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 (KAPA) reported statistically significant interim efficacy results from its Phase 2 trial of ENV-105 plus apalutamide in metastatic prostate cancer. Median progression-free survival, the time before disease worsens, was 17.7 months with the combination versus 2 months with apalutamide alone (P=0.0008) in patients with metastatic castration-resistant prostate cancer.
Kairos has modified the protocol to enroll patients earlier in disease progression: those with a PSA increase following upfront treatment with an androgen signaling inhibitor, rather than after one or two anti-androgen agents. Patients will be randomized to enzalutamide alone or enzalutamide plus ENV-105. The company intends the change to expand eligibility and facilitate enrollment, and targets completion of the Phase 2 trial in or before the fourth quarter of 2027. The trial remains ongoing, and the reported efficacy findings are interim.
Kairos Pharma (KAPA)/b) will present and moderate at the 24th Annual Discovery on Target drug discovery conference in Boston from Sept. 28 to Oct. 1, 2026.President and Chief Scientific Officer Neil Bhowmick will moderate an in-person breakout session on Sept. 30 titled “Winning the Race against Cancer Therapy Resistance,” highlighting Kairos’ strategy to extend efficacy of existing cancer drugs by targeting resistance rather than switching therapies. He will also deliver a plenary talk, “Targeting GITR for Immune Action against Tumor Progression,” focused on drug candidate KROS-101, designed to enhance T-cell function and anti-tumor activity in solid tumors. The oral presentation will be at 2:35 p.m. ET on Sept. 30 and available on demand to virtual attendees. Registration for virtual or in-person participation is via the Discovery on Target website.
Kairos Pharma (KAPA) will present an in-person corporate overview at the H.C. Wainwright 28th Annual Global Investment Conference on September 14, 2026, at 4:00 PM Eastern Time in the Holmes 1 room at the Lotte New York Palace Hotel.
The conference runs from September 14–16, 2026. A live webcast and a 90-day replay will be available via the investor relations section of Kairos Pharma’s website. CEO and Chairman John Yu, MD, will also be available for one-on-one meetings during the conference.
Kairos Pharma (NYSE American: KAPA) will implement a 1-for-7 reverse stock split of its common stock, effective September 1, 2026 at 12:01 a.m. ET. Trading on a split-adjusted basis will begin the same day under symbol KAPA with new CUSIP 48301N203.
Every seven shares will be automatically combined into one share, with no fractional shares issued; holdings will be rounded up to the nearest whole share. Conversion rates and exercise prices of outstanding convertible notes, warrants and equity awards will be proportionately adjusted. The reverse split does not change par value, authorized shares, or proportional ownership, and is intended to support NYSE American listing compliance.
Kairos Pharma (NYSE American: KAPA) announced a strategic collaboration with Bayer to evaluate Kairos’s lead antibody ENV-105 (carotuximab), a first-in-class CD105/BMP signaling inhibitor, in combination with Bayer’s XOFIGO (radium-223 dichloride) for metastatic castration-resistant prostate cancer (mCRPC) involving bone. The combination targets an estimated $570 million–$1.3 billion global addressable market.
According to Kairos Pharma, ENV-105 has shown an 86% clinical benefit rate and median progression-free survival of more than 13 months in a Phase 2 trial in castrate resistant prostate cancer, with interim data presented at the 2025 ESMO Congress. XOFIGO, the first FDA-approved alpha-emitting radiopharmaceutical for mCRPC with symptomatic bone metastases, has demonstrated a 24% reduction in mortality risk when combined with enzalutamide in the Phase III PEACE-3 trial (HR 0.76; p=0.009). Preclinical work cited by Kairos indicates ENV-105 can sensitize prostate tumors to radiation by targeting CD105, a resistance-associated protein upregulated after androgen receptor inhibition and ionizing radiation.
Kairos Pharma (NYSE American: KAPA), a clinical-stage cancer drug developer, issued a mid-2026 shareholder update. The company signed a term sheet to acquire worldwide rights to CL-741, a Phase 1-ready c-MET kinase inhibitor for EGFR-mutated NSCLC and other cancers.
The pipeline includes ENV-105, KROS-201, KROS-102 and ENV-205, with multiple 2026 milestones planned. Kairos reports a lean cost structure, over $8 million in non-dilutive funding, and a strategic collaboration network led by Cedars-Sinai and a new CRO consortium.
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.