Aligos Therapeutics Reports Recent Business Progress and First Quarter 2025 Financial Results
- Raised over $100M for Phase 2 study advancement
- Strong Phase 1 results for ALG-000184 with 100% HBV DNA suppression in HBeAg+ subjects
- ALG-055009 achieved up to 46.2% liver fat reduction in Phase 2a HERALD study
- Healthy cash position of $137.9M, extending runway into H2 2026
- Net income of $43.1M in Q1 2025, compared to net loss of $34.9M in Q1 2024
- Reduced operating expenses with R&D down to $14.5M from $16.4M YoY
- Diluted net loss per share of $(2.11) despite positive basic EPS
- Interest and other income decreased to $0.9M from $1.6M YoY
- Still seeking external funding/partners for ALG-055009 development
Insights
Aligos shows promising HBV drug with 100% viral suppression in Phase 1, secures $100M funding for Phase 2 trial starting mid-2025.
Aligos Therapeutics continues to generate compelling data for their lead hepatitis B candidate ALG-000184. The 96-week dosing data presented at APASL 2025 demonstrated 100% viral suppression in HBeAg+ subjects and 91% of HBeAg- subjects achieving HBV DNA below detection limits at week 48. These results are particularly impressive as the compound showed no viral breakthrough or development of resistance mutations throughout the extended treatment period.
The company's Phase 2 B-SUPREME study design appears well-constructed with approximately 200 subjects and appropriate primary endpoints focusing on viral suppression. The timeline puts potential interim data in 2026 and topline results in 2027, representing a critical value inflection point if positive.
Their THR-β agonist for MASH (ALG-055009) also demonstrated strong efficacy with up to 46.2% placebo-adjusted reductions in liver fat. Notably, 70% of subjects achieved ≥30% relative reduction in liver fat - a threshold that typically predicts histological improvements. The data showing benefits in patients already taking GLP-1 agonists is particularly intriguing, suggesting potential complementary mechanisms that could position this agent well in the evolving MASH treatment landscape.
The partnering discussions mentioned for ALG-055009 with multinational pharmaceutical companies represent a strategic prioritization of resources toward their lead HBV program while potentially securing non-dilutive funding through partnership.
Aligos strengthens financial position with $100M+ raise, extending runway into H2 2026; reports accounting-driven net income of $43.1M.
Aligos has significantly bolstered its balance sheet, with cash, equivalents and investments increasing to
While the company reported net income of
Operational expenses show disciplined financial management with R&D expenses decreasing
The company's approach of selectively partnering certain assets while maintaining full ownership of their lead HBV program represents a balanced strategy that could potentially bring in non-dilutive capital while preserving the most significant value driver. This capital-efficient approach is particularly important given the extended timeline to potential commercialization, with Phase 2 data not expected until 2027.
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biotechnology company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today reported recent business progress and financial results for the first quarter 2025.
“We continued to make progress towards our corporate development plans aimed at advancing life-saving therapies for viral and liver diseases,” stated Lawrence Blatt, Ph.D., M.B.A., Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “Over the past few months, we raised over
Recent Business Progress
Pipeline Updates
ALG-000184: Potential first-/best-in-class small molecule CAM-E for chronic hepatitis B virus (HBV) infection
- 96-week dosing recently completed in the Phase 1 study and data readouts are planned for scientific conferences this year
- Interim data from up to 96 weeks following an oral daily dose of 300 mg ALG-000184 in both HBeAg+ and HBeAg- subjects with chronic HBV infection were presented at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL) 2025
- ALG-000184 administered for up to 96 weeks was well tolerated, exhibited a favorable PK profile, and demonstrated potentially best-in-class antiviral activity
- Data from ≤84 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL, target detected or target not detected) in 9/9 (
100% ) HBeAg+ subjects - All 11/11 (
100% ) HBeAg- subjects achieved sustained HBV DNA suppression (<LLOQ <10 IU/mL, target detected or target not detected) by week 24 with 10/11 (91% ) subjects achieving HBV DNA below the lower limit of detection (LLOQ <4.29 IU/mL, target not detected) at week 48 - Multi-log10 reductions in HBsAg, HBeAg, and HBcrAg were observed in HBeAg+ subjects, and HBcrAg decline was observed in HBeAg- subjects. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough observed and no known CAM resistant mutations identified with monotherapy treatment
- The Phase 2 B-SUPREME study is expected to be a randomized, double-blind, active-controlled multicenter study evaluating the safety and efficacy of ALG-000184 compared with tenofovir disoproxil fumarate in approximately 200 untreated HBeAg+ and HBeAg- adult subjects with chronic HBV infection for 48 weeks. The expected primary endpoint in the HBeAg+ part will be HBV DNA <LLOQ (10 IU/mL, target detected [TD] or target not detected [TND]) and the primary endpoint in the HBeAg- part will be HBV DNA <LLOQ (10 IU/mL target not detected [TND]). The study will also evaluate the safety, pharmacokinetics, and other secondary and exploratory biomarkers, including reductions in HBV antigens and other markers of HBV infection. The Phase 2 study is expected to begin in mid-2025 with interim data projected in 2026 and topline data anticipated in 2027.
