TFF Pharmaceuticals Announces Q1 Financial Results and Corporate Update

TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company specializing in innovative drug products using its Thin Film Freezing (TFF) technology, has announced its financial results for the first quarter of 2024 and shared a corporate update. The company's Tacrolimus Inhalation Powder (TFF TAC) continues to show promise in ongoing Phase 2 trials for lung transplant recipients.

Dr. Harlan Weisman, CEO of TFF Pharmaceuticals, highlighted the company's progress with TFF TAC, noting positive feedback from physicians and the submission of a detailed study plan to the FDA. The company anticipates receiving feedback from the FDA in the second quarter, which will guide the next steps in TFF TAC's clinical development. Additionally, TFF Pharmaceuticals secured $6.0 million in financing after the quarter's end, which will support the advancement of TFF TAC toward potential registrational testing. The Phase 2 study for TFF TAC is ongoing, and the company plans to present updated data later this year.

Key clinical and corporate highlights include:

1. Funding Milestones:
- On May 1, 2024, TFF Pharmaceuticals closed a $4.8 million public offering. These funds will be used for working capital and general corporate purposes. This follows a $1.2 million public offering in March 2024.

2. Positive Clinical Data:
- On April 15, 2024, the company shared additional positive data from its ongoing Phase 2 study of TFF TAC for preventing organ rejection in lung transplant recipients. Gene expression analysis showed normalization of rejection-related genes after treatment with TFF TAC. Furthermore, TFF TAC prevented rejection at a fraction of the oral tacrolimus dose with significantly lower systemic exposure.
- Four patients who completed the 12-week treatment phase opted to continue with TFF TAC in a safety extension phase.
- Professor Gregory Snell presented these findings at the ISHLT 44th Annual Meeting in Prague, Czech Republic, on April 13, 2024.

3. Conference Call and Webcast:
- On March 27, 2024, TFF Pharmaceuticals hosted a conference call to discuss new data from the ongoing Phase 2 TFF TAC study and the Phase 2 study and Expanded Access Program (EAP) of TFF Voriconazole (TFF VORI) for invasive pulmonary aspergillosis (IPA) infections. Eight patients successfully transitioned from oral Tacrolimus to TFF TAC, with no acute rejection observed. All patients completing the 12-week treatment continued with the trial's long-term extension. TFF TAC demonstrated a favorable safety profile with no mortality or significant adverse events.

- In the TFF VORI clinical programs, nine patients were enrolled, with five of six patients completing treatment showing promising efficacy and maintaining an attractive safety profile.

4. Strategic Developments:
- In March 2024, TFF Pharmaceuticals prioritized the development of TFF TAC based on positive Phase 2 study data and its potential to address unmet needs in lung transplant medicine. For TFF VORI, the company is exploring strategic alternatives, including partnerships and funding sources for continued development.

5. January 2024 Presentation:
- The company presented Phase 2 trial data for TFF VORI at the Advances Against Aspergillosis & Mucormycosis (AAAM) Conference in Milan, Italy. The data showed positive treatment outcomes and a favorable safety profile.

First Quarter 2024 Financial Highlights:

- Cash and Equivalents: As of March 31, 2024, the company reported $3.2 million in cash and equivalents. A subsequent registered direct offering on May 1, 2024, raised $4.8 million.
- R&D Expenses: For the quarter ended March 31, 2024, R&D expenses were $3.6 million, down from $4.0 million for the same period in 2023. The decrease was primarily due to lower manufacturing expenses, partially offset by higher clinical and preclinical costs.
- G&A Expenses: G&A expenses for Q1 2024 were $2.4 million, down from $3.1 million in Q1 2023, attributed to reduced compensation, market research, and insurance expenses.
- Net Loss: The net loss for Q1 2024 was $5.7 million, an improvement from a net loss of $7.1 million in Q1 2023.

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