Executive Summary

Q1 2024 showed tighter cost control with R&D down 12% YoY and G&A down 22%, reducing net loss to $5.7M from $7.1M YoY, while revenue increased to $203K from $51K YoY .
The company prioritized TFF TAC and reported favorable Phase 2 signals (8/8 transition success, no acute rejection, gene normalization) and intends to advance toward potentially registrational testing pending FDA feedback in Q2 .
Liquidity declined sequentially, with cash falling to $3.2M at 3/31/24; post-quarter, TFFP raised $4.8M gross in May and $1.2M gross in March to support development .
No formal quantitative guidance was issued; the near-term catalyst is FDA feedback on TFF TAC’s clinical development plan and a planned data update later in 2024 .

What Went Well and What Went Wrong

What Went Well

Strong clinical momentum in TFF TAC: 8/8 patients successfully transitioned from oral tacrolimus; no acute rejection; 4/4 completers opted into long-term extension; favorable safety (no mortality or AE-related discontinuations) .
Emerging mechanistic support: gene expression analysis showed normalization of rejection-related genes and TFF TAC prevented rejection at 1/6 oral dose with ~2/3 oral systemic trough exposures, supporting differentiated delivery .
Cost discipline: R&D down $0.4M YoY to $3.6M and G&A down $0.7M YoY to $2.4M, improving operating loss versus prior year .
“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,” — CEO Dr. Harlan Weisman .

What Went Wrong

Cash burn and declining cash balance: cash fell to $3.2M at quarter-end from $5.5M at year-end 2023, necessitating equity financings in March and May 2024 .
Revenue remains minimal (Q1 revenue $203K), emphasizing dependence on external funding and non-product sources; limited near-term commercial contributions .
No quantitative guidance; regulatory timelines and funding remain execution risks explicitly flagged in forward-looking statements and risk disclosures .

Financial Results

P&L and EPS vs prior quarters

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($USD)	$234,763	$114,328	$203,273
R&D Expense ($USD)	$2,386,707	$2,974,158	$3,555,862
G&A Expense ($USD)	$2,268,656	$2,508,876	$2,438,304
Total Operating Expenses ($USD)	$4,655,363	$5,483,034	$5,994,166
Operating Income (Loss) ($USD)	$(4,420,600)	$(5,368,706)	$(5,790,893)
Net Loss ($USD)	$(4,409,244)	$(4,762,414)	$(5,735,144)
EPS ($USD)	$(0.09)	$(2.01)	$(2.40)
Weighted Avg Shares	47,441,693	2,365,848	2,387,906

Key comparisons:

Sequential: Revenue increased QoQ to $203K from $114K, while operating loss widened to $(5.79)M from $(5.37)M on higher R&D; EPS declined to $(2.40) from $(2.01) .
YoY: Revenue rose to $203K from $51K; operating loss improved versus $(7.09)M YoY; EPS improved from $(4.87) to $(2.40) on lower OpEx YoY .

Balance Sheet and Liquidity

Metric	Q3 2023 (9/30/23)	Q4 2023 (12/31/23)	Q1 2024 (3/31/24)
Cash and Cash Equivalents ($USD)	$9,725,755	$5,478,113	$3,211,930
Total Current Assets ($USD)	$10,892,899	$7,590,318	$4,862,516
Total Current Liabilities ($USD)	$1,142,012	$2,428,540	$3,871,270
Total Stockholders’ Equity ($USD)	$13,690,929	$9,567,034	$5,304,424

Financing updates:

Raised $1.2M gross on March 22, 2024 and $4.8M gross on May 1, 2024 .

Segment breakdown

Not applicable; the company reports consolidated results without segments .

Clinical KPIs (program highlights)

KPI	Q3 2023	Q4 2023	Q1 2024
TFF TAC: Patients transitioned from oral to inhaled	—	8/8 transitioned; no acute rejection	8/8 transitioned; no acute rejection; 4/4 completers entered extension
TFF TAC: Dose/Exposure signals	—	—	Rejection prevented at 1/6 oral dose; ~2/3 oral systemic trough exposures; gene normalization observed
TFF TAC: Safety	—	Favorable, no mortality or AE discontinuations	Favorable, no mortality or AE discontinuations
TFF VORI: Patients enrolled	—	9 total (Phase 2 + EAP)	9 total (Phase 2 + EAP)
TFF VORI: Efficacy	—	5/6 completers achieved clinical and mycologic response	5/6 completers achieved clinical and mycologic response
TFF VORI: Safety	—	No IPA-related or all-cause mortality	No IPA-related or all-cause mortality

