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spk01: Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals 2020 Financial Results Conference Call. As a reminder, this conference is being recorded. I will now turn the call over to our host, Mr. Paul Sagan of TFF Pharmaceuticals Investor Relations. You may begin your conference.
spk14: Thank you, Operator. Hello, everyone, and welcome to TFF Pharmaceuticals 2020 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. Bill Williams of the University of Texas at Austin, Dr. Dale Christensen, TFF's Director of Clinical Development, and Chris Cano, TFF's Chief Operating Officer. A press release announcing our 2020 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.
spk02: Good afternoon, and thank you for joining us today to review the company's third quarter operations and recent highlights. During this call, I will provide an update on our clinical and corporate progress, and then I will ask our Director of Clinical Development, Dr. Dale Christensen, to update us on the very significant progress we are making in our internal clinical programs. Then, our Chief Financial Officer, Kurt Coleman, will review the company's financials. We're also happy to have with us once again Dr. Bill Williams from the University of Texas at Austin, who will talk about some of the exciting progress and new data we are seeing in the application of our thin-film freezing technology to drugs, vaccines, and biologics. And Chris Cano, our Chief Operating Officer, who will update us on business development and operational initiatives for the company. And then we will open up the lines for your questions. While we are reporting on 2020 results, I can say that last year was one with numerous remarkable accomplishments. As we begin 2021, we are on course for a year of significant outcomes as we move our internal pipeline forward, capitalize on the transactions already completed, and secure important new partner agreements. As you have seen with the press releases yesterday and today, we continue to build TFF, and greatly enhance the value creation of the company. Today, I'll discuss the details of what TFF has accomplished and how these developments have set us up for near, mid, and long-term success. I want to take just a moment to reiterate our thin-foam freezing technology and company business strategy. This strategy is fundamental to our company and our commitment to sustainable value creation. The first part of our business strategy is the development of an internal pipeline of products. I'm eager to have Dr. Gail Christensen review the progress we've made on the clinical front as well as discussing the path forward for these assets. I am very proud of the clinical development programs as we have executed well on timing, budgets, and results. The second platform of the TFF strategy is in partnering the thin film freezing technology and collaborating with pharmaceutical companies, academia, and the government. In 2020, we were successful in this arena and we are confident the number of these transactions will increase this year. This confidence continues to build as we have new data about the ubiquitous nature of the technology in a broad array of platforms. Later in the call, Bill Williams and Chris Cano will go into greater detail about the unique nature of these data the new partnerships, and specifically where the potential exists for building our successes. Thin film freezing is a game changer. During today's call, we will discuss more details about the most recent transactions. Specifically, today we announced a collaboration with the United States government to formulate countermeasures to be used by our military forces. Our technology will be used to develop topical, ophthalmic, and inhaled products. As a result, and very importantly, TFF has been designated as an approved subcontractor, which will enable additional work with the government and the prime contractor. I would like to go into greater detail and will do so once it's clear what information I can share about the specifics of the work. I can tell you that Thin Film Freezing was selected for this contract based on a very rigorous diligence, and this also bodes well for additional awards in developing products for the military. We are incredibly proud of this accomplishment. Yesterday, we announced the work we are doing in partnership with NeurRx and Greenlight. Announcing feasibility agreements is not TFF's standard corporate practice, but given the collaborative nature of our partners, the current events of the COVID-19 pandemic the timing of the work, and applicability to real-time events, TFF has agreed to disclose certain aspects of these partnerships. These are very significant and important partnerships, and we look forward to working with these companies. Bill Williams will specifically address the potential of thin-film freezing to impact the need for cold chain distribution and storage in his discussion. And Chris Canna will update in greater detail opportunities in working in the mRNA vaccine space. I also want to take this opportunity to update you on some of the agreements we signed in 2020. We issued press releases earlier this quarter about the data we have generated at the University of Georgia and USAMRID. You will recall that we were working on a universal flu vaccine at UGA and on monoclonal antibody-based antiviral vaccines at USAMRID. The initial in vitro data on both projects are very positive, and we will now pursue definitive in vivo data to confirm animal activity. Chris will provide greater details in his segment of the call. Our partnership with Union Therapeutics on niclosamide is proceeding well. We are approaching important first-in-human trials on both oral and inhaled versions. Dale and Bill will elucidate further in a moment. We continue to progress our partnership with Felix on their lead macrophage asset, and the co-development work on the Augmenta BioWorks monoclonal antibody is also moving forward as scheduled. Details to follow. Finally, our partnership with Plus Products in the cannabinoid space is at a very exciting inflection point. Plus is working to enter a thin-film freezing version of cannabinoids into the commercial market later in the second quarter. I can tell you that the selection of Plus products as our initial partner was a wise decision. Plus has demonstrated market success with their current product line and has been working diligently to get up and running to produce product and enter into the highly lucrative and growing market in California. TFF is optimistic about this initial launch and the total market potential as we expand the distribution of product into more markets over time. In summary, TFF is on an amazing trajectory. While we are proud of our accomplishments, this is just the proverbial tip of the iceberg. The ground is fertile, and we are uniquely positioned to capitalize on this ubiquitous and disruptive technology, both with our internal development efforts and in business development across the stakeholder base. And so now, before we go over to the financials with Kirk Coleman, I want to turn the call over to Dr. Dale Christensen. our Director of Clinical Development, will give you more detail on the outstanding Phase I clinical results we achieved with our two lead internal programs and the implication of these results on our potentially pivotal trials in the future for voriconazole inhalation powder and tacrolimus inhalation powder. Dale?
