Company Overview - Galectin Therapeutics Inc. (GALT) currently holds a Momentum Style Score of B, indicating potential for strong performance in the momentum investing strategy [3][12] - The company has a Zacks Rank of 2 (Buy), which is associated with a strong track record of outperformance in the market [4][12] Price Performance - Over the past week, GALT shares have increased by 7.48%, while the Zacks Medical - Drugs industry remained flat during the same period [6] - In a longer time frame, GALT's monthly price change is 57.98%, significantly outperforming the industry's 1.35% [6] - Over the past quarter, GALT shares have risen by 80.55%, and over the last year, they have increased by 119.19%, compared to the S&P 500's gains of 9.68% and 20%, respectively [7] Trading Volume - GALT's average 20-day trading volume is 251,038 shares, which serves as a useful baseline for price-to-volume analysis [8] Earnings Outlook - In the past two months, one earnings estimate for GALT has moved higher, while none have moved lower, resulting in an increase in the consensus estimate from -$0.67 to -$0.49 [10] - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [10]

Group 1: Modular Medical Inc. (MODD) - Modular Medical Inc. experienced a significant stock price increase of 30.68% to $0.9150 after completing a clinical study for its MODD1 insulin pump, which aims to simplify diabetes management [1] - The company plans to submit its Pivot pump product to the FDA for clearance in October 2025 [1] - Insider activity has been notable, with executives purchasing over $500,000 worth of shares, contributing to heightened trading volume of over 4.5 million shares, significantly above the average of around 200,000 [2] Group 2: Galectin Therapeutics Inc. (GALT) - Galectin Therapeutics Inc. saw its stock rise over 14% to $6.78, continuing a remarkable year-to-date gain of over 360% [3] - The company reached a new 52-week high of $5.99 during intraday trading on September 11, 2025 [3] - CEO Joel Lewis indicated ongoing analysis of additional biomarkers for their lead candidate, belapectin, which is designed to treat MASH cirrhosis and portal hypertension [4] Group 3: Exicure Inc. (XCUR) - Exicure Inc. shares rose 11.11% to $4.00, despite no new company-specific news, indicating speculative interest or technical momentum [5] - The company reported a second-quarter net loss of $2.6 million, wider than the $0.6 million loss in Q2 of 2024, primarily due to higher operating expenses from the acquisition of GPCR USA [6] - Exicure is pursuing new clinical directions, including a completed Phase 2 study of GPC-100 for stem cell mobilization in multiple myeloma patients [6] Group 4: PepGen Inc. (PEPG) - PepGen Inc. rebounded 6.67% to $1.44 after a previous decline, with the movement likely driven by technical factors or speculative interest [6] - The company has shifted focus to PGN-EDODM1 for treating myotonic dystrophy type 1 (DM1) after discontinuing its Duchenne muscular dystrophy program [7] - The FREEDOM-DM1 trial is currently underway, with topline data expected in early Q4 2025, which is considered a key near-term catalyst [8] Group 5: BioSig Technologies Inc. (BSGM) - BioSig Technologies Inc. closed at $6.10 with a sharp gain of 37.08%, followed by a 4.09% rise in after-hours trading to $6.35 [8] - The company has officially rebranded as Streamex Corp., effective September 12, 2025, and will trade under the new ticker symbol "STEX" [8] - The rebranding follows a merger with Streamex Exchange Corp., marking a strategic pivot towards real-world asset tokenization, including an exclusive partnership with Monetary Metals for tokenized, yield-bearing gold products [9]

Summary of Galectin Therapeutics FY Conference Call Company Overview - **Company**: Galectin Therapeutics (NasdaqCM:GALT) - **Focus**: Development of therapies for NASH cirrhosis and portal hypertension, specifically the lead program involving belapectin Core Points and Arguments - **Belapectin Program**: Targeting patients with NASH cirrhosis and portal hypertension, with a focus on the development of esophageal varices as a primary clinical outcome [3][4] - **Epidemiology**: Approximately 1% of the U.S. population may have NASH cirrhosis and portal hypertension, highlighting a significant unmet medical need [5][6] - **Market Opportunity**: Estimated 1.7 million patients meet the target indication, suggesting a multi-billion dollar annual peak sales potential for belapectin [9] - **Clinical Data**: - Phase IIb study (GD26) showed a significant drop in portal pressure in patients without varices at baseline, although the primary endpoint was not statistically significant [10][16] - NAVIGATE trial design included a robust central-blinded review for assessing esophageal varices, with a focus on patients with NASH cirrhosis and portal hypertension [11][12] - The 2 mg dose showed a 43% reduction in the incidence of varices compared to placebo in the per-protocol population [15][22] Additional Important Content - **Safety Profile**: The safety profile of belapectin was favorable, with no systematic toxicity or dose-limiting adverse events reported [21][22] - **Synergistic Effects**: Observations suggested a potential synergistic effect with GLP-1 therapy, particularly in the U.S. patient population [18][23] - **Biomarker Data**: Key biomarkers for fibrosis, such as liver stiffness measurement (LSM) and ELF score, indicated positive outcomes correlating with clinical findings [19][23] - **Regulatory Discussions**: The company is actively engaging with regulatory agencies to discuss next steps for the belapectin program and exploring partnership opportunities [23] This summary encapsulates the key insights from the conference call, focusing on the company's strategic direction, clinical findings, and market potential.

