GT Biopharma Inc
For the period ended Jun 30, 2024. Filed Aug 14, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 14, 2024
GTBP$4.42-2.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-15.
0001493152-24-019970
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-14.
0001493152-24-032143
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 65 previous paragraphs and 68 current paragraphs.
22 unchanged; 12 reworded; 34 added; 31 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 8 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (34)
Current report
Organization
Current report
The corporate predecessor of GT Biopharma, Inc, Diagnostic Data, Inc., was incorporated in the state of California in 1965. Diagnostic Data, Inc. changed its incorporation to the state of Delaware on December 21, 1972 and changed its name to DDI Pharmaceuticals, Inc. on March 11, 1985. On September 7, 1994, DDI Pharmaceuticals, Inc. merged with International BioClinical, Inc. and Bioxytech S.A. and changed its name to OXIS International, Inc. On July 17, 2017, OXIS International, Inc. changed its name to GT Biopharma, Inc.
Current report
Our product pipeline as of June 30, 2024 is presented below:
Current report
Second Generation TriKE®s Utilize Camelid Nanobody Technology
Current report
Critical Accounting Policies and Estimates
Current report
The preparation of our consolidated financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. When making these estimates and assumptions, we consider our historical experience, our knowledge of economic and market factors and various other factors that we believe to be reasonable under the circumstances. Actual results may differ under different estimates and assumptions. The accounting estimates and assumptions discussed in this section are those that we consider to be the most critical to gain an understanding of our financial statements because they inherently involve significant judgments and uncertainties.
Current report
Use of Estimates
Current report
We evaluate our financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815, “Derivatives and Hedging”. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported in the statements of operations.
Current report
Our use of derivative financial instruments is generally limited to warrants issued by us that do not meet the criteria for equity treatment and are recorded as liabilities. We do not use financial instruments or derivatives for any trading purposes.
Current report
We periodically issue stock-based compensation to officers, directors, employees, and consultants for services rendered. Such issuances vest and expire according to terms established at the issuance date.
Current report
Stock-based payments made to officers, directors, employees, and consultants in exchange for goods and services, including grants of employee stock options, are recognized in the financial statements based on their grant date fair values in accordance with ASC 718,Compensation-Stock Compensation. Stock based payments to officers, directors, employees, and consultants, which are generally time vested, are measured at the grant date fair value and depending on the conditions associated with the vesting of the award, compensation cost is recognized on a straight-line or graded basis over the vesting period. Recognition of compensation expense for non-employees is in the same period and manner as if we had paid cash for the services. The fair value of stock options granted is estimated using the Black-Scholes option-pricing model, which uses certain assumptions related to risk-free interest rates, expected volatility, expected life, and future dividends. The assumptions used in the Black-Scholes option pricing model could materially affect compensation expense recorded in future periods.
Current report
Operating Expenses
Current report
Research and Development Expenses
Current report
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 report
Selling, General, and Administrative Expenses
Current report
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 report
Other Income (Expense)
Current report
Net Loss
Current report
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 report
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 report
Liquidity and Going Concern Analysis
Current report
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 report
The unaudited condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern. Accordingly, the unaudited condensed consolidated financial statements have been prepared on a basis that assumes we will continue as a going concern, and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
Current report
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 report
Cash Flows
Current report
Operating Activities
Current report
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 report
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 report
Investing Activities
Current report
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 report
Financing Activities
Current report
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 report
Working Capital
Current report
The following table summarizes total current assets, liabilities, and working capital for the periods ended June 30, 2024 and December 31, 2023:
Removed paragraphs (31)
Previous report
Throughout this Quarterly Report on Form 10-Q, the terms “GTBP,” “we,” “us,” “our,” “the Company” and “our Company” refer to GT Biopharma, Inc., a Delaware corporation formerly known as Oxis International, Inc., DDI Pharmaceuticals, Inc. and Diagnostic Data, Inc, together with our subsidiaries.
