TFF Pharmaceuticals Inc (TFFP) 2021 Q1 法說會逐字稿

Thank you for standing by, and welcome to the TFF Pharmaceuticals, Inc. First Quarter 2021 Financial and Business Results Conference Call. (Operator Instructions) As a reminder, today's program may be recorded. And 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 TFF Pharmaceuticals' First Quarter 2021 Financial and Business Results Conference Call. With me on the line today is Glenn Mattes, President and CEO of TFF; Kirk Coleman, Chief Financial Officer; Dr. Dale Christensen, TFF's Director of Clinical Development; Dr. Bill Williams of the University of Texas at Austin; and Chris Cano, TFF's Chief Operating Officer.

A press release announcing our first quarter results is available on the TFF 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 filed with the SEC. And now it's my pleasure to turn the call over to Mr. Glenn Mattes.

Good afternoon, and thank you for joining us today to review the company's first quarter operations and recent highlights. During this call, I will provide an update on our clinical and corporate progress, then I'll ask our Director of Clinical Development, Dr. Dale Christensen, to update us on the important progress we are 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 over other types of dry powder formulation approaches. And Chris Cano, 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 well as industry pharma and biotech partners. And then we'll open up the lines for your questions.

As you know, it's only been 2 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 2 flagship clinical development programs for Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The better-than-expected clinical data we've generated recently will 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 from our Tacrolimus Inhalation Powder trial indicate that we can achieve efficacious immunosuppressive blood levels from just a once-daily low dose of inhaled tacrolimus.

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 tacrolimus in all 4 indications exceeds $1 billion. And the potential for once-daily dosing could be a further market differentiator. Dale Christensen will highlight our progress in these 2 programs shortly.

The work we have undertaken with our strategic collaboration partners is also showing excellent progress as well. In our worldwide licensing agreement with UNION therapeutics for a Thin Film Freezing version used in combination with niclosamide, both niclosamide formulations are moving to first-in-human trials. And recent data from UNION suggests that niclosamide is effective against the new prevalent British and South African COVID-19 variants.

And in another strategic collaboration, our worldwide joint venture with Augmenta Bioworks 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 (inaudible) personalized protective biosystems program for chemical and biologic protection for U.S. war fighters is also proceeding. As is our R&D agreement with USAMRIID for biodefense countermeasures and 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 is seeing positive initial manufacturing data and strong market interest.

On the vaccine front, our technology has been recognized as being employed by some of the world's leading scientists and research organizations. We're very proud to report that Dr. 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 Dr. Kartik Chandran at the Albert Einstein College of Medicine, one of the leaders in the development of the first successful vaccine against the Ebola virus, is using our technology to develop a second-generation COVID vaccine that will be free of the cold chain requirements of the existing mRNA COVID vaccines. Chris Cana 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. Dr. Bill Williams is here with us today and will further discuss these developments. 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 Kirk Coleman, I want to turn the call over to Dr. Dale Christensen, who is our Director of Clinical Development, who will give you more detail on the outstanding progress we continue to make with our 2 lead clinical programs. Dale?

Thank you, Glenn, and good afternoon to everyone who has joined us today. I'm very pleased to give you an update on the TFF internal clinical development programs.

As Glenn mentioned, we are making considerable progress on our internal development pipeline. Our Voriconazole Inhalation Powder product development is proceeding well on plan. To support the upcoming clinical development program, we successfully completed dosing in a 13-week GLP 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, the dose level that will be used for our efficacy trials going forward. Finally, we are preparing for our end of Phase I meeting with the FDA that will be held after the dosing in the asthma study is complete.

With this progress, we are on track to begin our pivotal clinical trials that are designed to demonstrate efficacy of the product for treating patients with IPA or 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 a drug results in improved efficacy because higher doses kill the infectious organism more efficiently and with less opportunity for the development of resistance. The data generated in our voriconazole program to date has significantly removed risk from the program since we can safely administer a dose more than twice the dose of inhaled voriconazole, but is currently being used in hospitals in Europe to successfully treat patients with complicated aspergillus lung infections, even when the other treatment options failed due to toxicity or by not reaching sufficient doses in the lung that are required for efficacy.

