Executive Summary

Q1 2025 delivered a sharp sequential improvement in gross margin (62% vs 40% in Q4 2024) on $2.14M in pharma services revenue, reflecting lab automation and workflow enhancements; non-GAAP loss from operations was $4.96M and GAAP EPS was ($0.26) .
Management reaffirmed timelines: final FDA Q-Sub meeting “in the coming weeks,” FDA submission targeted by year-end 2025, with anticipated authorization in H1 2026, and a company rename with a new NASDAQ ticker in Q2 2025 .
Commercial momentum: 10 leading centers running GraftAssure RUO kits (3 US, 6 Europe, 1 Southeast Asia) and expectation that at least three of the top 10 US transplant centers will participate in the clinical trial (representing ~10% of US transplant volumes) .
Liquidity strengthened by February financing; cash, cash equivalents, and restricted cash ended Q1 at $32.7M; targeted cash burn about $6M per quarter; CFO guided Q2 pharma services revenue to be < $500k given lumpiness and focus on core priorities .
Subsequent catalyst: CMS increased reimbursement to $2,753 per result for the CLIA lab test (GraftAssureCore), aligning price with competitors and supporting future kit reimbursement “bridging” upon FDA authorization .

What Went Well and What Went Wrong

What Went Well
- Gross margin expanded to 62% on process improvements (automation, workflow efficiency), up from 40% in Q4 2024 .
- Strong stakeholder pull-in: at least three of the top 10 US transplant centers expected in the clinical trial; growing RUO adoption with 10 leading centers globally .
- Strategic clarity and tech differentiation: “It’s simpler, it’s faster and it offers better sample economics than NGS at low volumes,” positioning digital PCR for decentralized, in-lab testing .
What Went Wrong
- Revenue concentration and lumpiness: “vast majority” of Q1 pharma services from a single corporate customer; April had no services invoices; Q2 pharma services guide < $500k .
- Company remains pre-revenue on its core transplant kits; net loss of ($6.67M) persists pending regulatory milestones and commercialization .
- Physician behavior change and adoption friction acknowledged; centers are risk-averse and will require “show-me” side-by-side performance before flipping volumes in-house .

Financial Results

Metric	Q1 2024	Q3 2024	Q4 2024	Q1 2025
Revenue ($USD Millions)	$0.176	$0.115	$1.486	$2.138
Gross Profit ($USD Millions)	$0.045	$0.050	$0.595	$1.325
Gross Margin %	25.6% (calc. from rev/gp)	43.5% (calc. from rev/gp)	40.0%	62.0%
Operating Expenses ($USD Millions)	$9.312	$13.565	$34.222	$8.124
Net Loss ($USD Millions)	($9.129)	($13.493)	($33.511)	($6.671)
EPS (Basic/Diluted, $)	($1.13)	($0.98)	($1.93)	($0.26)
Non-GAAP Loss from Operations ($USD Millions)	($5.033)	($5.585)	($4.361)	($4.956)

Segment/Mix (where disclosed):

Metric	Q4 2024	Q1 2025
Pharma Services Revenue ($USD Millions)	$1.5 (pharma services)	$2.1 (pharma services)

KPIs and Operating Metrics:

KPI	Q1 2025	Reference
RUO Sites Running GraftAssure	10 centers (3 US, 6 Europe, 1 SE Asia)
Expected Clinical Trial Participation	≥3 of top 10 US centers; ~10% US transplant volume represented
Cash, Cash Equivalents & Restricted Cash	$32.729M
Net Cash Used in Operating Activities	($5.858M)
Capital Expenditures	$0.307M
Accounts Receivable (End of Q1)	$3.540M (collected $1.4M first week of April)
Weighted Avg Shares	25.694M
Shares Outstanding (as of May 12)	28.6M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
FDA Submission Timing (Transplant Kit)	2025	Mid-2025 (earlier commentary)	By end of 2025	Maintained/clarified timeline
FDA Authorization	H1 2026	H1 2026	H1 2026	Maintained
RUO Site Adoption	FY 2025	≥20 sites by YE 2025	On track for ≥20 sites	Maintained
Q2 Pharma Services Revenue	Q2 2025	N/A	< $500,000; no April invoices	New guide lower vs Q1
Cash Burn Target	2025	~$6M per quarter	~$6M per quarter; Q2/Q3 heavier	Maintained/updated phasing
Corporate Rename/NASDAQ Ticker	Q2 2025	N/A	Rename and new ticker in Q2	New

