Company Performance - Aligos Therapeutics reported a quarterly loss of $3.41 per share, significantly worse than the Zacks Consensus Estimate of a loss of $1.91, representing an earnings surprise of -78.53% [1] - The company's revenues for the quarter ended December 2024 were $0.63 million, missing the Zacks Consensus Estimate by 51.62%, and down from $2.68 million a year ago [2] - Over the last four quarters, Aligos Therapeutics has surpassed consensus EPS estimates only once and has topped consensus revenue estimates just once [2] Stock Movement and Outlook - Aligos Therapeutics shares have declined approximately 67.5% since the beginning of the year, contrasting with the S&P 500's decline of -1.9% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the revisions of earnings estimates [3][4] - The current consensus EPS estimate for the upcoming quarter is -$2.04 on $1 million in revenues, and for the current fiscal year, it is -$8.94 on $4 million in revenues [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Aligos Therapeutics belongs, is currently ranked in the top 26% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Aligos Therapeutics' stock performance [5][6]

Financial Performance - The company incurred significant net losses of $131.2 million for the year ended December 31, 2024, and $87.7 million for the year ended December 31, 2023[181]. - As of December 31, 2024, the company had a total stockholders' deficit of $29.0 million[181]. - The company has never generated revenue from product sales and does not anticipate doing so for the next several years[182]. - The company had cash, cash equivalents, and investments of $56.9 million as of December 31, 2024[185]. - The company may require substantial additional financing to achieve its goals, which may not be available on acceptable terms[185]. Funding and Investments - In October 2023 and February 2025, the company closed private investments generating approximately $92.1 million and $105.0 million in gross proceeds, respectively[185]. - The company expects to finance its cash needs through a combination of public or private equity offerings, debt financings, and collaborations[189]. - The company filed a Registration Statement on Form S-3 covering the offering of up to $400.0 million of various securities in November 2024[188]. Drug Development Challenges - The company has invested a significant portion of its resources in research and development activities since its inception[185]. - The company anticipates incurring significant costs associated with commercializing any approved drug candidates[184]. - The company has halted further development of drug candidate ALG-010133 due to insufficient antiviral activity observed in clinical trials[202]. - Development of drug candidate ALG-020572 was discontinued following a serious adverse event involving significant increase in alanine aminotransferase (ALT) levels in patients[202]. - The company is conducting clinical trials for drug candidate ALG-125755, which showed evidence of HBsAg lowering at all evaluated dose levels, but further evaluation is not prioritized due to funding constraints[202]. Regulatory and Compliance Issues - The company has limited experience in preparing and submitting regulatory filings, having not previously submitted a new drug application (NDA) to the FDA[205]. - Regulatory approval processes are lengthy and unpredictable, with no current drug candidates having received approval[213]. - The company plans to seek regulatory approval for its drug candidates in the United States and select foreign countries, which requires compliance with varying regulatory requirements[206]. - The company may face penalties or loss of marketing approval if it fails to comply with regulatory requirements post-approval[266]. - The FDA's review and approval processes can be affected by government funding and other disruptions, potentially delaying the company's product approvals[274]. Market and Competitive Landscape - The company is pursuing treatments for CHB and MASH, with significant investments in drug candidates like ALG-000184 and ALG-055009, respectively[229][232]. - The company faces competition from other firms developing more efficacious therapies for COVID-19, which could impact demand for its products[239]. - The availability of COVID-19 vaccines and oral COVID-19 drugs may reduce the need for potential COVID-19 therapies, negatively impacting commercial opportunities[288]. - The company may face significant delays in obtaining coverage and reimbursement for newly approved drugs, impacting commercial viability[300]. Intellectual Property and Patent Risks - The ability to obtain and maintain sufficient patent protection is critical for the company to compete effectively in the market and commercialize drug candidates[366]. - The company may face challenges in enforcing intellectual property rights, which could allow competitors to develop similar products, impacting its market position[367]. - The company currently holds several U.S. provisional patent applications, which require timely filing of non-provisional applications within 12 months to maintain priority dates[370]. - The company may lose patent protection if it fails to timely file non-provisional applications or if its licensors do not fulfill their obligations under licensing agreements[378]. Operational Risks - The company relies on third parties for clinical trials and studies, and any failure by these parties could substantially harm the business and delay marketing approvals[344]. - The company does not own manufacturing facilities and relies on third parties for drug supplies, increasing the risk of insufficient quantities or delays in development and commercialization efforts[350]. - There is a risk that third-party manufacturers may not be able to scale up production in a timely or cost-effective manner, potentially delaying regulatory approval or commercial launch of drug candidates[351]. Legal and Regulatory Compliance - Compliance with evolving data privacy laws, such as GDPR and CCPA, may impose significant operational challenges and financial penalties for non-compliance[324][323]. - The company must ensure compliance with various healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, to avoid significant operational and financial risks[363]. - The company anticipates ongoing legal complexity and uncertainty regarding international personal data transfers, which could adversely affect financial results[327].

