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spk03: Good evening and welcome to Dyadic International's Fiscal Year 2022 Financial Results Conference Call. Currently, all participants are on a listen-only mode. Following management's prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today, March 29, 2023. I would now like to turn the call over to Ms. Ping Rawson, Dyadoc's Chief Financial Officer. Please go ahead.
spk01: Thank you, operator. Good evening and welcome everyone to Dyadic International's fiscal year 2022 year-end conference call. I hope you have had the opportunity to review Dyadic's press release announcing financial results for the year-end of December 31st, 2022 and the recent company highlights. You may access our release and form 10-K under the investor section of the company's website at dyadic.com. On today's call, Our president and CEO, Mark Emelfarb, will give a review of our fiscal year 2022 business and corporate highlights, including a brief summary of our recent research and business development efforts. Our chief business officer, Joe Hazleton, will join Mark for the business updates. I will follow with a review of our financial results in more detail. We'll 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. DADC expressly disclaims any duty to provide updates to its forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the risk factors set forth in DADC's report filed with the SEC. It is now my pleasure to pass the call to our CEO, Mark Dimafar. Mark?
spk02: Thank you, Ping. Hello, everyone, and thank you for joining DIATIC's 2022 year-end conference call. On today's call, we will highlight several of the significant advances we made in our technology and the meaningful progress we made and continue to make in each of our three core verticals, human health, animal health, and alternative proteins. On today's call, Joe and I will discuss our 2023 strategy for growth and revenue. Throughout 2022, we've discussed the company's scientific advancements, focused on our core business in achieving commercial agreements in human health, animal health, and alternative proteins. Today, I would like to focus our key business drivers that we believe will help accelerate product commercialization and licensing. While we continue to drive broader pharmaceutical acceptance of the C1 platform in biopharmaceuticals to maximize your future potential for dyadic, our shareholders, and human health globally. In our Q3 update, I highlighted that the commitment it takes to build a commercially relevant filamentous fungal protein production platform is to support life sciences manufacturing demands, persistence, focus, and determination to see the process through. In addition to persistence, when to enter the biotech space, companies cannot underestimate the patience needed to undertake to painstaking scientific and clinical development plans for both platform technologies and biological products. On average, a traditional vaccine in the influenza market takes roughly five to seven years to develop, conduct clinical trials, receive regulatory approval, and commercialize. For dyadic, we had the additional tasks beyond the clinical development of a product, as we had to undertake the development, engineering, and validation of our C1 protein production platform to transition from industrial to biopharmaceutical applications. For perspective, Chinese hamster ovary or chill cell production systems and baculovirus or insect cells took decades and hundreds of millions, if not billions of dollars invested in the development and engineering of the host cells that get to the stage we are at today with C1 in less than seven years apart upon starting our transition from industrial biotech to biopharmaceuticals. What makes dyadic unique compared to these more standard cell lines in use today is our decades of bioindustrial heritage. We have shown that our C1 platform can be used to develop C1 cell lines to express stable antigens that have been shown to be up to 300 times more productive than baculovirus cells, which are being used in both human and animal health. To put that in perspective, C1 has the ability to produce 300 doses of a particular vaccine to one dose of a baculovirus-produced vaccine, which leads to improved cost and speed efficiencies. With all these outstanding attributes, our C1 platform offers the most common question we get from shareholders is, what is holding back broader and more rapid adoption of the C1 platform for pharmaceutical applications in human and animal health? And the question we do have asked repeatedly from pharmacists, do you have any human safety data from a regulatory body? A little over a year ago, we brought Joe Hazleton in as our chief commercial business officer, who has spent his 25-year career in pharmaceutical commercialization, business development, market access, and pricing to diagnose this very issue and to develop a strategic plan to address gaps in our current business efforts. I will now ask Joe to provide you with his perspective on this issue and to provide a brief update on our Phase I trial. Joe?
