Entry into a Material Definitive Agreement · Other Events
Item 1.01 Entry into a Material Definitive Agreement. On July 16, 2026, Kairos Pharma, Ltd. (the “Company”) entered into an Agreement for the Support of Investigator / Institution Initiated Research (the “IIR Agreement”) co-developed with Bayer HealthCare Pharmaceuticals Inc.…
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Item 1.01Item 1.01 - Entry into Material Agreement
Item
1.01 Entry into a Material Definitive Agreement.
On
July 16, 2026, Kairos Pharma, Ltd. (the “Company”) entered into an Agreement for the Support of Investigator /
Institution Initiated Research (the “IIR Agreement”) co-developed with Bayer HealthCare Pharmaceuticals Inc.
(“Bayer”), pursuant to which Bayer will provide the Company with radium for use in the
Company’s study into the therapeutic activity in models of prostate cancer bone metastasis of radium with ENV-105 (carotuximab) (the “Study”).
In
exchange, the Company has agreed to provide final analysis, interpretation and conclusions from the Study to Bayer within 6 months of
the completion date of the Study. Additionally, while the Company is solely responsible for initiating, managing, and financing
the Study, the Company must obtain prior written approval from Bayer prior to making any material changes to Study protocols.
The
IIR Agreement contains customary affirmative and negative covenants with respect to the Company, including, among other things, compliance
with laws, insurance, and indemnification covenants. Additionally, the IIR Agreement contains customary confidentiality, publication,
liability and remedies provisions.
The
description of the IIR Agreement contained in this Item 1.01 is qualified in its entirety by reference to the text of the IIR Agreement,
a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K.
Item 8.01Item 8.01 - Other Events
Item 8.01.
Other Events.
On
July 22, 2026, the Company published a press release announcing its entry into the IIR Agreement. The Company’s press release
is furnished herewith as Exhibit 99.1.
The
information provided in this Item 8.01 (including Exhibit 99.1 hereto), is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference into any filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such
a filing.
Filed exhibits (1)
EX-99.1 (by filename) ex99-1.htm
EX-99.1
3
ex99-1.htm
EX-99.1
Exhibit
99.1
Kairos
Pharma Announces Strategic Collaboration with Bayer to Enhance XOFIGO Activity in Metastatic Prostate Cancer
Combination
Targets a $570M - $1.3B Addressable Global Market; ENV-105 Phase 2 Data Show 86% Clinical Benefit Rate in Resistant mCRPC
LOS
ANGELES - July 22, 2026 - Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused
on overcoming cancer drug resistance, today announced a strategic collaboration with Bayer to evaluate Kairos Pharma’s lead antibody
ENV-105 (carotuximab), a first-in-class CD105/BMP signaling inhibitor, in combination with Bayer’s XOFIGO (radium-223 dichloride)
in metastatic castration-resistant prostate cancer (mCRPC) involving bone.
Kairos
Pharma’s current programs with ENV-105 include a Phase 1 trial in EGFR-driven non-small cell lung cancer and a Phase 2 trial for
castrate resistant prostate cancer. Last year, Kairos announced positive interim efficacy data from the Phase 2 trial showcasing
median progression-free survival was more than 13 months, a significant improvement from standard of care. These data were presented
at the 2025 ESMO Congress in Berlin. XOF…