FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, announced significant advancements in its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC), aimed at preventing lung transplant rejection. The company reported an accelerated patient enrollment with 10 patients now participating in the study.
The trial's update highlighted that all six patients who completed the initial 12-week treatment opted to continue therapy in the safety extension phase, with one patient being treated for over a year and three others for more than six months. This continuation suggests a favorable response to the treatment.
Initial pharmacokinetic (PK) data from the first cohort of patients indicates that TFF TAC has led to reduced variability in systemic exposure to tacrolimus. This consistency may lower the risk of acute rejection and systemic toxicities, such as chronic kidney disease, compared to the oral administration of the drug.
Patients have provided anecdotal evidence of experiencing fewer headaches, overall wellness improvements, and ease of use with the TFF TAC inhalation device, which requires no priming or spacer.
Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, expressed optimism about the trial's progress, citing positive physician feedback and emerging data as drivers for the accelerated enrollment. Dr. Zamaneh Mikhak, Chief Medical Officer, added that the targeted delivery of TFF TAC could potentially reduce incidence of acute rejection and kidney toxicity.
TFF Pharmaceuticals utilizes its proprietary Thin Film Freezing (TFF) technology to create dry powder formulations for various routes of administration. The technology aims to improve bioavailability, onset of action, and safety and is capable of delivering up to 75% of a dose directly to the lungs.
This update is based on a press release statement from TFF Pharmaceuticals.
InvestingPro Insights
As TFF Pharmaceuticals (NASDAQ:TFFP) progresses with its Phase 2 trial for TFF TAC, investors and stakeholders are closely monitoring the company's financial health and stock performance. According to recent data from InvestingPro, TFF Pharmaceuticals holds a market capitalization of $5.76 million USD and has experienced a notable revenue growth of 48.02% in the last twelve months as of Q4 2023. Despite this growth, the company's gross profit margin stands at an alarming -1531.39%, reflecting significant costs outweighing revenues.
An important metric for investors is the company's stock price performance over time. TFFP has seen a substantial price decline, with a 1-year price total return of -89.0%, and the stock is currently trading at approximately 10.96% of its 52-week high. This downward trend is also reflected in the short-term with a 1-month price total return of -47.16%. These figures may raise concerns about the company's current valuation and future prospects.
InvestingPro Tips for TFF Pharmaceuticals suggest that the stock is in oversold territory, which could indicate a potential rebound opportunity for investors who believe in the company's fundamentals and long-term strategy. Additionally, the company holds more cash than debt on its balance sheet, which could provide some financial flexibility in the near term. It's worth noting that TFFP does not pay a dividend to shareholders, which may influence the investment decisions of those seeking regular income.
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