TFF Pharmaceuticals, Inc. announced data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration. In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study. There has been no evidence of acute rejection, and four out of four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceed to the long-term extension of the trial.

TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events. For TFF VORI, a total of nine patients have enrolled between the Phase 2 trial and the EAP. The Company continues to see positive efficacy results, with five of six patients who have completed treatment achieving a clinical and mycologic response.

TFF VORI continues to maintain an attractive safety profile with no all-cause mortality or IPA-related mortality.