Q2 2023 Dyadic International Inc Earnings Call
Okay.
Good evening and welcome to Dyadic International second quarter, 2023 financial results Conference call.
Currently all participants are in a listen only mode. Following managements prepared remarks, there will be a brief question and answer session. As a reminder, this conference call is being recorded today August nine 2023, I would now like to turn the call over to Mr. Craig Rossman Dyadic Chief Financial Officer. Please go ahead.
Thank you good evening and welcome everyone to Diavik Internationals second quarter 2023 conference call.
I hope you have had the opportunity to be viewed Biotics press release announcing financial results for the quarter ended June 32023, and the recent company highlights.
You may access our release and the Form 10-Q, and there the investors section of the company's website at <unk> Dot com.
On today's call are president and CEO , Mark IMO, Bob will be Oh, a review of our second quarter business and corporate highlights, including a summary of our recent research and business development efforts.
Our Chief business Officer, Joe Hazelton, well, Joe Mark for the business update.
I will follow with a review of our financial results 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 maybe considered forward looking statements, which involve risks and uncertainties and other factors that could cause biotics actual results performance scientific or otherwise or achievements to be materially different from those.
Expressed or implied by these forward looking statements.
<unk> 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 Biotics reports filed with the SEC.
It is now my pleasure to pass the call to our C O Mark Hemophiliac Mark.
Thank you <unk> Hello, everyone and thank you for joining dynamics second quarter 2023 conference call.
We've continued the momentum seen in the first quarter of 2023.
As our <unk> technology continues to garner praise and recognition for its speed and efficiency in the U S and internationally for.
Academia and industry and government agencies.
In addition, our death on this platform has gained significant traction in both.
Turning to protein and bio industrial markets.
We are delivering multiple new research collaborations.
<unk> revenue growth of 38, 5% year over year for the first six months of this year.
On today's call, Joe and I will highlight the significant technological advances and recent business development successes we have.
Tinder to achieve across each of our core markets.
We're excited about our current and future prospects for growth in our revenues, while continuing the ongoing long term collaborations with Janssen.
Rick Rubin and others.
The continued positive data from our first in human Phase one study.
Recently announced advancements in our internal serum albumin projects.
Accelerating opportunities to enter into additional collaborations and partnerships like the recently announced two memorandum of understanding with the Italian government Foundation biotech Niccolo, Sienna, which performs the functions of an anti epidemic hub with a particular focus on the day.
Element and production of vaccines and monoclonal antibodies for the treatment of emerging epidemic pandemic pathologies.
And also Bangladesh is essential drugs company limited E. D. C. L. A state owned pharmaceutical company under the Ministry of Health and family Welfare, Bangladesh to facilitate biopharmaceutical research preclinical.
Development <unk>.
The GMP production and clinical development for the prevention and control of diseases and improvement of public health programs and Bangladesh.
Yeah.
Yeah.
We believe we are at or near the precipice of applying both around microbial protein production platforms, Ceylon and depth of this to develop a antigens antibodies enzymes and other proteins across each of our core verticals.
We believe will lead to monetization.
Significantly increase shareholder value for dyadic and our collaborators.
Well it makes it seem one film into a single protein production platform.
<unk> versus traditional cell lines currently used to manufacture vaccines and biologic drugs.
To produce safe and effective therapies and unparalleled quantities with the speed and cost required for pandemic and global health care needs.
We've repeatedly shown cause it's one platform is up to 300 times more productive and back of the virus namesake cells, which are being used in both human and animal health to British vaccines.
C. One also is significantly shorter fermentation times and no viruses that need to be removed and downstream processing versus either tobacco virus or Chinese hamster ovary chose cells.
Enabling the production and release, a recombinant vaccines more rapidly and greater quantities and at a lower cost than traditional cell lines currently being used today.
These characteristics coupled with the data from our first in human study of as anyone produce antigen has led to the increased awareness and interest in our sealing protein production platform for recombinant protein vaccine development and production in human and animal health.
Earlier this quarter, we provided an update on the first in human Phase one trial for <unk> 100.
Recombinant protein IBD COVID-19 booster vaccine candidate.
The data from this trial is helping to establish a safety record with regulatory agencies for proteins produced some of our C. One protein production platform.
We're continuing to expand attractions of seamless platform and receiving through multiple grant application submitted in collaboration with the U S.
Other scientists globally for a wide variety and for infectious disease candidates.
Such as seasonal and pandemic influenza H five N one bird flu.
