GALT

Our accumulated deficit as of December 31, 2025 was $431 million.
We had $17.7 million of unrestricted cash as of December 31, 2025 and $10 million of available borrowings under a line of credit provided by our chairman.
The Company believes there is sufficient cash, including the $10 million under the line of credit, to fund currently planned operations through April 2027.
We will require more cash to fund our operations after April 2027.
Through his investments in the Company, Mr.
Uihlein for financing, and there is no assurance that he will continue to provide funding.
Uihlein, the chairman of our board of directors, has been instrumental in providing the Company with debt and equity financing since 2012.
Uihlein has provided us with a line of credit and has made significant equity investments in the Company.
Uihlein's financial support to fund our operations, including our NAVIGATE clinical trial and ongoing operating expenses.
Uihlein is under no contractual obligation to provide additional financing to the Company beyond his existing commitments, and there can be no assurance that he will continue to provide funding in the future.
Uihlein is unable or unwilling to provide additional financing when needed, we may be unable to secure alternative financing on acceptable terms, or at all, which could require us to significantly curtail or cease our operations.
Our dependence on a single individual for a substantial portion of our financing represents a significant risk to our business and financial condition.
Index Our NAVIGATE trial was our only active clinical trial.
Because the data from the NAVIGATE clinical trial did not reach statistical significance, we may determine not to conduct an additional clinical trial to test the efficacy of our drug candidate, belapectin.
In December 2025, we announced that we will pursue a follow-up Type C meeting with the FDA to finalize remaining components of the next clinical trial design.
However, we are only in the preliminary process of advancing belapectin towards clinical development in a pivotal Phase 3 clinical trial, and we cannot provide any certainty that a Phase 3 clinical trial will be attempted or completed.
A Phase 3 clinical trial would require substantial additional funding, regulatory alignment with the FDA, successful resolution of trial design issues, and other factors that are uncertain at this time.
There can be no assurance that we will be able to secure the necessary financing, reach agreement with the FDA on trial design, or successfully execute a Phase 3 clinical trial even if we determine to pursue one.
We have from time to time faced substantial doubt about our ability to continue as a going concern.
In 2025, we experienced net losses of $29.7 million, had no revenue from operations, and used $23.9 million in cash to fund our operations.
Although management believes that we have sufficient cash to cover operating expenses requiring cash for a period of 12 months from the date of this annual report on Form 10-K, we have from time to time faced periods where there was substantial doubt as to our ability to continue as a going concern.
Based on current projections, we anticipate that our existing cash resources will be sufficient to fund operations through April 2027.
However, we may face liquidity challenges thereafter if we are unable to raise additional capital or generate sufficient revenue from operations.
Top-line results from the NAVIGATE trial were presented in December 2024.
Index We are dependent on third parties for clinical trial design, execution, and manufacturing, and their failure to perform could adversely affect our business.
We contract with independent parties to assist us in the design of trial protocols, arrange for and monitor clinical trials, provide lab kits, collect and analyze data and samples.
We have contracted with Covance (now known as Fortrea) for assistance with the design and conduct of our NAVIGATE trial.
In addition, we do not have, and do not intend to develop, facilities for the manufacture of any of our products, including belapectin, for clinical or commercial production.
We are not a party to any long-term agreement with any of our suppliers, and we have our products manufactured on a purchase-order basis from one of two primary suppliers.
We expect to depend on contract manufacturers to supply us with products manufactured in compliance with standards imposed by the FDA and foreign regulators.
If any of these third parties fail to perform their obligations, experience delays, or fail to meet regulatory requirements, our clinical trials and business could be materially adversely affected.
At this time, we are not a party to any long-term agreement with any of our suppliers, and accordingly, we have our products manufactured on a purchase-order basis.
We will require additional third-party manufacturing suppliers for belapectin.
Index The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized.
We have identified a material weakness in our internal control over financial reporting, which, if not remediated, could result in material misstatements in our financial statements.
As described in Item 9A of this Annual Report, our management identified a material weakness in our internal control over financial reporting related to the valuation of derivative liabilities associated with contingent interest on convertible notes payable.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
While the material weakness did not result in any misstatement in our consolidated financial statements, we cannot assure you that additional material weaknesses will not arise in the future or that we will be able to remediate the identified material weakness in a timely manner.
If we are unable to remediate this material weakness, or if we identify additional material weaknesses in our internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which could cause investors to lose confidence in our financial reporting, negatively affect the trading price of our common stock, and adversely impact our ability to access capital markets.
Additionally, ineffective internal control over financial reporting could expose us to an increased risk of fraud or misuse of corporate assets, subject us to regulatory investigations and civil or criminal sanctions and cause us to incur substantial costs in complying with legal and regulatory requirements.

