Executive Summary / Key Takeaways

• Targeted Innovation in Oncology: Kairos Pharma (NYSE American: KAPA) is a clinical-stage biopharmaceutical company focused on developing first-in-class immunotherapy and cell therapy treatments to overcome immune suppression and drug resistance in various cancers, including prostate, lung, breast, and glioblastoma.
• Promising Clinical Progress: The company has reported positive safety results from its Phase 2 trial of ENV-105 in metastatic castration-resistant prostate cancer, with efficacy data anticipated in September. KAPA also secured an $876,000 Department of Defense grant for ENV-105 in lung cancer, validating its lead compound.
• Proprietary Technological Edge: KAPA's pipeline, featuring assets like ENV-105 (a CD105 antagonist) and KROS 101 (a GITR ligand agonist), targets critical mechanisms of drug resistance and immune evasion, offering a differentiated approach in a competitive landscape.
• Significant Funding Requirements: As an early-stage biotech, KAPA operates at a substantial net loss, with cash used in operations of $1.519 million for the first half of 2025. Recent financings, including a $3.058 million PIPE and over $3.9 million from an Equity Line of Credit, provide an estimated 12-month cash runway, but further capital will be essential for commercialization.
• High-Risk, High-Reward Profile: KAPA presents a high-risk, high-reward investment opportunity. Its success hinges on positive clinical trial outcomes, regulatory approvals, and continued access to capital, balanced against the potential for significant market disruption if its innovative therapies prove effective.

The Battle Against Cancer's Defenses: KAPA's Strategic Offensive

Kairos Pharma, Ltd. (NYSE American: KAPA) stands at the forefront of oncology innovation, a clinical-stage biopharmaceutical company dedicated to developing groundbreaking immunotherapy and cell therapy treatments. The company's core mission is to reverse the insidious mechanisms of therapeutic resistance and immune suppression that often render conventional cancer treatments ineffective. This strategic focus positions KAPA in a high-stakes arena, aiming to transform cancer care by targeting the very defenses tumors erect.

KAPA's journey began in 2013 as NanoGB13, Inc., evolving into Kairos Pharma, Ltd. and later converting to a Delaware corporation. This foundational period involved intense business planning, capital raising, and the meticulous development of its intellectual property portfolio. A pivotal moment arrived in 2021 with the acquisition of Enviro Therapeutics, Inc., a move that expanded KAPA's pipeline through valuable licensing agreements with Cedars-Sinai Medical Center. These agreements form the bedrock of KAPA's current product candidates, providing exclusive rights to patented technologies critical for its therapeutic development. The company's transition to a public entity in September 2024, raising $6.20 million in its IPO, marked a significant step in securing the capital necessary to fuel its ambitious clinical programs.

Pioneering Technologies to Dismantle Tumor Defenses

KAPA's investment thesis is deeply rooted in its differentiated technological approach, which seeks to overcome the complex challenges of cancer treatment. The company's pipeline is built upon novel mechanisms designed to re-engage the body's immune system and circumvent drug resistance.

At the heart of KAPA's strategy is ENV-105 (carotuximab), a first-in-class CD105 antagonist. This antibody therapeutic is currently in a Phase 2 clinical trial for prostate cancer patients resistant to androgen-targeted therapy. The significance of ENV-105 extends to lung cancer, where it is in a Phase 1 trial for EGFR-driven non-small cell lung cancer (NSCLC) patients who have failed to respond to osimertinib, a frontline treatment. Recent peer-reviewed publications highlight the critical role of CD105 (endoglin) in mediating resistance to osimertinib, suggesting ENV-105 directly targets a key mechanism of resistance. This offers a tangible benefit by potentially extending the efficacy of existing therapies and providing a new option for patients who have exhausted other treatments. The U.S. Department of Defense's $876,000 grant to support ENV-105's study in preventing drug resistance further validates its potential.

Beyond ENV-105, KAPA is advancing a diverse portfolio of innovative candidates:

• KROS 101 is an orally available small-molecule GITR ligand agonist. It is designed to deplete regulatory T cells (Tregs) and activate effector T cells, thereby augmenting the antitumor immune response. This systemic immune modulator holds promise for solid cancers, with new data presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting highlighting its effect on T effector cells, T reg cells, and intratumoral CD8 T cell cytotoxicity.
• KROS 201 focuses on activating T cells using dendritic cells, specifically for the challenging treatment of glioblastoma.
• KROS 301 is a tumor-targeting small molecule and checkpoint inhibitor. Its mechanism involves blocking the intranuclear localization of RelA, a key component of the NF-KB pathway, targeting RelA/p65 biomarker-positive solid tumors. This precision medicine approach aims for highly targeted efficacy.
• KROS 401 acts as a tumor microenvironment immune modulator and a cyclic peptide inhibitor of IL-4 and IL-13. It is designed to reverse tumor-associated macrophage inhibition and block IL4/IL13 cytokine immune receptors, particularly for triple-negative breast cancer.
• ENV 205 is an antibody fragment that targets mitochondrial DNA, representing another avenue for therapeutic intervention.

These technologies collectively form KAPA's competitive moat. By focusing on novel, first-in-class mechanisms and leveraging biomarker-driven approaches, KAPA aims to develop therapies that offer superior efficacy in specific patient populations, potentially leading to higher average selling prices (ASPs) and improved market positioning. The strategic intent behind this robust R&D pipeline is to address significant unmet medical needs, which could translate into substantial long-term growth opportunities for investors.

Navigating the Competitive Currents in Oncology

The oncology market is fiercely competitive, dominated by pharmaceutical giants with vast resources and established commercial infrastructures. KAPA, as a clinical-stage company, operates in the shadow of industry titans such as Pfizer Inc. , Merck & Co., Inc. , Bristol-Myers Squibb Company , and Amgen Inc. . These larger players boast extensive, commercialized portfolios, robust revenue streams, and global distribution networks.