spk12: Thank you, Glenn, and good afternoon to everyone who has joined us today. I'm very pleased to give you an update on TFF's internal clinical development programs. Despite the effects of the pandemic on clinical trials globally, we've been quite fortunate in that the phase one trials of our two lead programs have had only minimal time delays. Most importantly, we've made great progress and continue to generate exciting clinical data from our human studies. I'm particularly pleased to provide a readout from the final data in our phase one clinical trial of voriconazole immolation powder for the treatment of invasive pulmonary aspergillosis or IPA. We chose to develop voriconazole because it is recommended as the first line agent for the treatment of IPA infections. However, it's not well tolerated and up to 20% of the patients discontinue therapy due to adverse events or tolerability issues. TFF is developing an inhaled dry powder version of Voraconazole to effectively deliver the drug right to the site of infection in the lung, and we are happy to announce that the phase one clinical trial was successfully completed. This study demonstrated that doses of 10, 20, 40, and 80 milligrams could be safely delivered twice daily using a dry powder inhaler device with no significant adverse events. A review of the final data demonstrated that there was no evidence of any treatment related or dose related trends in the single ascending dose or multiple ascending dose part of the study. No subjects experienced any dose limiting toxicity during the study. In addition to the absence of significant adverse events at all dose levels in the study, The pharmacokinetic profile demonstrated that mean peak plasma voriconazole levels reached concentrations of 227 nanograms per mil following repeated dosing at 80 milligrams twice daily for seven days. I mentioned the significance of this because these levels can be compared to a published report with the IV solution of voriconazole being compounded and delivered off-label using a nebulizer at a dose of 40 milligrams. which resulted in mean plasma levels of 98 nanograms per mil. Importantly, the Danish authors of this clinical study reported that 40 milligrams of nebulized IV boriconazole solution was both safe and efficacious in the treatment of complex invasive pulmonary aspergillosis. So our ability to more than double the blood levels that have been shown to clear complex IPA infections provides confidence that dosing patients with the 80 milligram dose should prove efficacious for IPA in future pivotal trials and our data demonstrating safety makes us even more confident. In addition to the very positive final data from the phase one clinical trial, We're continuing to enroll asthma patients in a phase 1B study to understand if the voriconazole inhalation powder is likely to trigger bronchospasm in patients with hyperactive airway disease. Other inhaled anti-infective drugs have demonstrated this effect and require pretreatment with a bronchodilator prior to dosing. We're completing this reactive airway study to guide the clinical practice in patients with hyper reactive airway diseases like asthma and COPD. The data from this study and from the completed healthy normal phase one study will lead to the initiation of the study that we consider to be pivotal for eventual approval of boriconazole inhalation powder, which will begin enrolling patients in the second half of 2021. In addition to the voriconazole results, I'm pleased to report that dosing of the sad part of the phase one study of our tacrolimus inhalation powder was successfully completed. In the case of tacrolimus, it's important to understand that the drug has a very narrow therapeutic index between effective immunosuppression and toxicity. The implication of this narrow window means that blood levels must be carefully monitored in clinical practice. And the dose level of the drug has to be adjusted to achieve blood levels that are efficacious for immunosuppression while not elevating the blood concentrations to levels associated with toxicity. This is made more difficult because the bioavailability of tacrolimus is poor at around 20% with a high degree of variability due to drug-drug interactions that alter its metabolism and absorption. For lung transplant patients, therapeutic drug monitoring is used to achieve maintenance trough to crolimus levels from 5 to 15 nanograms per mil after transplant to prevent acute allograft rejection. Heart, kidney, and liver transplant patients typically receive a lower level of 5 to 12 nanograms per mil. In our phase one study, we used therapeutic drug monitoring to measure when a sufficient dose level had been reached. The TFF tacrolimus inhalation powder was able to reach 12-hour trough blood levels between 5 and 16 nanograms per mil in all subjects dosed with just a single inhaled dose of 5 milligrams of tacrolimus inhalation powder. This ability to efficiently reach therapeutic drug levels with our tacrolimus inhalation powder following a single dose without any significant adverse events is quite significant. reaching therapeutic blood levels efficiently with low doses of the inhaled powder suggests that our product may have application beyond lung transplant patients, where interactions with other medications can cause blood levels to change in an unpredictable manner. This is particularly the case with heart, kidney, and liver transplant patients. In addition to completion of the SAD part of the clinical study, we've also completed a chronic toxicology study so that we are ready to move to an advanced phase trial that will build our data for eventual registration in lung transplant patients after we complete the MAD phase of this study. And as with our voriconazole pivotal trial, we expect this study to begin in the second half of 2021. I also want to report the TFS Pharmaceuticals has initiated toxicology studies with our niclosamide products designed to treat COVID-19, SARS-CoV-2, and other respiratory viral infections. As you know, over the past years, niclosamide has been identified as a drug with strong potential to treat a variety of viral infections and has been shown to exhibit particularly potent antiviral activity against SARS-CoV-2. It's inexpensive in cost and has a very low toxicity profile as an FDA-approved drug in clinical use. However, nyquosamide has very limited aqueous solubility as well as low absorption and oral bioavailability, creating challenges for its development as a potential antiviral therapy. Our thin-film freezing technology has demonstrated improvements to the solubility of oral forms of niclosamide as well as to dry powder forms of the drug for delivery directly to the lungs. We intend to progress to clinical trials as soon as the full report from the toxicology studies becomes available. And finally, at the end of 2020, we announced a collaboration agreement with Augmenta Bioworks to develop novel commercial products incorporating Augmenta's Gemma-derived monoclonal antibodies for potential COVID-19 therapeutics. I'm pleased to report that we anticipate beginning human trials for this therapeutic later this year. And with that update, I'd like to turn the call over to our Chief Financial Officer, Kirk Coleman, for a review of the financials. Kirk?
spk08: Thank you very much, Dale. For the year ended December 31, 2020, research and development expenses for the company were $10.7 million, compared to 8.8 million for the same period in 2019. The increase in research and development expenses during 2020 was due to the ramp up of research and development activities following the completion of our IPO in October of 2019. The ramp up includes our preliminary analysis and testing of dry powder formulations of certain drugs and vaccines we believe to have the potential to become product candidates. General administrative expenses for 2020 were $8 million compared to $3.2 million in 2019. The company reported the net loss for the year of $18.6 million compared to a net loss of $11.9 million in 2019. Weighted average common shares outstanding, basic and diluted for the year ended December 31, 2020 were $20,425,162 compared with $6,904,983 for the same period in 2019. At the end of 2020, we had total assets of approximately $38.7 million and our working capital of approximately $36.2 million. At the end of the year, our liquidity included approximately $35.3 million of cash and cash equivalents. And with that, I'd like to turn the call over to Dr. Bill Williams, who will be talking about some of the groundbreaking work we're doing using our thin film freezing platform in the broad field of small molecule drugs, as well as our work with large molecule biologics. This is an area where our technology is unique in its ability to reformulate these biologics into inhalable dry powder. Bill?
