BiondVax Pharmaceuticals Ltd.'s (BVXV) CEO Amir Reichman on Q4 2021 Results - Earnings Call Transcript

BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) Q4 2021 Earnings Conference Call April 4, 2022 10:00 AM ET

Company Participants

Kenny Green - Edison Group, IR

Josh Phillipson - Director of Business Development and Investor Relations

Amir Reichman - Chief Executive Officer

Matthias Dobbelstein - Professor at University Medical Center, Gottingen

Kenny Green

Hi everyone. Good day. I would like to welcome all of you to BiondVax's Webinar. My name is Kenny Green from Edison Group and I'm part of the IR team at BiondVax. I would like to remind everyone that this conference call today is being recorded and the recording will be available later today on BiondVax's Investor Relations Web site. Please note that this conference call will contain projections or other forward-looking statements regarding future events or the future performance of the company. These statements are only predictions and BiondVax cannot guarantee that they will in fact occur. BiondVax does not assume any obligation to update that information. Actual events or results may materially differ from those projected. Please see the risks identified in the company's documents filed with the Securities and Exchange Commission.

And now I'd like to hand the call over to Josh Phillipson, Director of Business Development and Investor Relations at BiondVax. Josh, please go ahead.

Josh Phillipson

Thank you, Kenny. I would like to thank everyone for attending this event. I'm pleased to welcome today our two presenters, Amir Reichman, BiondVax's CEO; and Professor Dr. Matthias Dobbelstein, who is a professor at the University Medical Center Göttingen and the fellow at the Max Planck Institute for Multidisciplinary Sciences. Amir will provide a recent business update, including our NanoAb pipeline development collaboration with Max Planck and the UMG. The progress of our in-house preparations for the manufacturing of NanoAb here at our GMP biologics manufacturing facility in Jerusalem. And he'll also provide some financial updates, including the recently announced restructuring, the pending restructuring of the European Investment Bank’s loan and our full year 2021 results, which were released last week. We are very pleased that Professor Dr. Matthias Dobbelstein is joining us on this call and look forward to hearing his discussion of some of the science behind his nanosized antibody research, where we'll highlight some of the results. Time permitting at the end of the webinar, we will open up the floor for questions and answers. You're invited to submit questions at any time via the chat box or the Q&A box on the Zoom platform.

And with that, I will hand the call over to BiondVax's CEO Amir Reichman. Amir?

Amir Reichman

Thank you very much, Josh, and thank you very much Kenny for the nice intro and opening for the nice video. So today with me, Professor Dr. Matthias Dobbelstein of University Medical Center Göttingen together we will give the presentation as mentioned by Josh, our Investor Relations Director. The recent business update for BiondVax include three points that I’ll mention today, one related to the pipeline development, the second one for the financial summary and the third one about our people.

So with regards to the pipeline development, I'm happy to share with you that we have progressed with the COVID-19 NanoAb development. We are now deep into the technology transfer from Germany into Israel into our manufacturing site in Jerusalem. Our team is fully focused now on scale up of the manufacturing process, process optimization, and then preparation for the development of an inhaled COVID-19 NanoAb that will be then later administered to seek animals to prove the concept of inhalation of NanoAb as a therapy for COVID-19.

We also have finalized the third contract with the University Medical Center Göttingen and Max Planck Institute as it relates to the NanoAb as a platform. I want to remind you that in December 2021, we have finalized the exclusive worldwide license for the NanoAb specifically for the COVID-19 treatment, and that was combined with research collaboration agreement to support us throughout the development process of that particular NanoAb, specifically with the challenges of the Omicron to ensure that we have an efficacious and strong drug against the Omicron variant of concern.

Now the recent research collaboration that was just signed with the Max Planck Institute and University Medical Center Göttingen, we’ll further expand our platform into additional, nine additional NanoAbs that will be delivered by these two institutes to BiondVax. And BiondVax will be then having an exclusive option for an exclusive worldwide license to further license for further development and commercialization of these NanoAbs.

These NanoAbs will be tackling targets that will be for the treatment of known disease with unmet medical needs, such as asthma, psoriasis, psoriatic arthritis and macular degeneration. As I mentioned before the tech transfer is started. We have acquired quite significant amount of equipment for our QC and R&D labs and further strengthened our manufacturing site so that it can fit to the NanoAb manufacturing. And we are now in preparation for GMP process scale up so that after we demonstrate the proof of concept in animals for the inhalation route of administration, we will be able to immediately after the turnaround and move to the first in human as we promised in 2023.

For the financial summary, as we just announced, we have agreed on terms for the restructuring of our outstanding debt to the European Investment Bank. The European Investment Bank has lent €24 million back the time to BiondVax, with which BiondVax has built its state-of-the-art GMP manufacturing site. The debt was due to be paid in 2023, €20 million, in '24 for additional millions of euros.

