TFF Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update
Company remains on track to report initial data from TFF VORI and TFF TAC Phase 2 trials by the end of 2023
Conference call and webcast, today Tuesday November 14, 2023, at 4:30 pm ET to provide overview of expected data readouts from ongoing Phase 2 studies
FORT WORTH, Texas, Nov. 14, 2023 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the third quarter of 2023 and provided a corporate update.
“Based on the considerable progress that we have achieved over the last several months, we continue to expect initial data from our ongoing Phase 2 trials of TFF VORI and TFF TAC by year-end,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “TFF VORI and TFF TAC have been designed to address the significant unmet need in two rare disease indications, each with high mortality rates in patient populations with very few treatment alternatives. We therefore expect these initial Phase 2 data will provide meaningful clinical insights on each drug’s safety, tolerability and efficacy to help guide our Phase 3 development strategy as we enter into 2024.”
Recent Clinical and Corporate Highlights:
For the quarter ended September 30, 2023, compared to quarter ended September 30, 2022
Conference Call and Webcast Information
The Company will host a conference call today, Tuesday, November 14, 2023, at 4:30 PM Eastern Time, to discuss third quarter 2023 financial results and the corporate update. To participate in the conference call, please utilize the following information:
Domestic Dial-In Number: Toll-Free: 1-888-886-7786
The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1637201&tp_key=3b92c57ca8
The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
SAFE HARBOR This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including, plans for releasing initial clinical data by the end of 2023, the adequacy of the Company’s cash runway to meet its near-term funding needs, and the benefits of the Company’s TFF platform. 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 release initial clinical data for TFF VORI and TFF TAC by the end of 2023 or, if it is able to do so, that such clinical data will be positive, (ii) the risk that the Company’s working capital after giving effect to the recently announced public offering will not be sufficient to fund the Company’s working capital requirements through Q1 2024, (iii) 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, (iv) the risk that the Company may not be able to successfully conclude clinical testing of its TFF VORI or TFF TAC or obtain pre-market approval of any of its dry powder product candidates, (v) 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, (vi) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (viii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (ix) 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 November 14, 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, except as required by law.
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