iBio, Inc. Q1 FY2021 Earnings Call

Good day, everyone, and thank you for being here. Welcome to the iBio Fiscal 2021 First Quarter Financial Results Conference Call. Currently, all participants are in listen-only mode. After the presentation, we will have a question-and-answer session. Now, I would like to hand the conference over to Mr. Stephen Kilmer from Investor Relations. Thank you. Please proceed.

Thank you, Andrew. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements regarding our financial figures. Often but not always, forward-looking statements can be identified by the use of words such as 'may,' 'might,' 'will,' 'should,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'continue,' 'predict,' 'forecast,' 'project,' 'plan,' 'intend' or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. Such statements are based on current expectations for management. The forward-looking events and circumstances discussed in this conference call may not occur by certain specified dates or at all, and could differ materially as a result of known and unknown factors of uncertainty affecting the company. This includes, but is not limited to, the Company's ability to obtain regulatory approvals for commercialization of its product candidates, including its COVID-19 vaccines, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize the Company’s product candidates for specific indications, acceptance of the Company’s product candidates in the marketplace, and the successful development, marketing or sale of the products. The Company’s ability to maintain its license agreements, the continued maintenance and growth of its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, or its ability to retain its key employees. Although iBio has attempted to identify important factors that could cause actual actions or uncertain results to differ materially from those described in forward-looking statements, there may be other factors that can cause actual results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed except as required by applicable securities laws. Forward-looking statements are only as of the date at which they are made, and iBio undertakes no obligation to publicly update or revise any forward-looking statements whether as a result of new information, future events, or otherwise, other than as required by law. On the call today, representing the company, are Thomas Isett, Chairman and Chief Executive Officer, and John Delta, iBio’s Principal Accounting Officer. With that said, I will now turn the call over to John.

Thank you, Steve. Good afternoon, everyone, and welcome to our inaugural conference call. On behalf of the management team and everyone at iBio, I would like to thank you for your interest in our company, and for those of you who are shareholders, we truly appreciate your support. Before I turn the call over to Tom for an overview and update on our activities, I'd like to provide a brief update on our financial results for the quarter ended September 30, 2020. To streamline things, all the numbers I will mention have been rounded and are therefore approximate. For the three-month period ended September 30, 2020, iBio reported revenue of $410,000, an increase of $302,000 from the same quarter last year. The increase is attributable to revenue generated from two new customers. As of September 30, 2020, revenue backlog was approximately $2.4 million. Total operating expenses, consisting primarily of research and development (R&D) and general and administrative (G&A) expenses for the quarter ended September 30, 2020, were $7.3 million compared with $4 million for the same period last year. R&D expenses for the quarter ended September 30, 2020, were $1.8 million compared with $1 million in the same period a year ago. The increase is primarily related to an increase in laboratory supplies and higher R&D personnel costs. G&A expenses for the quarter ended September 30, 2020, were $5.5 million compared with $3 million in the same quarter last year. The increase resulted primarily from higher professional and consulting fees and facility repairs and maintenance. We have been making significant investments in people, processes, and infrastructure to match our progress and position in our lifecycle. We believe that creating the solid foundation provides the expertise and compliance needed for a high-quality biotech company and will serve well as it moves forward with its value-creating objectives. As we continue to advance our clinical pipeline, we expect growth in R&D expense to begin outpacing that of G&A moving forward. Other expenses for the quarter ended September 30, 2020, were $600,000, which was consistent with the same quarter a year ago. Net loss attributable to iBio stockholders for the three months ended September 30, 2020, was $7.5 million or $0.05 per share, compared with a net loss of $4.5 million or $0.21 per share in the comparative period last year. As of September 30, 2020, iBio had cash and investments in securities of $83.5 million. With that, I will now turn the call over to Tom for an operational overview and an update on iBio's recent activities. Tom?

