iBio, Inc. (IBIO) Q2 2021 Earnings Report, Transcript and Summary

Thank you for standing by, and welcome to the iBio Fiscal 2021 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. [Operator Instructions] I would now like to turn the conference over to you 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 our 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 incur 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 risk 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 it’s product candidates for specific indications, acceptance of it’s product candidates in the marketplace and the successful development, marketing or sale of the products, it’s ability to maintain its license agreements, the continued maintenance and growth of its patter 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 of uncertain results to differ materially from those described in these forward-looking statements, there may be other factors that can cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed except if required by applicable securities laws, forward-looking statements the only of the date on which they are made and iBio undertakes no obligation to publicly update or revise any forward-looking statements 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 the small team of people who helped start the transformation of iBio in late 2019, and the investors who believed in us. That grew our passion in energy and belief that we could use the power of plants to not only help other companies speed the development of their 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 were plenty of skeptics who didn't think that plants could work as well as traditional mammalian cell production systems. But we added a few coverage 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 and bioprocess business. With three new businesses added to our existing services portfolio, we invested in recruiting experienced and talented leaders to help us build and grow these four segments. Now, you're 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. With COVID-19 evolves into a seasonal illness, as many experts are beginning to predict and the subunit vaccine carrying multiple SARS CoV-2 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 in a viral vaccine platforms. Meanwhile, we're advancing our lead anti-fibrotic molecule by optimizing its efficacy, safety profile and manufacturability. It was the creation of our new Animal Health Organization for 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. A significant as this progress maybe, 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 do a please 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 getting traction in the Contract Manufacturing Services segment. So, we expected 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 would make fast farming even more attracted to certain market segments. Bottom line, we believe the FastPharming platform provides sustainable competitive advantage by stripping time and cost for the early stage biologics development cycle. And we're confident that we build a strong multifaceted biotech and CDMO around it to capitalize on the optionality it provides into 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 in positioning for the remainder of the FY 2021, 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 31, 2020. To streamline things, all the numbers I will mention, have been rounded and are therefore approximate. For the three month period ended December 31, 2020, iBio reported revenue of $700,000, an increase a 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 31, 2020 were $8.3 million, compared with $3.5 million for the same period last year. R&D expenses for the quarter ended December 31, 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 31, 2020 were $5.8 million, compared with 2.6 million in the same quarter last year. The increase results 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 31, 2020 was $600,000, which was consistent with 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 like R&D, G&A and cost of goods 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've been making significant investments in people, processes and infrastructure to match our progress and position in our lifecycle. We believe that creating this solid foundation provides the expertise and capabilities needed for a high quality biotech company, and will serve iBio well as it moves forward with this value creating objectives. That said, as we continue to advance our clinical pipeline, we expect growth and R&D expense to begin significantly outpacing G&A expense moving forward, especially with the aforementioned expensive visibility we will be providing. Net loss attributable to iBio stockholders for the quarter ended December 31, 2020 was $8.2 million, or $0.04 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 31, 2020, iBio had cash and cash equivalents, plus investments in debt securities of $107.6 million. With that, I'll turn -- 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. We 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. 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 edition 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 considering Rob's impressive background, working with commercial stage companies to secure complimentary assets via licensing deals and partnerships. We believe he will be in position to readily contribute to the growth of our product portfolio. Joining Rob in our recently fast 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 is appointed embodies our iBio transformation from acquired CDMO until a dynamic biotech innovator in leading biologics contract manufacturing organization. He has a strong history of success heading drug discovery and development team several of the world's leading pharmaceutical companies, including AstraZeneca, Lilly, Pfizer, and Merck. Most recently, Martin served as the CSO in Pfenex and NYSE a listed company, which, using his 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 proprietary product platform. And as a self described drug owner, we believe his skill sets which rounds are highly complimentary. 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 biolonza, a multinational CDMO she led a global leadership development program. Rob, Martin and Lisa joined us for Randy Maddux, who was appointed COO in November, coming to us from GSK, the app, TiVo, as well as Dr. Melissa Berquist, who is 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. Alexandra Kropotova and Gary Sender earlier. So please join us in welcoming all to iBio is they help us execute on our strategy. So turning now to developments with our biopharmaceutical pipeline, I'd like to provide a few deep details on the advancement of our COVID-19 vaccine candidate. We've 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 pathology results in early Q4 fiscal year 2021. Although there are approved vaccines now on the market, we still see a need for continued development of alternatives given evolving mutations as well as global distribution and access constraints for the current products. As most of you know, we selected IBIO-201 as our leading COVID-19 vaccine and based upon its production of higher any spike neutralizing antibodies, compared to our DLP vaccine platform, IBIO-200. IBIO-201 is based on a subunit platform that combines antigens derived from the SARS-CoV-2 spike protein, fused with our patented ligand booster molecule to enhance immune response. The addition of ligand booster to a subunit antigen may provide improved 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 nucleocapsid, or N-protein. We're using fast farming to build the n plus s for us with the idea that the deliberate and types of toxicology results are favorable, we would take those two both in and as with like, test them with other adjectives and evaluate results. By the way, the same concerns around possible Sapiens that drove our decision to develop the n plus s facts provided the rationale for us signing the H2 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 the target receptor for the coronaviruses entry the cells, we believe the candidate will bring the benefit of traditional neutralising antibody prospectively limiting the potential for viral escape. We 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 properties 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 AI bio 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 up constructive pathway for this and other veteran air vaccines and therapeutics. Keep in mind, this is an initial albeit important step and 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 the progress with IBIO-400, we're excited to announce the patent issuance covering Endostatin peptides for treating fibrosis. The claims cover a novel expression cassette 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 therapeutic 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 system and Glycaneering technologies and unlike multiple runways of opportunity for our internal product catalogues and service capabilities, which can be seen in our CDMO agreements 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 contributor, driving the quarter-over-quarter and year-over-year growth. We believe that Safi agreements represent a great opportunity for us in two ways. First, we were able to grow our CDMO business and showcase our capabilities and number two, we were able to start building our own 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 bio process catalogue for a specific delivery system or product candidate will 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 candidates. We plan to begin offering a new catalogue of these high-quality research and bio process 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're happy to take any questions you might have. Operator?

