Good morning, ladies and gentlemen. Welcome. My name is Kevin Freeman, and I'm the Vice Chairman of the Board of Galectin Therapeutics, Inc. I will act as Chair of this meeting, and Mr. Jack Callicutt, our Chief Financial Officer and Corporate Secretary, will act as Secretary. Due to cost savings and other efficiencies, we are holding this year's annual meeting as a virtual meeting. Stockholders who require technical assistance during the meeting can call Broadridge's technical support line at the number listed on our virtual meeting website. Thank you. I hereby call the 2025 annual meeting for Galectin Therapeutics, Inc., to order. At this time, I would like to introduce the current members of the Board of Directors. We have Dr. Gilbert F. Amelio, Director, a member of the Compensation Committee, Chair of the Nominating and Corporate Governance Committee. Dr. Benjamin S. Carson Senior, Director. Mr.
Cary J. Claiborne, Director and member of the Audit Committee. I am the Director, a member of the Audit Committee, the Nominating and Corporate Governance Committee, and the Compensation Committee. Joel Lewis is a Director and the President and Chief Executive Officer. Dr. Gilbert S. Omenn, Director and Chair of the Compensation Committee. Dr. Mark A. Rubin, Director and member of the Nominating and Corporate Governance Committee. Dr. Elissa J. Schwartz, Director and member of Nominating and Corporate Governance Committee. Dr. Harold H. Shlevin, Director. Richard E. Uihlein, Chairman of the Board. Richard A. Zordani, Director and Chair of the Audit Committee. Other members of the Galectin Therapeutics management team present today consist of Dr. Khurram Jamil, Chief Medical Officer, and Jack W. Callicutt, Chief Financial Officer, Corporate Treasurer, and Corporate Secretary. Mrs. Beth Knowles serves as the Inspector of Elections for this meeting. Mrs.
Knowles has received a certified report from the transfer agent regarding proxies submitted prior to the meeting. We're also joined by Bob Tritt and Brian Lee of Dentons US LLP. Dentons serves as the company's corporate and securities law counsel. Our accounting team is represented by Matt Urbizo of Cherry Bekaert LLP, our independent registered public accounting firm. The Board of Directors set October 7, 2025, as the record date for this stockholders' meeting. Mr. Callicutt, would you please proceed with the administrative portion of the meeting?
Thank you, Mr. Vice Chairman. We have provided a meeting agenda. A link to the meeting agenda is available on the virtual meeting website on the bottom right side of the web page under Meeting Materials. As set forth in the meeting agenda, we will first address the business of the meeting and the results of the stockholder vote, followed by a corporate update from Mr. Joel Lewis, our President and Chief Executive Officer. I have a copy of the Notice of Annual Meeting of Stockholders dated October 22, 2025, which was first sent to our stockholders of record at the close of business on October 23, 2025. The Notice of Annual Meeting is ordered filed with the records of the company.
The first order of business at this meeting is to determine whether the shares represented at the meeting, either in person or by proxy, are sufficient to constitute a quorum for the purpose of transacting business. Mrs. Knowles?
Can you hear me? I'm sorry.
Yes.
Okay.
Go ahead.
The stockholders' list shows that 64,680,877 votes may be cast at this meeting by the holders of shares of common and preferred stock. According to the tabulation made before the meeting, there are represented in person or by proxy at least 45,709,159 shares of stock with common voting rights, or approximately 71% of all the shares entitled to vote at this meeting. The final report of the meeting will show the final number of shares represented at the meeting in person and by proxy.
Thank you. Because holders of at least one-third of the shares entitled to vote at this meeting are present in person or by proxy, I declare this meeting to be duly convened for the purposes of transacting such business as may properly come before it. The next order of business is a description of the matters to be voted on at today's meeting. The first proposal before the stockholders is a proposal for the election of 11 directors to serve until the next annual meeting and until their respective successors are elected and qualified. The Nominating and Corporate Governance Committee of our Board of Directors has nominated 11 members currently serving on our board to be re-elected at this 2025 annual meeting to serve until the 2026 annual meeting of stockholders and until their respective successors are elected and qualified.