Previous report
We are also using our TriKE® platform to develop therapeutics useful for the treatment of infectious disease such as for the treatment of patients infected by the human immunodeficiency virus (HIV). While the use of anti-retroviral drugs has substantially improved the health and increased the longevity of individuals infected with HIV, these drugs are designed to suppress virus replication to help modulate progression to acquired immunodeficiency syndrome (AIDS) and to limit further transmission of the virus. Despite the use of anti-retroviral drugs, infected individuals retain reservoirs of latent HIV-infected cells that, upon cessation of anti-retroviral drug therapy, can reactivate and re- establish an active HIV infection. For a curative therapy, destruction of these latent HIV infected cells must take place. The HIV-TriKE® contains the antigen binding fragment (Fab) from a broadly neutralizing antibody targeting the HIV-Env protein or a protein that binds infected CD4+ T cells. The HIV-TriKE® is designed to target HIV while redirecting NK cell killing specifically to actively replicating HIV infected cells. The HIV-TriKE® induced NK cell proliferation and demonstrated the ability in vitro to reactivate and kill HIV-infected T-cells. These findings indicate a potential role for the HIV-TriKE®in the reactivation and elimination of the latently infected HIV reservoir cells by harnessing the NK cell’s ability to mediate the antibody-directed cellular cytotoxicity (ADCC).
Previous report
The Next Generation of Camelid Nanobody TriKE®s
Previous report
Generation of humanized single-domain antibody targeting CD16 for incorporation into the TriKE® platform
Previous report
Reverse Stock Split
Previous report
On February 1, 2024, the Company announced a reverse stock-split of its common stock, par value $0.001 per share, at a ratio of 1 for 30. The reverse stock-split became effective on February 2, 2024. The Company’s common stock began trading on a reverse stock-split-adjusted basis on The Nasdaq Capital Market on February 5, 2024, under our existing trading symbol “GTBP.”
Previous report
As a result of the reverse stock-split, every thirty (30) shares of issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value per share. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise would be entitled to receive fractional shares of common stock will be entitled to receive their pro-rata portion of the net proceeds obtained from the aggregation and sale by the exchange agent of the fractional shares resulting from the reverse stock-split (reduced by any customary brokerage fees, commission and other expenses).
Previous report
Proportionate adjustments were made to the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options for the Company’s common stock and to the number of shares of common stock reserved for future issuance pursuant to the GT Biopharma, Inc. 2022 Omnibus Incentive Plan.
Previous report
All share and per share information within this report have been adjusted to retroactively reflect the reverse stock-split as of the earliest period presented.
Previous report
Economic Disruption
Previous report
While we make our strategic planning decisions based on the assumption that the markets we are targeting will grow in the long term, our business is dependent, in large part on, and directly affected by, business cycles and other factors affecting the economy generally. Our industry depends on general economic conditions and other factors, including consumer spending and preferences, changes in inflation rates, supply chain issues and impediments should they arise for us, as the U.S. and various other major economies are now experiencing, consumer confidence, fuel costs, fuel availability, environmental impact, governmental incentives and regulatory requirements, and political volatility.
Previous report
In addition, the outbreak of full-scale wars between Russia and Ukraine and Israel and Palestine (“Conflicts”) and global reactions thereto have increased U.S. domestic and global energy prices. Oil supply disruptions related to the Conflicts, and sanctions and other measures taken by the U.S. and its allies, could lead to higher costs for gas, food, and goods in the U.S. and other geographies and exacerbate the inflationary pressures on the worldwide economy, with potentially adverse impacts on our business, results of operations and financial condition.
Previous report
Research and Development Expenses (“R&D”)
Previous report
Selling, General and Administrative Expenses (“SG&A”)
Previous report
Selling, general and administrative expense (“SG&A”) was $2.31 million and $2.02 million for the three months ended March 31, 2024 and 2023, respectively. SG&A expenses increased by $299,000 as compared to the prior year comparable period, primarily due to reduction in stock-based compensation expense for officers, employees and board of directors by $616,000, offset by an increase in legal and professional fees of $794,000 and an increase in costs of filing regulatory fees and other SG&A expenses of $121,000.
Previous report
Unrealized (Gain) Loss on Marketable Securities
Previous report
We recorded an unrealized loss on marketable securities of $2,000 for the three months ended March 31, 2024 as compared to an unrealized gain on marketable securities of $29,000 for the three months ended March 31, 2023. This resulted from lower investments balances for the three months ended March 31, 2024 as compared to prior year comparable period.
