iBio Inc (IBIO) 2021 Q2 法說會逐字稿

Thank you for standing by and welcome to the iBio Fiscal 2021 Second Quarter Financial Results conference call.

(Operator Instructions)

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 iBio 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 expressions or statements 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 in this conference call may not occur by certain specified dates or at all and could differ materially as a result of known and unknown factors and uncertainties affecting the company including the risks regarding the company's ability to obtain regulatory approvals for commercialization of its product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of this product candidates in the marketplace and the successful development, marketing or sale of the products, its ability to maintain its license agreements, the continued maintenance and growth of its 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 retain its key employees.

Although iBio has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions -- that cause actions, events or results to differ from those anticipated, estimated or intended.

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 iBio 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. Tom Isett, iBio's Chairman and Chief Executive Officer; and John Delta, iBio's Principal Accounting Officer.

With that said I'll now turn the call over to Tom.

Great. Thank you, Steve, and good afternoon everyone. So, I would like to start off by thanking a small team of people who helped start the transformation of iBio in late 2019 and the investors who believed in us. That group brought passion, energy, and the belief that they could use the power of plants to not only help other companies speed the development of air products into the clinic but to also use our own technologies and scalable manufacturing platform to create our own portfolio of biological medicines to address unmet needs in human and animal health.

In 2020, we combined our new Glycaneering technologies with our FastPharming System to significantly enhance our protein engineering capabilities. That led to growing interest in our CDMO services while jumpstarting work on our proprietary vaccines and therapeutics.

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

With three new businesses added to our existing services portfolio, we invented -- invested in recruiting experience and talented leaders to help us build and grow these four segments.

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

If COVID-19 evolves into a seasonal illness, as many expects -- experts are beginning to predict, then the subunit vaccine carrying multiple SARS-CoV2 antigens that can be rapidly modified and scaled, like IBIO-201, could address some of the still significant unmet needs associated with recently introduced mRNA and adenoviral vaccine platforms.

Meanwhile, we're advancing our lead antifibrotic molecule by optimizing its efficacy, safety profile, and manufacturability. And with the creation of our new animal health organization, we're accelerating our work to bring our classical swine fever vaccine forward, which includes our effort to secure important regulatory approvals for our FastPharming facility in Texas.

As 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 our dedicated team has been focused upon. We've overcome the challenges of the pandemic to dutifully serve our CDMO clients and continue to deliver on the projects that we have underway with the likes of United Therapeutics, Safi Biosolutions, and ATB Therapeutics amongst others.

More generally, we're seeing our innovative FastPharming System gain traction in the contract manufacturing services segment. So, we expect that with our new commercial initiatives reflected in part by our recently launched website that we'll be able to spread the word about all the advantages of our truly green platform including speed, scalability, and quality. And notably to that last point, we've enhanced our monoclonal antibody engineering and characterization capabilities which should make FastPharming even more attractive to certain market segments.

Bottom line, we believe that FastPharming platform provides sustainable competitive advantage by stripping time and cost from the early stage biologics development cycle and we're confident that we built a strong, multi-faceted biotech and CDMO around it to capitalize on the optionality it provides and the return value to our shareholders.

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 FY21, I'll turn the call over to John to review our fiscal second quarter 2021 financial results. John?

Thanks, Tom. Good afternoon, everyone. I'd like to provide a brief update on our financial results for the quarter ended December 31st, 2020. To streamline things, all of the numbers I will mention have been rounded and are therefore approximate.

For the three-month period ended December 31st, 2020, iBio reported revenue of $700,000, an increase of $400,000 from the same quarter last year. Total operating expenses consisting primarily of research and development or R&D and general and administrative or G&A expenses for the quarter ended December 31st, 2020 were $8.3 million compared with $3.5 million for the same period last year.

R&D expenses for the quarter ended December 31st, 2020 were $2.4 million compared with $900,000 in the same period a year ago. The increase is primarily related to an increase in laboratory consumables, supplies, and higher R&D personnel costs.

