aibioKairos Pharma reports positive interim Phase 2 data for ENV-105 in prostate cancer
Tickers KAPA
Kairos Pharma says median progression-free survival was 17.7 months with ENV-105 plus apalutamide, compared with 2 months on apalutamide alone, and has changed the trial to enroll patients earlier.
Key facts
- Company
- Kairos Pharma, Ltd. (AMEX: KAPA)
- News type
- Company Updates
- Primary source
- Kairos Pharma, Ltd. 8-K (2026-10-06)
Kairos Pharma, Ltd. (NYSE American: KAPA) reported positive interim efficacy data from its ongoing Phase 2 trial of ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The company announced the results on October 6, 2026, in a press release filed as Exhibit 99.1 to a Form 8-K. The interim analysis showed a statistically significant difference in progression-free survival (PFS) between all patients in the trial treated with ENV-105 plus apalutamide and those treated with apalutamide alone. Median PFS was 17.7 months with the combination, compared with 2 months with apalutamide alone (P=0.0008).
The trial change
With the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the course of disease progression. Rather than treating patients after one or two anti-androgen agents, the modified protocol will enroll patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Those patients will be randomized to enzalutamide alone or enzalutamide in combination with ENV-105. The company says the change is intended to expand the eligible patient population and facilitate enrollment. Kairos is targeting completion of the Phase 2 trial in or before the fourth quarter of 2027.
Patients have been enrolled at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah. Chief Executive Officer Dr. John Yu said in the release: "These interim results provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug resistance." He added: "The protocol modification will allow more patients to be eligible for the potential benefits of ENV-105 treatment while evaluating the therapy earlier in disease progression."
Company background
In its annual report on Form 10-K, filed March 31, 2026, Kairos describes itself as a clinical-stage biopharmaceutical company developing antibodies and small molecules for prostate cancer, lung cancer, breast cancer and glioblastoma. Its proprietary technologies are licensed from Cedars-Sinai Medical Center. The company says its seven-drug portfolio includes five pre-clinical or clinical-trial stage drug candidates, two therapeutic agents developed by its Enviro Therapeutics, Inc. subsidiary, and technologies licensed by that subsidiary.
ENV 105 targets endoglin, also known as CD105. The company began a Phase 1 trial in non-small cell lung cancer in September 2023, and in the same month opened a randomized Phase 2 trial in prostate cancer. The 10-K also describes a Phase 2 trial in a heavily pre-treated prostate cancer population, in which the patients had been resistant to enzalutamide or abiraterone. The primary objective was the proportion of patients who had disease stabilization or regression at two months, and the 10-K reports a clinical benefit rate of 62%.
Financial position
SEC XBRL data show research and development expense of $2.1 million for 2025, compared with $414,000 for 2024. The net loss was $5.4 million for 2025 and $2.6 million for 2024. Cash flow from operations was negative $3.4 million in 2025 and negative $4.0 million in 2024. Year-end 2024 cash and cash equivalents were $1.3 million. A 10-Q filed August 12, 2026, reports $4.5 million for year-end 2025, and the same 10-Q reports cash and cash equivalents of $2.6 million at June 30, 2026.
What the release leaves out
Kairos has an interim result, not a finished trial. The release calls the data positive and statistically significant, but it does not say how many patients are in each group, how the groups were formed, or give a hazard ratio or confidence interval. It reports no safety data. The company also changed the protocol after the interim look, so the trial now enrolls an earlier-stage population than the one behind the 17.7-month figure.
Its 10-K says none of its product candidates has been approved as safe or effective by the FDA or any other comparable foreign regulator. Kairos reported a net loss of $5.4 million for 2025 and negative operating cash flow of $3.4 million, against cash of $2.6 million at June 30, 2026, and states no cash runway. The release names completion of the Phase 2 trial and uncertain regulatory approval among its risk factors.