Earnings Call Themes & Trends

Topic	Previous Mentions (Q-2: Q3 2024; Q-1: Q4 2024)	Current Period (Q1 2025)	Trend
Digital PCR vs NGS	Emphasized speed, simplicity; 4–8h PCR vs ≥30h NGS; single-sample economics	“Simpler, faster, better sample economics” reinforced; Bio-Rad platform ease-of-use	Strengthening value prop
Decentralization/In-house Testing	Land-and-expand RUO; concentrated markets; Bio-Rad partnership opening doors	Strong pull from top US centers; in-house preference; physicians likely to align with center platform	Adoption momentum building
Regulatory Path/Timing	De novo pathway clarified; Q-Sub underway; Phase-gate plan	Final Q-Sub “in coming weeks”; submission by YE 2025; H1 2026 authorization	Milestones approaching
Pharma Services Lumps	Modest, variable; not core focus	Q1 exceeded internal expectations; Q2 guide < $500k; April 0 invoices	Near-term decline as priorities pivot
IOTA (CMS model) & Market Expansion	IOTA rollout expected to raise adverse events/testing demand	Field skepticism; net likely demand increase; anti-CD38 therapies tailwind	TAM expansion narrative
Oncology (DetermaIO)	NeoTRIP CCR publication; CMS submission; partner interest	Partner discussions; SWOG 800-patient readout hoped EOY; kitted possibilities	Optionality improving

Management Commentary

“It’s simpler, it’s faster and it offers better sample economics than NGS at low volumes.” — CEO Josh Riggs on digital PCR differentiation .
“At this time, we expect Q2 pharma services revenue to be less than $500,000. And we did not invoice for any services in the month of April, which really speaks to its lumpiness.” — CFO Andrea James .
“We continue to target FDA approval in the first half of 2026.” — CEO Josh Riggs reaffirming timing .
“Ten leading transplant centers are now using our GraftAssure RUO kits… first commercial orders are expected later this year.” — Shareholder letter .
“Our reported revenues of $2.14 million in Q1 2025… gross margin—up from 40% in Q4 2024… operational efficiencies… higher number of samples per batch.” — Shareholder letter .

Q&A Highlights

Oncology optionality: larger pharma customer exploring DetermaIO kit potential; positioning vs MSI/TMB, with colon cancer use cases .
DetermaIO milestones: SWOG study (800 patients, 5-year, 2-year follow-up) samples in-house; hopeful readout late 2025 (e.g., SABCS) .
Trial site enthusiasm & adoption curve: top centers “enthusiastic,” but risk-averse; estimate 6+ months integration before meaningful volume ramp .
IOTA impact & anti-CD38 tailwinds: likely demand increase; need to manage marginal organs; felzartamab/daratumumab data supports monitoring utility .
Q-Sub focus: FDA education on digital PCR specifics; five targeted questions to align on final submission acceptance; central IRB already approved; first samples imminent .

Estimates Context

S&P Global (Capital IQ) consensus estimates could not be retrieved for OCX due to a mapping error (Missing CIQ mapping). As a result, Wall Street consensus for revenue/EPS/EBITDA is unavailable for direct comparison this quarter [SpgiEstimatesError].
Given the unavailability of SPGI consensus, we benchmarked performance vs prior quarter and prior year. Values retrieved from company documents as cited above.

Key Takeaways for Investors

Margin proof-point: A 62% gross margin on $2.14M of revenue demonstrates the Nashville lab’s efficiency gains and validates scalability ahead of kit commercialization .
Near-term revenue will be muted: CFO guiding Q2 pharma services revenue < $500k, reflecting the strategic focus on clinical trial and RUO site unlock; do not extrapolate Q1 run-rate .
Regulatory milestones in sight: Final Q-Sub and YE submission targets are intact; de novo pathway provides category leadership optics; watch for clinicaltrials.gov listing and first patient-in .
Adoption trajectory favors 2026+: Expect staged integration at centers (6–9 months) with the largest revenue inflection in 2027 from day-one sites; narrative aligns with decentralized testing economics .
CMS reimbursement uplift: New $2,753 rate for GraftAssureCore underpins economic attractiveness and supports reimbursement “bridging” for the future FDA-cleared kit, a key commercialization catalyst .
Strategic optionality: Oncology (DetermaIO) partnering and SWOG study readout create upside optionality without distracting capital; focus remains squarely on transplant .
Liquidity and burn under control: ~$32.7M cash and targeted ~$6M/quarter burn provide runway through submission; monitor Q2/Q3 phasing and instrument purchases for trial sites .

Appendix: Additional Data Points and Notes

Non-GAAP reconciliation: Adjusted loss from operations improved to ($4.96M) in Q1 2025 vs ($5.59M) in Q3 2024 and ($4.36M) in Q4 2024 .
RUO pipeline and commercialization sequencing: First commercial RUO orders expected later in 2025; US site mix to skew higher ahead of launch .
Name/ticker change: Rename and new NASDAQ ticker anticipated in Q2 2025, executed on a tight budget to preserve capital for R&D and commercialization .

Citations:
All figures, quotes, and statements are sourced from Oncocyte’s Q1 2025 press release and 8-K , Q1 2025 earnings call transcript , Q4 2024 materials , Q3 2024 materials , Q2 2024 materials , and the May 19, 2025 CMS reimbursement update .

Oncocyte Corp (OCX)·Q1 2025 Earnings Summary