spk07: Thanks, Mark. Before I speak to the adoption of C1, let me first provide a brief update on the Phase I trial for DYAI-100, the first human trial for a C1-produced protein. In order to establish a track record of safety in humans for antigens produced from our C1 cells, The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity or immune response of the DY-AI100 COVID-19 recombinant protein RVD booster vaccine in 30 healthy adults in South Africa. Regulatory approval was received in late 2022, and the first patients were dosed in January of this year. There are eight scheduled patient visits over a six-month period with safety data being collected throughout the trial and immunogenicity assessments are scheduled on six of the eight visits. Recently, we announced the dosing of all patients was completed in late February with no serious adverse events reported to date. Patients should complete the first six visits by the end of March with the remaining two visits taking place at days 90 and 180 from initial dosing. This timing projects the last patient, last visit to take place near the end of August, with the clinical study report being available in the late third or early fourth quarter. We're currently working with Rubic One Health, our South Africa partner for DYAI 100, on the next phase of development pending the results of this study. I wanted to start with a phase one update to highlight the importance of clinical data as pharmaceutical development, whether for a product, a technology, or a platform, The route to adoption and commercialization is full of obstacles. From the readily apparent ones like regulatory hurdles to the less visible ones such as market or political forces that shape the landscapes you want to enter. In the case of C1, my first assessment was amazement that the platform transitioned from industrial to pharmaceutical in under 10 years. Most platforms take years of genetic engineering, testing, and further process refinement that increase costs and the length of time until it can be utilized commercially. Dyadic's industrial heritage enabled that transition to happen in a shorter timeframe with a smaller investment than traditionally would be practical or feasible. Next, when you assess the sheer volume of data demonstrating safety and efficacy of C1-produced vaccines and therapeutic proteins in animal models, it was very apparent to me that C1 has the capability to produce safe and effective vaccines and biologics comparable to cell lines used today. However, when looking to commercialize a vaccine or a biologic drug, pharmaceutical companies must evaluate their potential product's probability of success across several key criteria, such as safety, efficacy, speed to market, and likelihood of approval. A critical part of this evaluation is managing risk across these criteria. The choice of which cell line to utilize for bioproduction of a particular vaccine or biologic product can potentially impact all of these criteria. The lack of human data and risk mitigation have been key barriers to the broader acceptance of the C1 platform to date. It is important that pharmaceutical companies choose a cell line that minimizes risk in terms of potential for successful production, manageable cost of goods, successful regulatory review, and ultimately approval. With the expected full study results later this year of dietics first in human data for a protein produced from the C1 platform, we continue to validate the C1 platform to reduce developmental risk for our partners. Additionally, over the last five years, Dyatic has developed a strong repository of safety, efficacy, and productivity data regarding the C1 protein production system across a wide range of vaccines and antibodies. Dyatic has also developed a suite of genetic tools to improve the ability to engineer the C1 cell line to achieve quality that is comparable or better than traditional cell lines while demonstrating speed and yield results that are significantly higher than standard cell lines in use today. The overall result is that for vaccine production for human and animal health markets, the C1 platform is ready for full commercialization. We continue to make great strides in antibodies, and the platform is ready for human trials for monoclonal antibodies. While this is encouraging news, development and approval of pharmaceutical products takes years to complete, which means that we must also focus our efforts on commercialization targets that drive revenue in the near term as well. I'll now turn the call back to Mark to take us through important business updates and our strategy to refine our focus on near-term commercialization opportunities on our path to revenue realization. Mark?
