Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing best-in-class therapies for liver and viral diseases [2] - The company aims to improve patient outcomes through its science-driven approach and deep R&D expertise [2] Financial Announcement - Aligos Therapeutics will report its fourth quarter 2024 financial results on March 10, 2025, before the U.S. financial markets open [1] Pipeline and Therapeutic Focus - The company is advancing a pipeline of therapeutics targeting high unmet medical needs, including chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses [2]

Core Viewpoint - Aligos Therapeutics, Inc. has announced a private placement expected to generate approximately $105 million in gross proceeds to fund the Phase 2 clinical study of ALG-000184 and extend its cash runway into the second half of 2026 [1][3]. Group 1: Private Placement Details - The private placement is led by a life sciences dedicated investment firm, with participation from new and existing institutional investors [2]. - Aligos plans to use the net proceeds from the private placement, along with existing cash and investments, to advance ALG-000184 into a Phase 2 clinical study for chronic hepatitis B virus infection (CHB) and for general corporate purposes [2][3]. - The private placement involves the sale of 2,103,307 shares of common stock, including voting and non-voting shares, as well as pre-funded warrants and accompanying warrants at a combined price of $26.0825 per share [4]. Group 2: Financial Advisors and Closing Conditions - Jefferies and Piper Sandler are acting as placement agents for the private placement, while H.C. Wainwright & Co. serves as the financial advisor [5]. - The private placement is expected to close on February 13, 2025, subject to customary closing conditions [4]. Group 3: Company Overview - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases, with a mission to improve patient outcomes [8]. - The company utilizes a science-driven approach and deep R&D expertise to advance its pipeline for diseases with high unmet medical needs, including chronic hepatitis B virus infection (CHB) and metabolic dysfunction-associated steatohepatitis (MASH) [8].

Core Insights - Aligos Therapeutics, Inc. announced positive data from presentations at the AASLD The Liver Meeting 2024, showcasing advancements in therapies for liver and viral diseases [1][2]. Group 1: ALG-000184 for Chronic Hepatitis B - ALG-000184 demonstrated sustained HBV DNA suppression in 100% of HBeAg-positive subjects and 91% of HBeAg-negative subjects by Week 48, with no viral resistance observed [3][4]. - All subjects achieved sustained HBV RNA suppression by Week 44 for HBeAg-positive and Week 8 for HBeAg-negative subjects, indicating strong antiviral activity [4]. - The therapy is positioned as a potential first-line treatment for chronic hepatitis B, with the CEO expressing confidence in its role as a backbone for future HBV treatments [7]. Group 2: ALG-055009 for Metabolic Dysfunction-Associated Steatohepatitis (MASH) - ALG-055009 treatment resulted in significant liver fat reductions, with a placebo-adjusted median relative reduction of up to 46.2% at Week 12, and 70% of subjects achieving a ≥30% reduction [5][6]. - The treatment was well-tolerated, with gastrointestinal-related adverse events similar to placebo, and demonstrated a dose-dependent reduction in lipoprotein (a) by up to 26.8% [6]. - The data suggests ALG-055009 may enhance liver fat reduction in patients already on GLP-1 agonist therapy, indicating its potential for broader therapeutic applications [5][7].

Company Performance - Aligos Therapeutics reported a quarterly loss of $3.07 per share, which was worse than the Zacks Consensus Estimate of a loss of $2.15, representing an earnings surprise of -42.79% [1] - The company posted revenues of $1.27 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 26.90%, but down from $2.15 million in the same quarter last year [2] - Over the last four quarters, Aligos has surpassed consensus EPS estimates two times and topped revenue estimates just once [2] Stock Performance - Aligos Therapeutics shares have declined approximately 40.8% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current Zacks Rank for Aligos is 4 (Sell), indicating expectations of underperformance in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$1.47 on $1 million in revenues, and for the current fiscal year, it is -$8.20 on $2.6 million in revenues [7] - The outlook for the Medical - Biomedical and Genetics industry is relatively strong, ranking in the top 38% of over 250 Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]