Moving on to our Tacrolimus Inhalation Powder program. The development activities are proceeding well after some delays due to COVID. Enrollment will be completed this month in our Phase I clinical trial. In the single-ascending dose, or SAD, portion of this trial, we safely administered single doses of 0.5, 1, 2.5 and 5 milligrams to help in normal volunteers. We had planned to dose an additional cohort of subjects at 10 milligrams, but we canceled this group when we found that dosing had 5 milligrams provided to co-limit blood levels that were previously shown to provide efficacious immunosuppression.

In the multiple ascending dose part of the study, we have completed dosing of subjects in cohorts 1 and 2 with 1/2 or 1 milligram twice daily doses over 7 days. We found that these dose levels provided steady state blood concentrations associated with effective immunosuppression due to enhanced bioavailability of the inhaled product. For cohort 3, subjects are being dosed with a single 1.5 milligram dose each day for 7 days. As Glenn reported, we have filed a U.S. patent application based on the ability to reach efficacious blood levels from once-daily dosing. This 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 GLP 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 tacrolimus for the prevention of lung allograft rejection in our upcoming pivotal studies.

The enhanced bioavailability and ability to bypass the gastrointestinal track could also open the door for treatment of other solid organ transplants, where significant drug-drug interactions and food effects are observed with oral tacrolimus. We believe that the inhaled tacrolimus' ability to reach the -- to reduce the fluctuations of bioavailability confers an advantage over oral tacrolimus, 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 with our augmented monoclonal antibody program and the niclosamide 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 Coleman, for a review of the financials. Kirk?

Thank you very much, Dale. For the 3 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 niclosamide and clinical activity related to Voriconazole Inhalation Powder and Tacrolimus 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 3 months ended March 31, 2021, were $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 the 3 months ended March 31, 2021, were 23,140,607 compared with 19,008,611 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, who 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. I'm pleased to report that we have continued to advance the science and partner applications supporting thin film freeze drying. thin film freeze drying was designed to provide a specific freezing rate, not too slow, like that required by conventional localization and not too fast, like that required by freight freeze drying, such that a particular and unique powder morphology and stability of drug in the powder form is obtained. Thin film freeze drying was also designed to not expose the protein to high shear stress like that used in spray drying and spray-freeze drying. Recognition of the benefits of thin film freeze drying technology to drug development is most recently evident by our newly accepted and invited 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 thin film freeze drying compared to other competing technologies like conventional localization, spray drying and spray-freeze drying.

First, we continue to validate our thin film freeze drying on larger molecular weight drugs like protein, including monoclonal antibodies, messenger RNA and plasma DNA. Our data confirms that the low shear stress and intermediate freezing rates designed for thin film freeze drying as compared to other technology offers a stable, inhalable dry powder protein. In fact, we have published studies confirming that thin film freeze drying produces more chemically stable inhalable powders of such difficult to formulate proteins as lysozyme and lactate dehydrogenase in direct head-to-head comparisons to spray-freeze drying. These are the types of difficult to formulate therapeutic biologics that thin 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 that the mRNA integrity from mRNA-loaded lipid nanoparticles was preserved and that the mRNA function was maintained using in vitro cell transfection assay. Based on our continuing validation work with partner mRNA-loaded lipid nanoparticles, thin film freeze drying will lead to a successful formulation of second and third generation COVID vaccines. In addition, our data confirms that thin film freeze drying offers important advantages of improved protein stability during processing and then storage stability at room temperature over that of conventional localization spray-freeze drying or spray drying.

In addition, we have transformed another partner's therapeutic peptide currently delivered by nebulization of a liquid into an inhalable dry powder, having excellent aerosol properties by thin film freeze drying. Also, we continue to apply thin film freeze drying to develop inhalable forms of monoclonal antibodies. We have recently shown in a mouse model that intratracheal insufflation of an siRNA dry powder made by thin film freeze drying led to a reduction of a target gene in lung tissue. We have also confirmed that thin film freeze drying applied to plasma DNA maintained its chemical integrity. Collaboration with a partner on their adjuvant-ed liquid 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 2 months.

Interestingly, this adjuvant and antigen was compared in a head-to-head study against spray drying, and those results were not acceptable. The intermediate freezing rate used in thin film freeze drying is superior to the much slower freezing rate used in conventional localization because that leads to antigen unfolding in adjuvant aggregation, which is irreversible. Lastly, regarding virus vector-based vaccines. In collaboration with another partner, we have shown that up to 100% of virus infectivity was preserved after the liquid suspension of virus were subjected to thin film freeze drying.

