Executive Summary

Q2 2024 showed operational progress with TFF TAC while narrowing losses: revenue rose to $0.65M and net loss improved to $4.48M; cash was $4.39M as of June 30, 2024 .
Results beat third‑party consensus: EPS of −$1.22 vs −$1.70 and revenue of $0.65M vs $0.15M; no S&P Global estimates available, so comparisons use Zacks/Nasdaq data; both were significant beats driven by SBIR grant revenue and lower G&A spending .
Clinical momentum: 13 patients enrolled in Phase 2 TFF TAC; 9/9 patients completing 12 weeks chose to remain on therapy; biomarker and DSA data supportive of immunosuppression adequacy; one protocol-related dose-too-low episode resolved after reverting to oral tacrolimus .
Funding remains tight and a key stock narrative driver: $4.8M financing in May and engagement of Outcome Capital to pursue partnerships/licensing; management acknowledges going‑concern risk and plans to end TFF TAC Phase 2 enrollment in 2H24 and next‑study design in collaboration with investigators and regulators .

What Went Well and What Went Wrong

What Went Well

Positive Phase 2 signals for TFF TAC: “growing body of positive safety, efficacy and confirmatory biomarker data… points towards TFF TAC becoming a significant new advancement” (CEO) .
Patient adherence and exposure: 9/9 patients chose long‑term extension; ~20% of oral dose achieved >80% oral trough levels, suggesting lower systemic burden at adequate immunosuppression .
Biomarkers supported mechanism: 6.5‑fold reduction in abnormally expressed rejection‑related gene sets; abnormal expression fell from 23% to 3.6% after 12 weeks on TFF TAC; DSA remained negative in first 8 patients .

What Went Wrong

One dose‑setting misstep: a patient transitioned to a dose “too low” (trough >50% below protocol minimum) experienced Grade A1 acute rejection; resolved after discontinuation and return to oral tacrolimus .
Cash runway remains constrained: cash $4.39M at quarter end; management disclosed substantial doubt about going concern without additional capital .
External financing costs and fair‑value mark: decrease in fair value of Augmenta note (−$0.56M) pressured other income, partially offsetting operating improvements .

Financial Results

Income Statement and Operating Metrics (Quarterly)

Metric	Q2 2023	Q4 2023	Q1 2024	Q2 2024
Revenue ($USD)	$333,351	$114,328	$203,273	$650,222
Net Loss ($USD)	$(5,020,206)	$(4,762,414)	$(5,735,144)	$(4,479,221)
EPS (basic & diluted, $)	$(3.47)	$(2.01)	$(2.40)	$(1.22)
R&D Expense ($USD)	$2,681,898	$2,974,158	$3,555,862	$2,588,316
G&A Expense ($USD)	$2,670,363	$2,508,876	$2,438,304	$2,024,473
Total Operating Expenses ($USD)	$5,352,261	$5,483,034	$5,994,166	$4,612,789
Net Loss Margin (%)	−1506%	−4166%	−2823%	−688.9%

Notes: Net loss margin computed from cited revenue and net loss values (citations reference source figures).

Balance Sheet Highlights

Metric	Dec 31, 2023	Mar 31, 2024	Jun 30, 2024
Cash and Equivalents ($USD)	$5,478,113	$3,211,930	$4,387,198
Total Assets ($USD)	$12,027,316	$9,186,550	$9,495,456
Total Liabilities ($USD)	$2,460,282	$3,882,126	$3,618,140
Stockholders’ Equity ($USD)	$9,567,034	$5,304,424	$5,877,316

Estimates vs. Actual (Q2 2024)

Metric	Actual	Consensus	Beat/Miss
EPS ($)	−$1.22	−$1.70	Beat +$0.48
Revenue ($USD)	$650,222	$150,000	Beat +$500,222

Note: S&P Global estimates unavailable for TFFP; comparisons use Zacks/Nasdaq/Moomoo third‑party consensus sources.

