Executive Summary

Q2 2025 loss narrowed: Net loss was $13.7M ($1.87 per share) vs $21.5M ($2.96) in Q2 2024 and $16.6M ($2.27) in Q1 2025, driven by materially lower R&D and G&A expense .
EPS beat vs S&P Global consensus: Actual Q2 2025 EPS of $(1.87) vs consensus $(2.29) (6 estimates) — a better-than-expected loss; revenue consensus was $0 and no product revenue was reported in the release. Values retrieved from S&P Global.
Cost discipline continued: Total operating expenses fell to $14.6M in Q2 2025 from $23.4M in Q2 2024 and $17.6M in Q1 2025, reflecting trial closeouts and lower manufacturing/personnel costs .
Regulatory and data catalysts: FDA lifted the partial clinical hold on PORTOLA (AIH), a Type C FDA meeting was requested for Q4 2025 to discuss a registration-enabling study, and PORTOLA data was selected for oral presentation at The Liver Meeting 2025 — all potential stock catalysts .
Liquidity: Cash, cash equivalents and marketable securities totaled $100.8M at June 30, 2025 (vs $114.4M at March 31, 2025 and $132.2M at Dec 31, 2024), funding operations through near-term regulatory milestones .

What Went Well and What Went Wrong

What Went Well

PORTOLA efficacy and safety: In relapsed or refractory AIH patients on steroid therapy, 36% (5/14) of zetomipzomib-treated patients achieved complete biochemical response with a clinically significant steroid taper to ≤5 mg/day by 6 months vs 0/7 on placebo; median duration of response 27.6 weeks, and no disease flares among responders; favorable safety profile in blinded period .
Regulatory progress: FDA removed the partial clinical hold on PORTOLA; company requested a Q4 2025 Type C meeting to align on a registration-enabling trial in AIH .
Expense control: R&D declined to $9.6M (from $16.3M YoY) and G&A to $5.0M (from $5.6M YoY), supporting a narrower net loss; management highlighted the path toward a registrational study in AIH. “We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis” — Chris Kirk, CEO .

What Went Wrong

Continued operating losses with no product revenue: Q2 2025 net loss was $13.7M (though improved YoY and QoQ); results remain driven by operating expenses and interest income .
Program risk in lupus nephritis: Development in LN remains suspended; while a complete response was submitted to FDA to lift the LN hold, there is no update of removal at this time .
Regulatory/design uncertainty ahead: A Type C meeting is requested (not yet completed), and the company still must align with FDA on a registration-enabling design, representing timing/outcome risk .

Financial Results

P&L Snapshot

Metric (USD)	Q2 2024	Q1 2025	Q2 2025
Research & Development ($M)	$16.298	$12.180	$9.583
General & Administrative ($M)	$5.603	$5.449	$5.016
Restructuring & Impairment ($M)	$1.482	—	—
Total Operating Expenses ($M)	$23.383	$17.629	$14.599
Interest Income ($M)	$2.237	$1.420	$1.197
Interest Expense ($M)	$(0.401)	$(0.347)	$(0.302)
Net Loss ($M)	$(21.547)	$(16.556)	$(13.704)
Diluted EPS ($)	$(2.96)	$(2.27)	$(1.87)

Notes: Dashes indicate not reported/applicable in the quarter’s summary.

Balance Sheet Snapshot

Metric (USD)	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash, Cash Equivalents & Marketable Securities ($M)	$132.245	$114.361	$100.849
Total Assets ($M)	$144.682	$125.260	$109.123
Total Current Liabilities ($M)	$20.329	$16.963	$14.365
Total Noncurrent Liabilities ($M)	$7.437	$5.228	$2.972
Total Stockholders’ Equity ($M)	$116.916	$103.069	$91.786

EPS and Revenue vs Estimates (S&P Global)

Metric	Q2 2025 Consensus	Q2 2025 Actual
Primary EPS (USD)	$(2.29)	$(1.87)
Revenue (USD)	$0	— (no revenue reported in 8-K)

Values retrieved from S&P Global. EPS consensus based on 6 estimates; revenue consensus based on 6 estimates. The company’s Q2 2025 8-K did not include a revenue line item .

Clinical KPIs (PORTOLA – AIH)

KPI	Result
CR with steroid taper to ≤5 mg/day by 6 months (relapsed/refractory on steroids)	36% (5/14) zetomipzomib vs 0/7 placebo
ITT population CR with steroid taper (≤5 mg/day)	31% (5/16) zetomipzomib vs 1/8 placebo
Median duration of response	27.6 weeks (incl. ongoing OLE)
Disease flares among CR responders	None reported during study
Safety	Favorable safety profile in 6-month blinded period

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance/Update	Change
Financial guidance	2025	None provided	None provided	Maintained (no financial guidance)
Regulatory: Type C FDA meeting (AIH)	Q4 2025	N/A	Type C meeting request submitted to discuss registration-enabling design	New update
Clinical hold (PORTOLA – AIH)	2025	Partial hold (post Q3’24 update)	FDA removed the partial clinical hold	Raised (positive regulatory update)
Clinical hold (LN)	2025	Full hold since Oct’24; development suspended	Complete response submitted to FDA seeking removal of hold	In process (no outcome yet)
Medical conferences	Nov 2025 (AASLD)	N/A	PORTOLA oral presentation accepted	New update

Earnings Call Themes & Trends

Note: We did not locate a Q2 2025 earnings call transcript in company filings or our document set; the company issued its Q2 press release on Aug 13, 2025. MarketBeat listed an earnings call date/time but no transcript link was available in our sources .

