TFF Pharmaceuticals Q1 2024 Financial Results and Corporate Update

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in innovative drug products based on its patented Thin Film Freezing (TFF) technology, recently announced its financial results for the first quarter of 2024 and provided an important corporate update. The company continues to make strides in developing Tacrolimus Inhalation Powder (TFF TAC) as a potential breakthrough in immunosuppressive therapy for lung transplant recipients.

According to Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals, the company has made significant progress with TFF TAC, receiving positive feedback from physicians at the International Society for Heart and Lung Transplantation (ISHLT) meeting. Subsequently, TFF Pharmaceuticals submitted a comprehensive briefing book with their proposed study plan to the FDA, and they anticipate receiving feedback by the end of this quarter. Additionally, the company has secured $6 million in funding, which will support the advancement of TFF TAC towards potentially registrational testing.

Recent clinical highlights include the successful completion of a $4.8 million public offering on May 1, 2024. The proceeds will be used for working capital and general corporate purposes. Additionally, on April 15, 2024, TFF Pharmaceuticals announced positive data from its ongoing Phase 2 study of TFF TAC, which is being evaluated for its efficacy in preventing organ rejection in lung transplant recipients. New gene expression analysis demonstrated normalization of rejection-related genes post-treatment with TFF TAC. Moreover, TFF TAC was found to prevent rejection at a significantly lower dose compared to oral tacrolimus.

Professor Gregory Snell, the lead Principal Investigator of the Phase 2 study, presented these findings at the ISHLT 44th Annual Meeting in Prague, Czech Republic. Notably, all patients who completed the 12-week treatment period opted to continue using TFF TAC in the safety extension phase. This high level of patient retention underscores the drug’s potential benefits and tolerability.

On March 27, 2024, the company hosted a conference call and webcast to present new data from the TFF TAC study and the Expanded Access Program (EAP) for TFF Voriconazole (TFF VORI), which is aimed at treating invasive pulmonary aspergillosis (IPA) infections. The data showed that all eight patients successfully transitioned from oral Tacrolimus to TFF TAC without any evidence of acute rejection. The nine patients enrolled in the TFF VORI program also showed promising results, with five of six patients achieving a positive clinical and mycologic response. Furthermore, TFF VORI demonstrated an attractive safety profile with no IPA-related or all-cause mortality.

In light of these positive results, TFF Pharmaceuticals has prioritized the development of TFF TAC, recognizing its potential to meet a significant unmet need in lung transplant medicine. The company is also exploring strategic alternatives for TFF VORI, including partnerships and government funding to support its continued development.

Financially, the company reported a decrease in research and development (R&D) expenses to $3.6 million for the quarter ended March 31, 2024, down from $4.0 million in the same period the previous year. The reduction was primarily due to decreased manufacturing and related expenses. General and administrative (G&A) expenses also decreased to $2.4 million, compared to $3.1 million in the previous year. The net loss for the quarter was $5.7 million, down from $7.1 million in the previous year.

As of March 31, 2024, TFF Pharmaceuticals had cash and cash equivalents totaling approximately $3.2 million. Following the $4.8 million public offering on May 1, 2024, the company is well-positioned to continue its clinical programs and advance its pipeline of innovative therapies.

TFF Pharmaceuticals’ TFF technology enables the transformation of various compounds into dry powder formulations that are advantageous for inhalation and other routes of administration. This technology aims to improve bioavailability, onset of action, and safety, making therapeutics and vaccines more accessible globally. The company’s lead drug candidates, TFF TAC and TFF VORI, are at the forefront of their efforts to revolutionize healthcare with their Thin Film Freezing platform.