Ladies and gentlemen, thank you for standing by, and welcome to the iBio fiscal 2022 second quarter financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask the question during this session, you will need to press star then one on your telephone. If you require any further assistance, please press star then zero. I would now like to turn the conference over to your speaker for today, Stephen Kilmer, investor relations. You may begin.
Thank you. Good afternoon, everyone. Before we begin, I would like to remind you that during this call, the company we'll 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 filings with the U.S. Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ from the results discussed in the forward-looking statements. The information on this conference call is provided only as of today, and we undertake no obligation to update any forward-looking statements made on this call on account of new information, future events, or otherwise, except as required by law. On the call today representing the company are Mr.
Tom Isett, iBio's Chairman and Chief Executive Officer, Martin Brenner, iBio's Chief Scientific Officer, and Rob Lutz, the company's Chief Financial and Business Officer. With that, I'll now turn the call over to Tom.
Thank you, Steve, and good afternoon, everyone. I'm pleased to report another highly productive quarter for our biopharmaceutical development activities, wherein we continue to grow and advance our recently established immuno-oncology pipeline while also advancing our second-generation COVID-19 vaccine candidate. Last month, we received the FDA's response to our pre-IND package for 202, iBio-202, which is our nucleocapsid protein subunit vaccine candidate against the SARS-CoV-2 virus. Given the agency's feedback, we are moving forward with IND-enabling studies, and we plan to file an investigational new drug application before the end of this calendar year. We were guided in the development of iBio-202 by what we call our DAVIE strategy, with the acronym reflective of the need for vaccines with greater durability, access, and variant inclusion.
These critical needs are currently unmet by commercially available vaccines, all of which rely in some way on the virus's spike protein as their basis for generating immunity. Spike protein is a major modulator of CoV-2's infectivity and immune evasion, and as we've seen, it is subject to frequent mutations. Indeed, since our last call, we saw the emergence and rapid spread of Omicron, a variant which had over 35 mutations in its spike. It's important to note that as one of the very few companies, if not the only company, developing a vaccine exclusively based on the far less mutable nucleocapsid protein, iBio has the opportunity to lead in the development of a true second-generation solution.
Our pre-clinical data suggests that IBIO-202 provides a durable memory T-cell response and, at least to date, none of the variants displayed mutations in the region of the virus that we used for our antigen. Thus, with our work on IBIO-202, we're aiming to deliver people's last COVID vaccine dose, not just their next dose. While we think that the switch to a nucleocapsid-based subunit vaccine to address issues with durability and the variants, we believe it also can favorably affect access as well. This is because subunit vaccines typically don't have the additional costs and logistical challenges associated with frozen transport and storage like mRNA vaccines do. However, we see technology solutions for other complementary ways to improve access even further.
In particular, there are new delivery technologies that can avoid the labor-intensive process of delivering intramuscular injections while making it easier for people with a fear of needles to seek getting vaccinated. To that end, in November, we executed an agreement with a leading innovator of microarray patch delivery systems to explore the feasibility of administering IBIO-202 intradermally. Microarray patches are minimally invasive and contain microneedles that painlessly penetrate the upper layers of the skin and dissolve to release their payload. This intradermal delivery method may even allow for vaccine self-administration, creating a more accessible alternative to intramuscular injections. Interestingly, this route of administration may also enhance durability as targeting the large pool of immune cells in the skin may elicit an enhanced immune response.
In turn, a stronger immune response could mean a lower dose of antigen is required, which then again could further improve access via lower cost of goods. Turning now to our therapeutics, we're very pleased to see the investments that we began making in drug discovery R&D a few quarters ago already bearing fruit with multiple new pipeline additions and advancements. I would like to start our discussion in this area by pointing out that going forward, we will classify our discovery and pre-clinical programs into four distinct stages for greater clarity, ease of tracking, and consistency with our peers. The stages are, one, early discovery, two, late discovery, three, lead optimization, and four, IND-enabling. Since we announced plans to create our in-house drug discovery capabilities at the end of last fiscal year, we went on to add six new immuno-oncology assets to our pipeline in just six months.
Our newest candidate, a monoclonal antibody designed with machine learning tools, has progressed the fastest. Emanating from our partnership with RubrYc Therapeutics, the concept for this molecule was only just identified in October, but due in part to its high-quality design, this candidate has already moved through to late discovery stage. This example helps demonstrate the power of artificial intelligence in developing higher quality therapeutic candidates, and Martin will speak to this further. Meanwhile, another element of our partnership with RubrYc is our worldwide exclusive license agreement to a novel IL-2-sparing anti-CD25 antibody for the depletion of immunosuppressive regulatory T cells. This is a promising anticancer therapeutic candidate with the potential to turn cold tumors hot. We've transitioned the development of the molecule from the mammalian cell culture production methods that RubrYc's CDMO was using to our plant-based FastPharming manufacturing system.
