Dyadic International, Inc. (DYAI) Q4 2023 Earnings Report, Transcript and Summary

Good evening, and welcome to the Dyadic International's Fiscal Year 2023 Year-end Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, March 28, 2024. I would now like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead.

Thank you, operator. Good evening, and welcome, everyone, to Dyadic International's fiscal year 2023 year-end conference call. I hope you have had a chance to -- an opportunity to review Dyadic's press releases announcing financial results for the year ended December 31, 2023, and a separate press release on changes in board and management leadership roles. You may access our release and Form 10-K in the Investors section of the company's website at dyadic.com. On today's call, our President and CEO, Mark Emalfarb; and our new Chief Operating Officer, Joe Hazelton, will give a review of our 2024 business and corporate highlights, including a brief summary of our recent research and business development efforts. I will follow with a review of our financial results of 2023 in more detail. We will then hold a brief Q&A session. At this time, I would like to inform you that certain commentary made in this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause Dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Dyadic expressly disclaims any duty to provide updates to its forward-looking statements, whether because of new information, future events or otherwise. Participants are directed to the risk factors set forth in Dyadic's reports filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Emalfarb. Mark?

Thank you, Ping. Hello, everyone, and thank you for joining Dyadic's full year 2023 conference call. I cannot overstate how exciting this time is in Dyadic's history. We are uniquely positioned to rapidly capitalize on the present opportunities and those on the horizon. Over the next 2 years, we anticipate reaching multiple revenue streams and other inflection points through fully funded collaborations in the company's pipeline products to enhance shareholder value. We are building upon momentum witnessed in 2023, and we have further accelerated our progress. The claim and acknowledgment of our C1 technology for its speed, productivity and effectiveness persist both domestically and globally, proceeding recommendations, accommodations from academia, industry and government bodies. The C1 platform's distinction is further bolstered by a clinical validation through our successful Phase I human trial, which not only demonstrated that the proteins produced on our C1 cells are safe for use in humans. Additionally, the DYAI-100 vaccine has been shown to induce immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus. We believe that our successful first-in-human clinical trial of a C1 produced protein redefine the benchmarks for recombinant protein antigen production levels. C1's productivity is up to 300x that of baculovirus cells, coupled with its abbreviated fermentation times and lack of need for viruses or endotoxins [ph] needing removal and downstream processing builds the future with a rapid, large-scale and cost-efficient production of recombinant vaccine becomes the norm rather than the exception. Speaking to our pharmaceutical initiatives, I cannot overstate the significance of the positive outcomes from our Phase I human study that has bolstered industry attention to our Dyadic in our C1 expression platform. Since the announcement of these top results, heightened interest from industry partners, including 2 top 10 pharmaceutical firms this [indiscernible] of over 1,200 vaccine and antibody projects. These projects span various disease areas except by our strategic partnership with Rabian BV, a Dutch innovative SME founded by seasoned entrepreneurs and vaccine scientists. Rabian secured €1.7 million in funding from Eurostars for the AVATAR project aiming to leverage its virology expertise to develop a rabies vaccine utilizing Dyadic C1 protein production platform. Additionally, the Israel Institute for Biological Research, the IIBR is harnessing Dyadic's microbial platform expertise in conjunction with their own capabilities in antibodies and antigens discovery to develop and manufacture treatments and vaccines for emerging diseases and potential bio threats for out-licensing opportunities. In the realm of infectious diseases, our recombinant vaccine capability continues to attract growing interest. We are engaged in an expanded research collaboration with a top 5 pharmaceutical companies to develop a number of antigens, preventing and treating various infectious disease. Furthermore, we have initiated a new research collaboration with a Vaccine and Immunotherapy Center, VIC, in Massachusetts General Hospital, which received over $5 million in funding from the Department of Defense, DoD, to develop and test