G&A expenses for the quarter ended December 31st, 2020 were $5.8 million compared with $2.6 million in the same quarter last year. The increase result is primarily from higher professional and consulting fees including recruiting as well as facility repairs and maintenance, public company costs, insurance, and board of director fees.

Other expense for the quarter ended December 31st, 2020 was $600,000 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 our R&D, G&A, and cost of good-sold expenses. In Q3, we will begin reporting on revenues and expenses associated with the three new profit centers within iBio, Inc., which include therapeutics, vaccines, and research and bioprocess products.

We have been making significant investments in people, processes, and infrastructure to match our progress and position in our life cycle. We believe that creating the solid foundation provides the expertise and capabilities needed for a high-quality biotech company and will serve iBio 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.

Net loss attributable to iBio stockholders for the quarter ended December 31st, 2020 was $8.2 million or $0.40 per share compared with a net loss of $25.4 million or $0.69 per share in the comparative period last year. As of December 31st, 2020, iBio had cash and cash equivalents plus investments in debt securities of $107.6 million.

With that, I'll now turn the call back over to Tom. Tom?

Thanks, John. While we're excited with our progress today, of course, we remain focused on delivering results in the near term that will also create long-term success. We believe that our investments, innovation, processes, and people today will be foundational for achieving our long-term goals.

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

As you may have seen in our separate press release earlier today, our most recent addition comes with the appointment of Mr. Robert Lutz as Chief Financial and Business Officer. He will manage our financial operations including reporting, budgeting, and strategic planning. And consider Rob's impressive background working with commercial-stage companies to secure our complementary assets via licensing deal and partnerships. We believe he will be in position to [rally], contribute to the growth of our product portfolio.

Joining Rob in our recently staffed C-suite is Randy Maddux, Chief Operating Officer; Lisa Middlebrook, Chief Human Resources Officer; and Dr. Martin Brenner, Chief Scientific Officer.

In many respects, Dr. Brenner's appointment embodies iBio's transformation from a quiet CDMO into a dynamic biotech innovator and leading biologics contract manufacturing organization. He has a strong history of success heading drug discovery and development teams in several of the world's leading pharmaceutical companies including AstraZeneca, Lilly, Pfizer, and Merck.

Most recently, Martin served as the CSO at Pfenex, an NYSEA-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 iBio's propriety product platform and, as a self-described drug hunter, we believe his skill sets with drugs are highly complementary.

Ms. Middlebrook is a proven team builder with a strong bottom-line focus. Coming to us from Lupin Incorporated, a global pharmaceutical company offering branded and generic formulations, biosimilars, and active pharmaceutical ingredients, Lisa has extensive experience delivering human resources, strategies, and recruiting talent. Notably, while in Lonza, a multi-national CDMO, she led a global leadership development program.

Rob, Martin, and Lisa join Mr. Randy Maddux who is appointed COO in November coming to us from GSK via Aptevo as well as Dr. Melissa Berquist, who was named Head of Animal Health Programs in October. Along with those recent additions, we greatly enhanced our biopharmaceutical industry experience on our board with the appointment of Dr. Linda Armstrong, Dr. Alexander Kropotova, and Gary Sender early in Q2. So, please join us in welcoming all to iBio to help us execute on our strategy.

So, turning now to developments with iBio pharmaceutical 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 phase of IND-enabling toxicology studies for our subunit vaccine, IBIO-201. The data is currently being analyzed by our Contract Research Organization and we expect to report toxicology results in early Q4 FY21.

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

As most of you know, we selected IBIO-201 as our leading COVID-19 vaccine candidate based upon its production of higher anti-spike neutralizing antibodies compared to our VLP vaccine platform, IBIO-200. IBIO-201 is based on a subunit platform that combines antigens derived from the SARS-CoV2 spike protein fused with our patented LicKM booster molecule to enhance immune response.

The addition of the LicKM booster to a subunit antigen may provide -- improve the likelihood of achieving single-dose, prolonged immunity. Additionally, considering the emergence of circulating mutations of COVID-19, we recently began designing a next-gen subunit vaccine with 201 that includes the spike or S protein plus the nucleic acid or N protein.

