GT Biopharma Inc

Previous wording

We are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies and solid tumors. The platform is scalable, and we are putting processes in place to be able to produce investigational new drug (IND) ready moieties in a timely manner after a specific TriKE® conceptual design. Specific drug candidates can then be advanced into the clinic on our own or through potential collaborations with partnering companies. We believe our TriKE®s may have the ability, if approved for marketing, to be used as both monotherapy and in combination with other standard-of-care therapies.

Current wording

We are using our TriKE® platform with the intent to bring to market immuno-oncology products that can treat a range of hematologic malignancies, solid tumors, and potentially autoimmune disorders. The platform is scalable, and we are putting processes in place to be able to produce investigational new drug (IND) ready moieties in a timely manner after a specific TriKE® conceptual design. Specific drug candidates can then be advanced into the clinic on our own or through potential collaborations with partnering companies. We believe our TriKE®s may have the ability, if approved for marketing, to be used as both monotherapy and in combination with other standard-of-care therapies.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

Research and development expenses decreased by $311,000 and $1.2 million, for the three and six months ended June 30, 2024 and 2023, respectively, primarily due to a decrease in project materials costs, partially offset by an increase in scientific research costs.

Current wording

Research and development expenses decreased by $57,000 and approximately $1.2 million, for the three and nine months ended September 30, 2024 and 2023, respectively, primarily due to a decrease in project materials costs, partially offset by an increase in scientific research costs.

Previous wording

Research and development expenses relate to our continued 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 GTB 3650. We anticipate our direct clinical and preclinical expenses to continue to increase in the second half of 2024 as we plan to advance our next generation GTB-3650 camelid nanobody product into the clinic, enroll patients, and perform tests for data collection. We also plan to complete the product development of GTB-5550 and anticipate submission of IND application for GTB-5550 in the first half of 2025. We do not, however, anticipate an increase in related R&D licensing and administrative costs.

Current wording

Research and development expenses relate to our continued 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 GTB 3650. We anticipate our direct clinical and preclinical expenses to increase in the second half of 2024 as we plan to advance our next generation GTB-3650 camelid nanobody product into the clinic, enroll patients, and perform tests for data collection. We also plan to complete the product development of GTB-5550 and anticipate submission of IND application for GTB-5550 in the first half of 2025. We do not, however, anticipate an increase in related R&D licensing and administrative costs.

Previous wording

Selling, general, and administrative expenses increased by $874,000 and $1.6 million, for the three and six months ended June 30, 2024 and 2023, respectively, primarily due to an increase in legal and professional fees.

Current wording

Selling, general, and administrative expenses increased by approximately $1.1 million and $3.0 million, for the three and nine months ended September 30, 2024 and 2023, respectively, primarily due to an increase in legal and professional fees and an accrual for the probable settlement of a legal matter where the amount of the settlement can be reasonably estimated.

Previous wording

Interest income decreased by $115,000 and $137,000 for the three and six months ended June 30, 2024 compared to the same prior year periods, respectively, primarily due to lower short term investment balances.

Current wording

Interest income decreased by $120,000 and $257,000 for the three and nine months ended September 30, 2024 compared to the same prior year periods, respectively, primarily due to lower short term investment balances.

Previous wording

Interest expense decreased by $213,000 for the six months ended June 30, 2024 compared to the same prior year periods, respectively. The interest expense for the six months ended June 30, 2023 was due to the financing costs incurred associated with warrants accounted as warrant liability sold during the six months ended June 30, 2023, which did not recur in the current period.

Current wording

Interest expense decreased by $213,000 for the nine months ended September 30, 2024 compared to the same prior year period, respectively, due to the financing costs incurred associated with warrants accounted as warrant liability, there were no similar transactions during the current period.

Previous wording

The change in fair value of warrant liability decreased by $1.3 million and $3.5 million for the three and six months ended June 30, 2024 compared to the same prior year periods, respectively, resulting from a reduction in our warrant liability due to the decline in the Company’s stock price at June 30, 2024 as compared to the prior comparable periods.

Current wording

The change in fair value of warrant liability decreased by approximately $390,000 and $3.9 million for the three and nine months ended September 30, 2024 compared to the same prior year periods, respectively, resulting from a reduction in our warrant liability due to the decline in the Company’s stock price at September 30, 2024 as compared to the prior comparable periods.

Previous wording

Gain on extinguishment of debt decreased by $14,000 and $547,000 for the three and six months ended June 30, 2024 compared to the same prior year periods, respectively. The gain on extinguishment of debt for the six months ended June 30, 2023 resulted from share settlements of a greater amount of vendor accounts payable than the fair value of the shares on the date of settlement, there were no similar transactions during the current period.

Current wording

Gain on extinguishment of debt decreased by $547,000 for the six months ended September 30, 2024 compared to the same prior year period, respectively, and resulted from share settlements of a greater amount of vendor accounts payable than the fair value of the shares on the date of settlement, there were no similar transactions during the current period.