In view of the new strategy of BiondVax and after conducting a thorough due diligence, EIB has agreed in principle to extend the maturity date and the payback date of the debt to December 31, 2027. This will be paid in a bullet payout that will allow BiondVax to have a runway to complete its development of the NanoAbs for the COVID-19 and for the further indications. And the upside for EIB will be mostly provided through participation in our future net sales as royalties. And that only speaks volumes about the trust of an institute like the European Investment Bank in the well-crafted strategy of BiondVax.

We have just filed our 2021 20-F report, which is our annual financial report, so I invite everybody to go to our website at biondvax.com to review the financial reports that were filed there and also filed of course, with SEC at the EDGAR system.

As of today, as we reported as of the end of the year, we held $17.4 million in cash and we are expected to have enough cash to complete our -- to arrive up to the first in human studies for the COVID-19 NanoAbs.

In regards to the people, we have been completing now a round of hiring of top talent to strengthen our R&D capabilities as it goes with the – since required for the NanoAb development, the manufacturing and other staff to support the NanoAbs program. We also strengthened our Board with the recruitment of Mr. Jay Green, the former CFO of GSK Vaccines, who joined our Board as well.

The collaboration with Max Planck and the University Medical Center Göttingen will be showing a massive synergy effect between them and the BiondVax. We can say that BiondVax will come with a vast experience with infectious disease and recombinant protein drug development. I want to remind the audience that BiondVax has had the experience of bringing the drug, biological drug, recombinant protein drug from the pre-clinical stage up to Phase III trial that was conducted internationally over 105 clinical sites and the 12,400 participants.

So the experience is there with BiondVax. We have also, as I mentioned before, built our own manufacturing site, which is GMP grade and is said to meet the FDA and European Medicinal Agency standards. The top tier big pharma and biotech leadership experience, I can testify for myself, as having an experience of working for Novartis Vaccines in North America for several years, and then followed by additional six years of my experience working with GSK Vaccines in Belgium. These were all global roles at the high level management in both companies. Prior to that I was participating in the establishment of a venture made [VAT] company, a start-up company called [Neuroderm] that eventually was sold to Mitsubishi Tanabe Pharma in a transaction valued at $1.1 billion in cash. So I will bring also both the large pharma and entrepreneurship experience.

Together with me on the team, we have our COO that comes with an experience from Novartis. We have a Board of Directors vastly experienced from many other companies as I just explained before. The Max Planck and UGM on their side will bring a world class science and access to leading scientists. I want to remind people, for example, of Max Planck, this is an organization that has won 20 Nobel prizes over the years and two of them just in the past year for physics and chemistry. NanoAb is a platform for development of a promising potent therapies. We aim to de-risk the strategy of BiondVax by building our capabilities towards platform that will hedge the risk for the development of each of the drugs by providing us the capabilities both for the drug development, quality control analysis and of course, and manufacturing, based on the same technologies, equipment and the knowhow.

The patents that they bring with are covering the NanoAb and their manufacturing and the R&D knowledge and capabilities of Max Planck and UMG are top of the tier. Biosafety level 3 lab that we have access to through the laboratory of Professor Dobbelstein is very important capability that is quite scares, people might not appreciate. But having such access, specifically these days in a pandemic, run towards drugs to treat the pandemic, it's a massive competitive edge. So I will say that exclusive worldwide license today that we have for COVID-19 and we have an option to exclusive license additional NanoAb for further development through commercialization through these collaborations.

With that, I want to hand over to Matthias Dobbelstein, professor at UMG for further scientific explanation of the NanoAb for COVID-19 and NanoAb as a platform. Please Matthias.

Matthias Dobbelstein

Thanks very much Amir for this kind introduction, your impressive talk. And I will now focus on the use of NanoAb for therapy, as exemplified by COVID-19 therapy. But I would like to remind everybody that we will go beyond that and also are in the process of developing nanobodies against cytokines to tackle a number of different diseases. So first about COVID-19, infection by SARS-CoV-2 and what's right at the beginning of any infection of a cell by this virus is the interaction of the virus spike proteins shown in the right here and the receptor on the cell shown in blue here. This interaction is instrumental to the infection and infection could not take place without that. So here's where the nanobody comes in. The nanobody here shown in green binds specifically to the spike protein and that's how it neutralizes the virus, because it keeps the virus from binding to the receptor protein on the surface of the cell. So that's the principle that's how it works.

