GT Biopharma, Inc. (GTBP) Business Model Canvas

GT Biopharma, Inc. (GTBP): Business Model Canvas [Dec-2025 Updated]

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You're digging into GT Biopharma, Inc.'s strategy, and honestly, it's the classic, razor-thin playbook for clinical-stage biopharma right now. This isn't about selling widgets; it's a high-stakes bet on their proprietary TriKE natural killer cell engager platform, currently running a Phase 1 trial for GTB-3650, all while managing a lean cash position-they had about $2.6 million on the books as of Q3 2025. We need to see how they plan to fund the next milestone, because right now, the revenue stream is purely capital markets, not product sales. Dive into the Canvas below to see the exact partnerships and activities funding this journey.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Key Partnerships

You're looking at the backbone of GT Biopharma, Inc.'s (GTBP) operational strategy-the external relationships that allow them to push their TriKE® platform from the lab into the clinic. These aren't just vendors; they are critical enablers for a company with no product revenue as of Q1 2025. GT Biopharma, Inc. has consistently reported net losses, such as a net loss of approximately $3.1 million for the third quarter ended September 30, 2025. This loss is directly tied to the costs associated with these partnerships.

Exclusive worldwide license with the University of Minnesota

The foundation of GT Biopharma, Inc.'s value proposition rests on the exclusive worldwide license agreement with the University of Minnesota for the TriKE® technology. This license covers the development and commercialization of therapies based on this proprietary platform. While the initial 2021 Scientific Research Agreement, which supported TriKE® development and GMP manufacturing efforts, had payments totaling approximately $2.1 million due over its life, that agreement expired on June 30, 2023. The ongoing R&D expenses, which were approximately $0.6 million in Q3 2025, primarily relate to the continued licensing and development of product candidates like GTB-3650 and GTB-5550.

Clinical Research Organizations (CROs) for Phase 1 trial execution

Execution of the Phase 1 dose escalation study for GTB-3650 relies on external clinical expertise. The trial is evaluating patients with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The structure involves cohorts, with the study advancing to Cohort 4 at a dose level of 10 µg/kg/day as of late 2025. The trial is designed to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity. While specific CRO partners aren't named, the R&D expenses reflect costs associated with these clinical operations; for instance, R&D expenses dropped to approximately $400,000 in Q2 2025 from $1.8 million in Q2 2024, partially due to a reduction in scientific research costs.

Contract Manufacturing Organizations (CMOs) for drug production

Producing the clinical trial material for the TriKE® candidates requires CMO partnerships. The R&D expense reduction from Q2 2024 to Q3 2025 suggests active management of these costs. Specifically, the R&D expense decrease of $0.7 million between Q3 2024 and Q3 2025 was primarily attributed to a reduction in production and material costs. This points directly to the financial impact of CMO agreements on the operating burn rate. The initial research agreement with the University of Minnesota also included support for GMP manufacturing efforts.

Academic and clinical investigators for trial enrollment

Enrolling patients for the GTB-3650 trial is a key activity driven by investigator sites. The Phase 1 study is evaluating a total of up to approximately 14 patients, structured in cohorts (initially two patients per cohort). The trial began enrollment in early 2025. The company is actively screening patients for Cohort 4, with dosing anticipated in the coming weeks as of the November 2025 update. The success of trial enrollment directly impacts the timeline for the next comprehensive update, which is anticipated in the first quarter of 2026.

Investment banks for capital raises and advisory

Access to capital is sustained through relationships with investment banks. H.C. Wainwright & Co. served as the exclusive placement agent for a warrant exercise offering that closed around February 27, 2025, which generated gross proceeds of approximately $0.7 million. The company also completed a financing in May 2025, which helped restart the final phase of product development for GTB-5550. Furthermore, the Executive Chairman and CEO, Michael Breen, participated in the H.C. Wainwright 27th Annual Global Investment Conference in September 2025, indicating an ongoing advisory or investor-facing relationship.