spk02: Thank you, Joe. In 2022, we reorganized our business into three core verticals. We also have listened to our shareholders and have structured today's call to be focused on results and our approach to each vertical. With that, I would like to begin with human health, where we have made significant progress both scientifically and in business development. Our primary scientific objectives for fiscal year 2022 were to initiate our first in human phase one trial of a C1 produced protein. to further demonstrate comparable safety and efficacy of C1 produced proteins to those produced by traditional cell lines and to design better biomolecules for enhanced vaccine efficacy and durability. We met those objectives as we recently announced the dosing has been completed for a phase one clinical trial for DYA100, a COVID-19 booster vaccine candidate. As Joe mentioned, our C1 protein production platform is fully ready for commercialization of recombinant protein vaccines. We have previously demonstrated that the C1 platform is capable of rapidly producing unparalleled quantities of complex vaccine antigens efficiently. The addition of first in human data for C1 produced protein provides data for a critical evaluation criterion that potential partners utilize when choosing a cell line for their commercialization targets. Similarly, it is imperative that the proteins produced by C1 are equal to or superior to those expressed in other cell lines in terms of quality. In today's press release, we shared how we have expressed a number of third-party monoclonal antibodies, which we assayed by multiple third parties who reported that the neutralizing and binding activity assays demonstrated great similarity between C1-produced MABs and CHO-produced MABs. As we reported in the third quarter, one of these C1-produced monoclonal antibodies for COVID-19 completed a non-human primate study showing comparability to the comparator CHO-produced monoclonal antibody. Again, this is critical for our potential partners as they select cell lines to produce their commercial targets to ensure their products have the quality standards and safety profile required for clinical and regulatory development. This year, we are also focused on designing better mild biomolecules. We have developed C1 cells to express complex proteins, such as conjugating antigens and ferritin nanoparticles. Additionally, we developed several AMHC2-targeting influenza and COVID-19 antigens, and an antigen that included a trimerization domain to increase vaccine efficacy and durability. In today's release, you may have seen that we are also testing these better biomolecules with our partners, like the University of Oslo and Verovax, where we have new targeting systems and adjuvants that are being used with C1-produced antigens in relevant diseases, such as H1N1 and H5N1, or commonly known as the bird flu, in animal trials. These advancements enable Dyadic and its partners the potential to develop more effective, and longer-lasting vaccines across a wide range of infectious and other diseases. We continue to focus on longer-term strategic partnerships with leading pharmaceutical partners like Hingru, one of the largest pharmaceutical companies in China, and our collaboration with Janssen Pharmaceuticals, as well as advancing commercial products and clinical development of our COVID-19 vaccine candidate, DYAI-100, with Rubik One Health, and Epigen in the developing countries of Africa and India. In certain cases, like we have successfully done with BDI and Alvazime, we expect to use our technology to obtain equity stakes in smaller companies who can't afford to pay an upfront access fee. This provides us with an opportunity to generate cash for the sale of our equity later, such as was the case with BDI in 2021 and Alvazime in Q1 2023. Note, the sale of these two equity positions generated a total of U.S. $2.87 million cash. Additionally, we have the potential to receive milestone and royalty payments based on sales of C1 Express products by AlphaZone. We anticipate that we will continue expanding and entering into new pharmaceutical license agreements in 2023. However, in order to accelerate our path to revenue, we're adjusting the focus among human health and other core verticals to products and partnerships with shorter commercialization timelines, high-end med market need, and smaller development costs with less obstacles to market approval and acceptance. An example of this focus is our recombinant serum albumin projects. The global serum albumin market is an approximately $5.7 billion market, growing at over 6% a year due to the increased use across a multiple of markets in human and animal health. In the pharmaceutical segment, serum albumin is not only being developed as a potential treatment for disease, but is currently used in product development of vaccines, as a diagnostic tool, and a common reagent in R&D. There are many different grades of albumin in price points across these markets, and Dyadic has the potential to produce animal-free serum albumin at a significantly competitive price due to our highly productive microbial platforms and low-cost media and production systems. Later, Joe will be back to share how serum albumin is being used in alternative proteins as well, providing Dyadic with an opportunity for product commercialization in shorter term. In a similar vein, in 2022, we issued the publication of a poster that showed the potentially being the first non-yeast cell to produce an active CYP450 enzyme. CYP450 enzymes are part of a $17 billion global enzyme market for use as diagnostic, therapeutic, research, and product development enzymes. As we discussed for several years, high protein yield is a major challenge in the pharmaceutical industry, specifically to enhance the production of vaccines and biologics or for enzymes required for the chiral synthesis of small drug molecules diagnostics, and other uses. This is another near-term example of a near-term opportunity that adheres to our corporate strategy that has risen from our collaboration with an academic institution. As we announced today, DIATIC is at the forefront of vaccine development, and more than a half a dozen animal trials have been carried out late last year alone. And additional animal trials are ongoing and are scheduled with C1-produced antigens for influenza, for example, H5N1, the bird flu, and other infectious diseases. Our C1 recombinant protein vaccine platform is fully ready for commercialization opportunities, and we and or our collaborators are working on developing better biomolecules to