Thank you, John, and good afternoon, everyone. As this is our inaugural call, we'll spend a little more time discussing developments that have occurred over the past several months than we normally would before turning to our near-term plans. First, to put the scope of iBio's transformation into perspective, it might be helpful to reflect on our position this very time last year. We were operating a very small business that focused almost exclusively on contract manufacturing. We had little industry brand recognition. We were working on the design of a plant-based production facility for one major client that had slowed, and our work for another new client was taking longer than expected to ramp up. We had two product assets whose development had essentially stalled. Our cash position was just over $2 million, and our stock price was around $0.13, which translated into a market cap below $10 million. In December 2019, we launched a new strategy designed to leverage our rebranded FastPharming technology platform and put it, as well as our 130,000 square foot manufacturing facility, to work producing our own proprietary products. We were able to achieve this in part because a few months earlier, we had begun development of our Glycaneering technology. This technology enables us to better control the way in which our plant-based system glycosylates proteins, thereby improving the quality and in some cases the efficacy of the biologics we produce with it. We launched it as a service in December and also began to use the technology in conjunction with our FastPharming system to restart work on our own biopharmaceuticals and evaluate recombinant proteins for use in research and bioprocessing applications like 3D bioprinting. By mid-January, we had reinvigorated activity related to our anti-fibrotic disease candidate iBio-100 and our classical swine fever subunit vaccine iBio-400, and we refocused our efforts with our two major service clients and began to see more awareness of and interest in our FastPharming and Glycaneering development services. The result was, in part, of some of our marketing efforts, as well as interaction with industry trade groups like the Advanced Regenerative Manufacturing Institute, which supports the emerging bio-fabrication and 3D bioprinting industries. We'd improved our cash position somewhat and began to think about other new products and service opportunities using our proprietary technology platforms, including virus-like particles (VLP) based vaccines, as well as cancer therapeutics that could be enabled with Glycaneering. The FastPharming and Glycaneering technologies, in addition to certain technologies and product candidates we have developed over the years, are covered by 106 issued patents, with 37 of those issued in the U.S. We have 20 patent applications pending and plan to continue to strengthen our IP portfolio with additional filings. At that point in January 2020, about mid-month, we were confident in our ability to deliver on a product and service strategy based upon our FastPharming system, which offers many advantages. For instance, first, a faster time to clinic by shaving months off of traditional mammalian cell development. Second, FastPharming is easily scalable because each little plant has its own bioreactor. Unlike competing systems which face production challenges moving from a few milliliters to 2000-liter bioreactors in mammalian-cell culture, our scale-up is achieved by simply growing more plants. Third, it can produce a wide range of proteins and glycoproteins, including monoclonal antibodies, antigens, virus-like particles, enzymes, bioinks, growth factors, and cytokines, most of which can all be enhanced using our Glycaneering technologies. Fourth, there are lower contamination risks since mammalian viruses and prions can't grow in plants. Finally, among the number of other advantages that I won't mention, the FastPharming system is eco-friendly as it avoids the single-use plastic disposables often implemented during mammalian cell-based biologics production. Needless to say, by late January 2020, the emerging COVID-19 pandemic began to take shape. Even though we had only just initiated our change from a CDMO services-only model to include more proprietary product development, we quickly shifted our focus onto SARS-CoV-2. At the time, we assumed this coronavirus outbreak would be short-lived, much like SARS-1 and MERS before it, but we nevertheless saw the opportunity to bring our capabilities to the task, such as our FastPharming manufacturing facility located in Bryan, Texas. That factory was originally built in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA) as part of the U.S. Department of Defense's Blue Angel initiative. That initiative aimed to establish facilities capable of rapid delivery of medical countermeasures in response to a disease pandemic. As the FastPharming system uses a relative of the tobacco plant as the bioreactor in the FastPharming factory, that plant is equipped with automated hydroponics and vertical farming systems for large-scale manufacturing of recombinant proteins. Only one week after the World Health Organization declared COVID-19 a global pandemic, we announced that we created SARS-CoV-2 VLP-based constructs using the FastPharming system. We subsequently filed four associated provisional patent applications. We also became the 20th member of the Alliance for Biosecurity. The alliance supports national health security by advocating for public policies and funding to support the rapid development, production, stockpiling and distribution of critically needed medical countermeasures. Our VLP-based vaccine candidate iBio-200 is designed to mimic the SARS-CoV-2 virus's glycosylation profile, which may allow for