Q4 2020 Dyadic International Inc Earnings Call
Good evening and thank you for holding welcome to dyadic internationals fourth quarter and full year 2020 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 March 30th 2020, one I'd now like to turn the call over to MS Ping, Ross and Biotics Chief Financial Officer. Please go ahead.
Thank you Joe.
But even he everyone and welcome to the attic internationals fourth quarter and full year, 2020 financial results Conference call.
Earlier today that it issued a press release announcing financial results for the full year ended December 31st 2020 and the recent company highlights you may access.
Our press release and form 10-K, and or the investors section of the company website at Diavik Dotcom.
On today's call on our president and CEO, and Mark and Bob will give a review of our business and copper and accomplishments for the full year, 2020, including a brief summary of our research on business developed assets.
I will follow with them and do you off on financial results and more detail. We will then hold a brief Q&A session.
Our senior management team, Matthew Jones, and enrolling and she'll latch with Joe and Mark and I put a Q&A session.
At this time I liked and 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 have caused that if 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 these forward looking statements, whether as a results of moving information future events or otherwise.
Participants are directed to the risk factors set forth in biotic reports filed with that simple.
It is now my pleasure to pass the call to our C O Martin and thought.
Mark.
Thank you and pink and welcome everybody.
And I'm very pleased with the substantial progress made thus far and 2021 and in 2020.
2020 was a year of considerable disruption.
Suffering and death worldwide.
Coronavirus rapidly spread across the globe.
And the COVID-19 pandemic has and continues to wreck havoc on humankind.
Our Hearts go out to those who have.
And to suffer and this horrible disease.
We have been working tirelessly to identify ways in which to apply our team and technology.
And speed of development.
And availability and lower the cost of Covid, 19, vaccines and treatments to make them affordable and available to everyone on the planet.
We and our collaborators and work to introduce and see what technologies and the world to enable as many COVID-19 programs as possible.
And we are continuing to do so and COVID-19 variant continued hard.
To our success and shovel animal studies, where we rapidly engineered T cells have achieved high levels of vantage and productivity and have shown to be safe effective and protective.
And so you want technology, and therefore gained the attention of a growing number on.
Infectious disease, and other scientists and industry and government.
And this momentum has begun to accelerate after our announcement that it from.
Terry and COVID-19 vaccine candidate.
Hey, Hi, 100 and.
Advancing into a first in human phase one clinical trial, which is expected to begin and the second half of 2021.
And sorry, just coffee to continues to mutate and of different variance, we've already begun on the engineering and <unk>.
<unk> seen one cell line to enable the development of next generation multi valent COVID-19 vaccine candidate.
The D Y a 100 and phase one clinical trials purpose and.
Among others.
Elevated to the C. One produce proteins are safe and humans, which we expect will accelerate and see one technology platforms adoption and commercialization of <unk>.
Prominent protein vaccines and drugs.
Muse.
There are articles on almost every day, highlighting the Sars cov, two mutations and like the U K, South African Brazilian and now New York Californian and other emerging COVID-19 variants and Japan, India and elsewhere are here to stay.
And new COVID-19 variants are expected to have a pair of yearly which like the seasonal flu may require annual or even semiannual booster shots.
Today, CNBC reported COVID-19 variants could render.
And COVID-19, vaccines, and effective and a year or less epidemic happen day, Molly just one.
In addition to validating that and see one produce proteins are safe in humans dyadic COVID-19, D Y 100, and vaccine candidate clinical trial will help to serve as a proof of concept and the development of potential next generation multi valent COVID-19.
And vaccine candidates and closing the B, one one and seven U K variant and others.
Because of the sea ones ability to rapidly develop COVID-19, Varian vaccine candidates coupled with its relative advantages.
Greater productivity and lower cost the world is waking up and in fact, and these variants are here and they're going to keep coming and more companies recognize we exist and are expressing interest and potentially using C. One to help solve their manufacturing productivity speed and cost concerns on.
And all of these attribute and see when a tremendous advantage over other vaccine and drug manufacturing and platforms.
Beyond our COVID-19 initiatives in 2020, we commenced 11, new projects and extend it to others, including five new funded collaborations with top pharmaceutical companies to produce therapeutics on commercial interest for human health applications.
And she started this year, we have entered into two new and three extended programs and are in discussions with others and all sectors of our business, including animal health non COVID-19, human health gross factors and other potential new biologic product markets, where I've seen one technology may have them.
Tangible to overcome gene expression challenges and.
Improved performance as well as to increase yield and lower cost.
And animal health, we continue to build a strong foothold and the animal health market.
And we previously announced we've entered into fully funded agreements with all four leading animal health companies.
Well the first global animal Health company to evaluate and he won the expression and production of vaccines and therapeutic proteins for animal diseases.
We expect candidates its price you've seen one way and to our animal trials and here.
We are particularly proud of the progress made on our long standing successful partnership with the Europeans, you'll notice there's anticipation preparative initiative tapie.
Copies of a five year $20 million Euro initiative, and it brought together experts and human and animal health and to create new platforms and technologies.
Military fast coordinated and practical response to new infectious diseases and as soon as they emerge and.
And that would be selected our <unk> technology platform taboos and agenda more fishing and Lee that are safe and effective and protect them from.
Relative schmale, and Berg and prevailing fever viruses.
Notably this human gene expression platform.
Demonstrating greater productivity and simple.
Billy and the backyard virus and tech sales from both the SPV and RV Effie antigens.
Enabling the Zappy project to meet its objectives and producing enough low cost doses and went to reduce fermentation and volume capacity.
Additionally, the siem and produce antigen and <unk>.
Administrated and full protection for cattle sheep and mice from the SPV virus.
