Q1 2021 TFF Pharmaceuticals Inc Earnings Call

Thank you for standing by and welcome to the T. F. F Pharmaceuticals, Inc. First quarter 2021 financial and business results Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star one on your telephone as a reminder, today's.

Program may be recorded.

Now I'd like to introduce your host for today's program, Paul Sagan Investor Relations. Please go ahead Sir.

Thank you operator, Hello, everyone and welcome to <unk> Pharmaceuticals, first quarter, 2021 financial and business results Conference call.

With me on the line today is Glenn Madis, President and CEO of TFS for Coleman, Chief Financial Officer, Dr. Dale Christiansen TFS director of clinical development, Dr. Bill Williams of the University of Texas at Austin, and Chris Cana.

As Chief operating officer.

A press release announcing our first quarter results is available on TFS Pharmaceuticals website.

Please take a moment to read the disclaimer about forward looking statements in the press release.

The earnings release and this teleconference. Both include forward looking statements and these forward looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made.

Factors that could cause actual results to differ are described in the disclaimer and in our filings with the U S Securities and Exchange Commission, including the risk factors section of our 2020 annual report on form 10-K for.

<unk> with the SEC.

And now it's my pleasure to turn the call over to Mr. Glenn matters.

Good afternoon, and thank you for joining us today to review the company's first quarter operations and recent highlights.

This call I will provide an update on our clinical and corporate progress.

And now I'll ask our director of clinical development, Dr. Christensen to update us on the important progress, we're making in our internal clinical programs.

Then our Chief Financial Officer, Kirk Coleman will review the company's financials.

We're also happy to have with US Dr. Bill Williams from the University of Texas at Austin, who will talk about some of the new data. We are seeing in the application of our thin film freezing technology to drugs vaccines and biologics.

And specifically about the important advantages that our thin film freezing technology offers or for other types of dry powder formulation approaches.

And Chris <unk>, our Chief operating officer.

And head of business development will update us on business development and operational initiatives for the company.

And particularly some of the groundbreaking work being done with liquid nanoparticles and mrna biologics, where the capabilities of our thin film freezing technology are generating enormous interest on the part of some of the world's leading academic research institutions.

As far as the industry pharma and biotech partners.

And then well open up the line for your questions.

As you know, it's only been two months since our last earnings call and in just that short period of time, we've made significant progress on all fronts.

This is true for our two flagship clinical development programs for our carnival inhalation powder and attack relentless innovation powder.

The better than expected clinical data, we've generated recently well allow us to begin the pivotal trial phase for both of these important programs by the end of 2021.

And significantly the data we have seen for them are tacker limits inhalation powder trial indicate that we can achieve efficacious immunosuppressive blood levels from just a once daily low dose of inhaled tack for limits.

We're pleased to report that we have filed a U S patent based on this important development, which has major implications for lung transplant patients and potentially for heart kidney and liver transplant patients as well.

Indeed, our recent market research indicates that the yearly market potential for tacker limits and all for indications exceeds $1 billion.

And the potential for once daily dosing could be a further market differentiator.

Well Christian soon will highlight our progress in these two programs shortly.

Okay.

The work we've undertaken with our strategic collaboration partners is also showing excellent progress as well.

And our worldwide licensing agreement with Union Therapeutics for a thin film freezing version used in combination with not close from IDE.

Is that close to my formulations are moving to first in human trials.

And recent data from unions suggests that in a closer mine is effective against the new prevalent British and South African COVID-19 variants.

And then another strategic collaboration our worldwide joint venture with augment to buy works is also progressing well. This first of its kind program is applying our thin film freezing technology for dry powder based monoclonal antibodies targeting COVID-19.

Our subcontract for dockers personalized protective biosystems program for chemical and biologic protection for U S War fighters, it's all for proceeding.

As is our R&D agreement with you Sam Reed for Biodefense countermeasures in our early stage Universal influenza work with the University of Georgia Center for vaccines and immunology.

And our partner in the cannabis space plus products has seen positive initial manufacturing data and strong market interest.

On the vaccine front, our technology has been recognized as being employed but some of the world's leading scientists and research organizations.

We're very proud to report that Doctor drew Weissman at the University of Pennsylvania, one of the original pioneers in the field of mrna is using our technology to generate a shelf stable vaccine.

And Doctor Karthik, Sean drawn at the Albert Einstein College of Medicine, one of the leaders in the development. The first successful vaccine against the Ebola virus is using our technology to develop a second generation COVID-19 vaccine there'll be free of the cold chain requirements of the existing mrna Cove.

Vaccines.

Chris can and will have a more comprehensive review on the status of our existing partnerships as well as a recap of our business development and strategic partnership portfolio progress shortly.

During the quarter, our scientific collaboration partners at the University of Texas at Austin generated very meaningful data that continues to demonstrate the advantages of our thin film freezing platform over other competing technologies Doctor Bill Williams is here with us today and will further discuss these <unk>.

Elements.

So in light of this and all of the other accomplishments. We have made to date. We are also very pleased to announce that we'll be hosting a virtual science day in June.

This event will provide a scientific perspective on our thin film freezing platform technology from leading scientific key opinion leaders.