Now let's consider our work on dry powders containing small molecular waste water-insoluble drugs like voriconazole, tacrolimus and niclosamide that Dale discussed earlier and that the company has reported advancing in various stages of clinical testing. Thin film 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 benefits that they provide in treating different diseases.

Just last week, our latest paper on inhaled niclosamide dry powder was published in the peer review journal, International Journal of Pharmaceutics. In this paper, we reported that our inhaled dry powder niclosamide formulation prepared by thin film freeze drying was safe after an acute 3-day multi-dose tolerability and exposure study in rats based on the histopathology analysis conducted by Drs. Peters and Heckman at 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 IC90 for at least 24 hours, following a single dose administration in the Syrian hamster, a well-known infection model for COVID-19. This IC90 metric is a key indicator of the effectiveness of niclosamide inhalation dry powder and delivered to the lungs of the hamsters for inhibiting the SARS-CoV-2 virus.

I want to acknowledge my colleague, Professor (inaudible), for his collaboration and contributions to our research. Lastly, I want to thank you for your continued support of TFF Pharmaceuticals and the collaboration with the University of Texas at Austin. And now I'd like to turn the call over to Chris Cano, 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, and good afternoon, everyone. Thank you for joining us today.

As I have previously shared, the TFF business development team is laser-focused on 3 key areas of growth for the company. These 3 key areas are: one, growing the TFF pipeline of internal development programs; two, our pharma-partnering efforts; and three, our government and academic contracting efforts. We continue to make great strides in each of these key areas. For today's call, I will be focusing on our pharma-partnering efforts in our government and academic partnerships.

To begin, TFF continues to be very active in the mRNA space. We have a large number of active mRNA programs underway. And this number of projects continues to grow. As we continue to elevate our expertise in understanding and formulating different LNPs and mRNA, generating data and delineating a clear distinction of our technology versus other technologies. Pharma partners are now knocking on TFF's door looking to engage with us. This is the 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 ailments. 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 on-site for injection.

For example, we are working with a large pharma partner formulating their proprietary mRNA into a TFF 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, our dry powder exhibits excellent viability and potency rates. We are very thrilled with our progress in the mRNA inhaled space.

In the mRNA vaccine space, we continue to make tremendous progress. We are 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 TFF 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 TFF technology addresses 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 2 leading academic institutions in the mRNA research space, and we are now collaborating with both institutions on mRNA vaccines. TFF is engaged with Dr. Drew Weissman, esteemed Professor of Medicine, Perelman School of Medicine at the University of Pennsylvania. These collaborative discussions focus on a feasibility arrangement, utilizing TFF's technology to generate a stable dry powder version of UPenn's mRNA vaccine. Dr. Weissman's 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 TFF. We will provide updates as this project progresses.

TFF is engaged in discussions with Dr. Kiat Ruxrungtham, Professor of Medicine at Chulalongkorn University, who established the Chula Vaccine Research Center, Chula VRC. These collaborative discussions focus on the feasibility arrangement utilizing TFF's technology to generate a stable dry powder version of Chula VRCs COVID 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. nonprovisional utility patent application and a PCT application, which when issued, will provide the company with a long runway of exclusivity and protection on our mRNA programs as we strive to bring these products to market with our partners. Building and strengthening our patent portfolio is a critical component of the TFF corporate strategy.

TFF is very pleased to announce that the company has entered into a collaboration agreement with the Albert Einstein College of Medicine. Under this collaboration, TFF is working with Dr. Kartik Chandran and his research team to develop stable dry powder formulations of recombinant vesicular stomatitis virus-based vaccines, or VSV. Dr. Kartik Chandran is one of the world's leaders in the development of VSV-based vaccines. These were the basis for the first successful vaccines with efficacy against the Ebola virus. In collaboration with Dr. Chandran, we will be exploring the use of a VSV vaccine for development of a second-generation COVID vaccine that will be free of the cold chain requirements that is faced by the mRNA COVID vaccines, and we plan to deliver this without a needle.

Over the last few months, we received VSV vaccine candidate from Dr. Chandran, and we successfully formulated a dry powder version of the VSV vaccine. We sent the dry powder samples back and based on in vitro testing, the VSV showed minimal tighter loss and we were able to generate a stable form of the VSV vaccine.

