Gt Biopharma Stock Price, News & Analysis

GT Biopharma Inc. (NASDAQ: GTBP) is a clinical-stage immuno-oncology company focused on developing and commercializing novel cancer therapeutics based on its proprietary TriKE® (Tri-specific Killer Engager) natural killer (NK) cell engager platform. According to the company’s SEC registration statements and public disclosures, GT Biopharma is a smaller reporting company incorporated in Delaware and listed on the Nasdaq Capital Market under the symbol GTBP. The company describes itself as a clinical-stage biopharmaceutical business centered on immuno-oncology products that harness NK cells to target cancer.

Core focus: TriKE® NK cell engager platform

GT Biopharma’s primary technology is its TriKE® platform, which is designed to create tri-specific NK cell engagers that bring together NK cells, immune-stimulating components, and tumor-associated targets. Company filings describe TriKE constructs, including second-generation molecules that incorporate camelid nanobody technology and interleukin-15 (IL-15) elements intended to drive NK cell proliferation, priming, and survival. These constructs are being developed for hematologic malignancies and solid tumors, with the goal of activating and expanding a patient’s own NK cells against cancer cells.

The company also references work on Tetra-specific Killer Engager (Dual) constructs in its registration materials, indicating a broader platform strategy around multi-specific NK cell engagers. Across its programs, GT Biopharma’s clinical and preclinical efforts are concentrated in oncology, particularly in relapsed or refractory blood cancers and B7-H3–expressing solid tumors.

Lead clinical program: GTB-3650 for CD33-expressing hematologic malignancies

GT Biopharma is conducting a Phase 1 dose-escalation trial of GTB-3650, described in company press releases and SEC-referenced materials as a second-generation TriKE candidate targeting CD33-expressing hematologic malignancies. The trial enrolls patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) whose tumors express CD33.

The Phase 1 study is structured as a multi-cohort dose-escalation trial. Public updates indicate that the protocol allows evaluation of GTB-3650 in up to approximately 14 patients across as many as seven cohorts, with doses ranging from low microgram-per-kilogram levels up to higher ranges. GTB-3650 is administered in two-week blocks, with two weeks on treatment followed by two weeks off, defining a treatment cycle that can continue for up to four months based on clinical benefit. The trial is designed to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and early clinical activity, and company communications have reported successful completion of early cohorts with formal safety reviews showing no safety or tolerability issues to date.

Emerging solid tumor program: GTB-5550 for B7-H3–expressing cancers

GT Biopharma has also disclosed GTB-5550, a TriKE candidate targeting B7-H3–expressing solid tumors. Press releases describe GTB-5550 as a camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 tri-specific NK cell engager. It is a single-chain recombinant TriKE comprised of three components joined by flexible linkers: a nanobody arm that engages the CD16 activating receptor on NK cells, a wildtype IL-15 linker arm intended to drive NK cell proliferation, priming, and survival, and a nanobody arm that specifically engages B7-H3 expressed on tumor cells.

The company has announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration for GTB-5550 for the treatment of B7-H3–expressing solid tumor cancers. Based on supportive preclinical data, GT Biopharma has outlined plans for a Phase 1 basket trial that will evaluate subcutaneous dosing and include multiple metastatic disease cohorts, such as castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer. The planned Phase 1a dose-escalation portion is expected to test multiple dose levels to identify a maximum tolerated dose, followed by a Phase 1b expansion to confirm tolerability and further evaluate the candidate across several solid tumor types.

Additional pipeline: GTB-7550 and broader indications

In its public communications, GT Biopharma has also highlighted GTB-7550, a program targeting CD19-positive lymphoid malignancies and autoimmune diseases. This candidate is described as remaining in preclinical development, with manufacturing plans referenced in company updates. Alongside GTB-3650 and GTB-5550, GTB-7550 reflects the company’s intent to apply its NK cell engager platform across hematologic cancers, solid tumors, and immune-mediated indications.

Clinical-stage status and regulatory environment

GT Biopharma characterizes itself in SEC filings and press releases as a clinical-stage company, meaning its product candidates are in clinical and preclinical development rather than commercialized. The company’s programs are subject to U.S. regulatory oversight, including FDA review of IND applications and clinical trial protocols. The Phase 1 GTB-3650 trial is listed on clinicaltrials.gov under the identifier NCT06594445, as referenced in multiple company announcements.

As a Nasdaq-listed issuer and smaller reporting company, GT Biopharma files periodic and current reports with the U.S. Securities and Exchange Commission. These filings include financial statements, risk factor disclosures, and detailed descriptions of its capital structure, such as its Series L 10% Convertible Preferred Stock and related warrants described in its S-1 and S-1/A registration statements. The company has also reported that, effective as of July 1, 2024, it became a fully remote company and does not maintain a principal executive office, noting in several 8-K filings how stockholder communications may be directed for regulatory purposes.

