Q1 2021 Ibio Inc Earnings Call
[music].
Good day, ladies and gentlemen, thank you for standing by.
The the bio fiscal 2000, <unk> first quarter financial results conference call at this time.
All participants will sit on the.
After the speaker's presentation, there will be a question and answer the question asked the question. During the session. You ended the press Star then one on your telephone keypad, if you're acquiring the further assistance. Please press Star then zero.
I would like to turn the conference over to Mr., Stephen Kilmer of Investor Relations. Thank you Sir please begin.
Thank you Robert Good afternoon, everyone. Let me start by pointed out. The this conference call will include forward looking statements regarding I buy on itself.
Often but not always forward looking statements can be identified by the use of words such as of May might will should believe that's the dissipate as they continue per day forecast project plan intend or similar expressions or statements regarding the intent belief that the current expectation from forward looking sales.
Statements on based on the current expectation of the management the.
Forward looking events and circumstances discussing the conference call may not occur by sort of satisfy dates or at all.
The from its really as a result of known and unknown benefactor of the uncertainties affecting the company and.
On the rest of regarding the company's ability to obtain regulatory approval for commercialization of that's part of the candidates, including the scope of 19 vaccine or.
For the comply with the ongoing regulatory requirements regulatory limitations relating to its ability to promote the commercialize its part of candidates for specified indication except the.
So the product candidates in the market, that's kind of pick up for bid on that Mark.
Marketing or sell the products.
The GAAP and its ability to maintain its license agreements with the continued momentum in the growth of the top in the space its ability to establish the maintained collaboration with the ability to obtain or outstanding or maintain the capital or grabs the sorry, the fund the research and development activities competition or the ability to retain the skilled employees.
Although the bio has attempted to identify important factors that could cause actual actions on sort of the results to differ materially from those described in forward looking statements. There may be a matter of fact or the cost of actual events or results to differ from those sorts of things about somebody that are inside of it.
No forward looking statement can be guaranteed except as required by applicable securities laws forward looking statements speak only as of the data, which they are made and I buy on undertakes no obligation to publicly update or revise any forward looking statements whether in the on the result of new information future events or otherwise other than the.
The required by law.
On the call today, representing the company having much of Thomas.
The chairman and Chief Executive Officer, and John Delta about the principal accounting officer with that said on the outside of the color, but the job.
Thank you Steve Good afternoon, everyone and welcome to our inaugural conference call on.
We have to manage the management team and every one of the I buy on.
Thank you for your interest in our company and the from for those of you were shareholders. We truly appreciate your support.
Before I turn the call over the time for an overview and update on our activities like to provide a brief update on our financial results for the quarter ended September Thirtyth 20 Twond.
The streamline things all the numbers I will mention had been rounded and are therefore approximately.
For the three month period ended September Thirtyth 2020, I bio reported revenue of 410000, an increase of 302000 from the same quarter last year. The increase is attributable to revenue generated from two new customers.
As of September Thirtyth 2020 revenue backlog was approximately 2.4 million.
Total operating expenses, consisting primarily of research and development, R&D and general and administrative or Gionee expenses for the quarter ended September Thirtyth 2027.
The seven point Threemillion.
Compared with 4 million for the same period last year.
R&D expenses for the quarter ended September Thirtyth, 2000, 21.8 million compared with 1 million in the same period a year ago.
The increase is primarily related to an increase in laboratory supplies and higher R&D personnel costs.
DNA expenses for the quarter ended September Thirtyth 2020 were 5.5 million compare.
Compared with 3 million of the same quarter last year.
The increase resulted primarily from higher professional and consulting fees.
And facility repairs and maintenance, the even making significant investments in people processes and infrastructure the match our progress in position in our lifecycle.
We believe the creating the solid foundation provides the expertise and compliance needed for a high quality biotech company, and we'll sort of I buy a well as it moves forward with its value, creating objectives that said as we continue to advance our clinical pipeline, we expect growth in R&D expense could begin outpacing that of G.
Moving forward.
Other expense for the quarter ended September Thirtyth, 2020, 600000, which was consistent with the same quarter a year ago.
Net loss attributable tie bio stockholders for the three months ended September Thirtyth 2020, let's.
The 7.5 million or five cents per share.
Paired with the net loss of 4.5 million or 21 cents per share in the current comparative periods last year.
As of September Thirtyth, 2020, I buy on had cash and investments in securities of 83.5 million.
With that I'll now turn the call over to Tom from an operational overview and an update on I buy this recent activities Tom.
Thank you John and good afternoon, everyone. As this is our and all of your call we'll spend a little more time discussing development sort of occurred over the past several months than we normally would before turning to our near term plans.
The first what's the scope of ipi its transformation into perspective.
Might be helpful to reflect on our position is very tired of last year.
We were operating a very small business the focus almost exclusively on contract manufacturing, we had little industry brand recognition.
We were working on the design of a plant based production facility for one major clients that had slowed and our work for another new client was taking longer than expected to ramp up.
