Home › Companies › ZBIO

Pipeline (11 active programs)

Discontinued (2)

• obexelimab — Rheumatoid Arthritis · Company does not intend to develop obexelimab further in RA due to the competitive landscape
• obexelimab — Warm Autoimmune Hemolytic Anemia · Determined not to progress to a registration-directed trial based on expected length and expense of a potential Phase 3 trial

Capital (as filed)

Cash

$178M cash and cash equivalents · Sep 30, 2026 (10-Q)

Short-term investments

$469M Sep 30, 2026

Long-term investments

$61.8M Sep 30, 2026

Operating cash flow

−$58.0M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)

As stated in coverage

$647M cash, runway into 2029 per the update of Nov 5, 2026 — the company's own words as read there, not the filed figure

Offering documents (2)

• 2026-11-06 424B5 · At-the-market program up to $200M
• 2026-09-11 S-3ASR · Shelf registration

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (3)

• 2026-11-06 UPDATE: Zenas BioPharma (ZBIO) - The Brake Proves It Can Be Released
• 2026-08-14 UPDATE: Zenas BioPharma (ZBIO) - The Clock Is Set, But It’s the Slow Clock 🔒 Paid
• 2026-06-10 Zenas BioPharma (ZBIO) — Scientific Deep Dive for Obexelimab, Orelabrutinib and Pipeline Products

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (3 calls)

Every verdict Biotech Distilled has published on Zenas BioPharma, oldest first — the full history, never a selection. How calls are scored: the track record.

1. 2026-06-10 Watch Zenas BioPharma (ZBIO) — Scientific Deep Dive for Obexelimab, Orelabrutinib and Pipeline Products A de-risked BLA-stage orphan asset offset by second-mover commercial setup behind Uplizna, single-source China CMO overhang, stacked royalty burden, and a binary SLE readout resting on a post-hoc subgroup — could clear toward Buy on favorable BLA-acceptance terms plus a clean SunStone.
2. 2026-08-14 Speculative buy speculative UPDATE: Zenas BioPharma (ZBIO) - The Clock Is Set, But It's the Slow Clock BLA acceptance and funded runway through 2029 partially clear the prior watch conditions, warranting a half-size speculative position ahead of the Q4 SunStone binary, sized so a miss is survivable.
3. 2026-11-06 Speculative buy speculative UPDATE: Zenas BioPharma (ZBIO) - The Brake Proves It Can Be Released New patient-level evidence supports the pausable-brake commercial thesis, but the post-hoc SLE biomarker hypothesis, WuXi supply chain, and open CFO seat remain unresolved with SunStone weeks away; maintain partial speculative position.

• Long call · opened Aug 14, 2026 at $29.51 · -4.2% vs XBI -3.3% (Nov 6, 2026)

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (8 quotes from 5 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

• 2026-11-05 10-Q in filings ↓

  • “We are conducting clinical trials in IgG4-RD through a registration-directed Phase 3 trial which reported topline data in January 2026, relapsing multiple sclerosis (“RMS”) through an ongoing Phase 2, double-blind, randomized, placebo-controlled trial which reported topline data in October 2025 (the “MoonStone” trial) and systemic lupus erythematosus (“SLE”) through an ongoing Phase 2, double-blind, randomized, placebo-controlled trial (the “SunStone” trial), for which we expect to report topline results, including biomarker data, in the fourth quarter of 2026.”

    matched to Obexelimab (SunStone, SLE) · topline data · read as fourth quarter of 2026
• 2026-10-13 8-K in filings ↓

  • “Phase 2 SunStone trial in Systemic Lupus Erythematosus (SLE) topline results expected in 4Q 2026.”

    matched to Obexelimab (SunStone, SLE) · topline data · read as 4Q 2026
• 2026-08-13 10-Q in filings ↓

  • “In August, the FDA accepted the Company’s BLA and assigned a Prescription Drug User Fee Act (“PDUFA”) target date of May 27, 2027.”

    matched to Obexelimab · regulatory submission · read as May 27, 2027 / matched to Obexelimab (SunStone, SLE) · topline data · read as May 27, 2027

  • “In April 2026, we completed enrollment in the SunStone trial and expect to report topline results, including biomarker data, in the fourth quarter of 2026.”

    matched to Obexelimab (SunStone, SLE) · topline data · read as fourth quarter of 2026
• 2026-08-13 8-K in filings ↓

  • ““2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027.”

    matched to Obexelimab · regulatory submission · read as May 27, 2027 / matched to Obexelimab (SunStone, SLE) · topline data · read as May 27, 2027
• 2026-08-13 10-Q in filings ↓

  • “In August, the FDA accepted the Company’s BLA and assigned a Prescription Drug User Fee Act (“PDUFA”) target date of May 27, 2027.”

    matched to Obexelimab · regulatory submission · read as May 27, 2027

  • “In April 2026, we completed enrollment in the SunStone trial and expect to report topline results, including biomarker data, in the fourth quarter of 2026.”

