Dyadic International, Inc. (DYAI) Q2 2016 Earnings Report, Transcript and Summary

Welcome to Dyadic International Second Quarter 2016 Financial Results Conference Call. [Operator Instructions] My name is [Jessica] and I will be your conference coordinator for today. As a reminder, please note that this call is being recorded. At this time I would like to introduce your host for today's call, Mr. Tom Dubinski, Dyadic's Vice President and Chief Financial Officer.

Good afternoon and thank you for joining today's conference call to discuss Dyadic's financial and operating results for the second quarter ending June 30, 2016, which were reported in the press release issued earlier today. The press release and Dyadic's quarterly report had been posted to both the Dyadic and the OTC Markets websites. I'm joined today by Dyadic's President and Chief Executive, Mark Emalfarb, and Dr. Ronen Tchelet, VP of Research & Development and Business Development. On today's call Mark will cover operating highlights, further details on our corporate strategy, provide an update on our professional liability lawsuit against our former professional service providers, and I will review our financial results in more detail. Dr. Tchelet will highlight some of our research and scientific goals and objectives and progress to date in some of these programs. We will then give you an opportunity to ask questions. Each caller will be allowed one question and one follow-up question in order to provide all callers an opportunity to participate. If time permits, the operator will allow additional questions from those who have already spoken. Before we begin, we would like to remind you that certain statements made in this conference call may be forward-looking statements, which involve risks and uncertainties that could cause Dyadic's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Dyadic expressly disclaims any intent or obligation to update any forward-looking statements except as required by law. I will now turn the call over to our President and CEO, Mark Emalfarb.