Yeah, the two product assets, whose development pad essentially stalled our cash position was just over $2 million and our stock price was around 13 cents, which translated into a market cap below $10 million.
So the.
December 2019, we launched the new strategy designed to leverage our rebranded fast farming technology platform and put it as well as our 130000 square foot manufacturing facility to work of producing our own proprietary products.
We were able to achieve this in part because a few months earlier, we begun development of our Glyconutrient technology.
The stack enables us to better control of the way in which our plant based system like cost of wage proteins, thereby improving the quality and in some cases the efficacy of the biologics we produced with it so.
So we lost it does the service in December but also began to use the technology in conjunction with our fast farming system to restart work on our own bio pharmaceuticals, and evaluate recombinant proteins from you some research and Bioprocessing applications like Threed printing.
So by mid January we had reinvigorated activity related to Arianna fiberoptic disease candidates I buy a 100 and our cash.
Classical swine fever sub unit vaccine I buy of 400, and we refocused our efforts with our two major services clients. The began to see more awareness of and interest in our fast farming and Glycan nearing development services.
That was the result in part of some of our marketing efforts as well as interaction with industry trade groups like the advance regenerative manufacturing Institute, which supports the emerging bio fabrication threed bio prospect of bio putting on the streets.
We had improved on cash position somewhat in the began to think about other new product and service opportunities using our proprietary technology platforms, including virus like particles on VLP GAAP based vaccines as well as cancer therapeutics, the could be enabled with like anyway.
So the first farming and GLAIC and GLIC nearing technologies. In addition to certain technologies and product candidates. We have developed over the years are covered by a 160 issued patents. The 37 of those issued in the U.S.
We have 20 patent applications pending and plan to continue to strengthen our IP portfolio on additional platforms.
So by that point in January 2020 about mid month, we were confident in our ability to deliver on a product and service strategy based upon our fast part of it system, which offers many advantages for instance, first a faster time to clinic by shaving a bunch of off of traditional mammalian cell development times.
The second fast farming is easily scalable because each little plants, because the tell by reactor. So unlike competing systems, which face production challenges moving from a few of the leaders to 2000 liter bio reactors and the Malians cell culture, our scale up as the chief I simply growing more plants.
Third the can produce a wide range of proteins, the glycol proteins, including monoclonal antibodies antigens virus like particles enzymes by wage growth factors inside of college, most of which could all be enhance using on questionnaire and technologies.
Force there are lower contamination lessons familiar viruses and clients can grow in plants and finally, the launch the number of other advantages on I wont mention the fast farming systems eco friendly is it avoids the single use plastic disposables often implemented during mammalian cell based biologics production.
Needless to say by late January 2020, the emerging COVID-19 pandemic began to take shape, even though we had all the just initiated our change from the CDMO services only model to include more proprietary product development, we quickly shifted our focus on the Sars koby too.
At the time, we assumed as Corona virus outbreak would be short lived much like Sars, one numbers before it but we nevertheless, all the opportunity to bring our capabilities to the task such as our fast part of manufacturing facility located in Bryan Texas.
That factory was originally built from 2010 with funding from the Defense Advanced Research projects agency or DARPA is part of the U.S. Department of Defense is Blue Angel initiative.
That initiative aimed to establish the so these capable of rapid delivery of medical countermeasures. The response to a disease pandemic.
As the fast farming system uses the relative of the tobacco plants is the bio reactor in the fast partnering factory that plant is equipped with automated hydroponics and vertical farming systems for large scale manufacturing of recombinant proteins.
So on the one week after the World Health organization declared Cobot 18 of global pandemic, we announced the we created Sars koby to the LP base constructs using the fast farming system.
We subsequently filed for associated Provisional patent applications.
We also then became the Twentyth member of the Alliance for Bio Security. Your line supports National Health security by advocating for public policies and funding to support the rapid development production stockpiling and distribution of critically needed medical countermeasures.
Our VLP based vaccine candidate I bio 200 is designed to mimic the Sars Toby to wireless is quite constellation profile, which may allow for more efficient uptake of the vaccine by human antigen presenting cells potentially resulting in enhanced protection.
With that theory of my we initiated the immunization studies, probably by a 200 of Texas eight of them University systems for Taboos laboratory. Shortly after we got from the program.
We also expanded our I buy of 200 vaccine collaboration to include the infectious disease Research Institute or injury to benefit from its vaccine development expertise as well as the portfolio of novel edge of its.
Recognizing the severity and urgency of the pandemic, we initiated our second Koby 19 vaccine program to on one.
In June while this further validated our ability to innovate. It also allowed us to put another vaccine candidate in the race mitigating the development risks associated with any preclinical program.
Hi, biofuel one is based on the sub unit platform. The combines antigens derived from the source koby to spike protein fused with our patented look on booster molecule to enhance the immune response. The addition of on the can boost or to a sub unit average and they approved the likelihood of the cheating single dose prolong community, while also increasing manufacturing capacity through the increase through the increase potency.
