Faeth Therapeutics (FTH) investor relations material

Scientific foundation and leadership

• Built on discoveries by Dr. Lewis Cantley (PI3K pathway) and molecules designed by Kevan Shokat, with a team of renowned cancer researchers and clinicians.

• Management and board have deep drug development experience, including expertise in oncology and finance.

Product and mechanism overview

• PIKTOR is an oral, multi-node inhibitor targeting the PI3K/AKT/mTOR pathway, combining serabelisib (PI3Kα inhibitor) and sapanisertib (mTORC1/2 inhibitor).

• Designed for potent, selective, and sustained pathway inhibition with reduced toxicity compared to single-node inhibitors.

• Demonstrated robust preclinical and clinical pathway suppression at lower concentrations than other agents.

Clinical development and efficacy

• In endometrial cancer, PIKTOR + paclitaxel showed an 80% overall response rate and 11-month median PFS in a Phase 1b trial.

• Ongoing Phase 2 trials in endometrial and breast cancer, with topline endometrial data expected by year-end 2026 and interim breast data in 2H 2027.

• Sapanisertib + paclitaxel improved PFS in platinum-resistant ovarian cancer (PROC) in the Phase 2 DICE trial (5.8 vs. 4.0 months, HR=0.66).

• Sapanisertib monotherapy showed 25% ORR and 8.9 months mPFS in NFE2L2-mutated squamous NSCLC, earning FDA Fast Track designation.