GALT 10-K & 10-Q changes, risk factors and insider trading
Galectin Therapeutics Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1133416 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We are significantly dependent on Mr. Uihlein for financing, and there is no assurance that he will continue to provide funding.”
New heading “We are dependent on third parties for clinical trial design, execution, and manufacturing, and their failure to perform could adversely affect our business.”
New heading “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.”
Removed heading “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.”
Removed heading “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.”
Removed heading “Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.”
Removed heading “Our failure to secure trademark registration could adversely affect our ability to market our product candidates and our business.”
Removed heading “We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.”
Largest changes
“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. …”see in full comparison
“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.”see in full comparison
“Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection. Patents issued to us may be challenged and subsequently narrowed, invalidated, or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. If we choose to enforce our patents, that individual or company would have the right to ask the court to rule that such patents are invalid or should not be enforced. These lawsuits are expensive, and we may not have the resources to pursue such litigation. …”see in full comparison
“If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive, and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court will decide that these patents are not valid and that we do not have the right to stop the other party from using the inventions. …”see in full comparison
“Obtaining and maintaining our patent protection depends upon compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.”see in full comparison
“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.”see in full comparison
Full comparison: every changed paragraph (108)
We have incurred net losses in each year of operation since our inception in July 2000 and have no revenues. Our accumulated deficit as of December 31,
2023 2025 was $354$431 million. We had $15.1$17.7 million of unrestricted cash as of December 31, 20242025 and $6$10 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$10 million under the two linesline of credit, to fund currently planned operations through August
2025.April 2027. We will require more cash to fund our operations after AugustApril 2025.2027. There can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.
We may raise capital through public or private equity financings, partnerships, debt financings, bank borrowings, or other sources. Additional funding may not be available on favorable terms or at all. ThoughThrough his
investments in the Company, Mr. Uihlein has been a critical source of funding via equity and debt financings. There is no assurance as to the level of future investments to be made in the Company by Mr. Uihlein. If adequate funds are not otherwise
available, we may need to significantly curtail operations. To obtain additional funding, we may need to enter into arrangements that require us to relinquish rights to certain technologies, products and/or potential markets. To the extent that
additional capital is raised through the sale of equity, or securities convertible into equity, our equity holders may experience dilution of their proportionate ownership of the Company.
We are significantly dependent on Mr. Uihlein for financing, and there is no assurance that he will continue to provide funding.
Mr. Uihlein, the chairman of our board of directors, has been instrumental in providing the Company with debt and equity financing since 2012. As of December 31, 2025, Mr. Uihlein has provided us with a line of credit and has made significant equity investments in the Company. We have relied heavily on Mr. Uihlein's financial support to fund our operations, including our NAVIGATE clinical trial and ongoing operating expenses. Mr. 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. If Mr. 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.
Our NAVIGATE trial was our only active clinical trial, and we currently do not have plans or funding to undertake another clinical trial.
In December 2024, we presented top-line results of the NAVIGATE clinical trial. The composite endpoint did not reach statistical significance. 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. Furthermore,In itDecember 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 difficultattempted foror uscompleted. 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 raise
secure the capital necessary forfinancing, anotherreach agreement with the FDA on trial design, or successfully execute a Phase 3 clinical trial.trial Theeven Companyif continueswe determine to analyzepursue 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.one.
ThereWe ishave from time to time faced substantial doubt about our ability to continue as a going concern.
In 2024,2025, we experienced net losses of $47.2$29.7 million, had no revenue from operations, and used $41.8$23.9 million in cash to fund our operations. DueAlthough tomanagement thebelieves currentthat levelwe ofhave liquiditysufficient at December 31, 2024 and the projected
shortfallcash to cover operating expenses requiring cash for a period of 12 months from the report date of thethis annual report,report managementon hasForm expressed10-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.
successfully complete development activities, including the necessary clinical trials;
complete and submit new drug applications, or NDAs, to the U.S. Food and Drug Administration, or FDA, and obtain regulatory approval for indications for which there is a commercial market;
complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities;
successfully complete all required regulatory agency inspections;
set a commercially viable price for our products;
obtain commercial quantities of our products at acceptable cost levels;
find suitable distribution partners to help us market, sell and distribute our approved products in other markets; and obtain coverage and adequate reimbursement from third parties, including government and private payers.
