Dyadic International Q2 2024 Earnings Call Transcript

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August 13, 2024

There are 6 speakers on the call.

Operator

Good evening, and welcome to the Dyadic International's Q2 2024 Conference Call. Currently, all participants are in a listen only mode. Following management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference is being recorded today, August 13, 2024. I would like to now turn the conference over to Ms.

Operator

Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Speaker 1

Thank you. Good evening, and welcome everyone to Dyadic International's Q2 2024 Conference Call. I hope you have had the opportunity to review Dyadic's press releases announcing financial results for the quarter ended June 30, 2024. You may access our release and Form 10Q under the Investors section of the company's website atdiatics.com. On today's call, our President and CEO, Mark Emalfarb and our Chief Operating Officer, Joe Hazleton, will give a review of our Q2 2024 business and corporate highlights, including a brief summary of our recent research and business development efforts.

Speaker 1

I will follow with a review of our financial results in more detail and our Chairman, Patrick Lusi, will provide a commentary on the strategic direction of the business at the end of the call. We'll then hold a brief question and answer session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward looking statements, which involve risks and uncertainties and other factors that could cause Dyadic's actual results, performance, scientific or otherwise or achievements to be materially different from those expressed or implied by these forward looking statements. Statix expressly disclaims any duty to provide updates to its forward looking statements, whether because of new information, future events or otherwise. Participants are directed to the risk factors set forth in Dyadic's report filed with the SEC.

Speaker 1

It is now my pleasure to pass the call to our CEO, Mark Emmergaard. Mark?

Speaker 2

Thank you, Ping. Welcome, everyone, and thank you for joining Dyadic's Q2 2024 conference call. We are excited to discuss how our business strategy centered on near term licensing and product candidates has strategically positioned Dyadic to swiftly take advantage of current and upcoming opportunities. Over the next 24 months, we're focusing on achieving multiple revenue streams and significant milestones through the commercialization of products, technology licensing, fully funded collaborations and advancing our pipeline, all aimed at enhancing shareholder value. Our C1 technology continues to garner widespread recognition of its remarkable speed and productivity, earning accolades not only across the country, but around the world.

Speaker 2

Esteemed voices from academia and industry such as world renowned vaccinology pioneer, Doctor. Rino Rapioli, government agencies like the U. S. FDA, BARDA, the NIH and NIMBLE, non profit organizations and 2 top 10 pharmaceutical collaborators are recognizing C1's groundbreaking potential. Meanwhile, our dapaviz protein expression platform is already gaining significant momentum and most importantly generating revenue in the rapid evolving alternative protein and bio industrial sectors.

Speaker 2

We are committed to leveraging our microbial protein production platforms, C1 and DAPAVIS, to develop recombinant proteins, enzymes, antigens and antibodies across our core sectors, alternative proteins, animal and human health. These efforts are expected to open up new revenue streams, driving substantial value creation for Dyadic and our partners in both the pharmaceutical and non pharmaceutical markets. I will now turn the call over to our Chief Operating Officer, Joe Hazleton to provide an update on our business results for the Q2. Joe?

Speaker 3

Thank you, Mark. In the Q2, our business development efforts in the alternative protein sector are continuing to bear fruit, showcasing the potential of our microbial platforms. As part of our strategy to drive near term revenue, we have concentrated on identifying and producing high value, high volume recombinant protein products that can quickly and efficiently be commercialized. Our recently announced partnership for recombinant serum albumin is a prime example unlocking numerous opportunities within the approximately $6,000,000,000 serum albumin market. This single product offers diverse commercialization prospects across various segments.

