UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On June 23, 2023, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, awarded TFF Pharmaceuticals, Inc. (“Company”) a Direct to Phase II Small Business Innovation Research (“SBIR”) grant of approximately $2.97 million to continue development of a novel, pan-flu multivariant mucosal vaccine using the Company’s Thin Film Freezing technology.
The purpose of the SBIR grant is to provide funding to support preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine, developed in the laboratory of Dr. Ted Ross at the Cleveland Clinic (previously of University of Georgia). Funding from the SBIR grant is expected to take place over three years.
SAFE HARBOR
This Form 8-K contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including, the benefits of the Company’s TFF platform and the Company’s plans to conduct preclinical and IND enabling studies to advance the development of a shelf-stable dry powder formulation of a novel universal influenza virus vaccine. 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’s preclinical and IND enabling studies of the dry powder formulation of the universal influenza vaccine may not be successful, (ii) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of the dry powder formulation of the universal influenza vaccine or any of its other dry powder product candidates, (iii) success in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not necessarily predict final results, (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023. 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.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TFF PHARMACEUTICALS, INC. | |
| Dated: June 23, 2023 | /s/ Kirk Coleman |
| Kirk Coleman, | |
| Chief Financial Officer |
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