GTBP — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on our proprietary Tri-specific Killer Engager (“TriKE®”), and Tetra-specific Killer Engager (“Dual Targeting TriKE®”) fusion protein immune cell engager technol…

• We are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies, solid tumors, and potentially autoimmune disorders. The platform is scalable, and we are implementing processes to produce investigational new drug (“IND”)…

• Our initial work was conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Professor of Medicine, and the Interim Director at the Masonic Cancer Center. Dr. Miller, who also serves as our Consulting Senior Medical Director…

• Our current product candidate pipeline (as of March 31, 2026) is summarized in the table below:

• GTB-3550 was our first TriKE® product candidate and its clinical development was suspended so that we could focus resources on second-generation TriKEs®. GTB-3550 is a tri-specific killer engager, or TriKE, comprised of two single-chain variable fragments (“scFv”) composed of the variable regions of…

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• The corporate predecessor of GT Biopharma, Inc, Diagnostic Data, Inc., was incorporated in the state of California in 1965. Diagnostic Data, Inc. changed its incorporation to the state of Delaware on December 21, 1972 and changed its name to DDI Pharmaceuticals, Inc. on March 11, 1985. On September …

• We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) fusion protein immune cell engager technology …

• We are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies, solid tumors, and potentially autoimmune disorders. The platform is scalable, and we are implementing processes to produce investigational new drug (IND) r…

• Our initial work was conducted in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Professor of Medicine, and the Interim Director at the Center. Dr. Miller, who also serves as our Consulting Senior Medical Director, is a recogniz…

• Our current product candidate pipeline is summarized in the table below:

Text added vs the prior filing · source: 10-Q · 2026-05-15

• A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.

• As described in Item 9A. “Controls and Procedures” of our Annual Report on Form 10-K for the year ended December 31, 2025, management identified a material weakness related to the Company’s failure to maintain effective controls over the accounting for complex financial transactions, specifically th…

• Subsequent to September 30, 2025, the Company implemented additional controls requiring that, prior to the execution of transactions involving stock purchase rights, derivative financial instruments, or other complex financial arrangements, management engages a qualified accounting consultant to eva…

• While management believes these controls are appropriately designed, the material weakness will not be considered fully remediated until the controls have operated for a sufficient period of time and management has completed testing to conclude that the controls are operating effectively.

• The Company will continue to monitor the effectiveness of its remediation efforts and will make refinements as necessary.

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• Management’s Report on Internal Control Over Financial Reporting

• Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the…

• ● Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets

• ● Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and

• ● Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

Text removed vs the prior filing · source: 10-Q · 2025-11-14

• On August 19, 2025, the Compensation Committee of the Board and the Board approved new stock option awards pursuant to the Plan for management and non-employee members of the Board. Michael Breen, the Company’s Executive Chairman and Chief Executive Officer, was awarded (i) 100,000 stock options for…

• Charles J. Casamento, a non-employee member of our Board, was awarded 31,250 stock options for the 2024-2025 period, fully vested upon issuance. Each non-employee member of our Board was awarded 31,250 stock options for the 2025-2026 period, fully vested upon issuance.