[Starts Abruptly] iBio Fiscal 2021 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to hand the call over to, 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 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 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 its 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 estate, 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 can cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required 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 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 Rob Lutz, the company's Chief Financial and Business Officer. With that said, I'll now turn the call over to Tom.

Great. Thanks, Steve. And good morning, everyone. So, please let me begin by providing some quick context to our fiscal third quarter results. As you may know, we undertook an initiative in December 2019 to transform iBio from a modest pharma services provider with a limited offering into a vibrant diversified biotechnology innovator. This initiative is rooted in the aspiration to fundamentally change the bioprocess paradigm with our FastPharming system. Today, not only are we in the process of transforming iBio by harnessing the power of plants to rapidly develop our own biopharmaceutical candidates, but we're ultimately seeking to enable our entire industry to reduce drug development times and costs with our FastPharming system. Importantly, we hope to continue to show how our platform provides a better, more sustainable alternative to the standard mammalian cell culture processes. To that end, today, we announced a major step forward in our transformation with the planned establishment of our own in-house drug discovery capabilities. Work has already begun to assemble a team of talented scientists in San Diego, a group who will be charged with discovering new drug targets with an initial focus upon molecules for use in oncology. We expect the team will help provide additional fuel, if you will, for our FastPharming machine, thereby creating a larger, more valuable pipeline of assets suitable for out-licensing or further internal development. I'd like to turn now to the advancement of our COVID-19 vaccine development program. Earlier this month, as you may have seen, we announced the successful toxicology study results for IBIO-201. This vaccine candidate combined antigens derived from the spike protein fused with our patented LicKM booster molecule to enhance immune response. As you know, there are now multiple vaccines approved for use in many countries. In addition, there are over 100…

Thanks, Tom. I'm excited to join the distinguished team at iBio and I look forward to helping the company unlock the value of its proprietary FastPharming technology based on the premise that plants can more quickly and sustainably produce biologics. Rather than reiterate the details of the company's financial results, which are available in the press release and the 10-Q, I will simply speak to a few highlights. Revenue for the nine months ended March 31, 2021 was $1.9 million, which is more than three times the revenue from the same period in 2020. Revenue is based primarily on contracts with a small number of customers and revenue recognition from development and manufacturing services is generally subject to volatility. So, we expect revenue will remain variable quarter to quarter in the near term. However, we believe that, directionally, revenue will continue to grow over time. Starting this quarter, iBio has chosen to reclassify some of the line items on its income statement. For the first time, we are breaking out cost of goods sold as a separate line item and we were also providing more distinction for the costs that are related to R&D. We believe that this presentation provides more clarity for investors and is more similar to the presentation provided by our peers. Our cost of goods sold and gross profit percentage will also be variable in the near term. Our R&D and G&A expenses in fiscal year 2021 for both Q3 and year-to-date were up significantly from comparable results in fiscal year 2020. R&D expense grew primarily due to increases in personnel and other expenses to support the company's development of a portfolio of proprietary therapeutics and vaccines. G&A growth resulted primarily from increased headcount and increased operations expense to support the growth of the business. In terms of liquidity, iBio had $103.9 million in cash, cash equivalents and debt instruments as of March 31, 2021. As mentioned previously, the company further strengthened its financial position through the settlement of litigation with Fraunhofer USA. We believe that we have sufficient liquidity to continue planned operations through at least March 2023, inclusive of our planned investment in the FastPharming discovery platform and potential in-licensing opportunities. With that, I will now turn the call back over to Tom. Tom?

Thank you, Rob. So, to summarize, as much as we are pleased with what we have achieved to date to develop our pipeline of biopharmaceutical candidates, we're even more excited about what we expect to follow from the investment in new drug discovery team in San Diego. We're also optimistic about the continued growth of our CDMO services business, as well as the strategic opportunities we see in our emerging RBP or Research & Bioprocess Products business. With a bolstered leadership team that carries an accomplished track record of success, strong balance sheet and an engaged supportive shareholder base, we continue to transition into a diverse, innovative, and industry-leading biotechnology and biologics contract manufacturing company. So, thank you. And with that concluding our highlights, we're happy to take any questions you might have. Operator?

[Operator Instructions]. Our first question comes from with Cantor Fitzgerald.