Here's a quick look at the financial context surrounding these operational partnerships as of late 2025:

Financial Metric (Period Ended Sept 30, 2025) Amount Relevance to Partnerships
Cash and Cash Equivalents $2.6 million Funds operations, including partnership obligations, into Q1 2026.
R&D Expenses (Q3 2025) Approximately $0.6 million Directly relates to ongoing licensing fees, development, and production costs with partners.
SG&A Expenses (Q3 2025, Excl. Stock Comp) Approximately $2.4 million Includes costs related to administrative support for clinical trial management and corporate advisory.
GTB-3650 Trial Patients (Target/Completed) Up to approximately 14 patients Measures progress with clinical investigators in the Phase 1 trial.
Gross Proceeds from Feb 2025 Warrant Exercise Approximately $0.7 million Capital raised via investment bank placement agent (H.C. Wainwright & Co.).

The reliance on external parties for manufacturing and clinical execution means that cash management is paramount. The cash position of approximately $2.6 million as of September 30, 2025, is anticipated to fund operations into the first quarter of 2026. You need to watch those R&D expenses closely, as they are the direct spend on the TriKE® platform development with the University of Minnesota and the execution costs with CROs.

  • Exclusive worldwide license with the University of Minnesota for TriKE® technology.
  • Phase 1 GTB-3650 trial advanced to Cohort 4 at 10 µg/kg/day dose level.
  • IND submission for GTB-5550 anticipated in late December 2025 or January 2026.
  • H.C. Wainwright & Co. acted as placement agent for a February 2025 offering.
  • The company had cash and cash equivalents of approximately $2.6 million as of September 30, 2025.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Key Activities

You're managing a clinical-stage biotech, so your key activities are all about advancing the science and keeping the lights on until the next inflection point. Here's the breakdown of what GT Biopharma, Inc. is actively driving as of late 2025, based on their Q3 reporting.

Research and development of the proprietary TriKE platform

The core activity is advancing the TriKE (Tri-specific Killer Engager) platform, which is designed to harness and enhance a patient's natural killer (NK) cells. This R&D focus is reflected directly in the spending figures. For the third quarter ended September 30, 2025, Research and Development (R&D) expenses were approximately $0.6 million. This is a notable decrease from the approximately $1.3 million reported for the same quarter in 2024, primarily due to a reduction in production and material costs. The R&D spend primarily relates to the continued development of GTB-3650 and GTB-5550 candidates.

Managing the Phase 1 dose escalation trial for GTB-3650

You're deep in the clinic with GTB-3650, which targets relapsed or refractory (r/r) CD33 expressing hematologic malignancies. This activity involves careful patient management and dose progression. As of the Q3 2025 update, the trial has advanced into Cohort 4, testing a dose level of 10 µg/kg/day. This is significant because management views this dose as more reflective of the potential efficacy threshold. The trial protocol is set to evaluate up to a total of 14 patients across seven cohorts, with doses escalating up to 100 µg/kg/day in Cohort 7, if necessary. The dosing schedule is strict: two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The first six patients across Cohorts 1 through 3 were successfully treated with no reported safety or tolerability issues.

Here's a quick look at the trial structure:

Metric Detail/Value
Target Patient Population r/r CD33 expressing hematologic malignancies
Total Planned Patients Approximately 14
Current Cohort (as of Nov 2025) Cohort 4
Cohort 4 Dose Level 10 µg/kg/day
Dosing Cycle Two weeks on / Two weeks off
Maximum Planned Dose (Cohort 7) 100 µg/kg/day

Preparing the Investigational New Drug (IND) submission for GTB-5550

You're pushing the next candidate, GTB-5550, which targets B7H3-expressing solid tumors, toward the regulatory gate. The key activity here is preparing the Investigational New Drug (IND) submission. The company anticipates submitting the IND application for GTB-5550 in late December 2025 or January 2026. This push was enabled by restarting the final phase of product development following financing secured in May 2025.

Securing non-dilutive and dilutive financing to extend cash runway

Cash management is a top priority when you're pre-revenue. As of September 30, 2025, GT Biopharma, Inc. had cash and cash equivalents of approximately $2.6 million. This amount is anticipated to be sufficient to fund the Company's operations into the first quarter of 2026. You definitely need to keep an eye on burn rate; the net loss for Q3 2025 was approximately $3.1 million. The company has no debt, reflected by a Debt-to-Equity Ratio of 0, which is a strong balance sheet feature.

