Executive Summary

Q3 showed strong clinical and regulatory execution (FULCRUM‑VT enrollment completed; preliminary 97% acute effectiveness), and a post‑quarter financing up to $50M (≈$19M upfront) to fund PMA submission and next‑gen catheter development; offset by a deeper net loss primarily driven by non‑operating fair value adjustments and interest expense .
Expenses mixed: SG&A fell sharply year over year while R&D rose modestly; operating loss was roughly stable vs Q2 but net loss widened q/q due to negative mark‑to‑market items on convert and warrants plus higher interest .
No revenue recognized in Q3; cash fell to $4.7M at quarter‑end, but liquidity strengthened in October via the private placement to support PMA submission preparations .
Stock reaction catalyst: completed enrollment with favorable preliminary data, FDA PMA pathway clarity, and fresh capital raise; potential near‑term attention around PMA filing timing and U.S. launch readiness .

What Went Well and What Went Wrong

What Went Well

Completed enrollment (209 patients) in FULCRUM‑VT pivotal IDE, intended to support PMA for vCLAS; preliminary FULCRUM‑VT results showed 97% acute effectiveness with favorable safety profile .
Strengthened balance sheet post‑quarter with private placement up to $50M (≈$19M upfront; up to $31M additional via warrants) to fund FDA submission activities and next‑gen development .
Leadership depth: appointment of Deborah Kaster as CFO (also CBO), supporting finance and commercialization readiness. CEO: “The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization.” .

What Went Wrong

No revenue recognized in Q3; cost of revenue down to $31K but operating model remains pre‑commercial; net loss widened to $(10.1)M vs $(4.6)M y/y and vs $(3.9)M in Q2, driven largely by non‑operating fair value losses and interest expense .
Cash decreased to $4.673M at 9/30 before the October raise, underscoring reliance on external financing through PMA and pre‑launch phase .
Continued R&D investment (to progress PMA and next‑gen) lifted R&D to $2.774M in Q3 (up vs prior year), while non‑cash convertible notes and warrant liability adjustments introduced P&L volatility .

Financial Results

Core P&L and Cash (Quarterly)

Metric	Q1 2025	Q2 2025	Q3 2025
Revenue ($M)	$0.000	$0.000	$0.000
Cost of Revenue ($M)	$0.253	$0.342	$0.031
R&D Expense ($M)	$3.659	$1.971	$2.774
SG&A Expense ($M)	$3.485	$2.404	$2.916
Loss from Operations ($M)	$(7.397)	$(4.717)	$(5.721)
Total Other (Loss)/Income, net ($M)	$(0.316)	$0.770	$(4.397)
Net Loss ($M)	$(7.713)	$(3.947)	$(10.118)
Basic EPS ($)	$(0.50)	$(0.26)	$(0.66)
Diluted EPS ($)	$(0.51)	$(0.35)	$(0.66)
Cash & Cash Equivalents ($M)	$12.963 (3/31)	$8.200 (6/30)	$4.673 (9/30)

Notes and drivers:

Year over year (company’s presentation): cost of revenue $0.031M vs $0.6M, R&D $2.8M vs $2.5M, SG&A $2.9M vs $7.8M, and net loss $(10.1)M vs $(4.6)M, reflecting lower SG&A but higher non‑operating losses in Q3 2025 .
Q/Q: Operating loss roughly flat vs Q2, but total other loss swung negatively (convertible notes fair value adjustment $(3.508)M; warrants $(0.231)M; higher interest expense), deepening net loss .

Selected Operating/Capital Structure Details (Q3 2025)

Item	Q3 2025
Convertible notes fair value adjustment ($M)	$(3.508)
Warrant liabilities fair value adjustment ($M)	$(0.231)
Interest expense ($M)	$(0.749)
Weighted‑avg shares (Basic)	15,381,565

Clinical/Regulatory KPIs

KPI	Q1 2025	Q2 2025	Q3 2025
FULCRUM‑VT enrollment status	>50% enrolled; Breakthrough Device Designation received	>85% enrolled; on track 2H‑2025 completion	Enrollment completed (209 pts)
FULCRUM‑VT preliminary acute effectiveness	—	—	97% acute effectiveness; favorable safety profile
Financing to fund PMA and next‑gen	—	—	Private placement up to $50M; ~$19M upfront; up to $31M via warrants

Guidance Changes

The company did not provide formal quantitative financial guidance; communications centered on regulatory and operational milestones.

Metric	Period	Previous Guidance	Current Update	Change
FULCRUM‑VT enrollment	2025	On track to complete H2’25	Enrollment completed (209 pts)	Raised (achieved earlier milestone)
PMA submission (vCLAS)	2025/2026	Not specified	Financing “provides the resources to advance our PMA submission”	Qualitative reinforcement
Liquidity to fund FDA submission activities	Q4’25 onward	N/A	~$19M upfront from private placement; up to $31M additional via warrants	New disclosure

Earnings Call Themes & Trends

No Q3 earnings call transcript was available in our document set; themes below reflect evolution across Q1–Q3 press releases.

