TFF Pharmaceuticals Announces Update on Clinical Programs

Company to Prioritize Clinical Development of Tacrolimus Inhalation Powder (TFF TAC) based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity

Company to Evaluate Strategic Options for TFF VORI, including Partnerships, Collaborations, and Grants following Positive Data from Phase 2 Study and the Expanded Access Program (EAP)

Company to Discuss Clinical Updates on TFF TAC and TFF VORI on Wednesday, March 27, 2024 at 4:30 pm ET

FORT WORTH, Texas, March 20, 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, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.

“For decades, legacy immunosuppressive drugs such as IV and oral tacrolimus, while effective in preventing acute rejection, have resulted in an unacceptable level of systemic toxicities, which has created constant challenges in maintaining the overall health of the transplant recipient,” said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals. “Based on our Phase 2 data and the overwhelmingly positive feedback that we have received from KOL and clinical investigators, we believe that TFF TAC has the potential to introduce a groundbreaking advancement in the delivery of immunosuppressive therapy that will overcome these limitations and fundamentally change how these life-saving medicines are delivered to patients. We have therefore made the decision to prioritize the TFF TAC program with the aim of accelerating its clinical development pathway toward registration, and we look forward to discussing updated data from our Phase 2 program.”

“With respect to TFF VORI, the positive safety and efficacy from the Phase 2 study and the EAP continue to suggest that this product represents a significant improvement over the oral and intravenous formulation of voriconazole,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC. We remain excited about the potential for TFF VORI based on the results from our Phase 2 study and the EAP and believe that there is strategic value to be unlocked with this asset. We are exploring strategic alternatives, including partnering opportunities, collaborations, and government-based funding sources.”

TFF TAC and TFF VORI Clinical Data Updates

On Wednesday, March 27, 2024 at 4:30 pm ET the Company will discuss data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and additional positive safety data from the TFF VORI Phase 2 study and the ongoing EAP for the treatment of invasive pulmonary aspergillosis (IPA).

In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study. There has been no evidence of acute rejection, and four out of four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceed to the long-term extension of the trial. TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.

For TFF VORI, a total of nine patients have enrolled between the Phase 2 trial and the EAP. The Company continues to see positive efficacy results, with five of six patients who have completed treatment achieving a clinical and mycologic response. TFF VORI continues to maintain an attractive safety profile with no all-cause mortality or IPA-related mortality.

Conference Call and Webcast Information

The Company will host a conference call on Wednesday, March 27, 2024, at 4:30 PM Eastern Time, to discuss updated clinical data for the TFF TAC and TFF VORI.

Domestic Dial-In Number: Toll-Free: 1-888-886-7786

International Dial-In Number: 1-416-764-8658

Conference ID: 24531709

Call me™: (will be made active 15 minutes prior to the scheduled start time)

The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, or directly at 

The conference call will also be available for replay for one month on the Company's website in the Events Calendar of the Investors section.

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 .

SAFE HARBOR 

This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF TAC into potentially registration-enabling studies; TFF TAC’s substantial market opportunity; the expectation that the further data from the ongoing Phase 2 clinical trial for TFF TAC will be consistent with the data readouts for TFF TAC to date; and our exploration of strategic alternatives for TFF VORI, including partnering opportunities, collaborations, and government-based funding sources; 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 trials for TFF TAC will not be favorably consistent with the initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC, (iii) the risk we may not be successful in our pursuit of strategic alternatives for TFF VORI; (iv) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF platform, (vii) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (viii) 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 November 14, 2023. 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