[Operator Instruction] We have our first question comes 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 inhibitors citing the benefit risk profile, excuse me, no longer supported continuing the studies. 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 space?

Yes. Thanks, Christian 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. And that combination is a safety and efficacy questions that are associated, when we take a look at our MOA, of course, it's quite different than the layers. 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 a 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 that's sort of in two areas, we have sort of a traditional mouse model, which used for testing, idiopathic against the impact of pulmonary fibrosis, where we saw really good results versus the standard of care right now. And then tentative and pirfenidone. But also to on diseased human long exploits. Our data was really good. So we saw not only spaces, but reversal in both of those particular models. So, we're optimistic that, with an important dropout in the competitive landscape are developing here to treat some of these diseases, for which, I mean, there's part of the embrace solutions and the material that I just mentioned, then tentative and pirfenidone and 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 to 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 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 regarding the second generation vaccine that you have in development here, do you think you're going to have to 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 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, lichenase or LicKM booster that we can have the spike protein and 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 those two 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 be Africa, South America and like, the cost is one component. The other thing I think worth noting is we see 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're getting 90%. And then that started to drop off prospectively, they 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 happen to get 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. I mean, it rivals what we can do with fast farming. But then ultimately, if one was to go with a 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 to from the cost and access standpoint as well. soon:

Great. Thanks so much, Tom.

Thank you. Great questions.

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

Hey, guys. Thanks for taking the questions. You know, just thinking about the veterinary side of things and -- the iBio-400. You mentioned that it might take a couple few years to get, kind of, the clearance to on the USDA side of things. But, you know, how -- what does the timeline look like for iBio-400? And, you know, when do you -- what do you anticipate investing that, kind of, take up to completion?

Hey, Ben. So great question. And, you know, it's interesting here, when you take a look at the regulatory pathway on the USDA side of things. Yes, 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, you know, to go ahead and produce the information necessary to go ahead and get it, for instance, 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 -- they will send somebody out to check out the manufacturing facility itself. So what one has to do if you're interested in moving down the regulatory pathway and that is that you have your site license for your facility travel along with your first product. And so to that end, we had good data in progress on our iBio-400. And what we need to do, of course, it’s just kind of play a little bit of catch up towards getting facility moving down the same path to get a, you know, 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'll be an outline of production for something specific in our case, that'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 it were moving things through to get the facility site license, we're going to have our, you know, our efficacy and safety studies that come along with.

That makes sense.

And by the way, the COVID has absolutely impacted, at least --

Yes.

