Pipeline - AADI Bioscience

**Pipeline: nab-sirolimus**

TSC1 and TSC2 Genetically Driven Tumors

Other mTOR-driven Tumors

Populations	Phase 1	Phase 2	Approved	Current Status
Advanced Malignant PEComa	nab-sirolimus			First FDA approved therapy for advanced malignant PEComa Based on Ph 2 Registrational AMPECT Trial
Tumor-agnostic with TSC1/TSC2 Inactivating Alterations	TSC1 Arm, nab-sirolimus			Registration-intended Fully enrolled as of May 2024 Interim analysis of 80 patients (two-thirds) expected in Q3 2024 Study completion expected by YE 2024 Full results expected by early 2025
Tumor-agnostic with TSC1/TSC2 Inactivating Alterations	TSC2 Arm, nab-sirolimus			Registration-intended Fully enrolled as of May 2024 Interim analysis of 80 patients (two-thirds) expected in Q3 2024 Study completion expected by YE 2024 Full results expected by early 2025
Advanced or recurrent endometrioid-type endometrial cancer	nab-sirolimus + letrozole			Open-label study currently enrolling patients Initial data expected in 2024
Neuroendocrine tumors (NETs)	nab-sirolimus			Open-label study currently enrolling patients Initial data expected in 2024

Drug	Stage	Current Status
Advanced Malignant PEComa nab-sirolimus	Approved	First FDA approved therapy for advanced malignant PEComa Based on Ph 2 Registrational AMPECT Trial
Tumor-agnostic with TSC1/TSC2 Inactivating Alterations TSC1 Arm, nab-sirolimus	Phase 2	Registration-intended Fully enrolled as of May 2024 Interim analysis of 80 patients (two-thirds) expected in Q3 2024 Study completion expected by YE 2024 Full results expected by early 2025
Tumor-agnostic with TSC1/TSC2 Inactivating Alterations TSC2 Arm, nab-sirolimus	Phase 2	Registration-intended Fully enrolled as of May 2024 Interim analysis of 80 patients (two-thirds) expected in Q3 2024 Study completion expected by YE 2024 Full results expected by early 2025
Advanced or recurrent endometrioid-type endometrial cancer nab-sirolimus + letrozole	Phase 2	Open-label study currently enrolling patients Initial data expected in 2024
Neuroendocrine tumors (NETs) nab-sirolimus	Phase 2	Open-label study currently enrolling patients Initial data expected in 2024

Evaluation of additional new single agent and combination trials ongoing