We're very pleased with the growing volume on scientific data and the results, we achieved and our own internal and externally funded programs last year and and the first quarter of 2021.
Based on a growing amount of productivity.
<unk> efficacy data generated and our own internal and third party R&D activities.
And we're being approached by many companies related and a growing number and type on infectious disease opportunities, both COVID-19 and others.
Okay.
And the non Covid human health, we're constantly looking for ways to improve our shots on goal for building shareholder value.
Beyond our COVID-19 collaborations and increasing number of global pharmaceutical and biotech companies are selecting our Cmos technology for diverse applications and human health.
Last month, we established and fully funded collaboration with turtle tree and scientific to develop several of our common and protein.
Doctors, which play a critical role and tissue development and healing, including regenerative therapies.
Manufacturing and how many human girl factors and large scale and affordable cost and it's been a major industry challenge.
And we're excited to play our Cmos technology to overcome this hurdle and a significant new commercial opportunity.
We've also expanded our presence in Europe, and Asia, and India and.
In addition to our partnership with Medi packs and South Korea, we have established a fully funded collaborations when hang too and grow Medicine company limited and largest pharmaceutical company in China by market capitalization for.
So the development on selected hanger on biologic drugs and.
Well the non exclusive research collaboration with Wuxi, biologics and leading contract development manufacturing organization and.
Korea and China.
From a strategic point of view, we believe these global co development partners and had been cornerstone on it.
Company's success to date.
The goal is to access commercial opportunities and large and growing human and animal health markets and.
Importantly, these partnerships also enable us to continually improve and accelerate development of our C and one platform and technology.
Now that our non compete with Dupont has expired and we also remain open to exploring new boat potential commercial opportunities and the industrial biotech markets.
In regard to some of our scientific achievements and for.
Our internal development. The company continues to make progress in terms of the stability and productivity of this human technology and.
Including two glad co engineering C. One sales to impart human like all I cant structures and reducing the extracellular as Proteus pack around by 50 volt.
Strides and clinical engineering, and non clinical engineering cell lines should broaden the potential applications on the C. One expression platform for juice, and developing and manufacturing vaccines monoclonal antibodies and.
A variety of other therapeutic proteins.
In closing Twenty-twenty was marked by many new partnerships and significant progress towards clinical development.
And we look forward to building on the momentum achieved in 2020 as we work towards advancing our COVID-19 vaccine candidate Py, AI and 100 and into a phase one clinical trial later this year.
We expect our extensive number of collaborations will continue to generate robust scientific data that highlights the broad potential impact of our C. One platform and diverse animal and human health applications.
And as always and we will continue to work tirelessly to advance our C. One platform, while evaluating other opportunities to maximize Italian it's really to meet the global need for rapid safe and scalable therapeutics.
And as recently announced Patrick Lucy has joined our board of directors.
I have known and Patrick over two decades.
His extensive experience and a development adoption and commercialization of cell lines. He used and the biopharmaceutical industry will be extremely helpful and guiding our strategic scientific and commercialization efforts.
And we're very excited and they have Patrik joined IONICS board of directors.
Lastly, I want to give special thanks to our employees and partners for their commitment and dedication during these challenging times.
I also would like to thank our shareholders and our board members for their continued confidence and support.
Work towards bringing more affordable health care solutions to our global population.
With that I will turn the call over to Ping for a financial update.
Ladies and gentlemen, we are experiencing.
Some technical issues with the MS Ross and we will be continue we will continue shortly.
And I read the script.
Yeah, I can read it.
In case, you tend to get on.
In addition, and financial results, we will discuss now you can find additional information on our form 10-K, which we filed earlier today.
Our cash and cash equivalents were approximately $20 6 million for the year ended December 31, 'twenty 'twenty compared to $4.8 million at December 31st 2019.
The carrying value of investment grade securities, including accrued interest at December 31, 20, Tony was approximately $8 6 million compared to 31.2 million and December 31 2019.
Our cash burn for the year ended December 31, 2020, when it's approximately $6.6 million in line with previous quarters.
And our expectations.
Our research and development revenue for the year ended December 31, 2020 was approximately 1.602 million compared to 1.681 million for year ended December 31 2019.
And we reported a slight decrease in costs and research and development revenue and a year.
And just and ending December 31, 2020 to approximately 1 million 425, compared to 1 million and for 60 or $450000.
Youre ending December 31 2019.
We also reported a provision for contract losses.
And by 187000 senior understand and at December 31, 'twenty 'twenty.
The slight decrease in brand and our cost.
Is this pain and back sorry, and it's this is why you dropped from <unk>.
Yes.
The flight interfaces.
Yes. Thank you.
The slight decrease in the revenue and cost of research and development revenue for the year ended December 31st at 2020 reflected a growing number of research collaborations to Portugal companion Tal collaborations for the year ended December 31st 2000, and mouthful, but with smaller dollar amounts for each project.
Importantly, our fully funded research collaborations continue to provide an additional source of income and particularly office assets are ongoing and.
R&D expenses. This has allowed us to mitigate our cash burn to extend and maintain a comfortable position to found our ongoing business activities.
R&D expenses for the year ended December 31st 2020 increased to approximately $3.868 million compared to $3.088 million for year ended December 31st 2000 Leitzel.
The increase primarily reflected additional costs on the COVID-19 related projects and the other internal research projects.
There were no with R&D expenses related party for the year ended December 31, 2020 compared to approximately $869000 for year ended December 31st 2000 and neitzel.
The decrease was due to the completion of the research service agreements with PDI and June 2000 and Nigel.
G&A expenses for year ended December 31st two 'twenty, and 'twenty increased 10.2% to approximately $8.085 million compared to five year and $520000 for year and December 31st 2000 and rifle the.