more efficient uptake of the vaccine by human antigen-presenting cells, potentially resulting in enhanced protection. With that theory in mind, we initiated immunization studies for iBio-200 at Texas A&M University System's laboratory shortly after announcing the program. We also expanded our iBio-200 vaccine collaboration to include the Infectious Disease Research Institute (IDRI) to benefit from its vaccine development expertise as well as its portfolio of novel adjuvants. Recognizing the severity and urgency of the pandemic, we initiated our second COVID-19 vaccine program, iBio-201, in June. While this further validated our ability to innovate, it also allowed us to put another vaccine candidate into the race, mitigating the development risks associated with any pre-clinical program. iBio-201 is based on a subunit platform that combines antigens derived from the SARS-CoV-2 spike protein fused with our patented LicKM booster molecule to enhance immune response. The addition of the LicKM booster to a subunit antigen may improve the likelihood of achieving single dose, prolonged immunity while also increasing manufacturing capacity through the increased potency. iBio-201 was also tested with several different adjuvants. While that was ongoing, in August, we obtained an exclusive license to Planet Biotechnology's COVID-19 therapeutic candidate ACE2-Fc. It is a recombinant protein comprised of human angiotensin-converting enzyme 2 (ACE2) fused with human immunoglobulin G Fc fragment. It's an immunoadhesion. ACE2-Fc targets the coronavirus virions directly by using the ACE2 extracellular domain as a decoy to bind spike protein and block infection of healthy cells, while the fused Fc domain prolongs the life of the protein in blood circulation. As ACE2 also is the target receptor for the coronavirus's entry into cells, we believe the candidate will bring the benefit of a traditional neutralizing antibody while prospectively limiting the potential for viral replication. ACE2-Fc has demonstrated the ability to block the SARS-CoV-2 virus from infecting Vero E6 cells in in-vitro studies conducted by Planet Biotech. In September, we selected iBio-201 as our leading COVID-19 vaccine candidate based on its production of higher anti-spike neutralizing antibody titers than iBio-200. We recently selected a contract research organization to support toxicology studies for iBio-201 and initiated discussions with the U.S. Food and Drug Administration regarding the program. We are also continuing pre-clinical development of our VLP platform as a potential plug-and-play vaccine development system. As you probably have heard, while final peer-reviewed data is still forthcoming, Pfizer and Moderna have recently reported success in later stage trials of their COVID-19 vaccine candidates. These companies are to be applauded for their remarkable accomplishments, and we sincerely hope that one or both of their vaccine candidates will be approved and successfully deployed. That said, at this point, some questions remain about durability, effectiveness in the elderly, safety, manufacturing, and global distribution and access. Vaccines can and do often still fail late in clinical development. The experts with whom we have consulted suggest that those factors point to the continued need for a number of COVID-19 vaccines to remain in development. Given how much remains to still be understood about the disease, combined with what we have seen in pre-clinical studies so far, it really is incumbent upon us to continue our COVID-19 vaccine development activities. Meanwhile, in addition to adding two proprietary COVID-19 vaccine candidates and a COVID-19 therapeutic candidate to our pipeline in 2020, as I mentioned earlier, we resumed development of two legacy biopharmaceutical programs, iBio-100 and iBio-400. iBio-100 is an endostatin E4-peptide anti-fibrotic candidate being developed for the treatment of systemic scleroderma and idiopathic pulmonary fibrosis. iBio-100 was previously granted FDA orphan drug designation for treatment of systemic scleroderma. It has been shown to reduce fibrotic symptoms in pre-clinical studies. We are currently working towards starting the last of our IND enabling studies for iBio-100, followed by CGMP manufacturing in the hopes that we have a molecule that can help meet current critically unmet medical needs in fibrotic disorders. Meanwhile, developed in collaboration with the Institute of Infectious Animal Diseases (IIAD), as well as Kansas State University, iBio-400 is an E2 classical swine fever vaccine candidate. Classical swine fever is a contagious, often fatal disease affecting both feral and domesticated pigs, and outbreaks have occurred in Europe, Asia, Africa, and South America, and recently in Japan specifically. iBio-400 has demonstrated complete protection in challenged pigs after a single-dose vaccination and is accompanied by strong virus neutralization antibody responses. We are presently planning an efficacy study for June with a large safety study to follow later in 2021. To help drive this project forward, we recently hired Dr. Melissa Berquist to fill the newly created role of Head of Animal Health Programs. Melissa came from Texas A&M, where she served as Director of the Institute for Infectious Animal Diseases, and we are excited to welcome her to our team. Having expanded our biopharmaceutical pipeline in 2020, I'd like to point out that our CDMO services and plans for our research and bioprocess proteins products represent important near-term revenue-generating opportunities. We aim to have these offerings provide non-dilutive funding for our biopharmaceutical development programs. We also continue to work with CDMO clients to support several development programs, including United