produce more effective and durable vaccines. In 2023, we've refined our human health objectives to include a focus on shorter-term product commercialization opportunities that have less time, cost, and risk associated with development. We are currently engaged in discussions and negotiations to license the C1 platform and our products that can meet these objectives, while also pursuing larger scope licensing agreements with pharmaceutical partners that will help drive greater long-term value. In animal health, I would like to turn our attention, as there are many similarities in the needs between human and animal health markets for vaccines and therapeutic proteins. And we are leveraging our science across these core verticals. What makes animal health an attractive segment for dyadic is the margin sensitivity of this market and the significant impact that an outbreak can have on the global supply chain and potentially human health. The ongoing avian flu outbreak has an immense impact on global poultry supply chain and ripple impacts in other markets as well. And egg production decreased, or as egg production decreased, it not only drove prices up at the store, but reduces the availability of eggs for vaccine production. This is why we and others, such as the FDA, believe that the C1 production platform can be a global solution to pandemic response in not just humans, but also animal health. Late last year, we announced that we had achieved a record antigen production level of 10 grams per liter, of a livestock antigen. We can produce very large quantities of antigens for infectious disease rapidly and at low cost, making C1 a potential pandemic preparedness platform for response or stockpiling. Our third vertical of alternative proteins is an area of great excitement for dyadic and one which we believe holds near-term potential promise in terms of opportunity and revenue. What makes this particularly interesting is that exploiting this segment does not require a significant departure from our human and animal health pursuits. This vertical is anchored by our fully funded joint development agreement with our Global Food Ingredients Collaborator, and Dyatoc is dedicating resources and support for existing and future products within this rapidly growing market. Dyatoc has launched its DAPAVIS platform, a filament filamentous fungal-based microbial gene expression and protein production platform, which is further designed and customized to enable the rapid development and large-scale manufacture of low-cost enzymes, proteins, metabolites, and other biological products for use in non-pharmaceutical applications such as food, nutrition, health, and wellness. Joe has been building out the strategy and value proposition for this segment, and he will describe our opportunity and efforts to maximize the potential in alternative proteins. Joe?
spk07: Thanks, Mark. What makes alternative proteins advantageous to dyadic is that we are able to leverage the advancement, innovation, and benefits of the dyadic technologies across broad and growing market opportunities. The excitement in this segment is well-founded and can be attributed to three key factors. First, due to shorter developmental timelines and approval processes, products and opportunities within alternative proteins can be commercialized in less time. Second, by focusing on products that have applicability across our core verticals, such as recombinant serum albumin, we can reduce developmental costs yet increase overall revenue potential for dyadic. Third, as there is overlap between the companies operating in alternative proteins across our business verticals, penetrating this market does not require significant additional resources from dyadic. The human and animal alternative protein market is an approximately $16 billion market and growing. The market is currently driven by plant-based proteins and it's being accelerated by cultured or lab-grown meat and seafood products, non-animal dairy products, and a host of other nutrition and wellness segments that, while smaller in scale, saw over several billion dollars of venture and other capital invested since 2021. The key unmet need across the diverse alternative protein segment is for the rapid production of large quantities of high-quality yet affordable recombinant proteins and enzymes to enable scale-up and commercialization, which fits our strategy of focusing on markets where our technologies can have the greatest impact. Our recently developed Dapabas microbial cell line is gaining interest across multiple applications and industries, for the development and manufacture of alternative proteins and enzymes. Our strategy to capitalize on this market is twofold. First, we are identifying target products with high unmet need, such as price or productivity, that transect our core business verticals. Second, we're engaging partners who have broader capability to commercialize quickly and effectively within key markets where our platforms would have the largest impact, and we are exploring expansive agreements for market segments that benefit both companies. An example of this strategy is our development of an animal-free recombinant serum albumin. The cultured meat industry can use serum albumin as a major part of cell culture media used to grow the animal cells for cultured meat products. They need vast amounts of serum albumin to commercialize at a global scale that cannot be supported by current production methods from a price or resource standpoint. The dyadic-developed recombinant serum albumin produced at food grade may have potential use as a component in cell culture media. When produced at reagent or CGMP grade, this product has potential commercial viability in the pharmaceutical segment as a product development or research material in our human and animal health verticals, as Mark described earlier. We've identified a target list of protein and enzymes that have applicability across our core verticals that are currently in need of an alternative, lower-cost recombinant production system, which Dyadic has either made previously or has related experience to improve our probability of success. We believe this can be an accelerator for Dyadic, as our Gapivus microbial cell line has the potential to provide our partners the ability to meet scale and cost demands for recombinant proteins and enzymes within their respective alternative protein markets. In addition, we are in active discussions and currently seeking partnerships and collaborations for non-animal food proteins, nutraceuticals, and metabolites. Mark, back to you.