Stay tuned for more details on what we believe will be an informative and scientifically significant event and the company plans on having these events on an ongoing basis quarterly.

And so now before we go over the financials with current Coleman I want to turn the call over to Doctor. Dr. Christensen, who is our director of clinical development, who will give you more detail on these outstanding progress we continue to make with our two lead clinical programs.

Ill.

Thank you Glenn and good afternoon to everyone, who has joined us today.

I'm very pleased to give you an update on the TFS internal clinical development programs.

Glenn mentioned, we are making considerable progress on our internal development pipeline.

Our work on us all inhalation powder product development is proceeding well on plant to support the upcoming clinical development program. We successfully completed dosing in a 13 week G. L. P. Chronic toxicology study.

In our ongoing clinical trial in asthma patients. We've completed the first cohort and are proceeding to dosing patients at 80 milligrams.

OS level that will be used for efficacy trials going forward.

Finally, we are preparing for our end of phase one meeting with the FDA that will be held after the dosing in the asthma study is complete.

With with this.

This progress we are on track to begin our pivotal clinical trials that are designed to demonstrate efficacy other products for treating patients with IPA.

For for preventing infection in patients at high risk for developing IPA infections.

For infectious disease therapy. It is accepted dogma that a higher dose of the drug results in improved efficacy because higher doses, clearly infectious organism more efficiently and with less opportunity for the development of resistance.

The data generated in our warrior Commonwealth program to date has significantly removed risk from the program. Since we can safely administered a dose more than twice the dose of inhaled for clients all of which is currently being used in hospitals in Europe to successfully treat patients with complicated aspergillus lung infections even win.

The other treatment options failed due to toxicity or by not reaching sufficient doses in the loans that are required for efficacy.

Moving onto our <unk> inhalation powder program. The development activities are proceeding well after some delays due to COVID-19.

Enrollment will be completed this month in our phase one clinical trial.

The single ascending dose or sad portion of this trial, we safely administered single doses of <unk>.

<unk> 512.5, and five milligrams to healthy normal volunteers.

We plan to dose an additional cohort of subjects at 10 milligrams, but we cancelled this group when we found it goes hitting at five milligrams provided to colon blood levels that were previously shown to provide efficacious immunosuppression.

In the multiple ascending dose part of this study we have completed dosing of subjects in cohorts, one and two with one half or one milligram twice daily doses over seven days, we found that these dose levels provided steady state blood concentrations associated with effective immunosuppression Q2 <unk>.

Lance bioavailability of the inhaled product.

For cohort three subjects are being dosed with a single one five milligram dose each day for seven days.

Glenn reported when you have filed a U S patent application based on the ability to reach efficacious blood levels from once daily dosing.

Can have clear implications for lung transplant patients and potentially for heart kidney and liver transplant patients as well.

In addition to these important clinical results, we've completed a G. L. P 26 week chronic toxicology study that will be used to support long term human clinical trials for registration.

With the clinical progress we've made to date and the completion of the toxicology study. We are on track to begin additional clinical trials designed to demonstrate efficacy of inhaled <unk> for the prevention of lung allograft rejection in our upcoming pivotal studies.

The enhanced bioavailability and ability to bypass for gastrointestinal track could also open the door for treatment of other solid organ transplants, where significant drug drug interactions and food effects observed with oral to call them us.

We believe that the inhaled to call them s's ability to reach that to reduce debt fluctuations of bioavailability conversion advantage over oral to problems.

As physicians, often attribute the peaks and troughs of oral delivery with suboptimal efficacy and exacerbated side effects.

We also have pipeline programs directed toward treatment of COVID-19 with our augmented monoclonal antibody program and the nightclubs for my program.

In the next few months, we'll be generating important data that will move these programs towards human clinical trials that will begin in the second half of the year.

And with that update I'll turn the call over to our Chief Financial Officer, Kirk Colon for a review of the financials Kirk.

Thank you very much style for the three months ended March 31, 2021 research and development expenses for the company were $5 3 million compared to $2 2 million for the same period in 2020.

The increase in research and development expenses. During 2021 was due to increased preclinical activity related to close them IDE clinical activity related to for condos, all inhalation powder and tech to Chromous inhalation powder.

The ramp up includes our preliminary analysis and testing of dry powder formulations of certain drugs and vaccines, we believe have the potential to become product candidates.

General and administrative expenses for three months ended March 31, 'twenty, 'twenty, one or $2.6 million compared to $1.6 million in 2020.

The company reported a net loss for the quarter of $7 7 million compared to a net loss of $3 8 million in 2020.

Weighted average common shares outstanding basic and diluted for.

For the three months ended March 30, <unk> 2021 for $23 million 140607 <unk>.

Compared with 19.008 million 611 for the same period in 2020.

As of March 31, 2021 we had total assets of approximately $61 3 million and working capital of approximately $59 5 million.

At the end of the quarter, our liquidity included approximately $58 1 million of cash and cash equivalents.

The offering completed in March has strengthened our cash position and will enable us to further the development of our current programs.

And with that I'd like to turn the call over to Dr. Bill Williams will talk about some of the groundbreaking work, we're doing using our thin film freezing platform.

