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). Ankündigung • 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 Ankündigung • 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 Ankündigung • 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. Ankündigung • Oct 07
Kairos Pharma to Present Positive Safety and Efficacy Data from Phase 2 Prostate Cancer Trial At ESMO 2025 Kairos Pharma, Ltd. announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress. Kairos's presentation, titled, "Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer" will take place in Berlin, Germany on October 17-21, 2025. Prostate cancer remains one of the most diagnosed cancers in men, with over a million new cases annually in the U.S. alone. Resistance to androgen-targeted therapies represents a major clinical challenge in patients with metastatic castration-resistant prostate cancer (mCRPC). The presentation will highlight results from an interim analysis of the randomized Phase 2 trial evaluating ENV105 (carotuximab), a first-in-class CD105 antagonist. The trial is enrolling 100 men at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah with mCRPC who had progressed on prior hormone therapies. Patients are randomized to receive apalutamide in the presence or absence of ENV105. Ankündigung • Sep 18
Kairos Pharma, Ltd. Announces Positive Interim Efficacy Analysis of Phase 2 Trial of ENV105 in Advanced Prostate Cancer with Median Progression Free Survival of over One Year Kairos Pharma, Ltd. announced positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). All patients enrolled in the trial had already failed at least one other hormone therapy modality. This mark was far exceeded by the ENV105/Apalutamide combination. The four-month timeframe is significant as 2nd or 3rd line standard of care hormone therapy has a 3.7-month median efficacy, as reported by the CARD trial (New Eng J. Med 381:2506). The same study also showed the use of chemotherapy (cabazitaxel) provided eight months' PFS, by imaging, accompanied with greater toxicity. The randomized Phase 2 trial aims to enroll 100 patients in total and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies. The interim safety analysis of the same trial, announced in July of this year, demonstrated that ENV105 was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first 10 enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. lead candidate, ENV105, is an antibody that targets CD105 - a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. Ankündigung • Sep 11
Kairos Pharma Announces Virtual KOL Event to Provide Perspectives on ENV105 Interim Efficacy Results in Advanced Prostate Cancer Kairos Pharma, Ltd. announced that it will host a premier KOL event on September 18, 2025 at 5 p.m. ET /2 p.m. PT to discuss diverse perspectives on the Company's interim efficacy results from a Phase 2 trial of its lead candidate, ENV105, in treating advanced prostate cancer patients. Registration is required to participate in the webcast. Interested participants can sign-up to receive the webcast link here. Ankündigung • Sep 03
Kairos Pharma, Ltd. Announces Presentation of New Phase 1 Data on ENV105 Combination Therapy in Non-Small Cell Lung Cancer At the World Lung Cancer Conference Kairos Pharma, Ltd. announced participation and presentation of initial Phase 1 data of ENV105 in non-small cell lung cancer by Principal Investigator Dr. Karen Reckamp. Dr. Reckamp will present at the World Lung Cancer Conference which takes place September 6-9, 2025, at the Fira de Barcelona Gran Via in Barcelona, Spain. The primary objective of the open-label trial is to evaluate the safety and tolerability of the combination therapy. New Risk • Jul 16
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 26% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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$4.7m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings are forecast to decline by an average of 39% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Market cap is less than US$100m (US$11.5m market cap). Ankündigung • Jul 15
Kairos Pharma Announces Positive Safety Results from Phase 2 Trial of ENV-105 in Advanced Prostate Cancer Kairos Pharma, Ltd. announced positive safety results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim safety analysis of the trial demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard of care hormone therapy, apalutamide, from the first ten enrolled patients. