Q2 2021 Ibio Inc Earnings Call

Thank you for standing by and welcome to the eye volume fiscal 'twenty 'twenty, one second quarter financial results Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance you're on.

The conference. Please press Star then zero on your Touchtone telephone I would now like to turn the conference over to your host Stephen Kilmer Investor Relations. Please go ahead.

Thank you good afternoon, everyone. Let me start by pointing out that this conference call will include forward looking statements regarding the <unk> and its business.

Often but not always forward looking statements can be identified by the use of words such as May might will should believe expect anticipate estimate continue predict forecast project plan intend or similar similar expressions.

Regarding intent belief or current expectations are forward looking statements such statements are based on the current expectations of management. The forward looking events and circumstances discussed on this conference call may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including the risks regarding.

The company the ability to obtain regulatory approvals for the commercialization of its part of the candidates or to comply with the ongoing regulatory requirements regulatory limitations relating to it the ability to promote our commercialized the product candidates for specific indications acceptance of this product candidates in the marketplace and the successful development marketing or sell of products.

Its ability to maintain its license agreements the continued maintenance of growth of at the patent state its ability to establish and maintain collaborations its ability to obtain or maintain the capital or grants necessary to fund its research and development activities competition or its ability to the ability to retain key employees.

Although all of our bio is has attempted to identify important factors that could cause actual result, actual accident. The results to differ materially from those described in these forward looking statements. There may be other factors that cause the actions that cause actions events or results to differ from those anticipated estimate the during the time.

No forward looking statement can be guaranteed.

Except as described by applicable securities laws forward looking statements speak only as of the date on which they are made and <unk> undertakes no obligation to publicly update or revise any forward looking statement, whether as a result of new information future events or otherwise other than as required by law.

On the call today, representing the company are Mr. Thomas the I bet of diodes, Chairman and Chief Executive Officer of Jive Delta <unk> Principal accounting officer with that said I'll now turn the call over at the top.

Great. Thank you, Steve and good afternoon, everyone.

So I would like to start off by thanking the small team of people who help start the transformation of the high bio of late 2019, and the investors who believed in us that group brought passion and energy in the belief that we could use the power of plants to not only help other companies speed the development of their products into the clinic with the.

Also use our own technologies and scalable manufacturing platform to create our own portfolio of biological medicines to address unmet needs in the human and animal health.

In 2020, we combined our new glass nearing technologies with our SaaS farming system to significantly enhance our protein engineering capabilities.

That led to growing interest in our C. D M O services, while jumpstarting to work on our proprietary vaccines and therapeutics.

There were plenty of skeptics, who didn't think the plants could work as well as traditional mammalian cell production systems, but we added a few converts to our team and even introduced the new business model that led to a novel partnership enabling us to accelerate the formation of our research in bioprocess business.

With three new business has added to our existing services portfolio, we invented invested in recruiting experienced and talented leaders to help us build and grow the esports segments.

Now here in 2021, we have a growing pipeline of biopharmaceutical was for human and animal health indications our lead COVID-19 vaccine candidate attempts to anticipate the potential for new Corona virus mutations with the design that includes the spike antigen as well as other more conserved viral proteins.

The COVID-19 evolves into a seasonal illness as many expects experts who are beginning to predict on a subunit vaccine carrying multiple sars COVID-19 two antigens that can be rapidly modified and scaled like on <unk>.

I O to O one could address some of the still significant unmet needs associated with recently introduced mrna and the viral vaccine platforms.

Meanwhile, we are advancing our lead anti fibrotic molecule by optimizing its efficacy safety profile the manufacturer ability.

With the creation of our new animal Health organization, we're accelerating our work to bring them on classical swine fever vaccine forward, which includes our effort to secure important regulatory approvals for our SaaS farming facility in Texas.

Okay.

The significant as this progress may be the advances we've made to establish a pipeline of human and animal health candidates is only part of the work of our dedicated team has been focused upon.

We've overcome the challenges of the pandemic to do of police serve our CMO clients and continue to deliver on the projects that we have underway with the likes of the United Therapeutics, Safi Bio solutions and the ATB therapeutics amongst others.

More generally we are seeing our innovative SaaS farming system gain traction of the contract manufacturing services segment.

So we expected with our new commercial initiatives reflected in part by a recently launched website, they will be able to spread the word about all of the advantages of our truly green platform, including speed scalability and quality.

Notably the that last point, we've enhanced our monoclonal antibody engineering and characterization capabilities, which should make transforming even more attractive to certain market segments.

Bottom line, we believe the fast forming platform provides sustainable competitive advantage by stripping time and costs from the early stage biologics development cycle, and we're confident that we've built a strong multifaceted biotech and CMO around debt to capitalize on the Optionality. It provides and the return value to our.

Holders.

We couldn't be more grateful to our employees vendors strategic partners and investors for their efforts and support with our transformation.

But before I go into our quarterly developments and positioning for the remainder of the FY 'twenty, one I will turn the call over to John to review, our fiscal second quarter 2021 financial results John.

Thanks, Tom good.