Compared to these behemoths, KAPA is a niche player. Its strength lies in its agility and focused innovation on specific, often underserved, mechanisms of cancer resistance and immune suppression. For instance, ENV-105's "first-in-class CD105 antagonist" designation offers a differentiated approach that larger companies might not prioritize in their broad pipelines. While Pfizer (PFE) and Merck (MRK) demonstrate consistent revenue growth and high profitability margins from their diversified products, KAPA's financial performance is characterized by significant operating losses, a common trait for early-stage biotechs. KAPA's R&D investment, while substantial relative to its current scale, is aimed at high-risk, high-reward opportunities that could yield breakthrough therapies.

KAPA's operational execution and market reach naturally lag behind its larger competitors. Companies like Amgen (AMGN) benefit from manufacturing efficiency and a robust pipeline, while BMS (BMY) leverages immunotherapy expertise and rapid clinical trial execution. KAPA's strategic positioning, therefore, is not to compete head-on across all oncology indications, but to carve out market share through superior efficacy and targeted solutions in specific cancer types or patient subgroups where its unique technologies can make a significant impact. The company's reliance on licensing agreements with institutions like Cedars-Sinai also highlights a strategy of leveraging external research for its pipeline development.

Financial Performance and Liquidity: Fueling the Pipeline

As an early-stage biopharmaceutical company, KAPA has not generated any revenue from product sales to date. Its financial profile reflects the substantial investment required for preclinical and clinical development. For the six months ended June 30, 2025, KAPA reported a net loss of $2.684 million, a significant increase from $576,000 in the same period of 2024. This expanded loss is primarily attributable to increased research and development (R&D) expenses, which surged to $989,000 in the first half of 2025 from $228,000 in 2024, driven by the progression of its Phase 2 prostate cancer trial. General and administrative (G&A) expenses also rose substantially to $1.733 million from $286,000, largely due to the amortization of vendor advances.

KAPA's liquidity is a critical factor for investors. The company used $1.519 million in cash from operations during the first half of 2025. To fund these operations, KAPA has actively pursued various financing avenues. During the six months ended June 30, 2025, it secured $3.058 million in net proceeds from a private financing (PIPE Offering) and an additional $210,000 from its Equity Line of Credit (ELOC). As of June 30, 2025, KAPA held $3.034 million in cash and cash equivalents. Crucially, subsequent to this period, in July 2025, KAPA closed an additional ELOC financing, bringing in a further $3.693 million in net proceeds. This brings the total net proceeds from the ELOC to $3.903 million as of the filing date (August 12, 2025). Management projects that these current cash reserves will fund operations for at least 12 months from the filing date.

Outlook and Strategic Imperatives

KAPA's outlook is characterized by continued investment in its clinical pipeline and a clear path towards potential commercialization. The company anticipates incurring significant and increasing expenses and operating losses for the foreseeable future as it advances its product candidates, scales manufacturing, navigates regulatory approvals, and expands its intellectual property portfolio. Revenue generation remains contingent on successful clinical trial completion and regulatory approval. Should KAPA achieve regulatory approval without a third-party commercialization partner, it expects to incur substantial expenses in building its own sales, marketing, manufacturing, and distribution capabilities.

Key operational milestones are on the horizon. The positive safety results from the Phase 2 trial of ENV-105 in metastatic castration-resistant prostate cancer are encouraging, with efficacy data expected in September. This timeline is a critical near-term catalyst for the company. KAPA's strategy for growth involves a combination of equity and debt financings, alongside potential collaborations, strategic alliances, and licensing arrangements to support its cash needs until it can generate product revenue. The company's ability to secure additional financing on favorable terms will be paramount to its long-term success.

Risks and Investor Considerations

Investing in KAPA carries inherent risks typical of early-stage biopharmaceutical companies. The most significant risk is the uncertainty surrounding future financing. While current cash reserves are projected to last for 12 months, there is no guarantee that additional capital will be available when needed, or on terms satisfactory to the company. Any future equity financing could lead to substantial dilution for existing stockholders, while debt financing might impose restrictive covenants on operations. A failure to secure adequate funding could force KAPA to delay, reduce, or even abandon its product development or commercialization efforts.

Clinical development and regulatory approval are also highly uncertain. The successful development and commercialization of any product candidate depend on numerous variables, including trial outcomes, regulatory agency requirements, manufacturing capabilities, and market acceptance. KAPA may never succeed in obtaining regulatory approval for any of its candidates. Furthermore, the company has identified a material weakness in its internal controls over financial reporting, specifically a lack of sufficient review procedures and segregation of duties. While management is actively monitoring and working to address this, full remediation will take time and could impact operational efficiency.

Conclusion

Kairos Pharma presents a compelling, albeit high-risk, investment opportunity for those seeking exposure to innovative oncology therapeutics. The company's strategic focus on overcoming drug resistance and immune suppression, backed by a pipeline of differentiated, first-in-class assets like ENV-105 and KROS 101, positions it to address critical unmet medical needs. Recent positive safety data for ENV-105 and the anticipated efficacy readout in September underscore the tangible progress being made.

While KAPA faces significant financial hurdles, requiring continuous capital infusion and operating at a substantial loss, its ability to secure recent financings demonstrates investor confidence in its long-term potential. The company's technological edge, particularly its targeted mechanisms of action, offers a potential competitive advantage against larger rivals. Investors should closely monitor clinical trial results, regulatory milestones, and KAPA's ongoing capital-raising efforts, as these will be the primary determinants of its ability to transition from a promising clinical-stage entity to a commercial success in the dynamic oncology landscape.