Thank you, Tom. As we bring to a close our second quarter of 2016, management and our Board continue to be very optimistic about our future and our ability to drive value, not just from our own development programs but for the growing weight of evidence in collaborative relationships we are establishing in the biopharma industry. The key management focus is working to identify the right partners to help maximize value for our shareholders. In our press release dated August 8, 2016, we notified you that Sanofi chose not to extend the vaccine proof-of-concept exclusive option and technology transfer agreement entered into on March 30, 2011. This research was conducted on and off over 5-1/2 years and was partially funded by Sanofi. However, many scientific challenges were overcome by Dyadic scientists during that same period. For example, we successfully demonstrated the C1 technology is capable of producing vaccines at high yields and has the potential to improve therapeutic vaccine performance. We reported one such specific example in our October 7, 2015 press release which described the only C1 produced antigen that was tested in mice showed an equal or better immune response in mice trials and the existing antigen. We are appreciative of the opportunity this project afforded us and have an enormous respect for the scientists and staff with whom we have collaborated. From our discussions with Sanofi, we understand that the decision not to extend our agreement was based on several factors, such as competition for internal resources, and we believe, to a lesser extent, the assessment of the scientists working directly on the C1 project tested the ultimate potential of the C1 technology for use in vaccine development and manufacturing. On October 5, 2016, the effective termination date of the agreement, Sanofi's prior option rights to the C1 technology, previously covered by the agreement, will revert back to Dyadic. You may recall that we entered into this agreement in 2011, at a time when our Company's financial position was tenuous at best. While we were prepared to continue our collaboration with Sanofi on this project, management views this as a potential opportunity to better monetize and leverage this vaccine. We consider the experience and knowledge obtained from the research and the progress made from the meaningful improvements to the C1 expression system invaluable. Looking forward, we expect to be able to generate a greater, new and enhanced interest in the C1 technology for developing and manufacturing biologic vaccines. We will continue to consider our strategic options regarding how best to advance the science and the potential commercial benefits from C1 for this vaccine indication. Over the next several weeks we hope to resolve with Sanofi exactly what research might be completed and how going forward Dyadic and Sanofi can part ways in such a way that someday in the future we might again work together, another less complicated vaccine project and/or with one of the other Sanofi Group companies on therapeutic enzymes, antibodies or other biopharmaceuticals where C1 may add value to the research and commercial efforts. Now I'd like to provide a bit more clarity on why we believe the experience and knowledge obtained from the Sanofi research project is invaluable and why we expect we'll generate greater interest in the C1 technology for use in developing and manufacturing vaccines and other biologics. The research project was an extremely challenging one. Unlike most other vaccines where you are not under a specified timeline to develop a single cell line to reach certain productivity levels, this research project ultimately required us to develop multiple cell lines in specified timelines, and twice per year. We are confident with the prior level of FTE lab resources in time the C1 technology would have overcome the remaining challenges with the potential to not only drive down cost of goods, making these vaccines [inaudible] and in greater quantities, potentially with greater improved efficiency -- or efficacy. Please keep in mind that, according to the World Health Organization, the vaccine market alone is anticipated to be circa $100 billion by 2025. If the preliminary encouraging immunogenicity results prove to be applicable and beneficial across only a portion of the vaccines, this is a very large opportunity for Dyadic. Even if the vaccines from C1 turn out to be equal in terms of the immunogenicity, the fact that we've already demonstrated such high productivity for one of these vaccines using the C1 expression system is already very exciting and promises to help bring the cost of producing vaccines down across the globe. Prior to the sale of the industrial biotech business to DuPont on December 31, 2015, due to resource constraints we were restricted as to what research products we could dedicate time and resources to. Despite the fact that Sanofi provided funding for this research project over the past five-plus years, despite our capital and other resource restrictions, Dyadic invested additional resources to overcome earlier challenges in the Sanofi project. We see ourselves as a solid and loyal partner to a biopharma company and we look -- and we took that relationship very seriously and still do. The breakthroughs in the Sanofi research project came from Dyadic's internal resources which led to successfully expressing the [inaudible] vaccine at sufficient levels to allow Sanofi to conduct the mice trials. And as discussed earlier, the immunogenicity data generated by Sanofi indicates that that C1 produced antigen generate an equal to better immune response in mice than the industry standard antigen. We continue to generate interest from pharmaceutical and biotech companies and the potential use of our C1 technology for use in developing vaccines and drugs. However, we've been somewhat restricted from pursuing other potential commercial and governmental parties because of the 2011 agreement with Sanofi. With the termination of this agreement, we will now be able to explore these additional opportunities. In fact, while I'm currently unable to mention the name of the company, I'm happy to report that we've just signed an NDA with a big pharma company that we hope will lead to a partially funded monoclonal antibody C1 expression project. If our negotiations are successful, we anticipate that this project will start later this quarter or in early Q4 2016. In addition to the opportunity to apply the C1 technology to vaccine industry, it was even a bigger potential opportunity to use the C1 technology for developing and producing biologic drugs such as antibodies, biosimilars and biobetters. The human insulin market alone is approximately $29 billion and is expected to increase to $40 billion plus by 2019. The global biological drug market is anticipated to be $287 billion by 2020, with biosimilars making up an estimated $26 billion by 2020 as well. Biologics are some of the, if not, the highest costing treatment for human disease and they are the fastest-growing sector within the pharmaceutical industry, already making up over 20% the entire pharmaceutical industry and still growth. This growth at these costs is not sustainable. It is putting a heavy burden on the world healthcare systems and on patients. We believe C1 has the potential to reduce those burdens. The C1 technology has the potential to help bring biologic drugs to market faster and greater volumes at lower cost and with new properties, to drug developers and manufacturers, and hopefully improve access and cost to patients and the healthcare system, most importantly, saving lives. We continue to make progress in our share repurchase program. During the second quarter we repurchased approximately 1.2 million shares in the open market at the average price of $1.69 per share. At June 30, 2016, we had approximately 36.9 million shares outstanding. Subsequent to June 30 and as of August 10, 2016, we repurchased approximately 800,000 additional shares at an average price of $1.62. As of August 10, 2016, we have approximately $10,700,000 still available under our announced stock repurchase program. We know that many of our shareholders have expressed an interest in having the company up-list to NASDAQ as soon as we're able to meet the listing requirements and expand our internal financial recording capability to support the ongoing requirements of a NASDAQ-listed company. We fully recognize the potential on up-listing to a national exchange. Clearly it is difficult to project credibility with potential partners; up-listing will provide us with a broader exposure, potential investors and partners, and will create much greater liquidity for our shareholders. I assure you that this topic has been at the top of mind of both management and the Board for many years. In particular, again, recently, given the conclusion of the DuPont transaction. I'm pleased to report, at our Board meeting in August 8, 2016, the Board authorized management to begin a process that will eliminate what we believe are the remaining obstacles in order to put the company in a position to be able to up-list [inaudible] management and the Board deems inappropriate to do so. In this regard we've already taken the following actions. On August 8, 2016, the Board approved a reverse stock split which is subject to shareholder approval. We anticipate preparing and mailing a special proxy in the fourth quarter which will outline the terms of the proposed reverse stock split. If the proposed reverse stock split is approved by our shareholders, we expect that this action will eliminate our primary obstacle, enabling the company to meet the minimum NASDAQ secure listing price. We anticipate meeting with SEC counsel and our financial advisors in the coming weeks to determine the most appropriate process, metrics and timing associated with the reverse split, eventual possible up-listing. We have hired a Director of Financial Reporting who will assist our CFO in upgrading our internal accounting and reporting capabilities to enable us to support the compliance requirements of registered and NASDAQ-listed company. Once we've addressed all the current obstacles we face and position the Company to consider registering an up-listing, management and the Board will evaluate if and when an up-listing is the most appropriate path for the Company. We will continue to build the talent we need to accelerate our research, business development, licensing, and other potential forms of collaborations with biotech and pharmaceutical companies. We are debt-free and have the financial resources which we expect to be supplemented by third-party research funding and grants and licensing income to fund our business plans. We are very sensitive as to how and when we make investments aimed at building shareholder value. We started this year with a book value of $1.83 per share. In the June 30, 2016, I'm pleased to report that we have a book value of $1.84 per share. Our CFO will elaborate further on the sources and uses of funds during the six months ended June 30, 2016 and for the remainder of the year. I previously reported to you that I have a strong belief in Dyadic's future to create shareholder value in both the animal health and human biopharmaceutical industries. This is the reason I decided to increase my already sizable position in the Company and I converted by $1 million of debt into equity at the time we retired all the Company's debt after the DuPont transaction. As we continue to talk with and meet with global biopharma companies, contract manufacturing companies, independent research organizations, and other professionals, we are gaining a deeper understanding of where the technology needs to go and what is going to take to get it there, and where best to try and apply the C1 technology now and into the future. Despite Sanofi's recent termination of our research program, I remain optimistic about the potential scientific achievements and advancements we can continue to make to the C1 technology, which we believe will lead to increased shareholder value as well as the business outlook for finding pharmaceutical and biotech companies to join us in leveraging the use of C1 to develop biological vaccines and drugs. I am very pleased with the progress and the reception we are receiving from our outreach to potential third parties that we anticipate will lead to research funding, licensees and other types of collaborations. We remain very busy with our limited staff. We'll not be able to accomplish all of the things we need to do going forward on our own. We are currently in discussions with various individuals and organizations for additional business development and research support. Our Board is also actively interviewing potential Board candidates who can supplement our existing capabilities with the requisite scientific and pharmaceutical experience and background, along with the ability to help us open up doors to key decision-makers within the pharmaceutical and biotech companies. We hope to be able to update you further on these discussions very soon. Unfortunately, despite all our efforts, we believe that the potential of C1 is not properly reflected in our stock price. I believe that part of the problem was investors may not fully understand what the C1 technology actually does and what it is potentially capable of accomplishing in this market. We're working hard to help you and the biotech and pharmaceutical industries better understand the potential of our C1 technology. With our highly regarded C1 technology and our strong financial position, we are uniquely positioned to provide additional shareholder value as we execute our near and longer-term business plans. At this point I would like to turn the call over to Dr. Ronen Tchelet, our Vice President of Research and Business Development, to discuss some of our ongoing programs and discuss a few of our internal research development goals.

