Dyadic International Inc. Q1 2023 Earnings Call
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Speaker 2: Good evening and welcome to the Diatic International's first quarter 2023 Financial Results 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, May 10, 2023.
Speaker 2: I would now like to turn the call over to Ms. Ping Rawson, Dyadics Chief Financial Officer. Please go ahead.
Speaker 3: Thank you. Good evening and welcome everyone to the Iodac International first quarter 2023 conference call. I hope you have had an opportunity to review that express release announcing financial results for the quarter ended March 31st, 2023. And the recent company highlights.
Speaker 3: You may access our press release and Form 10Q under the investors section of the company's website at diabetics.com. On today's call our president and CEO Mark Imophar will give a review of our first quarter business and corporate highlights including a brief summary of our recent research and business development efforts.
Speaker 3: Our Chief Business Officer, Joe Hazelton, will join Mark for the business updates.
Speaker 3: I will follow with a review of our financial results in more detail. We will then hold a brief question and answer session. At this time, I would like to inform you that certain commentary nates in this conference call may be considered for looking statements which involve risks and uncertainties.
Speaker 3: and other factors that could cause dietics actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these four looking statements.
Speaker 3: that could cause sciatic actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these four looking statements.
Speaker 4: multiple new research collaborations and strong growth revenue of 50.9% year-over-year for Q1.
Speaker 4: On today's call, Joe and I will highlight the significant technological advances and recent business development successes we have and continue to achieve across each of our core markets.
Speaker 4: We are excited about our current and future prospects for growth and our revenues while continuing the ongoing long-term collaborations with Janssen, Fibroabic, Rubik and others while working on bringing in additional collaborations and partnerships like the co-development marketing and commercialization agreement announced earlier this week with Firmbox Bio.
Speaker 4: The global demand for enzymes and proteins across our core verticals continues to grow exponentially.
Speaker 4: Our C1 and Dapidus microbial protein production platforms offer differentiating benefits for each of these markets.
Speaker 4: lostness and versatility, higher productivity, lower cost, and flexible commercial scale manufacturing, among others.
Speaker 4: We believe we are at or near the precipice of applying C1 and DAPA bus to develop enzymes and proteins across our verticals that will lead to monetization that will significantly increase shareholder value for dyadic and our collaborators. In our full year 2022 call.
Speaker 4: I highlighted what makes the C1 filamentous fungal protein production platform unique versus traditional cell lines that are currently used to manufacture vaccines and biologic drugs.
Speaker 4: In addition, C1 is up to 300 times more productive than baccala virus in sex cells, which are being used in both human and animal health to produce vaccines.
Speaker 4: And C1 also has a two or more week shorter fermentation time and no viruses that need to be removed in downstream processing like plastic, packet virus, or Chinese??-industrial
Speaker 4: The key aspect of these scientific achievements is that C1 can produce recombinant vaccines more rapidly in greater amounts in a lower cost than cell lines currently being used today.
Speaker 4: These characteristics, coupled with the data from our first in human study of a C1 produced antigen, has led to increased awareness and interest in the C1 protein production platform for recombinant protein vaccine development and production.
Speaker 4: This message has resonated with the FDA and BARDA and led to Dyadic being one of six companies and the only platform technology company invited to present at the April 27th FDA BARDA led workshop for next generation recombinant protein-based COVID-19 vaccines.
Speaker 4: Our inclusion in this workshop validates the growing pharmaceutical interest and our C1 protein production platform. In addition to highlighting the need for rapid, efficient and effective platforms to develop and manufacture for common vaccines for a pandemic preparedness in response.
Speaker 4: At the FDA workshop, I presented alongside major pharmaceutical companies such as Sanofi, Novavax, and SKBio, in efforts to enhance the role that recombinant protein vaccines can have to combat the current COVID-19 pandemic, to next-generation COVID vaccines.
Speaker 4: BY-100, a recombinant protein RBD COVID-19 booster vaccine candidate.
Speaker 4: a recombinant protein RBD COVID-19 booster vaccine candidate. Jill will provide more on that later.
Speaker 4: The data from this trial is helping to establish a safety record with regulatory agencies for proteins produced from our C1 protein production platform.
Speaker 4: We're continuing to expand the traction of the C1 platform in receiving through multiple grant applications, submitted in collaboration with US and EU scientists for a wide variety of infectious disease candidates.
