Aligos Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results
- Aligos made significant advancements in their drug development pipeline for liver and viral diseases in 2023.
- The company raised $92 million in a private placement financing to support their operations.
- Aligos completed Phase 2a enabling activities for ALG-055009 and presented positive antiviral activity for chronic hepatitis B.
- Financially, Aligos ended 2023 with $135.7 million in cash, with net losses decreasing compared to the previous year.
- Net losses for the three months and year ended December 31, 2023, were still significant despite a decrease compared to the previous year.
- Research and development expenses increased for the three months ended December 31, 2023, primarily due to third-party expenses.
- General and administrative expenses also increased for the year ended December 31, 2023, mainly due to higher legal and patent attorney costs.
Insights
The financial results and business progress reported by Aligos Therapeutics, Inc. indicate a strategic positioning for the company's upcoming clinical trials and product development. The successful closing of a $92 million PIPE investment is a robust indicator of institutional confidence in the company's pipeline, particularly noting the focus on liver and viral diseases which are areas of high unmet medical need. The cash position of $135.7 million suggests a strong liquidity status, providing runway through the end of 2025 according to the company's projections.
However, an increase in net losses for the fourth quarter year-over-year, from $21.9 million to $27.9 million, raises concerns about the company's growing expenses despite a decrease in annual net loss from $96.0 million to $87.7 million. This decrease might reflect a strategic reallocation of resources from discontinued programs to more promising ones, such as ALG-055009 and ALG-000184. The focus on R&D is evident with the reported expenses, yet investors should monitor the balance between investment in innovation and the potential for returns on these investments.
Aligos Therapeutics' progress in its clinical pipeline, particularly with ALG-055009 and ALG-000184, is noteworthy. ALG-055009's potential as a THR-β agonist for MASH, a condition with limited treatment options, could represent a significant market opportunity. The completion of Phase 2a enabling activities and the anticipation of topline HERALD data by Q4 2024 could be a pivotal moment for the company. For ALG-000184, a small molecule CAM-E for chronic hepatitis B (CHB), the continuation of dosing in the Phase 1a/1b study and planned interim data presentations may offer early insights into its efficacy and safety profile.
Furthermore, the development of a pan-coronavirus protease inhibitor, ALG-097558, supported by NIAID, reflects the ongoing need for broad-spectrum antiviral therapies in the wake of the COVID-19 pandemic. This diversification of the pipeline could mitigate risk and enhance the company's potential market reach.
Aligos' strategic focus on liver and viral diseases taps into a significant global healthcare market with a growing demand for innovative treatments. The liver disease market, including NASH and hepatitis, is expected to grow substantially, driven by a rising prevalence of obesity and diabetes. Aligos' positioning with ALG-055009 and ALG-000184 could capitalize on this trend, provided the clinical outcomes are favorable. The company's visibility at major conferences like APASL, EASL and AASLD will be key for engaging the medical community and potential partners.
Additionally, the pan-coronavirus protease inhibitor program addresses a broader infectious disease market, which has gained heightened awareness and investment following the COVID-19 pandemic. The ongoing Phase 1 study and upcoming presentation at ECCMID could enhance Aligos' profile in the infectious disease space. The diverse portfolio addresses a range of markets, which may appeal to investors looking for biotech companies with multiple shots on goal.
SOUTH SAN FRANCISCO, Calif., March 12, 2024 (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 reported recent business progress and financial results for the fourth quarter and full year 2023.
“Last year we built the foundation for a critical 2024 by closing a
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
- Phase 2a enabling activities, including completion of supporting nonclinical/Phase 1 studies and manufacturing of drug supply, were completed
- The Phase 2a HERALD protocol was filed with the FDA in Q4 2023
- First subject dosed expected in Q2 2024 and topline HERALD data anticipated in Q4 2024
ALG-000184: Potential best-in-class small molecule CAM-E for CHB
- Dosing continues in the ongoing Phase 1a/1b ALG-000184-201 study, with multiple subjects now having been dosed for >1 year (total planned dosing duration is 96 weeks). Interim data readouts are planned to be presented this year at the following conferences: Asian Pacific Association for the Study of the Liver (APASL), European Association for the Study of the Liver (EASL), and American Association for the Study of Liver Diseases (AASLD)
- Phase 2 enabling activities, including regulatory interactions and drug supply manufacturing, are underway
ALG-097558: Potential best-in-class small molecule pan-coronavirus protease inhibitor
- The ongoing Phase 1 first in human study is nearing completion of dosing (Q2), with topline data to be presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) Annual Meeting, occurring in April 2024
- Phase 2 enabling activities are underway with financial support from the National Institute of Allergy and Infectious Diseases (NIAID)
Financial Results for the Fourth Quarter and Full Year 2023
Cash, cash equivalents and investments totaled
Net losses for the three months ended December 31, 2023 were
Net losses for the year ended December 31, 2023 were
Research and development (R&D) expenses for the three months ended December 31, 2023 were
R&D expenses for the year ended December 31, 2023, were
General and administrative (G&A) expenses for the three months ended December 31, 2023 were
G&A expenses for the year ended December 31, 2023, were
About Aligos
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction associated steatohepatitis (MASH) and viruses with high unmet medical need such as chronic hepatitis B (CHB) and coronaviruses.