vaccine antigens for influenza A and other infectious diseases, including antigen produced using our C1 platform. Additionally, our depth of this expression platform has exceeded our initial expectations despite launching a little over a year ago, gaining substantial traction generating revenue in both their alternative protein in bio-industrial sectors. During today's call, Joe and I will review our strategic blueprint for enhancing revenue growth, highlighting significant technological strides and recent achievements in business development across our primary markets. We will elaborate on our near and longer term strategies aimed at bolstering our revenue outlook and enhancing shareholder value. I would like to extend our gratitude to long-term shareholders with a steadfast support as we successfully closed a $6 million convertible note financing. These funds will fuel the acceleration of our goal to introduce revenue generating products targeting both pharmaceutical and non-pharmaceutical sectors. Our recent announcements of both business and scientific achievements demonstrate that the success of our corporate strategy beginning to be realized and Dyadic is strongly positioned for new area of revenue growth. To further support our growth imperatives, we've announced changes in leadership roles at the Board level and management team. We expanded the responsibility of our Chief Business Officer, Joe Hazelton, appointing him as Chief Operating Officer. His demonstrated pivotal role in advancing our strategic objectives is undeniable. With strengthened financial resources and scientific progress, we are well-positioned to execute our strategic business objectives. Michael Tarnok is stepping down as Chairman of Dyadic's Board of Directors and making room for Patrick Lucy, who has been appointed to succeed him effective immediately. Mr. Tarnok will continue as a Director through the end of his current term, which ends in June 2025 at the time which we expect to retire. Dr. Barry Buckland is retiring from the Board at the end of his term in June 2024, which will result in a reduction of the size of the Board to 6 members. I would like to thank Mark -- Michael Tarnok for his leadership as Chairman over the past 10 years and for agreeing to serve on his remaining 1-year term, enabling a smooth transition of board leadership. I'm excited that Mr. Lucy, who has been an outstanding board member over the past 3 years has agreed to take on the role as Board Chairman at an important time for Dyadic. In our ongoing efforts to make clear our strategy and business perspectives, we will spotlight our focus on our three primary sectors: human health, animal health and alternative proteins. Joe and I will outline our achievements and strategic outlook expanding both pharmaceutical and non-pharmaceutical domains, along with providing a look into our road map for 2024 and beyond. We are poised at the edge of leveraging our microbial protein production platforms, C1 Dapibus to create antigens, antibodies, enzymes and other recombinant proteins pivotal to each of our core sectors. These efforts are anticipated to unlock the monetization avenues, significantly enhancing shareholder value for Dyadic and our partners. In defining Dyadic's value proposition against conventional platforms for the manufacture vaccines and therapeutics, it's pivotal to grasp the foundation of C1's uniqueness, which is in our industrial heritage. [Indiscernible] just a backdrop. It's the bedrock of our approach to biologic pharmaceutical production. Traditional cell lines typically evolve from research scales, struggling to balance increasing scale and yield against cost constraints. In stark contrasted at, Dyadic harness's microbial platforms and seasoned veterans economical production of large-scale bio-industrial proteins and enzymes at large scale. This deep rooted experience is being repurposed to navigate the complex landscape of biologic pharmaceutical development and production, marrying it with industrial scale efficiencies with pharmaceutical precision. As I highlighted earlier, the C1 platform distinction is further bolstered by its clinical validation through our successful Phase I human trial, which not only demonstrated that proteins produced from our C1 cells are safe for use in humans and that the DYAI vaccine has been shown to reduce immune responses at both dose levels, suggesting its potential efficacy in generating protective immunity against the target virus. We believe we are redefining the benchmark for our common protein antigen production levels. We are pleased with the progress of the C1 platform, but it's crucial to keep investing in validating and advancing our technology to match emerging science and support our partners' development efforts. To this end, more than a year ago, we engaged Cygnus Technologies to co-develop a C1 Host Cell