TFF Pharmaceuticals, Inc.

Greetings, ladies and gentlemen, and thank you for standing by. Welcome to the TFF Pharmaceuticals Third Quarter 2021 Results Conference Call. As a reminder, this conference call is being recorded. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. I would now like to introduce Corey Davis of LifeSci Advisors to begin the call.

Thank you, Operator. Hello, everyone, and welcome to the TFF Pharmaceuticals Third 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, and Dr. Bill Williams of the University of Texas at Austin. Chris Cano, TFF's Chief Operating Officer. Press release announcing our third quarter results is available on the TFF Pharmaceuticals website. Please take a moment to read the disclaimer about forward-looking statements in the release. Discerning's 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 13. 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 overall corporate progress. After my opening comments, I will ask Dr. Dale Christensen to update us on the outstanding progress we are making with our internal clinical programs. He will be followed by our CFO, Kirk Coleman, who will update financial results. Then Dr. Bill Williams will review the highlights of new data on thin film freezing generated in just the last quarter. And finally, our Chief Operating Officer and Vice President of Business Development, Chris Cano, will update the status of our partnering efforts. The third quarter was extremely productive with significant milestones in every area of the TFF business. These accomplishments are almost too many to discuss in a timely manner during this update. The positive outcomes have been accelerating throughout 2021 and continues to position TFF for positive value creation in the short, mid, and long-term periods. I'm going to begin by reviewing the significant milestones from our development of the internal pipeline. I'll provide a top line and Dr. Christensen will provide greater details. We concluded and reported results from both the Phase 1 and Phase 1B TFF inhaled voriconazole program. These data have confirmed safety and allowed us to select a dose to study in our upcoming pivotal Phase 2 program which we'll initiate by the end of this year. In addition, the results of the Phase 1B study gave us our first look at safety data in asthmatic patients. The data from both studies were quite positive and confirms our clinical strategy of pursuing an indication in patients with invasive pulmonary aspergillosis. We also concluded the Phase 1 study for TFS tacrolimus, And the results indicated that our inhaled product has an acceptable safety profile to achieve the appropriate balance of local and systemic concentrations for immunosuppression at the site of the lung transplant, while minimizing the risk of supertherapeutic exposure, well known to cause significant renal toxicity in patients. The outcome of this study allows us to initiate the pivotal phase two program shortly. Later in the call, Dr. Christensen will provide a more detailed overview of the data from both programs and inform you on our progress. We also achieved significant milestones in our two partner programs, which feature the novel antibody Augmenta 3387, co-developed with Augmenta BioWorks, and the antiviral niclosamide, who we partnered with Union Therapeutics. As a reminder, Augmenta 3387 is being formulated as a dry powder using TFF Pharmaceutical's proprietary thin-film freezing process to enable direct delivery to the lungs and remove the need of IV infusion that is required for delivery of current COVID-19 antibody therapies. In separate announcements, we described the high level of potency in animal testing. In these studies, Augmenta 3387 demonstrated the ability to reduce viral load in a dose-dependent manner after the animals have been fully inoculated. This is a unique finding, and in our view, Augmenta 3387 is fast emerging as one of the most promising new therapies for the treatment of COVID-19. Augmenta 3387 also demonstrated binding to the major COVID-19 variants, including Delta, Lambda, and Mu. Our inhaled niclosamide program has achieved a meaningful development milestone when we announced that TFS has received approval from Health Canada to begin a Phase I clinical trial of a dry powder version of niclosamide that will demonstrate safety data and allow for dose selection and subsequent clinical development of this potent antiviral agent. By way of additional background, niclosamide is included in the World Health Organization's list of essential medicines and has recently been shown to exhibit potent antiviral activity against SARS-CoV-2. The inhaled version of niclosamide will overcome the limited water solubility as well as low absorption in oral bioavailability. Using the TFS technology to develop a dry powder formulation of niclosamide that can be delivered directly to the site of viral replication within the lungs by inhalation, will be administered in the outpatient setting, providing an important treatment option for physicians. Again, Dale will provide greater details in just a few minutes. The significant progress we have made and will be making in the coming days and weeks moves all of our internal portfolio closer to monetization and meaningful revenue streams for TFF. Both the TFF for aconazole and TFF tacrolimus Phase II programs will be designed with an interim analysis of data. These data sets will be available mid-2022. Once we have the data, we'll begin a process to find a licensed partner to ultimately commercialize the assets. We've already received interest from pharmaceutical companies, and we'll use the interim data as the inflection point to pursue those partnerships. For Nyclosamide, the successful completion of the phase one study, in the early part of next year will be the inflection point for