Lipum (LIPUM) investor relations material

Clinical development and trial results

• Lead asset is a CD4 monoclonal antibody, metazolumab, developed for first-line metastatic pancreatic cancer and is Phase III ready.

• Combination with FOLFIRINOX chemotherapy more than tripled 24-month survival rates compared to chemotherapy alone, without significant added side effects.

• Phase II data show several patients achieving full remission or long-term tumor control, with a direct link between immune activation and clinical outcomes.

• At 30 months, 20% of patients were still alive, supporting readiness for Phase III trials with identical endpoints and treatment schedules.

Regulatory and strategic progress

• Both FDA and European authorities have approved the Phase III protocol, and trial materials are ready.

• Investigator-initiated trials are underway globally, supported by grants, to build value without heavy reliance on investor funding.

• A large randomized Phase II study in France, sponsored by the government, is set to start in Q2 next year, validating data and expanding to other solid tumors.

Pipeline and commercial outlook

• Additional preclinical assets include a bispecific antibody (4066) and a legacy HER2 monoclonal antibody (HLX22) out-licensed to a Chinese company.

• HLX22 is in Phase III for HER2-positive gastric cancers and could generate $15–40 million annually in the early 2030s if approved.

• Expanding metazolumab into other indications, such as biliary tract cancer, is a key strategy, leveraging its safety and mechanism for broader use.