So why nanobodies, what makes them different from conventional antibodies that you may have heard of in the past. Conventional antibodies as you can produce them in a mouse look like shown here, it composed of two different chains and two of a kind, so it’s four change in total. And this is a fairly complicated construct, it's not too stable and it's cumbersome to produce. So these antibodies still have their merits, including in the treatment of COVID-19 but we feel that you can actually do this in a better and smarter way. And that's where the alpacas come in that you see on the right hand side. These animals produce a kind of antibody that is only composed of one kind of a chain. And you can make this even more compact by taking just this bluish portion of the heavy chain only antibody in an isolated fashion. And this small protein would then serve as an antagonist to your target, we call it a NanoAb or nanoantibody, if you will. And we may -- actually the person who is pioneering and improving this technology ever since and getting in is still early. And we are fortunate enough to work together with [Dirk Görlich] in order to further validate the activity of such nanobodies against various diseases.

So why then nanobodies? Well, one advantage of nanobodies is that you have a much larger choice after making a library out of them. If you make a conventional library of monoclonal antibodies from a mouse, we're talking about couple of 100 or at best a couple of 1,000 different clones, clones to choose from. And we can only take the best antibody that is contained in there. In contrast, the single chain NanoAb format from the alpacas allows you to make a library of bacteria phages. And those comprises many as 100 million, 10 to the power of 8 different clones to choose from, and so we can easily come up with the strongest binders to our target molecules. So what you see on the next sheet is how these nanobodies actually work against COVID-19, and work against the virus that is causing the disease, SARS-CoV-2. So here is the green cells that are actually infected with the virus and you can tell that these cells are now thoroughly infected with the virus.

But if we had exposed the virus first with the nanobodies, you see that all these infections are eliminated and we can dilute them down to 50 picomolar concentrations, there is less than one nanogram per milliliter and this is still enough to keep the virus from infecting the cell. So those are extreme antiviral potency nanobodies, and the potency can be explained by the structure that is shown here. This is the nanobodies in purple with receptor binding domain of the virus in green and what you see is that they interact on the large surface which explains their high affinity. But not only that, it's the same surface that is normally used by the spike protein to bind its receptor. So we have perfect and frontal clash of the nanobody with the binding of the receptor and that's what explains why these nanobodies would neutralize the virus at such high efficiency as we have recently published in the EMBO Journal.

So what's more, we only also tested one of these nanobodies in an animal model of COVID-19. So those are hamsters. The blue box is the -- it's the healthy hamster, the gray box are hamsters that are infected with SARS-CoV-2. And as you see, they lose weight. They are sick, they got COVID-19. However, if these hamsters have been treated with nanobodies by different routes, especially by intranasal application but also by different parental applications, what we see is that these hamsters have been a lot healthier, because they have been protected from the disease by the antibodies. So they actually work in vivo too. So another advantage of NanoAbs is actually that you can produce them at locus of goods and with high efficiency as exemplified here. This is one of the NanoAbs and it's produced in a yeast called pichia pastoris. And if you do that, you find the NanoAbs in the supernate and there, as you see it's by far the predominant protein.

There are very few other proteins, but this NanoAb, and if you calculate the amounts, you see that you can get up to 9 grams per liter of culture, that's an unusually high yield, and it easily allows you to make kilogram amounts from a standard 1,000 liter fermenter. So on top of the production, also the thermostability of NanoAbs is an advantage over the conventional [IDGs]. And actually you can heat up some of these nanobodies all the way to 95 degrees, you can boil them and they still wouldn't lose activity. And that means all production purification as well as storage are a lot easier than with the conventional antibodies, because thermostability is actually the best predictor for all of these features. So even if you reach a higher temperature along the way, it wouldn't hurt anymore and antibodies would still remain stable.

Now just to summarize the advantages of nano antibodies, as opposed to conventional Immunoglobulins that you can choose from an extremely large library, a 100 million library, to find those nanobodies with extreme affinities and neutralizing capacities. And many of these nanobodies are extremely thermo stable. Meaning that you can store and produce them much more easily. They can actually also developed rapidly, thus adapting them to the needs in therapy. They are affordable in the production and we can also further engineer them to meet any requirements for the pharmacokinetics. So I think I'll leave it with that for now. I thank the people who are involved in this work, not only the people from BiondVax but also Dirk Görlich and his coworkers who are experts in producing these nanobodies. So I thank all these people for their contributions and I thank you all for listening. And I'll be very happy to take your questions as we move along. Thank you.

Amir Reichman

Thank you very much Matthias for this fantastic and very interesting presentation. I'd like to remind us where we are on the agenda. So now after discussing the recent business update and reviewing the sciences of the NanoAbs, we will move on the NanoAbs pipeline potential and timeline. We will then conclude with our in-house manufacturing and financial highlights and then we will move on and conclude with a Q&A. So why COVID-19 NanoAb? Some of you may wonder why are we developing today a COVID-19 NanoAb why -- the COVID 19 pandemic seems to be sustaining -- subsiding. So we -- basically what we believe today after consulting with top key opinion leaders and have conducted a large market research, the vast majority of the experts and epidemiologists today believe that COVID-19 will be -- unlikely to be eliminated, as mentioned by Anthony Fauci in December 2021 and let alone be eradicated. It will probably continue to circulate indefinitely in periodic outbreaks and endemics.

