Ladies and gentlemen, thank you for standing by and welcome to the iBio fiscal 2021, Fourth Quarter and Full Year 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. [Operator Instructions]. I will now turn the call over to your host, Stephen Kilmer, Investor Relations. You may begin.

Thank you. Good morning, everyone. Before we begin, I would like to remind you that during this call, the Company will be making forward-looking statements regarding our current expectations and projections about future events that are subject to risks and uncertainties. Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the Company's periodic and current event filings with the Electric Securities and Exchange Commission. No forward-looking statements can be guaranteed and the actual results may differ from the results discussed in the forward-looking statements. The information on this call is provided only as of the date of this call, and we undertake no obligation to update any forward-looking statements contained on this conference call on account of new information, future events or otherwise, except as required by law. On the call today representing the Company are Thomas Isett, iBio 's Chairman & Chief Executive Officer, Randy Maddux, iBio 's Chief Operating Officer, Martin Brenner, iBio 's Chief Scientific 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 all. I'm pleased to report another productive period for iBio, highlighted by a major expansion of our oncology portfolio. Specifically, in August, we announced the acquisition of the rights to RTX-003, a novel antibody developed by RubrYc Therapeutics for the treatment of solid tumors. We also entered a strategic collaboration with RubrYc, that provide us access to their proprietary antibody discovery platform. We think this will fit nicely with our own recently established drug discovery capabilities. And another recent highlight relates to our infectious disease area. In September, we took another step forward with our COVID vaccine candidate development by submitting a pre -IND package filed by 0202 to the FDA. But before going into more details on these advancements, I'd first like to take a step back and describe our structure and business model, and explain why we believe iBio represents such a unique and compelling investment opportunity. Our Company now operates across two distinct but highly complementary segments. First, biopharmaceuticals, which includes our therapeutics and vaccine businesses. Our areas of focus include oncology, fibrosis, and infectious diseases, as well as areas of unmet medical need, wherein, those specialties overlap. Our second segment is bioprocess, which houses our products and services business units. The latter operates as iBio CDMO LLC and offers contract development in manufacturing services to third parties, as well as to our bio-pharmaceutical segment where applicable. The areas of focus for the bio-process segment include the provision of recombinant proteins to biologics developers using our proprietary plant-based FastPharming manufacturing system. And that's not to mention development services for improved product quality with our Glycaneering technologies. Randy will be describing the FastPharming system in more detail shortly. But at the moment, it's worth noting that we intend to use the speed…

Thanks, Tom. I'm happy to be here on the call with you all today. On past calls, while we have focused on the many benefits of our FastPharming system, we haven't laid out exactly how they are derived. I'd like to take a few moments to do that now. As some of you may know, our FastPharming system allows us to produce bio-pharmaceuticals using plants. What you may not know is that greener options for the pharmaceutical industry are sorely needed. In fact, one surprising study showed that the pharmaceutical sector is 55% more emissions-intensive than the automotive industry. There are other benefits to our platform too, such as reduced time and cost to move from concept to clinic, easier scalability, and lower contamination risk from a mammalian viruses and prions. This ESD-based platform is at the heart of what we do. The process itself is straightforward. First, we start by growing our plants indoors using vertical farming techniques, which include advanced hydroponics and controlled LED lighting systems. The plants we use have a weak immune system and they are particularly susceptible to infection by certain types of bacteria. More on that in a minute. Next, we synthesize the gene, encoding the protein we want to make and clone it into one of our FastPharming vectors. The vectors are then loaded into a species of agrobacterium so that the microbes are armed to deliver the genome entrance to its ultimate destination. We then create a solution of the agrobacteria, dipped our iBio plant into the bath, apply vaccine, and infiltrate the bacteria into the leaf tissue. With the bacteria infecting the plants, they deliver the gene factors into the plant cells, essentially turning each plant into a little bioreactor. The target protein continues to be expressed in the leaves as…

Great. Thanks, Randy. So having provided a review of our business segments, I think it's appropriate to give a little bit of perspective on how we plan to build value for our shareholders with our business model. For instance, the deal struck which were a break to secure rights to an [Indiscernible] antibody was based upon a multitude of factors. Not the least of which was recognizing the external value placed on next-generation immunotherapies. To that end, we think it's important to remind investors that there has already been significant external validation for a molecule with the mechanism of action like iBio-101. Specifically, there was a recent M&A transactions centered around on anti-CD25 monoclonal antibody that, with attainment of various milestones, could reach a value of over $750 million. So as we evaluate future opportunities, we want our investors to know that we're not only looking for first-in-class or best-in-class therapeutic potential, but also, external third-party validation by highly reputable organizations. Of note, by taking this fast forward approach, we also have the added benefit of learning from a competitor who may be slightly ahead in clinical development. We intend to use their learnings in the clinic to our advantage as we think about how to formulate our [Indiscernible] plants. Now let me turn the call over to Martin Brenner, our CSO, for the more detailed review of our pipeline. Martin?