Key financial metrics supporting operations:

  • Cash on hand (Sep 30, 2025): $2.6 million
  • Projected cash runway into: Q1 2026
  • Q3 2025 Net Loss: $3.1 million
  • Debt-to-Equity Ratio: 0

Protecting and expanding the intellectual property portfolio

Protecting the TriKE platform is non-negotiable. While specific late-2025 filing numbers aren't public, the activity is ongoing, as evidenced by the IND clearance for GTB-3650 received in late June 2024, which followed an IND application filed in December 2023. The company's focus, as noted in earlier filings, has been on establishing this intellectual property portfolio. The success of the current trials directly feeds into the strength of this portfolio, especially as GTB-5550 is positioned competitively against modalities like bispecific antibodies and cell therapies targeting B7H3.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Key Resources

The core assets underpinning GT Biopharma, Inc.'s business model center on proprietary intellectual property, active clinical development, and current financial liquidity.

Proprietary TriKE natural killer (NK) cell engager platform

The TriKE® platform is the fundamental technology, designed to harness and enhance the cancer killing abilities of a patient's immune system's natural killer cells. This platform is the basis for generating novel immuno-oncology therapeutic products.

Exclusive worldwide license to the TriKE technology

GT Biopharma, Inc. holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using the TriKE® technology.

Clinical data from the GTB-3650 Phase 1 trial

The Phase 1 dose escalation study for GTB-3650, targeting relapsed or refractory (r/r) CD33 expressing hematologic malignancies, is actively enrolling patients. The trial protocol allows for evaluation in up to 14 patients across a maximum of seven cohorts.

  • Dose range evaluated spans from 1.25 µg/kg/day (Cohort 1) up to 100 µg/kg/day (Cohort 7).
  • As of the Q3 2025 update, the trial had advanced to Cohort 4 at a dose level of 10 µg/kg/day.
  • The trial assesses safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity.
  • The next trial update is anticipated in Q1 2026.

Furthermore, the company anticipates submission of an Investigational New Drug (IND) application for its next candidate, GTB-5550 (targeting B7H3-expressing solid tumors), in late December 2025 or January 2026.

Cash and equivalents of approximately $2.6 million as of Q3 2025

The financial position as of September 30, 2025, provides a specific, near-term operational runway. The company's market capitalization as of December 5, 2025, was $6.48 million on 10.64 million shares outstanding.

Financial Metric (As of September 30, 2025) Amount
Cash and Cash Equivalents Approximately $2.6 million
Projected Cash Runway Into the first quarter of 2026
Net Loss (Q3 2025) Approximately $3.1 million
R&D Expenses (Q3 2025) Approximately $0.6 million
SG&A Expenses, Excluding Stock Compensation (Q3 2025) Approximately $2.4 million

Key scientific and executive personnel

The operational execution relies on the experience of the management team. Key personnel include:

  • Michael Breen: Executive Chairman, Board of Directors, Chief Executive Officer.
  • Alan Urban: Chief Financial Officer.
  • Jeffrey S. Miller, M.D.: Consulting Chief Medical Officer (developer of TriKE™ technology).
  • Charles J. Casamento: Independent Director.
  • David C. Mun-Gavin: Member of the Board of Directors (appointed June 2025).

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Value Propositions

You're looking at the core value drivers for GT Biopharma, Inc. (GTBP) as they push their TriKE® platform forward. It's all about leveraging the body's own defenses with a novel molecular design.

Harnessing a patient's endogenous NK cells for cancer killing

The fundamental value is activating the patient's own Natural Killer (NK) cells to hunt cancer. GTB-3650 works by stimulating these endogenous NK cells to specifically target cancer cells expressing the CD33 protein. This mechanism supports the TriKE platform's ability to activate and expand NK cells in cancer patients. The technology utilizes specialized antibody fragments originally found in camels and llamas.

