iBio, Inc. (IBIO) Q1 2021 Earnings Report, Transcript and Summary

Good day ladies and gentlemen and thank you for standing by. Welcome to the iBio Fiscal 2021 First Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question-and-answer session. [Operator Instructions]. At this time I would like to turn the conference over to Mr. Stephen Kilmer of Investor Relations. Thank you. Sir please begin.

Thank you [Andrew]. Good afternoon everyone. Let me start by pointing out that this conference call will include forward-looking statements regarding our [biolimits 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 the current expectations for management. The forward-looking events and circumstances discussed in this conference call may not incur by certain specified dates or at all and could differ materially as a result of known and unknown factors of uncertainties affecting the company. Including this regarding 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 [indiscernible] 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 of uncertain results to differ materially from those described in forward-looking statements, there may be other factors that can cause actionable results differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed except if required by applicable securities laws forward-looking statements the only 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 Thomas Isett Chairman and Chief Executive Officer and John Delta iBio’s Principal Accounting Officer. With that said I will not turn the call over to John.

Thank you, Steve. Good afternoon everyone and welcome to our inaugural conference call. On behalf 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-months 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 or R&D and general and administrative or 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 life cycle. We believe that creating the solid foundation provides the expertise and compliance needed for a high quality biotech company and will survive bio-well as it moves forward with its value creating objectives. That said 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 expense of the quarter ended September 30, 2020 was $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 investment in securities of $83.5 million. With that I'll 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. The 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. So 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've begun development of our Glycaneering technology. This tech 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. So 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. So 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 services clients and began to see more awareness of an interest in our FastPharming and Glycaneering development services. That was a result 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 cache position somewhat and began to think about other new products and service opportunities using our proprietary technology platforms including virus-like particles or VLP based vaccines as well as cancer therapeutics that could be enabled with Glycaneering. So 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. So by 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 shading months off with traditional mammalian cell development types. Second FastPharming is easily scalable because each little plant has its own bioreactor. So unlike competing systems which face production challenges moving from a few milliliters to 2000 liter bioreactors in mammalian-cell culture our scallop 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 and finally amongst 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 on the 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 or DARPA is 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. So 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 then 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 viruses 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 systems or TAMUS, laboratory shortly after announcing the program. We also expanded our iBio-200 vaccine collaboration to include the Infectious Disease Research Institute or 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 by 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 [indiscernible] with a range of injuries 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 or 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 despite protein and block infection of healthy cells while the fused Fc domain prolongs the life of the protein and 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. ACE2-Fc has demonstrated the ability to block the SARS-CoV-2 virus from infecting Vero E6 cells in an 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. Also 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. So 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 in COVID-19 therapeutic candidate to our pipeline in 2020 as I mentioned earlier we resumed development of two legacy biopharmaceutical programs. iBio-100 and 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 [indiscernible] 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 and challenged pigs after a single dose vaccination and is accompanied by strong virus neutralization antibody responses. We're 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 Tamu where she served as director 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-diluted 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 bio better for China as well as other new customers. Additionally Safi Biosolutions have 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 customs 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 a board-certified pulmonologist and internist she served in a variety of roles at Novartis since 2007 and most recently is its global head of the respiratory development unit. Linda served as medical safety director and subsequently as senior director of medical affairs advisor and his group director respiratory diseases at the sharing plow research institute. Alexandra is a biopharmaceutical executive with expertise in all phases of global clinical development, translational medicine and medical affairs All right. Well, the joys of a live conference apologies everybody but as I was saying Alexandra is a biopharmaceutical executive with expertise in all phases of global clinical development, translational medicine and med affairs and since 2016 she served as VP global specialty R&D respiratory and inflammation therapeutic area at Teva pharmaceuticals. Alexandra previously served in various roles at Sanofi and Pfizer most recently is 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 senior vice president of finance and administration followed by its senior vice president of finance. Gary is now chair of our audit committee and joined by long-time members Glenn Chang and Seymour Flug. 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's got 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 of Human Genome Sciences and helped 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 in the next phase of our growth strategy. Also sadly we're 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 transition 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 selected for participation and operation warp speed 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 position to potentially still play an important role in the pandemic response. Of course beyond COVID-19 we are also targeting large market opportunities in other infectious and fibrotic disease categories and potentially cancer. In addition 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 aggressively executing on our new strategy and help 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. Operator?

[Operator Instructions] Our first question or comment comes from the line of 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 reading you correctly it sounds like some of the new recent developments news on the COVID-19 front have maybe resorted some of your priorities at least somewhat. Can you maybe share a little bit more on how you'd maybe rank the opportunities you have in front of you at present?

Well, that's a great question I think here there is, 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 a lot to happen still 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 is important. We also see a lot of opportunity with what we described as our research and bioprocess proteins. So 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 and Ben you heard me into a couple of times at 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. And in cancer glycosylation can be really important towards ADCC or 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 and then what we're seeing in infectious diseases and fibrotic disorders for sure. Now 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 really 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 and then can you talk a little bit maybe more maybe about the Safi Biosolutions agreement and also your investment there? It seems like that's maybe a new page that you're putting into the playbook and if I'm not mistaken there's a strategy that was employed at one of your former firms that in Atlanta that was similar?

