TFF Pharmaceuticals, Inc.

Good day and welcome to the TFF Pharmaceuticals, Inc. first quarter 2022 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Corey Davis. Please go ahead.

Thank you, Operator. Hello, everyone, and welcome to TFF Pharmaceutical's first quarter 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. 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 released in 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 factor section of our 2022 quarterly report on Form 10-Q filed with the SEC. And now it's my pleasure to turn the call over to Mr. Glenn Mattis. Go ahead, Glenn.

Thank you, Corey. 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 overall progress, then ask our Chief Financial Officer, Kirk Coleman, to review our first quarter financials. Having announced our fourth quarter and year-end 2021 results just a few weeks ago, we decided to provide a more focused formal commentary of our meaningful progress for this call. This will leave more time for Q&A, and please note that Chris Cano, Dale Christensen, and Dr. Bill Williams are present on today's call and will participate in that session. PFF continued to build strong momentum in our pipeline and partnership activity in the first quarter of 2022, and this momentum carries over from our very successful fourth quarter, which saw numerous accomplishments, including the final data from the Phase Ib study of inhaled voriconazole powder in asthma patients and the initiation of our Phase II studies for both inhaled tacrolimus and voriconazole powders. In addition, we began the Phase I inhaled niclosamide powder study in Canada to treat COVID-19. Advancement of our pipeline programs continued in the first quarter. CFF continues to progress with the inhaled voriconazole and tacrolimus inhaled powder Phase II programs. Both Phase II studies will produce interim analyses late in the third quarter of this year. This is a key milestone event as these data will be shared with potential pharmaceutical company partners in a licensing process. That process has been initiated working with Torea Partners to introduce the opportunity and invite interested companies to begin diligence. We have established a comprehensive data room and already have potential partners performing diligence as a result of inbound interest. EFF has also made voriconazole inhaled powder available on a limited compassionate use basis when requested by investigators. We have received very positive feedback on the first of these patients on Monday. The treating physician shared results with us that supports the efficacy and safety target product profile for voriconazole inhaled powder. In general, this patient was considering only palliative care for his disease and now has reported outstanding efficacy and safety. Dr. Dale Christensen will be happy to share more details should you have questions during the Q&A. CFS also advanced the inhaled niclosamide powder development program. After completing enrollment in the 40 patient phase one study earlier in the quarter, in April we announced positive safety and pharmacokinetic data showing that niclosamide inhalation powder was well tolerated with no serious adverse events across all subject cohorts. Importantly, the study also helped us identify what will be the optimal dosing level for the product in the Phase II program. At the 6 milligram dose level, niclosamide inhalation powder is estimated to produce a concentration of 10 micromolar in the epithelial lining fluid in the lung, following delivery as a dry powder. which would be considered highly potent with respect to inhibiting viral replication. A single administration of 6 mg of niclosamide inhalation powder to the lungs provided equal mean maximum drug concentration, or CMAX, in the blood as 100 mg, delivered as a nebulized spray to the lungs and nasal cavity, as demonstrated in a recent publication. Furthermore, the study's safety management committee also expressed no questions or concerns about the safety and recommended the 6-milligram BID dosing as safe for progression into Phase II testing. Further highlighting the product's potency, in February we announced the results from recently completed in vitro and viral replication assays, which showed the niclosamide inhalation powder completely inhibited viral replication of both the Delta and Omicron variants of SARS-CoV-2. The results also showed that our inhaled niclosamide demonstrated complete inhibition of Omicron replication in only one micromolar compared to the Pfizer and Merck antivirals that each showed complete inhibition of Omicron at 2.5 micromolar. In our view, the high potency of inhaled niclosamide powder suggests that the product may have major advantages over oral delivery, including improved safety and tolerability. The program reflects the exact type of value we hope to create in every one of our collaborations, which dramatically improve drug delivery so that an optimal amount of active molecule can be delivered while minimizing potential side effects to the patient. We continue to develop niclosamide inhalation powder in partnership with Union Therapeutics as a potential antiviral to treat COVID-19 and other respiratory viral diseases. Union Therapeutics is now evaluating the data DFF has generated for a niclosamide inhalation powder, which will inform the decision on the option to assume responsibility to further develop the compound. New and disruptive technologies are often supported by a steady stream of basic research and development, which over time leads to a significant body of scientific literature, and this is clearly the case with thin-film freezing. At this year's RDD meeting, Dr. Bill Williams and his colleagues at the University of Texas at Austin presented five separate papers highlighting the versatility of thin-film freezing technology. These data also support the differentiation of thin-film freezing from other methods to create dry powder, particularly in biologic. In fact, one of the papers, which explored the use of machine learning algorithms, to analyze how thin-film freezing impacts aerosol delivery of dry powder therapies. It received a poster on the podium recognition. The research being conducted by Dr. Williams and his colleagues to demonstrate the versatility of this unique innovation in pharmaceutical formulation development, and we look forward to highlighting additional research from our laboratories as they become available. Turning our attention to our collaboration activity, DFF announced a strategic partnership with the global CDMO Catalan during the first quarter. The client base of over 1,000 companies, we are confident in the short, mid, and long-term productivity from this relationship. In particular, Catalan will introduce thin-film freezing to a targeted list of potential licensing candidates. And with Catalan's focus on biologics manufacturing, provide a clear path forward in providing a source for product in this key arena. This matches very well the balance of TFS partnership portfolio. I'm happy to report that TFS and Catalan have been working very well together to successfully launch the partnering effort, and I look forward to reporting multiple successes as we work together. During the quarter, we were also pleased to announce a second cooperative research and development agreement with the United States Army Medical Research Institute of Infectious Diseases and the Geneva Foundation. We consider our partnering activity in the government, defense, and other public-related sectors as a core area of focus for our business. And, as applications of thin film freezing continue to expand, we anticipate that our public sector collaborations should provide a significant source of non-dilutive funding over time. Speaking of non-dilutive funding, TFF continues to work to capitalize on the language in the omnibus budget legislation, which highlighted the opportunities created by thin-film freezing. We are working through supportive groups to fully explore funding opportunities. Now, looking at progress on other existing collaborations, TFF is continuing to work with Plus Products, who recently announced a transaction with Glasshouse. this transaction will build a highly competitive company in the cannabinoid space. As this partnership is freshly minted, we are in discussions on a path forward on the TFF inhalation cannabinoid products that have been successfully tested with consumers. And finally, we are working with our development partners at Augmenta to identify next steps for Augmenta 3387, which has been identified as a highly potent monoclonal antibody to treat COVID-19 in preclinical animal models. In general, based on the robust pace of our ongoing partnership work and discussion, we remain highly confident that 2022 will see TFF Pharmaceuticals enter into meaningful, monetized new collaborations while expanding many of our existing partnerships. The number of companies in our portfolio continues to grow, and the work we are doing under open MTAs and statements of work continued to progress with successful scientific results and extreme purpose. The first quarter also saw TFF Pharmaceuticals bring in a wealth of new and diverse talent in the form of senior level and board of director appointments. As the number of collaborations grow and our internal clinical programs advance, an appropriate level of investment is required to optimize such growth. The new colleagues added to TFF Pharmaceuticals reflects a company fast becoming stronger across all facets of our business. We believe these additions will lead to the expansion of existing collaborations, the forging of new and more strategic partnerships, and the advancement of multiple programs into late-stage testing, all of which will generate significant value for our shareholders. And with that update, I will turn the call over to our Chief Financial Officer, Kirk Coleman, for review of the financials.