TFF Pharmaceuticals, Inc.

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.

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.

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?