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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 (NASDAQ: TFFP) announced approval from Health Canada to initiate a Phase 1 clinical trial for an inhaled dry powder formulation of niclosamide, targeting COVID-19 treatment. The first patient is expected to be dosed in November 2021, with complete enrollment anticipated by early Q1 2022. Preclinical studies showed a seven-fold reduction in lung viral load in hamsters post-administration of niclosamide. If successful, this trial could lead to a pivotal Phase 2/3 study in COVID-19 patients.
TFF Pharmaceuticals and Augmenta Bioworks announced the publication of positive preclinical results for their monoclonal antibody therapy, AUG-3387, aimed at treating SARS-CoV-2 infections. The study, published on bioRxiv, showed that a dry powder formulation of AUG-3387 reduced lung viral load in hamsters in a dose-dependent manner when administered after infection. Furthermore, the antibody exhibited strong binding to several SARS-CoV-2 variants, indicating potential efficacy against emerging strains. The companies plan to advance to toxicology studies and human clinical trials in 2022.
TFF Pharmaceuticals recently announced promising results from its Phase 1 clinical trial of Tacrolimus Inhalation Powder, indicating a favorable safety profile and effective therapeutic plasma concentrations at low doses. Conducted with healthy volunteers, the study showed a dose-dependent pharmacokinetic response, with mean trough blood levels reaching desired ranges for lung transplant patients. The company plans to initiate a Phase 2 study targeting lung transplant patients with kidney toxicity by the end of 2021, aiming to demonstrate the inhaled formulation's potential benefits in managing acute allograft rejection.
TFF Pharmaceuticals, a clinical-stage biopharmaceutical company focused on drug products using Thin Film Freezing technology, announced that President and CEO Glenn Mattes will present a corporate overview at the 23rd H.C. Wainwright Annual Global Investment Conference from September 13-15, 2021.
The presentation will be available on-demand starting at 7:00 a.m. ET on September 13. TFF is known for its drug candidates, including Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, and holds 58 patents related to its TFF technology.
TFF Pharmaceuticals (TFFP) reported Q2 2021 financial results with a net loss of $4.7 million, up from $3.8 million in Q2 2020. R&D expenses increased slightly to $2.8 million, while G&A expenses rose to $2.4 million. The company showcased advancements in its inhaled drug programs, particularly Inhaled Tacrolimus and Voriconazole, with pivotal trials expected in H2 2021. TFFP emphasized its partnerships, including developments with Augmenta Bioworks for a monoclonal antibody against COVID-19. The formation of a Scientific Advisory Board was also announced to aid in clinical advancement.
TFF Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that its President and CEO, Glenn Mattes, will present a corporate overview at the SNN Virtual Investor Conference from August 17-19, 2021. The presentation is scheduled for August 19 from 1:30 to 2:00 pm Eastern Time. TFF Pharmaceuticals specializes in developing innovative drug products utilizing its patented Thin Film Freezing technology, enhancing solubility and absorption of poorly water-soluble drugs. The company is known for its lead candidates, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder.
AUSTIN, Texas, Aug. 5, 2021 – TFF Pharmaceuticals (NASDAQ: TFFP) announced that President and CEO Glenn Mattes will present a corporate overview at the Investor Summit Virtual Conference on August 18, from 2:45 to 3:15 PM Eastern Time. The management team will be available for one-on-one meetings throughout the conference. TFF Pharmaceuticals focuses on innovative drug products utilizing its patented Thin Film Freezing (TFF) technology, aimed at enhancing the solubility and absorption of poorly water-soluble drugs, particularly for inhalation delivery to the deep lung, with high deposition potential.
TFF Pharmaceuticals (NASDAQ: TFFP) will release its Q2 2021 financial results on August 12, 2021, at market close. A conference call will follow at 4:30 PM EDT to discuss the results and recent corporate developments. The call can be accessed via domestic and international dial-in numbers, and also on the company's website. TFF's Thin Film Freezing technology aims to enhance drug delivery in respiratory medicine by improving the solubility of poorly water-soluble drugs.
TFF Pharmaceuticals announced that AUG-3387, its lead anti-COVID-19 monoclonal antibody, effectively neutralizes the SARS-CoV-2 Delta variant in recent in vitro assays. The Delta variant represents 83% of new cases in the U.S., underscoring the therapy's potential impact. The company has partnered with Catalent for manufacturing, with promising early batch results indicating rapid scale-up. TFF aims to develop AUG-3387 as an inhaled therapy for high-risk individuals. Ongoing formulation studies will assess delivery efficiency through approved inhaler devices.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) announced that President and CEO Glenn Mattes will participate in a fireside chat and one-on-one meetings at the BTIG Virtual Biotechnology Conference on August 9, 2021, at 2:00pm EST. The company focuses on developing innovative drug products using its patented Thin Film Freezing (TFF) technology platform, which enhances the solubility and absorption of poorly water-soluble drugs. TFF Pharmaceuticals has two lead candidates: Voriconazole Inhalation Powder and Tac-Lac Inhalation Powder, backed by 42 patents.
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