aibioKairos Pharma reports interim Phase 1 safety data for ENV-105 in lung cancer
Tickers KAPA
The company reports no serious adverse events, defined as Grade 3 or higher, in 13 patients treated with ENV-105 and osimertinib, and says the safety profile supports progression toward an early efficacy readout.
Key facts
- Company
- Kairos Pharma, Ltd. (AMEX: KAPA)
- News type
- Company Updates
- Primary source
- Kairos Pharma, Ltd. 8-K (2026-07-15)
Kairos Pharma, Ltd. (NYSE American: KAPA) reported interim safety data from its ongoing Phase 1 trial of ENV-105 (carotuximab) in combination with osimertinib, sold as Tagrisso, in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC). The release is dated July 15, 2026, and was filed as Exhibit 99.1 to a Form 8-K. It states that no serious adverse events (Grade 3 or higher) have been observed across 13 treated patients to date from ENV-105 treatment.
The interim safety results
The company describes the interim safety analysis as showing a clean early safety profile in the 13 patients treated with the combination. The trial is intended to assess safety, tolerability and the recommended Phase 2 dose. Adverse events are evaluated under the Common Terminology Criteria for Adverse Events (CTCAE) 5.0, and dose-limiting toxicities are monitored during the initial treatment cycles. The release says all side effects were manageable with standard supportive care. Kairos states that the safety profile supports continued progression toward an early efficacy readout.
Dr. Neil Bhowmick, Chief Science Officer of Kairos Pharma, said: "ENV-105 continues to be extremely well tolerated, now across two very different indications."
The market and mechanism the company cites
The release says NSCLC accounts for approximately 85% of all lung cancer diagnoses globally. It describes EGFR-mutated patients as the most commercially important subpopulation within NSCLC. The company puts the EGFR-NSCLC market at approximately $10 billion and osimertinib sales at about $6 billion a year, and states that resistance to the drug is inevitable. The release says there is currently no FDA-approved agent specifically designed to reverse or overcome osimertinib resistance.
Kairos states that CD105, also called endoglin, is pathologically elevated in patients who develop osimertinib resistance, and that ENV-105 blocks the signaling of this overexpressed protein. If the approach succeeds, the company says, ENV-105 would not compete with osimertinib and would instead extend its commercial life across the entire EGFR-mutated patient population. The release also refers to an ongoing Phase 2 trial in castrate-resistant prostate cancer, where it reports median progression-free survival exceeding 13 months.
Company background
In its annual report on Form 10-K, filed March 31, 2026, Kairos describes itself as a clinical-stage biopharmaceutical company with a seven-drug portfolio that includes ENV 105 and ENV 205. The filing says its proprietary technologies are licensed from Cedars-Sinai Medical Center, and that an Investigational New Drug application for ENV 105 has become effective with the FDA. The company began the Phase 1 lung cancer trial in September 2023.
The 10-K also reports that a Phase 2 prostate cancer trial recorded a clinical benefit rate of 62% at two months, in patients who had been resistant to enzalutamide or abiraterone.
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, and 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. The release does not state a cash runway.
What the release does not show
This is an early safety readout in 13 patients, not an efficacy result, and the release's own headline calls it breakthrough. It reports no tumor response or progression-free survival for the lung cancer trial, no recommended Phase 2 dose and no count of lower-grade side effects, and "extremely well tolerated" is the company's characterization, not an independent review. The release says the safety profile supports continued progression toward an early efficacy readout, and it names success and completion of the Phase 1 and Phase 2 clinical trials among its risk factors. The prostate cancer survival figure it repeats is from a different, ongoing trial. The 10-K says none of the company's product candidates has been approved as safe or effective by the FDA or any comparable foreign regulator. Kairos reported a net loss of $5.4 million for 2025 and cash flow from operations of negative $3.4 million, and the release does not state a cash runway. The market figures in the release are the company's own.