The first one is on the COVID-19 vaccine. So, I know this is still an emerging topic, but wanted to ask how you're thinking about the long-term need for vaccines and boosters. And then I saw you recently posted results from a third-party survey with epidemiologists regarding the virus mutating to the extent that the first generation vaccines may no longer be effective. So, I'm wondering if you could talk about your thoughts on this and what you've heard amongst your conversations as well.

I think as we've been looking at this situation, we started our work on 202 even before the British variant first came out. Knowing coronaviruses and how the evolution should have been expected, the pathway expected to take, this is not surprising in some respects, but in others, it really is. The number of variants, and in several cases, they're mutating to not only improve transmissibility, but then also severity of disease in a few of these instances is remarkable. So, I think as we looked at it for the reasons that we talked about in the introductory remarks, this issue around the variants, access globally to vaccines and durability is a big, big question. I noted with interest, I believe it was Moderna that put out a preprint last week looking at durability here for their vaccine. And in some respects, it looks like it's only a matter of maybe six months. So, some of the data suggests that and then when compared to natural COVID-19 infection, it was better, but COVID natural infection seems to give you neutralizing antibody titers only up to about four months. So, to your good question around boosters and some of the rest and needs, again, we've taken the decision to stay in the development of a vaccine because of the speed of the platform when it comes to scaling up for manufacturing and because we believe that there's enough data out there, and we've seen this last fall, to suggest that the more well conserved – in other words, less likely to mutate – nucleocapsid protein can prospectively convey some longer-term durability of immunity. And again, in addition to coverage for the variants that one presumably could expect to see with that particular antigen, the other thing that we're looking at, as we indicated in our preclinical studies, are alternative routes of administration. So intra nasal, certainly, is within scope. And there's also some reason to believe that an intra-nasal delivery could potentially convey greater durability of immunity as well. So, we think that there's a lot of uncertainty out there still and that, prospectively, we could potentially contribute to the future control of the pandemic, especially as long as some of these durability questions are out there.

In terms of your drug discovery capabilities that you're building out in San Diego, could you talk about how you're thinking about potentially roughly how many hires you might have for this site and when it could become operational? And then just on the back of your prepared remarks, for oncology, what might be some of the starting areas or criteria that you're considering when developing candidates? Is it going to be just based on the target selection indications with unmet need? And how might you decide what's most appropriate to bring forward in-house versus through partners?

In terms of the size of the team, we see two things at play here. One, because of the way in which we're thinking about the discovery platform itself, we're evaluating a certain method that would convey speed just on the upfront discovery. And so, we think about 20 scientists or more in the San Diego area would be able to run the platform as we envision it. And that group would then fairly quickly be able, in a translatable way, the method that we're thinking about using should scale directly into our plant-based system, so we're using a plant based discovery platform and then driving that into process development at the Texas location for scale up of any hits that we may get out of the discovery program. And then, in terms of how we're thinking about targets and in which spaces, we've communicated in the past to a degree that we think that the Glycaneering technologies that we have are important in the area of monoclonal antibody development, and in particular, aglycosylating monoclonal antibodies, which can give them greater ADCC or cancer cell killing effects. And so, that gives us the chance for both innovator molecules, so where we design and develop ourselves all the way through, or fast followers, the ability to take something that is out there and get the IP advantages of being able to produce novelty in our FastPharming systems and get the glycosylation profile correct, we think – to answer the question – that will have areas of significant unmet medical need in cancer that we can address here with some of the areas that we're targeting. That said, if the opportunity presents itself for a fast follower or a biosimilar, whereby perhaps a company or an institution may desire for us to develop a molecule for research purposes and then ultimately convert it over for therapeutic purposes, well, then we've got, as part of our CDMO business, the opportunity to do that on a contract basis for those that are interested and just provide a supply agreement. So, the creation of the four business units, as we have them, we think provides some synergy. But for us right now, we see the FastPharming platform, in particular, sort of its killer app seems to be monoclonal antibodies and with the Glycaneering and glycosylation controls that we can offer. We're going to be spending a little bit of time in the oncology field in developing the portfolio, in particular for likely solid tumors here as we go, but more to follow in terms of the specific areas.

On the CDMO business service, could you talk about some of the trends you've seen with some of your customers or potential customers in terms of returning to work in light of the pandemic? And then, how might you plan to utilize your team to highlight the expanding menu that you announced today?