Speaker 3

For instance, grade serum albumin has potential as a disease treatment, plays a crucial role in vaccine development, serves as a carrier protein for therapeutics and is a standard reagent in research and development. Additionally, recombinant albumin is valuable in diagnostics, cell and gene processing and cell culture media, particularly for growing animal muscle cells for lab grown meat. The recent completion of certificates of analysis for our recombinant human and bovine albumin confirms the analytical equivalents to currently commercialized research grade products, making them potentially viable for commercialization in R and D. We have also completed 3rd party testing of recombinant bovine albumin produced through our microbial platforms as a component of cell culture media. The results demonstrated its comparable effectiveness to animal derived bovine albumin in growing muscle cells for the cultured meat industry, further validating its potential in this rapidly expanding market.

Speaker 3

To unlock the potential of our recombinant albumin products, we have executed a strategic development and commercialization partnership with ProLiant Health and Biologics, a leading supplier of purified proteins for the diagnostic, nutrition and cell culture markets with a global customer base. This collaboration will initially focus on bringing recombinant human serum albumin to market with the first product launch expected in the first half of twenty twenty five. Under the terms of the agreement, Dyadic will receive a total payment of $1,500,000 and we expect to start receiving recurring revenue in 2025 from our share of the profits generated by ProLiant from the sale of animal free recombinant albumin products made using Dyadic's filamentous fungal microbial platforms. A portion of the upfront payment will support the technology transfer and commercialization efforts following successful scale up validation. We've already received a $500,000 payment and we anticipate the second $500,000 milestone payment in the late 3rd or early 4th quarter following product testing and expect the final milestone payment upon scale up validation projected for the Q4 of this year.

Speaker 3

We're actively working to accelerate and broaden the scope of commercialization opportunities within the alternative protein sector, particularly for non food applications. Recently, we completed the development of DNase 1 and the issuance of its certificate of analysis confirms its analytical comparability to existing commercial products. We've begun sampling this product and are aggressively seeking partners and customers in the global market for DNAases, ligases and RNA polymerases, a market that's valued at over $809,000,000 in 2023, projected to grow at a CAGR of 10.63 percent from 20 24 to 2,030. In addition, we've developed a recombinant transfer and strain at significantly high productivity, sparking interest from global cell culture media market, which was valued at $4,730,000,000 in 2023 and is expected to grow at a compound annual growth rate of 12.54% from 20 24 to 2,030. Transferring is a key component of serum free cell culture media with recombinant proteins and growth factors comprising the majority of the costs.

Speaker 3

Over 95% of which are driven by albumin and transferrin. Notably, more than 70% of the transferrin used in cell culture media today is produced recombinantly, making it particularly attractive product for Dyadic. Our goal is to expedite the analytical and application testing in the 3rd quarter and to begin sampling as soon as possible. In other efforts to expand our presence in cell culture media, we've also begun sampling our partner Biftech's patent pending cost reducing animal free growth medium for which will earn a share of their net sales. Outside recombinant cell culture products, we believe recombinant non animal dairy products offer Dyadic the potential for rapid commercialization opportunities.

Speaker 3

The global animal free dairy products market was valued at over $26,000,000,000 in 20.22 and is projected to reach more than $75,000,000,000 by 2,032. Today's animal free dairy products are produced via precision microbial fermentation technology, a market driven by evolving consumer preferences and concerns over health issues associated with traditional cow milk, such as lactose intolerance and allergies. Despite the current high cost of animal free dairy, this obstacle aligns with our expertise in producing large quantities of cost effective recombinant proteins using our microbial expression platforms. We're making steady progress with our partnership to develop non animal dairy enzymes, which was established less than a year ago. While we encountered a delay in earning the success fee due to a longer than expected validation, we believe we have now met our targets for this project and expect to receive a success fee of $500,000 in the Q4 of this year.

Speaker 3

In the Q2, interest in our non animal alpha lactalbumin product has resulted in a nonexclusive joint development agreement with a top 10 global dairy company to create a food grade alpha lactalbumin product. We're also in active discussions with 3 other alternative dairy protein companies interested in commercializing this product. To further expand our non animal dairy pipeline, we plan to begin sampling in the competitive beta lactoglobulin and lactoferrin markets. We are in ongoing discussions to develop a recombinant lactoferrin food grade product with a goal of finalizing the development and commercialization agreement in the Q3. Over the last year, we have been actively developing several bio industrial grade enzymes with applications across multiple industries, including nutrition, biofuels and biorefining.

