Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - SHF Holdings, Inc. (SHFS) increased by 150% to $8.17 - Lithium Americas Corp. (LAC) rose by 69% to $5.18 - Aqua Metals, Inc. (AQMS) gained 50% reaching $6.11 - CleanCore Solutions, Inc. (ZONE) up by 44% at $2.87 - Cyclerion Therapeutics, Inc. (CYCN) increased by 33% to $4.03 - Twin Vee Powercats Co. (VEEE) rose by 17% to $2.92 - Solidion Technology, Inc. (STI) up by 11% at $5.09 - China Pharma Holdings, Inc. (CPHI) increased by 11% to $2.18 - Stardust Power Inc. (SDST) rose by 10% to $3.04 - Aligos Therapeutics, Inc. (ALGS) increased by 7% to $11.03 [3] Premarket Losers - Aytu BioPharma, Inc. (AYTU) decreased by 15% to $2.11 - Professional Diversity Network, Inc. (IPDN) down by 13% to $4.10 - STRATA Skin Sciences, Inc. (SSKN) fell by 10% to $2.31 - Cohu, Inc. (COHU) decreased by 9% to $20.68 - Super League Enterprise, Inc. (SLE) down by 9% to $7.74 - CTW Cayman (CTW) fell by 9% to $2.29 - Fitell Corporation (FTEL) decreased by 8% to $7.70 - Soluna Holdings, Inc. (SLNH) down by 8% to $2.16 - StableX Technologies, Inc. (SBLX) decreased by 5% to $5.22 - Indaptus Therapeutics, Inc. (INDP) down by 5% to $2.95 [4]

Core Insights - Several biotech companies experienced significant after-hours stock gains due to clinical trial updates, funding announcements, and upcoming product showcases Group 1: Prime Medicine Inc. (PRME) - Shares rose 8.14% in after-hours trading, reaching $5.05 after a regular session close of $4.67, which was up 16.46% [2] - The company reported a narrowed net loss of $52.6 million or $0.41 per share on revenue of $1.12 million, highlighting early clinical data from its CGD program [3] - Upcoming catalysts include planned IND filings for Wilson's Disease and Alpha-1 Antitrypsin Deficiency in 2026, with initial clinical data expected in 2027 [4] Group 2: Meihua International Medical Technologies Co. Ltd. (MHUA) - Shares increased by 7.55% in after-hours trading, reaching $0.4444 after a regular session close of $0.4132, which was down 2.62% [4] - The company is set to report its quarterly earnings on September 18, 2025 [5] Group 3: Elutia Inc. (ELUT) - Shares rose 10.17% in after-hours trading, reaching $1.30 after closing at $1.18, which was down 3.28% [5] - Elutia announced clinical data showing its biologic envelopes significantly ease reoperations for cardiac implantable electronic devices, reducing procedural difficulty by over 40% [6] - The company will exhibit its EluPro antibiotic-eluting BioEnvelope at the Vizient Innovative Technology Exchange on September 17, 2025 [6] Group 4: Aligos Therapeutics Inc. (ALGS) - Shares increased by 2.79% in after-hours trading, reaching $9.20 after closing at $8.95, which was down 4.48% [7] - Aligos presented six preclinical studies at the 2025 International HBV Meeting, including new data on its capsid assembly modulator and a novel ASO strategy targeting hepatitis delta virus [8] - Upcoming catalysts include continued enrollment and data updates from the B-SUPREME study and a scheduled earnings report on November 5, 2025 [9] Group 5: Bionano Genomics Inc. (BNGO) - Shares fell 35.74% to $1.78 before rebounding 6.74% in after-hours trading to $1.90 [10] - The decline followed a $10 million public offering priced at $2.00 per share, expected to close around September 17, 2025 [11] - Bionano plans to use the funds for working capital and general corporate purposes, with recent publications highlighting the utility of its Optical Genome Mapping in cancer biomarker analysis [11] Group 6: Cognition Therapeutics Inc. (CGTX) - Shares climbed 6.21% in after-hours trading, reaching $1.71 after closing at $1.61, which was up 4.55% [12] - The company’s lead candidate, zervimesine, reached 75% enrollment in its Phase 2 START study for early Alzheimer's disease, backed by the National Institute on Aging [13] - Cognition recently closed a $30 million registered direct offering to support Phase 3 development [13]

