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New Alert: GT Biopharma, Inc. (NASDAQ: GTBP)
GTBP is our brand new NASDAQ breakout alert.
Yesterday the company announced massive news and started what could be just the beginning of a big move higher.
In June, the company traded over 3.00…
That's over 200% from here.
But it doesn't have to go up that high to experience double- or triple-digit gains.
GTBP has a 50 day moving average of 1.10.
A breakout and close above this level could present increased upside.
The momentum may already be in place.
With a chart setup pointing to a breakout higher.
GTBP is a NASDAQ listed "clinical stage biopharmaceutical company".
GTBP is "focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE® NK cell engager platform".
The company's "TriKE® platform is designed to harness and enhance the cancer killing abilities of a patient's immune system's natural killer cells".
GTBP has an "exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology".
CAR T-cell therapy is a personalized form of immunotherapy that trains your own immune cells to recognize and destroy cancer.
It can be a powerful option for treating certain hard-to-treat blood cancers, especially when other treatments are no longer effective.
However, as the company explains, "CAR-T therapy can require an individual approach that is expensive, can be time consuming, and may be difficult to apply on a large scale."
The company believes there is "an unmet need for targeted off-the-shelf therapies that can be used on a stand-alone basis, can augment current monoclonal antibody therapeutics, and can be used in conjunction with more traditional cancer therapy".
To accomplish this goal, GTBP has "generated a pipeline of clinical and non-clinical product candidates consisting of tri-specific killer engagers, or TriKEs, designed to target natural killer (NK) cells and tumor cells".
GTBP believes their "product candidates have the potential to overcome some of the limitations of CAR-T therapy and other antibody therapies".
"Unlike full-length tri-specific antibodies, TriKEs are small single-chain fusion proteins that bind the CD16 receptor of NK cells using nanobody technology, which has been shown in preclinical studies to produce a more potent and lasting response."
Additionally, "these product candidates may have an attractive biodistribution as a consequence of their smaller size – a factor that is expected to be important in the treatment of solid tumors".
"TriKEs are also designed to be non-immunogenic, have quick clearance properties, and can be engineered rapidly to target a variety of tumor antigens."
GTBP believes "these attributes make them an ideal pharmaceutical platform for potentiated NK cell-based immunotherapies".
Here is the company's "TriKE® Clinical Pipeline":
"GTB-3650 TriKE®"
- "The company plans on releasing more detailed results later in 2025 following enrollment and completion of additional dose cohorts. The trial plans to evaluate GTB-3650 in up to seven cohorts and GTB-3650 will be dosed in 72-hour continuous infusions in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity."
"GTB-5550 TriKE®"
- "GTB-5550 clinical material has been manufactured, is scheduled to be vialed this summer and FDA submission is planned for Q4 2025."
- "Based on supportive preclinical data, this will be the first TriKE® tested with more patient friendly subcutaneous dosing."
- "The clinical trial is planned to include several solid tumors including breast cancer, lung cancer, ovarian cancer, head and neck cancer, pancreatic cancer, bladder cancer and prostate cancer. Preclinical studies are ongoing to evaluate activity in multiple myeloma and brain tumors planning for separate trials in these settings."
"GTB-7550 TriKE®"
- "Based on its early preclinical activity targeting normal B-cells, studies are ongoing to develop GTB-7550 in autoimmune disease. We are evaluating manufacturing bids for production of clinical material in 2026 with plans for FDA submission thereafter."
"GTB-3550 TriKE® (discontinued)"
- "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."
In August, the company announced:
"GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2"
Here are the highlights from this press release:
- "The first patient in Cohort 3, the fifth patient in the trial, has completed the first week of cycle 1 following the successful safety review of Cohort 2 with no safety or tolerability issues observed"
- "The company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts"
In addition, the company also announced:
"GT Biopharma Reports Second Quarter 2025 Financial Results"
Here are the highlights from this press release:
- "GTB-3650 TriKE® Phase 1 trial has successfully completed Cohort 1 and Cohort 2 dosing, treating a total of four patients; following Cohort 2's formal safety review, it has advanced into Cohort 3 and initiated dosing of the fifth patient in the study; initial Phase 1 data expected later in 2025"
- "GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q4 2025; recent peer-reviewed publication highlights the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer"
- "Cash of approximately $5.3 million as of June 30, 2025, anticipated to be sufficient to fund operations into Q1 2026"
Here are some of the company's comments from this press release:
"We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Office of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)."
In addition, on Monday, the company announced:
"GT Biopharma to Participate in the Centurion One Capital 3rd Annual Bahamas Summit"
- "announced that Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma, will be participating in the Centurion One Capital 3rd Annual Bahamas Summit at the Rosewood Baha Mar Hotel from Tuesday, October 28th to Wednesday, October 29th, 2025, in Nassau, Bahamas."
On Wednesday, the company announced very big breaking news that could continue to be a growth catalyst for the company.
Here is the news from yesterday:
"GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies"
Here are the highlights from this press release:
- "The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date"
- "The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end"
- "Upon successful completion of the Cohort 3 safety assessment, the trial will continue to dose escalate with initiation of Cohort 4 dosing planned by year-end 2025, and flexibility to dose up to 7 cohorts if necessary; additional data updates anticipated in Q1 2026"
GTBP could be positioned for increased growth potential.
Make sure to do your own due diligence.
Sources: ACS, PR1, PR2, PR3, PR4, PR5, Website, Chart
Happy Trading!
AwesomeStocks
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