Pre-clinical studies and clinical trials are expensive, time-consuming and ultimately may not be successful. The results of pre-clinical and initial clinical testing of these products may not necessarily indicate the
results that will be obtained from later or more extensive testing. Also, it is possible to suffer significant setbacks in advanced clinical trials, even after obtaining promising results in earlier trials. For example, although there was positive
data from our NASH-CX Phase 2 trial for belapectin, it did not meet its primary endpoint. Similarly, our Phase 2a pilot trial NASH-FX for patients with advanced fibrosis, which explored three non-invasive imaging technologies, did not meet its
primary endpoint. Top-line results from the NAVIGATE trial were presented in the December 2024. Again, while there was positive data, especially in the 2 mg cohort, the composite endpoint did not reach statistical significance. We may engage
others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies. Additional clinical trials may not start or be completed as we forecast and may not achieve the desired results. The time
required to obtain FDA and other approvals is unpredictable but often can take years following the commencement of clinical trials, depending upon the complexity of the drug candidate.
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. Our dependence on independent parties and clinical sites involves risks including reduced control over the timing and other aspects of our clinical trials. 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.
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.
Our dependence on independent parties and clinical sites involves risks including reduced control over the timing and other aspects of our clinical trials.
We do not have,
and do not now intend to develop, facilities for the manufacture of any of our
products, including belapectin, for clinical or commercial production. 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.basis. We will require additional third-party
manufacturing suppliers for belapectin. We
are developing relationships with manufacturers and will enter into
collaborative arrangements
with licensees or have others manufacture our
products on a contract basis. We expect to depend on such collaborators to
supply us with products manufactured in compliance with standards imposed by
the FDA and foreign regulators.
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.
the duration of the clinical trials;
the number of sites included in the trials;
the countries in which the trial is conducted;
the length of time required and ability to enroll eligible patients;
the number of patients that participate in the trials;
the number of doses that patients receive;
the drop-out or discontinuation rates of patients;
per patient trial costs;
third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
our drug product candidates having different chemical and pharmacological properties in humans than in lab testing;
the need to suspend or terminate our clinical trials;
insufficient or inadequate supply or quality of drug product candidates or other necessary materials to conduct our trials;
potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;
problems engaging IRBs to oversee trials or in obtaining and maintaining IRB approval of studies;
the duration of patient follow-up;
the efficacy and safety profile of the product candidate;
the costs and timing of obtaining regulatory approvals; and the costs involved in enforcing or defending patent claims or other intellectual property rights.
DataClinical obtainedtrial from clinical trials are not necessarily predictive of future results,data may be negativenegative, inconclusive, or inconclusive, and are susceptiblesubject to varying interpretations, and our product candidates may cause undesirable side effects, any of which could
delay, limitlimit, or prevent regulatory clearances.approval.
Data already obtained, or in the future obtained,obtained from pre-clinical studies and clinical trials do not necessarily predict the results that will be obtained from later pre-clinical studies andor clinical trials. Moreover,
pre-clinicaltrials, and clinical data may be negative or inconclusive. InA 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 obtainedobtaining 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,drugs. In addition, undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay, or halt clinical trials and thus,could result in a more restrictive label or the delay or denial of regulatory approval. Although we are not currently aware of any undesirable side effects caused by our proposedproduct drugscandidates, it is possible that they may not be approvedidentified forin marketing.the clinical trial process. If later-stage
our clinical trials do not produce favorable results, ouror abilityif safety or toxicity issues arise, we may not receive approval to achieve regulatory approval formarket any of our product candidatescandidates, which could prevent us from ever generating revenues or achieving profitability. Even after approval, if undesirable side effects are later identified, we may be adverselyforced impacted.to suspend marketing, regulatory authorities may withdraw approvals or require additional warnings, we may be required to conduct post-market studies, we could be sued for harm caused to patients, and our reputation may suffer. The failure to adequately demonstrate the safety and effectiveness of a proposed formulation
orour product under developmentcandidates could delay or prevent regulatory clearance of the potential drug. The resulting delays in commercialization couldand materially harm our business.
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. Although we are not currently aware of any undesirable side effects caused by our product candidates, it is possible that they may be identified in the clinical trial
process.
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:
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved.
Our competitive position is contingentdepends upon the protection of our intellectual property.property, and we may be unable to adequately protect our proprietary rights.