Good afternoon, everyone I'd like to provide a brief update on our financial results for the quarter ended December 31 2020.

The streamlined things all of the numbers I will mention have been rounded and are therefore approximate.

For the three months period ended December 31 2020.

<unk> reported revenue of 700000, an increase of 400000 from the same quarter last year.

Total operating expenses consist.

Consisting primarily of research and development or R&D, and general and administrative or G&A expenses for the quarter ended December 31 2020.

Were $8 3 million compared with $3 $5 million per the same period last year.

R&D expenses for the quarter ended December 31 2020.

Were $2 4 million compared with 900000 in the same period a year ago.

The increase is primarily related to an increase in laboratory consumables.

<unk> and higher R&D personnel costs.

G&A expenses for the quarter ended December 31, 2020 were $5 8 million compared with $2 6 million in the same quarter last year.

The increase resulted primarily from higher professional and consulting fees.

Including recruiting as.

As well as facility repairs and maintenance public company costs insurance and board of director fees.

Other expense for the quarter ended December 31, 2020, with 600000, which was consistent with the same quarter a year ago.

As we move forward in our current quarter and with the establishment in January of our dedicated R&D group led by our new Chief Scientific Officer, we will be able to provide more visibility in regards to R&D G&A and cost of goods sold expenses in Q3, we will begin reporting on revenues and.

<unk> is associated with the three new profit centers with Ni Bio, Inc, which includes therapeutics vaccines and research in bioprocess products.

We've been making significant investments in people processes and infrastructure to match on progress and position on our lifecycle. We believe the creating the solid foundation provides the expertise and capabilities needed for a high quality the biotech company and we will sort of I buy on 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 to begin significantly outpacing G&A expense moving forward, especially with the aforementioned expense visibility we will be providing.

Okay.

Net loss attributable drive on stockholders for the quarter ended December 31 2020.

$8 2 million or <unk> <unk> per share.

Compared with the net loss of $25 4 million or <unk> 69 per share in the comparative period last year as.

As of December 31, 2020.

<unk> had cash and cash equivalents.

The investments in debt securities of $107 6 million the fat I'll turn now turn the call back over to Tom Tom.

Thanks, John on.

While we're excited with our progress to date of course, we remain focused on delivering results in the near term, but will also create long term success.

We believe that our investments in innovation processes and people today will be foundational for achieving our long term goals.

And we've added eight new leaders to the organization since the beginning of fiscal Q2, bringing with them a wealth of the industry experience to our team.

As you may have seen in our separate press release earlier today. Our most recent edition comes with the appointment of Mr. Robert loans, as Chief financial and business Officer.

He will manage our financial operations, including reporting budgeting and strategic planning.

Considering robs impressive background working with commercial stage companies to secure of complementary assets the of licensing deals and partnerships.

<unk> will be in position to readily contribute to the growth of our product portfolio.

Joining Rob and our recently stay of C suite as Randy Maddox, Chief Operating Officer, Lisa Middlebrook, Chief Human Resources Officer, and Dr. Martin Brenner, Chief Scientific Officer.

In many respects Dr. Brenner as of appointment and bodies on the Bios transformation from acquired CD amount until.

Until the dynamic biotech innovator and leading biologics contract manufacturing organization the.

A strong history of success heading drug discovery and development teams at several of the world's leading pharmaceutical companies, including Astrazeneca Lilly Pfizer and Merck.

Most recently Martin served as the CSO at Phoenix.

SCA listed company, which using its novel protein expression technology platform created an advanced pipeline of therapeutics vaccines biologics and Biosimilars.

We believe Martin will be able to leverage his prior experience to drive the growth of my bias proprietary product platform.

And there is a self described drug Hunter, we believe the skill sets with rounds are highly complementary.

MS Middlebrook as a proven team builder with a strong bottom line focus.

Coming to us from looping incorporated a global pharmaceutical company offering branded and generic formulations biosimilars in active pharmaceutical ingredients Lisa has extensive experience delivering the human resources strategies on recruiting talent.

Notably while on loans on a multinational CDM all she led the global leadership development program.

Yeah.

Rob Martin and Lisa joined Mr. Randy Matt ask who was appointed COO of November coming to us from GSK, the Tivo as well as Dr. Melissa Berquist, who was named the head of animal health programs in October.

Along with those recent additions we greatly enhanced our biopharmaceutical industry experience on our board with the appointments of Dr. Linda Armstrong, Dr. Alexandra crop of Tilda.

Gary sender early in Q2.

So please join us in welcoming all of two widebody or was the help us execute on our strategy.

So turning now to developments with our biopharmaceutical pipeline I'd like to provide a few details on the advancement of our COVID-19 vaccine candidate.

We recently completed the end of life things of <unk>.

Enabling toxicology studies for a subunit vaccine <unk> hundred one.

The data is currently being analyzed by our contract research organization and we expect to report pathology results in early Q4, FY 'twenty one.

Although there are approved vaccines now on the market, we still see a need for continued development of alternatives given the evolving mutations as well as global distribution and access constraints for the current products.