Company Participation - Galectin Therapeutics, Inc. will participate in the H.C. Wainwright 27 Annual Global Investment Conference from September 8-10, 2025 in New York, NY [1] - The company presentation is scheduled for September 8, 2025, at 1:00 PM ET, with a live and archived webcast available [2] Management Availability - The management team, including CEO Joel Lewis and CMO Khurram Jamil, will be available for one-on-one meetings during the conference [3] Company Overview - Galectin Therapeutics focuses on developing novel therapies for chronic liver disease and cancer, with its lead drug belapectin targeting the galectin-3 protein [4] - Belapectin has received Fast Track designation from the U.S. FDA and is primarily being developed for metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis [4] - The company is also exploring treatments for advanced head and neck cancers and other malignancies, with further development dependent on finding suitable partners [4]

Core Insights - Galectin Therapeutics, Inc. reported financial results and business updates for the second quarter and first half of 2025, highlighting progress in its NAVIGATE trial for belapectin, a treatment for MASH cirrhosis [1][2]. Financial Performance - As of June 30, 2025, the company had cash and cash equivalents of $13.8 million and a new $10 million line of credit to fund operations through mid-2026 [9]. - Research and development expenses for Q2 2025 were $3.3 million, a decrease from $9.8 million in Q2 2024, primarily due to the timing of expenditures related to the NAVIGATE trial [9]. - General and administrative expenses for Q2 2025 were $1.4 million, slightly down from $1.5 million in the same period last year [9]. - The net loss applicable to common stockholders for Q2 2025 was $7.6 million, or ($0.12) per share, compared to a net loss of $12.4 million, or ($0.20) per share for Q1 2024 [9][11]. Clinical Development - The NAVIGATE trial data indicates that belapectin shows a clinically significant response in Fibroscan® results, supporting its primary endpoint of preventing esophageal varices after 18 months of treatment [2][4]. - The 18-month analysis demonstrated a lower incidence of liver stiffness progression and varices in the belapectin 2 mg arm compared to placebo, suggesting its potential to modify disease progression in patients with MASH cirrhosis [3][4]. - The updated analysis confirmed that the effects of belapectin were maintained in patients who continued treatment into the second 18-month period, reinforcing its efficacy [4][5]. Strategic Initiatives - The company is focused on engaging with the U.S. Food and Drug Administration to discuss potential next steps for the belapectin program and is exploring strategic partnership opportunities [2][3]. - A KOL event in June featured discussions on the NAVIGATE trial results and the treatment landscape for MASH cirrhosis, indicating ongoing efforts to raise awareness and support for the treatment [4]. Market Position - Galectin Therapeutics aims to address the significant unmet medical need for patients with MASH-associated liver cirrhosis and portal hypertension, positioning belapectin as a potential new treatment option [3][4]. - The company is also developing additional programs for cancer treatment, indicating a broader therapeutic focus [7].

[Report Overview](index=1&type=section&id=Report%20Overview) [Introduction and Key Business Updates](index=1&type=section&id=Introduction%20and%20Key%20Business%20Updates) Galectin Therapeutics reported Q2 2025 financial results, highlighted positive NAVIGATE trial data, and secured debt financing for operations through H2 2026 - Galectin Therapeutics reported financial results and provided a business update for the three and six months ended June 30, 2025[1](index=1&type=chunk) - Continued analysis of data from the NAVIGATE trial further supports the clinical profile of belapectin in patients with MASH cirrhosis[2](index=2&type=chunk) - An additional **$10 million debt financing**, announced in early July, is expected to fund current planned operations through the **second half of 2026**[4](index=4&type=chunk) [Clinical Development and Business Strategy](index=1&type=section&id=Clinical%20Development%20and%20Business%20Strategy) [NAVIGATE Trial Data Analysis and Efficacy](index=1&type=section&id=NAVIGATE%20Trial%20Data%20Analysis%20and%20Efficacy) Belapectin's NAVIGATE trial data shows sustained efficacy in reducing liver stiffness progression and varices in MASH cirrhosis - The 18-month analysis showed a **lower incidence of both liver stiffness progression and varices** in the **2 mg belapectin arm** compared to placebo[4](index=4&type=chunk) - These effects were maintained in patients who continued into the second 18-month treatment period, confirming **less progression** in the belapectin group using LOCF methodology[5](index=5&type=chunk) - Fibroscan® data outcomes support the NAVIGATE trial's primary endpoint, the **prevention of esophageal varices** after 18 months of treatment with belapectin[2](index=2&type=chunk) [Recent Clinical and Corporate Highlights](index=2&type=section&id=Recent%20Clinical%20and%20Corporate%20Highlights) Galectin hosted a June KOL event on NAVIGATE data and MASH, and presented EASL 2025 results showing belapectin's sustained efficacy - In June, Galectin hosted a KOL event featuring Dr. Naga Chalasani and Dr. Naim Alkhouri, who discussed NAVIGATE trial results and the **unmet need in MASH cirrhosis**[5](index=5&type=chunk) - In May, Galectin presented NAVIGATE trial results at the European Association for the Study of the Liver (EASL) 2025 Congress, showing **sustained efficacy in reducing liver stiffness** and fewer patients experiencing clinically meaningful worsening[6](index=6&type=chunk) - Updated FibroScan® findings mirror previously reported **reductions in esophageal varices**, supporting belapectin's potential to reduce portal hypertension-related complications[6](index=6&type=chunk) [Strategic Outlook and Funding](index=2&type=section&id=Strategic%20Outlook%20and%20Funding) Galectin plans FDA engagement for belapectin, explores partnerships, and secured **$10 million** debt financing to fund operations through H2 2026 - Galectin remains focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for its program[3](index=3&type=chunk) - The company continues to explore strategic partnership opportunities[3](index=3&type=chunk) - Additional **$10 million debt financing** announced in early July is expected to fund current planned operations through the **second half of 2026**[4](index=4&type=chunk) [Financial Review](index=4&type=section&id=Financial%20Review) [Q2 2025 Financial Highlights](index=4&type=section&id=Q2%202025%20Financial%20Highlights) Galectin reported an improved Q2 2025 net loss due to decreased R&D, securing **$10 million** debt financing, bringing cash to **$13.8 million** **Q2 2025 Key Financials (in thousands):** | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :--------------------- | :------ | :------ | :----------- | | R&D Expenses | $3,261 | $9,813 | -$6,552 (↓66.8%) | | G&A Expenses | $1,364 | $1,478 | -$114 (↓7.7%) | | Net Loss | $(7,521) | $(12,371) | +$4,850 (↓39.2%) | | Net Loss per Share | $(0.12) | $(0.20) | +$0.08 (↓40.0%) | - As of June 30, 2025, the Company had **$13.8 million** of cash and cash equivalents[8](index=8&type=chunk) - On July 8, 2025, the Company entered into a new **$10 million line of credit** provided by its chairman of the board to fund operations through **June 30, 2026**[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Galectin reported a Q2 2025 net loss of **$7.521 million**, significantly reduced from prior year due to decreased R&D, with the six-month period also showing a reduced net loss **Condensed Consolidated Statements of Operations (Three Months Ended June 30, in thousands):** | Operating Expenses | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $3,261 | $9,813 | -$6,552 (↓66.8%) | | General and administrative | $1,364 | $1,478 | -$114 (↓7.7%) | | Total operating expenses | $4,625 | $11,291 | -$6,666 (↓59.0%) | | Net loss | $(7,521) | $(12,371) | +$4,850 (↓39.2%) | | Basic and diluted net loss per share | $(0.12) | $(0.20) | +$0.08 (↓40.0%) | **Condensed Consolidated Statements of Operations (Six Months Ended June 30, in thousands):** | Operating Expenses | 2025 | 2024 | Change (YoY) | | :-------------------------------- | :--- | :--- | :----------- | | Research and development | $9,746 | $17,867 | -$8,121 (↓45.5%) | | General and administrative | $2,776 | $3,072 | -$296 (↓9.6%) | | Total operating expenses | $12,522 | $20,939 | -$8,417 (↓40.2%) | | Net loss | $(17,152) | $(23,860) | +$6,708 (↓28.1%) | | Basic and diluted net loss per share | $(0.27) | $(0.39) | +$0.12 (↓30.8%) | [Condensed Consolidated Balance Sheet Data](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Galectin reported cash and equivalents of **$13.771 million**, a decrease from year-end 2024, with total liabilities increasing to **$132.769 million** and stockholders' equity deficit widening to **$(118.890) million** **Condensed Consolidated Balance Sheet Data (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $13,771 | $15,120 | -$1,349 | | Total assets | $15,602 | $17,495 | -$1,893 | | Total current liabilities | $10,774 | $35,409 | -$24,635 | | Total liabilities | $132,769 | $120,565 | +$12,204 | | Total stockholders' equity (deficit) | $(118,890) | $(104,793) | -$14,097 | [Company Profile and Disclosures](index=5&type=section&id=Company%20Profile%20and%20Disclosures) [About Galectin Therapeutics](index=5&type=section&id=About%20Galectin%20Therapeutics) Galectin Therapeutics develops novel therapies for chronic liver disease and cancer, focusing on belapectin for MASH cirrhosis, with cancer programs dependent on partnerships - Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer[10](index=10&type=chunk) - Galectin's lead drug belapectin, a carbohydrate-based galectin-3 inhibitor, has **Fast Track designation** by the U.S. FDA for its lead development program in **MASH with cirrhosis**[10](index=10&type=chunk) - Additional development programs in combination immunotherapy for advanced head and neck cancers and other malignancies are largely dependent on finding a suitable partner[10](index=10&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements, highlighting uncertainties and risks in clinical trials, regulatory approvals, funding, and partnerships that could impact actual results - Statements relate to future events or future financial performance and are based on management's current expectations, subject to factors and uncertainties that could cause actual results to differ materially[11](index=11&type=chunk) - Risks include, but are not limited to, the NAVIGATE trial data not producing positive results, failure to develop effective treatments or obtain requisite approvals, challenges in manufacturing, and inability to secure partnerships or raise additional capital[11](index=11&type=chunk) [Company Contacts](index=7&type=section&id=Company%20Contacts) Contact information for Galectin Therapeutics' CFO, Jack Callicutt, and Investor Relations, Kevin Gardner, is provided - Company Contact: Jack Callicutt, Chief Financial Officer, (678) 620-3186, ir@galectintherapeutics.com[12](index=12&type=chunk) - Investors Relations Contacts: Kevin Gardner, kgardner@lifesciadvisors.com[12](index=12&type=chunk)

[PART I — FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [ITEM 1. Unaudited Condensed Consolidated Financial Statements](index=3&type=section&id=ITEM%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section presents Galectin Therapeutics Inc.'s unaudited condensed consolidated financial statements for Q2 2025, detailing balance sheets, operations, cash flows, and stockholders' deficit, with notes on accounting policies and financial instruments [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a decrease in total assets and an increase in total liabilities from December 31, 2024, to June 30, 2025, primarily driven by changes in convertible notes payable and derivative liabilities, leading to an increased stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :------------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $13,771 | $15,120 | $(1,349) | -8.92% | | Total current assets | $15,427 | $17,252 | $(1,825) | -10.58% | | Total assets | $15,602 | $17,495 | $(1,893) | -10.82% | | Total current liabilities | $10,774 | $35,409 | $(24,635)| -69.57% | | Total liabilities | $132,769 | $120,565 | $12,204 | 10.12% | | Total stockholders' deficit | $(118,890) | $(104,793) | $(14,097)| 13.45% | - Convertible notes payable and accrued interest (non-current) increased significantly from **$10,733,000** at December 31, 2024, to **$32,308,000** at June 30, 2025[7](index=7&type=chunk) - Borrowing