iBio Inc (IBIO) 2022 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the iBio Fiscal 2022 First 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. (Operator Instructions)

I would now like to hand the conference over to Stephen Kilmer, iBio Investor Relation. Please go ahead, sir.

Thank you. Good afternoon, 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 as of closed and detailed on the company's periodic and current filings with the U.S. Securities and Exchange Commission. No forward-looking statements can be guaranteed. And actual result may differ from the results discussed in these forward-looking statements.

The information on this call is provided only as of this date -- date of this call. And we undertake no obligations 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 Mr. Tom Isett, iBio's Chairman and Chief Executive Officer; Dr. Martin Brenner, iBio's Chief Scientific Officer; Randy Maddux, our Chief Operating Officer; and Rob Lutz, the company's Chief Financial and Business Officer. With that said, I'll now turn the call over to Tom.

Thank you, Steve. And hello, everyone. I'm pleased to report another highly productive quarter for iBio wherein we continue to execute on our strategic plan by creating partnerships and assets that have the potential to generate significant shareholder value.

Leveraging the transformational nature of our FastPharming system, we are rapidly growing our pipeline while at the same time demonstrating the speed, scalability and quality of our platform to industry and academia. For instance, in the six months since we announced we would build our own drug discovery capabilities, we have already added six new assets to our pipeline. We added three immuno-oncology programs in July and entered into a research services agreement with FairJourney Biologics that gives us access to novel display technologies and proprietary antibody libraries.

We filed that up a month later in August when we entered into a definitive worldwide exclusive license agreement with RubrYc Therapeutics to have another oncology asset to our pipeline. Specifically, we secured rights to an antibody that targets and depletes regulatory T cells. Those are type of immune cell that hinders the body's ability to control the growth of the tumors.

We're moving the molecule onto our FastPharming system as part of the IBIO-101 program. And thus far, the high potency version of the antibody, which is made in plants with our Glycaneering technology is highly comparable to the version we'll reproduce using traditional mammalian bioproduction methods. So we're looking forward in publishing our comparability data as we work to bring this really promising immunotherapy candidate to the clinic.

Now, you may recall the license agreement with RubrYc was just one part of the relationship that we have established with them. We also entered into our research collaboration wherein we have the option to license additional antibodies built using RubrYc's AI driven discovery platform.

Any asset -- accessed to that platform is consistent with our approach to use cutting edge technologies like machine learning to increase the speed of discovery and development of clinical assets and thereby creating more shots on goal. To that end, we are thrilled to announce today that we've identified the first pipeline target emanating from the research collaboration with RubrYc that commenced in mid-September.

We have yet another announcement today related to our strategic focus on oncology. Specifically, we initiated a research collaboration with the University of Texas Southwestern Medical Center to explore the use of our anti-fibrotic endostatin E4 molecule in the treatment of cancer.

iBio is currently developing E4 molecule as IBIO-100 for fibrotic diseases. But along with UTSW, a world-renowned cancer research center, we believe there is potential for the molecule to help inhibit the growth and metastasis of solid tumors too.

So overall, we're pleased with the speed with which we've been able to stand up our oncology discovery and development programs. We've hired seven people into our San Diego-based discovery team, secured access to artificial intelligence and antibody display technologies to marry up with our Glycaneering and FastPharming platforms and partnered with a major cancer research center to explore first in class mechanism of action. We're even more pleased with the results of our investments meaning six promising new assets added to our pipeline in just six months.

Turning now to our infectious disease pipeline, we are awaiting feedback from FDA on our pre-IND submission for our lead COVID-19 vaccine IBIO-202. We were advised by the agency that their review is likely to take several months. So we're assuming we will be able to provide an update before the end of January.

As a reminder, IBIO-202 is being developed with our DAVI strategy in mind. DAVI is our acronym for Durability, Access and Variant-inclusion.

We believe that there are needs in each of those areas that are currently unmet by commercially available spiked protein-based vaccine. We believe that those needs may be better addressed with a nucleocapsid antigen-based vaccine like the one that we're developing.

For instance, presentations at the recent World Vaccine Congress indicate that the nucleocapsid or N protein plays an important role in generating a durable immune response. And then an N-based vaccine could be an important weapon to add in our arsenal in case of the emergence of a variant that could escape the spike vaccine. Also subunit protein vaccines by ours could increase access by avoiding certain cold chain challenges that base the distribution of the mRNA vaccines in some parts of the world.