In terms of our client base, we have to target early stage entity. Because it's very difficult for a biologics developer or biopharmaceutical developer to switch contract manufacturing suppliers midstream in a clinical trial setting, we need to target those, usually, in the preclinical stage. So, relative to return to work matters generally for our client base, we've not necessarily observed a significant impact. We can say that because of the speed of our platform that, in part, and also some available capacity, that's led early stage developers to turn to us because, oftentimes, they have to wait in line, if you will, at the large multinational CDMOs that are out there. So, in those terms, I think we're seeing everything kind of move along as planned there with development of the services. And to your second question around what does it mean in terms of the portfolio line extensions that we announced today, so we have a couple of product groups within the services business. So, one is development services, which is the majority of what we do, then there's the contract manufacturing, but then also there are bioanalytical services. So, that's where we get into the characterization of the molecule. And previously, we had only offered that service capability to those clients who were working with us to use the FastPharming development service to produce their molecules. However, what we're doing is we're opening it up today and making the service capability available to any third-party client who may wish to take advantage of the capacity and capability that we have for that service. So, we see the opportunity to monetize the capability and drive some incremental revenues through the Bioanalytical Services area, but then also all of that capability that we have, once again, back to this point of synergy between our business areas, we see this increased capability helping the work that we do in the future California drug discovery team, as well as with other collaborators and partners to do comparability analysis and molecule characterization to compare what comes out of the FastPharming system with the traditional mammalian cell culture or other production platform methods, and continue to demonstrate that we produce very high quality products – consistently high quality monoclonal antibodies and other recombinant proteins, if that makes sense.

Our next question comes from Jim Pisano [ph].

I have several questions. Some of them are aimed to help people in Stocktwits forum that were asking these things. 201 has the tox done. Some people were asking that – and we'd like to hear from you, I guess – does the tox on 201 also cover 202 and the tentative 203?

The tox on 201 was primarily driven by regulators' interest in seeing the results with the LicKM immunostimulator molecule. So, to the degree that we want to include that molecule or do include that molecule in future designs gives us the ability to go to the agency, and in our pre-IND reviews, to be able to request an exception for tox. And also, if one takes a look at others moving through processes, to your question around 202 and the like, several companies have been moving their candidates through with just a spike or just a nucleocapsid protein without necessarily having to perform tox studies. So we're encouraged by that. Needless to say, once again, this is a conversation with FDA. But we're optimistic about the prospects for our future vaccine candidates and prospectively not having to take that step. But, of course, Jim, we won't know that until we have the meetings.

Another one, small one. But in the lobbyist section, it looks like Steptoe is out if we're catching that correct and you still have Petrizzo there.

We've gotten the help of the Petrizzo Group. Steptoe had helped us last year. And have some notable strength with the defense side of the government. Petrizzo Group has a lot of strength with Health and Human Services areas. So, indeed, that's correct, we're working with the Petrizzo Group at this point.

I would think that probably the number one topic for the retail investors is a question of funding and to get some idea of where you're at on that. The situation's changed. But looks like CEPI is the hotspot for the company now. It appears they're trying to find – the company is similar to yours, you know that are early stage, looking for vaccines that will work against numerous strains and be affordable and have long-lasting effects. So, I assume, of course, that iBio has applied for CEPI funding.

I think it's fair to say this, which is that we don't intend to leave any stone unturned. As I think I've mentioned in earlier calls, back in March, when we had all of maybe even 12 weeks of making the move into being a biopharmaceutical developer rather than just a CDMO, we had gotten an invited submission from BARDA, and thanks to them had made the connection with IDRI, the Infectious Disease Research Institute, and then ultimately we moved very quickly to make those submissions and many more. I guess now, in hindsight, I suppose, to a degree, it's understandable that we did not get included in Operation Warp Speed, much like many other entities, but that we remained undaunted throughout the summer, even before we had understood fully what OWS meant and how other companies who had obviously been in this this field for many, many years, if not decades, how that process was rolling out. And so, in the meantime, we've continued to strengthen our offering, the design of our vaccines. We're continuing to demonstrate that with the platform that we can make a contribution here in this space. And so, we're aware of all of these funding opportunities that are out there. Some are new and forthcoming. Others have been tapered back to a significant degree. But we are looking globally for non-dilutive support across all the areas and categories and modalities in which we operate.

I hope that CEPI sees what most of us see with 202. Looks like you might well be in the lead in that nucleocapsid vaccine race. If there is no funding, at least for a while, what's the plan to into Phase I on 202?

