Name: Replimune Group, Inc. Q2 2026 Earnings Call
Start: 2025-11-06T13:20:39.000Z

Executive Summary

Q2 FY2026 EPS of -$0.90 missed Wall Street consensus of -$0.79*, with no revenue reported; net loss was $83.1M as operating expenses moderated sequentially while remaining elevated YoY .
Cash, cash equivalents and short-term investments fell to $323.6M from $403.3M in Q1 and $483.8M in Q4 FY2025; management reiterated a cash runway “late into the fourth quarter of 2026” .
FDA accepted the RP1 BLA resubmission with an April 10, 2026 PDUFA target action date; Type A meeting minutes indicated IGNYTE-3 could potentially support approval, reframing the regulatory narrative post-CRL .
Updated clinical/biomarker data at SITC showed RP1+nivolumab reversing resistance mechanisms with ORR 33.6% and median DOR 24.8 months; acral melanoma analysis presented at ESMO showed 44% ORR, supporting efficacy signals ahead of PDUFA .

What Went Well and What Went Wrong

FDA accepted RP1 BLA resubmission; IGNYTE-3 “could potentially support approval.” CEO: “We are currently partnering with the agency on the ongoing review to bring this important therapy to patients.” .
SITC late-breaking abstract: RP1+nivolumab upregulated gene signatures linked to PD-1 responsiveness; ORR 33.6% with 24.8-month median DOR, consistent responses across PD-L1 strata and resistance settings .
ESMO acral melanoma subgroup: ORR 44% (8/18) with 11.9-month median DOR; favorable safety with mostly transient grade 1–2 TRAEs .

EPS missed consensus; reported -$0.90 vs -$0.79*, reflecting sustained R&D and SG&A investment for IGNYTE-3 and commercialization readiness .
YoY operating expenses rose (R&D $57.9M vs $43.4M; SG&A $26.4M vs $15.5M), widening YoY net loss ($83.1M vs $53.1M) .
Rapid cash burn (cash down to $323.6M from $403.3M in Q1 and $483.8M in Q4), compressing balance sheet metrics (equity $263.3M vs $336.7M in Q1) .

Metric	Q4 FY2025	Q1 FY2026	Q2 FY2026
Net Loss ($USD Millions)	$74.1	$86.7	$83.1
Net Loss per Share ($)	N/A	$(0.95)	$(0.90)
R&D Expense ($USD Millions)	$54.0	$57.8	$57.9
SG&A Expense ($USD Millions)	$25.4	$32.6	$26.4
Total Operating Expenses ($USD Millions)	N/A	$90.4	$84.3
Cash, Cash Equivalents & ST Investments ($USD Millions)	$483.8	$403.3	$323.6
Working Capital ($USD Millions)	$433.5	$353.8	$280.8
Total Assets ($USD Millions)	$551.3	$469.5	$389.5
Total Stockholders’ Equity ($USD Millions)	$415.8	$336.7	$263.3

KPIs and clinical signals:

KPI	Q4 FY2025	Q1 FY2026	Q2 FY2026
RP1+nivolumab IGNYTE ORR (%)	N/A	N/A	33.6
RP1+nivolumab IGNYTE Median DOR (months)	N/A	N/A	24.8
Acral Melanoma ORR (%)	N/A	N/A	44
Acral Melanoma Median DOR (months)	N/A	N/A	11.9

Estimates comparison:

Metric	Q1 FY2026 Estimate	Q1 FY2026 Actual	Q2 FY2026 Estimate	Q2 FY2026 Actual
EPS ($)	-$0.80*	-$0.95	-$0.79*	-$0.90
Revenue ($USD Millions)	$0.00*	N/A	$0.50*	N/A

Values marked with * retrieved from S&P Global.