We're using FastPharming to build the N plus S versions with the idea that the LicKM types of toxicology results are favorable we would take those two, both N and S with LicKM, custom with other adjuvant and evaluate results.

By the way, the same concerns around possible (inaudible) that drove our decision to develop the N plus S vaccine provided the rationale for us signing a ACE2-Fc deal with Planet Biotechnology back in August. This COVID-19 therapeutic candidate is a recombinant protein comprised of human angiotensin converting enzyme 2 or ACE2 fused to a human immunoglobulin G Fc fragment.

This ACE2 also is a target receptor for the coronavirus' entry to the cells, we believe the candidate will bring the benefit of traditional neutralizing antibody while prospectively limiting the potential for viral escape.

We continue to see there is a potential strategic advantage in that approach in light of what we're seeing with competing therapeutics and we're now watching a regulatory and competitive landscape for opportunities to make ACE2-Fc 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 a U.S. Veterinary Biologics Establishment License as part of the development of IBIO-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 step in what is often a multi-year approval process. Meanwhile, we're planning to start an efficacy study in June on IBIO-400 with a large safety study to follow later in 2021.

In addition to progress with IBIO-400, we're excited to announce the patent issuance covering endostatin peptides for treating fibrosis. The claims cover a novel expression (inaudible) that enhances the yield of endostatin fragments and variants using our FastPharming System.

These patent claims are foundational to our work on antifibrotic therapies to support the development of our product candidate, IBIO-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 therapeutics, human and animal health pipeline, the emerging success of our CDMO business has also given us confidence in our ability to execute and deliver differentiated solutions to biologics manufacturers. Our FastPharming and Glycaneering technologies have unlocked multiple runways of opportunity for our internal product catalogue and service capabilities which can be seen in our CDMO agreement this year.

During the quarter, we continue to diversify our customer base with the ATB Therapeutics agreement. ATB Therapeutics will use iBio's FastPharming System to produce its bioengineered antibody toxin fusion proteins. 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 FastPharming System. This agreement has become a significant revenue contributing 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 are able to grow our CDMO business and showcase our capabilities. And number two, we are able to start building around catalogue of high-quality proteins for research and further manufacturing uses.

The proteins we are building with Safi that are not designated as customs by them can be commercialized by us. The opportunity for iBio is that if a manufacturer buys a product from our RBP, or Research and Bioprocess catalogue, for a specific delivery system or product candidate, we'll get specified for use in their manufacturing process as they move through their own clinical trials. Furthermore, a number of these products could be translated to our own proprietary product use.

We plan to begin offering a new catalogue of these high-quality research and bioprocess proteins by mid calendar 2021 initially focused upon growth factors and cytokines. Overall, we remain very encouraged by our growing success in CDMO services driven by the combined technologies of FastPharming and Glycaneering.

I'm also excited for the opportunities across our therapeutics and vaccine product candidate pipeline as well as for our emerging RBP 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, and with that concluding our highlights, we are happy to take any questions you might have. Operator?

(Operator Instructions). We have our first question coming from the line of Kristen Kluska 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 three development for IPF announced the discontinuation of their autotaxin inhibitor citing the benefit-risk profile -- excuse me -- no longer supported continuing the study. So, perhaps I could ask you based on the mechanism of action of IBIO-100 and what you've seen in preclinical studies why you think your therapy could be differentiated and overcome some of the hurdles we've seen in the space.

Thanks, Kristen, and great question. We saw that development with interest, of course, that ATX inhibitor class -- I think the whole class, actually may get called into jeopardy here -- that combination, the safety and efficacy questions that were associated when we take a look at our MOA, of course, it's quite different than theirs.

And so, as we've taken a look at our particular product, one thing that we have some relatively high confidence about is going to be its safety profile. I mean, this is ultimately just a derivative of collagen 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 sort of in two areas we have sort of a traditional mouse model that's used for testing against idiopathic pulmonary fibrosis where we saw really good results versus the standards of care right now, ninetdanib and pirfenidone, but also too on diseased human lung explants, our data was really good.