and accrued interest under convertible lines of credit (related party) increased from **$74,376,000** to **$88,150,000**[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a reduced net loss for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to a significant decrease in research and development expenses, despite an increase in interest expense and change in fair value of derivative liabilities Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $3,261 | $9,813 | $9,746 | $17,867 | | General and administrative | $1,364 | $1,478 | $2,776 | $3,072 | | Total operating expenses | $4,625 | $11,291 | $12,522 | $20,939 | | Total operating loss | $(4,625) | $(11,291) | $(12,522) | $(20,939) | | Interest expense | $(1,826) | $(1,269) | $(3,570) | $(2,321) | | Change in fair value of derivative | $(1,096) | $109 | $(1,121) | $(760) | | Net loss | $(7,521) | $(12,371) | $(17,152) | $(23,860) | | Net loss per common share | $(0.12) | $(0.20) | $(0.27) | $(0.39) | - Research and development expenses decreased by **67%** for the three months ended June 30, 2025, and by **45%** for the six months ended June 30, 2025, compared to the prior year periods[9](index=9&type=chunk) - Net loss applicable to common stockholders decreased from **$(12,435,000)** to **$(7,584,000)** for the three months ended June 30, 2025, and from **$(23,932,000)** to **$(17,189,000)** for the six months ended June 30, 2025[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to lower net loss and adjustments for non-cash items. However, net cash flows from financing activities also decreased, leading to a larger net decrease in cash and cash equivalents Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(17,152) | $(23,860) | | Net cash from operating activities | $(14,291) | $(20,438) | | Net cash flows from financing activities | $12,942 | $20,376 | | NET DECREASE IN CASH AND CASH EQUIVALENTS | $(1,349) | $(62) | | CASH AND CASH EQUIVALENTS, END OF PERIOD | $13,771 | $25,598 | - Net cash used in operating activities decreased by **$6,147,000**, from **$(20,438,000)** in 2024 to **$(14,291,000)** in 2025[11](index=11&type=chunk) - Net cash flows from financing activities decreased by **$7,434,000**, from **$20,376,000** in 2024 to **$12,942,000** in 2025, primarily due to decreased borrowings under related party lines of credit[11](index=11&type=chunk)[160](index=160&type=chunk) [Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders' Deficit](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Deficit) The statements detail changes in preferred stock and stockholders' deficit, reflecting net losses, preferred stock dividends, common stock issuances from option/warrant exercises, and conversions, leading to an increased accumulated deficit - Total stockholders' deficit increased from **$(104,793,000)** at December 31, 2024, to **$(118,890,000)** at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Common stock outstanding increased from **63,157,235** shares at December 31, 2024, to **64,060,262** shares at June 30, 2025[7](index=7&type=chunk)[16](index=16&type=chunk) - Additional paid-in capital increased from **$296,217,000** to **$299,318,000**, while retained deficit increased from **$(401,572,000)** to **$(418,761,000)** due to net losses and preferred stock dividends[7](index=7&type=chunk)[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide critical context to the financial statements, detailing the company's business, liquidity challenges, related-party debt, fair value measurements, stock-based compensation, and clinical development activities, highlighting the going concern uncertainty and reliance on future financing [1. Basis of Presentation and Liquidity](index=10&type=section&id=1.%20Basis%20of%20Presentation%20and%20Liquidity) Galectin Therapeutics Inc. is a clinical-stage biopharmaceutical company facing going concern uncertainty due to historical losses and no revenue, despite having $13.8 million cash and a new $10 million credit line to fund operations through June 2026 - The Company is a clinical stage biopharmaceutical company developing therapies for fibrotic disease and cancer by targeting galectin proteins[17](index=17&type=chunk) - The Company has operated at a loss since its inception and has had no revenues, anticipating continued losses[20](index=20&type=chunk) Liquidity Position (in thousands) | Metric | June 30, 2025 | | :-------------------------------- | :------------ | | Unrestricted cash and cash equivalents | $13,771 | | New line of credit (July 8, 2025) | $10,000 | - The Company believes it has sufficient cash, including the new line of credit, to fund planned operations through **June 30, 2026**, but needs to raise additional capital thereafter[20](index=20&type=chunk) [2. Accrued Expenses and Other](index=10&type=section&id=2.%20Accrued%20Expenses%20and%20Other) Accrued expenses decreased significantly from December 31, 2024, to June 30, 2025, primarily due to a reduction in accrued research and development costs and accrued compensation. The company accrues clinical trial expenses based on estimated work completed by CROs Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Legal and accounting fees | $71 | $74 | | Accrued compensation | $844 | $1,523 | | Lease liability | $52 | $19 | | Accrued research and development costs | $3,879 | $6,588 | | Total | $4,846 | $8,204 | - Accrued research and development costs decreased by **$2,709,000**, from **$6,588,000** to **$3,879,000**[22](index=22&type=chunk) - Accrued compensation decreased by **$679,000**, from **$1,523,000** to **$844,000**[22](index=22&type=chunk) [3. Convertible Notes Payable – Related Party](index=12&type=section&id=3.%20Convertible%20Notes%20Payable%20%E2%80%93%20Related%20Party) The company has three convertible promissory notes totaling $30 million from a related party (Richard E. Uihlein), all of which had their maturity dates extended to September 30, 2026. These notes bear 2% annual interest and include a contingent interest component recognized as a derivative liability, which has seen significant fair value changes - Three convertible promissory notes (April 2021, September 2021, December 2021), each for **$10,000,000**, were issued by Richard E. Uihlein[24](index=24&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk) - All three notes' maturity dates were extended to **September 30, 2026**, in connection with the July 2025 Supplemental Line of Credit[27](index=27&type=chunk)[28](index=28&type=chunk)[30](index=30&type=chunk)[103](index=103&type=chunk) - Contingent interest components of these notes are bifurcated and recognized as derivative liabilities, with fair values increasing significantly from December 31, 2024, to June 30, 2025[26](index=26&type=chunk)[29](index=29&type=chunk)[31](index=31&type=chunk)[34](index=34&type=chunk) [4. Fair Value of Financial Instruments](index=13&type=section&id=4.