Q1 2022 Ibio Inc Earnings Call

November 15, 2021

[music].

Good day, and thank you for standing by welcome to the eye by your fiscal 2022 first quarter financial results Conference call. At this time, all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session.

And you asked the question you will need to press the star one on your telephone keypad. 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.

Thank you good afternoon, everyone.

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

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

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

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

On the call today, representing the company are Mr. Thomas that I, Bio's, Chairman and Chief Executive Officer, Dr. Martin Brenner, our Chief Scientific Officer Randy.

Our chief operating officer, and Rob <unk>, the company's chief financial and business Officer.

With that said I'll now turn the call over to Tom.

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

Leveraging the transformational nature of our Paas farming system, we are rapidly growing our pipeline while at the same time, demonstrating the speed scalability and quality of our platform industry and academia.

For instance in the six months since we announced we would build our own drug discovery capabilities. We have already added six new assets to our pipeline.

We added three immuno oncology programs in July and entered into a research services agreement with fair Dirty Biologics. It gives us access to novel display technologies and proprietary antibody libraries.

We followed that up a month later in August when we entered into a definitive worldwide exclusive license agreement with rubric therapeutics, another oncology outside to our pipeline.

Specifically, we secured rights to an antibody that targets and depletes regulatory T cells.

Those are the type of immune cell that hinders the body's ability to control the growth of <unk>.

We're moving the molecule onto our Paas farming system as part of the guide by a one on one program and thus far the high potency version of the antibody, which has made implants with our like nearing technology is highly comparable to the version liberate produced using traditional mammalian bio production methods.

So we're looking forward to publishing our comparability data as we work to bring this really promising immunotherapy candidate.

Now as you may recall the license agreement with rubric, we chose one part of the relationship that we have established with them.

We also entered into a research collaboration we have the option to license additional antibodies built using rubrics AI driven discovery platform.

Gaming assets access to that platform is consistent with our approach to use cutting edge technologies like machine learning to increase the speed of discovery and development of critical assets and thereby create more shots on goal.

To that end, we're thrilled to announce today that we've identified the first pipeline target emanating from the research collaboration with Barbara that commenced in mid September.

We had yet another announcement today related to our strategic focus on oncology, specifically, we initiated a research collaboration with the University of Texas Southwestern Medical center to explore the use of our anti fibrotic Endostatin E. Four molecule in the treatment of cancer.

I buy it was currently developing the four molecule as I buy a 100 for fibrotic diseases, but along with UTI study you are world renowned cancer Research Center. We believe there is potential for the molecule to help inhibit the growth and metastasis of solid tumors too.

So overall, we're pleased with the speed with which we've been able to stand up our oncology discovery and development programs.

Seven people into our San Diego based discovery team secured access to artificial intelligence and antibody display technologies to marry up with our like an arrogant paas farming platforms.

<unk> partnered with a major cancer Research center to explore a first in class mechanism of action.

We're even more pleased with the results of our investments, meaning six promising new assets added to our pipeline in just six months.

Turning now to our infectious disease pipeline, we are awaiting feedback from FDA on our pre IND submission for a lead COVID-19 vaccine <unk> hundred two.

We were advised by the agency that their review is likely to take several months. So we're assuming we will be able to provide an update before the end of January.

As a reminder, our bio two O two is being developed with our JV strategy in mind Dave.

<unk> is our acronym for durability access and variant to include.

We believe that there are needs in each of those areas that are currently unmet by commercially available spike protein based vaccine.

We believe that those needs may be better addressed with a nucleocapsid antigen based vaccines like the one that we're developing.

For instance, presentations at the recent world vaccine Congress indicate that the nucleocapsid or N protein plays an important role in generating a durable immune response, and then and based vaccine could be an important weapon to have in our Arsenal in case of the emergence of a variant that could escape the fight back to them.

Also subunit protein vaccines like ours could increase access by avoiding certain cold chain challenges that face the distribution of the mrna vaccines in some parts of the world.

On another note related to accessibility, we're pleased to announce that we've executed a development agreement with a leading innovator of microarray patch delivery systems.

Microarray patches are applied painlessly under the skin like a bad thing later.

Later in the call our Chief Scientific Officer, Dr. Martin Brenner, who will provide a more detailed overview of this development as well as all of our vaccine programs.

So having touched on our key pipeline accomplishments I'd now like to focus a little bit on I bio's fast farming manufacturing capabilities and services.

The position the groundbreaking potential of S farming sustainable plant based production process has never been stronger on.

On November 3rd we announced the acquisition of the remaining 30% equity interest in our <unk> subsidiary.

Through this strategic transaction.

<unk> now has full control of our 130000 square foot manufacturing facility as well as the CMO entity, which holds the exclusive rights to produce biologics using a SaaS farming system in the United States.

In addition to providing certain P&L benefits this transaction should give us even greater strategic and operational flexibility to continue growing not only in the Bryan College station area of Texas, but anywhere else in the U S as well.

During the call are CFO, Rob Lutz will provide some more details behind this acquisition.

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

When Covid first hit we did not have an active government relations program to leverage but since that time, we've built capacity and capability to interact with the U S government.

We're now engaging with the senior leadership of both political parties to help build awareness interest and more funding for rapid sustainable domestic plant made biologics.

While securing non dilutive funding via government grants or partnerships isn't easy.

We're aware of a number of legislative efforts, which I bio's technologies and manufacturing capabilities could be a fit. These include initiatives such as the funding for aspirin BARDA and the current appropriations Bill Here's 2.0 manufacturing USA ARPA H and buy American to name just a few.

Thus, we plan to continue to pursue opportunities for public partnerships in the U S as well as non dilutive funding sources outside the United States.

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

Thank you Tom I'm excited to share some updates on <unk>.

Biopharmaceutical pipeline and drug discovery activities.

I buy a 101 the IL two sparing anti CD 25 antibody we have licensed from rubric is progressing as expected the team in San Diego has started to establish the preclinical pharmacology fly by a 101 and we are pleased with initial results show that the fuel produced with a fast farming community technologies is equally potent and if he can.

It's the mammalian cell <unk> antibody in a cell based assays PK studies have been initiated and we're expecting the first yourself before the end of this year.

As Tom pointed out our strategic partnership with Blueprint also granted US an option to license additional programs that are being developed with AI enabled discovery engine I'm excited to share today that the first of these programs has been started although we will not disclose the identity of the molecule targeted at this stage. It has been specifically selected.

Given our advantages, we expect to realize from boutiques predictive algorithms and I buy us collecting the ring technology.

For this program, we are specifically employing rubrics AI platform to generate meso scale engineered molecules, which we capitulate confirmations and dynamics of subdominant epitopes, some target proteins presenting such epitopes instead of full length proteins allows men programmed in vitro selections to rapidly and routinely discover.

The first panel so for antibody binding to otherwise inaccessible epitopes, we will provide updates in the future as the program progresses through the different discovery stages.

With regards to our new collaboration with the University of Texas Southwestern Medical Center I'm thrilled to provide more detail on the research we'll be doing with the laboratory of Dr. Ralph braking to explore the potential benefits of our anti fibrotic and Stephanie for insomnia tubes.

Breaking this one of the leading experts studying tumor host interactions with a particular emphasis on extra cellular matrix and angiogenesis as Tom mentioned many of you will recognize the E. Four molecule as I buy a 100, which we continue to develop for two major fibrotic diseases systemic scleroderma and idiopathic pulmonary type.

Process is.

There's different context of oncology, we will be exploring the potential of using <unk> to target the tumor microenvironment to enable or improve the efficacy of existing chemotherapeutic.

College had drugs targeting the tumor microenvironment has become an area of high interest for drug developers in recent years. Among all the cells that are present in the tumor microenvironment cancer associated fibroblast or caf or one of the most abundant and critical components of tumor tissue, which provide support to the tumor cells and can promote.

Tart tumorigenesis in a car.

Text dependent manner.

Cats are also involved in the modulation of many components of the immune system and recent studies have revealed their roots in immune evasion and poor responses to cancer immunotherapy. In addition, caf and the extra cellular matrix. They are producing can lead to highly variable responses to chemotherapy.

Consignors of plant in vitro and in vivo studies collaborations will evaluate the potential of the anti fibrotic effects of my bias and Stephanie for molecule to improve the efficacy of concomitant treatments, such as chemotherapy and immunotherapy in Kansas with a strong pipeline component.