Particularly with large molecule biologics and how our technology is unique in its ability to successfully transform these complex molecules into an inhalable dry powder bill.

Thank you Kirk good afternoon, everyone.

Pleased to report that we have continued to advance the science and partner applications supporting them from pretty strong.

Simple freeze drying, what's the line to provide a specific briefing right Bob too slow like that required by conventional <unk> and not too fast like that required by spray freeze drying.

Such that a particular and unique powder morphology and stability of drugs in the powder form is obtained.

That's on freeze dry was also designed to not expose the protein the high share stress like that used in spray drying that's free freestyle.

Recognition of the benefits of them film freeze drying technology to drug development.

As most recently evidenced by our newly accepted and then buy the paper by the peer reviewed journal Kona powder and particle journal.

As part of this effort, we have continued to focus on differentiation and benefits of simple freeze drying compared to other competing technologies like conventional waffles ocean spray dry and spray free style.

First we continue to validate our thin film freeze drying of larger molecular weight drugs like clothing, including monoclonal antibodies messenger RNA and plasmid DNA.

Our data confirmed that the low share stress and intermediate freezing right designed for thin film free stride as compared to other technology.

Offered a stable inhalable dry powder protein and.

In fact, we have published studies confirming that stem from freeze-drying produces more chemically stable inhalable powder of such difficult to formulate protein as life design and lactate dehydrogenase in direct head to head comparison, despite free strive. These.

For the types of difficult to formulate therapeutic biologics.

The film freeze drying is suitable for.

Now, let's discuss our most recent work with multiple therapeutic proteins from our partners.

First of all we have confirmed the mrna integrity from mrna loaded lipid nanoparticles.

Let's preserve and that's the mrna function was maintained using in vitro cell transfection assets.

Based on our continuing validation work with partner mrna loaded lipid nanoparticle thin film Freeze-drying will lead to a successful formulation of second and third generation COVID-19 vaccines.

In addition, our day that confirm that Samsung freeze drying offers important advantages of improved protein stability during processing and then storage stability at room temperature over that of conventional lawful ization spray freeze drying or spray drying.

In addition, we have transform another partners therapeutic peptides currently delivered by Nebulous Asian other liquid into an inhalable dry powder, having excellent aerosol properties bought them film freeze drying.

Also we continue to apply them film free starting to develop inhalable form for monoclonal antibody.

We have recently shown in a mouse model that interest tracheal Insufflator <unk> of an S. I RMA dry powder made by stem from freeze drying led to a reduction of a target genes in lung tissue.

We have also confirmed that thin film freeze-drying applied the plasmid DNA maintained its chemical integrity.

Collaboration with our partner on their adjuvant said lift with vaccine has yielded improved storage stability as indicated by antigen potency and particle size of the reconstituted powder at 40 degrees centigrade for up to two months.

Interestingly this adjuvant and Amazon was compared in the head to head study against spray dry and those results were not acceptable.

The intermediate freezing rate used in thin film freeze dry is superior to the much slower freezing right use and conditional authorization because that leads to antigen unfolding in adjuvant aggregation, which is irreversible.

Lastly regarding virus vector based vaccines in collaboration with another partner.

You have some debt up to 100% of virus infectivity was preserved after the liquid suspension of virus were subjected to symptom free strong.

Now, let's consider our work on dry powder containing small molecular weight water insoluble drug like for ecommerce all to call them us and the close of my the Dell discussed earlier the company has reported advancing in various stages of clinical testing.

Simple freeze-drying provides unique and desirable dry powder forms of these types of drugs advantageous for nasal and inhaled delivery and we continue to aggressively build and leverage our patent strategy around these properties and the benefit that they provide and treating different diseases.

Just last week, our latest paper on and held and are close to my dry powder was published in the peer reviewed journal International Journal of Pharmaceutics in.

In this paper, we reported that our inhaled dry powder will closely my formulation prepared by Samsung freeze drying what's safe after an acute three day multi dose tolerability and exposure study in rats.

Just on the Histopathology analysis conducted by doctors Peters and Hackmann, that's the University of Texas Health San Antonio.

We also reported that we were able to achieve lung concentration above the required inhibitory concentration known as the IC 90 for at least 24 hours. Following a single dose administration in the Syrian hamster, a well known infection model for COVID-19.

This IC 19 metric is a key indicator of the effectiveness of the close of my inhalation dry powder made by Samsung freeze drying and delivered to the ones of the hamsters for inhibiting the Sars COVID-19 two virus.

I want to acknowledge my colleague Professor Zhang from Cui for his collaboration and contributions to our research Lastly, I want to thank you for your continued support of TFS Pharmaceuticals, and the collaboration with the University of Texas at Austin.

And now I'd like to turn the call over to Chris <unk>, Chief Operating officer, who can update you on more of the progress that the company is making in its business development and partnership efforts Chris.

Thanks Bill.

Good afternoon, everyone. Thank you for joining us today.

As I have previously shared the TFS business development team is laser focused on three key areas of growth for the company.

These three key areas are one growing the T S S pipeline of.

Internal development programs to our pharma partnering efforts and three our government and academic contracting efforts, we continued to make great strides in each of these key areas.

For today's call I will be focusing on our pharma partnering efforts and our government and academic partnerships.

