Kairos Pharma, Ltd. Common Stock (KAPA)

Kairos Pharma (NYSE American: KAPA) has entered into a strategic collaboration with Bayer to evaluate its lead antibody candidate, ENV-105 (carotuximab), in combination with Bayer’s XOFIGO(R) (radium-223 dichloride) for the treatment of metastatic castration-resistant prostate cancer involving bone. ENV-105 is a first-in-class CD105/BMP signaling inhibitor designed to overcome cancer drug resistance and is currently being evaluated in Phase 1 and Phase 2 clinical trials. The company previously reported interim Phase 2 data showing median progression-free survival of more than 13 months in prostate cancer patients, while XOFIGO is the only FDA-approved alpha-emitting radiopharmaceutical for symptomatic bone metastases in this patient population.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on overcoming cancer drug resistance, today announced a strategic collaboration with Bayer to evaluate Kairos Pharma’s lead antibody ENV-105 (carotuximab), a first-in-class CD105/BMP signaling inhibitor, in combination with Bayer’s XOFIGO (radium-223 dichloride) in metastatic castration-resistant prostate cancer (mCRPC) involving bone.

Kairos Pharma (NYSE American: KAPA) announced favorable interim safety results from its ongoing Phase 1 trial evaluating ENV-105 (carotuximab) in combination with osimertinib (Tagrisso(R)) for patients with advanced EGFR-mutated non-small cell lung cancer (“NSCLC”) who have developed resistance to osimertinib. The company reported no Grade 3 or higher treatment-related adverse events among 13 patients treated with ENV-105 to date, supporting continued advancement of the program toward an early efficacy readout. ENV-105 is designed to inhibit CD105, a protein associated with acquired drug resistance, with the goal of restoring sensitivity to osimertinib.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, today announced compelling interim safety data from its ongoing Phase 1 clinical trial evaluating ENV-105 (carotuximab) in combination with osimertinib (AstraZeneca's Tagrisso®) in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). The data represent a pivotal milestone in Kairos Pharma's lead program: resensitizing patients who have acquired resistance to osimertinib, the global standard-of-care for EGFR-mutated NSCLC. With no serious adverse events (Grade 3 or higher) observed across 13 treated patients to date from ENV-105 treatment, the safety profile supports continued progression toward an early efficacy readout.

Kairos Pharma (NYSE American: KAPA) provided a mid-year 2026 update highlighting plans to expand its oncology pipeline through the proposed acquisition of worldwide rights to CL-741, a Phase 1-ready oral c-MET kinase inhibitor from Celyn Therapeutics targeting EGFR-mutated lung cancer and other cancers. The company said CL-741 would complement its existing portfolio, which includes ENV-105, KROS-201, KROS-102 and ENV-205. Looking ahead, Kairos expects to initiate a Phase 1 study of CL-741, advance ongoing clinical trials of ENV-105 in prostate cancer and non-small cell lung cancer, present data at scientific meetings and pursue pharmaceutical collaborations. The company also noted it has secured more than $8 million in non-dilutive funding to support development of its preclinical and clinical programs.

Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, provides a mid-year update for 2026 and a look ahead to the rest of the year in a letter to shareholders from CEO John Yu, M.D.:

Kairos Pharma (NYSE American: KAPA) announced it has been named a winner in the 2026 GHP Magazine Healthcare & Pharmaceutical Awards, receiving recognition as the USA leader in drug resistance development. The award highlights the company’s work in advancing cancer therapeutics designed to address treatment resistance, underscoring Kairos’ focus on extending the effectiveness of existing cancer therapies through innovative drug resistance-targeting approaches.

Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, announces that it has been named a winner of the 2026 GHP Magazine Healthcare & Pharmaceutical Awards as the Leaders in Drug Resistance Development 2026 - USA award recipient.

Kairos Pharma (NYSE American: KAPA) announced that CEO and Chairman Dr. John Yu will present at the 16th Annual LD Micro Invitational on May 18, 2026, at 1:00 p.m. PDT at the Luxe Sunset Boulevard Hotel in Los Angeles, where he will provide an update on the company’s clinical program and partnering activities.

Kairos Pharma (NYSE American: KAPA) announced that its annual meeting of shareholders will be held virtually at 9 a.m. PDT on June 29, 2026, with meeting materials to be mailed following finalization and filing with the SEC. The clinical-stage biopharmaceutical company also disclosed that its 2025 annual report included an audit report containing a going concern explanatory paragraph from its independent registered public accounting firm, as required under Section 610(b) of the NYSE American Company Guide, noting the disclosure does not reflect any change or amendment to previously filed financial statements.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, announces that its Annual Meeting of Shareholders will be held virtually at 9:00 am PDT on Monday, June 29, 2026. After the meeting materials are finalized and filed with the Securities and Exchanges Commission, such materials will be mailed to shareholders.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on cancer therapeutics, announced it has been named an Emerald honoree at the 2026 Pinnacle Awards for Healthcare, recognized for its innovative approach to addressing cancer drug resistance. The company’s strategy centers on resistance-modulating treatments, including its lead candidate ENV-105 (carotuximab), designed to inhibit tumor resistance pathways and enhance the effectiveness of existing therapies, as Kairos advances combination approaches aimed at improving durability of response across multiple cancer indications.

Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, announces that it has been named a winner of the 2026 Pinnacle Awards for Healthcare, being selected as an Emerald honoree for Innovator of Biotech Solutions for addressing cancer drug resistance.

Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Kairos Pharma, Ltd. (NYSE American: KAPA) resulting from allegations that Kairos Pharma may have issued materially misleading business information to the investing public.

Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf of shareholders of Kairos Pharma, Ltd. (NYSE American: KAPA) resulting from allegations that Kairos Pharma may have issued materially misleading business information to the investing public.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, has entered into binding terms to acquire CL-273 from Celyn Therapeutics, Inc., a company backed by OrbiMed and Torrey Pines Investment. CL-273 is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor discovered using a proprietary AI-driven drug discovery platform and designed to target resistant mutations in EGFR-mutant non-small cell lung cancer. The EGFR-mutated lung cancer treatment market is estimated at $16.2 billion in 2026, with mutations present in approximately 10–15% of NSCLC cases in Western populations and up to 50% in Asian populations. Kairos stated the transaction is expected to be value-accretive and accelerate development of a next-generation, AI-designed EGFR inhibitor, aligning the company with OrbiMed-backed innovation. D. Boral Capital, LLC acted as sole financial advisor.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces that it has entered into binding terms to acquire CL-273 from Celyn Therapeutics, Inc., a company backed by OrbiMed and Torrey Pines Investment.

Kairos Pharma (NYSE American: KAPA) announced it has signed a term sheet for a strategic asset acquisition from Celyn Therapeutics Inc., under which it would obtain worldwide rights to CL-273, a pre-IND, wild-type-sparing pan-EGFR inhibitor, and CL-741, a Phase 1-ready, oral type IIb c-MET kinase inhibitor targeting non-small cell lung cancer. The company said the proposed acquisition would expand its oncology pipeline with late-preclinical and Phase 1-ready candidates designed to address EGFR mutations and MET-driven resistance mechanisms in NSCLC, a multi-billion dollar market. Kairos indicated that dual inhibition of EGFR and MET pathways could overcome compensatory signaling and extend progression-free survival, positioning the assets for potential monotherapy and combination development pending completion of the transaction.