Protein, HCP, ELISA Kit. This step is vital for regulatory views and manufacturing, as HCP residues can cause toxicity and affects biologic stability. These kits are essential for detecting and quantifying HCPs during manufacturing to ensure product purity and quality. Necessary for marketing approval, and we are excited that C1 HCP ELISA Kits are now available to Dyadic and Cygnus customers. Expanding our portfolio with potential new commercial products, produced by the C1 platform is equally important. Dyadic has entered into a development and commercialization agreement with EU-based bYoRNA, to explore the development of messenger RNA using our C1 technology. This collaboration combines bYoRNA's innovative, new periodic bio RNA platform with Dyadic's proven C1 protein production platform. This aim is to use the pharmaceutical industry, a potentially more cost-efficient method for manufacturing large quantities of lower-cost messenger RNAs, facilitating broader global access to mRNA vaccines and drugs. Turning our focus to our therapeutic proteins, particularly monoclonal antibodies, we see significant potential in utilizing the C1 production system for the production of antibodies targeting infectious and other diseases such as arthritis, oncology and neurological diseases. Therapeutic proteins aimed at combating infectious disease often require shorter term treatment durations if they may necessitate larger quantities and shorter manufacturing time to effectively and efficiently address pandemics or outbreaks. Earlier this week, we announced the publication of a manuscript in the esteemed peer-reviewed journal Nature Communications, detailing the preclinical studies conducted on a monoclonal antibody produced using the C1 system, utilizing non-human primates and hamsters as models. In the non-human primate challenge study, a C1 produced COVID-19 monoclonal antibody, previously shown to present broad neutralization protection against various variants, including all the way from Wuhan to BA1 and BA2 Omicron, as well as the earlier variants, concerning in hamsters and underwent dosing findings from the challenge study involving the SARS-CoV-2 delta variant and non-human primates indicated promisingly high levels of protection. This marks for the instance -- of the first instance of a C1 produced monoclonal antibody being employed in non-human primate study, referring both the safety and efficacy of C1 produced antibodies for addressing infectious diseases. These recent findings regarding the safety and efficacy of monoclonal antibodies produced using C1 technology are significant in accelerating the research and development efforts in the field of infectious and other diseases. This is particularly noteworthy, taken with the previous reported data that C1 produced MABs are comparable in efficacy and safety to those produced using traditional [indiscernible] cell lines. Just this week, Dyadic entered into a collaboration with another top 10 pharmaceutical company to develop an infectious disease monoclonal antibody and a vaccine antigen using C1 technology, which marks a significant step forward in this area. The fact that this collaboration is fully funded by a top 10 pharmaceutical company underscores the confidence in the potential of C1 technology for producing effective treatments and vaccines against infectious and other diseases. Moreover, Dyadic existing collaborations with industry partners for producing monoclonal antibodies targeting diseases like Ebola and Marburg highlight the versatility and applicability of C1 technology across a range of infectious diseases. Overall, these developments suggest a promising future for C1 technology in the field of infectious and other disease, research and development, potentially leading to more effective treatments and vaccines against a variety of pathogens for global population. We are continuing our efforts to forge and sustain long-term strategic partnerships in the pharmaceutical sector for both humans and animals. This is evidenced as well as we enter the fourth year of our expanded collaboration with Rubic One Health to advance commercial products and clinical development of vaccines to human and animal health in Africa. Our collaboration with Phibro/Abic to develop C1-produced poultry vaccine is entering its 5th year has expanded to additional infectious diseases and disease areas over that time. Animal Health remains a targeted segment for Dyadic due to the higher margin sensitivity of pharmaceutical biologics and the significant impact of outbreaks on the global supply chain and potentially human health. We continue to expand our presence in the animal health market for vaccines and therapeutic proteins. I will now turn the call over to our Chief Operating Officer, Joe Hazelton, to provide an update on our non-pharmaceutical license and product opportunities. Joe?

