- Immutep Limited announced the **successful completion of FDA Project Optimus requirements**.  **[1506184_0001193125-25-237841_d94471dex991.htm:0]** 
- The US Food and Drug Administration (FDA) has agreed on **30mg eftilagimod alfa (efti) as the optimal biological dose** for Immutep's oncology pipeline.  **[1506184_0001193125-25-237841_d94471dex991.htm:0]** 
- This agreement is considered a **major de-risking event** and a building block towards future Biological License Applications (BLA).  **[1506184_0001193125-25-237841_d94471dex991.htm:0]** 
- The registrational **TACTI-004 (KEYNOTE-F91) Phase III trial** for first-line non-small cell lung cancer is now in the process of **opening clinical sites in the United States**.  **[1506184_0001193125-25-237841_d94471dex991.htm:0]**

Immutep Announces Successful Completion of FDA Project Optimus Requirements

- Immutep Limited reported a **loss after income tax expense of A$(61,434,165)** for the year ended **June 30, 2025**, primarily driven by a **A$19.9 million increase in R&D and intellectual property expenses**.  **[1506184_0001193125-25-194201_d85672dex991.htm:0]** **[1506184_0001193125-25-194201_d85672dex991.htm:11]** **[1506184_0001193125-25-194201_d85672dex991.htm:46]** 
- The company ended FY2025 with a strong balance sheet, holding **A$129.7 million in cash and term deposits**, which provides a cash runway through to the **end of CY2026**.  **[1506184_0001193125-25-194201_d85672dex991.htm:3]** **[1506184_0001193125-25-194201_d85672dex991.htm:11]** 
- Immutep advanced its lead immuno-oncology candidate, eftilagimod alfa (efti), into a global registrational **Phase III trial (TACTI-004/KEYNOTE-F91)** for non-small cell lung cancer, with the **first patient dosed in March 2025**.  **[1506184_0001193125-25-194201_d85672dex991.htm:2]** **[1506184_0001193125-25-194201_d85672dex991.htm:4]** 
- The company also reported positive maturing data from its **Phase IIb TACTI-003 trial** in head and neck squamous cell carcinoma, demonstrating a median overall survival of **17.6 months** in patients with PD-L1 expression below 1.  **[1506184_0001193125-25-194201_d85672dex991.htm:2]**

IMMUTEP (IMMP)