I think too, Jim, just to kind of go back to the point here on CEPI, as I understand it, their calls really are going to pan coronavirus vaccines, and in particular hitting on themes that we're hitting on here too for us to have relevance, right? So, once again, it's durability, access and the variants, right? And I think here and along the way, we'll be looking at seeing how much of a contribution that we can make towards providing a differentiated product and watching how the pandemic unfolds with the existing vaccines and their ability to provide a durable immune response. If this continues, and you're looking at something on the order of six months or seven or eight months or whatever that may be, and that's not to speak generally. I don't think there's enough data that's in there. But I'm just prospectively – as we think about our role here, if that turns out to be the case, well, then the capacity that we have and the potential for nucleocapsid based protein to provide more durability and more coverage for the variants will be important. But then also too, if one looks at COVAX and that organization and how it's relating to the World Health Organization, this pandemic raging in India, the impact of the P.1 variant down in Brazil, and so much more indicates that we may very well need more solutions. And if we can't get non-dilutive government funding, well, then it is a question. Can we and should we, on our own, fund a Phase I study, and I think we're going to look at not only the unmet medical needs that are out there, but also the commercial opportunity. If we believe we have a viable product candidate, then indeed we've got the funding in place, we have an understanding of what it would take in terms of the cost for that kind of the clinical trial. But in some respects, we're almost happy that we didn't get selected before because it looks like, in our view, that a spike-only based vaccine, if we're going into a Phase III clinical trial with that right now on our own versus competition, the likes of Pfizer and Moderna, AstraZeneca/J&J, I think that would be pretty tough to be – having to spend that money on a big Phase III with patients difficult to recruit at this point. So, in some ways, maybe we were lucky. But it's a long way of saying, I think, in the end, we'll make the best decision on behalf of prospective patients and our investors. If we think we can bring a differentiated product to market that can be commercially successful, then indeed we intend to move that forward and try to make an important contribution here towards at least mitigating some of the ongoing effects of this pandemic.

If you have a rough timetable or do you dare to go into that area?

As always, the science has to drive this and we need to see what kind of results we have. And then also, with regards to the big three that we've discussed – durability, access and the variants – once again, if we can pull it all together and really wind up creating a differentiated offering that can make a difference, then we'll go forward with that. And the better the data looks, the faster we're going to want to go. So, we'll promise to update as we've been doing here along the way.

Digressing off the original list because of today's news, your new San Diego facility. That was a good question. We had about 20 scientists. How long do you think it will take before it becomes operational or effectively operational?

We were keen to announce this here as early as we could. We have been evaluating both the system, the people, where to place the location, right? So, it was all about talent and talent access in a hotly – access to talent in this market is very, very challenging. But San Diego presents a terrific location. It's one of the top three. So, we've been thinking about it here for a number of weeks. And we think that we begin to turn it on and get yield certainly, I would say, as we get to the middle point of the first half of FY 2022?

Back in the December, there was an offering about $35 million, and in the use of proceeds, you had some of the uses being to accelerate vaccine candidates and also for the acquisition and possible investment and other businesses. I'm curious, the acquisition, where it stood out, it was like pretty darn good for a company that was near bankruptcy a year before when you were taking over, are those things still on the table? Is there still a possibility that there might be an acquisition or an investment in another business?

Of course, that kind of thing would necessarily be confidential, but directionally, Jim, I would say this. The incremental cash here is important to give us the business and our shareholders optionality, meaning not only are we investing behind a drug discovery platform, it will take time for hits to come from that program. And then, of course, one has to move from hit to lead and lead optimization before getting into an IND. But that's where having our pipeline enriched through that activity is very, very important. But while we get the San Diego operation – to your good point in the last question – is going to take a little bit of time to get that up and running, get the lease and get people hired. And then it takes several months thereafter to get it spooled up. Well, what about in the meantime. Are there opportunities for in-licensing? And you could be thinking about acquisition in that way too. The company could be acquiring assets or rights to assets as well as entire businesses. So, the position of financial strength and strategic optionality to take great advantage, prospectively, of opportunities that may come our way by having a strong balance sheet, we put ourselves in a good position here going forward. And that is the reason for the raise that we did previously and the cash accumulation up to this point. And I think, here, we're certainly pleased with the incremental cash that is coming to iBio as a result of the settlement of the case with Fraunhofer. So, we're happy about the position that we're at and the optionality that we have going forward.

