Aligos Therapeutics Reports Recent Business Progress and First Quarter 2024 Financial Results
Aligos Therapeutics, a clinical stage biopharmaceutical company, reported recent business progress and financial results for the first quarter of 2024. They initiated the Phase 2a HERALD study of their drug candidate ALG-055009 and presented positive data on their other programs at scientific conferences. The company's cash balance remains strong to fund operations until the end of 2025.
Initiated Phase 2a HERALD study of ALG-055009 with topline data expected in Q4 2024
Positive data presented on ALG-000184 and ALG-097558 at scientific conferences
Demonstrated favorable pharmacodynamic effects on atherogenic lipids and SHBG with ALG-055009
Consistent, potent antiviral activity shown across multiple cohorts with ALG-000184
Received an additional $1.3M grant from the NIH for ALG-097558
Net losses increased to $34.9 million for the first quarter of 2024
Decrease in cash, cash equivalents, and investments from December 2023 to March 2024
Net loss per common share increased compared to the same period in 2023
Decrease in R&D and G&A expenses offset by an increase in third-party expenses
Interest and other income (expense) shifted to an expense due to fair value changes
Insights
Financial health is a important parameter for investors gauging the viability of a biopharmaceutical company like Aligos Therapeutics. A key takeaway from their report is the cash runway, which is expected to last through the end of 2025. This signals a reduced risk of immediate dilution for shareholders and provides assurance that current research can proceed without financial hindrance. However, the quarterly net loss has widened to
On the operational side, reductions in R&D and G&A expenses reflect tighter cost control, potentially stretching the company's financial resources further and enhancing its sustainability. The positive shift in net loss per share, from
The progression of Aligos' clinical programs is noteworthy, with ALG-055009 entering Phase 2a and the anticipation of topline HERALD data in Q4 2024. Investors should recognize the value inflection points in clinical trial data readouts which can precipitate significant stock movement. The extension of dosing in the ALG-000184 study to 96 weeks and ongoing presentations at major liver disease conferences could reflect confidence in its long-term potential for treating CHB.
Notably, the additional grant from NIH for ALG-097558 suggests government interest and support for their therapeutic approach, which may provide additional credibility to the program. However, it's essential to weigh the inherent risks of drug development, including potential regulatory setbacks or unfavorable trial results, which can adversely affect the stock's performance.
When analyzing investment risks, one must consider the non-cash charges related to the change in fair value of the Common Warrants liability. Such fluctuations often do not impact the company's operational cash flow and may reflect market volatility rather than company performance. Despite this, a substantial non-cash charge as observed can affect investor sentiment and the perceived financial stability of the company.
With ongoing Phase 2 enabling activities and further clinical studies, Aligos Therapeutics seems to be moving forward with its pipeline. However, the risks associated with drug development are high and the success of these programs is critical to justifying the company's current valuation and ensuring future financial stability. Investors should remain cautious of the challenges ahead and evaluate the balance of scientific progress against financial prudence.
SOUTH SAN FRANCISCO, Calif., May 07, 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 first quarter 2024.
“We have executed on a number of key deliverables to position Aligos for success,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President & CEO of Aligos Therapeutics. “Importantly, we began dosing in the Phase 2a HERALD study of our THR- drug candidate, ALG-055009, and we expect topline data in Q4 2024. In addition, we recently presented data from our three clinical programs at scientific conferences, showcasing our robust pipeline of potentially best-in-class small molecule drug candidates. In particular, we demonstrated positive safety, tolerability, and antiviral activity data after dosing for up to 64 weeks with our hepatitis B virus capsid assembly modulator, ALG-000184, and positive safety and PK data for our ritonavir-free, pan-coronavirus protease inhibitor, ALG-097558. We remain excited by the potential of these programs and look forward to continuing to deliver for our shareholders.”
