Catalyst Database

3/11/25- Ph1 initiated. 3/20/25- Topline data in mid-2025. If successful, Ph2b in H2 2025 followed by EoPh2 w/ FDA and Ph3 trial in early 2026. Subject to funding and partnering opportunities.

VELA and MIRA trials. 6/26/23- Top-line 12wk data. 10/16/23- 24wk data. 2/26/24- Cleared path for Ph3 study (VELA). Randomize first patient in Q2 '24. 8/7/24- Topline data in mid-2025.

1/10/24- New Ph1b biomarker data. 5/1/24- Preclinical and Ph1b data at SID '24 on May 18, 2024. 6/5/24- Dosed first patient. 11/7/24- Enrollment completion on 12/2024. 3/6/25- Topline data in mid-2025.

Suspected Mover in H2 '25: APEX trial. 5/15/24- Interim Ph1 data exceeded all trial objectives. Initiated dosing in Ph2 trial. 2/3/25- First patient dosed in Part B Ph2 trial. Enrollment completed in Part A portion. 16-wk topline data from Ph2 Part A trial in mid-2025

RELIEF, RALLY, & RESILIENT studies. 7/8/24- Positive final Pre-NDA meeting. 7/25/24- Fast Track Designation. 9/23/24- Presentation at PDDS '24. 10/16/24- NDA submission. 12/17/24- NDA accepted. 3/24/25- No FDA Adcomm meeting needed for NDA. PDUFA goal date of Aug 15, 2025.

HARMONi-A trial. 12/5/22- Trial collab w/ Akeso. 5/23- Dosed 1st patient. 4/12/24 Enrollment ongoing, complete in H2 2024. 10/3/2024- Topline data in mid-2025.

BEACON trial. 12/8/24- Reported data at ASH'24. 1/23/25- Presentation at ASTCT'25. 2/25/25- Present updated data in mid-2025. Dose 30 participants by mid-2025.

6/3/24- RMAT designation. 7/9/24- Positive interim data. 8/1/24- Type B RMAT meeting w/ FDA in H2 2024. 3rd cohort completion in H2 2024 w/ interim data in mid-2025.

APEX trial. 2/22/24- Additional cohort initiated in Q3 '23 & enrollment continues. 12/9/24- Presented long term follow-up data from Part 1 at ASH. Part 2 topline result in Mid-2025.

10/11/24- Initiates Ph2 enrollment. 11/11/24- Enrollment continues. 12/19/24- Present initial data from ongoing Ph2 trial at at ASCO GI. 1/22/25- Initial Ph2 data announced. Updated data in mid-2025.