Q3 2022 Ibio Inc Earnings Call

May 12, 2022

Ladies and gentlemen, today's conference is scheduled to begin momentarily. Until that time, your lands will again be placed on hold. Thank you for your patience.

Ladies and gentlemen, todays conference scheduled to begin momentarily until that time unless again be please thank.

Thank you for your patience.

Again, ladies and gentlemen, today's conference scheduled to begin shortly. Until that time, let's again be placed on hold. Thank you for your patience.

Again, ladies and gentlemen, todays conference scheduled to begin shortly until that time again be placed on hold thank you for your patience.

And.

[music].

Good day and thank you for standing by welcome to the <unk> fiscal 2022 third 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 to ask a question. During the session you will need to press.

Good day and thank you for standing by. Welcome to the iBioFiscal 2022 third 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. To ask the question during the session, you will need to press star one on your telephone.

Star one on your telephone.

If you require any further assistance, please press star zero. I would now like to hand the conference over to Stephen Kilmer. Investor Relations, please go ahead, sir.

If you require any further assistance. Please press star Zero I would now like you had the conference over to Stephen Kilmer Investor Relations. Please go ahead Sir.

Thank you good afternoon, everyone before we begin I would like to remind you that during this call. The company will be making forward looking statements regarding our current expectations and projections about future events that are subject to risks and uncertainties.

Thank you. Good afternoon, everyone. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements regarding our current expectations and projections about future events that are subject to risk and uncertainty.

References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current filings with the U.S. Securities and Exchange Commission.

References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current filings with the U S Securities and Exchange Commission.

No port leakage statement can be guaranteed and actual results may differ from the results discussed in the port leakage

No forward looking statement can be guaranteed and actual results may differ from the results discussed in the forward looking statements.

The information on this conference call is provided only as of today, and we undertake no obligation to update any forward-looking statements made on this call on account of new information, future events, or otherwise, except this required by law.

The information on this conference call is provided only as of today and we undertake no obligation to update any forward looking statements made on this call on account of new information future events or otherwise, except as required by law.

On the call today, representing the company are Mr. Tom is that <unk>, Chairman and Chief Executive Officer, and Rob <unk>, the company's chief financial and business Officer.

On the call today represented the company are Mr. Tom Isatt, a Bios, Chairman, and Chief Executive Officer, and Rob Lutz, the company's Chief Financial and Business Officer. With that said, I'll now turn over the call to Tom.

I'll now turn over the call to Paul.

Great. Thank you, Steve and good afternoon, everyone as we reported during the third fiscal quarter. We received the Fda's response to our pre IND package, <unk>, which is our nucleocapsid protein sub unit vaccine candidate against the Sars Cov two virus.

As we reported during the third fiscal quarter, we received the FDA's response to our pre-IND package, FRIBIO-202, which is our nucleic acid protein subunit vaccine candidate against the SARS-CoV-2 virus.

We continue to plan for an IND filing for the intramuscularly delivered version of the candidate by the end of the calendar year.

We continue to plan for an IND filing.

Her muscular Lee delivered version of the candidate by the end of the calendar year <unk>.

Additionally, we have continued to advance our lead immuno-oncology asset, I-Bio 101, towards leeward contracts.

Additionally, we have continued to advance our lead immuno oncology asset <unk> hundred one towards the clinic.

Specifically, at the frontiers in immunotherapy conference earlier this week, we presented favorable preclinical efficacy data on this any CD 25 monoclonal antibody showing that it effectively depletes regulatory T cells as a prospective immunotherapy.

Specifically at the criteria of Immunotherapy conference earlier. This week, we presented favorable preclinical efficacy data on this any CD 25, monoclonal antibody showing did it effectively deplete regulatory T cells as a perspective immunotherapy for solid tumors.

While we've been focused on advancing those to lead biopharmaceutical programs, we've also published important performance data on the fast-farming development and manufacturing

While we've been focused on advancing those two lead biopharmaceutical programs. We've also published important performance data on the past farming development and manufacturing system.

This includes recently presented studies that show plant-made monoclonal antibodies are comparable to molecules produced using traditional mammalian manufacturing.

This includes recently presented studies could show planned made monoclonal antibodies are comparable to molecules produced using traditional mammalian manufacturing methods.

Importantly, in several cases, plant-produced antibodies had significantly greater homogeneity and thus quality when compared with traditional

Fortunately in several cases plant produced antibodies had significantly greater homogeneity, and thus quality when compared with traditional systems.

Additionally, we recently presented data showing that we can produce monoclonal antibodies with increased potency by applying our glycaneering technology.

Additionally, we recently presented data showing that we can produce monoclonal antibodies with increased potency by applying our <unk> technology.

Of note. We also use the <unk> platform as part of the process of moving the one O one molecule onto our past farming system.

Of note, we also use the glyconeering platform as part of the process of moving the I-Bio101 molecule onto our fast-farming platform.

We were thereby able to produce in a few costs related version of this monoclonal antibody, which resulted in the desired increase in cell, killing effects when compared with the few constellation merger.

We were thereby able to produce a few-cosylated version of this monoclonal antibody, which resulted in the desired increase in cell killing effects when compared with the few-cosylated antibody.

With this achievement, we're pleased to report as part of today's update that we have now successfully completed the LEED optimization stage for IBIO 101 and that IND enabling studies are now underway for this promising anti-tumor.

With this achievement, we're pleased to report as part of today's update that we have now successfully completed the lead optimization stage for <unk> hundred one and then IND, enabling studies are now underway for this promising antitumor candidate.

Given the positive developments for our biotech business. So this particular call, we're going to change things up with them.

Given the positive developments for our biotech business, for this particular call, we're going to change things up.

First, I'll turn the call over to Rob to review our financial results from the quarter and discuss the upcoming special meeting of stockholders that we announced.

First I will turn the call over to Rob to review, our financial results for the quarter and discuss the upcoming special meeting of stockholders that we announced today.

Then I would like to take the opportunity to revisit many of the questions about our development programs that our chief scientific officer Martin Brenner and I received from analysts and institutional investors during some recent fireside chats and panel.

Then I would like to take the opportunity to revisit many of the questions about our development programs that our chief Scientific Officer, Martin Brenner and I receive from analysts and institutional investors. During some recent fireside chats and panel discussions.

Normally, of course, I would ask Martin to join me here for this Q&A. Unfortunately, he has come down with COVID disease and isn't able to join our call.

Normally of course, I would ask Martin to join me here for the Q&A.

Unfortunately, he has come down with Covid disease and is unable to join our call today. So we'll do our best without them unless all wish them, a full and speedy recovery.

So we'll do our best without him, and let's all wish him a full and speedy recovery.

With that, let's get started with the review of our financial results for 2022's Third Fiscal Quarter. Rob?

Let's get started with the review of our financial results for 2020, twos third fiscal quarter Rob.

Thanks, Tom.

I will speak to a few of our financial highlights, but please refer to the press release in the 10Q for further details.

I will speak to a few of our financial highlights, but please refer to the press release and the 10-Q for further details.

Revenues for the third fiscal quarter of 2022 and did March 31st were approximately $1.9 million, an increase of 154 percent versus the third quarter of fiscal 2021.

Revenues for the third fiscal quarter of 2022 ended March 31.

We're approximately $1 9 million, an increase of 154% versus the third quarter of fiscal 2021.

In the third quarter of fiscal 2022, we recognized $1.8 million in royalty revenue from the technology license with Fraunhoff.

In the third quarter of fiscal 2022, we recognized $1 $8 million in royalty revenue.

Acknowledged license with Franco.

This license was part of the transaction that resolved our IP dispute with Frontline.

This license was part of the transaction that resolved our IP dispute with Fraunhofer.

On a related note, we received the first of two $5.1 million payments from Fawn Hoffer for the settlement of our IP claims. The second payment is due to $5.1 million from Fawn Hoffer.

On a related note we received the first of $215 $1 million payments from falling Hopper for the settlement of our IP claims.

Payment is due in March 2023.

R&D and G&A expenses for the third quarter of fiscal 2022.

R&D and GNA expenses for the third quarter of fiscal 2022 increased 157% and 60% respectively over the comparable period in fiscal 2021.

The increase to 157% and 60% respectively over the comparable period in fiscal 2021.

This reflects our growing investments in iBIOS Pipeline, platform technologies, employees, and related interests.

This reflects our growing investment pipeline platform technologies employees and related infrastructure.

We anticipate this trend continuing. However, the rate of growth is expected to moderate over

We anticipate this trend continuing however, the rate of growth is expected to moderate over time.

In terms of liquidity at quarter end, <unk> cash and cash equivalents plus debt securities of approximately $48 $6 million.

In terms of liquidity, a quarter-end iBio would cash and cash equivalents plus debt securities of approximately $48.6 million, excluding $5.9 million of restricted cash.

Adding $5 9 million of restricted cash.

We continue to believe based on assumptions related to our business that we have adequate cash to support activities through September 30, 2022.

We continue to believe based on assumptions related to our business. So we have adequate cash to support activities through September 32023.

I'll now turn to our upcoming special meeting of shareholders stockholders that we announced today.

I'll now turn to our upcoming special meeting of shareholders that we announced today.

We are seeking approval from our stockholders to authorize our board to implement a reverse stock split in an associated decrease in our authorized share share.

We are seeking approval from our stockholders to authorize our board to implement a reverse stock split.

And an associated decrease in our authorized share count.

Which together would result in a net increase in authorized shares for the company.

together would result in a net increase in authorized shares for the company.

We are pursuing these proposals for the same reasons as we described previously.

Today, we filed a preliminary proxy with the FCC for these proposals.

Today, we filed a preliminary proxy with the SEC for these proposals.

We are required to refrain from a detailed discussion of the rationale for approving the proposals until the proxy is approved by the SCA.

We are required to refrain from a detailed discussion of the rationale for approving the proposals until the proxy is approved by the SEC.

Once that approval is received, we plan to post answers to the questions we would expect from our shareholders on our website. With that, I will now turn the call to the next speaker.

Once that approval is received we plan to post answers to the questions. We would expect from our shareholders on our website.

With that I will now turn the call back over to Steve Steve.

Thanks, Rob. If I may, I'd like to ask you a question regarding some of the mechanics of this special

Thanks, Rob if I may I'd like to ask you a question regarding some of the mechanics of the special meeting.

In last quarter's earnings release, I bio-stated that it was working on solutions to overcome structural impediments to implement in the will of its shareholders. I bio-shared the solution today, Ms. Presley. Could you walk us through that?