Well, good read sir. Yes, I think there are really three factors that come in as a result. So first if one takes a look at Safi, they're a fairly young company. Noteworthy because they're linked to the department of defense's, well one of their key programs more to follow on that later but 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 and indeed I did do 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 we're looking for a little additional support with their process development. So this is where iBio can step in because we can help manufacture a diverse number of proteins for their bioprocess. So now you take the, this is the other advantage to this approach is that iBio is the provider of the proteins because of the speed of our platform where we've produced already we did 50 different constructs just over the course of the past six weeks to ultimately 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 iBio ultimately 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. Meanwhile, finally, for iBio we also get the advantage for anything that Safi doesn't designate as a custom for us to create, 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 and 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 have viruses, mammalian viruses or prions, folks may remember mad cow disease. So 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 certain other features that they'll have 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 for 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 of, the first week of May, 2020 now to the first week of March by in 2021 of note. 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 in this case and all others aggressively defend our intellectual property portfolio.

Okay. Thank you very much guys. Congrats on the progress.

Thanks Ben.

Thank you. Our next question or comment comes from the line of [indiscernible] Chapman. Your line is open. Mr. Chapman you may need to unmute your phone.

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

Yes. I mean I think it's 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 but 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 anything you kind of share and update investors with on that?

Well, the key to that one of course is us getting into the clinic next. So 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 contract research organization does support talk studies has been selected. Can you tell me do you have any 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. So essentially when would the end of talk 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. So it very much 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 talk studies which would take us into -- well into the beginning of next year. We would see certain leverage on that for its further use with other vaccines and in a way even though 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 [indiscernible]. Your line is open.

Hey, thanks for taking me today. Excuse me. I just wanted to ask a question on behalf of most retail investors like myself large contingency of people on places like stock twits and Yahoo who basically have kind of been put through a roller coaster here with the delay in toxicology on 201 and other things and 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?

Well, Chris I think it was, I would say look I'm disappointed of course by all that activity. The only thing I can -- we will commit to of course is more and more transparency and frequent updates on our programs. This is why the company now here we have our first inaugural conference call. We need to be here to answer your questions. We're putting out regular earnings releases with more and more detail and a lot's been happening for the company here. There has been a tremendous number of new initiatives and new activity in addition to everything that we're doing to help fight this awful COVID-19 pandemic and so there is, the good news is that there's a lot going on and we certainly hope to have more and more updates, credible updates right we don't want to spread your inbox with stuff that's not meaningful but as we make significant material developments, we'll commit to making that information available in a timely fashion.

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

Well, and thank you and everyone else for all the support there's there was all sorts of speculative stuff that was going on and obviously there's not a whole lot we can do to control that but here what I hope you can see from this call is that we are taking a lot of this marvelous technology capability and capacity and our teams are really doing some imaginative and ingenious work and it's starting to show up here and keeping in mind that biopharmaceutical development is measured in years and decades often. A lot of the players that are in this space right now Moderna, Novovax, Moore have been doing this for over a decade and we're very quickly deploying our capabilities here as I hope you can see to return shareholder value and we're looking to do it in a couple of different ways and that's not only the biopharmaceutical pipeline which has significant opportunities in some of the fields that we're discussing; the fibrosis markets alone are quite sizable with tremendous on that medical needs as I mentioned. I mean there's a couple of molecules are commercially available products but most patients don't even take them because they're so poorly tolerated and not that effective. So if we can do some things to solve problems like that and at the same time help innovative companies, small companies like Safi or large ones like United Therapeutics to make their products better well we have the capability to do that and certainly with the speed of our platform we get the chance to take more shots on goal here as we go. So I go out a bit too long but thanks for your question and your support.

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 what 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 and my main question is why should we vote yes? I can understand if you had the toxicologies you were in phase two or three we're asking for this increased share count but I can't really see a justifiable reason at this point to really 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 tox results and other reports to be actually in. Thank you.