As most of you know we selected <unk> hundred one is our leading COVID-19 vaccine candidate based upon its production of higher any spike in neutralizing antibodies compared to our DLP vaccine platform by about 200.

Hi by virtue of one is based on the subunit platform that combines antigen is derived from the Sars COVID-19 two spike protein fused with our patented look on booster molecule to enhance immune response.

The addition of the lithium booster to the subject of advantage of May provide the improve the likelihood of achieving single dose prolonged commodity.

Additionally, considering the emergence of circulating mutations of the COVID-19, we recently began designing of Nextgen subunit vaccine with two of one that includes the spike or escrow team plus the nucleus of capsid.

<unk>.

We are using SaaS farming to build the yen plus S versions with the idea of that but the lithium types of toxicology results are favorable we would take those two both NFS with like test them with other adjuvant and evaluate the results.

By the way the same concerns around possible escape into that drove our decision to develop the employee satisfaction provided the rationale for us signing of the H two FC deal with plenty of biotechnology back in August.

This COVID-19 therapeutic candidate is the recombinant protein comprised of human angiotensin converting enzyme to price too.

Two of human Immunoglobulin G FC fragment.

As these two also as the target receptor for the Corona viruses entry into cells. We believe the candidate it will bring the benefit of traditional neutralizing antibody, while prospectively limiting the potential for firewall escape.

We can continue to see there is a potential strategic advantage of that approach in light of what we're seeing with competing therapeutics and we're now watching the regulatory and competitive landscape of opportunities to make tweaks to FCC part of the solution.

Turning to our lead animal health product with the help of Dr. Berquist, We're planning to submit an outline of production for the U S. Veterinary biologics establishment of license as part of the development of abide by the 400, our classical swine fever vaccine.

If we secure such a license it will enable us to expand our development capabilities across our organization and open a constructive pathway for this and other veterinary vaccines and therapeutics.

Keep in mind. This is an initial albeit important stuff.

Often the multiyear approval process.

Meanwhile, we're planning to start an efficacy study in June.

<unk> 400, where the large safety study to follow later in 2021.

In addition to the progress with <unk> hundred we're excited to announce the patent issuance covering endostatin peptides for treating fibrosis.

The claims cover of novel expression cassette that enhances the yield of the endostatin fragments and variance using our cash farming system.

These patent claims are foundational to our work on the anti fibrotic therapies and support the development of our product candidates high buyer of $100 for the treatment of systemic scleroderma and idiopathic pulmonary fibrosis as potential lead indications.

We continue to make preparations to launch the last of our IND, enabling studies, which will be followed by GMP manufacturing.

As much as we are excited about the future of our therapeutic human and animal health pipeline. The emerging success of our <unk> business has also given us confidence on our ability to execute on delivering differentiated solutions to biologics manufacturers.

Our fast farming system like in hearing technologies of <unk>.

Multiple runways of opportunity for our internal product catalog and service capabilities, which can be seen in our CMO of agreements this year.

During the quarter, we continued to diversify our customer base with the ATB Therapeutics agreement.

<unk> Therapeutics will use <unk> bio's first farming system to produce its bio engineered antibody toxin fusion proteins we.

We are looking forward to helping the organization rapidly build a scalable manufacturing process as it prepares for its first safety trial.

Our Safi agreement continues to progress as we work towards generating cgmp growth factors and cytokines using our cash farming system.

This agreement has become a significant revenue contributor driving the quarter over quarter and year over year growth.

We believe the Safi agreements represent a great opportunity for us in two ways first we were able to grow our CMO business and showcase our capabilities and on.

On the two we were able to start building around catalog of high quality proteins for research and further manufacturing uses.

The proteins, we are building with Saffy that are not designated as customs by that and it can be commercialized buyouts.

The opportunity of <unk> was that if the manufacturer buys of product from our RVP on research in Bioprocess catalog for.

For a specific delivery system of product candidate will get specified for use in their manufacturing process as they move through their own clinical trials.

Furthermore, the number of these products could be translated to our own the proprietary product candidates.

We plan to begin offering of new catalog of these high quality research and bioprocess from teens by mid calendar 2021, initially focused upon growth factors and cytokines.

Overall, we remain very encouraged by our growing success in CD of most services driven by the combined technologies of gas farming like in here.

I'm also excited for the opportunities across our therapeutics and vaccine product candidate pipeline as well as per our emerging RVP business.

Importantly, I believe we now have the requisite leadership and expertise within our organization to maximize both our current and future opportunities.

Thank you.

With that concluding our highlights we are happy to take any questions you might have.

Operator.

At this time I would like to remind everyone in order to ask the question Press Star then the number one on your telephone keypad again that is star then the number of one on your telephone keypad will fosberg.

Fosberg, yes, Tim on them to compile the Q&A roster.

We have our first question coming from the line.

Of Kristen <unk> with Cantor Fitzgerald Your line is open.

Hi, everyone. Thanks for taking my questions and congrats on the progress hires as well as your new website.

So my first question is last week, one of the companies in Phase III development for IPF announced the discontinuation of the auto tax an inhibitor, citing the benefit risk profile.

Profile excuse me no longer supported continuing the study.