I will now provide an update on <unk> two two hour and protein based COVID-19 vaccine program.

While we are waiting for feedback from the FDA on our pre IDE submission, which we expect sometime before the end of January we have made further progress on <unk> until a Debbie strategy.

Based on our initial preclinical findings we have conducted a dose range study ranging study that further informed all formulation strategy and will allow us to significantly reduce the dose.

I'm also pleased to announce that we executed an agreement with a leading innovator of microarray patch delivery systems to explore the feasibility of administering <unk> to intradermal <unk>.

Micro repurchase a minimally invasive truck application devices that can be applied directly onto the skin.

Contained micro needles, which painlessly penetrate the upper layers of the skin and to solve rapidly, thereby releasing that drug or vaccine payload.

Intradermal.

Delivery method may allow for vaccine self administration, creating a more accessible alternative to intramuscular injections, not only that but by targeting the large pool of immune cells residing in the skin delivery of vaccines using petrol technologies may elicit an enhance immune response.

This could yield increased durability, while concurrently lowering cost due to the lower dose requirements.

We are also pleased to note that evidence recently presented at the World Vaccine Congress Europe 2021 continues to point to the nucleocapsid protein and protein of Sars Cov, two as a potential critical player in stimulating durable T cell memory response to prevent against future infection.

Turning now to our animal health activities I'm happy to report that we continue to advance our classical swine fever C. S. F vaccine candidate <unk> 400 through the USDA sensors for veterinary biologics regulatory process.

Additionally, we have announced today that studies are now underway at Texas, A&M University system to evaluate alternatives to I am injection of <unk>, including an oral dose option. We're excited about the prospects for oral dosing given it is an easier and friendly away to vaccinate animals and it typically provides for lower cost of goods.

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

I'd now like to turn the call over to our Chief financial and business Officer, Rob Lutz, who will provide an update on all financial myself well.

Nope.

Thanks Martin.

Rather than reiterate the details on the company's financial results, which are available in our press release and the 10-Q I will simply speak to a few financial highlights.

Revenues for the first fiscal quarter of 2022 ended September 30 were $210000, a decrease of 49% versus the first quarter of fiscal 2021.

Significant quarter to quarter revenue variability is commonplace for early stage pharma services companies to have a small number of clients and due to the timing of revenue recognition.

Consistent with these business dynamics I buy a continues to expect a sequential decline in revenue during the first half of fiscal 2022 compared to the second half of fiscal 2021, followed by higher growth in the second half of fiscal 2022.

As expected, both our R&D and G&A expenses for the first quarter of fiscal 2022.

Meaningfully over the comparable period in fiscal 2021.

This reflects the continued need to invest in our growing pipeline our platform technology, our employees and related infrastructure.

We expect this trend to continue but the rate of growth is expected to moderate over time.

In terms of liquidity high bio at $82 $3 million in cash marketable securities and investments and debt securities as of September 30th 2021.

After spending on operations, whilst investing in the Rupert therapeutic transactions.

I buy also recently announced would use approximately $6 million in cash.

Taking on debt in order to purchase its manufacturing facility in Bryan Texas.

That purchase is meant to be the first step of a two step process.

The second step.

It is an attempt to sell the facility to a new investor and lease it back with better terms than we had previously.

If successful this would allow us to pay down the debt and potentially recover our $6 million investment or even make a profit.

A new investor might also funds additional capital expenditures for the facility, which could improve our cash runway outlook in the near term.

While there is no guarantee we can accomplish the second step market for labs based in the U S had been strong recently.

We can complete a sale leaseback.

Continue to believe our cash position remains sufficient to fund operations through the third quarter of fiscal 2023.

However, if you can't we've concluded there is sufficient liquidity to fund operations through at least the second quarter of fiscal 2023.

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

Tom.

Thanks, Rob.

So we are off to a very strong start to our fiscal 2022, you can see.

And much as we are pleased with the pipeline growth and development of our biopharmaceutical candidates today.

Main committed to scaling this growth with additional new candidates and partnership opportunities going forward.

We are confident in our strategy and that our in house talent and capabilities are better than ever we.

We are also optimistic about the continued growth of the bioprocess products and services.

These aspects combined with our strong leadership team and board should ensure our continued growth as a developer of next generation Biopharmaceuticals and a pioneer in sustainable plant based biologics manufacturing.

Now before opening up the Q&A session I would like to address our shareholders with respect to the upcoming annual meeting scheduled for December nine.

We are encouraging shareholders of record as of October 15th to participate in the online proxy voting process input from our investors is vital for the continued strategic growth and development of our company.

As far we've been pleased to see a high level of engagement and debate and to facilitate the continued dialogue. We previously posted a Q&A page on the investors section of our website.

However, there are three questions about the proxy that we perceive today with some frequency. So we wanted to take the occasion of this call to address the general form of each of those so I'll turn it over to Steve to Tee those up for Us Steve.

Yes, Tom Thanks, Here's one that we got a lot.

How is this year's propose proposal different than last year and why the change.

So last year's proposal was for an increase in the authorized share count homely and although we had 55% of respondents voted in favor of the increase we did not have enough total votes to reach a core.

So this year's proposal differs in that it also.

Resulted in a net increase of the number of an issued authorized shares but the board of directors recommended a reverse split to so that the stock price might be more attractive to certain institutional investors as well as retail shareholders.

Okay. Thank you Susan.

The other one.

You reported having over $82 million in cash so why do this now.

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

So this is necessary to support the growth of our proprietary pipeline as was done by way of example, with the rubric opportunity and the ability to flexibly access capital when market conditions are favorable is of course critical for our future growth and our ability to drive shareholder returns.

Our annual shareholders meeting is of course also the appropriate time and venue for asking our investors for this added flexibility.

Great last one why reverse split at the expense of retail shareholders.

Alright, well, we recognize there is an underlying concern from some retail shareholders about the potential for stock price depreciation following the reverse split right. So frankly, I think that concern is often justified, particularly in cases, where the company is doing it primarily to avoid a delisting.

However outside of those cases, when we look at examples of companies enacting a stock consolidation because they are executing their growth plans and what it potentially appeal to a larger investor audience it could be quite positive.

It was a good example of the two sides of this coin.

So back in 2018 and this is before the current management team joined the company I Bio completed a one for 10 reverse split.

The company didn't have the news flow, nor the quarterly investor calls or the expanded clinical pipeline or progress in it services business that we do today.

Bio quickly experienced price declines all the way down to five cents a share.

The absence of any immediate and significant progress in the C. D M open.

So now juxtapose that with where we are presently with a today with a strong cash position demonstration of the performance of the fast farming platform and a growing list of biopharmaceutical assets in our pipeline and some of these high value areas, where there's tremendous unmet medical need, particularly in immuno oncology.

<unk>.

And of course, that's not to mention the.

Ongoing prospects here related to the pandemic and I bio two O two and there's still many unmet needs that are out there. So the board is recommending this move now in the hopes that it will benefit all of our shareholders retail and institutional like because we continue to execute on our strategic plan.

To address these important unmet medical needs and realize our vision to make sustainable paas farming the preferred alternative to traditional medallion.

Yes.

So.

Steve Thanks for teeing, those up and allowing us to talk through them. They are a little bit so I'm sure there's likely more questions on the proxy or the quarterly highlights.

Before we open up the line for questions I'd also like to remind our stockholders how to vote their shares.

So either way you decide so.

So you can locate the control number on your proxy card or voting instruction form and follow the voting instructions.

If you don't have a proxy card or voting instruction form shareholders in the U S and Canada can call a coffee partners at a 442 O 336 O five or from other locations at plus 1212.

290 70720.

And that would be from the hours of nine a M. Eastern time, a P M Eastern time Monday through Friday.

So thank you all and with that we're happy to take any questions you might have operator.

Thank you Tom reminder, to our audio attendees if he would like to register a question. Please press star followed by the number one on your telephone keypad.

If your question has been answered and you would like to withdraw your registration. Please press the pack one moment for your first question.

And right and our first question is from.

Kristen <unk> from Cantor Fitzgerald.

Your line is now open.

