Executive Summary

Clinical progress overshadowed by higher OpEx: Q4 featured a larger net loss ($48.6M) as R&D accelerated across ANX005 (GBS), ANX007 (GA) and ANX1502 (oral C1s) while cash/short-term investments stood at ~$312.0M with runway into 2H26 .
Regulatory momentum: Company is targeting a pre-BLA meeting for ANX005 in 1H25 ahead of BLA submission; ANX007 secured a “groundbreaking” single-study global path with Phase 3 ARCHER II data expected 2H26 .
Q4 portfolio catalysts: Positive real-world evidence (RWE) readout showed ANX005 outperformed IVIg/PE in matched cohorts on muscle strength and functional outcomes; fewer intubations reported in ANX005-treated patients (15/79 vs 32/79) .
Street estimates: S&P Global consensus data were unavailable at time of analysis (API limit). As a pre-revenue biotech, no revenue line was reported; comparisons focus on OpEx, EPS loss, and cash runway .

What Went Well and What Went Wrong

What Went Well

RWE strengthens ANX005 package: Matched cohort analysis showed faster and greater improvement in muscle strength and disability vs IVIg/PE; roughly half as many ANX005 patients required mechanical ventilation (15/79 vs 32/79) .
Clearer regulatory path for ANX007: Company established a single global registration program (ARCHER II) for vision preservation in GA, aligned with BCVA ≥15-letter loss as primary endpoint; data expected 2H26 .
Leadership and balance sheet support execution: Cash/short-term investments ~$312.0M at 12/31/24 with forecast runway into 2H26; added commercial leadership and a new director with launch experience .

“Importantly, our three flagship programs are showing tremendous promise to be game-changing, best-in-class therapies…” — Douglas Love, CEO .

What Went Wrong

Higher OpEx drives larger quarterly loss: R&D rose to $43.4M in Q4 (vs $30.1M in Q3), pushing total OpEx to $52.5M and net loss to $48.6M .
Execution risk into filings remains: Company still must complete pre-BLA and file ANX005; regulators could require more data despite positive RWE .
No earnings call transcript available: We did not find a Q4 2024 earnings call transcript, limiting color on finer financials and Q&A clarifications (no transcript located in the period searched) [ListDocuments 2025-02-20–2025-03-20 returned none].

Financial Results

P&L – Year-over-Year (Q4 2023 vs Q4 2024)

Metric (USD)	Q4 2023	Q4 2024
Research & Development	$23.3M	$43.4M
General & Administrative	$6.7M	$9.1M
Total Operating Expenses	$30.0M	$52.5M
Interest & Other Income (net)	$2.1M	$3.9M
Net Loss	$(27.9)M	$(48.6)M
Net Loss/Share (basic & diluted)	$(0.36)	$(0.33)
Weighted Avg Shares	78.2M	147.8M

Notes: YoY loss widened on higher R&D as programs advanced .

P&L – Sequential Trend (Q2 2024 → Q3 2024 → Q4 2024)

Metric (USD)	Q2 2024	Q3 2024	Q4 2024
Research & Development	$25.0M	$30.1M	$43.4M
General & Administrative	$8.6M	$9.3M	$9.1M
Total Operating Expenses	$33.6M	$39.4M	$52.5M
Interest & Other Income (net)	$4.0M	$4.6M	$3.9M
Net Loss	$(29.6)M	$(34.8)M	$(48.6)M
Net Loss/Share	$(0.23)	$(0.25)	$(0.33)

Notes: Sequential OpEx increase reflects intensifying clinical investment (GBS/GA/ANX1502) .

Liquidity – Balance Sheet Cash and Investments

Metric (USD)	12/31/2023	6/30/2024	9/30/2024	12/31/2024
Cash & Cash Equivalents	$225.1M	$157.3M	$79.5M	$49.5M
Short-term Investments	$34.6M	$211.4M	$260.6M	$262.5M
Total Cash + ST Inv. (calc)	$259.7M	$368.7M	$340.1M	$312.0M
Cash Runway (Mgmt view)	—	Into 2H26	Into 2H26	Into 2H26

Notes: Management reiterated cash runway into 2H26 each quarter . Totals align with press disclosures (~$368.7M, ~$340.1M, ~$312.0M) .

Segment breakdown: Not applicable (no product revenue reported) .

