ADDED
As of March 10, 2026, there were 171,550,698 shares of the registrant s common stock issued and outstanding.
These statements include, without limitation, statements about our anticipated expenditures, including research and development, and general and administrative expenses; our intent or ability to regain and maintain compliance with Nasdaq listing standards; our strategic collaborations and license agreements, intellectual property, U.S.
healthcare company developing and commercializing precision diagnostics and targeted radiopharmaceuticals for central nervous system ( CNS ) cancers.
CNSide Diagnostics, LLC ( CNSide Diagnostics ) is our wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests, such as CNSide , designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas.
In radiopharmaceuticals, our lead candidate, rhenium ( 186 Re) obisbemeda, is designed specifically for CNS cancers including recurrent glioblastoma ( GBM ), leptomeningeal metastases ( LM ), and pediatric brain cancers ( PBC ) by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery ( CED ) and intraventricular brain (Ommaya reservoir) catheters.
Our novel radioactive drug formulations, medical devices and therapeutic candidates have the potential to overcome these disadvantages as they are designed to deliver safe and effective doses of radiation at the tumors potentially in a single treatment.
The CNSide Cerebrospinal Fluid Assay is currently being utilized in the ReSPECT-LM clinical trial funded by the Cancer Prevention and Research Institute of Texas ( CPRIT ).
In connection with our business plan for developing the CNSide Platform, we formed CNSide Diagnostics and our board of directors appointed a board of managers for CNSide Diagnostics.
We re-introduced the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test (the CNSide Test ), which is a laboratory developed test ( LDT ) in August 2025.
The laboratory for the CNSide Test in Houston, Texas has received a certificate of accreditation from the Centers for Medicare Medicaid Services ( CMS ) which deems the lab compliant with Clinical Laboratory Improvement Amendments ( CLIA ) regulations.
REMOVED
As of March 21, 2025, there were 16,999,626 shares of the registrant s common stock issued and outstanding.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 103 Item 13.
Form 10-K Summary 104 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This report contains certain statements that may be deemed forward-looking statements within the meaning of U.S.
These statements include, without limitation, statements about our anticipated expenditures, including research and development, and general and administrative expenses; our strategic collaborations and license agreements, intellectual property, U.S.
4 Risk Factor Summary Below is a summary of the principal factors that may affect our business, financial condition, and results of operations.
Additional risks not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or results of operations in future periods.
Further discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading Risk Factors and should be carefully considered, together with other information in this Form 10-K and our other filings with the Securities and Exchange Commission ( SEC ).
Risks Related to Our Financial Position and Capital Requirements We have incurred losses since inception, we expect to incur significant net losses in the foreseeable future and we may never become profitable and our operating results have been and will likely continue to be volatile.
Uncertainties relating to our ability to fund our operations for at least the next 12 months raises substantial doubt about our ability to continue as a going concern.
We could be delisted from Nasdaq for failure to comply with the minimum stockholders equity continued listing requirement or other applicable continued listing requirements and standards of Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.