We are beginning some optimization work as we speak, and we are exploring a license to the VSV vaccine with the goal of performing some initial in vivo testing. This collaboration holds tremendous opportunity for TFF, where success in this program would allow COVID vaccinations to be distributed throughout the world so that we can reach global herd immunity to stop COVID transmission and prevent the emergence of new variants and save countless lives around the world.

For a quick update on our previously announced partnerships and collaborations, the feasibility arrangement with NeuroRx is progressing. TFF has successfully formulated NeuroRx's peptide for treating COVID in an inhalable dry powder. Optimization work and stability testing of the dry powder is underway. TFF 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 USAMRIID is actively moving forward. Our TFF dry powder was successful in in vitro testing for both the monoclonal antibody program and the VSV program. We are now planning in-vivo testing. And if successful, TFF would seek nondilutive 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 will be seeking to raise capital, and we plan to execute on our LOI and finalize a definitive agreement. As Glenn highlighted in his remarks, our partnership with UNION therapeutics on niclosamide is proceeding well. We are approaching important first-in-human trials on both programs. In addition, as Glenn updated everyone, our co-development work on the Augmenta Bioworks monoclonal antibody for COVID is also moving forward as scheduled. We are on target for starting our IND-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 siRNA, plasma DNA, oligonucleotides, [stage], peptides, monoclonal antibodies, cytokines, AAV, VLP and VSV product candidates, along with many other different proteins and small molecules.

On the government contracting side, we recently announced on April 13 our contract with Leidos on the DARPA project. This is the first government contract for TFF and we are actively pursuing additional government contracting opportunities. The work under this DARPA contract has begun. And as part of the DARPA project, TFF has leased its own laboratory space in Austin, Texas, in an effort to fulfill its obligations under the DARPA contract. This lab space is approximately 700 square feet, and it has been completely outfitted with TFF-owned equipment and is being managed and run by TFF staff, employees and consultants. This additional lab space is a welcome addition for TFF, 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 TFF 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 Freezing technology.

While I have this opportunity, I would like to thank our partners at the University of Texas at Austin. With the continuing support and tireless efforts of Dr. Bill Williams and his research team, we continue to expand the applications of the Thin Film Freezing technology into new and innovative areas of drug delivery. In closing, the BD team is focused on closing at least 2 licensing transactions in 2021. 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 TFF team who participated today.

This has been another quarter of progress and accomplishment for the company. As Chris just said, the recognition of the unique capabilities of our Thin Film Freezing technology platforms has generated a ground flow of interest among potential partners in the academic, governmental and pharma biotech fields. Particularly within the realm of biologics, our technology's ability to formulate a dry powder for inhalation to the lungs or to formulate vaccines into a stable dry powder that is not subject to cold chain storage issues is bringing 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 lyophilization, spray drying or even spray-freeze drying. These other technologies cannot effectively reformulate large complex biologics into a dry powder form, giving us a distinct competitive technological advantage that is further being recognized in the industry. As Dale elaborated, this technology has resulted in far better-than-expected clinical results in our 2 flagship clinical programs, programs that address unmet therapeutic needs with large market potentials. And in the case of our Tacrolimus Inhalation Powder, demonstrating immunosuppressive effectiveness with just a single dose, the market potential can indeed increase 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. I hope you all stay well.

And with that, I will turn the call back to the operator and open it up to questions. Operator?

(Operator Instructions) Our first question comes from the line of Jonathan Aschoff from ROTH Capital Partners.

Congrats on the progress. What organ transplant market shares and pricing assumptions do you factor into your tax forecast of around $1 billion?

Yes. 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 series of primary and secondary research with KOLs and payers. And they have forecasted based upon this feedback, about a 40% share of the heart, liver and kidney transplant market, assuming that we have at least equivalent efficacy profile, but certainly a better adverse event profile, reducing the number of comorbidities, specifically related to renal impairment. On the lung side, and this is actually compared to forecast we did about 1.5 years ago, that share went up to about 50%. And the price assumptions are on the very, very low end of what an orphan drug pricing plan scheduled will be. It's about a $6,000 annual use rate, which I think is conservative. I'd rather be conservative in this case, but when you do that calculation and you look at incentives and prevalence, we hit a peak according to these data of about $1.2 billion. Takes about 7 years to get there because of the numbers of procedures, but it's a very, very important forecast. It's a very big drug. And our data are continuing to inform the type of result we think we'll get in the marketplace. So that's great.

