공고 • Jul 15
Kairos Pharma Reports Interim Safety Data in Phase 1 Trial of Env-105 in Egfr-Mutated Lung Cancer Patients Kairos Pharma, Ltd. issued a press release reporting interim safety data from the Company's ongoing Phase 1 clinical trial evaluating ENV-105 (Carotuximab), in combination with osimertinib, in patients with advanced EGFR-mutated non-small cell lung cancer. 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. Non-small cell lung cancer is the dominant form of lung cancer, accounting for approximately 85% of all lung cancer diagnoses globally. Within NSCLC, EGFR-mutated patients represent the most commercially important and genetically actionable subpopulation. The EGFR-NSCLC market alone is valued at approximately $10 billion across leading current markets, growing at a CAGR of 10.5%, projected to be over $13 billion by 2030. Osimertinib (Tagrisso) is the gold-standard, first-line therapy for this patient population with about $6 billion in sales annually. Despite osimertinib's initial efficacy, resistance to the drug is inevitable. Once a patient progresses on osimertinib, therapeutic options are limited with a significant clinical setback with inferior survival outcomes. Currently, there is no FDA-approved agent specifically designed to reverse or overcome osimertinib resistance and restore drug sensitivity. Kairos Pharma's scientific thesis is grounded in a precision oncology insight of restoring sensitivity to standard of care cancer therapies. CD105 (endoglin) is pathologically elevated in patients who develop osimertinib resistance, and its overexpression drives one of the core resistance signaling pathways. ENV-105 (carotuximab) is a first-in-class CD105 antibody that blocks the signaling of this overexpressed protein, mechanistically dismantling the resistance phenotype and creating the biological conditions for osimertinib sensitivity. This strategy support extending progression-free survival, preserving quality of life, and fundamentally increasing the clinical utility of the world's most prescribed EGFR-targeted therapy. If successful, ENV-105 would not compete with osimertinib - it would extend its commercial life across the entire EGFR-mutated patient population. The scientific rationale for targeting CD105 is well-established: CD105 is a validated driver of resistance and disease relapse across multiple cancer types, including EGFR-driven NSCLC, and pre-clinical models have already confirmed ENV-105's capacity to sensitize tumors to both radiation and hormone therapy. Critically, ENV-105's clinical validation extends beyond lung cancer with an ongoing Phase 2 trial for castrate-resistant prostate cancer, ENV-105 delivered median progression-free survival exceeding 13 months, a significant improvement over standard of care. We believe that this demonstrated that the CD105 suppression mechanism translates into durable clinical benefit across fundamentally different tumor types and resistance contexts. Interim Phase 1 Safety Data: Clinical Highlights The interim safety analysis of the Phase 1 trial evaluating ENV-105 + osimertinib in EGFR-mutated advanced NSCLC patients demonstrates a clean early safety profile in the 13 patients treated with combination therapy. The trial is intended to assess safety, tolerability, and recommended Phase 2 dose, with adverse events evaluated under Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and dose-limiting toxicities monitored during the initial treatment cycles. All side effects were manageable with standard supportive care. New Risk • May 24
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 49% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$3.8m free cash flow). Earnings are forecast to decline by an average of 49% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$20m net loss in 2 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Market cap is less than US$100m (US$11.7m market cap). New Risk • May 14
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.93m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Revenue is less than US$1m. Market cap is less than US$10m (US$9.93m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$22m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). 공고 • Apr 24
Kairos Pharma, Ltd., Annual General Meeting, May 14, 2026 Kairos Pharma, Ltd., Annual General Meeting, May 14, 2026, at 16:00 Singapore Standard Time. Location: 1 temasek avenue 37-02b, millenia tower,039192, Singapore 공고 • Jan 13
Kairos Pharma, Ltd. has filed a Follow-on Equity Offering in the amount of $4.524949 million. Kairos Pharma, Ltd. has filed a Follow-on Equity Offering in the amount of $4.524949 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering 공고 • Oct 21
Kairos Pharma Presents on Phase 2 Trial of ENV-105 in Advanced Prostate Cancer at European Society Medical Oncologists (ESMO) Meeting Kairos Pharma, Ltd. 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. An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline. 