Hi, Biofuel was also test of the tender with the range of injury judgments.
Well that was on going in August we obtained an exclusive license the planet Biotechnologies COVID-19 therapeutic candidate piece to EPS.
It is a recombinant protein comprised of human angiotensin converting it to the board age to fuse to a human the immunoglobulin G FC from <unk>.
The immuno adhesion ace two F.C. targets the current of Irish variants directly by using the Ace two extra cellular domain as the T core to bind the spike protein the block infection of healthy cells, well the fused FC domain prolong the life of the protein the blood circulation.
As these two also is the target receptor for the crowd of viruses entry into cells. We believe the K that it will bring the benefit of the traditional neutralizing antibody what perspectively limiting the potential for viral escape.
These two FCD has demonstrated the ability to block as far as koby to virus from the infecting the bureau of peace fix cells and the need to be true studies conducted by plan of biotech.
In September we selected I biofuel, one is our leading koby 19 vaccine candidate based on its production of higher in the Spike neutralizing antibody titers did I buy on 200 the.
The recently selected the contract research organization to support the toxicology studies fried biofuel, one and initiated discussions with the U.S. food and drug administration regarding the program.
We're also continuing preclinical development of our PLP platform has the potential plug and play vaccine development system.
Because you probably have heard while final peer reviewed data is still forthcoming Pfizer in but there and I have recently reported success on later stage trials of their COVID-19 vaccine candidates.
Companies are to be applauded for the remarkable accomplishments, we sincerely hope the water both of their vaccine candidates will be approved and successfully deployed.
That said at this point some questions remain about durability effectiveness in the elderly safety manufacturing and global distribution and access on.
Also vaccines can do often still fail fleet in clinical development.
The experts with whom we of consultants adjusted those factors points of the continued need for a number of COVID-19 vaccines to remain in development.
So given how much remains to still be understood about the disease combined with what we have seen in preclinical studies. So far it really isn't coming upon us to continue our COVID-19 vaccine development activities.
Meanwhile, in addition to adding two proprietary COVID-19 vaccine candidates and of COVID-19 therapeutic candidate the tour pipeline in 2020.
I mentioned earlier, we resumed development of two legacy biopharmaceutical progress I buy a 104 hundred.
I buy a 100 is an end of study for peptide anti fibrotic head of it being developed for the treatment of systemic scleroderma in idiopathic pulmonary fibrosis.
I buy a 100 was previously granted at the orphan drug designation for treatment of systemic scleroderma has been shown to reduce fiberoptic symptoms in preclinical studies.
We are currently working towards starting the last of ROI in the enabling studies flow I buy a 100, followed by cgmp manufacturing in the hopes that we have a molecule the can help the a current.
Current critically unmet medical needs in the psychotic disorders.
Meanwhile, developed in collaboration with the Institute of infectious animal diseases, the Tamil as well as the Kansas State University I buy of 400 is in each of the classical swine fever vaccine candidate.
Classical swipe your keepers of contagious, often fatal disease affecting both fear on domesticated pigs and outbreaks of occurred in Europe, Asia Africa, and South America.
The recently in Japan, specifically.
Hi of 400 as demonstrated complete protection the challenge pigs. After a single dose vaccination and is accompanied by strong virus neutralization the antibody responses for.
The presently planning of the efficacy study for June with the large safety study the follow later in 2021.
To help drive this project forward, we recently hired Dr., Melissa berquist to fill the newly created role of head of animal health programs well.
The list of came died by on from Taboo, where she served as director Institute for infectious animal diseases, and we're excited to welcome her team.
I think expanded our biopharmaceutical pipeline at 2020, I'd like to point out that or CDMO services and plans for our research in bioprocess proteins products represent important near term revenue generating opportunities.
The aim to have these offerings provide non dilutive funding for our biopharmaceutical development programs.
We also continue to work with CDMO class to support several development programs, including the United Therapeutics for their development of recombinant human collagen based by a week for three the Bioprinted organ transplants hazard.
As surgeons bio similar with tuck submitted for the African costs kind of it and Cc Farming's bio better we're touching on for China as well as other new customers.
Additionally, Safi Biosolutions of recently selected I buyers of source of recombinant proteins the cell culture supplements for its blood cell therapy program.
As part of the relationship with SAP, we have the opportunity to build our own portfolio of research in bioprocess products by virtue of the fact that any proteins not designated as customs by Safi can be commercially commercialized by bile.
We plan to begin offering of new catalogue of high quality research in bioprocess proteins by mid calendar 2021, initially focused upon growth factors inside the cards.
To support I Bio's, continuing transformation, we recently saw to bring more biopharmaceutical develop this subject matter expertise to the task, while increasing our bench strength and enhancing our leadership team.
So now I'm pleased to welcome three New Board members Dr., Linda Armstrong Dr., Alexander profit Tillable Mr. Gary standard.
Linda has more than 20 years of experience on respiratory diseases and therapeutics.