In addition to the scalability, sustainability, and quality advantages we're now realizing by switching to FastPharming, we also avoid the costly and complicated process of licensing the intellectual property needed to produce an afucosylated version of the molecule in mammalian systems. We can achieve the same end by simply deploying our proprietary glycan engineering technology to afucosylate the antibody in plants. Data generated to date demonstrates that the quality of the FastPharming-produced antibody is comparable to traditional mammalian bioproduction methods. We continue to advance this candidate as IBIO-101 and estimate that we may enter the IND-enabling stage before the middle of calendar 2022. We added another candidate to our oncology pipeline in November when we announced a research collaboration with the University of Texas Southwestern Medical Center to explore the anticancer potential of the endostatin E4 molecule in solid tumors.
A version of this endostatin E4 protein has anti-fibrotic properties and makes up the core of the IBIO-100 program. While we continue to develop IBIO-100 for two major fibrotic diseases, systemic scleroderma and idiopathic pulmonary fibrosis, this new collaboration with UT Southwestern is based on E4's potential to address tumors with a strong fibrotic component, like those associated with pancreatic cancer, that make them so hard to treat. On a related note, last week, iBio and a licensor for the fibrotic indications, the University of Pittsburgh, signed an amended license agreement that extends a number of development milestone-related deadlines for IBIO-100. Now I'd like to turn the call over to our Chief Scientific Officer, Martin Brenner, who will provide us with an update on our recent R&D activities and pipeline drug candidates. Martin?
Thank you, Tom. We continue to be very pleased with the progress we are making building out our drug discovery and development infrastructure, which we initiated in May last year. We have since ensured access to multiple diverse antibody libraries and a broad range of screening capabilities through external partners, and at the same time have built a team of highly skilled drug hunters at our San Diego site. This team has not only entered six new oncology programs into the pipeline in less than seven months, but has also successfully advanced two of those programs from the early discovery to the late discovery stage. I want to put this effort into the context of the one-two years it typically takes to establish a new R&D center and the three-five years an antibody drug discovery program in oncology usually takes from target identification to clinical development.
As Tom mentioned earlier, there are four distinct stages of the discovery program. The early discovery phase includes the identification of a novel target, which is followed by an antibody screening campaign and can take somewhere between six and eight months and delivers early active molecules. In the late discovery stage, these molecules then undergo a thorough characterization where they have to show, among other things, potent and specific binding to their target protein, the desired biological effect on tumor cells, and their efficacy in a cancer animal model. This phase usually takes six-12 months and is followed by the lead optimization phase. During lead optimization, molecules undergo improvement of their overall characteristics, which might include increasing potency or manufacturability by altering physicochemical properties. Lead molecules are subjected to a whole battery of tests, including animal models, which more closely represent the cancer indication in patients.
At the end of this phase, the molecule with the best overall profile is selected as the clinical candidate and enters into the IND-enabling stage. The lead optimization phase, dependent on the complexity of the molecule, can take anywhere from eight months to 1.5 years. The following IND-enabling phase is focused to a large degree on developing the manufacturing process for the molecule and establishing that it is safe to be administered to patients. This is the most expensive phase apart from clinical development, and depending on the molecule and the indication, can take 18 months to sometimes even two years. We are obviously moving extraordinarily fast, enabled by our unique platform. Today, I will share some additional details all about our RubrYc partner discovery program, which we refer to as Target 6 on our website.
I hope you understand that we can't disclose the molecular target at this early stage due to the highly competitive nature of the biotech industry. Target 6 is a protein on the surface of cells and is widely distributed throughout the body. Mutations in several solid tumor indications change the structure and the function of this protein in a specific way. RubrYc's machine learning technology allowed us to exactly reproduce the three-dimensional shape of the mutated region through generation of artificial proteins, so-called meso-scale engineered molecules or MEMS. Using these MEMS as fishhooks, we were able to identify our PHISH antibodies from a library that specifically bind to the MEMS and therefore to the mutated region of our target protein.
