• 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.”

TFF TAC - updated Phase 2 data post ISHLT 2024 Meeting

The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety, tolerability, kidney function, and acute allograft rejection. In March 2024, the Company announced updated data from the first eight patients (N=8) enrolled in the trial. Today, the Company announced additional data from the trial, including new gene expression data assessing molecular markers of acute rejection, that were presented by Professor Gregory Snell at the ISHLT 2024 Annual Meeting on April 13, 2024.

Updated Efficacy

• Successful transition of eight of eight patients from oral Tacrolimus to TFF TAC
• No evidence of acute rejection:
  • No signs and symptoms suggestive of acute rejection
  • No use of pulse corticosteroids to treat acute rejection
  • No deterioration in spirometry suggestive of acute rejection
  • No chest x-ray findings suggestive of acute rejection
• No gene expression evidence of rejection in 4/4 patients with available gene expression data on endobronchial biopsies:
  • Rejection-related genes normalized on TFF TAC in 3/3 patients with abnormal expression of rejection-related genes at baseline while on oral tacrolimus
  • Rejection-related genes remained normal on TFF TAC in one patient with normal expression of rejection related genes at baseline.
• 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B.

Updated Safety

• No mortality
• No TFF TAC discontinuation due to an AE
• Majority of TEAEs were Grade 2 or lower in severity
• Maintenance of kidney function   

Based on these highly encouraging results, TFF Pharmaceuticals plans to open an IND in the US to explore the use of TFF TAC early post-transplant in preparation for a registrational trial.

ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY

TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.

ABOUT TFF PHARMACEUTICALS

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.

SAFE HARBOR 

This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF TAC into potentially registration-enabling studies; the expectation that the initial data readouts for TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trial; and the benefits of the Company’s TFF platform. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 2 clinical trial for TFF TAC will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for its TFF TAC candidate, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
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