Executive Summary

Q1 FY2026 was overshadowed by the July 22 FDA Complete Response Letter (CRL) for RP1; the FDA said IGNYTE was not an adequate and well‑controlled study providing substantial evidence of effectiveness, with no safety issues raised, leading to a ~77% one‑day stock decline and pivot to pursue alignment on the confirmatory Phase 3 IGNYTE‑3 design .
Operating expenses rose sharply (R&D $57.8M; SG&A $32.6M), driving a wider net loss of $86.7M and diluted EPS of $(0.95), missing S&P Global consensus EPS of $(0.80), largely due to scale‑up for commercial launch ahead of the CRL .
Liquidity remains solid: cash, cash equivalents and short‑term investments were $403.3M with working capital of $353.8M; runway maintained “into 4Q26,” unchanged from the prior quarter .
Pipeline execution continues: IGNYTE‑3 ongoing; RP2 trials enrolling (uveal melanoma, HCC), and ARTACUS showed 34.6% ORR in transplant patients with no RP1‑related allograft rejection; management “committed to finding an expeditious path forward with the FDA” .

What Went Well and What Went Wrong

What Went Well
- Maintained cash runway into 4Q26 despite higher spend; $403.3M cash/cash equivalents/short‑term investments and $353.8M working capital at quarter‑end .
- Pipeline momentum: IGNYTE‑3 Phase 3 ongoing; RP2 REVEAL (uveal melanoma) enrolling; RP2 HCC trial enrolling; BTC cohort planned 2H25 .
- ARTACUS in transplant patients: no RP1‑related allograft rejection; 34.6% ORR with 24‑month DoR in 61% of responders (ITT) .
- CEO tone: “We are committed to finding an expeditious path forward with the FDA” post‑CRL .
What Went Wrong
- Regulatory setback: FDA CRL for RP1 BLA; FDA indicated IGNYTE is not adequate and well‑controlled for substantial evidence of effectiveness; also flagged confirmatory trial design items (e.g., contribution of components) .
- Financials: EPS $(0.95) missed S&P Global consensus $(0.80) as R&D and SG&A stepped up for launch readiness .
- Stock reaction and litigation overhang: shares fell ~77% on the CRL; multiple law firm investigations/class‑action filings added noise .

Financial Results

P&L snapshot (oldest → newest)

Metric	Q3 2025	Q4 2025	Q1 2026
Net Loss ($USD Millions)	$(66.34)	$(74.10)	$(86.69)
Diluted EPS ($)	$(0.79)	$(0.82)*	$(0.95)

Liquidity (oldest → newest)

Metric	Q3 2025	Q4 2025	Q1 2026
Cash, Cash Equivalents & Short‑Term Investments ($USD Millions)	$536.54	$483.80	$403.34
Working Capital ($USD Millions)	$499.69	$433.52	$353.81

Operating Expense KPIs (oldest → newest)

Metric	Q3 2025	Q4 2025	Q1 2026
R&D Expense ($USD Millions)	$48.00	$54.00	$57.84
SG&A Expense ($USD Millions)	$18.02	$25.40	$32.58

Notes:

Replimune reported no product revenue; the income statement begins with operating expenses (pre‑revenue biotech) .
Items marked with * are values retrieved from S&P Global.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through	“Fund operations into 4Q26” (as of Mar 31, 2025)	“Fund operations into 4Q26” (as of Jun 30, 2025)	Maintained
RP1 Regulatory	2025	Priority review; PDUFA 7/22/25; no AdCom	CRL received 7/22/25; plan to discuss IGNYTE‑3 design with FDA	Negative update
RP2 HCC Data	1H 2026	—	Data anticipated 1H 2026	New timing detail
RP2 BTC First Patient	2H 2025	—	First patient 2H 2025	New timing detail

Earnings Call Themes & Trends

(Tracking narrative across Q3 2025, Q4 2025, and current Q1 2026)

Topic	Q3 2025 (prior‑2)	Q4 2025 (prior‑1)	Q1 2026 (current)	Trend
RP1 Regulatory Status	BLA accepted; priority review; PDUFA 7/22/25	Late‑cycle meeting and manufacturing inspections complete; on track for PDUFA	CRL; IGNYTE deemed not adequate/well‑controlled; no safety issues; plan FDA dialogue on IGNYTE‑3	Negative inflection post‑CRL
Commercial Readiness	“Well‑capitalized to execute” launch plans	“Commercial infrastructure fully hired; distribution and payer groundwork ready; >350 key accounts targeted”	Not reiterated in Q1 PR; implied deferral pending regulatory path	On hold pending FDA
Manufacturing	In‑house U.S. manufacturing capacity highlighted	Produced commercial inventory; resilient capacity; attractive COGS	Not updated in Q1 PR; capacity presumed intact	Stable
Confirmatory Trial (IGNYTE‑3)	Enrolling; ~400 pts planned	Enrollment on track; >100 global sites planned	Ongoing; design to be discussed with FDA post‑CRL	Continuing; design alignment needed
RP2 Pipeline	First pts enrolled (uveal melanoma, HCC)	Emphasis on RP2 future development	REVEAL (uveal) enrolling; HCC enrolling; BTC cohort 2H25	Advancing
Cash Runway	Into 4Q26	Into 4Q26	Into 4Q26	Maintained