This ensures that our antibodies only bind to the mutated protein on tumor cells and not to the normal protein on healthy cells, which is believed to improve the safety of the molecule. In collaborating with RubrYc, we were able to reduce the time in the early discovery phase from usually six-eight months down to three months. Since the molecule identified from RubrYc's antibody library have already built in a certain degree of optimization, we can also potentially reduce the length of the lead optimization phase. Lastly, if the program reaches the IND enabling stage, our FastPharming technology has the potential to further shave off 9 months, leading to development time savings of more than 1 year. I'd now like to turn the call over to our Chief Financial and Business Officer, Rob Lutz, who will provide an update on our financial results. Rob?
Thanks, Martin. Rather than reiterate the details of the company's financial results that are available in the press release and the 10-Q, I will simply speak to a few financial highlights. Revenues for the second fiscal quarter of 2022, ended December 31st, were approximately $200,000, a decrease of 76% versus the second quarter of fiscal 2021. As is commonplace for early-stage pharma services companies, iBio has experienced significant quarter-to-quarter revenue variability driven by factors such as the number and size of customer contacts, contracts, and the timing of revenue recognition. As previously communicated, the company expects revenue growth to return in the second half of fiscal 2022. R&D and G&A expenses for the second quarter of fiscal 2022 increased 40% and 48% respectively over the comparable period in fiscal 2021.
This reflects the company's growing investment in our pipeline, platform technologies, employees, and related infrastructure. iBio anticipates this trend continuing. However, the rate of growth is expected to moderate over time. In November, iBio used approximately $6 million in cash and took on debt to purchase our manufacturing facility in Bryan, Texas, as well as to acquire the remaining equity interest in our CDMO subsidiary, which is now wholly owned. This strategic transaction provided iBio with full control over a 130,000 sq ft manufacturing facility as well as a CDMO entity, which holds the exclusive rights to produce biologics using the FastPharming system in the United States.
Following the purchase, iBio will be exploring the potential for a sale leaseback, whereby a buyer would purchase the facility and lease it back to us, enabling us to repay the debt, to recover the cash we put in, and perhaps to receive financial help from the buyer with funds to expand the facility. For the transaction to be completed, it would help iBio raise non-dilutive capital to grow the business. In terms of liquidity, iBio had $57.4 million in cash, marketable securities, and investments in debt securities as of December 31st, 2021, excluding $5.9 million in restricted cash. Based on recent initiatives undertaken to extend our cash runway, iBio now believes that it has adequate cash to support our activities through September 30th, 2023. That's two quarters more than we were expecting previously.
With that, I will now turn the call back over to Tom. Tom?
Great. Thanks, Rob. We're of course very pleased with the performance of our recently established biopharmaceutical discovery and development capabilities here this past quarter. We've exceeded standard industry benchmarks for the speed with which we've added our six new oncology assets, and we are also encouraged by the forward momentum each of our therapeutic and vaccine programs have demonstrated this quarter. Looking ahead, we will focus on continuing to advance our oncology assets and in particular, moving IBIO-101 for its IND-enabling studies. We are looking forward to efficacy study results for IBIO-400 and progressing IBIO-100 to lead optimization stage. Finally, we will work to bring a last vaccine dose rather than the next vaccine dose as a response to the COVID-19 pandemic with the goal of filing an IND before calendar year end. Thank you.
With that, concluding our highlights, we are happy to take any questions you might have. Operator?
Ladies and gentlemen, as a reminder to ask the question, you will need to press star then one on your telephone. To withdraw your question, press the pound key. Again, that's star one to ask the question. Please stand by while we compile the Q&A roster. Our first question comes from the line of Kristen Kluska with Cantor Fitzgerald. Your line is open.
Hi. Good afternoon. Thanks so much for taking my questions here. The first one relates to oncology. I understand that Target three and the AI-driven IO Target 6 are undisclosed at this time, but wanted to see what information you could provide for us on a big picture basis. For example, I know with your RubrYc collaboration, you've highlighted the potential among challenging targets, but then also recognizing that some of these targets have been well understood in the cancer setting. Can you maybe speak high-level about like the validation of the targets you're going after or, you know, perhaps if these are a little bit more novel to the company?
Yeah, you bet. Thanks, Kristen, for the question. I'll hit it at the high level and then let Martin talk a little bit to the validation, second portion of the question. You know, at the high level, I think there's a lot of interesting targets out there, of course, but a lot of times, easier said than done, you know, to get to the endpoint. You know, I'll take what we're now calling IBIO-101, which RubrYc previously called, you know, their RTX-003 molecules is a really good example of this. You know, for years and years, people were, you know, trying to find a way to, you know, knock down the immunosuppressive regulatory T cells in the tumor microenvironment.