Now we know today that vaccinating the population shows high efficacy in the fight against the pandemic. However, development of vaccines require also the use and inoculation and introduction to very high percentages of the population, the more infectious the virus is the higher the compliance and use of the population that is required in order to have high efficacy and protection. It’s been demonstrated in the past couple of years, achieving a very high percentage of the population being vaccinated is a very tough task to take. Now if we want to move on and remove the masks and move to normal lives, we will need to have in addition to the vaccines that will have to be adapted from time-to-time also an arsenal of therapeutics by all vaccines targeting directly to these mature market of COVID-19 disease, and adding to the arsenal of -- and solutions and very important therapeutic agents. We believe that our therapeutic agent for COVID-19 as just been demonstrated by Matthias is going to be highly differentiated from the current drugs that mostly has been approved through an emergency use authorization.

We do not believe that these drugs are sustainable for the endemic and day-to-day market because of their high costs, highly complex manufacturing process and the very high doses that one should be administered with, and also the route of administration that requires an IV injection that basically brings all these treatments to the outpatient facility and the specialists. We think that in mature market we want to focus on drugs that will bring the therapy towards the primary care to the GPs, drug that should be self-administered, our is going to be inhaled, that should have very low adverse events profile. And ours is expected to be that because we expect to use approximately 100 times lower dose in protein -- milligrams versus our current competitors in monoclonal antibodies. And if we're thinking about the other drugs that are now in the market, like the ones of Merck and Pfizer, these are systemic drugs that are required to be swallowed, they're all in the mouth and they need to go directly to the blood, they need to go through the liver, they have adverse effects, they have also counter indications with different other drugs while our drug will be administered directly to the affected organ, self-administered, low amount of drug and potentially much safer while very highly efficacious use.

What's more, beyond the COVID-19 pandemic, we are already working with Professor Dirk Görlich and Professor Matthias Dobbelstein, on generating the next line and wave of nanobodies. Our alpacas in Germany have already been inoculated with the antigens required in order to produce antibodies for the treatment of many diseases. For example, the asthma, psoriasis, psoriatic arthritis and macular degeneration. These are examples of areas of therapies that can benefit vastly from introduction of differentiated NanoAbs for the treatment. These are also therapeutic areas and indications with a very nice CAGR of 8% to 12%, which signals that the spread of these disease is increasing. The need for therapeutic agents that are affordable, available, safe to use, and easy to use, and convenient for the patient is there and we believe that our NanoAbs can penetrate very nicely into these markets and generate a very good return on the investment there.

What's more, these are targets that are already validated, but for treatment with antibodies. I want to take your attention for one second about risk reduction strategy that we have applied. By selecting these particular indications, we have done a derisking of our strategy. Why? In the development of a normal drug, we normally face the new molecular entity, which presents one risk, because it was never tested before. The other one is the target. Many times the target is novel, not yet been used in order to exert a clinical efficacious result. The third one is the concept, okay, what platform are you using. And the fourth one is the commercial opportunity. And here, we basically have the risk of the new therapeutic agent indeed, but we already kind of derisk it with, first, it was already checked for contact in animals by our partners and secondly, there are already NanoAbs that have been developed by others. So we know the regulators can be approved, can approve these, but they are approved for different, totally different indications for rare disease. And also here the target molecules have been validated. So the specific targets we are going after have been validated to exert clinical beneficial result for the patient. And the concept of tackling these targets with an antibody has already been proven to work.

So what are we going to do? We are going to introduce a biobetter, it's an antibody, which is a different antibody, it's a NanoAb with superior characteristics that will enable us to present the competitive edge, but the risk of success has been majorly reduced. When we look at the potential markets that we are going after, we need to acknowledge that the smallest is actually the COVID-19 is still growing. Six months ago, it was $1.6 billion in the estimate of L.E.K. research and analysis. Recent studies have already shown that it's already beyond 2 billion. We will update these estimates once we have our hands on the recent data. But on the right side, we are looking on the future, the risk targets that I've just described, because as I said, these are targets that have already been validated to generate with a billion dollar annual sales drugs. These numbers that you see here are only the numbers for sales from antibodies, from monoclonal antibodies. The total market for this therapeutic -- for these disease indications is much larger than that. Only for monoclonal antibodies, for example, treating psoriasis, we are talking about $10 billion and we are talking about CAGAR of between 8% to 12%, once we introduce NanoAb with superior characteristics that will represent better convenience for use, better safety profile, same or higher efficacy with much better economics and manufacture ability. We believe truly that we will be able to curb very nice market share.

