Summit Therapeutics Inc (SMMT)

Metastatic Colorectal Cancer (CRC) · registered primary completion 2028-04-01 · NCT06767514

Published 2026-09-02Market cap $10,953M6 sourced statements

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1 · PHASE3 · n=780 · 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 2026-07-23

“quired in the future, the Company could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects. These conditions raise substantial doubt about the Company's ability to continue as a going concern. The accompanying unaudited condensed consolidated financial statements have been p…”

Market

fact

4 approved products already carry Metastatic Colorectal Cancer (CRC) on label, including KRAZATI, Stivarga, ERBITUX, OPDIVO. Approval would enter an occupied market.

Source: FDA label index

Trial registry

fact

Registered design for NCT06767514: randomized, quadruple-masked, 780 participants (estimated). Primary outcome: Overall Survival (OS). 1 further primary outcome(s) registered.

Source: ClinicalTrials.gov record

Share count and dilution

fact

797,749,602 shares outstanding against 916,860,836 if every outstanding option, warrant and convertible were exercised. In that case 13.0% of a gain in enterprise value would accrue to those holders rather than to current shareholders.

Source: antidilutive-securities disclosure, 10-Q filed 2026-07-23

Regulatory

fact

Designations disclosed: 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 2026-07-23

Pipeline

fact

4 distinct molecules in 4 active company-sponsored trials; Ivonescimab Injection accounts for 2 of them at 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.