Perhaps I could ask you based on the mechanism of action of <unk> bio of 100, and what you've seen in preclinical studies why do you think your therapy could be differentiated and overcome some of the hurdle rates seen in the space.

Yeah. Thanks, Chris Great question, we saw that development with interest of course debt.

<unk> inhibitor class.

I think the whole class actually may get called in the any jeopardy here in the call.

Combination the safety and efficacy questions that are associated.

When we take a look at our MLA of course its quite different.

Than theirs and so as we as we've taken a look at our particular product one thing that we have some relatively high confidence of Bob is going to be safety profile. I mean this is ultimately just a day.

The riveted on oncology on here.

Here that we're talking about.

So.

Relative to the opportunities that we see ahead with what we've done with some of our preclinical work and by the way that that's sort of been two areas. We have sort of of traditional mouse model that you use for testing idiopathic against the path of pulmonary fibrosis.

Where we saw really good results versus the standards of care right now.

In Canada.

Don.

But but also Q on diseased human lung X points of.

Jamie was really good so we saw not only stasis, but reversal.

And both of those particular models, so we're optimistic that with.

With an important drop out in the competitive landscape for development here the treat some of these diseases.

For which the.

I mean, theres not theres on the integrated solutions on the and the two that I.

Just mentioned and tentative in Pirfenidone of course, you know a lot of patients can't even stay on those medications due to such poor tolerability. So we're hopeful that we'll be seeing per I buy of 100, as we get around sort of designing the <unk>.

Files in some of the rest is that at least from the safety and Tolerability standpoint, we're certainly going to have our fingers crossed.

We will be able to deliver something there and with the preclinical data that we have around the efficacy of the molecule. We feel really good about that too which is why we're on.

Moving forward as quickly as possible to well just trying to get into the clinic.

Great. Thank you and then on the COVID-19 vaccine landscape front could you further elaborate on how youre thinking about how fast farming may allow for greater production and cost savings and kind of what you've seen and observed from some of the other key vaccine players. So far and then I also just wanted.

To elaborate on some of your prepared remarks so.

So regarding the second generation vaccine that you have in development here do you think youre going to have the conduct any further talks work similar to what you've done for the first generation or you would plan to move forward with them together assuming that the data next quarter for you will be positive.

Yeah, let's to I guess, the second question first.

The hope is here that with the Tox work that we're doing and taking a look at the booster molecule.

Ace or like on booster.

The we can have the spike protein in the nucleocapsid kind of ride along with that.

And hopefully get clearance to move forward from the agency.

So.

That's the expectation that we pair of those two well.

And then and then moving forward.

So turning to some of the unmet needs and I think the the question's a good one around cost, especially when we take a look at what's going on in and access and certain places not the least of which would be Africa, South America and alike.

The cost is one component the.

Other thing I think worth, noting as we've seen from the <unk>.

Pfizer and the majority of vaccines of course is that they have those pretty substantial cold chain requirements and the question is going to become as we see if in fact this becomes a seasonal illness and we have not only new mutations for which the current vaccines.

<unk>.

They have a different cut.

Coverage level of our efficacy.

Right. So what we've seen is in some of the early ones.

We're getting 90% and then that started to drop off prospectively. It could have been due to some of these new mutants and then the question becomes what the end up with whole entirely new strange too.

So I think it's as.

As we consider what goes on if we're going to have to be getting after this season after season than the speed with which the mrna vaccines can be produced.

To address new streams of Newton's is really good I mean, it rivals what we can do with fast farming, but then ultimately.

One was to go with the sub unit vaccine.

Then some of these cold chain requirements of some of the west.

Would be matters that we could perhaps better overcome and possibly two from the cost and access standpoint as well. So that's how we're looking at the evolution of the marketplace and as well as the disease of the disease state itself. So.

For those reasons, we continue to invest behind the platform as you well know there's a couple of other players that had patch on the ring, even those that were involved in operation Warped speed, who got substantial government funding that of <unk>.

Subsequently.

Stop production.

Of their stock moving forward with their development programs.

But we see enough promise and what we have here to keep that going and crucially. This is going to depend on two things a our design strategy do we havent REIT debt.

Maybe.

Targeting the nucleocapsid protein and this is not to say that we're not looking at some of the others too but that more well conserved protein might be of very good answer to help address more of mutants.

Of the virus as it occurs and then of course, we've got to get our toxicology study.

On a reported back in and have the all clear to go forward, but assuming those two things to be.

True or April for us able to move forward with we would we would look to bring this kind of solution here. If it continues to head down the path where that looks like it will be a season of loans.

Great. Thanks, so much Tom.

Thank you great questions.

We have our next question comes from the line of Ben Hayner with Alliance Global.

Your line is open.

Hey, guys. Thanks for taking the questions.

Just thinking about the the veterinary side of things in the eye.

400.

You mentioned the May take a couple of few years to get kind of the clearance to two.

On the the.

The FDA USDA.

Side of things, but.

What does the timeline look like for <unk> of 400.

When when do you.

Or what do you anticipate investing the kind of take debt to completion.

