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 $92 million PIPE from
healthcare-dedicated institutional investors and successfully
completing our Phase 2a enabling activities for ALG-055009,” stated
Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos
Therapeutics. “In addition, we presented unprecedented antiviral
activity from our ALG-000184 program for chronic hepatitis B (CHB).
With these important accomplishments in hand, we are well
positioned to deliver important planned milestones in 2024, which
include releasing topline data in subjects with metabolic
dysfunction-associated steatohepatitis (MASH) in the ALG-055009
Phase 2a study (HERALD) and completing Phase 2 enabling activities
for ALG-000184 by the end of the year. We look forward to sharing
our achievements with our stakeholders throughout this year.”
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 $135.7 million as of December 31, 2023, compared with
$125.8 million as of December 31, 2022. Additionally, in October
2023, we raised $92.1 million in gross proceeds in a private
placement financing, before deducting placement agent’s fees and
other expenses. Including the proceeds from the private placement
financing, we continue to believe our cash balance provides
sufficient cash to fund planned operations through the end of
2025.
Net losses for the three months ended December
31, 2023 were $27.9 million or basic and diluted net loss per
common share of $(0.22), compared to net losses of $21.9 million or
basic and diluted net loss per common share of $(0.51) for the
three months ended December 31, 2022.
Net losses for the year ended December 31, 2023
were $87.7 million or basic and diluted net loss per common share
of $(1.36), compared to net losses of $96.0 million or basic and
diluted net loss per common share of $(2.25) for the year ended
December 31, 2022.
Research and development (R&D) expenses for
the three months ended December 31, 2023 were $22.3 million,
compared with $19.1 million for the same period of 2022. The
increase was primarily due third party expenses due to the
milestone payments made as a result of dosing the first patient in
a clinical trial. Total R&D stock-based compensation expense
incurred for the three months ended December 31, 2023 was $1.5
million, compared with $1.9 million for the same period of
2022.
R&D expenses for the year ended December 31,
2023, were $73.0 million, compared with $85.1 million for the same
period of 2022. The decrease was primarily due to a decrease in
third-party expenses mainly related to our discontinued STOPs and
ASO programs in 2022, partially offset by increases in our ongoing
activities and related expenditures associated with our CAM
clinical trial activities and MASH program, as well as the
milestone payment to Katholieke Universiteit Leuven (KU Leuven)
under its collaboration agreement related to the coronaviruses and
the dosing of the first patient in a Phase 1 clinical trial. Total
R&D stock-based compensation expense incurred for the year
ended December 31, 2023 was $6.8 million, compared with $8.0
million for the same period of 2022.
General and administrative (G&A) expenses
for the three months ended December 31, 2023 were $6.4 million,
compared with $7.1 million for the same period of 2022. The
decrease in G&A expenses for this comparative period is
primarily due to a decrease in facility costs. Total G&A
stock-based compensation expense incurred for the three months
ended December 31, 2023 was $1.1 million, compared with $1.6
million for the same period of 2022.
G&A expenses for the year ended December 31,
2023, were $30.6 million, compared with $26.4 million for the same
period of 2022. This was due to an increase in third-party expenses
primarily due to higher legal and patent attorney costs, partially
offset by a decrease in facility expenses. Total G&A
stock-based compensation expense incurred for the year ended
December 31, 2023 was $5.8 million, compared with $6.7 million for
the same period of 2022.
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 |
_____________________________________________
(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 ContactJordyn TaraziVice President,
Investor Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
Media ContactVeronica EamesLifeSci
Communicationsveames@lifescicomms.com
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