Now, on another note related to accessibility, we're pleased to announce that we've executed a development agreement with a leading innovator of microarray patch delivery systems. Microarray patches are applied painlessly under the skin like a Band-Aid. Later in the call, our chief scientific officer Dr. Martin Brenner will provide a more detailed overview of this development as well as all of our vaccine programs.

So having touched on our key pipeline accomplishments, I'd now like to focus little bit on iBio's FastPharming manufacturing capabilities and services. Our ability to position the groundbreaking potential of FastPharming sustainable plant-based production process has never been stronger.

On November 3rd, we announced the acquisition of the remaining 30% equity interest in our CDMO subsidiary. Through this strategic transaction, iBio now has full control of our 130,000 square foot manufacturing facility as well as the CDMO entity, which holds the exclusive rights to produce biologics using the FastPharming system in the United States.

In addition to providing certain P&L benefits, this transaction should give us even greater strategic and operational flexibility to continue growing not only in the Bryan-College Station area of Texas but anywhere else in the U.S. as well. Later in the call, our CFO Rob Lutz will provide some more details behind this acquisition.

Having reviewed some of the returns we're seeing from our investments in our core drug development and platform technologies, let me turn now to another very important investment we're making in the category of business development and specifically our outreach to governments.

When COVID first hit, we did not have an active government relations program to leverage. But since that time, we've built capacity and capability to interact with the U.S. government. We're now engaging with the senior leadership of both political parties to help build awareness, interest in more funding for rapid, sustainable, domestic plant made biologic.

While securing non-dilutive funding via government grants or partnerships isn't easy, we're aware of a number of legislative efforts for which iBio's technologies and manufacturing capabilities could be a fit. These include initiatives such as the funding for aspirin BARDA in the current appropriations bill, CARES 2.0, Manufacturing USA, ARPA-H and Buy American to name just a few. Thus we plan to continue to pursue opportunities for public partnerships in the U.S. as well as non-dilutive funding sources outside the United States.

So now, I'd like to turn the call over to our Chief Scientific Officer Martin Brenner will provide us an update on our recent R&D activities and a little bit more detail on our pipeline of drug candidates. Martin?

Thank you, Tom. I'm excited to share some updates on iBio's pharmaceutical pipeline and drug discovery activities.

IBIO-101, the IL-2 sparing antiCD25 antibody we have licensed from RubrYc is progressing as expected. The team in San Diego has started to establish the preclinical pharmacology for IBIO-101. And we are pleased that initial results showed that the molecule produced with our FastPharming and Glycaneering technologies is equally potent and efficacious as the mammalian cell made antibody in our cell-based assays.

PK studies had been initiated. And we're expecting the first results before the end of this year.

As Tom pointed out, our strategic partnership with RubrYc also grants us an option to license additional programs that are being developed with RubrYc's AI enabled discovery engine. I'm excited to share today that the first of these programs has been started. Although we will not disclose the identity of the molecule we target at this stage, it has been specifically selected given advantages we expect to realize from RubrYc's predictive algorithms and iBio's Glycaneering technology.

For this program, we are specifically employing RubrYc's AI platform to generate Meso-scale Engineered Molecules, which will recapitulate confirmations and dynamics of SAP dominant epitopes and target proteins presenting such epitopes instead of full-length proteins allows MEM programmed in vitro selections to rapidly and routinely discover diverse panels of antibodies binding to otherwise inaccessible epitopes. We will provide updates in the future as the program progresses through the different discovery stages.

With regards to our new collaboration for University of Texas Southwestern Medical Center, I'm thrilled to provide more detail on the research. We'll be doing with a laboratory of Dr. Rolf Brekken to explore the potential benefits of our anti-fibrotic endostatin E4 in solid tumors.

Dr. Brekken is one of the leading experts studying tumor host interactions with a particular emphasis on extracellular matrix and angiogenesis. As Tom mentioned, many of you will recognize the E4 molecule as IBIO-100, which we continue to develop for two major fibrotic diseases, systematic scleroderma and idiopathic pulmonary fibrosis.

In this different context of oncology, we will be exploring the potential of using endostatin E4 to target the tumor microenvironment to enable or improve the efficacy of existing chemotherapeutics or immune oncology drugs. Targeting the tumor microenvironment has become an area of high interest with drug developers in recent years.

Among all the cells that are present in the tumor microenvironment, cancer-associated fibroblasts or CAFs are one of the most abundant and critical components of tumor tissue, which provides support for tumor cells and can promote or retard tumor regenesis in a context dependent manner. CAFs are also involved in the modulation of many components with the immune system. And recent studies have revealed their roles in the immunization and full responses cancer immunotherapy.