Hi, good afternoon, everybody. Thanks for taking the question. The first one I had is I know you're not disclosing the individual new target related to the partnership with the rubric, but given that it occurred just two months. After the collaboration could you help us understand based on the combinations of each of the company.

That form what specifically led to this.

And perhaps what might have been the case without it and then what's going to be the gating factor or what would you potentially look for to decide whether or not you want your option for additional target.

Yes, Great question Kristen Martin wants to take the first one and I'll take the second one.

Absolutely.

Well Kristen so what we've done is we have we've gone through an entire assessment of the target space. If you will and have identified targets that would fit both the rubric technology and would fit our fast farming slash like adhering technologies.

That has been boiled down to a small amount of targets that would be a potential great fit for both platforms and generating synergies with both platforms always thinking about differentiation that we can drive towards like sample mammalian made molecules, but also towards driving driving towards novel molecules that other platform.

On able to to generate and this could lead into improved efficacy. This could lead to improved safety and then where the criteria to select the target now as you know this is a discovery approach. So it's very early on we can't really disclose the target as of now but it is important to understand that we're utilizing rupert.

AI driven platform to target a very specific epitopes and then we're following up with almost like I'm hearing technology to kind of.

Improved the potency of this molecule.

And Christian with regards to our decision, making around optioning out any particular asset in the portfolio.

We really do like to maintain the optionality that we're going to have here going forward. So a lot of this will be opportunistic I suppose.

And then two where we're looking at areas of significant unmet medical need where there is.

Really interesting mechanism of action that we may have for the molecule and a significant opportunity to help patients.

And those sorts of instances, we might want to keep assets in the portfolio and advance them ourselves through.

Or at least a couple of the early stages in the clinic that said, we've got some flexibility here, particularly in immuno oncology we're in.

There's opportunities for both monotherapy and combination therapies as well so I think for right now we will be looking at the EPS on a case by case basis, but importantly, as we do though will also have the opportunity with our business model to be.

To evaluate not only.

What an out license might mean, a molecule in terms of.

The partnership revenue.

Millstones royalties et cetera, but also because we'll be putting these onto our SaaS farfetch platform.

<unk>.

In more instances theyre not there would be an accompanying supply agreement for the contract manufacturing of the molecule for clinical trials and then.

If almost make it through the commercial then that too so that's how we're looking at it.

Business model that we've set up gives us a lot of advantage AIDS.

To the point of being able to quickly and license and developed.

New molecules and advance them through and then in turn being able to out license them as well and provide contract development and manufacturing services.

As appropriate.

Sense.

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

Yes.

We're happy that you asked that because it's important to distinguish that what we're doing with two O. Two right now and what's been submitted to FDA is for intramuscular delivery. So that is on its own timeline and regulatory pathway. Our intent right now is to continue to drive.

Behind and I am delivered vaccine and so it is for that particular candidate they were expecting feedback from FDA before the end of January and so the.

We have a clear path to the clinic.

Would be proceeding with it.

Intramuscular delivery.

That particular.

Antigen adjuvant combination.

What we're announcing today goes more fundamentally to our vaccine platform. If you will so not only let's say manufacturing and in June.

As we would do with SaaS farming also having access to certain adjuvant technologies for instance, with <unk>.

The infectious disease Research Institute, but what we also believe strategically.

It is important not only for COVID-19, but presumably for other infectious diseases down the line is that.

Traditional way of delivery through I am injection doesn't really do much for.

Mobilizing.

Access to a vaccine in the amount of another pandemic right. So what is it better way to do this with the technologies that are emerging we believe that these micro array patches.

Well provide a much better pathway forward such that.

One could.

If all the technologies, we're able to come together.

Be in position, where you could mail out the vaccine.

Two people and they could.

Respectively self administer it so we think given the way that particular delivery technology has matured now's the right time for us to look at it now this is not to say that we couldn't also at some point.

Decide to produce a COVID-19 candidates that utilizes microarray patch for the delivery system, we could but that is a that is a separate track. So I don't mean to go on too long about that but does that clarify well and often can answer the question.

Yes. Thanks I appreciate it and then I wanted to ask about some of the supply chain disruption that we've seen across the country and the uncertainties around if this is something that's going to stay long term, but maybe you can touch upon from the plant based manufacturing standpoint anything that you think a standout here advantages.

Might have or anything else, we might consider along with some of these disruptions that are occurring.

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

The upstream is what's novel here for us that is where the protein gets expressed the traditional way of doing it is in with medallion sells oftentimes in the mountains and so culture, where.

Whereas in our case, we express it in a plant the downstream happens to be the same why do I share this because some of the.

Supply chain disruptions that occur on the downstream.

Back to us as well as our competitors.

And since the entire process is linked you can't do one without the other.

If there are supply chain issues on the downstream ultimately that impacts our ability to move forward just like it would any other competitor in this space.

That said one of the points there.

We're trying to underscore and emphasize especially as it for.

For instance, in the United States.

There are initiatives underway in legislation working its way through to bring home if you will.

A lot of biologics manufacturing it in that regard at least on the upstream side when you compare us to these other systems that utilize mammalian cell culture. There's oftentimes a lot of single use plastic disposables that are involved.

They've been very hard to get in this current.

Our supply chain Crunch, and we get to avoid their use so there there's less risk in the supply chain for us going forward because our raw materials are you now.

So you've done a little bit of water and you know some light.

So we're better positioned and have less risk to our supply chain of our competitors in that regard but is.

This hopefully more is done with regards to manufacturing USA. If you will then we believe that that's a better way to do biologics manufacturing anyway, not only by sourcing.

A lot of the raw materials here in the U S. But also because it's more sustainable you know one of these.

Backs that's out there is that while some may perceive the pharmaceutical industry to be a clean one in fact, the industry is 55% more emissions intensity than the automotive industry.

So we believe of course that green production of recombinant proteins is the way to go so you know not only.

Would one.

Would the industry be better positioned at least for the United States, where it to switch to what they asked farming plant based production system, but obviously.

Also having a.

Lighter carbon footprint is is a good thing too we believe so.

It's tough out there for all the competitors just to sort of sum up on the question is that we do see some impacts, particularly as it pertains to our downstream.

Raw material access.

Not anything that right now jeopardizes the development timelines that we have for our current products and for our customers.

Okay. Thank you so much for answering my question.

Yeah.

Interesting.

Next we have a Norman Carlyle private investor.

Your line is open.

I appreciate the time.

Question really surrounding your COVID-19 vaccine development program as you know on March 26, 2020, I buy announced the advancement of the COVID-19 vaccine program.

About 200 during the fourth 2020, I buy announced a second COVID-19 vaccine program with the birth of Ivo Buyouts, you got one.

Then you got to Sunday evening July the 19th on 2020 and article or so at least by the Battalion, Texas A&M titled and M. Experts offer updates on COVID-19 vaccine testing on campus Doctor James Sanyal, who is the head of the microbial department.

But they're a pretty detailed timeline within that article basically, saying hey phase one.

He began around 2021.

A potential phase two and three in April 2021, as well and then he went out to say that maybe we will have data accumulated about the protection Hampton by early summer 2021, as you know the following week bye.

How 'bout share price rocketed.

Two $7 45 a share.

Kenneth Dart then went on to basically divested assets in profit nearly $100 million in cash.

Would you like to maybe comment on whether Doctor James saying was authorized to speak on behalf of vial and then two I would like to give you an opportunity to maybe share your timeline on your COVID-19 vaccine development program.

Yeah, Thanks, Norman until the question and.

This was quite a time back then.

Good.

And our we've been pretty consistent with our communications all the way through and in particular as we got into summer of last year.

Was apparent to us was that we do.

Despite having.

And invited submission to BARDA Oh gosh.

The March April time claim it.

It was it was becoming clearer over the summer.

Operation Warped speed was going into effect and that there was a select few number of.

Companies.

That were identified to receive substantial government funding.

So irrespective of communications in the activities of any third parties.

Where we were at that summer a point in time was trying to evaluate strategically what was going to be the best path forward Fry bio and its shareholders visa the our abilities to produce a COVID-19 vaccine now once again unlike the other.

Participants that were selected for operation Warped speed, we at that point in our history of course not.

<unk> been a biopharmaceutical developer per se right. It has been done using our technology work had been done for others, but I bio itself didn't have clinical trials experience, where as you know, but darn it had been at it for 12 years Novavax about the same beyond tech et cetera. So.

