ADDED
The Company had 11,617,944 shares of common stock issued and outstanding as of March 31, 2026.
The Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers.
Liora s proprietary technology, known as LiGHT System (Linac for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy.
Liora is an excellent complement to the pharmaceutical side of the Company s business and ongoing clinical trials with LB-100 for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer, LB-100 The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use.
We expect to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending March 31, 2026.
As a result, the Phase 2 portion of this clinical trial will not proceed and the trial will be closed after completion of the first phase in Q1 2026.
On December 23, 2025 we announced that we are going to expand the enrollment of the trial from 21 to 42 patients in collaboration with GSK, MD Anderson and Northwestern University.
We completed the enrollment of the first 21 patients in Q4, 2025 and expect patient 22 to be enrolled in Q1 2026.
As of Q4 2025 the questions of the IRB have been sufficiently addressed, and the trial opened for enrollment again.
On March 31, 2025 we announced we will conduct a new pre-clinical study in collaboration with the NKI to test whether initiated cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE s proprietary compound LB-100.
REMOVED
The Company had 2,684,074 shares of common stock issued and outstanding as of March 14, 2025.
The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use.
We expect to have data on toxicity and preliminary efficacy from this portion of the clinical trial during the quarter ending December 31, 2025.
As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.
- 8 - National Cancer Institute Pharmacologic Clinical Trial In May 2019, the National Cancer Institute (NCI) initiated a glioblastoma (GBM) pharmacologic clinical trial.
This study was being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the Company being required to provide the LB-100 clinical compound.
Primary malignant brain tumors (gliomas) are very challenging to treat.
Radiation combined with the chemotherapeutic drug temozolomide has been the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little further benefit gained by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients.
In animal models of GBM, the Company s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic.
Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known.