Drug Development Pipeline - The company has a pipeline of seven drug candidates, including ENV 105 and ENV 205, targeting significant unmet needs in prostate and lung cancer markets, with the global prostate cancer therapeutics market valued at USD 7.9 billion and EGFR mutant non-small cell lung cancer at USD 1.7 billion[25]. - ENV 105 has shown a clinical benefit rate of 62% in a Phase 2 trial involving heavily pre-treated prostate cancer patients, indicating disease stabilization or regression[25]. - The Phase 2 trial for ENV 105 is being conducted at multiple centers, including Cedars-Sinai, University of Utah, and City of Hope, focusing on patients resistant to standard hormone therapies[31]. - The company initiated three clinical trials in the fall of 2023 for KROS 201 and ENV 105, with ENV 105 targeting both cancer cells and their supportive non-cancer environment to address resistance mechanisms[24]. - KROS 101, a small molecule targeting the GITR ligand, is in pre-IND studies and aims to enhance the antitumor immune response by depleting regulatory T cells[39]. - ENV 205 is designed to target elevated mitochondrial DNA in circulation, which is associated with chemotherapy resistance and aims to restore chemotherapy sensitivity while reducing side effects[33]. - The company is developing KROS 102, KROS 301, and KROS 401, which target various mechanisms of immune suppression at the tumor site[32]. - KROS 201 is an activated T cell therapy targeting glioblastoma, with the market for T cell therapy expected to grow from $4.9 billion in 2021 to $20.8 billion by 2030, reflecting a CAGR of 20.4%[62]. - ENV 105 is in a Phase 2 clinical trial for prostate cancer patients resistant to androgen-targeted therapy, with a potential market of $9 billion for a six-month dose in the U.S. alone[58]. - ENV 205 has shown promise in preclinical studies for limiting chemotherapy-resistant prostate cancer, with the chemotherapy market for docetaxel projected to grow from $137 billion in 2024 to $329 billion by 2033[55]. - KROS 301 is in active preclinical development, targeting the NF-kB pathway, with the global small-molecule cancer therapies market valued at $175.3 billion in 2021[63]. - KROS 401 is a cyclic peptide in preclinical development, with the global peptide therapeutics market size estimated at $117.3 billion in 2024, expected to grow at a CAGR of 10.77%[64]. - The global immune checkpoint inhibitor market size was $47.4 billion in 2023 and is anticipated to reach $189.1 billion by 2032, with a CAGR of 16.7% from 2024 to 2032[61]. - ENV 205 is positioned to address cachexia, a condition affecting 50% of cancer patients, with the specific cancer cachexia therapeutics market projected to grow from over $2 billion in 2022 to over $4 billion by 2032[65]. Clinical Trials and Regulatory Challenges - The company aims to develop innovative therapeutics targeting drug resistance and immune suppression in cancer treatment, with a focus on advancing its clinical pipeline[67]. - The company plans to complete enrollment in a Phase 2 trial of ENV 105 for prostate cancer and a Phase 1 trial for non-small cell lung cancer patients on Tagrisso[67]. - The time required to obtain regulatory approval is unpredictable and typically takes many years, influenced by various factors including the discretion of regulatory authorities and government funding levels[130]. - The company has not submitted a marketing application for any product candidates in any country or region, which is a lengthy and uncertain process requiring extensive data to establish safety and efficacy[133]. - Only a small percentage of drugs in development successfully complete the FDA approval process and are commercialized, posing a significant risk to the company's business and financial condition[134]. - Even if regulatory approval is obtained, it may be contingent on the performance of additional costly clinical trials, which could limit the approved indications or patient populations[145]. - The company relies on third-party contract research organizations for regulatory application support, which may introduce additional risks due to limited experience in this area[129]. - Regulatory approval processes may change during clinical development, impacting the ability to commercialize products in a timely manner[131]. - The company must demonstrate that its product candidates are safe and effective, which requires extensive preclinical and clinical studies that can be costly and time-consuming[139]. - Delays in clinical trials can occur due to various factors, including regulatory requirements, patient recruitment challenges, and unforeseen safety issues[141]. - The company faces significant risks related to the potential for negative clinical trial results, which could prevent obtaining regulatory approval or achieving market acceptance[138]. - Delays in clinical trials could harm the commercial prospects of product candidates and increase costs, potentially allowing competitors to market their products first[147]. - Future regulations from authorities like the FDA may increase the time and cost required for clinical trials, impacting the ability to obtain marketing approvals[148]. - The company has limited experience in designing and implementing clinical trials, which could lead to increased costs and delays in obtaining regulatory approvals[156]. - Serious adverse events (SAEs) or undesirable side effects identified during development could lead to the discontinuation of clinical programs or limitations on product