Certified Pulmonologists and interest she served in a variety of roles at Novartis since 2007, the most recently as its global head of the respiratory development.
When the served as medical safety director of subsequently of senior director of Medical Affairs of Pfizer and his group director respiratory diseases of the Schering Plough Research Institute.
Alexandria is the biopharmaceutical executive with expertise in all phases of global clinical development translational medicine and medical Affairs.
Ladies and gentlemen, please standby.
Go ahead.
Alright, well the joys of alive conference apologies everybody bye.
Now as I was saying Alexandria is the biopharmaceutical executives with expertise in all phases of global clinical development translational medicine embedded Med affairs and since 2016. She served as VP global specialty R&D respiratory and inflammation therapeutic area Teva Pharmaceuticals, Alex.
Alexandra previously served in various roles at Sanofi and Pfizer, most recently as Pfizer's director and head of global clinical of respiratory and analgesics.
Both lending and Alexandra of been appointed as members of our New Science and Technology Committee. The SNC Committee has already provided valuable insights to us relative to new opportunities, we've identified and Pulmonology and oncology.
Gary has more than 25 years of financial leadership experience on organizations ranging from large multinational pharmaceutical firms to early stage biotechnology companies. He joins us from the brief of therapeutics, where he was the CFO. Since 2016. He previously served as synergy pharmaceuticals executive VP and CFO.
At of Shire Senior Vice President of the Finance administration, followed by its senior Vice President of Finance GAAP.
He is now chair of our audit committee and joined by long time members quenching and high flow.
Gary has also been appointed to the board compensation Committee.
We also recently made a key addition to our management team mounting the appointment of Randy Jay Maddox as Chief operating Officer effective December Onest.
Randy joined Us from Aptevo Therapeutics, we receive your vice President and Chief Manufacturing Officer, He's got more than 20 years of global Biologics development of manufacturing business development and relationship management experience.
Randy was previously VP insight director of Glaxosmithklines VP of quality and operations of human genome Sciences, and held positions of increasing responsibility within biogen's quality organization.
On a bit about this true Jain of the world of back phonology.
In summary, the past four quarters, a bit of pivotal period Fry buyout during which we transitioned from a business model focused on CDMO services to one that also includes the development of our own proprietary products.
I'm proud that I buy as existing capabilities expertise and experience enabled us to quickly respond to the growing global the for COVID-19 vaccines and therapeutics the pro.
So basically what our state of the art facility was designed for and while the company selected for participation and operations Warp speed had been involved in clinical vaccine development for many years, while I bio it only because the focus on proprietary product development just a few short weeks before the pandemic head of Nevertheless, pleased that I bio is in position to potentially.
The still play an important role in the pandemic response.
Of course, the on COVID-19, we're also targeting large market opportunities in other infectious in fiber optic disease, the categories and potentially cancer.
In addition, the Threed bio printing market is growing rapidly and I buy it was well positioned to participate.
We continue to expand our portfolio with new products and services, we can bring to market more quickly than biopharmaceuticals with the new and expanded leadership team deploying our technologies and capabilities into exciting new markets. We are looking forward to continually aggressively executing on our new strategy and help the critical unmet medical needs while return.
Moving value to our shareholders.
Thank you and with that concluding our introductory remarks are happy to take any questions you might have operating.
Ladies and gentlemen, if you have a question or comment at this time. Please press Star then one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue simply press the pound key.
Again, if you have a question on our comment at this time. Please press Star then one on the telephone keypad.
Our first question or comment comes from the line of Ben Haynor from a line its global your line is open.
Good afternoon, gentlemen, thanks for taking the questions can you hear me all right.
Yes, Sir.
Excellent.
So congrats on all the progress clearly you've moved quickly into a lot of new areas here this year.
And if I'm reading you correctly it sounds like some of the net recent developments news on the the COVID-19 front have maybe resorted.
Some of your priorities.
The only somewhat.
Can you maybe share a little bit more on how you maybe rank the opportunities you have in front of you at present.
Well that's a great question I think here, there's we have to put what we see with high by a 104 fiber.
Hi, Broderick disorders pretty high on the list.
And for what we're doing with bio to a line for all the reasons that we mentioned there is a lot to happen so.
Still here in the co the 19 space by the.
The world needs more of vaccines come in the market not fewer and we still don't know how the course of the decent season and the pandemic is really going on hold.
Over the over the course of the next couple of years. So we see that is important.
We also see a lot of opportunity.
With what we described as our research and bioprocess proteins. So those are significant as well because we can supply them as part of the services package to clients like SAP as.
As well as offer than as our as part of our own product portfolio and Ben you heard me into a couple of times at oncology and what I'll say there is that.
Our Glycan engineering technologies, and the fast forwarding platform itself allows us certain advantages in terms of speed the clinic in cancer.
Glycosylation can be a really important towards.
ADCC or antibody dependent cell cytotoxicity, so well.
More to follow there.
But I think we see significant opportunities with the platforms and being able to turn them into products and then what we're seeing and infectious diseases and fiber optic disorders for sure now that said you know.
