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Zenas BioPharma, Inc. (ZBIO)·Q1 2025 Earnings Summary

Executive Summary

  • Zenas BioPharma reported Q1 2025 license and collaboration revenue of $10.0M, R&D of $34.9M, G&A of $12.4M, and net loss of $33.6M; cash, cash equivalents and investments were $314.2M, supporting runway into Q4 2026 .
  • Results were a significant beat versus S&P Global consensus: EPS of -$0.80 vs -$1.11* and revenue of $10.0M vs $1.67M*, driven by $10M Zai Lab upfront recognition; we flag this as a non-recurring revenue uplift. Bold beat: EPS +$0.31 and revenue +$8.33M vs consensus* .
  • Guidance largely maintained: INDIGO (IgG4‑RD) topline “around year-end 2025” unchanged; MoonStone (RMS) topline shifted from Q3 2025 (prior guide) to early Q4 2025; SunStone (SLE) enrollment completion by year-end 2025 and topline mid‑2026 unchanged .
  • Stock reaction catalysts: INDIGO Phase 3 topline (year-end 2025) and MoonStone Phase 2 12-week primary endpoint (early Q4 2025), with the quarter’s cash runway and program progress underpinning medium-term execution .

What Went Well and What Went Wrong

What Went Well

  • Strategic monetization and pipeline focus: $10.0M license/collaboration revenue recognized from the Zai Lab sublicense for the TED program in Greater China, helping fund operations while obexelimab remains in clinical stages .
  • Clinical execution momentum: “We are pleased with the continued momentum of our obexelimab program… we expect to report topline results later this year from trials in patients with relapsing multiple sclerosis and IgG4‑RD,” said CEO Lonnie Moulder .
  • Talent strength and organization build: Appointments of Lisa von Moltke, M.D. (Head of R&D & CMO) and Haley Laken, Ph.D. (CSO) broaden leadership depth ahead of pivotal milestones .

What Went Wrong

  • Elevated operating spend: R&D rose to $34.9M (+$12.3M YoY) due to increased clinical development and manufacturing costs; G&A rose to $12.4M (+$7.5M YoY) on personnel, pre-commercialization, and public company costs, widening net loss to $33.6M .
  • Timing push on RMS readout: MoonStone topline slipped from Q3 2025 (prior guide) to early Q4 2025, modestly deferring a catalyst by one quarter .
  • Continued reliance on external manufacturing/supply chain (e.g., WuXi Biologics, China) flagged in risk disclosures, exposing operations to geopolitical and supplier risks .

Financial Results

MetricQ1 2024Q3 2024Q1 2025
Revenue ($USD Millions)$0.0 $50.0 $10.0
Net Loss ($USD Millions)$(27.8) $(38.6) $(33.6)
Diluted EPS ($)$(17.89) $(5.02) $(0.80)
Loss from Operations ($USD Millions)$(27.6) $(41.0) $(37.3)
R&D Expense ($USD Millions)$22.6 $33.5 $34.9
G&A Expense ($USD Millions)$4.9 $7.5 $12.4
MarginsQ1 2024Q3 2024Q1 2025
Net Income Margin %N/A (0 revenue) N/A (no operating revenue) -335.7% (calc from revenue $10.0M and net loss $33.6M)
EBIT Margin %N/A (0 revenue) N/A (no operating revenue) -373.3% (calc from loss from ops $37.3M and revenue $10.0M)

KPIs and Liquidity

KPIQ3 2024Q4 2024 (Prelim)Q1 2025
Cash, Cash Equivalents & Investments ($USD Millions)$386.8 ~$350.0 (prelim unaudited) $314.2
Working Capital ($USD Millions)$349.8 N/A$268.7
Total Assets ($USD Millions)$403.4 N/A$333.8
Total Stockholders’ Equity ($USD Millions)$359.4 N/A$284.3
Cash Runway GuidanceInto Q4 2026 Into Q4 2026 Into Q4 2026

Segment breakdown: Not applicable (single segment per filings) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
INDIGO (IgG4‑RD) toplineYear-end 2025Year-end 2025 Year-end 2025 Maintained
MoonStone (RMS) topline (12-week)2025Q3 2025 Early Q4 2025 Lowered (timing push)
SunStone (SLE) enrollment complete2025By year-end 2025 By year-end 2025 Maintained
SunStone (SLE) topline20261H 2026 Mid-2026 Maintained
Cash runwayThroughInto Q4 2026 Into Q4 2026 Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our document catalog; themes reflect press releases, 8-Ks, and 10-K .