Speaker 4: such as the Sudan Ebola virus, the Marburg virus, the Rift Valley fever virus, West Nile virus, Zika, as well as second-generation COVID-19 vaccine candidates.
Speaker 4: While we have previously demonstrated that the C1 platform is capable of rapidly producing unparalleled quantities of complex vaccine antigens efficiently, we are now in the final
Speaker 4: 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.
Speaker 4: and other cell lines in terms of quality.
Speaker 4: We've expressed a number of 3rd party monoclonal antibodies, which were assayed by multiple 3rd parties who reported that the neutralizing and binding activity essays. Demonstrated great similarity between C1 produced and Chinese hands to reproduce. Or 2 maps 1 of these C1 produced monoclonal antibodies.
Speaker 4: choke-produced monoclonal antibody with no signs of antibody-mediated enhancement.
Speaker 4: 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.
Speaker 4: We also have been focusing on designing better biomolecules. We have developed C1 cell lines to express complex proteins such as conjugating antigens and ferritin nanoparticles.
Speaker 4: Additionally, we developed several antigens with the AMHC2 targeting system for influenza and COVID-19, as well as an antigen that included a trimerization domain to increase vaccine efficacy and durability. In today's release, you may not have seen or may have seen
Speaker 4: We're also testing these better molecules with our partners like Verivax, where new and improved adjuvants are being evaluated with semen-produced antigens in relevant disease areas such as COVID-19 and seasonal and pandemic influenza such as 8,5,N1 or more commonly known as bird flu.
Speaker 4: lasting vaccines across a wide range of infectious and other diseases that could be manufactured rapidly in larger quantities more affordably.
Speaker 4: with leading pharmaceutical partners like Hangru, one of the largest Chinese pharmaceutical companies, and our collaboration with Janssen Pharmaceuticals, as well as advancing commercial products and clinical development of our COVID-19 vaccine candidate, DYA100 with Rubik One Health for the African continent, and a bivalent COVID-19 vaccine with Epigen in India.
Speaker 4: Discussions are ongoing with several parties interested in the potential of using and applying C1 for additional developed and developing countries.
Speaker 4: We expect to continue using our technology to obtain equity stakes in smaller companies who can't afford to pay upfront access fees.
Speaker 4: similar to what we have done with BDI and albazone.
Speaker 4: This provides us with an opportunity to generate cash from the sale of our equity later, as was the case with BDI in 2021 and Elfaziam in K1 2023. The sale of these two equity positions generated a total of US $2.87 million in cash.
Speaker 4: Additionally, we have the potential to receive milestone and royalty payments based on sales of Semen Express products by Albezine.
Speaker 4: Also in 2023, we 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'll see what keeps us back on track for the next 24 hours.
Speaker 4: We are beginning our shift towards commercializing these opportunities.
Speaker 4: An example of this strategy is our recombinant serum, Elbium Projects, which as we shared in the release today, have been expressed at high levels, and we've begun to sample potential customers.
Speaker 4: The global serum albumin market is approximately 5.7 billion dollar market growing at over 6% a year due to the increased use of a multitude of markets in human and animal health.
Speaker 4: In the pharmaceutical segment, serum alveoli is not only being deployed as 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 and price points across these markets. There are many different grades of albumin and price points across these markets. There are many different grades of albumin and price points across these markets.
Speaker 4: Dyadic has the potential to produce animal-free serum albumin at competitive pricing due to our high productivity C1 and Daphnis microbial platforms using low-gloss media.
Speaker 4: of TYP 450 enzyme.
Speaker 4: CYP450 enzymes are part of a $17 billion global enzyme market for use as a diagnostic, therapeutic research and product development enzymes.
Speaker 4: Achieving high enzymes and other protein yields are a major challenge in the pharmaceutical industry. This specifically to enhance the production of vaccines and biologics of our enzymes required for the chiral synthesis of small molecule drugs, diagnostics, and other uses.
Speaker 4: This is another example of a potential near-term opportunity that adheres us to our corporate strategy to identify enzyme and protein targets where our technology can have the greatest impact. We are improving our capability to have an internal pipeline of proteins and enzymes with commercial potential across our core verticals.
Speaker 4: whose utilization is not dependent on lengthy clinical development programs or human trials.