I just finished commenting too on on animal health I don't want to necessarily put that third or fourth on the list because of some of the data that we've seen and really how we're really putting a lot of energy into the development there and we think the with the right combination of average events.
And with the candidate as we have it right now we are very much looking forward to both of those FX efficacy and safety studies.
Okay.
Very helpful. Thanks for that and then can you talk a little bit maybe more of maybe about the savvy Biosolutions agreement the and also your investment there. It seems like that's maybe a new page the you're putting into the play book and.
If I'm not mistaken the there's a strategy the was employed at.
One of your former from is that in line, so that though was similar.
Oh, well good read Sir Yes, I think there are really three factors the come in as a result, so first if one takes a look at safi.
They're they're fairly young company.
Noteworthy because they are linked to the department of defense is well one of their key programs more to follow on that later, but.
At the moment they.
They are looking for ways to accelerate their path forward with some of their red blood cell the neutrophil development programs.
So by virtue of the investment that I bio made into Safi, we're helping them accelerate their development pipelines.
And their progress as the company and indeed.
Did do this with an earlier employer, where we had manufacturing capacity, we looked for certain entities that had good management teams and good technologies of were looking for a little additional support with their process development. So this is where I bio can step in because we can help manufacturer diverse number of protein.
Sales for their bioprocess so.
Now you take the this is the other.
Advantage to this approach is that I bio is the provider of the proteins because of the speed of our platform.
Were we produced already we did 50 different constructs just over the course of the past six weeks to ultimately express more than.
More than 10 proteins already for southeast Bioprocess, So you give them the speed with which they can evaluate those proteins optimize their bioprocess anti bio ultimately the savvy continues to be successful.
And receives its various.
Support dollars as it goes forward than we establish ourselves as the contract manufacturer of any of the custom products for their process. Meanwhile, finally Fry bio we also get the advantage for anything the sappy doesnt designate as a customer for us to create begin to create a portfolio of our own.
On the cytokine and growth factors and other products for many entities just like Safi.
Who are doing bioprocessing and need high quality.
Either research or cgmp materials for their own cell bio processing projects, and that's where our plant based system has certain advantages in the industry. There are concerns by biopharmaceutical developers about animal origin raw materials, because often they can.
Of viruses Vermillion viruses or prior on so.
You may remember bed count as well.
Right right so prior rounds.
Of course caused mad cow disease, and you don't get the replication of either price bonds or mammalian viruses implant system. So we'll be able to designate our finished goods as animal free.
As well as certain other features that they'll have the should make them competitive.
Okay, Great and then one on one point of clarification there on the the of the compounds that Saf. He does designates as cost of.
The presumably there is something that.
The tax you guys from them designating everything has custom.
In the yeah, I think theres, usually the customs are maybe a small tweak to any given protein and there might be certain of documentation and or quality control or performance criteria that will be unique to SAP. These process and everything that falls outside of that which.
Theres theres going to be a substantial amount of room in the intellectual portfolio property portfolio space for us to be able to market quote on quote standard versions of any one of those molecules for sure.
Okay, Great and then one last one from me can you can you share any updates on the from.
Fraunhofer would of litigation.
Yes, so there was a hearing in June.
Went as expected.
And we are proceeding to trial.
Which was postponed due to co bid from May of first week of May 2020, now to the first week of March by 2021 of.
Of note the.
We are now in the damages phase earlier it was determined in summary judgment on that.
Net front offer did indeed.
Utilize I bio's intellectual property.
Without permission and so we expect to in this case and it all others aggressively defend our intellectual property portfolio.
Okay. Thank you very much guys congrats on the progress.
<unk> expense.
Thank you. Thank you.
Our next question or comment comes from the line of newer Chapman. Your line is open.
Mr. Chapman you may be on mute your phone.
Yes.
Yes, it was actually calling to see if you have any update the want to kind of provide on I buy on 400, specifically just a little bit deeper from what he shared earlier.
Yes, I mean, I think it's there's only so much detail we can go into with the clinical trial planning.
But I can say this when I referenced the we were doing the efficacy study by June.
That is still on the planning stages. The safety study later in 21 would follow but to give a sense of the size of that kind of study. We are presently this may change looking.
Looking at something that would involve the thousand head of swine here as we go. So we are looking at a number of factors around that particular trial design right now, but as you can get a sense, where we're obviously investing quite a bit.
From both clinical trial design project management and regulatory to help give that candidate a great shot of coming to market.
Thank you and on the last question on dresses.
In regards to out of the relationship with IBM and the Watson.
The main any kind of share an update investors with on that.
Well the key to that one of course is us getting into the clinic next so we need to complete regulatory reviews as well as any R&D, enabling studies, but as soon as we have that.
Watson stands ready to help support us.
The clinical trial management data solution, so were excited by that.
And the future relationship there.
Thank you.
Thank you. Our next question or comment comes from the line of cream on Lani. Your line is open.
Thanks, very much congratulations on the progress so far it's been quite a year.