Previous wording

Net loss increased $1,718,000 for the three months ended June 30, 2024, primarily due to the $1,270,000 decrease in the change in fair value of warrant liability, as described above.

Current wording

Net loss increased $995,000 for the three months ended September 30, 2024, primarily due to an increase in legal and professional fees and an accrual for the probable settlement of a legal matter, and the decrease in the change in fair value of warrant liability, all as described above.

Previous wording

Net loss increased $3,757,000 for the six months ended June 30, 2024, primarily due to the $3,536,000 decrease in the change in fair value of warrant liability and the $547,000 decrease in the gain on extinguishment of debt, both as described above.

Current wording

Net loss increased $4,752,000 for the nine months ended September 30, 2024, primarily due to the decrease in the change in fair value of warrant liability, an increase in legal and professional fees and an accrual for the probable settlement of a legal matter, and the decrease in the gain on extinguishment of debt, all as described above.

Previous wording

We do not have any product candidates approved for sale and have not generated any revenue from our product sales. We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future. Historically, we have financed our operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations. For the six months ended June 30, 2024, we recorded a net loss of approximately $6.0 million and used cash in operations of $7.7 million. As of June 30, 2024, we had a cash and cash equivalents and short-term investments balance of $9.2 million, working capital of $5.8 million, and stockholders’ equity of $5.5 million.

Current wording

The accompanying unaudited condensed consolidated financial statements have been prepared assuming that we will continue as a going concern. We do not have any product candidates approved for sale and have not generated any revenue from our product sales. We have sustained operating losses since inception, and we expect such losses to continue into the foreseeable future. Historically, we have financed our operations through public and private sales of common stock, issuance of preferred and common stock, issuance of convertible debt instruments, and strategic collaborations. For the nine months ended September 30, 2024, we recorded a net loss of approximately $9.4 million and used cash in operations of approximately $10.4 million. These factors raise substantial doubt about our ability to continue as a going concern within one year of the date that the financial statements are issued.

Previous wording

We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised doubts about our ability to continue as a going concern. While it is very difficult to estimate our future liquidity requirements we believe if we are unable to obtain additional financing, existing cash resources will not be sufficient to enable us to fund the anticipated level of operations through one year from the date the accompanying unaudited condensed consolidated financial statements are issued. There can be no assurances that we will be able to secure additional financing on acceptable terms. In the event that we do not secure additional financing, we will be forced to delay, reduce, or eliminate some or all of our discretionary spending, which could adversely affect our business prospects, ability to meet long-term liquidity needs and the ability to continue operations.

Current wording

We have evaluated the significance of the uncertainty regarding our financial condition in relation to our ability to meet our obligations, which has raised substantial doubt about our ability to continue as a going concern. While it is very difficult to estimate our future liquidity requirements we believe if we are unable to obtain additional financing, existing cash resources will not be sufficient to enable us to fund the anticipated level of operations through one year from the date the accompanying unaudited condensed consolidated financial statements are issued. There can be no assurances that we will be able to secure additional financing on acceptable terms. In the event that we do not secure additional financing, we will be forced to delay, reduce, or eliminate some or all of our discretionary spending, which could adversely affect our business prospects, ability to meet long-term liquidity needs and the ability to continue operations.

Previous wording

Net cash used in operating activities was $7.7 million for the six months ended June 30, 2024, and was primarily due to a net loss of $6.0 million, a decrease in accounts payable and accrued expenses of $1.2 million, and a decrease in the fair value of warrant liability of $775,000.

Current wording

Net cash used in operating activities was $10.4 million for the nine months ended September 30, 2024, and was primarily due to a net loss of $9.4 million, and a decrease in the fair value of warrant liability of $0.9 million.

Previous wording

Net cash used in operating activities was $4.4 million for the six months ended June 30, 2023, and was primarily due to a net loss of $2.2 million, a decrease in the fair value of warrant liability of $4.3 million, and partially offset by stock compensation of $1.2 million and an increase in accounts payable and accrued expenses of $1.1 million.

Current wording

Net cash used in operating activities was $6.8 million for the nine months ended September 30, 2023, and was primarily due to a net loss of $4.6 million, a decrease in the fair value of warrant liability of $4.8 million, and partially offset by stock compensation of $1.3 million and an increase in accounts payable and accrued expenses of $1.4 million.

Previous wording

Net cash provided (used) in financing activities for the six months ended June 30, 2024 and 2023, resulted from proceeds from the sale, or (purchase), of short-term investments.

Current wording

Net cash provided (used) in financing activities for the nine months ended September 30, 2024 and 2023, resulted primarily from proceeds from the sale, or (purchase), of short-term investments.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2024 and 2023, resulted from proceeds from the issuance of common stock and warrants.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 and 2023, resulted from proceeds from the issuance of common stock and warrants.