spk16: Thank you, Kirk. Good afternoon, everyone. I'm very pleased to give you an update on what has been a very busy and productive quarter for the research team at TFF Pharmaceuticals. In terms of scientific impact to TFF Pharmaceuticals since our last update, we have made significant advancements regarding our programs. To facilitate my summary today, I'd like to break the discussion down into small molecule drugs and biologics. Let's first review our work on small molecules. For our inhaled niclosamide dry powder for inhalation program, we recently reported in a bioarchive preprint paper the development of a formulation to reach the lungs as a therapeutic for COVID-19 and other viral infections. This inhaled dry powder formulation exhibited sustained niclosamide concentrations, which is very difficult to achieve by other routes of administration due to niclosamide's very low water solubility and high first metabolism. Specifically, We showed that niclosamide inhalation powder prepared by thin-film freezing not only proved to be safe after an acute three-day multi-dose pharmacokinetic study in rats as evidenced by histopathology analysis, but it also achieved excellent lung concentrations above the reported IC50 and IC90 levels for at least 24 hours after just a single dose administration in the Syrian hamster model. We selected this hamster small animal model because hamsters are susceptible to SARS-CoV infection and thus are a promising candidate as an animal surrogate to model COVID-19 disease. Our studies support the nicosamide dry powder inhalation formulation by FemFilm Freezing for further clinical testing against COVID-19 and other viral infections, as mentioned by Dr. Christensen earlier in this call. Regarding our oral niclosamide formulation, we recently reported in a newly published peer-reviewed paper on the development of an amorphous solid dispersion produced by hot melt extrusion. This is our companion antiviral niclosamide product and improved oral product to complement our dry powder TFF formulation of niclosamide for inhalation that I just discussed. Specifically, in our paper, for the first time, we report that the niclosamide amorphous solid dispersion formulation containing a polymer carrier increased the apparent drug solubility by about 60-fold relative to the current state-of-the-art crystalline form of niclosamide. The amorphous solid dispersion of niclosamide achieved a more than two-fold increase in oral bioavailability in rats compared to niclosamide and hydrate. These results are highly encouraging for its continued clinical development. Now I would like to discuss our advancements in applications of thin-film freezing to biologics. Biologics include mRNA, siRNA, and monoclonal antibodies. As Chris Cano will describe, TFF Pharmaceuticals has multiple technology validation agreements with pharmaceutical industry partners. Let's first discuss our progress with mRNA in lipid nanoparticles. The applications generally include pulmonary delivery to the lungs to treat diseases such as lung infections, including viral infections, and also include applying thin-film freezing to convert unstable liquid forms of the mRNA and lipid nanoparticles into stable powder form that can be stored without severe cold chain constraints, and then reconstituted back into the liquid form for injection at point of administration to the patients. The problem that thin film freezing is solving for cold chain includes the requirement that presently the liquid form must be stored frozen, either at minus 70 degrees C or minus 20 degrees C, achieving only limited shelf life storage. And in fact, the shelf life of either of these conditions is relatively short, complicating distribution channels. Based on recent work in my laboratory, we are highly confident that thin-film freezing can be applied to current mRNA vaccines to successfully formulate a version that can lessen the need for cold chain distribution and storage. To date, collectively, our studies confirm that the conventional method of slow-shell freezing and lyophilization as compared to thin-film freezing has failed to successfully convert these liquids into stable dry powder forms. We have been able to achieve this to convert the liquid form of mRNA and lipid nanoparticle into a stable dry powder, more stable than a direct side-by-side comparison to conventional lyophilization. In addition, we have also been able to form stable dry powder forms of mRNA and lipid nanoparticles that can be delivered by dry powder inhalation. In comparison, the current state-of-the-art are liquid forms of mRNA and lipid nanoparticles delivered to the lungs as a liquid using a nebulizer. Nebulizers have low delivery efficiency when delivering mRNA and lipid nanoparticles to the lungs. whereas we are able to convert the liquid form into a dry powder for inhalation while preserving the physical properties of the mRNA in lipid nanoparticles. With our work on monoclonal antibodies for multiple partners, we have successfully converted liquid preparations into dry powders while maintaining the chemical integrity and functionality of the monoclonal antibodies. These optimized powders have excellent aerosol performance properties, making them ideal for inhalation delivery to the lungs. We have also found that these monoclonal antibodies can be stored at refrigerated or controlled room temperatures, depending on the specific properties of the monoclonal antibody being studied, thus an advantage for cold storage requirements. We have also had the opportunity to apply thin-film freezing to formulate cytokines and enzymes as dry powders to administer by dry powder inhalation to treat lung diseases or to reconstitute back to the liquid form for administration to the patient at point of use. These protein-based dry powders can be stored at controlled room temperature. We recently published a peer-reviewed paper on applying thin-film freezing to the delivery of siRNA in solid lipid nanoparticles. The problem that thin-film freezing solved was the very low efficiency of lung deposition when inhaled as a nebulized liquid. We confirmed that thin-film freezing transformed the siRNA from a liquid suspension into a dry powder while preserving the chemical integrity and functionality of the siRNA. We continue to apply thin film freezing to protein antigen-based adjuvanted vaccines, including marketed vaccines and vaccines currently in clinical trials intended for immunization by needle-based injection after reconstitution at point of use or needle-free directly as a dry powder intranasally or by inhalation. These protein antigen-based adjuvanted vaccines require cold chain storage during distribution and other methods of converting these liquid forms to their more stable dry powder form have not been successful because their immunogenicity is not preserved. Thin film freezing has been successfully used to accomplish this. We also recently reported in a preprint on bio archives the application of thin film freezing to the formulation of dry powders for inhalation of bacteriophages. The problem we are solving is that presently bacteriophages are stored and administered as nebulized liquid aerosols. But these liquid forms of bacteriophages have low efficacy when inhaled because of titer loss and must be stored in a refrigerator to maintain their activity. Each bacteriophage presents its own challenges, and we are using thin film freezing to formulate dry powder bacteriophages one by one. Lastly, our technology validation work on virus vector-based vaccines is progressing quite well. Our goal for this work is to provide immunization by needle-based injection after reconstitution at point of use or needle-free directly as a powder intranasally or by inhalation. In our collaborations, we are addressing the required cold chain storage, as well as the lack of mucosal immunity in the respiratory tract when vaccines are administered by intramuscular injection, and the low efficiency of lung deposition when vaccines are inhaled as nebulized liquid aerosols. We have successfully transformed these virus vector-based vaccines from frozen liquid suspension form to dry powder by thin film freezing with minimal damage to the viruses. We have confirmed that our dry powder has excellent aerosol properties, ideal for pulmonary delivery. I want to acknowledge and thank my colleague, Professor Zhenrong Cui, for his significant contributions to our research programs. Lastly, I want to thank you all 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 the company is making in its business development and partnership efforts. Chris?