The increase principally reflected increases in noncash share based compensation and expenses up $397000.
Insurance premiums and other outside services up $216000 legal and ICT.
Registration expenses of $193000.
And this development and the Investor relations costs.
$191000 offset by reductions and executive compensation costs, and the accrued incentives of $216000.
Great show and travel expenses of $143000 and other decreases on $73000.
Interest income for the year and December 31st 2020 was approximately $447000 compared to $985000 for the year ended December 31st 2019.
The decrease was primarily due to a decrease and interest rates and yield on the company's investment grade securities, which are classified as held to maturity.
For the year ended December 31st at 2020. The company also reported an unrealized gain related to investments and Alpha Guy.
Resulting from the third party capital contribution.
As of December 31st the 2020, the fair value of the company's investments in opposition was approximately $285000.
Net loss for the year ended December 31st the 2020 was approximately lightweight and $3 million or $34 40 per cent per share compared to a net loss of $88.3 million or 31 cents per share for year ended December 31st 2000 and Nigel.
And <unk>.
Looking forward, we expect our total cash burn for 2020, one will be in the range of 10 million to $12 million taking into consideration our phase one clinical trials and other ongoing internal research projects.
We believe we have sufficient funds to provide the working capital needed for our research and operations for the next couple of years.
With that I will now ask the operator to begin our Q&A session Doctor role and Shallots and Matthew Jones will be joining mark and I to answer your questions. Each caller will be allowed one question and one follow up question to provide all callers and opportunity to participate if time permits.
The operator will allow additional questions from those who have already spoken.
Hi, Joe.
Thank you at this time and will be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is and the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing.
On the Star Keys, one moment, please while we poll for questions.
Okay.
Our first question is from Jason Kolbert from Dawson James. Please proceed.
Hey, Mark Hey, paying thank you very much for the update.
And I want to go after a couple of things Mark you talked a little bit about the coal co van variance.
Have you seen reason to believe that any of the vaccines are showing resistance to the variance because my understanding is that they are all targeting spike protein and while I don't want to use the word that its a conserved region. So far.
And the best and my knowledge, we have not seen mutations that are favorable in terms of resistance to the vaccines and maybe that's inevitable, but I'm asking you and your team scientifically do you think that could happen where that that is likely to happen.
Well you know I think that day scientists globally and I think there was a survey today and feel that day mutations of the <unk>.
Coronavirus could render a current vaccines and effective within a year.
And what and effective means to these experts and 28 countries.
You know I'm not sure, but our scientists from the Zappy group scientists, we've talked to and Oxford UCL.
And otherwise believed that he.
And what it's imminent.
Going to need to have very and vaccines to to give full protection, especially and some of these countries and arent getting fully vaccinated for years okay.
Okay. So what you're what you're saying is that the spike protein is not a concern free Jen and therefore like a chain of marble that can rearrange itself and sense of it.
All of the vaccines that I'm aware of or are getting that spike protein that you know it's inevitable that we will see some.
Escape variance.
And what you're seeing inchcape variance, now and South Africa, and Brazil, and Japan and India.
No New York.
To the best and my knowledge, we have not seen escape variants, and Japan, South Africa, or Brazil, and you know I've been really up to date on that so there had been variants and they have changed the profile, but nothing in terms of the ability to render say the mrna vaccines or the J&J vaccine.
Not effective because the reach and they're targeting and the spike protein so far has not changed.
Surrender the vaccine.
And that's why it becomes a very important question.
Well I think if you look at it the J&J vaccine and Novavax vaccines and some of these other vaccines.
And certainly less effective on us.
South Africa and variant and.
And I'll, let Ron and answer the question because he's more technically astute.
Corona and are you there.
Yes.
And I think that it was really nice and shown that it goes volumes also have a very important mutation on there.
And the receptor binding.
Motives.
And all of those changes really showed higher affinity book binding to the Ace two receptor and.
Obviously.
That shows that there is some benefit by having a different type sales.
Yeah.
Antigen.
So I think and general.
And obviously I think the current.
Vaccination and it does work on the Caribbean.
We continue to take time to understand who each level and really could take the population.
The strength of the bare steel and so many.
Infected people around the globe.
And there are many more.
Daria and Statoil abuse.
By all kinds of mutations for peak the ability.
To be able to quickly respond to.
So any kind of.
New variants.
He is a very important.
Sure.
Tooling and that's it.
What we are aiming to get no argument from me about that and what I'd like to do is if we extend the question a little bit further.
I know, you're working and Israel, Mark I know, you're working with Zappy. Congratulations on the deal you announced and Korea, among those deals or others that we're not aware of.
Are those partners working on different regions, so that they could potentially come up with a different vaccine that then incorporates the fee one platform.
And that you potentially are in a position to offer a new COVID-19 vaccine that.
And would not be that that would not be one that would be resistant to say some of the mrna vaccines that we're seeing today.
Yeah, They and answer is yes, and that's one and I think the significant advantages of a recombinant protein productions as simple as that we can produce individual vaccines the different variants, whether it be Brazil, South Africa in U K et cetera, and then we can blend those two specific ratios.
And now the vaccine to cover more broad protection and.
And whether that's a full spike or the air B D vaccine or a combination thereof.
But we also could provide those ingredients are the active ingredients to other people the mix and blend and with their Vic to make their vaccines.
So what I'm going after Mark here is that you know how excited are you with the current partners that you have that you guys will potentially have a novel b that the dyadic could be part of a novel vaccine that could emerge and what's the timing look like given the fact that you saw.
Starting to go into phase one with this first generation vaccine.
Is it a year is it two years.
You know how do we get a handle on kind of the timing and catalyst surround like COVID-19 related programs.