Development and protection of our intellectual property are critical to our business. Our success depends on our ability to obtain patent protection for our products or processes in the U.S. and other countries, protect trade secrets, and prevent others from infringing on our proprietary rights. If we do not adequately protect our intellectual property, competitors may be able to practice our technologies. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged in the United States, and the situation outside the United States is even more uncertain. Changes in patent laws or their interpretation may diminish the value of our intellectual property. The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection. For example, others may be able to make competitive compounds not covered by our patents; we might not have been the first to make or file for the inventions in our pending applications; our pending applications may not result in issued patents; and the patents of others may adversely affect our business. We also rely on trade secrets to protect our technology where patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect, and our competitors may independently develop equivalent knowledge or know-how.
Development and protection of our intellectual property are critical to our business. All of our intellectual property, patented or otherwise, has been invented and/or developed by employees or former employees of the
Company. Our success depends, in part, on our ability to obtain patent protection for our products or processes in the U.S. and other countries, protect trade secrets and prevent others from infringing on our proprietary rights. We will only be
able to protect our product candidates from unauthorized making, using, selling, offering to sell or importation by third parties to the extent that we have rights under valid and enforceable patents or trade secrets that cover these activities. If
we do not adequately protect our intellectual property, competitors may be able to practice our technologies.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy
regarding the breadth of claims allowed in biotechnology patents has emerged to date in the United States. The biotechnology patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations
of patent laws in the United States and other countries may diminish the value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may be allowed in our pending patent applications or enforced in our issued
patents or in third-party patents.
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
For example:
We also may rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. Although we require our
scientific and technical employees and consultants to enter into broad assignment of inventions agreements, and all of our employees, consultants and corporate partners with access to proprietary information to enter into confidentiality
agreements, these agreements may not be honored. Enforcing a claim that a third party illegally obtained, and is using, our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United
States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and otherfrom intellectual property rights,litigation, and we may be unable to protect our rights
to, or use of, our technology.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection. Patents issued to us may be challenged and subsequently narrowed, invalidated, or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. If we choose to enforce our patents, that individual or company would have the right to ask the court to rule that such patents are invalid or should not be enforced. These lawsuits are expensive, and we may not have the resources to pursue such litigation. In addition, third parties may claim that we are infringing their patents and may go to court to stop us from making or selling our product candidates. The biotechnology industry has produced a proliferation of patents, and it is not always clear which patents cover various types of products or methods of use. If we are sued for patent infringement, we would need to demonstrate that our products do not infringe or that the patent claims are invalid, which is difficult and expensive. Our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Any litigation could have a material adverse effect on our ability to raise funds necessary to continue operations. We must also comply with various procedural, documentary, and fee payment requirements imposed by patent agencies, and noncompliance can result in abandonment or lapse of patent rights.
Some or all of our patent applications may not issue as patents, or the claims of any issued patents may not afford meaningful protection for our technologies or products. In addition, patents issued to us or our
licensors, if any, may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or
to determine the scope and validity of third-party proprietary rights.
If we choose to go to court to stop someone else from using the inventions claimed in our patents, that individual or company would have the right to ask the court to rule that such patents are invalid and/or should not
be enforced against that third party. These lawsuits are expensive, and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the court will decide that these patents are
not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of these patents is upheld, the court will refuse to stop the other party on the ground that such other
party’s activities do not infringe our rights in these patents.