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue	FY/Q2-FY 2024	Not provided	Not provided	Maintained (no formal guidance)
R&D / G&A	FY 2024	Not provided	Not provided	Maintained (no formal guidance)
Operating Income / EPS	FY/Q2-FY 2024	Not provided	Not provided	Maintained (no formal guidance)
Regulatory milestones (FDA feedback on TAC)	Q2 2024	—	Expect feedback from FDA in Q2 regarding development plan	New qualitative milestone disclosed
Program prioritization	2024	—	Prioritized TFF TAC; exploring strategic alternatives for TFF VORI	Strategic shift reaffirmed

Note: No quantitative ranges were provided for revenue, margins, OpEx, or EPS in Q1 2024 communications .

Earnings Call Themes & Trends

(There was no separate Q1 2024 earnings call transcript available; the company referenced a March 27, 2024 webcast presenting program data and expects another data update later in 2024.)

Topic	Previous Mentions (Q3 2023)	Previous Mentions (Q4 2023)	Current Period (Q1 2024)	Trend
R&D execution (TFF TAC)	Anticipated initial Phase 2 data by YE 2023	8/8 transitioned; favorable safety	8/8 transitioned; no acute rejection; 4/4 remain on TAC; gene normalization signals; 1/6 dose, ~2/3 trough exposure	Improving
R&D execution (TFF VORI)	Anticipated initial Phase 2 data by YE 2023; EAP opened	9 enrolled; 5/6 responses; favorable safety	9 enrolled; 5/6 responses; favorable safety; exploring strategic alternatives	Stable; seeking partnership
Regulatory/legal	—	Late-breaking abstract at ISHLT; continued development focus	Expect FDA feedback in Q2 on TAC development plan	Near-term regulatory catalyst
Financing/liquidity	Extended runway into Q2 2024 post Aug financing	Cash $5.5M at YE; $1.2M raise in March	Cash $3.2M at Q1-end; $4.8M raise in May	Ongoing capital needs
Product performance narrative	—	TAC and VORI demonstrate potential to improve profiles of approved therapies	TAC signals of efficacy/safety; mechanistic gene normalization	Strengthening
Strategic focus	—	Prioritize TAC; explore alternatives for VORI	TAC prioritized; VORI partnerships/government funding explored	Consolidation on TAC

Management Commentary

“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.” — CEO Dr. Harlan Weisman .
The company submitted an FDA briefing book including its proposed study plan and expects feedback in Q2 to guide next steps toward potentially registrational testing .
Post-quarter financing activities ($4.8M in May; $1.2M in March) aim to support continued advancement of TAC .

Q&A Highlights

No Q1 2024 earnings call transcript was available in the document set; the company referenced a March 27 webcast presenting Phase 2 updates and indicated plans to host a call later in 2024 to present further TAC data .

Estimates Context

Wall Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable due to a missing Capital IQ mapping for TFFP; as a result, comparisons to estimates cannot be provided at this time [SpgiEstimatesError].
If S&P coverage is initiated or mapping is updated, future recaps will include consensus comparisons and identify beats/misses accordingly.

Key Takeaways for Investors

Clinical de-risking for TFF TAC continues: strong transition success, safety, and early mechanistic signals suggest differentiation; near-term FDA feedback is a pivotal catalyst. A positive FDA response could accelerate a path to registrational testing and re-rate the program’s probability of success .
Liquidity remains tight; despite March and May financings, cash trends underscore ongoing capital needs and potential future raises/partnerships, a key overhang to watch .
Operating discipline is evident with YoY OpEx declines, but sequential R&D spend rose, reflecting clinical progress investments; watch OpEx trajectory versus milestones .
VORI remains promising clinically but is non-core; management is pursuing strategic alternatives (partnering/government funding), which could provide non-dilutive capital or reduce cash burn .
With no formal guidance or S&P consensus available, trading will likely hinge on regulatory communications (FDA feedback) and subsequent clinical data disclosures; risk skew is event-driven.
For short-term positioning, monitor FDA feedback timing and contents; for medium-term thesis, the potential to deliver immunosuppression at lower doses with comparable exposure and fewer systemic toxicities represents a meaningful innovation in lung transplant care .

TFF Pharmaceuticals, Inc. (TFFP)·Q1 2024 Earnings Summary