Executive Summary

Annexon reported Q2 2025 with net loss per share of $(0.34), modestly better than Wall Street EPS consensus of $(0.36); operating expenses stepped down sequentially as R&D declined with the accelerated completion of ARCHER II enrollment .
Cash and short-term investments were $227.0M at 6/30/25; management extended runway to the fourth quarter of 2026, an improvement vs. prior guidance of “second half 2026” .
Strategic updates were the quarter’s primary drivers: vonaprument (ANX007) ARCHER II Phase 3 fully enrolled at 659 patients ahead of plan, EMA selected the program for its PDC pilot, and tanruprubart (ANX005) progressed toward an EMA MAA in Q1 2026 while FDA BLA timing awaits clarity on the generalizability package .
Near-term catalysts: clarity on ANX005 U.S. path (BLA generalizability package), ANX1502 CAD proof-of-concept update by year-end 2025 (pushed from mid-2025), and continued regulatory milestones across eye and neuro segments—likely stock drivers as investors recalibrate probabilities of regulatory success and timelines .

What Went Well and What Went Wrong

What Went Well

Accelerated ARCHER II enrollment completion (659 patients) for vonaprument with topline data expected 2H 2026; EMA selected ANX007 for the PRIME PDC pilot, supporting an expedited regulatory engagement path .
ANX005 (tanruprubart) showed strong Phase 3 outcomes and is advancing toward global registration; EMA MAA planned for Q1 2026, and the company is engaging FDA on generalizability requirements to support a BLA .
Spending discipline: sequential decline in R&D and G&A from Q1 to Q2 drove an extended cash runway into Q4 2026, providing funding through vonaprument Phase 3 topline in GA .

Quote: “We are well positioned… by the consistent validation generated by our innovative C1 platform across multiple potential best-in-class therapeutics.” — CEO Douglas Love .

What Went Wrong

ANX1502 CAD POC timing pushed from “mid-2025” to an “update by year-end 2025,” introducing a delay to this first-in-kind oral C1s program’s data visibility .
Elevated R&D vs. prior-year comp (reflecting program advancement) kept losses higher YoY; net loss widened YoY to $(49.2)M from $(29.6)M, despite sequential improvement from Q1 .
No earnings call transcript was made available for Q2, limiting visibility into management’s Q&A commentary and any intra-quarter color; investor communication came primarily via press releases and the 8-K .

Financial Results

Quarterly trend (oldest → newest)

Metric	Q4 2024	Q1 2025	Q2 2025
R&D Expense ($M)	$43.35	$48.18	$44.16
G&A Expense ($M)	$9.13	$9.23	$7.57
Total Operating Expenses ($M)	$52.48	$57.41	$51.73
Net Loss ($M)	$(48.59)	$(54.36)	$(49.16)
Diluted EPS ($)	$(0.33)	$(0.37)	$(0.34)
Cash + Short-term Investments (EOQ) ($M)	$312.0	$263.7	$227.0

Year-over-year comparison

Metric	Q2 2024	Q2 2025
R&D Expense ($M)	$25.03	$44.16
G&A Expense ($M)	$8.55	$7.57
Total Operating Expenses ($M)	$33.58	$51.73
Net Loss ($M)	$(29.61)	$(49.16)
Diluted EPS ($)	$(0.23)	$(0.34)

Results vs. Estimates (Q2 2025)

EPS: Actual $(0.34) vs. Consensus $(0.36)* → beat by ~$0.02 (driven by lower opex q/q).*
Revenue: $0 (pre-revenue biotech) vs. Consensus $0.0* — in line .*

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

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through	“Second half of 2026” (as of 3/31/25)	“Into the fourth quarter of 2026” (as of 6/30/25)	Raised/Extended
ANX005 (tanruprubart) MAA	Europe	Not specified previously	MAA submission expected Q1 2026	New/Specified
ANX005 FDA BLA	U.S.	FDA meeting in Q2 2025 ahead of planned BLA	Ongoing FDA discussions; BLA timing update upon clarity on generalizability package	Timing pending/Under review
ANX007 (vonaprument) ARCHER II Enrollment	Global	Completion expected Q3 2025	Enrollment completed at 659 patients in Q2/Q3 timeline	Achieved earlier
ANX007 Topline Phase 3	Global	2H 2026	2H 2026 (unchanged)	Maintained
ANX1502 CAD POC	CAD	Completion mid-2025	Update by year-end 2025	Pushed/Delayed

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available; themes reflect prior quarters’ disclosures and the Q2 press release .