In addition, CAFs and the extracellular matrix they are producing can lead to highly variable responses to chemotherapy. For a series of planned in vitro and in vivo studies, the collaboration will evaluate the potential of the antifibrotic effects of iBio's endostatin E4 molecule to improve the efficacy of concomitant treatments such as chemotherapy and immunotherapy in cancers with strong fibrotic components.

I will now provide an update on IBIO-202, our N protein based COVID-19 vaccine program. While we are waiting for feeding from the FDA on our pre-IND submission, which we expect sometime before the end of January, we have made further progress on IBIO-202 and our DAVI strategy. Based on our initial preclinical findings, we have conducted the dose ranging study that further informed our formulation strategy and will allow us to significantly reduce the dose.

I am also pleased to announce that 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 drug application devices that can be applied directly onto the skin. They contain microneedles, which painlessly penetrate the upper layers of the skin and dissolved rapidly thereby releasing the drug or vaccine payload.

This intradermal delivery method may allow for vaccine self-administration creating a more accessible alternative to intramuscular injections. Not only that, but by targeting the large pool of immune cells residing in the skin, delivery of vaccines using patch technologies may elicit an enhanced immune response. This could yield increased durability while concurrently lowering costs due to the lower dose requirements.

We are also pleased to note that evidence recently presented at the World Vaccine Congress Europe 2021 continues to point to the nucleocapsid protein or N protein of SARS-CoV-2 as a potential critical player in stimulating durable T cell memory response to prevent against future infection.

Turning now to our animal health activities, I'm happy to report that we continue to advance our classical swine fever, CSF vaccine candidate, IBIO-400, through the USDA's Centers for Veterinary Biologics regulatory process. Additionally, we have announced today that studies are now underway at Texas A&M University system to evaluate the alternatives to IM injections of IBIO-400 including an oral dose option. We're excited about the prospects for oral dosing given it is an easier and friendlier way to vaccinate animals and it typically provides for lower cost of goods.

Overall, we're very pleased with the state and progress of all of our development programs in drug discovery activities. We're also excited about the prospects for our new collaborations around advanced drug delivery technologies.

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, which are available in our press release and the 10-Q, I will simply speak to a few financial highlights.

Revenues for the first fiscal quarter of 2022 ended September 30th were $210,000, a decrease of 49% versus the first quarter of fiscal 2021. Significant quarter to quarter revenue variability is common place for early-stage pharma services companies, which have a small number of clients and due to the timing of revenue recognition. Consistent with these business dynamics, iBio continue to 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.

As expected both our R&D and G&A expenses for the first quarter of fiscal 2022 were up meaningfully over the comparable periods in fiscal 2021. This reflects the continued need to invest in our growing pipeline, our platform technology, our employees and related infrastructure. We expect this trend to continue. But the rate of growth is expected to moderate over time.

In terms of liquidity, iBio had $82.3 million in cash, marketable securities and investment in debt securities as of September 30, 2021 after spending on operations plus investing in the RubrYc Therapeutics transactions. iBio also recently announced it used approximately $6 million in cash in addition to taking on debt in order to purchase its manufacturing facility in Bryan, Texas.

That purchase is meant to be the first step of a two-step process. The second step is an attempt to sell the facility to a new investor and lease it back with better terms than we had previously. If successful, this would allow us to pay down the debt and potentially recover our $6 million investment or even make a profit.

A new investor might also fund additional capital expenditures for the facility, which could improve our cash runway outlook in the near term. While there is no guarantee we could accomplish the second step, the market for lab space in the U.S. has been strong recently.

If we can complete a sale leaseback, we continue to believe our cash position remains efficient to fund operations through the third quarter of fiscal 2023. However, if we can't, we've concluded there is sufficient liquidity to fund operations through at least the second quarter of fiscal 2023.

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

Thanks, Rob. So we are off to a very strong start to our fiscal 2022 as you can see. And much as we are pleased with the pipeline growth and development of our biopharmaceutical candidates today, we remain committed to scaling this growth with additional new candidates in partnership opportunities going forward.

We are confident in our strategy and that our in-house talent and capabilities are better than ever. We are also optimistic about that continued growth of the bioprocessed products and services. And 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.

