Press Release

TFF Pharmaceuticals Comments on Research on the Re-formulation of Remdesivir to a Dry Powder Form for COVID-19 Antiviral Treatment

July 29, 2020 at 9:33 AM EDT

Scientists at The University of Texas at Austin report on the use of Thin Film Freezing technology to deliver remdesivir through dry powder inhalation

AUSTIN, Texas--(BUSINESS WIRE)--Jul. 29, 2020-- 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 commented on the initial results of research evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing. Findings of the study conducted by a team of researchers at the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery, led by Robert O. (Bill) Williams III, the inventor of the TFF technology, was published yesterday as a preprint in bioRxiv.

The research team developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by Thin Film Freezing.

“We are very pleased to report on the efforts of Dr. Williams and his team, who in the span of less than a month and responding to the societal need caused by the global pandemic, worked tirelessly to reformulate what may be one of the most important new COVID-19 therapeutics into a form that has the potential to make treatment more potent, easier to administer and more broadly available” said Glenn Mattes, President and CEO of TFF Pharmaceuticals

“If patients can avoid a hospital visit to begin remdesivir treatment, it can lessen the current strains on our health system, lower cost and provide fewer points of contact with those who are still contagious,” Williams said. “More widely available early stage intervention methods could significantly lessen symptoms before they become potentially life-threatening, providing more hospital beds and ventilators to those who need them the most.”

“It’s important to note that remdesivir is the proprietary product of Gilead and, at this time, TFF has no agreements with Gilead concerning a collaboration built around remdesivir and our TFF platform,” continued Mattes. “And while we intend to pursue discussions with Gilead regarding the results of Dr. Williams’ formulation work, there can be no assurance that this effort would result in a collaboration between our companies. We are very encouraged and proud of the continued work done by Dr. Williams’ team as it further demonstrates the ability of our Thin Film Freezing platform to adapt to a variety of compounds that may be poorly water soluble and thus may be challenging to deliver therapeutically.”

“TFF is continuing to pursue a number of other potential opportunities and partnerships for our thin film freezing platform technology. We are, for example, evaluating biologics, oligonucleotides, small molecules, vaccines, and other therapeutics for COVID-19 and additional indications,” continued Mattes. “This also includes formulation work on repurposing niclosamide, an existing oral anthelminthic drug, as a therapeutic option to treat Covid-19.”

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 the dry powder version of remdesivir 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 engage Gilead, the owner of remdesivir, in discussions concerning a collaboration between the two companies or, if it does, that any such discussions will lead to a collaboration, (ii) the risk that the Company may be unable to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, 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.

Company:
Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973

Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358

Investor Relations and Media:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779

Source: TFF Pharmaceuticals, Inc.

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