Sudan, Ebola virus Marburg virus Harvey of the West Nile virus peloton as well as second generation COVID-19 vaccine candidates.
To ensure a human can produce therapeutic proteins, such as infectious disease monoclonal antibodies with the appropriate quality.
We've expressed a number of third party monoclonal antibodies or maps, which assayed by multiple independent external parties.
From Big Pharma and biotech Decodeme here.
Our reported neutralizing and binding activity assays demonstrated great similarity between C. One produce may have and show produce maps.
The next step was evaluating these proteins in animal studies.
We observed that it seem one produce monoclonal antibody for COVID-19 demonstrated comparability to the comparator or Joe produce monoclonal antibody, but no signs of antibody mediated enhancement in a nonhuman primate study.
In June 2023, a manuscript was submitted to a peer reviewed scientific journal title filament as long as produced human monoclonal antibody provides Sars cov, two protection and hamster and nonhuman primate models.
This was done in collaboration with Dr. Albert Osterhaus and several other authors.
Manuscript, describing the safety and efficacy results with a C. One sell produce monoclonal antibody obtained from studies in hamsters and nonhuman primates.
This data is critical for our potential partners as they select cell lines to produce their commercial targets to ensure that their products.
Quality standards and safety profile required for clinical and regulatory development.
Static must stay at the forefront of scientific advancement, we also have been focusing on designing better performing molecules.
We've developed human cells Express complex proteins touches congregating antigens and ferritin nanoparticles.
The interest in Farrington based vaccines have been increasing due to their safety and the ability to enhance immunogenicity.
Nanoparticle candidates against a wide range of pathogens and now in clinical trials in diseases, such as influenza Epstein Barr and Sars Cov two.
Manufacturing challenges related to particle heterogeneity and proper clothing, if he was antigens productivity and cost still need to be overcome and we feel that the <unk> platform is uniquely positioned to address some of these challenges.
We're also developing other technologies to increase vaccine efficacy and durability.
To improve targeting methods and new more powerful adjuvant.
We developed and are testing several antigens with the aim of cheap targeting system.
<unk> Plaza and COVID-19.
Well that answered and then included he try amortization domain.
With our partner <unk>, we are very new and improve adjuvant with cement produced farrington nanoparticle antigens in relevant disease areas, such as COVID-19, pandemic influenza as well as encephalitis meningitis and animal trials.
These are advancements enable dyadic partners with the potential to develop more effective and longer lasting vaccine.
That's a wide range of infectious and other diseases.
They have the potential to be manufactured using C. One cells rapidly in larger quantities more affordably.
We've continued our focus on building and sustaining longer term strategic partnerships with leading pharmaceutical companies and partners such as Janssen Pharmaceuticals.
Which continues to show positive results.
As well as advancing commercial products and clinical development of human and animal health vaccines with Rubicon health for the African continent, and the recent production of cement expressed Tommy Crown antigen under cgmp guidelines for potential COVID-19 vaccine with Epogen in India.
Furthermore, in today's press release, we announced we signed a memorandum of understanding with the foundation biotech Niccolo D Sienna or F. P. S.
F. B S. Its function is to perform as an anti epidemic hub with a particular focus on the development and production of vaccines. The monoclonal antibody for the treatment of emerging epidemic pandemic pathologies.
Scientific developments at Sps is led by one of the world's foremost leading experts in vaccine development Dr. Marino Rep. He only Dr.
Dr. Raphael he is known globally for his work in vaccines any minute y'all immunology.
Prior to his role at F. B S. Dr.
Dr. Raphael He was the global head of vaccines research for Novartis vaccines and diagnostics and most recently served as the chief scientists and head of external R&D and the vaccines division of Glaxosmithkline GSK.
F. B S is prepared and equipped to conduct research and development clinical study regulatory approval manufacturing and commercialization of vaccines and therapeutic proteins using the company's C. One protein production platform disc.
Discussions are also ongoing with several parties interested in the potential of C. One traditional developed and developing countries.
Our refined human health objectives include a focus on sugar to shorter term product commercialization opportunities that have less time cost and risk associated with development.
We're continuing to improve our competitive capability to have an internal pipeline of proteins and enzymes with commercial proteins and potential across our core verticals, whose utilization is not dependent on lengthy clinical development programs or human trials.
This is expected to decrease our timeline to revenue potential and commercialization opportunities.
Earlier this week, we provided an update on one of these internal projects, namely the recombinant serum albumin.