Hey, Ben So great question and it.

What's interesting here when you take a look at the regulatory pathway on the USDA side of things, it's a little bit like how the FCA used to be where you actually have to have your manufacturing facility inspected by the by the FDA well nowadays it's more incumbent upon the <unk>.

The developer.

Go ahead and kind of that.

Juice the information necessary to go ahead and get of for instance of BLA or biologics license application, whereas in the case of the USDA. It's still the case, where you have to pass of the facility inspection. So we'll send somebody out to check out the manufacturing facility itself. So what one has to do.

Interested in moving down the regulatory pathway in that instance is that you have your your site license for your facilities travel along with your.

Your first product and so to that end, we had good data and progress on <unk> 400, and what we need to do of course is kind of play a little bit of catch up towards getting the.

The facility moving down the same path together.

On the establishment license. So this times well in fact for us because what we're going to be able to do is submit this outline of production, which is kind of the first step it.

It will be an outline of production for something specific in our case, that's going to be the for the classical swine fever vaccine and then concurrently we're going to be doing a couple of.

Studies here so the we're in really good position around the same time as if we're moving things through.

The facility signed leases, we're going to have or one of our.

The.

Efficacy and safety studies that come along the way that makes sense at all of them by the way the Covid has absolutely impacted.

At least what we've seen and heard.

On the USDA has ability to go ahead in the process. Some of these new things. So we're mindful of that.

And Theres a couple of steps that we're taking to try.

The pull some of the time out there as of few new procedures and things that we're looking at that could help with that but we could see it.

It could be as long as two years depending upon.

The factors associated with the global pandemic.

Got it.

And then.

And you mentioned the site license.

Travels along with the first product.

I wanted to say and then maybe I'm misremembering this but.

Are the products than the.

Tied to the site I seem to recall that being the part of.

Some of the USDA regulatory stuff on on vaccines, but.

Correct me, if I'm wrong there.

Well I'm not of regulatory expert on that one Ben but I think that strobl believes the way. It works so in all of them too and I'll get back in check it out, but yes, I mean by virtue of the fact that you need the establishment license I.

I think that that's the case, so I don't know that it seems you the necessarily pack it up and move it there may be a procedure for doing that.

But I think generally it does it does focus on that.

My understanding of it as well as the.

I believe the good news is once you get it for your facility for one product you can make other products out of there without having to go through growth.

Additional inspection process.

Once again I'm.

Not the regulatory experts on that a lot of follow up with you.

The USDA is kind of interesting on the.

The veterinary side of that for biologic. So there's really not a pathway for a generic or biosimilar to gain approval. Once the once you get you have something like that so that always interest and of course.

And then just.

You mentioned the end of life phase for the innate.

Enabling study on <unk> two of one.

I think this is Tim.

<unk> taken longer than.

Some people had hoped of course it sounds like results in April.

Are there any concerns of worries that you guys have with regard to the toxicology the.

We should be thinking about or.

No.

It was really I think more than anything is looking at how the market evolves and as we were going through whatever it was I mean keep in mind.

Everybody else out there.

Everybody, who was part of the operation Warped speed.

It had platforms and platform technologies that <unk> been developing for a decade or more and so when it came time for well when the.

The pandemic hit.

One could take your platform having already gone through.

Something like toxicology, let's say.

And.

And kind of skip that staff and just load your antigen on the platform.

And frankly, that's what we were hoping we might be able to do with the virus like particle platform, but we didn't see the same sort of immunogenicity.

<unk> generated as we did with 201. So we were faced with that question of well now what do we do strategically of what do we do see the relative to efficacy and then there is that period of <unk>.

We'll look it looks like two three or four other competitors were going to come out there with the solution.

Could I bio compete right.

And so what I would say is happily.

A.

The <unk> bio ware, some global pharmaceutical the Hermosa said, okay, well, we're stepping out of the.

Out of the scenes either because of the.

Efficacy of their vaccine in development of the for other reasons.

Whereas we felt confident.

And our thinking is well I don't want to say comparable because theres still a lot of biology of wants to be done, but with our approach with the sort of the tried and true category of the sub unit vaccine.

When it comes to the safety and toxicology actually I would say no. We're not worried at all as a matter of fact, we think.

That should be should be better just fine, but we do need to run that we can as molecule through the talks we could get a surprise and find out debt okay.

No.

<unk> did not hit our expectations, but we are not expecting.

Sure.

We're expecting a more favorable we think of more favorable outcome is likely then we'll be able to move forward.

Okay. Thanks for all the color of that definitely helpful and then.

Just on the research of Bioprocess inside of things you know what what have you seen as far as the incoming interest there are.

Any color on on that that you can provide.

Well not too much only because we have not yet put the products into the catalog.

But what I suppose I can say is that <unk>.

Certainly we.

Got him off to what we think is a very good start with utilizing the platform too.

Pursue the walk.

Fleet doesn't.

The proteins as part of the program.

The cytokines and growth factors as part of what we're doing the SaaS fee.

No.

So those are going along really well, we can make a lot of them we made them quick.

As suggested in our remarks.