So, we saw not only stasis but reversal in both of those particular models. So, we're optimistic that with an important dropout in the competitive landscape for development here to treat some of these diseases for which -- I mean, there's not -- there's hardly any great solutions in the two that I just mentioned, ninetdanib and pirfenidone, of course. A lot of patients can't even stay on those medications due to such poor tolerability.

So, we're hopeful that what we'll be seeing for IBIO-100 as we get around designing the trials and some of the rest is that at least from a safety and tolerability standpoint we're certainly going to have our fingers crossed that we'll be able to deliver something there with the preclinical data that we have around the efficacy of the molecule. We feel pretty good about that too, which is why we're moving forward as quickly as possible to try to get into the clinic.

Great. Thank you. And then, on the COVID-19 vaccine landscape front, could you further elaborate how you're thinking about how FastPharming may allow for greater production, 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, regarding the second-generation vaccine that you have in development here, do you think you're going to have to conduct any further tox works similar to what you've done for the first generation or you would plan to move forward with them together assuming that this data next quarter for you will be positive?

Yes. Let's do, I guess, second question first. The hope is here that with the tox work that we're doing and taking a look at the booster molecule, the licanase or LicKM booster, that we can have the spike protein and the nucleic acid kind of ride along with that and hopefully get clearance to move forward from the agency. So, that's the expectation that we pair those two up and then move forward.

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

The other thing I think worth noting is we've seen from the Pfizer and the Moderna 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 may have a different coverage level or efficacy, right, so what we've seen is in some of the early ones you are 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 -- well, do you end up with whole, entirely new strains too.

So, I think it's -- as we consider what goes on if we're going to have to be getting after this season after season then the speed with which the mRNA vaccines can be produced to address new strains and mutants is really good, right? It rivals what we can do with FastPharming.

But then ultimately, if one was to go with the subunit vaccine then some of these cold-chain requirements and some of the rest would be matters that we could, perhaps, better overcome and possibly too 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 and the disease state itself.

So, for those reasons, we continue to invest behind the platform. As you all know, there's a couple of other players that had hats in the ring even those that were involved in Operation Warp Speed who got substantial government funding that have subsequently stopped production of their or stopped moving forward with their development programs. But we see enough promise in what we have here to keep that going.

And crucially, this is going to depend on two things; a, our design strategy. Do we have it right that maybe targeting the nucleic acid 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 a good answer to help address more mutants of the virus as it occurs, and then, of course, we got to get our toxicology study or report back and have that all clear to go forward.

But assuming those two things to be true or [enable] for us to be able to move forward, we would look to bring this kind of solution here if it continues down the path where -- that looks like it will be a seasonal illness.

Great. Thanks so much, Tom.

Thank you. Great questions.

We have our next question coming from the line of Ben Haynor with Alliance Global Partners. Your line is open.

Hey guys. Thanks for taking the questions. Just thinking about the veterinary side of things and the IBIO-400, you mentioned that it might take a couple of few years to get kind of the clearance to -- on the FDA/USDA side of things. But what is the timeline look like for IBIO-400? And when do you -- or what do you anticipate investing that kind of take that to completion?

Hey, Ben, so great question. And 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 FDA used to be where you actually have to have your manufacturing facility inspected by the FDA.

Well, nowadays, it's more incumbent upon the developer to go ahead and produce the information necessary to go ahead and get, for instance, a BLA -- Biologics License Application. Whereas in the case of USDA, it's still the case where you have to pass a facility inspection. So, they'll send somebody out to check out manufacturing facility itself.

So, what one has to do if you're interested in moving down the regulatory pathway in that instance is that you have your site-wise -- it's for your facility -- travel along with your first product.

And so, to that end, we had good data in progress, IBIO-400. And what we need to do, of course, is kind of play a little bit of catch up towards getting the facility moving down the same path to get an establishment license.

So, this ties well, in fact, for us because what we're going to be able to do is cement this outline of production, which is kind of the first step. It will be an outline of production for something specific. In our case, it's going to be for the classical swine fever vaccine.