KPIs (Clinical/Operational)

KPI	Q4 2023	Q1 2024	Q2 2024
TFF TAC patients enrolled	8 transitioned successfully	Ongoing enrollment; 4/4 remained on therapy	13 enrolled
Patients completing 12 weeks choosing extension	4/4	4/4	9/9 (100%)
TFF TAC dose vs oral & trough exposures	—	~1/6 oral dose; ~2/3 oral trough exposures	~20% oral dose; >80% oral trough levels
Biomarker change (rejection‑related gene sets)	—	Normalization signal reported	6.5‑fold reduction; abnormal gene sets from 23% → 3.6% (−85%)
DSA status	—	—	DSA negative at baseline and remained negative in first 8 patients
Safety	No mortality or discontinuations due to AEs	No mortality reported	Majority AEs grade ≤2; kidney function maintained; one protocol dose‑too‑low rejection episode resolved

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Financial revenue/earnings	FY/Q2 2024	None provided	None provided	Maintained (no guidance)
TFF TAC Phase 2 enrollment	2H 2024	Not previously specified	Plan to end enrollment in 2H24	New operational timeline
Next TFF TAC study design	Fall 2024	Not previously specified	Finalizing design; regulatory update planned later in fall	New operational milestone

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript was available in the document catalog; themes synthesized from the Q2 press release and 10‑Q.

Topic	Previous Mentions (Q4 2023 & Q1 2024)	Current Period (Q2 2024)	Trend
Clinical efficacy/safety (TFF TAC)	8/8 transitioned; 4/4 extension; favorable safety	13 enrolled; 9/9 extension; biomarker reduction; DSA negative	Strengthening evidence
Regulatory pathway	FDA feedback expected in Q2 (TFF TAC)	In communication with regulators; update in fall	Ongoing engagement
R&D prioritization	Prioritized TFF TAC; exploring options for TFF VORI	Continued TFF TAC focus; VORI de‑emphasized	Consistent prioritization
Funding/partnerships	$1.2M and $4.8M financings	Outcome Capital engaged for partnerships/licensing	Active BD efforts
Government/academic collaborations	SBIR grant; AAAM/ISHLT data	DARPA PPB program; Cleveland Clinic universal flu vaccines preclinical	Expanding collaborations
Going concern	Risk disclosed	Substantial doubt persists without new capital	Ongoing risk

Management Commentary

“Over the last several months, we have amassed a growing body of positive safety, efficacy and confirmatory biomarker data… that points towards TFF TAC becoming a significant new advancement for the prevention of lung transplant rejection.” – Harlan Weisman, M.D., CEO .
“We continue to make significant progress in demonstrating that Tacrolimus Inhalation Powder (TFF TAC) has the potential to become an important new advancement in transplant medicine… we submitted a briefing book… to the FDA.” – Harlan Weisman, CEO (Q1) .

Q&A Highlights

No Q2 2024 earnings call transcript was available; no Q&A highlights could be verified from primary sources [ListDocuments returned 0 transcripts; see above]. Management’s clarifications came via the press release and 10‑Q: plan to finalize next study design and provide a regulatory update later in the fall and intent to end Phase 2 enrollment in 2H 2024 .

Estimates Context

S&P Global consensus estimates were unavailable for TFFP (SPGI mapping error encountered).
Third‑party consensus indicates EPS −$1.70 and revenue $0.15M; actual EPS −$1.22 and revenue $0.65M represented material beats, implying upside vs expectations likely driven by SBIR grant revenue and lower G&A .

Key Takeaways for Investors

Clinical evidence is building for TFF TAC (adherence, biomarker reduction, DSA negativity), supporting the narrative for a lower‑dose lung‑targeted immunosuppression approach; next regulatory update in fall is a key catalyst .
Financial beats vs third‑party consensus (EPS and revenue) highlight near‑term cost discipline and grant revenue, but net loss margins remain highly negative due to the development‑stage profile; sustainable funding is critical .
Funding runway and going‑concern disclosure keep balance sheet risk front‑and‑center; Outcome Capital engagement signals pursuit of partnerships/licensing that could de‑risk the path forward .
DARPA and Cleveland Clinic collaborations broaden optionality around TFF’s platform beyond TAC, potentially aiding future non‑dilutive capital or strategic interest .
Near‑term trading setups likely hinge on: (1) regulatory feedback timing/stance, (2) partnership/licensing announcements, (3) additional financing steps, and (4) continued Phase 2 readouts/biomarker updates .
Medium‑term thesis depends on converting Phase 2 signals into a registrational pathway for TFF TAC with adequate capital and BD support; monitoring dose‑setting rigor (to avoid under‑dosing events) and reproducibility of biomarkers across a larger cohort is essential .

Citations:
All financials, KPIs, and commentary are sourced from the Q2 2024 8‑K press release and exhibits , the Q2 2024 10‑Q , and prior 8‑Ks for Q1 2024 and Q4 2023 . Estimates comparisons use third‑party consensus given S&P Global unavailability .

TFF Pharmaceuticals, Inc. (TFFP)·Q2 2024 Earnings Summary