CEO.CA's Inside the Boardroom: Kairos Pharma CEO on Phase 2 Safety Data, 165% Stock Move & September Efficacy TimelineJuly 28, 2025 12:28 PM EDT | Source: CEO.CA Technologies Ltd.Toronto, Ontario--(Newsfile Corp. - July 28, 2025) - CEO.CA ("CEO.CA"), the leading investor social network in junior resource and venture stocks, shares exclusive updates with CEOs of junior mining explorers.Founded in 2012, CEO.CA, a wholly owned subsidiary of EarthLabs, Inc., is one of the most popular free financi ...

Group 1 - Kairos Pharma's stock (KAPA) is experiencing a significant increase, trading at $1.12 with a volume of 221 million shares compared to an average of 874.3K [1][7] - The company released positive interim safety results from its Phase 2 clinical trial of ENV-105 in patients with metastatic castration-resistant prostate cancer, indicating it was well tolerated with no dose-limiting toxicities or unexpected adverse events reported [2][3] - The Phase 2 trial aims to enroll 100 patients to evaluate the safety, tolerability, and early efficacy of ENV-105, with interim efficacy data expected in September 2025 [3] Group 2 - The stock price of Kairos Pharma has increased by 57.64%, reaching $1.08 at the time of publication [7] - The treatment-related side effects of ENV-105 were manageable with standard supportive care, and no Grade 3 or 4 toxicities were observed [2]

Financial Performance - The company reported net losses of $1,262,000 for the three months ended March 31, 2025, compared to $323,000 for the same period in 2024, indicating a significant increase in losses [103]. - Total operating expenses for the three months ended March 31, 2025, were $1,266,000, compared to $287,000 for the same period in 2024, reflecting a substantial rise in operational costs [103]. - As of March 31, 2025, the company had an accumulated deficit of $10,077,000, highlighting ongoing financial challenges [83]. - The company incurred a net loss of $1,262 million in Q1 2025, compared to a net loss of $323 million in Q1 2024, with cash used in operations amounting to $714 million in 2025 versus $36 million provided in 2024 [107][112]. Research and Development - Research and development expenses increased to $493,000 for the three months ended March 31, 2025, from $165,000 in the same period of 2024, primarily due to the initiation of a Phase 2 trial in prostate cancer [104]. - The company anticipates continued significant operating losses as it advances its product candidates through clinical development and seeks regulatory approvals [83]. - The successful development and commercialization of product candidates remain highly uncertain due to various risks and uncertainties associated with the process [99]. - The company has entered into multiple agreements for clinical research and advisory services, including a $900 advance payment to Prevail Infoworks for clinical research services [118][120]. Financing Activities - The company entered into an Equity Line of Credit Agreement with Helena Global Investment Opportunities I LTD for up to $30,000,000 in common stock purchases [86]. - The January 2025 PIPE Offering raised a total of $3,498,000, with the issuance of 2,500,000 pre-funded units [91]. - Cash provided by financing activities was $3,058 million in Q1 2025, significantly up from $89 million used in Q1 2024, primarily due to gross proceeds from a private financing of $3,500 million [111][114]. - The company relies on equity and debt financings for funding, with potential dilution of ownership interest for current stockholders if additional capital is raised [117]. Expenses and Operational Costs - General and administrative expenses are expected to increase as the company expands its headcount and incurs additional costs related to being a public company [102]. - General and administrative expenses increased to $773 million in Q1 2025 from $122 million in Q1 2024, primarily due to a $132 million rise in stock-related and officer compensation expenses and a $240 million increase in vendor advance amortization expense [105]. - The company expects substantial increases in expenses related to ongoing research activities and public company operations, with funding requirements dependent on various factors including clinical trial progress and regulatory approvals [115][116]. Cash Position - The company had cash and cash equivalents of $3,616 million as of March 31, 2025, and expects these reserves to fund operations for at least 12 months [108][116]. - Non-cash expenses included stock-related expenses of $76 million in Q1 2025, compared to $20 million in Q1 2024 [112]. - The net change in operating assets and liabilities provided cash of $432 million in Q1 2025, compared to $299 million in Q1 2024, mainly due to a decrease in vendor advances of $636 million [113]. Licensing Agreements - The company has entered into exclusive license agreements with Cedars for patent rights related to cancer treatment and other medical applications [123][125].