spk02: Thank you, Joe. We will continue to leverage the learnings of C1 from our commercial-scale industrial manufacturing to accelerate that development process across our core verticals. In parallel, we remain fiscally responsible with our research and development while being strategically focused with our partnerships and collaborations to fund advancements of our science in critical areas. While we're happy with the progress we made in 22, we are not satisfied. And in 2023, our focus is on short-term commercial opportunities that can improve our revenue outlook in the near term. While we continue to drive broader pharmaceutical acceptance of the C1 platform and development of commercialized products. We refined our business development objectives to focus on core areas where our technologies can have the greatest impact. The result of this focus is being realized as Dyadic is gaining industry recognition to further develop our microbial platforms to human and animal health organizations worldwide. At the same time, we are evaluating new opportunities aligned with our verticals in targeted markets of high potential return, such as alternative proteins. With that, I would like to turn the call over to our CFO, Ping Ross and to run through our financials.
spk01: Thank you, Mark. Thank you, everyone, for joining our call today. Before I get into details of our financial results, let me first provide you an update on our change of external auditor situation. On February 16, 2023, we were informed that by Mayor Hoffman McCain, PC, MHM, our independent auditor of his decision to resign due to their own resource constraints. There was no disagreement with MHM on any matter of accounting principles or practices, financial statement disclosures, or audit scope or procedures. MHM's reports on our financial statements for fiscal year 2022 and the previous years were clean and did not contain any adverse opinion or disclaimer, as you can see from the report issued today. We fully anticipate that MHM will help with a smooth transition to our new auditor and provide Dyadic with any required consent going forward. We have already identified a potential new auditor who is currently in the process of completing their internal client acceptance. Once that process successfully completed, we will issue an 8 announcing the name of the new firm. Now I will go over our key financial results for the year ended December 31st, 2022. In addition to what I will be discussing now, you can find additional information in our earnings press release and Form 10-K, which we filed earlier today. Our research and development revenue and the license revenue for the year ended December 31st, 2022 increased to approximately $2,930,000 compared to $2,404,000 for 2021, which represents an increase of 21.9% year over year. Cost of research and development revenue for the year ended December 31st, 2022 increased to approximately $2,123,000 compared to $1,944,000 for the year ended December 31st, 2021. The increase in revenue and the cost of revenue year over year represents the increase in licensing revenues and the various larger research collaborations conducted in 2022. Research and development expenses for the year ended December 31st, 2022 decreased significantly to approximately $4,501,000 compared to $8,392,000 for the year ended December 31st, 2021. The decrease primarily reflects the winding down of activities for contract research organizations and the regulatory consultants to support the Phase 1 clinical trial of the DIA-100 COVID-19 vaccine candidate. GNA expenses for the year ended December 31, 2022 decreased to approximately $6,422,000 compared to $6,698,000 for the year ended December 31, 2021. The decrease primarily reflects a decrease in legal expenses of $500,000 offset by increases in incentives of $133,000, insurance premiums of $56,000 and other increases. Net loss for the year ended December 31st, 2022 was approximately $9.7 million or 34 cents per share. compared to a net loss of 13.1 million or 47 cents per share for the year ended December 31st, 2021. Our cash, cash equivalents and the carrying value of investment grade securities as of December 31st, 2022, including accrued interest were approximately $12.7 million compared to $20.4 million on December 31st, 2021. In January 2023, the company received an additional cash payment of $1.27 million associated with the sale of AlphaZyme LLC. Given the fact that the majority of our DYAL 100 Phase 1 clinical trial expenses have been incurred in 2022 and 2021, we expect our cash burn for 2023 will be approximately $6 million, significantly less than 2022. We started the year with $12.7 million in cash and investment-grade securities with additional $1.27 million received from the sale of our equity interest in AlphaZine. We reiterate our expectation that our existing cash position will be sufficient to fund our operations into 2024. With that, I will now ask the operator to begin our Q&A session. Joe Hazleton will join Mark and I to answer 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 who have already spoken. Operator?