Trading status and Nasdaq listing considerations

GT Biopharma’s common stock trades on the Nasdaq Capital Market under the symbol GTBP. An 8-K filed in November 2025 reports that the company received a Nasdaq notice that its common stock had closed below $1 per share for 30 consecutive business days, indicating non-compliance with the minimum bid price requirement for continued listing under Nasdaq Listing Rule 5550(a)(2). The filing explains that this notice has no immediate effect on the listing of the common stock and outlines the 180-calendar-day compliance period, potential additional compliance period, and possible consequences if the company does not regain compliance. The company states that it intends to monitor the closing bid price and assess options to regain compliance, while acknowledging that there can be no assurance of success.

Capital structure and financing framework

GT Biopharma’s S-1 and S-1/A registration statements describe offerings of common stock by selling stockholders, including shares issuable upon conversion of Series L 10% Convertible Preferred Stock, exercise of warrants, and exercise of pre-funded warrants. The company outlines private placement transactions completed in May 2025 and a common shares purchase agreement with certain investors, under which it may sell additional shares of common stock from time to time. These filings emphasize that the company will not receive proceeds from resale by selling stockholders, though it may receive proceeds from the exercise of warrants or from sales under its equity facility.

The company’s periodic financial press releases, furnished via 8-K, provide high-level information on cash balances, research and development expenses, and selling, general and administrative expenses, as well as net loss figures for recent quarters. These communications indicate that research and development spending is primarily related to licensing, development and production of its most advanced TriKE product candidates GTB-3650 and GTB-5550, along with progression of other candidates, and that GT Biopharma has undertaken cost reduction measures in certain areas.

Corporate governance and stockholder matters

GT Biopharma’s 8-K filings also describe corporate governance events, such as the appointment of new members to its Board of Directors and amendments to employment agreements with senior management. The company has reported the results of its annual meeting of stockholders, including votes on the election of directors, ratification of independent accountants, advisory approval of executive compensation, approval of share issuances related to financing transactions, and amendments to its omnibus incentive plan to increase shares available for awards.

In addition, GT Biopharma has disclosed material modifications to the rights of security holders, including waivers by holders of its Series L 10% Convertible Preferred Stock of certain redemption rights under the applicable certificate of designations. These waivers are summarized in 8-K filings and the full text of the waivers is incorporated by reference as exhibits.

Industry context and positioning

Within the broader oncology landscape, GT Biopharma positions itself, in public commentary, as part of the evolving field of NK cell–based immuno-oncology. Company communications reference the global oncology market and the potential for NK cell engagers to offer targeted approaches for patients with aggressive blood cancers and solid tumors. The company highlights early safety results and evidence of immune activation in its GTB-3650 trial, as well as preclinical activity for GTB-5550 against several solid tumor types, as support for continued development of its second-generation TriKE constructs.

According to recent press materials, GT Biopharma’s programs are intended to address relapsed or refractory hematologic malignancies, B7-H3–expressing solid tumors, and CD19-positive lymphoid malignancies and autoimmune diseases. The company emphasizes the potential of its NK cell engager platform to span hematologic, solid tumor, and immune-mediated indications, while acknowledging in SEC filings that investment in its securities involves a high degree of risk, as detailed in the risk factor sections of its incorporated reports.

Headquarters and operating model

GT Biopharma states in multiple SEC filings that, effective as of July 1, 2024, it became a fully remote company and does not maintain a principal executive office. For purposes of compliance with U.S. securities laws, the company provides a San Francisco, California mailing location for stockholder communications and an email address for its audit committee. This remote operating model is explicitly described in footnotes to several 8-K, S-1, and S-1/A filings.

Summary

In summary, GT Biopharma Inc. is a Nasdaq-listed, clinical-stage immuno-oncology company focused on NK cell engager therapeutics built on its TriKE platform. Its lead clinical candidate, GTB-3650, is in a Phase 1 dose-escalation trial for relapsed or refractory CD33-expressing hematologic malignancies, while GTB-5550 targets B7-H3–expressing solid tumors and has reached the IND submission stage. Additional pipeline work includes GTB-7550 for CD19-positive lymphoid malignancies and autoimmune diseases. The company operates as a smaller reporting company, has a capital structure involving convertible preferred stock and warrants as described in its registration statements, and continues to navigate Nasdaq listing requirements, clinical development milestones, and financing activities as disclosed in its SEC filings and press releases.