Sure. Second question first, tox it's actually I mean we're proceeding as mentioned it should be in early 2021 unless we get relief from needing to do that by the agency. Question number two, it's here one thing that the company did only recently is establish a shelf here this year as part of really good housekeeping in order to capitalize the company for the turnaround effort that we were seeking to do and of course as mentioned earlier in January and February, well probably this time last year it's sort of painful to remember in some ways but with only 2$ million in cash and the company is a growing concern being very much in question. We are keen to assure the stability of this firm and make sure that for our current customers that they know that they can count on our supply of these raw materials and of our services so that they can continue down the path of their multi-year product development. So that's point number one. Point number two is for our own biopharmaceutical development when we have novel molecules with unique properties and promise such as iBio-100 clinical development of those as well as iBio-201 are lengthy and costly processes. So it's important that we're well capitalized to move forward in the clinic with our clinical trials aspirations and expectations. Point number three, well there's unique opportunities given our position as a manufacturer with our novel platform to do things like we just did with Safi. So to Ben's question earlier there were a few aspects to that and yes we did wind up making an investment and that's the part that I didn't elaborate on too much but if Safi winds up being successful with the nature of our investment obviously we have equity in the company, well there are other opportunities like that down the road. So we think for our shareholders the best thing to do is to continue to invest in the company, take advantage of these multiple shots on goal, continue to utilize the benefits of both the FastPharming platform as well as our Glycogeneering capabilities to make uniquely qualified and high quality glycoproteins to solve some of these big problems and we think we can grow the company significantly and create a tremendous return for our shareholders. So for those fundamental reasons and growth aspirations that's the reason for the ask for you and everyone else to vote and help iBio support itself by building a very strong foundation as we take the company forward over the coming years.

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. So I noted just the prospective public records being available that the company has made some expenditures in the lobbying space so 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 strategy or board oversight of that lobbying activity, given 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 upcoming event, I think later this week 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 so either of those if you're able to elaborate I very much appreciate it.

Sure. And thanks for the question. With regards to the lobbying effort indeed I mean, we started on this journey here to try and favorably impact what was emerging back in January and February s this ultimately this global pandemic. And keeping in mind that iBio literally just weeks prior turned the corner to serious biopharmaceutical development activities, we had also not really ever very much interacted with the government as iBio operating out of that particular facility. So for us this was all a brand new world. We didn't have any of the mechanisms for doing direct government contracting. We had to make and we were fortunate enough to have done so a lot of these early connections into the government very much on our own and on the fly and was it not thankfully for a meeting with a certain someone at BARDA, I don't think we would have ever been introduced to [indiscernible] and some other group at a particular subset of [Tamu] all of whom very much helped us to create our submission and put that together in really some could argue record high. So for us to advance the company and this is without respect to all the lovely politics in the month of November. So specifically irrespective to a change of administration or not just fundamentally we have to, iBio has to do a better job with interacting with the government, being able to tell its story and that was the reason for engaging with Steptoe. Some of our competitors in this space, we know have multiple-multiple groups working for them. So it's important for us to assure that we're doing the best that we can for our government relations because we firmly believe that this story of manufacturing USA and on-shoring the nation's supply chain for biopharmaceuticals is important period, full stop and then certainly for iBio where we maintain a U.S. presence for all of our manufacturing we think we have something to contribute in that regard and we think it's just good period. So with that said, we don't see any changes in strategy there but probably some more investments. With regards to Moderna and Pfizer and some of the wave 2, I'll just reiterate quickly what I said before which is that we don't really know how this is all going to play out and it's possible certainly that we can still make an important contribution here for COVID-19 or other coronavir day diseases or viruses that may emerge here over time and with the speed of our platform certainly the mRNA platforms are proving out thus far but again there's still a lot to be determined down the road. So we want to be very well positioned for that going forward and I think and it's actually encouraging the Medicago developments. One of the things that those of us in the plant based manufacturing world have been up against is, well they're different it's not standard does it really work nothing else nothing's really been commercialized off of it in the past and by the way as I gave you that litany of things I'll throw in well they don't glycosylate the way the mammalian cells do. Well, I can say all that because I was the guy saying that just a few years before I ever met iBio. So I was a complete skeptic as well of the plant-based system and so I think it's actually quite positive that Medicago along with GSK providing the adjuvants is making progress there. They also had a plant-based system in an influenza vaccine in development. So it helps make the platform in this portion of the industry more standard, more acceptable, more visible of course we have certain advantages ourselves. So I think plus of course we believe more vaccines more solutions for this dreaded pandemic the better because we are going to need multiple shots on goal it's looking like maybe not as many if we keep seeing these early successes but we're encouraged by that in general.

Thank you. Our next question or comment comes from the line of David [indiscernible]. Your line is open. Mr. [indiscernible] you may need to un-mute your phone.

Yes, thank you very much. I appreciate it 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, I mean we're seeing the stock prices fluctuate at times that no reasons 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 and 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 kind of 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 and 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, there will be 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 and also 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. So 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 too 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 [indiscernible]. 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 over the 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. And secondly, my second question which ties into that is can you shed some light on clarify 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 thanks 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 and in any case the. So they did move their position in the iBio Inc. stock. To your good question on this ownership of the CDMO subsidiary by iBio CDMO LLC yes that one does need some clarification there's because there's certainly a wrinkle to it and if I lose anybody in the jargon I'll just we can certainly follow up and all this information is public but it was a 70/30 split iBio and Eastern Capital or actually a different subsidiary too is 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, that's 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 is 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 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's operating in the therapeutic areas of pulmonology fibrotic diseases, infectious diseases and meanwhile of course continue with our CDMO services and 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.