TFF Pharmaceuticals, Inc.

Cash and cash equivalents were $9.7 million at September 30, 2023, reflecting gross proceeds of $5.7 million from the August 17 financing. The company said that financing extends its runway into the second quarter of 2024. Third-quarter 2023 research and development expense was $2.4 million versus $4.0 million in the same period of 2022, down $1.6 million year over year due mainly to lower clinical and manufacturing costs. General and administrative expense was $2.3 million versus $3.3 million a year ago, down $1.0 million year over year, and net loss was $4.4 million versus $7.3 million. The company did not provide quarterly revenue or EPS, and no formal next-quarter or full-year financial guidance was given beyond the cash runway into Q2 2024.

Harlan Weisman framed the quarter around upcoming clinical data readouts, saying the company still expects initial Phase 2 data for both programs by year end and views those results as a potential major catalyst. He emphasized that the business is focused on managing expenses, deploying capital carefully, and preparing for possible Phase 3 development if the data are positive. He also highlighted the proxy proposals to increase authorized shares and authorize a reverse split if needed, saying both could support future fundraising and Nasdaq compliance.

Kirk Coleman said the company is tightly managing capital, with cash and cash equivalents of $9.7 million at September 30, 2023 after receiving gross proceeds of $5.7 million from the August financing. He said the current runway is expected to fund operations into Q2 2024. On expenses, R&D fell to $2.4 million from $4.0 million year over year, and G&A fell to $2.3 million from $3.3 million, with the lower spend tied to reduced clinical/manufacturing activity and lower professional, patent, insurance, consulting, market research, payroll, and related costs. Net loss improved to $4.4 million from $7.3 million.

Analysts focused on enrollment pace, the expected size of Phase 3, what data would be needed for an FDA meeting, and what safety/efficacy bar the agency may expect. Management said VORI enrollment has improved significantly, with 95% of sites active and 90% prescreening, and that roughly 10 patients should be informative enough to support a Phase 3 discussion with the FDA because the drugs are well known and the diseases are rare. On safety, management said they will watch for known voriconazole toxicities such as hepatic toxicity, visual disturbances, and rash, plus inhalation-related risks like bronchospasm or coughing. They also said the year-end VORI release will be a subset of patients with varying treatment durations, while Q1 2024 should bring a more complete dataset; for TAC, they similarly expect a subset at year end and more complete data by Q1 2024.