GT Biopharma Reports Second Quarter 2025 Financial Results

Rhea-AI Summary

GT Biopharma (NASDAQ: GTBP) has reported its Q2 2025 financial results and provided clinical updates. The company's GTB-3650 TriKE® Phase 1 trial has successfully completed Cohorts 1 and 2, advancing to Cohort 3 with the fifth patient now receiving treatment. The trial is evaluating GTB-3650 in patients with CD33 expressing hematologic malignancies.

Financial highlights include cash position of $5.3 million as of June 30, 2025, expected to fund operations into Q1 2026. The company reported reduced quarterly losses with a net loss of $1.4 million, down from $3.7 million in Q2 2024, driven by significant reductions in R&D expenses to $400,000 (down from $1.8M) and SG&A expenses to $1.1 million (down from $2.0M).

Additionally, GT Biopharma plans to submit an IND application for GTB-5550 TriKE® in Q4 2025 for the treatment of B7H3 positive solid tumors.

Positive

• Successful completion of GTB-3650 Phase 1 trial Cohorts 1 and 2 with advancement to Cohort 3
• Net loss decreased significantly by $2.3M year-over-year to $1.4M in Q2 2025
• R&D expenses reduced by $1.4M year-over-year to $400,000
• SG&A expenses decreased by $900,000 year-over-year to $1.1M

Negative

• Cash runway only extends into Q1 2026 with $5.3M cash on hand
• Significant reduction in R&D spending could potentially slow development progress

Insights

Oncology Clinical Trial Expert

GT Biopharma's GTB-3650 advancing through Phase 1 safely with promising early signs; GTB-5550 IND coming in Q4.

The progress report on GT Biopharma's lead candidate GTB-3650 TriKE® shows encouraging clinical momentum. The completion of two dosing cohorts and advancement to Cohort 3 after formal safety reviews indicates the drug is demonstrating a favorable safety profile so far - a critical hurdle for any novel immunotherapy platform. The trial design of six planned cohorts targeting 12 patients with CD33-expressing hematologic malignancies is following a standard dose-escalation approach with a two-weeks-on, two-weeks-off dosing schedule that enables careful safety monitoring.

What's scientifically notable is the mention of "encouraging early evidence of immunological activity" which suggests the TriKE® platform may be successfully engaging and activating the patients' natural killer (NK) cells as designed. The platform's mechanism aims to redirect endogenous NK cells to target CD33-positive cancer cells in relapsed/refractory AML and high-risk MDS – both difficult-to-treat conditions with poor prognoses and significant unmet needs.

The pipeline expansion with GTB-5550 targeting B7H3-positive solid tumors demonstrates rational portfolio development, leveraging their proprietary platform against a different target with preclinical validation in head and neck cancer. The IND submission timeline (Q4 2025) provides a clear regulatory milestone. The company's cash position of $5.3 million provides runway into Q1 2026, sufficient to reach important clinical data readouts expected later in 2025, though additional financing will likely be needed before completing the full development program.

Biotech Financial Analyst

GT Biopharma shows clinical progress while significantly reducing expenses; cash runway into Q1 2026 provides operational breathing room.

GT Biopharma's financial position shows meaningful operational efficiency improvements amid continued clinical advancement. The $5.3 million cash position provides a runway into Q1 2026, giving the company approximately 6-9 months of operational coverage from the reporting date. This timeline aligns strategically with their expected clinical milestones, particularly the anticipated Phase 1 data readout for GTB-3650 later in 2025.

The company has demonstrated impressive cost discipline, with R&D expenses declining by 78% year-over-year to $400,000 (from $1.8 million) while still advancing their lead candidate through the clinic. Similarly, SG&A expenses decreased by 45% to $1.1 million (from $2.0 million), primarily through reduced legal expenses and other operational efficiencies. This resulted in a 62% reduction in net loss to $1.4 million compared to $3.7 million in the same period last year.