Furthermore, a third party may claim that we are using inventions covered by the third party’s patent rights and may go to court to stop us from engaging in our normal operations and activities, including making or
selling our product candidates. These lawsuits are costly and could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would decide that we are infringing the third party’s
patents and would order us to stop the activities covered by the patents. In addition, there is a risk that a court will order us to pay the other party treble damages for having violated the other party’s patents. The biotechnology industry has
produced a proliferation of patents, and it is not always clear to industry participants, including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the
interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our products or methods of use either do not infringe the claims of the relevant patent and/or that the patent claims are invalid, and
we may not be able to do this. Proving invalidity in the U.S., in particular, is difficult since it requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
Management's Discussion & Analysis (MD&A)
New heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
New heading “Results of Operations from the Years Ended December 31, 2025 and 2024”
New heading “2025 compared to 2024”
Removed heading “Results of Operations from the Years Ended December 31, 2023 and 2022”
Removed heading “2023 compared to 2022”
Largest changes
“Management’s Discussion and Analysis of Financial Condition and Results of Operations”see in full comparison
“Results of Operations from the Years Ended December 31, 2025 and 2024”see in full comparison
“Results of Operations from the Years Ended December 31, 2023 and 2022”see in full comparison
“we have from time to time faced substantial doubt about our ability to continue as a going concern;”see in full comparison
Full comparison: every changed paragraph (42)
Management’s Discussion and Analysis of Financial Condition and Results of Operations
In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements as defined under Section
21E of the Securities Exchange Act of 1934, as amended, and is subject to the safe harbor created therein for forward-looking statements. Such statements include, but are not limited to, statements concerning our anticipated operating results,
research and development, clinical trials, regulatory proceedings, and financial resources, and can be identified by use of words such as, for example, “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” and “would,” “should,”
“could” or “may.” All statements, other than statements of historical facts, included herein that address activities, events, or developments that the Company expects or anticipates will or may occur in the future, are forward-looking statements,
including statements regarding: plans and expectations regarding clinical trials; plans and expectations regarding regulatory approvals; our strategy and expectations for clinical development and commercialization of our products; potential strategic
partnerships; expectations regarding the effectiveness of our products; plans for research and development and related costs; statements about accounting assumptions and estimates; expectations regarding liquidity and the sufficiency of cash to fund
currently planned operations through at least DecemberMarch 31, 20242027; our commitments and contingencies; and our market risk exposure. Forward-looking statements are based on current expectations, estimates and projections about the industry and markets
in which Galectin Therapeutics operates, and management’s beliefs and assumptions. These statements are not guarantees of future performance and involve certain known and unknown risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. Such risks and uncertainties are related to and include, without limitation, our early stage of development;
our dependence on Mr. Uihlein for financing;
our NAVIGATE trial was our only active clinical trial, and we currently do not have plans or funding to undertake another clinical trial;
we have from time to time faced substantial doubt about our ability to continue as a going concern;
we have incurred significant operating losses since our inception and cannot assure you that we will generate revenue or profit;
our dependence on additional outside capital;
we may be unable to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates;
uncertainties related to any litigation;
uncertainties related to our technology and clinical trials, including expected dates of availability of clinical data;
we may be unable to demonstrate the efficacy and safety of our developmental product candidates in human trials;
we may be unable to improve upon, protect and/or enforce our intellectual property;
we are subject to extensive and costly regulation by the U.S. Food and Drug Administration (FDA) and by foreign regulatory authorities, which must approve our product candidates in development and could restrict the sales and marketing and pricing of such products;
competition and stock price volatility in the biotechnology industry;
limited trading volume for our stock, concentration of ownership of our stock, and other risks detailed herein and from time to time in our SEC reports; and the occurrence of a widespread pandemic and its potential impact, which could delay clinical trial and development efforts, as well as the impact that such a pandemic has on the volatility of the capital market and our ability to access the capital market.
We
are a clinical stage biopharmaceutical company engaged in drug research and
development to create new therapies for fibrotic disease, cancer and selected
other diseases. Our drug candidates are based
on our method of targeting
galectin proteins, which are key mediators of biologic and pathologic
functions. We use naturally occurring, readily-available plant products as
starting material in manufacturing processes to create proprietary, patented
complex carbohydrates with specific molecular weights and other pharmaceutical
properties. These complex carbohydrate molecules are appropriately formulated
into acceptable pharmaceutical formulations. Using these unique
carbohydrate-based candidate
compounds that largely bind and inhibit galectin
proteins, particularly galectin-3, we are undertaking the focused pursuit of
therapies for indications where galectin proteins have a demonstrated role in
the pathogenesis of a given disease. We focus
on diseases with serious,
life-threatening consequences and those where current treatment options are
limited specifically in NASHmetabolic dysfunction-associated steatohepatitis (non-alcoholicMASH,
formerly steatohepatitisknown as nonalcoholic steatohepatitis, or NASH) with cirrhosis and
certain cancer indications. Our strategy is to establish and
implement clinical
development programs that add value to our business in the shortest period of
time possible and to seek strategic partners when one of our programs becomes
advanced and requires significant additional resources.
Our lead galectin-3 inhibitor is belapectin (GR-MD-02), which has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension
and prevent its complication: the development of esophageal varices. Belapectin has the potential to treat many diseases due to galectin-3’s involvement in multiple key biological pathways such as fibrosis, immune cell function and immunity, cell
differentiation, cell growth, and apoptosis (cell death). The importance of galectin-3 in the fibrotic process is supported by experimental evidence. Animals with the galectin-3 gene “knocked-out” can no longer develop fibrosis in response to
experimental stimuli compared to animals with an intact galectin-3 gene. We are using our galectin-3 inhibitor to treat advanced liver fibrosis and liver cirrhosis in NASHMASH patients. We have completed two Phase 1 clinical studies, a Phase 2 clinical
study in NASHMASH patients with advanced fibrosis (NASH-FX) and a second Phase 2b clinical trial in NASHMASH patients with compensated cirrhosis and portal hypertension (NASH-CX).