Topic	Previous Mentions (Q3 2024, Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory/clinical holds	Q3’24: Partial hold on PORTOLA OLE; LN full hold and termination of PALIZADE . Q1’25: Still engaging FDA; focus shifts to AIH .	FDA lifted partial clinical hold on PORTOLA; Type C meeting requested for Q4’25; LN hold response submitted	Improving in AIH; LN resolution pending
R&D execution	Q3’24: Completing PORTOLA DBTP; planning 1H’25 topline . Q1’25: Reported positive PORTOLA topline .	Preparing for registrational dialogue in AIH; data to be presented at AASLD	Advancing
Safety	Q3’24: LN trial had Grade 5 SAEs (incl. placebo); AIH safety acceptable to continue DBTP . Q1’25: Favorable safety in PORTOLA blinded period .	Favorable AIH safety reiterated; partial hold removed	Improving in AIH
Capital/liquidity	Q3’24 cash $148.4M . Q1’25 cash $114.4M .	Q2’25 cash $100.8M	Decreasing with operations
Strategic focus	Q3’24: Focus to AIH following LN hold . Q1’25: Continued AIH focus and regulatory engagement .	AIH program positioned for potential registrational study design	Consistent

Management Commentary

“We are on track with our clinical development and regulatory submission plan for zetomipzomib in autoimmune hepatitis.” — Chris Kirk, PhD, CEO and co-founder .
“We are pleased that the FDA has lifted the partial clinical hold on zetomipzomib in AIH after their review of our comprehensive safety assessment of the zetomipzomib program.” — Chris Kirk, PhD, CEO and co-founder .
“We shared exciting results this quarter from the PORTOLA trial, the first successful randomized study in treatment-refractory AIH... durable and steroid-sparing remissions observed...” — Chris Kirk, CEO and co-founder .

Q&A Highlights

We did not find a Q2 2025 earnings call transcript in our document set. The company communicated results via press release on Aug 13, 2025; MarketBeat lists an earnings call event, but no transcript was available from our sources .

Estimates Context

EPS: Q2 2025 actual $(1.87) vs consensus $(2.29) (6 est.) — better-than-expected loss. Values retrieved from S&P Global.
Revenue: Consensus $0; the company’s Q2 2025 8-K did not include a revenue line item. Values retrieved from S&P Global. Actual revenue not presented in the press release .
Potential estimate revisions: Given the continued reduction in R&D and G&A, some models may further lower forward OpEx/loss assumptions absent new trial starts or scale-up; monitoring the Q4 2025 Type C outcome will be critical for timeline/OpEx forecasting .

Values retrieved from S&P Global.

Key Takeaways for Investors

KZR delivered a cleaner-than-expected quarter on EPS driven by disciplined OpEx, narrowing losses vs both prior year and prior quarter .
Regulatory setup is constructive in AIH: FDA removed the partial hold and a Q4 2025 Type C meeting is requested to align a registrational plan — key stock catalysts into Q4/Q4–Q1 .
PORTOLA efficacy/safety remain the core value drivers: 36% CR with steroid taper in the zetomipzomib arm vs 0% placebo, with durability and no flares among responders, supporting advancement potential .
Liquidity of $100.8M at quarter end supports near-term milestones, but cash declined sequentially as the company funds AIH development; watch for runway commentary around the Type C path and trial design .
LN remains a risk overhang (historical SAEs, program halted), though a response to FDA to lift the hold has been submitted; investor focus squarely on AIH .
Near-term event path: AASLD oral presentation (Nov 7–11, 2025) and targeted FDA Type C meeting in Q4 2025 — outcomes/guidance here likely to drive estimate and sentiment resets .
Positioning: Risk-tolerant biotech investors may view the AIH regulatory path as the principal upside lever; absence of product revenue and ongoing cash burn remain the primary constraints .

Citations:

Q2 2025 8-K/press release and financials:
Q1 2025 8-K/press release and financials:
FDA partial hold lift PR (July 15, 2025):
Q3 2024 8-K (context):
Company IR press page (Q2 PR):
MarketBeat earnings event listing (no transcript found in our sources):

S&P Global disclaimer: All consensus estimate figures noted above were retrieved from S&P Global.

Kezar Life Sciences, Inc. (KZR)·Q2 2025 Earnings Summary