NORCROSS, Ga., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3 for patients with MASH cirrhosis and portal hypertension, today announced participation in the AASLD Liver Meeting 2025. The company will deliver two presentations, including one oral and one poster presentation, highlighting data from the NAVIGATE trial assessing belapectin for the treatment of MASH cirrhosis. The meeting will be held November 7-11, 2025, ...

At 7:50 a.m. ET on Friday, premarket trading is seeing notable activity in several stocks, with early price movements signaling potential opportunities before the opening bell.For active traders, premarket trading offers a head start in spotting potential breakouts, reversals, or sharp price swings. These early moves often indicate where momentum may carry into the regular session, making premarket analysis a key part of the trading day.In the Green - Premarket GainersThe following stocks are trading highe ...

Group 1: Stitch Fix, Inc. - Stitch Fix reported a quarterly loss of $0.07 per share, which was better than the consensus estimate of a loss of $0.10 per share [1] - The company's quarterly revenue was $311.22 million, exceeding the Street estimate of $305.83 million [1] - Despite the positive revenue results, Stitch Fix shares dipped 7.6% to $5.21 in pre-market trading [1] Group 2: Other Stocks - Transocean Ltd. saw a decline of 14.7% to $3.10 following the announcement of an upsized public offering of shares [4] - Nanobiotix S.A. fell 9.8% to $14.83 after previously gaining over 15%, related to new results from a Phase 1 study [4] - MBX Biosciences, Inc. dropped 5.5% to $19.00 due to the pricing of an upsized public offering [4] - Other companies such as Galectin Therapeutics Inc., Amprius Technologies, Inc., and Canaan Inc. also experienced declines in pre-market trading [4]

Group 1: AI Investment Opportunity - Artificial intelligence is identified as the greatest investment opportunity of our lifetime, with a strong emphasis on the urgency to invest now [1] - Wall Street is investing hundreds of billions into AI, but there is a critical question regarding the energy supply needed to support this technology [2] - AI data centers consume massive amounts of energy, comparable to the energy usage of small cities, leading to concerns about power grid strain and rising electricity prices [2] Group 2: Company Overview - A specific company is highlighted as a potential investment opportunity, owning critical energy infrastructure assets that are essential for supporting the anticipated surge in AI energy demand [3][6] - This company is positioned as a "toll booth" operator in the AI energy boom, benefiting from the increasing need for electricity as AI technologies expand [4][5] - It is noted that the company is debt-free and has a significant cash reserve, amounting to nearly one-third of its market capitalization, which provides financial stability [8] Group 3: Market Position and Growth Potential - The company plays a pivotal role in U.S. LNG exportation and is capable of executing large-scale engineering, procurement, and construction projects across various energy sectors [7] - It also holds a substantial equity stake in another AI-related company, offering investors indirect exposure to multiple growth engines in the AI sector [9] - The company is trading at a low valuation, less than 7 times earnings, which presents a compelling investment opportunity given its critical infrastructure and growth potential [10] Group 4: Future Trends and Talent Pool - The future of energy is closely tied to AI, with a focus on the need for infrastructure to support this technological advancement [6][14] - There is a significant influx of talent into the AI field, ensuring continuous innovation and advancements, which further solidifies the investment case for companies involved in AI and energy [12]

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]

NORCROSS, Ga., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and six months ended June 30, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "We are encouraged by the continued analysis of data from our NAVIGATE trial , which further supports the clinical profile of belapectin in patients with ...

[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)