Speaker 4: This decreases our timeline to revenue potential and commercialization opportunities. In addition to the clinical data being generated, we are protecting our technology with a robust IP estate. I'm pleased to say that last month, the IDIC received a notice of alliance from the U.S. Patent Trade Margot was for a patent application whose claims.
Speaker 4: cover the development and manufacture of seasonal and pandemic influenza vaccines for the company C1 Protein Production Platform.
Speaker 4: This timely patent allowance allows. Comes as we announced earlier this year, the diet is at the forefront of vaccine development. With more than a half dozen animal trials being carried out last year. And additional animal tries are ongoing and are scheduled with C1 produced antigens. For influenza.
Speaker 4: Such as 85 and one of the bird flu and other infectious diseases. There's a global on that need for more effective and more available flu vaccines.
Speaker 4: It's been reported that the human influenza market is currently valued at approximately 8 billion US dollars and expected to grow to over 12 billion by 2028 with multi-valent vaccines leading the market. The recognition, data, and scientific advancement we are generating have not only accelerated our efforts in human health, but also accelerated the efforts in the health of our patients.
Speaker 4: So they are translating into increased interest and a other core vertical such as animal health. There are many similarities in the needs between the human and animal health markets for vaccines and therapeutic proteins.
Speaker 4: Translating an increased interest and other core verticals such as animal health. There are many similarities and the needs between the human and animal health markets for vaccines and therapeutic proteins. We are leveraging our science across these core verticals.
Speaker 4: What makes animal health and 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 serves as one such example and has an immense impact on the global poultry supply chain and ripple impacts.
Speaker 4: And to other markets as well. This is why we believe the C1 production platform can be a global solution to pandemic response and not just human, but also in animal health. Late last year, we announced that we'd 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.
Speaker 4: making see when a potential pandemic preparedness platform for response or stockpiling. Our third vertical of alternative proteins is an area of great excitement for diatics.
Speaker 4: And 1, which we believe also holds near term potential promise in terms of opportunity and revenue.
Speaker 4: Exploiting this segment does not require a significant departure from our human and animal health pursuits in terms of technical capability or resource requirements.
Speaker 4: The alternative protein vertical is anchored by our fully funded joint development agreement with our global food ingredient collaborator.
Speaker 4: We have received the first milestone payment from our joint development agreement this quarter based on our achievement of the scientific data in this project.
Speaker 4: The dyadic is continuing to dedicate resources and support for the existing and future projects within this rapidly growing market.
Speaker 4: The ILAQ is launched as DEPABIS platform, a filamentous fungal-based mycorvola gene expression and protein production platform, which is further designed and customized to enable the rapid development in large scale manufacture of low-cost enzymes, proteins, metabolites, and other biology products.
Speaker 4: for using non-pharmaceutical applications such as food, nutrition, health, and wellness.
Speaker 4: I will now turn the call over to our chief business officer, Joe Hazleton to provide a more detailed update on our phase 1 trial progress and to discuss our business development efforts across core verticals. Joe, thank you. Mark. I'm happy to report that the phase 1 trial for 100 is progressing as planned for background in order to establish a track record of safety and humans.
Speaker 5: For antigens produced from our C1 protein production platform. The ongoing phase 1 trial is a randomized double blind placebo controlled trial. To evaluate the safety and immune response of the DYA 100, COVID-19 recombinant protein, or RBD booster vaccine in 30 healthy adults in South Africa.
Speaker 5: 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 scheduled on six of the eight visits.
Speaker 5: two visits taking place at days 90 and 180 from initial dosing.
Speaker 5: South Africa partner to evaluate the next development phase of the DYA 100 COVID-19 booster vaccine candidate pending the results of the study as well as the regulatory and market outlook.
Speaker 5: With the expected full study results later this year, we continue to validate the C1 platform to reduce development risk for our partners. Over the last five years, Static has developed a stronger repository of safety, efficacy, and productivity data regarding the C1 protein production system across a wide range of vaccines and antibodies.
Speaker 5: Diatic has also developed suite of genetic tools to improve the ability to rapidly and accurately 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 typical cell lines used today.
Speaker 5: For the human and animal health markets, the overall result is that for recombinant vaccine development and production the C1 platform is ready for full commercialization. To this point, Mark mentioned earlier, multiple grant applications have already been submitted in collaboration with US and EU scientists for a wide variety of infectious disease candidates.