Okay. The realities of the situation, where such that as we got through the summer we had to make the decision.

Could we be in the game and prospectively provide a solution here that could be useful and address problems that these other vaccines that were.

Making their way very swiftly through the clinic could could solved and I think credit to the pharmaceutical industry overall four chipset are amazing.

Amazingly rapid solution to a global pandemic. So that's obviously a huge win for the industry that these vaccines, where can fill up so quickly and were effective.

But as we then moved ourselves into the fall.

And again this is before.

Any of these new very instead emerged most notably the British one right.

We took a step back and said, okay, well, we didn't get picked her operation Warped speed, you've got Pfizer and Madera about to be approved and then easy and J&J. Shortly afterwards it appeared.

And so that's why we took the decision to say okay based on some literature review that we had done.

Going all the way back to Sars, one mers and some of the rest that we felt that with the ability of our manufacturing platform and the right strategy.

In fact, if if if variance were to emerge.

And to do so quickly than an answer might be to come up with a different antigen that wood.

Maybe not have some of the risks if these variance quarter to emerge. So that's when we took our first steps I think internally my timeline I think we made that decision around October.

2020, so that's that's what I'd say to all the abnormal is that we were evaluating the.

Our relationship with the government operation Warped speed the development of the pandemic and at this moment in time I'd say, we're happy that we chose to explore the nucleocapsid based subunit vaccine. We're happy with the data that we have we think that the news they will.

Seeing around the development of the pandemic.

Is suggestive of the value that a vaccine candidate like the one we're working on.

It could be recognized and we're of course hopeful.

The regulatory process.

It'll be such that we do have a path forward here and not just to get into the clinic for the sake of getting into the clinic, but too much to that daily strategy that we outlined make a real difference and address some unmet medical needs and and hopefully with this pandemic going the way it is.

You have the ability to make a contribution heritable space. So hope that makes sense and that's that's how we see the timeline, but we're we're pleased are committed to continuing to take a bio two O. Two forward here and then as you heard in.

Remarks that we made earlier, but looking at our core.

Platform technologies for our future vaccines as well by way of example that microarray patch.

Partnership we're working on now.

Next we have Philip Barnett shareholder your line is open.

I missed or is it nice to meet you via phone and thank you for taking my call.

A lot of questions here, but you know given the format.

Going to jump into a couple.

First just a commentary on the reverse split.

The worry for many investors here is not.

Not just the current one at hand, but the combination of the previous one to 10 split the ensuing dilution over the subsequent years and now risk of another.

<unk>.

I think the best way to get that stock price shop us.

To produce results tangible results I mean, we have an incredible pipeline.

I really look forward to to that developing here, but.

The questions here as far as I Bio 100 goes there's great update today concerning.

Our move into the oncological space here with with 100, but I'm wondering you know what progress have we made in the fibrosis scleroderma space.

I mean, we were collaborating with Doctor friend Golly Boswell back in 2015, we were granted orphan drug status by the FDA in 2016, we've had great preliminary results I believe.

Even saw sentence, suggesting disease reversal on this.

Why aren't we push them forward, where we've already seen great success, and instead moving into a new oncology space, especially when funds are already tight.

Okay.

Yes fill up well it's.

Nice to meet you too and thanks for the questions and.

I'll kind of go on order with regards to the reverse split.

Right. This is about producing results and part of the way in which that gets done is taking the business model from where we were before and offering fast farming services out to an industry that was unfamiliar with plant based production.

And without a track record being built was a bit of a challenge and you know quite frankly, the company was trying to appeal to people like me who were skeptical.

About the platforms. So we believe that the strategy change that we made.

Is a very good one because we're now demonstrating what the platform can do.

And by way of example, here's here's results. We've made these investments and have rapidly built a pipeline.

<unk>.

<unk> assets and in particular, some pretty interesting ones in oncology and we're showing the comparability of the platform while at the same time, you know the speed scalability.

The ability to modify the molecules to affect greater potency.

At least in the laboratory so we.

We're actually quite pleased with the progress and we think this is going to be and is already readily evident.

Some of the new partners that we have so we're building up our datasets.

The proof in the pudding. So I think that's all good and then with regards to I buy a 100 youre right to ask the question because we don't want to be.

Suggesting that somehow we're getting distracted or.

One.

Adds another asset then okay, well what what happened.

<unk> hundred for fibrosis so.

I hope you'll be pleased to know.

Program is alive and well as we shared earlier, we are anticipating moving into the clinic here in FY or towards the clinic here in FY 'twenty two.

So.

We have you mentioned Doctor Carol for Gateway Bostwick.

She is acting as an adviser along with two members of our board of directors with scientific background.

And we're continuing to advance the molecule forward and of course as we have updates.

Will will produce those in a timely fashion on this particular call.

We're still just moving through.

Some of the setup work here.

Here for that particular molecule, but it is on the track.

That we have and we are.

Expecting and hoping of course that everything will proceed. According to the plan that we have out there such that we're in position to move will.

Will do.

Let me, let me make sure I get this right I would say that we want to be in position to actually get into the clinic in FY 'twenty, three but taking certain steps towards the R&D, enabling studies in the filing here in FY 'twenty two.

That's I mean, that's great news and I appreciate that update.

It sounds.

Like you said everything is alive and well and that's.

That's awesome.

The next question you mentioned potency of our platform.

That leads into my next question.

We've had a rituxan rituximab bio better and our pipeline for several years now.

Remember and I buy a release, stating the anti body dependent cellular cytotoxicity was increased 30 fold potency.

Rituximab is one of the most prominently utilize oncology drugs I'm wondering what what results have been made on that.

And.

Both in the U S and then in regards to the partnership with <unk>, China there.

Yeah.

Yes, so we.

We have announced two partnerships both cc farming.

<unk> clients as well as a south African entities by the name of Allergan.

We are in we.

Were identified as the contract manufacturing.

Manufacturing partner for them. So you know what.

Those instances the client drives the bus in terms of development for there.

Geographic areas of interest.

So.

I can say that we still have allergan.

<unk> acquired a lot of the work that we did.

For Cc farming.

Did wrap up successfully so they're strategic decisions to pursue or not pursue.

A rituxan biosimilar.

Biosimilar a bio better.

Are really driven by them as clients, so needless to say I can't.

Comment on confidential client relationships other than what we've already put out and the prices that they had agreed to.

I think it's very fair to say that the data that was obtained in those projects and also in the work that we did in published independently on Rituximab.

Supported very much so.

Or like an earring technologies and how through.

Putting sugars on the right way, we're not putting certain sugars onto a recombinant protein can increase the potency and in fact.

This is what we were alluding to with the news that we just shared today about the comparability data that we have with the rubric molecule, what's our buy a one O. One made in plants and what was their <unk> zero, three meda and traditional mammalian cell culture that <unk>.

Been able to produce the high potency product and had a tremendous comparability. So.

As regards the platform is continuing to demonstrate.

The quality aspects and performance that we've said that account.

Yeah.

Alright, well I guess last question follow up on that so.

We are working on the Rituximab with Cc farming.

We work with Allergan in South Africa are there any.

Domestic U S efforts to commercialize the rituximab.

Okay.

We don't have that as a molecule in our pipeline as you will note a mill.

All right I guess by you.

You could say well how can I note that given that we've got a handful that are undisclosed so paradigm.

I think I can safely say that from the standpoint of our strategy. We are not looking to advance a rituxan biosimilar, a bio better ourselves as one of our own programs at this time I could always change, but it's not one of the molecules. It's listed in our current pipeline.

I think in every instance, we will want to use our investors' dollars.

In a very responsible way to really address major unmet medical needs.

And significant market opportunities at the same time and while Rituximab itself has got a very large global market. There are a lot of players in there the biosimilar and bio better space is crowded competitive.

And there are certain country to country issues that are associated with it so.

When we look at the United States right now, we don't believe that that particular opportunity is attractive enough for us to take dollars from these other programs in our platform investments to pursue.

But of course if.

If market conditions change or there's a technological advantage that we could identify.

We would we would always be in position to reconsider that.

If that makes sense for them.

And your last question is from David Sandrock private Investor Your line is open.

Hi, Thanks for taking my question.

You noted you were awaiting feedback on the <unk> pre IND package.