Looking at the upcoming catalysts for the next two years. In 2022, we expect now to sign the definitive agreement with EIB. We already announced our terms with them, as I explained at the beginning. And we will be finalizing the definitive agreements, legal documents within the next few weeks. The proof-of-concept in vivo co-inhalation route of administration should be provided for the COVID-19 in animals. We are going to conduct it in a well renowned institute. We will share the news once we sign a contract. But these in vivo inhalation route of administration is going to be a major step in proving that antibodies can be inhaled directly to the affected organ. Then the other thing will be the initiation of development of additional NanoAbs towards the future targets. I explained the psoriasis, psoriatic arthritis, asthma and macular degeneration. And in 2023, we will initiate clinical trial, we will be initially initiating the first in human trials and we expect to also publish the first readout of the Phase I/IIa of COVID-19 NanoAb.

In addition to that, we expect in 2023 to conduct an in vitro study together with help of Matthias Dobbelstein for some of the future NanoAbs, at least one or two. We believe that we will be able to accomplish that already within next year. And hopefully, we will also be able to demonstrate that in animals as well. So that will generate a situation where BiondVax will already have its hands on several NanoAbs to generate truly competitive platform. We have our own manufacturing site, which is a GMP grade and also an R&D facility. It's well suited for the NanoAb drug development. We have also supplemented that with additional equipment recently. And now we are fully at scale for process improvement, process scale up and GMP manufacturing in preparation for the toxicity studies and later on first in human. Our manufacturing site is a single use equipment, which is much more rapidly -- it allows much rapid -- more rapid drug development process. It's faster to market. And it allows a much lower risk of delays due to quality control testings that are required for cleaning, et cetera when one uses a lot of stainless steel equipment. So again, this is allowing a lot of adaptable manufacturing process and it can allow us to accelerate the timelines. As I mentioned, it's designed to meet the FDA and EMA, GMP requirements and the Israel Ministry of Health, and we have a very nice capacity of manufacturing there as well.

As for the financials, we have raised $9.8 million in December 2021. We really thank our investors for their trust in helping us raising additional capital to support these programs. We held $17.5 million in cash as of December 31st. And we expect to burn approximately $1 million a month over $3 million in every quarter in 2022 towards our first in human trials. You can see on the right side the cap table of the company. We have outstanding ABSs of approximately $18.5 million, about $4.3 million are held by our Encore investor and major shareholder, and the rest are in the float by the public. So just to summarize, we have significant potential for value creation for you. We are targeting massive validated addressable markets, as I mentioned, with the pipeline of NanoAb. We have signed strategic collaboration with the two lead world leading institutes, Max Planck Institute and University Medical Center in Göttingen. Our first lead candidate is going to treat the COVID-19, and we believe it has a very strong competitive edge. Our business plan is well validated and supported by L.E.K Consulting to validate our commercial assumptions with a very large market research. We are well positioned to bring innovative therapies to market with unique large pharma competencies. And then we have several catalysts that are expected in 2022 and 2023.

With that, I want to thank everybody for listening. And back to you Josh and Kenny for the Q&A session. Thank you very much.

Question-and-Answer Session

A - Kenny Green

Thank you, Amir, and thank you, Matthias. So we'll now open the call for the question-and-answer session. So I can see that some of you have already submitted some questions. You can do so either via the chat box or via the Q&A box. And we will give a few moments for some questions to come in, and then we will start the Q&A. Okay. So our first question, what are the advantages of NanoAbs over similar therapies in general?

Matthias Dobbelstein

Okay. I think that takes me to the point that I tried to make at the end of my talk. The advantages are mainly that these NanoAb can be developed to be more potent, and at the same time more stable. That means they can neutralize their targets at lower concentrations. Meaning that you can, as we anticipate, also use lower doses with lower -- with less side effects, if any, and you can also have lower frequency of applications given the fact that these nanobodies will be degraded at a lower pace than conventional antibodies. So those biochemical advantages that I have been listed here directly translate into clinical advantages in that way.

Kenny Green

Next question we have, what are the risks using NanoAbs?