You know, CD25 was a great target to search, and folks were able to, you know, create molecules that could go ahead and bind really nicely. Guess what? It interfered with IL-2 signaling to the T-effector cells, so you were getting rid of your immunosuppressive T cells, but you weren't letting, you know, the cancer-killing capabilities of your T effectors function.
It's areas like that that we're really seeking, you know, these hard-to-solve problems with antibody engineering that we think that, you know, with a combination of some of the ways in which we're designing our methods, some of the libraries, some of the Meso-scale Engineered Molecules that Martin mentioned that RubrYc has, and, you know, using some of the artificial intelligence techniques that are out there, we can solve for problems like the one Martin alluded to. Again, without getting into any detail, you can take a look at what's a really attractive marker, I'm sorry, target for going ahead and targeting solid tumors.
The particular molecule, you know, is also present on healthy cells, so, you know, the challenge there is engineering something that's specific enough for your tumors without obviously, you know, creating a toxicity issue with that particular molecule also being displayed on other healthy cells. That's, I hope, helpful towards sort of the big picture view, and then maybe Martin, you could talk a little bit further to, you know, how we get to the validation challenges that are out there.
Happy to, Tom. Hi, Kristen. Yeah. I think what is important to mention here is that we're utilizing the RubrYc technology here in this particular case to go after a relatively well-validated target, but where we see there's improvements and upsides on the safety side. As I mentioned earlier, this target is expressed in healthy cells and in tumor cells. It's slightly different. Our technology hopefully helps to only target this protein on the tumor cell, which then would avoid kind of the toxicities one would expect to see when you target the endogenous protein on the healthy human cells. This is mainly kind of a play here in going after a target that's relatively well-validated, but increasing the safety margin.
Got it. Thank you. For your oncology pipeline, how do you think about precision medicine approaches and different types of sequencing to identify who might most likely be a responder versus looking at targets that might potentially have a broad effect either as a monotherapy and/or in combination?
I'll make a comment here on, generally speaking, with regards to the markets and then let Martin chime in. It's to say that we're hoping to find in as part of our development efforts and goals, you know, solutions here for unmet medical needs for broader groups of people. We think like in the case that we just described, you know, or case studies, I guess I should say, between IBIO- 101 and some of the new targets that we've entered into our pipeline, that some of these hopefully will be broadly applicable, you know, to a whole variety of cancers and favorably help, you know, a lot of patients in the end.
That said, to your point on precision medicine and taking a look at smaller patient populations and maybe getting after some of these rare cancers, I think what we can say there is that the nature of the FastPharming manufacturing platform lends itself to helping in some of those cases. Because if you think about some of these really rare cancers where you may only have, you know, in some of these instances, a few dozen patients worldwide in any given year, being able to, you know, efficiently produce small quantities of molecules and of the therapies is not necessarily so easy when one thinks about some of the traditional methods.
You know, in our case, you know, as we need material, you know, we can obviously plant a lot of plants to, you know, make larger quantities of product. But if small quantities are required, our, you know, our production system's kinda modular. Each one of our little plants is its own protein factory, so if we only need a little, well, guess what? We can just plant only a little. You know, I think in that way, that's how I kinda think about your question, Kristen, with regards to precision medicine. Martin, anything, you know, to add with regards to, you know, this from a design and development strategy perspective?
I'm happy to weigh in here, Tom and Kristen. If you consider your typical solid tumor, immuno-oncology indication, Kristen, what you do is often an all-comer trial, right? These trials can be lengthy, they can be massive, and there have been, over the past few years, some efforts to characterize the tumors, specifically in individual patients better, but also kind of using machine learning to that effect as well. I think this is an evolving field. We keep a close eye on what's happening outside, specifically, you know, now that we're employing machine learning at an earlier stage.
Obviously, we wanna, you know, keep our eyes out to kind of see if there are other gains we can actually have with that technology, say on the clinical side, say on the biomarker side and so on.
Okay. Thank you. Last question is a two-parter. You talked about these four different stages in a little bit more detail, including the time frames that we typically see. Wanted to ask, with all of your platform capabilities, the AI, all of your partnerships, et cetera, you talk about lead optimization really being where the molecule with the best data is selected to enter IND-enabling stage. With all of your platform technologies and everything we talked about, do you think that process will be more seamless given in advance you're studying this in a little bit more detail? And then just in light of the updates related to your COVID-19 vaccine efforts, could you talk about the timeline you saw there versus what might be expected without your platforms? Thank you.
