Executive Summary

Q2 2025 maintained clinical momentum and clarified regulatory timing: management now targets initiating the BLA submission for cretostimogene in Q4’25, narrowing prior “2H’25” guidance and reinforcing a path to first filing in BCG‑unresponsive HR NMIBC .
Operating scale-up continued: R&D rose to $31.3M and G&A to $17.4M as programs advanced and legal costs increased; net loss widened to $41.4M (–$0.54) vs $18.9M (–$0.28) YoY .
Balance sheet remains a strength with $661.1M in cash, cash equivalents and marketable securities (June 30, 2025), supporting operations into 1H’28; runway reiterated from Q1 .
Legal de‑risking catalyst: Delaware jury verdict removes a potential 5% future royalty on cretostimogene sales; management cited focus on redeploying resources toward execution .
Against S&P Global consensus, CGON posted an EPS miss (–$0.54 vs –$0.48*) and revenue below expectations ($0.00 vs $0.109M*) as the company remains pre‑commercial; we view the narrative as dominated by clinical/regulatory milestones over near-term P&L beats/misses . Values retrieved from S&P Global.

What Went Well and What Went Wrong

What Went Well
- Clarified timeline to filing: “poised to initiate our BLA submission … in the fourth quarter of the year” for HR BCG‑unresponsive NMIBC, narrowing prior guidance and improving visibility .
- Best‑in‑disease durability reinforced: BOND‑003 Cohort C reported 75.5% CR at any time, 12/24‑month CR rates of 50.7%/42.3% (K‑M), median DoR 28 months ongoing; 97.3% progression‑free from muscle‑invasive disease at 24 months .
- Legal overhang removed: unanimous Delaware jury verdict eliminates a potential 5% royalty obligation to ANI on future cretostimogene sales, a material long‑term economic de‑risking .
What Went Wrong
- Wider loss per share than consensus as scale‑up continued: –$0.54 vs –$0.48*; operating expenses grew with clinical trial activity, headcount, and legal costs . Values retrieved from S&P Global.
- No revenue recognized in Q2 (pre‑commercial), below modest expectations ($0.109M*), keeping near‑term financials reliant on financing cash and interest income . Values retrieved from S&P Global.
- Expense intensity rising YoY: R&D $31.3M vs $18.5M; G&A $17.4M vs $7.5M; signals investment needs ahead of regulatory and potential commercial transition .

Results vs prior periods (USD millions except per-share)

Metric	Q2 2024	Q1 2025	Q2 2025
License & collaboration revenue	$0.111	$0.052	$0.000
R&D expense	$18.470	$27.467	$31.331
G&A expense	$7.494	$14.789	$17.410
Total operating expenses	$25.964	$42.256	$48.741
Net loss	$(18.902)	$(34.452)	$(41.426)
Diluted EPS ($)	$(0.28)	$(0.45)	$(0.54)

Consensus vs actual (Q2 2025)

Metric	Actual	Consensus
Diluted EPS ($)	$(0.54)	$(0.48)*
Revenue ($M)	$0.000	$0.109*

Values retrieved from S&P Global.

Balance sheet liquidity (cash, cash equivalents & marketable securities)

Metric	Q4 2024	Q1 2025	Q2 2025
Cash, cash equivalents & marketable securities ($M)	$742.0	$688.4	$661.1

Clinical KPIs (select BOND‑003 / CORE‑008 program metrics)

KPI	Detail
BOND‑003 Cohort C CR at any time	75.5% (83/110); 12‑mo CR 50.7%; 24‑mo CR 42.3% (K‑M)
Duration / progression	Median DoR 28 months (ongoing); 97.3% free from progression to muscle‑invasive disease at 24 months
BOND‑003 Cohort P (Ta/T1, no CIS)	Estimated 90.5% high‑grade recurrence‑free survival at 3 and 9 months in 24 treated pts

Metric	Period	Previous Guidance	Current Guidance	Change
BLA submission (cretostimogene, HR BCG‑unresponsive NMIBC)	2025	Initiate in 2H’25	Initiate in Q4’25	Refined timeline (more specific)
PIVOT‑006 enrollment completion (intermediate‑risk)	2025	Complete in 2H’25	Complete in 3Q’25	Refined earlier window
BOND‑003 Cohort P topline	2025	2H’25	4Q’25	Refined timing
CORE‑008 Cohort A topline	2025	2H’25	4Q’25	Refined timing
Cash runway	Multi‑year	Funded into 1H’28	Funded into 1H’28	Maintained

Note: A Q2’25 call transcript was not posted/available as of this analysis; themes reflect press release and prior disclosures .

Topic	Previous Mentions (Q4 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory path (BLA)	Anticipated BLA initiation in 2H’25	BLA initiation targeted for Q4’25	Increasing clarity
Durability/efficacy data	74.5% CR, DoR >27 mo (SUO 2024); updated 75.5% CR, DoR >28 mo (EAU 2025)	Best‑in‑disease durability reaffirmed; 12/24‑mo CR 50.7%/42.3%	Strengthening dataset
Legal overhang	Not discussed previously	Jury verdict eliminates potential 5% royalty to ANI	De‑risking
Cash runway	Into 1H’28	Into 1H’28	Stable
R&D execution	CORE‑008 Cohort CX initiated in April	Program progress reiterated; multiple 2H’25 toplines targeted	On track

“We remain laser focused on bringing forward cretostimogene… The recent positive outcome of the ANI litigation allows us to continue to focus our resources and energy on delivering this innovative therapy. We are poised to initiate our BLA submission… in the fourth quarter” — Arthur Kuan, CEO .
“Best‑in‑disease durability and tolerability data from the Phase 3 BOND‑003 Cohort C registrational trial” — framing Q2 updates and differentiation .

A Q2 2025 earnings call transcript was not available at the time of this analysis; no verbatim Q&A themes could be validated. MarketBeat listed a call time (Aug 8, 8:00am ET) but did not provide the full transcript .

EPS: –$0.54 actual vs –$0.48 consensus mean (9 ests*) — modest miss as operating costs scaled with late‑stage programs . Values retrieved from S&P Global.
Revenue: $0.00 actual vs $0.109M consensus mean (7 ests*) — company remains pre‑commercial . Values retrieved from S&P Global.
Implication: We expect minimal changes to out‑year revenue estimates near term; focus of estimate revisions likely shifts to opex cadence and the timing/probability of regulatory milestones rather than quarterly P&L.

Regulatory visibility improved: BLA initiation targeted for Q4’25; watch for completeness of the initial module and FDA interactions as timing catalysts .
Clinical narrative remains favorable: durability and tolerability data continue to screen best‑in‑disease, supporting a potential differentiated profile in HR NMIBC .
Legal de‑risking boosts long‑term economics: the ANI verdict removes a potential 5% royalty on future sales, enhancing eventual profitability if approved .
Cash runway to 1H’28 provides execution time without near‑term financing pressure; interest income offsets some opex while pre‑commercial .
Near‑term trading catalysts: BLA initiation in Q4, PIVOT‑006 enrollment completion in 3Q’25, and multiple topline data readouts (BOND‑003 Cohort P; CORE‑008 Cohort A) in 4Q’25 .
Risk watch: execution on BLA quality/timing, regulatory feedback, and maintaining strong safety/efficacy signals in forthcoming readouts .

Additional relevant press releases during Q2 2025:

Delaware Superior Court Jury verdict eliminating potential future royalties to ANI (July 29, 2025) .
Participation announcement: Goldman Sachs 46th Annual Global Healthcare Conference (June 5, 2025) .

Notes