use, affecting commercial potential[150]. - Positive results from early clinical trials may not predict future outcomes, and there is a high failure rate for drugs in clinical development[154]. Financial and Operational Considerations - The company has incurred significant losses since inception and expects to continue incurring losses over the next several years, with no products approved for commercial sale[118]. - The company requires substantial additional funding to meet financial needs and pursue business objectives, with future capital requirements dependent on various factors[119]. - The company has limited operating history, making it difficult to evaluate its prospects for achieving business objectives and commercial success[123]. - The company may face dilution of stockholder ownership if additional capital is raised through equity offerings or debt financings[121]. - The company is committed to employee development, offering competitive compensation and benefits to attract and retain skilled personnel[112]. - The company lacks a sales or marketing infrastructure and limited experience in the sale, marketing, or distribution of pharmaceutical products[200]. - Establishing sales, marketing, and distribution capabilities will require substantial resources and could delay product launches[200]. - Market acceptance of approved product candidates will depend on various factors, including the size of the target market[199]. - Coverage and adequate reimbursement from third-party payors are critical for the commercial success of any product candidates[203]. Patent and Intellectual Property - The company holds multiple patents related to cancer treatment, including compositions and methods for treating cancer and autoimmune diseases, with expiration dates ranging from 2037 to 2040[91][92][93]. - The patent for "Sensitization of Tumors to Therapies through Endoglin Antagonism" is currently in application status in Australia and Canada, with a protection date until June 14, 2037[91][92]. - The company holds a patent for "Method of Generating Activated T Cells for Cancer Therapy," which is set to expire on August 10, 2040 in Canada[91]. - The patent portfolio includes compositions for treating diseases by depletion of mitochondrial or genomic DNA from circulation, with a protection date until November 25, 2040 in Canada[91]. - The company has secured patents in multiple jurisdictions, including China, Europe, and Japan, for various cancer treatment methods and compositions[92][93]. - The patent for "Antibody Formulations and Uses Thereof" is granted in India and Japan, with an expiration date of September 5, 2033[93]. - The company has a granted patent for treating fibrosis, which is applicable in France, Germany, Switzerland, and the United Kingdom, expiring on September 18, 2035[93]. - The patent for "Compositions and Methods for Treating Cancer and Autoimmune Diseases" is granted in Japan, with a protection date until August 8, 2039[93]. - The company is actively pursuing new technologies and methods for cancer treatment, as evidenced by its extensive patent applications and granted patents[91][92][93]. - The company’s patent strategy indicates a strong focus on innovative cancer therapies, positioning it well for future market opportunities[91][92][93]. Acquisitions and Corporate Structure - The company acquired Enviro Therapeutics, Inc. in June 2021, enhancing its pipeline with advanced drug candidates in Phase 1 and Phase 2 trials[21]. - Kairos Pharma conducted a 1-for-2.5 reverse stock split on May 10, 2023, resulting in 10,334,357 shares of common stock outstanding[98]. - The company acquired AcTcell Biopharma, issuing 5,045,000 shares for all outstanding shares of AcTcell[99]. - The acquisition of AcTcell was treated as a transaction under common control, recognizing the historical cost basis of AcTcell's assets and liabilities[100]. - Kairos acquired Enviro in a share exchange, issuing 6,000,000 shares of restricted common stock, representing approximately 20% of the outstanding shares on a fully diluted basis[102]. - Following the Enviro-Kairos share exchange, Kairos had approximately 19,825,957 shares of common stock issued and outstanding on a fully diluted basis[103]. - Effective April 17, 2025, Kairos assumed all responsibilities and liabilities of Enviro under existing agreements, leading to Enviro's dissolution[104]. Market and Economic Factors - The global cancer drug spending was valued at approximately $232 billion in 2024 and is expected to reach $532 billion by 2031, driven by targeted therapies and immuno-oncology[56]. - The healthcare industry's trend towards cost containment may impact the demand and pricing of drugs, affecting commercialization efforts[205]. - The company faces risks associated with international marketing, including differing regulatory requirements and potential economic instability in foreign markets[212]. - The company is exposed to product liability claims that could result in substantial liabilities and limit commercialization of its products[208]. - The company may not be able to obtain adequate product liability insurance coverage, which could adversely affect its operations and share price[209]. - The reliance on single-sourced third parties for clinical trials and manufacturing may lead to delays if those parties fail to perform satisfactorily[215]. - The company must navigate various risks related to compliance with healthcare laws and regulations, which could result in significant penalties and reputational harm[214].