Thank you, Mark. This quarter we continued the R&D activities to which our ambitious but what we believe are achievable goals to create a cost-effective platform for developing and manufacturing biologic vaccines and therapeutic proteins using the C1 technology as follows. One, we have evaluated the variety of scientific organizations and are now in the late stages of negotiating and entering into a research program with renowned research group to begin to further develop our C1 biopharmaceutical production strain, including glycol-engineering C1 to produce proteins that resemble the human glyco structure; and two, to develop high levels of a few [ph] monoclonal antibodies. We will initially be funding most of this research with internal funds, although we anticipate supplementing this research with additional funds received from biotech and pharma companies. In fact, we are in the late stages of entering into a small research collaboration with one of the big pharmaceutical companies to try and express a few proteins of interest to them. The CRO we are expecting to begin working with is known for its high skill in developing funded [ph] strains from genetic engineering to process optimization. We anticipate starting the activities in the new CRO at the end of Q3 or early in Q4 2016. We plan to increase our product development activities by using this CRO in addition to our ongoing strong collaboration with DuPont, formerly Dyadic Netherlands Lab. Again we believe that increase our investment in developing the C1 platform and increasing our product portfolio will accelerate our timeline to penetrate into the annual health and the biopharmaceuticals industries. Nevertheless, we should continue to search for additional CROs with the best scientific skills that can provide us with flexibility and access to specific tasks we might need. All those activities have one direct goal, to further improve the C1 technology and to develop more products for use in the human and animal pharmaceutical industries. Now I shall brief you about our current projects. Sanofi Pasteur. As you know, Sanofi Pasteur decided to terminate the proof-of-concept project with us. However, as Mark said, this project enable us to successfully demonstrate that through the use of our C1 technology, we are able to produce a vaccine at high level with the potential to improve therapeutic vaccine performance. I'd like to briefly mention a few of our achievements in as much as I can due to the confidentiality restrictions. As previously reported, the only C1-produced antigen that was tested in mice generated an equal or better immune response in mice trials than in industry antigen chosen for comparison by Sanofi Pasteur. The productivity of this antigen variant was considerably higher than the production of such antigens as obtained by an optimized [inaudible] process in laboratory [inaudible]. Even though the expression levels of this antigen are already high, we anticipate that by optimizing the [inaudible] process further, we can reach even higher expression levels for this antigen over time and for other antigens in general. We have managed to express more antigen variants, however, at varying expression levels. Thus, this project enable us to successfully demonstrate that, though the use of our C1 technology, there is potential to improve therapeutic vaccine performance. In addition, we consider that the experience, knowledge and achievements obtained from the research are invaluable and expect it will generate a greater interest in the C1 technology for developing and manufacturing other biologic vaccines. ZAPI. ZAPI is a research and development program sponsored by the E.U., which aims to develop a platform suitable for the rapid development and production of vaccines and protocols to fast-track registration of developed products to combat epidemic Zoonotic diseases that have the potential to affect the human population. Our Dutch subsidiary, Dyadic Netherlands B.V, is participating in the project by using DuPont Labs as a CRO. We are following the project timeline to express sufficient quantities of [inaudible] antigen using the C1 expression system. We anticipate that we should be ready to send samples of these antigens to be further characterized within the consortium. We believe that in the next month of the ZAPI research program that is ongoing, we can develop better expression trends and develop efficient improved fermentation processes and that one or more of the ZAPI antigens will be able to be produced at similar high productivity yields similar to those that were demonstrated in the Sanofi Pasteur project and possible even better. New projects. We are now starting a development collaboration with an Israeli company which is a part of a bigger project they had with the veterinary vaccine company, to develop a veterinary vaccine to protect poultry. The purpose of the project is to reach expression level that will enable those companies to evaluate the expressed protein by in vivo challenge test in chicks. If the collaboration is successful, we expect to be able to find a commercial partner for this vaccine, will penetrate the market of poultry veterinary vaccines. We are in discussion with a variety of large animal health companies that are interested in the potential of C1 to produce local vaccines and antibodies. In fact, we are in the process of setting up a face-to-face meeting with one of the largest animal health companies to further explore how we can create value together for our respective shareholders. In addition to that, we are in the late stages of discussing an initial research proof of concept project with a big pharma company to express several therapeutic molecules. We believe that these collaborations and other collaborations we anticipate we will be successful in obtaining will enable us to generate the proof of concept and other data needed to demonstrate the benefits of using the C1 technology as a production host for developing and manufacturing biological actions and drugs. I will now turn it over to Tom Dubinski, our Chief Financial Officer, to discuss the financial results.