All 11 nominees who have been nominated by the Nominating and Corporate Governance Committee have agreed to serve on the board if elected. The board has recommended that all such 11 nominees be elected as directors. The 11 nominees are Dr. Gilbert F. Amelio, Dr. Benjamin S. Carson Senior., Mr. Cary J. Claiborne, Mr. Kevin D. Freeman, Mr. Joel Lewis, Dr. Gilbert S. Omenn, Dr. Mark A. Rubin, Dr. Elissa J. Schwartz, Dr. Harold H. Shlevin, Mr. Richard E. Uihlein, and Mr. Richard A. Zordani. The second proposal before the stockholders is a proposal to vote on a non-binding advisory resolution to approve the compensation paid to our named executive officers, as disclosed in the proxy statement. The third proposal before the stockholders is a proposal to recommend by non-binding vote the frequency with which the company will conduct stockholder advisory votes on executive compensation.
The fourth proposal before the stockholders is a proposal to ratify the appointment of Cherry Bekaert LLP as the independent registered public accounting firm to audit the financial statements for fiscal year ending December 31, 2025. The company knows of no other business to be presented. The polls are now open. If you previously voted by proxy, you do not need to vote today unless you wish to change your vote. All proxies will be voted as the stockholders mark them. Any shareholder as of the record date who has not yet voted may do so now at the web portal for the 2025 annual meeting by entering the 16-digit control number included on your proxy card. I hereby declare the polls closed, and we will take a short break in order to tabulate the votes. Mrs. Knowles, as Inspector of Elections, have the votes and proxies been counted?
Yes.
Will the Inspector then please report the preliminary results of the voting?
The votes have been counted. Based on favorable votes taken together with the favorable votes filed by proxy, a plurality of the shares of the company entitled to vote and present at this meeting in person or by proxy have been voted in favor of each of the 11 nominees for director. Accordingly, Dr. Gilbert F. Amelio, Dr. Benjamin S. Carson Sr., Mr. Cary J. Claiborne, Mr. Kevin D. Freeman, Mr. Joel Lewis, Dr. Gilbert S. Omenn, Dr. Mark A. Rubin, Dr. Elissa J. Schwartz, Dr. Harold H. Shlevin, Mr. Richard E. Uihlein, and Mr. Richard A. Zordani have been elected as directors of the company to hold office until the 2026 annual meeting of stockholders and until their successors are duly elected and qualified.
With respect to Proposal 2, the votes cast for exceed the votes cast against the non-binding advisory resolution to approve the compensation paid to our named executive officers as disclosed in the proxy statement. Accordingly, Proposal 2 has been duly passed by the stockholders. With respect to Proposal 3, the votes cast for three years exceed the votes cast for one year and two years on frequency with which the company will conduct stockholder advisory votes on executive compensation. Accordingly, Proposal 3 for the frequency of conducting a stockholder advisory vote every three years has been duly passed by the stockholders. With respect to Proposal 4, the votes cast for exceed the votes cast against the ratification of Cherry Bekaert LLP as the independent registered public accounting firm to audit the financial statements for the 2025 fiscal year. Accordingly, Proposal 4 has been duly passed by the stockholders.
Mrs. Knowles, thank you for serving as our Inspector of Elections for this meeting. Please note that the Inspector of Elections will provide a written report of the final voting results after the meeting that will be included with the minutes of this meeting. Mr. Vice Chairman, this concludes the results of voting. The final results of today's vote will be disclosed in a current report on Form 8-K filed with the SEC within four business days.
Thank you. The formal portion of the 2025 stockholders' annual meeting of Galectin Therapeutics is hereby adjourned. I want to thank our stockholders for their continued support and interest in the company. And now I invite Mr. Joel Lewis, our President and CEO, to make a corporate presentation. Joel?