And before opening up the Q&A session, I would like to address our shareholders with respect to the upcoming annual meeting scheduled for December 9. We are encouraging shareholders of record as of October 15th to participate in the online proxy voting process. Input from our investors is vital for the continued strategic growth and development of our company.

Thus far, we had been pleased to see a high level of engagement and debate. And to facilitate the continued dialogue, we previously posted a Q&A page on the Investor section of our website.

However, there are three questions about the proxy that we've received today with some frequency. So we wanted to take the occasion of this call to address the general form of each of those.

So I'll turn it over to Steve to tee those up for us. Steve?

Yes, Tom. Thanks. Here's one that we get a lot. How is this year's proposal different than last years and why the change?

So last year's proposal was for an increase in the authorized share account only. And although we had 55% of respondents who voted in favor of the increased, we did not have enough total votes to reach a quorum.

So this year's proposal differs in that it also results into that increase of the number of unissued authorized shares. But the Board of Directors recommended a reverse split too so that the stock price might be more attractive to certain institutional investors as well as retail shareholders.

Okay. Thanks. Here's another one. You reported having over $82 million in cash. So why do this now?

Right. Although we don't necessarily have to pursue a financing at this moment, it's important to bear in mind that consistent with the operating model for all development stage biopharmaceutical companies, iBio requires a necessary flexibility to access capital markets at opportune times.

So this is necessary to support the growth of our proprietary pipeline as was done by way of example with the RubrYc opportunity. And the ability to flexibly access capital when market conditions are favorable is of course critical for our future growth and our ability to drive shareholder returns. Our annual shareholders' meeting is of course also the appropriate time and venue for asking our investors for this added flexibility.

Great. Last one, why reverse split at the expense of retail shareholders?

Right. Well, we've recognized there is an underlying concern from some retail shareholders about the potential for stock price depreciation following a reverse split, right.

So frankly, I think that concern is often justified particularly in cases where company is doing it primarily to avoid a delisting. However, outside of those cases, when we look at examples of companies enacting a stock consolidation because they are executing their growth plans and what potentially appeal to a larger investor audience, it could be quite positive.

iBio is a good example of the two sides of this coin. So back in 2018, and this is before the current management team joined the company, iBio completed a 1 for 10 reverse split. The company didn't have the news flow nor the quarterly investor calls nor the expanded clinical pipeline or progress in its services business that we do today. So iBio quickly experienced our price declines all the way down to $0.05 a share in the absence of any immediate and significant progress in its CDMO business.

So now, juxtapose that with where we are presently with a -- today with a strong cash position, demonstration of the performance of the FastPharming platform and a growing list of biopharmaceutical assets in our pipeline and some in these high value areas where there is tremendous unmet medical needs particularly in oncology. And you know of course that's not to mention the ongoing prospects here related to the pandemic IBIO-202 and the still many unmet needs that are out there.

So the board is recommending this move now in the hopes that it will benefit all of our shareholders, retail and institutional alike as we continue to execute on our strategic plan to address these important unmet medical needs and realize our vision to make sustainable FastPharming the preferred alternative to the traditional mammalian bioprocessing.

So, Steve, thanks for teeing those up and allowing us to talk through in there a little bit. So I'm sure there is likely more questions on the proxy or that quarterly highlights. But before we open up the line for questions, I'd also like to remind our stockholders how to vote their shares. So either way, you decide, right. So please vote.

So you can locate the control number on your proxy card for voting and instruction form and follow the voting instructions. If you don't have a proxy card or voting instruction form, shareholders in the U.S. and Canada can call our copy partners in 844-203-3605 or from other locations at +1-212-297-0720. And that would be from the hours of 9 a.m. Eastern Time to 8 p.m. Eastern Time Mondays through Fridays.

So thank you all. And with that, we're happy to take any questions you might have. Operator?

Thank you, Tom. (Operator Instructions)

All right. And our first question is from Kristen Kluska from Cantor Fitzgerald. Your line is now open.

Hi. Good afternoon, everybody. Thanks for taking the question. The first one I had is I know you're not disclosing the individual new target related to the partnership with RubrYc. But given that it occurred just two months after the collaboration, could you help us understand based on the combinations of each of the company platforms what specifically led to the speed and perhaps what might have been the case without it? And then what's going to be the gating factor or what will you potentially look for to decide whether or not you want to option for additional target?

Yes. A great question now, Kristen. Martin, why don't you take the first one. And I'll take the second one?