FDA Approvals & Rejections - Armata Pharmaceuticals received FDA QIDP designation for AP-SA02, a bacteriophage-based candidate for complicated Staphylococcus aureus bacteremia, providing five years of market exclusivity and eligibility for Fast Track status [2][3] - Allurion Technologies gained FDA PMA approval for the Gastric Balloon System, a swallowable Smart Capsule that promotes fullness for about four months, targeting patients with a BMI of 30-40 [4][5] - Eton Pharmaceuticals' DESMODA oral solution was approved for managing central diabetes insipidus, with an expected peak annual sales of $30 million - $50 million [9][11] Deals - Gilead Sciences announced the acquisition of Arcellx for $115 per share, totaling an implied equity value of $7.8 billion, enhancing its position in cell therapy [12][13] - Vir Biotechnology entered a global collaboration with Astellas for VIR-5500, receiving $335 million in upfront payments and potential additional milestones of up to $1.37 billion [14][15][16] - Kairos Pharma signed a term sheet to acquire two oncology assets from Celyn Therapeutics, focusing on cancer therapeutics [17][18][20] Clinical Trials - Breakthroughs - MoonLake Immunotherapeutics reported positive Phase 2 trial results for Sonelokimab in axial spondyloarthritis, with 81% of patients achieving an ASAS40 response at Week 12 [21][22] - Novo Nordisk's CagriSema missed its primary endpoint in a Phase 3 trial against Zepbound, showing 23% weight loss compared to 25.5% with Tirzepatide [25][26][27] - Gossamer Bio's seralutinib missed the primary endpoint in the PROSERA Phase 3 study for pulmonary arterial hypertension, showing a placebo-adjusted improvement in Six-Minute Walk Distance [28][30][31] - Argenx's VYVGART met primary goals in the Phase 3 ADAPT OCULUS trial for ocular myasthenia gravis, demonstrating significant improvement in ocular scores [37][38][39]

Core Insights - Kairos Pharma Ltd. has been awarded the 2025 Clinical Trials Arena Excellence Award for its Research and Development efforts in Advanced Prostate Cancer [1] - The award recognizes the company's innovative approach in developing ENV105 (carotuximab), a first-in-class monoclonal antibody targeting CD105 to combat treatment resistance in metastatic castration-resistant prostate cancer (mCRPC) [2][4] Company Overview - Kairos Pharma Ltd. is a clinical-stage biopharmaceutical company based in Los Angeles, focusing on oncology therapeutics and utilizing structural biology to address drug resistance and immune suppression in cancer [5] - The lead candidate, ENV-105, targets CD105, a protein linked to resistance in various cancer treatments, aiming to restore the effectiveness of standard therapies [5] Clinical Trial Results - Positive interim results from a Phase 2 randomized clinical trial of ENV-105 in combination with apalutamide showed clinical benefit in 86% of treated patients, with all responders remaining progression-free for at least four months and half for over one year [3] - ENV-105 is currently in a Phase 2 trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer, addressing significant unmet medical needs [5] Industry Recognition - The Clinical Trials Arena Excellence Awards highlight advancements in clinical research and drug development that can improve patient outcomes and redefine standards of care in the life sciences industry [4]

Financial Performance - The company reported net losses of $4,082,000 for the nine months ended September 30, 2025, and $2,603,000 for the year ended December 31, 2024, with an accumulated deficit of $12,897,000 as of September 30, 2025[88]. - For the nine months ended September 30, 2025, total operating expenses were $4,157, up from $897 in the same period of 2024, resulting in a net loss of $4,082[113]. - Cash used in operating activities was $2,357 for the nine months ended September 30, 2025, compared to $2,152 in the same period of 2024[121]. - Other income improved to $37 in Q3 2025 compared to a loss of $(664) in Q3 2024, driven by interest income from a money market account[112]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $1,435,000, compared to $383,000 for the same period in 2024, representing an increase of 274%[109]. - Research and development expenses for the three months ended September 30, 2025, were $608,000, up from $14,000 in the same period in 2024[109]. - General and administrative expenses increased to $827,000 for the three months ended September 30, 2025, compared to $369,000 for the same period in 2024, reflecting a rise of 124%[109]. - The increase in vendor advances amortization expense in 2025 was a significant factor in the rise of general and administrative expenses[115]. - The company incurred non-cash expenses of $2,301 during the nine months ended September 30, 2025, primarily from vendor advances amortization[121]. Revenue Generation - The company has not generated any revenue from product sales to date, with no sales recorded during the nine months ended September 30, 2025, and 2024[101]. 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[91]. - During the nine months ended September 30, 2025, the company sold 3,510,000 shares of common stock to Helena for net proceeds of $3,205,000[94]. - Financing activities generated $6,660 in cash for the nine months ended September 30, 2025, compared to $5,276 in the same period of 2024, including $3,058 from private financing[123]. - The company expects to finance its operations through public or private equity offerings, debt financings, and potential collaboration agreements[90]. Regulatory Status - The company has not yet received regulatory approval for any of its product candidates, which are still in clinical trials[86]. - The company anticipates significant and increasing expenses and operating losses as it advances its product candidates through clinical development[88]. Going Concern - The company’s ability to continue as a going concern depends on raising additional capital to meet operating needs and repay liabilities[118]. - The company had cash and cash equivalents of $5,575 and shareholders' equity of $7,664 as of September 30, 2025, with expectations to fund operations for at least 12 months[117].