Therapeutics for their development of a recombinant human collagen-based bioink for 3D bio-printed organ transplants, Argent's biosimilar rituximab for the African continent, and CC Pharming's BioBetter for China, as well as other new customers. Additionally, Safi Biosolutions has recently selected iBio as its source of recombinant proteins as cell culture supplements for its blood cell therapy program. As part of the relationship with Safi, we have the opportunity to build our own portfolio of research and bioprocess products by virtue of the fact that any proteins not designated as custom by Safi can be commercialized by iBio. We plan to begin offering a new catalog of high-quality research and bioprocess proteins by mid-calendar 2021, initially focused upon growth factors and cytokines. To support iBio's continuing transformation, we recently sought to bring more biopharmaceutical development subject matter expertise to the task while increasing our bench strength and enhancing our leadership team. So now I'm pleased to welcome three new board members: Dr. Linda Armstrong, Dr. Alexandra Kroptova, and Mr. Gary Sender. Linda has more than 20 years of experience in respiratory diseases and therapeutics, she is a board-certified pulmonologist and internist, and she served in a variety of roles at Novartis since 2007 and most recently as its global head of the respiratory development unit. Linda served as medical safety director and subsequently as senior director of medical affairs advisor and head group director of respiratory diseases at the Shire Plough Research Institute. Alexandra is a biopharmaceutical executive with expertise in all phases of global clinical development, translational medicine, and medical affairs. Since 2016, she has served as VP of global specialty R&D in the respiratory and inflammation therapeutic area at Teva Pharmaceuticals. Alexandra previously served in various roles at Sanofi and Pfizer, most recently as Pfizer's director and head of global clinical respiratory and analgesics. Both Linda and Alexandra have been appointed as members of our new Science and Technology Committee. The S&T Committee has already provided valuable insights to us relative to new opportunities we've identified in pulmonology and oncology. Gary has more than 25 years of financial leadership experience in organizations ranging from large multinational pharmaceutical firms to early-stage biotechnology companies. He joins us from Nabriva Therapeutics, where he was the CFO since 2016. He previously served as Synergy Pharmaceuticals executive VP and CFO at a Shire, and senior vice president of finance and administration followed by its senior vice president of finance. Gary is now chair of our audit committee, joined by long-time members Glenn Chang and Seymour Flug, and Gary has also been appointed to the board's compensation committee. We also recently made a key addition to our management team, announcing the appointment of Randy J. Maddux as Chief Operating Officer effective December 1st. Randy joined us from Aptevo Therapeutics, where he was Senior Vice President and Chief Manufacturing Officer. He has more than 20 years of global biologics development and manufacturing, business development, and relationship management experience. Randy was previously VP and site director at GlaxoSmithKline, VP of quality and operations at Human Genome Sciences, and held positions of increasing responsibility within Biogen's quality organization. During his career, he served in key roles supporting the licensure and launch of several products including Avonex®, Tysabri®, Benlysta, and Abthrax. On behalf of everyone at iBio, I'd like to extend our warmest welcome to the new members of our leadership team. Their combined experience and expertise should be invaluable as iBio executes the next phase of our growth strategy. We're also, sadly, sorry to say goodbye to our esteemed Dr. Phil Russell, who recently had to step down from our board due to health reasons. We'll be posting to our website a short tribute to our own Dr. Phil later this week, and I'd invite you to read a little bit about this true giant in the world of vaccinology. In summary, the past four quarters have been a pivotal period for iBio, during which we transitioned from a business model focused on CDMO services to one that also includes the development of our own proprietary products. I'm proud that iBio's existing capabilities, expertise, and experience enabled us to quickly respond to the growing global needs for COVID-19 vaccines and therapeutics. This is precisely what our state-of-the-art facility was designed for, and while the company was selected for participation in Operation Warp Speed, we had been involved in clinical vaccine development for many years, while iBio had only begun to focus on proprietary product development just a few short weeks before the pandemic hit. I'm nevertheless pleased that iBio is in a position to potentially still play an important role in the pandemic response. Beyond COVID-19, we are also targeting large market opportunities in other infectious and fibrotic disease categories and potentially cancer. Additionally, the 3D bioprinting market is growing rapidly, and iBio is well-positioned to participate. We continue to expand our portfolio with new products and services we can bring to market more quickly than biopharmaceuticals. With a new and expanded leadership team deploying our technologies and capabilities into exciting new markets, we are looking forward to continually executing aggressively on our new strategy and helping meet critical unmet medical needs while returning value to our shareholders. Thank you, and with that concluding our introductory remarks, we're happy to take any questions you might have.