spk05: 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 areas are, one, growing the TFF pipeline of internal development programs, two, our pharma partnering efforts, and three, our government contracting efforts. We continue to make great strides in each of these key areas. As Dale discussed, we continue to expand our pipeline beyond our existing products, including voriconazole inhalation powder, tacrolimus inhalation powder, and TFF niclosamide. We are now actively collaborating on the joint development of a monoclonal antibody for COVID with our partners at Augmenta Bioworks. We continue to aggressively progress this project through early stage development. The TFF BD team continues to hunt for new assets, compounds that have specific formulation and delivery challenges that would benefit from the TFF dry powder technology and that would generate a differentiated and value-added product for patients, physicians, and payers. In addition, I want to update everyone on all of our pharma partnerships and the collaborations we are working on. As Dr. Williams has described, TFF is very active in the mRNA space. We have multiple active mRNA programs underway. We are working with a large pharma partner formulating their proprietary mRNA into the TFF dry powder for delivery directly to the lung. We are also working with a mid-cap pharma company delivering their proprietary mRNA directly to the lung via the TFF dry powder technology. No two mRNAs are the same, but they do have similar delivery challenges. We are able to overcome these challenges with our innovative technology. Announcing feasibility agreements is not TFF's standard corporate practice, but given the collaborative nature of our partner, the current events of the pandemic, the timing of this work, and applicability to real-time events, TFF has agreed to disclose certain aspects of a new partnership. We recently entered into a new feasibility and material transfer agreement with Greenlight Biosciences, an mRNA company, in order to formulate their mRNA COVID vaccine. As you may have seen in our recent announcement dated March 9th, we are working with Greenlight Biosciences to formulate their mRNA vaccine for COVID into a dry powder, which will be quickly reconstituted onsite for injection, therefore generating a more stable formulation, which removes cold chain storage and transportation challenges faced by many, if not all, of the current mRNA competitive products. In addition, we are working on other mRNA programs, and we are actively engaged in meaningful discussions with the leading mRNA vaccine companies. We strongly believe that our thin-film freezing technology will play an important role in formulating second-generation COVID-19 vaccines. To the best of our knowledge, we are the only technology able to formulate a dry powder of mRNA, and our TFF dry powder maintains particle size, has superior aerosol properties, has an encapsulation efficiency of greater than 90% and maintains the activity level of the mRNA. As previously mentioned, announcing feasibility agreements is not TFF's standard corporate practice, but staying in the COVID space and given the collaborative nature of our partner and the current events of the pandemic, TFF has agreed to announce another project. TFF is working with NeuroRx on their product candidate, Zysami, which is Avaptadil, a synthetic form of a naturally occurring peptide found in the lung called vasoactive intestinal peptide, or VIP. This product is currently in late-stage clinical trials for critically ill COVID patients, and based on the results of these trials, the hope is to file and receive emergency use authorization. By formulating a TFF dry powder version of VIP, it would offer patients and physicians an alternative route of administration of VIT for treating the disease state much earlier, which would be of tremendous value to COVID-stricken patients. Also, as Dr. Williams discussed, we are very active in the monoclonal antibody space. We have multiple active monoclonal antibody or MADD programs underway. As we disclosed back on February 19th, We are working very closely with Dr. John Guy at USAMRID formulating their MABs. Based on recent in vitro testing, we are very pleased to announce that the TFF technology was able to generate dry powder forms of USAMRID MABs that maintain the same activity as the initial liquid formulation. This is a very exciting accomplishment. It validates our technology and clearly supports pursuing the next steps of development. That next step of development is in vivo testing, and if successful, TFF would seek non-dilutive funding to move the vaccines forward in development. In addition, we are working with another government agency on their proprietary MABs, generating a dry powder that exhibits very favorable aerosol properties while maintaining high activity levels. These MABs are in development as a COVID therapeutic to be delivered directly to the lung. We are also engaged with a large pharma company, and we are currently formulating their proprietary MABS for delivery to the lungs, and we are preparing for initial in vitro testing. To round out our MABS programs, we continue to progress our joint collaboration and development arrangement with Augmenta Bioworks. In addition to these programs, we are actively engaged in discussions with other leading MAB companies. Again, to the best of our knowledge, we are the only technology able to formulate a dry powder monoclonal antibody that maintains the activity and integrity of the MAB and has superior aerosol properties. To complete our pharma partnerships, we are currently formulating our partner's siRNA, plasma DNA, oligonucleotides, phage, peptides, cytokines, AAV, and VSV product candidates, along with many small molecules. Also, we recently entered into a collaboration agreement with a second leading academic institution where we are formulating their VSV vaccines into a dry powder. This arrangement is very new, but holds tremendous opportunity for TFF. We hope to provide updates on this collaboration as in vitro testing gets underway and testing results are achieved. In addition, we continue to work very closely with our partners at UGA. We are pursuing the advancement of the universal influenza protein-based product candidate that we announced our positive results on back on October 27th. We are pursuing additional protein-based universal influenza vaccine candidates from our University of Georgia colleagues. Last week, we were honored to present to the CIVIX group. CIVIX stands for the Collaborative Influenza Vaccine Innovation Centers. We presented to an audience of over 80 participants, which included key opinion leaders and decision makers at numerous academic institutions and government agencies. We were privileged to share with this group our innovative technology and the exciting projects and programs we are working on. Our strategy is to engage with key academic centers and researchers, positioning Thin Film Freezing as the formulation partner, and then securing tech transfer and or licensing those assets to TFF. Lastly, Glenn mentioned the government contract in his opening remarks. We hope to be able to share additional details on this arrangement in the near future. We were very excited about this contract, which now establishes TFF as an approved contractor in the government arena. It opens doors for more opportunities for TFF to apply its thin-film freezing technology to different products, for partnering opportunities with these government agencies, and for additional value creation for TFF pharma. In summary, the TFF BD team has been making tremendous progress in our partnering efforts. We currently have over two dozen pharma partners that we are collaborating with, and that list is growing. In each of these partnerships and arrangements, we are taking our partners' proprietary compounds and formulating these compounds in our TFF technology. These different compounds are being formulated, optimized, tested in our labs and being shipped to partners for testing. First, the dry powder samples are run through specified in vitro testing by our partner to confirm viability and activity. Then these samples are run through in vivo testing by our partner to confirm knockdown and activity in animal testing. Upon successful in vivo results, we then expect to engage with these partners in a full-blown collaboration and licensing agreement. While I have this opportunity, I think it is extremely important to thank our most valued collaborator and partner. All of these business development efforts are supported by the tireless efforts and support of our collaboration partners at the University of Texas at Austin. With the continuing support 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, from a BD perspective, we are very excited about the growth opportunities of our technology and of our company. We believe we have only scratched the surface of the many applications of the thin film freezing technology. We are highly confident, as we have said repeatedly, that TFF will close at least two signature development transactions in 2021. We are laser focused on accelerating that outcome. Thank you for your time today. I will now hand it back over to Glenn.