Thank you, Mark. Dyadic remains truly excited about the non-therapeutic uses of its microbial platforms, which are adept to producing recombinant proteins and enzymes. We believe this field offers a significant promise in terms of both opportunity and revenue in the near-term. To this end, Dyadic is committed to allocating appropriate resources and providing support for current and future products within this rapidly expanding sector. Our gene expression and protein production platforms, including the recently launched Dapibus are tailored to facilitate swift development and large-scale manufacturing and cost-effective enzymes, proteins, metabolites and other biological products. These products span the full spectrum of production grades from research to food grade and ultimately, pharmaceutical grade materials. Their applications are diverse and encompass diagnostics, research, nutrition, health and wellness, reflecting the increasing demand in these areas. Diving deeper into our strategic plans to boost short-term revenue potential, we remain focused and confident by identifying and producing high-value recombinant targets that can be rapidly and efficiently commercialized, provides the best near-term revenue potential. We are now seeing the strategy creating value as evidenced by the recent term sheet we've executed with a global albumin manufacturer distributor to develop and license Dyadic's recombinant serum albumin products initially for diagnostic and research grade purposes. This strategic partnership will allow for more rapid commercialization of our recombinant products to enter the market within the next 12 months, and we hope to be able to share more information in the very near future on this important collaboration. Recombinant serum albumin serves as a prime illustration of our focus on valuable recombinant products, offering diverse commercialization prospects across various market segments. For example, pharmaceutical grade serum albumin holds potential as a disease treatment and is integral to vaccine development, serving a security protein for therapeutics and as a standard agent in research and development. Recent completion of certificates of analysis for our recombinant human and recombinant bovine albumin affirms their analytical equivalents to currently commercialize research grade products on the market today. Moreover, we're exploring recombinant bovine albumins application at food grade in cell culture media for cultured meat production. This showcases Dyadic's capacity to produce animal-free recombinant serum albumin across different grades at competitive prices using our efficient and affordable microbial platforms. Such opportunities may lead to broader strategic options, including joint ventures or spin-offs akin to successful companies like Albumedix, which was acquired for over ₤400 million in 2022. To strengthen Dyadic's foothold in the alternative protein sector and explore broader exit opportunities, we've executed the co-promotion agreement with Turkish company, Biftek Incorporated. Their patent pending animal-free growth medium supplement aims to reduce expenses linked to costly culture media components. This collaboration enables Dyadic to extend its reach into the cell culture media domain earning a share of all net sales from Biftek supplement. Additionally, our successful initial production of the recombinant transferrin using our microbial platforms presents another potential product for the alternative protein and cell culture sectors. Outside of recombinant cell culture products, we believe recombinant non-animal dairy products offer Dyadic the potential for more rapid commercialization opportunities. The global animal-free dairy products market was valued at over $26 billion in 2022 and is projected to reach more than $75 billion by 2032. Today's animal-free dairy products are crafted through 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. Our 2023 agreement involving our Dapibus platform for developing and commercializing non-animal dairy enzymes for food production, inclusive of upfront payments, milestones and royalties, validates our focus on this sector and reflects growing interest in use of Dapibus for the development and manufacture of non-animal dairy products. We also anticipate success fees from this collaboration in the first half of 2024. Furthermore, we have engineered a highly productive strain of non-animal recombinant alpha-lactalbumin, a key whey protein commercially available in large volumes. We are actively sampling our alpha-lactalbumin and casein products and have commenced development of beta-lactoglobulin, another widely used whey protein and lactoferrin for food-grade products, with sampling anticipated to begin in the third quarter of this year. Numerous discussions with potential partners are ongoing, bolstering our confidence in the short-term revenue prospects of the non-animal dairy segment in 2024. Beyond our focus on cell culture and non-animal dairy products, we are further expanding our potential pipeline through the development of several bio-industrial grade enzymes that have the potential for use in multiple industries such as nutrition, biofuels and biorefining. By increasing the volume of internal pipeline products and external partnerships, within non-pharmaceutical and pharmaceutical applications, we believe we can accelerate more consistent revenue generation in the coming year that is not strictly reliant on platform licensing and inclusive of potential product licensing for targets such as recombinant albumin, enzyme catalysts or cell culture media components. With the funding secured in the first quarter and the recent organizational adjustments, Dyadic is poised for a new phase of growth. I'm grateful to Mark and Dyadic's Board of Directors for the trust in me as the new Chief Operating Officer. Mark's support has been invaluable and I'm eager to play a more active role in daily operations, aligning our research and development with our business needs, streamlining our operating model to ultimately achieve our goals efficiently. While the future looks promising, there's still work ahead to capitalize on the opportunities before us and drive near-term revenue growth across our core sectors. Our strategic plan has been refined, and we have commenced its implementation in key areas where our technologies such as adept of this platform can have significant impact. Additionally, we are exploring new opportunities aligned with our verticals in target markets with high potential returns, particularly those seeking cost effective solutions for affordable recombinant protein production. With that, I'd like to turn the call over to our CFO, Ping Rawson, to go through our financials. Ping?

