Galecto, Inc.

Previous wording

In September 2023, we announced a corporate restructuring that resulted in a substantial reduction of our workforce and that we had initiated a process to evaluate strategic alternatives. On October 7, 2024, we announced that we had completed our strategic alternative review process and determined to focus on oncology and severe liver diseases. In connection with this announcement, we announced that we had entered into an Asset Purchase Agreement (the “Bridge Purchase Agreement”) with Bridge Medicines LLC (“Bridge Medicines”), pursuant to which we acquired global rights to Bridge Medicines’ BRM-1420 program, a novel dual ENL-YEATS and FMS-like tyrosine kinase 3 (“FLT3”) inhibitor for multiple genetic subsets of acute myeloid leukemia (“AML”), and assumed certain of Bridge Medicines’ liabilities associated with the acquired assets. As a result of the conclusion of the strategic alternatives review process and the entry into the Bridge Purchase Agreement, our focus is now on the development of GB3226 (formerly BRM-1420) and GB1211. As part of the strategic alternative review process, we determined not to further advance GB2064, our LOXL-2 inhibitor candidate.

Current wording

In September 2023, we announced a corporate restructuring restructuring (the “Restructuring Plan”) that resulted in a substantial reduction of our workforce and that we had initiated a process to evaluate strategic alternatives. On October 7, 2024, we announced that we had completed our strategic alternative review process and determined to focus on oncology and severe liver diseases. In connection with this announcement, we announced that we had entered into an Asset Purchase Agreement (the “Bridge Purchase Agreement”) with Bridge Medicines LLC (“Bridge Medicines”), pursuant to which we acquired global rights to Bridge Medicines’ BRM-1420 program, a novel dual ENL-YEATS and FMS-like tyrosine kinase 3 (“FLT3”) inhibitor for multiple genetic subsets of acute myeloid leukemia (“AML”), and assumed certain of Bridge Medicines’ liabilities associated with the acquired assets. As a result of the conclusion of the strategic alternatives review process and the entry into the Bridge Purchase Agreement, our focus is now on the development of GB3226 (formerly BRM-1420) and GB1211. As part of the strategic alternative review process, we determined not to further advance GB2064, our LOXL-2 inhibitor candidate.

Previous wording

We are developing GB3226, a preclinical small molecule dual inhibitor of ENL-YEATS and FLT3 for multiple molecularly defined subsets of AML, pursuant to a license agreement with Rockefeller University. We anticipate that an ENL-YEATS/FLT3 inhibitor such as GB3226 may have the potential to address a broad portion of the AML patient population, including those with high-risk genetic mutations. For instance, preclinical models have demonstrated that GB3226 is active against MLLr (or KMT2Ar), NPM1m, and FLT3+ driven AML, and we believe that GB3226 has the potential to be further developed to become a treatment option for other high-risk genetic drivers of AML.

Current wording

We are developing GB3226, a preclinical small molecule dual inhibitor of ENL-YEATS and FLT3 for multiple molecularly defined subsets of AML, pursuant to a license agreement with Rockefeller University. We anticipate that an ENL-YEATS/FLT3 inhibitor such as GB3226 may have the potential to address a broad portion of the AML patient population, including those with high-risk genetic mutations. For instance, preclinical models have demonstrated that GB3226 is active against mixed-lineage leukemia-rearrange (“MLLr”) (or KMT2Ar), NPM1m, and FLT3+ driven AML, and we believe that GB3226 has the potential to be further developed to become a treatment option for other high-risk genetic drivers of AML.