Union Therapeutics to trigger their option period. And for Augmenta 3387, we are committed to share funding of the development of the monoclonal antibody through phase one, at which time we will pursue a pharma partner to license the asset for further development and commercialization. So, TFF is rapidly reaching meaningful economic milestones for our internal portfolio. I also want to congratulate the TFF team for advancing all four of our development programs in a timely manner in the face of the global pandemic. As you know, COVID-19 has been a significant issue for clinical development in the industry, and TFF has been able to successfully navigate these issues and produce results with limited or no delay and on budget. Also on this call, Dr. Bill Williams will highlight important new data that he has generated during the quarter. Specifically, he will review new data demonstrating the applicability of thin-film freezing in creating successful formulations in biologics and complex molecules. These are the opportunities where thin-film freezing is highly differentiated from other methods for creating dry powders. It is important to note that these data were generated with materials provided by companies who are partnered with TFF. The results of these MTAs and statements of work with companies who we intend to partner with continues to expand the proof of the value of the technology and allows us to attract additional opportunities. It is also important to note that these observations and findings has enabled PFF to greatly expand our IP estate. We now have approximately 100 patents either granted or pending both in the U.S. and the rest of the world. Our academic and government collaborations are also proceeding very well. We have initiated the work with DARPA on formulating countermeasures and the development of novel vaccines at USAMRID is also progressing. We expect a second CRADA shortly, expanding the work we are doing in the vaccine area at USAMRID. Our collaboration with Dr. Ted Ross at the University of Georgia on universal flu, and Dr. Karthik Chandran at the Albert Einstein College of Medicine on VSV vaccines are now in the animal testing phase. And our work with Dr. Drew Weissman at the University of Pennsylvania is now in full swing, looking at the application of the thin-film freezing technology in mRNA vaccines and therapeutics. Dr. Weissman is the inventor of the current BioNTech Pfizer mRNA COVID vaccine. And we're honored to be working with Dr. Weitzman and believe this collaboration will result in important new products to prevent and treat viral infection. Dr. Weitzman provided this quote. The freeze-dried powder formulation by TFF has enormous potential to move the mRNA LNP vaccine platform to efficient worldwide use by allowing room temperature storage and the development of oral inhaled delivery. That's quite high praise from Dr. Weissman. I also want to thank our partner, Plus Products, for their work in optimizing the TFF formulation of cannabinoids and implementing thorough market testing. Plus has successfully completed a number of formulations which are being evaluated by potential consumers, leading to what we hope will be a successful commercial launch in the very near future. In relation to the status of our partnership business development activities, I continue to strongly believe with confidence they were on track to sign meaningful partnership licensing agreements. I'm aware that it is November 15th and we're entering into the final weeks of the year. The number of programs or MTAs continues to grow. Moreover, we are also seeing expansion of thin-film freezing application across a more diversified set of companies and drug candidates, mostly in the biologics arena. The work we are conducting with partners closest to finalizing transactions are focused on animal testing, the thin-film freezing formulations, stability work, and in some cases, production of GMP material. We are also discussing specific terms and agreements with a significant number of potential partners. In our discussions with these companies, we have agreed to the specific data that needs to be realized as the potential seminal milestone leading to a completed transaction. TFF works with great purpose to get these data produced and delivered to the partner for their assessments and analysis. At that point, we are at the mercy of the partner's timing to evaluate the data and provide feedback to TFF. There are situations we were asked to optimize the material, and the process continues. And TFF has been billing the partner for the additional work performed that has been outside of the original MTA and statement of work. It's certainly great news that many of our current partners with open MTAs and SOWs are large commercial-stage pharmaceutical companies. The pace of moving forward with these companies can be a challenge. The process has led to extended evaluations and, in some cases, are taking a bit longer than we expected. We do not have the ability to accelerate these discussions. We have communicated our strong desire to close these agreements by the end of this year and remain confident that this will happen. We strongly believe that we're on track. We will communicate and update the status of this work and ongoing negotiations. We have every reason to be confident that our numerous technology evaluation programs will result in meaningful collaborations and will drive near, mid, and long-term shareholder value. Later on the call, Chris Cano, our Chief Operating Officer and Head of Business Development, will provide more details on the total view of this effort and how the opportunities are progressing as well as expanding. I will now turn the call over to Dr. Dale Christensen, who will provide detail on our development efforts supporting our internal portfolio. Dale?