Drug Development and Clinical Trials - The company has a portfolio of seven drug candidates, including ENV 105 and ENV 205, targeting drug resistance and immune suppression in cancer treatment[20]. - ENV 105 is currently in a Phase 2 trial for prostate cancer, showing a clinical benefit rate of 62% among heavily pre-treated patients[27]. - The company initiated three clinical trials in fall 2023 for KROS 201 and ENV 105, with ENV 105 targeting both cancer cells and their supportive environment[26]. - The company has filed an Investigational New Drug (IND) application for ENV 105, which became effective, allowing the commencement of clinical trials[24]. - A three-gene panel is being developed as a companion biomarker for patient selection in the ENV 105 trial, although it has not yet been approved by the FDA[29]. - The NIH awarded a grant of USD 3.2 million to support the development of biomarkers related to ENV 105, which will aid in identifying potential responders in future trials[30]. - KROS 101 is an orally available GITR ligand small-molecule antagonist currently in pre-IND studies, aimed at enhancing the antitumor immune response for cancer treatment[40]. - KROS 201 is an activated T cell therapy targeting glioblastoma, with IND-enabling pharmacology and toxicology studies completed and an IND application submitted[47]. - ENV 105 is in a Phase 2 clinical trial for prostate cancer patients resistant to androgen-targeted therapy, with a potential market of USD 9 billion for a six-month dose in the U.S.[57]. - ENV 205 has shown potential to sensitize chemotherapy-resistant prostate cancer to docetaxel, with the global docetaxel market projected to grow from USD 137 billion in 2024 to USD 329 billion by 2033[54]. - The company aims to complete enrollment in multiple clinical trials, including a Phase 2 trial of ENV 105 for prostate cancer and a Phase 1 trial for KROS 201 in glioblastoma patients[68]. Market Potential and Financial Projections - The global prostate cancer therapeutics market is valued at USD 7.9 billion, while the EGFR mutant non-small cell lung cancer market is valued at USD 1.7 billion[27]. - The global cancer drug spending is expected to reach USD 532 billion by 2031, driven by targeted therapies and immuno-oncology[55]. - The immune checkpoint inhibitor market size was USD 47.4 billion in 2023 and is anticipated to grow to USD 189.1 billion by 2032, with a CAGR of 16.7%[60]. - The T cell therapy market size is projected to reach USD 20.8 billion by 2030, up from USD 4.9 billion in 2021, reflecting a CAGR of 20.4%[61]. - The specific cancer cachexia therapeutics market was over $2 billion in 2022, projected to exceed $4 billion by 2032[64]. - The maximum aggregate milestone payment for ENV 105 will be $7,150,000 when cumulative net sales exceed $100,000,000[85]. Strategic Partnerships and Acquisitions - The acquisition of Enviro Therapeutics, Inc. in June 2021 expanded the company's pipeline with advanced drug candidates in Phase 1 and Phase 2 trials[23]. - Kairos has entered into four Exclusive License Agreements with Cedars-Sinai Medical Center, requiring various fees and milestone payments totaling up to $4,400,000[76][77]. - Enviro is obligated to pay an upfront license fee and additional fees upon raising capital, with potential aggregate fees of approximately $690,000 as of December 31, 2024[83]. - The strategic partnership with Tracon is expected to enhance Enviro's market position and product offerings in the biotechnology sector[88]. Intellectual Property and Patent Strategy - The patent portfolio includes eight issued U.S. patents and 24 patent applications in foreign jurisdictions, enhancing Enviro's intellectual property position[89]. - The company is focused on expanding its patent protection across multiple jurisdictions, including Australia, Canada, China, and Europe[91]. - The company has a strong patent protection strategy, with several patents set to expire in the late 2030s, ensuring long-term market exclusivity[92]. - The company is actively pursuing new treatments for fibrosis and cancer, with multiple patents granted and applications pending in various jurisdictions including Japan and the United States[93]. - The company is focusing on both product and method patents, which enhances its competitive advantage in the market[95]. Financial Performance and Risks - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years[116]. - The company has no products approved for commercial sale and may never achieve profitability[116]. - The company relies on additional financing to achieve business objectives, and adequate financing may not be available on acceptable terms[118]. - The company has limited operating history, making it difficult to evaluate its prospects for achieving intended business objectives[122]. - The company may face unforeseen expenses and complications as it transitions from a research-focused entity to one capable of supporting commercial activities[123]. Regulatory Challenges - The time required to obtain regulatory approval is unpredictable and typically takes many years, influenced by various factors including regulatory authority discretion[129]. - The company may need to relinquish valuable rights to technologies or future revenue streams if it raises additional funds through collaborations or strategic alliances[121]. - The company has not submitted a marketing application for any product candidates, and obtaining marketing authorization is a lengthy and uncertain process[132]. - The company may experience delays in preclinical testing and clinical trials, which could adversely affect its ability to obtain regulatory approvals[136]. - The regulatory approval process is lengthy and unpredictable, with no guarantee of obtaining approval for drug therapy candidates[165]. Sales and Marketing Challenges - The company lacks a sales and marketing infrastructure and has limited experience in the sale, marketing, or distribution of pharmaceutical products, which may hinder commercialization efforts[198]. - Establishing a sales force and marketing capabilities in the U.S. is critical, as delays could lead to significant commercialization costs without corresponding revenue[199]. - The company may face lower revenues and profitability if it relies on third parties for sales and marketing, limiting control over these operations[200]. - Coverage and adequate reimbursement for in-development products are uncertain, impacting market acceptance and sales potential[202]. Clinical Trial Integrity and Patient Recruitment - Enrollment and retention of patients in clinical trials is challenging and could delay trial completion[173]. - Serious adverse events or side effects from drug candidates could lead to interruptions in clinical trials and affect regulatory approval[175]. - The potential for adverse side effects could affect patient recruitment and the overall success of clinical trials[177].

Company Overview - Kairos Pharma (NYSE: KAPA) is focused on developing several oncology drugs aimed at overcoming resistance seen with existing therapies [2] Pipeline Development - The primary clinical drug in Kairos Pharma's pipeline is ENV105, which acts as a CD105 inhibitor [2]

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].