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TFF PHARMACEUTICALS TFF Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update November 15 , 2021 Positive Updates Announced for Inhaled Voriconazole and Tacrolimus Programs ; Both Programs Advancing into Phase 2 Testing Continued Progress with Partnered Antiviral Programs for AUG - 3387 and Niclosamide Thin Film Freezing Applications Continue to Expand Across Diverse Set of Drug Candidates ; IP Estate Now Includes Over 120 Patents Granted or Pending Conference Call and Webcast Scheduled Today , Monday , November 15 , 2021 , at 4:30 PM ET AUSTIN , Texas , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) -- TFF Pharmaceuticals , Inc. ( NASDAQ : TFFP ) , a clinical - stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing ( TFF ) technology platform , today reported financial results for the third quarter ended September 30 , 2021 , and also provided an update on recent corporate and clinical developments . The Company will discuss the highlights on a conference call and webcast , scheduled today , Monday , November 15 , 2021 , at 4:30 PM ET . " Over the last three months , we have made significant progress in every aspect of our business , " said Glenn Mattes , CEO of TFF Pharmaceuticals . " Starting with our two lead in - house programs , Inhaled Voriconazole and Tacrolimus Powder , we achieved important clinical milestones that we believe will drive significant shareholder value . With respect to voriconazole , the safety results from both our Phase 1 and Phase 1b studies have allowed us to select a dose to study in our upcoming Phase 2 programs , which we plan to initiate around year - end . " " Results from our Phase 1 study for Inhaled Tacrolimus Powder indicate 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 supra therapeutic exposure well known to cause significant renal toxicity in patients . Based on the data , we expect to initiate the Phase 2 program shortly . " " We are also making outstanding progress in our two antiviral - focused partnerships , which provided yet another major source of external validation showing how our Thin Film Freezing technology can be applied to both small molecules and biologics . In October , TFF Pharmaceuticals and Augmenta announced the publication of positive in vivo data showing that the dry powder formulation of COVID - 19 antibody AUG - 3387 neutralizes SARS - CoV - 2 infection and reduces viral load in a well - accepted preclinical model . The data from the AUG - 3387 animal efficacy trial confirmed activity in the most virulent COVID - 19 variants , including Delta , Lambda , and Mu . For niclosamide , a broad - spectrum antiviral , just two weeks after receiving approval from Health Canada , we enrolled and dosed the first patient in the Phase 1 trial . " " From our perspective , momentum only continues to build across the breadth of our diverse portfolio . The progress we have made and expect to make moves our entire internal portfolio closer to monetization and meaningful revenue streams for TFF . " " Looking ahead , we believe 2022 is shaping up to be another year of significant accomplishments . As our clinical programs with inhaled tacrolimus and voriconazole continue to advance , we expect to generate substantial proof - of - concept data within each program's targeted patient populations . Both the Inhaled Voriconazole and Inhaled Tacrolimus Powder Phase 2 programs will be designed with an interim analysis of data , and we expect these datasets will be available by mid - 2022 . We will begin a process in the first quarter of 2022 to identify license partners to ultimately commercialize these assets . We have already received interest from pharmaceutical companies and will use the interim data as the inflection point to pursue the partnerships . " " Importantly , the applicability of Thin Film Freezing in creating successful formulations in biologics and complex molecules continues to grow . For example , we have recently seen a strong uptick in the number of mAbs and mRNA - based therapeutics being evaluated by our large pharma partners , and we expect this trend will continue . The applicability of our Thin Film Freezing technology across a broad array of different molecules has also enabled us to greatly expand our IP estate . TFF now has approximately 120 patents either granted or pending both in the United States and the rest of the world . " " Without question , another important source of expanding applications of Thin Film Freezing comes from our academic and government collaborations , and I am pleased to report that each of these highly valued partnerships are proceeding very well . Our work with Dr. Ted Ross at the University of Georgia in testing a universal flu vaccine has proceeded to 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 Thin Film Freezing technology in mRNA vaccines and therapeutics . Noting the potential of our technology platform , Dr. Weismann provided the following comment : ' 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 . " " We have also made substantial progress with the Defense Advanced Research Projects Agency ( DARPA ) Personalized Protective Biosystem ( PPB ) contract on formulating countermeasures and the development of novel vaccines at the United States Army Medical Institute of Infectious Diseases ( USAMRIID ) is also progressing . We expect a second Cooperative Research and Development Agreement ( CRADA ) shortly expanding the work we are doing in the vaccine arena . " " On the partnering front , the number of drug candidates being evaluated by our partners continues to grow and , just as importantly , we are seeing an