Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on oncology therapeutics, announced that its annual meeting of shareholders will be held virtually at 9 a.m. PDT on June 29, 2026. Meeting materials will be mailed following finalization and filing with the Securities and Exchange Commission. The company also disclosed that its 2025 annual report included an audit report containing a going concern explanatory paragraph from its independent registered public accounting firm, as required under Section 610(b) of the NYSE American Company Guide. The disclosure does not reflect any change or amendment to previously filed financial statements.
The going concern notice indicates substantial doubt about the company's ability to continue as a going concern, a standard disclosure for early-stage biotech firms that have yet to generate revenue from product sales. Kairos Pharma, based in Los Angeles, is developing therapies to overcome drug resistance and immune suppression in cancer. Its lead candidate, ENV-105, is an antibody targeting CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy. ENV-105 aims to reverse drug resistance and restore the effectiveness of standard therapies across multiple cancer types.
Currently, ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for non-small cell lung cancer, addressing significant unmet medical needs. As of the date of the press release, ENV-105 has not been approved as safe or effective by the U.S. Food and Drug Administration or any other comparable foreign regulator. The company's ability to continue development depends on securing additional financing.
The news highlights the financial challenges faced by clinical-stage biopharmaceutical companies, where research and development costs are high and revenue is absent until regulatory approval. The going concern notice may impact investor confidence, but such disclosures are not uncommon for companies in this stage. The virtual annual meeting will allow shareholders to vote on key matters and receive updates on the company's progress.
For more information, the full press release is available at https://ibn.fm/sQ0pm. Latest news and updates relating to KAPA can be found in the company's newsroom at https://ibn.fm/KAPA.