Well keep in mind, the first day, why a 100 and we're going and do human beings first and foremost improve safety and initial efficacy not just for a COVID-19 vaccine, but to demonstrate the proteins therapeutic proteins and other vaccines for human disease can be produced safely and <unk> and T. One.
So that's the primary goal and it was always to go at the beginning but in addition to that to your point, we've already started day engineer T. U K variant of South African variant.
South American or Brazilian variant to have these mixtures of vaccines to actually come out with a unique and novel better protecting vaccine how fast it happens.
After we prove safety and preliminary efficacy of the T Y a 100 or before that and discussions, we're having with pharma and biotech companies.
And as well they join in and speed that development and that's what we're hoping will happen either before or after we announce the results and which we believe will be safe and share.
Prelim preliminary efficacy.
And I think mark and realizing.
Good morning, and realize Yeah go ahead and two more quick questions. One is I want to keep it short because I.
Yeah, but the pizza line.
The the vaccine economics traditionally haven't been great and when I look at dyadic I'm trying to understand what your vaccine economics on it because youre not necessarily be originator right you're more of the manufacturing partner should I be looking at that that way or should I be looking out a little bit differently.
<unk>.
And this particular case, we are the originator we have the cheesecake weighted ours to cell line is ours and we're moving it into phase one human trials and ours. So it's and owned vaccines and dyadic not just at the cell line provider to you all the variance being loaded into this he won for the next multi <unk>.
Rod.
And at a multivalent tetravalent trivalent vaccine and those are ours now those can be licensed out to other people, but in addition to our own vaccine we have other well other people, bringing us gene sequences and addition to this when second generation and vaccines, which are theirs, which we're helping to enable.
And then obviously Sharon.
Sure and and reward to that and then they can use and Randy tax we're partners and that deal when we shared greatly and the economics on it.
And I understand and.
So two two last questions first of all in terms of the financial burn guidance. Thank you paying your guidance was exactly you know its been you'd be expense control. It's been great at the company and your guidance is right and the right and the middle of my numbers. So that's exactly right. Thank you bought where I.
Get a little bit confused mark when you and I sat down two years ago, and we started thinking about all of the different areas, where we could see business. We talked about bio generics, we talk about traditional pharma products and of course now vaccines and we had said that you could see a business development deals and partnerships.
Submerge over the next couple of years from any of those sectors. Today, we're very focused on COVID-19, but should we still be modeling and yields and partnerships in those other areas.
Absolutely as we mentioned, we signed deals with five people and pharma last here on <unk>.
<unk> and some of the new deals and we've mentioned and some of the recent conference presentations we have a.
Pharma Big Pharma company that funded research last year net funding and additional research moving towards oncology and rheumatoid arthritis, and with two of their protein drug candidates and it could go to regulatory that could turn into a license agreement. We're in discussions with a lot of different animal and human health companies and addition to the ones that are already in.
Doing research and development I think this year, you're going to see and accelerated pace and.
11, 13, 11, new deals and two or three extension and last year.
And we're already at the pace and a five and it's accelerating right now and its most day non COVID-19 Mark. Thank you very much really thanks for letting me take up some time with all the questions I appreciate it. Thank.
Thank you from your help.
Thank you Jason.
Thank you. Our next question is from John vendor muslin from Zacks.
Investment research. Please proceed.
Hey, good evening.
Wanted to ask about the IMD and interaction with the FDA that you're anticipating over the next few months.
What what what do you anticipate some milestones to be and that in that area and are preparing the I N D and then.
Ensuring that our it gets cleared within the normal time frame.
And Rona and you want to pick that up.
Okay.
Okay.
Yeah. So currently we.
Going forward the.
Total hygiene. So currently we are going to do.
Two.
So the cash.
Oxy colleges study.
Stone soon.
And then.
Once we get.
And the Green light.
The next day it would be to go through a phase one clinical study.
And.
And to stop it and see.
And in August.
And I think after that which enabled the paperwork to submit in order to have it.
To be able to go full day next clinical studies.
Does that answer your questions.
Okay. Thank you. Thank you and then.
And you know looking down the road a bit how far can and dyadic go with UA I 100, before you need a partner.
Well, it's not a question on how far we can go and telephone you want to go.
And I think the point is and we will look for a partner a centrally show safety and efficacy and your preliminary efficacy, but we're also and discussions and talking about partners right now and haven't been about picking that up.
And I think what the main interest is the do you want again I'm going to repeat the D Y and a 100 is to prove safety and human beings not just for this COVID-19 opportunity, but for virtually and hundreds if not thousands of potential products and the future for human drugs and vaccines that's there.
The main purpose and sell.
Secondary purpose and addition to that as you work on a variance, which we've already started to engineer because we believed and we can make variant and larger amounts and a short amount of time and less cost to help the world out of this horrific situation that sitting in and we believe that recombinant protein based technologies and.
And I recombinant based cell line and far more productive than any other cell line. That's out there today as you know and the Sappy program and otherwise we've shown vs. In tech sales tobacco virus, 300, and fold improvement and productivity.
We have now demonstrated and cattle sheep and mice safety efficacy and protection.
So if we achieve the goals and objectives of this clinical trial, not only we're going to demonstrate safety and human beings and it can be leveraged and accelerate the commercialization efforts for human pharmaceuticals, but potentially we could be the one company that can make the quantities and the cost on.
Flexible commercial scales for trivalent or tetravalent, COVID-19 vaccines on an annual basis, what's the world may need like seasonal flu shots and that continues to persist as many experts.
Basically you predicted.
And then I think we're in great shape to pick up partners to pick this up and run with it and it finance and all the way.
Yeah, just two of them on the adds a little bit on Mark's comments I think it was from financial perspective, we are constantly evaluating our collaborators and partners to either co develop our has a non diluted funding in the case of Natty talks and this is a co develop scenario.