Previous report
As a result of the above, the Company recorded a net loss of $2.27 million for the three months ended March 31, 2024 as compared to a loss of $227,000 for the same comparable period in 2023.
Previous report
Liquidity and Capital Resources
Previous report
The Company’s current operations have focused on business planning, raising capital, establishing an intellectual property portfolio, hiring, and conducting preclinical studies. The Company does not have any product candidates approved for sale and has not generated any revenue from its product sales. The Company has sustained operating losses since inception and expects such losses to continue into the foreseeable future. We anticipate that cash utilized in the twelve months following this filing date for selling, general and administrative expenses will range between $3.0 and $3.5 million, and used for research and development expenses will range between $3.5 and $4.0 million.
Previous report
The Company reported cash and cash equivalents of $1.95 million and short-term investments of $7.86 million as of March 31, 2024. Management believes that the Company has sufficient cash and cash equivalents, and short-term investments to fund its operations for more than twelve months from the date of this filing.
Previous report
Management is currently evaluating different strategies to obtain the required funding for future operations. These strategies may include but are not limited to public offerings of equity and/or debt securities, payments from potential strategic research and development, licensing and/or marketing arrangements with pharmaceutical companies.
Previous report
Critical Accounting Policies
Previous report
We consider the following accounting policies to be critical given they involve estimates and judgments made by management and are important for our investors’ understanding of our operating results and financial condition.
Previous report
Basis of Presentation and Principles of Consolidation
Previous report
The accompanying condensed consolidated financial statements have been prepared in accordance with GAAP. These condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Oxis Biotech, Inc. and Georgetown Translational Pharmaceuticals, Inc. Intercompany transactions and balances have been eliminated in consolidation.
Previous report
Accounting Estimates
Previous report
The Company accounts for share-based awards to employees, nonemployees and consultants in accordance with the provisions of Accounting Standards Codification 718,Compensation-Stock Compensation. Stock-based compensation cost is measured at fair value on the grant date and that fair value is recognized as expense over the requisite service, or vesting period.
Previous report
The Company values its equity awards using the Black-Scholes option pricing model, and accounts for forfeitures when they occur. Use of the Black-Scholes option pricing model requires the input of subjective assumptions including expected volatility, expected term, and a risk-free interest rate. The Company estimates volatility using its own historical stock price volatility. The expected term of the instrument is estimated by using the simplified method to estimate expected term. The risk-free interest rate is estimated using comparable published federal funds rates.
Previous report
Inflation
Previous report
We believe that inflation has not had a material adverse impact on our business or operating results during the periods presented other than the impact of inflation on the general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.
Reworded paragraphs (12)
Previous wording
We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on our proprietary Tri-specific Killer Engager (TriKE®) fusion protein immune cell engager technology platform. Our TriKE® platform generates proprietary therapeutics designed to harness and enhance the cancer killing abilities of a patient’s own natural killer cells, or NK cells. Once bound to an NK cell, our moieties are designed to enhance the NK cell, and precisely direct it to one or more specifically targeted proteins expressed on a specific type of cancer cell or virus infected cell, resulting in the targeted cell’s death. TriKE®s can be designed to target any number of tumor antigens on hematologic malignancies or solid tumors and do not require patient-specific customization.
Current wording
We are a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on our proprietary Tri-specific Killer Engager (TriKE®), and Tetra-specific Killer Engager (Dual Targeting TriKE®) fusion protein immune cell engager technology platforms. Our TriKE® and Dual Targeting TriKE® platforms generates proprietary therapeutics designed to harness and enhance the cancer killing abilities of a patient’s own natural killer cells, or NK cells. Once bound to an NK cell, our moieties are designed to enhance the NK cell, and precisely direct it to one or more specifically targeted proteins expressed on a specific type of cancer cell or virus infected cell, resulting in the targeted cell’s death. TriKE®s can be designed to target any number of tumor antigens on hematologic malignancies or solid tumors and do not require patient-specific customization.
Previous wording
GTB-3550 was replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650, both targeting CD33 on relapsed/refractory Acute Myeloid Leukemia (AML) and high-risk Myelodysplastic Syndromes (MDS). The pivot from GTB-3550 to GTB-3650 in our clinical development was based on a solid preclinical foundation that showed markedly enhanced potency of the camelid modification of the first-generation TriKE. This is illustrated below by better tumor control of AML bearing animals with GTB-3650 (purple dots) compared to GTB-3550 (blue dots). This provided the rationale for pausing further development of GTB-3550 and moving over to solely develop the 2 nd generation TriKE platform.
