Immunitybio Inc (IBRX)

Bladder Cancer · registered primary completion 2028-09-01 · NCT06745908

Published 2026-09-02Market cap $8,532M8 sourced statements

Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In · PHASE3 · n=507 · recruiting

Balance sheet

fact

Management has concluded there is substantial doubt about the company's ability to continue as a going concern.

Source: 10-Q filed 2026-08-04

“nd our other product candidates, we may need additional funds to meet our needs sooner than planned. As a result of continuing anticipated operating cash outflows as we commercialize our approved product and accelerate our development efforts, we believe that substantial doubt exists regarding our ability to continue as a going concern without additional funding or financial support. However, we believe our existing …”

fact

Total liabilities of $1,674M exceed total assets of $629M as of 2026-06-30 — stockholders' equity is negative.

Source: balance sheet as of 2026-06-30 (XBRL)

Market

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7 approved products already carry Bladder Cancer on label, including Cisplatin, CISPLATIN, KEYTRUDA QLEX, CISplatin. Approval would enter an occupied market.

Source: FDA label index

Trial registry

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Registered design for NCT06745908: randomized, open-label, 507 participants (estimated). Primary outcome: Compare Overall Survival between the experimental and control arms.

Source: ClinicalTrials.gov record

Runway

fact

Cash of $357M against operating outflow of $65M per quarter gives roughly 5.5 quarters of runway; the registered primary completion is 8.1 quarters out.

Source: 10-Q filed 2026-08-04

Share count and dilution

fact

1,059,836,273 shares outstanding against 1,227,273,273 if every outstanding option, warrant and convertible were exercised. In that case 13.6% of a gain in enterprise value would accrue to those holders rather than to current shareholders.

Source: antidilutive-securities disclosure, 10-Q filed 2026-08-04

Regulatory

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Designations disclosed: RMAT, Breakthrough Therapy, Fast Track, Orphan Drug. These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.

Source: 10-Q filed 2026-08-04

Pipeline

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33 distinct molecules in 20 active company-sponsored trials; N-803 accounts for 8 of them at Phase 1/Phase 2/Phase 3.

Source: ClinicalTrials.gov, company as lead sponsor

Don't see a name? Request a sheet. Any US-listed biotech with a Phase 3 or a pending FDA decision — it gets built the same way, from the filings.

This sheet is dated and will not be edited. When the registered primary completion passes, its outcome is recorded on the scoreboard and a new dated sheet is published if the filings change materially.