KPIs (Clinical)

ANX005 RWE matched cohorts n=79 vs n=79; fewer ventilations with ANX005 (15/79) vs IVIg/PE (32/79) .
Early strength benefit >10-point MRC advantage by week 1 (p<0.0001) .
GA Phase 2: 0% ≥15-letter loss in “less advanced” monthly-treated subgroup (0/56) vs 17% sham (10/59); overall monthly-treated 6% vs 21% sham (nominal p-values 0.0013 and 0.0021) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Company operating plan	Into 2H26 (Q2’24)	Into 2H26 (Q4’24)	Maintained
ANX005 (GBS) Regulatory	BLA timing	BLA 1H25 (Q2/Q3’24)	Pre-BLA meeting 1H25 ahead of BLA (Q4’24)	Clarified milestone timing; maintained 1H25 path
ANX007 (GA) Pivotal Readout	Phase 3 ARCHER II	Topline 2H26 (Q2/Q3’24)	Topline 2H26 (Q4’24)	Maintained
ANX1502 (CAD) POC	Dataset timing	Initial data Q4’24 (Q2’24)	Expanded dataset up to seven patients mid-2025 (Q4’24)	Updated timing (later, broader dataset)

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was available in our corpus search; themes derived from company press materials for Q2–Q4 2024.

Topic	Q2 2024 (Earlier Quarter)	Q3 2024 (Prior Quarter)	Q4 2024 (Current Period)	Trend
ANX005 GBS – Clinical/Regulatory	Positive Phase 3 topline; initiated RWE via IGOS; targeting BLA 1H25	Continued RWE work; BLA 1H25 targeted	Positive RWE matched-cohort results; pre-BLA mtg 1H25 ahead of BLA	Strengthening dataset; regulatory prep advancing
ANX007 GA – Registration Path	Dosing in ARCHER II; alignment on BCVA ≥15-letter loss	Global registrational trial ongoing	Single-study global path; enrollment complete 2H25; data 2H26	Registration clarity improved
ANX1502 – Oral C1s	Bridging study done; initial POC data Q4’24	Enhanced tablet; POC data 1Q25	Three pts dosed; expanded dataset up to seven pts mid-2025	Timeline extended; dataset broadened
Commercial readiness	Not emphasized	Hires across commercial/medical/HEOR	Added experienced director BJ Jones	Building launch capabilities
Balance sheet/runway	~$368.7M; runway into 2H26	~$340.1M; runway into 2H26	~$312.0M; runway into 2H26	Runway reiterated; cash burn rising with OpEx

Management Commentary

“Our lead program, ANX005 for the treatment of Guillain-Barré Syndrome (GBS), has consistently demonstrated early and durable functional improvements with a differentiated safety profile… We look forward to the pre-BLA meeting with FDA targeted for the first half of 2025 ahead of our BLA submission.” — Douglas Love, CEO .
“Following positive engagement with EU and U.S. regulators… groundbreaking global registration path [for ANX007]… the primary endpoint of ARCHER II is prevention of ≥15-letter loss of BCVA.” .
“Three patients [ANX1502] enrolled to date with observed reduction in key clinical and biomarker outcomes consistent with complement inhibition; awaiting full data… dataset in up to seven CAD patients mid-2025.” .

Q&A Highlights

We did not locate a Q4 2024 earnings call transcript; no Q&A highlights available in our document set [ListDocuments 2025-02-20–2025-03-20 returned none].

Estimates Context

S&P Global/Capital IQ consensus estimates for Q4 2024 (revenue/EPS) were unavailable at the time of analysis due to API request limits; no estimate comparisons are provided. As a clinical-stage, pre-revenue biotech, results primarily reflect operating expenses, net loss per share, and cash runway rather than revenue/margin beats or misses .

Key Takeaways for Investors

ANX005 path-to-filing is the near-term value driver: positive RWE plus Phase 3 and an imminent pre-BLA meeting in 1H25 set up a potential BLA filing; regulatory feedback is the key catalyst to watch .
For GA, ANX007 has a clearer, single global pivotal path centered on a functional vision endpoint (BCVA ≥15-letter loss); enrollment targeted to complete 2H25 with topline 2H26—longer-dated but high-impact .
OpEx is scaling with execution: R&D ramped to $43.4M in Q4, lifting OpEx and net loss; expect burn aligned with pivotal and regulatory activities .
Balance sheet supports execution through major readouts: ~$312.0M in cash and ST investments at year-end and runway into 2H26 reduce near-term financing overhang amid higher spend .
ANX1502 offers optionality in autoimmune disease with an oral agent; timeline extended to mid-2025 for a larger CAD dataset, which may refine development plans across indications .
Absent Q4 call transcript, monitor upcoming conference disclosures (e.g., AAN oral presentation for ANX005 on Apr 8, 2025) for deeper clinical and regulatory color .

Sources

Q4/FY 2024 8-K and press release: financials, cash runway, and portfolio updates .
Q3 2024 8-K/press release: prior-quarter financials and milestones .
Q2 2024 8-K/press release: earlier-quarter financials and milestones .
Q4 period press releases: ANX005 RWE (Dec 16, 2024) ; ANX007 presentations (Dec 5, 2024; Oct 22, 2024; Oct 15, 2024) .

Annexon, Inc. (ANNX)·Q4 2024 Earnings Summary