Our first question or comment comes from Ben Haynor from Alliance Global. Your line is open.

Good afternoon, gentlemen. Thanks for taking the questions. Can you hear me all right?

Yes, sir. Hey, Ben.

Excellent. So congrats on all the progress. Clearly, you've moved quickly into a lot of new areas here this year, and if I'm interpreting you correctly, it sounds like some of the new recent developments on the COVID-19 front have maybe reorganized some of your priorities at least somewhat. Can you maybe share a little bit more about how you'd rank the opportunities you have in front of you at present?

Well, that's a great question. I think we have to put what we see with iBio-100 for fibrotic disorders pretty high on the list, and for what we're doing with iBio-201, for all the reasons that we mentioned, there's still a lot to happen here in the COVID-19 space. The world needs more vaccines coming to market, not fewer, and we still don't know how the course of the disease and the pandemic is really going to unfold over the course of the next couple of years. So we see that as important. We also see a lot of opportunity with what we described as our research and bioprocess proteins. Those are significant as well because we can supply them as part of a services package to clients like Safi, as well as offer them as part of our own product portfolio. You heard me mention a couple of times oncology, and what I’ll say there is that our glycan engineering technologies and the FastPharming platform itself allows us certain advantages in terms of speed to clinic. In cancer, glycosylation can be really important towards Antibody-Dependent Cell Cytotoxicity. So more to follow there, but I think we see significant opportunities with the platforms and being able to turn them into products, as well as what we’re seeing in infectious diseases and fibrotic disorders for sure. That said, I just finished commenting too on animal health. I don't want to necessarily put that third or fourth on the list because of some of the data that we've seen and really how we’re putting a lot of energy into the development there, and we think that with the right combination of adjuvants and with the candidate as we have it right now, we are very much looking forward to both those efficacy and safety studies.

Okay. That's very helpful. Thanks for that. Can you talk a little more about the Safi Biosolutions agreement and also your investment there? It seems like that's a new page that you're putting into the playbook, and if I'm not mistaken, it's a strategy that was employed at one of your former firms that is similar?

Well, good read, sir. Yes, I think there are really three factors that come in as a result. First, Safi is a fairly young company. Noteworthy is that they are linked to one of the Department of Defense's key programs, more to follow on that later. At the moment, they are looking for ways to accelerate their path forward with some of their red blood cell and neutrophil development programs. So by virtue of the investment that iBio made into Safi, we’re helping them accelerate their development pipelines and their progress as a company. Indeed, I did this with an earlier employer where we had manufacturing capacity, and we looked for certain entities that had good management teams and good technologies and were looking for a little additional support with their process development. This is where iBio can step in because we can help manufacture a diverse number of proteins for their bioprocess. This is the other advantage to this approach: iBio is the provider of the proteins because of the speed of our platform, where we've produced already 50 different constructs just over the course of the past six weeks to express more than 10 proteins already for Safi's bioprocess. So you give them the speed with which they can evaluate those proteins, optimize their bioprocess, and if Safi continues to be successful and receives its various support dollars as it goes forward, then we establish ourselves as the contract manufacturer of any of the custom products for their process. At the same time, for iBio, we also get the advantage that for anything that Safi doesn't designate as a custom for us to create, we can begin to create a portfolio of our own cytokines and growth factors and other products for many entities just like Safi, who are doing bioprocessing and need high-quality either research or CGMP materials for their own cell bioprocessing projects. That's where our plant-based system has certain advantages. In the industry, there are concerns by biopharmaceutical developers about animal origin raw materials because often they can carry viruses, mammalian viruses or prions; folks may remember mad cow disease. Prions, of course, cause mad cow disease, and you don't get the replication of either prions or mammalian viruses in plant systems. So we'll be able to designate our finished goods as animal-free, as well as some other features that should make them competitive.

Okay, great. And then one point of clarification there. On the compounds that Safi designates as custom, presumably there's something that protects you guys from them designating everything as custom.

Indeed, yes. I think there's usually the customs are maybe a small tweak to any given protein, and there might be certain documentation and/or quality control or performance criteria that'll be unique to Safi's process, and everything that falls outside of that, which there's going to be a substantial amount of room in the intellectual property portfolio space, will allow us to be able to market standard versions of any one of those molecules for sure.

Okay, great. And then one last one for me: can you share any updates on the Fraunhofer litigation?