Okay. How do you anticipate monetizing your academic vaccine relationships?

Yes. So first of all, if you take a look at what Chris discussed, the breadth of the relationships that we have are important to note, adding the work now with Dr. Weissman, adding the work out at Albert Einstein to what we already have with USAMRIID, at UGA and there are other institutions that we're working with. The plan is to -- once we get the in vitro data, is to work with the tech transfer of groups to license the technology to TFF. With the purpose of then looking at gaining financing, mostly non-dilutive financing through the academic institutions to progress those assets through Phase I development.

And not all of them, but the ones that are the best-in-class, we would then see commercial partners. So the technology license of TFF through the academic institution, and then we find a development partner to take these two in commercial. So very -- it's -- maybe all of them get there, highly doubtful. But look at who we're working with here. It's sort of like the Mt. Rushmore of 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 TFF.

Okay. And then 2 really quick ones that could be one answer, one-word answers. Can the inhaled voriconazole be used in prophylaxis as well as treatment? And is the R&D number a new run rate?

And what's the second question, I'm sorry, Jon, is the R&D?

The 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 run rate?

And I'll answer the first question. So yes, prophylaxis is an opportunity for us back in a recent KOL meeting. The KOLs were actually urging us to take a more deep look at that. And they think they can get a more important share of that market. Kirk, could you answer Jonathan's question about the R&D expense, please?

Sure. As you know, Jonathan, we haven't given formal cash burn guidance. So -- but I'll kind of give you some idea on how to think about it. We had $58 million in cash in the quarter. We 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 it's going to show a dramatic departure from the historical run rate and the trend that we 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 certainty so.

Okay. So it sounds like it will be somewhere in between, fourth quarter and first quarter?

It's a fair assessment.

Our next question comes from the line of [Daniel Kauffman] from TW Research Group.

Glenn, first off, this new relationship with UPenn and Dr. Weissman, can you tell me a little more about it and what exactly you'll be working on?

Yes. So 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. Weissman through a presentation we gave to a group called [CIVICs], and that's basically a United States group of top vaccine specialists in the country. Dr. Weissman was part of that presentation, he actually reached out to us with interest in the technology, which is in it itself, a really -- we were very quick to take that call. As you can imagine, given Dr. Weissman's reputation and he's basically the father of mRNA vaccine. So very quickly, we established a relationship. And at that point, since Chris is closest to it, I'll have him talk about what happened there and what we're working on.

Sure. And thanks, Dan. So with Dr. Weissman, we are going to be working on 2 different mRNA vaccines. I can't really share what the indications are. But we are going to be formulating them in our dry powder, and we are planning with -- to work with our partner in initial in vitro work and in vivo work, and give our technology a run. So looking forward to working with them. There -- it's a fantastic opportunity to work with their research group.

Yes. I mean I just Googled him, and he's a very impressive individual to say the lease, so congrats on that. Glenn, can you talk a little bit about what you're intending to do with the use of proceeds from the recent capital raise?

Yes. Thanks, Daniel. Good question. So at this point, the money is in the bank, and if it's a good thing because it certainly extends our runway. And as you know, Danny, we invest very carefully. So the 2 areas we're looking at, is there a potential program we want to add to our internal development pipeline, potentially a 505(b)(2) program, something that maybe we want to co-develop like we did with Augmenta where we sort of share the cost and take it through Phase I. So that's -- that gives us an opportunity to invest when we see the right opportunity.

The other thing that we're looking at is where can we selectively invest in enhancing our sort of ability to be in control of our IP and do some specific manufacturing, perhaps in the area of where partners are coming to for sterile preparation. Those decisions there, we're not committing to anything. Chris described the fact that we do now have new lab space at UT Austin, on the sixth floor and where Dr. Williams is that help with some of the DARPA work and some other work there. So we're not talking, but it's just been 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, the revenues we anticipate from the existing partnerships and new partnerships will also continue to improve the cash position and make the company profitable, ultimately. So nothing imminent, but that's what we're thinking.

