Philogen (PHIL) Status Update summary

Scientific and clinical pipeline progress

• Significant advances in targeted therapies for cancer, with strong results in melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC), including high complete response rates in BCC and SCC trials.

• Nidlegy demonstrated a doubling of recurrence-free survival in phase III melanoma trials and is under regulatory review in Europe, with a U.S. trial ongoing and a pre-BLA meeting planned.

• Soternec (Fibromun) is progressing rapidly in glioblastoma and soft tissue sarcoma, with phase III and II trials nearing full enrollment and readouts expected by end of 2024 for sarcoma and late 2025 for glioblastoma.

• Chemistry pipeline includes promising radionuclide and drug conjugate programs, with OncoFAP and OncoACP3 showing strong tumor targeting and early compassionate use in patients.

Regulatory and commercial strategy updates

• Marketing authorization application for Nidlegy submitted to EMA, with validation received and further regulatory interactions scheduled for September.

• Plans for accelerated regulatory submissions in other countries post-EMA decision, including Australia, New Zealand, U.K., and Switzerland.

• Third-line BCC registration trial planned for rapid market entry, with first-line trials under consideration based on regulatory and clinical advice.

• Active search for commercial partners for Soternec, with ongoing discussions and a focus on global distribution capabilities.

Clinical trial timelines and expectations

• U.S. phase III trial for Nidlegy expected to read out in 2026, with more than 100 patients already treated and recruitment accelerating.

• Third-line BCC trial to launch by end of 2024, with recruitment expected to complete in 2025 and readout in 2026.

• OncoFAP therapy trial to start in November 2024, with phase I completion in 2025 and expanded patient data by end of 2026.

• Soternec soft tissue sarcoma trial to complete enrollment by July 2024, with readout anticipated by year-end.