Financial Performance - The company reported net losses of $1,623,000 for the nine months ended September 30, 2024, and $1,812,000 for the year ended December 31, 2023, with an accumulated deficit of $7,835,000 as of September 30, 2024[102]. - The company has not generated any revenue from product sales to date, with no sales recorded during the year ended December 31, 2023, and the nine months ended September 30, 2024[121]. - The net loss for the three months ended September 30, 2024, was $1,047, significantly higher than the net loss of $312 for the same period in 2023[129]. - The company incurred a net loss of $1,623 for the nine months ended September 30, 2024, compared to a net loss of $694 for the same period in 2023[139]. - Cash used in operating activities for the nine months ended September 30, 2024, was $2,152, a significant increase from cash provided of $15 in the same period of 2023[143]. Cash Position and Funding - As of September 30, 2024, the company had cash on hand amounting to $3,217,000, which is critical for its ability to continue as a going concern[107]. - As of September 30, 2024, the company had cash totaling $3,217, expected to last into the fourth quarter of 2025[140]. - Existing cash and net proceeds from the IPO are projected to fund operating expenses and capital requirements for at least the next 12 months, but additional funding will be necessary for clinical development and commercialization of product candidates[156]. - The company raised $5,524 in net proceeds from its initial public offering (IPO) during the nine months ended September 30, 2024[140]. Operating Expenses - The company anticipates an increase in general and administrative expenses as it expands its headcount and incurs costs related to being a public company[127]. - Operating expenses for the three months ended September 30, 2024, totaled $383, an increase of 33.5% from $287 in the same period of 2023[129]. - General and administrative expenses increased to $369 for the three months ended September 30, 2024, compared to $254 in the same period of 2023, marking a 45.1% increase[133]. - Total other expenses for the three months ended September 30, 2024, were $664, a substantial increase from $25 in the same period of 2023, primarily due to financing costs[134]. - The company expects substantial increases in expenses related to ongoing research activities and clinical trials, with costs dependent on various factors including regulatory approvals and market acceptance[154]. Research and Development - The company is engaged in Phase 1 and Phase 2 clinical trials for product candidates ENV-105 and KROS-201, with ongoing preclinical research[123]. - Research and development expenses decreased to $14 for the three months ended September 30, 2024, from $33 in the same period of 2023, representing a 57.6% reduction[132]. - For the nine months ended September 30, 2024, research and development expenses rose to $242 from $75 in the same period of 2023, reflecting a 222.7% increase primarily due to Phase 2 clinical trial expenses[136]. - The company expects to continue incurring significant operating losses as it advances its product candidates through clinical development and seeks regulatory approval[102]. - The company has not yet received FDA approval for any of its product candidates, which are still in the clinical development stage[100]. Agreements and Contracts - The company has entered into a master service agreement with Prevail Infoworks, Inc. for clinical research services, requiring an advance payment of $900 and monthly payments of approximately $80 during the service period[158]. - A bioassay services agreement with PreCheck Health Services, Inc. includes an advance payment of $900 for biomarker screening services related to ongoing clinical trials[159]. - The company has a consulting agreement with Cross Current Capital LLC, involving a cash payment of $200,000 and restricted shares valued at $500,000 for financial and business consulting services over a 24-month term[163]. - The company has entered into four Exclusive License Agreements with Cedars, granting licensing rights for various patent rights related to cancer and autoimmune disease treatments[164]. - The company has a contractual obligation to pay $50 to the former Chief Financial Officer upon raising over $900 in financing, with $50 owed as of September 30, 2024[167]. Compliance and Governance - As of September 30, 2024, the company's disclosure controls and procedures were deemed not effective at a reasonable assurance level[169]. - The company is not currently involved in any legal proceedings that could materially affect its business or financial condition[173]. - Kairos Pharma, Ltd. filed its Certificate of Incorporation on May 10, 2023, with the Secretary of State of Delaware[177]. - The company has filed certifications pursuant to the Sarbanes-Oxley Act of 2002 for its principal executive and financial officers[178]. - The company is committed to compliance with the Securities Exchange Act of 1934, as evidenced by its recent filings[178]. Strategic Focus - Kairos Pharma, Ltd. is focused on developing new technologies and products in the pharmaceutical sector[177]. - The company is actively pursuing market expansion through strategic partnerships and consulting agreements[177]. - Kairos Pharma, Ltd. continues to enhance its operational framework through various agreements and amendments to support its growth strategy[177].
Kairos Pharma, Ltd.(KAPA) - 2024 Q3 - Quarterly Report