In last quarter's earnings release by by updated that was working on solutions to overcome structural impediments to implemented in the will of the shareholders.

But how should go to the solution today and this press release could you walk us through that.

Certainly.

We believe the increasing prevalence of brokerage firms opting to forego discretionary or proportionate voting of the shares held by them in street name.

opting to forego discretionary or proportioned voting of the shares held by them in treatment.

has made it significantly more difficult for companies with a large retail shareholder base like iBuy.

It has made it significantly more difficult for companies with a large retail shareholder base like <unk>.

to secure affirmative votes from the majority of the outstanding chairs.

To secure affirmative votes from a majority of the outstanding shares.

as is required to pass proposals on a reverse talk split or a change in authorization.

As is required to pass proposals on a reverse stock split or a change in authorized shares.

In order to help overcome this challenge, we recently entered into a stock purchase agreement of Convertible Preferred Stocks.

In order to help overcome this challenge we recently entered into a stock purchase agreement of convertible preferred stock.

Pursuant to the agreement, we issued and sold 1,000 shares of Series 2022 convertible preferred stocks.

Pursuant to the agreement, we issued and sold 1000 shares of series 2022 convertible preferred stock.

to an accredited investor for $0.27 per share.

Two an accredited investor for 27 per share.

which was the closing price of the common stock the day the preferred stock was issued.

Which was the closing price of the common stock the day the preferred stock was issued.

The preferred stock permits the holder to vote at the special meeting of shareholders for the reverse stock split proposal only.

The preferred stock permits the holder to vote at the special meeting of shareholders for the reverse stock split proposal only, with each preferred share and title to

With each preferred share entitled to a 5 million votes.

But any votes cast by such preferred stock with respect to the reverse stock split proposal must be voted in the exact same proportion as the aggregate shares of common stock.

As a result, if a majority of common shareholders who vote are in favor of the reverse stock

As a result.

And majority of common shareholders, who vote in favor of the reverse stock split.

Proposal will likely pass.

And conversely, if the majority of shareholders who vote are against the proposal, it will not pay.

And Conversely, if the majority of shareholders, who vote or against the proposal it will not pass.

The votes of the preferred stock merely reflect the same proportion of the votes of the common

The votes of the preferred stock merely reflect the same proportion of the votes of the common stock.

Thanks, Rob. And finally, before I turn it over to Tom, I'd like to ask a finance-related question regarding IBIOS acquisition of the fast farming facility.

Thanks, Rob and finally before I turn it over to Tom I'd like to ask the finance related questions.

Regarding to the <unk> acquisition, but the past farming facilities, what is the company's strategy there.

As we previously announced.

as the primary part of a larger transaction, we purchased full ownership of our fast farming facility and all the rights to operate and grow the

As the primary part of a larger transaction, we purchased full ownership of our fast farming facility and all the rights to operate and grow the facility.

Now, we're evaluating the sale leaseback of our facility that could free up capital.

Now, we are evaluating a sale leaseback of a facility that could free up capital.

We believe a sale leaseback with the right partner might give us most, if not all, for the benefit of ownership while freeing up capital to invest.

We believe a sale leaseback with the right partner it might give us most if not all the benefits of ownership.

While freeing up capital to invest in our asset pipeline.

Great. Thank you, Rob. I'm now going to post some frequently asked questions to Tom regarding our BIOS development program.

Great. Thank you Rob.

Now going to postpone frequently asked questions that Tom regarding <unk> development programs.

So, Tom, our first question is regarding, I bio is overall COVID vaccine strategy and specifically why you think targeting the end protein will be successful despite the ample supply of competing vaccines already on the.

So part of my first question is regarding <unk> overall, COVID-19 vaccine strategy and specifically why do you think targeted in the end protein will be successful despite the ample supply of competing in vaccines already on the market.

Okay, Steve, you're diving right in with a great question. So all the currently approved vaccines are based on generating immunity to the SARS-CoV-2 virus with technologies that mimic exposure to the viruses.

Okay, Steve your diving right in with a great question. So all of the currently approved vaccines are based on generating immunity to the Sars Covid two virus with technologies that mimic exposure to the virus spike protein.

That initially made sense as part of the industry's swift response to this pathogen, given that's the protein the virus uses to bind to ourselves and infect them. And also, it generates a strong neutralizing antibody response in humans.

That initially made sense as part of the industry Swift response to this pathogen given that's the protein the virus uses to Baidu ourselves and in fact and also it generates a strong neutralizing antibody response in humans.

However, as the virus has evolved, selective pressures favored spike protein mutations that led to the emergence of new variants that were better able to overcome the immunity generated by vaccines and natural.

However, as the virus has evolved selective pressures favored spike protein mutations that lead to the emergence of new variants that we're better able to overcome the immunity generated by vaccines and natural infection.

So, we've already seen the issues that occur by relying on spike based vaccines with the emergence of the highly infectious Omicron variant and it's up.

So we've already seen the issues that occur by relying on spike based vaccines with the emergence of the highly infectious omicron variant and at Sudbury.

These are more than 30 mutations in their spike protein compared with the original strain. So, the more mutations that accumulate, the less effective and durable the spike protein based vaccines may become, and some experts have even been predicting that we'll ultimately see an escape variant that completely eludes spike based vaccine immune.

These are more than 30 mutations in their spike protein compared with the original strength.

So the more mutations that accumulate less effective and durable the spike protein based vaccines may become an.

Experts it has even been predicting that we'll ultimately see an escape area the completely alluded spike based vaccine immunity.

So even if not, we're seeing that overreliance of spike based vaccines is leading to the continuation of the pandemic and perhaps now going forward, COVID becoming an endemic.

So even if not we're seeing that overreliance on spike based vaccines is leading to the continuation of the pandemic and perhaps now going forward COVID-19, becoming an endemic disease.

So, we continue to believe that the nuclear caps it, or I may refer to it as the end protein represents an important target for next generation COVID vaccines for for several reasons.

So we continue to believe that the nucleocapsid or be referred to it and protein represented important target for next generation Covid vaccines for several reasons.

First, the end protein is abundantly expressed during infection and contains multiple immunogenic epitomes, and that translates to multiple opportunities to elicit an immune.

The <unk> protein is abundantly expressed during infection and contains multiple immunogenic epitopes and that translates to multiple opportunities to elicit an immune response.

second, the end protein is more highly conserved, and so therefore it's less likely to mutate than the spike.

Second the M protein is more highly conserved and so therefore, it's less likely to mutate the spike protein.

Thus, new variants should be less likely to escape and protein-based vaccine protein.

Thus, new variance should be less likely to escape and protein based vaccine protection.

And third, research has shown that the nucleic acid protein appears to be more effective than the spike. It's stimulating T cell activation, which is a critical element of the adaptive immune response that SARS-CoV-2 virus attempts to evade. So add that to our novel antigen adjuvant combination that we have built into the design and that may afford greater durability and all that has us believe that we've got a winning.

Add that to our novel antigen adjuvant combination that we had built into the design and that may afford greater durability.

All that has us belief that we've got a winning approach here.

Thanks, Tom. Building on that question, why is it taking so much time to develop Bio202? Considering that Bio seemed to be working on a vaccine soon after the pandemic hit.

Thanks, Tom building on that question why is it taking so much time to develop <unk> hundred two considering that <unk> seem to be working on a vaccine sooner after the pandemic hit.

Yeah, that's fair. Well, first, I'd like to preface my answer by noting that the circumstances of the COVID pandemic have been changing rapidly as we all know.

Yes, that's fair.

First I'd like to preface my answer by noting that the circumstances of the Covid pandemic have been changing rapidly as we all know.

And we certainly hit the ground running with our own spike-based vaccine in the earliest days of the pandemic.

And we certainly hit the ground running with our own Spike based vaccine in the earliest days of the pandemic.

In fact, we went from generating a spike protein sequence in the early days of February 4th, 2020, to our first manufactured material in just five weeks, which rivals the speed of the mRNA vaccine.

We went from generating a spike protein sequence in the.

The early days of February February four 2022, our first manufactured material in just five weeks, which rivals the speed of the mrna vaccine platforms.

But as we were generating our preclinical data to advance what at the time was our IBIO 200 and 201 programs, other spike protein-based vaccines entered late-stage clinical development. Bolstered in part by funding from Operation Warp Speed in a favorable regulatory environment for platforms like the mRNA ones and some of the others that had already been through late-stage clinical trials with other diseases like influenza.

As we were generating our preclinical data to advance what at the time was <unk> 201 programs. Other spike protein based vaccines entered late stage clinical development bolstered in part by funding from operation Warped speed and a favorable regulatory environment for platforms like.

The mrna ones and some of the others that had already been through late stage clinical trials with other diseases like influenza.

Now, while we're all fortunate that our industry and governments were able to achieve what arguably is the most rapid and effective response to a pandemic in our history, it just didn't make sense for iBio to continue to pursue a Me Too spike-based vaccine given there were satisfactory solutions about to gain regulatory clearance with those existing first generation vaccines.

Now, while we're all fortunate that our industry and governments were able to achieve.

Arguably has the most rapid and effective response to a pandemic in our history. It just didn't make sense for <unk> to continue to pursue a me too spike based vaccine given that were satisfactory solutions about to gain regulatory clearance with those existing first generation.

Vaccines.

So, a little more than a year ago, we took a step back and anticipated what could happen, which is that the pandemic would evolve as it has with rapid spike protein mutations resulting in reduced protection from first generation vaccine.

So a little more than a year ago, we took a step back and anticipated what could happen, which is that the pandemic would evolve as it has with rapid spike protein mutations, resulting in reduced protection from first generation vaccines.

So, we looked at the research for previous SARS virus outbreaks like SARS 1 and MERS, for instance, that's Middle East respiratory syndrome and identified the nucleic acid protein is a better choice for creating more durable vaccine.

So we looked at the research from previous Sars virus outbreaks like Sars, one Mers for instance, the middle East respiratory syndrome.

And identified the nucleocapsid protein is a better choice for creating more durable vaccine.

Today, we believe we are therefore now very well positioned to move into the clinic with a second generation vaccine that enables us all to move more so towards our last COVID shot, hopefully not just our next.

Today, we believe we are.

Therefore, now very well positioned to move into the clinic with a second generation vaccine that enables us all to move more so towards our last COVID-19 shot hopefully not just our next shot.

Great, thanks, Tom. Okay, let's move on to iBio 202's development pathway. Were you expecting the FDA to make you do an IMD-enabled child study?