Speaker 5: such as Sudan and Ebola and Marburg virus, Rift Valley fever, West Nile virus, and Zika, and second generation COVID-19 vaccine candidates. We anticipate additional grant applications will continue to be submitted, and we expect to further expand our research development and commercial collaborations globally.
Speaker 5: We continue to make great strides in antibodies and we believe that the C1 platform is ready for use in human trials for monoclonal antibodies, bi and tri-specific antibodies, Fc fusion, and other types of therapeutic proteins.
Speaker 5: While this is encouraging news, development approval of pharmaceutical products take years to complete, which also means that we must continue to focus our efforts on commercialization targets that drive revenue in the near term as well.
Speaker 5: The increased recognition the C1 platform is generating coupled with the continued advancements of our scientific data is leading to business opportunities across our core verticals. The expanded licensing agreement with Rubik 1 Health announced in April is 1 such example. The agreement goes beyond COVID vaccines and accomplishes not just human health vaccines and therapeutic proteins.
Speaker 5: but also animal health pharmaceutical products as well.
Speaker 5: This provides ruby the potential for a broader number of commercializable opportunities in multiple product segments.
Speaker 5: We've also re-evaluated our research and development approach, focusing mainly on those projects that have potential commercial outcomes.
Speaker 5: One such example is a recently announced new collaboration with a top five pharmaceutical company to express and produce a vaccine antigen from C1 for human health.
Speaker 5: This agreement is different from our traditional research projects in that it also grants an option for a future commercialization license for use in a multi-billion dollar market.
Speaker 5: This does not mean we will not pursue opportunities that offer other potential value as evidenced by the research collaboration we recently signed to express an enzyme involved in biosimilar development for human health. However, we will continue to prioritize projects with near-term commercial potential.
Speaker 5: We're leveraging our science across our core verticals as the need for a cost effective way to produce large quantities of recombinant proteins and enzymes exists in human and animal health as well as alternative proteins. Within the animal health vertical, we've continued to advance our business development objectives in the 1st quarter. As previously mentioned, we've expanded our licensing agreement with Rubik to include.
research project we started in 2022 to develop another animal vaccine for a different disease target.
We also have a fully funded research and development collaboration that is currently underway with a top five animal health company to produce therapeutic monoclonal antibodies for treating diseases and companion animals that is on target to meet development milestones for the research agreement. We're also in discussion with several other interested parties in animal health.
To further support our business development efforts across the animal, human, and alternative protein verticals, Dietic is building a portfolio of proteins and enzymes with commercial potential applicable across those verticals whose utilization are not solely dependent on lengthy clinical development programs or human trials.
We've expressed human serum albumin and bovine serum albumin stably and at high levels. It is important to note that the process to commercialize a non-therapeutic version of either albumin product for pharmaceutical use does not necessarily require human clinical trials depending on the end use of the albumin.
These types of products are analytically tested against reference samples to ensure that they meet quality control requirements for potential purchasers. This is a much shorter and less costly development process than a human vaccine or therapeutic protein.
We are currently beginning to sample our serumaldomum products and have discussions with several interested companies. This is also where our strategy of pursuing opportunities for products that transect our curve articles becomes clearer as bovine serumaldomum is currently being used in cell culture media within the cultured or lab grown meat industry.
This and other high value and high cost targets for non-pharmaceutical applications will require further development to reduce manufacturing costs to satisfy the margin requirements for the food industry, which is where our Dappabus platform is rapidly generating increasing market attention. Dappabus, which literally means protein in Latin, is designed and customized to enable the rapid development and large-scale manufacturing costs to the food industry.
marketing and commercialization agreement with Firmbox Bio to help accelerate our ability to exploit the depth of this platform and expand Dyadic's non-pharmaceutical product offerings for animal-free recombinant protein products.
the agreement, Firmbox will utilize Diadx Dapyvis platform to develop animal-free, recombinant protein targets for non-pharmaceutical applications, which can then be co-marketed in enhancing the breadth and scope of each company's product portfolio. This partnership will further improve the Dapyvis platform and will also provide Diadic with an experience bio-manufacturing partner which can be leveraged for future projects.
The FermBox Bio-Partnership is an example of how we are actively pursuing opportunities with a target list of proteins and enzymes we've identified that have applicability across our core verticals that currently need an alternative, lower cost recombinant protein production system with shorter development and commercialization timelines and a higher probability of success.