Speaker 3

In a partnership with FernBox, we have successfully developed a cellulosic enzyme for the biofuel industry, which is now undergoing testing by potential customers. Additionally, Dyadic has created enzymes initially targeted at the pulp and paper industry with promising potential for use in the biogas and biofuel sectors as well. Our goal is to be in commercializing these products within the next 12 months, which we believe will drive revenue growth in the future. While the alternative protein segment is our primary focus for near term growth in revenue, we remain deeply committed to the long term potential of Animal and Human Health Pharmaceutical segments. The successful completion of our 1st in human Phase 1 study for a C1 produced protein has generated significant interest from academia, government, industry and non profit organizations.

Speaker 3

Since the beginning of the year, we've initiated over 14 fully funded human health vaccine and antibody projects, including 2 with top 10 pharmaceutical companies. These 3rd party funded programs cover a wide range of disease areas and further showcase Dyadic's ability to produce both standard and complex molecules. Our C1 platform has successfully expressed multiple potential infectious disease vaccine antigens, including those for HBV, HIV, several RSV antigens and plasmodium parasitic diseases. Additionally, in the Q2, Dyadic delivered 3 successfully expressed monoclonal antibodies or mAbs for evaluation as neutralizing agents for infectious disease with 2 more mAbs in development, one of which is for a top 10 pharmaceutical company. As the H5 bird flu continues to spread globally affecting wild birds, poultry and even U.

Speaker 3

S. Dairy cows, there has been a growing interest from human and animal pharmaceutical companies, especially with the recent human cases reported among U. S. Dairy and poultry workers. In response, Dyna commissioned an independent vaccine expert to assess its adjuvanted H5Claud 2.3.3.4.bA Ostracon Avian Influenza or Bird Flu ferritin nanoparticle human vaccine candidate developed in collaboration with Virovax LLC.

Speaker 3

The expert assessment provided a positive outlook on the initial animal studies, highlighting both the strength of the C1 vaccine manufacturing platform and the H5 avian influenza or bird flu ferritin nanoparticle vaccine candidates potential to generate strong neutralizing antibodies for use in humans as well as possibly in poultry, cattle and other animals. Earlier in the Q2, Dyadic and Virovax announced preclinical animal testing for our H5 H5 avian influenza or bird flu ferritin nanoparticle vaccine candidate, which demonstrated a robust immune response in rabbits. The potential H5 bird flu recombinant protein human vaccine candidate combines Dyadic's C1 single step ferritinanoparticle antigen production with Virevax's novel antigen and adjuvant. This promising candidate has been presented to several government agencies, including BARDA TechWatch, NIH and the White House Office of Pandemic Preparedness and Response Policy. 2 additional U.

Speaker 3

S. Government presentations are currently scheduled for next week. Furthermore, the initial preclinical animal studies indicate the C1 produced H5 avian influenza or bird flu ferritin nanoparticle vaccine candidate generates high levels of neutralizing antibodies against the 3 primary circulating bird flu viruses. This has increased the potential interest in the animal health sector, particularly for use as a vaccine in poultry and cattle to combat the ongoing avian influenza outbreak. We're actively providing samples of the C1 produced bird flu recombinant ferritin nanoparticle vaccine antigen to various human and animal pharmaceutical companies for further evaluation.

Speaker 3

Alongside the continued progress and expansion of our partnership with Fibril Animal Health, we're capitalizing on the heightened awareness brought by the bird flu outbreak in the Animal Health segment by intensifying our business development efforts in Animal Health initially focusing on recombinant protein vaccines for pandemic response and preparedness. We remain laser focused on evaluating product opportunities with financial rigor, ensuring we fully capture the value of Dyadic's technology and expertise. We're committed to driving near term revenue growth in the alternative protein segment, while simultaneously building mid- to long term value in the animal and human health markets. With that, I'll turn the call over to CFO, Ping Rawson to cover our financials. Ping?

