TFF Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2021 Financial Results Conference Call. As a reminder, this conference is being recorded. I will now turn the call over to our host, Corey Davis of LifeSci Advisors. You may begin your conference.

Thank you, Operator. Hello, everyone, and welcome to the TFF Pharmaceuticals Second Quarter 2021 2021 Financial and Business Results Conference Call. With me on the line today is Glenn Mattis, President and CEO of TFF, Kirk Coleman, CFO, 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. Announcing our second quarter results is available on the TFF Pharmaceuticals website. Please take a moment to read the disclaimer about full-looking statements in the release. The earnings release and this teleconference both include forward-looking statements, and these 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.

Thank you, Corey. Good afternoon, and thank you for joining us today to review TFF's second quarter operations and recent highlights. During the call, I will provide an update on our clinical and corporate progress, and then I will ask our head of clinical development, Dr. Dale Christensen, to update us on the important progress we're making in our internal clinical programs. Following Dale's remarks, Kurt Coleman, our chief financial officer, will then review the company's financials for the quarter. Following Kurt's comments, Dr. Bill Williams of the University of Texas at Austin will provide an update on the latest R&D advancements using our thin-film freezing platform technology, as well as an update on the expansion of our intellectual property estate. Finally, Chris Cano, our Chief Operating Officer and Head of Business Development, will update us on business development and operational initiatives for the company with the value of our thin-film freezing technology is enabling us to expand the number of meaningful partnerships with pharmaceutical companies, academic institutions, and the government health agencies. We'll then open up the call for your questions. As we enter the second half of 2021, TFF is now poised to reach several value-creating inflection points in the voriconazole and tacrolimus development programs. Each of the therapeutic markets represent a substantial commercial opportunity For our company, we estimate the yearly market potential for both compounds to be meaningful. Boriconazole is forecasted to take a significant share of the invasive pulmonary aspergillosis market, focusing on the patient segment requiring treatment beyond 30 days. For tacrolimus, we have forecasted sales potential to exceed $1 billion once approved for lung, kidney, heart, and liver transplant patients. Given the optimal pharmacokinetics of our inhaled formulations, we are confident that both Vori and TAC will demonstrate efficacy and better adverse events profiles over the oral formulations currently on the market. Let me briefly review our progress made to date and then what investors can expect in terms of our catalysts in the second half of 2021. In July, we announced the successful completion of single ascending and multiple ascending dose studies for tacrolimus. Later in the call, Dale Christensen will describe the significance of these data in greater detail on why TFF tacrolimus represents an exciting opportunity in the setting of lung treatment. With respect to voriconazole, earlier in the year, we announced the successful completion of the Phase I clinical trial, and based on these results, TFF plans to study the 80 milligram dose of TFF borine in the planned pivotal trial. So for you, the investors, I want the message to be clear. TFF Pharmaceuticals is now poised to enter 2022 with pivotal trials being conducted for our two lead internal programs, each of which represents a substantial commercial opportunity. At our present valuation, I believe that many investors are simply not paying close enough attention to the progress we have made to date. But with expected advancement of TFF Tacrolimus and Voraconazole, into pivotal testing, we anticipate a positive shift in how investors perceive the value of our internal pipeline. TFF has two later stage differentiated proprietary drug candidates, each targeting highly attractive markets with the potential to generate significant future revenues. To help investors better understand the TFF story, we held a virtual Science Day event back in June. highlighting our thin-film freezing technology and its applications in transplants and vaccines. The event featured three key opinion leaders' perspectives. Dr. Deborah Levine from UT Health San Antonio provided background on lung transplantation, the current toxicity limitation of oral tacrolimus for immunosuppression, and the potential improvements with an inhaled formulation of tacrolimus, referencing, of course, our TFF tacrolimus program. Dr. Kartik Chandran from the Albert Einstein College of Medicine then discussed the benefits of using the TFF technology to create a dry powder pulmonary formulation for RVSV vaccine against COVID-19. And Dr. Ted Ross from the University of Georgia discussed his experience utilizing the TFF process for creating a universal influenza vaccine for pulmonary delivery and its potential benefit over their existing annual vaccination. For those investors who could not attend our science day, the webcast and presentation materials for this event can be accessed on the TFF corporate website. As the TFF development programs advance for voriconazole, tacrolimus, niclosamide, and our antibody collaborations with augmented biosciences, we also understand the importance of building the company's capabilities to further