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spk12: Thank you for standing by, and welcome to the TFF Pharmaceuticals, Inc. First Quarter 2021 Financial and Business Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 1 on your telephone. 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.
spk08: 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 Mattis, 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 Mattis.
spk11: 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 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, boriconazole 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 four 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 two 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 unions suggest 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 DARPA's personalized protective biosystems program for chemical and biologic protection for U.S. warfighters is also proceeding, as is our R&D agreement with USAMRID for biodefense countermeasures and our early-stage universal influenza work with the University of Georgia's 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. Karthik 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 Canna 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 two lead clinical programs. Dale?
spk07: 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 one meeting with the FDA that will be held after the dosing and 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 that is currently being used in hospitals in Europe to successfully treat patients with complicated aspergillus lung infections. even when the other treatment options fail 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 one 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 healthy 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 at 5 milligrams provided to colonless 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 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 due to enhanced bioavailability of the inhaled product. For cohort three, subjects are being dosed with a single 1.5 milligram dose each day. for seven days. As Glenn reported, we have filed a US 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're 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 tract 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 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 Augmenta 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?
spk01: Thank you very much, Dale. For the three months ended March 31st, 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 administrative expenses for three months ended March 31st, 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 three 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 in 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. We'll 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.
spk04: 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 law authorization, and not too fast, like that required by spray freeze drying, such that a particular and unique powder morphology and stability of drug in the powder form is attained. 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. Recognitions of the benefits of thin film freeze drying technology to drug development is most recently evidenced 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 proteins. including monoclonal antibodies, messenger RNA, and plasmid DNA. Our data confirmed that the low shear stress and intermediate freezing rates designed for thin-film freeze drying, as compared to other technologies, 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 PIM 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 assays. 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 confirmed 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 plasmid DNA maintained its chemical integrity. Collaboration with a partner on their adjuvanted 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 two 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 and 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 weight water insoluble drugs like boriconazole, 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 strategies 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-reviewed International Journal of Pharmaceuticals. In this paper, we reported that our inhaled dry powder miclosamide formulation prepared by thin-film freeze-drying was safe after an acute three-day multi-dose tolerability and exposure study in rats based on the histopathology analysis conducted by Drs. Peters and Hackman 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 made by thin-film freeze drying and delivered to the lungs of the hamsters for inhibiting the SARS-CoV-2 virus. I want to acknowledge my colleague, Professor Zhenrong Cui, 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?
spk10: 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 three key areas of growth for the company. These three 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 and 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 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 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 onsite 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 two 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. Kayat Raksrungtham, Professor of Medicine at Chulalongkorn University, who established the Chula Vaccine Research Center, Chula VRC. These collaborative discussions focus on a feasibility arrangement utilizing TFF's technology to generate a stable dry powder version of Chula VRC's 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. non-provisional 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 a 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 titer 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 Usamerid 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 non-dilutive funding to move both the vaccine programs forward into development. These activities are underway. Our partner, FelixBio, 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 partners' proprietary siRNA, plasma DNA, oligonucleotides, phage, 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 13th 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 TFFBD 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 two 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.
spk11: 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 groundswell of interest among potential partners in the academic, governmental, and farm 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 two 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 could 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 of 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?
spk12: Certainly. Ladies and gentlemen, if you have a question at this time, please press star then 1 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 to the line. Jonathan Ashcroft from Roth Capital Partners. Your question, please.
spk09: Thank you, guys. Congrats on the progress. What organ transplant market shares and pricing assumptions do you factor into your tax forecasts of around a billion?
spk11: Yeah. Thanks, Jonathan. So we actually employ a group called Trinity Partners who – 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 events profile, reducing the number of comorbidities specifically related to renal impairment. On the lung side, and this is actually compared to forecasts we did about a year and a half 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 schedule would be. So 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 incidence and prevalence, we hit a peak, according to these data, of about a billion two. It takes about seven 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 you know, the type of result we think we'll get in the marketplace. So that's great.
spk09: Okay, thanks for that. How do you anticipate monetizing your academic vaccine relationships?
spk11: Yeah, so first of all, you know, if you take a look at what Chris discussed, you know, the breadth of the relationships that we have are important to note. Adding the work now with Dr. Weissman, adding the work out of Albert Einstein to what we already have with USAMRID, 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 groups to license the technology to TFF with the purpose of then looking at gaining financing, mostly non-diluted financing to the academic institutions to progress those assets through phase one development. And, you know, not all of them, but the ones that are the best in class, we would then seek commercial partners. So the technology gets licensed to TFF through the academic institution, and then we find a development partner to take these through to commercial. So, you know, 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 Mount Rushmore of vaccine developers. 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.
spk09: Okay, and then two really quick ones that could be one-word answers. Can the inhaled fluoroconazole vaccine 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, John. 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?
spk11: 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?
spk01: Sure. As you know, Jonathan, we haven't given formal cash burn guidance, but I'll kind of give you some idea on how to think about it. We had $58 million in cash in the quarter last 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.