To begin T.

T. S. F continues to be very active in the <unk> space.

We have a large number of active M RNA programs underway.

And this number of projects continues to grow.

As we continue to elevate our expertise in understanding and formulating different L N p's and mrna.

Generating data and delineating a clear distinction of our technology versus other technologies.

Pharma partners are now knocking on TFS door looking to engage with us.

This is a most welcome shift.

We are working with pharma partners to formulate their proprietary mrna into a dry powder.

For some partners, we are formulating a dry powder for inhalation delivering the dry powder mrna deep into the lung to treat respiratory elements.

For other partners, we are formulating their proprietary mrna vaccines into a dry powder to form a more stable vaccine that is not subject to cold chain storage and transportation.

This dry powder is then quickly reconstituted onsite for injection.

For example, we're working with a large pharma partner formulating their proprietary mrna into a T F F dry powder for delivery directly to the lung.

We are very pleased with the data we are generating we are formulating their mrna into a dry powder with superior aerosol properties, showing very good lung deposition very high encapsulation rates and based on recent in vitro testing performed by our partner are dry.

Powder exhibit excellent viability and potency rates, we're very thrilled with our progress in the mrna inhaled space.

In the mrna vaccine space, we continue to make tremendous progress we're working with different mrna vaccine companies, where we are taking their proprietary liquid mrna vaccines formulating a dry powder version, which creates a more stable vaccine.

Removes the cold chain storage and transportation challenges.

And can be quickly reconstituted back into a liquid for injection.

We continue to engage and speak with all of the leading mrna vaccine companies in an effort to put our TFS technology to the test.

There is a global need for our technology in order to develop and distribute mrna vaccine products around the world.

Getting vaccines to remote countries, where cold chain storage is an overwhelming challenge.

The T F F technology for dresses and overcomes this challenge.

We strongly believe that our thin film freezing technology will play an important role in formulating second generation COVID-19 vaccines.

In addition, since our last earnings call. We are now fully engaged with two leading academic institutions in the mrna research space and we are now collaborating with both institutions on mrna vaccines.

T F. F is engaged with Doctor drew weisman for steamed professor of medicine per.

Perelman School of Medicine at the University of Pennsylvania.

These collaborative discussions focused on a feasibility arrangement utilizing T. S. That's technology to generate a stable dry powder version of Upends mrna vaccine.

Dr. Weisman pioneering work on mrna vaccines laid the groundwork for the stunning success of the COVID-19 mrna vaccines that are being administered to Americans every day.

This collaboration holds tremendous opportunity for T F N.

We will provide updates as this project progresses.

T F. F is engaged in discussions with Doctor Kayak Rux shrunk from professor of Medicine at Chulalongkorn University, who established the Chula vaccine Research Center.

Tula V R C.

These collaborative discussions focused on the feasibility arrangement utilizing TFS technology to generate a stable dry powder version of Chula VR sees COVID-19 mrna vaccine.

Lastly.

On our mrna progress with all of this work being performed on the formulation of dry powder mrna for inhalation therapeutics and reconstituted vaccines. We recently filed a U S. Non provisional utility patent application and a P. C T application, which when issued will provide the company with the.

A long runway of exclusivity and protection on our mrna programs as we strive to bring these products to market with our partners Bill.

Building and strengthening our patent portfolio is a critical component of the T F F corporate strategy.

TFS is very pleased to announce that the company has entered into a collaboration agreement with the Albert Einstein College of Medicine.

Under this collaboration T. S. F is working with Doctor cartridge Sciandra and his research team to develop stable dry powder formulations of recombinant particular stomatitis virus based vaccines for V. S D.

Doctor cartridge Sciandra is one of the world's leaders in the development of V. S V based vaccine.

These were the basis for the first successful vaccines with efficacy against the Ebola virus.

In collaboration with Doctor Sciandra, and we will be exploring the use of a V. S. D vaccine for development of the second generation COVID-19 vaccine that will be free of the cold chain requirements.

That is faced by the mrna COVID-19 vaccines and.

And we plan to deliver this without a needle.

Over the last few months, we received the S V vaccine candidate from Doctor genre.

And we successfully formulated a dry powder version of the V. S V vaccine.

We sent that dry powder samples back and based on in vitro testing. The V. S. V show minimal tighter loss and we were able to generate a stable form of the V. S V vaccine.

We are beginning some optimization work as we speak and we are exploring a license to the V. S V vaccine with the goal of performing some initial in vivo testing.

This collaboration holds tremendous opportunity for T F F where success in this program would allow COVID-19 vaccinations to be distributed throughout the world. So that we can reach global herd immunity to stop COVID-19 transmission and prevent the emergence of new variants and saved countless lives around the world.

For a quick update on our previously announced partnerships and collaborations.

The feasibility arrangement with neuro Rx is progressing T.

T F. F has successfully formulated neuro Rx is peptide for treating COVID-19 and an inhalable dry powder.

Optimization work and stability testing of the dry powder is underway.

T F. F is fully engaged with our collaboration partner Greenlight bio and we are planning to perform our formulation testing over the next few weeks.

As we reported on our last earnings call. The partnership with your Shammer. It is actively moving forward.