The global serum albumin market is an approximate $5 7 billion dollar market growing at over 6% a year.
The increase use across a multitude 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 it's currently using product development of vaccines as a diagnostic tool and a common reagent and R&D.
There are many different grades of albumin and price points across these and other markets.
I had a kid of attention to produce animal free serum.
All of them in a competitive pricing due to our highly productive C. One and depth of his microbial platforms using low cost media.
In addition to the clinical data being generated weird protect.
Protecting our technology with a robust IP estate.
Earlier this year dyadic received a notice of allowance for you.
S patent and trademark office for patent application, whose claims cover the development and manufacture of seasonal and pandemic vaccine from the company's key one protein production platform.
This timely patent allowance comes as we announced earlier this year. The dyadic is at the forefront of vaccine development with more than a half dozen animal trials being carried out last year and an additional animal trials, which are ongoing rescheduled with C. One produce antigen for influenza.
For example, H five N one bird flu and other infectious diseases.
It was a global unmet need for more effective and more available flu vaccines.
It's been reported that the human seasonal influenza vaccine market alone.
Currently valued at approximately 8 billion U S dollars.
And expect it to grow to over $12 billion by 2028 with multivalent vaccines, leading the market.
There are many similarities in the needs between the human and animal health market for vaccines and therapeutic proteins.
And we are leveraging our science across these core verticals.
What makes the animal health and attractive segment for dyadic cause the margin sensitivity of this market.
And a significant impact and the outbreak can have on the global supply chain and potentially human health.
Cognition data and scientific advancements we were generating if not only accelerate our efforts in human health, they're translating an entry increased interest.
In our other core vertical such as animal health has demonstrated today's announcement, we've expanded our collaboration with February brick and started another collaboration with a new animal health partner on a fully funded project targeting a livestock and agenda to be produced in his sleep C. One platform.
This is why we believe this human production platform can be a global solution to emerging infectious disease threats and pandemic response and not just humans, but also in animal health.
As we mentioned late last year, we announced that we had achieved a record antigen production level of 10 grams per liter of our livestock antigen demonstrating that our platforms can produce very large quantities of antigens for infectious disease and.
In addition to the production of large quantities of antigens antibodies and therapeutic proteins. These products can also be made rapidly and at a low cost making.
Making C. One a potential pandemic preparedness platform for response or stockpiling.
Our third vertical of alternative proteins is yet another area of great excitement.
Dyadic and one which we believe also holds near term potential promise in terms of opportunity and revenue.
Exploiting this segment does not require a significant departure from our human and animal health pursuits in terms of technical capability or resource requirements.
Okay Attic is continuing to dedicate resources board for the existing and future projects.
[laughter].
Within this rapidly growing market.
The attic as launches to half of its platform.
Hey, filamentous fungal based microbial gene expression and protein production platform.
They have invested in further design and customize to enable the rapid development and large scale manufacture of low cost enzymes proteins metabolites and other biologic products for use in non pharmaceutical applications, such as food nutrition health and wellness.
One area of focus within this segment is a dairy protein and enzyme Margaret we announced today initial positive analytical results.
Successful compression of casing proteins using GAAP a S R.
Non pharmaceutical protein production platform.
Growing global demand for protein and rich foods is expected to drive casein market growth.
Use of casing for industrial applications, such as plastics chemicals, and synthetic fibers is driving market expansion.
This further demonstrates our commitment to developing commercial opportunities that transact more than one core vertical.
I will now turn the call over to our Chief business Officer, Joe Hazelton to provide a more detailed update on our phase one trial progress and discuss our business development efforts across our core verticals Joe.
Thank you Mark.
I'm happy to report that the phase one trial for <unk> 100 is progressing as planned for background to establish a track record of safety in humans for antigen is produced from our C. One protein production platform. The ongoing phase one trial is a randomized double blind placebo controlled trial to evaluate the safety and immune response of the D 100.
COVID-19, recombinant protein booster vaccines in 30 healthy adults in South Africa at two different dose levels.
There are eight scheduled patient visits throughout the 180 day trial period with safety data being collected throughout the trial and email.
Testaments scheduled on six of the eight visits.
Think of all patients was completed in late February and we currently project. The last patient last visit to take place near the end of August with the clinical study report being available in the late third early fourth quarter pacing.
Patients in both the high and low dose cohorts have reached day 90 with all patients at the low dose group, reaching day 180 from initial dosing.