Great. Thanks, Tom Okay, let's move on to our <unk> development pathway are you expecting the FDA to make you do an IND, enabling challenge study.

Well, the short answer is we were hoping to avoid it, but at the same time understood that it was possible if not likely the FDA would ask for it. In fact, it's typical for a novel vaccine to be tested in a pre-clinical challenge model before entering clinical trials. And the unprecedented situation at the height of the COVID pandemic when no vaccines were available allowed drug developers some additional flexibility. But generally these tests,

Well the short answer is we were hoping to avoid it but at the same time understood that it was possible if not likely the FDA would ask for it in fact, its typical for our novel vaccine to be tested in a preclinical challenge model before entering clinical trials.

The unprecedented situation at the height of the Covid pandemic when no vaccines, where available allow drug developers some additional flexibility, but generally these tests are required. So we launched our challenge study and expect to provide outcome.

So we've watched our challenge study and expect to provide outcome in data by July , 2020.

Data by July 2022.

And on that note, what would be the next steps if we mean our Bio 202s INDs?

And on that note what would be the next steps assuming <unk> was RMB is clear.

Well once we have submitted the IND for our <unk>. It will be of course review by the FDA, which will either accept or reject our plans or may ask for changes to the submission just like with any other one but any company might.

Well, once we have submitted the IND for IBIO-202, it'll be, of course, reviewed by the FDA, which will either accept or reject our plans, or may ask for changes to the submission, just like with any other one that any company might submit. Now, once the agency is satisfied with the IND submission, we are allowed to enter clinical phase one clinical trials, but there is a certain time period, usually four to eight weeks of intense preparations before the first subject can be introduced.

Now once the agency is satisfied with the IND submission we are allowed to enter clinical phase one clinical trials.

But there is a certain time period, usually 48 weeks of intense preparations before the first subject can be immunized.

Thanks, Tom. Just moving on to the plant-based manufacturing aspects of I-202. Does FDA have any issues with this?

Thanks, Tom.

Moving onto the plant based manufacturing that Banco <unk>, two does that have any issues with it.

Now, the FDA has not expressed concerns regarding iBio 202 in the manufacturing platform associated with it or any of iBio's therapeutic candidates being manufactured.

No. The FDA has not expressed concerns regarding our <unk> two and the manufacturing plant program associated with it or.

<unk> therapeutic candidates being manufacturing plants. In fact, there are already several plant or plants sell produce biopharmaceutical.

In fact, there are already several plant or plant cell produced biopharmaceuticals that are in various stages of development. Or even FDA-cleared, you know, Portalex's enzyme replacement therapy received FDA clearance in 2012. And that product is manufactured using plant

That are in various stages of development.

Or even FDA cleared <unk>.

<unk> enzyme replacement therapy.

Received.

FDA clearance in 2012.

And that product is manufactured using plant cell culture.

Great. Thanks.

Great, thanks. Now some questions about the other candidates, my BIOS pipeline. The first one is regarding a BIOS endostatin E4 molecule for fibrotic disease.

Now some questions about the other candidates in <unk> pipeline. The first one is regarding our bylaws.

<unk> four molecule for fibrotic diseases.

What makes that bio think that this anti-fibrotic effect, that the anti-fibrotic will be effective for the treatment of solid tumor?

What makes us think that that's adequate product.

The anti fibrotic will be effective for the treatment of solid tumors.

So you cut out a little bit there, Steve, but I think I got the question. So there are a wide variety of cells that are present in the tumor microenvironment, including what's called cancer associated fibroblasts or cash. So caps are one of the most abundant and critical components.

We cut out a little bit there, Steve, but I think I got the question. So there are a wide variety of cells that are present in the tumor microenvironment, including what's called cancer-associated fibroblasts or CAH.

So, CAFs are one of the most abundant and critical components of tumor tissue since they provide this physical support for tumor cells and can promote or slow tumor genesis in a context-dependent manner.

Of tumor tissue since they provide this physical support for tumor cells and can promote or slow tumor agenesis context dependent manner.

So these cells are also involved in the modulation of many components of the immune system.

These sales were also involved in the modulation of many components of the immune system. So recent studies have revealed the role of Cas and immune evasion poor responses to cancer immunotherapy and variable responses to chemotherapy.

Recent studies have revealed the role of CAFs in immune evasion, poor responses to cancer immunotherapy, and variable responses to chemotherapy, which are all serious problems here. So we believe the endostatin E4 molecule has the potential to normalize fibrosis without the detrimental effects of CAF to show.

All serious problems here, so we believe.

The <unk> four molecule has the potential to normalized fibrosis without the detrimental effects of caf destruction, thereby improving responses to current standard of care treatments, such as chemotherapy and immunotherapy.

thereby improving responses to current standard of care treatments such as chemotherapy and

So our partner, University of Texas Southwestern, is performing proof-of-concept studies, which, if successful, would see the molecule advance into the next stages.

So our partner.

University of Texas southwestern is performing proof of concept studies, which if successful would see the molecule advance into the next stage of development.

Thanks, Tom. Let's turn to our partnership with rubric. What have these priorities brought to the table and what is your outlook for the partner?

Thanks, Tom.

Let's turn to our partnership with rubric.

These priority brought to the table and what is your outlook for the partnership.

Yeah, rubric technology enables us to specifically target conformational and subdominant epitopes for which it's hard or even impossible to find antibodies. What does that mean? I'm referring to their discovery engine where they use predictive algorithms to do better targeting and create these binding sites for brands.

Yes, rubrics technology enables us to specifically target conformational and subdominant epitopes for which it is hard or even impossible to find antibodies. So what does that mean I'm, referring to their discovery engine, where they use <unk>.

Addictive algorithms to do better targeting.

And create these binding sites for for antibiotics. So while rubrics expertise lies in the front end of the drug discovery process.

So while Merubricks expertise lies in the front end of the drug discovery process, IBIO provides extensive expertise in building an advancing drug discovery pipeline.

<unk> provides extensive expertise in building and advancing drug discovery pipelines.

So we envision leveraging rubric selection expertise partnering with rubric on the screening and then using the fast farming system to rapidly develop drug candidates while really at the same time using what we're advancing is a way to validate rubric platform and their discovery.

So we envision leveraging rubric selection expertise partnering with rubric on the screening and then using the past farming system to rapidly develop drug candidates.

We're really at the same time, using what we're advancing as a way to validate rubrics platform.

And their discovery engine.

And, you know, kind of by way of example, I guess, so RTX 003, that's the anti CD 25 antibody that we in licensed from rubric, that's a good example of how our fast farming system can outperform traditional medallion system so.

And.

Kind of by way of example, I guess, so Archie <unk> zero three that's the anti CD 20 by the antibody.

That we in licensed from <unk>. That's a good example of how our fast farming system can outperform traditional medallion system. So.

Generating a few-cosylated antibodies, so that's basically a few coasts of the sugar, the traditional mammalian cell manufacturing methods kind of like to put on antibodies.

Generating a few costs related antibody, so basically few coast as a sugar.

The traditional mammalian cell manufacturing methods kind of like to put on antibodies, but that's bad.

But that's bad. And it's bad because if you're looking for tumor cell killing, Fucose on the antibody messes that up.

As bad because if youre looking for tumor cell killing.

<unk> on the antibody message that up so.

So, the, the idea of a few consolating the antibody, making sure that that sugar never gets put on there increases the antibodies, you know, it's antibody dependent cellular cytotoxicity. So, basically, it's self killing capability.

The idea of a few costs related to the antibody being making sure that that sugar never gets put on their increases the antibody.

Antibody dependent cellular cytotoxicity, so basically it's cell killing.

<unk>.

So doing that with mammalian cells can be costly at both the front and the back end of development, oftentimes because for mammalian cells, that technology is owned by others. So there's IP access, intellectual property access, ease, milestones, royalties, et cetera.

So doing that with mammalian cells can be costly at both the front and the back end of development oftentimes because for medallion cells that technology is owned by others. So there is.

IP access intellectual property access fees milestones and royalties et cetera as it can be involved. So we are developing the plan made version of our <unk> 003 is I buy a one on one and we.

So we are developing the plan made version of RTX 003 is iBio 101 and we got freedom to operate for being able to do the APU constellation in our own.

We got freedom to operate for being able to do the Ecu consultation in our own plants.

and thereby avoiding some of those third-party IP actions.

And thereby avoiding some of those third party IP access requirements.

So we've demonstrated that by applying our glyconeering technologies, we talked about a little bit earlier here in the call that the fast farming system can produce a potent, high quality, a few-cost-related molecule that is equivalent to the same version of the antibody produced with traditional mammalian cells.

So.

We've demonstrated that by applying our gleick adhering technologies, we talked about a little bit earlier here in the call that the past farming system can produce a potent high quality HQ costs related molecule that is equivalent.

To the same version of the antibody produced with traditional mammalian cell culture manufacturing methods.

Great, and can you talk a little bit about iBio101 and its potential?

Great and could you talk a little about the boat about I buy a 101 and its potential.

Certainly.

While many immunotherapies have remarkable effects on cancer treatment, certain solid tumors remain true.

While many of these therapies have remarkable effects on cancer treatment certain solid tumors remained challenging.

even in indications where they show efficacy, a significant percentage of patients don't respond.

Even in indications, where they show efficacy a significant percentage of patients don't respond.

The immunosuppressive effects of regulatory T cells or T-regs has been known for quite a while, so eradicating them from the tumor microenvironment is long been thought to be a potentially attractive way of helping to treat cancer.

The immunosuppressive effects of regulatory T cells or T. Regs has been known for quite a while so eradicating them from the tumor microenvironment has long been thought to be a potentially attractive way of helping to treat cancers.

However, the first attempts at creating an anti-CD25 antibody that could bind to and destroy these regulatory TCS.

However, the first attempt to creating an anti CD 25 antibody that could bind to and destroy these regulatory T cells.

We're a little disappointing, and that's because although they depleted the T-regs, these antibodies wound up walking an important signal to other T-regs.

A little disappointing and thats, because although they depleted the T. Regs. These data bodies wound up walking an important signal.

To other T cells.

that, and those T cells, T effector cells, kill cancer cells. So essentially, even though the T regs were being cleared, the effects were canceled out because the T effector cells and the signaling to them to tune up the cancer cell killing the activities canceling.

And those T cells T effector cells kill cancer cells, so essentially even though the T regs were being cleared.

The effects were canceled out because the T effector cells and the signaling to them to tune up the cancer cell, killing activities cancel each other out.