spk09: Okay, so it sounds like it'll be somewhere in between fourth quarter and first quarter.
spk01: It's a fair assessment.
spk09: Okay, thank you very much, guys.
spk12: Thank you. Our next question comes from the line of Daniel Acosta from TW Research Group. Your question, please.
spk03: Yeah, hey, Glenn. Thanks for taking my question. 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?
spk11: 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. Weissman through a presentation we gave to a group called Civics, and that's basically a United States group of the 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 itself a really very quick to take that call, as you can imagine, given Dr. Weissman's reputation and He's basically the father of mRNA vaccines. 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 then and what we're working on.
spk10: Sure. And thanks, Dan. So with Dr. Weissman, we are going to be working on two 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 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. It's a fantastic opportunity to work with their research group.
spk03: Yeah, thanks. I mean, I just Googled him, and he's a very impressive individual to say the least, so congrats on that. Glenn, can you talk a little bit about what you intend to do with the use of proceeds from the recent capital race?
spk11: Yeah, thanks, Daniel. Good question. So at this point, you know, the money is in the bank, and that's a good thing because it certainly extends our runway. As you know, Daniel, we invest very carefully. So the two areas we're looking at is, is there a potential program we want to add to our internal development pipeline? potentially a 505 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 one. So 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, you know, in the area where partners are coming for sterile preparation. You know, no 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 Dr. Williams is to help, you know, with some of the DARPA work and, you know, some other work there. So we're not talking, you know, but it's just nice to have, 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. So nothing imminent, but that's what we're thinking.
spk03: Great, thanks. And then if I could, one last question. Sure. 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, you know, a lot of times you look at it sort of as it fails in a funnel. You're definitely putting a lot into the funnel. I'm wondering if you could talk about just the progress on existing programs to moving them through, and how do you quantify progress? 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.
spk11: All right. So the way we track it is, yeah, so what's coming in at the top of the funnel? But, you know, when we want to really determine how well we're doing in moving these things forward, you know, we quantify it with, you know, how many relationships do we have where we're doing in vivo work, right? And that then needs to mature and I'm sorry, in vitro work. You start with the in vitro work, and that needs to mature into the in vivo piece. So you, you know, I'm not going to give a number, but take a number, it's in that bucket, you know, you've got your MTA, the in vitro work, almost all the time, about all the time is successful. Then how many you have in in vivo, and ultimately how many are you, where are you negotiating a transaction, right? I can tell you that that progress from in vitro to in vivo, to negotiation, you know, the numbers are tracking very, very positively. And, you know, negotiations sometimes take a little longer. We only want to do deals that make sense for us, and then we get the value creation we want. But that real sort of determinant of progress becomes the transition from in vitro to in vivo, as Duke demands. And then, you know, when you're done with that successfully, And when are you actually at the negotiating table for a deal? And, you know, I hearken back to Chris's statement, which is, you know, we're highly confident that we'll get at least two deals done this year. And that position is not changing. Great. Well, thanks, Glenn.
spk03: And congrats on all the progress. Keep it up.
spk12: Thanks, Daniel. Appreciate it. Thank you. Our next question comes from the line of Ram Savaraju from HC Wainwright. Your question, please.
spk02: 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, 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.
spk10: 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 our thin film freezing. So, this particular patent, the provisional, was just filed earlier this week, just to give you kind of a timeframe, 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, right, so we filed the provisional. In one year, that patent will be reviewed. And then upon successful review, you know, we would expect to get that 20 years.
spk11: Bill or Dale, I don't know if you have anything to add to that.
spk04: Yeah, this is Bill. Since we just filed, it'll be a year before anything happens. We'll convert in a year. And then it'll be sometime after that month to a year before we get the first office action. based on experience.
spk02: Okay, very helpful. Thanks. 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-sewn freezing formulations of cannabis to the market?
spk11: Yeah, so at this point, Ron, the best guidance I can give would be very, very late. towards the end of the second quarter, early third. You know, we crossed a very, very important threshold in that the powder was made in their facility. Actually, the quote from their CEO, Jake, references that. Now, you know, it's a matter of doing some different strengths, you know, and I think because there really isn't a need for any reformulation, we move into the testing phase. It almost starts to look like, you know, it is a consumer launch. So they have a really nice plan laid out for consumer testing, you know, through some of the bud tenders. And then, you know, it's off to the races. So to me, the most important hurdle is can we make it? Can it be inhaled? Do people cough, you know, and we passed that test, you know, big sirely. So now it's maybe some fine tuning, get the feedback, how do you market it? And, um, you know, I guess we're off to the races there.
spk02: Okay. Um, and then just two other quick ones with respect to your work in the dry powder vaccine domain, uh, 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 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.
spk11: You know, I want Chris to first answer the question about flu. I want to make a comment, I think, beyond that, and then Kirk, you may be the one to answer the second question from Rob, so you can begin to think of that answer. But Chris, if you can start.