And where maddie task on up to their own resources and folding into the part of what they are doing so as you and John you know we are very careful about our cash and also how we use the money to most economically and.
Making more sense for our shareholders too.
Events are signs, but at the same time, you know maker, it's a more efficient all from financial perspective.
And sorry about start dropping off the call earlier and it's just a typical a pandemic situation and working from home and I'm trying to and new debt sales.
But we're on bottom.
So I think John.
Yeah. So John I think it's important you know if you remember doctor Yang from many talks as you pointed out they started working with us and July of 2020.
And that was after day basically evaluated chose health and inject cells and they saw the remarkable versatility and Piper productivity of C O and with their own hands and we've already transferred on the technology and have grown it up and they've reproduced a productivity and their own tanks.
And so and he pointed out the <unk>.
One giant derived T. One expression system and his mind is and most realistic technology to develop and manufacture multivalent, our trivalent tetravalent vaccines.
And these COVID-19 variance if people are struggling today to produce one protein one single vaccine based on one protein how are they going to do three or four and and economically viable manner at affordable cost and the volumes and the world needs.
So we're hoping that this puts us and even a better position this year.
And we were last year because of the variance and the need because if you realize seasonal flu vaccines are comprised of four different proteins.
So we're gonna need potentially tetravalent on a quadrivalent were trivalent vaccines and potentially on annual basis and if that's the case I believe we can make more for less and fly so commercial scale with a technology that can be tech transferred and <unk>.
Brown and single use where stainless steel standard micro for microbial from enters that are basically available on every continent and multiple countries. So I think we're sitting pretty and Thats why were going forward day, why a 100 and it's proved the safety preliminary efficacy and we're already engineering the variance.
And we think quite a great position to help the world to help our shareholders create significant value and and together we can help eradicate this horrific disease.
Yeah.
Great. Thanks, Kurt Thanks for taking the questions you guys.
Yeah.
Yeah.
Thank you. Our next question is from skip Gaza.
Clooney Road rental please proceed.
Hey, Mark How're you doing.
Good how about you.
Good so mark I kind of I want to kind of piggyback off of what Dawson James was talking about what's the fellows name there.
Hi, Jason Kolbert.
Yeah, Jason.
So you mentioned to him that.
Yeah.
This this vaccine that we're working on the Covid vaccine.
We have to get through preliminary to make sure that we're safe you ever you already gone through animal trials.
We have every reason to think.
That it should be say.
When it goes into human trials based on our past experience of word of what you've done now. This has been a long road you got you sold out on the industrial side and 2000 and at the end of 2016 or June of 2060.
And here, we are almost five years later.
And we still don't have any income right, we have and we've been you know advance and the technology for the last five years, when you got that $75 million.
And we're at the point right now I'm going to try to dummy down dummy. This down so that you don't have to be a scientist to understand these phone calls ive been and Investor and this company for a long time.
Let's just say.
And.
And we're we're baking bread and.
And the bread that we wanted to make is whatever there's only a few ingredients 345 ingredients water sugar the Doe etsy.
Et cetera, but not a not a lot of ingredients I'm, assuming these COVID-19 vaccines that are out right now have a lot of different ingredients and it is that right or not right.
What do they have a number of different components and to make up the vaccine candidate.
And ultimately became the product.
And then D Y a 100 and he's on the same parallel path hits comprised of different can't different components that make up the actual vaccine and addition to the protein that we produce from Tijuana.
Yeah, Mark it's not.
And like I stated is that the same is it the same amount of components or is it is it much less because of the C. One technology is my question.
Yeah, well, it's actually less than that because it does seem on technology and because we think keeping it simple allows us to produce and effective safe vaccine that can be made and billions of doses.
More quickly and more cheaply using standard manufacturing facilities all over the globe, but it contains and adjuvant, which is basically helps boost him and agility and other components to make and stable.
Okay, So and the last five years when you got that money and you started focusing on.
On a.
On the pharmaceutical side and 2016 is when you started moving towards pharmaceutical and got got out of the industrial side.
You have.
I'm assuming that this technology has advanced tremendously.
With the amount of money that you have spent and the last five years and that's why you're at the point right now where you're saying you know what we're gonna take 12 million 10 or $12 million and we're going to get this into humans and make sure it's safe and once we get on it the humans and I'm just trying to make this as simple as possible and once we get this into humans and we.
No I'd say now we're gonna get People's attention and partners that can come in with a lot of money and start manufacturer on either partnerships.
I don't see you dyadic do and this alone and that's you guys are and our royalty business youre, not the manufacturer and business and going to be spending hundreds of millions of dollars develop and a vaccine which is what most people think it was what it cost and probably what Jay what these two vaccines caused by Madonna and Pfizer right.
Yeah, I think what do you have to realize your question over the last four plus years because by the time, we transfer and detect nowadays Dupont and got started with the genetic engineering and and synthetic biology, just as an example.
And if we didn't knock on these protease genes, where we've knocked out fortino Dom and he won and we would not be making these vaccines at the levels, we're making them at went to stability and we have so the investment and the platform has paid off and speeds not only for dyadic and it seems to shareholders by making.
And what we believe is the most productive.
Recombinant protein sub unit vaccine manufacturing platform on the planet, it's paying off for human beings potentially and potentially use non over this pandemic, but future pandemics and and variance, but also to your point for 100 and potentially if not more of vaccines and drugs once we prove safety.
And human beings and when this whole thing started.
Isn't it taken our own vaccine and make it on their own but to partner it out to your point, but we wanted to start out and this is the quickest easiest least expensive way for us to get into human beings improves safety and guess, what we're going to do that and.