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
Regulatory pathway	Breakthrough Device Designation; pivotal study >50% enrolled	Enrollment completed; PMA preparation funding secured	Improving visibility
Clinical efficacy/safety	—	FULCRUM‑VT prelim: 97% acute effectiveness; favorable safety	Positive data momentum
Commercialization readiness	Streamlined focus on pivotal and next‑gen design	Financing cited to “prepare for commercialization”	Building readiness
R&D/Next‑gen catheter	“Smaller, faster next generation ULTC” in development	Proceeds support “ongoing next generation catheter development”	Continued investment
Expense discipline	Corporate prioritization lowered cash burn q/q in Q2	SG&A sharply lower y/y; R&D elevated for PMA/next‑gen	Mixed: lean SG&A, targeted R&D

Management Commentary

CEO (Q3): “Adagio made exceptional progress this quarter, with strong clinical momentum, a clear regulatory path and a solid pipeline… The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization.”
CEO (Q2): “Continued strong momentum in the enrollment of our FULCRUM‑VT study… [and] meaningful progress in advancing our pipeline through the continued development of our next-generation product.”
CEO (Q1): “Breakthrough Device Designation… multiple impactful presentations… optimized smaller, faster next generation ULTC… continued momentum in enrolling patients.”

Q&A Highlights

No earnings call transcript for Q3 2025 was available in our document set to extract Q&A themes or clarifications; we will update if a transcript is subsequently filed or published [ListDocuments returned no earnings‑call‑transcript for Q3 2025].

Estimates Context

Wall Street (S&P Global) consensus for Q3 2025 EPS and revenue was unavailable; company appears not broadly covered by sell‑side at this time. Values retrieved from S&P Global.
With no consensus, we benchmark actuals as follows: Revenue $0.000M; Basic EPS $(0.66). Comparative context comes from internal trend and y/y disclosures in the company’s press release . Values retrieved from S&P Global.

Metric	Q3 2025 Consensus	Q3 2025 Actual
Revenue ($M)	N/A*	$0.000
EPS (Basic, $)	N/A*	$(0.66)

*Values retrieved from S&P Global.

Clear Implications

The operating P&L remains pre‑revenue and levered to non‑cash valuation swings (convertible notes/warrants) and interest; near‑term reported EPS will be volatile until financing structure normalizes and commercialization begins .
Execution risk pivots from enrollment to PMA quality, FDA review, and launch readiness; October capital reduces near‑term financing overhang for submission and next‑gen workstreams .
Positive preliminary clinical data and Breakthrough Designation underpin a differentiated profile in VT ablation; investors will focus on PMA timing, U.S. labeling scope, and early commercialization strategy .

Detailed Financial Comparison Tables

Y/Y Metrics Disclosed by Company (Q3 2025 vs Q3 2024)

Metric	Q3 2025	Q3 2024	Delta/Comment
Cost of revenue ($M)	$0.031	$0.6	Down y/y per company disclosure
R&D ($M)	$2.8	$2.5	Up y/y per company disclosure
SG&A ($M)	$2.9	$7.8	Down sharply y/y per company disclosure
Net loss ($M)	$(10.1)	$(4.6)	Wider y/y per company disclosure

Capital and Liquidity Progression

Quarter End	Cash & Cash Equivalents ($M)
3/31/2025	$12.963
6/30/2025	$8.200
9/30/2025	$4.673
Post‑quarter financing	~$19 upfront; up to $31 additional via warrants

Key Takeaways for Investors

Clinical/regulatory execution de‑risked: pivotal enrollment completed with favorable preliminary efficacy/safety; next catalyst is PMA submission quality and timing .
Liquidity strengthened post‑quarter with ~$19M upfront; watch cash burn into PMA and pre‑launch and any warrant‑driven proceeds timing .
P&L volatility likely persists near term due to non‑cash fair value swings (convert/warrants) and interest; operating loss profile reflects focused R&D and leaner SG&A .
No revenue yet; U.S. commercialization remains the inflection—CE mark and European use provide external validation while U.S. approval is pending .
Stock catalysts: PMA submission/acceptance, panel/review milestones, any early commercialization updates, and next‑gen device progress leveraging the financing .
Estimate revisions: With limited coverage and no formal guidance, models should emphasize cash runway, PMA timeline, regulatory probabilities, and staged commercialization adoption curves .
Competitive positioning: Purpose‑built ULTC technology and Breakthrough Designation may confer an early‑mover advantage in VT ablation if PMA is secured with a broad label .

Adagio Medical Holdings, Inc. (ADGM)·Q3 2025 Earnings Summary