The May 2025 financing (details not specified in the release) has enabled the company to resume development of their second candidate, GTB-5550, with an IND submission planned for Q4 2025. This pipeline expansion, coupled with the ongoing Phase 1 trial for GTB-3650, provides multiple potential value inflection points in the near term. While the reduced R&D spend indicates careful cash management, it's worth monitoring whether this level of investment is sufficient to optimally advance their clinical programs or if additional financing will be required before reaching significant clinical milestones.

• 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
  
  

SAN FRANCISCO, CALIFORNIA, Aug. 14, 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 natural killer (NK) cell engager TriKE^® platform, today announced second quarter 2025 financial results for the period ended June 30, 2025.

“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)."

The Phase 1 dose escalation study is evaluating GTB-3650 in 12 patients (six cohorts) with relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). GTB-3650 is dosed 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. GT Biopharma plans on releasing more detailed results later in 2025 following enrollment and completion of additional dose cohorts.

Second Quarter 2025 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $5.3 million as of June 30, 2025, anticipated to be sufficient to fund operations into Q1 2026.

Research and Development (R&D) Expenses: R&D expenses for the second quarter ended June 30, 2025 were approximately $400,000 compared to $1.8 million for the same comparable quarter of 2024, the $1.4 million decrease was primarily due to a reduction in production and scientific research costs. Research and development expenses relate to our continued licensing, development and production of our most advanced TriKE^® product candidates GTB-3650 and GTB-5550 along with the progression on other promising candidates. In late June 2024, we received clearance from the FDA with respect to our IND Application in relation to our next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and we have advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. Following our May 2025 financing we have restarted the final phase of product development of GTB-5550 and anticipate submission of an IND application for GTB-5550 in fourth quarter of 2025.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the second quarter ended June 30, 2025 were approximately $1.1 million compared to $2.0 million for the same comparable quarter of 2024, the $900,000 decrease was primarily due to a significant decrease in legal fees and other cost reduction measures.

Net Loss: The Company reported a net loss of approximately $1.4 million for the second quarter ended June 30, 2025 compared to a net loss of $3.7 million for the same comparable quarter in 2024, the $2.3 million decrease consisted primarily of significant decreases in R&D and SG&A expenses (as described above).

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on our proprietary TriKE^® NK cell engager platform. Our TriKE^® platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE^® technology. For more information, please visit gtbiopharma.com.

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" regarding future events and our future results. All statements other than statements of historical facts are statements that could be deemed to be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements are subject to a number of risks, uncertainties and assumptions that are difficult to predict, estimate or verify. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Such risks and uncertainties include those factors described in our most recent annual report on Form 10-K, as such may be amended or supplemented by subsequent quarterly reports on Form 10-Q, or other reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements are made only as of the date hereof, and we undertake no obligation to publicly release the result of any revisions to these forward-looking statements. For more information, please refer to our filings with the Securities and Exchange Commission.

TriKE^® is a registered trademark owned by GT Biopharma, Inc.

Investor Relations Contact:

LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
212-915-2577

FAQ

What are the Q2 2025 financial results for GT Biopharma (GTBP)?

GT Biopharma reported a net loss of $1.4 million, with cash position of $5.3 million as of June 30, 2025. R&D expenses were $400,000 and SG&A expenses were $1.1 million, both showing significant year-over-year reductions.

What is the status of GT Biopharma's GTB-3650 TriKE clinical trial?

The GTB-3650 TriKE Phase 1 trial has completed Cohorts 1 and 2, treating four patients, and has advanced to Cohort 3 with the fifth patient now receiving treatment. Initial Phase 1 data is expected later in 2025.

When will GT Biopharma submit the IND for GTB-5550?

GT Biopharma expects to submit the IND application for GTB-5550 TriKE in Q4 2025 for the treatment of B7H3 positive solid tumors.

How long can GT Biopharma fund its operations with current cash?

With approximately $5.3 million in cash as of June 30, 2025, GT Biopharma anticipates having sufficient funding to operate into Q1 2026.

What is the design of GT Biopharma's GTB-3650 Phase 1 trial?

The Phase 1 trial is evaluating GTB-3650 in 12 patients across six cohorts with CD33 expressing hematologic malignancies. Treatment is administered in two-week blocks (two weeks on/off) for up to four months based on clinical benefit.