Results of Operations from the Years Ended December 31, 2025 and 2024
Clinical programs expenses decreased in the year ended December 31, 2025 over the year ended December 31, 2024 primarily due to costs winding down related to our NAVIGATE clinical trial activities and a decrease in costs related to contract manufacturing of belapectin. Pre-clinical activities decreased due to activities incurred in support of the clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive activities. Payroll and other costs decreased primarily due to fewer employees in research and development.
General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The primary reasons for the decrease for the year ended December 31, 2025, as compared to the same period for 2024 are due to a decrease in non-cash stock-based compensation of $301,000 offset by increases other administrative costs.
During the year ended December 31, 2025, other income and expense consisted of $126,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $7,329,000 and change in fair value of derivatives of $2,378,000.
During the year ended December 31, 2024, other income and expense consisted of $338,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $5,540,000 and change in fair value of derivatives of $(588,000).
Clinical programs expenses increased in the year ended December 31, 2024 over the year ended December 31, 2023 primarily due to costs related to our the NAVIGATE clinical trial activities and an increase
in costs related to contract manufacturing of belapectin. Pre-clinical activities decreased due to activities incurred in support of the clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive
activities. Payroll and other costs increased primarily due to additional employees being hired in research and development.
Results of Operations from the Years Ended December 31, 2023 and 2022
Clinical programs expenses decreased in the year ended December 31, 2023 over the year ended December 31, 2022 primarily due to costs related to our the NAVIGATE clinical trial activities and a decrease
in costs related to contract manufacturing of belapectin. Pre-clinical activities increased due to activities incurred in support of the clinical program such as development and reproductive toxicity studies, clinical supplies and other supportive
activities. Payroll and other costs increased primarily due to additional employees being hired in research and development.
General and administrative expenses consist primarily of salaries including stock-based compensation, legal and accounting fees, insurance, investor relations, business development and other office
related expenses. The primary reasons for the decrease for the year ended December 31, 2023, as compared to the same period for 2022 are due to a decrease in non-cash stock-based compensation of $624,000.
During the year ended December 31, 2023, other income and expense consisted of $230,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and
convertible line of credit of $2,792,000 and change in fair value of derivatives of $432,000.
During the year ended December 31, 2022, other income and expense consisted of $52,000 of interest income and change in fair value of derivatives of $557,000 offset by interest expense and amortization of
debt discounts on convertible notes payable and convertible line of credit of $1,033,000.
As described above in the Overview and elsewhere in this Annual Report on Form 10-K, we are in the development stage and have not
generated any revenues to date. Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As of December 31, 2024,2025, we raised a net total of $314.5$341 million from these
offerings. At December 31, 2024,2025, the Company had $15.1$17.7 million of unrestricted cash and cash equivalents in addition to $6$10 million available under a line of credit provided by our chairman available to fund future operations. 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 $11$10 million under the two linesline of credit, to fund
currently planned operations through AugustApril 2025.2027. We will require more cash to fund our operations after AugustApril 2025.2027. There can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will
be on terms favorable to us.
2025 compared to 2024
Net cash used in operations decreased by $17,892,000 to $23,875,000 for 2025, as compared to $41,767,000 for 2024. Cash operating expenses decreased principally due to decreased research and development activities primarily related to our NAVIGATE clinical trial and associated activities.
There were no equipment purchases or other investing activities in 2025 or 2024.
Net cash provided by financing activities was $26,475,000 during 2025 as compared to $31,227,000 during 2024, due primarily to the transactions described below.
In 2025, we received $21,000,000 in proceeds under a convertible line of credit provided by our chairman in addition to $2.3 million in proceeds from exercises of stock options and purchase warrants, and $3.2 million in net proceeds from issuance of shares under our At the Market sales program. In 2024, we received $30,000,000 in proceeds under a convertible line of credit provided by our chairman in addition to $1.2 million in proceeds from exercises of stock options and purchase warrants.
2023 compared to 2022
Net cash used in operations increased by $1,909,000 to $32,965,000 for 2023, as compared to $31,056,000 for 2022. Cash operating expenses increased principally due to increased research and development
activities primarily related to our NAVIGATE clinical trial and associated activities.