Absolutely. Well, Kristen, so what we've done is we have -- we've gone through an entire assessment of the target space if you will and have identified targets that would fit both of RubrYc technology and would fit our FastPharming/Glycaneering technologies that has been boiled down to a small amount of targets that would be a potential great fit for both platforms and generating synergies with both platforms always thinking about differentiation that we can drive towards for example mammalian made molecules but also towards driving -- driving towards novel molecules that other platforms aren't able to generate.

And this could lead into improved efficacy. This could lead to improved safety and that with the criteria to select this target.

Now, as you know, this is at discovery approach. So it's very early on. We can't really disclose the target as of now. But it is important to understand that we're utilizing RubrYc's AI driven platform to target a very specific epitope. And then we're following up with our Glycaneering technology to kind of improve the potency of this molecule.

And, Kristen, with regards to our decision making around optioning out any particular asset in the portfolio, we really do like to maintain the optionality that we're going to have here going forward. So a lot of this will be opportunistic I suppose. But then, two, where we're looking at areas of significant unmet medical need, where there is a really interesting mechanism of action that we may have for the molecule and the significant opportunity to help patients, in those sorts of instances, we might want key assets in the portfolio and advance them ourselves through at least the -- a couple of the early stages in the clinic.

That said, we've got some flexibility here particularly in immuno-oncology wherein there is -- there's opportunities for both monotherapies and combination therapies as well. So I think for right now, we -- we'll be looking at these on a case by case basis. But importantly, as we do that, we'll also have the opportunity with our business model to be able to evaluate not only what an out-license might mean on a molecule in terms of that, the partnership revenues, milestones, royalties, et cetera, but also because we'll be putting these out to our FastPharming platform presumably.

In more instances than not, there would be an accompanying supply agreement for the contract manufacturing of the molecule for clinical trials and then inform us to make it through the commercial then that too. So that's how we're looking at it.

You know in the -- in the business model that we've set up gives us a lot of advantage to, A, to the point out of being able to quickly in-license and develop new molecules and advance them through and then in turn being able to out-license them as well and provide contract development and manufacturing services as appropriate. Make sense?

Yes. Thank you. And then on your prepared remarks, you talked about potentially lowering the dose of the COVID-19 vaccine. Is this something you anticipate needing to further discuss with the agency or was this submitted? And will this information also be reviewed out of their decision that you're expecting by the end of January?

Yes. And happy that you asked that because it's important to distinguish that what we're doing with 202 right now and what's been submitted to FDA is for intramuscular delivery. So that is on its own timeline and regulatory pathway. Our intent right now is to continue to drive behind an IM delivered vaccine.

And so it is for that particular candidate that we're expecting feedback from FDA before the end of January. And so the -- if we have a clear path to the clinic, then we would be proceeding with an intramuscular delivery of that particular antigen adjuvant combination.

What we're announcing today goes more fundamentally to our vaccine platform if you will, so not only let's say manufacturing the antigen as we would do with FastPharming, also having access to certain adjuvant technologies for instance with IDRI, the Infectious Disease Research Institute. But what we also believe strategically as important not only for COVID-19 but presumably for other infectious diseases down the line is that, this traditional way of delivering through IM injection doesn't really do much for mobilizing access to a vaccine in the event of another pandemic, right.

So what is a better way to do this? And with the technologies that are emerging, we believe that these microarray patches provide a much better pathway forward such that one could if all the technologies were able to come together be in position where you could mail out the vaccine to people. And they could prospectively self-administer it.

So we think given the way that particular delivery technology has matured, now is the right time for us to look at it. Now, this is not to say that we couldn't also at some point decide to produce a COVID-19 candidate that utilizes microarray patch for the delivery system, we could. But that is a -- that is a separate track.

So I don't mean to go on too long about that. But does that clarify well about then and answer the question?

Yes. Thanks. Appreciate it. And then I wanted to ask about some of the supply chain disruptions that we've seen across the country and the uncertainties around if this is something that's going to stay long term. But maybe touch upon from a plant-based manufacturing standpoint anything that you think stands out here, advantages you might have or anything else we might consider along with some of these disruptions that are occurring.

Yes, for sure. When one takes a look at our process for producing a biologic, you can split it into two parts. There's an upstream and a downstream.

The upstream is what's novel here for us. That is where the protein gets expressed. The traditional way of doing it is in with mammalian cells oftentimes -- the mammalian cell culture whereas in our case, we express it in a plant.

The downstream happens to be the same. Why do I sharing this, it's because some of the supply chain disruptions that occur on the downstream affect us as well as our competitors. And since the entire process is linked, you can't be one without the other, if there are supply chain issues on the downstream, ultimately, that impacts our ability to move forward just like it would any other competitor in the space.