And when we do that to your point, we believe although we havent multiple conversations multiple collaborations already more coming that accelerator will expand dramatically and we're seeing that now and basically what we're doing and as every day. It seems like we're on phone calls two or three calls.
Discussing either science business development collaborations and potential licenses on animal health and human health and COVID-19, vaccines and antibodies and.
Other treatments.
Because it's a plateau it's almost.
So it's almost like you build and a 50 story building.
And you're finally getting to the top floor and now these apartments or whatever it is they're starting to.
Now you're going to reap the benefits all the hard work has been done over these last five years you made your investment you got to fish and on your technology through your partners and all these different scientist on every partner that comes in and now you're getting to the point, where you're getting to be able to cross the finish line and what it sounds like and in layman terms simple layman's terms.
And I think if you think about Elon musk and Tesla, how many naysayers aware right.
We saw the future we believe that bio manufacturing was inefficient and too slow too costly to existing technology that people are using her and effective and too costly. So we looked at we had away from the industrial business and we had spent two and a half decades and hundreds of millions of dollars were spent by us and Oracle.
Operators and licensees and we felt and have now demonstrated.
And with data.
Nipping and amount of data safety and efficacy potency and animals and now we're moving toward humans and as I mentioned, we believe from a recombinant protein production system, we have the most efficient way to develop and produce <unk>.
And in vaccines and any other cell line or any other technology on the planet.
And net debt.
<unk> and drive significant value and Covid and otherwise.
So I know you like a simple examples where I can take example, analogy I usually use is comparing the Microsoft operating system versus Apple you know people.
And how long it take people to switch from them and to realize the benefits of Apple Cisco and Dell.
Iris right I think that that's kind of.
What we are doing to introduce C. One fifth and as our new operating system and Florida for the biotech industry and that the more people realize the benefit of assets and more people.
Doing more task to drive like March and.
Mark's example, there the more people will know this technology and that's how we increase the awareness.
And that's what we had in doing and the past.
Yes.
And on transaction.
Well I think we did have quite a lot.
Lot of achievements, such as pharma collaborations and also the comments from the DAP he content.
This is from now you'll know the top notch science and stuff.
They're complementary and their comments on pool, one technology, so took on deals and to show people on.
And the benefits you know and convince them to switch from Microsoft and Apple computer is a process and the same time will take on.
And leadership and also vision for people to use that but at the end up you know maybe some people just don't like Apple computer liked it for me I will never use excel spreadsheets and from Apple and its just not a lot to do on what I wanted to do so just give you that example, and the whole thought that will help you to understand and so what are we are trying.
And to do it here and there.
Yeah.
Well and I think what and skipped a pandemic.
What is on the radar screen of more people than we ever would have imagined.
So it brought the attention due to inefficiencies of the current manufacturing processes. Virtually every day somebody is writing an article about one or more of these companies failing to meet the manufacturing quantities that they promised.
And at the technologies that people are using are failing and and in some ways and we believe that our technology can solve the problem better more efficiently at a lower cost and can be used locally from people to manufacture their own vaccines for the next pandemic and a variance and that's what we're doing we're looking to partner.
And as technology for animal health and human health vaccines, Covid vaccines COVID-19 antibodies other treatments, all biologics and we're getting more and more attention because of the results and and pinpointed out. He was low you watch those presentations from Zappy.
And five year recap.
Eight hours of videos and 14 presentations, where they basically talk about and part of there is nothing else came out of staffing and five years see one was fantastic and if nothing else happened that was a phenomenal thing and those are from some of the best Independent third party infectious disease, Kona and Corona.
Iris scientists on the planet and.
And so we didn't pay them to do that and they came up on their own conclusion, because they tried it and they felt it so when they see it firsthand just like the Israelis and now I'd like to Korea, and this is the most realistic way to develop recombinant protein antigens.
COVID-19 variants and other protein antigens for traditional vaccines and drugs.
So once we know that it's safe and humans, which we're gonna know and about six months right.
And then that is a big part of the equation is that correct.
And what else that's why we're doing it as a stepping stone to exploding the adoption and use of.
New platform, but even despite not having that data.
More and more pharma companies biotech companies animal health companies governmental agencies are still excited about same line and already funding research expecting there those results are going to be positive and we will show safety and Theres No reason.
And that we know of the C. One won't be safe and in fact, probably the pedigree on at Siemens airline and as far as favorite and he called line, which is used to make drugs. Because there you have endotoxin and did you have to remove and we don't have those and the first place and see one we don't have viruses like they chose health.
So we believe all the animal data all the clinical data and we've had so far a preclinical all the other data on the graph toxicity.
Pathogenic studies show Us and we should be.
Safe and human beings, and we intend on demonstrating that and then obviously using that has and accelerating tool to expand the breadth and scope and depth of where we can apply it as on human health animal health and for infectious disease, Covid and otherwise.
So.
And six one were.
We're gonna have escaped like and I think we should let someone else ask some questions. If there is anyone else from here, Let me get let me just let me just finish up with this so when when when.
And when we finish.
Human.
To get through the the the first part to find out whether that whether C. One is safe at that point, you're thinking that that's when the big pharmaceuticals could come to you and say hey, listen we're ready to rock and roll with you, we'll put up the money and do whatever or go into a partnership or whatever is that one.
And you're expecting some income as there is the question and I'm getting too.
Although we're expecting and gum, even before that because some pharmaceutical companies are already and the door. As we mentioned one is already heading potentially towards the later stage and that clinical trial, but and our development for potential late stage preclinical for oncology and rheumatoid arthritis and those.
And could go to regulatory and so they're going to need a license to do that.
And so we're also and discussion with a variety of other pharma companies and animal health companies.
And may jump in before that so yeah.
You know some people have vision.
