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ZB

Zenas BioPharma, Inc. (ZBIO)·Q2 2025 Earnings Summary

Executive Summary

  • Zenas reported Q2 2025 net loss of $52.2M and EPS of $-1.25, driven by higher R&D and G&A; revenue was $0 as no collaboration revenue was recognized in the quarter .
  • Versus Wall Street consensus, EPS missed by $0.23 (actual $-1.25 vs. mean estimate $-1.03*) and revenue missed (actual $0 vs. $1.25M*) as licensing revenue did not recur from Q1 2025 .
  • Cash, cash equivalents and investments were $274.9M, with runway guided “into the fourth quarter of 2026,” maintained from Q1 guidance despite increased operating spend .
  • Clinical execution advanced: MoonStone (RMS) enrollment completed with 12-week data expected early Q4 2025; INDIGO (IgG4-RD) topline expected around year-end 2025; SunStone (SLE) enrollment completion by YE25 with topline mid-2026—key upcoming catalysts .

What Went Well and What Went Wrong

What Went Well

  • Completed enrollment for the Phase 2 MoonStone RMS trial; 12-week primary endpoint data expected early Q4 2025, reinforcing near-term clinical catalysts .
  • Maintained cash runway guidance “into the fourth quarter of 2026” despite higher OpEx, evidencing disciplined balance sheet management .
  • Management reiterated confidence in obexelimab’s differentiated non-depleting B-cell mechanism and commercialization experience: “we are well positioned to execute on the significant opportunity ahead” .

What Went Wrong

  • EPS missed consensus (actual $-1.25 vs. estimate $-1.03*), primarily due to higher R&D (+$9.2M YoY) and sharply higher G&A (+$6.2M YoY) tied to clinical progress, pre-commercialization, and public company costs .
  • Revenue missed (actual $0 vs. $1.25M*) as license/collaboration revenue recognized in Q1 did not repeat in Q2, revealing sensitivity to non-recurring BD inflows .
  • YoY OpEx inflation: total operating expenses rose to $55.2M from $39.7M, widening loss from operations to $-55.2M from $-39.7M .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.0 $10.0 $0.0
Research & Development ($USD Millions)$33.8 $34.9 $43.0
General & Administrative ($USD Millions)$5.9 $12.4 $12.1
Total Operating Expenses ($USD Millions)$39.7 $47.3 $55.2
Loss from Operations ($USD Millions)$(39.7) $(37.3) $(55.2)
Other Income, net ($USD Millions)$1.7 $3.6 $3.0
Net Loss ($USD Millions)$(38.0) $(33.6) $(52.2)
Diluted EPS ($USD)$-24.23 $-0.80 $-1.25

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

KPIs and Balance Sheet

MetricQ4 2024 (Prelim)Q1 2025Q2 2025
Cash, Cash Equivalents & Investments ($USD Millions)~$350.0 (prelim) $314.2 $274.9
Working Capital ($USD Millions)N/A$268.7 $225.4
Total Assets ($USD Millions)N/A$333.8 $293.1
Total Stockholders’ Equity ($USD Millions)N/A$284.3 $239.6
Accumulated Deficit ($USD Millions)N/A$(421.0) $(473.2)
Weighted Avg Shares (Basic & Diluted)N/A41,800,802 41,865,400

Consensus vs. Actual (Q2 2025)

MetricActualConsensus Mean# of Estimates
Diluted EPS ($USD)$-1.25 $-1.03*4*
Revenue ($USD)$0 $1,250,000*4*

Values with asterisk (*) retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough Q4:26Into Q4:26 (Q1 2025) Into Q4:26 (Q2 2025) Maintained
INDIGO (IgG4-RD) ToplineAround YE25Around YE25 (Q1 2025) Around YE25 (Q2 2025) Maintained
MoonStone (RMS) 12-week Primary EndpointEarly Q4 2025Early Q4 2025; enrollment concluding (Q1 2025) Early Q4 2025; enrollment completed (Q2 2025) Status Improved (completed enrollment)
SunStone (SLE) Enrollment CompletionBy YE25By YE25; topline mid-2026 (Q1 2025) By YE25; topline mid-2026 (Q2 2025) Maintained

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was available in the document set; themes below reflect press releases and corporate materials.

TopicPrevious Mentions (Q1 2025)Current Period (Q2 2025)Trend
R&D ExecutionTeam strengthened (CMO, CSO); trials advancing across INDIGO, MoonStone, SunStone MoonStone enrollment completed; INDIGO and SunStone milestones reaffirmed Positive execution momentum
Clinical Milestones (Obexelimab)RMS 12-week data early Q4 2025; INDIGO topline YE25; SLE topline mid-2026 RMS 12-week data early Q4 2025; INDIGO topline YE25; SLE topline mid-2026 (unchanged) Maintained timelines
Financial Runway$314.2M cash; runway into Q4:26 $274.9M cash; runway into Q4:26 Runway maintained; cash down with higher OpEx
Manufacturing/Supply Chain RiskSole CMO WuXi Biologics in China referenced in risk factors WuXi Biologics location and supply chain risk reiterated Ongoing risk disclosure
Regulatory/LegalStandard forward-looking risk language; clinical/regulatory uncertainty Similar disclosures; geopolitical and supplier risks reiterated Stable risk profile

Management Commentary

  • CEO perspective: “We are very pleased with the rapid advancement of our broad obexelimab development program… Given the differentiated profile of obexelimab… we are well positioned to execute on the significant opportunity ahead” .
  • Strategic framing (Q1): “We are pleased with the continued momentum… we are well positioned to execute… as a differentiated B cell inhibitor” .
  • Cash runway emphasis: Runway into Q4:26 reiterated alongside near-term clinical catalysts .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available; no Q&A details could be extracted. This recap relies on the 8-K earnings press release and corporate presentation materials .

Estimates Context

  • EPS missed consensus: actual $-1.25 vs. mean estimate $-1.03*, reflecting higher R&D and G&A as trials scale and pre-commercialization activities expand .
  • Revenue missed: actual $0 vs. $1.25M*, driven by absence of licensing/collaboration revenue in Q2 versus Q1’s one-time $10.0M recognition .
  • Coverage depth: 4 estimates for EPS and revenue*, indicating limited but present Street coverage typical for clinical-stage biopharma.
    Values with asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Upcoming catalysts are central: INDIGO (IgG4-RD) topline around YE25 and MoonStone (RMS) 12-week data early Q4 2025 are likely stock-moving events; SunStone (SLE) topline mid-2026 extends the catalyst stack .
  • Balance sheet supports execution: $274.9M cash at Q2 with runway into Q4:26; expect continued OpEx elevation as programs progress .
  • Near-term trading implication: Expect sensitivity to clinical readouts and any interim regulatory or BD updates; absent recurring revenue, quarter-to-quarter prints hinge on OpEx and other income .
  • Medium-term thesis: Obexelimab’s non-depleting B-cell inhibition and weekly SC dosing could position it favorably vs. depletors if Phase 3/2 data validate efficacy and safety; commercial opportunity particularly acute in IgG4-RD .
  • Risk monitoring: Manufacturing concentration at WuXi Biologics and geopolitical exposure remain explicit in risk disclosures; keep watch on mitigation plans and redundancy .
  • Estimates likely to adjust: Street models may lower near-term revenue assumptions (licensing timing) and raise OpEx trajectories until commercialization visibility improves .
  • No non-GAAP reporting: Company provided GAAP results only; focus on net loss and cash runway over margin metrics typical for commercial-stage peers .