Breast Cancer · registered primary completion 2026-10-31 · NCT06016738
Management has concluded there is substantial doubt about the company's ability to continue as a going concern.
6 approved products already carry Breast Cancer on label, including Doxorubicin Hydrochloride, capecitabine, Docetaxel, Fulvestrant. Approval would enter an occupied market.
Registered design for NCT06016738: randomized, open-label, 510 participants (estimated). Primary outcome: Dose-Selection Part: Incidence of adverse events. 3 further primary outcome(s) registered.
Cash of $461M against operating outflow of $55M per quarter gives roughly 8.4 quarters of runway, clearing the registered primary completion 0.7 quarters out by 7.7 quarters.
87,497,607 shares outstanding against 106,431,993 if every outstanding option, warrant and convertible were exercised. In that case 17.8% of a gain in enterprise value would accrue to those holders rather than to current shareholders.
23,084,149 pre-funded warrant shares outstanding at a nominal exercise price — economically issued equity.
Share count up 28% year over year to 87,497,607 as of 2026-08-06.
Designations disclosed: Breakthrough Therapy, Fast Track, Orphan Drug, PRIME (EU). These accelerate review and, for Orphan, confer exclusivity if approved; none is evidence of efficacy.
12 distinct molecules in 5 active company-sponsored trials; Palazestrant accounts for 5 of them at Phase 1/Phase 3.