Thus, the recent development of an anti-CD-25 antibody like Ibioma 101, which depleted T-regs without interfering with the signals to other T-cells.

Thus the recent development on an anti CD 25 antibody like <unk> hundred one, which depleted T regs without interfering with the signals to other T cells has the potential to address the unmet medical need of non responding patients.

has the potential to address the unmet medical need of non-responding.

So we're very excited about iBio101's potential, and even more so when we think about its potential in combination.

So we're very excited about <unk> 100 one's potential and even more so when we think about its potential in combination with checkpoint inhibitors.

Thank you again, Tom. The final question is what is bio, what is iBio focused on for their remainder of 2020?

Thanks again, Tom. The final question is what is what is the final focus off for the remainder of 2022.

We have two areas to focus for the remainder of the year. First, continuing to advance our oncology assets and especially our lead, IVIA 101, by executing on RIN DNA.

We have two areas of focus for the remainder of the year first continuing to advance our oncology assets and especially our lead by by a 101 by executing on our IND, enabling studies and of course, we are working to bring our last dose not nx dose to the COVID-19 pandemic with an.

And of course, we are working to bring a last dose, not a next dose, to the COVID-19 pandemic with an IND filing for iBio 202 before Europe .

IND filing for <unk> hundred two before year end.

As we mentioned in our press release today, we believe becoming a clinical stage company will be a major value in flexion point.

As we mentioned in our press release today, we believe becoming a clinical stage company will be a major value inflection point Brian .

Great. Thank you gentlemen. That's all the questions I have. Operator, we are now happy to open the call to address any additional questions from our audience.

Great. Thank you gentlemen, that's all the questions.

Operator, we are now happy to open the call to address any additional questions from our audience.

Thank you. At this time, if you would like to ask a question, please press star 1 on your telephone keypad. To ask a question, simply press star 1 on your telephone keypad.

Thank you.

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Your first question comes from the line of Roy Buchanin from JMP Security. Your line is open. Please go ahead.

Your first question comes from the line of.

What's your name.

From JMP Securities. Your line is open. Please go ahead.

I agree, thanks for taking the questions. I guess the first question, I want to follow up on what you were saying there towards the end, Tom, on the AFU co-isolation seems particularly powerful and broadly relevant to drive efficacy, and maybe I'll speculate a little bit on maybe life cycle management. And I know you guys are, you mentioned it in the last comment, focus on the proprietary pipeline, but also how active are you in seeking out partners for the technology at this point? Do you still have kind of that business?

Okay, great. Thanks for taking the questions I guess the first question.

I wanted to follow up on what you are saying there towards the end Tom a few constellation.

He is particularly powerful and probably relevant.

Now to drive efficacy, maybe I'll speculate a little bit on maybe lifecycle management.

And I know you guys are you mentioned it and then the last comment and focus on the proprietary pipeline, but also how active are you in seeking out partners for the technology at this point do you still have.

That business line going thanks.

Yeah, excellent. Roy, and maybe there's two ways you mean that question, right? Because it could be partners, those that are interested in accessing our glyconeering capabilities so that they can make their molecules and where you're also referring to maybe partners for iBio101 itself.

Yeah excellent ROI and maybe there is two ways you mean that question right because it could be partners. Those that are interested in accessing our lake and <unk> capabilities. So that they can make their molecules and where you also referring to maybe partners or I buy a 101 itself.

Yeah, that's good, and also, yeah, that sounds great, thanks.

Yes that is good and also.

Yeah that sounds great. Thanks.

Oh, great. So I'll take both. In terms of the outbound and using the fast farming system and the glycanering technology, one of the things that we're able to do is maybe help some smaller biotechs in particular that have innovative, newly antibodies for whom they're looking or for which I guess I should say they're looking to increase the potency through that few consolation.

Alright, great So I'll take both.

In terms of the outbound and using the SaaS farming system and the <unk> technology, one of the things that we're able to do is maybe helped some smaller biotechs in particular that have innovative newly antibodies for whom they're looking for.

Which I guess I should say theyre looking to increase the potency through that a few constellation.

and without having to go and tap into those who own the intellectual property in the space for doing so in the traditional mammalian

Without having to go in.

Tap into those who own the intellectual property in this space for doing so in the traditional mammalian methods.

You know, at the moment, we've got a royalty free, license free method to help them move that forward quickly by producing in plants with the fast farming system and just doing the services really for the early process development work and some of the rest is part of our standard contract development and management.

At the moment, we've got a royalty free license free method to help them move that forward quickly by producing and plants with the past farming system and just doing the service fees really.

For the early process development work and some of the rest is part of our standard contract development and manufacturing services.

But what's interesting here too for us, because in our business model, we have

But what's interesting here too for us because in our business model, we have opportunities to generate growth for the business not only through those sorts of CDN services.

opportunities to generate growth here for the business, not only through those sorts of CDMO services, but by virtue of the fact of what we've done here in our relationship with Verbrick, we found a way to take their molecule, which by the way, the pre-costalated version performs better, and by putting it onto our plant-based system where we could easily

Virtue of the fact of what we've done here in our relationship with rubric, we found a way to take their molecule, which by the way.

Constantly to version performs better and by putting it onto our plant based system, where we could easily.

can cost effectively a few-cosylate that molecule as well to produce a more potent version than the few-cosylated, whether that was in mammalian or plants. We're now putting ourselves in position whereas we look forward and bring that molecule into the clinic that perhaps there are partnerships that would make a lot of sense. And I think it's

Cost effectively AP constantly that molecule as well to produce a more potent version.

The costs related whether that was in mammalian work or plants.

We're now putting ourselves in position, where as we look forward and bring that molecule into the clinic.

That perhaps there are partnerships that would make a lot of sense and I think it's fair to note.

Fair to know in comparison, really the only other any CD 25 molecule out there that doesn't have.

In comparison really the only other <unk>.

CD 25 molecule out there.

Does it have.

the, you know, this IL-2 blocking component to it is, or I guess I should say was a company by the name of Cust therapeutic. So they had an IL-2 sparing any CD-25 Treg depleting monoclonal antibody themselves and

This IL two blocking component to it.

Is or I guess I should say was accompanied by the name of tests therapeutics. So they had an IL two sparing ADC to 'twenty five T. Reg depleting monoclonal antibody themselves in.

you know, with data kind of about what we have right now in terms of our pre-clinical data, you know, they wound up ultimately doing a partnership and really a sale of that asset to Roche, who now has it in a Phase 1 clinical trial and I believe not only is a monotherapy but married up with a checkpoint inhibitor. So, you know, we're

With data kind of about what we have right now in terms of our preclinical data.

They wound up ultimately doing a partnership with really a sale of that asset to Roche.

<unk> now has it in.

These one clinical trial and I believe not only as a monotherapy.

But married up with a checkpoint inhibitor so.

We're certainly looking at that situation.

Looking at that situation, you know, they did that deal, it was all preclinical at the time.

That deal was all preclinical, but the time and the opportunity for us to be able to manufacture the product hit it into the clinic.

and the opportunity for us to be able to manufacture the product, get it into the clinic,

Certainly, we're going to be eager to see how the Roche clinical trials proceed.

Certainly we are going to be eager to see how the Roche clinical trials proceed.

But we, we think there's just a ton of promise. Obviously they do too. And, you know, for, for those other entities that are out there with a checkpoint inhibitor, we think that, you know, the, the way the technology works.

But we think there's just a ton of promise obviously, they do too.

And.

Or for those other entities that are out there with a checkpoint inhibitor we think.

The way the technology works that there could be some nice opportunities for partnership in a clinical trial that looks at that so of course, we're going to.

that there could be some nice opportunities for a partnership and a clinical trial that looks at that. So, of course, we're going to remain open to that, but, you know, look at what's in the best interest of the company and its shareholders in terms of the value of the asset, which we, you know, per the presentations here recently of the data that we've had, you know, we'll just make the best decision in the interest of our shareholders and of the best.

We remain open to that.

Look at what's in the best interest of the company and its shareholders.

In terms of the value of the asset which we.

Per the.

Presentations here recently of the data.

That we've had.

We'll just make the best decision in the interest of our shareholders.

Yeah.

Okay. Makes a ton of sense. Thanks. So I'm going to have a follow-up on the endostatin program for cancer, and then I'll jump back in the queue. I guess maybe I missed it, but can you talk a bit more about the data that we're going to get in the second half, you know, kind of what our expectations should be, and then what your next steps are after that, assuming it's positive?

Okay. It makes a ton of sense. Thanks, So I have a follow up on the Endo statin.

Program for cancer, then I'll jump back in the queue I guess, maybe I missed it but can you talk a bit more about the data that we're going to get in the second half.

Kind of what our expectations should be and then what your next steps are after that assuming it's positive.

Yeah, I mean, we look at great question. We look at UT Southwestern is a real leader here in this area, especially with these fibrotic tumors. I think your pancreatic cancers and some of the rest, which sadly took the life of a dear friend of mine not that long ago.

Yes, I mean, we look at Great question, we look at it.

UT southwestern as a real leader here in this area, especially with these fibrotic tumors.

Your pancreatic cancers.

And some of the rest which sadly.

On the deal front of mind.

Not long ago and.

You know, you get these tough fibrous tumors and UT Southwestern is one of the leaders in the area. They have some excellent models in preclinical and early stage research things. So they're running those studies for us at the core.

When you get these tough fibers tumors and Ut southwestern who's one of the leaders in the area. They have some excellent models.

Preclinical and early stage research things, so they're running those studies for us.

Don't hold me to this. I think we're expecting some of our data towards the end of this calendar where I'll have to get back to you on that with a specific without without Martin here, but I think it's some of the initial data is coming in here in in calendar 2022, but I'll get you an update on that.

Don't hold me to this I think we're expecting some of our data towards the end of this calendar Maury I'll have to get back to you on that with a specific without without Martin here, but I think it's some of the initial data is coming in here in calendar 2022.

Get you an update on that.

Okay. Thank you.

Thank you. Your next question comes from the line of Kristen Kloska from Cantert, six-year-olds. The line is open. Please go ahead.

Thank you. Your next question comes from the line of Kristen <unk> from Cantor Fitzgerald. Your line is open. Please go ahead.

Hi, everyone. This is Rick on for Kristin. Thank you for taking our questions. We have a couple here for you. In the poster recently presented at Frontiers and Cancer Immunology, I'm sorry, Immunotherapy 2022, what would you say about the binding kinetics of the plant versus cho-cell expressed iBio 101 candidates? Are you satisfied that both seem to have similar binding profiles or were you hoping to see something different with the plant expressed candidate?

