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Zenas BioPharma, Inc. (ZBIO)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was execution-heavy: Zenas advanced obexelimab across indications, announced a transformational InnoCare licensing deal (BTK, IL‑17AA/AF, TYK2), and secured up to $300M in non‑dilutive funding from Royalty Pharma; cash and investments were $301.6M at quarter-end, with runway guided into Q4 2026 (Q1 2027 assuming INDIGO milestone) .
  • Reported net loss of $51.5M and diluted EPS of −$1.22; higher G&A and $5.0M AIPR&D (InnoCare license deposit) drove expenses versus prior year . Consensus EPS was −$1.02*, implying a miss; consensus revenue was $10.0M* while the company recognized no revenue, implying a miss.
  • Guidance unchanged to “topline INDIGO (IgG4‑RD) around year‑end 2025”; RMS MoonStone delivered “highly positive” 12‑week primary endpoint (−95% Gd‑enhancing lesions vs placebo, p=0.0009) with 24‑week data due in Q1 2026; orelabrutinib PPMS Phase 3 initiated; SPMS Phase 3 planned for Q1 2026 .
  • Near‑term stock catalysts: INDIGO topline readout; MoonStone 24‑week follow‑up; operational visibility from Royalty Pharma funding and $120M PIPE; portfolio expansion via InnoCare licensing .

What Went Well and What Went Wrong

What Went Well

  • MoonStone (RMS) 12‑week primary endpoint met with a highly statistically significant 95% relative reduction in new Gd‑enhancing T1 lesions vs placebo (p=0.0009); safety consistent with prior trials. “The outstanding results...validate the rapid, deep and sustained inhibitory mechanism of obexelimab...” — CEO Lonnie Moulder .
  • Strategic pipeline expansion: exclusive orelabrutinib rights (MS) and two novel small molecules (IL‑17AA/AF, TYK2), with PPMS Phase 3 initiated and SPMS Phase 3 planned Q1 2026 .
  • Strengthened balance sheet and runway: cash/investments $301.6M at Q3‑end; $120M private placement and up to $300M from Royalty Pharma (5.5% royalty on worldwide net sales) extend operating runway into Q4 2026; Q1 2027 assuming INDIGO milestone .

What Went Wrong

  • Higher operating expenses: Q3 total OpEx $52.6M (+$11.6M YoY), with G&A up $5.7M YoY due to personnel, stock‑based comp, pre‑commercialization, and public company costs; AIPR&D $5.0M tied to InnoCare license deposit .
  • Continued net losses: Q3 net loss of $51.5M vs $38.6M YoY; diluted EPS −$1.22 vs consensus −$1.02*, driven by elevated G&A and AIPR&D .
  • Revenue expectations mismatch: Street modeled revenue ($10.0M*) while Zenas reported no revenue in Q3 (loss from operations equaled total OpEx, consistent with zero revenue reporting in prior quarter) .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$10.0 $0.0 N/A (no revenue line; loss from operations equals OpEx)
Net Loss ($USD Millions)$33.6 $52.2 $51.5
Diluted EPS ($USD)−$0.80 −$1.25 −$1.22
R&D Expense ($USD Millions)$34.9 $43.0 $34.4
G&A Expense ($USD Millions)$12.4 $12.1 $13.2
AIPR&D ($USD Millions)——$5.0
Total Operating Expenses ($USD Millions)$47.3 $55.2 $52.6
Other (Income), net ($USD Millions)$3.6 $3.0 $1.1
Cash, Cash Equivalents & Investments ($USD Millions)$314.2 $274.9 $301.6
Working Capital ($USD Millions)$268.7 $225.4 $244.2
Weighted Avg Shares (Basic/Diluted)41.80M 41.87M 42.16M
Estimate vs ActualQ1 2025Q2 2025Q3 2025
EPS Consensus Mean ($)−1.11*−1.03*−1.02*
EPS Actual ($)−0.80 −1.25 −1.22
Revenue Consensus Mean ($USD Millions)1.67*1.25*10.00*
Revenue Actual ($USD Millions)10.0 0.0 N/A

Estimates marked with * are values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q2 vs Q3Into Q4 2026 Into Q4 2026; into Q1 2027 assuming $75M INDIGO success milestone Maintained; extended with milestone scenario
INDIGO (IgG4‑RD) ToplineAround year‑end 2025Around year‑end 2025 Around year‑end 2025 Maintained
MoonStone (RMS) 12‑week readoutEarly Q4 2025Early Q4 2025 Reported positive 12‑week primary endpoint Achieved
MoonStone (RMS) 24‑week readoutQ1 2026Not specifiedQ1 2026 Introduced
Orelabrutinib PPMS Phase 3Initiation timingNot specifiedInitiated in Q3 2025 Introduced
Orelabrutinib SPMS Phase 3Initiation timingNot specifiedExpected Q1 2026 Introduced