That said, one of the points that we're trying to underscore and then decide especially as -- and for instance, in the United States, there are initiatives underway and legislation working its way through to bring home if you will a lot of biologics manufacturing. And in that regard, at least on the upstream side, when you compare us to these other systems that utilized mammalian cell culture, there is oftentimes a lot of single used plastic disposables that are involved. Those have been very hard to get in this current supply chain crunch. And we get to avoid their use. So there would -- there is less risk in the supply chain for us going forward because our raw materials are seeds and a little bit of water and some light.

So we're better positioned and have less risk for our supply chain and our competitors in that regard. But it is this hopefully more is done with regards to Manufacturing USA if you will. Then we believe that that's a better way to do biologics manufacturing anyway not only by sourcing a lot of the raw materials here in the U.S. but also because it's more sustainable.

You know one of these facts that's out there is that while some may perceive the pharmaceutical industry to be a clean one, in fact, the industry is 55% more emission intensive than the automotive industry. So we believe of course that green production of recombinant proteins is the way to go. So not only would one -- would the industry be better positioned at least for the United States for it to switch to a FastPharming plant-based production system. But obviously also have a lighter carbon footprint is a -- is a good thing too we believe.

So it's tough out there for all the competitors. Just to sort of sum up on the question is that we do see some impacts particularly as it pertains to our downstream raw material access but not anything that right now jeopardizes the development timelines that we have for our current products and for our customers.

Okay. Thank you so much for answering my question.

Thanks, Kristen.

Next, we have a [Norman Carlyle], a private investor. Your line is open.

Thank you. Appreciate the time. Had a question really is surrounding your COVID-19 vaccine development program. As you know, on March, the 26th, 2020, iBio announced the advancement of the COVID-19 vaccine program, announcing IBIO-200. June, the 4th, 2020, iBio announced the second COVID-19 vaccine program with the birth of IBIO-201.

Then you got to Sunday evening, July, the 19th on 2020. An article was released by "The Battalion" Texas A&M titled, "A&M Experts Offer Updates on COVID-19 Vaccine Testing on Campus." Dr. James Samuel, who is the head of the microbial department went through a pretty detailed timeline within that article basically saying, hey, phase one potentially begin around 2021, potential phase two and three in April 2021 as well. And then he went on to say that maybe, we'll have data accumulated about the protection incidence by early summer 2021.

As you know, the following week, iBio share price rocketed to $7.45 a share. Kind of Dart then went on to basically divested assets and profit nearly $100 million in cash. Would you like to maybe comment on whether Dr. James Samuel was authorized to speak on behalf of iBio? And then, two, I'd like to give you an opportunity to maybe share your timeline on your COVID-19 vaccine development program.

Yes. Thanks, Norman, for the question. And was quite a time back then as you noted.

And our -- we've been pretty consistent with our communications all the way through. And in particular as we got into summer of last year, what was apparent to us was that we -- despite having an invited submission to BARDA, oh, gosh, in the March-April timeframe, it was -- it was becoming clear over the summer that Operation Warp Speed was going into effect and that there was a select few number of companies that were identified to receive substantial government funding.

So irrespective of communications and activities of any third parties there, we were at that summer point in time was trying to evaluate strategically what was going to be the best path forward for iBio and its shareholders vis-a-vis our abilities to produce a COVID vaccine.

Now, once again, unlike the other participants that were selected for Operation Warp Speed, we at that point in our history of course had not been a biopharmaceutical developer per se, right, then done -- using our technology, the work had been done for others. But iBio itself didn't have clinical trials experience whereas Moderna had been at it for 12 years, Novavax about the same, BioNTech, et cetera.

So okay, the realities of the situation were such that as we got through the summer, we had to make the decision could we be in the game and prospectively provide a solution here that could be useful and address problems that these other vaccines that were making their way very swiftly through the clinic could solve. And I think credit to the pharmaceutical industry overall for just an amazingly rapid solution to a global pandemic. So that's obviously a huge win for the industry that these vaccines were developed so quickly and were effective.