Potential for enhanced potency with second-generation camelid nanobodies

GT Biopharma, Inc. (GTBP) is advancing its second-generation therapy, GTB-3650. Early clinical observations support this evolution; cohorts in the Phase 1 trial demonstrated increased NK cell activity, validating the mechanism of immune activation and expansion. The therapy is designed to bring the activating cytokine IL-15 directly to the immune synapse, which suggests a competitive advantage over other modalities.

Product Candidate Generation Dosing Schedule (GTB-3650) Observed Activity
GTB-3650 Second-generation TriKE® Two weeks on, two weeks off, for up to 4 months Increased NK cell activity observed in early cohorts
GTB-5550 Dual camelid nanobody design Planned subcutaneous dosing Preclinical anti-tumor activity demonstrated

Targeting difficult-to-treat cancers like relapsed/refractory AML

The immediate focus is on high-unmet-need hematologic malignancies. GTB-3650 is being evaluated in patients with relapsed or refractory (r/r) CD33 expressing blood cancers, specifically acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). As of October 2025, all six patients across the first three dosing cohorts had been successfully treated, with the formal safety review for Cohort 3 clearing the way for advancement. The trial is now progressing to Cohort 4 at a dose level of 10 µg/kg/day. The overall Phase 1 trial is designed to evaluate up to 14 patients across up to seven cohorts, with dose levels tested ranging from 1.25 µg/kg/day to 100 µg/kg/day.

The company's financial position as of September 30, 2025, showed cash and cash equivalents of approximately $2.6 million, which is anticipated to fund operations into the first quarter of 2026. The net loss for Q3 2025 was approximately $3.1 million.

GTB-5550's potential for patient-friendly subcutaneous self-administration

GTB-5550 represents a strategic expansion into solid tumors, targeting the B7H3 antigen. This candidate is designed with a dual camelid nanobody structure and is slated to be the first TriKE® tested with subcutaneous dosing. This method offers a potentially more convenient alternative to the continuous infusion required for GTB-3650. The IND submission for GTB-5550 is anticipated in late December 2025 or January 2026. Preclinical data supports activity against several solid tumors.

  • Targets B7H3-positive solid tumors.
  • Preclinical activity shown in breast, lung, ovarian, pancreatic, bladder, prostate, and head and neck cancers.
  • IND submission planned for late December 2025 or early January 2026.
  • Designed for subcutaneous dosing, potentially allowing patient self-administration.

The R&D expenses for the third quarter ended September 30, 2025, were approximately $0.6 million, supporting the continued development of GTB-5550 alongside GTB-3650.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Relationships

The customer relationships for GT Biopharma, Inc. (GTBP) are highly specialized, focusing on key stakeholders in the clinical development and financing ecosystem of its TriKE® platform.

High-touch engagement with clinical trial sites and investigators

Engagement with clinical sites is intensive, given the Phase 1 dose-escalation nature of the lead candidate, GTB-3650, for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The relationship management is centered on data integrity, patient safety, and timely progression through dose cohorts.

The Phase 1 protocol allows for evaluation in up to seven cohorts, with doses escalating from 1.25 µg/kg/day in Cohort 1 up to 100 µg/kg/day in Cohort 7. Enrollment for this trial began on January 27, 2025.

Here's the quick math on the trial progression as of late 2025:

Milestone/Metric Data Point (As of Late 2025)
Total Patients in Protocol (Max) Up to 14 patients (two patients per cohort)
Cohorts Completed (Safety Review) Cohort 3 completed; Cohort 4 dosing anticipated soon
Dose Level of Cohort 4 10 µg/kg/day
Patients Treated Through Cohort 3 Six patients across cohorts 1-3
Dosing Schedule Two-week blocks, two weeks on and two weeks off, for up to four months
Next Data Update Anticipated First quarter of 2026

Investigators are closely monitoring safety, pharmacokinetics, pharmacodynamics, and in vivo expansion of endogenous patient NK cells. The trial is designed to translate heightened immune activation into clinically meaningful evidence of therapeutic activity.

Investor relations via conferences and corporate updates

Investor communication is managed through regular financial reporting and participation in industry events to update stakeholders on clinical and corporate progress. GT Biopharma, Inc. reported its third quarter 2025 financial results for the period ended September 30, 2025, on November 14, 2025.