Speaker 1

Thank you, Joe. Thank you everyone for joining our call today. I will now go over our key financial results for the quarter ended June 30, 2024 in more detail. You can find additional information in our earnings press release and Form 10 Q, which we filed earlier today. Revenue for the quarter ended at June 30, 2024 decreased to approximately $386,000 compared to $837,000 for the same period a year ago.

Speaker 1

The decrease in revenue was due to the winding down of several large research collaborations conducted in 2023. Cost of research and development revenue for the quarter ended June 30, 4 decreased to approximately $302,000 compared to $793,000 for the same period a year ago. The decrease followed the winding down of several large research collaborations. Research and development expenses for the quarter ended June 30, 2024 decreased to approximately $516,000 compared to $918,000 for the same period a year ago. The decrease primarily reflected the winding down of activities related to the company's Phase 1 clinical trial of CYF-one hundred and several internal research projects.

Speaker 1

G and A expenses for the Q2 of 2024 increased to approximately $1,608,000 compared to $1,403,000 for the same period a year ago. The increase was due to increases in share based compensation expenses of $84,000 legal expenses of $81,000 business development and Investor Relations expenses of $60,000 and other increases, partially offset by decreases in management incentives of $36,000 and insurance expenses. Loss from operations for the quarter ended June 30, 2024, decreased to $2,043,000 compared to $2,290,000 for the same period a year ago. Net loss for the quarter ended June 30, 2024 was approximately $2,045,000 or $0.07 per share compared to a net loss of $2,153,000 or $0.07 per share for the same period a year ago. On March 8, 2024, the company issued and aggregates principal amounts of CNY6 million of 8% senior secured convertible promissory notes due March 8, 2027 in the private placement.

Speaker 1

The convertible notes have a conversion price of $1.79 with no warrants. During the Q2, dollars 400,000 of the notes were converted into the company's common shares. As of June 30, 2024, we had cash and investment grade securities, including accrued interest of CAD10.1 million compared to CAD7.3 million as of December 31, 2023. In July, the company received an initial payment of $500,000 pursuant to our license and development agreement with Perion. We expect our cash burn for the second half of twenty twenty four will be approximately $3,000,000 I will now turn the call over to Dyadic's Chairman, Patrick Lucey, for closing remarks.

Speaker 1

Patrick?

Speaker 4

Thank you, Ping. First, I would like to thank you all for joining the call today and your continued support of Dyadic. Several months ago, we redefined the Dyadic corporate strategy to focus on opportunities to deploy the Dyadic C1 and DAPA BIS platform protein production technologies to generate significant near term revenue and near term recurring revenue, while also advancing our efforts in mid to long term value creation. This strategy is focused on 3 distinct market sectors, including alternative proteins, animal health and human health. In today's call, you've heard that strategy playing out with executed agreements and significant activity in each of the sectors with a particular emphasis on the alternative protein sector.

Speaker 4

The transaction with ProLiant is a great example of that focus. We believe the Avian Influenza vaccine candidate presents Dyadic with a significant opportunity and we are currently seeking pathways to advance the candidate through non dilutive approaches. We will continue to update investors on progress in the coming months. I'm extremely pleased with our management team and our Board for their focus and commitment to our company's strategy and look forward to announcing additional transactions in the future. With that, I will ask the operator to begin our Q and A session.

Speaker 4

Our CEO, Mark Emalfarb and our management team will respond to your questions. Each caller will be allowed one question and one follow-up question to provide all callers an opportunity to participate. If time permits, the operator will allow additional questions from those of you from those who have already spoken. Operator?

Operator

Thank you. We will now conduct a question and answer The first question comes from John Vandermosten with Zacks. Please proceed.

Speaker 5

Thank you. Congratulations on the new alpha lactalbumin deal. I had a couple of questions on that. I guess, first of all, what's the size of that market and who are the customers for the product?