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care. Notably, no Grade 3 or 4 toxicities were observed. With one million men in the U.S. being diagnosed with prostate cancer annually, and millions more worldwide, the development of resistance to current hormone therapies is a growing unmet need with an increasingly aging population. Castration-resistant prostate cancer refers to tumors that grow despite receiving hormone blocking agents. Treatment options remain limited after hormone therapies fail. Kairos Pharma seeks to provide a safe and effective alternative for these patients with ENV-105. The randomized Phase 2 trial aims to enroll 100 patients in total, and is presently accruing patients at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to evaluate the safety, tolerability, and early signs of efficacy of ENV-105, a CD105 antagonist, in men whose disease has progressed following standard hormone-based therapies. Interim efficacy data from the trial are expected to be reported in September 2025. Kairos Pharma plans to engage with regulatory agencies to discuss the design of a potential pivotal Phase 3 study, based on emerging data. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$4.7m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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$4.7m free cash flow). Earnings are forecast to decline by an average of 39% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Share price has been volatile over the past 3 months (17% average weekly change). Market cap is less than US$100m (US$11.9m market cap). Ankündigung • May 02
Kairos Pharma, Ltd., Annual General Meeting, Jun 10, 2025 Kairos Pharma, Ltd., Annual General Meeting, Jun 10, 2025. Ankündigung • Mar 31
Kairos Pharma Ltd. Announces Completion of the Safety Arm of Its Phase 2 Clinical Trial of ENV105 in Metastatic, Castration-Resistant Prostate Cancer Kairos Pharma Ltd. announced the completion of the safety lead-in of its Phase 2 clinical trial of ENV105 for the treatment of metastatic, castration-resistant prostate cancer. The trial, titled, "Phase II study of Apalutamide with Carotuximab (ENV105) in Metastatic, Castration Resistant Prostate Cancer," began with the safety lead-in, which combined apalutamide, a standard of care for prostate cancer, with the Company's compound ENV105. The second part of the study, which randomizes patients to receive either apalutamide alone or in combination with ENV105 is ongoing. The Company expects to announce the safety and efficacy data readout from the safety arm of the trial beginning in the first half of 2025. The Company is also validating biomarkers throughout the study to best identify those patients believed to have the most benefit for the combination therapy. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI). Ankündigung • Mar 30
Kairos Pharma, Ltd. announced delayed annual 10-K filing On 03/28/2025, Kairos Pharma, Ltd. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Ankündigung • Mar 20
Kairos Pharma Ltd. Announces Peer Reviewed Publication Highlighting Potentially Groundbreaking Discovery in Overcoming Drug Resistance in Non-Small Cell Lung Cancer Kairos Pharma Ltd. announced a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC) patients. Recent findings published in Drug Resistance Updates highlight the critical role of CD105 (endoglin) in mediating resistance to oimertinib, a frontline treatment for EGFR-mutant NSCLC. The study, titled, "CD105 blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung cancer," demonstrated that CD105 expression is upregulated as a mechanism of therapy resistance, correlating with poor prognosis in patients. Notably, combining osimertinib with ENV105 reinstated susceptibility to EGFR inhibition through metabolic reprogramming and enhanced chromatin accessibility. These findings confirm the efficacy of this novel combination therapy strategy in overcoming drug resistance in this model of non-small cell lung cancer. The global NSCLC treatment market is projected to reach $45 billion by 2030, driven by advancements in targeted therapies. However, drug resistance remains a major challenge. The ability of ENV105 to enhance EGFR-targeted therapy effectiveness positions it as a high-value asset in next-generation oncology treatment. Kairos Pharma is currently evaluating this transformative cancer therapy in ongoing clinical trials for EGFR-driven lung cancer patients. Ankündigung • Feb 18
Kairos Pharma, Ltd. Receives Received $600,000 in Funding from the Department of Defense Lung Cancer Research Kairos Pharma, Ltd. announced that through its academic partnership with Cedars-Sinai Medical Center, Cedars-Sinai has received $600,000 in funding from the Department of Defense Lung Cancer Research Program to advance the development of ENV205, a new drug to treat chemotherapy drug resistance and cachexia. This funding will accelerate the Company's research efforts to develop ENV205, a first-in-class therapy designed to reverse chemotherapy drug resistance, counteract muscle loss, improve strength, and enhance the effectiveness of existing cancer treatments. By targeting key pathways that drive cachexia, Kairos seeks to develop ENV205 to provide a much-needed solution to help patients maintain their health and resilience throughout cancer therapy. The Company has long been partnering with Cedars-SINAi in its research and development of ENV205.Cachexia is a severe muscle-wasting condition that affects over half of cancer patients and significantly impacts quality of life, treatment tolerance, and survival. It is a complex metabolic syndrome characterized by voluntary weight loss, muscle atrophy, and systemic inflammation, which currently lacks effective treatment options. Ankündigung • Feb 11
