Executive Summary

Vera Therapeutics reported Q3 2025 net loss of $80.3M and diluted EPS of -$1.26, with operating expenses rising on continued clinical development and company buildout; cash and marketable securities were $497.4M, supporting runway through potential atacicept approval and U.S. launch .
Atacicept’s ORIGIN 3 Phase 3 interim results showed a 46% baseline reduction in proteinuria and a 42% placebo-adjusted reduction at week 36 (p<0.0001), featured in ASN Kidney Week’s opening plenary and published in NEJM; the BLA was submitted to FDA via Accelerated Approval in Q4 2025 .
Management reiterated potential U.S. approval and launch in 2026 and highlighted broad pipeline efforts (ORIGIN Extend, PIONEER basket trial) and commercial preparation already underway .
Versus S&P Global consensus, Q3 EPS missed (-$1.26 actual vs -$1.18 estimate) and EBITDA was slightly below estimate; target price consensus stood at $62.25 (12 estimates) at quarter-end* (Values retrieved from S&P Global).
Stock-relevant catalysts: NEJM publication, ASN plenary visibility, BLA submission (priority review expected), and near-term PIONEER readouts, with 2-year ORIGIN 3 data expected in 2027 .

What Went Well and What Went Wrong

What Went Well

ORIGIN 3 featured plenary at ASN with strong efficacy: 46% reduction from baseline and 42% vs placebo in UPCR at week 36 (p<0.0001), consistent across prespecified subgroups; safety comparable to placebo .
BLA submitted to FDA for accelerated approval in IgAN; management emphasized disease-modifying profile and dual BAFF/APRIL mechanism as potentially best-in-class .
Commercial readiness progressing: leadership hired, market education underway, and financial runway supported by cash plus undrawn debt facility; “poised for a potential commercial launch of atacicept in 2026” .

Management quotes:

“We remain on track to submit the BLA for atacicept in IgAN to the FDA this quarter…a robust data package…” — Marshall Fordyce, CEO (Q3 PR) .
“ORIGIN 3 is the first Phase 3…to show clinical improvements in proteinuria, Gd-IgA1, and hematuria…suggests dual BAFF and APRIL inhibition…may modify disease course.” — Richard Lafayette, MD (NEJM/ASN PR) .

What Went Wrong

Elevated operating expenses continued as programs advanced: Q3 R&D $56.5M and G&A $27.5M, increasing YoY, driving wider net loss and EPS versus Q3 2024 .
EPS missed S&P Global consensus and EBITDA tracked slightly below; absence of revenue leaves GAAP margins and revenue benchmarks inapplicable* (Values retrieved from S&P Global).
Formal quarterly “earnings call transcript” was not available; investor/KOL events served as the primary source of management commentary (Nov 6 plenary investor call) .

Financial Results

Note: Vera reports no product revenues; focus is on operating expenses, net loss, EPS, and liquidity.

Metric (USD)	Q3 2024	Q1 2025	Q2 2025	Q3 2025
Research and development ($ Thousands)	40,314	41,278	58,195	56,473
General and administrative ($ Thousands)	9,487	15,916	21,946	27,459
Total operating expenses ($ Thousands)	49,801	57,194	80,141	83,932
Net loss ($ Thousands)	(46,632)	(51,694)	(76,531)	(80,293)
Other income, net ($ Thousands)	3,169	5,500	3,610	3,639
Diluted EPS ($)	(0.85)	(0.81)	(1.20)	(1.26)
Weighted-average shares (basic/diluted)	54,898,297	63,671,558	63,789,303	63,847,055

Liquidity and Capital

Metric (USD)	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025	Sep 30, 2025
Cash, cash equivalents & marketable securities ($ Thousands)	640,852	589,834	556,827	497,389
Long-term debt ($ Thousands)	50,687	50,908	74,464	74,648
Total stockholders’ equity ($ Thousands)	577,155	534,999	468,277	398,880

Consensus vs Actual (Q3 2025)

Metric	Consensus	Actual
Primary EPS Consensus Mean ($)	-1.18*	-1.26*
EBITDA Consensus Mean ($ Millions)	-82.0*	-83.8*
Revenue Consensus Mean ($ Millions)	0.0*	0.0*

Values retrieved from S&P Global.
Underlying data: EPS estimate -1.17663 vs actual -1.26; EBITDA estimate -$82.0M vs actual -$83.803M; revenue estimate $0.0M [GetEstimates]*.

KPIs (Clinical/Program)

ORIGIN 3 interim: UPCR -42% vs placebo at week 36; baseline reduction -46%; Gd-IgA1 -68%; hematuria resolved in 81% with baseline hematuria .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Atacicept BLA submission (IgAN, U.S.)	Q4 2025	“On track to submit in Q4 2025” (Q2 PR)	Submitted November 7, 2025 (Accelerated Approval)	Raised (completed)
U.S. approval and commercial launch	2026	“Potential launch in 2026” (Q2 PR)	“Potential FDA approval and U.S. launch in 2026” (Q3 PR)	Maintained
ORIGIN 3 36-week results	Q4 2025	“Present full 36-week results Q4 2025” (Q2 PR)	Presented Nov 6, 2025; NEJM publication	Raised (completed)
PIONEER initial results	Q4 2025	“Expected in Q4 2025” (Q2 PR)	“Initial results expected in Q4 2025” (Q3 PR)	Maintained
ORIGIN 3 2-year completion (eGFR)	2027	“Expected to be completed in 2027” (Q2 PR)	“2-year data…expected in 2027” (Q3 PR)	Maintained
Cash runway	Through launch	“Sufficient to fund…through potential approval and launch” (Q2 PR)	“Sufficient…through potential approval and U.S. commercial launch…beyond” (Q3 PR)	Maintained/clarified

Earnings Call Themes & Trends

Note: No formal “earnings-call-transcript” found; analysis uses Nov 6 investor/KOL webcast transcripts.