Financial Performance - Aligos Therapeutics reported a net loss of $82.2 million for Q4 2024, compared to a net loss of $27.9 million in Q4 2023, resulting in a basic and diluted net loss per share of $(13.08) versus $(5.50) in the prior year[8][20]. - For the full year 2024, the net loss was $131.2 million, compared to $87.7 million in 2023, with a basic and diluted net loss per share of $(20.94) compared to $(34.20) in 2023[9][20]. - Cash, cash equivalents, and investments totaled $56.9 million as of December 31, 2024, down from $135.7 million at the end of 2023; following a $105 million private placement completed in February 2025, funding is expected to last into the second half of 2026[7][5]. - General and administrative (G&A) expenses for Q4 2024 were $5.2 million, compared to $6.4 million in Q4 2023, with total G&A expenses for the year at $22.8 million, down from $30.6 million in 2023[12][13]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $16.0 million, down from $22.3 million in Q4 2023, while total R&D expenses for the year were $70.3 million, slightly down from $73.0 million in 2023[10][11]. - Interim data from a Phase 1 study of ALG-000184 showed 100% sustained HBV DNA suppression in HBeAg-positive subjects by Week 48, with no viral breakthrough or known CAM resistant mutations observed[5][10]. - The Phase 2 clinical study for ALG-000184 is expected to begin in mid-2025, with the potential to replace standard care for chronic hepatitis B virus infection[2][5]. - ALG-055009 demonstrated statistically significant reductions in liver fat of up to 46.2% at Week 12, with 70% of subjects achieving a ≥30% relative reduction compared to baseline[5][12]. - Aligos commenced three additional clinical trials for ALG-097558 in 2024, with ongoing studies evaluating its efficacy in high-risk COVID-19 patients[6][12]. Funding and Development Strategy - The company is evaluating options for continued development funding, including potential out-licensing of its products[12][14].

Core Insights - Aligos Therapeutics reported significant business progress and financial results for Q4 and full year 2024, highlighting advancements in their clinical pipeline and financial activities [1][2]. Recent Business Progress - The company is advancing ALG-000184 towards a Phase 2 clinical study expected to begin in mid-2025, with the potential to replace standard care for chronic hepatitis B virus infection [2][3]. - ALG-055009 demonstrated statistically significant reductions in liver fat in a Phase 2a study, with up to 70% of subjects achieving a ≥30% relative reduction in liver fat compared to baseline [5][15]. - The company completed a $105 million private placement financing in February 2025, enhancing its financial position for ongoing operations [5]. Financial Results - As of December 31, 2024, cash, cash equivalents, and investments totaled $56.9 million, down from $135.7 million a year prior, but expected to fund operations into the second half of 2026 following the recent financing [7]. - The net loss for Q4 2024 was $82.2 million, compared to a net loss of $27.9 million in Q4 2023, with a basic and diluted net loss per share of $(13.08) [8][20]. - For the full year 2024, the net loss was $131.2 million, compared to $87.7 million in 2023, with a basic and diluted net loss per share of $(20.94) [9][20]. Research and Development Expenses - R&D expenses for Q4 2024 were $16.0 million, down from $22.3 million in Q4 2023, primarily due to decreased third-party expenses for clinical trials [10]. - For the full year 2024, R&D expenses totaled $70.3 million, slightly down from $73.0 million in 2023, with reductions in employee-related costs offset by increases in third-party expenses [11]. General and Administrative Expenses - G&A expenses for Q4 2024 were $5.2 million, down from $6.4 million in Q4 2023, attributed to decreased third-party expenses [12]. - For the full year 2024, G&A expenses were $22.8 million, compared to $30.6 million in 2023, reflecting a reduction in legal and other third-party expenses [13].

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].