The Executive Chairman and CEO, Michael Breen, participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. The company's net loss for Q3 2025 was approximately $3.1 million. Cash and cash equivalents as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026.

Key investor touchpoints include:

  • Reporting Q3 2025 financial results on November 14, 2025.
  • Anticipating the next trial update in Q1 2026.
  • Providing a corporate update on November 14, 2025.

Direct communication with the FDA and other regulatory bodies

Direct regulatory engagement centers on advancing the pipeline through Investigational New Drug (IND) applications. The IND application for GTB-3650 was cleared in late June 2024. The most recent FDA-related event was a 'Provided Update' on November 19, 2025, regarding GTB-3650.

For the next candidate, GTB-5550 TriKE®, which targets B7H3-expressing solid tumors, the company plans to submit the IND application in late December 2025 or January 2026. This therapy is being designed as a subcutaneous injection.

Scientific collaboration with licensing partners (future)

A foundational relationship for GT Biopharma, Inc. is its licensing agreement that underpins the core technology. GT Biopharma, Inc. holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using the TriKE® technology. This collaboration is critical for the development of both GTB-3650 and GTB-5550.

Research and Development (R&D) expenses for Q3 2025 were approximately $0.6 million, compared to $1.3 million for the same quarter in 2024, reflecting ongoing licensing and development costs related to these assets.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Channels

You're looking at how GT Biopharma, Inc. (GTBP) gets its science-the TriKE® platform-out to the world, whether that's to patients in a trial or to the capital markets funding the next step. It's a multi-pronged approach, typical for a clinical-stage biotech, relying heavily on clinical sites and regulatory milestones to prove value.

Clinical trial sites for drug delivery to patients

The primary channel for drug delivery right now is through active clinical trial sites for the lead candidate, GTB-3650 TriKE®. This drug, targeting CD33 positive leukemias like AML and high-risk MDS, is being tested in a Phase 1 dose escalation study. Enrollment started on January 21, 2025, and the company is using these sites to deliver the drug and collect critical safety and activity data.

The trial structure dictates the channel cadence. GTB-3650 is administered via 72-hour continuous infusions in two-week blocks (two weeks on, two weeks off) for up to four months. As of late 2025, the trial has advanced to Cohort 4, where patients receive a dose level of 10 µg/kg/day. The study is planned to evaluate GTB-3650 across up to seven cohorts. The next major data update from these sites is anticipated in the first quarter of 2026.

For the next candidate, GTB-5550, which targets B7H3-expressing solid tumors, the channel shifts to preparation for human trials. This drug is being developed for a more patient-friendly subcutaneous injection, which could eventually allow for patient self-administration at home.

Regulatory filings (INDs, NDAs) with the FDA

Regulatory filings are the gatekeepers for expanding the delivery channels into human use. GT Biopharma, Inc. already cleared its Investigational New Drug (IND) application for GTB-3650 in late June 2024. The immediate focus for a new channel opening is the next-generation candidate, GTB-5550.

The company is actively working toward an IND submission for GTB-5550, with the target window set for late December 2025 or January 2026. This filing is crucial because it unlocks the channel to start human trials for solid tumors, a market segment distinct from the hematologic malignancies currently being addressed by GTB-3650.

Scientific publications and conference presentations

This channel is about disseminating data to the scientific community and potential partners, which is vital for validating the TriKE® platform technology. GT Biopharma, Inc. actively uses conferences to present progress.

The company participated in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. An on-demand webcast of their presentation became available on September 5, 2025. Furthermore, a recent peer-reviewed publication highlighted the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer. The Corporate Presentation was updated as recently as August 14, 2025.

You can see the cadence of their scientific outreach:

  • H.C. Wainwright 27th Annual Global Investment Conference: September 8-10, 2025
  • Corporate Presentation Update: August 14, 2025
  • Initial Phase 1 Data Expected: Later in 2025 (for GTB-3650)
  • GTB-5550 IND Submission Target: Q4 2025

Investor relations website and SEC filings for capital markets

This channel is how GT Biopharma, Inc. communicates its financial health and operational status to current and prospective investors. You see this activity reflected in their required filings and investor updates.