We believe this can be an accelerator for Dyadic as both our C1 and Dapabis microbial cell lines have the potential to provide our partners the ability to meet timelines, scale, and cost demands for recombinant proteins and enzymes within their respective pharmaceutical or non-pharmaceutical market applications. Hopefully what I shared today is demonstrating that Dyadic is executing and delivering a solution that can help us to make our lives better.
in key markets and we're exploring agreements for market statements that benefit both companies.
I'll now turn the call back to Mark for some final comments on the first quarter. Mark? Thank you, Joe. We will continue to leverage our decades of commercial-scale industrial manufacturing knowledge and experience to accelerate the development process across our core verticals.
In parallel, we remain fiscally responsible with our research and development spending and being strategically focused with our partnerships and collaborations to help fund advancements of our science in critical areas.
We believe that our C1 platform is well positioned to be an alternative platform in developing next generation vaccines for public health and future pandemics. And we're happy to see C1 is getting more recognition globally within academia, government and industry. We have refined.
our business development objectives to focus on core areas where our technologies can have the greatest impact in the shortest amount of time. And we are evaluating new opportunities aligned with our verticals and targeted markets of high potential return such as alternative proteins.
With that, I turn the call over to our CFO , Ping Ross, and to run through our financials.
Thank you Mark. Thank you everyone again for joining our call today. Before I discuss our financial results, I want to comment on our recent change in auditors.
On April 10th, 2023, we issued an 8K and announced a change in auditors from Mayor Hoffman McCain, PC to grow LLP. Mayor Hoffman McCain's MHM resigned due to their internal staff resource constraints.
and their inability to continue to serve their public clients. As I mentioned on the year-end call, there was no disagreement with MHM on any accounting or audit matters.
MHM's reports on our financial statements for fiscal year 2022 and the previous years contained clear opinions without any significant deficiencies or material weaknesses on internal controls. The report also contained clear opinions on our financial statements for fiscal year 2022 and the previous years contained clear opinions without any significant differences or material
As we announce our first quarter financial results today, I am pleased to let you know that we had a smooth transition to our new auditor flow, which has an excellent reputation and extensive experience in the biotech industry. I will now comment on our financial results for the quarter.
increased to approximately $978,000 compared to $648,000 for the same period a year ago.
for the quarter increased to approximately $727,000 compared to $405,000 for the same period a year ago.
The increase in revenue and cost of revenue year-over-year represents the increase in licensing revenues and the several larger ongoing research collaborations conducted in 2023.
Research and development expenses for the quarter ended March 31, 2023 decreased by 39.6% to approximately $811,000 compared to $1,343,000 for the same period a year ago. The decrease in research and development expenses
was due to the winding down of activities of CRO and consultants to manage and support the preclinical and clinical development, as well as a decrease in C. D. N. P. manufacturing costs as the company completed a dosing of phase one clinical trial of the Y. A. one hundred RBD, COVID-19 booster vaccine.
$6,000 for the same period a year ago.
The decrease principally reflected decreases in management incentives of $86,000, insurance expenses of $36,000, business development and investor relations expenses of $61,000, and other decreases of $48,000.
Offset by an increase in legal expenses of $55,000. Other income for the quarter and March 31, 2023 was from the sale of the minority interest in AlphaZon, LLC.
Net loss for the quarter-ended March 31, 2023 was approximately $956,000 or $3 cents per share compared to $2,492,000 on nice end per share for the quarter-ended March 31, 2022. Are cash, cash equivalent?
And the carrying value of investment grade securities as of March 31st, 2023, including accrued interest, were approximately $11.8 million compared to $12.7 million on December 31st, 2022.
We expect our cash burn for 2023 will be approximately $6 to $7 million. And we expect that our existing cash position will be sufficient to fund our operations into mid to late 2024. With that, I will now ask the operator to begin our Q and A session.
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.
Thank you. We will now conduct a question and answer session. If you would like to ask a question, please 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. We ask that you limit to one question and one follow up to provide all callers opportunity to participate.
You may reenter by queuing star one. One moment while we poll for questions.
Our first question comes from John VanderMolten with SACS. Please proceed. All right, thank you, and good afternoon, everyone. I was reading about Nimble, and it seems like it's a good organization to work with, but I'm wondering what's expected after the research work is complete. Does the organization find a commercial partner and pass on the work, or what happens to that, I guess, IP that's developed?
