Kairos Pharma (KAPA) H.C. Wainwright 28th Annual Global Investment Conference summary

Key scientific insights and clinical rationale

• CD105 identified as a key protein driving drug resistance and cancer stem cell-like behavior in multiple tumor types, including prostate and lung cancers.

• ENV105, a neutralizing antibody targeting CD105, reverses resistance and restores sensitivity to standard therapies in preclinical and early clinical studies.

• Cancer stem cells, comprising 2%-5% of tumors, are uniquely capable of indefinite division and resistance to therapies, making them critical targets.

• Blocking CD105/BMP4 signaling with ENV105 reduces tumor growth and enhances response to anti-androgen and radiation therapies.

• Preclinical and early clinical data show ENV105 downregulates resistance mechanisms, including androgen receptor variants and mutated receptors.

Clinical development and trial updates

• ENV105 is in phase II trials for prostate cancer (with apalutamide) and phase I trials for non-small cell lung cancer (with TAGRISSO), with interim safety data showing good tolerability.

• Phase II prostate cancer trial is active at Cedars-Sinai, City of Hope, and University of Utah, with a companion biomarker study funded by a $3.2M NIH grant.

• Interim results show progression-free survival of 15.8 months, significantly exceeding historical controls, and a 35% mean PSA reduction.

• Strategic collaboration with Bayer to combine ENV105 with XOFIGO in bone metastatic prostate cancer, supported by preclinical synergy data.

• Additional assets include KROS-201 (activated T cell therapy for glioblastoma) and IND-ready KROS-101 (small molecule), with further preclinical programs in development.

Strategic partnerships and operational model

• Academic CRO consortium established with Cedars-Sinai, Mayo Clinic, Stanford, Vanderbilt, and Rutgers to enable efficient, multi-center trial activation.

• Non-dilutive funding from NIH and Department of Defense supports ongoing clinical trials.

• Intellectual property protection extends to 2040, covering molecules and methods of use.

• Strategic collaborations with pharma companies focus on co-development rather than competition, especially in radioligand therapies.

• 2024 is positioned as a year of expanding strategic collaborations to advance cancer therapy platforms.