And then concurrently, we're going to be doing a couple of studies here so that we're in really good position around the same time as we're moving things through to get the facility site license. We're going have our efficacy and safety studies that come a long way. That makes sense?

And by the way, the COVID has absolutely impacted at least what we've seen and heard the USDA's ability to go ahead and process some of these new things. So, we're mindful of that. And there's a couple of steps that we're taking to try to pull some of the time out.

There's a few new procedures and things as we're looking that could help with that. But we could see it -- it could be as long as two years depending upon factors associated with the global pandemic.

Got it. And then, you mentioned site license travels along with the first product, I want to say and maybe I'm misremembering this but are the products then tied to the site? I seem to recall that being part of some of the USDA regulatory stuff on vaccines but correct me if I'm wrong there.

Well, I'm not a regulatory expert on that one, Ben, but I think that's probably the way it works. So, I want to make [sure] and I'll get back and check it out but yes, I mean by virtue of the fact if you need the establishment license, I think that's the case. I don't know if it's easy, they necessary pack it up and move it there.

There maybe a procedure for doing that but I think generally it does -- it does focus on another -- my understanding of it as well is the -- I believe the good news is once you're get it for your facility for one product, you can make other products out of there without having to go -- go through a whole additional inspection process. But once again, I'm not the regulatory expert on that, I'll have to follow up with you.

Well and the USDA is kind of interesting on the veterinary side in that -- for biologics, there's really not a pathway for generic or biosimilar to gain approval once you have to [point that threat], always interesting of course.

And then just, you mentioned the end-of-life phase for the IND enabling study on iBio-201, I think this is taking longer than some people had hope of course. It sounds like results in April -- are there any concerns or worries that you guys have with regard to toxicology that we should be thinking about or --

No. It was really I think more than anything is looking at how the market evolved and as we were going through, whatever it was, I mean keep in mind everybody else out there, certainly everybody who was part of Operation Warp Speed, it had platforms and platform technologies that they had been developing for a decade or more, right.

And so when it came time for -- well, when the pandemic hit, one could take your -- their platform having already gone through something like toxicology, let's say, and kind of skip that step and just load your antigen onto 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 generated as we did with 201. So, we were faced with that question of well, now what do we do strategically and what do we do relative to efficacy.

And then, there is that period of well, look, it looks like two, three, four other competitors were going to come out there with the solution and could iBio compete, right. And so what I would say is, happily, this little iBio where some global pharmaceutical behemoth have said, Okay, well, we're stepping out of those scene either because of the efficacy of their vaccine and development and for other reasons.

Whereas, we felt confident and are thinking is -- well, I don't want to say confident because there are still a lot of biology left to be done but with our approach with the sort of the tried and true category of a subunit 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 just fine but we do need to run that licanase molecule through that tox. We could get a surprise and find out that, okay, that did not hit our expectations but we are not expecting -- we're expecting a more favor -- we think a more favorable outcome is likely, then we'll be able to move forward.

Okay. Thanks for all the color there, definitely helpful. And then just on the research and bioprocess side of things, what -- how are you seeing as far as incoming interest there, any color on that you can provide?

Well, not too much only because we have not yet put the products into the catalog but what I supposed I can say is that certainly we have gotten off to what we think is a very good start with utilizing the platform to pursue the roughly dozen proteins as part of the program or cytokines and growth factors as part of what we're doing with Safi.

So, those are -- 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 those and plus get our revenue recognition fairly quickly, so that gives you a sense or the fact that we're able to turn on the FastPharming machine and crank the products out and they looked 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 pudding when we get the products into a catalog. So, we got to -- and get them fully ready for commercialization and launch and then of course we're going to want to make them available online while others test them and when we turn that business on.

So, that will be coming as we suggested before in the next few months but -- sorry to add too much color here I supposed, what we think could be really attractive for the customer base that we're targeting is that many might choose to use these products first for research to maybe make a cellular therapy.