Earlier this quarter the data safety monitoring board evaluated the 29 day data for all patients and found no major vaccine related safety events at either dose level and to date there've been no serious and local or systemic adverse events reported.
While the primary endpoint is safety and immune response, which produced at both the low and high dose levels, giving.
Given the evolving regulatory and market outlook for Covid. We're currently working through Big one health or South African partner to evaluate the next development phase of the D. Wave 100, COVID-19 booster vaccine candidates pending the final results of the study and the market conditions.
With the expected results later this year, we continue to validate the C. One platform to reduce clinical development risk for our partners and adding to our stronger depository of safety efficacy and productivity data regarding the C. One protein production system across a wide range of vaccines and antibodies.
For human for the human and animal health markets. The overall result is that the recombinant vaccine development and production. The C. One platform is ready for full commercialization.
Increased recognition that the C. One platform is generating coupled with the continued advancement of our scientific data is leading to business opportunities across our core verticals in.
In addition to the new vaccine project with the top biopharmaceutical company, a large infectious disease market, we have expanded our licensing agreement with rubik.
One help going beyond Covid vaccines, and accomplishing not just human health and therapeutic proteins, but also animal health pharmaceutical products.
This provides rubik the potential for a broader number of commercialized opportunities in multiple product segments. We've also renewed and expanded our research collaborations with U box and this collaboration is expected to help your bags overcome gene expression challenges using the C. One protein production platform for human health.
Beyond the acceleration of human health vaccine collaborations, we're seeing increased interest and traction of animal health as well.
In addition to extending our research collaboration with Phibro Abid to applied newly developed techniques and methods to further increase the expression level of recombinant livestock antigen using C. One.
The collaboration of February but has also expanded to include the development of additional antigens for use in livestock animal health applications and in June we entered another fully funded collaboration with a new animal health company to develop except for a different antigen for livestock animals.
We continue to make great strides in antibodies as well and we believe that the C. One platform is ready for use in human trials for monoclonal antibodies volume price specific antibodies FC fusion and other types of therapeutic proteins. The.
The advancement of our antibody development has led to new opportunities and collaborations in human health.
The Mou, we signed with Italy's D C O in biotech the poll of the Seattle to conduct research and development through commercialization activities of vaccines and therapeutic proteins, usually the C. One platform provides us with a strong partnership to advance development of antibodies for infectious disease through human clinical trials. Additionally.
Our Mou with Bangladesh as essential drugs company limited has the potential to expand the utilization of the C. One platform to facilitate research and development through clinical trials for the prevention and control diseases and improvement of public health programs in Bangladesh and other countries.
We are also in late stage discussions with key pharmaceutical partners to develop monoclonal antibodies for a number of infectious pandemic preparation.
This was encourage news development and approval of pharmaceutical products. It takes 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.
This year, we revised our research and development approach focusing mainly on those projects that have potential commercial outcomes. Examples of this revised approach is the previously mentioned research collaborations with a top biopharmaceutical company to express who produce a vaccine antigen from C. One for human health the collaboration with a new animal health company to develop a livestock.
Jim and new collaborations to develop monoclonal antibodies for pandemic threats. These agreements differ from our traditional research projects that they granted option for future commercialization license for use in their respective markets.
We're leveraging our science across our core verticals as the need for cost effective ways to produce large quantities of recombinant proteins and enzymes exist not just in human and animal health, but also in the margin sensitive segment of alternative proteins.
To support our business development efforts across these core verticals bad because building a portfolio of proteins and enzymes with commercial potential applicable across these verticals, whose utilization are not solely dependent lengthy clinical development programs for human trials.
Last quarter, we shared the data they can express human serum albumin and bovine serum albumin stably and at high levels.
These types of products are politically tested against reference samples to ensure they meet the quality control requirements for potential purchases.
This is a much shorter and less costly development process than the human vaccine or therapeutic proteins.
Now we are one step closer to commercialization and initial independent analytical testing of the company's recombinant bovine albumin demonstrated it structurally equivalent to commercially available.
Animal derived worldwide albumin and recombinant bovine albumin referenced products.
It's us a step closer to commercialization and enables business development discussions with several inches of companies as we are currently supplying samples to the market.
These and other high value and high cost targets for non pharmaceutical applications such as the recombinant Casey proteins. Mark mentioned earlier will require further development to reduce manufacturing costs to satisfy the margin requirements for the alternative protein and food industries.
We're adopting this platform is rapidly generating increasing market attention Casey.