Thank you, Ronen. At June 30, 2016, cash and cash equivalents were approximately $15 million, compared to $62.6 million at March 31, 2016 and $68.6 million at December 31, 2015. The Company used approximately $47.6 million of cash during the quarter, principally for the purchase of investment securities of $47.6 million, stock repurchases of $2 million, operating cash burn of $1.1 million, and payment of DuPont related transaction costs of $100,000, offset by cash received from the litigation settlement of $2.1 million and cash received by Dyadic on DuPont's behalf in connection with the DuPont transition service agreement of $1.1 million. The Company used $53.6 million of cash during the six-month period, principally to purchase -- the purchase of investment securities of $47.6 million, stock repurchases of $6 million, operating cash burn of $2.1 million, and payment of DuPont related transaction costs of $1.9 million, offset by cash received from the litigation settlement of $2.1 million, cash received by Dyadic on DuPont's behalf in connection with the DuPont transition service agreement of $1.7 million, and all other cash items of $200,000. Our expected operating cash burn for the last six months of 2016 was approximately $2.4 million to $2.7 million. If we happen to identify additional opportunities we wish to pursue, this could possibly change. And if so, we will update you accordingly on our future conference calls. For the full year we expect to use approximately $62 million to $64 million of cash for the year, which includes the purchase of investment securities of $47 million to $48 million, stock repurchases of $10 million to $11 million, operating cash burn of $4.5 million to $4.8 million, and the payment of DuPont transaction liabilities of $2 million, offset by cash provided by the litigation settlement of $2.1 million. Cash and cash equivalents do not include approximately $7.4 million of cash held in escrow in connection with the DuPont transaction, which we anticipate will be released on July 1, 2017. Although we do not anticipate any, this amount is subject to reduction should DuPont identify any claims. The Company repurchased approximately 1.2 million shares of common stock at the -- at an average price of $1.69 per share during the second quarter and approximately 4 million shares of common stock at an average price of $1.49 per share as of June 30, 2016. Subsequent to June 30, 2016, the Company repurchased approximately 800,000 additional shares of its common stock at an average price of $1.62 through August 10. As of August 10, 2016, we have approximately $10.7 million available under our announced stock repurchase program. On June 30, 2016 and August 10, 2016, we had approximately $36.9 million and $36.1 million shares, respectively, of common stock outstanding. Net income from continuing operations for the quarter ended was approximately $600,000 or $0.01 per basic and diluted share, compared to a net loss of $1.5 million or $0.04 per basic and diluted share for the same period a year ago. Net loss from continuing operations for the six months ended June 30 was approximately $400,000 or $0.01 per basic and diluted share, compared to a net loss of $2.3 million or $0.06 per basic and diluted share for the same period a year ago. Revenue and gross profit for the three and six-month periods of 2016 and 2015, respectively, reflect one ongoing and one discontinued biopharmaceutical R&D project. General and administrative expenses for the six-month period ended June 30, 2016 decreased 9% to approximately $2 million, compared to $2.2 million for the same period a year ago. The decrease primarily reflects lower costs due to the organizational downsizing in connection with the DuPont transaction of $600,000, cost reimbursement received from DuPont for transition services rendered of $200,000, and lower litigation costs of $100,000. This was offset primarily by non-cash compensation in connection with executives and board special committee compensation of $0.5 million, an increase in costs to the Company's transition to a biopharmaceutical research company of $100,000, and an increase in financial personnel and related recruitment costs of $100,000. Research and development expenses for the three and six-month periods ended June 30 reflect R&D activities and the service agreement with DuPont to support our ongoing third-party biopharmaceutical projects such as ZAPI and internally funded programs. Net income from discontinued operations for the quarter and six months ended June 30, 2015 were approximately $1.1 million and $1.5 million, respectively, or $0.03 and $0.04 per basic and diluted share, respectively. Now I'd like to turn the call back to our operator to take your questions. Jessica?

Thank you. [Operator Instructions] We'll go to Walter Schenker from MAZ Partners.

Thank you. A short technical question, then the primary question. What are investment securities?

A basket of short - of hold-to-maturity corporate bonds with the maximum maturity of 18 months.

Okay. With de minimis credit risk I assume or?