Thank you, Joe. Thank you, everyone, for joining our call today. As Mark mentioned earlier, on March 8, 2024, the company issued an aggregate principal amount of $6 million or 8% senior secured convertible promissory notes due March 8, 2027, in the private placement. The convertible notes have a conversion price of $1.79 with no warrants. The purchasers of the convertible notes include immediate family members and family trust related to Mark Emalfarb, our President and CEO, The Francisco Trust, an existing holder of more than 5% of the company's outstanding common stock. As of December 31, 2023, we have cash and investment grade securities of $7.3 million. Combined with the $6 million we just raised, $1.3 million from the sale of our equity interest in Alphazyme and $600,000 upfront payment from an animal-free dairy enzymes licensing agreement in 2022. We believe we are well-positioned financially to support our near-term revenue growth, and accelerate our strategic objective of commercialization opportunities for pharmaceutical and non-pharmaceutical applications. I will now go over our key financial results for the year ended December 31, 2023, in more detail. You can find additional information in our earnings press release and Form 10-K, which we filed earlier today. Research and development revenue and the license revenue for the year ended December 31, 2023, slightly decreased to approximately $2.9 million compared to $2.93 million for the year ended December 31, 2022. Cost of research and development revenue for the year ended December 31, 2023, decreased to approximately $2 million compared to $2.1 million for the year ended December 31, 2022. The decrease was related to higher individual contract amounts on certain research funding and related work performed during 2022. Research and development expenses for the year ended December 31, 2023, decreased to approximately $3.3 million compared to $4.5 million for the year ended December 31, 2022. The decrease primarily reflected the winding down of activities related to the company's Phase I clinical trial of DYAI-100, COVID-19 vaccine candidate. G&A expenses for the year ended December 31, 2023, decreased to approximately $5.8 million compared to $6.4 million for the year ended December 31, 2022. The decrease principally reflected a decrease in management incentives of $466,000 business development and investor relations cost of $219,000 and the legal expenses, partially offset by increases in insurance premiums of $96,000 and other increases. Net loss for the year ended December 31, 2023, was approximately $6.8 million or $0.24 per share compared to a net loss of $9.7 million or $0.34 per share for the year ended December 31, 2022. With that, I will now ask the operator to begin Q&A session. 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 who have already spoken. Operator?

