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]

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]