Executive Summary

Q4 2023 was a transitional quarter: operating expenses fell materially year over year and full-year net loss improved, while grant/other revenue remained minimal and the company pivoted strategic focus to TFF TAC based on Phase 2 signals .
No formal financial guidance was provided; management highlighted cash of ~$5.5M at year-end and a March 2024 $1.2M raise, with continued evaluation of funding options and strategic alternatives for TFF VORI .
Clinical catalysts: prioritization of TFF TAC; late-breaking data at ISHLT (April) and an FDA feedback expected in Q2 2024 regarding clinical pathway; VORI placed under strategic review (partnering/government funding) .
Near-term stock catalysts center on regulatory clarity and clinical progress for TFF TAC, alongside ongoing capital raises to extend runway .

What Went Well and What Went Wrong

What Went Well

TFF TAC Phase 2 transition success: eight of eight patients moved from oral tacrolimus to TFF TAC; no acute rejection; all four patients completing 12 weeks opted into long-term extension; favorable safety (no mortality or AE-driven discontinuations) .
Cost discipline: FY23 R&D decreased 35% YoY to $12.1M and G&A fell 23% YoY to $10.6M; FY23 net loss improved by $10.6M YoY to $21.2M .
Strategic clarity: company prioritized TFF TAC for registrational path and pursued alternatives for TFF VORI; planned late-breaking TAC update at ISHLT and FDA interaction timeline improved visibility .

Management quote: “We made the decision to prioritize the clinical development of TFF TAC… and we look forward to our Late-Breaking Abstract Presentation… at ISHLT 2024” — CEO Harlan Weisman, M.D. .

What Went Wrong

Minimal revenue base persisted: Q4 grant/other revenue was $0.11M, down 63% YoY and down 51% QoQ, underscoring pre-commercial stage dynamics .
Liquidity tightened: cash fell from $9.7M at Q3 end to ~$5.5M at year-end, necessitating March 2024 financing; balance sheet equity declined YoY to $9.6M .
VORI remains non-core in near term: strategic alternatives sought rather than immediate registrational trajectory, reflecting resource constraints and prioritization .

Financial Results

Metric	Q4 2022	Q3 2023	Q4 2023
Revenue ($USD)	$312,780	$234,763	$114,328
R&D ($USD)	$4,136,047	$2,386,707	$2,974,158
G&A ($USD)	$3,557,512	$2,268,656	$2,508,876
Total Operating Expenses ($USD)	$7,693,559	$4,655,363	$5,483,034
Net Loss ($USD)	$(7,373,234)	$(4,409,244)	$(4,762,414)
EPS (Basic & Diluted, $)	$(6.13)	$(0.09)	$(2.01)
Weighted Avg Shares (Basic & Diluted)	1,202,743	47,441,693	2,365,848

Notes:

The large EPS swing vs Q3 reflects share count dynamics between periods (reverse split/authorizations discussed in prior calls), not operational volatility .

Liquidity and Balance Sheet snapshots:

Metric	Sep 30, 2023	Dec 31, 2023	Mar 31, 2024
Cash & Equivalents ($USD)	$9,725,755	$5,478,113	$3,211,930
Total Assets ($USD)	$14,885,171	$12,027,316	$9,186,550
Stockholders’ Equity ($USD)	$13,690,929	$9,567,034	$5,304,424

Operational KPIs (clinical programs):

KPI	Q4 2023 Update	Subsequent Events (Q1/Q2 2024 context)
TFF TAC Phase 2 transition success	8/8 patients transitioned; 0 acute rejection; 4/4 completed opted for extension; favorable safety	ISHLT late-breaking TAC data; gene expression normalization, prevention of rejection at ~1/6 oral dose with ~2/3 systemic trough exposure
TFF VORI Phase 2/EAP status	9 total patients across Phase 2 and EAP; 5/6 completing showed clinical and mycologic response; favorable safety and no IPA/all-cause mortality	Continued positive efficacy/safety profile noted; strategic alternatives (partnering, collaborations, government funding) pursued

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial guidance (revenue/EPS/margins)	FY/Q4 2023	None provided	None provided	Maintained (no guidance)
Program priority	2024 TAC program	Dual focus on TAC/VORI	Prioritized TFF TAC; VORI under strategic alternatives	Raised priority for TAC
Regulatory next steps (TAC)	Q2 2024	Not specified	FDA feedback expected in Q2 2024 on clinical plan; path to registrational testing	New timing clarity
Capital	Mar–May 2024	N/A	$1.2M raise (Mar 22); $4.8M offering (May 1)	Raised

Earnings Call Themes & Trends

Topic	Q2 2023 Mentions	Q3 2023 Mentions	Current Period (Q4 2023 press release)	Trend
R&D execution/enrollment	Ramp-up of sites; EAP launch; modest early enrollment; ~10 patients targeted for go/no-go decisions	95% sites active; enrollment rate improved; aiming for initial data by year-end; ~10 patients sufficient	TAC data positive; VORI shows responses; TAC prioritized for registrational path	Improving execution; focus sharpened
Regulatory interactions	Plan to engage FDA/EMA post initial data; ~10 pts sufficient to meet with FDA	Reiterate plan to use ~10 pts for FDA interaction	Expect FDA TAC feedback in Q2 2024	Timelines firmed
Safety/tolerability profile	Expect lower systemic toxicities vs oral therapies; early signals encouraging	Track AEs vs historical oral voriconazole/tacrolimus profiles	Favorable safety (no mortality/AE discontinuations; rejection prevented)	Consistent positive safety signals
Capital runway	Cash ~$7.7M; burn ~$4M/qtr; runway through Q1’24	Cash ~$9.7M; runway into Q2’24	YE cash ~$5.5M; $1.2M raise March; additional raises in May	Ongoing financing required
Strategic focus	Advance TAC/VORI; evaluate pipeline; non-dilutive gov’t collaborations	Preparing for registrational decisions; governance items (stock authorization/reverse split)	Prioritize TAC; explore alternatives for VORI	Prioritization finalized