Casing for example, axis excellent Emulsifiers stabilizers, and ticketing agent, making it very valuable for various food products.
The dairy sector Casey was crucial for cheese production enhances the texture of dairy products, such as yogurt and ice cream.
Pharmaceutical sector Casey was used as a stabilizer, an excipient that drug formulations, ensuring controlled release and approve bioavailability of medications and serves as another example of our focus on targets that cut across our core verticals.
To maximize that potential to commercialize these high value targets, we entered a fully funded co development marketing and commercialization agreement with farebox buyout to accelerate our ability to exploit the depth of this platform and expand our non pharmaceutical product offerings for animal free recombinant protein applications, such as food nutrition.
Wellness and other bio products. This partnership will help further improve the depth of this platform will also provide data with an experienced by our manufacturing partner, which can be leveraged for future products.
We believe this could be an accelerator for diavik as both our C. One and depth of this microbial cell lines have the potential to provide our partners the ability to meet timelines scale and cost demands for recombinant proteins or enzymes within their respective pharmaceutical or non pharmaceutical market applications.
While the future is bright we still have work ahead to maximize and monetize the various opportunities that lay before us and mark and I are working on revising our strategic plan to ensure we have the right infrastructure and resources to adequately address key business opportunities across our core verticals.
I'll now turn the call back to Mark for some final comments on our second 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 all our CRO 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 the advancements of our science in critical areas.
We believe that our sealing platform is well positioned to be an alternative platform and developing next generation vaccines antibodies and other therapeutic proteins for public health and future Pandemics and.
And we were happy to see you've seen one is gaining more recognition globally within academia government and industry.
We have refined our business development objectives and focus on core areas, where our technologies can have the greatest impact and we're evaluating new opportunities aligned with our verticals in targeted markets.
High potential return such as alternative proteins.
I'd like to turn the call over to our CFO paying rosin to run through our financials.
Thank you Mark. Thank you everyone for joining our call today I will now go over our key financial results for the quarter ended June 32023.
You can find additional information in our earnings press release, and Form 10-Q, which we filed earlier today.
Research and development revenue and the license revenue for the second quarter of 2023 increase to approximately $837000 compared to $659000, but its own P&L, we gotta go things.
The increase is primarily due to higher individual contract that Mount Arthur can be searched envelope compared it to the same period a year ago.
Cost of research and development revenue for the second quarter of 2023 increased to approximately $793000 compared to $411000.
A year ago.
R&D expenses for the second quarter decreased by 49, 9% to approximately $918000 compared to two $1.831 million. What do you think here a year ago.
The decrease in R&D expenses for the quarter ended June 32023 versus the same period in 2020 Chi was due to the winding down of activities a contract research organization and the consultants to manage and support the preclinical and clinical development as well.
I'll ask a decrease in C. D M T manufacturing cost as the company completed the dose in a phase one clinical trial, obviously like yeah, 100 vaccine candidates in Fabry 'twenty to 'twenty two.
G&A expenses for the second quarter decreased by 18, 1% to approximately $1.403 million compared to $1.714 million for the same period a year ago.
The decrease in G&A expenses.
Quarter of 2000, Twenty's me compared to the same period in 2022 includes decreases in legal expenses.
103000.
Management incentives of approximately $81000 business development and Investor relations expenses of $75000.
Sure, it's expenses of $37000 and other tranches of $50000.
Other income for the quarter and six months ended June 32023 was primarily from the sale of our aggregate interest.
Oftentimes L L C.
Net loss for the second quarter of 2023 was approximately $2.153 million or seven cents per share compared to $3.288 million or 12 cents per share for the same period a year ago.
Net loss for the six months ended June 32023 was approximately $3.109 million or 11 cents per share compared to 597 hundred $80000 or 25 per share for the same period a year ago.
As of June 32023, our cash cash equivalents and the carrying value of backman green hearings, including accrued interest were approximately 10.2 dollars compared to $12 $7 million as of December 31st 2022.
As the company's existing F. Three shelf registration will be expired on August 22023, we filed a new registration statement on form S. Three which contains our base shelf prospectus with the accuracy.
Meanwhile, we have notified the jaffray's to terminate at the open market sale agreement with respect to the ATM program effective August 22023 there.
There had been no sales rate and that ATM program with Jefferies.
Fighting off the shelf registration statement is intended to provide us with greater financial flexibility to access the capital markets in the future.
Sure they have to become in the Bath the interests of our shareholders.
