SOUTH SAN FRANCISCO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from three oral presentations at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025, being held March 26 - 30, 2025 in Beijing, China. “We are pleased to present preliminary da ...

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].