Current wording
GTB-3550 was replaced by a more potent next-generation camelid nanobody TriKE®, GTB-3650, both targeting CD33 on relapsed/refractory AML and high-risk MDS. The pivot from GTB-3550 to GTB-3650 in our clinical development was based on a solid preclinical foundation that showed markedly enhanced potency of the camelid modification of the first-generation TriKE®. This is illustrated below by better tumor control of AML bearing animals with GTB-3650 (purple dots) compared to GTB-3550 (blue dots). This provided the rationale for pausing further development of GTB-3550 and moving over to solely develop the second-generation TriKE® platform.
Previous wording
Our goal is to be a leader in immuno-oncology therapies targeting a broad range of indications including hematological malignancies and solid tumors. A key element of our strategy includes introducing a next-generation camelid nanobody platform. Camelid antibodies (often referred as nanobodies) are smaller than human immunoglobulin and consist of two heavy chains. These nanobodies have the potential to have greater affinity to target antigens, potentially resulting in greater potency. GT Biopharma is utilizing this camelid antibody structure for all its new TriKE® product candidates.
Current wording
Our goal is to be a leader in immuno-oncology therapies targeting a broad range of indications including hematological malignancies and solid tumors. A key element of our strategy includes introducing a next-generation camelid nanobody platform. Camelid antibodies (often referred as nanobodies) are smaller than human immunoglobulin and consist of two heavy chains. These nanobodies have the potential to have greater affinity to target antigens, potentially resulting in greater potency. We are utilizing this camelid antibody structure for all of our new TriKE® product candidates.
Previous wording
(Purple line represents the GTB-3650 and Blue line represents GTB-3550)
Current wording
The purple line represents the GTB-3650 and the blue line represents GTB-3550.
Previous wording
GTB-3650 is a CD33 targeted TriKE® which targets CD33 on the surface of myeloid leukemias and an agonistic camelid engager to the potent activating receptor on NK cells, CD16. Use of this engager enhances the activity of wild type IL-15 included in GTB-3650, no longer needing the mutant IL-15 included in GTB-3550. The TriKE® approach provides a novel way to specifically target these tumors by leveraging NK cells, which have been shown to mediate relapse protection in this setting, in an anti-CD33-targeted fashion. We are moving GTB-3650 clinically based on pre-clinical data showing a marked increase in potency compared to GTB-3550, which we anticipate could lead to an enhanced efficacy signal in AML and MDS. We are advancing GTB-3650 through preclinical studies and have filed an Investigational New Drug (IND) application with the FDA in December 2023. The Company continues to be in a productive dialogue with the FDA with respect to its IND Application in relation to GTB 3650. We further anticipate approval to start study enrollment targeting patients with relapsed/refractory AML and high grade MDS by the second half of 2024. This initial study will test GTB-3650 as monotherapy testing administration 2 weeks on and two weeks off (to prevent NK cell exhaustion) for at least 2 cycles of therapy. The design of the trial has been agreed on with the FDA.
Current wording
GTB-3650 is a CD33 targeted TriKE® which targets CD33 on the surface of myeloid leukemias and an agonistic camelid engager to the potent activating receptor on NK cells, CD16. Use of this engager enhances the activity of wild type IL-15 included in GTB-3650, no longer needing the mutant IL-15 included in GTB-3550. The TriKE® approach provides a novel way to specifically target these tumors by leveraging NK cells, which have been shown to mediate relapse protection in this setting, in an anti-CD33-targeted fashion. We are moving GTB-3650 clinically based on pre-clinical data showing a marked increase in potency compared to GTB-3550, which we anticipate could lead to an enhanced efficacy signal in AML and MDS. We have advanced GTB-3650 through preclinical studies and filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in December 2023. In late June 2024, we received clearance from the FDA with respect to our IND Application in relation to GTB 3650. We further anticipate approval to start study enrollment targeting patients with relapsed/refractory AML and high grade MDS in the second half of 2024. This initial study will test GTB-3650 as monotherapy testing administration 2 weeks on and two weeks off (to prevent NK cell exhaustion) for at least 2 cycles of therapy. The design of the trial has been agreed on with the FDA.