spk10: Sure. It really, you know, 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, you know, with USAMRID on filoviruses and alfaviruses. Those are both vaccinated. Yeah, monoclonal antibodies. So we're really across many different modalities when it comes to vaccines.
spk11: Yeah, so if you think about it, Robin, it's a portfolio play. You know, so you've got MAPS, as Chris says, for antifungals. You've got flu, universal flu, COVID-19. We're also, we haven't disclosed this feasibility work we're doing with a company that's looking at just COVID, period, not even COVID-19, but broad-based 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 than with a technology and a formulation that isn't subject to a need for cold chain. So, you know, if you kind of put it all together and you can step back, I hope the listener, and it sounds like you are putting the pieces together, because these guys are building a very, very big vaccine portfolio that, frankly, if any of them hits, are important. If all of them hits, great. But, you know, we're not a COVID-19 company. We're not a fluke company. We're not a Ebola company. We're working with a company that approached us about chicken gunwa. Now, you'd say, chicken gunwa? Well, there's been chicken gunwa outbreaks in Puerto Rico recently, and that's a start, right? And it goes on and on, you know, 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 an answer on Ron's question about R&D?
spk01: Yeah, sure. On the first one with the current, you know, contract that we have in place, you know, Philado's contract, the financial terms were 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, you know, for additional opportunities for the product candidates as well as getting additional government work in the future.
spk11: You know, Ram, if I can take a little bit of a second here since you've opened the door for me to say this. You know, when we get selected for work by, you know, Drew Weissman or Ted Ross or John Dye or Cartek, it's not automatic. You know, they do a tremendous amount of diligence. They look at every potential formulation partner. Some of these relationships started a year or more ago. You know, the DARPA... announcement was about 18 months in the making. A year of that was diligent by Light Up. 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. Every time we're put up in a bake-off or a beauty contest, we win.
spk02: That is clearly a testament to the disruptive nature of the TFF platform's level of innovation. So I have no problem seeing how that would be the case. But, you know, that's very impressive. Thanks very much for answering my questions.
spk12: Thank you. Once again, ladies and gentlemen, if you have a question at this time, please press star then 1. Next question. Our next question comes from the line of Bill Morrison from National Securities. Your question, please.
spk05: Hi, guys. A couple questions. Just to follow through on the previous question about the pipeline, it's 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?
spk11: That's my first question. It's all stacking, Bill. you could start to think about some of the networking, right? So you've got Drew Weissman, MRNA, you fill in the blank, right? But yeah, the academic relationships, if you want to call them that, and the pharma relationships are really distinct. And they're sort of think about it as you know if you want to look at it as my cycle you know certainly the father relationships are more near term um you have some midterm and then longer term opportunities some of these can go very very quickly and you know i think you've got you've got researchers that know how to do this so um but it's all creative it's all stacked they're now there's not a lot of overlap there if any but there are You know, there are networks, and, you know, it's great to have a Drew Weissman on our side, you know, when you're talking to a pharma company.
spk05: Right. So would that accelerate, you know, licensing opportunities with existing partners?
spk11: Hopefully. I don't want to overcommit, but you can certainly see where that would be an opportunity for us.
spk05: Okay, good. And with the existing licensed partners, what are the, you know, what's the outlook for upfronts, you know, and when might those happen?
spk11: So Bill, I tried, I guess, to Dan's question, you know, we now have sort of crossed over to this world of in vivo testing and negotiation. So that's good. You know, if you do a tracking and kind of track it over time and, you know, I, I, still stick to what we said at the beginning of the year. You know, two deals, at least two deals by the end of the year. Hopefully sooner rather than later. But it's, you know, annual, at least two. And no reason to back off of that expectation at all.
spk05: Okay, great. Good job, guys. Really appreciate it. Thanks.
spk11: Thank you, Bill. Next question. Thank you. Andy, Quan? Hi.
spk12: Our next question, Andy from East Private Investor. Your question, please.
spk06: Hi, guys. Thank you. Great to hear some progress on Union Plus and Augmenta, but can you give an update on the status with Felix?
spk11: What I can say about Felix is they are recruiting to a trial, a university-based trial. They're at a certain point of recruitment in that trial. They are saying that that will initiate the ability 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 their CEO, Rob McBride, frequently. He gives us updates. 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.
spk06: Another question for me, please. So you announced NeuroX and GreenLight just a couple months ago, and NeuroX seems to be progressing to the next phase. How about GreenLight?
spk11: So, yes, NewRx is progressing nicely. We're happy about that. We actually have done some work already. We have some other work going on that's about ready to be finished, and we're far along in discussing with them next steps. Greenlight, 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, three weeks or so to turn it back to them. There may be other formulations they want us to try as well. So the feasibility work is underway.
spk12: Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Clint Matz for any further remarks.
spk11: Well, 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 to the company and we'd be happy to talk to you. Thank you.
spk12: 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.
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