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]

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 (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 participate at two investor conferences being webcast in October: H.C. Wainwright 8th Annual MASH Virtual Conference Fireside Chat at 3:00pm ET/12:00pm PT on October 7, 2024 H.C. Wainwright 5th Annual Viral Hepatiti ...

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]

Group 1: Company Overview - Aligos Therapeutics, Inc. (ALGS) closed at $14.48, with a 5.3% gain over the past four weeks, indicating potential upside based on Wall Street analysts' short-term price targets [1] - The mean price target is $108.33, suggesting a 648.1% upside potential, with the lowest estimate at $75 (418% increase) and the highest at $175 (1108.6% increase) [1] Group 2: Analyst Insights - Analysts show strong agreement on ALGS's ability to report better earnings, with a positive trend in earnings estimate revisions, which is a strong indicator of potential upside [2][5] - The Zacks Consensus Estimate for the current year has increased by 63.7% over the past month, with no negative revisions, indicating a positive outlook for the company's earnings [5] Group 3: Price Target Considerations - While price targets are often sought after, their reliability is questioned, as they can mislead investors more often than guide them accurately [3][4] - A low standard deviation among price targets indicates high agreement among analysts regarding the stock's price movement direction, serving as a starting point for further research [4]