Faeth Therapeutics (FTH) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Key clinical insights

• Multi-node inhibition targeting PI3K/AKT/mTOR pathway with two oral small molecules shows a 47% overall response rate in phase I-B, including complete responses and favorable tolerability, especially regarding hyperglycemia and stomatitis.

• PK/PD data from skin biopsies confirm full pathway shutdown at selected doses, supporting that the regimen is active and not at placebo levels.

• Phase II in endometrial cancer is ongoing, with prior phase I-B data showing 3 complete responses out of 5 patients; phase II will have a more homogeneous patient population.

• Upcoming data readout by year-end will include response rate, adverse events, discontinuation, and durability measures.

• In breast cancer, dose escalation studies are ongoing with fulvestrant and palbociclib, with high demand for enrollment and a focus on balancing efficacy, tolerability, and durability.

Differentiation and competitive landscape

• Oral administration provides a pharmacokinetic advantage, maintaining effective drug levels with lower peak concentrations, reducing side effects compared to intravenous alternatives.

• Multi-node inhibition is believed to overcome resistance seen with single-node inhibitors, especially relevant in endometrial cancer with high PTEN mutation rates.

• The evolving treatment landscape in endometrial cancer includes new ADCs and maintenance strategies, with second-line therapy considered wide open for innovation.

• In breast cancer, the goal is to excel in efficacy, tolerability, and route of administration, aiming to improve standard of care and potentially move away from fulvestrant toward oral SERDs.

• Benchmarks for efficacy in upcoming trials include response rates above 25% and PFS of six months or more, with reference to recent KEYNOTE-775 and sacituzumab govitecan studies.

Forward-looking statements and development plans

• Phase II endometrial cancer data will be presented by year-end, with phase III planning to follow if results are favorable.

• In breast cancer, a comprehensive data update is expected by year-end 2027, with a potential phase III trial in 2028.

• Future development may include combinations with ADCs in gynecologic cancers, leveraging non-overlapping toxicities and high pathway mutation rates.

• Dose selection in breast cancer will prioritize long-term tolerability and activity, with careful maturation of dose cohorts before advancing.

• Regulatory strategy includes demonstrating contribution of components in endometrial cancer and leveraging prior data in breast cancer for FDA requirements.