On this page of StockholderLetter.com we present the latest annual shareholder letter from TFF Pharmaceuticals, Inc. — ticker symbol TFFP. Reading current and past TFFP letters to shareholders can bring important insights into the investment thesis.
TFFP Shareholder/Stockholder Letter Transcript:
TFF Pharmaceuticals, Inc. 2023 Annual Report to Stockholders Letter to Stockholders Dear Stockholders, Over the past six months, we have made considerable progress and made key decisions that we believe will generate the most value for shareholders as our company progresses forward. We have delivered three data updates on our TFF TAC and TFF VORI Phase 2 programs since last October, contributing to our effort to maximize shareholder value and supporting our dedication to transparency. TFF closed out 2023 on a positive note with initial Phase 2 data providing meaningful clinical insights on TFF VORI and TFF TAC s safety, tolerability, and efficacy. These data demonstrated that our Thin Film Freezing technology platform has the potential to offer a safer and more effective option to both IPA and lung transplant patients. Subsequently, we announced updated positive data in March 2024 for both Phase 2 trials and while these results garnered excitement for both programs, we made the strategic decision to focus our clinical development efforts and financial resources on the TFF TAC program. TFF VORI s potential remains strong, and we will continue to explore strategic alternatives. As of our latest update on the ongoing TFF TAC Phase 2 study, eight of eight patients in the trial were successfully transitioned from oral tacrolimus to TFF TAC. No evidence of acute rejection was seen, and new gene expression data showed no evidence of rejection in all four patients with available gene expression data from endobronchial biopsies. These updated data were presented by Professor Gregory Snell at the ISHLT 2024 Annual Meeting that took place on April 13, 2024. Based on these highly encouraging results, we plan to open an IND in the US to explore the use of TFF TAC early post-transplant in preparation for a registrational trial. For TFF VORI, a total of nine patients have been enrolled between the Phase 2 study and the Expanded Access Program (EAP) and results remain positive. In support of TFF VORI s efficacy profile, five of six patients who completed treatment achieved a clinical and mycologic response. Updated data demonstrate that TFF VORI continues to maintain an attractive safety profile with no IPA-related mortality or all-cause mortality. In March, we strengthened our balance sheet through a registered direct offering of $1.2M and we continue to evaluate all potential funding opportunities to move our pipeline forward. We would like to thank our shareholders for your continued support and confidence in TFF Pharmaceuticals, and we look forward to updating you on our progress throughout the rest of the year. Yours sincerely, Harlan Weisman, M.D., Chief Executive Officer4/22/2024 Letter Continued (Full PDF)