Executive Summary

Q2 2025 was defined by clinical momentum and a strengthened balance sheet: Trevi reported CORAL Phase 2b IPF chronic cough data confirming robust, dose‑responsive efficacy, while completing a $115M offering that extended cash runway into 2029 .
Financially, EPS of ($0.09) modestly beat S&P Global consensus of ($0.10), a ~$0.01 beat; revenue remains non-material as a clinical-stage company (consensus revenue $0) . EPS consensus values from S&P Global*.
Management aims to request an End‑of‑Phase 2 FDA meeting in Q4 2025 and initiate Phase 3 in IPF chronic cough in 1H 2026; non‑IPF ILD and RCC (Phase IIb, parallel arm) programs are being readied for starts in 1H 2026, subject to FDA input .
Near-term stock catalysts: EOP2 FDA meeting request (Q4 2025), Phase 1 safety/DDI readouts supporting EOP2, CHEST/ERS medical meeting data flow, and Phase 3 trial initiation guidance in 1H 2026 .

What Went Well and What Went Wrong

What Went Well
- CORAL Phase 2b IPF chronic cough success with statistically significant reductions in 24‑hour cough frequency across all doses; strong LCQ quality‑of‑life improvements at 54 mg and 108 mg BID, reinforcing clinical benefit .
- Financing de‑risked: $115M underwritten offering closed; cash, cash equivalents and marketable securities totaled $203.9M at Q2 end, extending cash runway into 2029 .
- Clear dose directionality for Phase 3: 54 mg BID identified as the “sweet spot,” expected as a key dose going forward, helping to optimize risk/benefit and trial design .
What Went Wrong
- Operating expenses rose sequentially (R&D and G&A up vs Q1 2025), with G&A also higher YoY due to added professional fees and SOX 404 readiness; net loss widened QoQ though essentially flat YoY .
- Continued absence of product revenue; margin metrics remain not applicable for a clinical‑stage company .
- Timing risk remains: multiple studies must align (respiratory safety, DDI with pirfenidone/nintedanib) ahead of EOP2 and Phase 3, and execution across larger, global Phase 3 programs always adds operational complexity .

Financial Results

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue ($USD Millions)	— (no product revenue reported)	— (no product revenue reported)	— (no product revenue reported)
R&D Expense ($M)	$10.021	$7.811	$9.389
G&A Expense ($M)	$3.268	$3.659	$4.333
Total Operating Expenses ($M)	$13.289	$11.470	$13.722
Other Income ($M)	$0.929	$1.119	$1.400
Net Loss ($M)	$(12.352)	$(10.340)	$(12.301)
Diluted EPS ($)	$(0.12)	$(0.09)	$(0.09)
Weighted Avg Shares (M)	101.042	117.611	130.350

Balance sheet and liquidity

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Equivalents ($M)	$34.097	$19.374	$117.058
Marketable Securities ($M)	$73.525	$83.883	$86.827
Cash + Investments ($M)	$107.6	$103.3	$203.9
Working Capital ($M)	$98.919	$98.755	$197.987
Total Assets ($M)	$110.900	$107.004	$208.339
Stockholders’ Equity ($M)	$99.644	$99.457	$198.493

Clinical KPIs (CORAL IPF chronic cough)

KPI (Week 6)	Placebo	27 mg BID	54 mg BID	108 mg BID
Relative change in 24h cough frequency vs baseline	-16.9%	-47.9% (p<0.01)	-53.4% (p<0.0001)	-60.2% (p<0.0001)
Placebo-adjusted difference	—	-30.9%	-36.5%	-43.3%
LCQ Total Score (mean change)	—	—	+3.7 (p=0.01)	+3.4 (p=0.01)

Notes: No product revenue reported; operating lines presented without a revenue line in the company’s selected financial data .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through	Into H2 2026 (as of Q4’24 report)	Into 2029 (post‑June offering)	Raised runway
FDA End‑of‑Phase 2 (IPF cough)	Timing	“By end of 2025” (Q4’24)	Request meeting in Q4 2025	Maintained/Specified
Phase 3 (IPF cough)	Start	Not specified previously	Initiate in 1H 2026	New specific timing
Non‑IPF ILD cough study	Start	Under planning (Q1’25)	Request FDA meeting in 2025; initiate after input	Updated/advanced
RCC next study	Start	Next trial design under development (Q1’25)	Phase IIb parallel‑arm, dose‑ranging; initiate 1H 2026	New specific timing
OpEx Trajectory	2025	Not specified	Expect OpEx to remain ~flat from Q2 levels for remainder of 2025	New qualitative guidance

