Kairos Pharma Ltd. (NYSE American: KAPA)

Kairos Pharma Ltd. (NYSE American: KAPA) is a clinical-stage biopharmaceutical company focused on advancing innovative oncology therapeutics that target drug resistance and immune suppression, two significant barriers in effective cancer treatment. By addressing these mechanisms, Kairos aims to restore the efficacy of standard cancer treatments while enhancing the body’s natural immune responses against tumors.

The company’s mission is to develop a diverse portfolio of drug candidates to provide novel options for patients with limited treatment pathways. Kairos is advancing its therapeutic pipeline with a focus on partnerships, precision medicine, and clinical trial efficiency, moving closer to delivering new solutions for durable cancer remissions and improved patient quality of life.

Headquartered in Los Angeles, California, Kairos Pharma combines research excellence with patient-centered care. Led by an accomplished team of scientists and executives, the company is committed to transforming the cancer treatment landscape through next-generation therapeutic solutions that meet the highest standards of efficacy and safety.

Development Pipeline

Kairos Pharma’s development pipeline features multiple candidates across clinical and preclinical stages, each targeting unique mechanisms of resistance to cancer treatment:

• ENV105: Currently in a Phase 2 trial for castrate-resistant prostate cancer, ENV105 is administered in combination with Apalutamide to overcome anti-androgen resistance. The company recently dosed the first patient in this trial, marking an important milestone in advancing prostate cancer treatment. ENV105 is also in a Phase 1 trial for EGFR-driven non-small cell lung cancer, where it is combined with Osimertinib to address resistance in this hard-to-treat cancer type. Kairos’s partnership with PreCheck Health Services supports the confirmation of biomarkers to identify patients most likely to benefit from ENV105, enhancing precision in patient selection​.
• KROS201: This candidate has received IND clearance for glioblastoma and focuses on activating T cells outside the body to target and destroy tumor cells, specifically addressing aggressive and treatment-resistant cancers.
• KROS101: Designed to increase the number and efficacy of T cells, KROS101 shows promise in enhancing the immune system’s response to cancer, complementing existing immunotherapies.
• KROS102: Targeted at autoimmune diseases, KROS102 works by decreasing T cell activity, potentially offering a new approach to managing autoimmune conditions.
• KROS301 and KROS401: These candidates focus on inhibiting cancer cell growth and mitigating immune suppression in advanced cancers, including triple-negative breast cancer​.

Intellectual Property Portfolio

Kairos Pharma’s intellectual property portfolio secures exclusive rights to its advanced drug technologies and forms the backbone of its innovative approach in oncology. Key patents cover ENV105, protecting its mechanism of targeting CD105 to reverse resistance in prostate and lung cancers. This IP extends internationally and is valid until 2040, ensuring a secure competitive position in the cancer therapeutics market.

Additionally, Kairos’s portfolio includes patents for the KROS series (KROS101, KROS201, KROS301, and KROS401), covering applications in both cancer and autoimmune diseases. Many of these patents were developed through research at Cedars-Sinai Medical Center, from which Kairos holds exclusive, worldwide licensing rights. This robust IP framework positions the company to leverage its unique technologies across multiple therapeutic areas, with a clear focus on addressing unmet medical needs in cancer and immune-related conditions​.

Market Opportunity

Kairos Pharma is positioned to address high-growth oncology markets that demand innovative solutions to overcome drug resistance. The prostate cancer market, estimated at $11.3 billion, and the EGFR-driven lung cancer market, valued at $14 billion, represent key segments where Kairos’s drug candidates, particularly ENV105, have significant potential. Rising cancer incidence globally further underscores the demand for effective treatments that can restore sensitivity to existing therapies.

The broader immunotherapy market, which is projected to reach up to $148 billion by 2030, represents another major growth area for Kairos Pharma. The company’s targeted approach aligns with the precision medicine trend in oncology, enabling the development of therapies tailored to patient needs. By addressing underserved areas in cancer treatment, Kairos is poised to meet substantial unmet needs in the oncology and immunotherapy markets​.

Leadership Team

Dr. John S. Yu serves as CEO and Chairman of Kairos Pharma. An accomplished neurosurgeon and immunotherapy expert, Dr. Yu has developed numerous investigational drugs and led multiple clinical trials. He holds degrees from Stanford, Harvard Medical School, and MIT, and his career is centered on groundbreaking research in cancer therapeutics.

Dr. Neil Bhowmick, Chief Scientific Officer, brings over 20 years of extensive biochemistry expertise, including filing and prosecuting patents for therapeutics and devices, authoring 110 peer-reviewed publications, and leading foundational and pre-clinical cancer research. He has successfully obtained regulatory approvals and conducted clinical trials. With more than 15 years of continuous NCI/NIH funding, Dr. Bhowmick’s work has been cited over 15,000 times. He holds six patents, including innovations in biomarker detection platforms and stromal-targeted therapeutics such as ENV 105 and ENV 205.

Dr. Ramchandran Murali, VP of Research and Development, is an immunologist and molecular engineer recognized for his work in developing pharmacological agents to counter immune suppression in cancer. His extensive research background is instrumental in advancing Kairos’s innovative drug pipeline​.

Doug Samuelson, Chief Financial Officer, brings over 25 years of experience in finance, having served as CFO for various biopharma companies. His expertise in financial management and regulatory compliance provides strong support to Kairos Pharma’s strategic initiatives as a clinical-stage company.