Summary of Kairos Pharma Conference Call Company and Industry - **Company**: Kairos Pharma (NYSEAM: KAPA) - **Industry**: Oncology, specifically focusing on prostate cancer treatment Key Points and Arguments 1. **Phase II Trial Update**: The conference call discussed the interim efficacy analysis for the Phase II trial of ENV-105 (Carotuximab) in combination with apalutamide for advanced prostate cancer treatment [2][5][7] 2. **Unmet Need**: There are approximately 1,000,000 new prostate cancer diagnoses annually in the U.S., with a significant unmet need for effective treatments as resistance to current hormone therapies develops [5][6] 3. **Safety and Efficacy**: The interim safety analysis indicated that ENV-105 was well tolerated with no dose-limiting toxicities or unexpected adverse events reported among the first 10 patients [6][7] 4. **Efficacy Results**: The interim efficacy analysis showed a median progression-free survival (PFS) of 13.7 months for the combination therapy, which is significantly higher than previous benchmarks [22][24][70] 5. **Comparison with Other Treatments**: The PFS of 13.7 months compares favorably to other treatments, such as cabazitaxel (8 months) and lutetium (11.6 months) [22][41][70] 6. **Mechanism of Action**: ENV-105 is a neutralizing antibody that blocks CD105, which is elevated in cancer cells and associated fibroblasts, potentially resensitizing patients to hormone therapies [17][18] 7. **Clinical Implications**: The data suggests that ENV-105 may provide a new treatment option for patients who have previously failed hormone therapies, with manageable side effects [39][42] 8. **Expert Panel Insights**: Key opinion leaders discussed the potential of ENV-105 to resensitize patients to androgen receptor pathway inhibitors, which is a significant advancement in prostate cancer treatment [44][46][60] Other Important but Possibly Overlooked Content 1. **Patient Selection**: The trial specifically excluded patients who had received more than two different AR pathway inhibitors or previous chemotherapy to ensure a more homogeneous patient population [58][60] 2. **Toxicity Management**: The side effects observed, such as nosebleeds and hypertension, were manageable and comparable to other treatments in the field [30][39] 3. **Future Research Directions**: The company is collecting biospecimens to further investigate biomarkers that may predict treatment efficacy, which could enhance patient selection and treatment outcomes in future studies [92][94] 4. **Regulatory Considerations**: The discussion highlighted the lack of a standardized treatment protocol for prostate cancer, emphasizing the need for individualized treatment plans based on patient-specific factors [53][60] This summary encapsulates the critical insights from the conference call, focusing on the advancements in prostate cancer treatment through Kairos Pharma's ENV-105 and its implications for future therapies.

Core Viewpoint - Kairos Pharma, Ltd. is hosting a KOL event to discuss interim efficacy results from a Phase 2 trial of its lead candidate ENV105 for advanced prostate cancer treatment [1] Company Summary - Kairos Pharma, Ltd. is a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics [1] - The KOL event is scheduled for Thursday, September 18th at 5 p.m. ET / 2 p.m. PT [1] - Registration is required to participate in the webcast [1] Industry Context - The event will provide diverse perspectives on the efficacy results, indicating a focus on collaboration and expert insights within the oncology sector [1]

Summary of Kairos Pharma Conference Call Company Overview - **Company**: Kairos Pharma - **Industry**: Biopharmaceuticals focused on cancer therapeutics - **CEO**: John Yu, a neurosurgeon dedicated to reversing cancer drug resistance and immune suppression [2][18] Core Points and Arguments - **Cancer Drug Resistance**: Kairos Pharma aims to address the challenge of cancer drug resistance, particularly in prostate cancer and non-small cell lung cancer, where standard therapies often fail [2][4] - **Lead Drug - EMV-105**: - EMV-105 is an antibody designed to block CD105, a protein that mediates tumor cell survival and therapy resistance [4][15] - Currently in a randomized multi-institutional phase II trial for prostate cancer, funded by an NIH grant [3][14] - Demonstrated a 62% clinical benefit rate in a phase II trial, significantly higher than the expected 0% response after resistance [5][6] - **Clinical Trials**: - Three clinical programs are ongoing, including trials for prostate cancer and non-small cell lung cancer [3][14] - A phase I trial for non-small cell lung cancer is also in progress, targeting patients who have failed standard treatments like Tagrisso [10][14] - **Market Potential**: - The prostate cancer market is valued at $11 billion, while the EGFR-dependent lung cancer market is estimated at $14 billion, with Tagrisso alone representing $6.6 billion [14][15] - The immunotherapy market is substantial, valued at $118 billion, but currently has a low response rate of only 17% [11][15] Additional Important Content - **Biomarker Development**: A three-gene assay has been identified to predict patient response to EMV-105, improving the likelihood of success in pivotal trials from 55% to 76% [6][15] - **Immunotherapy Innovations**: - Kairos 101 and 102 are being developed to enhance T cell responses against tumors and target autoimmune diseases [11][12] - These therapies aim to complement existing checkpoint inhibitors, potentially increasing their efficacy [12][15] - **Strategic Partnerships**: The company has a strategic relationship with Cedars-Sinai Medical Center, enhancing clinical efficiency and providing expertise [18] - **Upcoming Milestones**: - Efficacy results from the phase II prostate trial are expected to be reported in September 2025, along with safety data from the lung trial [16][18] - The company has strong patent protection extending through 2040, ensuring a competitive edge in the market [16][17] Conclusion - Kairos Pharma is positioned to make significant advancements in cancer treatment through innovative therapies targeting drug resistance and immune suppression, with a robust pipeline and strategic partnerships enhancing its potential for success in the biopharmaceutical industry [17][18]

