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TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative drug products utilizing their patented Thin Film Freezing (TFF) technology. This groundbreaking technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations. The TFF platform provides numerous advantages, including high absorption and yield, uniform particle size, and a gentle process that preserves the integrity of complex therapeutic components.
Core Business and Products
TFF Pharmaceuticals has two lead drug candidates currently under clinical evaluation: Voriconazole Inhalation Powder (TFF VORI) and Tacrolimus Inhalation Powder (TFF TAC). These inhaled dry powder drugs are designed to treat lung disorders and organ transplant rejection, respectively.
Recent Achievements and Projects
Recently, TFF Pharmaceuticals announced positive data from their ongoing Phase 2 study of TFF TAC, which is being developed to prevent organ rejection in lung transplant recipients. The study indicates that TFF TAC provides sufficient immunosuppression to prevent rejection at significantly reduced doses compared to oral tacrolimus, potentially reducing the risk of kidney toxicity.
Financial Condition and Partnerships
As of the first quarter of 2024, TFF Pharmaceuticals has secured additional financing to continue advancing their TFF TAC program toward registrational testing. The company is actively collaborating with large pharmaceutical companies, academic institutions, and government partners to expand their pipeline and revolutionize healthcare globally.
Technology and Patents
The TFF technology platform is protected by over 170 patents issued or pending in the U.S. and internationally. This versatile platform can convert vaccines, small and large molecules, and biologics into elegant dry powders, making them ideal for inhalation or topical delivery.
The company’s proprietary TFF process allows for the direct delivery of therapies to target organs such as the lungs, which can improve bioavailability, reduce dosages, and minimize side effects. Laboratory data suggest that the aerodynamic properties of TFF powders can deliver as much as 75% of the dose to the deep lung.
Conclusion
TFF Pharmaceuticals is at the forefront of transforming biopharmaceutical delivery methods with its innovative TFF technology. By developing dry powder formulations that offer enhanced efficacy, safety, and stability, the company is poised to make significant impacts in the treatment of lung disorders and beyond.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) will release its fourth quarter 2021 financial results and business update on March 24, 2022, following the close of U.S. markets. A conference call is scheduled for the same day at 4:30 PM ET, where management will discuss financial results and recent corporate developments. Investors can join via a toll-free number or webcast, with a question-and-answer session following the presentation. The company focuses on innovative drug products using its patented Thin Film Freezing technology, enhancing the delivery of poorly water-soluble drugs.
TFF Pharmaceuticals (NASDAQ: TFFP) has announced a collaboration with Catalent to enhance the scalability and manufacturing of its proprietary Thin Film Freezing (TFF) technology. This agreement aims to develop dry powder formulations for biotherapeutics, particularly focusing on inhaled delivery systems. Catalent will utilize its expertise in dry powder development to support TFFP's technology, potentially increasing the adoption of pulmonary drug delivery. This partnership is expected to expand TFFP’s manufacturing capabilities and open opportunities for technology licensing.
TFF Pharmaceuticals (NASDAQ: TFFP) announced promising results from its inhaled niclosamide product against COVID-19 variants, Delta and Omicron. The in vitro assays revealed complete viral replication inhibition at concentrations as low as 1μM, outperforming other treatments like nirmatrelvir. A Phase 1 trial showed the 6 mg dosage is well tolerated, producing effective concentrations in lung fluid. The company anticipates delivering safety and pharmacokinetic data by the end of Q1 2022, enhancing confidence in niclosamide's therapeutic potential against COVID-19 in vulnerable populations.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) announced the completion of enrollment in its Phase 1 clinical trial of a dry powder formulation of niclosamide, aimed at treating COVID-19 and respiratory viral diseases. The trial included 40 healthy subjects, with safety results expected by the end of Q1 2022. The Safety Management Committee has recommended a 12 mg daily dose for Phase 2 testing. Niclosamide has shown potential against SARS-CoV-2 variants, with a previous study reporting a seven-fold reduction in viral load in treated models. UNION Therapeutics holds an option for exclusive licensing of the formulation.
TFF Pharmaceuticals (TFFP) has announced the full readout of safety and pharmacokinetic data from its Phase 1b study of Inhaled Voriconazole Powder (TFF VORI) in asthma patients. The study shows TFF VORI is well tolerated, with no differences in drug absorption between asthma and healthy patients. The company plans to advance to Phase 2 trials in 2022, potentially expanding the treatment to Allergic Bronchopulmonary Aspergillosis. TFF Pharmaceuticals aims to improve efficacy and safety of IPA treatment through direct lung delivery, enhancing patient outcomes.
TFF Pharmaceuticals (NASDAQ: TFFP) reported substantial progress in its clinical and corporate developments during Q3 2021, with significant advancements in its Inhaled Voriconazole and Tacrolimus programs, which are set to enter Phase 2 trials by year-end. The company also noted positive outcomes in its partnerships for antiviral programs, particularly AUG-3387 and niclosamide, with the latter's Phase 1 trial recently initiated. Financially, TFFP reported a net loss of $8.7 million, up from $5.1 million in Q3 2020, with R&D expenses increasing to $6.3 million from $2.8 million, reflecting ongoing investments in their drug development pipeline.
TFF Pharmaceuticals, Inc. announced positive results from its Phase 1b clinical trial for Voriconazole Inhalation Powder (TFF VORI), designed for the treatment of Invasive Pulmonary Aspergillosis (IPA) in asthma patients. The data indicates that TFF VORI is well tolerated, supporting the move to Phase 2 trials which may include patients with hyperreactive airway diseases. This development could also open avenues for treating Allergic Bronchopulmonary Aspergillosis (ABPA). The innovative TFF platform enhances drug delivery directly to the lungs, potentially improving efficacy and safety.
AUSTIN, Texas, Nov. 08, 2021 - TFF Pharmaceuticals (NASDAQ: TFFP) announced that President and CEO Glenn Mattes will present a corporate overview at the 12th Annual Jefferies London Healthcare Conference from November 16-19, 2021. The presentation will be available on demand starting November 18, 2021, at 3:00 AM ET. TFF Pharmaceuticals specializes in drug products using its patented Thin Film Freezing technology, which enhances the solubility and absorption of poorly water-soluble drugs.
The replay will be accessible for 30 days post-event on the Company’s website.
TFF Pharmaceuticals (NASDAQ: TFFP) announced it will release its Q3 2021 financial results on November 15, 2021, after U.S. markets close. The company will host a conference call at 4:30 PM ET to discuss its financials and provide updates on corporate and clinical developments. The TFF platform aims to enhance the solubility of poorly water-soluble drugs for inhalation delivery, focusing on lead candidates Voriconazole and Tacrolimus. The company holds 42 patents related to its technology and seeks collaborations with major pharmaceutical partners.
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