We were able to deliver on loans in the state our revenue recognition fairly quickly. So that gives you a sense for the fact that we're able to turn on on the cash one of the machine.

Frank the products out in.

They look pretty good so far.

What I can say is that we've had interest from one or two others, but really the proof is in the putting when we get the products into the catalog. So we've got to.

Get them fully ready for commercialization and launched and then of course, we don't want to make them available on lowering others test of us.

Really turned that business on so that'll be coming as we suggested before.

And the next few months, but sorry to add too much color here I suppose what we think could be really attractive for the customer base that we're targeting is the.

The many might choose to use these products first for research.

To maybe make a cellular therapy and as part of that often times you have to add in.

The cytokine or a growth factor or something to the cell culture media.

The good news about our platform is since it's plant based.

It means it's animal free and that means the risk of.

Had been tissue agents, they call them or.

Essentially.

Contaminants with.

It could be stopped for BSC or mammalian viruses or whatever greatly reduced with the plant based protein.

And then the fact that we can translate so quickly from research to.

Are you old labeled product to further manufacturing use label product.

We think creates notable.

The competitive advantage for this line of products. It sounds like there's not other competitors out there, but theres a couple of advantages here with using our system that we think will make.

I'll make it a really interesting market and we think we can.

Pete and grow the product line.

Okay got it.

That's great. Thanks, and then lastly for me the any update on the front of the Hopper lawsuit.

I'll leave it there thanks for taking the questions.

Alright, Thanks, Dan.

<unk>.

The it's still scheduled for trial to begin March 1st.

We.

Certainly see it as others do the where we're in the damages phase some wood.

Contend that the Delaware Court of Chancery ruling back in 2016.

Was very.

Very much in <unk> favor. So we think we're going to prevail.

And I suppose we'll we'll see in a matter of weeks.

The deal well best of luck to you there.

Thanks, guys alright, thanks, Sean.

Okay. All of our next question comes from the line of James Hassan on private Investor. Your line is open.

Thank you for taking my call I have several questions and I'll start with a couple of comments on Tom.

<unk> been in <unk>.

Two full years now and I follow the company closely.

And it wasn't on the call last time, but I did want to thank you because I know how hard it was the sale of the company back in late 2019 that wasn't our deal and kind of spoken to many people. So.

I think very few people realize the difficulty involved in what you had to do.

And on here of Hey, I wanted to thank Steve Kilmer, because he has been my go to.

The bio source for two years and he has performed fantastically is the best of best IR Guy have never worked with.

The way I've several questions I have I can move on quickly.

You have of DLP platform that you developed for.

202 hundred has kind of fallen off the radar.

But the DLP platforms, it looks to be one of the best in the industry.

Here's to have the need for some candidate molecules where are you at with the <unk> platform.

Well two things first.

Thank you of course for having been with us since the beginning and it was a.

Certainly investors like you I was referring to in one of the same Mike. Thanks, again for believing in US back in those early days here of the.

Of the transformation.

With regards to LP as maybe you and others, who were shareholders at the time in the early stages you may recall that that was the first.

The platform.

We announced moving forward with and it was for the reasons that you mentioned.

There was a lot of promise the the.

The LP that we had in our early manufacturer ability studies.

Really good.

And frankly, we got here, we also wanted to pick that because we thought that we could get.

On the exception from.

From FDA and being able to skip Tox studies.

<unk>.

Debt.

That was a good assumption on our part but what.

What we've said and communicated a couple of times is the when we did the bake off.

And we were fortunate we ran a bake off we could have just assumed well look every single day.

Optimal with the virus like particle platform and just taken one through the process but.

But fortunately, we said well look let's give a let's have a peek at what the sub unit vaccine would do and when it came down to it just based on performance to.

<unk> hundred one was better.

And there was a surprise no doubt.

And then of course, we needed to go through the talks now the <unk>.

Silver lining to that is.

By getting the <unk> platform through toxicology here, hopefully that'll be one of platform that we can use going forward. So with regards to the DLP the way in which we're treating that as that we do think it still has promise, but we need to work on it as the platform.

We've got a program in mind for that as to how to enhance it because to your good point.

We are seeing others use the virus like particle modality, if you will.

To good effect and so we'd like to be able to move that forward, but in terms of resource deployment and the investments. We we don't want to try to do everything all at once so we had to go we had only pick one horse to ride I guess is the way to put it when it comes to the COVID-19.

Vaccine portfolio because.

We do need to also obviously concurrently be moving forward with the anti fibrotic, what we want to do with high by the 400 in the west.

So that's.

It's still something that we want to advance we Justin focused our energies on 201 instead of in the meantime.

Alright, well along those lines on.

I noticed that your advertising for a head of oncology.

And I was wondering if the <unk> platform the <unk> platform with high end of that but.

On the head of oncology is of interest on.

Is there any comment you have on that.

As to where I buy on might be on in terms of oncology.

Okay.

So interesting notation on that posting yes indeed.

Let me see I guess, what I would say is that as we shared earlier here in the remarks.