See the future and they want and get ahead of it.
Some people want to wait.
Maybe too late and that's why and that and that's when the royalties could start right.
Or their upfront access cash like we saw on the industrial side upfront cash payments milestones and royalties.
So you're still on the royalty part right, you're not going to be you're not going to be funding. This yourself to come up with the vaccine and youre going to be getting a partner. After you get through the initial phase of human trials as is my point.
And that's the point and yeah, and you point to 10 and $12 million is not about the findings of the Covid phase one that's the total spending.
Burn for the year, that's just part of it and that's a small part of it.
We're not burning a lot of money to do this trial, we're investing money that you can accelerate the development and increasing shareholder value and have the technology.
Yeah.
And maybe we can get the next question is here somewhere in there.
Yes. Thank you. Our next question is from Dick Williams from Williams Resource Group.
Please proceed.
Hello, Mark on the next question and I've been patiently waiting for you.
I mean I haven't read.
Hi, I have two kind of short questions. The one thing is it in relation to the new vaccine and diet of 100.
And you've kind of sold all of the aspects and merits of why that is so terrific and let's see one platform and so terrific.
So and and getting some color on the filing you're going to have to file and I M D.
With the F D a.
When you're finished doing the things that ronen said and mentioned at that juncture you are ready to file.
The I and day to get approval for the trial.
At that juncture have you thought about the ability to file for breakthrough designation and this filing.
I've already given all the answers that I was going to try to throw in as to why you should do it.
C. One and the fact that it's totally a typical towards the other.
Drugs and everything else developed and number one the platform and everything that goes with it and most especially.
Throwing in another advantage, that's very very major at least in today's day and age and that's to be able to scale up production at low cost to get this into the hands of billions of people worldwide.
So combining that aspect of it as well as all the things you brought to four.
That heretofore have not been done by anybody filing for and I and the for drugs. This is the very first time.
We should qualify for breakthrough designation and have you given thought to that or review of course and of course, we have and of course, we're going to take the quickest path forward.
But dyadic itself is not going to go on phase two and phase III clinical trials that would be a partner or it'll be a partnership or a collaboration like many talks where we're a co developer, but theyre going to be doing to financing and moving forward at their dime and our financing and a range.
<unk>, four as well and we're going to share and and commercialization profits of that product.
And if those products come to market taken we could decide to expand to south East Asian licensure and if they take that at the time and to further opportunities, where we could take that technology, and Bridget and run and other markets as well. So we've done a lot of different angles and getting the job done.
But first and foremost we're focused on getting the human trial up and proven and then we're already working on the variance. So we can quickly.
Slip those and modify it and make a better vaccine with broader coverage and.
Jason was talking about.
And we're wondering and we don't know if and how the FDA will react but how these mrna vaccines are going to make tetravalent and quadrivalent vaccines, because that's going to require and it.
And put three or four genes and a vector that goes and near body and asking a body to do three or four things and once instead of one thing. So we think there is a recombinant protein production and says Tim and we believe we have the most efficient effective one and is not just about large scale production because we can make.
And massive amounts of human and small from enters because of the productivity. So it can be made regionally. So.
So we believe that recombinant proteins.
Going to be a big let's say help and combating these COVID-19 variance because if we can make numbers of them and we can blend them off.
Two specific ratios so the day F D. A knows exactly what's going in and what proportion each time, and we think that the cost and the yield that we can do that add to your point that and where it actually better shape as I mentioned earlier. This year than we are really last year, because now people know we exist Theres a new.
And exist. These variance if they don't go away and there.
And can it be around a long time potentially year after year and then you can make more for less with broader protection when does it race.
And Oh and I like the tortoise, we're not going to burn out on the way up.
[laughter], Okay last question and in terms of where we are today and the marketplace and obviously for some reason we don't seem to get the same recognition and from the financial community.
And that we have gotten and are continuing to get and the medical community and scientific community.
How are we doing and stepping up to additional analytical type coverage, where the story will get broader.
Reach and to the financial markets and any comments on that.
Yeah paying do you want to comment on by that firsthand and I can follow up.
And what's not just me and answer any questions.
Sure I think you know it takes time and the assets that you get attention from the investment community and we are.
We're putting a lot of assets and doing that and and we also are engaged the difference Oh, you know investor relations firm to help us to again awareness Opex I think.
And.
And also takes time and effort and you guys know that we are running very lean and efficient and how it's all about management tool you know just with all the.
Business size ongoing it takes a long time of March time.
And also you know going on the math you are used to be on the road. All the time this year and we actually had the benefits and you know working from home and to have those online virtual calls.
Sometimes you know I think it takes to and several calls too far enough to understand our business to really understand what is the one on what's the onetime accomplish just like a you know a lot of long term investors on the call, including skip and from other people I can't recognize that rule on it too.
A while for them to truly understands our business and and the module on the busy.
And a strategy and a business model that we are happy and so.
So I think we're working on that and we will we will get there.
And our opinion I think one of the things that's really exciting and.
And we're seeing growing demand and interest from the analysts and the banks. The banks have always been excited by the analysts and our kicking in and it certainly and as you have conversations with us much deeper.
Think about whether they want to launch coverage or not and.
Addition to the tax and.
Jason Kolbert, who were thankful, arguing coverage, but there are a variety of other analysts that are involved and a space and recognize the science and the technology and a significant advances we've made on both and the business development efforts and the expanding partnerships and collaborations like Matti <unk>.
<unk> and others.
So I would change and stay tuned and we hope to get broader coverage by more analysts and.
And have a deeper understanding of what we're doing.
And it can help us gain and exposure on wall Street, but be honest weighted exposure, we need we're getting because of pandemic brought us and a forefront and they bought the problem and a forefront of bio manufacturing.
