Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical
stage biopharmaceutical 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 third quarter 2024.
“This quarter we reached a key milestone when we announced the
positive topline HERALD data in MASH subjects,” stated Lawrence
Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer
of Aligos Therapeutics. “With placebo-adjusted median relative
reductions in liver fat of up to 46.2%, we continue to believe
ALG-055009 has best-in-class potential. We are completing Phase 2b
enabling studies and evaluating a variety of options to fund
continued development, including potential partnering where
discussions are underway. In addition, we are progressing
ALG-000184 for CHB towards a Phase 2 study next year. Lastly, we
expect to begin externally funded clinical studies for ALG-097558
later this year in COVID subjects. 2024 has been an exciting year
for the company, and we believe we are laying the groundwork for
important future successes in 2025 and beyond.”
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-000184:
Potential first-/best-in-class small molecule CAM-E for
CHB
- Dosing continues in this ongoing Phase 1a/1b study, with
subjects expected to dose for up to 96 weeks. Additional interim
data readouts are planned to be presented this year at the American
Association for the Study of Liver Disease’s (AASLD) The Liver
Meeting (TLM) 2024
- Received positive feedback from the FDA and the National
Medical Products Administration in China to move forward with
sustained HBV DNA suppression as the primary efficacy endpoint for
future studies designed to support the potential registration of
ALG-000184 for the treatment of hepatitis B infection
- Announced a clinical collaboration with Xiamen Amoytop Biotech
Co., Ltd.
- Amoytop agreed to sponsor and perform a Phase 1b exploratory
clinical study evaluating the efficacy and safety of ALG-000184 in
combination with PEGBING® (mipeginterferon alfa-2b) in chronic
hepatitis B (CHB) patients in China
- Phase 2 enabling activities are underway, including drug supply
manufacturing
ALG-055009: Potential best-in-class small molecule THR-β
agonist for MASH
- Topline HERALD data were presented in September 2024,
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 to 70% of subjects achieved ≥30% relative reduction
in liver fat compared to baseline
- ALG-055009 demonstrated a favorable tolerability profile with
no clinical hyper/hypothyroidism. Incidence of
gastrointestinal-related treatment emergent adverse events were
similar in ALG-055009 dose groups compared to placebo.
Specifically, a non-dose-related, lower incidence of diarrhea was
observed in ALG-055009 dose groups compared to placebo
- Treatment with ALG-055009 resulted in significant reductions in
atherogenic lipids, including LDL-C, lipoprotein (a) (LpA), and
apolipoprotein B (ApoB). In addition, dose dependent increases in
sex hormone binding globulin (SHBG), a marker of THR-β target
engagement in the liver, were observed
- Additional data readouts are planned to be presented this year
at AASLD’s The Liver Meeting (TLM) 2024
ALG-097558:
Potential best-in-class small molecule pan-coronavirus protease
inhibitor
- Three additional clinical studies are expected to begin in 2024
- AGILE University of Liverpool, a UK-government supported
platform trial (with MRC and Wellcome Trust funding), has agreed to
sponsor and perform a study in high-risk COVID patients evaluating
ALG-097558 as monotherapy or in combination with remdesivir
- The NIAID has agreed to sponsor clinical studies evaluating
pharmacokinetic (PK) differences in special populations
(renal/hepatic impairment subjects)
- Phase 2 enabling activities, including nonclinical and clinical
studies, are underway with financial support from the NIH
Financial Results for the Third Quarter
2024
Cash, cash equivalents and investments totaled $74.9 million as
of September 30, 2024, compared with $135.7 million as of December
31, 2023. We continue to believe our cash balance provides
sufficient cash to fund planned operations through the end of
2025.
Net loss for the three months ended September 30, 2024 were
$19.3 million or basic and diluted net loss per common share of
$(3.07), compared to net losses of $18.0 million or basic and
diluted net loss per common share of $(10.37) for the three months
ended September 30, 2023.
Research and development (R&D) expenses for the three months
ended September 30, 2024 were $16.8 million, compared with $15.9
million for the same period of 2023. The increase was primarily due
to an increase in third party expenses for the clinical trials.
Total R&D stock-based compensation expense incurred for the
three months ended September 30, 2024 was $1.2 million, compared
with $1.6 million for the same period of 2023.