We reiterate our projections for annual cash burn of 2023 will be in the range of six to seven new U S dollars.
Our current plan, we expect that our existing cash balance will be sufficient to fund our operations until mid to late 'twenty 'twenty four.
With that I will now ask the operator to begin our Q&A session, Joe Hazelton, John 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 package right.
If time permits the operator will allow additional questions from those who have already spoken operator.
Thank you we will now be conducting a question and answer session.
Like to ask a question. Please press star one on your telephone keypad.
A confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.
First question comes from Jon Vander, Boston with Zacks. Please go ahead.
Thank you and good evening, Mark and Joe.
Let me start off with a question about the serum albumin that sounds exciting to me is it.
Sounds like it is.
Closer than most of the other assets that you have or arrangements that you have to generating revenues what remains to be done before that could be a product that could be.
So and what is the revenue potential there I mean, I know you outlined that's about $5 billion and the market size and how that kind of flowed through dyadic.
Able to sell.
Yes.
And Joe you want to take that.
Yeah sure. So John is a great questions.
Couple of steps left for us to fully commercialize them, obviously from a licensing standpoint.
They're chasing those options today, but for a product that we would potentially look to market ourselves there still application testing and then making sure that we have full oh basically full.
Stability.
Cgmp requirements that we would need to basically make sure. We have a certificate of analysis that performs exactly like what's currently available today. So there's still some development work that does need to be done for us to do it ourselves, but from a licensing standpoint, we're actually in those discussions today.
Great and I guess.
Just the second part of that question was related to <unk>.
The revenue potential I guess.
What.
You know I think the albumin market is pretty diverse there is a lot of different uses for it as you guys had mentioned on the call what what seem to be the most likely.
End markets for the product.
Cities.
R&D as well as diagnostics would be the quickest and easiest market to penetrate there obviously, there's use of alternative proteins, because there's some other markets but.
For excipient drug formulation drug development and diagnostics those are the areas because they can be made in a wide range of grades from research grade all the way through cgmp. So it really is a wide range of markets that we can get into it's just a question of war potential customers want or what we would potentially want to do ourselves.
Okay.
Great.
And regarding the Bangladesh collaboration.
There's a there's a serious.
Outbreak of dengue fever, I believe there.
Along with that it is serious need for treatment and I don't think there's necessarily a vaccine for that is that something that they can produce in that you could help them and I'm just wondering you know.
With the need is so tremendous.
Hmm.
To me that they might be able to get something approved if they had something right and I know that the resources there aren't what they are in other countries, but what what.
It might be done there in terms of taking advantage of that potentially.
Essentially a.
More accelerated approval because the need for something that's so.
Dire.
Yeah. So let me take that call. So I've actually been in contact with Bangladesh on that very issue.
Also been in contact with one of the major pharmaceutical company that produces a dengue vaccine that.
Hey, they have registered but have not registered in the U S.
So there's an opportunity to develop a dengue vaccine using C. One.
The dengue as you May know, it's a very difficult vaccine.
To produce necessarily but to design.
And we've been in discussions for at least a year, where certain companies whether they be in India.
Bangladesh and the traffic regions, where this is a growing problem.
And Unfortunately, this problem is probably going to be heading into the U S.
Heat and the temperatures rising this year as you can see temperatures rise dramatically in the United States and there are different diseases that are popping up here that havent been here before so.
You know, where we've learned from the pandemic is.
We don't control it it's coming home to roost.
And so we've been working with different developers because one of the benefits we have as a platform company and having worldwide access whether it be Europe , India, Bangladesh, China Korea.
You you name it you know in Brazil, where we're talking to people that have these issues and we're talking about towards scientists that have ideas and as we've talked about earlier. Some of those ideas are being turned into research funded projects here in the U S. For example, bird flu, which as you may remember is.
Some are between 20 and 30% and deadly.
Hops into the.
The U S or into human beings.
You know we're already getting prepared for that we've got two different bird flu H five N. One.
Fair to nanoparticle vaccines in development with Arrow Vacs that are now in animal studies some.
Some of the next 60 to 90 days, we should get our first read out to find out how well those are doing and we think with the ferrington nanoparticle and induce higher immunogenic protection much.
Much higher neutralizing antibodies.
The response and of course can be made.
Very very large amount very little cost but.
Tango is something dengue is something that there's four different antigens that go into that.
Vaccine in the shift.
So there's different people with different strategies and.
We're having those discussions with some of the world.
Experts in that space.
Including conversation with the Bangladesh government.