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 that the company is well positioned to deliver planned milestones in 2024 and looking forward to sharing achievements with stakeholders throughout 2024; with respect to ALG-055009, that the first subject is expected to be dosed in Q2 2024 and that topline HERALD data are anticipated in Q4 2024; with respect to ALG-000184, that interim data readouts from the Phase 1a/1b study are planned to be presented in 2024 at the APASL, EASL and AASLD conferences; with respect to ALG-097558, that the Phase 1 first in human study is nearing completion of dosing for Q2 2024 with topline data to be presented at the ECCMID Annual Meeting in April 204; and that the company continues to believe its cash balance provides sufficient cash to fund planned operations through the end of 2025. 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’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2024 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.
| Aligos Therapeutics, Inc | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| Three Months Ended | Twelve Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (audited) (1) | |||||||||||||
| Revenue from Collaborations | $ | 2,009 | 3.537 | 9,338 | 13,907 | |||||||||||
| Revenue from Customers | 672 | - | 6,191 | - | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 22,257 | 19,100 | 73,040 | 85,077 | ||||||||||||
| General and administrative | 6,421 | 7,119 | 30,616 | 26,410 | ||||||||||||
| Total operating expenses | 28,678 | 26,219 | 103,656 | 111,487 | ||||||||||||
| Loss from operations | (25,997 | ) | (22,682 | ) | (88,127 | ) | (97,580 | ) | ||||||||
| Interest and other income, net | (1,925 | ) | 845 | 1,243 | 1,640 | |||||||||||
| Loss before income tax expense | (27,922 | ) | (21,837 | ) | (86,884 | ) | (95,940 | ) | ||||||||
| Income tax benefit (expense) | 30 | (49 | ) | (795 | ) | (106 | ) | |||||||||
| Net loss | (27,892 | ) | (21,886 | ) | (87,679 | ) | (96,046 | ) | ||||||||
| Basic and diluted net loss per common share | $ | (0.22 | ) | $ | (0.51 | ) | $ | (1.36 | ) | $ | (2.25 | ) | ||||
| Weighted-average number of shares used in computing basic and diluted net loss per common share | 126,726,942 | 42,836,163 | 64,260,588 | 42,695,227 | ||||||||||||
| Aligos Therapeutics, Inc. | |||||
| Condensed Consolidated Balance Sheets | |||||
| (In thousands) | |||||
| December 31, 2023 | December 31, 2022 | ||||
| (Unaudited) | (audited) (1) | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 135,704 | $ | 81,347 | |
| Short-term investments | - | 44,480 | |||
| Prepaid expenses and other current assets | 5,380 | 7,718 | |||
| Total current assets | 141,084 | 133,545 | |||
| Other assets | 10,443 | 13,148 | |||
| Total assets | $ | 151,527 | $ | 146,693 | |
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities | $ | 23,906 | $ | 33,129 | |
| Other liabilities, noncurrent | 35,541 | 9,664 | |||
| Total liabilities | 59,447 | 42,793 | |||
| Total stockholders’ equity | 92,080 | 103,900 | |||
| Total liabilities and stockholders’ equity | $ | 151,527 | $ | 146,693 | |
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(1) The condensed, consolidated statement of operations for the year ended December 31, 2022, and balance sheet as of December 31, 2022 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, 2022.
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
Media Contact
Veronica Eames
LifeSci Communications
veames@lifescicomms.com
FAQ
What was Aligos Therapeutics' cash, cash equivalents, and investments total as of December 31, 2023?
What was the net loss for the three months ended December 31, 2023?
What Phase 2a enabling activities were completed for ALG-055009?
Where are the interim data readouts planned to be presented for the ALG-000184-201 study?
What financial support is Aligos receiving for the Phase 2 enabling activities of ALG-097558?
