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Zenas BioPharma, Inc. (ZBIO)·Q4 2024 Earnings Summary

Executive Summary

  • Zenas did not issue a stand‑alone Q4 P&L; instead, its Feb 5, 2025 8‑K furnished preliminary unaudited cash of approximately $350 million at Dec 31, 2024 and outlined 2025 objectives, with cash expected to fund operations into Q4 2026 .
  • FY 2024 results reflect a scale‑up year: license/collaboration revenue $5.0M, R&D $139.1M, G&A $29.7M, net loss $156.99M; cash and equivalents $319.74M, short‑term investments $31.02M, equity $312.46M .
  • Key operational positives: completed Phase 3 INDIGO enrollment in IgG4‑RD, initiated Phase 2 MoonStone (RMS) and SunStone (SLE), and executed an upsized IPO raising $258.7M gross; out‑licensed ZB005 regional rights .
  • Near‑term stock catalysts: MoonStone 12‑week MRI lesion readout (Q3 2025) and INDIGO topline (YE 2025); SunStone topline expected 1H 2026, with cash runway guided through Q4 2026 .

What Went Well and What Went Wrong

What Went Well

  • Completed targeted enrollment of the global Phase 3 INDIGO trial (largest ever in IgG4‑RD); CEO: “With the achievement of targeted enrollment… we expect to report topline results… by the end of 2025.” .
  • Initiated Phase 2 MoonStone (RMS) and SunStone (SLE) trials, advancing multi‑indication obexelimab strategy; “We enter 2025 with an opportunity to achieve major value‑driving milestones…” .
  • Strengthened balance sheet via IPO (~$258.7M gross; ~$234.4M net) to fund growth strategy and expanded clinical development .

What Went Wrong

  • Operating loss widened with R&D investment: Q3 2024 R&D $33.5M vs $9.4M prior‑year; Q3 net loss $38.6M vs Q3 2023 net income $35.6M (due to prior BMS $50M upfront) .
  • Cash declined from $386.8M at Sep 30, 2024 to preliminary ~$350M at Dec 31, 2024 as programs scaled and manufacturing spend rose .
  • Manufacturing concentration risk: dependence on WuXi Biologics (China) and potential BIOSECURE Act impacts highlighted in 10‑K risk factors .

Financial Results

FY 2024 vs FY 2023

MetricFY 2023FY 2024
License & Collaboration Revenue ($USD Millions)$50.0 $5.0
Research & Development ($USD Millions)$60.0 $139.1
General & Administrative ($USD Millions)$17.1 $29.7
Net Loss ($USD Millions)$(37.1) $(157.0)
Cash & Equivalents ($USD Millions)$56.86 $319.74
Short‑Term Investments ($USD Millions)$0.00 $31.02
Total Assets ($USD Millions)$68.18 $369.97
Stockholders’ Equity ($USD Millions)$(225.72) $312.46

Quarterly Snapshot (Q3) for Trend Context (company did not furnish Q4 P&L)

MetricQ3 2023Q3 2024
Collaboration Revenue ($USD Millions)$50.0 $0.0
R&D Expense ($USD Millions)$9.35 $33.53
G&A Expense ($USD Millions)$5.02 $7.45
Net (Loss) / Income ($USD Millions)$35.61 $(38.61)
Cash, Cash Equivalents & ST Investments ($USD Millions)N/A$386.80

KPIs and Liquidity

KPIPeriodValue
Preliminary Cash, Cash Equivalents & ST Investments ($USD Millions)Dec 31, 2024~$350
Cash Runway GuidanceAs of Q4 2024Into Q4 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2026“fund… into the fourth quarter of 2026” (Q3 update) “expected to fund… into the fourth quarter of 2026” (Feb 5) Maintained
MoonStone (RMS) – 12‑week MRI primary endpointQ3 2025Initiated; timing TBD (Nov 12) Results expected Q3 2025 Set timeline
INDIGO (IgG4‑RD) – toplineYE 2025Completed enrollment; topline by YE 2025 (Nov 12) Topline YE 2025 (affirmed) Maintained
SunStone (SLE) – topline1H 2026Enrollment in 2025; topline 1H 2026 Enrollment in 2025; topline 1H 2026 Maintained
SApHiAre (wAIHA) – initial SRP data2024Initial data “later this year” (Nov 12) Preliminary Phase 2 SRP data announced Dec 2024; not progressing to registrational trial Completed data; strategic change