%20Fair%20Value%20of%20Financial%20Instruments) The company's Level 3 derivative liabilities, primarily contingent interest on convertible notes, increased substantially from December 31, 2024, to June 30, 2025. These are valued using a Monte Carlo Geometric Brownian Stock Path Model, with key assumptions including stock price, term, risk-free rate, credit-adjusted discount rate, and volatility Level 3 Derivative Liabilities (in thousands) | Derivative Liability | June 30, 2025 | December 31, 2024 | | :------------------------------------- | :------------ | :---------------- | | Contingent Interest April Note | $650 | $47 | | Contingent Interest September Note | $298 | $94 | | Contingent Interest December Note | $589 | $275 | | Total | $1,537 | $416 | - The fair value adjustment for the April Note derivative liability was **$603,000** for the six months ended June 30, 2025[35](index=35&type=chunk) - Key valuation assumptions for derivatives include a stock price of **$2.11** at June 30, 2025 (up from **$1.29** at Dec 31, 2024) and volatility ranging from **101%** to **102%**[35](index=35&type=chunk) [5. Stock-Based Compensation](index=16&type=section&id=5.%20Stock-Based%20Compensation) Total stock-based compensation expense decreased for both the three and six months ended June 30, 2025, compared to 2024. Stock option activity included significant grants and exercises, while restricted stock units were issued to employees with vesting tied to a partnership or year-end Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $254 | $386 | $530 | $709 | | General and administrative | $246 | $352 | $436 | $633 | | Total stock-based compensation expense | $500 | $738 | $966 | $1,342 | - **1,211,000** stock options were granted during the six months ended June 30, 2025, with a weighted-average grant date fair value of **$0.87**[37](index=37&type=chunk) - **504,000** restricted stock units valued at **$620,000** were issued to employees during the six months ended June 30, 2025, vesting on the earlier of a partnership or December 31, 2025[40](index=40&type=chunk) [6. Common Stock Warrants](index=18&type=section&id=6.%20Common%20Stock%20Warrants) The number of common stock warrants outstanding increased slightly from December 31, 2024, to June 30, 2025, with new grants and some forfeitures. The weighted average exercise price remained stable Common Stock Warrant Activity | Metric | Shares | Weighted Average Exercise Price | | :-------------------------- | :------- | :------------------------------ | | Outstanding, Dec 31, 2024 | 9,595,940| $4.22 | | Granted | 220,000 | $3.00 | | Forfeited/cancelled | (111,510)| $3.00 | | Outstanding, June 30, 2025 | 9,704,430| $4.20 | - The weighted average expiration of warrants outstanding as of June 30, 2025, is **1.6 years**[46](index=46&type=chunk) [7. Loss Per Share](index=18&type=section&id=7.%20Loss%20Per%20Share) Basic and diluted net loss per common share decreased for the six months ended June 30, 2025, compared to 2024. A significant number of potential common shares from warrants, options, convertible notes, and preferred stock were anti-dilutive and thus excluded from diluted EPS calculation Net Loss Per Common Share | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Net loss per common share — basic and diluted | $(0.27) | $(0.39) | Anti-Dilutive Shares (shares) | Instrument | June 30, 2025 | June 30, 2024 | | :------------------------------------------------ | :------------ | :------------ | | Warrants to purchase shares of common stock | 9,704,430 | 9,426,853 | | Options to purchase shares of common stock | 7,541,818 | 7,369,758 | | Restricted stock units | 496,520 | 408,000 | | Shares from convertible notes payable – related party | 7,327,374 | 6,721,188 | | Shares from convertible line of credit – related party | 29,621,834 | 21,016,837 | | Shares from preferred stock conversion | 495,007 | 499,174 | | Total Anti-Dilutive Shares | 55,186,983 | 45,441,810 | [8. Common Stock](index=18&type=section&id=8.%20Common%20Stock) The company issued 419,904 shares of common stock under its At Market Issuance Sales Agreement for net proceeds of $1,218,000 during the quarter ended June 30, 2025. Additionally, shares were issued for preferred stock dividends and conversions - **419,904** shares of common stock were issued under the 2020 At Market Agreement for net proceeds of approximately **$1,218,000** during the quarter ended June 30, 2025[49](index=49&type=chunk) - No shares were issued under the 2020 At Market Agreement during the quarter ended June 30, 2024[49](index=49&type=chunk) - **25,000** shares of Series A Convertible Preferred Stock were converted into **4,167** shares of common stock during the three months ended June 30, 2025[50](index=50&type=chunk) [9. Convertible Line of Credit – Related Party and Supplemental Convertible Lines of Credit – Related Party](index=19&type=section&id=9.%20Convertible%20Line%20of%20Credit%20%E2%80%93%20Related%20Party%20and%20Supplemental%20Convertible%20Lines%20of%20Credit%20%E2%80%93%20Related%20Party) The company has multiple convertible lines of credit from a related party, totaling $81 million, with various draws made and associated warrants issued. All maturity dates for these lines of credit were extended to September 30, 2026. Interest rates vary, and the principal and accrued interest are convertible into common stock at the lender's option - The original Line of Credit (July 2022) provided up to **$60 million**, with its maturity extended to **September 30, 2026**[51](index=51&type=chunk)[52](index=52&type=chunk)[103](index=103&type=chunk) - Several promissory notes were executed under this line, each for **$10 million**, with associated warrants issued to the lender[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk) - New supplemental lines of credit were established in March 2024 (**$10M**), November 2024 (**$6M**), and March 2025 (**$5M**), with draws made and warrants issued under each[69](index=69&type=chunk)[76](index=76&type=chunk)[82](index=82&type=chunk) - Accrued interest on these lines of credit increased significantly from December 31, 2024, to June 30, 2025, reflecting ongoing borrowings[56](index=56&type=chunk)[58](index=58&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk)[64](index=64&type=chunk)[66](index=66&type=chunk)[73](index=73&type=chunk)[80](index=80&type=chunk) [10. Segments](index=24&type=section&id=10.