Kairos Pharma Adds Huntsman Cancer Institute for Phase 2 ENV105 Clinical Trial Kairos Pharma Ltd. announced the addition of Huntsman Cancer Institute in Salt Lake City, Utah for the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients. Huntsman Cancer Center is another renowned center to be added to support the Company’s randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI). Ankündigung • Jan 16
Kairos Pharma, Ltd. announced that it expects to receive $3.5 million in funding Kairos Pharma, Ltd announced it has entered into a Securities Purchase Agreement to issue 2,500,000 common units at purchase price for each Common Unit was $1.40 per Common Unit for gross proceeds $3,500,000 and pre-funded units at purchase price $1.399 per Pre-Funded Unit, for aggregate proceeds $3,500,000 on January 14, 2025. Each common unit consisting of one Common Stock and one purchase warrant to purchase one and half Common Share. Each pre-funded unit consists of one Pre-Funded Warrant to purchase one Common Share and one and half Common Share purchase warrant to purchase one and half Common Share. The Pre-Funded Warrants have an exercise price of $0.001 per Warrant Share, are immediately exercisable and will expire when exercised in full. The Common Warrants have an exercise price of $1.40 per Common Share, will be exercisable six months from issuance and will expire five and a half years from the issuance date. The Units, Common Shares, the Pre-Funded Warrants, the Common Warrants and Warrant Shares, are being sold and/or issued without registration under the Securities Act in reliance on the exemption provided by Section 4(a)(2) of the Securities Act as a transaction not involving a public offering and/or Rule 506(b) of Regulation D promulgated thereunder as well as available exemptions under applicable state securities laws. The final closing of the sales of the Units pursuant to the Purchase Agreement is expected to occur on or about January 15, 2025 Ankündigung • Dec 15
Kairos Pharma, Ltd. Announces Board and Committee Changes On December 10, 2024, Dr. Rosemary Mazanet resigned from her position as a member of the board of directors of Kairos Pharma, Ltd, with such resignation to be effective upon the Company’s appointment of a new independent director to fill her role. Dr. Mazanet’s resignation was not due to any disagreement with the Company on any matter relating to the Company’s operations, policies or practices but rather was due to personal reasons. On December 10, 2024, the Board appointed Dr. Rahul Singhvi to serve as a director of the Board, effective immediately. Dr. Singhvi will also serve as a member of the Board’s audit committee and chair of the Board’s compensation committee and nominating and corporate governance committee. Dr. Singhvi, age 59, is a global leader in the Life Sciences industry and is cofounder of the U.S.-based biomanufacturing company, Resilience (National Resilience Inc.). Prior to cofounding Resilience in 2020, Dr. Singhvi was an Operating Partner at Flagship Pioneering, where he founded and operated companies launched from Flagship’s innovation foundry, Flagship Venture Labs. Before joining Flagship, he was the Chief Operating Officer of Takeda’s Vaccine Business Unit where he led worldwide vaccine manufacturing operations. Before Takeda, Dr. Singhvi was President and CEO of Novavax Inc. where he led the company’s transformation into a global vaccine player. Dr. Singhvi’s career began at Merck & Co in 1994, where he held several positions in R&D and manufacturing. Dr. Singhvi serves on the Board of Trustees of the Keck Graduate Institute, and on the Board of Directors for Codexis and for Garuda Therapeutics (private). Dr. Singhvi graduated as the top ranked chemical engineer from the Indian Institute of Technology, Kanpur, India and obtained both his M.S. and Sc.D. degrees in chemical engineering from MIT. He received an MBA from the Wharton School of the University of Pennsylvania, where he graduated as a Palmer Scholar. Ankündigung • Dec 03
Kairos Pharma Adds City of Hope Cancer Center for Phase 2 Env105 Clinical Trial Kairos Pharma Ltd. announced the addition of City of Hope Cancer Center in Duarte, California to the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients. City of Hope Cancer Center is the first of several planned new centers to be added in the coming weeks to support the Company's randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The additional centers allow Kairos Pharma to test ENV105 in a broader patient population to identify blood markers that could help select patients expected to benefit most from ENV105 treatment. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI). 
