TFF Pharmaceuticals Receives Additional Funding from Leidos to Advance Next-Generation Personalized Protective Biosystems under the DARPA PPB Program

FORT WORTH, Texas, May 01, 2023 (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 Leidos, a leading Fortune 500 information technology, engineering and science solutions and services leader, has awarded the Company additional funding under the DARPA Personalized Protective Biosystems (PPB) program to develop next-generation countermeasures for military and healthcare personnel.

The PPB research program, managed by the Defense Advanced Research Projects Agency (DARPA), is developing an integrated system that simultaneously reduces protective equipment needs while increasing protection for the individual against existing and future chemical and biological (CB) threats. This will be achieved through lightweight materials that protect the military or healthcare personnel from exposure to CB threats, while simultaneously providing a second layer of protection, at the tissue barrier, with bio-molecular, commensal organisms, or other technologies that protect the skin, eyes, and airway from CB threats. Successful PPB technologies could change how the military and public health communities perform in unpredictable threat environments.

In April 2021, the Company entered into a 60-month, three-phase subcontract with Leidos to utilize its Thin Film Freezing platform to formulate a series of countermeasures designed to neutralize chemical and biological agents at the site of vulnerable tissue barriers, including the skin, the eyes and the respiratory system. 

“We are pleased with the continued advancement of this program and our relationship with Leidos,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “There is an unmet need to develop next-generation countermeasures to adequately protect our military and civilian populations. Our technology not only allows for delivery of various countermeasures to neutralize biochemical threats directly at the site of entry, but is also needle-free and temperature independent, making these countermeasures easily deployed and administered with ease for future biochemical threat preparedness and biodefense. We believe our Thin Film Freezing platform has extraordinary potential to improve upon numerous applications, including the development of the next generation of chemical and biological protective technologies that can significantly improve the level of protection for our military and front-line personnel.”

ABOUT LEIDOS

Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world’s toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company’s 37,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Va., Leidos reported annual revenues of approximately $11.09 billion for the fiscal year ended January 3, 2020. For more information, visit www.leidos.com.

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 Thin Film Freezing 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 Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing 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 Thin Film Freezing 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 Thin Film Freezing (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, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus 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 120+ 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 benefits of the Company’s TFF platform and the Company’s plans to add to its existing pipeline of product candidates. 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 Company may not be able to successfully conclude clinical testing or obtain pre-market approval of any of its dry powder product candidates, (ii) success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (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, (v) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Prospectus Supplement filed with the SEC on November 18, 2022. 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.

“This Press Release was cleared by DARPA under Distribution Statement “A” (Approved for Public Release, Distribution Statement).”

Company Contact:
Bill Begien
TFF Pharmaceuticals, Inc.
bbegien@tffpharma.com

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

Media Contact:
Raena Mina
LifeSci Communications
rmina@lifescicomms.com