So in the case of Nimble, it's the National Institute of Internet, I guess, Manufacturing Biologics here in the US. I think there's somewhere around 300 to 400.
members, including I don't know most of the majority of the big farmer companies. So the data gets shared with those members and posters and presentations. And in fact, I'm going to be making a poster and a presentation in Nimble. And I think it's in June , so in the middle of June .
Sometime this year, I remember June , where there's an annual meeting every year. And a lot of the big pharma customers are there and clients and we go through the data. So that's what happens with the data that was more of a funding to demonstrate. The power, the yield, the speed at which we can produce. In this particular case, it was a fab.
The same fab that we're general on use in the COVID-19. At a higher level, quicker and faster, and then also a nest. Anybody they use as a standard to show for quality in terms of productivity and speed. So that's what happens with the nimble program in terms of that. And leverage is hopefully a new larger deals.
Higher credibility and more opportunity for us to move the technology forward. Okay, thanks Mark and also wanted to ask about India and the clinical trials there. I mean, now that you've already done a vaccine trial using. Uh, C1 in South Africa, does that smooth the way and then where do we or when do we expect that trial to start based on what you see now and.
We're going to kind of have that precedent underway and we kind of understand it. How will that help the any future vaccine work in India?
Well, I think it helps future vaccine words on a global basis, not just in India. We're having incredible inbound reaches into us from academia, industry, and government agencies. I think that the phase 1 trial kickoff and the fact that we've had to date, no adverse effects
has brought the attention of BARDA and the FDA, and I think led to potentially why we were selected as only one of six companies to present in the recombinant protein vaccine, next-generation COVID vaccines.
So I think it's much broader, wider, and deeper than just India. And I think that the whole thing with India is they're working on a bivalent because they came second. And the bivalent like Moderna and Pfizer, where they had the Wuhan and the Omicron 5, they're working on a Wuhan and Omicron 5 bivalent.
So that's a blessing in disguise that they were a little behind us because we had to pivot with them to move towards that. So it took a little longer and then moving towards CGMP manufacturing of that product and then getting the talk study started and kicked off to go into human clinical trials. And that's what's happening there in India.
And the other thing that's really in that particular case is that factory can do everything from taking the master cell bank, producing C. G. M. P. material all the way from drug substance in the drug product, and they put it in vials and ready to go. So they can do everything from the beginning to all the way the end where in the case of.
The African trial we made the cGMP material with BtG in Israel, which is part of Faring Pharmaceutical as a drug product and then had to ship it to Holland where we used a company to put it in the vials as drug product. So this way it's all in one house. It's a simpler process.
And they've got a lot of experience. They run multiple C, G and P runs both for the Wuhan and now Omicron 5.
But John , to your point, the major benefit we've already received from the African clinical trial in terms of epigen is the fact that we've already done the process. So we've already leveraged the key learnings for that transition. So the data that's coming in obviously would be helpful from many different regards to Mark's earlier point, but we've actually already leveraged the key learnings that we needed to accelerate.
with one of the top five pharmaceutical companies. That's a new project.
It's sort of confusing because we had a top five pharmaceutical project, but it was an animal. It was for animal health, but with big pharma. This one's for human health. And this is a very, very big opportunity in a very, very big market. So, unfortunately, we couldn't put out a press release on it. Because of the relationship.
And the restriction in our NDA with them, but this is a really, really big opportunity. And if we can succeed and they want this and move it forward. This is another potential game changer, just like Janssen.
It sounds like they're watching what you're doing with that DYA 100 right now. I think that's all mine.
John , I think the world's watching what we do with the PY300. But more importantly, with our C1 protein production platform, with the presentation, there was about 400 plus people on the call with the FDA and BARDA. And we're getting a lot of inbound excitement about where we are as people are seeing. And we're getting a lot of inbound excitement about where we are as people are seeing.