But as we then moved ourselves into the fall -- and again, this is before any of these new variants had emerged, most notably the British one, right, we took a step back and said, "Okay. Well, we didn't get picked for Operation Warp Speed. You got Pfizer and Moderna about to be approved and then AZ and J&J shortly afterwards it appeared." And so that's when we took the decision to say, "Okay. Based on some literature review that we had done, going all the way back to SARS-1, MERS and some of the rest, that we felt that with the ability of our manufacturing platform and the right strategy, that in fact, if variants were to emerge and to do quickly, then an answer might be to come up with a different antigen that would maybe not have some of the risks, if these variants were to emerge."

So that's when we took our first steps. I think internally, my timeline, I think we made that decision in around October of 2020.

So that's what I would say to all that, Norman, is that we were evaluating the relationship with the government, Operation Warp Speed, the development of the pandemic. And at this moment in time, I'd say we're happy that we chose to explore the nucleocapsid-based subunit vaccine. We're happy with the data that we have.

We think that the news that we're seeing around the development of the pandemic is suggestive of the value that a vaccine candidate like the one we're working on could be recognized. And we're of course hopeful that the regulatory process will be such that we do have a path forward here and not just to get into the clinic for the sake of getting into the clinic but to much to that DAVI strategy that we outlined make a real difference and address some unmet medical needs and hopefully with this pandemic going the way it is, have the ability to make a contribution here in this space.

So hope that made sense. And, yes, that's how we see the timeline and -- but we're pleased and committed to continuing to taking IBIO-202 forward here. And then as you heard in the remarks that we made earlier, we're looking at core platform technologies for our future vaccines as well by way of example that microarray patch partnership that we're working on now.

Next, we have a [Philip Barnett], the shareholder. Your line is open.

Hi, Mr. Isett. Nice to meet you via phone and thank you for taking my call.

Got a lot of questions here, but given the format, just going to jump into a couple. First, just a commentary on the reverse split. I think the worry for many investors here is not just the current one at hand, but the combination of the previous 1 to 10 split, the ensuing dilution over that subsequent years and now risk of another.

I think the best way to get that stock price up is to produce results, tangible results. I mean we have an incredible pipeline and really look forward to that developing here. But the question's here as far as IBIO-100 goes, there was a great update today concerning our move into the oncological space here with 100. But I'm wondering what progress have we made in the fibrosis scleroderma space.

I mean we were collaborating with Dr. Feghali-Bostwick back in 2015. We were granted orphan drug status by the FDA in 2016. We've had great preliminary results, I believe, even saw something suggesting disease reversal on this. Why aren't we pushing forward where we've already seen great success and instead moving into a new oncology space especially when funds are already tight?

Yes, Philip. Well, it's nice to meet you too. And thanks for the questions. And I'll kind of go in order with regards to the reverse split.

You're exactly right. This is about producing results. And part of the way in which that gets done is taking the business model from where we were before and offering FastPharming services out to an industry that was unfamiliar with plant-based production. And without a track record being built was a bit of a challenge.

And quite frankly, the company was trying to appeal to people like me who were skeptical about the platform. So we believe that the strategy change that we made is a very good one because we're now demonstrating what the platform can do.

And by way of example, here is -- here is results. We've made these investments. And it rapidly built a pipeline of assets and in particular some pretty interesting ones in oncology. And we're showing the comparability in the platform while at the same time the speed, scalability, the ability to modify the molecules to affect greater potency at least in the laboratory.

So we're actually quite pleased with the progress. And we think this is going to be and is already readily evident to some of the new partners that we have. So we're building up our datasets, letting the proof be in the pudding. So I think that's all good.

And then with regards to IBIO-100, you're right to ask the question, right, because we don't want to be suggesting that somehow we're getting distracted or that one adds another asset, and okay, well, what happened to IBIO-100 for fibrosis. So I hope you'll be pleased to know program is alive and well.

As we shared earlier, we are anticipating moving into the clinic here at FY -- or towards the clinic here at FY '22. So we have -- you mentioned Dr. Carol Feghali-Bostwick. She's acting as an advisor along with two members of our Board of Directors with scientific background. And we're continuing to advance the molecule forward. And of course, as we have updates, we'll produce those in a timely fashion.

On this particular call, we're still just moving through some of the setup work here for that particular molecule. But it is on the track that we have. And we are expecting and hoping, well, of course, that everything will proceed according to the plan that we have out there such that we're in position to move, we'll do -- let me -- let me make sure I get this right.

I would say that we want to be in position to actually get into the clinic in FY '23 but taking certain steps towards the IND enabling studies in the filing here in FY '22.

Now, that's -- I mean that's great news. And I appreciate that update. It sounds -- like you said, everything is alive and well. And that's awesome.