Matthias Dobbelstein

So the risks are the same as for any biologicals that you apply. So they are protein molecules, still relatively large and complex molecules as compared to small compounds. So those always have a certain risk of eliciting immune response and their NanoAb are not exceptions. But the point I would like to make here is that NanoAbs have a comparatively compact structure, they are smaller and have a very tight conformation as compared to conventional antibodies, which would at least raise the hope that those will be less immunogenic than larger and more complex molecules that are composed of several supplements of the same type. This may not be the case in each and every application, but the general tendency is that we would at least expect less of such immunological reactions. But be that as it may, those are still, as with any biologicals, this is what I would consider the major risks in general. And what comes up in top is always the on target risks. Whenever you try to neutralize a molecule, you will eliminate the impact of such a molecule and if that impact can be beneficial, you will eliminate that as well. Those are the usual on target risks that you're facing with any medical application of any drug actually.

Amir Reichman

I'd like maybe to complement the answer here of Matthias, with the fact that one of our strategies for the derisking was to select well validated targets for -- of existing monoclonal antibody treatments. So – means, we can understand that today there are already monoclonal antibodies that were well validated and regulatorily approved for the treatment of these diseases. While the NanoAbs presented molecular size of about one-tenth of these monoclonal antibodies, we anticipate that potentially the side effects will be lower than that. And also, the side effects of the targeting of these molecular targets are going to be either known or lower, because, first of all, the targeting will be much more accurate, it's very small. And secondly, these are drugs that already been approved, so the regulators, specifically FDA and EMA, have already considered the trade-off between the benefits to the patient and the risks. So our assumption that by targeting the same targets, we will be launching a biobetter while our assumption is that the risk that the regulators will think that this benefit to risk is -- tilted to the risks is quite small. So we believe that if it's going to be working, it's probably going to be approved.

Kenny Green

We have another question here. What do you estimate will be the retail cost per unit of the COVID treatment relative to other COVID therapies?

Amir Reichman

So if I look at the retail cost, for example, of the Vir/GSK, we can see that -- that was, by the way, just announced by FDA that should not be approved for use in several states where Omicron is the predominant strain. But nevertheless looking at how it was priced, it's approximately $2,000 per dose and plus about $1,000 to $1,300 for the chair time and administration in outpatient facility. We expect to price ours at substantially lower pricing, yet still be profitable and competitive. The other thing that we need to remind everybody is that ours is going to be designed to be self-administered and therefore reducing the cost for the payer also by saving the chair time, et cetera. We are always focused on the three P's, the payer, the provider and the patient.

So not only ensuring that the patient has the best drug most efficacious and safe, but also that it's affordable to the payer and more competitive to the payer and easier to reuse by the provider. And by bringing it down to the primary care, it’s going to be much better for the whole system and therefore we believe that we will be able to price it in a competitive way. We cannot predict today the exact pricing of the drug. We will be -- of course, it's too early for us to reveal such information, but we believe we can be very competitive and much more profitable from a manufacturing point of view.

Kenny Green

[Operator Instructions] So another question we have, what are the upcoming catalysts, which are coming, which means buying backs is a good investment today and we don't need to wait?

Amir Reichman

So as I’ve shown before we have a list of catalysts coming in 2022 and 2023. First and foremost is the definitive agreement with EIB, which will remove the risk of the debt repayment for the next five years, that will allow a runway to BiondVax to continue its way for development of the COVID-19 NanoAbs, and also the development of the future pipeline of NanoAbs.

In addition to that, we will be conducting the proof-of-concept of the inhalation route of administration. We have already completed the full scale, full run of manufacturing upstream purification downstream, and now we are working on formulation. And we have already started assessing specific inhalation devices with top tier inhalation suppliers and then to be able to combine the two in an inhalation system that will be used then for humans.

But in order for us to show that the inhalation actually generates a clinical efficacy science, we will test it in sick animals. It'll be a challenge study in hamsters that will be COVID-19 infected. And then in the same way that was shown by professor Dobbelstein before, we will then treat them and see how they react. And our expectations that they will react very nicely and that will show the proof-of-concept of self-administered inhale NanoAb for the treatment of COVID-19.

In addition to that, as I mentioned already, the Max Planck Institute already inoculated, or let's say, injected today alpacas, the antigens that are required in order to generate NanoAbs for the future indications and they are now receiving several boosters. And we expect that in the next months, we will start to receive the first NanoAbs transferred from Germany to Jerusalem for further process manufacturing development and then scale up and further testing, and that will bring us in 2023. So, for the COVID one, we will then expect to move to the toxicity studies and right after to the clinical trials. It's going to be, at least the COVID pandemic, is going to continue as it is now or similar, we will conduct a Phase I/IIa, but it all depends on how the disease is spreading. And then with that, it means that we will be in a position to share the first result of initial efficacy science signs in human beings, sick people treated with COVID-19 NanoAb in an inhalation mode of action.