Earlier this year in September was the intent of that submission to have a pre IND meeting with the FDA and if so has that meeting happened already or is it currently scheduled.

Yes, I mean, I'll, let Martin will start us off.

And then follow up as appropriate margins.

Yeah, absolutely so.

So we have submitted a package to the FDA request again pre IMD meeting, but as you can imagine due to current ongoing approvals of existing vaccines. The agent has told us that it would take a little bit more time, but the goal is to sit down and in this case very likely being a phone call with the agency to discuss.

Plans, how we can move up to two in the clinic most efficiently.

C being absolutely sure that we're not changing any patients.

And this is the goal of the pre IMD meeting.

And compared to this time last year, our experience with the agency was very favorable and Swift. So when we followed up for a pre IND request I mean, it was it was a matter of weeks to get a response I think it was.

Something like under two months, what we are seeing now like others is that unless wanted in a certain category a lot of a lot of the reviews are.

Taking upwards of four months, which is why.

We commented that we're assuming that we'll hear something back before the end of January of course.

The regulatory review and process is what it is and we don't have any control over that.

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

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

Great. Thank you operator, and thank you everyone for your time and attention.

And look forward to updating our next call and as always we'll be sharing.

Any material information, but in the interim thanks again, everyone.

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

Okay.

[music].

Good day, and thank you for standing by and welcome to the eye by your fiscal 2022 first quarter financial results Conference call. At this time, all participants are in a listen only mode.

After the Speakers' presentation, there will be a question and answer session.

And you asked the question you will need to press star one on your telephone keypad. If you require any further assistance. Please press star zero.

I would now like Johanna conference over to Stephen Kilmer.

Investor Relations. Please go ahead Sir.

Thank you good afternoon, everyone.

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

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

On the call today, representing the company are Mr. Thomas <unk>, Chairman and Chief Executive Officer, Dr. Martin Brenner, our Chief Scientific Officer Randy.

Our chief operating officer, and Rob <unk>, the company's Chief financial and business officer with.

With that said I'll now turn the call over to Tom.

Thank you, Steve and Hello, everyone. I am pleased to report another highly productive quarter for <unk>, bio where and we continue to execute on our strategic plan by creating partnerships and assets that have the potential to generate significant shareholder value.

For instance in the six months since we announced we would build our own drug discovery capabilities. We have already added six new assets to our pipeline.

We added three immuno oncology programs in July and entered into a research services agreement with fair journey Biologics. It gives us access to novel display technologies and proprietary antibody libraries.

We followed that up a month later in August when we entered into a definitive worldwide exclusive license agreement with <unk> therapeutics, another oncology assay to our pipeline.

Specifically, we secured rights to an antibody that targets and depletes regulatory T cells.

Those are the type of immune cell that hinders the body's ability to control the growth of tumors.

We're moving the molecule onto our SaaS farming system as part of the <unk>, One program and thus far the high potency version of the antibody, which has made implants with our like nearing technology is highly comparable to the version liberate produced using traditional mammalian bio production method.

And we're looking forward to publishing our comparability data as we work to bring this really promising immunotherapy candidate into the clinic.

Right now as you May recall license agreement with her break we chose one part of the relationship that we have established with them.

We also entered into a research collaboration we have the option to license additional antibodies built using robotics AI driven discovery platform.

Gaming assets access to that platform is consistent with our approach to use cutting edge technologies like machine learning to increase the speed of discovery and development of clinical assets and thereby create more shots on goal.

To that end, we're thrilled to announce today that we've identified the first pipeline target emanating from the research collaboration with Burberry that commenced in mid September.

We have yet another announcement today related to our strategic focus on oncology, specifically, we initiated a research collaboration with the University of Texas Southwestern Medical center to explore the use of our anti fibrotic <unk> four molecule in the treatment of cancer.

Hi, Bio is currently developing a four molecule is <unk> 100 for fibrotic diseases, but along with UTI study you are world renowned cancer Research Center. We believe there is potential for the molecule to help inhibit the growth and metastasis of solid tumors too.

So overall, we're pleased with the speed with which we've been able to stand up our oncology discovery and development programs.

Seven people into our San Diego based discovery team secured access to artificial intelligence and antibody display technologies to marry up with our like an arrogant paas farming platforms.

<unk> partnered with a major cancer Research center to explore a first in class mechanism of action.

We're even more pleased with the results of our investments, meaning six promising new assets added to our pipeline in just six months.

Now to our infectious disease pipeline, we are awaiting feedback from FDA on our pre IND submission for a lead COVID-19 vaccine <unk> hundred two.

We were advised by the agency that their review is likely to take several months. So we're assuming we will be able to provide an update before the end of January.

As a reminder, bio two O two is being developed with our Davey strategy in mind Dave.

<unk> is our acronym for durability access and variance included.

We believe that there are needs in each of those areas that are currently unmet by commercially available spike protein based vaccine.

We believe that those needs may be better addressed with a nucleocapsid antigen based vaccines like the one that we're developing.

For instance, presentations at the recent world vaccine Congress indicate that the nucleocapsid or N protein plays an important role in generating a durable immune response and then an end based vaccine could be an important weapon to have in our Arsenal in case of the emergence of a variant that could escape the fight back to them.

Also some peanut protein vaccines like ours could increase access by avoiding certain cold chain challenges that face the distribution of the mrna vaccines in some parts of the world.

On another note related to accessibility, we're pleased to announce that we've executed a development agreement with a leading innovator of microarray patch delivery systems.

Microarray patches are applied painlessly under the skin like a bad day later.

Later in the call our Chief Scientific Officer, Dr. Martin Brenner, who will provide a more detailed overview of this development as well as all of our vaccine programs.

So having touched on our key pipeline accomplishments I'd now like to focus a little bit on <unk> fast farming manufacturing capabilities and services.

Our ability to position the groundbreaking potential of S farming sustainable plant based production process has never been stronger.

On November 3rd we announced the acquisition of the remaining 30% equity interest in our <unk> subsidiary.

Through this strategic transaction I bio now has full control of our 130000 square foot manufacturing facility as well as the CMO entity, which holds the exclusive rights to produce biologics using the paas farming system in the United States.

During the call are CFO, Rob Lutz will provide some more details behind this acquisition.

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

When Covid first hit we did not have an active government relations program to leverage but since that time, we've built capacity and capability to interact with the U S government.

We're now engaging with the senior leadership of both political parties to help build awareness interest and more funding for rapid sustainable domestic plant made biologics.

While securing non dilutive funding via government grants or partnerships isn't easy.

We're aware of a number of legislative efforts, which I bio's technologies and manufacturing capabilities could be upset. These include initiatives such as the funding for aspirin BARDA and the current appropriations Bill Here's two point now manufacturing USA ARPA H and buy American to name just a few.

Thus, we plan to continue to pursue opportunities for public partnerships in the U S as well as non dilutive funding sources outside the United States.

Thank you Tom I'm excited to share some updates on I thought it was probably a biopharmaceutical pipeline and drug discovery activities.

I buy a one on one the IL two sparing anti CD 25 antibody we have licensed from a real break is progressing as expected the team in San Diego has started to establish the preclinical pharmacology five by a 101 and we are pleased with initial results show that the kiln produced with a fast farming and black and drilling technologies is equally potent and if a case.

This is the mammalian cell <unk> antibody in cell based assays PK studies have been initiated and we're expecting the first yourself before the end of this year.

As Tom pointed out our strategic partnership with <unk> also granted US an option to license additional programs that are being developed with rubrics AI enabled discovery engine I'm excited to share today that the first of these programs has been started although we will not disclose the identity of the molecule that targets at this stage. It has been specifically selected.

Given the advantages, we expect to realize from blueprints predictive algorithms and I'm biased nearing technology.

For this program, we are specifically employing rubrics AI platform to generate massive scale engineered molecules, which would recapitulate confirmations and dynamics of subdominant epitopes, some target proteins presenting such epitopes instead of full length proteins allows men programs in vitro selections to rapidly and routinely discover.

Diverse panel of antibodies binding to otherwise inaccessible epitopes, we will provide updates in the future as the program progresses through the different discovery stages.

With a particular emphasis on extracellular matrix and angiogenesis as Tom mentioned many of you will recognize that E molecule as I buy on 100, which we continue to develop for two major fibrotic diseases, systemic scleroderma and idiopathic pulmonary fibrosis.