Summary of Aligos Therapeutics Conference Call Company Overview - **Company**: Aligos Therapeutics - **Industry**: Biotechnology, focusing on liver and viral diseases - **Mission**: To improve patient outcomes by developing best-in-class therapies for chronic hepatitis B virus (HBV) infection and metabolic dysfunction-associated steatohepatitis (MASH) [1][34] Key Drug: ALG-000184 - **Type**: Capsid assembly modulator for HBV - **Discovery**: Originated from research by Professor Raymond Schinazi at Emory University, known for developing several antiviral drugs [3][4] - **Mechanism of Action**: - Binds to HBV core protein, preventing encapsulation of pregenomic RNA, thus blocking DNA production [4][16] - Evokes a secondary mechanism that reduces CCC DNA, a long-lived viral reservoir [6][17] - **Pharmacokinetics**: - Improved from 5% to 80% oral bioavailability [5] - Demonstrated significant reductions in HBV DNA and surface antigens in clinical studies [6][7] Clinical Data and Efficacy - **Phase 1B Study**: - 96-week data showed no emergence of drug resistance, allowing for potential monotherapy [10][11] - Achieved 100% of E antigen negative patients below 10 international units of HBV DNA at week 48, compared to historical data of around 20% for standard treatments [21][22] - **Endpoints**: - Primary endpoint for monotherapy is chronic suppression of HBV DNA [18][19] - Importance of achieving below 10 international units for better long-term outcomes, including reduced liver cancer progression [20][22] Future Development: B Supreme Study - **Design**: Ongoing phase 2 study comparing ALG-000184 with TDF in both E positive and E negative patients [24][25] - **Goals**: - Superiority in HBV DNA endpoints and antigen reductions [27][28] - Paired biopsies to quantify integration events and CCC DNA levels [28] Competitive Landscape - **Positioning**: ALG-000184 aims to become the standard of care for chronic HBV suppression and a backbone for functional cure regimens [30][31] - **Antisense Oligonucleotide Program**: Aligos is developing its own ASO program to complement ALG-000184, enhancing potential treatment options [31] Other Drug: ALG-055009 for MASH - **Mechanism**: Targets metabolic dysfunction in liver disease, showing significant fat reduction in phase 2A studies [36][37] - **Combination Potential**: Compatible with GLP-1 therapies, enhancing fat reduction and weight loss [38][39] Upcoming Milestones - **2025-2027 Timeline**: - Final data from the 96-week study of ALG-000184 to be presented at AASLD [41] - Interim readout from the B Supreme study in 2026 [41] - Partnership announcement for ALG-055009 expected early next year [42] Conclusion - Aligos Therapeutics is positioned to address significant unmet needs in the treatment of HBV and MASH, with promising clinical data and a robust pipeline aimed at improving patient outcomes in these areas [40][43]

Core Insights - Aligos Therapeutics, Inc. announced six presentations at the 2025 International HBV Meeting, highlighting its commitment to advancing therapies for liver and viral diseases [1][2][3] Group 1: Presentations Overview - The presentations include three oral presentations and cover topics such as novel approaches and molecular strategies for treating hepatitis B and delta virus infections [2][3] - The Phase 2 B-Supreme study is progressing well, with new data showing the effects of ALG-000184 in reducing HBV cccDNA in preclinical settings [3] - The company is also focusing on a proprietary antisense oligonucleotide (ASO) approach aimed at potentially curing hepatitis delta virus (HDV) infection [2][3] Group 2: Specific Presentation Details - Oral Presentation 52: "The CAM-E ALG-001075 potently reduces HBV cccDNA in preclinical experiments" presented by Yannick Debing on September 11, 2025 [3][4] - Oral Presentation 53: "Antisense oligonucleotide-based strategy to target hepatitis delta virus infections" presented by Julie Lucifora on September 11, 2025 [3][4] - Oral Presentation 2: "A Syrian hamster model of persistent HDV infection" presented by Elias Broeckhoven on September 8, 2025 [3][4] Group 3: Company Background - Aligos Therapeutics is a clinical stage biotechnology company focused on developing best-in-class therapies for liver and viral diseases, including chronic hepatitis B virus (HBV) infection and metabolic dysfunction-associated steatohepatitis (MASH) [5]

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that members of management will present at the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025. A webcast of the on demand presentation will be accessible by visiting the Presentation & Events section on the ...

