Kairos Pharma Ltd. (KAPA:NYSE.American) new preclinical data on its GITR ligand agonist KROS101 are compelling, reported D. Boral Capital Analyst Jason Kolbert in a June 4 research note. Kairos develops therapeutics to overcome cancer drug resistance and to reverse cancer-induced immune suppression.
"The findings support KROS101's dual mechanism of action and its potential superiority over previous anti-GITR (glucocorticoid-induced tumor necrosis factor receptor) therapies, positioning it as a promising candidate in the cancer immunotherapy landscape," Kolbert wrote.
1,737% Uplift Indicated
D. Boral reiterated its US$9 per share target price on the California-based biopharma company, whose share price at the time of Kolbert's report was $0.49, the analyst noted. The target implies a potential return for investors of 1,737%.
Kairos remains a Buy. Its market cap is US$8 million. Its 52-week low and high are US$0.85 and US$4 per share.
Performs as Intended
Kairos' KROS101 is designed to bolster T-cell activity and thereby reverse tumor-driven immune suppression. Data, presented at the recent American Society of Clinical Oncology's 2025 annual meeting, demonstrated KROS101 actually does both, reported Kolbert. It enhances cytotoxic CD8+ T-cell function while simultaneously downregulating regulatory T cells (Tregs) within the tumor microenvironment.
Results showed, too, that KROS101 outperformed TRX518, an earlier anti-GITR antibody, in terms of several immunological parameters, including T-cell infiltration, effector function and immune exhaustion reduction.
KROS101 is differentiated in the space by its approach, maximizing GITR activation via a small molecule pathway. This may provide "more favorable pharmacodynamics and tissue penetration than biologics," wrote Kolbert. Further, the results "validate Kairos' broader strategy of addressing immune evasion and therapeutic resistance through structurally informed drug design."
Multipronged Oncology Platform
Kolbert pointed out that with KROS101, Kairos has a second asset in its oncology pipeline. The first is the biopharma's overall lead candidate, ENV105, an antibody targeting CD105 to reverse resistance to anti-androgen drugs. Currently, ENV105 is in Phase 2 for castrate-resistant prostate cancer and in Phase 1 for nonsmall cell lung cancer.
"With a mechanistically novel immunomodulator in preclinical development and a first-in-class antibody in midstage trials, the company is building a multipronged oncology platform," Kolbert wrote.
Possible Catalysts Ahead
Kairos has some upcoming clinical milestones, noted the analyst. As for KROS101, the biopharma next intends to do formal investigational new drug-enabling studies with an eye toward moving the candidate into the clinic next year.
Regarding ENV105, Kairos is expected to complete the Phase 1 trial in nonsmall cell lung cancer in H2/25, with initial data readouts to follow soon after. By year-end, interim data from the ongoing Phase 2 study of ENV105 in prostate cancer are anticipated.
"These upcoming events, coupled with ongoing partnership discussions, could serve as meaningful catalysts in advancing Kairos Pharma's efforts to address drug resistance in multiple oncology indications," Kolbert commented.
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Disclosures for D. Boral Capital and Kairos Pharma Ltd., June 4, 2025:
Analyst Certification: I, Jason Kolbert, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed in this research report.
Company-Specific Disclosures: D. Boral Capital, managed or co-managed a public offering of securities for Kairos Pharma Ltd. during the past 12 months. D. Boral Capital, or its affiliates have received compensation from Kairos Pharma Ltd. for investment banking services within the past 12 months.
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