spk02: Thank you very much, Chris, and thanks to the rest of the TFF team who participated today. I realize that we presented you with a lot of very detailed information on today's call. Well, there's quite a bit to discuss and share. I trust that you have a strong sense of the level of excitement at TFF. The excitement for the future is what everyone involved is feeling and working towards every day. Our goal is to build a strong and formidable foundation while accelerating the positive outcomes. Today, we share with you the positive progress we're making with our internal pipeline. The completed clinical trials of TFF boriconazole and TFF tacrolimus confirmed the target product profiles and set us up for meaningful pitiful trials. In addition, the niclosamide program is off to a strong start as is the co-development of the augmenta monoclonal antibodies. In addition, we are tracking well in our collaboration with Felix in the macrophage space, and Plus Products is moving ahead toward commercialization with thin-film freezing versions of cannabinoids. Bill Williams discussed the newest data he and his colleagues at UT have generated. Most importantly, the dossier of data in the biologics arena has grown significantly since the last time we spoke. And Chris Cano has given a strong update on the current status of our business development activities with pharmaceutical company partners, academia, and the government. The agreements announced earlier this week with Greenlight and NeuroRx, along with the important recently signed government provider agreement, are truly significant. We are laser-focused on growing the portfolio of signature development agreements. As I said in the opening of the call, the achievements of 2020 and the beginning of 2021 are just the tip of the iceberg. I believe we are on a steady trajectory of meaningful growth as a company. We have planted great seeds in fertile soil. The harvest should be bountiful. As always, we appreciate the support of our investors and partners, and we look forward to speaking with you next quarter. And with that, I will turn the call back to the operator and open it up to questions. Operator?
spk09: Ladies and gentlemen, if you'd like to ask a question at this time, please press the star, then the number one key on your touchtone telephone. To withdraw your question, press the pound key. Again, that is star, then one, if you'd like to ask a question at this time. Our first question comes from the line of Jonathan Ashoff with Roth Capital Partners. Your line is now open.
spk07: Thank you. Hi, guys. I was wondering, maybe, Glenn, can you give me any more specifics about the effort of this startup? I'm not sure. I'm not sure.
spk00: I'm not sure. I'm not sure.
spk02: Jonathan, we could barely hear you. Could you possibly repeat that question?
spk06: Yes, can you hear me now?
spk02: Yes, it's much better. Thank you, Jonathan. Okay, great.
spk06: So can you give me any more specifics about the effort at Plus Products? You know, why did you partner with them and how will you expand in cannabinoids because they are a fairly significant part of my model?
spk02: Yeah, thanks for the question, Jonathan. So as I said in the call, first of all, as you know, we have an intermediary company, RTR, that's run by Rob Romero, who's a managing director at Connect Capital. So he is in direct contact with PLUS. And actually, we have folks out there this week that are beginning to produce product at one of the PLUS facilities. We believe that PLUS has a great plan for commercializing. They're testing a bunch of different formulations as we speak. They're doing great science. They have great market penetration in California, as you probably know, with their edibles products. And once they get into the market, Plus has given me some very robust commercial forecasts that are well north of $100 million, almost $200 million. And we get a very significant royalty on those sales. Once Plus is in the California market, we plan on expanding and PLUS and RTR plan on expanding the penetration nationally, either through PLUS or through other partnerships. So we believe that this is going to be a very lucrative endeavor for PLUS and through RTR and a very meaningful contributor of revenue to TFF in the very, very near future. Very exciting.
spk06: Thank you, Glenn. My next one's about TAC. I mean, that data looks pretty strong. And I was curious if you could get, you know, a bioequivalence approval outside of lung. Okay.
spk02: You know, to answer that question, can I turn that over to Dr. Christensen? Dale, could you answer that, please?
spk12: Yes. Thank you, Glenn. So it is, let me take one step back. It is possible that there would be what is essentially a matching exposure level, because ultimately there's widely varying PK among individual subjects, and each subject, they do dose adjustments to reach the therapeutic drug level. And so it's not just a straightforward Dose with one dose of oral, dose with, you know, an equivalent dose of inhaled and show that they give an equal exposure. So there's a little more to it than a normal BE that would be required. And so that is something that we are certainly evaluating what it would take to get there with the FDA.
spk06: Okay, and I didn't see that much on the VORI asthma trial. Can you tell me anything about that? Dale, again?
spk12: Yeah. Yes, thank you, Glenn. Ultimately, we are continuing to enroll subjects, and I can say that to date there's been no bronchospasm, but, you know, again, we're just continuing to enroll patients, asthma patients in the study, and You know, we look forward to completing that study in the next couple months.
spk02: Yeah, just quickly, the reason we're doing that is we want to be able to include asthma patients in the pivotal IPA trial for Voriconazole and the FDA required to be able to see that we have not caused any bronchospasm in these patients with the twitchy airways. And so far, the data is supportive of everything we've seen. in all of the clinical trials that we've done for Vori and TAC, et cetera. Thanks, Jonathan. Thanks, Glenn.
spk09: Our next question comes from Ram Selvaraju with H.C. Wainwright.
spk13: Hi, this is Bubalan dialing in for Ram Selvaraju. Can you hear me okay?
spk02: Yes.
spk13: All right, awesome. So a few questions. So just to start off, I know you're running a trial and you're obviously planning to start a Phase II study. for TFO4 in the near future. So I'm just trying to understand what are the similarities and differences between these two trials and what new information you're planning to obtain from the asthma study that will not be a focus of the upcoming phase two study.
spk02: So as I just said and Gail spoke to, we decided at the urging of the FDA to run a study in asthma patients to be sure we can include them in the trial that has looking at TFF for a console powder in the phase two trial. So this is a way to enhance the patient population of the next trial.
spk13: Okay. All right. Thanks. And with respect to the upcoming phase two study, how do you define sexes in this study? and what specific metrics will be given importance?
spk02: So the trial will be powered for non-inferiority in efficacy, and we will mine the data for superior efficacy. This doesn't mean that we don't expect to see better efficacy, but the power will be non-inferiority in efficacy and a better adverse event profile.
spk13: Okay. so with respect to your tf of that lag so we understand delivering uh drugs to the lungs for treating lung indications but with respect to like what is the rationale began delivering drugs to the lungs for treating non-lung indications such as kidney disease so on what kind of challenges one could potentially anticipate during this route and what are the possible ways to attack these challenges
spk02: Yeah, Dale, could you give a brief answer, and then I'd like to move on to other questions. I know there are a lot of people in the queue. Thank you.
spk12: Yeah, so briefly, tacrolimus has widely differential bioavailability based on, you know, if somebody is eating a high-fat meal, it is poorly absorbed in someone if they eat a high-fat meal because it's very fat-soluble and not water-soluble. and so it stays in the GI tract. There are also wide variations in Tercolimus bioavailability based on other drugs that are taken orally. And so when it's delivered via the lung, you bypass all of that gastrointestinal, the drug-drug interactions that would occur there, and that gives you a more defined, tighter PK range from a single dose or from a given dose. And so we think that that's going to be the advantage. And ultimately, it'll be balancing the lung levels and potential for any toxicity in the lung versus the advantages gained by safety versus any potential for localized toxicity in the lung. but we're addressing that from our toxicology studies.