Core Insights - Aligos Therapeutics, Inc. has appointed Ramón Polo as Senior Vice President, Head of Global Regulatory Affairs, effective immediately, to enhance its leadership team during the development of ALG-000184 [1][2] - Dr. Polo brings extensive regulatory expertise from his previous roles at Shionogi Inc. and Johnson & Johnson, where he managed global regulatory strategies and played a key role in the COVID-19 vaccine rollout [2][3] Company Overview - Aligos Therapeutics is a clinical stage biotechnology company focused on developing therapies for liver and viral diseases, with a mission to improve patient outcomes [3] - The company is advancing a pipeline targeting high unmet medical needs, including chronic hepatitis B virus (HBV) infection and metabolic dysfunction-associated steatohepatitis (MASH) [3]

Core Insights - Aligos Therapeutics, Inc. has appointed Ramón Polo as Senior Vice President, Head of Global Regulatory Affairs, effective immediately, to enhance its leadership team during the development of ALG-000184 [1][2] - Dr. Polo brings extensive regulatory expertise from his previous roles at Shionogi Inc. and Johnson & Johnson, where he managed global regulatory strategies and played a key role in the COVID-19 vaccine rollout [2][3] - Aligos is focused on developing therapies for liver and viral diseases, with a pipeline targeting unmet medical needs such as chronic hepatitis B virus infection and metabolic dysfunction-associated steatohepatitis [3] Company Overview - Aligos Therapeutics, Inc. is a clinical stage biotechnology company dedicated to improving patient outcomes through innovative therapies for liver and viral diseases [3] - The company employs a science-driven approach and has a robust R&D pipeline aimed at addressing significant medical needs [3]

Group 1 - Aligos Therapeutics, Inc. (ALGS) closed at $8.77, with a 1.5% gain over the past four weeks, and a mean price target of $95 suggests a potential upside of 983.2% [1] - The mean estimate includes three short-term price targets with a standard deviation of $69.46, indicating variability; the lowest estimate of $50.00 suggests a 470.1% increase, while the highest target of $175.00 indicates a potential surge of 1895.4% [2] - Analysts agree that ALGS is expected to report better earnings than previously estimated, which strengthens the view of potential upside [4][11] Group 2 - The Zacks Consensus Estimate for ALGS has increased by 14.9% due to one upward revision in earnings estimates over the last 30 days, with no negative revisions [12] - ALGS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for near-term upside [13] - While the consensus price target may not be a reliable indicator of the extent of gains, it does provide a directional guide for price movement [14]

Core Insights - Aligos Therapeutics has initiated dosing in the Phase 2 B-SUPREME study for its investigational compound ALG-000184 targeting chronic hepatitis B virus (HBV) infection [1][2][3] - The study aims to evaluate the safety and efficacy of ALG-000184 compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects over 48 weeks [2][3] - Chronic HBV infection affects 254 million patients globally, with approximately 1.08 million deaths attributed to complications in 2022 [4] Company Overview - Aligos Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for liver and viral diseases [5][6] - The company aims to improve patient outcomes through best-in-class therapies, leveraging its R&D expertise [5][6] Product Details - ALG-000184 is a small molecule capsid assembly modulator (CAM-E) showing promising antiviral activity and good tolerability in Phase 1 studies [3] - The Phase 1 studies demonstrated sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg [3] - The regulatory path for ALG-000184 has been acknowledged by the FDA, EMA, and NMPA for further studies [3] Clinical Study Information - The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial [2][3] - Primary endpoints include achieving HBV DNA levels below the lower limit of quantification (LLOQ) [2] - Interim data is expected in 2026, with topline data anticipated in 2027 [2][3] Industry Context - Chronic HBV infection is a significant global health issue, with increasing mortality rates associated with liver cancer [4] - The need for improved therapies is underscored by the limitations of current treatment options [2][4]

Company Performance - Aligos Therapeutics reported a quarterly loss of $1.53 per share, which was better than the Zacks Consensus Estimate of a loss of $2.35, representing an earnings surprise of +34.89% [1] - The company posted revenues of $0.97 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 3.5%, and down from $1.06 million a year ago [2] - Over the last four quarters, Aligos has surpassed consensus EPS estimates two times and topped revenue estimates only once [2] Stock Movement and Outlook - Aligos Therapeutics shares have declined approximately 80.2% since the beginning of the year, contrasting with the S&P 500's gain of 7.1% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$2.48 on $1 million in revenues, and for the current fiscal year, it is -$9.71 on $2.16 million in revenues [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Aligos belongs, is currently ranked in the bottom 42% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aligos's stock performance [5][6]