Do see our ability to take our Glen can nearing technologies combined with the past farming two in particular being able to manipulate the sum of the sugars.

On for instance, a monoclonal antibody such that in particular.

For indications in oncology.

You can make them more potent.

On pumps can.

You can see on the literature, there's something called.

ADC.

The antibody dependent cellular cytotoxicity wondering if you can in particular when it comes to.

No.

Greg can engineering, if you can remove a certain kind of the sugar from a monoclonal antibody you can give it a greater ADC and so because of that and some of the other data that we have on hand, we have a history actually with some earlier work done on the company on.

The.

The monoclonal antibody.

By the name of Rituxan, we do think that there.

Theres a lot of opportunity there for us and as a matter of fact, we have experience now.

With 10.

10.

Arguably a little closer to a dozen.

Any cancer monoclonal antibodies so.

Yes.

What we have out there we published on some of that in the past and I think like in hearing technologies, we underscore and this is what I think makes the cash farming CMO services more attractive and this is part of the story, we want to tell.

It's more and more customers, we can do oncology mab well.

So.

And part of.

A leader for the program.

We think is important in.

It can really help us leverage the technology for opt.

The changes that we want to explore in the space, but nothing definitive that we've.

The established there and we don't have any projects identified per se just yet here for that program.

But.

That's the nature of the position.

Alright, let me go on another one quick one I hope.

On 201.

This established we're targeting the S and the N proteins. The website had a little blurb under the 201 section mentioning multiple proteins and I'm wondering have have you. Your team investigated also targeting like the E and or the M proteins as part of the 201.

<unk>.

So I can't disclose of share some of the other research activities that we may have Jim, but alright, I don't want people to say, yes, right in and here, we're obviously trying to be as transparent as we can.

The competitive giveaway of course, yes, exactly alright, let's move on he.

Hard to pin down the rough timeline for 201, we.

I'd never calculated in data analysis.

In terms of months instead of quarters, what rough month like April and May or June of whatever what month period do you think.

On the toxicology analysis would be done and then when might an IND filed.

The best again, yes, so I mean.

I think what we want to say on that is really what we've already said, which is the early Q4. So you can kind of get you are saying if you cut the quarter in the middle.

We want to figure it sometime in there and again, we're not doing that.

Dana.

Net analysis ourselves we have on third.

<unk> provider, that's doing that work we've paid to have an expedited.

And so that is our expectation that we'll have that data in hand in the beginning of the quarter.

And then the next quarter that is and then we have to.

I mentioned before combined debt.

The talks info with some of the other preclinical day.

Peter.

Then we want to generate on Ken.

<unk> plus us together as well as anything else that we might be doing with the vaccine what the.

He is at the end are we going to be able first because theyre going to be of market right.

Alright.

Or what other is predicting.

About this becoming a seasonal.

The disease or illness is that going to unfold and then Ken the solution in fact bring differentiation versus the mrna and the and the adenovirus.

Based vaccines I think those questions combined with our own performance.

With the design that we have really are going to rule the day and if we've got a good answer or a better answer then we're going to press forward, if we don't or if the market conditions change or the.

The lease itself.

If the winds up stabilizing work.

Here's the other thing of a bunch of the state it may become less lethal some of our project projecting as you as you see it.

Go through these various mutations in and of all of that can occur too.

So we're going to have to weigh all of those Jim as we go.

Because that has to be considered as we make the portfolio decisions.

Our pipeline, let me makes sense total sense, alright, I think thats it and ill let you go to the next one thanks so much.

Thanks, Jim.

Okay. All of our next question coming from the line of Jim Jones mature side capital. Your line is open.

Hey, Tom how are you doing first of all thanks, all for taking our questions here and I want to congratulate you on all of the new talent that we're seeing coming in to join the team. Additionally.

Additionally, and this goes to my question.

We have seen the launch of a new logo and fantastic New web site and so we have these.

Outward facing brand changes that reflect a bullish direction for the company since the last call and it looks to me that a lot of things are starting to move in house. So that said I just wanted to ask quickly if theres plans to move things like.

Investor Relations in house.

And you spoke earlier on your opening statement about spreading the word on <unk> and I wanted to find out if you have any plans to bring on strategic communications consultants or anyone that can help build shareholder value and really just kind of build the story because we believe in the story is retail, but we'd love to see more people will get that confidence.

<unk>.

So Jim Thanks for your questions and.

Look in terms of talent and I've mentioned this before to other Jim.

True, who just preceded you.

I started off banking with a small team of people, who helped us through some pretty challenging times in late 2019 and in early 2020, and Oh by the way it's been.

It's been quite a wild ride here through all of 2020 on up until this point and I would say our investor relations partner.

He was one of those groups.

Matter of fact, the company has.

To dig out.

From a really challenging.

Financing in October of 2019, and we had a lot of folks help us get through that.

I think as we move things forward.

And now that we've brought on some help here into the organization and Oh by the way I don't want to give thanks here to John Delta.

It was yet another.

Person and then part of the bigger group.

The provided certain outsourced services and support for our organization because we started this whole thing off with like a couple of thousand people.