Financial Performance - The company reported net losses of $49.1 million and $59.8 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $535.9 million as of September 30, 2024[104]. - The company has incurred net losses and negative cash flows from operations since its formation, with no revenue from product sales reported[104]. - The company expects to continue incurring significant expenses and increasing operating losses over the next several years due to ongoing research and development activities[104]. - Revenue from collaborations decreased by $2.1 million (99%) for the three months ended September 30, 2024, and by $7.0 million (96%) for the nine months ended September 30, 2024, primarily due to the completion of the Amended Agreement with Merck[114]. - General and administrative expenses decreased by $1.8 million (28%) for the three months ended September 30, 2024, compared to the same period in 2023, and decreased by $6.5 million (27%) for the nine months ended September 30, 2024[117]. - Total operating expenses for the three months ended September 30, 2024, were $21.400 million, a decrease of $0.910 million (4%) compared to $22.310 million in the same period of 2023[113]. - Interest income, net decreased by $0.548 million (55%) for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to a general decrease in market interest rates[118]. - Other income, net increased by $0.452 million (838%) for the three months ended September 30, 2024, compared to the same period in 2023, due to changes in fair value of common warrants[118]. - For the nine months ended September 30, 2024, the company utilized $62.3 million in cash for operating activities, primarily due to a net loss of $49.1 million[129]. - The net cash used in operating activities for the same period in 2023 was $56.3 million, resulting from a net loss of $59.8 million[129]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $100.3 million for the nine months ended September 30, 2024[128]. - The company has no committed external sources of funds and may need to raise additional capital, which could dilute existing ownership interests[126]. - The company expects to incur substantial additional funds to achieve its business objectives, as its drug candidates may not achieve commercial success[125]. - The company’s future capital requirements will depend on various factors, including the costs of research, development, and commercialization of its drug candidates[123]. Research and Development - The company is developing ALG-000184, a Capsid Assembly Modulator for chronic hepatitis B (CHB), which demonstrated HBV DNA suppression in 60% of subjects by Week 48 and 90% in HBeAg-positive subjects by Week 72[100]. - ALG-055009, a thyroid hormone receptor beta agonist for metabolic dysfunction associated steatohepatitis (MASH), showed statistically significant reductions in liver fat of up to 46.2% at Week 12 in Phase 2a trials[102]. - The company has initiated Phase 1 clinical trials for ALG-097558, a small molecule coronavirus 3CL protease inhibitor, which has shown to be at least 6-fold more potent than nirmatrelvir against SARS-CoV-2 variants[103]. - The Phase 1b study of ALG-000184 indicated potentially best-in-class antiviral activity with no viral breakthrough observed in HBeAg-negative subjects[101]. - The company plans to submit a new Phase 2 protocol for ALG-000184 in Q1 2025, following FDA clearance for a Phase 1 drug-drug interaction study[101]. - The Phase 2a HERALD study for ALG-055009 included 102 subjects and demonstrated a favorable tolerability profile with no evidence of clinical hyper/hypothyroidism[102]. - Research and development expenses for the three months ended September 30, 2024, increased by $0.9 million to $16.774 million compared to $15.867 million in the same period of 2023, primarily due to increased clinical study costs[115]. - Total direct research and development expenses for the nine months ended September 30, 2024, were $28.529 million, up from $22.179 million in the same period of 2023, reflecting a 29% increase[109]. - The company expects research and development expenses to increase substantially in connection with ongoing clinical development activities related to its drug candidates[120]. Funding and Capital Requirements - The company is exploring external funding options, including approximately $13.8 million from NIH awards to support the development of ALG-097558[104]. - The company has no material changes to its contractual obligations and commitments as of September 30, 2024[133]. - The company did not have any off-balance sheet arrangements during the periods presented[134]. - The company may need to relinquish valuable rights to its technology or future revenue streams if it raises additional funds through collaborations or licensing arrangements[127].

Financial Performance - Aligos reported a net loss of $19.3 million for Q3 2024, with a basic and diluted net loss per share of $(3.07), compared to a net loss of $18.0 million and $(10.37) per share in Q3 2023[7]. - Cash, cash equivalents, and investments totaled $74.9 million as of September 30, 2024, down from $135.7 million as of December 31, 2023, indicating a decrease of approximately 44.8%[6]. - Total operating expenses for Q3 2024 were $21.4 million, compared to $22.3 million in Q3 2023, indicating a slight decrease[15]. - Aligos believes its current cash balance is sufficient to fund planned operations through the end of 2025[6]. Research and Development - Research and development (R&D) expenses increased to $16.8 million in Q3 2024 from $15.9 million in Q3 2023, primarily due to higher third-party expenses for clinical trials[8]. - Aligos is progressing ALG-000184 for chronic hepatitis B (CHB) towards a Phase 2 study next year, with positive feedback from the FDA regarding its primary efficacy endpoint[3]. - The company expects to begin externally funded clinical studies for ALG-097558 in COVID subjects later this year, with three additional clinical studies planned for 2024[5]. Clinical Trial Results - The company announced positive topline HERALD data for ALG-055009, showing placebo-adjusted median relative reductions in liver fat of up to 46.2%[2]. - Up to 70% of subjects treated with ALG-055009 achieved a ≥30% relative reduction in liver fat compared to baseline[4]. General and Administrative Expenses - General and administrative (G&A) expenses decreased to $4.6 million in Q3 2024 from $6.4 million in Q3 2023, reflecting a reduction in third-party expenses including legal costs[9].