There were no equipment purchases or other investing activities in 2023 or 2022.
Net cash provided by financing activities was $40,033,000 during 2023 as compared to $10,000,000 during 2022, due primarily to the transactions described below.
In 2023, we received $30,000,000 in proceeds under a convertible line of credit provided by our chairman in addition to $10 million in proceeds from stock purchase warrants exercised by our chairman. In
2022, we received proceeds of $10,000,000 under a convertible line of credit provided by our chairman.
EffectiveIn FebruaryMarch 28, 2022,2025, the Company entered into an amendment to its operating lease for office space in Norcross, GA for a term of thirty-eighttwelve months, beginning on MarchMay 1, 20222025 and ending
April 30, 20252026 at an average rate of approximately $4,250$5,400 per month. The amended lease provided for free rent for the first six months of the lease and continues the security deposit of $6,000. In addition to base rental payments included in the
contractual obligations table above, the Company is responsible for our pro-rata share of the operating expenses for the building.
Our
significant accounting policies are more fully described in Note 2 to our
consolidated financial statements included elsewhere in this annual report on
Form 10-K. Certain of our accounting policies,
however, are critical to the
portrayal of our financial position and results of operations and require the
application of significant judgment by our management, which subjects them to
an inherent degree of uncertainty. In applying our accounting
policies, our
management uses its best judgment to determine the appropriate assumptions to
be used in the determination of certain estimates. Our more significant
estimates include stock option valuations and performance vesting features of
certain certain
of these instruments, accrued liabilities, deferredderivative income taxesliabilities, and
cash flows. These estimates are based on our historical experience, terms of
existing contracts, our observance of trends in the industry, information
available from other outside
sources, and on various other factors that we
believe to be appropriate under the circumstances. We believe that the critical
accounting policies discussed below involve more complex management judgment
due to the sensitivity of the methods,
assumptions and estimates necessary in
determining the related asset, liability, revenue and expense amounts.
Research
and Development Expenses. Research
and development expenses, including personnel costs, allocated facility costs,
lab supplies, outside services, contract laboratory costs related
to manufacturing drug product, clinical trials and preclinical studies are
charged to research and development expense as incurred. The Company accounts
for nonrefundable advance
payments for goods and services that will be used in
future research and development activities as expense when the service has been
performed or when the goods have been received. Our current NAVIGATE clinical trial is
being supported by third-party
contract research organizations, or CROs, and
other vendors. We accrue expenses for clinical trial activities performed by
CROs based upon the estimated amount of work completed on each trial. For
clinical trial expenses and related expenses
associated with the conduct of
clinical trials, the significant factors used in estimating accruals include
the number of patients enrolled, the number of active clinical sites, and the
duration for which the patients have been enrolled in the trial.
We monitor
patient enrollment levels and related activities to the extent possible through
internal reviews, review of contractual terms and correspondence with CROs. We
base our estimates on the best information available at the time. We monitor
patient enrollment levels and related activities to the extent possible through
discussions with CRO personnel and based our estimates of clinical trial costs
on the best information available at the time. However, additional information
may become
available to us which will allow us to make a more accurate estimate
in future periods. In that event, we may be required to record adjustments to
research and development expenses in future periods when the actual level of
activity becomes more
certain.
What changed in the latest 10-Q
Risk Factors
The information set forth in this report should be read in conjunction with the risk factors set forth in Item 1A, “Risk Factors,” of Part I of our Annual Report on Form 10-K for the year ended December 31, 2025, which could materially impact our business, financial condition or future results.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Other Income and Expense”
Largest changes
Since our inception on July 10, 2000, we have financed our operations from proceeds of public and private offerings of debt and equity. As ofsee in full comparisonMarchJune31,30, 2026, we raised a net total of$341$342 million from these offerings. AtMarchJune31,30, 2026, the Company had$14.1$13.3 million of unrestricted cash and cash equivalents in addition to $10 million remaining available undertwoalinesline of credit provided by our chairman available to fund future operations. The Company believes there is sufficient cash to fund currently planned operations throughMayJune 2027. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of 12 months from the issuance date of this Form 10-Q. The ability of the Company to continue as a going concern is likely dependent on its ability to raise capital; however, the Company’s cash position may not be sufficient to support its daily operations after June 2027. We willwillrequire more cash to fund our operations afterMayJune 2027. There can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.