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was found; themes below reflect press releases and corporate updates.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Obexelimab INDIGO (IgG4‑RD)Topline around year‑end 2025; largest IgG4‑RD trial Timeline reaffirmed; INDIGO success milestone tied to Royalty Pharma funding Stable; financing-linked
RMS MoonStoneEnrollment completed (Q2); 12‑week results early Q4 2025 12‑week primary endpoint positive (−95% GdE lesions, p=0.0009); 24‑week data Q1 2026 Positive inflection
SLE SunStoneEnrollment completes by year‑end 2025; topline mid‑2026 Timeline reaffirmed Stable
Funding/Runway$274.9M cash (Q2) into Q4 2026 $301.6M cash; $120M PIPE; up to $300M Royalty Pharma; runway Q4 2026/Q1 2027 (with milestone) Strengthened
Portfolio ExpansionN/AInnoCare license: orelabrutinib (MS), ZB021 (IL‑17AA/AF), ZB022 (TYK2) Broadening pipeline
Manufacturing/Supply chainReliance on CMOs (WuXi) risks highlighted Similar risk disclosures continued Ongoing risk disclosure

Management Commentary

  • “Our recent achievements mark a significant step toward our vision of becoming a fully integrated, global development and commercial‑stage biopharmaceutical company... The outstanding results from our Phase 2 MoonStone trial... provide strong evidence of [obexelimab’s] potential to broadly address the pathogenic role of B cells in autoimmune conditions.” — Lonnie Moulder, CEO .
  • “Obexelimab... may broadly and effectively address the pathogenic role of the B cell lineage in chronic autoimmune disease.” .
  • On funding: “This transaction underscores our conviction in the potential of obexelimab as a franchise molecule and provides us with financial flexibility to rapidly advance our clinical programs and fund the commercial launch... if approved...” — Lonnie Moulder on Royalty Pharma agreement .

Q&A Highlights

No Q3 2025 earnings call transcript was available; therefore, no Q&A highlights or call‑specific tone shifts can be provided.

Estimates Context

  • EPS: Q3 actual −$1.22 vs consensus −$1.02* → miss of $0.20, driven by $5.0M AIPR&D deposit and elevated G&A as the company scales pre‑commercial activities .
  • Revenue: Consensus $10.0M* vs no revenue recognized in Q3 (loss from operations equals total OpEx; prior quarter showed $0 revenue explicitly) → miss .
  • Trajectory: EPS sequentially improved modestly (−$1.25 to −$1.22) as OpEx fell from $55.2M to $52.6M despite AIPR&D; however, the shift to portfolio expansion and pre‑commercial spend likely keeps near‑term losses elevated .

Estimates marked with * are values retrieved from S&P Global.

Key Takeaways for Investors

  • Near‑term binary: INDIGO topline around year‑end 2025 is the core stock catalyst; Royalty Pharma milestone ($75M) hinges on defined INDIGO success criteria .
  • RMS optionality: Strong MoonStone 12‑week efficacy signal de‑risks obexelimab’s B‑cell modulation in MS; 24‑week data in Q1 2026 can further validate the mechanism .
  • Pipeline broadening: InnoCare deal adds late‑stage orelabrutinib and earlier IL‑17AA/AF and TYK2 assets, creating multiple shots on goal and Phase 3 momentum in PPMS/SPMS .
  • Funding visibility: $301.6M cash at Q3‑end plus $120M PIPE and up to $300M Royalty Pharma supports operations into Q4 2026/Q1 2027 (with INDIGO milestone); royalty burden (5.5% worldwide net sales) is manageable vs de‑risking benefits .
  • Expense profile: Expect continued G&A uplift from pre‑commercialization and portfolio integration; AIPR&D can create quarterly noise tied to business development .
  • Trading lens: Positioning into INDIGO readout and MoonStone 24‑week data is key; downside risk from clinical outcomes; upside from franchise validation and milestone unlocks .
  • Medium‑term thesis: If INDIGO succeeds, obexelimab’s unique CD19/FcγRIIb mechanism plus MS signal and a BTK franchise could support a multi‑indication autoimmune platform with non‑dilutive funding to accelerate commercialization .