Yes. So there was a hearing in June. It went as expected, and we are proceeding to trial, which was postponed due to COVID from May to now the first week of March 2021. We are now in the damages phase. Earlier, it was determined in a summary judgment that Fraunhofer did indeed utilize iBio's intellectual property without permission, and so we expect to aggressively defend our intellectual property portfolio in this case and all others.

Okay, thank you very much, guys. Congrats on the progress.

Thanks, Ben.

Thank you. Our next question or comment comes from the line of Chapman. Your line is open.

Yes. I was actually calling to see if you have any updates you want to provide on iBio-400, specifically just a little bit deeper for what you shared earlier?

Yes. I mean, I think there's only so much detail we can go into with the clinical trial planning, but I can say this: when I referenced that we were doing the efficacy study by June, that is still in the planning stages. The safety study later in ‘21 would follow. To give a sense of the size of that kind of study, we are presently, this may change, looking at something that would involve a thousand head of swine here as we go. So we are looking at a number of factors around that particular trial design right now, but as you can get a sense, we're obviously investing quite a bit from both clinical trial design, project management, and regulatory, to help give that candidate a great shot at coming to market.

Thank you. And the last question just is in regards to the relationship with IBM and the Watson team. Is there anything you can share and update investors with on that?

Well, the key to that one, of course, is us getting into the clinic next. We need to complete regulatory reviews as well as any IND enabling studies, but as soon as we have that, IBM Watson stands ready to help support us with their clinical trial management data solutions. So we're excited by that and the future relationship there.

Thank you.

Thank you. Our next question or comment comes from the line of Karim Amlani. Your line is open.

Thank you very much. Congratulations on the progress so far. It’s been quite a year. I wanted to circle back to 201. I think a lot of the share price appreciation, market cap increase this year has been dependent on that, and I recognize from your update today that a contract research organization does support toxicology studies has been selected. Can you tell me, do you have firm timelines? Back in July 30, the anticipation was to see the end of pre-clinical studies in a few weeks and the end of pre-clinical studies then by the end of Q3, but we’re here in November now. Essentially, when would the end of toxicology studies be? The filing of the IND as the next catalyst, please?

Right. So good question. A lot of this depends upon the FDA response to our pre-pre-IND submission as to the extent of toxicology and other studies that are required. Nevertheless, as you can tell from our remarks here today, we are proceeding with that work as if we are not going to get an allowance to go forward. It depends on that particular regulatory review. We don't expect, well, I shouldn't comment as to what we do or don't expect the FDA to rule on that, but clearly, we need to move as quickly as possible, and we're certainly going to do that with iBio-201. The LicKM booster portion of that molecule we think is important, and so even if we are required to go ahead and complete those toxicology studies, which would take us into early next year, we would see certain leverage for further use with other vaccines, and while we have to go through this process at this point, it does give us some opportunities for some other pre-clinical work that won't be time-to-clinic dependent, but other pre-clinical work that we want to do really on that molecule as well as our VLP platform. So we have other background R&D and platform development activities ongoing at the same time. Does that make sense? Okay. Thanks for your question.

Thank you. Our next question or comment comes from the line of Chris. Your line is open.

Hey, thanks for taking me today. I just wanted to ask a question on behalf of most retail investors like myself, a large contingency of people on places like StockTwits and Yahoo, who basically have been put through a roller coaster here with the delay in toxicology on 201 and other things. I was just wondering if there was any sort of push to work on the branding side of iBio. There was a lot of fake information, a lot of false information flowing around, fake Instagram accounts, fake Twitter accounts, and I just want to know what your plan was to sort of ease the retail investor as we ride this roller coaster and support you guys moving forward.

I understand your disappointment regarding the recent activity. We are committed to increasing transparency and providing frequent updates on our programs. This is why we are holding our first conference call. We want to be available to address your questions. We are releasing regular earnings updates with more details, and there have been many new initiatives and activities alongside our efforts to combat the COVID-19 pandemic. The positive aspect is that there is a lot happening, and we hope to deliver credible updates. We aim to avoid overwhelming your inbox with irrelevant information, but we will ensure that any significant developments are communicated in a timely manner.

Thanks, Tom. I appreciate that. And I know speaking on behalf of all retail, we appreciate that too; the transparency is key here.

