GT Biopharma Reports Fourth Quarter and Full-Year 2023 Financial Results

Rhea-AI Summary

GT Biopharma, Inc. announces progress with FDA for GTB-3650 and plans for Phase 1 trial, submission of IND for GTB-5550, and cash position of $14 million. Financially, the company had a decrease in R&D and G&A expenses, an increase in other income, and reported a reduced net loss for Q4 and full-year 2023.

Positive

• Progress with FDA for GTB-3650
• Phase 1 trial initiation anticipated in 2H 2024
• IND submission for GTB-5550 targeting solid tumors in Q4 2024
• Cash position of $14 million as of December 31, 2023
• Decrease in R&D expenses for Q4 and full-year 2023
• Decrease in G&A expenses for Q4 and full-year 2023
• Increase in other income for Q4 and full-year 2023
• Reduced net loss for Q4 and full-year 2023

Negative

• None.

Insights

Financial Analyst

The financial summary provided by GT Biopharma, Inc. highlights a strategic reduction in both Research and Development (R&D) and General and Administrative (G&A) expenses year-over-year. The company has effectively managed to decrease its R&D expenses by streamlining licensing and administrative costs while maintaining investment in product development. This cost management reflects a disciplined approach to capital allocation, which is vital for a clinical-stage biopharmaceutical company with no revenue-generating products on the market.

On the G&A front, the substantial decrease in expenses is indicative of an operational efficiency strategy, which is critical for the company's sustainability. The reduction in stock compensation and consulting fees suggests a shift towards a more cash-conservative remuneration model, which is often appreciated by investors during the high-risk development phases.

Another notable financial metric is the net loss reduction, which may be positively perceived by the market as it indicates a more controlled burn rate. However, it is essential to keep in mind that the company's ability to continue reducing losses while simultaneously advancing their product candidates will be a important factor in assessing their long-term financial health and investment potential.

The cash position, with a runway into 2025, offers the company some leeway to progress its clinical trials without the immediate need for additional capital raises, which could dilute existing shareholders. However, the anticipated increase in clinical and preclinical expenses in 2024 will likely require careful financial planning to avoid future financial strain.

Medical Research Analyst

The clinical development of GTB-3650 and the planned IND submission for GTB-5550 are significant milestones in GT Biopharma's pipeline progression. The transition of GTB-3650 into Phase 1 clinical trials for CD33+ leukemia represents an advancement in the company's proprietary TriKE® platform, which aims to enhance natural killer (NK) cell engagement. The potential of this platform lies in its novel approach to immuno-oncology, a field that has seen substantial interest and investment over the past decade.

GTB-5550's targeting of B7H3 for multiple solid tumors, including prostate and breast cancers, suggests that the company is looking to address a broad range of oncological indications with significant unmet needs. Successful development of these therapies could position GT Biopharma in a lucrative market segment. However, the long-term impact on the company's valuation will heavily depend on the clinical outcomes and the ability to navigate a highly competitive landscape.

It is essential to monitor the initial data from the GTB-3650 Phase 1 trial expected by the end of 2024/early 2025. This data will provide insights into the efficacy and safety profile of the therapy, which are critical determinants of its commercial viability and potential market impact. Investors should also consider the inherent risks associated with clinical-stage biopharmaceuticals, as any setbacks in the development process can significantly affect the company's prospects and stock performance.

Market Research Analyst

The immuno-oncology sector continues to be a hotbed of innovation and investment, with significant growth potential. GT Biopharma's focus on NK cell engagers positions it within a niche yet expanding area of cancer treatment research. The company's strategic decision to target both hematologic malignancies and solid tumors could open up diverse revenue streams should these treatments prove successful in clinical trials.

However, it is important to consider the competitive environment. Major pharmaceutical companies and biotech firms are also investing heavily in immuno-oncology. GT Biopharma will need to differentiate its TriKE® platform not only through clinical efficacy but also by demonstrating cost-effectiveness and manageable safety profiles compared to existing treatments.

From a market perspective, the IND clearance and the start of Phase 1 trials may serve as catalysts for the company's stock, as positive regulatory milestones often do. Yet, the actual impact on stock performance will likely hinge on broader market conditions and investor sentiment towards the biotech sector, which can be volatile and influenced by regulatory news, clinical trial outcomes and competitive developments.

• Remain in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2^nd generation nanobody TriKE^® for treatment of CD33+ leukemia
• Phase 1 trial with GTB-3650 anticipated to start in 2H 2024
• Anticipate submitting an IND for GTB-5550 targeting B7H3 for multiple solid tumors, including prostate and breast, in Q4 2024
• Cash of approximately $14 million as of December 31, 2023, provides sufficient runway to fund operations into 2025

BRISBANE, CALIFORNIA, March 26, 2024 (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 fourth quarter and full-year 2023 results for the period ended December 31, 2023.