spk03: Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you'd like to ask a question, you may press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of John Vandermosten with Zax. Please proceed with your question.
spk06: Good evening. I thought I'd start out with just a congratulations on the completion of dosing of the trial and wanted to find out what's next. I think we have the clinical study report coming up in a few months. Following that, are there plans for a phase two and also have the good results here bond any interest from, you know, perhaps the vaccine trial that was that was being planned in India?
spk07: Hey, John, it's Joe Hazelton. First of all, thanks for the question. And for the first part, yes, obviously, it spans a lot of interests. What we're hoping for is that we do have the clinical study report sometime in the third quarter of this year. I think that we're hoping that we get our last patient last visit in August. And that ultimately will then lead to potentially looking at next phase of development will be in like early 2024. We're now talking with Rubic One Health, which is our South African partner on next steps. And obviously we'd need regulatory guidance from SAFRA to make that happen. So we're cautiously optimistic that we're going to continue that development as rapidly as possible.
spk02: And I think to the Indian trial, John, it's Mark. That trial is on, you know, plans that continue going on at the moment. They actually pivoted from a monovalent vaccine, which initially they were going to do like we have going on in South Africa, to a bivalent. So that delayed them somewhat. But the beautiful thing there is because they were running behind us, provided they get into the phase one and hopefully even in phase two, which is what they're talking about, that they will actually get better results and more meaningful results. Because as you know, the bivalence from Pfizer and Moderna are basically Omicron 5 and Wuhan, and that's exactly what we're planning on doing in India. So they're working on the CGMP and the preclinical studies to get the support to move forward with that in India. So the delay there actually is going to work out better than it would otherwise have done. So together we talked about pivoting from the monovalent to the bivalent because that seems to be what the FDA, for example, here in the U.S. and the world's looking for.
spk07: Well, and the completion of dosing, I think, you know, indicates that this platform is ready for full commercialization. And that's what's generating the broader interest in the platform on the vaccine front. And that's what we're looking to capitalize on here in the near term.
spk06: Great. And for follow-up, what kind of long-term follow-up is required for the patients that were enrolled in the South Africa trial?
spk07: In phase one, it is a six-month study. There is no long-term follow-up plan at this point. Phase one will end at six months, and that will be the end of the study. So there's 30 patients. So usually phase one doesn't require, you know, follow-on until one does study.
spk04: Great. Thank you, Joe.
spk03: So as a reminder, it's star one to ask a question. Our next question comes from the line of Vernon. Bernardino with HC Wainwright. Please proceed with your question.
spk05: Hi, everyone. Thanks for taking my question and congrats on the progress. Lots of things moving across the board. Regarding DUI AI 100, you mentioned completing dosing of all patients in both the low and high-dose testing groups and expect a full report in second half 23. Can we expect an interim readout, let's say, of antibody levels or other biomarkers, et cetera, or are we just going to wait for a full report?
spk07: We will have – I'm sorry, Vernon, this is Joe. And first of all, thanks again for the question. So great question. We will have some initial preliminary safety data from a day safety monitoring board analysis that will be done hopefully in May. We'll be able to report on some of that. The immunogenicity data, the lab values, those will not be available until the end of the study on database law because it is a blind study. So, we're not going to have access to be able to report on that data.
spk05: Great. That makes sense. And I suppose you'll need the full data to enter further discussions regarding C1 technology?
spk07: Not from the standpoint of safety. Not necessarily. Obviously, from DY100, from moving that forward, you'd want the immunogenicity results to have further discussions on that and what that would look like, you know, to potential partners moving forward and even, you know, with RubicOne Health. But when you're looking at just the safety of the platform, that type of information obviously will be available a little bit sooner.
spk05: Thanks. I'll get back in the queue. Hey, Mark.
