TFF Pharmaceuticals Reports First Quarter Financial Results and Provides Corporate Update

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TFF Pharmaceuticals, Inc.
TFF Pharmaceuticals, Inc.

Growing Body of Clinical Data from Ongoing Phase 2 Trial Suggests that Tacrolimus Inhalation Powder (TFF TAC) Could Represent an Important New Innovation for Optimizing Immunosuppressive Therapy in Lung Transplant Recipients

Raised $6.0 Million to Support Continued Advancement of TFF TAC into Potentially Registrational Testing

Company expects to receive feedback from FDA in Second Quarter Regarding TFF TAC Clinical Development Plan and Next Steps

FORT WORTH, Texas, May 14, 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 reported financial results for the first quarter 2024 and provided a corporate update.

“We continue to make significant progress in demonstrating that Tacrolimus Inhalation Powder (TFF TAC) has the potential to become an important new advancement in transplant medicine,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Following the positive physician feedback for our updated Phase 2 study presented at this year’s International Society for Heart and Lung Transplantation (ISHLT) meeting, we submitted a briefing book, inclusive of our proposed study plan, to the FDA. We expect to receive feedback from the FDA this quarter that will help guide our next steps in the clinical development pathway for TFF TAC. I am also pleased to note that we were able to secure additional financing following the close of the quarter to help us further advance TFF TAC toward registrational testing. Our Phase 2 study for TFF TAC continues to enroll additional patients, and we look forward to hosting a call and presenting updated data from the trial later this year.”

Recent Clinical and Corporate Highlights:

  • On May 1, 2024, the Company announced the closing of its previously announced $4.8 million public offering. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes. This follows a $1.2 million public offering in March 2024.

  • On April 15, 2024, the Company announced additional positive data from its ongoing Phase 2 study evaluating TFF TAC) for the prevention of organ rejection in lung transplant recipients.

    • New gene expression analysis demonstrated normalization of rejection-related genes after treatment with TFF TAC.

    • 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

    • These new data were presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, in an oral presentation ISHLT 44th Annual Meeting at a late breaking clinical science abstract session, on April 13, 2024, in Prague, Czech Republic.

  • On March 27, 2024, the Company hosted a conference call and webcast to present new data from the ongoing Phase 2 study of TFF TAC for the prevention of organ rejection in lung transplant recipients and from the Phase 2 study and the Expanded Access Program (EAP) of TFF Voriconazole (TFF VORI) for the treatment of invasive pulmonary aspergillosis (IPA) infections. On the call, our executive leadership team disclosed that:

    • Eight out of eight patients (100%) successfully transitioned from oral Tacrolimus to TFF TAC in the study. There was no evidence of acute rejection. Four out of the four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceeded to the long-term extension of the trial. TFF TAC demonstrated favorable safety results with no mortality or discontinuations due to adverse events.

    • The Company enrolled a total of nine patients in its TFF VORI clinical programs, inclusive of its ongoing Phase 2 study and the EAP. Five of six patients who had completed treatment by the data cut date achieved a clinical and mycologic response providing promising positive efficacy data. TFF VORI maintained an attractive safety profile with no IPA-related mortality or all-cause mortality.