I wanted to circle back to two of one.
I think a lot of the the share price appreciation mark the cap the increase this year has been the non that.
And I recognize from your.
Update today that the recent contract research organization to support talk studies.
Has been selected or can.
Can you tell me do you have any from.
Line.
Bakken on July Thirtyth.
The anticipation was to see the end of preclinical studies.
On a few weeks.
And at the end of preclinical studies, then by the end of Q3, but were here on November now so essentially the one with the end of talk studies be the filing of the eye in the.
As of the next catalyst please.
Right. So good question a lot of this depends upon the FDA of response to our pre pre I in the submission.
As to the extent of toxicology and other studies that are required. Nevertheless, as you can tell from our remarks here today. We are proceeding with that work is if we are not going to get an allowance to go forward. So.
It very much depends on that particular regulatory review, we don't expect.
Well I shouldn't comment as to what we do or don't expect the FDA to rule on that but clearly we need to move as quickly as possible and.
We are certainly going to do that with the bio two or one the Lincoln booster portion of that.
The molecule we think is important.
So even if we are required to go ahead and complete those Tox studies, which would take us into well into the beginning of next year.
We would see certainly leverage on that for its further use with other vaccines.
And in a way even though we have to go through this process at this point it does give us some on opportunities for some other preclinical work the won't be time.
Timed the clinic dependent but other preclinical work that we want to do really on that molecule as well as our VLP platform. So we have other background R&D and platform development activities ongoing at the same time, so it makes sense.
Okay. Thanks for your question.
Thank you. Our next question on comment comes from the line of Chris Portugal. Your line is open.
Hi, Thanks for taking the on today.
Excuse me I just wanted to ask the question on behalf of.
Most retail investors like myself.
Large contingency of people on places like stock tweets on young from.
Well basically have kind of been put through a rollercoaster here are you.
With the delay in toxicology onto a one and other things.
And I was just wondering if there was any sort of push to work on the branding side of IPO, Hi, bio sorry. There was you know a lot of big information on false information point around thick Instagram accounts Vic Twitter accounts and I just want to know what your plan was to sort of ease.
The retail investor as we ride this roller coaster and support you guys moving forward.
Well, Chris I think it was I would say look I'm disappointed of course by all that activity. The only thing I can we will commit to of course.
Is more and more transparency and frequent updates on our programs. This is why you know the.
The company now here, we have our first inaugural conference call.
We need to be here to answer your questions.
We're putting out regular earnings releases with more and more detail and you know a lots been happening for the company.
Here Theres been a tremendous number of new initiatives and new activity. In addition to everything that we're doing to help fight the.
This awful Kobe 19 pandemic and so there is the good news is that the Theres a lot going on that Theres, a lot going on and we certainly hope to have more and more updates credible.
Credible updates right, we don't want to.
Your inbox with stuff that's not meaningful.
But you know as we make significant material developments, we will commit to making that information available on the timely fashion.
Thanks, Tom I appreciate that and I know of speaking on behalf of on retail. We appreciate that two of the transparency of key here.
Well on thank you and everyone else for all of the support the others on there was all sorts of speculative stuff that was going on and obviously there is not a whole lot. We can do to control that but here what I hope you can see from this call is the we are taking you know a lot of this marvelous technology capability and capacity.
And our teams are really doing some imaginative and ingenious.
Work and it's starting to show up here and keeping in mind that bio pharmaceutical development is measured in years of decades, often a lot of the players that are in the space right now Madonna Novavax bore have been doing this for over a decade, and we're very quickly deploying our capability.
He's here as I hope you can see two.
The return shareholder value and we're looking to do it in a couple of different ways and that's not only the biopharmaceutical pipeline, which has significant opportunities and some of the fields that were discussing the fibrosis markets alone are quite sizeable with tremendous unmet medical needs as I mentioned I mean, there's there's a couple of molecules are current.
The commercially available products, but those patients don't even take them because they're so poorly tolerated and not that effective. So if we can do some things to solve problems like that and.
And at the same time help innovative companies small companies like Safi.
The large ones like United Therapeutics to make their products better well, we have the capability to do that and certainly with the speed of our platform, we get the chance to take more shots on goal here as we go so I go out of it too long, but thanks for your question and your support appreciate it. Thank you.
Thank you our next question or comment comes from the line of Patrick Wolf. Your line is open.
Hi, everyone. Thank you for taking my call its been a pleasure to listen in on this conference call I'm just kind of quick question again on the retail side. I know you guys are going to ask soon for us to vote in your favor of increasing your share count as one of these new board of directors and my main question is why should we vote, yes, I can understand if you have the toxic.
Ecologies you were in phase two or three more asking for this increased share count on I can't really see a on justifiable reason at this point to really give you guys that go ahead with the share count and I just wanted to get some further and more detailed justifications and possibly may be better timeline.
On when you expect these talks results and other reports to be actually in thank you.
Sure second question first Tox, it's actually I mean, we were we're proceeding as mentioned it should be in.
Early 2021, unless we get relief from needing to do that by the agency cash.
Question number two it's here the one thing that the company did only recently is establish the shelf here this year.
As part of really good housekeeping.
In order to capitalize the company for the turnaround effort.
That we were seeking to do and of course as mentioned earlier.
In January and February.
I'll, probably this time last year.
Sort of painful the remember in some ways, but with only $2 million in cash in the company as a going concern being very much in question.
We are keen to assured the stability of this from and make sure that for our current customers that they know that they can count on our supply of these raw materials and of our services. So that they can continue down the path of their multi year on product development sets price.
The number one point number two is for our own biopharmaceutical developing when we have novel molecules with unique.
Properties and promise such as I buy a 100 clinical development of those as well as I bio tumor one on.
Our lengthy and costly process.
So it's important that we are well capitalized to moving forward in the clinic with our clinical trials aspirations and expectations.
Point number three.
Well, there's unique opportunities given our position as a manufacturer with our novel platform to.
The do things like we just did with half of so to Ben's question earlier.
There were a few aspects to that and yes, we did wind up making an investment and that's the part that I didn't elaborate on too much but if safi winds up being successful with the nature of our investment obviously, we of equity in the company well there are other opportunities like that down the road. So we think for our shareholders. The best thing to do.
Is the continue invest in the company take advantage of these multiple shots on goal continue to utilize the benefits of both the fast farming platform as well as our glycan hearing capabilities to make uniquely qualified and high quality clinical proteins to.
The solve some of these big problems and we think we can grow the company significantly in.
And creates tremendous return for our shareholders. So for those fundamental reasons and growth aspirations. That's the that's the reason for the ask.
For you and everyone else.
The the and help hi, bio support.
Itself by building a very strong foundation is we take the company forward.
The forward over the coming years.
Thank you our next question or comment comes from the line of Matthew How your line is open.
Hello, gentlemen, I appreciate you taking the question in the house and I appreciate your kind of on.
On going transparency.
Hello.
Potentially unrelated question on maybe half of the hearings on T 16.
Address hospital, so I noted on the.
The effective public record being available on the company and making the expenditures in the Mobbing strength.
The degree of around 80000 dollar investment from us.
The appealing Johnston out of just curious.
If you're able to operating more detail regarding the current strategy, but more importantly on.
You have anything to offer by way of.
The anticipating any changes in strategy on our board oversight of that lobbying activity given.
The likely change in administration or just given the team on political landscape.
And then potentially on related to that but.
Yes, the important be curious to know on.
Again, I noted earlier, you mentioned the guarantee on Pfizer and we're anticipating you're participating in the.
Coming event second weighted we hosted by EGPC.
I think the that subject of the about emerging weve vaccine, which I suppose we have to consider ourselves in the market now and I Wonder if you might address on the progress being made by net hoggatt, specifically, yes, either of those of you are able to elaborate on very much appreciate it.
Sure sure and thanks for the question with regards to the library lobbying effort.
Indeed, I mean, we we started on this journey here to try and.
Favourably impact what was emerging you know back in January and February is the so ultimately this global pandemic and keeping in mind that I bio it moving.
Literally just weeks prior turned the corner to serious biopharmaceutical development activities.
We had also not really ever very much interacted with the government as I bio out of operating out of that particular facility. So for US. This was all the brand new world. We didnt have any of the mechanisms for doing direct government contracting we.
We had to make.
And we were fortunate enough to have done so a lot of these early connections into the government very much on our own and on the fly.
And.
Was it not.
Thanks, Lee from meeting with the certain someone.
BARDA I.
I don't think we would have ever been introduced the injury and some of the group at a particular subset of taboo.
All of whom very much helped us.
To create our submission and put that together.
And really some could argue record type so for us to advance the company.
And this is without respect to hold the lovely politics in the month of kind of hurt so.
So specifically your respective to a change of administration or not.
Fundamentally we have to I bio has to do a better job.
With the interacting with the government being able to tell its story and that was the reason for engaging with steptoe some of our competitors in this space.
We know have multiple multiple groups working for them. So it's important for us to.
Sure. The we're doing the best that we can for our government relations because we firmly believe that the story of manufacturing USA and on shoring the nation supply chain for Biopharmaceuticals is important.
Period full stop and then certainly Fry bio where we maintain the U.S. presence for all of our manufacturing.
We think we have something to contribute in that regard every.
We think it's just good period so.
With that said, we don't see any changes in strategy, there, but probably some more investments.
With regards to the Donna and Pfizer and some of the wave two yeah I'll just reiterate quickly what I said before which is the we don't really know how this is all going to play out.
And it's possible.
Certainly the we can still make an important contribution here from COVID-19 or other.
One of your day.
Diseases are viruses that may emerge share over time and with the speed of our platform certainly the MRT platforms are proving out thus far but again theres still a lot to be determined down the road. So we want to be very well positioned for that going forward and I think it's actually encouraging the medic cargo device.
