TFF Pharmaceuticals, Inc. announced positive initial data from the Company's ongoing Phase 2 trials of TFF VORI and TFF TAC, along with clinical data from the ongoing TFF VORI Expanded Access Program (EAP). The efficacy results are equally remarkable with treatment response seen in all patients. Initial results from the TFF TAC study are also impressive.

Patients treated with TFF TAC did not experience clinically acute rejection at significantly reduced blood tacrolimus levels. Trial endpoints include safety, tolerability, clinical response, mycologic response, radiologic response, and all-cause mortality. The initial efficacy data presented below include patients from the Phase 2 trial and the Company's EAP who received at least 8 weeks of therapy with either TFF VORI (N=5) or oral voriconazole (N=1).

Safety data included all TFF VORI-treated patients (N=7) and oral voriconazole-treated patients (N=2). Trial endpoints include safety/tolerability, kidney function, and acute allograft rejection. The initial data presented below are from the first four patients enrolled in the trial.

Efficacy-- the fofour patients enrolled in the TFF TAC Phase 2 study: All four patients wereu successfully tritioned from oral tacrolimus to TAC; Successfully lowered tacrolimus blood levels to 1/2 to 2/3 of the levels on oral tacrolimus in all four patients; No clinical evidence of acute rejection; No signs and symptoms suggestive of acute rejection; No use of pulse corticosteroids; No deterioration in spirometry; No chest X-ray findings suggestive of acute rejection; All three patients who completed Part A chose to remain on TFF TAC and advance to Part B (extension study) TFF TAC was well tolerated, with no mortality and no TFF TAC discontinuations due to an AE; kidney function was maintained in all patients treated with TFF TAC. Based on the promising Phase 2 data for both products, the Company plans to accelerate the initiation of registration-enabling studies.