TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions

New Gene Expression Analysis from Ongoing Phase 2 Study Provides Strong Biomarker Evidence that Treatment with TFF TAC Results in Normalization of Rejection-Related Genes

TFF TAC Prevented Rejection at 1/6 of Oral Tacrolimus Dose and with 2/3 of Oral Tacrolimus Systemic Trough Exposures

4 out of 4 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase

FORT WORTH, Texas, April 15, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of organ rejection in lung transplant recipients. These new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 44^th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic.

“The updated Phase 2 data presented at this year’s ISHLT Meeting support the continued advancement of TFF TAC as a highly differentiated immunosuppressive therapy for the prevention of rejection in lung transplant recipients,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “Thus far, the data suggest that TFF TAC is providing sufficient immunosuppression to prevent rejection at only 17% of oral tacrolimus dose leading to systemic trough levels that are 65% of oral tacrolimus, with the lower exposure levels potentially decreasing the risk of kidney toxicity. These results support our hypothesis that inhalational delivery of tacrolimus leads to higher concentrations of tacrolimus in the lung for a given systemic exposure and has the potential to optimize lung immune suppression while decreasing systemic exposures and toxicities.”

“The monitoring of rejection-related genes in transplant recipients through Molecular Microscope Diagnostic System (MMDX) is an innovative approach commonly used in transplant medicine to assess the status of the transplanted organ, giving actionable data to guide immunosuppressive therapy,” said Professor Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital and Lead Principal Investigator of the Phase 2 TFF TAC trial. “The decreased expression of multiple, rejection-related genes provides compelling evidence at a molecular level that patients who have transitioned from oral tacrolimus onto TFF TAC are not experiencing rejection. Based on these updated Phase 2 data, I am encouraged by the evolving profile of TFF TAC as a potentially new advancement in the field of immunosuppression, and I look forward seeing this program move into late-stage testing.”