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents Kairos Pharma's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Kairos Pharma's unaudited consolidated financial statements and notes for periods ended June 30, 2025, and December 31, 2024 [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030,%202025%20and%20December%2031,%202024) Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $3,034 | $1,272 | | Vendor advances, net | $1,717 | $2,859 | | Total Current Assets | $4,839 | $4,169 | | Deferred offering costs | $1,692 | $1,377 | | Intangible assets, net | $142 | $222 | | Total Assets | $6,673 | $5,768 | | Accounts payable and accrued expenses | $676 | $992 | | Total Current Liabilities | $676 | $992 | | Total Shareholders' Equity | $5,997 | $4,776 | [Unaudited Condensed Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Condensed Consolidated Statements of Operations (in thousands, except per share data) | Item | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Revenues | $0 | $0 | $0 | $0 | | Research and development | $496 | $63 | $989 | $228 | | General and administrative | $960 | $159 | $1,733 | $286 | | Total operating expenses | $1,456 | $222 | $2,722 | $514 | | Loss from operations | $(1,456) | $(222) | $(2,722) | $(514) | | Total other income (expenses), net | $34 | $(31) | $38 | $(62) | | NET LOSS | $(1,422) | $(253) | $(2,684) | $(576) | | BASIC AND DILUTED LOSS PER COMMON SHARE | $(0.08) | $(0.02) | $(0.16) | $(0.05) | | WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING | 17,213,017 | 10,562,640 | 16,307,308 | 10,562,640 | [Unaudited Condensed Consolidated Statements of Shareholders' Equity (Deficit)](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(Deficit)%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Condensed Consolidated Statements of Shareholders' Equity (in thousands) | Item | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Common Stock (Amount) | $14 | $18 | | Additional Paid-in Capital | $13,577 | $17,478 | | Accumulated Deficit | $(8,815) | $(11,499) | | Total Shareholders' Equity | $4,776 | $5,997 | - Net loss for the six months ended June 30, 2025, was **$2,684 thousand**, contributing to the accumulated deficit[16](index=16&type=chunk) - Additional paid-in capital increased by **$3,901 thousand**, primarily from proceeds of **$3,058 thousand** from the sale of common shares and pre-funded warrants, and **$210 thousand** from the equity line of credit[16](index=16&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Condensed Consolidated Statements of Cash Flows (in thousands) | Item | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(1,519) | $(132) | | Net cash provided by financing activities | $3,281 | $60 | | Net increase (decrease) in cash | $1,762 | $(72) | | Cash and cash equivalents, beginning of period | $1,272 | $93 | | Cash and cash equivalents, end of period | $3,034 | $21 | - Cash provided by financing activities in 2025 included **$3,058 thousand** from the sale and exercise of prefunded warrants and **$223 thousand** from the equity line of credit[19](index=19&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [NOTE 1 – BASIS OF PRESENTATION](index=9&type=section&id=NOTE%201%20%E2%80%93%20BASIS%20OF%20PRESENTATION) Kairos Pharma, an early-stage oncology biotech, prepares interim GAAP financials, with its going concern status reliant on future capital and profitability - Kairos Pharma, Ltd. is an early-stage biotechnology company focused on developing immunotherapy and cell therapy treatments for oncology[21](index=21&type=chunk) - The company incurred a net loss of **$2,684 thousand** and used **$1,519 thousand** in cash from operations during the six months ended June 30, 2025[24](index=24&type=chunk) - As of June 30, 2025, the company had cash and cash equivalents of **$3,034 thousand** and shareholders' equity of **$5,997 thousand**; subsequent to June 30, 2025, an additional **$3,693 thousand** was raised from its Equity Line of Credit (ELOC), expected to fund operations for at least 12 months[24](index=24&type=chunk) [NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=10&type=section&id=NOTE%202%20-%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This section details significant accounting policies, including consolidation, estimates, asset accounting, and fair value measurements - The condensed consolidated financial statements include the accounts of Kairos Pharma, Ltd. and its wholly-owned subsidiary, Enviro Therapeutics, Inc[27](index=27&type=chunk) - Intangible assets, primarily a licensing agreement, are amortized over five years using the straight-line method, with **$80 thousand** amortization expense for the six months ended June 30, 2025 and 2024, respectively[31](index=31&type=chunk) - Deferred offering costs related to the Equity Line of Credit (ELOC) totaled **$1,692 thousand** as of June 30, 2025, with **$13 thousand** amortized as cost of capital during the three and six months ended June 30, 2025[35](index=35&type=chunk) [NOTE 3 – VENDOR AGREEMENTS](index=12&type=section&id=NOTE%203%20%E2%80%93%20VENDOR%20AGREEMENTS) The company has various vendor agreements involving advance payments, with net vendor advances decreasing to **$1,717 thousand** by June 30, 2025 