TFF Pharmaceuticals and Leidos to Advance Next-Generation Biodefense Countermeasures Under the DARPA PPB Program into Preclinical Testing

The Leidos team's Next-Generation Medical Countermeasures (MCMs) Successfully Formulated with Company's Proprietary Thin Film Freezing Technology

MCM Candidates Demonstrated Chemical and Biological (CB) Neutralizing Activity in Well-Validated In Vitro and Ex Vivo Models

FORT WORTH, Texas, May 23, 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 government will be advancing several next-generation medical countermeasures (MCMs) formulated with its Thin Film Freezing technology into advanced preclinical testing. TFF Pharmaceuticals is collaborating with Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, to develop next-generation MCMs designed to protect military and healthcare personnel against future chemical and biological (CB) threats. The research is funded by the Defense Advanced Research Projects Agency (DARPA) under a contract through the Personalized Protective Biosystems (PPB) program.

Program Update

The candidate MCMs delivered by Leidos to TFF Pharmaceuticals have been successfully formulated utilizing the Company's proprietary Thin Film Freezing technology platform. Formulated materials have demonstrated neutralizing activity in well-validated in vitro models. The MCMs are now progressing into in vivo preclinical testing, which will be conducted at DARPA-contracted laboratories.

"Over the last several months, we have made significant progress working with Leidos to develop innovative new medical countermeasures utilizing our Thin Film Freezing technology," said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. "The ultimate goal of this research collaboration is to develop products that protect the lives of our military personnel and first responders, and our Thin Film Freezing technology is once again demonstrating its versatility by addressing a uniquely challenging problem in biodefense drug development. In the months ahead, we hope to demonstrate that MCMs formulated with Thin Film Freezing can neutralize biochemical threats in vivo directly at the site of entry. We also expect that our formulation technology will enable these countermeasures to be developed as needle-free and temperature independent products, which could dramatically improve storage and deployment capabilities in the face of urgent future biochemical threats."

About DARPA's PPB Program

Please see https://www.darpa.mil/program/personalized-protective-biosystem

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 expectation that the preclinical testing of the Company's medical countermeasures formulated with its Thin Film Freezing technology will be favorably consistent with formulation testing conducted to date and the benefits of the Company's TFF platform. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk the preclinical testing of the Company's MCM candidates will not be favorably consistent with the formulation testing to date, (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

[email protected]