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Gone since FY2024

Our accumulated deficit as of December 31, 2023 was $354 million.
We had $15.1 million of unrestricted cash as of December 31, 2024 and $6 million of available borrowings under a line of credit provided by our chairman.
Additionally, in March 2025, we signed a new supplemental line of credit agreement with our chairman for an additional $5 million of available borrowings.
The Company believes there is sufficient cash, including the $11 million under the two lines of credit, to fund currently planned operations through August 2025.
We will require more cash to fund our operations after August 2025.
Though his investments in the Company, Mr.
Our NAVIGATE trial was our only active clinical trial, and we currently do not have plans or funding to undertake another clinical trial.
Because the data from NAVIGATE clinical trial did not reach statistical significance, we may determine not to conduct an additional clinical trial to test the efficacy of our drug candidate, belapectin.
Furthermore, it will be difficult for us to raise the capital necessary for another clinical trial.
The Company continues to analyze data from the 57 patients that completed 36 months of treatment prior to the ending of the trial in February 2025.
While data from this group patient would not change the results of results of the NAVIGATE clinical trial, the Company believes that encouraging results from this group of patients may draw interest from potential strategic partners.
There is substantial doubt about our ability to continue as a going concern.
In 2024, we experienced net losses of $47.2 million, had no revenue from operations, and used $41.8 million in cash to fund our operations.
Due to the current level of liquidity at December 31, 2024 and the projected shortfall to cover operating expenses requiring cash for a period of 12 months from the report date of the annual report, management has expressed substantial doubt as to our ability to continue as a going concern.
Top-line results from the NAVIGATE trial were presented in the December 2024.
There are risks associated with our reliance on third parties to design trial protocols, arrange for and monitor the clinical trials, and collect and analyze data.
As we develop products eligible for clinical trials, we will contract with independent parties to assist us in the design of the trial protocols, arrange for and monitor the clinical trials, provide lab kits, collect data and analyze data and samples.
In addition, certain clinical trials for our products may be conducted by government-sponsored agencies and will be dependent on governmental participation and funding.
We have contracted with a third party, Covance (now known as Fortrea), for assistance with the design and conduct of our NAVIGATE trial.
At this time, we are not a party to any long-term agreement with any of our suppliers, and accordingly, we have our products manufactured on a purchase-order basis from one of two primary suppliers.
The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our proposed products, even if commercialized.
Even if we obtain regulatory approvals, our marketed drugs will be subject to ongoing regulatory review.
Data obtained from clinical trials are not necessarily predictive of future results, may be negative or inconclusive, and are susceptible to varying interpretations, which could delay, limit or prevent regulatory clearances.
Data already obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily predict the results that will be obtained from later pre-clinical studies and clinical trials.
Moreover, pre-clinical and clinical data may be negative or inconclusive.
In addition, data is susceptible to varying interpretations.
Negative or inconclusive data, or data interpreted in various ways, could delay, limit or prevent regulatory approval.
A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after they obtained promising results in earlier trials.
Despite the results reported in some of our earlier clinical trials for belapectin, our clinical trials may not demonstrate sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approvals for our drugs, and thus, our proposed drugs may not be approved for marketing.
If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted.
The failure to adequately demonstrate the safety and effectiveness of a proposed formulation or product under development could delay or prevent regulatory clearance of the potential drug.
The resulting delays in commercialization could materially harm our business.
Index Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority.
As a result of undesirable side effects or safety or toxicity issues that we may experience in our clinical trials, we may not receive approval to market any product candidates, which could prevent us from ever generating revenues or achieving profitability.
Results of our trials could reveal an unacceptably high severity and prevalence of side effects.
In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development or deny approval of our product candidates for any or all targeted indications.
These side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims.
Additionally, if any of our product candidates receives marketing approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result, including: • we may be forced to suspend marketing of such product; • regulatory authorities may withdraw their approvals of such product; • regulatory authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success of such products; • we may be required to conduct post-market studies; • we could be sued and held liable for harm caused to subjects or patients; and • our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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