Hi, everyone. This is Frank on for Christian. Thank you for taking our questions. We have a couple here for you in the poster recently presented at frontiers in cancer Immunology I'm, sorry, immunotherapy 2022, what would you say about the binding kinetics of the plant versus Cho cell expressed <unk> 101 candidate.

Are you satisfied that both seem to have similar binding profiles or what are you, hoping to see something different with the plant expressed candidate.

Yeah, we were, we saw what we were hoping to see. So the sort of the bind and release.

Yes, we were we saw what we were hoping to see so the sort of the <unk>.

Buying them reliefs.

was what we expected, we were expecting something very similar to, you know, the mammalian and that's, in fact, what we got, which is often, you know, well, actually, that's.

Was what we expected we were expecting something very similar to the mammalian and Thats in fact, what we got which is often.

Well actually that's been our everything that we've seen on the past farming planted platform.

Everything that we've seen on the fast farming plant made platform, you know, we we do expect it to perform similarly if not in some cases slightly better than the mammalian technologies. And so the quality of what we're getting and then having it in practice in the animal models turn out the way it did, you know, from the, from the binding kinetics and some of the rest matched up pretty well versus.

We do expect it to perform similarly, if not in some cases slightly better than the mammalian technologies.

So the quality of what we're getting and then having it in practice in the animal models turn out the way it did.

From the binding kinetics and some of the rest are matched up pretty well versus expectations.

Understood, and maybe on sort of a follow-up there also on the poster, also on the same poster, you compare the 8th eucosalated version produced in plants to the version produced in show cells.

Understood and maybe on sort of a follow up there also on the poster.

Also on the same pasture you compare the AEP costs related version produced in plants to the version producing show cells.

While we understand the advantages of fast farming system for production at scale, how should we be thinking about differences in terms of the effective concentrations of antibody that you used? You saw effective in vitro cancer cell killing between the plant and show cell. How should we be thinking about sort of concentration differences seen there?

While we understand the advantages of SaaS farming system for production at scale, how should we be thinking about differences in terms of the effective concentrations of antibody that you used.

You saw it effective in vitro cancer cell, killing between.

Plant in Cho cell, how should we be thinking about sort of concentration differences seen there.

Well, as you're pointing out, Rick, you know, you really did have a like for a like when it came to the few co-slated versus the a few.

Well as you're pointing out Rick you really did have a like for like when it came to the few coastal weighted versus the <unk>.

So, what we saw is essentially what we expected this whole way through that, you know, with regardless of manufacturing platform, you saw, you know, the same sort of concentration dependent.

So what we saw is essentially what we expected this whole way through that.

Regardless of manufacturing platform you saw the same sort of concentration dependent.

Correct in vivo right. So.

in vivo, right? So, you know, in a few-cosylated versions, in both cases performed better in a concentration-dependent manner than a few-cosylated one.

And a few concentrated version.

In both cases performed better in a concentration dependent manner and a few coast related one.

which is, you know, what you'd want to see, you know, there was not an expectation that a plant, you know, a glycon ear plant version would

Which is what you'd want to see.

There was not an expectation that a plan look like in your plant version.

Good.

you know, if that performed better than a million, if you consolidated version, the expectation was they would be the same. Now, that may change over time with more data coming in and all the rest, but.

It performed better than in Dalian, a few constantly to emerge as the expectation was they would be the same now that may change over time with more data coming in and all the rest but.

Work, we're very happy by what we saw.

You know, we're, we're very happy by what we saw in terms of both the quality and the consistency of the molecule producing plants.

In terms of both the quality of the consistency of the molecule.

<unk> plants and also the data that we got which at the end of the day, what it's all about us.

And also, you know, the data that we got, which, you know, at the end of the day, what it's all about is.

You know, can you deplete these regulatory T-shells from the tumor micro-environment and do it effectively and then free up, you know, the immune system to go ahead and take down, you know, these solid tumors and, you know, that's what's most important. But, of course, we're, you know, we're thrilled to see the comparability of the two systems, both AFU-comps.

Kate you deplete these regulatory T cells from the tumor microenvironment and do it effectively and then free up.

The immune system to go ahead and take down.

These solid tumors.

That's what's most important.

But of course, we're thrilled to see the comparability of the two systems.

If you calculate it did not.

Okay.

Okay, maybe if I could just ask one more, with iBio101 moving into IND enabling trials, could you talk about what we could expect in terms of potential updates during this next phase? Could you look to present data at relevant conferences, or should we be looking for updates via press release, for example? Thanks.

Okay, maybe if I could just ask one more with <unk> 101, moving into IND, enabling trials could you talk about what we could expect in terms of potential updates. During this next phase could you look to present data at relevant conferences. So should we be looking for updates via press release for example, thanks.

Yes.

Yeah, Rick, probably both. And so what we would expect is, you know, as we go forward, you know, as there's opportunities to present more on, let's say, the, you know, plant main versus mammalian produced molecules, we're interested in continuing to roll out the data, much as you've seen, especially over the past two weeks, showing that comparability on the platform side of things.

Probably both and so what we would expect is.

As we go forward is there is opportunities to present more on let's say the.

Plant made versus mammalian produced molecules that we're interested in continuing to rollout the data much as you've seen especially over the past two weeks showing that comparability on the platform side of things than most importantly on working towards getting into the clinic with this molecule.

Then, most importantly on working towards

getting into the clinic with this molecule, which we're thinking about, you know, this time next year. What we anticipate is the next big chunk of data for iBio101, in respect of how we're making it, is TOCS data,

But you were thinking about.

At this time next year.

What we anticipate is the next big.

A big chunk of data for <unk> hundred one irrespective of how were making it as tox data.

And we would expect, you know, to put out a paper on some of the in vivo efficacy for one on one as well. So you'll get that both in probably, I would say, or one might expect that there could be both publications.

And we would expect to put out a paper on some of the in vivo efficacy for one on one as well so you'll get that both in probably I would say or one might expect that there could be both publications and press releases.

and press releases, you know, sort of depending upon.

Depending upon.

Merit.

I hope that helps. And most of this is going on with the next six to nine months.

Hope that helps again most of them don't.

Within the next six to nine months.

Yes.

Okay. Thank you.

Thank you. Your next question comes from the line of John Oldham from EasyBytes. Your line is open. Please go ahead.

Thank you. Your next question comes from the line of John <unk> from <unk>. Your line is open. Please go ahead.

Thank you very much for taking my call. I'm a longtime shareholder ever since November 2019 before COVID. And I was curious as I have a two-part question.

Thank you very much for taking my call.

A longtime shareholder ever since November 2019 before Covid.

And I was curious as I have a two part question.

and it's on iBio 400 just wondering what our timeline is for the USDA approval of the facility and after the facility was approved when do we expect shipments

Yes.

<unk> 400, just wondering what our timeline is for the USDA approval of the facility.

After the facility was approved when do we expect shipments.

from the IBIO 400 project. Thank you.

From the 400 project.

Great.

Great. Thank you, John . And as I believe we put into the press release, what we're doing right now is working forward with USDA to get a reviewer assigned first and foremost. And, you know, it's unfortunate sometimes these things change, and especially with.

Great. Thank you John .

And I believe we put into the press release.

We're doing right now is working forward with USDA.

To get a reviewer find first and foremost.

And.

It's unfortunately, sometimes these things change, especially with.

with COVID-19 and some of the rest so we we wound up having the reviewer slash inspector get changed that you know cost a little bit of delay we were hopeful you know that we would have already been down the road by now.

With Covid and some of the rest so we wound up having.

The reviewers flourish and spectrum get changed.

That caused a little bit of delay we were hopeful that we would.

I've already been down the road by now so is this travel together, we're a little bit hesitant to comment to when the regulatory process will free us up to be able to move forward, but after you get the right after we get presumably.

So, you know, as this travels together, we're a little bit hesitant to comment.

to when the regulatory process will free us up to be able to move forward. But after we get presumably the regulatory clearance on the facility, as we may have noted,

The regulatory clearance on the facility.

As we May have noted.

You know, a first-time submitter, it tends to take a little longer there, too, anyway. Now, the good news about a vaccine that goes through the animal health pathway in the U.S., once you get there, it's oftentimes much quicker and less costly than the human health side of things, but the key is that first barrier, so it could be upwards of.

Our first time submit or it tends to take a little longer there to any way now the good news about <unk>.

Vaccine that goes through the animal health pathway in the U S. Once you get there, it's oftentimes much quicker and less costly than the human health side of things, but the key is that first barrier. So it could be upwards of.

You know, a year, even after we get the regulatory clearance on the facility. So more to follow on that, of course, we're keen to update. Well, they're going to continue to update as everyone as we did here to.

A year, even after we get the regulatory clearance on the facility. So more to follow on that of course, we're keen to update.

<unk> update everyone as we did.

Here today.

on developments on that front, but the key is getting the next reviewer slash inspector put on to our particular file and then move on.

On developments on that front, but the key is getting.

The next review or slashing Spector put onto our particular trial and then moving forward.

Okay, very good. And last question, after the RS is approved, when would we expect to enact it?

Okay very good and last question. After the IRS is approved when would we expect to enacted.

Ah, well, the the board would help make that decision. So we're just asking for, you know, the shareholder approval to do the reverse.

Well the.

The board.

That would.

To help make that decision. So we're just asking for.

Shareholder approval to do the reverse.

And we would do it and look to be considered with timing because what we want to do is obviously what's in the best interest of the company and shareholders and one of the things that we've talked about in the past and I want to be careful.

And we would do it and look to be.

Considered with timing.

Because what we want to do is obviously, what's in the best interest of the company and shareholders and one of the things that we've talked about in the past and I want to be careful here only because of what Rob mentioned, a little bit earlier, which is that.

here only because of what Rob mentioned a little bit earlier, which is that

until the SEC clears our proxy and we're okay to talk about this. I guess I would probably be best just to point us back to some of the stuff that we've had on the website before, but I think it's probably fair to say that, you know, it would be, once we get the approval, you know, it would be the board, then we'd make the determination on the timing, but Rob, is there anything I'm missing there? No, I think that's the right time.

Until the SEC clears our.

Proxy and we're okay to talk about this I guess I would probably be best just to point us back to some of the stuff that we've had on the web site before but I think it's probably fair to say that we would be at.

Once we get the approval it would be the board that would make the determination on the timing, but Rob is there anything I'm missing there.

No I think that's right Tom.

Okay. So John I hope that helps.