Earnings Call Themes & Trends

Topic	Previous Mentions (Q4 2024)	Previous Mentions (Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory path (EOP2, NDA package)	Plan EOP2 by end‑2025; long‑term safety (52 weeks) expected in package	Type C engagement positive; plan EOP2 post‑CORAL	Request EOP2 in Q4 2025; align Phase 3 protocol and safety database expectations	Steady progress, higher specificity
Dose selection (IPF)	CORAL to inform dose range	Await CORAL to refine dosing	54 mg BID highlighted as anchor “sweet spot”; 27 mg BID as titration	Clarity improved
Non‑IPF ILD strategy	Under evaluation; basket-like thinking	Non‑IPF ILD trial contemplated	Parallel‑arm design across fibrotic ILDs with cough; FDA meeting in 2025	Broader scope, accelerated
RCC positioning & competition	Best-in-class potential; target treatment failures	Maintain treatment‑failure focus; no stratification planned	Confident on dose‑ranging Phase IIb; unaffected by competitor delays	Consistent, execution next
Safety/abuse potential/scheduling	HAP positive; expectation to remain unscheduled	—	Respiratory safety (TITLE) and DDI studies progressing; no impact on DEA scheduling expected	Risk managed via Phase 1s
Placebo management	Parallel‑arm may see higher placebo; CORAL powered accordingly	—	Large effect sizes reduce concern; early AEs during titration dissipate	Execution confident
Financing & runway	$50M raise (Dec’24); runway into H2’26	$103.3M cash & investments at Q1; runway into Q4’26	$203.9M cash & investments; runway into 2029	Materially strengthened
Manufacturing/commercialization	U.S. self‑commercialization; ex‑U.S. partnering considered	Similar stance	No manufacturing issues anticipated; U.S. commercialization internal, ex‑U.S. partnering considered	Unchanged, confidence higher

Management Commentary

“The recently received full data set from our CORAL trial … shows consistency and clinically meaningful benefit … We expect our current cash and investments to provide us with cash runway into 2029.” — Jennifer Good, CEO .
“The 54 mg BID dose is really a sweet spot dose … anticipate that 54 is going to be a key dose bringing forward.” — James Cassella, CDO .
“We expect to request [the End‑of‑Phase 2] meeting in the fourth quarter of this year … [and] initiate the Phase 3 program in the first half of next year.” — Jennifer Good / James Cassella .
“OpEx to remain relatively flat from 2Q levels for the remainder of the year.” — Lisa Delfini, CFO .
“We know how to make the drug… We don’t anticipate any problems [running larger trials].” — James Cassella, CDO .

Q&A Highlights

Safety/Phase 1 work: Respiratory physiology study (TITLE) and DDI study with pirfenidone/nintedanib are on track; DDI is a “check‑the‑box” PK characterization with no expected interaction but done pre‑Phase 3 per FDA expectations .
Phase 3 dose strategy: 54 mg BID expected as anchor dose; 27 mg BID will be used at least as titration; specifics to be finalized with FDA at EOP2 .
Non‑IPF ILD: Parallel‑arm design across fibrotic ILDs with cough; broader inclusion reflecting fibrosis and cough commonality; FDA input this year to enable initiation .
RCC competitive landscape: Program unaffected by competitor delays; Trevi maintains treatment‑failure positioning and plans a Phase IIb, dose‑ranging, parallel‑arm study in 1H 2026 .
Operating expenses: Expect OpEx to stay roughly flat for the rest of 2025; part of G&A increase tied to SOX 404 readiness as market cap grows .

Estimates Context

Q2 2025 results vs S&P Global consensus: modest EPS beat, revenue in line at zero.

Metric	Q2 2025
EPS (Consensus Mean)*	$(0.1013)$*
EPS (Actual)	$(0.09)$
Revenue (Consensus Mean, $M)*	$0.0*
Revenue (Actual, $M)	— (no product revenue reported)

Values retrieved from S&P Global*.
Implication: Small EPS beat (~$0.01) reflects higher interest income and disciplined OpEx; no revenue surprise. Expect Street to focus on Phase 3 design/timelines and durability of OpEx guidance rather than quarterly P&L .

Key Takeaways for Investors

CORAL validated efficacy and QoL impact in IPF chronic cough with dose‑responsive effects; 54 mg BID looks like the registrational anchor dose, de‑risking Phase 3 design .
Balance sheet is a strategic asset: $203.9M cash/investments and runway into 2029 support two IPF Phase 3s plus non‑IPF ILD and RCC programs without near‑term financing, a key differentiator in small‑cap biotech .
Near‑term catalysts cluster into Q4 2025–1H 2026 (EOP2, Phase 1 readouts, Phase 3 initiation), creating potential inflection points for the stock .
Execution risk shifts to Phase 3 and regulatory alignment; management emphasized early onset of effect, large deltas vs placebo, and manageable AEs concentrated in titration—factors that should translate into registrational success if replicated .
OpEx discipline: CFO expects flat OpEx through year‑end despite scaling; monitor G&A as SOX 404 work progresses and headcount supports scaling .
Strategy coherence across indications: IPF lead with sNDA path for RCC; non‑IPF ILD broadens TAM leveraging same pulmonology call point and cough‑fibrosis commonality .
Risk checks: Regulatory (endpoint alignment, safety database), operational (global Phase 3), and class‑specific (abuse/scheduling) mitigated by HAP data and planned safety studies; no expected DEA scheduling impact from respiratory safety studies per CDO .

Additional Relevant Press Releases and Events in Q2/Q3 Timing

Positive CORAL topline (June 2, 2025) with full dose‑response table and key secondary endpoints .
$115.1M offering closed June 5, 2025, strengthening runway .
Q2 earnings/financials press release (Aug 7, 2025) with updated cash and OpEx details .
Conference participation in September (Wells Fargo, Cantor, Morgan Stanley, H.C. Wainwright, Leerink; ERS with RCC abstracts; IPF data planned for CHEST) .

Footnotes:

All financial and clinical data points are cited from Trevi Therapeutics’ press releases, 8‑K, and earnings call transcript as indicated.
*Estimates (EPS, revenue) are from S&P Global via GetEstimates.

Trevi Therapeutics, Inc. (TRVI)·Q2 2025 Earnings Summary