The latest comprehensive financial snapshot came from the Third Quarter 2025 Financial Results, reported on November 14, 2025, covering the period ended September 30, 2025. These filings are the backbone of investor communication, detailing cash burn and runway.

Here's a look at the key financial metrics from that Q3 2025 report, which directly impacts their ability to fund the clinical channels:

Metric Amount (as of Sept 30, 2025) Period Reported
Cash and Cash Equivalents Approximately $2.6 million Q3 2025 End
Net Loss Approximately $3.1 million Q3 2025
R&D Expenses Approximately $0.6 million Q3 2025
SG&A Expenses Approximately $2.4 million Q3 2025
Cash Runway Estimate Sufficient into the first quarter of 2026 As of Q3 2025

The company also filed a Form S-1 on October 24, 2025. Separately, on November 20, 2025, GT Biopharma, Inc. disclosed receiving a notice from Nasdaq regarding a minimum bid price deficiency, giving them until May 19, 2026, to regain compliance at a closing bid price of at least $1.00 for ten consecutive business days. That compliance effort is a critical, immediate channel focus for maintaining their listing on the Nasdaq Capital Market.

You can track these official disclosures via the Investor Relations section of their website, which provides access to:

  • SEC Filings (10-Q, 10-K, S-1)
  • Press Releases and 8-K filings
  • Corporate Presentation updates
  • IR Calendar for past and future events

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Customer Segments

You're looking at the distinct groups GT Biopharma, Inc. (GTBP) targets to deliver value and secure its development capital. These segments range from specific patient populations in clinical trials to the financial community funding the pipeline.

Patients with relapsed/refractory CD33-expressing hematologic malignancies

This segment is the current focus for the lead candidate, GTB-3650 TriKE®. The Phase 1 dose escalation study, which began enrollment in early 2025, is actively targeting these patients, including those with refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

  • The trial is evaluating GTB-3650 in a total of 14 patients across dose cohorts as of September 30, 2025.
  • The study has advanced to Cohort 4, testing a dose level of 10 µg/kg/day.
  • The overall protocol allows for evaluation in up to approximately seven cohorts.
  • The broader hematologic malignancies market is valued at USD 77.5 billion in 2025.
  • Leukemia, a key indication, is expected to hold a 41.2% market share within that segment.

Patients with B7H3-expressing solid tumors (future target for GTB-5550)

This represents a significant expansion opportunity beyond blood cancers for the GTB-5550 TriKE® candidate. GTB-5550 targets the B7H3 protein found in various solid tumors.

  • GT Biopharma, Inc. anticipates submission of an Investigational New Drug (IND) application for GTB-5550 in late December 2025 or in January 2026.
  • Solid tumors targeted include breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers.
  • This pipeline expansion targets a segment within the global cancer treatment market projected to grow from $282 billion in 2025 to $643.5 billion by 2034.

Large pharmaceutical and biotech companies for potential licensing deals

These entities are crucial for non-dilutive funding, validation, and future commercialization pathways, especially as clinical milestones are met. The company's proprietary TriKE® platform technology is the core asset attracting this segment's interest.

Institutional and retail investors providing development capital

As a clinical-stage company, GT Biopharma, Inc. relies on capital markets to fund its Research and Development (R&D) and general operations. The company trades on the Nasdaq Capital Market under the symbol GTBP. Here's a quick look at the financial position as of the end of the third quarter of 2025.

Financial Metric (As of September 30, 2025) Amount
Cash and Cash Equivalents approximately $2.6 million
Cash Runway Expectation Into the first quarter of 2026
Net Loss (Q3 2025) approximately $3.1 million
R&D Expenses (Q3 2025) approximately $0.6 million
SG&A Expenses (Excluding Stock Comp, Q3 2025) approximately $2.4 million

This cash position, while supporting operations into Q1 2026, makes near-term clinical catalysts and the GTB-5550 IND timing material factors for follow-on financing discussions with this segment.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Cost Structure

You're looking at the cost drivers for GT Biopharma, Inc. as of late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward getting their science through trials and regulatory hurdles. Here's the quick math on the major outflows from the third quarter of 2025.