Great. Thanks, Kristen. Yeah. In terms of the platforms and all in and the relative seamlessness, here, yes, we are expecting that with the way in which we've built these capabilities. We think that'll come together and be, you know, the end result being a much more efficient process here with fundamentally more shots on goal for less money than, you know, the traditional way in which pharma has done it. I'll just cite some studies that are out there that take a look at, you know, all of these processes together. As we all know, if you just start with, let's say 10,000 prospective, you know, discovery initiatives, you know, usually the numbers are something like five ever make their way to an IND out of that 10,000.
What's interesting about it, of course, is that, you know, the time and the money that it takes. You're often seeing, as Martin, you know, started to characterize there, you know, better part of three, four, five, six years to get to IND, and you're spending $20 million-$25 million to get to that point. This whole initiative and everything that we're doing both on our own and in partnerships, the idea is that indeed we do expect that, you know, the power of these, you know, approaches and sort of a measure twice cut once, even in the early go, will significantly help, you know, to bring down the cost and time for development. And again, this concept of taking more shots on goal, we think really applies here.
I think what we're seeing, granted it's early days and we've only got a handful here, but really, really promising. We're seeing what we had hoped and expected we would see with this build. With respect to the COVID vaccine and, you know, timing, again, yes, we do believe that we'll be looking at, you know, an IND filing before the end of calendar. You know, it's just very interesting to watch the environment as it is right now. A lot's changing still from the standpoint of the regulatory approach, and I think here too, seeing this emergence of Omicron and all the other, you know, variants that we think will still be coming.
While indeed, you know, this change is likely where we're moving from an environment where we're dealing with a pandemic and we're moving to an endemic, you know, an endemic doesn't mean, you know, less of a problem. It's still, you know, some serious issues out there. You know, as we deal with this virus, it'll likely pick its spots. It's microbiology, and we do believe that, you know, we're likely to see more variants. We're, like everybody, hopeful that you don't see a true escape variant come out. We do believe firmly that, you know, a second- generation solution that's not solely dependent on the constantly changing spike protein as the basis for providing the immunity is the way to go. You know, we need.
We think that there needs to be alternatives. We know that there's a couple handfuls of companies out there working on it. You know, we also think that there's the opportunity to look at these second- generation vaccines to also, in the end, whether ours or somebody else's, you know, we believe that there is the opportunity to provide cross-protection with other beta coronaviruses, you know, depending upon the design, whether it's ours or some of the others that are moving through development.
We think, you know, governments and others should continue to look to fund, you know, iBio improvements here so that we can get after not only, you know, this boosting and dosing so frequently, but also improve the accessibility so that, you know, we can move into endemic and, you know, hopefully from there, get it even more under control, for long-term, you know, doses of vaccine that can, you know, last for a very long time, not just a few months. Does that hopefully answer the question, Kristen.
Yes. Thank you again.
Thank you. Our next question comes from the line of Roy Buchanan with JMP Securities. Your line is open.
Hi. Great. Thanks for taking the question. I guess the first one to follow up on Kristen's first question, around the targets in immuno-oncology. You know, for Target 6 or the other targets, I guess anything you can say about the level of validation, you know, IBIO-101, you have a pretty good amount of preclinical data. Is Target 6 similar? Just your general philosophy around whether you're going after totally novel targets or things that have some degree of validation. Thanks.
Yeah, I'll let Martin speak to this. The worthwhile point to underscore is that not dissimilar, again, to what we saw with CD25, you can have a well-validated target, but not necessarily an antibody that's engineered properly to maximal effect, either for efficacy or for safety. As you know, I think we've got obviously more data for the molecules that are later in the stages. You know, 101 is that case. We've got a you know, a decent amount of preclinical data. What we're seeing on Target 6 is that it's moving through quickly and putting us in position to you know, to possibly move over to animal studies. Martin, do you wanna comment a little further?
Yeah. Roy, I think it's fair to say, right, we are currently looking at targets that do have clinical validation. Ideally, you know, we're in batting distance to our competitors, and we're specifically looking at targets that are clinically to a degree de-risked, but at the same time, also provide a path forward for us, might it be on safety, might it be on efficacy. I think it's fair to say that, you know, we don't take on the risk right now to go after a completely novel target. Considering we're trying new technologies, considering we're applying our existing technology to antibodies right now, this would just be a dramatic increase in risk if we went after very early targets.
At the moment, we're more focused on areas where we already know the target or a molecule might have worked but might have failed due to safety reasons in the clinic or hasn't gotten to the efficacy we're expecting.
Okay, perfect. That's super helpful. For IBIO- 202, do you still need to do the challenge study? FDA, I thought, was requesting a challenge study, and I still have some questions around that, but if not, then I don't.
