TFF Pharmaceuticals, Inc.

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.

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.

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?