Akari Therapeutics (AKTX) Study update summary

ADC pipeline expansion and platform scalability

• Introduction of AKTX-102 as a second ADC candidate demonstrates the platform's scalability and ability to generate a diverse pipeline by attaching its novel payload to various antigen targets and molecules.

• The lead program, AKTX-101, targets TROP2 and uses a novel PH1 spliceosome-modulating payload, advancing toward clinical trials with IND/CTA filing targeted by the end of the year.

• The platform's flexibility allows for parallel development of multiple assets, with AKTX-102 progressing at an earlier discovery stage using limited resources.

• Recent patent filings highlight the scalability of the PH1-powered ADC platform for multiple programs and support long-term value creation and potential partnerships.

Lead program and preclinical progress

• Preclinical studies show AKTX-101 induces cancer cell death, activates immune response, and prolongs survival compared to traditional ADCs.

• AKTX-101 demonstrates synergy with checkpoint inhibitors and activity against cancers with key oncogenic drivers.

• IND-enabling studies for AKTX-101 are underway, with first-in-human trials planned for late 2026 or early 2027.

Differentiation and innovation in CEACAM5 targeting

• CEACAM5 is a challenging but relevant oncology target, especially in stomach, colon, and pancreatic cancers with high unmet need.

• The new antibody design overcomes issues related to antigen shedding, providing a competitive advantage over previous CEACAM5-directed therapies.

• Combining a novel antibody with a best-in-class lysosome-modulating payload creates a unique ADC construct, differentiated from existing clinical candidates.