T S F dry powder was successful in in vitro testing for both the monoclonal antibody program and the V. S V program.

We are now planning in vivo testing and if successful T. F. F would seek non dilutive funding to move both the vaccine programs forward into development.

These activities are underway.

Our partner Felix Bio continues to enroll CF patients for their investigator initiated study.

Upon successful results Felix we'll be seeking to raise capital and we plan to execute on our LOI and finalize the definitive agreement.

As Glenn highlighted in his remarks, our partnership with Union Therapeutics on Nyclu semis is proceeding well.

We're approaching important first in human trials on both programs.

In addition, as Glenn updated everyone. Our co development work on the augmented by works monoclonal antibody for COVID-19 is also moving forward as scheduled.

We are on target for starting our I N D, enabling studies with an eye on entering the clinic as quickly as possible.

To round out our pharma partnerships. We are currently formulating our partner's proprietary SA RNA plasmid DNA oligonucleotides stage.

Peptides monoclonal antibodies cytokines AAV D. L. P. N V. S V product candidates along with many other different proteins and small molecules.

On the government contracting side, we recently announced on April 13th our contract with lighthouse on the DARPA project. This is the first government contract for T. F F and we were actively pursuing additional government contracting opportunities.

The work under this DARPA contract has begun.

And as part of the DARPA project P. F. F has leased its own laboratory space in Austin, Texas and in effort to fulfill its obligations under the DARPA contract. This.

This lab space is approximately 700 square feet and has been completely outfitted with T. F. F owned equipment and is being managed and run by T. F. F staff employees and consultants. This additional lab space is a welcome addition for TFS not only for the DARPA project, but also to handle and manage overflow.

Of the many pharma partnering projects that are underway and on the horizon.

In summary, the T F. S. BD team has been making significant progress in our partnering efforts.

We continue to grow the number of collaborations we have with pharma partners with government agencies, and with leading academic institutions and we continue to expand the application of our thin film for using technology.

Well I had this opportunity I would like to thank our partners at the University of Texas at Austin.

With the continuing support and tireless efforts of Doctor built Williams and his research team. We continue to expand the applications of the thin film for using technology into new and innovative areas of drug delivery.

In closing the BD team is focused on closing at least two licensing transactions in 2020 one.

We are very well positioned to meet this objective and we continue to foster future growth opportunities for both our technology and our company and we believe that we have only scratched the surface of the many applications of the thin film freezing technology.

Thank you for your time today enjoy your evening and I will now hand, it back over to Glenn.

Thank you very much Chris and thanks to the rest of the T F team who participated today.

This has been another quarter of progress and accomplishment for the company as.

As Chris just said the recognition of the unique capabilities of our thin film freezing technology platforms has generated a groundswell of interest among potential partners in the academic governmental and Pharm biotech fields.

Particularly within the realm of biologics, our technology's ability to formulate a dry powder for emulation from the lungs or a formula vaccines into a stable dry powder that is not subject to cold chain storage issues.

Bring people across the world to our door.

As Bill explained our thin film freezing technology has capabilities that are unmatched by other forms of conventional actualization spray drying or even spray freeze drying.

These other technologies cannot effectively reformulate large complex biologics into a dry powder for them, giving us a distinct competitive technological advantage that is further being recognized in the industry.

As Dan elaborated this technology has resulted in far better than expected clinical results and our two flagship clinical programs.

Programs that address unmet therapeutic needs with large market potentials.

And in the case of our tacker limits inhalation powder, demonstrating immunosuppressive effectiveness with just a single dose the market potential can be increased significantly.

So to sum up we hope this call has given you a sense of the pace and progress of our clinical business and scientific developments during the quarter.

It's been enormously gratifying to see the efforts of our professionals as they move the company forward and especially to see the recognition within the industry that our technology can have game changing consequences.

As always we appreciate the support of our investors and partners as we look forward to speaking with you next quarter and hope you all stay well and with that I will turn the call back to the operator and open it up for questions operator.

Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one on your Touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue. Please press the pound key our first question comes from the line of Jonathan Ashcroft from Roth Capital Partners for your question. Please.

Thank you guys congrats on the progress.

What organ transplant market shares and pricing assumptions do you factor into your cash forecast of around $1 billion.

Yeah, Thanks, Jonathan So we actually.

Employ a group called Trinity partners, who are very well known in the industry to do our work they do a theory zone.

Primary and secondary research with Kols and payers.

And they are for capital based upon that feedback about a 40% share of the heart liver and kidney transplant market assuming that we have.

At least equivalent efficacy profiles, and certainly a better adverse event profile, reducing the number of.

Comorbidities, specifically related to our renal impairment.

On the one side and this is actually compared to forecast, we do about a year and a half ago that share went up to about 50% and the the price assumptions or other very very low and go for an orphan drug.

Pricing plan schedule what pieces about.

About $6000 annual use rate, which I think is conservative I would rather be conservative in this case, but.

When you do that calculation and you look at it.

And prevalent we hit a peak according to these data about a billion two takes about seven years to get there because of that.

The number of procedures, but.

It's a very very important for.

For cash, but very big drug.

And you know our data are continuing to inform the type of result, we think will get in the marketplace.