There's different context of oncology, we will be exploring the potential of using endostatin equal to target the tumor microenvironment to enable or improve the efficacy of existing chemotherapeutic.

College, he drugs targeting the tumor microenvironment has become an area of high interest for drug developers in recent years. Among all the cells that are present in the tumor microenvironment cancer associated fibroblast or caf or one of the most abundant and critical components of tumor tissue, which provides support for tumor cells and can promote all.

It's hard to more of a genesis in a context dependent manner.

<unk> also involved in the modulation of many components of the immune system and recent studies have revealed their rules and immune evasion and pool responses to cancer immunotherapy. In addition, cats and the extra cellular matrix. They are producing can lead to highly variable responses to chemotherapy.

Through a series of plant in vitro and in vivo studies collaborations will evaluate the potential of the anti fibrotic effects of iOS and just studying a molecule to improve the efficacy of concomitant treatments, such as chemotherapy and immunotherapy in Kansas with strong fibrotic component.

I will now provide an update on <unk> two two hour and protein based COVID-19 vaccine program.

While we are waiting for feedback from the FDA on our pre IDE submission, which we expect sometime before the end of January we have made further progress on <unk>, two and I'll, let Debbie strategy.

And our initial preclinical findings we have conducted a dose range study ranging study that further informed all formulation strategy and will allow us to significantly reduce the dose.

I'm also pleased to announce that we executed an agreement with a leading innovator of microarray patch delivery systems to explore the feasibility of administering on bio two O two intradermal <unk>.

Microarray purchase a minimally invasive truck application devices that can be applied directly onto the skin. They contained micro needles, which painlessly penetrate the upper layers of the skin and to solve rapidly, thereby reducing their truckload vaccine payload.

This intradermal.

Delivery method may allow for vaccine self administration, creating a more accessible alternative to intramuscular injections, not only that but by targeting the large pool of immune cells residing in the skin delivery of vaccines using patch technologies may elicit an enhanced immune response this could yield increased durability while concurrently.

Ignoring cost due to the lower dose requirements.

Turning now to our animal health activities I'm happy to report that we continue to advance our classical swine fever C. S. F vaccine candidate I buy a 400 through the USDA sensors for veterinary biologics regulatory process. Additionally, we have announced today that studies are now underway at Texas.

University system to evaluate alternatives to I am injection of IL 400, including an oral dose option. We're excited about the prospects for oral dosing given it is an easier and friendlier way to vaccinate animals and it typically provides for lower cost of goods.

I'd now like to turn the call over to our Chief financial and business Officer, Rob Lutz, who will provide an update on all financial myself well.

Thanks Martin.

They're then reiterate the details on the company's financial results, which are available in our press release and the 10-Q I will simply speak to a few financial highlights.

Revenues for the first fiscal quarter of 2022 ended September 30th or $210000, a decrease of 49% versus the first quarter of fiscal 2021.

Significant quarter to quarter revenue variability commonplace for early stage pharma services companies to have a small number of clients and due to the timing of revenue recognition.

As expected, both our R&D and G&A expenses for the first quarter of fiscal 2022 were up meaningfully over the comparable period in fiscal 2021.

This reflects the continued need to invest in our growing pipeline our platform technology, our employees and related infrastructure.

We expect this trend to continue but the rate of growth is expected to moderate over time.

In terms of liquidity high bio at $82.3 million in cash marketable securities and investments and debt securities as of September 30th 2021.

After spending on operations Boston Best in the group with therapeutic transactions.

I buy also recently announced it used approximately $6 million in cash.

Taking on debt in order to purchase its manufacturing facility in Bryan Texas.

That purchase is meant to be the first step of a two step process.

The second step.

And then attempts to sell the facility to a new investor and lease it back with better terms than we had previously.

If successful this would allow us to pay down the debt and potentially recover our $6 million investment or <unk>.

Even make a profit.

A new investor might also funds additional capital expenditures for the facility, which could improve our cash runway outlook in the near term.

While there is no guarantee we can accomplish the second step.

For less space in the U S had been strong recently.

We can complete a sale lease back we continue to believe our cash position remains sufficient to fund operations through the third quarter of fiscal 2023.

However, if you can't we've concluded there is sufficient liquidity to fund operations through at least the second quarter of fiscal 2023.

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

Tom.

Thanks, Rob.

So we are off to a very strong start to our fiscal 2022 as you can see.

And much as we are pleased with the pipeline growth and development of our biopharmaceutical candidates today.

Main committed to scaling this growth with additional new candidates and partnership opportunities going forward.

We are confident in our strategy and that our in house talent and capabilities are better than ever.

We are also optimistic about the continued growth of the bioprocess products and services.

Now before opening up the Q&A session I would like to address our shareholders with respect to the upcoming annual meeting scheduled for December nine.

Thus far we've been pleased to see a high level of engagement and debate and to facilitate the continued dialogue. We previously posted a Q&A page on the investors section of our website.

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

I'll turn it over to Steve to Tee those up for Us Steve.

Yes, Tom Thanks.

It's one that we got a lot.

This year's propose proposal different than last year and why the change.

So last year's proposal was for an increase in the authorized share count only and although we had 55% of respondents voted in favor of the increase we did not have enough total votes to reach a cool.

So this year's proposal differs in that it also results.

Our results in a net increase of the number of an issued authorized shares but the board of directors recommended a reverse split to so that the stock price might be more attractive to certain institutional investors as well as retail shareholders.

Okay, Here's another one.

You reported having over $82 million in cash so why do this now.

So this is necessary to support the growth of our proprietary pipeline as was done by way of example, with the rubric opportunity and the ability to flexibly excess capital when market conditions are favorable and of course critical for our future growth and our ability to drive shareholder returns.

Our annual shareholders meeting is of course also the appropriate time and venue for asking our investors for this added flexibility.

Great last one why reverse split at the expense of retail shareholders.

Okay.

Alright, well, we recognize there is an underlying concern from some retail shareholders about the potential for stock price depreciation following a reverse split right. So frankly, I think that concern is often justified, particularly in cases, where a company who is doing it primarily to avoid a delisting.

It was a good example of the two sides of this coin.

So back in 2018 and this is before the current management team joined the company I Bio completed a one for 10 reverse split.

The company didn't have the news flow, nor the quarterly investor calls or the expanded clinical pipeline or progress in it services business that we do today.

So I bio quickly experienced price declines all the way down to five cents a share.

In the absence of any immediate and significant progress in the C. D M open.

So now juxtapose that with where we are presently with a today with a strong cash position demonstration of the performance of the SaaS farming platform and.

A growing list of biopharmaceutical assets in our pipeline and in some of these high value areas, where there's tremendous unmet medical need particularly in oncology.

And of course, that's not to mention the.

The ongoing prospects here related to the pandemic and I bio two O two and there's still many unmet needs that are out there. So the board is recommending this move now in the hopes that it will benefit all of our shareholders retail and institutional alike, because we continue to execute on our strategic plan.

To address these important unmet medical needs and realize our vision to make sustainable SaaS farming the preferred alternative to traditional medallion bioprocess.

So.

Steve Thanks for teeing, those up and are allowing us to talk through them, they're a little bit so I'm sure there's likely more questions on the proxy or the quarterly highlights.

Before we open up the line for questions I'd also like to remind our stockholders how to vote their shares.

So either way you decide so.

So you can locate the control number on your proxy card or voting instruction form and follow the voting instruction.

If you don't have a proxy card or voting instruction form shareholders in the U S and Canada can call Okapi partners at a 442 O 336 O five or from other locations at plus 1212.

2970720.

And that would be from the hours of nine a M. Eastern time to eight P M Eastern time Monday through Friday.

So thank you all and with that we're happy to take any questions you might have operator.

Thank you Tom.

Two our audio attendees if he would like to register a question. Please press the star followed by the number one on your telephone keypad.

If your question has been answered and you would like to withdraw your registration. Please press the pack one moment for your first question.

Yeah.

And right and our first question is from Chris.

Kristen <unk> from Cantor Fitzgerald.

Your line is now open.

Hi, good afternoon, everybody. Thanks for taking the question. The first one I had is I know youre not disclosing the individual new target related to the partnership with the rubric, but given that it occurred just two months. After the collaboration could you help us understand based on the combinations of each of the coming.