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-055009: Potential best-in-class small molecule THR-β agonist for MASH
- Data presented at the Asian Pacific Association for the Study of the Liver (APASL) conference highlighted ALG-055009 Phase 1 data that showed multiple-ascending doses (MAD) over 14 days in hyperlipidemic subjects produced favorable, dose-dependent pharmacodynamic effects on atherogenic lipids and sex hormone binding globulin (SHBG), an indicator of target engagement in the liver
- The Phase 2a HERALD study was initiated in Q1 2024 with the first subject dosed in April 2024
- Topline HERALD data are anticipated in Q4 2024
ALG-000184: Potential first-/best-in-class small molecule CAM-E for CHB
- Interim data from Parts 3 and 4 of Study ALG-000184-201 were presented at the APASL conference and showed consistent, potent antiviral activity across multiple cohorts of untreated chronic hepatitis B (CHB) patients receiving once daily doses of ALG-000184 as monotherapy or in combination with entecavir (ETV) x ≤ 64 weeks
- Dosing continues in this ongoing Phase 1a/1b study, with subjects planning to dose for up to 96 weeks. Additional interim data readouts are planned to be presented this year at the following conferences: 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
- Topline data presented at the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Annual Meeting demonstrated single (up to 2000 mg) and multiple (up to 800 mg Q12 for 7 days) doses of ALG-097558 were well tolerated in healthy volunteers with a pharmacokinetic (PK) profile supporting twice daily, ritonavir-free dosing without a food effect
- Received an additional
$1.3M grant from the National Institutes of Health (NIH) - Phase 2 enabling activities, including nonclinical and clinical studies, are underway with financial support from the NIH
Financial Results for the First Quarter 2024
Cash, cash equivalents and investments totaled
Net losses for the three months ended March 31, 2024 were
Research and development (R&D) expenses for the three months ended March 31, 2024 were
General and administrative (G&A) expenses for the three months ended March 31, 2024 were
Interest and other income (expense), net, for the three months ended March 31, 2024 was an expense of
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 hepatitis B 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 with respect to Aligos being positioned for success; the potential of the company’s three clinical programs and the company looking forward to continuing to deliver for its shareholders; the expectation of topline Phase 2a HERALD data for ALG-055009 in Q4 2024; the continuation of dosing in the ongoing Phase 1a/1b study for ALG-000184 with subjects planning to dose for up to 96 weeks and the planned presentation of additional interim data readouts at this year’s EASL and AASLD; and the company’s continued belief 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 the 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 7, 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 | ||||||
| March 31, | ||||||
| 2024 | 2023 | |||||
| (Unaudited) | (Unaudited) | |||||
| Revenue from Collaborations | $ | 292 | $ | 2,583 | ||
| Revenue from Customers | 694 | 140 | ||||
| Operating Expenses: | ||||||
| Research and development | 16,366 | 18,135 | ||||
| General and administrative | 6,666 | 8,506 | ||||
| Total operating expenses | 23,032 | 26,641 | ||||
| Loss from operations | (22,046 | ) | (23,918 | ) | ||
| Interest and other income (expense), net | (12,793 | ) | 1,002 | |||
| Loss before income tax expense | (34,839 | ) | (22,916 | ) | ||
| Income tax expense | (24 | ) | (39 | ) | ||
| Net loss | (34,863 | ) | (22,955 | ) | ||
| Basic and diluted net loss per common share | $ | (0.22 | ) | $ | (0.53 | ) |
| Weighted-average number of shares used in computing basic and diluted net loss per common share | 156,154,156 | 42,910,065 | ||||
| Aligos Therapeutics, Inc. Condensed Consolidated Balance Sheets (In thousands) | |||||
| March 31, 2024 | December 31, 2023 | ||||
| (Unaudited) | (audited) (1) | ||||
| Assets | |||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 24,151 | $ | 135,704 | |
| Short-term investments | 88,588 | - | |||
| Prepaid expenses and other current assets | 5,325 | 5,380 | |||
| Total current assets | 118,064 | 141,084 | |||
| Other assets | 9,838 | 10,443 | |||
| Total assets | $ | 127,902 | $ | 151,527 | |
| Liabilities and Stockholders’ Equity | |||||
| Current liabilities | $ | 18,880 | $ | 23,906 | |
| Other liabilities, noncurrent | 49,226 | 35,541 | |||
| Total liabilities | 68,106 | 59,447 | |||
| Total stockholders’ equity | 59,796 | 92,080 | |||
| Total liabilities and stockholders’ equity | $ | 127,902 | $ | 151,527 | |
_____________________________________________
| (1) | The balance sheet as of December 31, 2023 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, 2023. | |
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
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