Vendor Advances, Net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total Vendor Advances | $3,271 | $3,115 | | Less: accumulated amortization | $(1,554) | $(256) | | Vendor advances, net | $1,717 | $2,859 | - Amortization expense relating to vendor advances was **$1,298 thousand** for the six months ended June 30, 2025[41](index=41&type=chunk) - An additional **384,459 common shares**, valued at **$328 thousand**, were issued to Helena Global Investment Opportunities on April 24, 2025, related to the ELOC agreement, recorded as deferred offering costs[50](index=50&type=chunk) [NOTE 4 – SHAREHOLDERS' EQUITY](index=14&type=section&id=NOTE%204%20%E2%80%93%20SHAREHOLDERS'%20EQUITY) This section details changes in shareholders' equity, including common stock issuances from a private financing and an Equity Line of Credit (ELOC), the adoption of the 2023 Equity Incentive Plan, and the granting and vesting of Restricted Stock Units (RSUs) and stock warrants Common Stock Issued and Outstanding | Date | Shares Issued and Outstanding | | :---------------- | :---------------------------- | | June 30, 2025 | 17,743,765 | | December 31, 2024 | 13,736,597 | - The company closed a private financing on January 16, 2025, selling **2,500,000 pre-funded units** for net proceeds of **$3,058 thousand**[52](index=52&type=chunk)[53](index=53&type=chunk) Restricted Stock Unit (RSU) Activity (6 Months Ended June 30, 2025) | Item | Number of Restricted Shares | Fair Value (in thousands) | | :-------------------------------- | :-------------------------- | :------------------------ | | Unvested, December 31, 2024 | 172,000 | $314 | | Granted | 20,120 | $31 | | Vested | (78,521) | $(153) | | Unvested, June 30, 2025 | 113,599 | $192 | Stock Warrant Activity (6 Months Ended June 30, 2025) | Item | Number of Warrant Shares | Weighted Average Exercise Price | | :-------------------------------- | :----------------------- | :------------------------------ | | Balance, December 31, 2024 | 278,188 | $4.29 | | Granted | 6,460,700 | $0.85 | | Exercised | (2,500,000) | $0.001 | | Forfeited/Expired | (150,000) | $4.17 | | Balance, June 30, 2025 | 4,088,888 | $1.49 | [NOTE 5 – COMMITMENTS AND CONTINGENCIES](index=17&type=section&id=NOTE%205%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) The company holds multiple exclusive license agreements with Cedars-Sinai for cancer and autoimmune disease, involving fees, royalties, and milestone payments - Kairos Pharma holds four exclusive license agreements with Cedars-Sinai Medical Center for patent rights related to compounds binding to RelA of NFkB, fibrosis treatment, cancer and autoimmune disease treatments, and T-cell generation for cancer therapy[66](index=66&type=chunk) - Milestone payments for these licenses range from **$150 thousand** upon Phase I completion to **$1,500 thousand** upon FDA approval of a new drug application, and additional payments for cumulative net sales[66](index=66&type=chunk) - Enviro Therapeutics has two exclusive license agreements with Cedars for patent rights related to mitochondrial DNA depletion and Endoglin antagonism for cancer therapy, with potential milestone payments totaling mid-to-high seven-figures[67](index=67&type=chunk)[69](index=69&type=chunk) - Enviro is obligated to meet specific commercialization milestones, including obtaining INDs, commencing Phase I/II trials, and submitting NDA/BLAs within defined timelines, with potential license conversion or termination if not met[70](index=70&type=chunk) [NOTE 6 – SEGMENT INFORMATION](index=19&type=section&id=NOTE%206%20%E2%80%93%20SEGMENT%20INFORMATION) Kairos Pharma operates as a single reportable segment, focusing on cancer immunotherapy, with the CEO reviewing net income (loss) for resource allocation - The company operates and manages its business as one reportable segment, focusing on clinical-stage biopharmaceutical development for cancer[73](index=73&type=chunk) Significant Segment Expenses (in thousands) | Item | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Research and development, less officer compensation | $899 | $228 | | Officer compensation and wages | $200 | $0 | | Insurance | $203 | $21 | | Stock-based compensation | $153 | $0 | | Operating expenses | $1,267 | $265 | | Net Loss | $(2,684) | $(576) | [NOTE 7 – SUBSEQUENT EVENTS](index=19&type=section&id=NOTE%207%20%E2%80%93%20SUBSEQUENT%20EVENTS) Subsequent to June 30, 2025, the company further utilized its Equity Line of Credit (ELOC) with Helena, selling 3,000,000 common shares for net proceeds of $3,693 thousand and issuing additional warrants to placement agents - In July 2025, the company sold **3,000,000 common shares** to Helena through the ELOC for net proceeds of **$3,693 thousand**[75](index=75&type=chunk) - Warrants to purchase **210,000 common shares** were issued to Placement Agents in July 2025, with exercise prices of **$0.40** and **$0.46** per share[75](index=75&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operations, losses, funding needs, and performance for periods ended June 30, 2025 and 2024 [Overview](index=20&type=section&id=Overview) This section provides an overview of Kairos Pharma's clinical-stage biopharmaceutical business, accumulated deficit, and future funding requirements - Kairos Pharma is a clinical-stage biopharmaceutical company focused on developing therapeutics for cancer patients to overcome immune suppression and drug resistance[79](index=79&type=chunk)[80](index=80&type=chunk) - The company has not generated any revenue from product sales and has incurred significant operating losses, with an accumulated deficit of **$11,499 thousand** as of June 30, 2025[81](index=81&type=chunk)[82](index=82&type=chunk) - Substantial additional funding will be required to support continuing