Any platforms, what specifically, let's be than perhaps what might have been the case without it and then what's going to be the gating factor or what would you potentially look for to decide whether or not you want your option for additional targets.

Yeah, Great question, Kristen Martin wants to take the first one and I'll take the second one.

Absolutely.

Well Kristen so what we've done is we have we gone through an entire assessment off the target space. If you will.

And have identified targets that would fit both of Rupert technology and would fit our fast farming slash like I'm hearing technologies.

That has been boiled down to a small amount of targets that would be a potential a great fit for both platforms and generating synergies with both platforms always thinking about differentiation that we can drive towards like sample mammalian make molecules, but also towards driving driving towards novel molecules on the platform.

I'm, sorry, unable to to generate and this could lead into improved efficacy. This could lead to improved safety and then with the criteria to select this target now as you know this is a discovery approach, though it's very early on we country do you disclose the target as of now but it is important to understand that we're utilizing rupert.

AI driven platform to target a very specific epitopes and then we're following up with all cloud computing technology to kind of improve.

Improved the potency of this molecule.

And Christian with regards to our decision, making around optioning out any particular asset in the portfolio.

We really do like to maintain the optionality that we're going to have here going forward. So a lot of this will be opportunistic I suppose, but then to where we're looking at areas of significant unmet medical need where there is a really interesting mechanism of action that we may have for the molecule.

And a significant opportunity to help patients.

And those sorts of instances, we might want to keep assets in the portfolio and advance them ourselves.

Or at least a couple of the early stages in the clinic that said, we've got some flexibility here, particularly in immuno oncology where in.

There's opportunities for both monotherapy and combination therapies as well so I think for right now we will be looking at these on a case by case basis, but importantly, as we do that will also have the opportunity with our business model to be.

Able to evaluate not only.

What an out license might mean of our molecule in terms of.

The partnership revenue milestones royalties et cetera, but also because we'll be putting these onto our fast heartbeat platform.

<unk> in more instances theyre not there would be an accompanying supply agreement. So the contract manufacturing of the molecule for clinical trials and then.

Almost make it through the commercial then that too so that's how we're looking at it for me.

Business model that we've setup gives us a lot of advantage.

Aid to the point of being able to quickly and license and develop.

New molecules and advance them through and then in turn being able to out license them as well and provide contract development and manufacturing services.

As appropriate.

Makes sense.

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

Yes.

Behind and I am delivered vaccine and so it is for that particular candidate that we're expecting feedback from FDA before the end of January and so the if.

We have a clear path to the clinic.

Would be proceeding with an intramuscular delivery.

That particular.

Antigen adjuvant in combination.

What we're announcing today goes more fundamentally to our vaccine platform. If you will so not only let's say manufacturing and in June.

As we would do with SaaS farming also having access to certain adjuvant technologies for instance, with <unk>.

Adrian the infectious disease Research Institute, but what we also believe strategically.

It is important not only for COVID-19, but presumably for other infectious diseases down why is that.

Traditional way of delivery through I am injection doesn't really do much for.

Mobilizing.

Access to a vaccine in the amount of another pandemic right. So you know what is it a better way to do this with the technologies that are emerging we believe that these micro array patches.

Well provide a much better pathway forward such that you know.

One could.

If all the technologies, we're able to come together.

Be in position, where you could mail out the vaccine.

Two people and they could.

Yes. Thanks I appreciate it and then I wanted to ask about some of the supply chain disruption that we've seen across the country and the uncertainties around if this is something that's going to stay long term, but maybe you can touch upon from a plant based manufacturing standpoint anything that you think stands out here advantages.

Might have or anything else, we might consider along with some of these disruptions that are occurring.

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

The upstream is what's novel here for us that is where the protein gets expressed the traditional way of doing it is in with medallion sells oftentimes in the mountains and so culture.

Whereas in our case, we express it in our plan the downstream happens to be the same why do I sure.

Cause some of the.

Supply chain disruptions that occur on the downstream.

US as well as our competitors.

And since the entire process is linked you can't do one without the other.

If there are supply chain issues on the downstream ultimately that impacts our ability to move forward just like it would any other competitor in this space.

That said one of the points that we're trying to underscore and emphasize especially as it for.

For instance, in the United States there are initiatives underway in legislation working its way through to bring home if you will.

A lot of biologics manufacturing it in that regard at least on the upstream side when you compare us to these other systems that utilize mammalian cell culture. There is often times a lot of single use plastic disposables that are involved those have been very hard to get.

In this current.

Our supply chain Crunch, and we get to avoid their use so there there's less risk in the supply chain for us going forward because our raw materials are you now see them a little bit of water and some light.

So we're better positioned and have less fish to our supply chain of our competitors in that regard, but it is.

This hopefully more is done with regards to manufacturing USA. If you will then we believe that that's a better way to do biologics manufacturing anyway, not only by sourcing.

A lot of the raw materials here in the U S. But also because it's more sustainable you know one of these.

The facts that's out there is that while some may perceive the pharmaceutical industry to be a clean one in fact, the industry is 55% more emissions intensity than the automotive industry.

So we believe of course that green production of recombinant proteins is the way to go so you know not only.

Would one.

Would the industry be better positioned at least for the United States, where it to switch to what they asked farming plant based production system, but obviously.

Also having.

A lighter carbon footprint is is a good thing too we believe so it's it's tough out there for all the competitors just to sort of sum up on the question is that we do see some impacts, particularly as it pertains to our downstream.

Raw material access.

Not anything that right now jeopardizes the development timelines that we have for our current products and for our customers.

Okay. Thank you so much for answering my questions.

Which was.

Next we have a Norman Carlyle private investor.

Your line is open.

I appreciate the time had a a question really surrounding your COVID-19 vaccine development program. As you know on March 26, 2020, I buy announced the advancement of the COVID-19 vaccine program.

200 <unk>.

During the fourth 2020, I buy announced a second COVID-19 vaccine program with the birth of Ivo Buyouts U L. One.

Then you got to Sunday evening July the 19th on 2020.

An article or so at least by the Battalion, Texas A&M title and M experts offer updates on COVID-19 vaccine testing on campus Doctor James Sanyal, who is the head of the microbial department.

But they're a pretty detailed timeline within that article basically, saying, hey phase one could potentially begin around 2021.

Potential phase two and three in April 2021, as well and then he went out to say that maybe we will have data accumulated about the protection of infants by early summer 2021, as you know the following week.

I bought a share price rocketed.

Two $7 45 a share.

Kenneth Dart then went on to basically divested assets in profit nearly $100 million in cash.

Would you like to maybe comment on whether Doctor James saying it was authorized to speak on behalf of vial and then two I'd like to give you an opportunity to maybe share your timeline on your COVID-19 vaccine development program.

Yeah.

Okay, Yeah, Thanks, Norman until the question and was.

It was quite a tie back then.

And our we've been pretty consistent with our communications all the way through and in particular as we got into summer of last year.

Was apparent to us was that we.

Despite having an.

And invited submission to BARDA Oh gosh.

The March April timeframe.

It was it was becoming clearer over the summer.

Operation Warped speed was going into effect and that there was a select few number of.

Companies.

That were identified to receive substantial government funding.

So irrespective of communications activities of any third.

<unk>.

We were at that summer a point in time was trying to evaluate strategically what was going to be the best path forward Fry bio and its shareholders visa the our abilities to produce a COVID-19 vaccine now once again unlike the.

The other.

Participants that were selected for operation Warped speed, we at that point in our history of course had not been a biopharmaceutical development per se right. It has been done using our technology. The work had been done for others, but I bio itself didn't have clinical trials.

Periods, where as you know, but <unk> been at it for 12 years Novavax Abbas Hussain beyond Tech et cetera. So.

Okay. The realities of the situation, where such that as we got through the summer we had to make the decision.

Could we be in the game and prospectively provide a solution here that could be useful and address problems that these other vaccines that were.

Making their way very swiftly through the clinic could could solved and I think credit to the pharmaceutical industry overall for chips that are amazing.

Amazingly rapid.

Solution to a global pandemic. So that's obviously a huge win for the industry that these vaccines, where can fill up so quickly and were effective.

But as we then moved ourselves into the fall.

And again this is before.