Previous wording

Bridge Medicines, prior to our acquisition of GB3226, conducted a number of preclinicalin vitroand in vivo studies of GB3226 that suggest it is a potent and selective inhibitor of cell proliferation in MLLr cell lines, with durable anti-tumor activity. GB3226 has shown dose-dependent effects on key genetic drivers of leukemogenesis and maintenance, including HOXA9 and MEIS1, indicating suppression of leukemic stem cell development in the bone marrow. Reductions of blasts cells in peripheral blood, bone marrow, and spleen have been demonstrated in animal models, in addition to cell cycle arrest, differentiation of blasts, and apoptosis. Preclinical studies have shown that GB3226 is active against several molecular drivers of AML, including MLL-r, NPM1m, cKIT+, FLT3+ and TET2+. In vitro modeling of GB3226 in combination with AML standard of care therapies and menin inhibitors in several relevant cell lines showed synergistic or additive effects. GB3226 has shown a promising tolerability profile at encouraging exposure multiples in rat and dog toxicology studies performed to date, and we plan to initiate additional IND-enabling toxicology studies in August 2025. We believe that this preclinical data demonstrates GB3226’s unique dual-mechanism that promotes rapid onset (FLT3 inhibition) and duration of response (ENL-YEATS inhibition).

Current wording

Bridge Medicines, prior to our acquisition of GB3226, conducted a number of preclinicalin vitroand in vivo studies of GB3226 that suggest it is a potent and selective inhibitor of cell proliferation in MLLr cell lines, with durable anti-tumor activity. GB3226 has shown dose-dependent effects on key genetic drivers of leukemogenesis and maintenance, including HOXA9 and MEIS1, indicating suppression of leukemic stem cell development in the bone marrow. Reductions of blasts cells in peripheral blood, bone marrow, and spleen have been demonstrated in animal models, in addition to cell cycle arrest, differentiation of blasts, and apoptosis. Preclinical studies have shown that GB3226 is active against several molecular drivers of AML, including MLL-r, NPM1m, cKIT+, FLT3+ and TET2+. In vitro modeling of GB3226 in combination with AML standard of care therapies and menin inhibitors in several relevant cell lines showed synergistic or additive effects. GB3226 has shown a promising tolerability profile at encouraging exposure multiples in rat and dog toxicology studies performed to date. We initiated additional IND-enabling toxicology studies in August 2025. We believe that this preclinical data demonstrates GB3226’s unique dual-mechanism that promotes rapid onset (FLT3 inhibition) and duration of response (ENL-YEATS inhibition).

Previous wording

We enrolled a total of 13 patients in Part A of the GALLANT-1 trial (100 mg: six; 200 mg: seven). Four patients in Part A of the GALLANT-1 trial (100 mg: three; 200 mg: one) showed a partial response according to Response Evaluation Criteria in Solid Tumors (“RECIST”), criteria (version 1.1). One patient receiving GB1211 at 200 mg twice daily, alongside atezolizumab (Tecentriq®) demonstrated a sustained partial response over the course of the trial. At the 12-week mark, tumor shrinkage exceeded 70%, and this reduction was maintained throughout subsequent study visits. In accordance with local treatment guidelines, this patient was discontinued from the trial after receiving checkpoint inhibitor therapy for two consecutive years. Additionally, three of the five patients treated for at least six weeks with 100 mg of GB1211 twice daily, combined with atezolizumab, showed a partial response. Currently, one patient continues to receive GB1211 in combination with atezolizumab in the extension phase of the trial and will continue to be followed until the earlier to occur of progression, unacceptable toxicity or the completion of the extension phase at the end of October 2025. This patient, who has been treated for over two years, demonstrated tumor shrinkage exceeding 80%, consistently recorded during all study visits between week 36 and week 126. Insights from biomarker analyses from the GALLANT-1 trial revealed a trend showing that responders had increased levels of galectin-3 at baseline, and stable or decreasing galectin-3 levels during treatment. In contrast, patients with progressive disease demonstrated increasing levels of galectin-3 during treatment. This correlation suggests that the detection of galectin-3 levels could potentially be used to select and monitor patient populations.

