Kamis, 14 Mei 2026

Low Float (Nasdaq: GTBP) Is Surging Green First Thing Following Massive Breaking News

Any content you receive is for information purposes only. Always conduct your own research.

*Sponsored

Low Float (Nasdaq: GTBP) Is Surging Green First Thing Following Massive Breaking News


*Click Here To Get Our Alerts Faster Via SMS*


May 14th

Dear Reader,


GT Biopharma, Inc. (Nasdaq: GTBP) is generating some serious buzz this morning.


Making a strong green move early in pre-market to $.40, GTBP was up approx. 27% before the bell rang.


Now up approx. 43% at the time of writing after hitting an early high of $.4488, it's critical we bring GTBP's breaking news to your attention.


Check it out:


GT Biopharma Announces First Patient Dosed in Phase 1 Trial of GTB-5550, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors


GTB-5550 is now the 3rd TriKE® to enter the clinic and an expansion into a broader solid tumor opp., with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase


Company anticipates providing updates in 2H 2026 as enrollment progresses through dose escalation cohorts


SAN FRANCISCO, CALIFORNIA, May 14, 2026 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3.


Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE® platform into the broader opportunity of treating patients with a variety of solid tumors. The ongoing Phase 1 progress with GTB-3650 in hematologic malignancies now gives us the confidence to advance the platform with GTB-5550 to target B7-H3, which is broadly expressed across many of the most common and difficult-to-treat solid tumor cancers. We look forward to providing updates on the trial's progress throughout the second half of 2026,said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.


...


Read the full article here.


Don't forget. GTBP has a relatively low float.


At roughly 30.83Mn shares in its float, the potential for heightened volatility may be significant on a daily basis.


Spend a moment to review our initial (Nasdaq: GTBP) report below and consider this profile for your radar.

-----


Recent momentum in the immuno-oncology space is creating new opportunities as global cancer rates continue to rise.


With the market reaching $120.37Bn in 2025 and projected to grow to $226.31Bn by 2030 at a 13.5% CAGR, attention is shifting toward innovative approaches that aim to improve precision and outcomes in cancer treatment.


One under-the-radar company is developing a differentiated strategy designed to enhance how the immune system targets tumors while addressing limitations seen in existing therapies.


Early progress suggests potential across multiple indications, making this a development worth a closer look.


And with a low float just over 30Mn shares and key oversold leaning technicals, this little-known Nasdaq idea is on our radar:


GT Biopharma, Inc. (Nasdaq: GTBP)


GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on their proprietary TriKE® NK cell engager platform.


The TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells.


And based on multiple potential catalysts we've uncovered, (Nasdaq: GTBP) is all over our radar Thursday. Check them out:


#1. The Company Can Proceed To A Phase 1 Clinical Trial Following FDA Clearance.


#2. Successful Completion Of The Cohort 3 Formal Safety Review Returns No Safety Or Tolerability Issues Observed.


#3. Multiple Technical Indicators Point To This Profile Trending Around Oversold Levels On Wednesday.


#4. There Is A Giant Market Opp. In Immuno-Oncology Drugs.


#5. A Relatively Small Float May Help Establish An Environment For Heightened Volatility Potential.


But more on those in a second...

GT Biopharma has developed a platform technology that engages the CD16 Fc receptor on NK cells, mediating tumor specific antigen targeting and an IL-15 moiety between them to induce NK cell proliferation and activation.


This platform technology can be applied to any known or proprietary tumor (or other target [e.g. HIV reservoirs]).


Several are in research development or planned.


The platform is based on the finding that the 2nd generation TriKE® are 10-40 times more potent than 1st generation TriKE and all TriKE development is now focused on this platform.

GTB-3650 TriKE®


GTB-3650 is the company's first 2nd generation camelid nanobody TriKE® being tested clinically for the treatment of CD33 positive leukemias, including AML and MDS


GTB-3650 TriKE is the first TriKE clinical product that utilizes camelid nanobody technology. GTB-3650 TriKE is a Tri-specific Killer Engager molecule composed of a camelid nanobody that binds the CD16 receptor on NK cells, a single chain variable fragment (scFv) that recognizes CD33 on tumor cells, and human wild type IL-15.


The IND application was cleared and enrollment started January 21, 2025.


The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.


Enrollment in Cohort 4 (10 µg/kg/day) is ongoing, and the Company expects to initiate dosing in Cohort 5 (25 µg/kg/day) in Q2 2026.


The Company anticipates providing the next update in the third quarter of 2026, which would include longer term follow-up on the six patients in Cohort 1 through 3 as well as initial observations from patients in Cohort 4 and Cohort 5. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort).


The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.