Topic	Q1 2025 (Previous Mentions)	Q2 2025 (Previous Mentions)	Q3 2025 (Current Period)	Trend
Regulatory path (BLA, priority review)	Planning BLA submission in 4Q25	On track for Q4 BLA	BLA submitted; priority review expected	Positive progression
Clinical efficacy (proteinuria, hematuria, biomarkers)	ORIGIN 3 enrollment completed; anticipation of results	36-week data positive; 42% vs placebo	ASN plenary; consistent subgroup efficacy; Gd-IgA1 -68%, hematuria ~80% resolution	Strengthening
Safety (infections, hypogammaglobulinemia)	Favorable safety in prior studies	Safety favorable, comparable to placebo	No hypogammaglobulinemia reported; serious infections lower vs placebo	Stable/favorable
Commercial readiness	Not detailed	New Oxford Finance facility; runway beyond launch	Sales leadership in place; disease-state education ramping	Building
Combination therapy stance	N/A	N/A	Preference for atacicept first-line disease modification; limited need for combo beyond SOC	Clearer positioning
Adjacent indications (PIONEER basket)	Program introduced	Initiated PIONEER	Enrollment ongoing; near-term initial data	Advancing

Management Commentary

“We look forward to presenting the most recent data from the ORIGIN 3 trial…We remain on track to submit the BLA for atacicept in IgAN to the FDA this quarter.” — Marshall Fordyce, CEO (Q3 PR) .
“These results support our planned BLA submission…we look forward to a potential approval and US commercial launch in 2026.” — Marshall Fordyce, CEO (NEJM/ASN PR) .
“The consistent benefit for key disease markers and favorable safety profile…suggests that dual BAFF and APRIL inhibition with atacicept may modify disease course.” — Richard Lafayette, MD (NEJM/ASN PR) .
“Priority review [is] expected given breakthrough designation.” — Rob Brenner, CMO (Investor webcast) .

Q&A Highlights

Combination strategies: KOLs and CMO emphasized atacicept as first-line disease-modifying therapy with SOC (RASi/SGLT2) as appropriate, but limited need for add-on antiproteinurics if eGFR stabilization is achieved .
Subgroup consistency: No differential efficacy by age, sex, region, baseline eGFR/proteinuria, or SGLT2 use in ORIGIN 3 interim .
Safety/hypogammaglobulinemia: No hypogammaglobulinemia observed; infections and opportunistic infections not increased vs placebo .
Regulatory timeline: BLA filing imminent/submitted with expectation of priority review; 2026 U.S. launch targeted .
Commercial approach: Sales leadership hired; disease-state education active; large addressable IgAN population targeted .

Estimates Context

Q3 2025 EPS missed: -$1.26 actual vs -$1.18 consensus; EBITDA slightly below: -$83.8M actual vs -$82.0M consensus; revenue $0 matched consensus* (Values retrieved from S&P Global).
Coverage depth: 11 EPS and revenue estimates in quarter; target price consensus $62.25 (12 estimates) at quarter-end* (Values retrieved from S&P Global).
Implications: Near-term revisions likely focused on OpEx cadence and cash runway; clinical/regulatory catalysts (NEJM/ASN, BLA submission) may support target price stability or upward bias absent negative FDA feedback .

Key Takeaways for Investors

Clinical data momentum and NEJM publication materially strengthen atacicept’s disease-modifying narrative; subgroup consistency and safety are de-risking elements .
Regulatory path advanced with BLA submission; priority review expected, anchoring 2026 launch timeline and creating actionable catalyst windows (filing acceptance, PDUFA date) .
Operating expenses elevated as programs and commercial infrastructure scale; net loss widened sequentially and YoY, but liquidity remains robust (cash $497.4M; LT debt ~$74.6M) .
Consensus metrics: EPS/EBITDA slight misses reflect higher OpEx; focus should shift to regulatory milestones and PIONEER/ORIGIN Extend updates rather than quarterly GAAP variability* (Values retrieved from S&P Global).
Competitive positioning: Dual BAFF/APRIL mechanism, two-year Phase 2b eGFR stability, and ASN plenary exposure differentiate atacicept versus APRIL-only agents .
Near-term trading setup: Watch for BLA acceptance and priority review designation; KOL sentiment and market education may support sentiment into early 2026 .
Medium-term thesis: If ORIGIN 3 two-year eGFR results confirm Phase 2b trajectory, market penetration into high-risk IgAN and adjacent autoimmune kidney indications could expand materially .

Notes:

Primary sources: Q3 2025 Form 8-K and Exhibit 99.1 earnings press release , ORIGIN 3 NEJM/ASN press release , BLA submission press release , investor/KOL webcast transcripts .
Formal earnings call transcript not available; investor/KOL events were used for management commentary .
All consensus values marked with asterisks are from S&P Global GetEstimates; Values retrieved from S&P Global.

Vera Therapeutics, Inc. (VERA)·Q3 2025 Earnings Summary