Patient Enrollment Has Accelerated with Now 10 Patients Enrolled in Phase 2 Trial

6 out of 6 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase; 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months

Variability in Systemic Exposure to Tacrolimus Was Reduced with TFF TAC Which Could Lower Risk of Acute Rejection and Systemic Toxicities

FORT WORTH, Texas, May 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 provided an update from the Company's ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.

"I am pleased to report that patient enrollment has accelerated due to positive physician enthusiasm based on emerging data, and we have now enrolled 10 patients in the TFF TAC Phase 2 study," said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. "As we continue to grow the body of clinical data for TFF TAC, we anticipate providing a more detailed clinical update on the Phase 2 trial later in the year."

Program update

• The Phase 2 study now has 10 patients enrolled and 6 out of 6 patients who completed the 12-week treatment period with TFF TAC have chosen to remain on the therapy by proceeding to the safety extension phase. 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months

• PK data from first patient cohort indicate that TFF TAC dosing results in reduced systemic variability of tacrolimus; the systemic tacrolimus trough to peak concentration swings that occur with oral tacrolimus are not present with TFF TAC, which is predicted to reduce the risk of acute rejection and systemic toxicities such as chronic kidney disease, respectively

• Patients on TFF TAC have provided anecdotal feedback to investigators noting a reduction in headaches, overall improvements in wellness, and/or ease of use in administration
  

"We are encouraged by the initial positive feedback we are receiving from patients who have been receiving TFF TAC over an extended period of time, which is not altogether surprising given TFF TAC's more precise, targeted delivery into the lungs versus oral administration of tacrolimus," said Dr. Zamaneh Mikhak, Chief Medical Officer. "Furthermore, initial PK data from the first patient cohort indicate that dosing with TFF TAC results in less variability in the levels of systemic tacrolimus. By reducing systemic tacrolimus trough and peak concentration swings through more targeted delivery, we believe TFF TAC has the potential to reduce the incidence of acute rejection and kidney toxicity, respectively. In addition, we have received positive feedback on the ease of use of the TFF TAC inhalation device, which is a small portable inhaler that requires no priming or spacer, making it easy for patients to inhale drug and likely leading to improved compliance."

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.

SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to 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 Quarterly Report on Form 10-Q filed with the SEC on May 14, 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
cdavis@lifesciadvisors.com