Three and Six Months Endedsee in full comparisonMarchJune31,30, 2026 Compared to Three and Six Months EndedMarchJune31,30, 2025
“The Company submitted a Type C meeting request in the first quarter of 2026. Subsequently, FDA granted an in-person Type C meeting which was held in the second quarter of 2026. The Company reached agreement with FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin for patients with MASH cirrhosis and portal hypertension. …”see in full comparison
“During the six months ended June 30, 2026, other income and expense consisted of $65,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $3,992,000 and change in fair value of derivatives of $2,173,000.”see in full comparison
“During the year ended June 30, 2025, other income and expense consisted of $61,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $3,570,000 and change in fair value of derivatives of $1,121,000.”see in full comparison
Full comparison: every changed paragraph (15)
In
addition to historical information, the following Management’s Discussion and
Analysis of Financial Condition and Results of Operations contains
forward-looking statements as defined under Section 21E of the Securities
Exchange Act of 1934, as amended, and is subject to the safe harbor created
therein for forward-looking statements. Such statements include, but are not
limited to, statements concerning our anticipated operating results, research
and development, clinical trials, regulatory proceedings, and financial
resources, and can be identified by use of words such as, for example,
“anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” and
“would,” “should,” “could” or “may.” All statements, other than statements of
historical facts, included herein that address activities, events, or
developments that the Company expects or anticipates will or may occur in the
future, are forward-looking statements, including statements regarding: plans
and expectations regarding clinical trials; plans and expectations regarding
regulatory approvals; our strategy and expectations for clinical development
and commercialization of our products; potential strategic partnerships;
expectations regarding the effectiveness of our products; plans for research
and development and related costs; statements about accounting assumptions and
estimates; expectations regarding liquidity and the sufficiency of cash to fund
currently planned operations through MayJune 2027; our commitments and
contingencies; and our market risk exposure. Forward-looking statements are
based on current expectations, estimates and projections about the industry and
markets in which Galectin Therapeutics operates, and management’s beliefs and
assumptions. These statements are not guarantees of future performance and
involve certain known and unknown risks and uncertainties that could cause
actual results to differ materially from those expressed or implied by such
statements. Such risks and uncertainties are related to and include, without
limitation, our early stage of development, our dependence on Mr. Uihlein for financing;
●
● Belapectin reduced clinically significant portal hypertension category and risk of hepatic decompensation. Using Baveno VII criteria incorporating liver stiffness measurement (LSM) by transient elastography (FibroScan®) and platelet count, belapectin treatment reduced the presence of clinically significant portal hypertension (CSPH) and lowered the risk of hepatic decompensation in patients with MASH cirrhosis. Notably, among recent MASH cirrhosis trials reported, NAVIGATE enrolled one of the most advanced patient populations, as evidenced by the high proportion of subjects meeting CSPH criteria at baseline.
●
● All portal hypertension risk categories were improved comparing belapectin to placebo. Over 18 months, a higher proportion of patients treated with belapectin transitioned from the CSPH or probable CSPH categories to the no/low-risk category, compared to placebo.
The Company submitted a Type C meeting request in the first quarter of 2026. Subsequently, FDA granted an in-person Type C meeting which was held in the second quarter of 2026. The Company reached agreement with FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin for patients with MASH cirrhosis and portal hypertension. The Company plans to file a Phase 3 protocol with the FDA in the third quarter of 2026 and is actively exploring strategic and financial partnership opportunities to support the continued development and commercialization of belapectin.
The Company submitted a Type C meeting request
in the first quarter of 2026. Subsequently, FDA granted an in-person Type
C meeting to be held in the second quarter of 2026.
Three and Six Months Ended MarchJune 31,30, 2026 Compared to Three and Six Months Ended MarchJune 31,30, 2025
Clinical activities decreased primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial which ended in the first quarter of 2025. Pre-clinical activities decreased due to decrease in work onin those areas. All other research and development expenses decreased primarily due to fewer employees in 2026 than in 2025.
General
and administrative expenses consist primarily of salaries including stock-based
compensation, legal and accounting fees, insurance, investor relations,
business development and other office related expenses. The primary reasons for
the increase in general and administrative expenses for the three-monthsthree and six month
periods ended
March 31,June 30, 2026 as compared to the same periodperiods in 2025 isare due to
increases in non-cash
stock basedstock-based compensation expenses of approximately $302,000.$463,000
and $680,000, respectively.