Yes, all investment grade -- all investment grade securities.

Okay. Thank you. Secondly, if I understood this presentation correctly, the Company plans to ramp up research on the vaccine area after the leading company in the world or one of, who spent three years evaluating this technology, decided not to proceed. What is the magnitude of the investment, Mark, you foresee in going forward on our own on this, or looking for partners?

Yeah. First of all, we were operating with Sanofi for 5-1/2 years, not three years, but it was on and off during that 5-1/2 period. Second of all, we're not ramping up research and development on vaccines. What we're saying we expect to take the knowledge, the experience and the information that we have and to be able to go out and reach out to other companies that are in the vaccine space, both now with the indication that Sanofi had tied up, which is not free, and try to find a partner in that space that's more committed from a dollars-and-cents research and development support than Sanofi was over the last 5-1/2 years, and to leverage the knowledge, experience and information we have that we think is very positive. The other thing that we have learned in that timeframe is not only do we have [inaudible] that we can produce high levels of vaccines, because we've done that with that one particular vaccine in that project, but we also surprisingly saw encouraging results which we reported last October based on Sanofi's data given to us, that the immunogenic response was equal or better than the antigen that we tested against, that was a commercial product. So we're very encouraged and we believe that we can find someone out there in the either industry, government, combination of both, that will be very excited about potentially taking over the project and driving it home in a much shorter timeframe and may have more vested interest in wanting to do so than apparently Sanofi did in the end. And maybe I can let Ronen chime in a little bit because he's closer to that. So, Ronen, you want to make any comments about that?

Yeah. I just want to let you know that we really think that the C1 can serve as a host for vaccines and learn from - through this collaboration with Sanofi that the results we have can certainly be used for other vaccines and have the potential to really be better or at least better than other vaccines that are being developed not just for human but also for veterinary.

And then the other thing, Walter, that we believe is, if we can demonstrate, which we may have to spend some money on to do so on our own and we're evaluating that, that that immunogenic potential, better immunogenic response, will translate across broader classes of vaccines that could be worth more than the production and cost of vaccines.

Again just to make sure, we are going to - you plan on spending fairly modest amounts to go through this process?

Yes.

Thank you.

And we'll now take a question from a private investor, Steven Rafael [ph].

Hi guys.

Hi, Steven [ph].

The first questioner asked the question I was going to ask which with respect to what is an investment security. The -- my question is, given the Sanofi experience, which you say is a terrific experience in terms of improving therapeutic vaccine performance and producing vaccines at high levels. But that relationship has obviously terminated. What is the Company's strategy, or better yet, can you give us a roadmap, and more importantly, how long do you think it's going to take to bring C1 to a commercial -- to commercialization. So far the technology has been only tested in mice. So, are we going to have to wait 10 or 20 years before we commercialize this thing? How long is it going to take?

Yeah, let me address first here your investment security question because I want to make it clear to everybody, that, you know, these are bonds that we're purchasing that are investment grade bonds, with maturities from one month but no longer than 18 months. And [inaudible] approach so that we can actually get a much higher yield than the very minimal market yields that we all have to suffer with today in the banks. So that's what those are. So that's not taking a high risk, taking very, very low risk with investment grade securities that are being purchased through a relationship with a bank, because it's very well-respected, and so we feel very confident that we're actually getting a higher level of interest that gives us more money for investment per share or our future research and development than leaving in a money market. As to the Sanofi situation, I think we've been pretty clear as to our opinion on that and what we expect to do. But again we believe that we have shown clearly that we could make high levels of vaccines. That's something that we didn't know we could do. We theorized we could do it, but we've demonstrated we've now put it in a fermenter in our laboratory to DuPont, and this particular strain we got very high level of productivity. We also are encouraged by the Sanofi data that we saw in a report last year about equal or better immunogenicity. And again we're not going to bring these drugs across the goal line. We are not going to spend our money long term to develop drugs and launch a number of vaccines. We hope to stimulate the interest in another vaccine company for this indication or a variety of vaccine companies for this indication. And in addition, to be able to leverage that information across broader classes of vaccines and to show people that potentially, if they have a vaccine that has been failed in the trial with the FDA because -- not because the vaccine wasn't good enough, but potentially because it didn't create a big enough immune response, it's possible that if C1 properties will go across and stimulate better vaccination, then we might be able to help them bring those back, in addition to new vaccines that people are developing, where they want to have higher immunogenicity to create a better response. So that all has to be proven out. Those are some of the things we're hoping to still get proven out in the collaboration with Sanofi. But again, we'll have to see how that all plays out. So, you know, we're just -- this is all very new news to us. As we mentioned, we got a notification from Sanofi on August 5, so.

So, Mark, how long is it going to take? That's my question. Give me a guess as to -- I mean it sounds like what you're saying is that you're going to sell this technology to various biopharmaceutical and pharmaceutical companies and it almost sounds like you're going to do it with more than one. I want to get some sort of sense as to the timeline. Can you give me that?