And so as pinpointed out some people are never going to change from Microsoft Apple, but the market is so big.
And a few change a huge win for dyadic can see one and then more and more people just like I said with Elon Musk and we now believe it is I guess, what all the manufacturers are now making electric cars.
So we believe and time see one would become embedded and laboratories all over the globe from really good reasons.
Enablement.
Hello, and high productivity low cost and flexibility.
And across.
Hundreds if not thousands of opportunities.
Outside of Covid, and let alone and Covid, our other infectious disease.
And I'd say stay tuned because the infectious disease people and our scientists.
Scientists and we talked to at UCL, and Oxford and you tracked at Tahoe. These guys are a biggest supported because they've seen firsthand.
Power and not pull it caught up and the politics and why.
And to do the right thing for the right reasons and that does and she and one is there to do the right things the right reasons, and the largest productivity and lowest cost and flexible commercial scales and and and that's kind of went out so we need to be patient and we don't need davita here and we need to be to tortoise, because we're not going to burn out.
On the way up.
And so.
Okay, Mark Thank you keep up the great work.
Thank you. Our next question is from Lee Alper from Hammock investors. Please proceed hi, Mark.
Gratulation zone.
Progress you've been making but can we step back a little bit from Covid and talk about animal health.
And that'd be tanks.
Sanofi.
And telling us that you know we've been waiting for them to make a decision for quite a long time.
I mean, what's going on with the program with them and.
Well again I'm on a health people.
Yeah, So sanofi, we talked about before they there and trying to find some protein that fits exactly and for C. One and something that as I mentioned before they were one of the Microsoft people that are having a difficult time switching and Apple.
And it isn't and they don't know we have a more powerful way to make proteins and interesting.
I'm gonna find one virtually that they can't make efficiently and effectively and their existing technologies and use that to sort of paved the way on that.
And on the health side high if you have been watching or paying attention to these yappy data and have generated for the SPV antigen and <unk>.
And when he showed the hyper productivity.
300 fold higher productivity than and check sales are back and the virus per day showed now safety efficacy and potency and sheep cattle and mice and now theyre doing even further trials with that more animal studies on both SPV and a rift valley fever virus.
We're also involved on it.
Top animal health companies and some of those programs are moving forward as well.
So I would say stay tuned and hopefully someone else ahead on heading to their own commercial animal trials and moving towards the commercialization.
What's it going to take to.
Get one across the line and give you some money upfront and and work and deal.
Well I mean, we're working on it every day and I can tell you is that you know we're we're busy every day with calls, but some of them and existing research new ones coming in new discussions about potential licenses with one or more of them.
And so it's a work in progress.
Is it going to take certainly the data is and they're on the vaccine side, it's compelling and I think.
And probably as I mentioned, we believe and I think if you talk to the scientist from Japanese and other people firsthand at I B are that we have the most productive way to make recombinant antigens.
On the antibody side, it's still cake being baked and we're making progress.
Haven't achieved everything we wanted to do there, but we're we've made a significant let's say and roads and are getting where we want to go we've got high productivity and certain of those molecules. We've got stability on certain of those and we've done Gleg engineering now, we're putting all those pieces back together.
So we have the tires and we have the engine and we have the chassis.
And we're building it so that it all runs when you put in the race and actually run smoothly and efficiently producing the protein you want whether a profit at properties and the right quantities and the right quality.
And that's on the Mab side.
So there's a variety of different uses and applications and web.
Primetime and.
On a common and vaccines and we're being developed and put together all the pieces of the C. One mab production system.
And so is it productivity quality and stability and glycol engineering.
Thank you. Our next question is from Robert Smith of Center of performance investment. Please proceed.
Alright.
Thank you Mark.
It's been a long time here and thanks.
Thanks for.
Staying low standing by and except and Michael So Mark I, just wanted to circle back for a moment and look.
Look at the time line from the clinical trial. So here we are at the end of March and end of Q1.
You said, you're going to go into the clinic and the second half of the year.
So that's anywhere from July one to December 31st and.
Give me an idea or color on what what's going to impact when you're going into the clinical trial and the second half.
And Ronen mentioned earlier, we expect to start to talk study.
And next month.
And we expect to start the clinical trial phase one clinical trial sometime at the end of August.
Okay.
And tomorrow, there's a little more zero and four yeah.
And that's good.
And that's what I was waiting for and thanks for Coke, we would start the clinical trial last year. If we have the data, but what we did if you remember we ran multiple animal studies all over the globe with multiple parties and academics.
From a surgical biotech companies and governmental agencies to get a good feel for the performance the efficacy the safety and animals and.
And then we put all that together and made a decision on.
To put what we think is a slam dunk in terms of safety because the most important thing we got approved first.
Safety of our protein produced from tier one and human beings and that's the overriding factor of a clinical trial.
So thank you and me to.
Oh, Yeah go ahead.
And you get and thereby August 1st how long will to try and lands.
I don't know how long it lasts and I will get a good read out and I'm sure by the end of the year on the safety have not right towards the first.
'twenty 'twenty, two but I think by the end of the year, we'll have a good read out on the safety and.
And although we've been able to report something to you there.
Great. Thanks again.
Great Good luck.
Thank you.
There are no further questions I will now turn the call back over to Diane.
Dyadic CEO, Mr Emo, Florida.
Thank you again to everyone and for joining us on the call. We're pleased you could join us to hear our achievements over 2020.
But we started to achieve in 2020 one.
We look forward to the continued advancement of our innovative Seo and platform.
Business development efforts maturing and do bigger and broader deals and keeping you updated on our progress along the way.
Okay.
Yeah. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.
And that's true.
So how are we clear now or no.
And that's actually now.
Well.
Yes or no.