Executive Summary

Q3 2025 EPS of -$0.31 missed Wall Street consensus of -$0.24 by $0.07; revenue was $0.02M vs $0.00M consensus, reflecting minimal cost-reimbursement revenue while development spending stepped up for Phase 2 acute studies in asthma/COPD (4 estimates). Results matched the 8-K and 10-Q figures.* [Values retrieved from S&P Global]
Cash, cash equivalents and short-term investments were $54.8M at 9/30/25; management reiterated runway into 2027. Cash declined from $71.8M at 6/30/25 as R&D ramped with study initiations.
Execution remained on-track: Phase 2 Seabreeze STAT acute-exacerbation studies in asthma and COPD are recruiting, with topline data expected 1H26; Simcere’s NDA for rademikibart in atopic dermatitis was accepted by China’s NMPA; positive ERS 2025 data underscored rapid lung-function gains across Type 2 markers.
Corporate simplification completed: ADR program terminated and ordinary shares directly listed on Nasdaq under CNTB, aimed at improving visibility and eliminating depositary fees. Near-term stock catalysts center on 1H26 Phase 2 readouts and potential China AD approval/milestones.

What Went Well and What Went Wrong

What Went Well
- Clinical momentum: Seabreeze STAT Phase 2 (asthma/COPD) enrollment ongoing; topline data expected 1H26. “We are focused on patient recruitment and clinical execution in both studies and expect to deliver topline data in the first half of 2026.” — Barry Quart, CEO.
- China progress: Simcere’s NDA for rademikibart (AD) accepted by NMPA; remaining milestones up to ~$110M and tiered royalties up to low double-digits remain possible upon achievements.
- Scientific validation: ERS 2025 analyses supported rapid, significant FEV1 and asthma control improvements, with greatest gains in higher EOS/FeNO subgroups.
What Went Wrong
- Revenue collapsed YoY as prior-year Simcere upfront/milestones rolled off: Q3 revenue $0.016M vs $1.219M in Q3 2024.
- Operating spend rose with clinical execution: R&D $11.1M (+23% YoY) and G&A $6.6M (+8% YoY), driving wider net loss (-$17.2M vs -$12.9M LY).
- Other income fell vs prior year, contributing to wider loss; management cited lower government subsidies and lower interest income vs 2024.

Financial Results

P&L and cash (oldest → newest; $USD Millions unless noted)

Metric	Q3 2024	Q2 2025	Q3 2025 (Actual)	Q3 2025 Cons. Mean*
License & collaboration revenue	$1.219	$0.048	$0.016	$0.000*
R&D expense	$9.009	$8.773	$11.110	—
G&A expense	$6.056	$4.699	$6.583	—
Net (loss)	$(12.876)	$(12.899)	$(17.200)	—
Diluted EPS ($)	$(0.23)	$(0.23)	$(0.31)	$(0.24)*
Cash & short-term investments (period-end)	—	$71.768	$54.781	—

Notes: Q3 2025 figures per 8-K/10-Q; consensus from S&P Global (4 estimates for both EPS and revenue). Values with asterisks retrieved from S&P Global.

KPIs and operating context

KPI	Q1 2025	Q2 2025	Q3 2025
Cash, cash equivalents & ST investments ($M)	$83.995	$71.768	$54.781
Shares outstanding (WASO, basic & diluted, M)	55.352	55.498	55.716
Other income, net ($M)	$1.229	$0.580	$0.538

Margin context: Net income margin is not meaningful given de minimis revenue and clinical-stage profile.

Cross-check: Q3 2025 10-Q matches 8-K line items and per-share metrics.

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash runway	Multi‑year	“Fund operations into 2027” (Q2 2025)	“Fund operations into 2027” (Q3 2025)	Maintained
Phase 2 Seabreeze STAT topline (asthma/COPD)	1H26	1H26 (Q2 2025)	1H26 (Q3 2025)	Maintained
ADR program status	2025	Termination planned; direct listing intended (Q2 2025)	ADR terminated; ordinary shares directly listed on Nasdaq (Q3 2025)	Completed

No revenue/margin/OpEx/tax-rate guidance was issued.

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 & Q1 2025)	Current Period (Q3 2025)	Trend
Acute-exacerbation strategy (asthma/COPD)	Phase 2 Seabreeze STAT initiated; topline 1H26 targeted.	Enrollment ongoing; topline 1H26 reaffirmed.	Consistent execution
China/Simcere milestones	NDA submission announced (Jul 9). Milestones remaining up to ~$110M.	NDA acceptance by NMPA; milestones/royalties reiterated.	Positive regulatory progress
U.S.-centric pivot	Announced ADR termination plan and board strengthening.	ADR termination completed; direct Nasdaq listing.	Completed structural shift
Scientific validation	ATS/EAACI 2025 data supported rapid FEV1 and reduced exacerbations.	ERS 2025 data reinforced rapid lung function and control in Type 2 markers.	Strengthening clinical narrative
Manufacturing/readiness	U.S. CMO transfer in progress; multiple batches made (webinar).	Continuing process development; IV PK pilot ongoing (webinar).	Building for Phase 3
Estimates vs reality	No specific prior discussion.	EPS miss vs consensus due to higher OpEx; revenue minimal as expected.	Monitor estimate resets

