AUSTIN, Texas–(BUSINESS WIRE)–TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), 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 U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection.

Tacrolimus Inhalation Powder is an inhaled dry powder version of tacrolimus, an immunosuppressive drug used in solid organ transplants. Prograf^® (Tacrolimus oral or IV) is currently the second most commonly administered immunosuppressive agent in solid organ transplantation despite what the Company believes to be the many challenges for patients and physicians when used for extended periods. Prograf^®, when delivered orally or intravenously, has been shown to have numerous serious side effects including nephrotoxicity, particularly when used in high doses. The Company intends to begin Single Ascending Dose Phase I studies in Tacrolimus Inhalation Powder later this month in Australia, with Multiple Ascending Dose studies beginning in Q3-2020.

“The FDA’s orphan drug designation is an important milestone in our development plan for Tacrolimus Inhalation Powder for the prevention of rejection of solid organ transplants,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “We believe that our dry powder version of tacrolimus can provide for greater local lung concentrations that provide enhanced lung transplant rejection without the typical systemic toxicity frequently experienced with oral dosage form immunosuppressants, and be an important treatment option for lung transplant patients.”

About Orphan Drug Designation

Orphan drug designation is granted by the U.S. FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product will be entitled to orphan drug exclusivity.

About TFF Pharmaceuticals’ Thin Film Freezing technology platform

TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology. allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals

TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 41 patents issued or pending in the US 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 its dry powder versions of Voriconazole and Tacrolimus and the Company’s plans to add to its existing pipeline of product candidates and license its technology to PLUS Products and third-parties. 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) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (ii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iii) the risk that the Company will not be able to conclude a long-term commercial agreement with PLUS Products or any other third-party, (iv) the legal and regulatory risks associated with cannabis-based products and (v) those other risks disclosed in the section “Risk Factors” included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.