I mean I can give what we theorize. We don't actually know that. But, you know, again, we think that we will, in the next two to three years, be completed with all the things we need to do to be able to show both the vaccine companies, animal and human, pharmaceutical companies, biologics, have evidence that we will or won't be able to produce insulin at high levels, potentially Lucentis at high levels, antibodies at high levels, and hopefully be able to demonstrate either to license, collaborations, partnerships, or sales of one or both of those assets, the vaccine asset on its own, the biologic asset on its own, combination of both together, and generate a significant value for our shareholders. So we have no intention at this moment of going past two to three years to prove this out. And we're not going to spend or we don't believe then $15 million, $16 million [inaudible] we get nothing in from anybody else --

Okay. So, if two or three years from now you find that the stuff is not working, or is not working well enough to commercialize it, are you going to liquidate the Company and distribute cash to the shareholders?

That is certainly a high probability of happening.

Okay. Thanks, Mark.

Ephraim Fields from Echo Lake Capital has our next question.

Hi. Thank you for providing the guidance for the full year uses of cash and sources of cash. And I just want to make sure I understand something. It seems as though you're increasing rather significantly the amount of cash you're spending or you plan to spend this year on the stock buyback. Did I hear that correctly?

Yes. We've had -- we're making good progress and expecting that to continue. But if it doesn't, then we'll curtail it.

Got it. And how exactly are you -- do you have a 10b5 plan or how exactly does the Company go about buying back stock?

Well, we're operating under a 10b18 plan that's managed by Canaccord, and there's a firewall between them. They're transacting and negotiating on our behalf. The Company is not involved. There's not any 10b5 plans been filed as to officers and directors selling shares.

Just to clarify, I think what you were asking is we have a plan in place, I don't know the definition, if it's a 10b18, whatever the number is. But that plan has been in place in February. There were certain parameters that were put in place in February. There's some limitations as to trading volume based on a 30-day average that they can buy at any given day. And they're able to buy blocks of stock once per week. And so that's what they're doing. They're executing on that. They're doing that consistently. And obviously we feel at this price, if we can buy more stock than less, we're happy to do so.

Great. Thank you.

And we'll now take a question from Skip Gozzo [ph] from Clooney Road LLP [ph].

Hi, Skip [ph].

Skip [ph], your line is open. If you are on a speakerphone, please depress mute button and pick up the receiver.

Yeah, hi. Sorry, I was on mute. Can you elaborate a little bit more on this non-disclosure agreement that you either you said you're in the process of signing, or you did sign, as to what it is that you're going to be doing and how excited or not excited you are about doing this with whoever it is? Can you elaborate a little more about that please?

Yeah. So we have signed an NDA. We've been in discussions with this company for a very long time. It sort of goes back to the last conference call which we described the process it takes to actually move things forward. In the past, even industrial biotech and with the pharmaceutical industry, it's even a longer process in between. But this is one of the big pharmaceutical companies. They have an interest in seeing the potential of how high C1 can produce these monoclonal antibodies and we're very excited to have this company take a peek at and look at and hopefully become a strong partner and a bigger collaborator over time and there will be funding part of this research and development effort that we have that demonstrate that monoclonal antibodies can be reproduced in C1 at far greater yields than [inaudible] for example. I don't know if that answers your question, and Ronen, I don't know if you have anything you want to add to that or not.

Yeah, I just want to say that we are very happy about it because I think the fact that the big pharmaceutical companies are interested, seriously interested, in the C1, it's a big thing that those companies are open to use such host and they are particularly interested in C1 based on the information that we all know and we generate in the last years. So we are -- I think it's not just the fact that we are going to, hopefully, those negotiation will be a full collaboration, but also it is saying about the C1 technology.

You mentioned that, since you got out of the Sanofi deal, and you learned so much from that deal, that your arms are kind of untied now. Do you see any benefit to getting out of that Sanofi deal and applying that information that you learn, that you spoke about to this particular deal that we're talking about right now, is that going to help you with this?

The particular deal we're talking about right now is monoclonal antibodies and not vaccines, it's completely different. However, the same company [inaudible] a vaccine group, because it's one of the big pharma companies. And so we obviously will be trying to encourage them and show them what we can in terms of getting potentially one or the other divisions to pay attention to the vaccine side as well. But the project we're working on is completely different, it's a monoclonal antibody project, for multiple monoclonal antibodies. I think what I'd like to also clarify, that, as I mentioned in my earlier part of the conference call, that we are evaluating and meeting and we've talked to other potential Board members, and some of those potential members have vast experience in the pharmaceutical space and in biologics, both in vaccines and in monoclonal antibodies, biosimilars, both from engineering organisms to fermenting them, to business and development deals, to all kinds of opportunities. And I -- we vet our plans with these people and find out how closely tied the thoughts are, and if our thoughts are on track or they're not. So, you know, as mentioned, we expect to be able to share news with you down the road here as we move on that process and try to bring on more scientific help on the board that will advance the technology, help us make sure that our plans are targeting the right things for the right reasons and create the value we expect. And they can open up doors in key executives at large pharma and large biotech that we don't have direct access to on our own.

Based on past experience about this non-disclosure agreement, do you have any kind of timeline when you think there could be an announcement based on past experience of who this pharmaceutical company is and whether or not that you will do something with them? Do you have any kind of timeline?