Developments you know the one of the things the.
Those of us in the plant based manufacturing world have been up against is well. They are different it's not standard does it really work nothing else nothing's really been commercialized off of it in the past and by the way as I gave you that litany of things I'll throw it well they don't quite cosily the way the medallion cells.
Well I can say all that because I was the guy say that just a few years before I ever met I bio. So I was the complete skeptic as well of the plant based system and so I think it's actually quite positive they've been of cargo along with GSK provided of the AD units.
Is making progress there. They also had a plant based system.
In a on influenza vaccine in development. So it helps make the the platform in this portion of the industry more standard more acceptable more visible of course, we have certain advantages ourselves so.
I think plus of course, we believe more vaccines more solutions for the stranded pandemic the better because we are going to need multiple shots on goal. It's looking like maybe not as many if we keep seeing these early successes, but we're encouraged by that in general.
Thank you our net.
Next question or comment comes from the line of David The Bear your line is open.
Mr. Barry you maybe on mute your phone.
Yes, thank you very much.
I appreciate all the work you guys are doing.
Lumping this goes back to the I forgot the the John those names that asked the question on that vessel of prospective.
Well I mean, we're seeing the stock prices fluctuate from.
A time zone.
No reasons that all the it goes up in times of goes down and I think that goes back to the question of what what what are you guys doing so to help.
The the investors who are.
Core seen us and want to continue investing but there's just uncertainties of where we're headed and what you guys are doing.
You know are you guys looking at these prices of fluctuating and you know from a PR perspective, we're on.
Looking on the other biotech companies and they seem to be consistently assuring investors and coming out with news on the and I think that's kind of the same question on of the transparency.
Maybe if you can speak to that right on again please.
David will all I can say to that is that we're seeking to build a fundamentally strong.
On biotech and CDMO services organization, and given where we came from 13 cents. This time last year to where we are today, which is above 13 cents. It we're happy.
They were able to be here today and talk about it at all the things that we're doing to build the strong foundation. There will be of course, just like investing in any company of all of those fluctuations of we can't control any speculation.
It may go on there, but once again will commit to timely of material information and also you have our commitment as the company every member of this team and all of the folks that are joining and have joined.
We want to make something special happen so sure there will be.
Great days, where we have wonderful success is there will be down days, where we have failures you're over the coming years.
But given what we are doing to diversify the business and given the fundamental advantages that we have we have confidence over the very long term.
I certainly do too that were going to be successful and build a great company that ultimately helps patients and our clients both on the services and researching bioprocess products line.
But thanks for your question.
Thank you. Our next question or comment comes from the line of the matrix Margaret plus your line is open.
Good afternoon to the whole team of thank you for taking the time to to answer questions today and congratulations on the progress that you folks have made.
Over the course of the pass a of the summer we had.
I had an event that occurred regarding.
The sale of ownership of of the majority shareholder the hasn't been touched upon from the company and I would like some clarity on that if you kind of holds up please and I'm alluded to eastern capital and kind of start.
And secondly of.
My second question, which which ties into that is.
Could you shed some light on clarified the ownership of the facility.
And Bryan Texas.
'cause under my understanding that facility is currently owned by Eastern capital, which the subsidiary of kind of the.
Thank you very much.
Thank you dilution as for your questions of things for the recognition yeah, we've been working hard to make some special things happen with regards to Darden Eastern obviously, we don't have deep insight into their investment decision making processes.
On got opinions, but theyre just that and.
The case.
The so they did move their position in the high bio Inc. stock.
To your good question on the ownership of the CD of those subsidiary I Bios CDMO LLC.
Yeah that one does need some clarification there is because there is certainly a wrinkle to it and if I lose anybody in the jargon I'll just.
We can certainly follow up at all this information is is is public but.
It was the 70 30 split I bio and eastern capital or actually a different subsidiary to is involved in the ownership of the sub there was the conversion to a tracking stock a couple of years ago.
But that is sort of a temporary mechanism defacto.
Eastern still owns some share of their position.
You know, that's a little south of 30%, but once the if the tracking stock gets converted back they will resume their other position right now it will show up in the documentation is something like 99.9, some odd percent ownership by hi, bio but.
I hope that clarifies the the top level enough. It's it's roughly 70 30, 80 20 kind of split.
Thank you very much.
Thank you.
Afraid the test all the time, we have for Q1 day at this time I'd like to turn the conference back over the management for any closing remarks.
I just want to thank everybodys participation here today and for your excellent questions and as we shared before.
We're looking to build a strong growth oriented company.
The its operating in the therapeutic areas of Pulmonology.
Hi, Broderick diseases infectious diseases, and Meanwhile of course continue with our CDMO services and we're looking forward to what we can do with our new line of research in Bioprocess products that we hope to introduce later in the year and not to leave out animal health and the rest.
Again, thanks, everyone for your attention and participation the scene.
Ladies and gentlemen, thank you for participating on todays conference. This concludes the program you may now disconnect everyone have a wonderful.
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