What we've seen and heard. You know, the USDAs ability to go ahead and process some of these new things. So you know, 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 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 factors associated with the global pandemic.

Got it. And then you mentioned the site license travels along with the first product. I want to say, and then maybe I'm misremembering this, but are the products then tied to the site? I seem to recall that been 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 it’s probably the way it works. So why don’t we do it -- I'll get back and check it out. But, yes, I mean, by virtue of the fact that you need the establishment license. I think that's the case. So I don't know that it's easy to necessarily pack it up and move it. There may be a procedure for doing that. But I think generally, 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 all of the additional inspection process. But once again, I'm not the regulatory expert on that. I’ll have to follow up with you.

Well, I know, the USDA is kind of interesting on the -- other than veterinary side in that for Biologics. There's really not a pathway for a generic or biosimilar to gain approval once you have something like that for that. It's 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 hoped. 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, is looking at how the market evolved. And as we were going through whatever it was and in the mind -- everybody else out there, certainly everybody who was part of Operation Warp Speed, it had platforms and platform technologies that they've 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? Or what do we do relative to efficacy? And then, there was that period of go look, it looks like, two, three, four other competitors we're going to come out there with a solution and could iBio compete? Right. And so, what I would say is, happily, little iBio, where some global pharmaceutical behemoths have said, Okay, well, we're stepping out of the scene, either because of the efficacy of their vaccine in development or for other reasons. Whereas we felt confident, and our thinking is, well, I don't want to say confident, because there's still a lot of biology left to be done. But with our approach with a sort of a tried and true category of the 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 better, just fine. But we do need to run that, work the next molecules through the talks, we could get a surprise and find out that, okay, it did not hit our expectations, but we are not expecting, we're expecting a more favor -- we think a more favorable outcome is likely that we'll be able to put forward.

Okay. Thanks for all the color there. Definitely helpful. And then, just on the research and bioprocessing side of things, what have you seen as far as incoming interest there, any color on that, that you can provide? Well, not too much only because we have not yet put the products into the catalogue. But what I suppose 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 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 thus get our revenue recognition fairly quickly. So that gives you a sense for the fact that we're able to turn on the test monitoring machine and crank the products out, and 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 pudding when we get the products into a catalogue. So we've got to get them fully ready for commercialization and launched. And then, of course, we're going to want to make them available online, let others test them and, really turn that business on. So that'll be coming, as we suggested, before, in 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 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 growth factor or something to the cell culture media. Well, the good news about our platform is, since it's plant based, that means its animal free. And that means the risk of adventitious agents, they call them, or essentially contaminants, right, used to be, stuff for BFC or mammalian viruses or whatever greatly reduced with a plant based protein. And then the fact that we can translate so quickly from research to RUO labeled product to further manufactured used label product, we think creates durable -- competitive advantage for this line of products. It's not like there is not other competitors out there, but there is a couple of advantages here with using our system that we think will make -- will make it 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 -- update on the Fraunhofer lawsuit? And I'll leave it there. Thanks for taking the questions.

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

Good to hear. Well, best of luck to you there.

Thanks.

Thanks, guys.

Our next question comes from the line of Jim Tassano [ph], 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, you know, I've been in iBio for two full years now and I follow 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 think I've spoken to many people. So I think very few people realize the difficulty involved in what you had to do. And I'm here. Hey, I wanted to thank Steve Kilmer, because he's been my go to high bio source for two years, and he's performed fantastically. He is the best the best IR guy I've ever worked with. But anyway, I have several questions, I'd like to move on quickly. You have a VLP platform that you developed for 202, and 200 has kind of fallen off the radar. But the VLP platform 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 I was referring to and one of the same I thanks again for believing in us back in those early days here 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 it, we also wanted to pick that because we thought that we could get an exception from FDA and be able to skip toxic. And that was a good assumption on our part. But what we've said and communicated a couple of times as -- when we 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 taking one through the process. 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, you know, 201 was better. And it was a surprise, no doubt. And then, of course, you know, we needed to go through the talks. Now, the silver lining to that is, you know, by getting the liquidation platform through toxicology here, you know, hopefully, that'll be one, a platform that we can use going forward. So with regards to the VLP the way in which retreating that is that, we do think it still has promised, but we need to work on it as a platform. And we've got, a program in mind for that as to how to enhance it, because to the 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 you know, 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, you know, 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 fibre optics, when we want to do with my iBio 400 in the last. So you know that it's still something that we want to advance. We just focus our energies on to 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 comments you have on that as to where iBio might be 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, you'll mostly see in 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, in some of the other data that we have in hand, we have a history actually, with some earlier work done in the company on a monoclonal antibody, by the name of Rituximab. We do think that there's a lot of opportunity there for us. And as a matter of fact, we have experience now, with 10, arguably a little closer to a dozen, anti-cancer monoclonal antibodies. So that's, just what we have out there, we published on some of that in the past, and, the Glycaneering technologies we underscore, and 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 mAbs well. So, in part, a leader for that program, who we think is important and can 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 here for that program. But that's -- that's the nature of the position.