spk02: Thanks, Gail. I will be happy to talk to Ram and you on further calls. I just want to be sure that we get some more questioners on the line here. Thank you so much for your understanding.
spk09: Our next question comes from Maya Kamatani with the Riley Securities.
spk10: Hi, good afternoon, team. Congrats on the progress on so many friends and the new government contract announced today. And thanks for the comprehensive update. Appreciate you taking our question. So maybe starting with Dale here, so great to see you can go with the higher dose, 80 mgs versus 40 mgs. I'm just curious as you think about the FDA dialogue. wouldn't they want you to also pursue a lowest therapeutic effective dose? So in other words, would you have two different dose arms in your pivotal study?
spk02: Dale, again, just if we can, a brief answer. We're running out of time and there are a lot of folks in the queue.
spk12: Yes, good question. But ultimately for anti-infectives, they want you to be at the highest tolerated dose that doesn't induce toxicity so that you can avoid the potential for development of resistance. And so there's no requirement to go to a minimally efficacious dose because that's where you would see resistance develop.
spk10: Understood. And then maybe for Chris, quickly on the, I think in the last update you had said there was a partnership with an RNAI top 10 kind of player. I'm just curious, the kind of work that is progressing on that front, and trying to kind of also visualize the work, obviously, a different modality that you're doing a lot of MRNA. How should we think about, you know, one of these partnerships getting to a meaningful inflection point? Any update you could provide also in light of, you know, a publication you had with the SIRNA modality?
spk02: Chris, you can answer that.
spk05: Yeah, sure. Thanks, Glenn, and thanks for the question, Mike. So we're really excited about our work. As you mentioned, we did speak last quarter about a top 10 pharma company, and that work continues. As I've shared with everyone, it's a process, right? And so when we receive the materials, formulating the materials, optimizing in vitro, in vivo, and so it does take time. We're continuing to pursue that partnership. That continues very well. as well as I had earlier mentioned, you know, we're dealing with over, you know, 24 different partners. And so we're flowing everyone successfully to our pipeline. And as I closed in my comments, you know, we expect to do at least two signature transactions this year. That's our goal. And I'm obviously laser focused on exceeding that goal.
spk02: Mike, I can add just a brief color on that. So, you know, I'm... With the bigger companies, we're doing really outstanding data. The data is very supportive. They'll come back with another round of experiments they want us to do. All of these are coming out positive. We're moving everything very steadily towards the end of the experimentation. We want the listeners to really understand. We have so many shots on goal. I have this big whiteboard in my office with all the companies that we're working with. That's the only way we can really keep track of where we're at. We, more than anybody, want to get these things to the finish line. We know they will get to the finish line. We've done so much already. This is just the tip of the iceberg. I think we're getting very close. Okay.
spk10: I really appreciate the color and maybe Glenn, another time I'll push you on how many CDAs and MTAs you have in place. But I do want to respect, we have Bill with us. Just quickly, Bill, if I may, can you share some data that any qualitative color on lyophilization versus thin film for mRNA. And I'm also not just looking at stability and cold chain storage benefit, but also, you know, this point about mucosal immunity, very important to investors as we think about transmission and sterilizing immunity. Could you maybe comment on that? And maybe if any color, how mRNA might be different from, again, a stability standpoint when you think about other protein-based vaccine approaches? Because you've kind of tested it all. Yeah.
spk16: Yeah, yeah. Thanks, man. Excellent question. So I have recently in my research lab, we've looked directly for the first time at one of the two mRNA vaccines that are approved for emergency use for COVID. So I actually have looked at those by thin film freezing, one of those vaccines. And we've done a side-by-side comparison with conventional localization. And our thin film freezing powder maintained the encapsulation of the mRNA and the lipid nanoparticle. It produced a dry powder that to date has been stable as a dry powder at room temperature for several weeks now. So, and we've done this and we compared to conventional localization where that was not able, that process was not able to produce the original nanometer particle size upon reconstitution. So I am highly confident thin film freezing works with mRNA lipid nanoparticles, especially in one of the two vaccines that are approved for COVID right now. And then with regards to inhalation, Yeah, several of the partners that we're working with, they've designed their mRNA lipid nanoparticle for lung delivery for mucosal immunity. And again, even if the conventional localization happened to work with their particular mRNA lipid nanoparticle modality, it's not a powder that's amenable to dry powder inhalation. So thin film freezing is, and it's working for those applications. So hopefully that answered your really good question, Maya.
spk02: Maya, can we move on to other questioners? We can always have a way of catching up. And by the way, for all of you on the line, we will stay on the line as long as you have questions. So we're so excited about the fact that you're all interested and have questions here. So We're not looking at the clock here.
spk09: Our next question comes from Jason McCarthy with Max Group.
spk15: Hey, this is Michael Okunowich on the line for Jason McCarthy. Thanks for taking the question. So I figure we are coming up on time, so I'll just keep it to a short one. We can always circle back at another time. But I'd like to see if you have... any color on the kind of trial sizes needed for the pivotal studies of VORI and TAC, especially as we're heading towards those studies as early as late this year?
spk02: Yeah, if I can, we have not been public with announcing the number of patients in those pivotal trials based upon just receiving the VORI final report and waiting on the TAC report. We're still kind of looking at specifics of those trials. We'll let you and Jason know as soon as we've got those numbers. I think at last look, though, I will tell you the first view we had of the VORI pivotal was about 140 patients, which is pretty consistent with what we've been thinking all along. But if you give us just a little more time to zero in, Dale's conducting some advisory boards with some really notable investigators to help us craft that, and we are going to meet with the agency to run our protocols by them.
spk15: All right. Thank you. And then just one more, if you don't mind. I'd like to see if you could discuss in just a bit more greater detail what exactly that subcontractor license means and what that allows you to do with the U.S. government that would have been more difficult before. Well, I'm really glad you asked that question because
spk02: We are so unbelievably excited about this opportunity. I can tell you that we really hope to be able to go into great detail on what we're doing here. We had a kickoff meeting yesterday, and we're waiting to hear just how classified this government agency feels this information is. So we're really at the mercy, as you can understand, of the government agency to allow us and the other subcontractors and the primary contractor to make an announcement. What I can tell you is that we started talking with the contractor almost a year and a half ago. I probably alluded to the potential of a government contract coming to some of you on one-on-one conversation. We went through an incredible diligence process where we were compared other potential formulators. And we also now, based on this work, are in the position to look at not only inhalation to the lungs, but intranasal and specific in this arena, topical formulations and formulations to be given through the eye. So what does this do for TFF? Number one, great opportunity. We can't disclose the financial terms at this point. But we are now set up to systematically and systemically be a contractor to the government. So we've been talking to the government about other potential opportunities. We've organized here internally. We know how to work the system. The contractor we're working with is very experienced in this arena. So I really hope that all of the investors that are listening to this call although we can't be really as open about the terms and what's happened here as we'd like to be, appreciates what a significant opportunity this is, not only in the government arena, but in all of our outreach and all of our partnerships. So unless asked, I wasn't going to say this, and I hope you can hear in our voice and on behalf of the team, you know, what tremendous work we've done and what a great position and testament this is to our just how disruptive this technology is.