You bet. Thank you.

No more questions for me.

Thank you. Your next question comes from the line, or it's a follow-up question from Roy which none from JMP Security. Your line is open. Please go ahead.

Thank you. Your next question comes from the line. Its a follow up question from Brian <unk> from JMP Securities. Your line is open. Please go ahead.

Thanks for taking the follow-up. I just noticed you guys have a presentation at ASCO in the calendar. I know there's embargoes and all that kind of stuff, but can you give us a general sense about what you're planning to present?

Hi, Thanks for taking the follow up I just noticed you guys have a presentation at Costco and.

And the calendar I know theres embargoes, and all that kind of stuff, but can you give us a general sense of what youre planning to present.

Okay.

I think, I don't want to be premature with what we have going there to your point, Roy. I think when appropriate, we'll, of course, release additional information on what we have going on at ASCO. Okay, fair enough. Thought I'd try. Thanks.

I think.

I don't want to be premature with.

What we have going there to your point Roy.

I think when when appropriate.

We will of course release additional information on what we have going on at <unk>.

Okay fair enough thought I'd try thanks.

Yeah.

Well don't think.

Thank you. Your next question comes from the line of Phillip Barnett from a private investor. Your line is open. Please go ahead.

Thank you. Your next question comes from the line until that bond debt.

A private Investor Your line is open. Please go ahead.

I'm Mr. Isaac. Thanks for taking the call. I just have a comment and then just two quick questions.

I missed or I said, thanks for taking the call I just have a comment and then just two quick questions.

You know, three to four years ago, I bioposted data, which showed the Rituximab bio-similar had a 30x increased cytotoxicity, asked about it in the last call. You said it wasn't worth pursuing, that it was only used as proof of concept. It's like, you know, looking at Rituximab, it's one of the best-selling oncology drugs on the market. And, you know, to hear that it's not being pursued is crazy. Two years ago, you spoke, I know, heavily with shareholders about...

Three to four years ago.

<unk> posted data, which showed the Rituximab biosimilar had a 30 X increased cytotoxicity.

Asked about it in the last call you said it wasn't worth pursuing that it was only used as proof of concept.

Looking at <unk> and Thats, one of the best selling oncology drugs on the market and to hear that that's not being pursued as crazy.

Two years ago, you spoke.

Heavily with shareholders about.

golf scores and you know you were the company's biggest hype man. And you know the hill interview you mentioned you know driving around having conversations with BARDA and then fell silent and all the while the shared prices fell. You know you mentioned the dark days feels like we're there again.

Golf scores in the company's biggest heitman and.

He'll interview, you mentioned driving around having conversations with BARDA, and then fell silent and all the while the share prices fell.

You mentioned the dark days it feels like we're there again.

Previously, we did a 1-10 reverse split back in 2018. That didn't save the company, I don't think.

Previously we did have a one to 10 reverse split back in 2018 that Didnt save the company I don't think.

Then you cancel the reverse split in 2020. Then you tried to ram one down our throats, 10 to 1 back in 2021. Now we're going 1 to 25. It just feels like you're punishing shareholders at this point.

Then you canceled a reverse split in 2020, then you tried to ramp down our throats tend to one back in 2021 now we're going 1% to 25, it just feels like Youre punishing shareholders at this point.

Reverse splits do not save companies. I think products

Reverse splits do not save companies I think products like.

Like, they would talk from that bio better, save companies, funding from government, you know, maybe that RFI.

But we're talking about a bio better save companies funding from government.

Maybe that RFID.

would have been a great way to save the company rather than push this reverse split through. Not happy to hear that. You know, iBio has got incredible technology and it seems to just have gone nowhere. I won't make you comment on any of that, just want you to know that there's a lot of frustrated shareholders out there. For my first question.

Been a great way to save the company rather than push this reverse split through.

Not happy to hear that <unk> got incredible technology, and it seems to have gone nowhere.

I won't make you comment on any of that just want you don't know that theres a lot of frustrated shareholders out there.

For my first question.

You have heavily expanded the bio team, but there has only been vertical pipeline movement. There has been no horizontal movement, which is really what counts.

You've heavily expanded the iBio team, but there's only been vertical pipeline movement. There's been no horizontal movement, which is really what counts. Why are you hiring so many employees and expanding a very expensive executive team?

Why are you hiring so many employees and expanding a very expensive executive team.

Yeah.

Well, so, I mean, I'd actually be happy to comment on some of the other stuff, but I'll just take this question and challenge the premise. I think we've done both.

Well I mean.

Actually be happy to comment on some of the other stuff, but I'll just I'll just take this question and challenge the premise I think we've done both so what we've clearly demonstrated as the vertically.

So what we've clearly demonstrated is that vertically, we have added new pipeline candidates. And I think if one was to look, comparatively at the rest of the industry, what we've been able to accomplish in a very short period of time, we only just announced our drug discovery capability right around this time last year.

We have added.

New pipeline candidates and I think if one was to look comparatively at the rest of the industry.

We've been able to accomplish in a very short period of time, we only just announced our drug discovery capability right around this time last year.

And we're only beginning to hire the team. We didn't actually have anybody hire them. We announced it.

And we're only beginning to hire the team we had we didn't actually have anybody can we announced yet so I think it's very fair to say that we have the vertical stood up but if you were to look at anybody else try to accomplish the same thing I think on a comparative basis. Its very strong performance and then just last quarter as well.

So I think it's very fair to say that we have the vertical stood up. And if you were to look at anybody else, try to accomplish the same thing, I think on a comparative basis, it's a very strong performance. And then just last quarter as well, when one takes a look at the horizontal progression, we significantly moved 101 forward, which is a major opportunity. Again, you have to look at the cops in this space.

When one takes a look at the horizontal progression.

We have significantly moved 101 forward, which is a major opportunity again, you have to look at the comps in this space.

For an entity like <unk>, who has just come into its own biopharmaceutical development, which was our strategy to change the course of the company.

And to move where we were.

with our market cap when I kind of mostly got involved with the firm in late 2019 from whatever we were, $5 or $10 million market cap, to now beginning to have a pipeline with real value in this, I'll point to 101 again, the Tusk-Rosch deal was, I don't know, $75-$80 million up front, three-quarters of a billion.

With our market cap.

Mostly got involved with the firm in late 2019.

Whatever we were five or $10 million market cap now beginning to have a pipeline with real value in this.

I'll point to 101 again, the task Roche deal was I don't know $75 million to $80 million upfront three quarters of $1 billion.

and you know if milestones are achieved additional payments and so here we are advancing 101 forward towards IND enabling and then also with the deal with rubric again that's just a few short months ago you know we're in a position where we've taken

<unk>.

If milestones are achieved.

Additional payments and so here we are advancing 101.

Forward towards IND, enabling and then also with the deal with rubric again, that's just a few short months ago.

We're in a position where we've taken.

you know, an initial candidate concept, design an antibody, move straight through early discovery to late-stage discovery, and are progressing that particular target at a speed much faster than the rest of the industry does it. So just by the way, you know, from concept to clinic on an IND,

And initial candidate concept design and antibody move straight through early discovery to la.

Late stage discovery.

And our progress.

Progressing that particular target at a speed much faster than the rest of the industry does it so just by the way from concept to.

Clinic on an island.

For every 5000 molecules that start out maybe five get to clinic and Oh by the way those take four to five years and $20 million to $25 million to get there.

for every 5,000 molecules that start out, maybe five gets a clinic. And oh, by the way, those take four to five years.

and $20 to $25 million to get there. And, you know, as we talked about on the last call, we're already progressing those in a significant way, not to mention the rest of the pipeline.

As we talked about a little bias call. We're already progressing those at a significant way not to mention the rest of the pipeline.

So, you know, I think the track record is great and you got to keep in mind this piece brand new, so we hired folks.

So.

The track record is great and you've got to keep in mind. This team's brand new so we hired folks to.

to answer the question directly to do just this.

To answer the question directly to do just this.

And, you know, one can, you know, I suppose some other time debate, you know, the merits of a strategic choice in what areas to target, but, you know, by way of example, we're touching that, sure, that's a great molecule. There are gigantic competitors in place all across the world that have done biosimilars and for us to put cash behind that would have been in our humble opinion.

One Ken.

I suppose some other time debate.

The merits of our strategic choice in what areas to target.

But by way of example, Rituximab sure Thats a great molecule.

Do you think competitors in place all across the world that have done biosimilars and for us to put cash behind that would have been in.

In our humble opinion.

probably about as wise as trying to take on Pfizer, Moderna, and J&J and COVID vaccines with something that they're already doing with another spike-based protein.

About his wise is trying to take on Pfizer, Madonna and J&J and Covid vaccines with something that they're already doing it with another spike based protein. So we're very proud quite honestly of.

So, you know, we're very proud, quite honestly, of.

the talent that we've brought in, the assets that we're creating, opening up the partnering opportunities.

The talent that we've brought in.

The assets that were creating opening up the partnering opportunities for our molecules, but unlike a lot of other biotechs also if we if we choose or when we choose to partner at any given one of those assets.

for our molecules, but unlike a lot of other biotechs, also if we choose or when we choose to partner at it and give it one of those assets.

Then we've got the opportunity, unlike many other small biotechs who do their deal and that's that, because of our manufacturing services and platform, we actually have the opportunity for a captured supply agreement with some of those folks. So, you know, appreciate the two things.

Then we've got the opportunity. Unlike many other small biotechs, who do their deal and that is that because.

Because of our manufacturing services and platform.

We have the opportunity for a captured supply agreement.

With some of those folks so I appreciate it.

The two things the.

The disappointment, obviously, I think the entire biotech markets are, it's sort of, you know, incredible lows, and we, we, not that we're, you know.

The disappointment, obviously I think the entire biotech markets are.

It's sort of.

Incredible Lowes and we not that we are.

We shouldn't be moving forward with trying to outperform the market, which, of course, we are, but, you know, this has been across the board, but what we've built, you know, we feel very positive about a sorry for the disappointment on the stock price. Obviously, we wish.

We shouldnt be moving forward with trying to outperform the market, which of course, we are but this has been across the board, but what we've built.

We feel very positive about.

Sorry for the disappointment on the stock price, obviously, we wish it was up but we have full confidence in its going to be recognized over time, and we're going to return value to our shareholders. So.

It was up, but we have full confidence that it's going to be recognized over time, and we're going to return value to our shareholders.

We like our strategy, I like the execution, and we have a very positive outlook for the business.

We like our strategy I like the execution and we have a very positive outlook for the business going forward.

