Kairos Pharma Provides Business Update and Outlook into 2025

Rhea-AI Summary

Kairos Pharma (NYSE American: KAPA), a clinical-stage biopharmaceutical company, shared an update on its business milestones for 2024 and the outlook for 2025.

Key highlights from 2024:

• Closing of the Initial Public Offering and listing on the NYSE American on September 16, 2024.
• Agreement with PreCheck Health Services to develop a biomarker panel for ENV105 targeting cancer drug resistance in prostate and lung cancer.
• Addition of City of Hope Cancer Center to the Phase 2 trial of ENV105 for castrate-resistant prostate cancer.
• First patient dosed in combination therapy of ENV105 and Osimertinib for EGFR-driven lung cancer.
• Initiation of research coverage by EF Hutton and Rodman and Renshaw.

For 2025, Kairos expects:

• Continuation of Phase 2 and Phase 1 trials of ENV105 in prostate and non-small cell lung cancer, respectively.
• Safety data readouts for both trials, with prostate cancer data expected in the first half of 2025 and NSCLC data by year-end.
• Pre-IND studies of KROS 101 and initiation of partnering discussions.

The company raised $3.5 million through a PIPE transaction and expanded patent coverage to protect their technologies. Kairos aims to provide significant shareholder value through continued development and presentation of their clinical data.

Positive

• Closed Initial Public Offering and listed on NYSE American.
• Raised $3.5 million through a PIPE transaction.
• Expanded patent coverage domestically and internationally.
• Initiated research coverage by EF Hutton and Rodman and Renshaw.

Negative

• None.

Insights

Clinical Research Analyst

The company's clinical pipeline shows meaningful progress with two key programs: ENV105 in Phase 2 for prostate cancer and Phase 1 for non-small cell lung cancer (NSCLC). The addition of City of Hope Cancer Center strengthens their Phase 2 trial credibility. The biomarker panel development with PreCheck Health Services is strategically important for patient selection and could improve trial outcomes.

The expected safety data readouts in H1 2025 for prostate cancer and year-end for NSCLC are important catalysts. The combination study of ENV105 with Osimertinib in EGFR-driven lung cancer represents a smart strategic approach to tackle resistance mechanisms. The pre-IND studies of KROS 101 suggest pipeline expansion potential.

Financial Analyst

The company's financial position shows mixed signals. While they successfully completed their IPO in September 2024 and raised an additional $3.5 million through a PIPE transaction in 2025, this level of funding may be insufficient for extensive clinical development. For a clinical-stage biotech with multiple ongoing trials, cash burn rate concerns exist. The initiation of research coverage by EF Hutton and Rodman & Renshaw provides needed visibility, but the relatively small market cap of $22.2 million suggests significant market skepticism about their programs.

The planned partnering discussions in 2025 could be important for securing additional funding or validation through potential collaboration deals. Without specific cash runway guidance, investors should monitor burn rate and potential dilution risks carefully.

Biotech Patent Specialist

The expansion of patent coverage mentioned in the update is important for protecting their intellectual property portfolio, particularly for ENV105 and KROS 101. However, without specific details on patent claims, territories, or expiration dates, it's difficult to assess the strength of their IP protection. The focus on both domestic and international patent expansion suggests a comprehensive IP strategy, which is essential for future partnering discussions and maintaining competitive advantages in key markets.

LOS ANGELES--(BUSINESS WIRE)-- Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, provides an overview of key 2024 milestones and outlook into 2025 in a Letter to Shareholders:

Dear Kairos Pharma Shareholders,

The management team and Board of Directors of Kairos Pharma Ltd. are pleased to provide you with a brief update on the state of business and noteworthy milestones of 2024 and outlook into 2025. Last year was focused on building the foundation for our business based on breakthrough science and impactful therapeutics, while creating the fundamental infrastructure that facilitated our entry into the public markets.

Highlights from 2024 include:

• Closing of our Initial Public Offering and listing of our common stock on the NYSE American stock exchange on September 16, 2024.
• Agreement with PreCheck Health Services to further develop a biomarker panel to identify patients responsive to ENV105 to target cancer drug resistance in prostate and lung cancer patients.
• Addition of City of Hope Cancer Center to the Company’s Phase 2 clinical trial of ENV 105 for castrate-resistant prostate cancer.
• First patient dosed in combination therapy of ENV105 and Osimertinib to improve therapy sensitivity for EGFR-driven lung cancer.
• Participation in and presentation at various investor conferences and non-deal road shows
• Initiation of research coverage by two leaders in the healthcare industry, Jason Kolbert of EF Hutton and Tony Butler at Rodman and Renshaw; we look forward to attracting additional research coverage of our exciting clinical programs as we move forward.
• In 2025, we completed a PIPE transaction, raising gross proceeds of $3.5 million, ensuring continuous execution of our clinical trials and rigorous development of our key preclinical assets.
• Expansion of patent coverage of our assets to protect our technologies domestically and internationally.

Having built the key foundations of our business, we anticipate the following key upcoming milestones for 2025, including:

• Continuing to execute Phase 2 randomized clinical trial of ENV 105 in prostate cancer.
• Continue to conduct our Phase 1 clinical trial of ENV 105 in non-small cell lung cancer.
• Report safety data of both trials and interim efficacy data, with an initial readout of the prostate cancer safety data anticipated in the first half of 2025 and the NSCLC by year end.
• Presenting data at national scientific meetings.
• Pre-IND studies of KROS 101, which we also anticipate publishing.
• Initiation of partnering discussions.

In the meantime, we continue to feel confident in the paradigm-shifting potential of our therapeutics, which are based on breakthrough science of our officers. We believe these therapeutics will show the potential to make a lasting impact by stopping the relentless spread of human neoplastic disorders.

We continue to be grateful to our partners and our shareholders and look forward to expanding upon our science, while providing value to our shareholders both in the near and long term. We look forward to continuing to provide updates on our progress.

Sincerely,

John Yu, M.D.
CEO
Kairos Pharma

About Kairos Pharma Ltd.

Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105—a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com.

Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 1 and Phase 2 clinical trials; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s prospectus and other filings made with the SEC. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250121337929/en/

CORE IR

Louie Toma

investors@kairospharma.com

Source: Kairos Pharma, Ltd

FAQ

What are the key milestones for Kairos Pharma (KAPA) in 2024?

Key milestones include closing the IPO and listing on NYSE American, developing a biomarker panel with PreCheck Health Services, and dosing the first patient in combination therapy for lung cancer.

What are Kairos Pharma's plans for 2025?

Kairos plans to continue Phase 2 and Phase 1 trials of ENV105, report safety data, conduct pre-IND studies of KROS 101, and initiate partnering discussions.

How much did Kairos Pharma raise through the PIPE transaction?

Kairos Pharma raised $3.5 million through the PIPE transaction.

What is Kairos Pharma's (KAPA) focus in cancer treatment?

Kairos Pharma focuses on developing therapies to overcome cancer drug resistance and immune suppression, particularly in prostate and lung cancer.

When is the safety data for Kairos Pharma’s prostate cancer trial expected?

The safety data for the prostate cancer trial is anticipated in the first half of 2025.

What new partnerships did Kairos Pharma establish in 2024?

Kairos Pharma established a partnership with PreCheck Health Services to develop a biomarker panel and added City of Hope Cancer Center to its Phase 2 clinical trial.