TFF Pharmaceuticals and Catalent Announce New Inhalation Dry Powder Development and Manufacturing Agreement

AUSTIN, Texas & SOMERSET, N.J. – March 1, 2022 — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) and Catalent today announced their collaboration agreement focused on the generation, testing and manufacture of dry powder formulations for a range of biotherapeutics through the application of TFF Pharmaceuticals’ patented Thin Film Freezing (TFF) technology. Under the agreement, Catalent will provide its scale-up expertise and manufacturing capabilities to TFF Pharmaceuticals as its preferred development and manufacturing partner, and Catalent will be able to offer its customers access to the innovative TFF technology, which has the potential to increase the adoption of the pulmonary route for the systemic delivery of biotherapeutics.

“Catalent is widely known as a global leader in enabling pharmaceutical development and manufacturing and has distinguished itself by demonstrating cutting-edge expertise across multiple modalities and innovative projects. We are therefore delighted to significantly expand our collaboration with the Catalent team,” stated Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. “This strategic collaboration significantly expands our access to manufacturing capabilities and provides scalability for our technology, while simultaneously affording us the opportunity to build our portfolio of technology licensing partnerships.”

Jonathan Arnold, President, Oral and Specialty Delivery at Catalent added, “Catalent is pleased to leverage its extensive expertise in the development and CGMP manufacture of dry powders in order to potentially bring TFF Pharmaceuticals’ unique and differentiated technology to scale.”

Thin Film Freezing may potentially be used to generate dry powder formulations for inhalation, and it complements Catalent’s existing capabilities in spray drying for the development of inhalable drugs established by its 2021 acquisition of the manufacturing and packaging operations of Acorda Therapeutics in Boston, Massachusetts.

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CONTACTS

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Catalent

About TFF Pharmaceuticals’ Thin Film Freezing (TFF) 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: Inhaled Voriconazole Powder and Inhaled Tacrolimus Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by over 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.

ABOUT CATALENT

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 18,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.

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Safe Harbor

This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the expectations for its collaboration and referral arrangement with Catalent, 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 achieve the favorable results expected from its collaboration and referral agreement with Catalent, (ii) 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, (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 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.