Management Commentary

“Our Thin Film Freezing technology can be successfully applied, with both TFF TAC and TFF VORI demonstrating the potential to significantly improve the product profiles for two FDA-approved therapies… we made the decision to prioritize the clinical development of TFF TAC” — CEO Harlan Weisman, M.D. .
CFO update on R&D/G&A discipline and net loss improvement: FY23 R&D $12.1M (−35% YoY), G&A $10.6M (−23% YoY), FY23 net loss $21.2M (improvement of $10.6M YoY) .
Liquidity actions: “On March 22, 2024, we completed a registered direct offering… gross proceeds of $1.2 million… The Company continues to evaluate additional funding opportunities” .
FDA pathway: “Company expects to receive feedback from FDA in Second Quarter Regarding TFF TAC Clinical Development Plan and Next Steps” .

Q&A Highlights

Enrollment and trial sizing: management reiterated ~10 patients could be sufficient to inform FDA interactions and Phase 3 design in rare indications given well-characterized active ingredients (voriconazole/tacrolimus) .
Safety expectations: team will compare inhaled formulations’ AE profile against common toxicities seen with oral/IV voriconazole (hepatic toxicity, visual disturbances, rashes) and monitor inhalation-specific events (bronchospasm/cough) .
Expanded Access Program (EAP) data: EAP data will be collected systematically and could contribute to regulatory packages; provides broader real-world evidence across additional indications (e.g., chronic pulmonary aspergillosis, ABPA) .
Capital and prioritization: management emphasized data-driven priority between TAC and VORI, commercial potential, FDA feedback, and funding availability guiding next steps .

Note: A standalone Q4 2023 earnings call transcript was not available in the repository; Q4 2023 press release referenced a March 27, 2024 data presentation call, but transcript was unavailable; Q&A highlights reflect Q2/Q3 2023 calls relevant to Q4 context .

Estimates Context

Wall Street consensus estimates (EPS, Revenue) via S&P Global were unavailable for TFFP due to missing SPGI/CIQ mapping; as a result, we cannot present “vs. estimates” comparisons for Q4 2023. Values retrieved from S&P Global were unavailable due to coverage constraints.*

Key Takeaways for Investors

Clinical momentum favors TAC: robust Phase 2 transition/safety outcomes position TFF TAC as the lead asset; FDA feedback in Q2 2024 and ISHLT data act as near-term catalysts .
Financial discipline improved P&L YoY, but revenue remains negligible; liquidity requires continued access to capital markets and/or non-dilutive funding (government/partnering) .
Strategic repositioning: VORI moves to partnering/government-funding track, allowing resource concentration on TAC’s registrational trajectory .
Valuation drivers near term: clarity on Phase 3 pathway for TAC and incremental patient data; any partnership/funding announcements for VORI could add optionality .
Risk factors: pre-commercial profile, trial execution/enrollment in rare diseases, regulatory outcomes, and financing needs remain core risks as highlighted by safe harbor .
Trading implications: anticipate headline sensitivity around TAC data disclosures and FDA feedback; financing events may be dilutive short term but are necessary to fund pivotal development .
Medium-term thesis: if TAC demonstrates prevention of rejection at lower systemic exposure with acceptable safety, the asset could address significant unmet need in lung transplant medicine with potential for expedited development pathways in rare indications .

Sources:
- Q4 2023 8-K/Press Release and financial statements **[1733413_0001213900-24-027199_ea0202827-8k_tff.htm:1]** **[1733413_0001213900-24-027199_ea020282701ex99-1_tff.htm:0]** **[1733413_0001213900-24-027199_ea020282701ex99-1_tff.htm:1]** **[1733413_0001213900-24-027199_ea020282701ex99-1_tff.htm:3]**
- Q3 2023 8-K/Press Release and financial tables **[1733413_0001213900-23-086927_ea188313ex99-1_tffpharm.htm:0]** **[1733413_0001213900-23-086927_ea188313ex99-1_tffpharm.htm:1]** **[1733413_0001213900-23-086927_ea188313ex99-1_tffpharm.htm:3]**
- Q2/Q3 2023 earnings call transcripts for themes and Q&A **[1733413_TFFP_3386043_0]** **[1733413_TFFP_3386043_2]** **[1733413_TFFP_3386043_5]** **[1733413_TFFP_3386043_10]** **[1733413_TFFP_3386043_11]** **[1733413_TFFP_3386043_12]** **[1733413_TFFP_3386043_14]** **[1733413_TFFP_3367107_0]** **[1733413_TFFP_3367107_7]** **[1733413_TFFP_3367107_8]** **[1733413_TFFP_3367107_9]** **[1733413_TFFP_3367107_11]**
- Q1 2024 8-K/Press Release for subsequent events context **[1733413_0001213900-24-042919_ea020606901ex99-1_tffpharma.htm:0]** **[1733413_0001213900-24-042919_ea020606901ex99-1_tffpharma.htm:1]** **[1733413_0001213900-24-042919_ea020606901ex99-1_tffpharma.htm:3]** **[1733413_0001213900-24-042919_ea020606901ex99-1_tffpharma.htm:4]**

TFF Pharmaceuticals, Inc. (TFFP)·Q4 2023 Earnings Summary