TFF Pharmaceuticals Enters into CRADA with the National Institute of Environmental Health Sciences to Develop Dry Powder Formulations of Hyaluronan to Prevent and Treat Respiratory Diseases

FORT WORTH, Texas, May 04, 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 it has entered into a Collaborative Research and Development Agreement (CRADA) with the National Institute of Environmental Health Sciences (NIEHS) to develop respirable, dry powder formulations of high molecular weight hyaluronan (HMW-HA) for treating or preventing respiratory diseases. Today’s agreement follows prior research which showed that HMW-HA formulated with Thin Film Freezing yielded dry powder formulations that possess desirable aerosol performance.

Under the terms of the agreement, NIEHS and TFFP will evaluate the pharmacokinetics and therapeutic efficacy of the TFF-HMW-HA formulations using in vitro and in vivo models of select respiratory diseases, with a primary focus on chronic obstructive pulmonary disorder (COPD) and viral respiratory diseases caused by SARS-CoV-2, influenza virus, and/or respiratory syncytial virus (RSV). Other indications may also be explored such as halogen-induced acute lung injury, acute and chronic lung allograft rejection, cystic fibrosis and asthma.

“Thin Film Freezing is a technology that possesses several advantages in engineering particles for various routes of administration, including for delivering drug to the lungs, which could hold significant potential for the treatment of numerous respiratory diseases,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “Since 2020, TFF Pharmaceuticals has entered into multiple CRADAs with various U.S. government agencies that cover a broad range of applications, and today’s announcement with NIEHS is further recognition in Thin Film Freezing’s potential.”

“Delivering potentially life-saving medicine into the deep lung structures is essential towards improving clinical outcomes in respiratory disease,” said Dr. Anthony Hickey, Chief Scientific Officer of TFF Pharmaceuticals. “However, due to physical limitations, many commercialized drugs cannot sufficiently reach their intended target, leading to suboptimal efficacy. As a natural, high-viscosity mucopolysaccharide, we believe hyaluronan can be reformulated using Thin Film Freezing technology to reduce its viscosity and improve its solubility so that more drug can be delivered to the lungs.”

“As part of our commitment towards developing innovative respiratory medicines, we continually seek technologies that can aid the delivery of the medications we discover to the lungs,” said Dr. Stavros Garantziotis, Principal Investigator for the NIEHS. “Our preliminary results suggest that generation of hyaluronan powder via Thin Film Freezing has the potential to significantly improve upon current formulations of hyaluronan, which could have broad applications in the treatment of several respiratory diseases that are treatable by hyaluronan. We look forward to conducting preclinical studies to confirm our hypothesis.”

About the National Institute of Environmental Health Sciences (NIEHS): 
The NIEHS supports research to understand the effects of the environment on human health and is part of the National Institutes of Health. For more information on NIEHS or environmental health topics, visit www.niehs.nih.gov or subscribe to a news list.

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.

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