Thanks, Kevin. Since I became President and CEO of Galectin Therapeutics, I can honestly say that I have never been as excited as I am today, nor have I had the luxury of sharing such an extensive amount of meaningful information. As I'm writing this to you, frankly, the only appropriate word I could think of is, wow. Around a year ago, I think it's safe to say we had many doubters. And while today we are trading at close to multi-year highs, even that metric does not properly articulate the state of Galectin. However, before I enthusiastically dive into my update for today, there are a few things I would like to address. The combined efforts of many people, some very apparent and some behind the scenes, are why we are in this enviable position.
I want to thank my entire staff, both employees and consultants, for their tireless efforts in mining a massive amount of data from Navigate. Additionally, I want to thank our KOLs for their support this year, including Naga Chalasani, Naim Alkhouri, and Raj Vuppalanchi for their review and interpretation of the Navigate results, as well as all of the investigators that helped us generate and present the data at EASL and AASLD conferences. I also want to express my profound gratitude to our Chairman, Richard E. Uihlein. Without his unwavering support and commitment to our program, we would not have achieved the milestones that we have this year. Finally, I want to acknowledge our Chief Medical Officer, Dr. Khurram Jamil. There are a select few doctors who have overseen drug approvals for compounds in late-stage liver disease.
Not only were we fortunate enough to have Khurram, a member of that exclusive group, join the company. His enthusiasm, work ethic, and drive are beyond anything I've witnessed in biotech or anywhere else. I'm honored to have Khurram on our team and thank him for getting us to this stage in our development. Without Khurram, we simply would not be where we are today. At the beginning of 2025, the company was in a difficult position. We committed to presenting the top-line results from Navigate in December of 2024 and did so without the benefit of any of our biomarker data, which had not been fully analyzed at that time. We believe that the top-line data alone does not provide a complete picture of the potential benefits of belapectin. Just to remind everyone, Navigate was designed as an adaptive trial.
However, due to ongoing communication with FDA, the company made the decision to unblind at the end of 2024, something that was not originally planned. As a result, a large volume of data was not centralized. During 2025, our team has been focused on consolidating and analyzing all available data, including FibroScan reports and blood samples from around the world. Each trial participant had many scans and blood samples, so the task was monumental for my small team. Our perseverance yielded what we believe to be some extremely compelling results to date, and we are still continuing to analyze data from the trial. While I will let Khurram discuss the results in more detail, most biomarkers we analyzed seem to support our preliminary endpoint data in the completer population with respect to prevention of varices.
This ranged from analysis of FibroScan, ELF, specialized biomarkers from Nordic Biosciences, and even more general cytokine biomarkers. During 2025, we also focused on educating both the scientific community and investor audiences on three key areas: the advanced nature of patients enrolled in Navigate, the use of a novel but meaningful clinical endpoint, and most importantly, biomarker data to confirm Belapectin's mechanism of action. Our participation at both EASL and AASLD, with late breaker, oral, and poster presentations, has allowed us to meaningfully re-engage with KOLs who are encouraged by our results. Near-term goals include additional KOL events with respect to our biomarker data, presentations at upcoming congresses, as well as peer-reviewed publications from Navigate. And finally, the unique nature of our patient population compared to other trials has led to what we view as groundbreaking discussions with respect to patients with MASH cirrhosis and portal hypertension.
We are looking forward to continued engagement with clinicians in the coming months and sincerely appreciate their insight with respect to this extremely large and unfortunately growing patient population. As I mentioned in our last quarterly update, we submitted our FDA package and are anticipating feedback soon. Additionally, we are continuing to explore strategic opportunities to maximize the value of our program. We believe this program has the potential to change the treatment landscape for a patient population that currently has no FDA-approved therapy and will update you as more information becomes available. Finally, before I turn the program over to Khurram, I would like to again thank our Chairman, Richard E. Uihlein, for extending our cash runway and enabling us to achieve what I believe was the best year in the company's history.
As we approach 2026, I believe we are stronger than ever, both from a scientific and strategic perspective. Khurram?