Yeah. With respect to the challenge study, it is guidance that we took from the review that led us to go to this next step for the challenge studies. Martin, you wanna take it from there?
Yes. Roy, as you know, both Pfizer and Moderna went through challenge studies. Since COVID-19, the pandemic is a very fluid environment, this is something, you know, now, drug manufacturers and developers have to kind of take into consideration. We are at the moment in the planning stage of this study, and once we have more details about it, we will report out, you know, about the results of that study.
Okay, great. I guess if it's still in planning, but anything in the guidance that says whether you'll need... I know you've shown both antibody and T-cell responses, but it's I guess more of a focus on the T-cell response given that it's an antigen internal to the virus. It's not a surface antigen. Anything you can say about T-cells versus antibodies? Thanks.
Martin?
Yeah. I think it is an evolving area, Roy, and it shows basically we have more and more evidence from academic scientists around the world that there is, you know, specifically an N mediated T-cell response that seems to be protective. I have to say here that this is small studies, but it's accumulating evidence that kind of shows that the N protein might be more important than we initially even thought. I think this is speaking towards kind of a long-range plan in our, you know, strategy to try to be ahead of the pandemic for once and not kind of chasing one variant after the next.
Going after the N protein might cover us in the broader variant inclusion range, but also might cover us from a durability perspective. Again, I wanna caution everybody here, it's early data, and we have not done the studies yet. One of the areas why we do a challenge study is to actually do that proof of concept, and then obviously clinical data has to tell if the hypothesis actually holds true.
Okay, great. Last one I have for Rob, just remind us if the cash guidance includes some component for the sale of the manufacturing facility. I think it did previously. I know you guys also bought, you know, your portion of this CDMO business back, correct? So presumably you're not reselling that again. So that, essentially that's some discount to the price you could get for the manufacturing facility, correct? How do we think about that? Thanks.
Yeah. Thanks, Roy. Generally speaking, right, the assumptions we're using, we try to be right down the middle of what we think is the most likely to happen or on the conservative side, so we're not out there ahead of ourselves. I think that's the best way to position the guidance across all areas. Does that give you enough color?
Yeah, that's fair. The CDMO part of the business, that's not what you're looking to. You're maintaining the full ownership, correct?
That's correct. Yeah, absolutely.
Okay. Got it. Thanks.
Thank you. Our next question comes from the line of Matthew Herm with Matthew Herm LLC. Your line is open.
Hi, Tom Isett. Congratulations on the progress, and thanks for taking my question. I was wondering if you could offer any further insight or explanation regarding the board's recently adopted resolutions regarding the change in the, was it the percent of shareholder ownership that constitute a proxy? For example, is that related to any future plans for requests for increase in authorized share or further stock split proposal?
Yeah, Matthew, thanks for the question. As we noted in our release here today and previously, there are certain structural impediments that are in place here. Without getting into too much of the detail, I think you may be aware that you know there's you know for companies that have very large retail shareholder bases like our very valued one you know the voting of the shares and people's ability to do that there were mechanisms in place previously with some of the large brokerage houses whereby there were things such as proportional voting and other mechanisms to help more easily translate the will of shareholders forward. Now a lot of those mechanisms have gone away.
There's many individual shareholders who have small stakes or may only, you know, be in anyone , you know, biotech company or any company for that matter, for a short period of time. You know, voter turnout, and there are many other companies that are in this in a similar situation as iBio, whereby, you know, there's difficulties in even just doing the basics, such as, having enough shares voted to even hold one's annual shareholders meeting. Yes, some of the changes that we're making are in an effort to try to enable the company to be able to move forward with conducting its business while still being in compliance, you know, with rules of exchanges and Delaware law.
Yeah, we think, as we've said before, you know, we did have strong support, 2-to-1, in favor of the proposals that we have out there, both, you know, a reverse split we had out there, I guess I should say, as well as, you know, a net increase in authorized shares, but an actual decrease on an absolute basis. Some of those changes are related to that and putting the company in, you know, the best position to conduct its business in light of circumstances.
Okay. I appreciate the answer. Thanks.
Thank you.
Thank you.
Our next question comes from the line of Philip Barnett. Your line is open.
Hi, Mr. Isett and team. Thank you for your time today. It's always great to get updates on the company's progress. I have a couple quick questions. There was a request for information posted by HHS and BARDA for next generation COVID-19 vaccines. It was due back on February 2nd. Reading through that, it looked like the RFI was written for iBio. Just wondering if you were aware of that and if you submitted a proposal for the RFI.
Tom, are you on mute?