    matched to Obexelimab (SunStone, SLE) · topline data · read as fourth quarter of 2026

  • ““2026 continues to be a transformative year for Zenas, highlighted by FDA acceptance of the obexelimab BLA for the treatment of IgG4-RD, with a PDUFA date of May 27, 2027.”

    matched to Obexelimab (SunStone, SLE) · topline data · read as May 27, 2027

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (34)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Aug 13, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

• Nov 6, 20268-KCurrent report: other eventsWith SunStone weeks away, Zenas quietly reloaded its ATM program after-hours on Friday — resetting to a fresh $200M capacity after drawing ~$153M from the prior tranche, a move that lands before the binary and not reflected in today's +9% session close.
• Nov 6, 2026424B5Prospectus supplement (offering)Summary on the 8-K
• Nov 5, 2026ReleaseZenas BioPharma Reports Third Quarter 2026 Financial Results and Provides Corporate Update→ BD updateSummary on the 8-K
• Nov 5, 20268-KCurrent report: results of operations · EX-99.1 EXHIBIT 99.1→ BD updateNew OLE data shows 93% of patients remain flare-free at 12 months and obexelimab's B-cell brake can be released for vaccination — directly answering the reversibility and infection-risk questions — while the Q3 burn rate accelerates to ~$108M/quarter, SunStone inches closer, and the EMA clock starts ticking.
• Nov 5, 202610-QQuarterly report→ BD updateSummary on the 8-K
• Oct 13, 20268-KCurrent report: Reg FD disclosure · EX-99.1 EXHIBIT 99.1New INDIGO open-label extension data show obexelimab's flare protection holding at 93% probability through 12 months, and a vaccine sub-study delivers the first human proof that the drug's "pausability" feature actually works — six of seven patients mounted influenza immunity during a ~35-day treatment-free window with zero flares.BD extracted 1 program update from this document → ZBIO pipeline
• Oct 12, 2026ReleaseZenas BioPharma Announces the Presentation of New Obexelimab Data in IgG4-Related Disease at the 6th International Symposium on IgG4-Related DiseaseBD extracted 1 program update from this document → ZBIO pipeline
• Oct 7, 2026ReleaseZenas BioPharma Announces Upcoming Presentations of Orelabrutinib Data in Relapsing Remitting Multiple Sclerosis, Clinical Trial Designs in Progressive Multiple Sclerosis and Other Multiple SclerosisBD extracted 1 program update from this document → ZBIO pipeline
• Oct 6, 2026ReleaseZenas BioPharma to Host Virtual R&D Event
• Sep 22, 2026ReleaseZenas BioPharma Announces Upcoming Presentations of Obexelimab Data in IgG4-Related Disease at the IgG4ward! 6th International Symposium on IgG4-Related Disease and ACR Convergence 2026BD extracted 1 program update from this document → ZBIO pipeline
• Sep 11, 2026S-3ASRAutomatic shelf registration
• Sep 8, 2026ReleaseZenas BioPharma to Host Obexelimab IgG4-RD Investor Event
• Sep 4, 2026ReleaseZenas BioPharma to Present at Upcoming Healthcare Investor Conferences
• Aug 19, 2026SCHEDULE 13D/A13D amendment
• Aug 17, 2026SCHEDULE 13D/A13D amendment
• Aug 13, 2026ReleaseZenas BioPharma Reports Second Quarter 2026 Financial Results and Provides Corporate UpdateBD extracted 1 program update from this document → ZBIO pipeline
• Aug 13, 20268-KCurrent report: results of operations, officer / director change · EX-99.1 EXHIBIT 99.1
• Aug 13, 202610-QQuarterly report
• May 13, 20268-KCurrent report: results of operations, officer / director change, shareholder vote · EX-99.1 EXHIBIT 99.1
• May 13, 202610-QQuarterly report
• May 5, 2026SCHEDULE 13DActivist / >5% holder (13D)
• Apr 2, 2026SCHEDULE 13D/A13D amendment
• Mar 31, 20268-KCurrent report: material agreement, debt / obligation, other events
• Mar 30, 2026424B5Prospectus supplement (offering)
• Mar 30, 2026424B5Prospectus supplement (offering)
• Mar 27, 2026FWPFree writing prospectus (offering terms)
• Mar 27, 2026FWPFree writing prospectus (offering terms)
• Mar 26, 2026FWPFree writing prospectus (offering terms)
• Mar 26, 2026424B5Prospectus supplement (offering)
• Mar 26, 2026424B5Prospectus supplement (offering)
• Mar 16, 2026DEFA14AProxy soliciting material
• Mar 16, 2026DEF 14AProxy statement
• Mar 16, 20268-KCurrent report: results of operations · EX-99.1 EXHIBIT 99.1
• Mar 16, 202610-KAnnual report