Thanks, Tom. I'm excited to share some updates on iBio's bio-pharmaceutical pipeline and drug discovery activities, particularly in the area of oncology. In August, iBio significantly expanded its immuno -oncology pipeline and R&D capabilities in a partnership with RubrYc Therapeutics. As Tom mentioned earlier, through this strategic collaboration with RubrYc, iBio expanded its pipeline by licensing the next-generation anti - CD25 antibody immuno -oncology asset, RTX-003, which we will refer to as iBio-101 as we bring it on to the FastPharming platform. CD-25 has emerged as a promising target for cancer therapeutics. It is expressed by immune-suppressive regulatory T-cells or T - regs, which allow cancer cells to evade the immune response, but also by tumor attacking T - effector cells, or TFs. First-generation anti - CD25 antibodies potently blocked CD25, but unintentionally also suppressed the IL-2 signaling pathway, which resulted in the depletion of both the immune-suppressing T - regs, as well as the cancer-killing TFs. Depleting both types of T-cells therefore had no impact on the tumor micro-environment. While blocking IL-2 signaling, also led to unwanted toxicities. However, second-generation anti-CD-25 antibodies, like iBio-101, have more refined epitope binding, which enables them to block CD-25 while preserving IL-2 signaling, which leads to preferential depletion of immune-suppressing T-Rex while allowing the TS to attack tumor cells, thereby creating a tumor microenvironment highly inhospitable to cancer cells. Pre-clinical data showed that this molecule generates a strong anti-tumor response when administered as a monotherapy or in combination with checkpoint inhibitors. IND -enabling studies for iBio-101 are expected to begin by mid-2022. Beyond iBio-101, we aim to bring additional new immuno -oncology candidates to clinic faster and more cost-effectively, through our discovery collaboration with RubrYc. RubrYc's robust discovery engine uses propriotary predictive algorithms to generate Mesa scale engineered molecules, MEMS, which are antigens…

Thanks, Martin. Rather than reiterate the details of the Company's financial results, which are available in the press release and the 10-K, I will simply speak to a few financial highlights. Revenues for the fiscal year-end of June 30, 2021, were $2.4 million, an increase of 50% over fiscal 2020. We expect further growth in revenue in fiscal 2022 as our bioprocessing business continues to attract interests from companies who wish to sustainably and quickly develop biologics implants. However, significant quarter-to-quarter revenue variability is commonplace for early-stage pharma service Company like ours, given the relatively small number of contracts and the timing of revenue recognition. Based upon the current outlook, we expect a sequential decline in revenue during the first half of fiscal 2022 compared to the second half of fiscal 2021, followed by higher growth in the second half of fiscal 2022. Both our R&D and G&A expenses for the fourth quarter and full-year of fiscal 2021, were up significantly over the comparable period in fiscal 2020. This reflects our strategy to invest in our proprietary bio-pharmaceutical pipeline and our platform technology. Across R&D and G&A, we invested in staff, an external spend. to implement our strategy. We expect R&D and G&A will continue to grow in fiscal 2022, but at a lower growth rate than we saw in fiscal 2021. You will also note in fiscal 2021 that iBio recorded $10.2 million in settlement income. This reflects the value of our settlement of litigation with Fraunhofer. While we recognize the income in fiscal 2021, Fraunhofer owes us two cash payments of $5.1 million each, one in March of 2022 and one in March 2023. Fraunhofer also agreed to pay iBio $1.8 million for a licensed iBio intellectual property. Revenue for that license will be recognized when Fraunhofer pays for the license in two installments of $900,000 each in March 2022 and March 2023. In terms of liquidity, iBio had $97 million in cash, marketable securities, and investments in debt securities, as of June 30th, 2021. Based on current plans, we believe our cash position is sufficient to fund operations through the first calendar quarter of 2023. However, if we find more opportunities to in-license assets like RTX-003, our cash needs could change. With that, I will now turn the call back over to Tom. Tom.

Thank you, Rob. To summarize, we are proud of all that the iBio Team was able to accomplish in fiscal 2021. As much as we are pleased with the pipeline growth and development of our bio-pharmaceutical candidates, to date, we remain committed to scaling this growth with additional new candidates and partnership opportunities going forward. We're confident in our strategy, and our in-house talent and capabilities are better than ever, along with -- further demonstrating, improving out the platform, comparability to Traditional Mammalian Cell Culture Platforms that are out there, only with many additional advantages. We're also optimistic about the continued growth of our bio-process business for that reason. And it remains a core segment of iBio. These aspects combined with our strong leadership team and board should ensure our continued growth as a developer of next-generation biopharmaceuticals and a pioneer in sustainable plant-based biologics manufacturing. Thank you all. And with that concluding our highlights, we are happy to take any questions you might have. Operator?