Current wording

We enrolled a total of 13 patients in Part A of the GALLANT-1 trial (100 mg: six; 200 mg: seven). Four patients in Part A of the GALLANT-1 trial (100 mg: three; 200 mg: one) showed a partial response according to Response Evaluation Criteria in Solid Tumors (“RECIST”), criteria (version 1.1). One patient receiving GB1211 at 200 mg twice daily, alongside atezolizumab (Tecentriq®) demonstrated a sustained partial response over the course of the trial. At the 12-week mark, tumor shrinkage exceeded 70%, and this reduction was maintained throughout subsequent study visits. In accordance with local treatment guidelines, this patient was discontinued from the trial after receiving checkpoint inhibitor therapy for two consecutive years. Additionally, three of the five patients treated for at least six weeks with 100 mg of GB1211 twice daily, combined with atezolizumab, showed a partial response. We completed dosing in the extension phase of the this trial, with the final patient receiving their last dose of GB1211 in combination with atezolizumab in late October 2025. In accordance with local treatment guidelines, this patient will continue to receive checkpoint inhibitor therapy until disease progression or unacceptable toxicity. This patient, who had been treated for over 2.5 years, demonstrated tumor shrinkage exceeding 80%, consistently recorded during all study visits between week 36 and week 138. Insights from biomarker analyses from the GALLANT-1 trial revealed a trend showing that responders had increased levels of galectin-3 at baseline, and stable or decreasing galectin-3 levels during treatment. In contrast, patients with progressive disease demonstrated increasing levels of galectin-3 during treatment. This correlation suggests that the detection of galectin-3 levels could potentially be used to select and monitor patient populations.

Previous wording

In the seven patients who received GB1211 200 mg twice daily in combination with atezolizumab, we observed six serious adverse events, of which three of these serious adverse events were determined not to be related to either GB1211 200 mg or atezolizumab. No serious adverse events were deemed to be solely attributed to GB1211 200 mg. One case of grade 4 hypocellular bone marrow was determined to be related to both GB1211 200 mg and atezolizumab. The other two serious adverse events were autoimmune-type skin rashes (showing perivascular lymphocytic infiltrates), one of which was a grade 3 case of autoimmune pemphigus determined to be related solely to atezolizumab and the other was a grade 4 case of skin rash determined to be related to both GB1211 200 mg and atezolizumab. In the six patients who received GB1211 100 mg twice daily in combination with atezolizumab, GB1211 and atezolizumab appeared to be well-tolerated, with predominantly Grade 1 and Grade 2 TEAEs observed. In this cohort, we observed two serious adverse events, neither of which were determined to be related to GB1211 100 mg or atezolizumab. Importantly, we did not observe any autoimmune-type skin rashes in the 100 mg cohort.

Current wording

In the seven patients who received GB1211 200 mg twice daily in combination with atezolizumab, we observed six serious adverse events, of which three of these serious adverse events were determined not to be related to either GB1211 200 mg or atezolizumab. No serious adverse events were deemed to be solely attributed to GB1211 200 mg. One case of grade 4 hypocellular bone marrow was determined to be related to both GB1211 200 mg and atezolizumab. The other two serious adverse events were autoimmune-type skin rashes (showing perivascular lymphocytic infiltrates), one of which was a grade 3 case of autoimmune pemphigus determined to be related solely to atezolizumab and the other was a grade 4 case of skin rash determined to be related to both GB1211 200 mg and atezolizumab. In the six patients who received GB1211 100 mg twice daily in combination with atezolizumab, GB1211 and atezolizumab appeared to be well-tolerated, with predominantly Grade 1 and Grade 2 treatment-emergent adverse events observed. In this cohort, we observed two serious adverse events, neither of which were determined to be related to GB1211 100 mg or atezolizumab. Importantly, we did not observe any autoimmune-type skin rashes in the 100 mg cohort.

Previous wording

We will incur significant expenses relating to our development of GB3226 and GB1211. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on our advancement of these two assets, as well as partnering and/or funding additional activities in order to achieve the successful development and eventual commercialization of one or more of these product candidates. Our operations to date have been financed primarily from our initial public offering (“IPO”), the issuance of common stock through our Open Market Sale Agreement SMwith Jefferies LLC, as sales agent, to provide for the issuance and sale of up to $50.0 million of our common stock from time to time in “at-the-market” offerings under a previously effective registration statement on Form S-3 and related prospectus (the “ATM Program”), and the issuance of convertible preferred shares and convertible notes. Since inception, we have had significant operating losses. Our net loss was $3.4 million and $6.0 million for the three and six months ended June 30, 2025, respectively. Our net loss was $5.3 million and $10.8 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $283.5 million and $10.2 million in cash and cash equivalents.