spk15: Lots of exciting stuff. Thanks for taking the questions. Yeah, thank you so much for the question.
spk09: Our next question comes from Daniel Carlson with the TW Research Group.
spk03: Hey, guys. Thanks for taking my question. I'll try to be quick. I know you're running over time. Regarding RNA modalities, you seem to be seeing good activity What gives you the confidence that you can formulate mRNA, siRNA, RNAi, et cetera, into an inhalable dosage formulation? Dr. Williams, could you answer, Daniel?
spk16: Sure. Hey, Daniel, great question. So fortunately, we have experience in our research group with probably five different mRNA lipid nanoparticle formulations from different partners. Um, and I mentioned a minute ago, most recently, uh, we've I've used in the research group, uh, the 10 film precinct technology to work directly with one of the two approved MRNA lipid nanoparticle COVID-19 vaccines. And so the powder produced from those, we have characterized, uh, uh, those powders and, and they have characteristics that are amenable to, uh, inhaled delivery by dry powder inhalation. So we've done it. We know it can be done. And what we do is we focus on the parameters. Each mRNA lipid nanoparticle is a different composition. And it presents its own unique properties. And that's what part of our technology validation studies, that's what we're coming up with the best approach to use on each individual one. Thanks for the question.
spk02: One thing I want to add before, Daniel, I don't know if you have any other questions, but we will have a TFF Science Day. We're looking at sometime in late May or early June. So we'll be announcing that. And the reason we're picking that time is we'll have some more mature data. And at that point, maybe some more partnerships in the academic space. So stay tuned for a specific announcement on that. I'm sorry, Daniel, if I interrupted or others.
spk09: Our next question comes from Bill Morrison with National Securities.
spk11: Hi, guys. Thanks for taking the questions. I'm trying to write as fast as I can. Lots of good stuff going on. But did you say there was 20 or greater than a couple of dozen partners in biologics or both biologics and small molecules?
spk02: Hi, Bill. Good to hear from you. Hope you're doing well. We're trying not to count specifically. It's north of 24. I think Chris did a really good job of giving the breadth of the different opportunities we're working on. He mentioned monoclonals, mRNA, sRNA, phages, peptoids, VSV vaccines. We do have a couple of partners that actually we're doing work with for quite some time. They are just sort of formulation, new chemical entity plays. In fact, one of the first companies we mentioned without specifics was a top five company. Well, we actually now are working on three of their compounds. They've actually asked us to do GMP materials for in vivo testing. They won't let us use their name yet, but we hope We hope that's in the near term offing. In fact, we'll probably be experiencing some revenue from that transaction just for manufacturing. So it really spans, and every week it just kind of grows, you know, in each of those categories. And, you know, I think, Bill, you'll understand. You know, we don't want to say it's 25 this week, 28 next week, 32. You know, we're going to just kind of keep doing this 24 and above so, you know, we're not having to check ourselves on numbers, but the funnel, the funnel is really full. You know, I mentioned this whiteboard, Chris is probably chuckling because he comes in and we, we just can erase and add names. And so far we haven't erased any, we just keep adding names. So it's, it's, I don't know if you ever saw when I'm dating myself, Ed Sullivan and the guy with the judgment seven plates at one time, kind of like what we're doing here, but it's, it's fun. It's unbelievable.
spk11: Yes, it seems so. And then just on union, any update on the upfronts?
spk02: Yeah, so Dale and Bill mentioned that the upfront is going to be triggered by the conclusion of our first in-human trial, and those trials are initiating. So I would look for something definitive there in the latter part of the year.
spk11: Beautiful. Thanks, guys. Great job.
spk02: Thanks, Bill.
spk09: Our next question comes from Dick Williams with Williams Resources.
spk04: Hi, Glenn. I'd like to firstly say congratulations to you and the medical professionals all on your team that you guys have done a phenomenal job year to date as well as last year. I know this is annual, but I'm more interested in the current times than I was in the prior times, but you guys have done a wonderful job. So, I just have one question, and I'm sure a lot of investors have been disappointed with the results of our stock in the marketplace in the last day or so with the last two announcements that were out. And, of course, we all have to realize one thing, that we are a microcap in the biotech sector and that the biotech sector itself is in the marketplace ran out of favor i guess weeks ago and took a hit of i don't know whether it was 30 but significant and we were just a part of that so we have to just live with those kinds of things but i wanted to relate to neuro rx and the announcement you made yesterday i i think there were some things in there that went totally unnoticed uh because I felt this was very significant. Firstly, the management team of that company is superb. They're very, very high-level executives from big pharma and biological companies. And in the release, we talked about what we're doing for them, and that's fine. But I think this particular opportunity is very close. It's not the norm of what we have in our pipelines. They are in a process with that, I'm probably going to pronounce this wrong, and a trial that the FDA dictated to them should be for 28-day endpoint to achieve what they're achieving with this product to do something with, I forget the name of the cell, that controls a lot of the oxygen-slash-blood in the body. and is extremely important. And with COVID, that cell gets damaged, and that's one of the parts of the cytokine and whatever else occurs thereafter. So they have started to have success with this trial, and I don't know how many people are currently in it, but they were discovering early on in the trial that the results, A, were good, and that they were starting to achieve more than they thought they would, and that it would continue to be achieved beyond 28 days. So they went back to the FDA and said, hey, guys, this really should be a 60-day endpoint, not a 28-day endpoint. And the FDA, in the last several days, agreed with them and extended it to the 60 days. So my question is if you can add some color as to how we fit in there with the powder and how quickly we can determine if we're doing it for that particular drug, how we can determine that it could be applicable to be used in that trial or an extension of that trial. But obviously, they are ready at the end of 60 days, assuming results, to ask for an emergency youth authorization from the FDA. So my question is, does anyone appreciate how close this all is and how we fit into that, if at all?