Thank you. I've been here since 2015, so I'm very hopeful for the company as well, and I was here during those dark days, so I have

Thank you.

I've been here since 2015, so I'm very hopeful for the company as well and it was here during those dark days so.

I have.

Confidence in the company, but I'm just like, you know, looking at it right now going, you know, what's what are we looking at here, you know And so I guess

Confidence in the company, but I'm just looking at it right now going whats what are we looking at here.

And so I guess.

in the spirit of directly generating revenue, what is, in your view, iBio's focus? What's that first thing that we're going to bring to market that's going to finally generate revenue for the company? It seems like the deadlines just keep getting pushed out.

In the spirit of directly generating revenue what is in your view.

Bio's focus like what's that first thing that we're going to bring to market that is going to finally generate revenue for the company. It seems like deadlines keep getting pushed out.

Okay.

I don't know about that, but I guess what I would say is, you know, focus on when it comes to the biotech pipeline, you know, 101 and 202 once again, you know, not to be redundant on this.

I don't know about that but I guess, what I would say is focus on.

When it comes to the biotech pipeline.

101, and two to once again.

Be redundant on this but.

you know, tested their deal with Roche, roughly the same point, you know, or maybe a couple of months behind, technically speaking, where they were, when that deal went forward. And this is, again, I don't mean to indicate in any way that we wouldn't want to hold on to the molecule and not park it until much, much later, right? You know, we're not going to get into our, you know, whatever business strategy for any particular instance. We want to just see how that performs in the

Tested their deal with Roche at roughly the same point, where maybe a couple of months behind typically speaking where they were when that deal went forward and this is again I don't mean to indicate in any way that we wouldn't want to hold onto the molecule not park until much much later right, we're not going to get into or.

One of our business strategy and for any particular instance, we want to just see how that performs in the clinic <unk> got 202, that's advancing we have a long list of mental long list, we have a list now happily.

You've got 202 that's advancing, we have a long list, not a long list, we have a list now, happily, of assets that we're developing on our own.

Of assets that we're developing on our own.

And we have a few dollars here and there on the sources business. So that's our view. You know, again, every investor has to make their own decisions, evaluate critically your view of our pipeline. I'd encourage everybody to, of course, you know, do your research.

And we have a few dollars here or there on the services business. So.

That's our view.

Every investor has to make their own decisions evaluate critically.

Your view of our pipeline I'd encourage everybody to of course to.

Do your research.

Look at the indications that we're going for and look at the space in the oncology and, you know, we're of course being transparent with what we're moving forward and hopefully we continue to advance number of these molecules.

Look at the indications that we're going to look at the space immuno oncology and.

Well of course being transparent with what we're moving forward.

We continue to advance a number of these molecules with the platforms and technology strategies that we have and some of those targets that are presently undisclosed not all of them will move forward, we've already talked about the numbers, there's a lot of drop outs.

with the platforms and technology strategies that we have and some of those targets that are presently underscored.

Not all of them will move forward, we already talked about the numbers, there's a lot of dropouts.

in early stage drug discovery. But our plan is to design better molecules, take more shots on goal.

And early stage drug discovery, but our plan is to design better molecules take more shots on goal.

You know, where there are failures, fail more quickly and move forward, but we believe

Where there are failures scale more quickly.

Forward, but we believe.

that we're designing better molecules and we'll have more shots on goal and you know that kind of portfolio returns value to biotech investors over time because of the partnering opportunity. So you know I guess that's how I would sort of summarize that but you know I appreciate your comments sorry for a long time.

We are designing better molecules.

And we will have more shots on goal and that kind of portfolio returns value to biotech investors over time because of the partnering opportunity.

I guess, that's how I would sort of summarize that but I. Appreciate your comment sorry for a long time.

Ups and downs, but you know, we're very happy and confident with what we've built here. We think we've got a great team and we made these investments to take the company to a very different place. You know, we're not terribly interested in, I buy a 2008 or 2015 or any of that, you know, we've been.

Ups and downs.

But.

We're very happy and confident with what we've built here. We think we've got a great team and we made these investments to take the company to a very different place were not terribly interested in.

<unk> 2008, or 2015 or any of that.

pretty clear with our strategy and direction, you know, since whatever, you know, 2000 when we took the turn to add in our own molecules and capabilities, these things take time. As you know, I think the average is 10 years and a billion dollars.

Ben.

Pretty clear with our strategy and direction.

Since.

Or whatever.

2000, when we took the turned added around molecules and capabilities. These things take time as you know I think the average is 10 years and $1 billion.

for a molecule to go all the way through and get released, but a lot happens in the biotech world with parkering and all the rest in between. So anyway, but again, thanks for all.

For a molecule to go all the way through.

Can't really spent a lot happens in the biotech world with partnering and all the rest in between so anyway, but again, thanks, Paul I appreciate the questions.

Thank you. Your next question comes from Al Fredi Gonzalez from <unk>. Your line is open. Please go ahead.

First, I'd like to say congratulations on everything that you have accomplished with iBio. I don't think that you are getting a fair review. I am in stock tweets literally day and night, and I could see the good and the bad comments.

First I would like to say congratulations on everything that you have accomplished with <unk> I don't think that you are getting.

A fair review.

I am in spec suites.

Literally day, and night and I could see the good and the back comments.

And I don't think that you're getting a fair review of everything that you have accomplished. Now, having said that...

And I I don't think that Youre getting a fair review what everything that you have accomplished now having said that.

I think to the point of transparency, it could be done better because right now...

I think to the point of transparency.

It could be done better because right now.

you guys increase your inventory on hand from $27,000 to $3.2 million.

You guys to increase your <unk>.

Inventory on hand.

27003.

$3 $2 million now.

Anybody looking at that would say, well, this guy is getting ready for some major manufacturing because...

Anybody looking at that would say well those guys are getting ready for some major manufacturing because.

Historically, iBuy has not cared that much inventory in hand and even with the prospect of, you know, supplying chain problems.

Historically <unk> has not done much inventory on hand, and even with the prospect of <unk>.

Supply chain problems.

That's still a huge amount of inventory compared to what has been historically kept on hand by iBio.

Still a huge amount of inventory compared to what it's been.

Historically kept on hand by buyer.

So what I'd like to know is, why is such a huge increase in the inventory in hand?

So what I'd like to know is why such a huge increase in the inventory on hand.

And.

Is it because you are, in fact, considering that you're going to be manufacturing a whole lot in the next few months?

If it is it because you are in fact, considering that youre going to be manufacturing a whole lot in the next few months.

because if you were to tell me that this was just only due to

Because if you are telling me that this was just finally do too.

supply chain issues, then I would say, wow, you know, you guys are not planning well.

Supply chain issues than I will say Wow, you guys are not planning well.

Because to me, that's just an enormous amount of inventory and end.

Because to me that's just.

This amount of inventory on hand.

compared to what historically iBio has been keeping on hand.

Compared to what historically has been keeping on hand so.

So can you elaborate on that.

Sure I mean, you take a look at <unk> bio.

Sure. I mean, you take a look at iBio and, you know, from when it was only doing CDMO services and not really having, you know,

From when it was only doing CMO services and not really having.

You know, I suppose introduced even the glycaneering technology and some of the other capabilities, you know, there wasn't much in the way of revenues, right? So if you're not manufacturing, a lot of folks don't need a lot of inventory. And so I guess I would just guide to say the historical comparison is not really useful here because A, number one.

I suppose introduced even look like an earring technology in some of the other capabilities.

No.

There wasn't much in the way of revenues right. So if youre not manufacturing.

There'll be a lot of a lot of inventory and so I guess I would just guide to say the historical comparison.

It's not really useful here because.

A number one.

you know the the manufacturing game you know this whole industry it's very expensive this is why it costs

The baby factoring game.

This whole industry. It's Barry expense. This is why cost 10 years and $1 billion.

10 years and a billion dollars to move a molecule through because making a biological molecule is very, very costly. Just the production of it and the purification, some of those consumables, those raw materials,

To move our molecule through because making a biological molecule.

It's very very costly just the production of it and the purification some of those consumables those raw materials, you'll spend a couple of million dollars to do so.

you'll spend a couple million dollars to do a CGMP manufacturing

Cgmp manufacturing runs so you put that so to answer one aspect of your question absolutely.

So you put that, so to answer one aspect of your question, absolutely, we're increasing the inventory because we've got one-on-one that we're getting ready to move towards the clinic. And same thing for iBio 202. So you have to do your engineering runs, you have to then plan your manufacturing. And the second thing is also what you said, which is affecting the entire industry.

The inventory because we've got 101 that we're getting ready to move towards the clinic.

And same thing for <unk> 202. So you have to you have to do your engineering runs you'd have to then planned.

<unk> manufacturing in the second thing is also what you said, which is impacting the entire industry.

Not to mention the globe arguably, which are these serious supply chain constraints. Take a look at any other biotech company.

As I mentioned the globe arguably.

The serious supply chain constraints take a look at any other biotech company out there all of them are suffering you see major what you see biotechs, you see contract development and manufacturing organizations really struggling to get some of these critical raw materials in place and for many companies who don't have the round.

all of them are suffering. You see major, you see biotechs, you see contract development and manufacturing organizations really struggling to get some of these critical raw materials in place.

and for many companies who don't have their own, many biotechs I guess I should say, they don't have their own manufacturing.

Many biotechs I guess I should say they don't have their own manufacturing capability and have to rely on third party service providers. Many of their clinical trials are delayed completely because they can get their CMO to manufacture their stuff with them. So easy answer is yes, we are.

capability and have to rely on third-party service providers.

Many of their clinical trials are delayed completely because they can't get their CDMO to manufacture their stuff for them. So easy answer. It's both. Yeah, we're getting ready to advance our products to the clinic, which is what we told everybody. Number one and number two, we can't hear as a team make these claims and just pretend like we're going to be able to

Getting ready to advance our products through the clinic, which is what we told everybody.

Number one and number two we can't.

Here as a team make these claims and just pretend like we are going to be able to.

you know access critical consumables at the drop of a hat the supply chain situation requires us.

Access critical consumables at the drop of a hat.

The supply chain situation requires us to make sure that we have ample backup.

to make sure that we have ample backup and can really execute behind these timelines that we're promising everybody or attempting to promise. But once again, as we put in our risk factors, just like everybody else, supply chain could torpedo anyone of our particular timeline. So that's why we're working aggressively to build up the inventory of raw materials that we're gonna need to deliver on time and keep our programs moving.