ALG-055009: Potential best-in-class small molecule THR-β agonist for metabolic dysfunction-associated steatohepatitis (MASH)
- The Phase 2a HERALD data were presented at APASL 2025, demonstrating that ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at week 12 as measured by MRI-PDFF
- Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at week 12, with placebo-adjusted median relative reductions up to
46.2% as measured by MRI-PDFF. Up to70% of subjects achieved ≥30% relative reduction in liver fat compared to baseline, a positive prognostic indicator of histological improvements in MASH resolution and fibrosis reduction - Eighteen subjects who were on stable GLP-1 agonist therapy qualified for enrollment in the study, with liver fat content meeting the inclusion criteria of ≥
10% at baseline as measured by MRI-PDFF. Notably, 11/14 subjects on stable GLP-1 agonists treated with ALG-055009 had liver fat decreases, whereas 4/4 subjects on stable GLP-1 agonists treated with placebo had increases in liver fat over the 12-week dosing period - Significant reductions in atherogenic lipids, including LDL-C, lipoprotein (a) and apolipoprotein B and dose-dependent increases in SHBG were observed. In particular, ALG-055009 demonstrated a dose-dependent median reduction from baseline of up to
26.8% at week 12 for lipoprotein (a), which is an established risk factor for cardiovascular disease that has been resistant to treatment with statin therapy - Treatment with ALG-055009 was well-tolerated, with rates of gastrointestinal-related AEs similar to placebo
- Doses of 0.5 mg to 0.9 mg ALG-055009 demonstrated statistically significant reductions in liver fat at week 12, with placebo-adjusted median relative reductions up to
- The company is continuing to evaluate a variety of options to fund continued development, including potential out-licensing
ALG-097558: Potential best-in-class ritonavir-free small molecule pan-coronavirus protease inhibitor
- Three additional clinical trials evaluating ALG-097558 commenced in 2024
- The NIAID is also sponsoring a drug-drug interaction and relative bioavailability study of ALG-097558 in healthy volunteers that is expected to start dosing in the second quarter of 2025
- The company expects any future development of ALG-097558 to be funded by external sources
Financial Results for the First Quarter 2025
Cash, cash equivalents and investments totaled
Net income for the three months ended March 31, 2025 was
Research and development (R&D) expenses for the three months ended March 31, 2025 were
General and administrative (G&A) expenses for the three months ended March 31, 2025 were
Interest and other income, net, for the three months ended March 31, 2025 was income of
Change in fair value of 2023 common warrants for the three months ended March 31, 2025 was income of
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biotechnology company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of therapeutics for high unmet medical needs such as chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements with respect to Aligos being positioned for success; the expectation that a Phase 2 clinical study for ALG-000184 will begin in mid-2025 and begin dosing in mid-2025; the potential of CAM-E and ALG-000184; the planned presentation at upcoming scientific conferences for ALG-000184; the expectation of continued development and potential out-licensing for ALG-055009 and future development of ALG-097558; the expectations regarding ALG-055009 and ALG-097558 funding; and the company’s continued belief its cash, cash equivalents and investments provide sufficient funding of fund planned operations into the second half of 2026. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the impact of global events and other macroeconomic conditions on Aligos’ business. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2025 and Aligos’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2025 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
| Aligos Therapeutics, Inc | ||||||||
| Condensed Consolidated Statements of Operations | ||||||||
| (In thousands, except share and per share amounts) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Revenue from Collaborations | $ | - | $ | 292 | ||||
| Revenue from Customers | 311 | 694 | ||||||
| Operating Expenses: | ||||||||
| Research and development | 14,502 | 16,366 | ||||||
| General and administrative | 5,052 | 6,666 | ||||||
| Total operating expenses | 19,554 | 23,032 | ||||||
| Loss from operations | (19,243 | ) | (22,046 | ) | ||||
| Interest and other income, net | 880 | 1,579 | ||||||
| Change in fair value of 2023 common warrants | 61,494 | (14,372 | ) | |||||
| Income (loss) before income tax provision | 43,131 | (34,839 | ) | |||||
| Income tax provision | (43 | ) | (24 | ) | ||||
| Net income (loss) | $ | 43,088 | $ | (34,863 | ) | |||
| Net income (loss) per share, basic | $ | 5.12 | $ | (5.58 | ) | |||
| Net loss per share, diluted | $ | (2.11 | ) | $ | (5.58 | ) | ||
| Weighted-average shares of common stock, basic | 8,408,481 | 6,246,113 | ||||||
| Weighted-average shares of common stock, diluted | 8,709,693 | 6,246,113 | ||||||
| Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| (Unaudited) | (audited) (1) | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 73,763 | $ | 36,997 | |||
| Short-term investments | 64,098 | 19,942 | |||||
| Prepaid expenses and other current assets | 5,344 | 5,202 | |||||
| Total current assets | 143,205 | 62,141 | |||||
| Other assets | 7,494 | 7,953 | |||||
| Total assets | $ | 150,699 | $ | 70,094 | |||
| Liabilities and Stockholders’ Equity (Deficit) | |||||||
| Current liabilities | $ | 18,948 | $ | 21,737 | |||
| Other liabilities, noncurrent | 15,306 | 77,330 | |||||
| Total liabilities | 34,254 | 99,067 | |||||
| Total stockholders’ equity (deficit) | 116,445 | (28,973 | ) | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 150,699 | $ | 70,094 | |||
| _____________________________________________ | |
| (1) | The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements at that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. |
FAQ
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