Current wording

We will incur significant expenses relating to our development of GB3226 and GB1211. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on our advancement of these two assets, as well as partnering and/or funding additional activities in order to achieve the successful development and eventual commercialization of one or more of these product candidates. Our operations to date have been financed primarily from our initial public offering (“IPO”), the issuance of common stock through our Open Market Sale Agreement SMwith Jefferies LLC, as sales agent, which provided for the issuance and sale of up to $50.0 million of our common stock from time to time in “at-the-market” offerings under a previously effective registration statement on Form S-3 and related prospectus (the “ATM Program”), and the issuance of convertible preferred shares and convertible notes. Since inception, we have had significant operating losses. Our net loss was $3.1 million and $9.1 million for the three and nine months ended September 30, 2025, respectively. Our net loss was $3.9 million and $14.7 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $286.6 million and $7.6 million in cash and cash equivalents.

Previous wording

Based on current estimates of our expenses going forward, we believe that our existing cash and cash equivalents of $10.2 million as of June 30, 2025 will be sufficient to fund the preclinical development of GB3226 into 2026, including the submission of an IND to the FDA. However, we will require substantial additional capital to finance our operations, including clinical development of any of our GB3226 and GB1211 programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements. We will require substantial additional capital to finance our operations, including clinical development of any of our GB3226 and GB1211 programs. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date our financial statements are issued. We have developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or convertible debt financings and/or potential new collaborations, but there can be no assurances any such financing will be available when needed, or on acceptable terms. If we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back, or eliminate some or all of our development programs, relinquish rights to our intellectual property on less favorable terms than we would otherwise choose, or cease operations entirely. These actions could materially impact our business, results of operations and future prospects, and the value of shares of our common stock, and investors may lose all or a part of their investment. In addition, attempting to secure additional financing may divert the time and attention of management from day-to-day activities and distract from our discovery and product development efforts.

Current wording

Based on current estimates of our expenses going forward, we believe that our existing cash and cash equivalents of $7.6 million as of September 30, 2025 will be sufficient to fund the preclinical development of GB3226 into 2026, including the submission of an IND to the FDA. However, we will require substantial additional capital to finance our operations, including clinical development of any of our GB3226 and GB1211 programs. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. We have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements. We will require substantial additional capital to finance our operations, including clinical development of any of our GB3226 and GB1211 programs. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date our financial statements are issued. We have developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or convertible debt financings and/or potential new collaborations, but there can be no assurances any such financing will be available when needed, or on acceptable terms. If we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back, or eliminate some or all of our development programs, relinquish rights to our intellectual property on less favorable terms than we would otherwise choose, or cease operations entirely. These actions could materially impact our business, results of operations and future prospects, and the value of shares of our common stock, and investors may lose all or a part of their investment. In addition, attempting to secure additional financing may divert the time and attention of management from day-to-day activities and distract from our discovery and product development efforts.

Previous wording

Although, to date, our business has not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such instability could impact our business and results of operations. The extent and duration of these market disruptions, whether as a result of the military conflicts in Iran and between Russia and Ukraine and effects of the Russian sanctions, current armed conflict in Israel and the Gaza Strip, geopolitical tensions, volatile inflation rates, tariffs or otherwise, are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this report.

Current wording

Although, to date, our business has not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such instability could impact our business and results of operations. The extent and duration of these market disruptions, whether as a result of the military conflicts in Iran and between Russia and Ukraine and effects of the Russian sanctions, conflict in Israel and the Gaza Strip, geopolitical tensions, volatile inflation rates, tariffs or otherwise, are impossible to predict, but could be substantial. Any such disruptions may also magnify the impact of other risks described in this report.

Previous wording

We have historically met the requirements to receive a tax credit in Denmark of up to $0.8 million per year for losses resulting from research and development costs of up to approximately $3.6 million per year. The tax credit is reported as a reduction to research and development expense in the condensed consolidated statements of operations. We recorded a tax credit of $0.4 and $0.8 million during the six months ended June 30, 2025 and 2024, respectively. The credits are available the following year, in 2026 and 2025, respectively.