I think we mentioned that we expect to start this project at the end of this quarter some time or beginning of Q4. Whether we'll be able to announce the name or not is still up in the air as part of the negotiation, and I'm not sure they're going to want to let us, but we're certainly asking for the ability to do so.

Okay. One last question. As far as the up-listing of the stock and as far as recruitment, did you recruit somebody that is on your payroll now that has had experience in up-listing the stock before that can help you guys get through this process? Are they in fact on your payroll or is it sublet out?

I'll let Tom talk about that.

Yes, Skip [ph]. We were able to identify somebody in the market. We did have the assistance of a recruiter to help us with the indemnification [ph]. The person has an excellent SEC pedigree, did research, spent five to seven years at Deloitte, was most recently with a publicly-traded company that went private. And early indications are she's going to be an outstanding fit.

And when does she start, or has she started?

She started at the end of June.

Okay. That's all my questions.

And in addition to -- this person's name is Ping, by the way, Ping Rosend [ph]. So she's been identified as a person.

Say that again? How do you spell her first name? King?

P-I-N-G, Ping.

Okay.

And she -- we seem to believe that, in the experience we've seen to date in preparation of this Q and otherwise, she's very skilled, very talented, very pleasant, very excited about the opportunity to be at Dyadic. We're excited to have her. We're also in discussions with advisors, otherwise legal and otherwise, to help us with sorting through the proxy, with the reverse shares, and with the up-listing potential program that we have. So we're all over it with a lot of people. We've been all over it for a long time. As we mentioned in the past, there was no way we could do this until we had the finances in place. And after the DuPont deal we did. We just completed the DuPont transfer on April 30, which is like three months ago. And I think that the investors have been very patient and we appreciate that. And we will obviously be working towards that goal and objective and putting in with Ping and below Ping the infrastructure to make sure that, when we do up-list, and if we do, it will be done properly, and that we will dot every I and cross every t, because we want to make sure it's done right.

And you see that happening, especially if you do make this announcement with this drug company, you see that probably happening end of the fourth quarter, the up-listing?

I honestly can't give you that timeframe. There's things going on. Obviously we have a trial coming on January 6 against Greenberg Traurig, and obviously we'd like to see the outcome of that. We want to take our yearend financial statements that are audited versus Qs which are not audited, and use those numbers. That's more likely the timeframe that we will do that.

Which means first quarter of next year somewhere maybe, probably.

That's what the -- we think is the most conservative and the best approach for our shareholders, to get clarity on the lawsuit, to find out what the jury has to say, hopefully in our favor. We believe we have a very strong case, we made that very clear. We also would like to obviously have audited financials at the time we do this, rather than an interim financials. And it'll give Ping and her team and Tom the time, and our Board and our audit committee, to get everything in order.

And one last question in regards to that, and your burn rate for the last six months, you said about 2.1 to 2.4. I believe those are the right numbers or thereabouts.

I think it was 2.4 to 2.7.

Okay. So in that 2.4 to 2.7, is that including -- is there any more out-of-pocket going to trial?

The out-of-pockets for trial is court costs, fees for transcripts, expert witness testimony that will obviously have to go to trial, we will have to pay those expert witnesses and go to trial. But the lawyers are on a contingency, which would have been --

But is that part of your -- is that part of your 2.4 to 2.7 projection, the expert fees and so forth?

I believe, yes.

Yes, I've included a provision for estimated costs.

Okay. That's all my questions. I think you guys are executing the way you said you were going to. I think it's pretty exciting if you can make this announcement soon, hopefully. And yeah, keep going, sounds good. Thanks.

And our next question will come from Robert Hoffman from Princeton Opportunity Partners.

Good morning -- or afternoon, I'm sorry. Just a couple of follow-up. First, on the kind of the subject of big pharma and cash burn, do you anticipate that this kind of agreements will be accompanied by a couple of million bucks upfront payment, that would obviously -- would be evidence of their seriousness but also alleviate some of the cash burn?

Yeah, I think we're going to have a variety of license agreement potentials, collaborations, partnerships that are going to come from big pharma, biotech, government funding programs like the ZAPI program, etcetera. And I don't think we're going to expect on the short term the deals like we have with Evangola [ph], Sudexis [ph], DSF [ph], but I think we'll get some funding and R&D that'll lead to those deals. And I think that's what's the most important thing, is finding molecules that actually, if we're successful where there's a partner at the end of the road that can commercialize something at a very high value. And I think that we're not in a position where we have to give up certain rights for less like we used to. So I don't think we're going to get upfront short term, but long term I think we will get a lot of license agreements and/or ultimately somebody will come in and recognize the value of this company and probably [inaudible] the vaccine space, the biologics space, or both. And it's all about science, Rob. If we deliver on the science and we can make C1 do the things that it's capable of doing or potentially capable of doing, then we'll all be very happy. If it's not, we're going to hopefully create more value by putting money into it today than it's worth now, and we'll get our money back that way, whether it's 1 times, 5 times, 10 times, 50 times. It's all about the science and what kind of results we can find. If we can make insulin at very high levels, obviously that would be a phenomenal thing. If we could make Lucentis at very high levels, that will be a very good thing. If we can demonstrate vaccine immunogenicity across a broad scope of vaccines, that will be a great thing. And most importantly, not only will our shareholders benefit but so will the patients and the healthcare system across the globe.