And that was everybody in the organization, including line workers and the folks in Texas you name it and so we had the lean very heavily on our <unk>.

Strategic suppliers vendors support staff in all of the rest so.

I feel like as we go forward I mean, hopefully you're seeing continuous improvement in all areas.

Hi.

I come from a place where one can.

You just never good enough.

Started this journey and we have a lot more to do for you and the rest of our investors.

Hopefully you see it return each month each week.

We believe that we're not only building a strong foundation for the company.

But generating real value real assets here.

Here going forward, so whether it's something like the website. A pipeline addition of novel deal that we do with the with a unique business model.

Or heck just.

Just on.

Getting our commercial organization in place.

To start now that we've got the glycogen range plus fast forming in the service portfolio of better define going out on telling that story.

Look we're going to just keep doing better every day and to the best of our ability because we think we've got some good here and again I think it's a matter of turning on the machine.

And using the capabilities of the platform to really strip that time out of that early stage product development cycle and you bring the ability to make higher quality products, along with it and oh by the way eco friendly and safer.

You bet, so you've got our commitment to keep working hard across all fronts all functions.

To build a great company so.

But thank you for the question.

Got it.

Commitment to continuous improvement in every facet.

We have our next question coming from the line of Matthew Breese of Matthew Herm LLC. Your line is open.

Hey, Tom This is Matt I appreciate you taking the question.

Sure you are aware I know a lot about <unk>.

Is that really a couple of questions.

First of all of you don't want to recognize the progress that you've made.

Alright, the phrase on new <unk>.

There.

Yes, definitely kind of long term private retail investor here.

I'm familiar with the company.

Beyond your personal involvement.

And.

To that end.

I think a lot of us.

We're involved with.

We're focused on the partnership with <unk>.

The key farming I have recently on 2019, and I think they were kind of.

Thats kind of PRC.

Ethan.

The latter.

As in the Investor Relations.

Press releases about that partnership and since then.

Our debt.

Not really the partnership thing right of vendor and at the same time.

CPP and I buy on the same line item.

On the W. H L lift.

For coronavirus.

In Canada.

And I.

Just.

Leave it open ended to hear from you what is going on internationally with respect to license the pattern whether.

The CCP, whether it's as of Jan whether it's South Africa or Korea of places, we've not even heard of.

How is that contributing to revenue how is that a priority of our focus of any of the business the best because really.

I have to comment on like in 2019 that really seem to be a huge focus in the back part of the new like bio where on the work.

Good to hear about that a little bit more with the.

The transparency that you promised us thanks, again, I really do appreciate it.

Again the pace.

The change in direction.

We just need to understand why.

Well, Matt Thanks for your question and.

As well as your support I think it's it's possible then we may have even preceded me here.

<unk> with.

With <unk> bio so here's the good news.

Those relationships are still very much in place and very strong.

And what I can say is relative to let me just break it down a little bit on cc farming. So youre right when it came to the.

COVID-19 vaccines it wound up being the two that I bio pad.

We were able to successfully manufacture and drive forward.

On the version of a version of a vaccine that.

An antigen that cc farming had.

Didn't actually materialize. So when it came to the COVID-19 stuff it was more of.

On the vendor short of the relationship.

As opposed to a partnership because we didn't have anything to drive necessarily at that type of dry form together on other than eventually cc farming could have.

<unk> taken our our COVID-19 vaccine forward into China right.

However, when it comes to the west of the relationship that's still in place and as a matter of fact, we drove really hard towards the end of last fiscal year.

Two.

Deliver on the commitments that were in the the statement of work of the contract that we had so that's why we had a big quarter relative.

The relatively speaking for <unk> at the end of last fiscal year that was a lot of that and I think we spoke to this in our filings was cc farming. So you can see all of that there.

We have a very good relationship with the leadership over there.

And they are looking at different strategies themselves.

But obviously I can't I can't speak to that too much.

That relationship is still still strong and we delivered on everything that we had in place and when it comes to some of the others and we have named Azure, Jim So I would say same thing.

We have a very good.

The relationship with more of the CEO over there and in terms of them executing to their strategy, we're helping them here.

You are all along the way.

Notably to the earlier question around oncology.

In both of the relationships. The first start was with that molecule rituxan or rituxan that.

In the generic sense.

So we're happy that those relationships are there we do have active work.

Certainly with Allergan right now so we've we've changed some things, but we in no way shape or form given up on our CMO services factory solutions and things that help our partners overseas being able to adopt utilized.

The platform to their own.

Business goals here on along the way so great questions I hope that clarifies things a little bit.

But we are still strong with those relationships and in fact.

So I can't speak to them, but we.

Have other international partners that were speaking with right now and may or may not.

To be able to move some of those forward two agreements.

But ex U S or an extra point of America.

We're still active.

We have now reached the allotted time for today's call I will now turn the call back over to Tom I said.

Alright, well I would say once again, everyone. Thanks for your time and attention today.

And thank you for joining we look forward to updating you again on our next call. Thanks again.

Ladies and gentlemen, thank you for your participation that concludes the presentation. You may now disconnect and have a wonderful day.

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