Great. And then if I could, one last question. Just you go through a ton of different programs, which is awesome. I mean, you've got so much going on in many different areas. And I'm wondering, a lot of times you look at it sort of as sales funnel, you're definitely putting a lot into the funnel. I'm wondering if you can talk about if the progress on existing programs to 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 how the progress is going in the funnel.

All right. So the way we track it is here. So what's coming in is at the top of the funnel. But we want to really just determine how well we're doing and moving these things forward, we quantify it with how many relationships do we have where we're doing in vivo work, right? And that then needs to mature as that rounds our in vitro work, we start with in vitro work. And that needs to mature into the in vivo piece. So you -- I'm not going to give a number, but take a number. It's in that bucket. You've got your MTA, in vitro work, almost all the time. It's not all the time is successful.

Then how many you have in in vivo, and ultimately, how many are -- were you negotiating a transaction, right? I can tell you that, that progress from in vitro to in vivo to negotiation, the numbers are tracking very, very positively. And negotiations sometimes take a little longer. We only want to do deals that make sense for us, and we get the value creation we want. But that real sort of determinant of progress becomes the transition from in vitro to in vivo has demand. And then when are you -- when you've done with that successfully and when you actually negotiating table for a deal. And I harken back to Chris' statement, which is we're highly confident so we'll get at least 2 deals done this year, and that position is not changing.

Our next question comes from the line of Ram Selvaraju from H.C. Wainwright.

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, can you give us a sense of the degree to which you anticipate highly strategic protection coming from the claims in that patent as well as what you anticipate the expiration date to be?

Chris, can you take that one?

Sure. And thanks, Ram, for the question. So we have a very [IP] is really the core foundation, right, around our thin film freezing. So this particular patent, the provisional was just filed earlier this week, just to give you kind of a time frame because it's based on, right, the work that we're doing in the clinic right now. But we have formulation patents, right, and a multitude of patents that protect the product, the 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 1 year. That patent will be reviewed. And then upon successful review, we would expect to get that 20 years.

Bill or Dale, I don't know if you have anything to add to that? If you can please.

Yes. Yes. This is Bill. Since we just filed, it will be a year before anything happens, we'll convert in the year. And then it will be sometime after that, month to a year, before we get personal perfection, just based on experience.

Okay. Very helpful. Also, with respect to your PLUS Product collaboration, do you have any more granularity on specifically when they anticipate introducing the first product based on the thin film freezing formulations of cannabis to the market?

Yes. So at this point, Ram, the best guidance I can give would be very, very late, towards the end of the second quarter or early third. We crossed a very, very important threshold in that the powder was made in their facility. Actually, to quote from their CEO, Jay, references that. Now it's a matter of doing some different strengths. And I think because there really isn't a need for any reformulation if we move into the testing phase. It starts to look like it is a consumer launch. So they have a really nice plan laid out for consumer testing through some of the (inaudible) tenders. And then it's off the top to the rate. So to me, the most important hurdle is, can we make it? Can it be inhaled, do people cough, and we passed that test, big (inaudible) . So now it's maybe some fine tuning, get the feedback, how you market it and I guess we're off to the races there.

Okay. And then just 2 other quick ones. With respect to your work in 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 pathogens 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 be? And then the second question is just a technical financial question. Based on the nature of the collaboration agreements that you have in place, 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 de minimis?

Okay. I want Chris first to answer the question about flu. I want to comment, I think, beyond that. And then Kirk, you may be the one to answer the second question from -- 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 and CIVICs, right, there is a tremendous focus on influenza. We're also universal influenza. We're also focused very heavily on COVID. It's really any vaccine that is a liquid that would benefit from the characteristics of our technology and a dry powder. So we are working with USAMRIID on filoviruses and alpha viruses. Those are both vaccine, monoclonal antibodies. So we're really across many different modalities when it comes to vaccines.

Yes. So if you think about it, Ram, it's a portfolio play. So you've got maps, as Chris said, for antifungals, you've got flu, universal flu, you've got COVID-19. We're also -- we haven't disclose the feasibility work we're doing with the company is looking at just COVID, period. Not even COVID-19, but broad base COVID-19. GreenLight. So GreenLight, if you know about them, they're looking at basically developing vaccines for the developing world and how better could they play then with a technology and a formulation and 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 the listener, it sounds like you are putting the pieces together. Now these guys are building on a very, very big vaccine portfolio, that frankly, if any of them hits, are important, if all of them, it's great. But we're not a COVID-19 company. We're not a flu company. We're not a (inaudible) company. We're working with a company that approached us about chikungunya. Now you'd say chikungunya, well, there's been chikungunya outbreaks in Puerto Rico recently. And that's a start, right? So -- and it goes on and on. And that's the strategy. And it sounds like you're breaking the code on what we're thinking there. So thanks for that. And then, Kirk, do you have any answer on Ram's question about R&D?