Okay, great. Thanks, a lot.
Okay.
Once again, if you would like to ask a question. Please press star one on your telephone keypad.
Yeah.
Okay.
Your next question comes from Jack Williams with Williams Research Group. Please go ahead.
Hi, Mark Hi, Joe.
I just have a cool color type of question for you Mark in terms of the BARDA situation and funding of grants that they're in process of doing so.
So with the summer months for smaller grant so I don't know what they consider to be smaller grants.
But then very large grants.
Starting I guess, it's a September 25th fish.
So we I presume have started or have submitted small grants for whatever you thought were appropriate to develop.
So the question is have we done anything in that area and what would we expect that time frame to know what the government is going to do and who they are going to give these grants too.
And then secondarily do we expect to participate in the larger grants that there'll be giving out.
September 21st if you can give color on that.
Yeah first of all we have submitted the smaller grants one or two or maybe three of those in combination with different universities and scientists here in the U S for BARDA on that program, which is the advanced COVID-19, but also for other diseases as well and then we're also in discussions with.
BARDA and F T a and others on how we can participate potentially.
I mean larger grants.
As you pointed out whether those are actually going to come September 25th well I think that's that take you have to file by September 25.
I'm actually going to be announced by them.
But there is a lot of funding and theres actually BARDA, reaching out to certain people and telling them to get a hold of us. So.
Stay tuned and we'll see what happens with some of those are conversations we have ongoing.
Okay is there any approximate timeline when they're finished with this program that theyre doing.
And all of these grants are handed out I mean, when we talk about larger grants in our arena.
Well Roger Grant maybe.
$20 million grant and of course in that arena.
Giving a billion dollar grant so.
When do you think this whole area is going to conclude and we'll know if we're a player in it and we've got the grants or we're not a player in any idea as to the timing.
I don't think they've given us any specific timing ideas, but it's kind of like you pointed out is a rolling program.
So we can potentially being the first wave second wave third wave fourth wave.
We're in discussions with both BARDA and FTA, we're in discussions with people that are applying for some of those grants.
Or maybe potentially why do you see one to produce their vaccine.
So you got to remember our function enrolling that is to produce the antigens and large amounts of low cost rapidly and get the platform used as broadly as possible.
All the other funding is gonna be going virtually the other people so whether we get a direct.
We participate in it it's virtually the same thing ultimately a commercial product that gets to the clinic well have to be paying us access fees milestones and royalties on that technique and are seeing one technology, so whether it'd be potential bird flu paying a COVID-19 vaccine amount.
Antibody or things, you know like Marburg, and Ebola or other things.
So there's a variety of things that we're working with him in discussions with a variety of fronts with big pharma small biotech FTA, BARDA et cetera, and including obviously painting.
The new relationship, we just announced that Joe and I talked about in Italy.
And the gentleman there is world renowned and they're.
Funded by the Italian government for pandemic preparedness for vaccines and antibodies in that case, we're actually going to be enabling them with the technology to develop these things in house that they can move forward in the preclinical and clinical studies hopefully up to phase two b, whether they can out license those to a big pharmaceutical.
Companies.
Next question Robert Smith Center performance. Please go ahead.
No.
Hi, good afternoon, everyone. Thanks for taking my question.
Mark and Joe can you speak to the ton.
Thinking of the Janssen.
[noise] arrangement and what's been happening there.
Yes.
Yeah, I mean, we're moving and advancing forward with Janssen, we've working on two different proteins.
<unk> is a monoclonal antibody one device specific I cant actually tell you what the disease state is because that's confidential and we've made very good progress and we're in discussions with Janssen to potentially accelerate that program and he can provide more resources. So that we can get that done sooner and potentially hit our milestones.
Faster than they can get the platform embedded into Janssen sooner.
Mhm.
Uh huh.
So the I guess the.
Keyword as patients, but as the months go into the quarters.
Yes, I mean, what what is the your first shot at really some.
Central a breakthrough as far as the production on them.
What's your best guess.
Well first of all I think we've had a substantial breakthrough a major milestone where in a human being showing safety and he.
You mean Jesse.
With an antigen first time produce from San Juan.
That's a gate to opening item for big pharma for governments, academia, it's driving more and more input driving more and more program opportunities.
So I think we've already hit one of those points now.
A question well how are we going to monetize that.
Yeah Yeah.
What do you think you have to recognize is to be honest with you. We've excelled on the science, we've exceeded even our own expectations of the transformation of the technology.