General and administrative (G&A) expenses for the three
months ended September 30, 2024 were $4.6 million, compared with
$6.4 million for the same period of 2023. The decrease in G&A
expenses for this comparative period is primarily due to a decrease
in third party expenses including legal expenses. Total G&A
stock-based compensation expense incurred for the three months
ended September 30, 2024 was $0.9 million, compared with $1.6
million for the same period of 2023.
Interest and other income, net, for the three months ended
September 30, 2024 was income of $1.0 million compared with income
of $1.1 million for the same period of 2023.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage
biopharmaceutical 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 metabolic
dysfunction-associated steatohepatitis (MASH) and viruses with high
unmet medical need such as hepatitis B 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 potential of the company’s three
clinical programs, Phase 2 enabling activities, and financial
support from the NIH for ALG-097558; the collaboration with Xiamen
Amoytop; studies to support potential registration, and Phase 2
enabling activities for ALG-000184; the planned readouts for
ALG-055009 at this year’s AASLD; the continuation of dosing in the
ongoing Phase 1a/1b study for ALG-000184 with subjects planning to
dose for up to 96 weeks; the planned presentation of additional
interim data readouts at this year’s 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 November
6, 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.
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Aligos Therapeutics, Inc |
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Condensed Consolidated Statements of
Operations |
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|
(In thousands, except share and per share
amounts) |
|
(Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
|
2024 |
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2023 |
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|
2024 |
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|
2023 |
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|
|
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|
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|
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|
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Revenue from
Collaborations |
19 |
|
|
2,154 |
|
|
311 |
|
|
7,329 |
|
Revenue from
Customers |
1,250 |
|
|
1,085 |
|
|
3,005 |
|
|
5,519 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
16,774 |
|
|
15,867 |
|
|
54,238 |
|
|
50,783 |
|
General and administrative |
4,626 |
|
|
6,443 |
|
|
17,669 |
|
|
24,195 |
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Total operating expenses |
21,400 |
|
|
22,310 |
|
|
71,907 |
|
|
74,978 |
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|
|
|
|
|
|
|
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Loss from operations |
(20,131 |
) |
|
(19,071 |
) |
|
(68,591 |
) |
|
(62,130 |
) |
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|
|
|
|
|
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Interest and other
income, net |
963 |
|
|
1,059 |
|
|
19,834 |
|
|
3,168 |
|
Loss before income tax expense |
(19,168 |
) |
|
(18,012 |
) |
|
(48,757 |
) |
|
(58,962 |
) |
|
|
|
|
|
|
|
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Income tax
expense |
(91 |
) |
|
(29 |
) |
|
(304 |
) |
|
(825 |
) |
Net loss |
(19,259 |
) |
|
(18,041 |
) |
|
(49,061 |
) |
|
(59,787 |
) |
Basic and diluted
net loss per common share |
(3.07 |
) |
|
(10.37 |
) |
|
(7.84 |
) |
|
(34.59 |
) |
Weighted-average
shares common stock, basic and diluted |
6,272,291 |
|
|
1,739,847 |
|
|
6,258,706 |
|
|
1,728,282 |
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Aligos Therapeutics, Inc.Condensed
Consolidated Balance Sheets(In
thousands) |
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|
September 30, 2024 |
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December 31, 2023 |
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|
(Unaudited) |
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|
(audited) (1) |
Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
35,331 |
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$ |
135,704 |
Short-term investments |
|
39,591 |
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|
- |
Prepaid expenses and other current assets |
|
4,900 |
|
|
5,380 |
Total current assets |
|
79,822 |
|
|
141,084 |
Other assets |
|
8,604 |
|
|
10,443 |
Total assets |
$ |
88,426 |
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$ |
151,527 |
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|
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Liabilities and
Stockholders’ Equity |
|
|
|
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Current liabilities |
$ |
20,956 |
|
$ |
23,906 |
Other liabilities, noncurrent |
|
17,374 |
|
|
35,541 |
Total liabilities |
|
38,330 |
|
|
59,447 |
Total stockholders’
equity |
|
50,096 |
|
|
92,080 |
Total liabilities and
stockholders’ equity |
$ |
88,426 |
|
$ |
151,527 |
_____________________________________________
(1) |
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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. |
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Investor ContactJordyn TaraziVice President,
Investor Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
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