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Kairos Pharma reports news as a clinical-stage biopharmaceutical company developing cancer therapeutics designed to address drug resistance and immune suppression. Its updates center on ENV-105, also described as carotuximab, a CD105-targeting antibody program studied in prostate cancer and non-small cell lung cancer, along with broader oncology pipeline and structural-biology themes.
Company news also covers scientific conference presentations, clinical-data disclosures, annual meeting and shareholder matters, award recognition, and annual filing updates. Kairos has stated that ENV-105 has not been approved as safe or effective by the FDA or comparable foreign regulators.
Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on cancer therapeutics, has received GHP Magazine’s Leaders in Drug Resistance Development 2026 – USA award.
The recognition follows a merit-based evaluation of innovation, impact, business performance and contributions to patient outcomes in combating cancer drug resistance.
Kairos Pharma (NYSE American: KAPA) will present at the LD Micro Invitational XVI at the Luxe Sunset Boulevard Hotel in Los Angeles on Monday, May 18, 2026 at 1:00 PM PDT. CEO and Chairman Dr. John Yu will provide an update on the company’s clinical program and partnering activities.
The LD Micro Invitational XVI runs May 18–19, 2026, featuring micro and small-cap companies presenting in half-hour slots and meeting investors. A webcast link is indicated for Kairos Pharma’s presentation.
Kairos Pharma (NYSE American: KAPA) will hold its Annual Meeting of Shareholders virtually at 9:00 am PDT on Monday, June 29, 2026. Meeting materials will be mailed to shareholders after they are finalized and filed with the Securities and Exchange Commission.
The company disclosed that the consolidated financial statements in its Form 10-K for the year ended December 31, 2025 include an auditor's explanatory paragraph noting preparation under the going concern assumption. This disclosure is being released to satisfy Section 610(b) of the NYSE American Company Guide and does not amend prior filings for 2025.
Kairos Pharma (NYSE American: KAPA) was named an Emerald honoree and winner of the 2026 Pinnacle Awards for Healthcare as Innovator of Biotech Solutions on April 15, 2026.
The company was recognized for its resistance‑modulating approach centered on ENV‑105 (carotuximab), an investigational antibody developed to restore and extend the effectiveness of existing cancer therapies by targeting tumor resistance mechanisms.
Kairos Pharma (NYSE:KAPA) signed binding terms to acquire exclusive worldwide rights to CL-273 from Celyn Therapeutics on March 2, 2026. CL-273 is an AI-designed, reversible, wild-type-sparing pan‑EGFR inhibitor targeting EGFR‑mutant NSCLC and resistance mechanisms.
The deal expands Kairos’s oncology pipeline into a market estimated at $16.2 billion in 2026 and is described by the company as expected to be value-accretive; D. Boral Capital acted as sole financial advisor.
Kairos Pharma (NYSE:KAPA) signed a term sheet to acquire worldwide rights to two clinical oncology assets from Celyn Therapeutics: CL-273, a pre‑IND wild‑type‑sparing pan‑EGFR inhibitor, and CL-741, a Phase 1‑ready oral type IIb c‑MET inhibitor. CL-273 completed GLP toxicology and is projected for first‑in‑human trials in 2026. The pairing targets EGFR-mutant and MET-driven NSCLC resistance mechanisms, supports a differentiated dual‑inhibition strategy, and cites a 4–5× wider therapeutic window for CL-273 and favorable brain/lung permeability. The agreement is a term sheet and remains subject to completion.
Kairos Pharma (NYSE American: KAPA) will participate in the 3rd Annual DealFlow Discovery Conference at The Borgata Hotel in Atlantic City, NJ on Jan. 28-29, 2026. Chief Scientific Officer Neil Bhowmick will deliver a company presentation and be available for one-on-one investor meetings throughout the event. Investors may request an investor pass at the conference website; the announcement states there is no cost to attend.
Kairos Pharma (NYSE: KAPA) won the 2025 Clinical Trials Arena Research and Development Excellence Award for Advanced Prostate Cancer for advancing ENV-105 (carotuximab), a first-in-class CD105-targeting monoclonal antibody designed to modulate resistance pathways in metastatic castration-resistant prostate cancer (mCRPC).
The company reported positive interim Phase 2 safety and efficacy data for ENV-105 combined with apalutamide: clinical benefit in 86% of treated patients to date; all responders were progression-free for at least 4 months, and half remained progression-free beyond 1 year. ENV-105 is investigational and has not been approved by the FDA or comparable foreign regulators.
Kairos Pharma (NYSE:KAPA) provided a shareholder update on November 4, 2025 outlining 2025 progress and 2026 outlook. Key clinical highlights include positive interim Phase 2 safety and efficacy results for ENV105 + apalutamide in metastatic prostate cancer: 86% clinical benefit rate among treated patients, median PFS 13.7 months by imaging, PSA reductions in 7 of 9 evaluable patients, and no dose‑limiting or Grade 4/5 toxicities.
Other 2025 achievements: presentations at ESMO, ASCO and AACR IO, peer‑review publication on CD105, and Department of Defense grants supporting ENV105 and ENV205. Planned 2026 milestones include completing Phase 2 enrollment (up to 100 patients), ongoing Phase 1 work in NSCLC, additional publications, and partnership announcements.
Kairos Pharma (NYSE American: KAPA) presented interim Phase 2 efficacy data for ENV-105 (carotuximab) in metastatic castration-resistant prostate cancer at the ESMO meeting on October 20, 2025. The interim analysis reported a clinical benefit in 86% of treated patients when ENV-105 was combined with apalutamide, with all responders progression-free at least 4 months and half remaining progression-free beyond 1 year. Seven of nine evaluable patients showed PSA reductions from baseline. Imaging-reported median progression-free survival with the combination was 13.7 months. The randomized Phase 2 is actively accruing up to 100 patients across three U.S. cancer centers; results are interim and the trial is ongoing.