The proof-of-concept in vitro and in vivo, we expect to work together with Dirk and Matthias to generate the new NanoAbs that we will be then transferring here to Jerusalem for scale-up to test them in animals, and in vitro first and then in animals to show that they are also efficacious for the future indications. As I mentioned before, the asthma psoriasis, psoriatic arthritis and macular degenerations are example of indications. We may also test for other indications, because these are antibodies that can be used for several indications. So each time we get to marketing approval, we anticipate the ability to do indication expansion for users of this drug in different -- in additional indications.

Kenny Green

Just a follow on question to that. When do you expect the first COVID-19 drug to be in the market?

Amir Reichman

This is very crystal ball question. Let's say -- the reason I'm answering like that is if you look back -- actually the COVID-19 drug approved by Pfizer, they were in Phase I/IIa that we now plan to have in 2023. They were there -- and let's say in July of last year and then by December, they already finished the trials of the Phase III and then they already approved, filed for submission and early this year they already got the approval to start and distribute. That was really enabled by the infection rate of the COVID, and the fact that there was no real efficacious drug in the market. However, if the COVID pandemic situation subsides and we have a lower infection rate, we expect them to have -- the worst case to have the clinical trials concluded and marketing authorization applied in 2026.

And as I mentioned, this is truly a drug for the mature market where the COVID-19 becomes part of the arsenal of diseases that humanity needs to deal with, and we would like to emphasize and basically amplified the toolkit. The arsenal of solutions that the humankind has against the disease, not only the vaccine but also several options for drug. So to the bottom-line, worst case 2026 filing for marketing approval. But suddenly unfortunately, the pandemic situation increases or becomes worsen, it means that we will be able to prove our efficacy quite fast. So it might be much shorter but it really depends on the infection rate.

Kenny Green

Another question. Are there any other companies developing NanoAbs, nano antibodies?

Amir Reichman

There are a few. So first and foremost, there was a first in Belgian, NanoAb and nanobody company, they trademarked the name nanobody. This is a company called Ablynx, they were the pioneers in this area. And they were developing nanobodies for the treatment of rare blood disease. And they were acquired in 2018 by Sanofi in a transaction valued at $4.8 billion. Their first drug was already approved and is in the market and represent sales of $130 million as of last year, and they are expected to grow up to $450 million in the coming years. Ablynx is focused on several other diseases. We look at different diseases than them. And we believe that our capabilities that are presented by the team that we have in Max Planck Institute and the University Medical Center Göttingen present superior antibody arsenal and capabilities that will enable us to compete very strongly. But indeed BiondVax will be one of the vanguards in the area of nanobody. We want to be one of the first to introduce this platform. There are other companies that are there, but looking at the performance of their nanobodies or NanoAbs, they do not perform as well as ours. And so we currently predict to be faster than others.

Matthias Dobbelstein

I mean, if I may just follow-up on this. The way we try to be different from our competitors is by the quality of the entire production chain of the entire platform, all the way from the immunization to the production in microorganisms. Each and every step has been refined and optimized. And as you might imagine, I'm not allowed to talk about the details here. But the net result is that we -- in the case of the SARS-CoV-2, we have achieved affinities that reach up to, down to thousand folds higher affinities than some of our competitors here in this field. And that's what we're currently trying to build on for the other targets as well.

Kenny Green

So we have another question by an investor. COVID mutation has rendered more [MAB] therapies less effective than other drug classes. So why do you feel that [pursuing] COVID with more antibodies is a good approach?

Amir Reichman

So there are two reasons for that, or let's say several reasons for that. One, when you -- you can choose a systemic approach like Pfizer took with PAXLOVID, I cannot suggest that this is not a valid approach. However, when you go up the chain and you tackle a biochemical process in the body, you have the potential for side effects, you have the potential for counter indications with other drugs. And so by virtue of the situation, our aim is to protect those that are at risk, the populations that are at risk, by providing a drug that has many counter indications, for example, or not -- is not allowed for people with different -- that are on different drugs, specifically the ones that are regarded by at risk populations, it's a little bit self-defeating the situation. So you know you develop something but those that are really [admit] cannot really take it. The other thing with NanoAbs you can target directly the affected organs, specifically because we inhale. And thirdly we direct it at the virus and not at the body of the person. And that generate situation for potentially faster and higher efficacy, faster result and also potentially safer. Because we do not, as mentioned by Matthias earlier, when you do not mess up with a specific human target, you don't have the unexpected result or unfortunate result where you actually eliminate some beneficial actions of that particular target.