Thank you all for your support. There has been a lot of speculation, and while we can't control that, I hope you can see from this call that we are leveraging our technological capabilities and our teams are doing remarkable work, which is starting to be evident. It's important to remember that biopharmaceutical development often takes years or even decades. Many players in this field, like Moderna and Novavax, have been in it for over ten years, and we are rapidly utilizing our abilities to enhance shareholder value. We aim to achieve this through various means, not just through our biopharmaceutical pipeline, which has significant opportunities. For instance, the fibrosis markets are large and have vast unmet medical needs. While there are a few commercially available products, many patients avoid them due to poor tolerance and limited effectiveness. If we can address such challenges and assist innovative companies, whether they're small like Safi or large like United Therapeutics, we have the capability to make improvements. Our platform enables us to take more chances as we move forward. I may have taken too long, but thank you for your question and your support.

I appreciate it. Thank you.

Thank you. Our next question or comment comes from the line of Patrick Wolf. Your line is open.

Hi, everyone. Thank you for taking my call; it's been a pleasure to listen to this conference call. I just got a quick question again on the retail side. I know you guys are going to ask soon for us to vote in your favor of increasing your share count as well as these new board directors. My main question is: Why should we vote yes? I can understand if you had the toxicologies you were in phase two or three, asking for this increased share count, but I can't really see a justifiable reason at this point to give you guys that go-ahead with the share count, and I just want to get some further and more detailed justifications and possibly maybe a better timeline on when you expect these toxicology results and other reports to be actually in. Thank you.

Sure. Addressing your second question first: we are indeed moving forward as previously stated, and we anticipate this to occur in early 2021 unless we receive any relief from requirements set by the agency. Recently, the company established a shelf registration as part of good management practices to better position ourselves for the turnaround effort we are pursuing. Reflecting on the situation a year ago, it’s somewhat difficult to recall, as we had just $2 million in cash and the company’s viability was uncertain. We are committed to ensuring the stability of the firm, as it is essential for our current customers to rely on our supply of raw materials and services to support their multi-year product development efforts. Regarding our biopharmaceutical development, advancing unique novel molecules like iBio-100 and iBio-201 through clinical development is both time-consuming and costly. It is crucial that we are well-funded to pursue our clinical trial goals. Additionally, our position as a manufacturer with an innovative platform offers unique opportunities, such as our recent collaboration with Safi. In response to Ben's earlier question, there are several facets to this engagement, and while I didn't elaborate much, we did make an investment—this gives us equity in Safi and potentially more opportunities like this in the future. We believe the best approach for our shareholders is to continue investing in the company, leveraging the advantages of both our FastPharming platform and Glycaneering capabilities to produce high-quality glycoproteins that address significant challenges. We are confident that we can achieve substantial growth and deliver considerable returns for our shareholders. For these fundamental reasons and our growth ambitions, I urge you and others to vote in support of iBio as we work to establish a robust foundation for the future of the company.

Thank you. Our next question or comment comes from the line of Matthew Hern. Your line is open.

Hello, gentlemen. I appreciate you taking the question, and I also appreciate your commitment to ongoing transparency. I had sort of two potentially unrelated questions, maybe I can ask both of them, and you can choose which to address possible. I noted just the prospective public records being available that the company has made some expenditures in the lobbying space, specifically around an $80,000 investment with a firm, Steptoe and Johnson. I was just curious if you're able to offer any more detail regarding the current strategy, but more importantly, if you have anything to offer by way of anticipating any changes in the strategy or board oversight of that lobbying activity, given the likely change in administration or just given the change in political landscape. And then potentially unrelated to that but just as important, be curious to know again, I noted earlier that you’ve mentioned Moderna and Pfizer and we're anticipating you're participating in an upcoming event hosted by AGP. I think that that subject was about emerging wave two vaccines, which I suppose we’d have to consider ourselves in that bucket now, and I wonder if you might be able to address the progress that’s being made by Medicago specifically.

Sure, thank you for the question. Regarding our lobbying efforts, we began this process back in January and February to positively influence the situation as the global pandemic unfolded. Keep in mind that iBio had only recently transitioned to serious biopharmaceutical development, and we had minimal previous interaction with the government from our facility. This was entirely new territory for us, and we lacked the experience for direct government contracting. Fortunately, we were able to make early connections with the government independently and quickly. If it hadn't been for a meeting with someone at BARDA, we wouldn't have connected with specific groups at Texas A&M, who were instrumental in helping us compile our submission in what we believe was record time. Moving forward, despite political changes in November, we do not anticipate changes in our strategy, though we may see additional investments. Regarding Moderna and Pfizer and the second wave of developments, I want to emphasize that we are uncertain about how things will unfold, but we believe we can still make significant contributions to COVID-19 and other emerging viruses. Our platform is proving to be fast, and while mRNA platforms have shown promise, much remains to be determined. The progress of Medicago is encouraging, especially as those of us in plant-based manufacturing have faced skepticism due to the lack of standardization and prior commercialization. I admit to having been a skeptic about the plant-based system until I began working with iBio. It's promising that Medicago, along with GSK, is making strides, and they even have a plant-based influenza vaccine in development. This helps to standardize and enhance the visibility of our industry. We believe that having more vaccines will lead to more solutions for this pandemic, and we will need various approaches as we see early successes, so we are generally optimistic about this situation.