Yeah, Phil, thanks for that question. Indeed, we were aware of that. In particular, we've been very active in evaluating all the RFIs, actual calls for proposals and contracts, with the U.S. government for related areas. Without being able to get into too much detail, obviously, about whether it's RFIs or contracts that we're applying for either at the federal or state levels, indeed, we've put resources in place here within the company, as well as bringing on key advisors to help us, you know, with responding to opportunities for the U.S. government and really even looking at those rarer instances worldwide.
This is a capability that the company didn't have when we first switched from being a CDMO over to pursuing our biotech interests in December of 2019. We've gotten a lot of that in place. Thanks for that question. Indeed, we're hopefully not leaving any stones unturned with regards to those kinds of opportunities.
All right. Well, I appreciate that. I know you know, you never wanna hear about reverse splits and dilutions, and so I will trust that leadership is exploring all of those opportunities. On the topic of 202 here, I'm interested to hear that we're tackling both IND-enabling studies and alternative drug delivery at the same time. As I understand, IND-enabling studies focus on that molecule efficacy. I'm wondering how we're able to also look at alternative deliveries like intramuscular or the microarray patch. How are we able to investigate both at the same time? It seems to me like you would look at the molecule first, make sure it's efficacious, and then look at alternative deliveries. Could you speak to more of that effort?
Sure. Good question. We are firmly committed to driving behind the intramuscularly delivered IBIO-202, and what we can say is that effort is delinked from the exploration of some of these alternative routes of administration. To a degree, you're right. I mean, we've got the antigen and the adjuvant combination that we're very happy with, and that's led to us taking the decision to move forward here with IBIO-202. We can progress that, but then also, you know, walk and chew gum at the same time because all we're doing is evaluating the feasibility of the same antigen for sure, and to a degree, adjuvant combination with a different platform. These are feasibility studies. More to follow on this, but we've seen these microarray patch technologies improve significantly here over the years.
You know, these first emerged in the mid-2000s and look really attractive from the standpoint of what they can do to, you know, provide a durable immune response. There's a lot to like about them. Some of the manufacturability issues and some of the rest were a question. Now, especially, you know, in the past three, four, five years, there's been a lot of progress made on that front. We don't think it negatively affects at all our plans and timing to push forward, you know, with an IM second gen nucleocapsid-based subunit vaccine for us to go ahead and do this feasibility work here. We're going to be looking at SARS-CoV-2, the antigen adjuvant combination for that as we evaluate feasibility.
Also, if this is successful, we would see this prospectively being, you know, a platform, part of a platform, for vaccine delivery in the human health area, generally speaking. Does that make sense, Phil?
Yeah, absolutely. It's exciting. I know I'm a little averse to needles, so I was excited to hear about that. Last question here. I know back in May 2021, we heard that we won the case against Fraunhofer. Got a couple cash delivery dates there, but part of the settlement was confidential. I'm wondering if we're ever going to hear about what that information is, and if not, if we could hear like a high level. Is it confidential financials or is it possible contracts, manufacturing, potential future business? Just, there's a large part of that that's never really been settled for me.
Well, two things, Phil. One, don't feel bad about being one of those folks who's not fond of the needles. You're one of approximately 90 million other Americans out there who are in the same boat and heaven knows how many worldwide. I mean, that's part of the other reason why, you know, we want to bring these kinds of innovations out here and, you know, solve big problems and that's one of them. You have people who don't want to get vaccinated just because they're, you know, deathly afraid of getting a shot. Moving on to the Fraunhofer thing, I would point you to certain 8-K filings that we have out there. While the press release didn't necessarily have a lot of the financial details in it, some of our other filings did.
There's, in fact, quite a bit out there. Yes, I think it even includes you know, the specifics around some of the financial splits, timing of when those come into the rest. At the end of the day, it was you know, the $28 million. We've got the cash and the cash payments. You know, the first set is due this quarter for both settling the case and then for the license to the FastPharming technology and other IP actually that was created as part of the relationship. They've also taken out a license to that, and there's you know, revenue expected from that coming up here in this second half of the fiscal year. It's out there and available.
All right. Thank you. I'm still wondering about that because, you know, it said there was something confidential there, and I don't know if those filings ever really spelled that out. Thank you very much for your time, and that's all I have today.
Okay, great. Rob, I don't know if you want to add anything to that, but you know, Philip, some of the confidential stuff goes to, you know, these legal cases and can have elements of them that certain parties don't want to have broadcast in the press release. Rob, do you wanna comment at all on specifics on the financial side?
