FORT WORTH, Texas, June 26, 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 that the Company has engaged Outcome Capital as a strategic advisor for the purpose of evaluating potential corporate partnerships and licensing opportunities.

“We are pleased to announce this engagement with Outcome Capital, which is a well-recognized investment bank specializing in corporate advisory services to the life sciences industry,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Today’s announcement reflects the significant innovation and commercial potential of our two lead clinical assets, TFF VORI and TFF TAC, and we welcome the opportunity to work with Outcome Capital in evaluating select partnering or licensing opportunities that can bring significant value to our shareholders.”

“In recent months, TFF Pharmaceuticals has made extraordinary progress in demonstrating how its leading formulation technology can be applied to generate innovative clinical-stage products with the potential to improve upon the current standard of care,” said Oded Ben-Joseph, Ph.D., MBA, Managing Partner of Outcome Capital. “We look forward to identifying and evaluating opportunities to realize the full potential value of TFF Pharmaceutical’s exciting Phase 2 assets.”

About TFF TAC

TFF TAC is an inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. Oral tacrolimus is currently the first line calcineurin inhibitor used for prevention of rejection after solid organ transplantation but it is associated with many toxicities such as kidney toxicity, particularly when high doses are needed as is the case after lung transplantation

TFF TAC delivers tacrolimus directly to the lung to yield improved lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus to improve efficacy and decrease systemic toxicities such as kidney toxicity. TFF TAC is delivered via an easy-to-use dry powder inhaler.

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 and tolerability including kidney function, acute allograft rejection and pharmacokinetics.

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 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 innovation and commercial potential of the Company’s TFF VORI and TFF TAC product candidates. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the Company may not realize the innovation and commercial potential of TFF VORI and TFF TAC through its collaboration with Outcome Capital or otherwise, (ii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (v) 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. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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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