Only execute behind these timelines that we're promising everybody are attempting to promise, but once again.

We put in our risk factors, just like everybody else.

Supply chain torpedo anyone.

Of our particular timeline. So that's why we're working aggressively to build out the.

Inventory of raw materials that we're going to need to deliver on time and to keep our programs moving.

Hope that helps.

Thank you. And your next question comes from Sammy Daniels from Ola and your line is open. Please go ahead. Again, your line is open.

Thank you next.

Our next question comes from Sam Daniel from <unk>. Your line is open. Please go ahead.

Okay.

Again your line is open.

All of them.

Hello.

Yes go ahead Sir.

Okay.

Yeah.

Sure.

Hello.

Yes.

Can you hear me.

Yes.

Yeah, operator, maybe we move on.

Yes.

Operator, maybe we move on.

Yes, my only question was the reason behind this reverse split.

Yes, My only question what's.

The reason behind this reverse split again.

Well, several fall as we put in to the announcement, once again, we're being a little cautious until we get the FCC approval on some of this, but again, referring back to what we had mentioned in the past, if you look at the reverse split, there are investment firms and houses that may not initiate.

Well several fold as we as we put in to the announcement once again, we're being a little cautious until we get the SEC approval on some of this but again, referring back to what we had mentioned in the past if you look at the reverse split.

There are.

Okay.

<unk> firms and houses.

May not initiate.

with companies who, you know, have stock prices.

With companies, who have stock prices that are low sometimes below $5.

that are low. So sometimes, you know, below five dollars.

You know, an initial investment into the firm is impossible for some of their roles.

An initial investment into the firm is impossible for some of their rules.

You can take a look even at some of the indices.

You can take a look even if some of the indices that are out there I believe such as the Russell and some of the rest of the Fiat stock prices that are under a dollar.

that are out there, I believe, such as the Russell in front of the rest. So if you have stock prices that are under a dollar.

that can impact and then, you know, just general perception of the stock.

That can impact and then just general perception of the stock.

You know, especially as the number is sitting there below a dollar significantly, you know, there's not really a change. On the day that one goes ahead and institutes a reverse split, you know, the market cap, you know, at the moment that it occurs, obviously doesn't change, you know, the kind of, it's just a different number of shares, it's just an exchange.

Especially as the number is sitting there below $1 significantly.

There's not really a change on the day that one goes ahead and institutes a reverse split the market cap at the moment that it occurs obviously it doesn't change the kind of it's just a different number of shares it just an exchange.

which is simply a transactional thing, but if the perception or certain qualifiers for investment purposes can be improved by a reverse stock split, naturally one would want to do it. And that's why the board has recommended to all shareholders.

Which is simply a transactional thing, but if the perception or certain qualifiers.

For investment purposes can be improved by a reverse stock split naturally one would want to do it and that's why the board.

As recommended all shareholders to move forward.

Thank you. And there are no further questions at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Thank you.

And there are no further question at this time, ladies and gentlemen. This concludes today's conference call. Thank you for your participation you may now disconnect.

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Good day and thank you for standing by. Welcome to the iBioFiscal 2022 third quarter financial results conference call. At this time, all participants are listed in only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during the session, you will need to press star one on your telephone.

You will need to press star one on your telephone if you require any further assistance. Please press star zero.

If you require any further assistance, please press star zero. I would now like to hand the conference over to Stephen Kilmer. Investor relations, please go ahead, sir.

All right you had the conference over to Stephen Kilmer Investor Relations. Please go ahead Sir.

Thank you and good afternoon, everyone before we begin I would like to remind you that during this call. The company will be making forward looking statements regarding our current expectations and projections about future events that are subject to risks and uncertainties.

References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current violence with the U.S. Securities and Exchange Commission.

References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current filings with the U S Securities and Exchange Commission.

No forward-leaked statements can be guaranteed, and actual results may differ from the results discussed in the forward-leaked...

No forward looking statements can be guaranteed and actual results may differ from the results discussed in the forward looking statements.

The information on this conference call is provided only as of today and we undertake no obligation to update any forward-looking statements made on this call on account of new information, future events, or otherwise, except this required by law.

On the call today represented the company, our Mr. Tom Isatt, I Bios, Chairman and Chief Executive Officer, and Rob Lutz, the company's Chief Financial and Business Officer. With that said, I'll now turn over the call to Tom.

On the call today, representing the company are Mr. Tom is that <unk>, Chairman and Chief Executive Officer, and Rob <unk>, the company's chief financial and business Officer.

I'll now turn it over the call to Tom.

As we reported during the third fiscal quarter, we received the FDA's response to our pre-IND package, FRIBIO-202, which is our nucleic-capsid protein subunit vaccine candidate against the SARS-CoV-2 virus.

We continue to plan for an IND filing for the intramuscularly delivered version of the candidate by the end of the calendar year.

We continue to plan for an IND filing.

Her muscular Lee delivered version of the candidate by the end of the calendar year. Additionally.

Additionally, we have continued to advance our lead immuno-oncology asset, I-Bio-101, towards the end.

Additionally, we have continued to advance our lead immuno oncology asset <unk> hundred one towards the clinic.

Specifically, at the Frontiers in Immunotherapy Conference earlier this week, we presented favorable preclinical efficacy data on this anti-CD25 monoclonal antibody, showing that it effectively depletes regulatory T-cells as a prospective immunotherapy.

Specifically at the criterion Immunotherapy conference earlier this week, we presented favorable preclinical efficacy data on this.

25, monoclonal antibody showing that it effectively deplete regulatory T cells as a perspective immunotherapy for solid tumors.

While we've been focused on advancing those to lead biopharmaceutical programs, we've also published important performance data on the fast-farming development and manufacturing

While we've been focused on advancing those two lead biopharmaceutical programs. We've also published important performance data on the past farming development and manufacturing system.

This includes recently presented studies that show plant-made monoclonal antibodies are comparable to molecules produced using traditional mammalian manufacturing.

This includes recently presented studies that show plant made monoclonal antibodies are comparable the molecules produced using traditional mammalian manufacturing methods importantly in several cases plant produced antibodies had significantly greater homogeneity, and thus quality when compared with traditional systems.

Importantly, in several cases, plant-produced antibodies had significantly greater homogeneity and thus quality when compared with traditionals.

Additionally, we recently presented data showing that we can produce monoclonal antibodies with increased potency by applying our glycaneering technology.

Additionally, we recently presented data showing that we can produce monoclonal antibodies with increased potency by applying our <unk> technology.

Of note, we also use the glyconeering platform as part of the process of moving the I-Bio-101 molecule onto our fast-farming

Of note. We also use the <unk> platform as part of the process of moving the <unk> hundred one molecule onto our past farming system.

We were thereby able to produce an a few-cosylated version of this monoclonal antibody, which resulted in the desired increase in cell killing effects when compared with the few-cosylated antibody.

With this achievement, we're pleased to report, as part of today's update, that we have now successfully completed the lead optimization stage for IBIO 101, and that IND enabling studies are now underway for this promising anti-tumor.

Given the positive developments for our biotech business for this particular call, we're going to change things up.

Given the positive developments for our biotech business. So this particular call, we're going to change things up a bit.

First, I'll turn the call over to Rob to review our financial results from the quarter and discuss the upcoming special meeting of stockholders that we announced.

First I will turn the call over to Rob to review, our financial results for the quarter and discuss the upcoming special meeting of stockholders that we announced today.

Normally, of course, I would ask Martin to join me here for this Q and A. Unfortunately, he has come down with COVID disease and isn't able to join our call.

Normally of course, I would ask Martin to join me here for the Q&A.

Unfortunately has come down with Covid disease and is unable to join our call today. So we'll do our best without them and Thats, all wish them, a full and speedy recovery.

So we'll do our best without him, and let's all wish him a full and speedy recovery.

With that, let's get started with the review of our financial results for 2022's Third Fiscal Quarter. Rob?

With that let's get started with the review of our financial results for 2020, twos third fiscal quarter Rob.

Thanks, Tom.

I will speak to a few of our financial highlights, but please refer to the press release in the 10Q for further details.

I will speak to a few of our financial highlights, but please refer to the press release and the 10-Q for further details.

Revenues for the third fiscal quarter of 2022 and did March 31st were approximately $1.9 million, an increase of 154% versus the third quarter of fiscal 2021.

Revenues for the third fiscal quarter of 2022 ended March 31.

Approximately $1 $9 million, an increase of 154% versus the third quarter of fiscal 2021.

In the third quarter of fiscal 2022, we recognized $1.8 million in royalty revenue from the technology license with Fraunhoff.

In the third quarter of fiscal 2022, we recognized $1 $8 million in royalty revenue from the technology license with Fraunhofer.

This license was part of the transaction that resolved our IP dispute with front-end.

This license was part of the transaction that resolved our IP dispute with Fraunhofer.

On a related note, we received the first of two $5.1 million payments from Fawn Hoffer for the settlement of our IP claims. The second payment is due to Fawn Hoffer.

On a related note we received the first of $215 $1 million payments from fallen Hopper for the settlement of our IP claims the.

The second payment is due in March 2023.

R&D and G&A expenses for the third quarter of fiscal 2022 increased 157 percent and 60 percent respectively over the comparable period in fiscal 2021.

R&D and G&A expenses for the third quarter of fiscal 2022.

The increase to 157% and 60% respectively over the comparable period in fiscal 2021.

This reflects our growing investments in iBIOS Pipeline, platform technologies, employees, and related input.

This reflects our growing investment pipeline platform technologies employees and related infrastructure.

We anticipate this trend continuing. However, the rate of growth is expected to moderate over

We anticipate this trend continuing however, the rate of growth is expected to moderate over time.

In terms of liquidity, a quarter-round iBio would cash and cash equivalents plus debt securities of approximately $48.6 million, excluding $5.9 million of restricted cash.

In terms of liquidity at quarter end, <unk> cash and cash equivalents plus debt securities of approximately $48 $6 million.

<unk> $5 9 million of restricted cash.

We continue to believe based on assumptions related to our business that we have adequate cash to support activities through September 30, 2022.

We continue to believe based on assumptions related to our business. So we have adequate cash to support activities through September 32023.

I'll now turn to our upcoming special meeting of shareholders that we announced today.

I'll now turn to our upcoming special meeting of shareholders stockholders that we announced today.

We are seeking approval from our stockholders to authorize our board to implement a reverse stock split and a associated decrease in our authorized share

We are seeking approval from our stockholders to authorize our board to implement a reverse stock split and an associated decrease in our authorized share count.