%20Segments) The company operates as a single segment focused on fibrotic disease therapeutics, with no product revenue. The Chief Executive Officer, as CODM, assesses performance based on net loss, net cash used in operating activities, and cash on hand, using cash forecast models for resource allocation - The Company's operations are viewed as one operating segment, focused on creating new therapies for fibrotic disease based on targeting galectin proteins[89](index=89&type=chunk) - The Company has not generated any product revenue and expects to incur significant expenses and operating losses for the foreseeable future[91](index=91&type=chunk) Segment Operating Results (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | | Total operating expenses | $12,522 | $20,939 | | Total operating loss | $(12,522) | $(20,939) | | Net loss | $(17,152) | $(23,860) | | Net cash used in operating activities | $(14,300) | $(20,400) | [11. Commitments and Contingencies](index=25&type=section&id=11.%20Commitments%20and%20Contingencies) The company has no significant pending legal proceedings and accrues for contingencies when probable and estimable. Clinical trial and research commitments are generally cancellable with 30 days' notice, and the company is negotiating with a contract vendor for clinical trial management services - There are no significant pending legal proceedings[98](index=98&type=chunk) - Agreements with contractors for R&D activities are generally cancellable with **thirty days' notice**[99](index=99&type=chunk) - The Company has accrued its estimate of the amount owed to a contract vendor for clinical trial management services[99](index=99&type=chunk) [12. Leases](index=26&type=section&id=12.%20Leases) The company has one operating lease for office space, renewed in March 2025 for twelve months. The lease liability and right-to-use asset are $52,000 as of June 30, 2025 - The Company renewed its office space lease in March 2025 for **twelve months**, effective March 1, 2022[100](index=100&type=chunk) Operating Lease Maturity (in thousands) | Year | Amount | | :--- | :----- | | 2025 | $33 | | 2026 | $22 | | Total| $55 | | Less imputed interest | $(3) | | Present value of lease liability | $52 | - The discount rate used for lease payments is **14%**[101](index=101&type=chunk) [13. Galectin Sciences LLC](index=26&type=section&id=13.%20Galectin%20Sciences%20LLC) Galectin Therapeutics Inc. co-owns Galectin Sciences LLC, a joint venture for galectin-3 inhibitor research. The company's ownership increased to 85.4% as of June 30, 2025, due to disproportionate funding contributions, and it accounts for the LLC as a consolidated, less than wholly owned subsidiary - Galectin Sciences LLC is a collaborative joint venture co-owned by SBH Sciences, Inc., focused on researching and developing small organic molecule inhibitors of galectin-3[102](index=102&type=chunk) - As of June 30, 2025, the Company's ownership percentage in the LLC was **85.4%**, up from an initial **50%**, due to providing more funding[102](index=102&type=chunk) - The Company has contributed a total of **$4,166,000** to the LLC cumulatively as of June 30, 2025[102](index=102&type=chunk) [14. Subsequent Event](index=26&type=section&id=14.%20Subsequent%20Event) On July 8, 2025, the company secured a new $10 million Supplemental Line of Credit from its chairman, Richard E. Uihlein, extending the maturity dates of all existing convertible notes and lines of credit to September 30, 2026. This new line also includes the issuance of warrants to the lender - On July 8, 2025, the Company entered into a new **$10 million** Supplemental Line of Credit with Richard E. Uihlein[103](index=103&type=chunk) - The maturity dates of all Convertible Notes Payable – Related Party and all borrowings under Convertible Lines of Credit – Related Party were extended to **September 30, 2026**[103](index=103&type=chunk) - In connection with this new line, the Company agreed to issue warrants to purchase up to **200,000** shares of common stock to the lender[106](index=106&type=chunk)[107](index=107&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, focusing on its clinical-stage drug development, particularly belapectin for NASH and cancer, and financial performance for Q2 2025, including R&D, G&A, and liquidity [Overview](index=29&type=section&id=Overview) Galectin Therapeutics is a clinical-stage biopharmaceutical company developing therapies for fibrotic diseases and cancer by targeting galectin proteins, particularly galectin-3. Its lead candidate, belapectin, is in development for NASH cirrhosis (NAVIGATE trial results presented) and cancer immunotherapy (Phase 2 trial planned for head and neck cancer) - The company is a clinical stage biopharmaceutical company focused on developing new therapies for fibrotic disease, cancer, and other conditions by targeting galectin proteins[112](index=112&type=chunk) - Belapectin (GR-MD-02) is the lead galectin-3 inhibitor, demonstrated in preclinical models to reverse liver fibrosis and cirrhosis, and in clinical studies to decrease portal hypertension[113](index=113&type=chunk) - Top-line results from the NAVIGATE Phase 2b/3 clinical trial for NASH cirrhosis showed a **49.3%** reduction in varices incidence in the per-protocol population (p<0.05) and a **68.1%** reduction in U.S. completer patients (p=0.02) for the belapectin **2 mg/kg** dose group[115](index=115&type=chunk)[140](index=140&type=chunk) - A Phase 2 trial for advanced or metastatic head and neck cancer using belapectin in combination with a checkpoint inhibitor is planned, pending financing[121](index=121&type=chunk)[152](index=152&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses decreased significantly for both the three and six months ended June 30, 2025, compared to 2024, primarily driven by a substantial reduction in research and development expenses due to the conclusion of the NAVIGATE clinical trial. General and administrative expenses also