[Operator Instructions] Our first question comes from the line of John Vandermosten with Zacks. Please proceed with your question.

Thank you and good evening, everyone. Now that Dyadic has C1 produced protein that's been administered in humans and you've completed the trial. And Mark, you also mentioned that several top pharma companies had come in and asked to work with you. Has that changed the nature of what the collaborators want to work on having that data?

Yes, I'll let Joe answer that first.

Yes. Hi, John, great question. And to be honest, it has. So traditionally, as you look at some of our projects, they're more comparative using C1 versus products that have already been produced in our cell lines. And I'm not saying that's typically not always going to be the case moving forward. But what we've seen is an increase in C1 actually being chosen as either the first or producing hard to target express proteins and other systems. So it's less comparative and more actual commercialization targets that are being put into the system.

Okay. And Joe, congratulations on your ascension to COO. I wanted to mention that to you. And then my second question is on some of the partnerships you have, the Rabian partnership, there was an equity component to that. And do you have any other arrangements like this? And is this going to be a push in the future to have a component like that as part of the arrangement?

Well, I think if you look back, Alphazyme was similar to that, where we netted $1.3 million because when a small biotech company start out, or whether it's biotech or an enzyme industrial company, they don't traditionally have money to spend on license agreements. So we take equity rather than take nothing and sort of leave opportunities on the shelf. BDI, if you remember, a couple of years ago, we also got about €1.3 million. So both of those have already turned to do cash. So they're both good decisions. Rubic One Health is another example where we actually have an equity position right in that company. And of course, they're with Rabian. So we are gaining not only potential opportunity to get revenue in the future from equity positions, we are also getting more products in the marketplace, more products in [technical difficulty] human being to expand the use and adoption of speed, the adoption of the technology platforms, whether it be C1 or pharmaceuticals or Dapibus or non-pharmaceutical applications. So there's a lot of really benefits that are intangibles that you might not see that we see and we're recognizing and we are actually commercializing in some cases, turning to cash as we did with BDI and Alphazyme already. So we'll do those if and when they make sense. But of course, with big pharma and big industrial companies, as we did with Shell and BSF and [indiscernible] go in the past and ultimately [technical difficulty], we generated $110 million of non-dilutive money by doing those kind of deals, so upfront cash rather than equity. So we are looking for upfront cash milestones and royalties, and those are the goals and objectives. As we take some longer to get that in some of the big pharmaceutical companies, but we're on the west.

And I'd say just, John, to that point, we are flexible in that approach. But to Mark's point, it's not a priority. The priority obviously is non-dilutive funding as early as possible in any of our agreements. But we need to remain open because Mark is absolutely right. The more products and the more data we can generate, especially in human beings, potentially non-human primates, that consistently adds to the validation of the platform. But again, it's not going to be our primary focus to retain equity, but we will do so when appropriate.

Great. Thank you for taking my question.

And John, just to add to that, the Rabian project not only potentially gives us a payment as an equity, we have milestone payments and royalties on the product. But just as importantly as these agencies like WHO, CEPI, the Gates Foundation, [indiscernible] IVI. These people are looking at what we are doing with this technology. And the more tickets adopted, the more opportunities we can get to get funding from a lot of these non-profit organizations at fund vaccine development, and we'll absolutely need to be funding monoclonal antibody development, what we think, which is a game-changing platform.

[Operator Instructions] There are no further questions in the queue, I'd like to hand it back to Mark Emalfarb for closing remarks.

In fiscal year 2023, we are witnessing the positive impact of our Phase I human clinical safety trial, further validating the C1 platform potential for pharmaceutical use in both human and animal health. Moreover, the investment in our Dapibus platform for alternative proteins and enzymes is beginning to yield revenue, marking a significant milestone. Our primary focus remains on enhancing Dyadic value within the life science industry, which in turn benefits our shareholders and promote global access to affordable vaccines and therapeutics. We refined our focus and adjusted our business strategies to capitalize on existing and emerging commercialization opportunities in the near-term, aligning with our mission as a global biotechnology company to revolutionize how we feed fuel and heal the world. The company remains dedicated to driving near-term revenue and growth through innovation and commercialization efforts, expanding the use of Dapibus platform for developing alternative for common proteins such as alpha-lactalbumin or common human albumin and non-animal dairy enzymes for food production across various other applications. Once again, I cannot overstate how exciting this time is in Dyadic's history. We are uniquely positioned to rapidly capitalize on the present opportunities and those on the horizon. Thank you for joining us in today's fiscal year 2023 conference call. We look forward to keeping you informed as we progress in commercial and scientific endeavors during our next call. Please stay tuned for additional updates from us.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.