The primary operational expenses for GT Biopharma, Inc. in Q3 2025 show a clear focus on development activities. Research and Development (R&D) expenses were approximately $0.6 million for the third quarter ended September 30, 2025. This figure represented a significant decrease from the $1.3 million reported in the same quarter of 2024.

Selling, General, and Administrative (SG&A) costs, excluding stock compensation, were approximately $2.4 million in Q3 2025, which was relatively flat compared to the $2.3 million in Q3 2024. The overall net loss for the quarter was approximately $3.1 million.

Here is a breakdown of the key cost components based on the latest reported figures:

Cost Category Q3 2025 Approximate Amount Comparison Point
Research and Development (R&D) Expenses $0.6 million Down from $1.3 million in Q3 2024
Selling, General, and Administrative (SG&A) Expenses (Excluding Stock Comp) $2.4 million Relatively flat from $2.3 million in Q3 2024
Net Loss for the Quarter $3.1 million Improvement from $3.4 million net loss in Q3 2024

The R&D cost reduction is directly tied to specific operational activities. You can see where the money is being managed:

  • Clinical trial operations and material production costs: The decrease in R&D expenses was primarily due to a reduction in production and material costs.
  • Intellectual property maintenance and licensing fees: R&D expenses relate to the continued licensing, development, and production of TriKE® product candidates like GTB-3650 and GTB-5550.
  • General corporate and legal expenses: These fall under SG&A, and a significant decrease in legal fees was noted in Q2 2025, suggesting cost control measures were in place.

The R&D spend is focused on specific pipeline progression. For instance, the Phase 1 GTB-3650 study was actively enrolling 14 patients and had advanced to Cohort 4 at a dose level of 10 µg/kg/day as of the Q3 report. Also, the company anticipated an Investigational New Drug (IND) submission for GTB-5550 in late December 2025 or January 2026. This clinical advancement dictates a substantial portion of the ongoing R&D outlay, even with the recent cost reductions.

To be fair, the cash position as of September 30, 2025, was approximately $2.6 million, which management anticipated would fund operations into the first quarter of 2026. That's a tight runway, so managing these cost centers precisely is defintely critical for the next financing event.

Finance: draft 13-week cash view by Friday.

GT Biopharma, Inc. (GTBP) - Canvas Business Model: Revenue Streams

You're looking at a classic clinical-stage biotech revenue profile right now, which means the focus is almost entirely on funding operations until a product gets approved and commercialized. For GT Biopharma, Inc., the revenue streams as of late 2025 are heavily weighted toward capital raising rather than product sales.

Currently reports no product revenue, typical for a clinical-stage company. As of the third quarter ended September 30, 2025, GT Biopharma, Inc. has not generated product revenue; analyst consensus revenue forecast for 2025Q4 is 0.000 USD. This is expected since the company is advancing its lead candidates, GTB-3650 and GTB-5550, through Phase 1 clinical trials.

The primary source of cash to fund ongoing Research and Development (R&D) expenses, which were approximately $0.6 million for the third quarter ended September 30, 2025, comes from financing activities. The company's cash position as of September 30, 2025, stood at approximately $2.6 million, anticipated to fund operations into the first quarter of 2026. This cash runway is directly supported by recent equity activity.

Here's a look at the specific proceeds from the Post IPO financing rounds that occurred in 2025, which serve as the current lifeblood for GT Biopharma, Inc.:

Financing Event Date in 2025 Proceeds Amount (USD)
Post IPO Round May 2025 $5.95M
Post IPO Round February 2025 $1.28M

The total identifiable proceeds from these two specific 2025 financing rounds amount to $7.23 million. Honestly, this capital is what keeps the lights on while they push GTB-3650 through dose escalation and prepare the IND submission for GTB-5550, anticipated in late December 2025 or January 2026.

Future potential revenue streams are entirely contingent on clinical and regulatory success, which is standard for this stage. These include:

  • Future potential milestone payments from strategic partnerships.
  • Future potential royalty payments from licensed products.

To be fair, these streams are theoretical until a partnership is announced or a product is licensed out, but they represent the long-term, high-value revenue potential beyond just selling equity.


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