Topic	Previous Mentions (Q4’24 and Q1’25)	Current Period (Q2’25)	Trend
Regulatory: ANX005 (GBS)	Pre-BLA meeting targeted 1H25; strong Phase 3/RWE package	EMA MAA planned for Q1 2026; FDA BLA timing pending generalizability clarity	Advancing in EU; U.S. path pending
Ophthalmology: ANX007 (GA)	Registration path established; Phase 3 ARCHER II enrollment to complete 2H25	Enrollment completed (659); EMA PRIME PDC pilot; topline 2H26	Improving momentum
ANX1502 (oral C1s)	POC ongoing; mid-2025 dataset anticipated	Exposure exceeded target in fasted patients; POC update by year-end 2025	Timing pushed; pharmacology encouraging
Cash/OpEx	Cash $312M YE’24; runway into 2H26	Cash $227M 6/30; runway into Q4’26	Runway extended
External Engagement	AAN presentations; disease education campaign for GBS -	EMA PDC selection; enrollment announcement; conference participation	Stronger visibility

Management Commentary

“We are well positioned to achieve our mission… by the consistent validation generated by our innovative C1 platform across multiple potential best-in-class therapeutics.” — Douglas Love, President & CEO .
“We are actively engaged in global regulatory interactions… preparing to submit our MAA to the EMA in the first quarter of 2026… working with the FDA to gain clarity on the generalizability package to support a BLA submission.” — Douglas Love .
“We are… excited by the positive momentum of vonaprument… accelerated enrollment of our Phase 3 ARCHER II trial… on pace to deliver topline pivotal data in the second half of 2026.” — Douglas Love .
“We remain disciplined with our financial and operational execution, and are capitalized into the fourth quarter of 2026.” — Douglas Love .

Q&A Highlights

No Q2 2025 earnings call transcript was available; the company’s updates were communicated via the 8-K and press releases .
Key areas where investors would likely seek clarification: FDA BLA “generalizability package” requirements for ANX005, EMA interactions under the PDC pilot for ANX007, and drivers behind the ANX1502 POC update timing shift .

Estimates Context

EPS: Q2 2025 actual $(0.34) vs. consensus $(0.36)* — a modest beat likely reflecting lower sequential opex .*
Revenue: Pre-revenue; consensus $0.0* (inline) .*
FY 2025 EPS consensus: $(1.38); Target price consensus: $11.4 (5 estimates); EPS and revenue estimate counts: 4 and 6, respectively.*
Estimates marked with * are values retrieved from S&P Global.

Key Takeaways for Investors

Regulatory execution is the core driver: ANX005 EU MAA timing is now explicit (Q1 2026) while U.S. BLA timing awaits FDA feedback on generalizability—monitor for updates that could re-rate probability of approval .
Vonaprument’s faster-than-planned enrollment and EMA PDC selection de-risk operational execution and regulatory engagement; topline 2H26 remains the pivotal event for the ophthalmology franchise .
Cash runway extended to Q4 2026, now clearly through ARCHER II topline, reducing near-term financing overhang; sequential opex moderation supports this stance .
The ANX1502 timeline push introduces interim uncertainty for the oral C1s program; however, exposure exceeding target in fasted patients is an encouraging pharmacologic signal ahead of year-end update .
Stock catalysts over the next 6–12 months: ANX005 U.S. regulatory clarity (BLA path), EMA engagement milestones (ANX007 under PDC pilot), and ANX1502 POC update by year-end 2025 .
No non-GAAP adjustments were presented; disclosures remain GAAP-focused, which simplifies comparison across periods for opex and net loss .
For trading: incremental regulatory clarity—especially on ANX005 U.S. BLA acceptance path—could be a near-term upside catalyst; conversely, any further slippage on ANX1502 timelines may weigh on sentiment toward the oral franchise .