GTB-5550 TriKE®


GTB-5550 is a camelid (cam) anti-CD16/WT IL-15/cam anti-B7-H3 tri-specific natural killer (TriKE) cell engager, with a single chain recombinant TriKE® comprised of three components joined by flexible linkers: 1) a nanobody arm that engages the CD16 activating receptor (camelid anti-CD16) on natural killer (NK) cells; 2) a wildtype IL-15 (WT IL-15) linker arm to drive NK cell proliferation, priming, and survival; and 3) a nanobody arm that specifically engages B7-H3 (camelid anti-B7-H3) to target the antigen expressed on tumor cells.


The Phase 1 basket trial with GTB-5550 will be the first dual nanobody TriKE® tested with more patient-friendly subcutaneous dosing.


The Phase 1a dose escalation portion of the trial will test up to 6 dose levels to identify the maximum tolerated dose (MTD).


After the dose escalation phase, the Phase 2 expansion component of the trial will then confirm the MTD identified in the Phase 1a trial in up to seven different possible metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity.


The Company remains well on track to initiate the trial in mid-2026.


GTB-7550 TriKE®


The GTB-7550 TriKE product candidate is in development for the treatment of CD19 positive lymphoid malignancies and autoimmune disease.


GTB-7550 TriKE is a tri-specific molecule composed of a camelid nanobody that binds the CD16 receptor on NK cells, the single chain variable fragment (scFv) of an anti-CD19 antibody, and human wild type IL-15.


GTB-7550 TriKE has been tested and published pre-clinically using models of lymphoma and chronic lymphocytic leukemia.


Based on its early preclinical activity targeting normal B-cells, studies are ongoing to develop GTB-7550 in autoimmune disease.


GTB-3550 TriKE® (Supplanted by Second Generation GTB-3650)


GTB-3550 was the company's 1st clinical trial using a 1st generation TriKE product candidate that was initially evaluated in a Phase 1 clinical trial for the treatment of relapsed/refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS).


GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and human mutant IL-15.


In the completed Phase 1 clinical study, GTB-3550 was shown to be safe and well-tolerated.


The study of GTB-3550 demonstrated clinical proof of concept of in vivo activity. GTB-3550 and the 1st generation platform was discontinued after strong data suggested that the 2nd generation TriKE was more potent and exhibited better preclinical anti-tumor activity with camelid nanobody technology and wild type IL-15.

Natural Killer Cell ENGAGERS to Fight Cancer


Natural Killer Cells


  • Cytotoxic lymphocytes in the innate immune system


  • Recognize and kill cancer cells


  • Mediate antibody-dependent cellular cytotoxicity (ADCC) via the highly potent CD16 activating receptor

NK Cell ENGAGERS


  • TriKE® nanobody platform designed to activate endogenous NK cells to target specific cancer cells


  • Potential for less toxicity than other cellular therapies such as CAR-T therapy


  • Less cytokine release syndrome (CRS)


  • Fewer neurological complications


TriKE®: Tri-Specific Natural Killer (NK) Cell ENGAGERS - A Modular Platform


Proprietary platform utilizing camelid nanobody technology designed to bridge NK cells to tumor cells while inducing NK cell activation and expansion at the site of the tumor to enhance killing.

Recent M&A and BD Deals Highlight Value of NK Cell ENGARERS and Immuno-Oncology

See Sources And More Here: GTBP Website. GTBP Presentation.

-----


And as we mentioned earlier in the report, (Nasdaq: GTBP) has multiple potential catalysts on watch. Check them out:


#1. GTBP Potential Catalyst - The Company Can Proceed To A Phase 1 Clinical Trial Following FDA Clearance.


GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors Expressing B7-H3


GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026


Phase 1 protocol allows multiple solid tumor types known to express B7-H3


Unaudited proforma cash balance as of January 31, 2026 of approximately $9Mn anticipated to extend cash runway through Q4 2026


SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026.


FDA clearance of our third TriKE® IND, GTB-5550, represents a defining moment for GT Biopharma as we bring another NK cell engager into the clinic,said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.We expect to commence enrollment of the Phase 1 basket trial in mid-2026. While the phase I trial is open to patients with common solid tumors that express B7-H3, in the dose-escalation component we will prioritize enrollment for advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies. Based on the encouraging trends we have seen from our ongoing Phase 1 trial with GTB-3650 in AML patients, we are even more enthusiastic about the potential benefits of GTB-5550 treatment in patients with solid tumors known to express B7-H3.


...


Read the full article here.

-----


#2. GTBP Potential Catalyst - Successful Completion Of The Cohort 3 Formal Safety Review Returns No Safety Or Tolerability Issues Observed.


GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies


The formal safety review of Cohort 3 (5ug/kg/day) has been successfully completed with no safety or tolerability issues observed, allowing advancement into Cohort 4 with a dose of 10 ug/kg/day


Actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks


Cohort 4 dose is potentially more reflective of the clinical efficacy threshold given positive trend in observations on multiple immunological biomarkers from the previous six patients in Cohorts 1 through 3, the absence of dose limiting toxicities, and the associated lower dose levels


SAN FRANCISCO, CALIFORNIA, Oct. 23, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced successful completion of the Cohort 3 formal safety review with no safety or tolerability issues observed and advancement into Cohort 4 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.


The six patients in Cohorts 1 through 3 have been successfully treated with GTB-3650 and the formal safety review of Cohort 3 showed no safety or tolerability issues observed. This has allowed progression to actively screening patients for Cohort 4. With a dose of 10 ug/kg/day, Cohort 4 is more reflective of the potential efficacy threshold. The Phase 1 trial protocol allows for three additional cohorts with much higher dose levels ranging from 25 ug/kg/day with Cohort 5, 50 ug/kg/day with Cohort 6 and 100 ug/kg/day for Cohort 7, if necessary. ...


...


Read the full article here.

-----


#3. GTBP Potential Catalyst - Multiple Technical Indicators Point To This Profile Trending Around Oversold Levels On Wednesday.


At 2:30PM EST Wednesday, Barchart was reporting GTBP to have multiple oversold leaning technical indicators.


These technicals could be signaling a healthy reversal is approaching in the near term.


Here's the definition of a "reversal" from Investopedia:


"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."


Here's the technicals to pay close attention to (as of 2:30PM EST Wednesday):


  • 9-Day Relative Strength Index: 36.85%
  • 14-Day Relative Strength Index: 39.00%


When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.


  • 9-Day Raw Stochastic %D: 2.05%


As the Raw Stochastic nears the 10% range and lower it may also be viewed as oversold and undervalued.


Keep an eye on these technicals closely.

-----


#4. GTBP Potential Catalyst - There Is A Giant Market Opp. In Immuno-Oncology Drugs.


GT Biopharma could emerge as a disruptive force in the rapidly expanding immuno-oncology drugs market, valued at $120.37Bn in 2025 and projected to reach $226.31Bn by 2030, growing at a 13.5% CAGR.


As global cancer incidence rises, demand for more precise, scalable, and effective immune-based therapies is intensifying.


By advancing a novel NK cell engager platform that enhances targeted tumor killing while minimizing toxicity, GT Biopharma has the potential to address key limitations of current treatments.


Strategic clinical progress or partnerships could accelerate adoption and position the company at the forefront of next-generation immunotherapies across multiple cancer indications worldwide.

-----


#5. GTBP Potential Catalyst - A Relatively Small Float May Help Establish An Environment For Heightened Volatility Potential.


According to info from the Yahoo Finance website, GTBP has a relatively low float.


The website reports this profile to have roughly 30.83Mn shares in its float.


Why is that important? It's important on one crucial level. Volatility potential.


If the company provides positive news during the first half of 2026, could it help provide a breakout spark when paired with this volatility potential?

-----


(Nasdaq: GTBP) Recap - 5 Potential Catalysts Triggering Our Radar


#1. The Company Can Proceed To A Phase 1 Clinical Trial Following FDA Clearance.


#2. Successful Completion Of The Cohort 3 Formal Safety Review Returns No Safety Or Tolerability Issues Observed.


#3. Multiple Technical Indicators Point To This Profile Trending Around Oversold Levels On Wednesday.


#4. There Is A Giant Market Opp. In Immuno-Oncology Drugs.


#5. A Relatively Small Float May Help Establish An Environment For Heightened Volatility Potential.

-----


Coverage is now officially underway on GT Biopharma, Inc. (Nasdaq: GTBP).


Be on the lookout for updates heading your way shortly. Talk soon.


Sincerely,

FierceAnalyst | Jaks Swift

Editorial Writer



(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)


*FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors.


Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 05/13/2026 and ending on 05/14/2026 to publicly disseminate information about (GTBP:US) via digital communications. Under this agreement, TD Media LLC has paid SWN Media LLC twenty thousand USD ("Funds"). To date, including under the previously described agreement, SWN Media LLC has been paid twenty thousand USD ("Funds"). These Funds were part of the one hundred fifty thousand USD funds that TD Media LLC received from GT Biopharma Inc., the issuer of (GTBP:US).


Neither SWN Media LLC, TD Media LLC and their member own shares of (GTBP:US).


Please see important disclosure information here: https://fierceinvestor.com/disclosure/gtbp-7efk4/#details

Tidak ada komentar:

Posting Komentar