TopicPrevious Mentions (Q-2: Q3 2024; Q-1: Q4 2024)Current Period (Q1 2025)Trend
R&D execution (obexelimab)INDIGO enrollment completed; multiple Phase 2s initiated Timelines reaffirmed; MoonStone enrollment concluding; INDIGO year-end topline Stable-to-positive momentum
Supply chain/manufacturingReliance on WuXi Biologics, China; risk noted Continued reliance and risk acknowledgment Persistent risk
Regulatory/macro (US–China)Risk factors highlight geopolitical exposures Risks reiterated in forward-looking statements Unchanged vigilance
Leadership/talentAdded CCO and CLO in 2024 Added Head of R&D & CMO and CSO Organizational strengthening
Business developmentBMS regional license; divested ZB005 Zai Lab sublicense cash recognized; portfolio sharpened Monetization continues

Management Commentary

  • Lonnie Moulder (CEO): “We are pleased with the continued momentum of our obexelimab program… we expect to report topline results later this year from trials in patients with relapsing multiple sclerosis and IgG4‑RD.”
  • Corporate update: Out-licensed Greater China thyroid eye disease program (ZB001/anti‑IGF‑1R) to Zai Lab with upfront payment and future milestones/royalties .
  • Strategic posture: Company emphasizes becoming a leader in autoimmune therapies with a disciplined acquisition strategy and a self‑administered subcutaneous obexelimab regimen .

Q&A Highlights

No Q1 2025 earnings call transcript was found; therefore, no Q&A highlights are available in the period. We searched SEC filings and earnings materials and found the Q1 2025 press release and 8-K but no call transcript and document listings returned zero earnings-call-transcript for the window.

Estimates Context

MetricS&P Global Consensus (Q1 2025)*Actual (Q1 2025)Surprise
Primary EPS-$1.11*-$0.80 +$0.31
Revenue ($USD)$1.67M*$10.00M +$8.33M

Values retrieved from S&P Global*.
Interpretation: The upside to consensus was driven by the $10.0M one-time non-refundable upfront cash payment recognition from the Zai Lab sublicense, which is not recurring operating revenue; EPS benefited from that revenue and other income .

Key Takeaways for Investors

  • Near-term catalysts: INDIGO Phase 3 topline (IgG4‑RD) around year-end 2025 and MoonStone Phase 2 12-week readout in early Q4 2025; both are likely stock-moving events .
  • Revenue quality: Q1’s beat was primarily from non-recurring license revenue; core P&L remains R&D-heavy until clinical validation converts to approvals .
  • Execution capacity: Strengthened R&D and scientific leadership adds confidence ahead of multiple data readouts .
  • Cash runway: $314.2M in cash and investments supports operations into Q4 2026, mitigating near-term financing overhang absent unforeseen events .
  • Risk watch: Manufacturing concentration and geopolitical exposure (China) remain key operational risks; diversification steps are noted but not yet de‑risked .
  • Trading implication (short term): Expect sensitivity to any timeline changes and interim clinical signals; license/BD headlines can affect cash optics but won’t change clinical risk.
  • Thesis (medium term): If INDIGO delivers and RMS signals persist into 24-week data, obexelimab’s differentiated B cell inhibition profile could support an orphan-first path (IgG4‑RD) and expansion into larger autoimmune indications .

Additional Data Sources and Notes

  • Q1 2025 press release and 8‑K include full financial statements and corporate updates .
  • Q3 2024 8‑K press release used for trend context .
  • 2025‑02‑05 8‑K provided business objectives and preliminary 12/31/2024 cash .
  • Q1 2025 earnings slides provided background and program detail; no transcript found for Q1 call –.
  • Company site press release mirrors GlobeNewswire content for Q1 2025 .