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

Hi everyone, this is Rick on for Kristen this morning. I have 2 questions for you. Now that you have access to the RubrYc computational platform, do you believe that this technology will be most useful for development in the new oncology pipeline, or do you envision this being broadly applicable throughout iBio's pipeline?

Rick, great question. The initial focus really will be on oncology. That's where we see a lot of opportunities. The whole category of Immuno -oncology. because you know it's a really attractive space. And when we pair up this capability, the targeting capability that the RubrYc discovery engine brings, along with the antibody libraries that we have access to, and then our Glycaneering technology where we can control the glycosylation patterns well, our monoclonal antibodies, there's a tremendous amount of value there. I'll ask Martin to comment on this a little bit further here in a minute, but also, two in the field of Immuno -oncology, there are a lot of combination therapies wherein you got a monoclonal antibody that can be paired with a checkpoint inhibitor to really drive some favorable any tumor responses. And so for those reasons, we see the most value coming from the oncology side of the portfolio. That said, there are other epitopes targeting benefits in other areas of the portfolio that we won't turn a blind eye to. But, Martin, would you like to comment a little further?

Absolutely. So as Tom mentioned already, it is absolutely our priority to drive the RubrYc discovery platform and collaborate with RubrYc on immuno-oncology targets. As you know, there are several epitopes -- several targets that have hard-to-target epitopes. And those would be initial high-priorities for us. And as Tom also mentioned, this is applicable to other target classes, not just your traditional Immuno -oncology targets, which we will definitely explore going down the road.

Understood. Thank you. And one more question. Could you please discuss a little bit about the discontinued ACE to EPCI project and whether there were any significant learnings to come out of the program despite the discontinuation? Thank you.

Sure. The molecule we were able to bring that into our portfolio at an interesting time. And this is a little bit similar to what we're doing, but in a very different way with anti-CD-25, where you get another player in the space and a pre-look at how their clinical trials were going. When we brought that molecule in, there was the opportunity to pursue a certain pathway with it and we work closely watching appear on biologics who also had an ACE-2, FC in the clinic. And following their Phase 2 readout and our review of the regulatory landscape, as well as the clinical trial pathway that FDA had commented on, we simply felt that the opportunity for that particular strategy as a treatment for COVID-19 disease was risky at best. And the two companies in addition to [Indiscernible], I believe also Sorento and others had Ace-2FC molecules that were in their portfolios. and similarly discontinued those offerings and ultimately the cost-benefit of continuing with the molecule we deemed to not be worth it. That said, others may still continue to go forward. We returned the asset back to its originator and it's quite possible that someone else may choose to move forward with it. If that were to be the case, we still have the manufacturing capability. We've been able to produce the molecule on our platform. So we'd be available as a contract manufacturer if somebody else was to pick up the asset. But Martin did I miss anything there?

No, Tom, I think you've covered everything, specifically the APR on data, that did not meet every -- all of the primary endpoints was disappointing to see.

All right. Thank you all.

I guess in the end --

Okay.

Yeah, you bet. And just in terms of learning, I think it was one of those where you know was the good news was it was a low-cost asset to bring in. I think in hindsight, it was worth doing. At the moment had things gone different -- turned out a different way, and has some of the regulatory agencies got a different route, we would've been very well-positioned to take it forward. So I think if anything, it goes to our modeling strategy, it's biologics, drug development, not everything works out. But that was a low-cost, low-risk way to be poised to move forward and prospectively create a high-value asset, but it's just not, as it turns out. Thanks for the question.

[Operator Instructions] Our next question comes from Matthew Herm with Matthew Herm, LLC.

Good morning, everyone. Tom, I appreciate you sharing the information with us this morning. My question has to do with the San Diego facility, specifically wondering if you could authorize any detail with regard to the budget for that facility, and kind of most importantly, is the expense factored into your declared cash burn?

Yes, it is, Matthew, and in terms of the spending that we're associating with it, it's not only going to be the lease for the facility, of course but then also, the staff that we're hiring in that location. In terms of the capability that we're getting, we get -- we get a nice bang for the buck, especially with the synergy associated with what we have in for RubrYc. In fact, in our cash burn estimates, we had previously also factored in the potential for the collaboration with RubrYc and the in-license of the molecule. So that's all fairly well-baked in. Rob, anything I missed?

No, that's correct, Tom.

And I'm not showing any further questions at this time. I'd like to turn the call back over to Tom for any closing remarks.

Great. Just want to thank everybody for your time and attention. We're continuing to be bullish on the platforms as we have them. And as well as the growth of our biopharmaceutical pipeline. So just wishing everyone a great rest of Monday and the week.

Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.