I'm not as worried about the patients right now. But one of the -- I think when we talk about the next two or three years of cash burn, I think that will really be evidenced by your ability to extract cash from some of these agreements, because it's easy enough for any company to ask for a free look. It's whether or not, you know, they're putting money behind that look, or if there's been enough progress to put some more money on further development. So I guess it's not really a question as much as a comment that if at the end of 2017 you have not had any cash come in the door and you burned an additional call it $7.5 million, I would hope that that would be an, you know, you'd step back and say, well, what is the likelihood, here we are a year and a half later, what is the likelihood of us having success. So that's just my soapbox there. But on a particular --

Well, let me respond to your soapbox because -- soapbox comment. As you know, I mean, I own a big stake in this company. And even if I didn't own a big stake in this company, I have the responsibility to make sure, as do the whole Board and the management team, that if we feel that C1 is not advancing in a way that it should be, that we're not going to be able to drive the value that we expect, we're obviously not going to throw money down the drain, for so many different reasons that you can just imagine. So I'm going to lose or make money than anybody on this phone call by a pretty good factor, and I'm going to watch your money like it's mine because it is. It's both.

Got it. I appreciate you clarifying or reiterating that. But just a quick question on the Sanofi deal. Back in your, I think it was your last Q, you made a statement that said, as it pertains to Sanofi. If the Company is successful in delivering sufficient quantities of the remaining vaccine variants to Sanofi by the middle of the second quarter, the Company anticipates a decision on this research project by the end of 2016. I guess my question is, is this a -- was their decision not to go forward because the number of vaccines that C1 worked in is limited, or is it something different? I mean, were you able to deliver what they asked for?

Well, we delivered partially what they asked for, for sure. In fact, we delivered a vaccine that we expect -- or expected that they would put in the mice and we would find out the answer as to the immunogenicity, reproducibility, and I don't know that they will or won't still put that -- won't purify it and it put in into mice. So that's part of our next 60 days, is between now and October 5, discussions of what they are going to do, what they're not going to do, what we feel they're obligated to do, what we feel that they should do, what we can maybe do that they don't do. Those are all ongoing discussions. But I think that we believe, and as we mentioned, that this was a decision that was made not by the people that are working day to day with C1 at Sanofi, the people that we believe believe in it and that's what they've told us, it was a decision made for a variety of reasons. And I think the least or the lesser of the reasons was whether they believed that ultimately C1 could actually deliver on this particular vaccine. But this vaccine was a unique, very difficult project that they gave us, that, you know, there's a lot of other things that we could have had that are much, much easier. And if this was, for example, a cancer vaccine and you needed to make one strain and you use that same strain over and over again for a decade or 20 years to make this cancer vaccine, we made enough of a vaccine, and with that vaccine and encouraging results, would have taken it in the phase one and potentially then into a phase two and phase three, but in this particular indication that's not quite how that seemed to work. So I unfortunately can't share with you the indication. At some point Sanofi may let us, but I doubt it.

I guess moving backwards. So you are not being asked to produce vaccines that they already can easily produce already?

I will say that I really can't get into the details of that, but I would say that the vaccine that we were asked to use or to produce may be produced in a different way that was inefficient, although it may be something commercially useful, that they were looking for a better way to do it.

Got it. Okay. But it's not --

And we showed that in -- huh?

-- that's being 100 million vials a year being made and they were just going to try to make it cheaper, this is more of a specialized vaccine.

No, I didn't say that. I said that it's a vaccine that they commercially probably use and may use another way to do it, a different method, maybe expression, not expression, and they wanted to find potentially a better way to do it, a quicker way to do it, and maybe, which we now saw, potentially even a better immunogenistic [ph] way to do it or at least equal. And so I think that it was something that they believed in. I think they saw the future. I think that the team they were working with, which we have a very good relationship with, and even some of our own people that we work with, I think believed that that could get across the goal line and achieve the ultimate goal. And we hope to actually be able to talk to Sanofi about potentially applying this to other vaccines that aren't as difficult or that are one-offs that might make sense for them. But as a big organization with all kinds of reasons, they do all kinds of things.

Just a final quick question for me. On the monoclonal antibody that you have the NDA on, is that something that this company is already producing or is this something that they want to produce?

I can't tell you that, the answer to that question, due to confidentiality.

Okay. Thank you.

And our final question will come from a private investor, George Preable [ph]. George [ph], your line is open. If you're on a speakerphone, please de-press your mute button and pick up the receiver. And hearing no response, we will end our question-and-answer session. I'll turn the conference back over to our presenters for any additional and closing remarks.

I want to thank everybody. I just want to go through our business and research plans are continuing to evolve, are being refined as we evaluate our cash position, personnel needs, R&D and other resources required to execute our business plans. I am very optimistic about the prospects that lie ahead for Dyadic as we further improve the C1 technology for its potential use in the development and manufacturing of biologic vaccines and drugs. I want to take this opportunity to thank our very hard-working employees, our dedicated Board of Directors, our research partners, and our shareholders for their support in helping us achieve our business objectives. Thank you all who have taken the time to participate on today's conference call.

This concludes today's presentation. Thank you for your participation.