Any of these are new very instead emerged most notably the British one right.

We took a step back and said, okay, well, we didn't get picked her operation Warped speed, you've got Pfizer and Madera about to be approved and then AZ and J&J. Shortly afterwards it appeared.

And so that's why we took the decision to say okay based on some literature review that we had done.

Going all the way back to Sars, one mers and some of the rest that we felt that with the ability of our manufacturing platform and the right strategy.

In fact, if if F variance were to emerge.

And to do so quickly than an answer might be to come up with a different antigen that wood.

Maybe not have some of the risks if these variance quarter to emerge. So that's when we took our first steps I think internally my timeline I think we made that decision around the tumor.

2020, so that's that's what I'd say to all the abnormal is that we were evaluating the.

Seeing around the development of the pandemic.

Is suggestive of the value that a vaccine candidate like the one we're working on.

It could be recognized and we're of course hopeful.

The regulatory process.

You have the ability to make a contribution here until space. So hope that makes sense and that's that's how we see the timeline, but we're we're pleased that committed to continuing to take a bio two O. Two forward here and then as you heard in.

Remarks that we made earlier, but looking at our core.

Platform technologies for our future vaccines as well by way of example that microarray patch.

Partnership we're working on now.

Next we have Philip Barnett shareholder your line is open.

I missed or is it nice to meet you via phone and thank you for taking my call.

A lot of questions here, but you know given the format.

Going to jump into a couple.

First just a commentary on the reverse split I think the worry for many investors here is not.

Not just the current one at hand, but the combination of the previous one to 10 split the ensuing dilution over the subsequent years and now risk of another.

<unk>.

I think the best way to get that stock price shop us.

To produce results tangible results I mean, we have an incredible pipeline.

And I really look forward to to that developing here, but.

The questions here as far as I Bio 100 goes it was great update today concerning.

Our move into the oncological space here with with 100, but I'm wondering what progress have we made in the fibrosis scleroderma space.

I mean, we were collaborating with Doctor for Engawa Boswell back in 2015, we were granted orphan drug status by the FDA in 2016, we've had great preliminary results I believe even saw sentence, suggesting disease reversal on this.

Why aren't we push them forward, where we've already seen great success, and instead moving into a new oncology space, especially when funds are already tight.

Okay.

Fill up well, it's nice to meet you too and thanks for the questions and.

I'll kind of go on order with regards to the reverse split.

Exactly right. This is about producing results and part of the way in which that gets done is taking the business model from where we were before and offering SaaS.

<unk> farming services out to an industry that was unfamiliar with plant based production and without a track record being built was a bit of a challenge and you know quite frankly, the company was trying to appeal to people like me who were skeptical.

About the platforms. So we believe that the strategy change that we need.

Is a very good one because we're now demonstrating what the platform can do.

And by way of example, here's here's results. We made these investments and have rapidly built a pipeline.

<unk>.

<unk> assets and in particular, some pretty interesting ones in oncology and we're showing the comparability of the platform while at the same time, you know the speed scalability.

The ability to modify the molecules to affect greater potency.

At least in the laboratory so we.

We're actually quite pleased with the progress and we think this is going to be and is already readily evident.

Some of the new partners that we have so we're building up our datasets.

The proof in the pudding. So I think that's all good and then with regards to I buy a 100 youre right to ask the question because we don't want to be.

Suggesting that somehow we're getting distracted or the one.

Adds another asset then okay, well, what what happened 100 for fibrosis. So.

I hope you'll be pleased to know.

Program is alive and well as we shared earlier, we are anticipating moving into the clinic here in FY are towards the clinic here in FY 'twenty two.

No.

We have you mentioned your Doctor Carol for Gateway Bostwick. She is acting as an adviser along with two members of our board of directors with scientific background and we're continuing to advance the molecule forward and of course as we have updates.

Will will produce those in a timely fashion on this particular call.

We're still just moving through.

Some of the setup work.

Here for that particular molecule, but it is on the track that we have and we are.

<unk> and hoping of course that you know.

Everything will proceed according to the plan that we have out there such that we're in position to move will.

Will do.

Let me make sure I get this right I would say that we want to be in position to actually get into the clinic in FY 'twenty three but.

Certain steps towards the R&D, enabling studies and the finally here in FY 'twenty two.

That's I mean, that's great news and I appreciate that update it sounds.

Like you said everything is alive and well and that's.

That's awesome.

The next question you mentioned potency of our platform.

That leads into my next question.

We've had a rituxan rituximab bio better and our pipeline for several years now.

Remember and I buy a release, stating the anti body dependent cellular cytotoxicity was increased 34 potency.

Rituximab is one of the most prominently utilize oncology drugs I'm wondering what what results have been made on that.

And both.

Both in the U S and then in regards to the partnership with <unk>, China there.

Yeah.

Yes so.

We have announced two partnerships both cc farming as a client as well as a south African entities by the name of Allergan.

We are in we.

Were identified as the contract development and.

Manufacturing partner for them so.

Those instances client drives the bus in terms of development for there.

Areas of interest.

So.

I can say that we still have <unk>.

<unk> acquired a lot of the work that we did.

For Cc farming.

It did ramp up successfully so they're strategic decisions to pursue or not pursue.

A rituxan biosimilar.

Biosimilar a bio better.

Are really driven by them as clients so.

Needless to say I can't.

Comment on confidential client relationships other than what we've already put out and the prices that they had agreed to but I think it's very fair to say that the data that was obtained in those projects and also in the work that we did in published independently on Rituximab.

Supported very much so are likely nearing technologies and how through.

Putting sugars on the right way, we're not putting certain sugars onto a recombinant protein can increase the potency and in fact.

Been able to produce the high potency product and had a tremendous comparability. So.

As regards the platform is continuing to demonstrate.

The quality aspects and performance that we've said that a cat.

Yeah.

Alright, well I guess last question follow up on that so.

We are working on the Rituximab with Cc farming.

We work with Allergan in South Africa are there any.

Our domestic U S efforts to commercialize the rituximab.

Okay.

We don't have that as a molecule in our pipeline as you will note.

All right I guess by [laughter].

You can say well you know how can I note that given that we've got a handful that are undisclosed so paradigm.

I think I can safely say that from the standpoint of our strategy. We are not looking to advance a rituxan biosimilar, a bio better ourselves as one of our own programs at this time that could always change, but it's not one of the molecules. That's listed in our current pipeline.

I think in every instance, we will want to use our investors' dollars.

Responsible way to really address major unmet medical needs and significant market opportunities at the same time and while Rituximab itself has got a very large global market. There are a lot of players in there the biosimilar and bio better space is crowded.

Competitive.

And there are certain country to country issues that are associated with it so.

If market conditions change or there's a technological advantage that we could identify we would we would always be in position to reconsider that.

If that makes sense for them.

And your last question is from David Sandrock private Investor Your line is open.

Hi, Thanks for taking my question.

You noted you were awaiting feedback on the <unk> pre IMD package submitted to the FDA earlier. This year in September was the intent of that submission to have a pre IND meeting with the FDA and if so has that meeting happened already or is it currently scheduled.

Yes.

I'll, let Martin will start us off.

And then follow up as appropriate model.

Yeah, absolutely so.

So we have submitted a package to the FDA requested can pre IMD meeting, but as you can imagine due to current ongoing approvals of existing vaccines. The agent has told us that it would take a little bit more time, but the goal is to sit down and in this case very likely being a phone call with the agency to discuss.

Plans, how we can move up to two in the clinic most efficiently.

<unk> being absolutely sure that we're not changing any patients.

And this is the goal of the pre IMD meeting.

Something like under two months, what we are seeing now like others is that.

Unless wanted in a certain category a lot of a lot of the reviews are.

Taking upwards of four months, which is why.

We commented that we're assuming that we'll hear something back before the end of January of course.

The regulatory review and process is what it is and we don't have any control over that.

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

And that concludes the Q&A session I will now turn the call back to Tom is it clear.

<unk> remarks.

Great. Thank you operator, and thank you everyone for your time and attention.

And look forward to updating at our next call and certainly as always we'll be sharing.

Any material information, but in the interim thanks again, everyone.

And this concludes today's conference call. Thank you all for your participation.

The rest of your day and you may now disconnect.

Q1 2022 Ibio Inc Earnings Call

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