Thank you. Our next question or comment comes from the line of David. Your line is open. Mr. David, you may need to unmute your phone.

Yes, thank you very much. I appreciate all the work you guys are doing. I think this goes back to the, I forgot the gentleman's name that asked the question from an investor perspective; we're seeing the stock prices fluctuate at times that have no reason at all. It goes up and at times it goes down, and I think that goes back to the question of what are you guys doing to help the investors who are seeing this and want to continue investing, but there’s just uncertainties of where we're headed and what you guys are doing. Are you guys looking at these prices and fluctuating? From a PR perspective, I’m looking at other biotech companies, and they seem to be consistently assuring investors and coming out with news, and I think that’s the same question with the transparency; maybe if you can speak to that a little again please?

David, well, all I can say to that is that we're seeking to build a fundamentally strong biotech and CDMO services organization, and given where we came from, $0.13 this time last year to where we are today, which is above $0.13, we’re happy that we’re able to be here today and talk about it, and all the things that we're doing to build this strong foundation will of course just like investing in any company, all of those fluctuations that we can't control, any speculation that may go on there. But once again, we’ll commit to timely material information. You have our commitment as a company, every member of this team and all the folks that are joining and have joined, we want to make something special happen. Sure, there will be great days where we have wonderful successes. There will be down days when we have failures here over the coming years, but given what we're doing to diversify the business and given the fundamental advantages that we have, we have confidence over the very long term. I certainly do that we're going to be successful and build a great company that ultimately helps patients and our clients, both on the services and research and bioprocess products side. And thanks for your question.

Thank you, our next question or comment comes from the line of Demetrics. Your line is open.

Good afternoon to the whole team. Thank you for taking the time to answer questions today, and congratulations on the progress that you folks have made. Over the course of the past summer, we had an event that occurred regarding a sale of ownership of the majority shareholder that hasn't been touched upon from the company, and I would like some clarity on that if you can divulge that please, and I'm alluding to Eastern Capital and Kenneth Dart. Secondly, my second question, which ties into that, is can you shed some light on clarifying the ownership of the facility in Bryan, Texas? Because under my understanding, that facility is currently owned by Eastern Capital, which is the subsidiary of Kenneth Dart. Thank you very much.

Thank you, Demetrics, for your question and for the recognition. Yes, we've been working hard to make some special things happen. With regards to Dart and Eastern, obviously, we don't have deep insight into their investment decision-making processes. I've got opinions, but they're just that. As for the ownership of the CDMO subsidiary by iBio CDMO LLC, yes, that one does need some clarification, because there’s certainly a wrinkle to it. If I lose anybody in the jargon, we can certainly follow up and all this information is public. But the ownership split is roughly a 70/30 split between iBio and Eastern Capital, or actually a different subsidiary too that’s involved in the ownership of the sub. There was the conversion to a tracking stock a couple of years ago, but that is sort of a temporary mechanism. De facto, Eastern still owns some share of their position, which is a little south of 30%, but once the, and if the tracking stock gets converted back, they will resume their other position. Right now, it'll show up in the documentation as something like 99.9 some odd percent ownership by iBio, but I hope that clarifies at a top level enough it’s roughly 70/30, 80/20 kind of split.

Thank you very much.

Thank you. I'm afraid that that's all the time we have for Q&A at this time. I'd like to turn the conference back over to management for any closing remarks.

I just want to thank everybody's participation here today and for your excellent questions. As we shared before, we're looking to build a strong growth-oriented company that operates in the therapeutic areas of pulmonology, fibrotic diseases, infectious diseases, and meanwhile, of course, continue with our CDMO services. We're looking forward to what we can do with our new line of research and bioprocess products that we hope to introduce later in the year, and not to leave out animal health and the rest. Again, thanks everyone for your attention and participation this evening.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone have a wonderful day.