Current wording

We have historically met the requirements to receive a tax credit in Denmark of up to $0.8 million per year for losses resulting from research and development costs of up to approximately $3.6 million per year. The tax credit is reported as a reduction to research and development expense in the condensed consolidated statements of operations. We recorded a tax credit of $0.7 and $0.8 million during the nine months ended September 30, 2025 and 2024, respectively. The credits are available the following year, in 2026 and 2025, respectively.

Previous wording

We have qualified for the R&D Expenditure Credit (the “RDEC”) in United Kingdom for preclinical laboratory and in-patient clinical trials. The RDEC net tax benefit is reported as a reduction to research and development expense in the consolidated statements of operations. There was no RDEC recorded during the six months ended June 30, 2025. We recorded an overall reduction for the RDEC, net of the UK corporation tax rate of $0.07 million during the six months ended June 30, 2024.

Current wording

We have qualified for the R&D Expenditure Credit (the “RDEC”) in United Kingdom for preclinical laboratory and in-patient clinical trials. The RDEC net tax benefit is reported as a reduction to research and development expense in the consolidated statements of operations. There was no RDEC recorded during the nine months ended September 30, 2025. We recorded an overall reduction for the RDEC, net of the UK corporation tax rate of $0.1 million during the nine months ended September 30, 2024.

Previous wording

Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product candidates or programs. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of our product candidates. The duration, costs, and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:

Current wording

Because of the numerous risks and uncertainties associated with product development and the current stage of development of our product candidates and programs, we cannot reasonably estimate or know the nature, timing and estimated costs necessary to complete the remainder of the development of our product candidates or programs. We are also unable to predict if, when, or to what extent we will obtain approval and generate revenues from the commercialization and sale of our product candidates.

Previous wording

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $1.8 million for the three months ended June 30, 2024. The decrease of $0.3 million was primarily related to decreased preclinical studies and clinical trial-related expenses of $0.1 million, decreased personnel costs of $0.6 million, and decreased consulting and other research and development costs of $0.3 million, offset by increased chemistry, manufacturing, and control costs of $0.7 million.

Current wording

Research and development expenses were $1.4 million for the three months ended September 30, 2025, compared to $1.1 million for the three months ended September 30, 2024. The increase of $0.3 million was primarily related to increased chemistry, manufacturing, and control costs of $0.3 million, increased preclinical studies and clinical trial-related expenses of $0.1 million and increased consulting and other research and development costs of $0.1 million, offset by decreased personnel costs of $0.2 million.

Previous wording

General and administrative expenses were $2.0 million for the three months ended June 30, 2025, compared to $2.8 million for the three months ended June 30, 2024. The decrease of $0.8 million was primarily related to decreased personnel costs of $0.3 million, decreased legal related costs of $0.3 million, and decreased other general administrative costs of $0.2 million.

Current wording

General and administrative expenses were $1.7 million for the three months ended September 30, 2025, compared to $2.7 million for the three months ended September 30, 2024. The decrease of $1.0 million was primarily related to decreased personnel costs of $0.6 million, decreased legal related costs of $0.2 million, and decreased other general administrative costs of $0.2 million.

Previous wording

Other income (expense), net, for the three months ended June 30, 2025 was $(12,000), compared to $281,000 for the three months ended June 30, 2024. The decrease of $293,000 was primarily due to decreased interest income, net, resulting from lower investable balances and increased foreign exchange transaction loss, net.

Current wording

Other income (expense), net, for the three months ended September 30, 2025 was $23,000, compared to ($36,000) for the three months ended September 30, 2024. The increase of $59,000 was primarily due to decreased interest income, net, resulting from lower investable balances and decreased foreign exchange transaction loss, net.

Previous wording

The following sets forth our results of operations for the six months ended June 30, 2025 and 2024:

Current wording

The following sets forth our results of operations for the nine months ended September 30, 2025 and 2024:

Previous wording

Research and development expenses were $2.1 million for the six months ended June 30, 2025, compared to $4.3 million for the six months ended June 30, 2024. The decrease of $2.2 million was primarily related to decreased personnel costs of $1.8 million, decreased preclinical studies and clinical trial-related expenses of $0.4 million, and decreased consulting and other research and development costs of $0.6 million, offset by increased chemistry, manufacturing, and control costs of $0.7 million.