Tom, that was a good lead into my next question. On the Fraunhofer suit, that was great news. I think the stock price didn't do what many of us had expected because – it was a $300 million lawsuit, which iBio had a chance to get $150 million, and when it finally came down, it was about IP rights. Kind of surprised, I think, all of us. So that surprise, I can understand it, the IP rights, but only a little, because when I when I dug into everything I could to find out just exactly what IP was up for grabs, so to speak, it's really hard to find it anywhere online. So, do you have any words about the value of securing those IP rights when you did and what they will do for the company?

Maybe I should speak to first something that was a little bit before my time with the company. But I understood those news articles and pieces that may have been out for many, many years ago with some pretty big numbers associated with them, $100 million or $300 million. Of note, that was before there was a ruling in the court, wherein both Fraunhofer USA and Fraunhofer Germany was attempted to be included and, then partway through the case, because of timing, iBio was not able to continue to have Fraunhofer Germany as part of the litigation. Again, as numbers evolved over time, and projections around those, not really sure where a lot of that comes from. But nevertheless, in the end, what was at issue in the case was IP that was developed by Fraunhofer on a contract basis for iBio. So, that's what the two parties were disputing. So, it was always an IP and an IP tech transfer lawsuit. And so, in the end, because the litigants were arguing over whether or not the tech transfer had, in fact, been made from Fraunhofer to iBio, there was some IP that was developed that iBio was claiming that it did not have visibility to. So, that was generally speaking the context of the case. That's all out there in the public filings. And so, I think in the end, here, the outcome was a good one for iBio continued likely appeals and other distracting aspects for the company here. In the end, as you can see, from the announcements, the parties agreed. And so, there was a license fee. You can see, in the 8-K filing that went along with it, what the value of the license fee was separate and apart from the balance. And if you were to subtract one from the other, you get a sense for how the parties thought about the settlement and what the impact was upon iBio. So, I guess, that's about as much as I'll say on that, Jim, but hopefully that clarifies it a little bit.

[Operator Instructions]. Our next question comes from Matthew Hearn [ph] with Matthew Hearn, LLC [ph]. Your line is open.

Congratulations, Tom, on wrapping up the Fraunhofer case. I also have two or three questions if we have time today. If it's okay, I'll ask them all and you can answer as you see fit. First, I just have another quick one about IBIO-202. Can you let us know, are Texas A&M and IDRI involved in conducting preclinical studies again? And then two, I think you were just discussing talent recruitment being a primary driver for opening the San Diego location. I was just sort of wondering if there's anything you can share with us about Dr. Marcel no longer being with the company. And then lastly, I think I heard Jim asking about the last offering. So, I guess I'll just have to press you a little bit more on that point. With such limited revenue and enough cash on hand to remain operational until March of 2023, do you plan on increasing the number of authorized shares or performing the reverse split to fund operations? I think that's it.

With regards to IBIO-202, indeed, as I referenced, we are still working with IDRI. And, yes, I can share that, in fact, TAMU – Texas A&M University rather – is indeed continuing to work with us. So, relative to San Diego, yeah, there was a couple of thoughts on talent and some of the rest and where we wanted to take the organization. I'll just say that, with regards to Dr. Marcel, nothing particularly noteworthy to mention there in that regard. And then, finally, with regards to the shares and some of the rest, clearly, as a biopharmaceutical development firm, it's a long haul. I think everybody is probably very well aware, takes any company, typically, about 10 years and $1 billion to bring a major biologics molecule to market. So, there will be cash needs going forward. That said, we're quite satisfied with the liquidity that we have through now and in our business model. It's worth noting this synergy that I keep referencing and the optionality that's there. Because if we take a look at having the benefit of the manufacturing capability, that puts us in a position to – and you'll hear me say this on occasion – to work this FastPharming machine, in other words, we can drop assets in, quickly develop them to a point and then make the decision ourselves if we have something that's really attractive to take it through a Phase I or Phase II clinical trial and perhaps beyond. And alternatively, there may be instances where we start that work and perhaps identify a partner who may want to license that asset from us. And in the field of oncology, or in fibrosis, yet another key area in which we operate, depending upon the how far the asset is advanced, one…

That's all the time we have for questions. I'd like to turn the call back over to Tom Isett for closing remarks.

Great. Thank you, operator. And thanks, everyone, again, for your time today and your interesting questions. We appreciate all of our shareholders' support and hope everyone has a great rest of the week.

Ladies and gentlemen, this does conclude the program. You may now disconnect. Everyone, have a great day.