TFF Pharmaceuticals, Inc. (TFFP)·Q3 2023 Earnings Summary

Executive Summary

• TFF Pharmaceuticals reported Q3 2023 grant revenue of $0.23M, net loss of $4.41M, and diluted EPS of -$0.09, reflecting a materially lower operating loss versus Q3 2022 as R&D and G&A fell year over year . Management reaffirmed cash and equivalents of $9.7M and runway into Q2 2024 following an August $5.7M equity financing .
• Clinical catalysts were emphasized: initial Phase II data for TFF VORI (voriconazole inhalation powder) and TFF TAC (tacrolimus inhalation powder) expected by year-end 2023, with more complete datasets by end of Q1 2024, directly framing near-term stock reaction risk/reward .
• Operational execution improved: 95% of VORI sites active and 90% prescreening; trial randomization amended to 3:1 to increase patient access to VORI; EAP launched in July across multiple geographies to broaden access and collect real‑world data .
• Corporate items with potential market impact: planned shareholder votes to increase authorized shares and to enable a reverse stock split if needed (NASDQ compliance/funding flexibility) .
• Wall Street consensus via S&P Global was unavailable for TFFP in this period; therefore, estimate comparisons are not provided (we attempted retrieval but mapping was missing in SPGI/CIQ).

What Went Well and What Went Wrong

What Went Well

• Clinical milestones on track: “continue to expect initial clinical data from our ongoing Phase 2 trials of TFF VORI and TFF TAC by year-end,” and more complete datasets by end of Q1 2024 .
• Site activation and screening momentum: 95% of VORI trial sites active; 90% prescreening; enrollment rate “increased very significantly” after protocol amendment (3:1 randomization) and broadened eligibility .
• Cost discipline and runway: R&D fell to $2.4M and G&A to $2.3M, lowering net loss to $4.4M; $5.7M August equity financing extended runway into Q2 2024 .

What Went Wrong

• Enrollment challenges in a severe rare disease: many IPA candidates end in hospice/palliative care or fail strict diagnostic criteria; eligibility broadened to address real-world diagnosis but underscores enrollment fragility .
• Small sample size dependency: Phase II go/no-go decisions targeted at ~10 patients per program, raising sensitivity to individual patient outcomes and timing of complete data into Q1 2024 .
• Funding constraints necessitate prioritization and corporate actions: management highlighted need for future fundraising and shareholder votes to increase authorized shares and allow a reverse split if necessary .

Financial Results

Income Statement and EPS (Quarterly)

Notes:

• For Q2 2023, CFO disclosed R&D, G&A, net loss; EPS and grant revenue were not available in the documents read with the tool. Additional SEC exhibit exists; we refrain from using non-tool sources for EPS.
• All data reflect GAAP.

Year-over-Year Comparisons (Q3 2023 vs Q3 2022)

Cash Position and Runway

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We continue to expect initial clinical data from our ongoing Phase 2 trials of TFF VORI and TFF TAC by year-end.” (CEO Harlan Weisman) .
• “We define success [VORI] as an overall decrease in toxicities…a decrease in drug-drug interactions… and evidence of mycologic, clinical and/or radiologic response after 12 or 13 weeks of treatment…in the majority of patients.” (CMO Zamaneh Mikhak) .
• “We define success [TAC] as the ability to transition patients from oral tacrolimus to TFF TAC, achieve tacrolimus blood levels… approximately 2/3 to 1/2 of… oral tacrolimus… prevent rejection at these diminished blood levels, while stabilizing kidney function.” (CMO Zamaneh Mikhak) .
• “In August, we closed a $5.7 million equity financing… extending our runway into the second quarter of 2024.” (CEO Harlan Weisman) .
• “95% of our sites active…90% actively prescreening…enrollment rate has increased very significantly.” (CMO Zamaneh Mikhak) .

Q&A Highlights

• Enrollment trajectory: Active sites and prescreening rates materially improved; expectation reaffirmed to present initial data by year-end and complete datasets by end Q1 2024 .
• Sample size sufficiency: ~10 patients targeted for Phase III go/no-go and FDA discussion given well-characterized molecules and rare indications for both VORI and TAC .
• Safety focus (VORI): Comparative tracking of hepatic toxicity, visual disturbances, rashes; inhaled-related events monitored (bronchospasm, cough), with plans to report directionally informative data at year-end .
• EAP utility: Systematic data collection with Durbin to add real-world evidence to the package; broadens indications beyond IPA, aiding future design .
• Capital prioritization: If constrained, data will guide prioritization between programs; board initiatives (authorized shares, reverse split) to maintain NASDAQ compliance and fundraising flexibility .

Estimates Context

• We attempted to retrieve Wall Street consensus (EPS and revenue) via S&P Global but the CIQ mapping for TFFP was unavailable at the time of query; therefore, consensus and estimate comparisons are not provided for Q3 2023, Q2 2023, or Q1 2023 (Values retrieved from S&P Global)*.

Key Takeaways for Investors

• Near-term catalysts: Initial Phase II readouts by year-end for both VORI and TAC, with fuller datasets by end Q1 2024; strong potential to re-rate on clinical validation amid reduced development risk (known molecules) .
• Execution momentum: Site activation/prescreening improvements and EAP launch broaden data sources and improve probability of timely readouts .
• Financial discipline: YoY operating expense reductions lowered net loss; August financing extends runway into Q2 2024, enabling data delivery and FDA engagement .
• Corporate flexibility: Share authorization increase and reverse split authority provide levers for future financing and NASDAQ compliance, an important consideration ahead of pivotal development steps .
• Program prioritization risk: Small sample sizes (~10 patients) driving go/no-go decisions amplify outcome sensitivity; TAC’s clinical profile and market need could attract prioritization if capital is tight .
• Trial population realities: IPA severity and strict criteria challenge enrollment; broadened eligibility and 3:1 randomization aim to mitigate, but timelines remain sensitive to operational execution .
• Strategy for data packaging: EAP data adds breadth beyond the randomized study, potentially strengthening regulatory discussions and informing Phase III design .

Appendix: Source Documents Read

• Q3 2023 Earnings Call Transcript (full) .
• Q3 2023 8-K with Item 2.02 and Exhibit 99.1 press release (full), including financial statements .
• Q2 2023 Earnings Call Transcript (full) – and duplicate transcript –.
• Q1 2023 8-K with Item 2.02 and Exhibit 99.1 press release (full) –.
• Other relevant press releases in Q3 2023: VORI Expanded Access Program (July 31, 2023) .
• Q2 2023 press release reference (SEC) .