Current wording

Research and development expenses were $3.6 million for the nine months ended September 30, 2025, compared to $5.4 million for the nine months ended September 30, 2024. The decrease of $1.8 million was primarily related to decreased personnel costs of $2.0 million, decreased preclinical studies and clinical trial-related expenses of $0.3 million, and decreased consulting and other research and development costs of $0.5 million, offset by increased chemistry, manufacturing, and control costs of $1.0 million.

Previous wording

General and administrative expenses were $3.9 million for the six months ended June 30, 2025, compared to $6.1 million for the six months ended June 30, 2024. The decrease of $2.2 million was primarily related to decreased personnel costs of $0.9 million, decreased legal related costs of $0.8 million, and decreased other general administrative costs of $0.5 million.

Current wording

General and administrative expenses were $5.6 million for the nine months ended September 30, 2025, compared to $8.8 million for the nine months ended September 30, 2024. The decrease of $3.2 million was primarily related to decreased personnel costs of $1.5 million, decreased legal related costs of $1.0 million, and decreased other general administrative costs of $0.7 million.

Previous wording

There were no restructuring costs for the three months ended June 30, 2025. Restructuring costs were $1.0 million for the three months ended June 30, 2024, primarily related to employee severance and notice period payments, benefits and related costs.

Current wording

There were no restructuring costs for the nine months ended September 30, 2025. Restructuring costs were $1.0 million for the nine months ended September 30, 2024, primarily related to employee severance and notice period payments, benefits and related costs.

Previous wording

Other income, net, for the six months ended June 30, 2025 was $56,000, compared to $545,000 for the six months ended June 30, 2024. The decrease of $489,000 was primarily due to decreased interest income, net, resulting from lower investable balances and increased foreign exchange transaction loss, net.

Current wording

Other income, net, for the nine months ended September 30, 2025 was $79,000, compared to $509,000 for the nine months ended September 30, 2024. The decrease of $430,000 was primarily due to decreased interest income, net, resulting from lower investable balances.

Previous wording

Our operations to date have been financed primarily through our IPO, the issuance of common stock through our ATM Program, the issuance of convertible preferred shares and convertible notes. Since inception, we have had significant operating losses. On November 2, 2020, we completed our IPO in which we raised $86.3 million in net proceeds. During each of the three and six months ended June 30, 2025 and 2024, we had no sales under the ATM Program.

Current wording

Our operations to date have been financed primarily through our IPO, the issuance of common stock through our ATM Program, the issuance of convertible preferred shares and convertible notes. Since inception, we have had significant operating losses. On November 2, 2020, we completed our IPO in which we raised $86.3 million in net proceeds. During each of the three and nine months ended September 30, 2025 and 2024, we had no sales under the ATM Program.

Previous wording

Our net losses were $3.4 million and $6.0 million for the three and six months ended June 30, 2025, respectively. Our net losses were $5.3 million and $10.8 million for the six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $283.5 million and $10.2 million in cash and cash equivalents. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

Our net losses were $3.1 million and $9.1 million for the three and nine months ended September 30, 2025, respectively. Our net losses were $3.9 million and $14.7 million for the nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $286.6 million and $7.6 million in cash and cash equivalents. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

Cash used in operating activities of $4.7 million during the six months ended June 30, 2025 was primarily attributable to our net loss of $6.0 million together with non-cash items of $0.4 million principally with respect to stock-based compensation and a net increase of $0.9 million in components of our working capital.

Current wording

Cash used in operating activities of $7.3 million during the nine months ended September 30, 2025 was primarily attributable to our net loss of $9.1 million together with non-cash items of $0.6 million principally with respect to stock-based compensation and a net increase of $1.2 million in components of our working capital.

Previous wording

Cash used in operating activities of $10.0 million during the six months ended June 30, 2024 was primarily attributable to our net loss of $10.8 million together with non-cash items of $2.5 million principally with respect to stock-based compensation and a net decrease of $1.7 million in components of our working capital.

Current wording

Cash used in operating activities of $13.7 million during the nine months ended September 30, 2024 was primarily attributable to our net loss of $14.7 million together with non-cash items of $3.3 million principally with respect to stock-based compensation and a net decrease of $2.3 million in components of our working capital.