That's great.

Okay. Thanks for that how do you anticipate monetizing your academic vaccine relationships.

Yeah. So first of all if you take a look at what Chris discussed.

The breadth of the relationships that we have are yeah.

Important to note.

Adding the work now with Doctor Weizmann, adding you know for the work out of Albert Einstein to what we already average Sam Reed Alright, UGA and there are other institutions that we're working with the plan is to once we get the in vitro data to work with the tech transfer groups.

Who licensed the technology Tfl.

With the purpose of then looking at gaining finding.

Financing, mostly non dilutive financing through the academic institution to progress those those assets through phase one development and not all of them, but the ones that are the best in class. We would then seek commercial partners. So the technology get quite to Tfl through the academic.

The tuition and then we find a development partner to take these two new commercials so very.

Maybe all of them get their highly doubtful.

But look at who we're working with here, it's sort of like the Mount Rushmore vaccine developer.

So that's the plan and the discussions that we're having right now are with the tech transfer groups and the licensing directly to PFS.

Okay, and then two really quick ones there could be a one answer one word answers.

Kenny inhaled for console.

Used in prophylaxis, as well as treatment and as the owner and D number a new run rate.

Yeah.

And what's the second question I'm, sorry, John is the R&D.

R&D expense number is that a new run rate. It bumped up a lot is that just a kind of a temporary hump there or is it a new line.

I'll answer the first question. So yes, prophylaxis is an opportunity for us back in a recent kols meeting.

The kols were actually urging us to take more.

Look at that and you know we basically.

They think they can get a more important share of that market are Kirk could you answer jonathan's question about the R&D expense.

Sure.

As you know Jonathan we haven't given formal.

Cash burn guidance, so, but kind of give you some idea on how to think about it we had $58 million in cash.

In the quarter.

So we're roughly burned approximately 7 million during the quarter and that's consistent going back to 2020, although there's a slight uptick in this quarter.

So we really don't anticipate that's going to show a dramatic departure from the historical run rate and the trend that were just reported in Q1, but given the nature of the business, there's likely to be some fluctuations quarter to quarter that we can't predict with complete certain day. So okay. So it sounds like it'll be somewhere in between.

Fourth quarter and first quarter.

It's fair assessment.

Okay. Thank you very much guys.

Yes.

Thank you. Our next question comes from the line of Daniel Carlson from Tw Research Group. Your question. Please.

Yeah, Hey, Glenn Thanks for taking my questions first.

First off this new relationship with U Penn and Doctor Weizmann can you tell me a little more about it and what exactly you will be working on.

Yes, I'll answer the first part of the question I'll turn it over to Chris to talk about.

What we're working on so we actually met Dr Weisman, who.

Presentation, we gave to group called Civics is basically.

The United States.

For the.

Top vaccine specialists in the country.

Dr Weisman with part of that presentation, and he actually reached out for us.

With interest in the technology, which is in itself.

Really we were very quick to take that call as you can imagine given the doctor wife and reputation in the space.

Simply the father of mrna vaccine.

So very quickly we established a relationship and at that point.

For Christmas closest drive him to talk about what happened there and what we're working on.

Sure and thanks, Dan So with Dr. Weisman.

We are going to be working on two different mrna vaccines I can't really share.

What what the indications are we're going to be formulating them in our dry powder and we are planning.

To work with our partner in initial in vitro work and in vivo work.

And people are technology.

For one so looking forward to working with them there is a fantastic opportunity to work with other.

Their research group.

Yeah. Thanks, I mean, I I, just Google for him and he said very impressive individual to say the least so congrats on that.

Glen can you talk a little bit about what you're intending to do with the use of proceeds from the recent capital raise.

Yeah. Thanks, Dan Good question. So at this point the.

The money from the bank and that's a good thing because that certainly extends our runway.

Danny we reinvest very carefully for the two areas we're looking at.

Is there a potential program, we want to add to our internal development pipeline.

Essentially a $5 five with two program something that maybe we want to co develop like we did with <unk>, where we share the cost and take it through phase one. So that's debt gives us an opportunity to invest when we see the right opportunity and the other.

Other thing that we're looking at is where can we selectively in bags.

Enhancing our ability to.

Be in control of our IP and do some specific manufacturing perhaps.

In the area of where partners are coming for for sterile preparation.

Those decisions there we're not committing to anything Chris described the fact that we do NAV new lab space at.

U T Austin down at six four and reduction of Williams is the how.

With some of the DARPA work and some other work there so a pocket of air but it's just nice to have the cushion should we want to make some selective investments there, but we also know that in addition to what we have in the bank.

Revenues, we anticipate from the existing partnerships and new partner share.

We'll also continue to improve the cash position and make the company profitable so nothing eminent but that's what we're thinking.

Great. Thanks, and then if I could one last question just you go through.

Kind of different programs, which is awesome.

Got so much going on.

In many different areas.

And I'm wondering you know a lot of times you look at it.

Net sales.

Sales of the funnel.

Definitely putting a lot into the funnel I was wondering if you could talk about just the progress on existing programs.

Moving them through and how do you quantify.

Where you're at I mean, we've talked about the Red zone in the past I'm just trying to understand for how the progress is going on the funnel.