Management Commentary

“We are focused on patient recruitment and clinical execution in both studies and expect to deliver topline data in the first half of 2026.” — Barry Quart, CEO, Q3 press release.
“We saw… over 70% of the [one-week FEV1] benefit was already achieved the very next morning after a dose [of rademikibart].” — Barry Quart, Nov 3 investor webinar.
“We’ve powered the [acute] studies for a 50% reduction in treatment failure… achieving that goal would be… a very dramatic improvement.” — Barry Quart, Nov 3 investor webinar.
“We have a very strong cash position… with $72 million in the bank as of the end of second quarter… we have cash into 2027.” — Barry Quart, Nov 3 investor webinar.

Q&A Highlights

Acute program design and expectations: Trials powered for ~50% reduction in 28‑day treatment failure (return visits/new exacerbations); anticipates onset within 24 hours sub‑Q, exploring IV to compress onset to minutes.
Competitive positioning: No biologic competitors labeled/positioned for acute treatment; rademikibart’s rapid onset and eosinophil profile vs dupilumab highlighted.
Partnering and non-dilutive funding: Actively discussing regional partnerships; milestone inflows possible upon China approvals; goal to partner before chronic Phase 3.
Manufacturing and scalability: Multiple successful CMO batches; high‑yield cell line transfer planned to support Phase 3 and pricing flexibility across hospital/outpatient settings.

Note: A formal Q3 2025 earnings call transcript was not available in our document set; the Nov 3 investor webinar transcript was used for management Q&A context.

Estimates Context

EPS: Actual -$0.31 vs consensus -$0.24 (miss $0.07; 4 estimates). Revenue: Actual $0.016M vs consensus $0.000M (in‑line to marginally above a de minimis base; 4 estimates).* [Values retrieved from S&P Global]
Estimate recalibration: With the spend cadence rising and revenue limited to cost reimbursements absent new milestones, models may need lower near‑term EPS and minimal revenue until 1H26 data/China events potentially unlock milestone recognition.

Key Takeaways for Investors

Near-term binary catalysts sit outside P&L: 1H26 acute-exacerbation Phase 2 toplines (asthma/COPD) and China AD decision could re-rate the stock; until then, financial prints will mainly reflect clinical burn and minimal revenue.
Q3 miss was OpEx-driven; not thesis-breaking for a clinical-stage name focused on rapid-onset acute use — a differentiated angle with limited head-to-head competition today.
Cash runway into 2027 provides execution visibility through key readouts; watch quarterly cash burn and any incremental non-dilutive inflows from Simcere or new partners.
Scientific narrative is strengthening (ERS/ATS/EAACI): rapid FEV1 effects and favorable eosinophil safety profile vs dupilumab support acute positioning.
Corporate cleanup (ADR termination; direct listing) may broaden ownership and liquidity; investor engagement messaging is aligned with U.S.-centric strategy.
Upside optionality from Simcere milestones/royalties (AD first, asthma potentially later) remains a secondary but material lever to extend runway or reduce dilution.
Risk factors: execution/timing of enrollment, readout risk in acute settings, and limited near-term revenue streams; monitor “other income” trends as a smaller offset to burn.

Supporting Data (Detail)

Condensed statement items (Q3 2025 vs prior periods)

Metric	Q3 2024	Q2 2025	Q3 2025
License & collaboration revenue ($M)	$1.219	$0.048	$0.016
Research & development expense ($M)	$9.009	$8.773	$11.110
General & administrative expense ($M)	$6.056	$4.699	$6.583
Other income, net ($M)	$1.027	$0.580	$0.538
Net (loss) ($M)	$(12.876)	$(12.899)	$(17.200)
Diluted EPS ($)	$(0.23)	$(0.23)	$(0.31)

Balance sheet/cash

Metric	3/31/25	6/30/25	9/30/25
Cash & cash equivalents ($M)	$83.995	—	$37.845
Short-term investments ($M)	—	—	$16.936
Cash + ST investments ($M)	$83.995	$71.768	$54.781

Clinical and regulatory milestones referenced

ERS 2025: Rapid and significant improvement in lung function and asthma control across Type 2 markers; greatest improvements with EOS ≥300/µL and FeNO ≥25 ppb.
China NMPA: NDA for AD accepted (Simcere), with remaining potential milestones up to ~$110M plus tiered royalties.
ATS/EAACI 2025 earlier in the year also supported efficacy/safety in Type 2 asthma.
Seabreeze STAT topline guidance maintained at 1H26.

Additional references

Company Q3 2025 press release (IR site/GlobeNewswire).
Investor webinar transcript (Nov 3, 2025) covering strategic positioning and Q&A.
Q3 2025 10-Q cross-check of financials and disclosures.

Estimate disclaimer: *Values retrieved from S&P Global.

Connect Biopharma Holdings Ltd (CNTB)·Q3 2025 Earnings Summary