Now with regards to the variants. Yes, we see that monoclonal antibodies are being dumped now by some of the regulators because of the inability to tackle Omicron. To that I have two points. One, we do develop now our NanoAb to be able to neutralize all the variants of concern including, Omicron. Secondly, when we look at the market and again, we are aiming at the mature market with a biobetter. So mature market will mean we believe that the regulators will be forced to adopt a scheme that is very similar to the one that we see today with the influenza vaccines. So once you have a marketing authorization for influenza vaccine, every year WHO distributes the specificities of the different strains, and the manufacturers adapt their vaccine to the most prevalent strain. And then they are required to do just very simple and small testing and very limited few people of clinical trial to show the comparability and the safety. But it's a very thorough process. And once you are holding in your hand the marketing authorization, you can adjust your process every year to the specific strain. So we expect the business to be very similar to that. So once we finish the runway and we hold the marketing authorization, we expect to have the changes be part of the normal business. Now the NanoAbs, as presented by Matthias, a very simple manufacturing process, which is very easy to adapt. So our ability to react to a strain change is much, and I expect it to be much more rapid than the speed of monoclonal antibodies. And therefore, if anything, our nanobodies, our NanoAbs, let's say, antibodies will be there before other monoclonal antibodies will be ready.

Matthias Dobbelstein

And if I may quickly just illustrate this by saying that in our published paper and in the journal, we have rapidly adapted the anobodies to be reactive to all the SARS-CoV-2 variants that had been known at that time, by looking at the structure and adapting the nanobodies accordingly, which we can do based on the production process for the NanoAbs, which is more flexible and more adaptable as compared to the conventional monoclonal antibodies. So the questions is a very valid one but I think that's exactly where we can play out the advantages of the production chain for nanobodies.

Amir Reichman

So one point of the NanoAbs in an inhaled situation, because they target directly the virus and expected to be fairly safe and affordable, we do anticipate a situation that if the drug is approved, populations at risk and also others that, let's say, like first responders, et cetera, may choose to have the prescription and have the drug in their purse or pocket, when they go out there with the ambulance, to the war, to the COVID ward, to the -- at high risk person going to the theater, et cetera. You can take several puffs the day before or on the day and you should be fairly protected via prophylactic use of that, we should still demonstrate that in a structured clinical trial. But think about it, you won't go to an outpatient facility to receive an infusion of a one hour of half an hour infusion of a drug, because you want to go to the theater. But if you had an inhaler, just take it and then you are probably prophylactically protected, that's a major differentiator from the others.

Kenny Green

We are almost to the end of time. So we have time just for one last question. So there is a question about the company's cash position, value of the assets, including the GMP facility and the funding needs over the next year or two.

Amir Reichman

So as I mentioned here, we held at December 31st about $17.5 million, we burn about $1 million a month and we think that this money is going to be sufficient to carry us all the way to the first in human. We need to raise additional capital. We are looking into several options for such capital to be injected into the company, either through a non-dilutive funding, through partnering, through sublicensing and through other ways of deals. And if needed, we will probably go and raise more capital from the open market from NASDAQ. But we are now well funded and we are first aiming to demonstrate strongly milestones. And if there is an opportunity, we will find it in order to raise additional capital so that we can strengthen our cash positioning. In the end of the game, our game now is fully focused on bringing this company to a situation where it's fully diversified with a very competitive portfolio and the pipeline of future drugs. And total value of this -- the NPV of such a portfolio will be far exceeding any potential dilution that will be in the short term. But we are well working on other, as I said, opportunities such as partnering, sublicensing, et cetera.

Kenny Green

Okay, thank you for that. That's all we have time for in terms of questions. We still have some more questions that we've received. And we would be very happy if we didn't get to answer your questions if you could contact us directly at Investor Relations at BiondVax. And with that, I'm going to hand back to Josh. Josh?

Josh Phillipson

Thank you, Kenny. I like to thank everyone who joined us today on the call and to thank Amir Reichman, our CEO and particularly, Professor Dobbelstein for sharing his research results and his insights. We are looking forward to working together with you. As Kenny mentioned, there are additional questions. And if anybody has questions at any time, please feel free to reach out. My email is IR -- for Investor Relations [e-mail] and our contact information is also available on the site. Amir, do you have any last words you'd like to say before we sign off?

Amir Reichman

I think, first of all, I want to thank everybody for their participation. I'd like to ask everybody to look into our fundamentals, into the pipeline that we have presented here, into the exceptional contract of collaboration, into our manufacturing and drug development capabilities. And realize through comparing to comparable companies that BiondVax, as of today, we believe is a truly undervalued asset in the market. And we invite you to look into our Web site to see and find the two analyst reports that were released, both concluded that at the discount rate of 20% our current value in the future year should be around $12 per share. Again, it's an independent analysis. But what we feel today that based on the cash positions, talent, the capabilities and the assets that we have the IP and our partners that are truly exceptional, BiondVax can present a very interesting investment opportunity. We invite you to contact our IR team if you'd like to have investor one to ones or discussions with us. And thank you very much for your time and for your interest in BiondVax.

A - Josh Phillipson

Thank you. You may all go ahead and disconnect.