You know, if you go to our slide deck, if you guys haven't done that yet and to our website that's recorded on there, you go to slide 11 Joe put a slide together that showed the advantage of speed, not just yield, but we can get.
product produced much faster and much higher yields and much lower cost. So I think and if you look at all the parameters of what you need if and when a pandemic would occur, speed, yield, cost, global access, ease the transferability to Joe's point about how we had to see GMP in Israel now brought it over to India. So I think we're
were primed with the Bricombinant vaccine platform to help the world with public health, which is just traditional vaccines for all kinds of applications and also potentially for to address this pandemic with the next generation, which is what the BART and FDA workshop was. In fact, today we got an email that on May 17th, they have a follow up to that.
where we can ask more questions and get more definition as to how and when we can apply and what we need to apply for to get potential government grants for the next generation COVID-19 vaccine. Got it. Thank you, Mark. Once again, to ask a question at this time, please press star 1 on your telephone keypad. One moment while we pull for more questions.
Our next question comes from <expletive> Williams with Williams Resource. Please proceed. Terrific job. Terrific job.
We've had a lot of calls together with a lot of the people who have been stuck all over this company and some of them wander well. And this one was particularly very overwhelming. So Mark, I have a question for you regarding border. Can you hear me? Yeah, I hear you.
I got calls together with a lot of the people who have been stockholders of this company and some of them were underwhelming and this one was particularly very overwhelming. So Mark, I have a question for you regarding border. Can you hear me? Yeah, I can hear you. Okay, okay.
There's a date of the motor confused the 17th date was a day that I presume was for the submission.
of grants to barter based on the $5 billion budget that has recently been created for the pandemics.
future pandemics. So are we applying
and future pandemics. So are we applying to them for a grant?
several grants in terms of partners, singly by ourself. Can you give some color on that part of the deal, forgetting the workshop per se, but the grant.
in barter with the funding that's available and also if you have any color as to when since it's a due date of the 17th or 16th of the month
when would they be in a position to give out the grants and advise who they're giving them to?
First of all, they've extended the 17 to the 26th. And so by doing that a week earlier in the 17th, they're trying to like that questions people like us may have about the middles that we intend on submitting.
In some cases, we may have already submitted 1 of those applications in conjunction with other partners. And then there's another even bigger opportunity. Which is another bar to call that is not due for several months. It's a deeper longer potential for greater funding than they need.
what you call the now that make 26 application. So BARDA, we don't know if and when we're going to get a grant from them. But what we do know is, we were put on center stage because they see what we have and the capabilities of what we have. I think they're going to try to work with us to try to fit a square peg in a square hole where we can bring the greatest help.
to the US government in the world at large. Maybe Joe, you want to add something to that? I don't know. I think, but at a dig to your point, obviously we are looking to submit multiple applications. But to Mark's point, the two different processes, the May date is more an accelerator project to accelerate early stage development.
The September date for BARDA that actually has the larger grants associated with it, or for products that are a little further along in development that actually have phase 1 data associated with it, and those they're looking to fund all the way potentially into phase 2 or 2B.
So, those are just some of the highlights that we'll be obviously trying to get some of that funding if we can in conjunction with some of our partners, or even on our own if we're able to. So.
is just some of the highlights that we'll be obviously trying to get some of that funding if we can in conjunction with some of our partners or even on our own if we're able to. So. Appreciate the question.
work with Rubik. Are there any milestones there that are associated with that if you meet what you're targeting?
Yeah, John , great question. There are commercialization milestones and obviously, royalty payments associated with this contract as well for both human and animal health.
Maybe give them a little color on the animal health part of the deal.
And why that's important or why it's important. I mean, obviously, in Africa, there's very few actually, there's only 1 major pharmaceutical partner that's manufacturing vaccines in Africa. Most of their animal vaccines are imported. Which is leading to very low vaccination rates among their livestock. So it's a, it's a very big need in Africa, specifically South Africa. That's 1 that has actually copy.
When you're looking at animal vaccines, and they've identified 5 targets that they're going to be looking for. Okay, thank you, Joe.
There are no further questions I will now turn the call over to Diatic CEO , Mr. EmoFob, for closing comments.
Thank you. 2023 is after a great start for diatic. We're focused on improving the value of diatic for the life science industry, which will in turn improve value for our shareholders.
And we are improving access to affordable vaccines and therapeutics globally. We've refined our focus and revised our business strategies to exploit existing and new commercialization opportunities in the near term while enabling us to fulfill our mission as a global biotechnology company to improve the way we feed, fuel, and heal the world. Thank you for joining us in today's key one 2023 conference call. Thank you.
And we look forward to keep me updated as we advance our commercial and scientific initiatives on the next call.
Please keep an eye out for our other periodic updates. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.