Previous wording
GTB-5550 is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors (figure above). B7-H3 is an exciting target as it displays specific expression on a broad spectrum of solid tumor malignancies, allowing our team to target these malignancies through GTB-5550. Pre-clinical work has shown that this molecule has NK-cell targeted activity against a variety of solid tumor settings, including head and neck cancer squamous cell carcinoma (figure below), prostate cancer, breast cancer, ovarian cancer, glioblastoma, and lung cancer (amongst others). We are advancing GTB-5550 through preclinical studies and have initiated a GMP manufacturing campaign in anticipation of filing an IND in the late second half of 2024. A pre-IND packet was submitted to the FDA in October 2023 with a written response from the FDA in December 2023. The main question to the FDA was regarding pre-clinical toxicology and a pivot to subcutaneous dosing. The initial trial is designed as a basket trial for patients with B7-H3+ solid tumors using Monday through Friday dosing (2 weeks on and 2 weeks off to prevent immune exhaustion). This is dependent on manufacturing of clinical materials. We expect a study targeting patients with B7-H3 positive solid tumors in the first half of 2025.
Current wording
GTB-5550 is a B7-H3 targeted TriKE® which targets B7-H3 on the surface of advanced solid tumors (figure above). B7-H3 is an exciting target as it displays specific expression on a broad spectrum of solid tumor malignancies, allowing our team to target these malignancies through GTB-5550. Pre-clinical work has shown that this molecule has NK-cell targeted activity against a variety of solid tumor settings, including head and neck cancer squamous cell carcinoma (figure below), prostate cancer, breast cancer, ovarian cancer, glioblastoma, and lung cancer (amongst others). We are advancing GTB-5550 through preclinical studies and initiated a GMP manufacturing campaign in anticipation of filing an IND in the first half of 2025. A pre-IND packet was submitted to the FDA in October 2023 with a written response from the FDA in December 2023. The main question from the FDA was regarding pre-clinical toxicology and a pivot to subcutaneous dosing. The initial trial expected in 2025 is designed as a basket trial for patients with B7-H3+ solid tumors using Monday through Friday dosing (2 weeks on and 2 weeks off to prevent immune exhaustion), and is dependent on manufacturing of clinical materials.
Previous wording
Comparison of the Three Months Ended March 31, 2024 and 2023
Current wording
Comparison of the Three and Six Months Ended June 30, 2024 and 2023
Previous wording
During the three months ended March 31, 2024 and 2023, we incurred $777,000 and $1.65 million of R&D expenses, respectively. R & D 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. R&D expenses decreased by $873,000 primarily due to reduction in raw material purchases of $657,000 as we benefit from the near completion of product development for GTB 3650 and continue to advance our progression to the new stage of our product development of GTB 5550, and reduction of $216,000 in consulting fees due to better management of other research and development costs. 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.
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 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.
Previous wording
We recorded interest income of $142,000 and $164,000 for the three months ended March 31, 2024 and 2023, respectively. The decrease in interest income was due to lower short term investment balances during the three months ended March 31, 2024 as compared to prior year comparable period.
Current 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.
Previous wording
We recorded interest expense of $0 and $212,000 for the three months ended March 31, 2024 and 2023, respectively. The interest expense for the three months ended March 31, 2023 was due to the financing costs incurred associated with warrants accounted as warrant liability sold during the three months ended March 31, 2023 which did not recur in the current year.
Current 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.
Previous wording
We recorded a gain of $658,000 due to a change in fair value of warrant liability for the three months ended March 31, 2024, compared to a gain of $2.92 million for the three months ending March 31, 2023. The decrease in gain resulted due to a reduction in our warrant liability because of the decline in the Company’s stock price at March 31, 2024 as compared to the prior comparable period.
Current 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.
Previous wording
We recorded a gain on extinguishment of debt of $0 and $533,000 for the three months ended March 31, 2024 and 2023, respectively. The gain in the three months ended March 31, 2023 was as a result of share settlement of a greater amount of vendor accounts payable than the fair value of the shares on the date of settlement. There was no similar transaction during the current period.
Current 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.