Earnings Call Themes & Trends

(Note: No Q4 2024 earnings call transcript was available; themes compiled from Q3 press release and Q4 8‑K.)

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Obexelimab clinical expansionQ3: INDIGO enrollment complete; Phase 2 MoonStone & SunStone initiated Reaffirmed 2025 milestones (MoonStone Q3 2025, INDIGO YE 2025) Consistent execution
Capital strategyQ3: IPO completed; cash $386.8M; runway to Q4 2026 Preliminary cash ~$350M; runway to Q4 2026 Stable runway, cash draw from ops
BD/licensingQ3: Out‑licensed ZB005 regional rights Affirmed ZB005 novation to Tenacia; ZB001 sublicensed to Zai Lab (Jan 2025) Portfolio focus; monetizing non‑core
Manufacturing & supplyRisk disclosure (WuXi dependence) Expanded in 10‑K risk; BIOSECURE Act watch Heightened regulatory focus

Management Commentary

  • “We enter 2025 with an opportunity to achieve major value‑driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials… we enter the year well‑financed and able to focus on execution” – Founder & CEO Lonnie Moulder .
  • “With the achievement of targeted enrollment for INDIGO… we expect to report topline results… by the end of 2025.” .

Q&A Highlights

No Q4 2024 earnings call transcript was available in the document set; therefore, Q&A highlights and clarifications are not applicable for this period.

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024 EPS and revenue was not retrievable due to data access limits encountered during request execution; as a result consensus comparison is unavailable for this quarter. We attempted to fetch S&P consensus using the estimates tool, but the daily request limit was exceeded (error returned).

Financial and Operational Detail (additional context)

  • FY cash flow: net cash provided by financing $412.96M (Series C and IPO), net cash used in operating $(119.67)M .
  • Balance sheet at year‑end: total assets $369.97M, liabilities $57.51M, stockholders’ equity $312.46M .

Key Takeaways for Investors

  • Obexelimab readouts drive the 2025–2026 narrative: MoonStone (RMS) MRI lesion data in Q3 2025 and INDIGO (IgG4‑RD) topline YE 2025 are the primary stock catalysts; SunStone topline 1H 2026 adds medium‑term optionality .
  • Balance sheet supports execution: ~$350M preliminary cash at year‑end and runway guided through Q4 2026 mitigate financing overhang in the near term .
  • 2024 P&L reflects intentional investment: R&D nearly doubled, widening losses as programs advanced; expect continued elevated spend ahead of pivotal data .
  • Manufacturing/regulatory risk warrants monitoring: dependence on WuXi Biologics and potential BIOSECURE Act implications highlighted; diversification efforts (new U.S. CMOs) are prudent .
  • BD strategy crystallizing: monetization of regional/non‑core assets (ZB005 to Tenacia; ZB001 to Zai Lab) complements focus on obexelimab and could add milestone/royalty upside .
  • Trading lens: data‑driven setup with binary events in 2025; liquidity and runway reduce near‑term dilution risk, but headline sensitivity (manufacturing policy and clinical timelines) remains elevated.

Notes on data sources and coverage

  • Q4 2024 did not have a separate earnings release with detailed quarterly P&L; Zenas furnished an 8‑K focused on accomplishments, objectives, and preliminary cash. Quarterly trend analysis therefore uses Q3 2024 and FY 2024/2023 audited figures. All figures and statements above are sourced from company filings and press releases as cited.
  • Consensus estimates from S&P Global were not available due to access limits at the time of query execution; consequently, estimate comparisons are omitted.