ANNX (Annexon Biosciences) Q4/FY2025 Earnings & Business Update

Price: $4.96 (as of March 30 close) Market Cap: ~$745M Shares Outstanding: ~150M Stage: Late clinical (Phase 3 / MAA filed) Focus: Classical complement pathway (C1q inhibition). Three programs across ophthalmology, neurology, and autoimmune

The Numbers

• Revenue: Zero. Pre-revenue, clinical stage

• R&D FY2025: $184.7M (up from $119.4M, driven by Phase 3 ARCHER II enrollment and GBS regulatory filings)

• R&D Q4 2025: $42.7M (vs $43.4M prior year, essentially flat)

• G&A FY2025: $31.7M (down from $34.6M, disciplined cost management)

• G&A Q4 2025: $7.6M (vs $9.1M, nice trim)

• Net Loss FY2025: $208.5M ($1.34/share, vs $138.2M/$1.01 in 2024. Loss widened due to ARCHER II Phase 3 spend)

• Net Loss Q4 2025: $48.3M ($0.28/share, vs $48.6M/$0.33)

• Cash (Dec 31, 2025): $238.3M (includes $86.3M from November 2025 public offering)

• Runway: Into H2 2027

$238.3M cash with quarterly burn around $48M gives roughly 5 quarters of runway, consistent with H2 2027 guidance. The November raise was smart timing, got the capital before the pivotal data reads.

Pipeline

Vonaprument (ANX007, C1q inhibitor, geographic atrophy/dry AMD): This is the big one. ARCHER II is an ongoing global pivotal Phase 3, 659 patients, sham-controlled. Enrollment completed July 2025. Primary endpoint is proportion of patients with confirmed 15-letter BCVA loss through month 15. This is the first GA study using vision preservation as the primary endpoint, not lesion growth. That's a differentiated approach. Downstream C3/C5 inhibitors (Apellis/Syfovre, Astellas/Iveric) slow lesion growth but haven't shown vision preservation. C1q blockade upstream is designed to protect functional photoreceptors directly. EMA gave PRIME designation and selected vonaprument for the exclusive Product Development Coordinator pilot. Topline data Q4 2026.

Tanruprubart (ANX005, C1q inhibitor, Guillain-Barre syndrome): MAA filed with EMA. Potential first targeted fast-acting therapy for GBS, which affects ~150,000 people annually worldwide. Currently treated with IVIg and plasma exchange, neither of which are targeted therapies. Data package showed rapid and durable benefit on function and disability versus placebo, plus favorable outcomes versus IVIg and PE in real-world evidence. FORWARD study ongoing in US/Europe to broaden Western experience including pediatric patients. BLA submission planned 2026.

ANX1502 (oral C1 inhibitor, autoimmune): First-in-kind oral small molecule inhibiting activated C1s. POC study ongoing in cold agglutinin disease. Twice-daily dosing, evaluating PK/PD and hemolysis markers. Adjusted dose timing relative to food intake based on early patient learnings. POC data expected 2026. This is the earlier stage optionality play but an oral complement inhibitor would be a big deal commercially.

Analyst Coverage

7 analysts covering. 5 Buy, 1 Hold, 1 Sell. Average PT $17.00. HC Wainwright at $14 (Buy, reiterated March 20). Chardan Capital initiated Buy. Range $8-$27 across the street. At $4.96, the average target implies ~240% upside.

Notable insider activity: Director Muneer Satter bought 500,000 shares at $3.94. Insiders bought 1.86M shares ($7.24M) in the past 3 months. Insider ownership at 11.87%. That's significant skin in the game ahead of the Q4 data read.

Catalysts

• 2026 (timing TBD): ANX1502 POC data in cold agglutinin disease

• 2026: Tanruprubart BLA submission with FORWARD data

• Q4 2026: Vonaprument Phase 3 ARCHER II topline data. This is the binary event

• EMA review ongoing: Tanruprubart MAA for GBS

The Risk

The whole thesis rides on ARCHER II in Q4 2026. If vonaprument shows vision preservation where C3/C5 inhibitors couldn't, this re-rates massively. GA affects 8M+ patients worldwide and the current approved therapies have been commercially disappointing because slowing lesion growth without improving or preserving vision isn't compelling enough for patients and doctors. But if the primary endpoint misses, vonaprument's differentiation claim collapses and you're left with a GBS program and an early-stage oral asset on a $238M cash pile that's burning $48M/quarter. The dilution risk is real too, shares outstanding jumped from 119M to 150M+ in the past year.

Bottom Line

Complement space is validated, well-funded, strong insider buying, differentiated mechanism targeting vision preservation where competitors failed. Q4 2026 ARCHER II data is the event that either makes this a multi-billion dollar company or sends it back to the lows. At $745M mcap with $238M cash, you're paying about $500M for the pipeline. If ARCHER II hits, that's a fraction of what the GA opportunity is worth. GBS approval in Europe would be a bonus catalyst ahead of the pivotal read.

Tag: Dual Catalyst

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How much cash will Annexon burn through 2026 before ARCHER II data?What's the commercial opportunity if vonaprument wins versus if it fails?Should you worry about dilution risk from future equity raises?How does Annexon's cash runway compare to competitor timelines?

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