And as part of that, oftentimes, you have to add in a cytokine or a growth factor, something to the cell culture media. Well, the good news about our platform is since it's plant-based, that means it's animal-free and that means the risk of adventitious agents they called them or essentially contaminants, right, was to be stuff for [BSC] or mammalian virus or whatever, greatly reduced with the plant-based protein.

And then the fact that we can translate so quickly from research to [RUL] label product to further manufacturing use label product, we think creates notable competitive advantage for this line of products. It's not like there's no other competitors out there but there's a couple of advantages here with using our system that we think make -- we're making a really interesting market and we think we can compete and grow the product line.

Got it. No, that's great. Thanks. Then, lastly for me the -- any update on the Fraunhofer lawsuit, then I'll leave it there. Thanks for taking the questions.

Great. Thanks, Ben. Yes, the -- it's still scheduled for trial to begin March 1st and we certainly see it as others do that we're in the damages phase, some would contend that the Delaware Court of Chancery's ruling back in 2016 was very much in iBio's favor. So, we think we're going to prevail and I supposed we'll see in a matter of weeks.

Good deal. Well, best of luck to you there. Thanks, guys.

All right, thanks, Ben.

We have our next question coming from the line of [Jim Tasano], private investor. Your line is open.

Hey, thank you for taking my call. I have several questions and I'll start with a couple of comments, Tom. I've been an iBio for two-full years now and I followed the company closely. And I wasn't on the call last time but I did want to thank you because I know how hard it was to save the company back in late 2019. It was an ordeal and I've spoken to many people. So, I think very few people realized the difficulty involved in what you had to do.

And I'm here and I wanted to thank Steve Kilmer because he's been my go-to iBio source for two years and he's performed fantastically. He's the best IR guy I've ever worked with.

Anyway, I have a several questions, I like to move on quickly. You have a VLP platform that you developed for 200 and 200 kind of fallen off the radar but the VLP platforms looks to be one of the best in the industry and it appears to have a need for some candidate molecules. Where are you at with the VLP platform?

Well, Jim, two things. First, thank you of course for having been with us since the beginning and it was certainly investors like you who I was referring to and wanted to say my thanks again for believing in us back in those early days here of the transformation.

Secondly with regards to VLP is maybe you and others who were shareholders at the time in the early stages, you may recall that, that was the first platform that we announced moving forward with. And it was for the reasons that you mentioned, there's -- there was a lot of promise. The VLP that we had in our early manufacturability studies looked really, really good.

And frankly, we got -- we also wanted to pick that because we thought that we could get an exception from FDA to be able to skip tox stuff. And it -- that was a good assumption on our part but what we said and communicated a couple of times has been when did the bake-off and we were fortunate that we ran a bake-off, we could have just assumed, well look everything will be optimal with the virus-like particle platform and just taken one through the process.

But fortunately, we said, look, let's give a -- let's have a peek at what the subunit vaccine would do and when it came down to it just based on performance, 201 was better. And it was a surprise, no doubt, and then of course we needed to go through the tox. Now the silver lining to that is by getting the licanase platform through toxicology here, hopefully that will be one platform that we can use going forward.

So with regards to the VLP, the way in which we're treating that is that we do think it still has promise but we need to work on it as a platform and we 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 don't want to try to do everything all at once. So, we had to go -- we had to 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 antifibrotics, what we want to do with IBIO-400 and the rest. So, it's still something that we want to advance. We just have focused our energies on 201 instead in the meantime.

All right, well along those lines, I noticed that you're advertising for a head of oncology and I was wondering if the VL platform -- VLP platform would tie into that but the head of oncology is of interest. Is there any comment you have on that as to where iBio might be on in terms of oncology?

Well -- 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, we do see our ability to take our Glycaneering technologies combined with FastPharming to -- in particular be able to manipulate some of the sugars on for instance a monoclonal antibody, such that in particular for indications in oncology that you can make them more potent.

Folks who've seen the literature, there's something called ADCC, antibody-dependent cellular cytotoxicity, where if you can, in particular, when it comes to glycan engineering, if you can remove a certain kind of sugar from a monoclonal antibody, you can give it a greater ADCC.