Alright, so the way so the way we track it as yet for what what's coming in at the top of the funnel but.

But when we want to really determine how well we're doing and moving forward, we quantify it with how many relationships that we have where we're doing in vivo work alright, and that then needs to mature.

I'm sorry in vitro work started in vitro work that needs to mature.

Vivo piece so you.

Not going to give a number but take your number.

Net bucket.

MTA in vitro work almost almost all the time about all the line is successful then how many you have in an in vivo.

How many are you where are you negotiating a transaction right.

Can tell you that debt progress from in vitro and in.

Evo to negotiation.

The numbers are tracking very very positively.

And negotiation from tires take over the longer we only want to deal with.

Makes sense for us and we give for that value creation, we want.

But.

Debt real sort of determinant of progress because the transition from in vitro in vivo have peak demand.

And then when are you when you're done when you're done with that thoughtfully and when are you actually.

<unk> payable for it for a deal.

I harken back to Kristin statement, which is where are we confident that we will get at least two deals done this year and that position has not changed.

Great well, thanks, Glenn Congrats on other progress keep it up.

Thanks, Daniel I appreciate it.

Thank you. Our next question comes from the line of Rams have Roger from H C. Wainwright Your question. Please.

Thanks, very much for taking my questions and congrats on all the progress very impressive on all these fronts here.

Firstly I wanted to ask about the status of the patent application pertaining to the once daily dosing and if you have a sense of when you expect to see office action on that patent application and assuming it is issued and you give us a sense of.

The degree to which you anticipate highly strategic protection coming from the claims in that pattern as well as what you anticipate the expiration date for that.

Chris can you handle that one.

Sure and thanks, Rob for the question. So we have a very IP is really the core foundation right around or then from prison. So this particular patent the provision was just filed earlier. This week just to give you kind of the timeframe because it's based on the work that.

We are doing in the clinic right now.

But we have formulation patents.

And a multitude of patents that protect the product formulation and now we're expanding into the clinic. So.

It's all about building that strong foundation.

As far as protection right. So.

The patent.

In rates, we filed the provisional in one year.

Debt patent will be reviewed and then upon successful review.

We would expect to get that 20 years.

Our bill or D. O I don't know if you have anything to add to that.

Yeah.

Yeah. This is bill.

And since we just filed it'll be a year before anything happens will convert in the year.

And then it'll be some time after that once a year before we get first of all for <unk> just based on.

Experienced.

Okay very helpful. Thanks also with respect to your plus product collaboration you have any more granularity on specifically when they anticipate introducing the first products based on the thin film for using formulations of Barnabas for the market yeah. So at this point.

The best guidance I can give it would be very very late.

Towards the end of the second quarter early third.

We cross the very very important threshold and that the powder was for.

Made in their facility.

Actually the quote from their CEO Jay references at <unk>.

Now Eric.

It's a matter of doing some different.

<unk>.

And I think we grew up there really isn't a need for any reformulation moving through the testing phase.

Oh it starts to look like it is a consumer lines. So they have a really nice plan laid out for for consumer testing.

Some of the bug standard.

And then.

We thought for the rate so.

For me the most important hurdle of can we make it.

Can it be inhaled people cough narrow and we pass that pass expiring lease. So now it's maybe some fine tuning and get the feedback how do you market it and.

If it were up for the rigs there.

Okay, and then just two other quick ones with respect to your work and the dry powder vaccine domain.

Do you anticipate this to be primarily focused on the influenza space for the foreseeable future or are there other respiratory viral pathogen that you anticipate going after in the future in the wake of the work that's been done that's being done on influenza and if so what might some of these b and then the second question.

That's just for technical financial question.

The nature of the collaboration agreements that you haven't quite.

Should we be anticipating going forward.

Meaningful offsetting of your R&D spend by what is Reimbursable under the terms of these collaborations or is that effectively going to be.

As a minimum.

Okay.

Chris first answered the question about flu I wanted to comment I think beyond that and then Kirk.

You may be the one to answer the second question. So from a so you can begin to think of that answer but Chris. If you can start sure. It really when we look at the vaccines and the work that we're doing right. It's really driven a lot by our partnership so the University of Georgia Civics right there.

Is a tremendous focus on influenza.

We're also universal influenza, we're also focused very heavily on COVID-19.

It's really any vaccine that is a liquid debt.

Would benefit from the characteristics of our technology and a dry powder. So we are working with <unk> on.

File viruses in Alpha viruses those are both vaccine and.

Monoclonal antibody so so we're really across.

Many different modalities when it comes to vaccines, yeah. So if you think about it as a portfolio play.

So you've got maps as Chris says for Antifungals, you've got flu Universal for COVID-19, We're also we haven't.

Closed with feasibility work, we're doing with the company is looking at this COVID-19 period, not even COVID-19, but broad base quote COVID-19.

Greenlight, So green light if you narrow that down there they're looking at.

Basically developing vaccines for the developing world and have better good day.

Play than weather.

Technology in a formulation that isn't subject for to a need for cold chain. So.

If you kind of put it all together and you can step back I hope for listen Eric How are you are putting the pieces together and these guys are building.

Very very big vaccine portfolio.