Other Income and Expense
During the six months ended June 30, 2026, other income and expense consisted of $65,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $3,992,000 and change in fair value of derivatives of $2,173,000.
During the year ended June 30, 2025, other income and expense consisted of $61,000 of interest income offset by interest expense and amortization of debt discounts on convertible notes payable and convertible line of credit of $3,570,000 and change in fair value of derivatives of $1,121,000.
Since
our inception on July 10, 2000, we have financed our operations from proceeds
of public and private offerings of debt and equity. As of MarchJune 31,30, 2026, we
raised a net total of $341$342 million from these offerings. At MarchJune 31,30, 2026, the
Company had $14.1$13.3 million of unrestricted cash and cash equivalents in addition
to $10 million remaining available under twoa linesline of credit provided by our
chairman available to fund future operations. The Company believes there is
sufficient cash to fund currently planned operations through MayJune 2027.
These factors raise substantial doubt about the Company’s ability to
continue as a going concern for a period of 12 months from the issuance date of
this Form 10-Q. The ability of the Company to continue as a going concern is likely
dependent on its ability to raise capital; however, the Company’s cash position
may not be sufficient to support its daily operations after June 2027. We
will will
require more cash to fund our operations after MayJune 2027. There can be no
assurance that we will be successful in obtaining such new financing or, if
available, that such financing will be on terms favorable to us.
Net
cash used in operations decreased by $3,823,000$7,986,000 to $3,866,000$6,305,000 for the three
six months ended MarchJune 31,30, 2026, as compared to $7,689,000$14,291,000 for the threesix months
ended MarchJune 31,30, 2025. Cash operating expenses decreased principally due to the completion
of our NAVIGATE clinical trial with belapectin in 2025.
GALT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 5 filings (2 insiders, 5 trade dates, 106,412 shares, about $521.8K; 5 of these filings say the sales were made under a Rule 10b5-1 trading plan). Net open-market shares: -106,412 (purchases minus sales); net value about -$521.8K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-07-31 | Uihlein Richard E |
Option exercise | 2,550,932 | $4.05 | $10.3M |
| 2026-07-31 | Uihlein Richard E |
Option exercise | 31,825,235 | $3.00 | $95.5M |
| 2026-07-14 | Jamil Khurram |
Open-market sale |
16,250 | $5.13 | $83.4K |
| 2026-07-14 | Jamil Khurram |
Option exercise |
16,250 | $3.04 | $49.4K |
| 2026-06-29 | Shlevin Harold H. |
Open-market sale |
22,268 | $5.04 | $112.2K |
| 2026-06-29 | Shlevin Harold H. |
Option exercise |
22,268 | $1.23 | $27.4K |
| 2026-06-29 | Jamil Khurram |
Open-market sale |
47,467 | $5.04 | $239.2K |
| 2026-06-29 | Jamil Khurram |
Option exercise |
47,467 | $2.50 | $118.7K |
| 2026-06-26 | Shlevin Harold H. |
Option exercise |
7,732 | $1.23 | $9.5K |
| 2026-06-26 | Shlevin Harold H. |
Open-market sale |
7,732 | $5.00 | $38.7K |
| 2026-06-26 | Jamil Khurram |
Option exercise |
2,037 | $2.20 | $4.5K |
| 2026-06-26 | Jamil Khurram |
Open-market sale |
2,037 | $5.00 | $10.2K |
| 2026-06-26 | Jamil Khurram |
Open-market sale |
2,533 | $5.00 | $12.7K |
| 2026-06-26 | Jamil Khurram |
Option exercise |
2,533 | $2.50 | $6.3K |
| 2026-06-23 | Jamil Khurram |
Option exercise |
7,557 | $1.23 | $9.3K |
| 2026-06-23 | Jamil Khurram |
Open-market sale |
7,557 | $3.14 | $23.7K |
| 2026-05-26 | Jamil Khurram |
Open-market sale |
568 | $3.10 | $1.8K |
| 2026-05-26 | Jamil Khurram |
Option exercise |
568 | $1.23 | $699 |
Well-known investors holding GALT (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Two Sigma Investments | 2026-06-30 | 318,245 | $1.5M | 0.0% | Reduced 32% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 198,701 | $922.0K | 0.0% | Reduced 32% |
| Renaissance Technologies | 2026-06-30 | 43,343 | $201.1K | 0.0% | Reduced 71% |
| Millennium Management (Israel Englander) | 2026-06-30 | 35,863 | $166.4K | 0.0% | Reduced 96% |