spk02: And I think Vernon also can answer. I think part of your question is, you know, these pharmaceutical companies are already waking up and recognizing when there's been no adverse events and the study's going very well so far, that they're looking at this just like we are, as this is a platform technology and this is establishing and putting a flag in the ground. It's basically saying this is the first step, the human being that we've ever put a protein And this is demonstrating, as we would expect, and we won't know until obviously we get the final results, but that we will have safety and that this platform can then be used for dozens, if not hundreds or thousands of potential things going down the road. And particularly, as Joe's pointed out, it's ready now for commercialization use for recombinant protein antigens, not only to produce more of something, potentially to produce better vaccines with broader durability, You know, our global reach into academia, industry, and government is expanding. We're getting multiple inputs, not only from pharmaceutical and biotech companies, but from academic groups that are looking to get the NIH or the European Union or other governments to fund Zika or dengue or West Nile or Ebola. I can go on and on and on. The list of potential vaccines that these guys are applying for that they intend on using C1 now. instead of Baclovirus or other systems. So they seem to have starting to get buy-in and expansion and adoption, certainly in the academic world of the people from the Zappi scientists that we've been working with for seven years that have been involved in this. Now that the safety data, not only in preliminary from South Africa, but they've also spent the money with the European Union to go into a non-human primate study on a monoclonal antibody. that showed not only equal performance to the CHO cell, but with no safety issues at all. So I think all this momentum is building, and I think it's just going to grow. And over time, our expectations are, you know, just like water seeps to lowest level, that C1 is going to become a standard in many, many, let's say, academic, government, and industry labs, that that's where it starts. Putting the gene into the cell line, it can produce more for less, reach more patients more affordably, and that's the way the world needs to go. And we're seeing that pressure is finally mounting on the cost of goods. In China, the government's been forcing down the price. So companies like Hangru, who we're working with, one of the largest companies in China and others, are getting the margins squeezed. So they're looking for alternatives. With insulin prices coming down in the U.S. and the pressure coming, and I think this whole thing is coming to the forefront. And in the meantime, But we're focusing on these long-term, extreme high-value propositions in animal health and in alternative proteins and in industrial uses of dapabis. We're looking to generate revenues and profits in the meantime as we go along. And I think Joe can talk about more, but let's see what the next question is about the food tech and the food tech conference. Maybe, Joe, you want to ask something about that or put some input about that?
spk07: Where you're going there and how things look, I think I think to your point of the conference, we just attended in San Francisco, obviously focusing on alternative proteins. That segment continues to eat up. The investment dollars flowing, but the 1 key need that that segment continues to have is how do we commercialize that? We're common proteins. that they have a clear need for large quantities of low-cost proteins. And food grade is going to continue to be an area where they're going to need alternative production systems. And right now, we've got a lot of interest and a lot of traction in finding alternative ways to make these proteins. And I think that's one area where, again, it's a shorter development cycle and a shorter commercialization timeline, which is something, obviously, we would be very, very interested in. It's one area that's continuing to drive for us and we'll continue to focus on and hopefully have news in the near term.
spk05: Thank you.
spk04: That's helpful information and insight. Thanks for taking that question. I'll get back in the queue. There are no other questions in the queue at this time. I'd like to hand the call back to management. for closing remarks.
spk02: 2022 was a breakout year in several ways for dyadic. The launch and further commercial development of the DepMAPIS platform has provided dyadic a strong foundation and has already generated interest from companies in the alternative protein industry. Most importantly, we received regulatory approval and have already completed dosing in our first in human ever phase one study for a C1 produced protein. We believe this first in human safety data for C1 produced protein, in addition to the continued advances in productivity, quality, and efficiency, will help to accelerate the adoption of the C1 protein production platform within the human pharmaceutical industry to the benefit of patients across the globe. This was a significant undertaking for the company and marks a new phase for Dyadic now that our C1 platform for recombinant protein vaccine is ready for commercialization. We are not only focused on improving the value of Dyadic, the life science industry, which will in turn improve value for shareholders, but will also improve access to affordable vaccines and therapeutics globally. The reorganization of our infrastructure has enabled Dyadic to refine our focus and revise our strategy to exploit existing and new commercialization opportunities in the near term while enabling us to fulfill our mission as a global biotechnology company in order to improve the way we feed, fuel, and heal the world. Thank you once again for joining us in today's fiscal year 2022 conference call, and we look forward to keeping you updated as we advance our commercial and scientific initiatives across the companies and our collaborators' programs. We also look forward to seeing you on the next call, and I hope you all keep an eye out for our periodic updates.
spk04: Ladies and gentlemen this does conclude today's teleconference.
spk03: Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.
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