And so because of that and some of the other data that we have in hand and we have a history actually with some earlier work done in the company on a monoclonal antibody by the name of Rituxan, we do think that there's a lot of opportunity there for us.

And as a matter of fact, we have experienced now with 10, arguably a little closer to a dozen, anticancer monoclonal antibodies. So, that's just what we have out there. We published some of that in the past and the Glycaneering technologies we underscore. This is what I think makes the FastPharming CDMO services more attractive and this is part of the story we want to tell to more and more customers that we can do oncology labs well.

So in part, a leader for that program we think is important then to really help us leverage the technology for opportunities that we want to explore in the space but nothing definitive that we've established there. We don't have any projects identified per se just yet for that program but that's the nature of the position.

All right, let me go, another one, a quick one I hope. On 201, established we're targeting the S and the N proteins. The website had little blurb under the 201 section mentioning multiple proteins and I'm wondering, have you -- your team investigated also targeting like the E and or the M proteins as part of the 201 therapy?

So, I can't disclose or share some of the other --

I know.

-- research activities that we may have, Jim, but happy --

All right. I don't want you to say anything you're not supposed to say. Yes.

Right. And here, we're obviously try to be as transparent as we can.

Without competitive giveaway of course, yes.

Exactly, exactly.

All right, let's move on. Hey, to pin down the rough timeline for 201, we -- and I never calculated in data analysis, in terms of months instead of quarters, what rough month like April or May or June, whatever, what month period do you think that toxicology analysis would be done? And then, when might an IND be filed? Best guess.

Yes, so I mean I think what we want to say on that is really what we already said which is that early Q4. So, you can kind of get your -- so if you cut the quarter in the middle, you would want to figure it some time in there. And again, we're not doing that data set analysis ourselves. We have a third-party provider that's doing that work. We paid to have it expedited and so that is our expectation that we'll have that data in hand in the beginning of the quarter.

And then -- next quarter that is and then we have to, as I mentioned before, combine up that tox info with some of the other preclinical data that we want to generate on and process together as well as anything else that we might be doing with the vaccine. What the key is at the end, are we going to be able -- first, is there going to be a market, right. Are what others predicting about this becoming a seasonal disease or illness, is that going to unfold?

And then, can this solution in fact bring differentiation versus the mRNA 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 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 [leads] itself, if it winds up stabilizing work, if there's -- there's the other thing, a bunch of us that it maybe become less lethal.

Some are projecting as you see it go through these various mutations and evolve that can occur too. So, we're going to have to weigh all those, Jim, as we go because that has to be considered as we make the portfolio decisions for our pipeline. Does that make sense?

Total sense. All right, I think that's it and I'll let you go to the next one. Thank you so much.

Thanks, Jim.

We have our next question coming from the line of [Jim Jones] with (Inaudible) Capital. Your line is open.

Hey Tom, how are you doing? First of all, thanks 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 and this goes to my question, we have seen the launch of a new logo and a fantastic new website. 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 there's plan to move things like investor relations in-house. And you spoke earlier, in your opening statement, about spreading the word iBio 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 stories we tell but we'd love to see more people get that confidence.

So Jim, many thanks for your questions and -- look, in terms of talent and I mentioned this before to other Jim, who just preceded you, I started off thanking the small team of people who helped us through some pretty challenging times in late 2019 and early 2020 and oh by the way, it's been -- it's been quite a wild ride here through all of 2020 and up until this point. And I would say, our investor relations partner was one of those groups.

As a matter of fact, the company had to dig out from a really challenging financing in October of 2019 and we had a lot of folks helped us get through that. I think as we move things forward and now that we brought out some help here in the organization and by the way, I want to give thanks here to John Delta who was yet another person and then part of the bigger group that provided certain outsource services and support for our organization.

Because, we started this whole thing off like a couple of dozen people and that was everybody in the organization including line workers and the folks in Texas, you name it. And so, we had to lean very heavily on our strategic suppliers, vendors, support staff and all the rest. So, I feel like as we go forward and we hopefully you're seeing continuous improvement in all areas, I come from a place where -- look, it's just never good enough.