Core Insights - Aligos Therapeutics reported significant progress in its clinical programs and financial results for Q3 2024, highlighting the potential of its drug candidates for liver and viral diseases [1][2]. Recent Business Progress - The company achieved a milestone with positive topline HERALD data for ALG-055009, showing placebo-adjusted median relative reductions in liver fat of up to 46.2% [2][4]. - ALG-000184 is advancing towards a Phase 2 study for chronic hepatitis B (CHB), with positive feedback from the FDA and the National Medical Products Administration in China [3][4]. - ALG-097558, a pan-coronavirus protease inhibitor, is set to begin three additional clinical studies in 2024 [5]. Financial Results for Q3 2024 - Cash, cash equivalents, and investments totaled $74.9 million as of September 30, 2024, down from $135.7 million at the end of 2023, with sufficient funds projected to support operations through the end of 2025 [6]. - The net loss for Q3 2024 was $19.3 million, or $(3.07) per share, compared to a net loss of $18.0 million, or $(10.37) per share, in Q3 2023 [7]. - Research and development expenses increased to $16.8 million from $15.9 million year-over-year, primarily due to higher third-party clinical trial expenses [8]. Drug Candidates Overview - ALG-000184 is positioned as a potential first-/best-in-class treatment for CHB, with ongoing Phase 1a/1b studies and plans for future registration studies [3]. - ALG-055009 demonstrated significant efficacy in reducing liver fat and improving lipid profiles, with favorable tolerability [4]. - ALG-097558 is being evaluated in high-risk COVID patients, with studies sponsored by the AGILE University of Liverpool and the NIAID [5].

Company Announcement - Aligos Therapeutics, Inc. has appointed David Perry as Vice President of Business Development, effective immediately [1] - The company aims to maximize the potential of its pipeline, including ALG-055009, which has recently shown positive topline data [1] Leadership Background - David Perry brings over 20 years of experience in the life sciences industry, focusing on corporate strategy, business development, and investment management [1][2] - His previous role was Senior Director of Business Development at Sangamo Therapeutics, where he led significant licensing deals [1][2] - Perry has also held positions at Apexigen Inc. and Sumitomo Chemical, contributing to M&A and early-stage investments [2] Company Overview - Aligos Therapeutics is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases [3] - The company employs a science-driven approach to advance its pipeline targeting metabolic dysfunction-associated steatohepatitis (MASH) and high unmet medical needs such as hepatitis B and coronaviruses [3]

Group 1 - Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing therapies for liver and viral diseases, aiming to improve patient outcomes [2] - The company will participate in two upcoming investor conferences in October 2024, including the H.C. Wainwright 8th Annual MASH Virtual Conference and the H.C. Wainwright 5th Annual Viral Hepatitis Virtual Conference [1] - A live webcast of the events will be available on Aligos' website, with replays accessible for at least 30 days after the presentations [1] Group 2 - Aligos Therapeutics is dedicated to addressing high unmet medical needs in conditions such as metabolic dysfunction-associated steatohepatitis (MASH) and hepatitis B [2] - The company utilizes a science-driven approach and extensive R&D expertise to advance its pipeline of therapeutics [2]

Group 1 - Aligos Therapeutics, Inc. (ALGS) is currently outperforming its peers in the Medical sector with a year-to-date performance of 17.1%, compared to the sector average of 10.3% [2] - The Zacks Consensus Estimate for ALGS' full-year earnings has increased by 55.3% over the past 90 days, indicating improving analyst sentiment and a positive earnings outlook [2] - Aligos Therapeutics, Inc. holds a Zacks Rank of 2 (Buy), suggesting a favorable investment opportunity [1][2] Group 2 - Aligos Therapeutics, Inc. is part of the Medical - Biomedical and Genetics industry, which ranks 83 in the Zacks Industry Rank, while this industry has shown an average gain of 0% year-to-date [3] - Clover Health Investments, Corp. (CLOV), another outperforming stock in the Medical sector, has seen a year-to-date increase of 163.6% and holds a Zacks Rank of 2 (Buy) [2][3] - The Medical Info Systems industry, to which Clover Health belongs, is currently ranked 74 and has experienced a decline of 12.9% year-to-date [3]