TFF Pharmaceuticals Receives Notice of Intention to Grant European Patent for Its Thin Film Freezing Process, Providing IP Protection in Europe until 2028

AUSTIN, Texas–(BUSINESS WIRE)–TFF Pharmaceuticals, Inc., an early-stage biopharmaceutical company focused on developing and commercializing new inhalation drug products for the treatment of chronic respiratory diseases and lung conditions, today announced having received a European Patent Office (EPO) Notice of Intent to Grant Patent Application No. 08771657.7, “Formation of Stable Submicron Peptide or Protein Particles by Thin Film Freezing.” The proprietary Thin Film Freezing (TFF) process can create significant new opportunities for oral, depot, pulmonary, and transdermal drug delivery worldwide.

The new patent includes claims that the Company’s novel TFF technology can provide a simple, efficient and robust process for freezing small quantities of protein solution, or commercial quantities, that can produce high surface area stable submicron particles and micron-sized protein particles.

Glenn Mattes, CEO of TFF Pharmaceuticals, said, “We are very pleased to receive this notice regarding the first European patent for our Thin Film Freezing technology. It will substantially expand the scope of our IP protection and further strengthen the Company’s patent portfolio. We are in a strong proprietary position to develop our pipeline of unique dry powder formulations for innovative new pulmonary product solutions that address broad unmet drug delivery needs.”

Thin Film Freezing (TFF) Technology

Although intended for the lungs, many drugs are not administered via the airway because drug properties make it very 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 difficulty, 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.

Utilizing its proprietary Thin Film Freezing technology, TFF Pharmaceuticals can generate dry powder inhaler versions of these drugs using nothing but the drug itself and approved lung friendly ingredients. This means that drugs of all types – small molecules, biologics, and combinations – can be dosed direct to the lungs with few, if any, side effects.

The Company’s 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 technology, with a combination of 30 patents and applications, is licensed exclusively from the University of Texas at Austin.

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.

Contacts

Media Contact:
Nsight Public Relations
Sandra Oak, 321-591-1508
soak@nsightpr.com
or
TFF Pharmaceuticals, Inc.
Company Contact:
Glenn Mattes, 215-880-2632
Chief Executive Officer
investorinfo@tffpharma.com
or
Investor Contact:
Robert Mills, 860-488-8227
Chairman of the Board
investorinfo@tffpharma.com

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