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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 announced the completion of enrollment in the Phase 1 clinical trial for Inhaled Tacrolimus Powder. The trial demonstrated systemic therapeutic drug levels in participants, achieving trough blood levels from 1.1 ng/mL to 14.9 ng/mL, supporting effective immunosuppression. The company anticipates reporting safety data in Q3 2021 and plans to initiate a lung transplant study in H2 2021 to further explore the drug's potential. TFF is also developing additional programs, including inhaled voriconazole and niclosamide for COVID-19.
TFF Pharmaceuticals (TFFP) and Augmenta Bioworks have developed AUG-3387, a monoclonal antibody targeting the SARS-CoV-2 virus, effective against all tested variants, including UK, South African, Indian, and Brazilian strains. This inhaled therapy aims to treat COVID-19 in high-risk patients and prevent infections. Initial in vitro tests confirm AUG-3387's neutralization capabilities. The companies plan to conduct in vivo preclinical efficacy studies and scale up manufacturing to enable human clinical trials, aiming for impactful therapeutic delivery without cold chain restrictions.
TFF Pharmaceuticals (NASDAQ: TFFP) will host a webinar on June 15, 2021, focusing on its Thin Film Freezing (TFF) technology applications, particularly TFF Tacrolimus for lung transplants and improvements to vaccines. Leading experts will present insights on the inhalation of tacrolimus and its potential over oral formulations, and TFF's role in developing vaccines for COVID-19 and influenza. The management team will also update on the pipeline and upcoming clinical data releases for TFF TAC and TFF voriconazole.
TFF Pharmaceuticals (NASDAQ: TFFP) will present a corporate overview at the Jefferies Virtual Healthcare Conference on June 1, 2021, at 11:30am EST. The company focuses on innovative drug products using its patented Thin Film Freezing technology, enhancing the solubility of poorly water-soluble drugs, which represent one-third of major pharmaceuticals. TFF Pharmaceuticals is advancing its lead candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder and aims to expand its pipeline through partnerships. A replay of the presentation will be available on their website.
TFF Pharmaceuticals (NASDAQ: TFFP) reported a net loss of $7.7 million for Q1 2021, marking an increase from $3.8 million in Q1 2020. R&D expenses rose to $5.3 million from $2.2 million, and G&A expenses increased to $2.6 million from $1.6 million. The company highlighted progress in its clinical programs, particularly for Voriconazole and Tacrolimus Inhalation Powders, with plans to initiate trials aimed at regulatory registration by year-end 2021. Notable potential sales for Tacrolimus were estimated to exceed $1 billion across multiple transplant indications.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) will release its first quarter 2021 financial results on May 13, 2021, after the U.S. markets close. A conference call will be held at 4:30 PM EDT to discuss these results and recent corporate developments. Investors can participate via a toll-free domestic number or an international dial-in. The company focuses on improving the solubility and absorption of poorly water-soluble drugs using its patented Thin Film Freezing technology platform, which aims to enhance inhalation delivery efficiency.
TFF Pharmaceuticals (NASDAQ: TFFP) has been awarded a subcontract by Leidos to contribute to the Personalized Protective Biosystems (PPB) Program, aimed at developing advanced chemical and biological protection for U.S. military personnel. Over a 60-month contract, TFF will utilize its Thin Film Freezing technology to create countermeasures for chemical and biological threats. The project will unfold in three phases, including formulation, preclinical studies, and plans for human trials. The collaboration with Leidos highlights TFF's strategic role in enhancing military safety against rising global threats.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) announced an underwritten offering of 2,855,000 shares, priced at $14.00 per share, expected to yield approximately $40 million in gross proceeds. Of this, $10 million will benefit the Selling Stockholder, Lung Therapeutics, Inc. The offering is set to close around March 30, 2021, pending customary conditions. The proceeds will support general corporate purposes and working capital. Roth Capital Partners is the sole book-running manager for this offering, made under TFF's effective shelf registration statement.
TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) reported its fourth-quarter and full-year 2020 financial results, highlighting a net loss of $18.6 million for the year, up from $11.9 million in 2019. The company saw progress in its clinical programs, with successful Phase 1 trials for Voriconazole and Tacrolimus inhalation powders. These products reached therapeutic levels without significant adverse events. Additionally, TFF secured a strategic contract with a U.S. government agency for formulating biological countermeasures, strengthening its position in the market.
NeuroRx and TFF Pharmaceuticals announced a feasibility and material transfer agreement to develop a long-term stable inhalable formulation of ZYESAMI™. This agreement involves testing ZYESAMI™, a synthetic peptide, aimed at treating COVID-19 by potentially improving lung function. The collaboration leverages TFF's thin film freezing technology to enhance aerosol delivery of the drug to patients. ZYESAMI™ has shown significant results in reducing hospital discharge times for COVID-19 patients, emphasizing its therapeutic potential for respiratory distress.
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