Yes. Sure. On the first one with the current contract that we have in place, for Leidos 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. There will be offsets, obviously, as you alluded to. 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.

Ram, if I can take a little bit of a second here since you've opened the door for me to say this. When we get selected for work by Drew Weissman or Ted Ross or John Dye or Kartik, it's not automatic. They do a tremendous amount of diligence. They look at every potential formulation partner. Some of these relationships started a year or more ago. The DARPA announcement was about 18 months in the making, a year of that was diligent by (inaudible). So it's not like, "Oh, we pick you." They pick us because they've done their work. So I think it's validating. Yes, there's a bit of a way to go here, maybe not too long. But we win every time. I'll stop there. We -- every time we've put up in a bake-off or a beauty contest, we win or (inaudible).

Yes, that is clearly a testament to the disruptive nature of the TFF platforms level of innovation. So I have no problem seeing how that would be the case but that's very impressive.

(Operator Instructions) Our next question of Bill Morrison from National Securities.

A couple of questions. Just to follow through on the previous question about the pipeline, just a little more color. The research institutes that you're working with, does that work in conjunction with your existing mRNA partners in vaccines, or is it to generate new interest with new partners for vaccines? That's my first question.

Yes. It's all stacking, Bill. So now look, you could start to think about some of the networking, right? So you've got Drew Weissman, mRNA, you fill in the blank, right? So -- but yes, the academic relationships, if you want to call them that, and the pharma relationships are really distinct. And they're sort of you think about it as -- and if you want to look at it as my cycle, certainly, the pharma relationships are more near-term. You have some midterm and the longer-term opportunities. Some of these could go very, very quickly and I think you've got researchers that know how to do this. So -- but it's all accretive. It's all stacked. They're now -- there's not a lot of overlap there, if any. But there are networks, and it's great to have a Drew Weissman on our side when you're talking to a pharma company.

Right. So would that accelerate licensing opportunities with existing partners?

Hopefully, I don't want to overcommit, but you can certainly see where that would have be an opportunity for us.

Okay. Good. And with the existing license partners, what are -- what's the outlook for upfront? And when might those happen?

And so Bill, I try -- I guess to Dan's question, we now have sort of crossed over to this world of in vivo testing and negotiation. So that's good, if you are tracking and kind of track it over time. And I still stick to what we said at the beginning of the year, 2 deals, at least 2 deals by the end of the year, hopefully sooner rather than later, but it's annual with these 2. And no reason to back off of that expectation at all.

Our next question, [Andy Mine] from is a private investor.

Great to hear some progress on UNION, Plus and Augmenta. But can you give an update on the status with the Felix?

Yes. So what I can say about Felix, this is obviously Felix. They are recruiting to a trial, to a university-based trial. They're at a certain point of recruitment in that trial. They are saying that, that will initiate the ability for them to raise their capital. It's not totally to the completion of the trial but there's a certain threshold they want to hit, and that's what their potential investors are requesting. So we do speak with CEO, Rob McBride, frequently. He gives us update and behind the scenes, there's even some continued optimization going on so that we can hit the ground running with the thin film freezing version of their compound quickly.

Another question for me, please. So you announced NeuroRx and GreenLight, just a couple of months ago, and NeuroRx seems to be progressing to the next phase, how about GreenLight?

So yes. Yes NeuroRx is progressing nicely. We're happy about that. We actually have done some work already. We have some other work going on that's ready to be finished and we're far along in discussing with them next steps. Greenlight, we are -- we actually had a conversation with them today and they're forwarding us some material to start the specific feasibility work there. That -- generally, when we get material, it takes us about, Chris, 3 weeks or so to turn it back to them. There may be other formulations they want 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 Glenn Mattes 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. So I wish you all the best, be well, be safe. And you know you could always reach out for the company, and we'd be happy to talk to you. Thank you. Good night.

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