TFF Pharmaceuticals Receives Notice of Allowance for New Foundational Patent Broadly Covering Novel Inhaled Dry Powder Drug Delivery Platform

AUSTIN, Texas, July 11, 2018 /PRNewswire/ -- TFF Pharmaceuticals, Inc., an early-stage biopharmaceutical company focused on developing and commercializing innovative drug products for the treatment of lung diseases and conditions, announced today the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 12/778,795, "Compositions and Methods of Making Brittle-Matrix Particles Through Blister Pack Freezing." The patent application concerns TFF Pharmaceuticals' novel delivery method for advanced performance dry powder drugs to be used in the treatment of pulmonary diseases and conditions, such as lung transplant recovery, severe asthma, COPD, and pulmonary infections. The patent is expected to provide protection to at least 2033.

Glenn Mattes, CEO of TFF Pharmaceuticals, said, "We are pleased to receive this key patent approval which secures the protection of our novel drug delivery system for years and will mean a significant competitive advantage. It is an important milestone in moving forward with commercializing a suite of drug products in development. The patent represents further validation of our proprietary Thin Film Freezing technology. It expands our already extensive intellectual property portfolio of more than 30 patents. This is another progress step toward providing safer and more effective dry powder inhalation drug delivery options to benefit the global health community."

TFF Pharmaceuticals Dry Powder Delivery Platform

Although intended for the lungs, many drugs are not given via the airway because drug properties make it too difficult to formulate for direct to lung delivery. Given systemically, these drugs often produce unwanted and potentially life-threatening side effects. To get around this companies have tried to use microcapsules, carriers, and other agents to try to dose drugs direct to the lungs, but these other delivery agents often produce their own problems.

Using its proprietary technology, TFF can generate dry powder inhaler versions of these drugs and approved lung friendly ingredients. This means that drugs of all types – small molecules, biologics, even combinations – can be dosed direct to the lungs with few, if any, side effects. The Company has generated numerous formulations of dry powder delivery to the lungs to develop and commercialize.

TFF Pharmaceuticals' patent portfolio includes licensed Thin Film Freezing drug delivery technology from The University of Texas at Austin, developed by Robert O. (Bill) Williams III, Ph.D. and his research team. Dr. Williams is Professor and Division Head of the College of Pharmacy's Molecular Pharmaceutics and Drug Delivery Division. He received the 2017 Inventor of the Year award from the university's Office of Technology Commercialization.

Dr. Williams said, "The new patent is a foundational patent for TFF Pharmaceutical's novel delivery system of dry powder drugs for inhalation of both biologic and small molecule drugs, allowing multiple opportunities to develop advanced drug products in a way not currently available. The patent complements and extends the Company's IP. It will enable TFF to leverage broad applications of the innovative technology for commercialization, providing alleviation of suffering and improved therapeutic outcomes for patients with serious lung diseases and conditions."

For more information, visit TFF Pharmaceuticals.

About TFF Pharmaceuticals, Inc.

TFF Pharmaceuticals, Inc. is an early-stage biopharmaceutical company focused on the development and commercialization of new inhalation products for the treatment of chronic respiratory diseases and lung conditions. In early testing the Thin Film Freezing (TFF) proprietary platform significantly improved the solubility of drugs that have poor water solubility.

The Company has generated numerous formulations for dry powder delivery to the lungs. The initial focus is on dry powder drugs for inhalation of both biologic and small molecule drugs that currently cannot be formulated for dry powder delivery by other means. TFF Pharmaceuticals expects that these dry powder formulations, which can be delivered directly to the lungs via inhaler, will avoid certain negative side effects that come from delivering these drugs systematically. For more information, visit https://www.tffpharma.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of any such securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Forward-Looking Statements:

Any statements in this release that are not historical facts may be considered "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding TFF's expected use of the proceeds from its Series A financing round; the market opportunity for TFF's product candidates; and the business strategies and development plans of TFF. Some of the potential risks and uncertainties that could cause actual results to differ significantly from those predicted include TFF's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, TFF does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

Media Contact: Sandra Oak, Nsight Public Relations, 321-591-1508, [email protected]

TFF Pharmaceuticals, Inc. Company Contact: Glenn Mattes, Chief Executive Officer, TFF Pharmaceuticals, 215-880-2632, [email protected]

TFF Pharmaceuticals Investor Contact:  Robert Mills, Chairman of the Board, TFF Pharmaceuticals, 860-488-8227, [email protected]

SOURCE TFF Pharmaceuticals