operations and growth strategy, expected to be financed through equity/debt offerings, collaborations, strategic alliances, and licensing arrangements[84](index=84&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) This section highlights recent financing activities, including the ELOC agreement and the January 2025 PIPE Offering - The company entered into an Equity Line of Credit (ELOC) agreement with Helena Global Investment Opportunities I LTD for up to **$30,000 thousand** of common stock[85](index=85&type=chunk) - As of the report date, the company sold an aggregate of **3,510,000 shares** of common stock for net proceeds of **$3,903 thousand** under the ELOC agreement[90](index=90&type=chunk) - The January 2025 PIPE Offering closed on January 16, 2025, for a total purchase price of **$3,498 thousand** from the sale of **2,500,000 pre-funded units**[91](index=91&type=chunk)[92](index=92&type=chunk) [Components of Results of Operations](index=22&type=section&id=Components%20of%20Results%20of%20Operations) This section describes the components of the company's results of operations, focusing on R&D and G&A expenses - The company has not generated any sales revenue to date[96](index=96&type=chunk) - Operating expenses consist of research and development (R&D) and general and administrative (G&A) expenses[97](index=97&type=chunk) - R&D expenses are highly variable, influenced by factors such as clinical trial costs, number of trials, patient enrollment, and regulatory requirements[99](index=99&type=chunk) - G&A expenses are expected to increase due to public company operations, including accounting, audit, legal, regulatory, and investor relations costs[103](index=103&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) This section compares the company's financial performance for the three and six months ended June 30, 2025 and 2024 [Comparison of the Three Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial performance for the three months ended June 30, 2025 and 2024 Net Loss Comparison (in thousands) | Period | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | Three Months Ended | $(1,422) | $(253) | - Research and development expenses increased from **$63 thousand** in 2024 to **$496 thousand** in 2025, primarily due to the Phase 2 prostate cancer trial[105](index=105&type=chunk) - General and administrative expenses rose from **$159 thousand** in 2024 to **$960 thousand** in 2025, mainly due to increased vendor advance amortization[106](index=106&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=25&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) This section compares the company's financial performance for the six months ended June 30, 2025 and 2024 Net Loss Comparison (in thousands) | Period | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :------------ | :------------ | | Six Months Ended | $(2,684) | $(576) | - Research and development expenses increased from **$228 thousand** in 2024 to **$989 thousand** in 2025, primarily related to the Phase 2 prostate cancer trial[109](index=109&type=chunk) - General and administrative expenses increased from **$286 thousand** in 2024 to **$1,733 thousand** in 2025, largely due to increased vendor advance amortization[110](index=110&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, equity, and recent financing activities for liquidity - The company incurred a net loss of **$2,684 thousand** and used **$1,519 thousand** in cash from operations during the six months ended June 30, 2025[112](index=112&type=chunk) - Cash and cash equivalents totaled **$3,034 thousand** at June 30, 2025, and shareholders' equity was **$5,997 thousand**[112](index=112&type=chunk) - Proceeds from private financing (**$3,058 thousand**) and the ELOC (**$223 thousand**) contributed to liquidity; subsequent ELOC financing of **$3,693 thousand** is expected to fund operations for at least 12 months[112](index=112&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) This section analyzes the company's cash flows from operating, investing, and financing activities Cash Flow Activities (in thousands) | Activity | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Operating activities | $(1,519) | $(132) | | Investing activities | $0 | $0 | | Financing activities | $3,281 | $60 | | Net increase (decrease) in cash | $1,762 | $(72) | - Cash used in operating activities increased significantly in 2025 due to a higher net loss and non-cash expenses, primarily **$1,298 thousand** in vendor advance amortization[116](index=116&type=chunk) - Cash provided by financing activities increased substantially in 2025, driven by **$3,058 thousand** from private financing and **$223 thousand** from the ELOC[118](index=118&type=chunk) [Funding Requirements](index=27&type=section&id=Funding%20Requirements) This section outlines the company's expected future funding needs for research, clinical trials, and commercialization - The company expects substantial increases in expenses due to ongoing research, clinical trials, and public company operations[119](index=119&type=chunk) - Existing cash, including IPO and January 2025 PIPE Offering proceeds, is estimated to fund operations for at least the next 12 months[120](index=120&type=chunk) - Additional funding will be required for clinical development and commercialization, likely through equity/debt financings, collaborations, strategic alliances, or licensing arrangements[121](index=121&type=chunk) [Contractual Obligations and Commitments](index=28&type=section&id=Contractual%20Obligations%20and%20Commitments) This section details the company's advance payment and exclusive license agreements, including fees and milestones - The company has advance payment agreements with Prevail Infoworks (**$900 thousand**), PreCheck Health