Checkpoint Therapeutics (CKPT) Corporate Presentation summary

Portfolio overview

• UNLOXCYT (cosibelimab-ipdl) approved by FDA for metastatic and locally advanced cSCC; EMA/UK submissions pending.

• Pipeline includes olafertinib (3rd gen EGFR inhibitor), CK-103 (BET inhibitor), CK-302 (anti-GITR), and CK-303 (anti-CAIX) in various preclinical and clinical stages.

• UNLOXCYT is the first and only anti-PD-L1 mAb approved for cSCC in adults not eligible for curative surgery or radiation.

• No post-marketing commitments or pediatric study requirements for UNLOXCYT.

UNLOXCYT mechanism and differentiation

• UNLOXCYT is a fully human anti-PD-L1 mAb with dual mechanisms: T-cell reactivation and NK cell-mediated ADCC.

• High tumor target occupancy and functional Fc domain enable cell-mediated cytotoxicity.

• Preclinical data show cosibelimab induces higher NK cell-mediated cytotoxicity than control antibodies.

Clinical efficacy and safety

• Registration-enabling study included 109 cSCC patients across 40 sites in 9 countries.

• Objective response rates: 48–55% in locally advanced and metastatic cSCC, with robust complete response rates (up to 26%).

• Median duration of response not reached as of March 2023 data cutoff.

• Low rates of severe immune-related adverse events (irAEs), with 0.9% dermatologic grade ≥3 events.