ZBIO

#1956
Zenas BioPharma, Inc. - Common Stock
32.9 2 USD
-0.01%
Market Price
Settore: Salute
Base: USD
Valuta di Profitto: USD
Intervallo Giornaliero
32.92
32.92
Intervallo Annuale
16.41
34.04
Variazione giornaliera
-0.63%
Variazione Mensile
+3.52%
Variazione di 6 mesi
+30.89%
Variazione Annuale
+24.41%
Chiusura Precedente
33.1 3
Open
32.9 2
Minimo
32.9 2
Massimo
32.9 2
Volume
71
Apri il grafico completo

Financials

Panoramica Estratto Conto Statistiche Dividendi Documents

2026

Current report, Q3 FY2026
Zenas Biopharma, Inc. current report, Q3 FY2026
8-K
Quarterly report, Q2 FY2026
Zenas Biopharma, Inc. quarterly report, Q2 FY2026
10-Q
Current report, Q2 FY2026
Zenas Biopharma, Inc. current report, Q2 FY2026
8-K
Quarterly report, Q1 FY2026
Zenas Biopharma, Inc. quarterly report, Q1 FY2026
10-Q
Current report, Q1 FY2026
Zenas Biopharma, Inc. current report, Q1 FY2026
8-K
Current report, Q1 FY2026
Zenas Biopharma, Inc. current report, Q1 FY2026
8-K
Current report, Q1 FY2026
Zenas Biopharma, Inc. current report, Q1 FY2026
8-K
Current report, Q1 FY2026
Zenas Biopharma, Inc. current report, Q1 FY2026
8-K

2025

Annual report, FY2025
Zenas Biopharma, Inc. annual report, FY2025
10-K
Current report, Q4 FY2025
Zenas Biopharma, Inc. current report, Q4 FY2025
8-K

Zenas Biopharma, Inc. current report, Q1 FY2026

Full document

Zenas Biopharma, Inc. (ZBIO) - Form 8-K Summary

Business Context and Reporting Period

This Current Report on Form 8-K was filed on January 5, 2026, by Zenas Biopharma, Inc., a Delaware corporation and emerging growth company. The filing reports preliminary unaudited financial data as of December 31, 2025, and announces positive topline results from the registration-directed Phase 3 INDIGO trial for obexelimab in immunoglobulin G4-related disease (IgG4-RD).

Key Financial Metrics

  • Cash and Liquidity: As of December 31, 2025, the Company reported preliminary unaudited cash, cash equivalents, and investments of approximately $360.5 million.
  • Runway: Management expects this liquidity to fund operating expenses and capital expenditure requirements through the end of 2026.
  • Revenue and Profit: The filing does not provide specific revenue, net income, or margin figures for the period. The Company anticipates incurring substantial and increasing losses for the foreseeable future.
  • Debt: No specific debt figures are disclosed in this filing.
  • Financing Activity: On September 2, 2025, the Company entered a Royalty Purchase Agreement with Royalty Pharma Investments 2019 ICAV (RPI) for up to $300 million in consideration. $75 million was paid on September 2, 2025. Three additional $75 million milestone payments are contingent on INDIGO trial data, FDA approval for IgG4-RD, and FDA approval for systemic lupus erythematosus (SLE).

Material Changes and Clinical Results

The primary material event is the successful completion of the Phase 3 INDIGO trial for obexelimab in IgG4-RD, involving 194 patients (97 obexelimab, 97 placebo). Key outcomes include:

  • Primary Endpoint: Obexelimab met the primary endpoint with a highly statistically significant 56% reduction in the risk of IgG4-RD flare requiring rescue therapy compared to placebo (Hazard Ratio 0.443, p=0.0005).
  • Secondary Endpoints: The drug met all four key secondary endpoints, including time to first flare, number of flares, proportion of patients achieving complete remission, and cumulative use of rescue therapy.
  • Safety Profile: Obexelimab was well tolerated. Serious adverse events were lower in the obexelimab arm (10%) compared to placebo (19%). Infection rates, including Grade 3 infections, were also lower in the treatment arm.

Guidance, Outlook, and Risks

Regulatory and Development Outlook:

  • BLA Submission: The Company anticipates submitting a Biologics License Application (BLA) to the FDA for obexelimab in IgG4-RD in the second quarter of 2026.
  • MAA Submission: A Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) is planned for the second half of 2026.
  • Upcoming Data: 24-week Phase 2 MoonStone trial results (Relapsing Multiple Sclerosis) are expected in Q1 2026. Phase 2 SunStone trial results (SLE) are expected in Q4 2026.
  • Pipeline Expansion: Phase 3 trials for orelabrutinib in non-active Secondary Progressive Multiple Sclerosis (naSPMS) are expected to initiate in Q1 2026. Phase 1 studies for ZB021 (IL-17AA/AF inhibitor) and ZB022 (TYK2 inhibitor) are expected to initiate in 2026 subject to IND clearance.

Risks and Contingencies:

  • Financial Runway: The Company notes a need for substantial additional financing to achieve long-term goals beyond the current runway.
  • Milestone Uncertainty: While the INDIGO Data Milestone criteria appear met, the Company is not currently eligible for the payment and is in active discussions with RPI; receipt of future milestones is not assured.
  • Operational Risks: Risks include reliance on third-party manufacturers (including WuXi Biologics in China), clinical trial enrollment delays, regulatory rejection, and the inherent uncertainty of clinical development.

Investor Verification Checklist

  • Verify the final audited cash balance for the year ended December 31, 2025, in the upcoming 10-K filing, as the $360.5 million figure is preliminary and unaudited.
  • Monitor the status of the INDIGO Data Milestone payment ($75 million) with Royalty Pharma, as the filing states the Company is not currently eligible despite positive trial results.
  • Confirm the specific timeline for the FDA BLA submission in Q2 2026 and the EMA MAA submission in H2 2026.
  • Review the full safety data and adverse event details in the press release (Exhibit 99.1) to assess long-term tolerability.
  • Assess the Company's capital raise strategy given the stated need for additional financing beyond the end of 2026.