very fast. We've already developed 2 of the -- both of the different antibodies. So the goal there was to see how fast we can create these antibodies and then see how far we can push the yield and productivity. So it's already moving and starting into it's -- it's probably halfway through it is my guess right now, somewhere in the neighborhood.

  • John D. Vandermosten - Senior Biotechnology Research Analyst

  • Great. And then those revenues, I guess this one is for Ping, are those going to be recognized as revenues over, I guess, the 2022 year? Or how should we think about that? Are those counter R&D or something like that? How should we look at that?

  • Ping Wang Rawson - CFO

  • It will be part of the revenue because it's a grant, and we follow 606 in terms of revenue recognition. Most of them will be in 2022. It could be. Depends on how that is going. It's a 10-month project. So [servicings] maybe fall into next year.

  • Operator

  • Our next question is coming from Robert Smith from the Center for Performance Investing.

  • Robert Smith

  • With the COVID-19 virus continuing to evolve, what is your approach in the development of the vaccine? I mean how do you look at this?

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Yes. So it's a good question, Robert. It's one that is constantly evolving, right? But if you remember, our primary goal of doing DYAI-100 is to demonstrate safety and efficacy and potency of proteins produced from the platform to open up the doors to big pharma, biotech, government agencies, [tagging up] speed adoption and use of the platform. That's our primary purpose.

  • However, in addition to that, to your point, we think we might have an ideal booster vaccine because your body has already recognized from the different variants. And as I mentioned in this call, we've made not only the Wuhan, we've made Alpha, we've made Beta, Gamma, Delta and Omicron, and we can very quickly do that. As I mentioned, within 60 days of getting a gene synthesized, we can have a stable cell line that becomes your master cell bank for production and a protein that can be used for animal studies, preclinical studies, and to be honest, our conversations with the Paul-Ehrlich-Institut in Germany is we can pop out one gene, put then one in. If we don't have to change the adjuvant, we don't need a new tox study. And I think, as I mentioned earlier in this call, we have a publication coming out, which if you're a toxicologist, I think you'll find that not only do we have excellent safety in a protein, but we have longer persistence than the other vaccines that they've looked at.

  • So our goal here is not only for our own vaccine, but we have people approaching us and talking to us about running other studies on their vaccines using C1. So we sort of opened the door up [endemic] to the speed at which we can do things, at the yield which we can produce things, at the low cost, the easy tech transfer.

  • So we're going to take a multivalent approach, I think, on our own is our current thinking, where we would take maybe Wuhan, Delta and Omicron as a blend. And I would say stay tuned because we probably have or we'll soon have animal data showing those results.

  • Robert Smith

  • And my follow-up concerns the Janssen agreement. So can you give me some color on what the succeeding steps in the Janssen program would look like? And I think you have time lines that they might have shared with you on their own trial progress.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • Well, first of all, the Janssen agreement has opened up the doors and opened up the eyes of a lot of other pharmaceutical companies to recognize that this technology may or may not be here when they want to use it.

  • And so between the first-in-human data, safety, efficacy and protection with Janssen and the other deals we have going, I think that that's an eye opener for, I think, the industry in general. Kind of like what happened in the industrial side again, BASF, Shell, Abengoa and DuPont to be not an exclusive license to the industrial biotech business.

  • But the Janssen deal itself is currently for a limited number of proteins. So the upfront cash payment and their potential 7-figure payment, they can go from an X number of molecules to Y with that first 7-figure payment. We're now working on 2 different proteins, one being an antibody, the other one we're not sharing because that wasn't in the -- what we put in our 8-K filing. So that's moving along. That's already started.

  • Keep in mind, we've already done business in the past with Janssen. This is them coming back now and focusing on the success they saw before on a couple of different molecules to then be able to bring this technology in-house. The goal here is to get it -- demonstrate success with what we're doing, them to bring it in-house, them to do the purification through the trials on their own, to use it to discover and develop magnitude times numbers of things that they already have today.

  • And all those things come along with either low figure -- 7-figure milestones, mid-figure or 9 figures per product potentially on the back end. And the timing is unknown at this point of when and if we'll be receiving some of those milestone payments, commercial payments. We just -- right now, we're receiving the royalty -- I mean the funded research and development, which is fully funded with the margin. And also, we already received the first $500,000.

  • Operator

  • We've reached the end of our Question-and-Answer Session. I'd like to turn the floor back over for any further or closing comments.

  • Mark A. Emalfarb - Founder, CEO, President & Director

  • I want to thank everyone for joining us on tonight's call. We hope you've come away with a greater sense of Dyadic's many achievements in 2021 in addition to the renewed focus on broadening the commercial potential of the company's C1 cell protein production platform and other technologies for animal and human health, including vaccines, food and other industry protein manufacturing challenges which C1 and other technologies can help address.

  • Even though the company remains under CTA and it's just not possible to disclose all the potential prospects we are currently gaining traction with, we also hope that you leave with a sense of the magnitude and breadth and scope of industries that we are working with. With each partnership and licensing agreement, we believe that we are just one step closer from making a breakthrough that we'll someday hope to transform and revolutionize the biomanufacturing industries very broadly that we have targeted.

  • With a conservative development approach and sensible licensing strategy, we are also well positioned to brace for and withstand the current pressures early-stage companies in the health care space are facing today.

  • Lastly, our strong IP protection and ownership will allow our shareholders to participate in the intrinsic value creation that Dyadic has proposed.

  • Thank you once again, and we look forward to keeping you updated on our progress along the way, and we'll see you on the next call.

  • Operator

  • Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.