Management Commentary

“Based on the compelling clinical data and safety profile… the melanoma community… strongly believe RP1 should be made available… We are committed to finding an expeditious path forward with the FDA.” — Sushil Patel, CEO (Q1 PR) .
“Our U.S. manufacturing facility has produced commercial inventory to support the RP1 launch, with capacity to support long‑term global demand.” — Sushil Patel (Q4 call) .
“We remain on track for our July 22 PDUFA.” — Emily Hill, CFO (Q4 call, pre‑CRL) .
“ARTACUS… well tolerated with no cases of RP1‑related allograft rejection… ORR 34.6% with DoR of 24 months in 61%” — (Q1 PR) .

Q&A Highlights

Launch adoption and account readiness: ~350 key accounts identified; ~150 expected to have intratumoral injection experience by launch; >90% of interviewed clinicians expressed willingness to use RP1 upon approval .
ASCO education and data: planned posters on superficial vs visceral injection outcomes and biosafety analyses to support practice adoption (pre‑CRL) .
Access enablement: immediate compendia submissions and EMR integration strategy to minimize administrative barriers (pre‑CRL) .
Manufacturing resiliency and COGS: in‑house facility designed for RPx scale; attractive cost of goods profile highlighted .
Financial disclosure cadence: company planned to share early launch metrics before providing revenue guidance (pre‑CRL) .

Note: No Q1 FY2026 earnings call transcript was found in our document set; Q&A insights are from the Q4 FY2025 call [ListDocuments 2025‑08 to 2025‑09 returned no Q1 transcript] -.

Estimates Context

Consensus vs. Actual (Q1 FY2026)

Metric	Consensus	Actual	Surprise
Revenue ($USD Millions)	$0.0*	$0.0 (pre‑revenue; no revenue line item reported)	In‑line
Diluted EPS ($)	$(0.80)*	$(0.95)	Miss (driven by higher R&D and SG&A supporting launch readiness)

Items marked with * are values retrieved from S&P Global.

Where estimates may need to adjust: with the CRL deferring potential commercialization, near‑term expense cadence and cash runway assumptions may shift; street models should remove near‑term product revenue and reflect continued opex for IGNYTE‑3 and regulatory engagement .

Key Takeaways for Investors

Regulatory reset: CRL fundamentally delays commercialization; near‑term thesis pivots to achieving FDA alignment on IGNYTE‑3 and clarifying a registrational path; no safety concerns were cited by FDA .
Expense discipline vs. enablement: step‑up in R&D and SG&A (Q/Q and Y/Y) reflects pre‑launch build; expect continued investment in IGNYTE‑3 and RP2 programs while re‑prioritizing commercial spend post‑CRL .
Liquidity adequate: $403.3M cash and runway into 4Q26 provide time to pursue regulatory and clinical milestones without near‑term financing, assuming spend aligned to the updated path .
Pipeline diversification matters: RP2 (uveal melanoma, HCC, planned BTC) offers additional shots on goal; monitor 1H26 HCC readout timing and REVEAL enrollment updates for value inflection .
Trading lens: stock’s ~77% CRL drawdown reflects binary risk crystallization; incremental stock drivers are (1) clarity on FDA feedback for IGNYTE‑3, (2) any BLA remediation strategy, and (3) RP2 data cadence .
Operational assets remain intact: in‑house manufacturing capacity, established account targeting, and IR/oncology coordination platform could be re‑activated if/when regulatory path re‑opens .
Estimate adjustments: remove near‑term revenues; widen EPS losses in the near term given continued R&D and regulatory costs until approval visibility improves .

Appendix: Additional Quantitative Details

Q1 FY2026 Income Statement Highlights

Total operating expenses: $90.4M; R&D $57.8M (incl. $4.7M SBC), SG&A $32.6M (incl. $4.1M SBC) .
Net loss: $86.7M; diluted EPS $(0.95); shares outstanding ~91.5M .

CRL Summary (July 22, 2025)

FDA unable to approve RP1 BLA in present form; IGNYTE deemed not adequate and well‑controlled; confirmatory study design issues (e.g., contribution of components); no safety issues raised .
Company acknowledged CRL and intent to engage FDA; Q1 PR reiterated intent to discuss IGNYTE‑3 design .

Stock Reaction

Shares fell ~77% on July 22, 2025 following CRL disclosure .

Replimune Group, Inc. (REPL)·Q1 2026 Earnings Summary