The <unk> technology for pharmaceutical use and recombinant protein vaccines.
Light years ahead of people like Novavax, and Sanofi is back with virus or insect cell platforms. So now. The question is now that we're in human beings getting data and by the end of the last quarter. This year, we should have the final report and the final data complete.
And you know right now people are seeing the data within the industry.
The 2009 day data, we have 90 day data coming up soon I mean, we're already through 180 days with patients on a low dose and almost any day and high dose.
So the safety of the platform is being proven for the first time ever.
So now it's gonna be who wants to step up and get their hands on this.
For what rights, what access what fields what applications what areas. In addition to the many things we already have going on all over the world. So.
Think about it.
I mean.
Rina Rep, Hey, Orly, which if you look them up and he is now let's say, helping us showing not just for his own use.
The approach the industry in general to solve the problem of human health and human equity.
Because there is no human health and equity outside of the let's say the developed countries.
So we're getting the people in the world that are the experts who've taken things through the clinic multiple times with big pharma now jumping in and saying we want to help and.
Including some of the major pharmaceutical companies, we are in discussions with.
The top five pharma company, we're working on a vaccine with that they are fully funded that could be the major breakthrough because if we can develop that and show that that is functionally equal or better and can produce faster and larger amounts of lower cost as Joe pointed out earlier, there's a commercially say.
Ration pack into that already baked into the agreement.
So that might be the first one the cracks Diego open.
There's a variety of other ones that could happen in between.
Yeah.
Next question, Tony Bowers with Intro Act. Please go ahead.
Hi, Mark.
I think with with Covid now not so much in the news I mean that was a huge distraction, but a lot of pharma companies got a very fat and happy off of Oh, the money they made on that program.
You've talked to people for a lot of years about the advantages of C. One do you think that there is.
There's.
Urgency or complacency versus a year or so ago and is their funding.
And.
Do you think that it's it's gonna be overseas where.
Somebody gets ahead of the pack and then everybody else has to.
To get onboard so whether its the south Africans or the Italians.
Somebody will move show that they believe that there's economic advantages and then the rest of the industry will wake up.
So there you see this playing.
Yes, but I don't think it's just economic advantage I think is a life and death.
That's what people are missing areas quite frankly.
I'll tell you, who but I had a call this week with a zoom call with five or six people.
Senior people, who had one of the big let's say biopharmaceutical supply houses.
And they said the thing that I like shaking their head, saying. This is just incredible what we've accomplished to date with the science.
And you know we were talking to them about helping.
Expand the market access and we need obviously the horsepower of one of the big players to come in and help us accelerate adoption and use.
And we have that now with the foundation in biotech the polo in Italy that memorandum of understanding and we're in discussions and the contracts have been shared back and forth on drafts.
Provided we can get that sign which we're pretty confident we will.
That group and that gentleman he has contacts into everybody I'm not going to name names, but you can go from the top to the bottom and everywhere in between and every country virtually on the planet.
And he has to reach into there so he's going to bring industrial credibility.
He wanted to do the same thing we do he wants to make sure people have access.
Affordable is.
Technology can be used in countries for distribution, you don't need the cold cold chain storage.
You can produce it at a price that actually you can not bankruptcy countries by doing it.
And so I think we've got a lot of momentum going.
We've got momentum at the FDA with BARDA, we've got in Europe .
In Bangladesh and India, So I'm not quite sure there's a few other continents.
South America, we're working on that.
It might be the last frontier I don't know, but there's things happening everywhere and I would say that.
We're excited about where we are we're excited about where we're going.
But we're more excited about what we have and the next step is perfecting the antibody program because the vaccine platform as Joe pointed out it's prime time ready to go and it is being applied.
Thank you I will now turn the call over to Diotic CEO , Mr. <unk> for closing remarks.
Thank you Stacey and 2023, we're seeing the impact of a phase one further validate the siem one platform for pharmaceutical use and human and animal health.
We're also beginning to realize the investment and the depth of its platform and alternative proteins.
We remain focused on improving the value of dyadic for life science industry, which will in turn improve value for shareholders and improve access to affordable vaccines and therapeutics globally.
We've refined our focus and revise 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 Halo world.
I want to thank you for joining us on today's Q2 2023 conference call and we look forward to keeping you updated as we advance our commercial and scientific initiatives on the next call.
And I would say please keep an eye out for other periodic updates.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.
Yes.
Okay.
Yeah.
Yeah.
Yes.
[noise].