We started this journey and we have a lot more to do for you and the rest of our investors. Hopefully, you see in every turn each month, each week. We believe that we're not only building the strong foundation for the company but generating real value, real assets here going forward.

So whether it's something like the website, a pipeline addition, a novel deal that we do with the unique business model or heck, just getting a commercial organization in place to start now that we got the Glycaneering plus FastPharming in the service portfolio better defined, going on telling that story, look, we're going to just keep doing better everyday to the best of our ability because we think we've got something 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 got -- so you got our commitment to keep working hard across all fronts, all functions to build a great company.

So -- but thank you for the question and that's it. You got our commitment to continuous improvement in every facet.

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

Hey Tom, this is Matt. I appreciate you taking the question. I'm sure you're aware, I know a lot about iBio. I just have really a couple of questions and first of all, I want to recognize the progress that you made. I've heard the phrase a new iBio and there are definitely some long-term private retail investors who had been familiar with the company beyond your personal involvement.

And to that end, I think a lot of us who were involved, we're focused on this partnership with CC-Pharming as recently as 2019. You know, I think there were some visits to the PRC even and a lot of -- even investor relations and press releases about that partnership. And since then, we heard that's not really a partnership, they were a vendor. And at the same time, CCP and iBio are on the same line item, on the WHO list even for coronavirus vaccine candidates.

And I just like to leave it open-ended to hear from you what is going on internationally with respect to licenses, patents, whether it's CCP, whether it's AzarGen, whether it's South Africa or Korea, places we've not even heard of, how is that contributing to revenue, how is that a priority or a focus of any of the business these days?

Because, really, with -- I just have to comment like in 2019 that really seem to be a huge focus and if that's part of the new iBio, we're on board. We just need to hear about that a little bit more with the transparency that you promised us. So, thanks again. I really do appreciate, again, like it's a change in a direction. We just need to understand why.

Well, Matt, thanks for your question and as well as your support. I think it's possible then you may even preceded me here with some of the involvements with iBio. 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 -- I want to just break it down a little bit on CC-Pharming, so you're right, when it came to the COVID-19 vaccines, it wind up being that the two that iBio had, we were able to successfully manufacture and drive forward.

A version of a vaccine that an antigen that CC-Pharming had didn't actually materialize. So when it came to the COVID-19 stuff, it was more of a vendor sort of relationship as opposed to a partnership. Because we didn't have anything to drive necessarily at that time to drive forward together on, other than eventually CC-Pharming could have taken our COVID-19 vaccine forward into China, right.

However, when it comes to the rest 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 to deliver on the commitments that we're in the statement of work, in the contract that we had. So, that's why we had a big quarter, relatively speaking, for iBio at the end of last fiscal year.

That was -- a lot of that I think we spoke to this in our filings was CC-Pharming, so you can see all that there. We have a very good relationship with leadership over there and they are looking at different strategies themselves but obviously I can't -- I can't speak to that too much. So, that relationship is still strong and we delivered on everything that we had in place.

And when it comes to some of the others and we have made AzarGen, so I would say same thing. We have a very good relationship with Mauritz, the CEO over there. And in terms of them executing to their strategy, we're helping them to here all along the way. And notably to the earlier question around oncology, in both of the relationships, the first start was with that molecule, Rituxan or rituximab in the generic sense.

So, we're happy that those relationships are there. We do have active work certainly with AzarGen right now. So, we've changed some things but we -- in no way shape or form given up on our CDMO services, factory solutions and things that help our partners overseas be able to adopt, utilize the platform to their own business goals here and along the way.

So, great questions. I hope that clarifies things a little bit but we're still strong with those relationships and, in fact, obviously, I can't speak to them but we have other international partners that we're speaking with right now and may or may not be able to move some of those forward to agreements but actually [last year] -- actually North 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 Isett.

All right, well, I would say once again everyone, thanks for your time and your 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.