Frankly, if any of them are important for all of them, it's great but.

We're not COVID-19 out of COVID-19 company without a flu company whenever boiler company, we're working with a company that approached us about.

Chicken <unk> net.

Now you'd say chicken go anymore, well, it's been chicken going for outbreaks in Puerto Rico recently, that's a start right.

So and it goes on and on and.

That's the strategy it sounds like Youre breaking the code on on what were thinking there. So.

Thanks for that.

And then Kirk do you have an answer on.

On Ron's question about R&D.

Yes sure on the first one with the current contract that we have in place you know for a lot of contract. The financial terms are not disclosed publicly it did not cross the threshold for materiality, but this will be P&L neutral.

As well that there will be offsets obviously as you.

Loaded too and we really hope that these are ultimately strategically accretive for additional opportunities for the product candidates as well as getting additional government work in the future.

You know, Rob if I can pick up a little bit of a second here since you've opened the door from unit sales.

When we get selected for work by Weizmann.

Weizmann or Ted raws for John di or cardiac.

Its not automatic they do a tremendous amount of dealers as they look at every potential formulation partner. Some of these relationship started a year or more ago.

The DARPA.

No announcement was about 18 months in the making a year of that was diligent by wider.

So it's not like Oh, we pick you pick us because they've done their work.

So I think it's validating yes. It is a bit of a weighted go here, maybe not too long, but we win every time.

Stop there.

Every time, we put up.

Bake off or beauty contest we win.

Oh, Brian <unk>.

Yeah that is clearly a testament to the disruptive nature of the PFF platform level of innovation. So I have no problem seeing how that would be the case.

That's very impressive. Thank you very much for answering my questions. Okay.

Thank you once again, ladies and gentlemen, if you have any questions. At this time. Please press Star then one.

Next question. Our next question comes from the line of Bill Morrison from National Securities. Your question. Please.

Hi, guys.

Questions.

Fall through on the previous question about the pipeline.

A little more color.

The research Institute for you're working with.

Does that work in conjunction with your existing EMR.

<unk> partners and vaccines.

Or is it to generate new interest with new partners for vaccines for yet.

It's all it's all stacking bill.

Bill so.

No.

You can start to think about some of the net working right.

So your guidance drew Weizmann mrna, we filament line right.

So, but yes, the academic relationships, if you want to call them that.

In the pharma relationships.

Are really distinct.

And.

They are sort of you think about it as you know and if you want to look at it as a lifecycle.

Certainly the pharma relationships are more near term.

You have some midterm and longer term opportunities. Some of these can go very very quickly.

You've got you've got researchers that know how to do this so.

It's all.

Accretive it's all stacked they're now not a lot of overlap there is anything.

But there are you know there are networks and great to have drew weizmann.

On our side.

When you're talking for farmer calculate.

Right, so would that accelerate.

Licensing opportunities with existing partners.

Hopefully I don't Overcommit, but you can be you can certainly see where that would ever be an opportunity for us.

Okay. Good and then with the existing licensed partners what are the.

What's the outlook for upfront.

And when might those happen.

And so we tried I guess for Dan question, Yeah, we know sort of crossed over to the new world of in vivo testing in the negotiation.

So that's good for you.

We were tracking contracted over time.

Yeah.

Still stick to what we said at the beginning of the year to deal with these two deals by the end of the year.

Hopefully sooner rather than later, but it's an annual lease too.

No reason to back off of that expectation at all.

Okay great.

Job guys really appreciate it thanks.

Thank you Bill.

Next question.

Any crime.

Our next question antibody from he's a private investor your question. Please.

Hi, Yes, hi, guys. Thank you great to hear some progress on Union plus in Atlanta, but can you give an update on the status with the Felix.

Mhm.

So you know what I can say about Felix geography.

They are recruiting.

A trial.

University based trial there.

Certain point of.

Our recruitment in that trial.

They are saying that that will initiate the bill expense they raised their capital.

For that totally to the completion of the trial, but there is a certain threshold they want to hit it.

That's what their potential investors are requesting so we do speak with.

CEO Rob Mcbride.

Frequently it gives us update.

And behind the scenes there's either some.

Continued optimization going on from there.

We can hit the ground running with the federal free conversion of their compound quickly.

Another question for me please so.

You announced new robotics and Green line, just a couple months ago in your AG seems to be progressing to the next phase how about greenlight.

So yes, so it gets new Rx is progressing nicely.

We're happy about that we actually have done some work already we have some other work going on that revenue.

To be finished in line.

We're far along in discussing with them. The next steps are green.

Greenlight we are.

Actually I had a conversation with them today and they're forwarding some material to start the <unk>.

Specific feasibility work their debt.

Generally when we get material.

It takes us about Chris three weeks or so to turn it back for them. There may be other formulations, they want us to try as well.

So the feasibility work is underway.

Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to Pat's for any further remarks.

For those of you that are still on the line. Thank you so much for your participation and your support of the company.

We're.

Anxious to have our next call with you because we believe we'll have some very interesting more information to share and hopefully even before that but I wish you all the best.

Be well be safe.

And you know you could reach out for the company and we'd be happy to talk to you. Thank you.

Good day.

Thank you, ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.

Yes.

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