Speaker 2

Joe, do you want to answer that?

Speaker 3

Sure. And John, thanks for the question. The market, the alpha lactalbumin market is approximately a $700,000,000 market. Now that includes milk derived products. The recombinant segment is smaller.

Speaker 3

I don't have a great number for that for you, but I would say it's probably in that $30,000,000 to $40,000,000 range currently. It's obviously expanding as people are looking into producing this recombinantly similar to what they've done for HMOs and other products in this space. So with that being said, that's the essential market potential. The customers are everything from the large dairy companies like the Danone's, Nestle to just about well and also a lot of the newer companies in precision fermentation. So we have obviously multiple opportunities, but it's essentially the food grade dairy companies that we're looking at.

Speaker 5

Okay. And I guess that would be DAPA BIS, right? This is the DAPA BIS expression system.

Speaker 3

Yes. You're correct.

Speaker 5

Okay. And then just another question on that same, is there a clear pathway here to revenues outlined in the JDA with the dairy company kind of as you have with the other albumin deal with ProLiant?

Speaker 3

Yes. Based obviously on the performance of the strain and hitting certain commercial targets, there are milestones and royalty payments associated with the development.

Speaker 5

Okay, great. Thanks, Joe.

Speaker 2

Joe, I think maybe you can expand on the transferring opportunity as well, because I think that's a huge opportunity for us. And I think explaining that a little bit would be helpful.

Speaker 3

Sure, Mark. The transfer in opportunity is similar to that of alpha lactalbumin and that it's a very high growth market for recombinant products given that it's a very high price point. So the average cost of a kilogram of transferrin is roughly $400,000 to $500,000 Now that's obviously animal derived. Recombinant production is increasing, but it's a tricky component to produce. So being able to produce it at the titers that we are today, we believe that we can significantly reduce that cost.

Speaker 3

And as I mentioned in the portion of the call, the majority of cell culture media costs and that's the media that you grow, not just animal muscle cells, but it's also used to grow CHO cells for production of other monoclonal antibodies and other pharmaceutical agents. Any cell culture media component can grow basically mammalian cells. So it has multiple uses, multiple off takes across the segments. The differences is that albumin and transferrin make up 95% of the costs of cell culture media. So if you look at, let's just say a leader of media that you use to grow either animal muscle cells for lab grown meat or you'd use it to grow, CHO cells for making a monoclonal, 95% of those costs are from albumin and transfer and the remainder is from growth factors and some other high value targets in there as well, which we're looking at.

Speaker 3

But that's the particular opportunity with transfer. And given in that space, 70% of the utilization today is already recombinant and it's looking to increase because again, it's one of those markets where it's an extremely expensive product to drive naturally because there's not a lot of it in basically mammalian blood. So it's much easier to produce recombinantly and potentially more regulatory acceptable as well. So I do believe that's a significant opportunity that's already generating interest and obviously we have continued development we need to do.

Speaker 5

Great. Thanks for the extra color.

Operator

Thank you.

Speaker 2

Yes, is there anything you want to add or we're waiting to see if anyone else is

Speaker 1

coming in?

Speaker 4

No, I think I've covered it in the remarks.

Operator

We do have a follow-up from John Van Wusterman with Zacks. Please proceed.

Speaker 5

Thanks. I had kind of a bigger picture question for you on C1. As we look at how the expression system has evolved over time, how has it changed over the last 5 years?

Speaker 2

It's a good question. It's changed from, I guess, from darkness to light or night to day. And what I mean by that is, when we transitioned the C1 cell line from the industrial sector into biopharmaceuticals, There was a lot of work we had to do to make it so that it not only produced a lot of something, but it produced in a stable form. And as you know, we've knocked out total now 14 or 15 different genes with proteases in addition to other background proteins, so that we can produce high levels of low cost proteins that are stable. And then most importantly, although we had certain animal data prior to doing all of that.