saw a modest decrease Operating Expenses (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | % Change | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | % Change | | :----------------------- | :--------------------------- | :--------------------------- | :------- | :--------------------------- | :--------------------------- | :------- | | Research and development | $3,261 | $9,813 | -67% | $9,746 | $17,867 | -45% | | General and administrative | $1,364 | $1,478 | -8% | $2,776 | $3,072 | -10% | | Total operating expenses | $4,625 | $11,291 | -59% | $12,522 | $20,939 | -40% | - The decrease in research and development expenses is primarily due to lower expenses related to the NAVIGATE clinical trial, which ended in the first quarter of 2025[155](index=155&type=chunk) - General and administrative expenses decreased due to lower stock compensation expense and investor relations/business development expense[158](index=158&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash and cash equivalents stood at $13.8 million as of June 30, 2025, supplemented by a new $10 million line of credit, which is expected to fund operations through June 30, 2026. Net cash used in operations decreased, but cash provided by financing activities also declined, indicating a continued need for future capital Liquidity and Cash Flow (in thousands) | Metric | June 30, 2025 | June 30, 2024 | | :------------------------------------- | :------------ | :------------ | | Cash and cash equivalents | $13,800 | $25,600 | | Net cash used in operations (6 months) | $(14,291) | $(20,438) | | Cash from financing activities (6 months) | $12,942 | $20,376 | - The Company had **$13.8 million** in unrestricted cash and cash equivalents at June 30, 2025, and secured a new **$10 million** line of credit in July 2025[159](index=159&type=chunk) - Management believes current cash and available credit are sufficient to fund operations through **June 30, 2026**, but additional financing will be required thereafter[159](index=159&type=chunk) [Off-Balance Sheet Arrangements](index=39&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements that are reasonably likely to materially affect its liquidity or capital resources - The Company has not created, and is not a party to, any special-purpose or off-balance sheet entities[161](index=161&type=chunk) [Application of Critical Accounting Policies and Estimates](index=39&type=section&id=Application%20of%20Critical%20Accounting%20Policies%20and%20Estimates) The preparation of financial statements requires significant estimates and judgments, particularly concerning accrued expenses, stock-based compensation, and contingencies. Critical accounting policies include stock-based compensation, accrued expenses, and income taxes - Critical accounting policies include stock-based compensation, accrued expenses, and income taxes[163](index=163&type=chunk) - Estimates are based on historical experience, contract terms, industry trends, and other factors, with actual results potentially differing under various assumptions[162](index=162&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures about Market Risk](index=39&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risk exposure is to changes in U.S. interest rates. However, due to its short-term investments in operating bank accounts and money market funds, the company believes it is not subject to any material market risk - The primary market risk is the risk of loss due to changes in U.S. interest rates[164](index=164&type=chunk) - The Company maintains its cash and cash equivalents in operating bank accounts and money market funds[164](index=164&type=chunk) - Due to the short-term duration of investments, the Company believes it is not subject to any material market risk exposure[164](index=164&type=chunk) [ITEM 4. Controls and Procedures](index=40&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025. No material changes in internal control over financial reporting occurred during the quarter - Disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[165](index=165&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[167](index=167&type=chunk) - Management acknowledges that no control system can provide absolute assurance against all errors and fraud[166](index=166&type=chunk) [PART II — OTHER INFORMATION](index=40&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [ITEM 1. Legal Proceedings](index=40&type=section&id=ITEM%201.%20Legal%20Proceedings) There are no significant pending legal proceedings to report - No significant pending legal proceedings are reported[169](index=169&type=chunk) [ITEM 1A. Risk Factors](index=40&type=section&id=ITEM%201A.%20Risk%20Factors) The company refers readers to the comprehensive list of risk factors detailed in its Annual Report on Form 10-K for the year ended December 31, 2024, which could materially impact its business, financial condition, or future results - Readers are directed to the risk factors in the Annual Report on Form 10-K for the year ended December 31, 2024[170](index=170&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - No unregistered sales of equity securities or use of proceeds to report[171](index=171&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=40&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - No defaults upon senior securities to report[171](index=171&type=chunk) [ITEM 4. Mine Safety Disclosures](index=40&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable[171](index=171&type=chunk) [ITEM 5. Other Information](index=40&type=section&id=ITEM%205.%20Other%20Information) The company announced its 2025 Annual Meeting of Stockholders will be a virtual meeting on December 3, 2025, and provided updated deadlines for stockholder proposals and nominations. Additionally, all three executive officers adopted Rule 10b5-1 trading arrangements during the quarter - The 2025 Annual Meeting of Stockholders is scheduled for **December 3, 2025**, as a virtual meeting[171](index=171&type=chunk) - Stockholder proposals for inclusion in the proxy statement must be received by **September 1, 2025**[173](index=173&type=chunk) - All three executive officers adopted Rule 10b5-1 trading arrangements during the fiscal quarter ended June 30, 2025[176](index=176&type=chunk) [ITEM 6. Exhibits](index=41&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications, XBRL taxonomy documents, and the interactive data file - Exhibits include Certifications Pursuant to Rule 13a-14(a) and 18 U.S.C. Section 1350[177](index=177&type=chunk) - Inline XBRL Instance Document and Taxonomy Extension Documents are also included[177](index=177&type=chunk)[178](index=178&type=chunk) [SIGNATURES](index=43&type=section&id=SIGNATURES) The report is duly signed on behalf of Galectin Therapeutics Inc. by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer, on August 14, 2025 - The report was signed by Joel Lewis, Chief Executive Officer and President, and Jack W. Callicutt, Chief Financial Officer[183](index=183&type=chunk) - The signing date for the report was **August 14, 2025**[182](index=182&type=chunk)