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

So I can't disclose or shares some of the other research activities that we may have Jim, but --

All right. I don't want you to say anything -- not suppose to say. Yes.

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

Without competitive giveaway, of course, yes.

Exactly.

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

So I mean, I think what we want to say on that is, is really what we've already said, which is that early Q4, so you can kind of get your safety, cut the quarter in the middle, would want to figure it sometime 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've paid to have it expedited. And so, you know, 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 as I mentioned before, combine that tox info with some of the other preclinical data that we want to generate on 10 plus us 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? What others are predicting about this becoming a seasonal disease or illness? Is that going to unfold? And then, you know, can this solution in fact, bring differentiation versus the mRNA and the antivirus based vaccines? I think those questions combined with our own performance, with the design that we have really are going to roll the day and you know, 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 disease itself, the winds up stabilizing work, here's the other thing that a bunch of us that it may become less lethal, some are projecting as you -- as you see it go through these various mutations and evolve, that could 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. That makes sense?

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

Thank you.

We have our next question coming from the line of Jim Jones with [indiscernible] 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, 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 plans to move things like investor relations in house, and you spoke earlier in your opening statement about spreading the word on iBio, and I wanted to find out if you know, you have any plans to bring on strategic communications consultants, or anyone that can help build shareholder value, and really just kind of build a story, because we believe in the story is retail. But we'd love to see more people get that confidence.

So, Jim, many thanks for your questions. And, you know, look in terms of talent, Imentioned this before to other Jim, who just preceded you. I started off thanking, a small team of people who helped us through some, you know, pretty challenging times in late 2019 and in early 2020 and by the way, 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, 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 by the way, I want to give thanks here to John Delta, who was yet another person and then part of a bigger group that provided certainly outsourced services and support for our organization because we started this whole thing off like a couple 1000 people. And as everybody in the organization, including line workers and folks in Texas, you name it. And so, you know, 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, I mean, hopefully, you're seeing continuous improvement in all areas, I come from a place where like, 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 it every turn, 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 going forward. So whether it's something like the website, a pipeline edition, a novel deal that we do with a with a unique business model, or hack, you know, just, you know, getting a commercial organization in place, you know, to start now that we've got the Glycan area plus fast forming in the service portfolio better define, going out and telling that story. Look, we're going to just keep doing better every day to the best of our ability, because we think we've got something good here. And, you know, 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 we play the ability to make higher quality products along with it and by the way, eco friendly and safer? You bet. So, you know, 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 and that's it, you got our commitment to continuous improvement in every facet.

Yes. Our next question coming from the lines of Matthew Hern [ph] with Matthew Hern, 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 my iBio. Just -- really a couple of questions and first of all, I want to recognize the progress that you've made. I've heard the phrase a new iBio in there. Definitely some long term, private, retail investors, you've been familiar with the company beyond your personal involvement. And to that end, I think a lot of us who were involved were focused on this partnership with CC-Pharming as recently as 2019. I think there were some visits to the PRC event in a lot of -- in investor relations and press releases about that partnership. And since then, we heard that that's not really partnership, they were a vendor. And at the same time, CCP and iBio are on the same line item, on WHO list, even for coronavirus docking 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 you have to comment, like in 2019, that really seemed to be a huge focus. And if that's part of the new iBio were on board, we just need to hear about that a little bit more with the transparency that you've promised us? So thanks, again, I really do appreciate, again, like it's a 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 possible that you may even precede me here with 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 and let me just break it down a little bit on CC-Pharming. So you're right. When it came to the COVID-19 vaccines, it wound up being that the two that iBio had, we were able to successfully manufacturer and drive forward the marine 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 were in the statement of work and 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 the leadership over there. And they are looking at different strategies themselves. But, obviously, 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 named 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 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 of 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 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 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, 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 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.