Speaker 2

We've expanded the animal data from rats to lambs to chickens to all kinds of other hamsters. But most importantly, with the DY-one hundred SARS CoV-two RBD booster Phase 1 trial, we've now demonstrated for the first time ever a protein produced from our C1 cell line and for that matter filamentous fungal cells can be used safely and induce an immune response. We did that both at the high and low dose and we got good neutralizing antibodies and cellular immunity. So that has opened up the doors very wide and it seems to be growing even wider as we develop more and more antigens for the vaccine. So when we're common in protein vaccine platform, we believe that we have the most efficient, fastest way to make the largest quantity, lowest cost antigens for vaccines that can be released sooner.

Speaker 2

Because in the end, we don't have viruses to remove like toe cells, antiviral clearance or the baculovirus cells. So it's not only faster, quicker and cheaper, but you can release it sooner. So we believe we're going to transform our common protein production of antigens for human and animal health. So hopefully that gives you an idea of the tremendous progress we have made and now the validation as we've talked about from academia, industry, government, nonprofits, you name it, and virtually on every continent on this planet, we're starting to get recognition, we're getting more and more credibility, The technology is getting more broadly applicable. And as Joe pointed out, we've produced things like HPV, which as you know is a massive market opportunity and sales today in the 1,000,000,000 and 1,000,000,000 of dollars.

Speaker 2

We've also produced multiple versions of an RSV antigen and a variety of others as well.

Speaker 5

Great. Thanks for the summary. Do you have time for one more from me? I don't want to use up all my questions.

Speaker 2

Yes. No, we're happy to answer the questions and you provide information that's helpful.

Speaker 5

Yes. So just one other thing on ProLiant, and Joe and I had a chance to talk about this before, but I don't know if I asked this question about just the relative margin on the C1 produced product versus what their what Freliance is already doing right now, the animal based albumin. Do you get a sense of what the relative attractiveness is of the recombinant C1 versus their product right now in terms of margins?

Speaker 2

Well, unfortunately no answer is that. Just to clarify, they're making bovine albumin, not human albumin right now. So this is a whole new market opportunity for them on the human side. But Joe, you can go forward.

Speaker 3

No, actually that's exactly what I was going to say. It's an expanding customer market for them because they don't have a recombinant product today and they don't have human serum albumin. They only work in the bovine protein space at the current time. So this is a nice expansion. The use case though for human serum albumin and bovine albumin in certain instances is the same for things like cell culture or medical device coding.

Speaker 3

Those are things that you could potentially use other product depending on what the need of the application is. There'd be certain reasons why you'd want to use human versus bovine and vice versa as a lot of it is driven by cost. But as far as the margin attainment, I really don't want to speak for them, but obviously we want to look to be able to provide a cost effective product to the market in terms of recombinant human serum albumin for any application. And obviously there's room for improvement in the price points in that space. But I don't want to predict obviously what the potential margins for them could potentially be or what they're shooting at the current time.

Speaker 2

And just to add, John, to that, keep in mind with the strength of our upstream processing, Reliant also brings in the strength of downstream processing in terms of scale and cost. And of course, they have access to the market because they've been selling in this market for years. So we have immediate market access to them.

Speaker 5

Great. Thank you.

Operator

There are no further questions in queue at this time. I would like to turn the call back over to Dyadic's CEO, Mr. Mark Elfar. Please proceed.

Speaker 2

Thank you. As Pat and Joe have indicated, Dyadic is fully committed to driving near term revenue and growth by pushing the boundaries of innovation and accelerating commercialization. We are expanding the use of our C1 and Apophis microbial protein production platforms across our 3 core sectors, alternative proteins and animal and human health. This is an incredibly exciting time in Dyadic's history and I believe we're uniquely positioned to swiftly capitalize on both current and emerging opportunities. Want to thank you for joining us on today's Q2 2024 Conference Call.

Speaker 2

We look forward to updating you on our continued commercial and scientific progress during our next call. Stay tuned for more exciting developments from Dyadic.

Operator

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

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Dyadic International Q2 2024
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