The next question, you mentioned potency of our platform. That leads into my next question. We've had a rituximab biobetter in our pipeline for several years now. I remember when iBio released stating the antibody dependent cellular cytotoxicity was increased 30-fold potency. Rituximab is one of the most prominently utilized oncology drugs, wondering what results have been made on that and -- both in the U.S. and then in regards to the partnership with CC China there.

Yes. So we have announced two partnerships, the -- both CC-Pharming as a client as well as a South African entity by the name of AzarGen wherein we were identified as the contract development and manufacturing partner for them. So in those instances, the client drives the bus in terms of development for their geographic area of interest.

So I can say that we still have AzarGen as a client. A lot of the work that we did with and for CC-Pharming did wrap up successfully. So they're strategic decisions to pursue or not pursue a rituximab biosimilar or biobetter are really driven by them as clients. So needless to say, I can't comment on confidential client relationships other than what we've already put out in the price that they have agreed to.

But I think it's very fair to say that the data that was obtained in those projects and also in the work that we did and published independently on rituximab supported very much so our Glycaneering technologies and how through putting sugars on the right way -- we're now putting certain sugars onto our recombinant protein -- can increase the potency.

And in fact, this is what we were alluding to with the news that we just shared today about the comparability data that we have with the RubrYc molecule, what's our IBIO-101 made in plants and what was their RTX-003 made in traditional mammalian cell culture that we've been able to produce the high potency product and have tremendous comparability. So in those regards, the platform is continuing to demonstrate the quality aspects and performance that we've said that it can.

All right. Well, so I guess last question, follow-up on that. So we are working on the rituximab with CC-Pharming. We've worked with AzarGen in South Africa. Are there any domestic U.S. efforts to commercialize the rituximab?

We don't have that as a molecule in our pipeline as you will note now I guess by -- we -- you could say, well, how could I note that given that we've got a handful of it are undisclosed, so fair enough. But think I can safely say that from the standpoint of our strategy, we are not looking to advance a rituximab biosimilar or biobetter ourselves as one of our own programs at this time. That could always change. But it's not one of the molecules that's listed in our current pipeline.

You know it -- I think in every instance, we will want to use our investors' dollars in a very responsible way to really address major unmet medical needs and significant market opportunities at the same time. And while rituximab itself is -- got a very large global market, there are a lot of players in there, the biosimilar and biobetter space is crowded, competitive. And there's certainly country-to-country issues that are associated with it.

So it -- when we look at the United States right now, we don't believe that that particular opportunity is attractive enough for us to take dollars from these other programs in our platform investments to pursue. But of course, if market conditions change, or there is a technological advantage that we could identify, we would -- we would always be in position or reconsider that if that makes sense more.

And your last question is from [David Sandrock], a private investor. Your line is open.

Hi. Thanks for taking my question. You noted you were awaiting feedback on the IBIO-202 pre-IND package submitted to the FDA earlier this year in September. Was the intents of that submission to have a pre-IND meeting with the FDA? And if so, has that meeting happened already or is it currently scheduled?

Yes. I mean I'll let Martin start us off and then follow up as appropriate. Martin?

Yes. Absolutely. So we have submitted a package to the FDA requesting an - a pre-IND meeting. But as you can imagine, due to current ongoing approvals of existing vaccines, the agency has told us that it would take a little bit more time.

But the goal is to sit down, and in this case very likely being a phone call with the agency to discuss plans, how we can move IBIO-202 in the clinic most efficiently obviously being absolutely sure that we're not endangering any patients. And this is the goal of the pre-IND meeting.

And compared to this time last year, our experience with the agency was very favorable and swift. So when we followed up for a pre-IND request, I mean, it was -- it was a matter of weeks to get a response. I think it's something like under two months.

What we've seen now like others is that unless one is in a certain category, a lot of -- a lot of the reviews are taking upwards of four months, which is why we commented that we're assuming that we'll hear something back before the end of January of course. You know the regulatory review and process is what it is. And we don't have any control over that.

But it was indeed a standard pre-IND submission that we did make in September. And hopefully, we will hear something back before the end of January.

And that concludes the Q&A session. I will now turn the call back to Tom Isett for closing remarks.

Great, thank you, operator. And thank you, everyone, for your time and attention. And look forward to updating at our next call. And certainly as always, we'll be sharing any material information in the interim. Thanks again, everyone.

And this concludes today's conference call. Thank you all for your participation. Enjoy the rest of your day. Keep safe. And you may now disconnect.