Previous wording

We had no investing activities during the six months ended June 30, 2025.

Current wording

We had no investing activities during the nine months ended September 30, 2025.

Previous wording

Cash provided by investing activities of $11.7 million during the six months ended June 30, 2024 was the result of proceeds from the sale of marketable securities.

Current wording

Cash provided by investing activities of $11.7 million during the nine months ended September 30, 2024 was the result of proceeds from the sale of marketable securities.

Previous wording

We had no financing activities during the six months ended June 30, 2025 and 2024.

Current wording

We had no financing activities during the nine months ended September 30, 2025 and 2024.

Previous wording

Based on current estimates of our expenses going forward, we believe that our existing cash and cash equivalents of $10.2 million as of June 30, 2025 will be sufficient to fund the preclinical development of GB3226 into 2026, including the submission of an IND to the FDA. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date our financial statements are issued. We have developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or convertible debt financings and/or potential new collaborations, but there can be no assurances any such financing will be available when needed, or on acceptable terms. If we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, relinquish rights to our intellectual property on less favorable terms than we would otherwise choose, or cease operations entirely. These actions could materially impact our business, results of operations and future prospects and the value of shares of our common stock, and investors may lose all or a part of their investment. In addition, attempting to secure additional financing may divert the time and attention of management from day-to-day activities and distract from our discovery and product development efforts. If our available cash resources are insufficient to fund our expenses and the development of our product candidates and/or completion of a transaction identified above, we may implement further cost reduction and other cash-focused measures to manage liquidity, and we may pursue a plan of liquidation or dissolution or seek bankruptcy protection. If we decide to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of our current liquidity position, it is unlikely that cash would be available for distribution to stockholders.

Current wording

Based on current estimates of our expenses going forward, we believe that our existing cash and cash equivalents of $7.6 million as of September 30, 2025 will be sufficient to fund the preclinical development of GB3226 into 2026, including the submission of an IND to the FDA. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect. These conditions raise substantial doubt about our ability to continue as a going concern for a period of at least one year from the date our financial statements are issued. We have developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or convertible debt financings and/or potential new collaborations, but there can be no assurances any such financing will be available when needed, or on acceptable terms. If we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, relinquish rights to our intellectual property on less favorable terms than we would otherwise choose, or cease operations entirely. These actions could materially impact our business, results of operations and future prospects and the value of shares of our common stock, and investors may lose all or a part of their investment. In addition, attempting to secure additional financing may divert the time and attention of management from day-to-day activities and distract from our discovery and product development efforts. If our available cash resources are insufficient to fund our expenses and the development of our product candidates and/or completion of a transaction identified above, we may implement further cost reduction and other cash-focused measures to manage liquidity, and we may pursue a plan of liquidation or dissolution or seek bankruptcy protection. If we decide to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of our current liquidity position, it is unlikely that cash would be available for distribution to stockholders.

Previous wording

The fair value of our awards in the six months ended June 30, 2025 has been estimated using Black-Scholes based on the following assumptions: expected term of 5.9 years; expected volatility of 95.9%; risk-free interest rate of 4.4%; and no expectation of dividends. The fair value of our awards in the six months ended June 30, 2024 has been estimated using Black-Scholes based on the following assumptions: expected term of 5.3 years; expected volatility of 99.3%; risk-free interest rate of 4.2%; and no expectation of dividends.

Current wording

The fair value of our awards in the nine months ended September 30, 2025 has been estimated using Black-Scholes based on the following assumptions: expected term of 5.9 years; expected volatility of 95.9%; risk-free interest rate of 4.4%; and no expectation of dividends. The fair value of our awards in the nine months ended September 30, 2024 has been estimated using Black-Scholes based on the following assumptions: expected term of 5.3 years; expected volatility of 99.3%; risk-free interest rate of 4.2%; and no expectation of dividends.

Previous wording

Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our consolidated financial statements for the six months ended June 30, 2025 and 2024 appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.

Current wording

Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our consolidated financial statements for the nine months ended September 30, 2025 and 2024 appearing elsewhere in this Quarterly Report on Form 10-Q for a discussion of recent accounting pronouncements.