Faeth Therapeutics (FTH) investor relations material

Strategic focus and scientific approach

• Focused on multi-node inhibition of the PI3K/AKT/mTOR (PAM) pathway, the most frequently mutated pathway in solid tumors.

• Two lead drugs, sapanisertib and serabelisib, target PI3K alpha, mTORC1, and mTORC2, showing a 47% overall response rate in phase Ib.

• Multi-node inhibition aims to improve efficacy and tolerability by targeting multiple points at lower doses, reducing toxicity compared to single-node inhibitors.

• Oral administration and unique pharmacokinetics (PK) are designed to maximize time above IC90 and minimize toxicity, especially stomatitis.

• The oral regimen is positioned as a key differentiator, especially for breast cancer patients seeking lower treatment burden.

Clinical development and upcoming milestones

• Well-funded with $186 million, sufficient to reach endometrial phase II readout by year-end and breast cancer phase Ib/II by end of next year.

• Phase II endometrial cancer data expected by year-end, with focus on efficacy (ORR, PFS) and tolerability, especially in a metabolically challenged population.

• Fast Track designation received for endometrial cancer; post-data plans include a randomized phase III trial with PIKTOR plus paclitaxel versus paclitaxel.

• Breast cancer program progressing, with interim efficacy data for PIKTOR plus fulvestrant and palbociclib expected by year-end 2027.

• Dose flexibility between indications allows for tailored regimens based on disease biology and patient robustness.

Competitive landscape and future opportunities

• Recent approval of a competitor’s multi-node inhibitor validates the approach; oral administration and tolerability are seen as key competitive advantages.

• All-oral regimens are prioritized for future combinations, aiming to pair with oral SERDs and CDK4/6 inhibitors for improved patient experience.

• Expansion opportunities identified in gynecologic malignancies, ovarian, and lung cancer, with ongoing and planned studies in these areas.

• Intellectual property extends to 2037 for composition of matter, with method patents and potential fixed-dose combinations extending exclusivity into the 2040s.

• Long-term vision is to build a premier oncology company impacting a broad range of solid tumors and rare diseases.