May 14th, 2026

Gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus alpelisib + fulvestrant in the PIK3CA mutant cohort; the gedatolisib doublet (gedatolisib + fulvestrant) also showed a statistically significant PFS improvement. Both regimens were generally well tolerated with no new safety signals. Detailed results to be presented at ASCO (June 2).

Previously reported VIKTORIA-1 wild-type results set new benchmarks: a 7.3-month incremental improvement in median PFS for the gedatolisib triplet over fulvestrant (noted as higher than any Phase III in this setting), 17.5 months median duration of response for the triplet, and a 31 percentage-point incremental increase in objective response rate for the triplet vs control. Low adverse event-related discontinuation rates (2% triplet, 3% doublet) and rapid improvement in stomatitis (median 12 days for Grade 2, 14 days for Grade 3) were reported.

VIKTORIA-2 amended to include two studies: Study 1 (endocrine-resistant) and Study 2 (endocrine-sensitive). Study 1 sample size reduced from 638 to 440 (≈31% reduction) while preserving power; Study 2 expected to enroll ~740 endocrine-sensitive patients. Primary endpoints are BICR-assessed PFS. Top-line expectations: Study 1 by end of 2028, Study 2 by 2030.

Company advancing development of a subcutaneous formulation to support long-duration treatments, submitted first U.S. patent application for an injectable formulation, progressing formulation optimization, stability and animal studies with multiple candidates, and targeting functional volume requirements to make the dose injectable. Aim is to demonstrate clinical equivalence to IV formulation and align subcu availability with potential approvals.

Gedatolisib + darolutamide in metastatic castration-resistant prostate cancer (Phase Ib): 6-month radiographic PFS rate of 67% (vs historical ~40%), median radiographic PFS 9.1 months. Combination generally well tolerated with no dose-limiting toxicities and no discontinuations due to adverse events.

Commercial organization substantially built; oncology sales specialists fully hired and onboarded with average experience of 24 years in pharma and 16 years in oncology. Extensive payer and account outreach underway. Estimated U.S. second-line total addressable market >$5 billion annually; company estimates potential peak second-line revenue up to $2.5 billion.

Cash, cash equivalents and short-term investments of $387.1 million at March 31, 2026. Company expects cash, investments and drawdowns on its debt facility to finance operations through 2027.