support maturing clinical programs. As part of that effort, today I'm very pleased to announce the formation of TFF Pharmaceuticals Scientific Advisory Board. We have assembled an extraordinary group of accomplished individuals who are globally recognized as thought leaders in their respective fields. The members of the TFF Scientific Advisory Board are Dr. David Kornfield. Dr. Kornfield is Professor of Pulmonary Medicine and the Director of the Center for Excellence in Pulmonary Biology. at Stanford University. Dr. David Denning, who is a Professor of Infectious Diseases and Global Health, University of Manchester. Dr. Anthony Hickey, Director of the University of North Carolina UNC at Chapel Hill, Catalyst for Rare Diseases. Dr. Jay Peters, Chief of Pulmonary and Critical Care Medicine at the University of Texas Health Science Center in San Antonio. Dr. Ted Ross, Professor at the University of Georgia in the Animal Health Research Center, Center for Vaccines and Immunology, and the Department of Infectious Diseases. Dr. Michael Sag, Professor of Medicine and Associate Dean for Global Health at the UAB School of Medicine in Alabama. And last but not least, Dr. Drew Weissman, Professor of Medicine for the Perelman School of Medicine at the University of Pennsylvania. I'm sure you will agree that this is an outstanding scientific advisory board. These renowned experts share the interest in the potential of the thin-film freezing technology and are excited to help contribute their expertise and guidance to help the company optimize its potential. At this point in our company's growth, we believe that this was the right time to add significant depth and expertise in medicine, medicinal chemistry, virology, and the formulation sciences as we continue to advance multiple programs, both internally and for our numerous and growing portfolio of partnerships. The full biographies of our SAB will be posted on our company website. Before moving on to a review of our existing partnership and business development programs, I also want to share with you some important additions to the TFF team. In the area of manufacturing and product development, Dr. John Kohling will be transitioning from his current role as consultant to a full-time position as Vice President of Product Development and Manufacturing. John has been a key contributor to TFF since its inception. Now, as the internal programs progress and the number of partnership programs increase, I've asked John to join the team in this role. We've also added another key person to this group reporting to John. That person is Don Owens, who will join the company as Director of Product Development. Don has an extensive background in the field of inhaled drug delivery and formulation. Now, having reviewed the progress on our internal programs and company growth initiatives, let me review the recent development in our external partnerships. As you all know, the TFF business strategy has two elements, applying the thin-film freezing technology to developing products internally and then licensing those assets to partners for commercialization, and then licensing access to the technology to pharmaceutical company partners to formulate their assets. Last quarter, we highlighted our worldwide licensing agreement with Union Therapeutics for thin-film freezing to produce both an oral and inhaled version. Importantly, recent data from Union suggests that niclosamide is effective against the new prevalent COVID-19 variants. TFF is progressing the development of niclosamide and will begin the Phase I programs later this year. Just recently, TFF announced additional progress in our second COVID-19-directed program with our partner, Augmenta Bioworks. TFF and Augmenta announced the selection of a lead monoclonal antibody, AUG-3387, which is being developed for the prevention and treatment of COVID-19. Similar with our union collaboration, we considered our partnership with Augmented to be an important example of how our thin-film freezing technology can be applied to develop proprietary therapeutics addressing a large unmet medical need in the area of public health, and also demonstrates the application of the thin-film freezing technology in biologics. We're also pleased that Catalan Biologics has been selected to conduct cell line development utilizing their proprietary GPEX platform, and to lead drug substance manufacturing and scale-up efforts for AUG 3387 as the program advances through our clinical development. Our work with PLUS products on the syn-film freezing versions of cannabinoids has entered into the market testing phase. PLUS has successfully produced formulations that they determined to be ready for consumer input. We expect feedback from those efforts shortly. And finally, our work with NeuroRx and Greenlight is also moving forward well. Currently, we were working with the majority of the top 20 pharmaceutical companies as measured by sales, in some cases on multiple open MTAs at various stages. Our number of material transfer agreements and statements of work also steadily increases. I remain highly confident in our ability to close two meaningful transactions by the end of 2021. This has been our stated annual goal for licensing transactions. Later in our call, our Chief Operating Officer and Head of Business Development, Chris Cano, will provide a more detailed review of our partnership and business development activities. Before reviewing our quarterly financial results, I want to turn the call over to Dr. Dale Christensen, our Head of Clinical Development, who will give you more detail on the outstanding progress we continue to make with our programs. Dale?