“We continue to make good progress with the FDA regarding IND clearance for GTB-3650, and eagerly anticipate the start of Phase 1 this year,” said Michael Breen, Executive Chairman and Interim Chief Executive Office of GT Biopharma. “We are also anticipating an IND submission for our 2^nd asset, GTB-5550, for multiple solid tumors, including breast and prostate cancers, in Q4 of this year. We have sufficient cash runway into 2025 and anticipate having initial data from our Phase 1 trial with GTB-3650 by the end of 2024/early 2025.”

Fourth Quarter and Year End 2023 Financial Summary

Cash Position: The Company had cash, cash equivalents and short-term investments of $13.97 million as of December 31, 2023 compared to $16.51 million as of December 31, 2022. This is anticipated to provide sufficient runway to fund operations into 2025.

Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2023 were $1.36 million compared to $2.84 million for the same quarter of 2022. R&D expenses for the year ended December 31, 2023 were $6.47 million compared to $8.81 million for the year ended December 31, 2022. The $2.34 million reduction in R&D for the year ended December 31, 2023 over 2022 was primarily due to a $3.59 million reduction in licensing and administrative costs, offset by an increase of $1.25 million in R&D costs related to our continued development and production of our most advanced TriKE® product candidates GTB-3650 and GTB-5550 along with the progression of other promising product candidates. The reduction of $3.59 million in licensing and administrative costs over the previous year was primarily due to better management of R&D expenses with consultants and reduction in stock compensation to employees. We anticipate our direct clinical and preclinical expenses to continue to increase in 2024 as we plan to advance our next generation GTB-3650 camelid nanobody product into the clinic and enroll patients, perform tests for data collection, complete the product development of GTB-5550 and anticipate submission of IND application for GTB-5550 in the fourth quarter of 2024. We do not, however, anticipate an increase in related R&D licensing and administrative costs.

General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2023 were $1.81 million compared to $2.94 million for the same quarter in 2022. G&A expenses for the year ended December 31, 2023 was $7.11 million compared to $12.45 million for the year ended December 31, 2022. The decrease in G&A of $5.34 million for the year ended December 31, 2023 as compared to 2022 was primarily attributable to a reduction of $1.68 million in stock compensation expenses for officers, employees and board of directors and $1.92 million for outside consultants, a reduction of $1.31 million in consulting board advisory board fees, and a reduction of $0.50 million in patents and insurance costs. G&A decreased due to better managing and use of consultants and advisors, and overall reductions in other general and administrative expenses in 2023.

Other Income

Other income net of other expenses, for the fourth quarter ended December 31, 2023 was $0.21 million compared to $0.19 million for the same quarter ended December 31, 2022. Other income, net of other expenses for the year ended December 31, 2023 was $5.98 million compared to $0.37 million for the year ended December 31, 2022. Other income and expenses consisted of interest income, interest expense, change in the fair value of warrant lability, gain on extinguishment of debt, and unrealized gain and loss on marketable securities. The increase in other income net of expenses for the year ended December 31, 2023 was primarily due to the change in fair value of warrant liability as a result of fair value remeasurement which resulted in a gain of $4.8 million and $0.12 million for the years ended December 31, 2023 and 2022, respectively.

Net Loss: The Company reported a net loss of $2.96 million for the fourth quarter ended December 31, 2023 compared to a loss of $5.58 million for the same quarter in 2022. The Company reported a loss of $7.60 million for the year ended December 31, 2023, compared to a net loss of $20.88 million for the year ended December 31, 2022.

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce two main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of two heavy chains and two light chains. They also produce another type of antibody that is made up of only two heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

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. Examples of forward-looking statements in this press release include statements regarding our IND applications, Phase 1 trials and operating expenses and cash runway. 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 is the status of GTB-3650 with the FDA?

GT Biopharma is in active dialogue with the FDA regarding IND clearance for GTB-3650, a 2nd generation nanobody TriKE® for the treatment of CD33+ leukemia.

When is the Phase 1 trial for GTB-3650 anticipated to start?

The Phase 1 trial with GTB-3650 is anticipated to start in the second half of 2024.

What is the plan for GTB-5550?

GT Biopharma anticipates submitting an IND for GTB-5550 targeting B7H3 for multiple solid tumors, including prostate and breast cancers, in the fourth quarter of 2024.

What is the cash position of GT Biopharma as of December 31, 2023?

GT Biopharma had approximately $14 million in cash as of December 31, 2023, providing sufficient runway to fund operations into 2025.

How did R&D expenses change in Q4 and full-year 2023 compared to the previous year?

R&D expenses for Q4 and full-year 2023 decreased compared to the previous year, primarily due to better management of expenses and reduction in stock compensation.

What was the net loss reported by GT Biopharma for Q4 and full-year 2023?

GT Biopharma reported a reduced net loss of $2.96 million for Q4 2023 and $7.60 million for the full-year 2023 compared to the previous year.