KAPA

Kairos Pharma, LTD. - 10-K Filing Summary

Business Context and Reporting Period

Company: Kairos Pharma, LTD. (KAPA)
Reporting Period: Fiscal Year Ended December 31, 2025
Business Model: Clinical-stage biopharmaceutical company developing immunotherapies and cell therapies to overcome drug resistance and immune suppression in cancer (prostate, lung, breast, glioblastoma).
Key Assets: Seven-drug portfolio including ENV 105 (Phase 2), KROS 201 (Phase 1), and pre-clinical candidates. Technologies licensed primarily from Cedars-Sinai Medical Center.
Operational Status: Virtual operations with one full-time employee (CFO) and three part-time executive officers. No products approved for commercial sale.

Key Financial Metrics (Year Ended Dec 31, 2025)

Note: The filing text does not provide specific margin or debt figures as the company has no revenue and minimal debt obligations (convertible notes converted to equity in 2024).

Material Changes vs. Prior Period

• Expense Growth: Total operating expenses increased 138% from $2.34M to $5.57M. R&D expenses surged 416% ($0.41M to $2.14M) driven by the initiation of Phase 2 trials for ENV 105. G&A expenses increased 78% due to public company costs, insurance, and vendor advance amortization.
• Financing Activity: Significant capital raised in 2025 via a January 2025 PIPE offering ($3.5M gross) and an Equity Line of Credit (ELOC) with Helena Global ($3.6M proceeds). In 2024, capital was raised via IPO ($6.2M gross).
• Cash Position: Cash and cash equivalents increased from $1.27M to $4.49M, though management states this may not fund operations for the next 12 months.
• Going Concern: The company continues to raise substantial doubt about its ability to continue as a going concern due to recurring losses and need for additional funding.

Guidance, Outlook, and Risks

Outlook & Strategy:

• Focus on completing enrollment for the Phase 2 trial of ENV 105 in prostate cancer and Phase 1 trial in lung cancer.
• Initiating Phase 1 trial for KROS 201 (glioblastoma).
• Seeking strategic partnerships and additional financing to fund clinical development.

Material Risks & Contingencies:

• Liquidity Risk: Substantial doubt exists regarding the ability to continue as a going concern. Additional funding is required to sustain operations beyond the next 12 months.
• Internal Controls: Material weaknesses in internal control over financial reporting were identified, including lack of segregation of duties and insufficient IT general controls.
• Regulatory Risk: No products are approved. Clinical trial results are uncertain, and regulatory approval is not guaranteed.
• Intellectual Property: Reliance on exclusive licenses from Cedars-Sinai and Tracon; failure to meet milestones could result in loss of exclusivity.
• Management Depth: Only one full-time employee (CFO); reliance on part-time executive officers may impede business execution.

Investor Verification Checklist

• Cash Runway: Verify if the $4.49M cash balance is sufficient to fund the planned Phase 2 trial completion given the $5.4M annual burn rate.
• Internal Controls: Assess the remediation plan for the identified material weaknesses in financial reporting and IT controls.
• License Milestones: Confirm the status of commercialization milestones owed to Cedars-Sinai and Tracon to ensure exclusive rights are maintained.
• ENV 105 Trial Data: Review the full data readout from the Phase 2 prostate cancer trial (62% clinical benefit rate reported in a small cohort) to validate efficacy claims.
• Dilution Risk: Monitor the utilization of the $30M ELOC and ATM offering, which could significantly dilute existing shareholders.