Services (**$900 thousand**), CEO.CA Technologies (**$250 thousand**), Belair Capital Advisors (**$365 thousand**), and Cross Current Capital LLC (**$200 thousand** cash + **$500 thousand** in shares)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - Exclusive license agreements with Cedars-Sinai Medical Center involve initial license fees, annual maintenance fees, royalties (**3.75% to 4.25%** of net sales), sublicense fees (**5% to 35%**), and milestone payments upon clinical trial success and FDA approvals[127](index=127&type=chunk)[66](index=66&type=chunk)[68](index=68&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risks](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) As a "smaller reporting company," Kairos Pharma is not required to provide detailed quantitative and qualitative disclosures about market risks in this report - The company is exempt from providing detailed market risk disclosures as a "smaller reporting company"[129](index=129&type=chunk) [Item 4. Control and Procedures](index=30&type=section&id=Item%204.%20Control%20and%20Procedures) The company's disclosure controls were not effective as of June 30, 2025, due to a persistent material weakness in review and segregation of duties - Disclosure controls and procedures were concluded to be **not effective** at a reasonable assurance level as of June 30, 2025[130](index=130&type=chunk) - A material weakness persists due to insufficient review procedures and segregation of duties, and a lack of process documentation for review[132](index=132&type=chunk) - No material changes in internal control over financial reporting occurred during the six months ended June 30, 2025[132](index=132&type=chunk)[133](index=133&type=chunk) [PART II - OTHER INFORMATION](index=31&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) Kairos Pharma is not currently involved in any material legal proceedings or claims that are expected to have a significant adverse effect on its business, financial condition, or operating results - The company is not currently party to any pending or threatened material legal proceedings or claims[135](index=135&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, Kairos Pharma is exempt from new risk factor disclosures, with no material changes from its Annual Report - The company is exempt from providing new risk factor disclosures as a "smaller reporting company"[136](index=136&type=chunk) - No material changes to the risk factors described in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, have occurred as of the report date[136](index=136&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company completed its IPO, raising **$6,200,000** gross proceeds, and issued **1,055,100 shares** under an ELOC agreement via Section 4(a)(2) exemption - The IPO was completed on September 17, 2024, raising **$6,200,000** in gross proceeds from **1,550,000 shares** at **$4.00 per share**[137](index=137&type=chunk) - No material change in the planned use of IPO proceeds has occurred[138](index=138&type=chunk) - A total of **1,055,100 shares** were issued to Helena Global Investment Opportunities I Ltd. in conjunction with an Equity Line of Credit agreement, under a Section 4(a)(2) exemption[139](index=139&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[140](index=140&type=chunk) [Item 4. Mine Safety Disclosure](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosure) This item is not applicable to the company - Not applicable[141](index=141&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) During the period ended June 30, 2025, none of the company's directors or executive officers adopted or terminated any "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" - No directors or executive officers adopted or terminated Rule 10b5-1 trading arrangements during the period ended June 30, 2025[142](index=142&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Certificate of Incorporation, Bylaws, Form of Representative's Warrant, various certifications (302 and 906), a Services Agreement, and Inline XBRL Taxonomy documents - The report includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[143](index=143&type=chunk) - A Services Agreement dated June 10, 2025, between Kairos Pharma Ltd. and Baretto Pacific Corporation is incorporated by reference[143](index=143&type=chunk) [SIGNATURES](index=33&type=section&id=SIGNATURES) The report is duly signed on August 12, 2025, by John S. Yu, Chief Executive Officer and Chairman of the Board of Directors, and Douglas Samuelson, Chief Financial Officer - The report was signed on August 12, 2025, by John S. Yu (Chief Executive Officer and Chairman of the Board of Directors) and Douglas Samuelson (Chief Financial Officer)[146](index=146&type=chunk)

Core Insights - CEO.CA is a leading investor social network focused on junior resource and venture stocks, providing exclusive updates to CEOs of junior mining explorers [1][6] - The platform has gained popularity since its founding in 2012, attracting millions of global investors to discuss stocks, commodities, and emerging companies [2][6] - The "Inside the Boardroom" series offers insights from industry leaders, enhancing understanding of their vision and strategies [3][4] Company Highlights - Dr. John Yu, CEO of Kairos Pharma, discussed the company's prostate cancer trial, which reported zero grade 3 or 4 toxicities, a significant improvement compared to over 50% with standard treatments [4] - The upcoming efficacy data in September and plans for expansion into lung cancer and other tumor types were also highlighted [4][8] - CEO.CA serves as a platform for showcasing companies and connecting with investors, emphasizing its role in the investment community [5][6]

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]