TFF Pharmaceuticals Q2 Financial Results and Corporate Update

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company headquartered in Fort Worth, Texas, has released its financial results for the second quarter of 2024 and provided updates on its corporate activities. TFF Pharmaceuticals specializes in the development and commercialization of innovative drug products utilizing its proprietary Thin Film Freezing (TFF) technology. CEO Harlan Weisman, M.D., emphasized the company's progress, particularly in the development of TFF TAC, a promising new treatment aimed at preventing lung transplant rejection.

In the recent Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC), significant advancements have been made. Enrollment has increased, with 13 patients now participating. The trial has shown that TFF TAC at about 20% of the oral tacrolimus dose can prevent acute rejection and achieve over 80% of the oral trough blood levels, reducing systemic drug burden. All nine patients who completed the 12-week treatment have chosen to continue with the long-term extension phase.

Pharmacokinetic (PK) data from the trial indicate that TFF TAC results in reduced systemic variability compared to oral tacrolimus, potentially lowering the risk of organ rejection and systemic toxicities like chronic kidney disease. Confirmatory biomarker data also support TFF TAC's efficacy. After 12 weeks of treatment, there was a significant reduction in rejection-related gene expressions, and donor-specific antibodies (DSA) remained negative, suggesting adequate immunosuppression.

The safety profile of TFF TAC remains positive, with no reported mortality. Most adverse events were mild to moderate, with no cases of bronchospasm or wheezing, and kidney function was maintained. However, one patient who was given a low dose experienced minimal severity acute rejection but recovered after reverting to oral tacrolimus.

TFF Pharmaceuticals is finalizing the design for the next study of TFF TAC, collaborating closely with clinical investigators and regulatory authorities. Additional updates on the program, including regulatory developments, are expected later in the year.

In June 2024, TFF Pharmaceuticals engaged Outcome Capital to explore potential corporate partnerships and licensing opportunities. In May 2024, the U.S. government advanced several next-generation medical countermeasures (MCMs) using TFF technology into advanced preclinical testing. This initiative, funded by DARPA, aims to protect military and healthcare personnel from chemical and biological threats, in collaboration with Leidos.

Additionally, TFF Pharmaceuticals is working with the Cleveland Clinic to develop multivalent universal influenza vaccines. These candidates are moving into preclinical testing, following successful formulation testing with stability data on the combination of hemagglutinin (HA) antigens and various adjuvants. Three HA antigen/adjuvant vaccines have been selected for preclinical testing at Cleveland Clinic Florida.

Financially, TFF Pharmaceuticals reported cash and cash equivalents of approximately $4.4 million as of June 30, 2024. The company completed a registered direct offering on May 1, 2024, raising gross proceeds of $4.8 million.

Research and Development (R&D) expenses for the quarter ended June 30, 2024, were $2.6 million, a slight decrease from the previous year's $2.7 million. The decrease was primarily due to lower manufacturing expenses, partially offset by higher compensation-related costs. General & Administrative (G&A) expenses were $2.0 million, down from $2.7 million the previous year, due to reduced compensation and insurance expenses. The net loss for the quarter was $4.5 million, an improvement from the $5.0 million net loss in the same period in 2023.

TFF Pharmaceuticals' Thin Film Freezing technology enables the transformation of various compounds into dry powder formulations with unique properties, particularly for inhalation and other delivery methods. This technology allows for improved bioavailability, faster onset of action, and enhanced safety and efficacy by delivering therapies directly to the target organ, such as the lung. This reduces the required dose compared to oral drugs, minimizing toxicities and side effects. The company continues to leverage this technology to develop next-generation pharmaceutical products.