spk02: Well, Dick, first of all, thank you for the question. I think you've done a great job, I think, in fully understanding why we're so, I think it was such an important transaction for both NeuroRx and the company. Chris is the closest to this. He gets so much of the credit for bringing this forward. So, Chris, do you want to comment on Dick's question? I just don't, before you do, I think this is a very analogous situation to, you know, some of the early work we did at Build It on remdesivir with the hope that if remdesivir had been effective, which I guess we're still wondering about, we would have been the ability for them to take that product earlier on into the less severe COVID patients. But your appreciation of how close this is, you've really grasped the real value here. Chris, I hope I didn't steal your thunder, but could you comment, please?
spk05: Yeah, absolutely. And thank you, Dick, for the question, and thank you for your support. When it comes to NeuroRx, we're really excited about it. You know, being able to formulate that, right, and deliver it as a dry powder to treat COVID-stricken patients is really exciting for us, right? Right now, they're treating critically ill patients, right? And so we've always viewed if we can create a dry powder, we can treat patients earlier in the sickness or disease state. So, you know, You're correct that this is really at the goal line there. I'll just call it their lead asset. Uh, this, um, is still, you know, we're going to be doing feasibility work and this I view as kind of a second generation of their lead product. So hopefully I addressed your question satisfactorily.
spk04: Okay. So we won't, we can't be involved in essence in the 60 day window. but it would be a secondary product to add on or come at a later date because if it's approved at the end of 60 days that it works, they're going to file for EUA and they're going to be out with the product, obviously.
spk02: So we think that the follow-on would be right behind it. So a lot of this will come down to discussions with the FDA on how quickly... the work can be done. We've got a lot of experience in thinking through these sort of transitions from the existing product to the powder version. There'll probably still need to be some, and Dale would be able to comment, but on some toxicity work and then the amount of bridging you have to do in the clinical arena is just to be determined. I know we use the word exciting a lot. We'll have to find another word here, but it is a very terrific opportunity for us.
spk04: Well, I'll use the word exciting. I'm able to do that, and thanks for the answer to that. I think you gave the color that I was looking for, and congratulations on that deal. It's terrific. Thanks.
spk09: Our next question comes from Stephen Glassman, private investor.
spk02: I got your name wrong, Steve.
spk07: That's okay. Glenn, can you talk about how you plan on monetizing the work you're doing on the universal flu vaccine? What's the strategy there?
spk02: Sure. So, Steve, what we're hoping to do is be as engaged as we possibly can with all of the leading flu vaccine academic researchers and pie up the, do tech transfers from the academic institutions to TFF. And then as these individual flu vaccines or antigens are developed, we will hope to find non-diluted funding to bring those forward. And then it kind of becomes, Steve, if you can imagine a bake-off or a beauty contest, one or two of those will emerge, right? And as they emerge to be the leading potential universal flu vaccine, we then will be able to, in the work that we're doing, take those forward and then more than likely find a commercial partner to take them into further development. So we're trying to be, again, this word sort of ubiquitous around partnering. And that was really the purpose of this civics presentation we gave, which was enabled by Dr. Ted Ross at UGA, where we presented, I think there were 84 participants on the line, where the technology was exposed, you know, Bill and Dale and John Colling presented. And we have a second academic institution that has agreed to work with us. We're actually just working on their materials. Their internal policy is not to let us announce that until the first data are generated, so that's a few months away. And then there are actually two other academic institutions that are on the Mount Rushmore, if you will, of universal flu vaccine programs. researchers. We hope to have engagements with them and others that are interested. So once we have those done in tech transfer, we think we have a high likelihood of getting a non-diluted financing and then monetizing them through partnerships.
spk07: 180 million doses per year in this country. That's a very big opportunity.
spk02: Well, especially with a new one. Especially with a new vaccine. Yeah, exactly.
spk07: Yes, it'll be much more ubiquitous because a dry powder will let young, young children and very old, frail people take it as well. Plus, it'll be way more effective, so less resistance.
spk02: Yeah, and think, Steve, about all the parts of the world that can't, you know, access vaccines for a number of reasons, especially if they need to be refrigerated, right? So if there's any place, any place at all where this technology plays is in the ability to bypass cold chain and either have needleless vaccines through the powder or reconstituted vaccines. So, you know, I'm glad these questions are coming because it gives us an opportunity to really talk about just how big these opportunities are.
spk07: Very exciting. I know we've used that word. I have a question for Daniel, if I may. Yes. Have there been any problems inhaling the powder in vivo in human trials for any substances, adverse reactions?
spk12: Thanks, and that is a good question. So far in all of our clinical trials in asthma patients and healthy normals for boriconazole, there have been... A few patients that have experienced headache, a few that seem to have, you know, mild lightheadedness that appears to be most likely due to the inhalation and some of that practice. But in general, and this goes across the board, there are no experiences of cough for either tacrolimus or reports of cough following inhalation of either tacrolimus or voriconazole. And even more important, there has been no reported drops in FEV1. That's the ability to inhale that is indicative of the induction of bronchospasm and an adverse effect on the lung. So to date in all trials, all healthy normals as well as patients, there's been no pulmonary function testing that has shown any abnormalities.
spk07: Excellent. Thank you, Dale. Thank you, everybody.
spk05: You're welcome.
spk09: We have a follow-up question from the line of Daniel Carlson with PW Research Group.
spk03: Yeah, hey, Dr. Withers, just to follow up on the COVID vaccines, I know that there's internal programs, there's other technologies out there. Do you see any other technology as being competitive with TFF on these?
spk16: Not that I'm aware of, no. I mean, the question at the end of the day is whether conventional law authorization will work if it's a product for reconstitution back to a liquid for injection at the point of use. But for inhalation and for a lot of these products, conventional localization, as I mentioned earlier, it's too slow a freezing process. And so you get damage to the lipid nanoparticle, which causes degradation of the mRNA. And that's the type of data that we're finding because
spk03: we we do that comparison in our studies that's our that's like our control uh to understand that so yeah great question and then um if i could just follow up one more question you said you have run one of the vaccines the coveted vaccines i'm wondering if that was done under an mta or if that was done uh as you did with remdesivir just uh going out and getting it on your own if you can
spk02: Yeah, I'll answer that, Daniel.
spk03: Phil ran it as a researcher. That's all I can say at this point. Okay. Well, thanks, guys. Great progress. Appreciate it. Yeah, thank you.
spk09: That concludes today's question and answer session. I'd like to turn the call back to Glenn Mattis for closing remarks.
spk02: Well, for all of you that have stayed on with us for the entire call, it's greatly appreciated. For those of you that know me, we're highly accessible. We love to talk about what we're doing here. Those of you who don't know me well, we are very accessible, and we'd love to answer your questions. So thank you for your support. I hope you all are well and stay well, and we look forward to updating you on our progress as we move forward. Thank you very much.
spk09: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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