Thank you, Joel. Good morning, everyone, and thank you for joining us. As many of you will recall, we announced the Navigate top-line results nearly a year ago. In that readout, the two-milligram dose of belapectin showed a lower rate of new varices compared with placebo after 18 months. While this was not statistically significant in the overall population, the effect was statistically significant in the group of patients who completed the protocol-mandated 18-month course of therapy and had endoscopic evaluation at baseline and end of treatment, hence called per protocol or completer population. Throughout 2025, our goal has been to strengthen, validate, and communicate the full body of evidence supporting this clinical finding with belapectin. We analyzed widely used biomarker panels collected in Navigate to better understand how belapectin works in patients with MASH cirrhosis and portal hypertension.
We shared those results at major hepatology symposia, various KOL webcasts, investor events, and during one-on-one scientific sessions, all with a consistent objective: to show the clinical and biological effects of Belapectin in compensated MASH cirrhosis and portal hypertension. Across all these analyses, the consistency between the clinical outcomes and the biomarker results strengthen our confidence in Belapectin's potential for slowing disease progression and improving clinical outcomes in this high-risk patient population. Let me walk you through some of the key findings we shared this year. Number one, reducing the progression of fibrosis on FibroScan. Using widely accepted and clinically meaningful cutoffs of either a greater than or equal to 30% increase or an absolute greater than or equal to 5 kilopascal rise, significantly fewer patients on Belapectin 2 milligrams experienced worsening of liver stiffness compared with placebo.
Since rising liver stiffness is closely linked to worsening of portal hypertension and risk of complications, this signals that Belapectin likely stabilizes MASH cirrhosis over time. Number two, Belapectin effects on FDA-approved marker for fibrosis, ELF test. When patients were grouped by their fibrosis level using the validated FDA-approved enhanced liver fibrosis or ELF test, Belapectin consistently showed a lower rate of new varices across all categories. The largest benefit appeared in patients with ELF greater than 11.3, which is indicative of high likelihood of cirrhosis. In these patients, the incidence of new varices was 22.7% Belapectin versus 42.9% with placebo, a meaningful difference in those at greatest risk of developing complications. Number three, mechanistic biomarkers showing impact on fibrosis and inflammation. Pro-C3, a marker of active fibrogenesis, showed more than 50% reduction from baseline 18 months with Belapectin 2 milligrams compared with placebo.
This supports a direct antifibrotic effect that aligns with belapectin's mechanism of action. YKL-40, associated with galectin-3 activity and liver inflammation, showed greater than or equal to 20% reduction in a higher proportion of belapectin-treated patients than placebo. This indicates that belapectin may be reducing key inflammatory pathways that drive disease progression. There are additional biomarker results that were shared with stakeholders and can be found in our latest corporate deck. Number four, we also reported clinically meaningful changes in portal hypertension risk category on belapectin. Using the established criteria of Baveno Expert Consensus Guidelines, belapectin was associated with a reduced presence of clinically significant portal hypertension at 18 months. More belapectin-treated patients moved from high-risk clinically significant portal hypertension or probable clinically significant portal hypertension into the no or low-risk category compared with placebo. Last but not least, belapectin continued to show a clean and consistent safety profile.
There was no drug-related serious adverse event in the entire trial. Discontinuation rates were similar to placebo, and no drug-induced liver injury was reported in Navigate. Across clinical findings, non-invasive markers, mechanistic biomarkers, and portal hypertension metrics, the Navigate data continues to reinforce Belapectin's potential to slow disease progression and improve outcomes for patients with compensated MASH cirrhosis and portal hypertension. This is especially important because Navigate enrolled one of the most advanced compensated MASH cirrhosis populations studied to date, with many patients already meeting clinically significant portal hypertension criteria at baseline. As we finalize the remaining analyses, we look forward to working with the FDA to determine next steps for the program. In parallel, we continue active discussion with potential partners, partners who share our commitment to advancing Belapectin for patients who currently have no approved treatment options.
We remain grateful to our patients, investigators, and scientific collaborators for their essential contributions. We look forward to a productive year ahead for the program, for our shareholders, and most importantly, for the patients we aim to serve. Back to you, Joel.
Thank you, Khurram. And thank you to everyone for your continued interest in Galectin Therapeutics and for your attention today. We look forward to sharing more updates as they become available. Operator, please close the call.
This concludes today's annual meeting. You may now disconnect.