Core Viewpoint - Galectin Therapeutics Inc. has secured a new $10 million unsecured line of credit from Richard E. Uihlein, the Chairman and largest individual stockholder, to support its MASH cirrhosis program and ongoing operations [1][2]. Financial Details - The new credit line allows borrowings at the company's discretion until April 30, 2026, with an interest rate of 6.05% (4.05% plus 2%) [2]. - Principal and interest are due on September 30, 2026, and can be converted into shares at a minimum price of $3.00 per share [2]. - Up to 200,000 stock purchase warrants will be issued to Mr. Uihlein, with exercise prices ranging from $3.00 to $10.00 per share [2]. Existing Financial Obligations - The maturity dates for three existing $10 million convertible notes payable to Mr. Uihlein and $81 million in borrowings under other lines of credit have been extended to September 30, 2026 [3]. Company Strategy and Development - The financing is expected to cover projected expenditures through June 2026, allowing the company to focus on its NAVIGATE trial and potential FDA presentations [4]. - The company is actively seeking partnerships to support the development and commercialization of its lead drug, belapectin, for MASH cirrhosis and portal hypertension [4][5]. Product Information - Galectin Therapeutics is focused on developing therapies for chronic liver disease and cancer, with belapectin being its lead drug targeting galectin-3, which is involved in various diseases [5]. - The company has received Fast Track designation from the FDA for belapectin, which is aimed at treating MASH cirrhosis, a significant unmet medical need [5].

Belapectin for MASH Cirrhosis and Portal Hypertension - Belapectin, a galectin-3 inhibitor, has shown potential in reducing galectin-3 expression and fibrogenic activity in preclinical studies[7] - A Phase 2b trial (GT-026) indicated that Belapectin at a 2 mg dose significantly improved portal pressure (HVPG) and reduced the incidence of esophageal varices in patients without baseline varices at 52 weeks[7] - There are currently no FDA-approved therapies to reverse fibrosis in MASH cirrhosis, highlighting a significant unmet need[7] Market Opportunity and Patient Landscape - MASH cirrhosis affects an estimated 3%-5% of the global population and is considered underdiagnosed[14] - In the U S, approximately 5 million people progress to MASH cirrhosis, with 3.3 million having cirrhosis and portal hypertension[16] - The addressable market in the U S for compensated MASH cirrhosis is significant, with peak Belapectin sales estimated at $18 billion[28] NAVIGATE Trial Results - The NAVIGATE trial design involved randomizing 357 patients with MASH cirrhosis and no varices at baseline into three groups: Placebo, Belapectin 2 mg/kg/LBM, and Belapectin 4 mg/kg/LBM[37] - In the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of varices compared to placebo (11 3% vs 22 3%, p=0 04)[48] - In the U S subgroup of the per-protocol population, Belapectin 2 mg/kg significantly reduced the incidence of new esophageal varices compared to placebo (6 7% vs 21 0%, p=0 02)[56] - The study showed a favorable safety profile for Belapectin, with adverse events and discontinuation rates comparable to placebo[59]

Summary of Galectin Therapeutics (GALT) Update / Briefing Company Overview - **Company**: Galectin Therapeutics (GALT) - **Focus**: Development of belapectin as a treatment for NASH cirrhosis and portal hypertension, addressing a significant unmet medical need [2][4] Industry Context - **Condition**: NASH cirrhosis is a leading cause of liver transplantation in the US, with an estimated 5 million adults affected, including 3.3 million with portal hypertension [8][9] - **Market Opportunity**: Belapectin is positioned as a first-in-class therapy for NASH cirrhosis, with peak sales potential estimated at $18 billion [15] Clinical Trial Insights - **Clinical Trials**: Multiple Phase IIb trials conducted, including the NAVIGATE trial, which focused on patients with NASH cirrhosis and portal hypertension [5][19] - **Mechanism of Action**: Belapectin is a Galectin-3 inhibitor, which has shown anti-inflammatory and anti-fibrotic effects in preclinical studies [5][6] NAVIGATE Trial Findings - **Patient Population**: Included patients with compensated NASH cirrhosis and portal hypertension, with no baseline varices [20][21] - **Primary Endpoint**: Focused on the development of esophageal varices and other hepatic decompensation events [22][36] - **Results**: - Statistically significant reduction in new varices in the belapectin 2 mg/kg group (11.3% vs. 22.3% in placebo) [27] - Reduction in liver stiffness observed, indicating less disease progression [28][30] - Safety profile comparable to placebo, with no significant adverse events reported [31][37] Key Opinion Leaders' Perspectives - **Expert Opinions**: KOLs emphasized the urgent need for effective therapies in the NASH cirrhosis population, highlighting belapectin's potential to fill this gap [8][9][12] - **Market Feedback**: Positive responses from payers and physicians regarding the clinical and economic benefits of belapectin [14] Additional Insights - **Endoscopic Endpoint**: The NAVIGATE trial utilized centrally adjudicated endoscopy videos to track variceal development, enhancing the reliability of results [39][41] - **Comparison with Other Therapies**: Belapectin targets a more advanced patient population compared to other investigational therapies, which often select for less severe cases [62][63] Conclusion - **Future Outlook**: Belapectin shows promise in addressing the unmet needs of patients with advanced NASH cirrhosis and portal hypertension, with a favorable safety profile and significant market potential [36][60]