No. I think the financial information is out there. To reiterate what Tom said, some of the confidential information is to protect the parties, but it's not relevant. I don't think there are any surprises hidden out there that we'd be required to make shareholders aware of those. Nothing material should be out there that is meaningful.
Thank you.
Thank you. Our next question comes from the line of Patrick Wolf. Your line is open.
Hi, Tom. I'm just kind of wondering, looking at our sales numbers last quarter and seeing how really weak they are. I'm just wondering, what are you doing to put some food on the table here or get some cash under the, you know, for the 225 million shareholders that are starving to death when you're sitting on a $100 million production plant producing nothing? I'm just kind of wondering, where are we going with this? You bought in on this extra percentage of this production plant. Where are the sales? I mean, $200,000 a quarter. Shock.
Yeah, Patrick. A couple things. We do have a large and diverse shareholder base. I don't think we quite have 225 million shareholders, but you know, we do have you know, that number of roughly that number of shares out there and held. With regards to the CDMO services and the revenue generating capability, I think we've tried to be clear here with respect to the business model that we were moving to.
When it comes to, you know, the bioprocess areas, whether that's the service provision or other products that we're looking to put into the catalog, part of the reason the company struggled previously was that, you know, with this business model where they were CDMO only, that's how they operated, that's how we operated at iBio from roughly 2016 to 2020.
The ability to deploy that plant and have large volume contract development and manufacturing business switch over to it is a challenge because, you know, once a molecule has already found its way onto a manufacturing platform like the standard that's out there, mammalian cell culture, well, you know, once somebody has gotten into preclinical, and then certainly by the time that they're in the clinic, you know, they don't switch that business over. It's, you know, they'd have to oftentimes create so much risk that they might even have to rerun the clinical trial. Which is why you take a look at this kind of example with RubrYc and, you know, we were able to switch and move it on to our platform because they hadn't gotten too far down the path.
We, you know, let everybody know that when we changed the strategy and built the team, that we were going to build a biotech business and in it along the way, demonstrate and validate the strengths of FastPharming and begin after we got the biotech portion of the business stood up, which you can see here this quarter, and the previous one, we've added quite a few assets to our pipeline. I wanna get back to that in a second. In the course of doing that, we're also self-validating, if you will, FastPharming platform and putting ourselves in position to go out and commercialize the facility and the manufacturing services with this extra comparability data that we now have in hand. That's a lot of what we're doing right now.
I think, you know, the other point when you take a look at revenues in any given quarter, I just wanna underscore what Rob said and what we said in our press releases and what we saw last year and really what any fairly young in its business development cycle CDMO is gonna confront as a result, and that's a certain lumpiness to the business and high quarter-to-quarter variability. You know, there's a lot of reasons for that. You know, it goes to everything from RevRec to certain manufacturing campaigns that get done at some times and not others. You will see some ups and downs in the quarters.
I mean, you know, you look at last year. I think we had a quarter where, you know, or the one before where, you know, we had $1 million in a quarter and $200,000. Look, these are those small numbers. The business ramps over time, and as part of what we're doing here, I just wanna also make the other point, as I mentioned that I would, is that this business has the ability to generate non-dilutive revenues from the sale of the CDMO services, which we're continuing to offer. Also, what we're doing is we build a pipeline here of new molecules. Folks will know, right, that biotechs don't necessarily always take all of their molecules all the way through the development cycle.
To that end, because we're taking more shots on goal here, our business model as such is that we're projecting the opportunity over time to have some of our molecules be partnered. One perhaps noteworthy comp that's out there goes to the anti-CD25 monoclonal antibody that we personally have in our portfolio. What's comparable is to Tusk Therapeutics, which was a biotech with just two, I think maybe three assets in its pipeline. They had a preclinical anti-CD25 antibody directed against those immunosuppressive regulatory T cells. They partnered with Roche, and Roche bought just that one asset for $75 million up front, approximately maybe 81. I forget, but I think, you know, the total deal was $750 million if all the milestones were met.
We're giving the, you know, we've promised everybody that we would build a business that de-risks where the company was before with its CDMO only model and create optionality to monetize the technology, whether it be in CDMO services or in ultimately driving for our own commercially available products, taking them through the clinic and then also in partnership. That's a little bit on it. Patrick, hopefully that helps answer the question a little bit.
Thank you. All right. Ladies and gentlemen, this concludes the Q&A portion. I would now like to turn the call back over to Stephen for closing remarks.
Thank you, operator, and thanks everyone for taking the time to join us today. This concludes iBio's fiscal second quarter 2022 investor call. We look forward to updating you again on our next call.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.