Kairos Pharma (KAPA) investor relations material

Platform and rationale

• ENV-105 is a neutralizing antibody targeting CD105 and BMP4 signaling, which is linked to cancer stem-cell-like behavior and resistance to cancer therapies.

• The approach targets resistance to hormone therapy, EGFR inhibitors, radiation and immunotherapy; CD105 expression was associated with shorter survival in lung cancer patients.

• Management sees potential across prostate, lung, colon, breast, head and neck cancers, with a strategy to combine ENV-105 with existing therapies.

Clinical progress

• Prostate cancer: an 80-patient randomized Phase II trial is evaluating ENV-105 plus apalutamide; reported survival was ~7 months with the combination vs ~2 months with apalutamide alone, P=0.0008.

• The prostate protocol shifted to patients at first failure of an antiandrogen, with planned enrollment through an academic consortium including Mayo Clinic, Stanford, Vanderbilt, Rutgers and Cleveland Clinic.

• Lung cancer: Phase I trial is enrolling 20 TAGRISSO-resistant and 20 incompletely treated patients; no Grade 3+ toxicities were reported among 11 treated patients, with an interim efficacy readout planned for Q4 2026.

• Glioblastoma trial is getting underway with donor funding; the presentation also described a 60-patient lung trial.

Pipeline and collaborations

• KROS-101, a small molecule targeting GITR ligand to increase effector T cells and reduce suppressive T cells, is supported by NIH grants for immune-therapy resistance.

• A Bayer collaboration evaluating ENV-105 with Xofigo was nearing completion; results were expected soon afterward, potentially supporting a Phase II trial.

• The antibody is administered systemically by IV and targets CD105 on cancer cells and surrounding fibroblasts.