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	FY2026	“Into Q4 2026” (as of 3/31/25)	“Late into Q4 2026” (as of 9/30/25)	Maintained (clarified timing)
RP1 BLA Status	Advanced Melanoma	CRL received July 21, 2025	BLA resubmission accepted; PDUFA April 10, 2026	Raised (path to potential approval restored)
IGNYTE-3 Role	Confirmatory	Post-CRL design to be discussed with FDA	FDA indicated IGNYTE-3 could potentially support approval	Positive regulatory signal
RP2 HCC Protocol	Phase 2	RP2 + atezolizumab/bevacizumab; data H1 2026	Protocol amended to include RP2 monotherapy; data by end of 2026	Timeline extended; scope broadened

Topic	Previous Mentions (Q4 FY2025)	Previous Mentions (Q1 FY2026)	Current Period (Q2 FY2026)	Trend
Regulatory/Legal	Priority review on schedule; launch-ready ahead of July 22 PDUFA	CRL received; path forward with FDA; IGNYTE-3 design to be discussed	BLA resubmission accepted; PDUFA 4/10/26; IGNYTE-3 could support approval	Recovering/regulatory momentum
R&D Execution (RP1)	Global IGNYTE-3 enrollment underway	Continued evaluation across NMSC; ARTACUS monotherapy data encouraging	SITC biomarker/clinical updates (ORR/DOR); ESMO acral melanoma data	Strengthening clinical narrative
Commercial Readiness	Full commercial infrastructure in place pre-PDUFA	Scaling personnel/medical affairs pre-launch	Continued prep for potential RP1 launch; elevated SG&A	Ongoing investment
Cash/Runway	$483.8M; runway into Q4 2026	$403.3M; into Q4 2026	$323.6M; late into Q4 2026	Cash burn sustained
RP2 Program	REVEAL uveal melanoma enrolling	REVEAL ongoing; HCC trial enrolling	HCC protocol amended; BTC cohort to begin in Q4 2025	Broader development scope

CEO on BLA acceptance: “We are currently partnering with the agency on the ongoing review to bring this important therapy to patients.” .
CEO on RP1 post-CRL: “We are committed to finding an expeditious path forward with the FDA.” .
CMO on SITC data: “RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade.” .
Strategic focus: Maintain IGNYTE-3 momentum and broaden RP2 program while preserving late-Q4 FY2026 runway .

The Q2 FY2026 earnings call transcript was not accessible via our tools; MarketBeat lists the conference call as Nov 6, 2025 at 8:30am ET, but no transcript content is available to extract Q&A themes .
No guidance clarifications beyond press release disclosures could be confirmed due to transcript unavailability .

EPS: Q2 FY2026 actual -$0.90 vs consensus -$0.79* (miss of -$0.11); Q1 actual -$0.95 vs -$0.80* (miss of -$0.15). Persistent opex investment drove underperformance vs consensus despite sequential opex moderation .
Revenue: Company did not report revenue; consensus expected $0.50M* in Q2 and $0.00M* in Q1. The pre-revenue status remains consistent with clinical-stage profile.
Estimates likely need to reflect: sustained SG&A for launch readiness, IGNYTE-3 costs in R&D, and the PDUFA timing shift to April 2026.
Values marked with * retrieved from S&P Global.

Regulatory path re-established: RP1 BLA resubmission acceptance with 4/10/26 PDUFA and FDA signaling IGNYTE-3 could support approval resets the medium-term catalyst calendar .
Clinical momentum: SITC/ESMO data reinforce efficacy/durability claims and mechanistic rationale, supporting approval prospects and potential label discussions post-approval .
Cash runway to late Q4 FY2026 provides operational flexibility through PDUFA and early commercialization, but burn rate warrants monitoring as SG&A and R&D remain high .
Near-term trading lens: Expect stock sensitivity to FDA interactions, IGNYTE-3 updates, and SITC/ESMO data reception; an additional data de-risking could improve sentiment into PDUFA .
Estimate revisions: Consensus should reflect continued opex, lack of revenue until commercialization, and timing changes in RP2 programs; EPS misses driven by investment rather than execution shortfalls .
Watch confirmatory design clarity: Detailed IGNYTE-3 operational progress and endpoints (OS primary) may shape payer and clinician expectations post-approval .
Risk checks: Prior CRL and compressed balance sheet necessitate tight execution on manufacturing, commercial build, and regulatory timelines; emphasis on capital discipline through 2026 .