Kairos Pharma, Ltd. Common Stock (KAPA)

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing innovative cancer therapeutics, released a Letter to Shareholders from CEO John Yu, M.D., outlining 2025 accomplishments and the outlook for 2026. The Company reported positive interim safety and efficacy results from its Phase 2 trial of ENV105 in combination with apalutamide for advanced metastatic prostate cancer, showing clinical benefit in 86% of treated patients, with durable progression-free survival and no dose-limiting toxicities. The findings, presented at the European Society for Medical Oncologists Meeting, suggest ENV105 may extend the effectiveness of standard care while maintaining strong tolerability. Kairos continues patient recruitment, with enrollment expected to reach 100 across leading U.S. cancer centers.

Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, provides an overview of key 2025 milestones and outlook into 2026 in a Letter to Shareholders from CEO John Yu, M.D. presented below.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing innovative cancer therapeutics, announced positive interim efficacy data from its ongoing Phase 2 trial of ENV-105 (carotuximab) in men with metastatic castration-resistant prostate cancer. Presented at the European Society for Medical Oncology meeting in Berlin, the study showed clinical benefit in 86% of patients treated with ENV-105 combined with apalutamide, with all responders remaining progression-free for at least four months and half beyond one year. Seven of nine evaluable patients experienced PSA reductions, supporting the therapy’s potential to restore hormone responsiveness. The randomized trial, led by Cedars-Sinai and partner institutions, continues to enroll patients to further evaluate safety and long-term efficacy.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today presents on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company dedicated to addressing resistance to current cancer therapeutics, today announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress. Kairos’s presentation, titled, “Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer” will take place in Berlin, Germany on October 17–21, 2025.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing cancer therapeutics, announced positive interim efficacy data from its ongoing Phase 2 trial of ENV105 (carotuximab) in metastatic castration-resistant prostate cancer. Among eight evaluable patients, the ENV105 and apalutamide combination achieved median progression-free survival of more than 13 months, with five patients still on treatment and seven of nine showing declines in prostate-specific antigen levels. This exceeded the trial’s target of a 45% improvement in progression-free survival compared with the standard 3.7 months for second- or third-line hormone therapy. The treatment was well tolerated with no dose-limiting toxicities observed. Kairos is hosting a KOL webcast today at 5 p.m. ET / 2 p.m. PT to review the findings with clinical experts.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). Kairos Pharma is hosting a virtual KOL (key opinion leader) event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT today. Interested participants can sign-up to receive the webcast link here.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing innovative cancer therapeutics, announced it will host a key opinion leader event on Sept. 18, 2025, at 5 p.m. ET to discuss interim efficacy results from its Phase 2 trial of lead candidate ENV105 in advanced prostate cancer. CEO Dr. John Yu said the event will highlight safety and efficacy findings from the ENV105 and apalutamide combination therapy, with expert perspectives underscoring the compound’s potential role in addressing cancer drug resistance.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces that it will host a premier KOL event on Thursday, Sept. 18th at 5 p.m. ET / 2 p.m. PT to discuss diverse perspectives on the Company’s interim efficacy results from a Phase 2 trial of its lead candidate, ENV105, in treating advanced prostate cancer patients. Registration is required to participate in the webcast. Interested participants can sign-up to receive the webcast link here.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announced that CEO and Chairman John Yu, MD, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference, being held Sept. 8–10, 2025, at the Lotte New York Palace Hotel in New York.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, announced participation and presentation of initial Phase 1 data of ENV105 in non-small cell lung cancer by Principal Investigator Dr. Karen Reckamp at the World Lung Cancer Conference, taking place Sept. 6–9, 2025, at the Fira de Barcelona Gran Via in Barcelona, Spain. Dr. Reckamp’s presentation, titled “Combination of Osimertinib and Carotuximab for Advanced, EFGR-Mutated Non-Small Cell Lung Cancer Patients,” highlights the combination therapy of ENV105 with osimertinib, with the open-label trial’s primary objective being to evaluate safety and tolerability.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces participation and presentation of initial Phase 1 data of ENV105 in non-small cell lung cancer by Principal Investigator Dr. Karen Reckamp. Dr. Reckamp will present at the World Lung Cancer Conference which takes place September 6-9, 2025, at the Fira de Barcelona Gran Via in Barcelona, Spain.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces that John Yu, MD, CEO and Chairman, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference. The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharma company advancing cancer therapeutics, will participate in the H.C. Wainwright 27th Annual Global Investment Conference, scheduled for September 8–10, 2025, at the Lotte New York Palace Hotel in New York City. The company will host one-on-one meetings and deliver a presentation available virtually via kairospharma.com.

Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces participation and presentation at the H.C. Wainwright 27th Annual Global Investment Conference, taking place September 8–10, 2025, at the Lotte New York Palace Hotel in New York City. Kairos Pharma will participate in on-on-one meetings and present at the meeting which will be available virtually and hosted on the kairospharma.com website.

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Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharma company developing cancer therapies, announced favorable interim safety results from its ongoing Phase 2 trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer. The first-in-class CD105 antagonist showed no dose-limiting toxicities or unexpected adverse events in the first ten patients, and no Grade 3 or 4 toxicities were observed. ENV-105 was well tolerated when combined with apalutamide, a standard hormone therapy. The 100-patient trial is underway at Cedars-Sinai, City of Hope, and Huntsman Cancer Center, with interim efficacy data expected in September 2025. Kairos plans to engage regulators on a potential Phase 3 study.

Kairos Pharma, Ltd. (NYSE American:KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim safety analysis of the trial demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first ten enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or 4 toxicities were observed.

Kairos Pharma (NYSE American: KAPA) presented new preclinical data at the ASCO 2025 Annual Meeting on its investigational small molecule GITR ligand agonist, KROS101. The study, titled “Effect of KROS 101, a small molecule GITR ligand agonist, on T effector cells, T reg cells and intratumoral CD8 T cell cytotoxicity,” demonstrated KROS101’s dual mechanism of enhancing effector T cell activity while reducing immune-suppressive T reg cells. Results showed that KROS101 outperformed TRX518, a prior anti-GITR antibody, in promoting tumor infiltration, boosting cytotoxicity, and preventing T cell exhaustion. CEO Dr. John Yu emphasized the potential of KROS101 to advance cancer immunotherapy by simultaneously stimulating immune response and tumor destruction.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, announces its presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting highlighting data on its investigational small molecule GITR ligand agonist KROS101. ASCO is being held May 30-June 3, 2025 at McCormick Place in Chicago, Ill.

Kairos Pharma (NYSE American: KAPA) announced it will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, at The Plaza Hotel in New York City. CEO and Chairman John Yu, MD, will host one-on-one meetings with investors from 9 a.m. to 3 p.m. ET.

Kairos Pharma (NYSE American: KAPA), announced it will present new data on KROS 101, a small molecule GITR ligand agonist, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster, titled “Effect of KROS 101, a small molecule GITR ligand agonist, on T effector cells, T reg cells and intratumoral CD8 T cell cytotoxicity,” will be presented June 2 at McCormick Place in Chicago. Kairos CEO John Yu, M.D., highlighted the opportunity to share findings and advance discussions around KROS 101’s potential in optimizing cancer treatment.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, announces it will be presenting at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting to be held May 30-June 3, 2025 at McCormick Place, Chicago, Ill.

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company, issued a shareholder letter from CEO John Yu, M.D., outlining recent progress and strategic developments. The company is advancing two clinical trials for lead candidate ENV105 in prostate and EGFR-dependent non-small cell lung cancers, with safety and interim efficacy results expected in Q2 2025. Kairos is also developing KROS101, an immune response modulator, with recent data presented at key oncology conferences. Supported by non-dilutive government grants, an expanding trial network, and analyst coverage from firms including EF Hutton and HC Wainwright, Kairos emphasized its strong financial position and robust IP portfolio extending into the 2030s.

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, today provides a letter to stockholders from CEO John Yu, M.D.: