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 $112.7 million as
of March 31, 2024, compared with $135.7 million as of December 31,
2023. Additionally, in October 2023, we raised $92.1 million in
gross proceeds in 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 March 31, 2024 were $34.9
million or basic and diluted net loss per common share of $(0.22),
compared to net losses of $23.0 million or basic and diluted net
loss per common share of $(0.53) for the three months ended March
31, 2023.
Research and development (R&D) expenses for the three months
ended March 31, 2024 were $16.4 million, compared with $18.1
million for the same period of 2023. The decrease was primarily due
to a decrease in employee related costs, partially offset by an
increase in third party expenses. Total R&D stock-based
compensation expense incurred for the three months ended March 31,
2024 was $1.4 million, compared with $2.2 million for the same
period of 2023.
General and administrative (G&A) expenses for the three
months ended March 31, 2024 were $6.7 million, compared with $8.5
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 March 31, 2024 was $1.2 million, compared with $1.5 million
for the same period of 2023.
Interest and other income (expense), net, for the three months
ended March 31, 2024 was an expense of $12.8 million compared with
income of $1.0 million for the same period of 2023. The change in
interest and other income (expense), net, is primarily due to an
increase in the fair value of the Common Warrants liability, which
resulted in a non-cash charge, associated with the Securities
Purchase Agreement entered into in October 2023 following the
private investment in public equity (PIPE) offering.
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 ContactJordyn TaraziVice President,
Investor Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
Media ContactMichael FitzhughLifeSci
Communicationsmfitzhugh@lifescicomms.com
Aligos Therapeutics (NASDAQ:ALGS)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Aligos Therapeutics (NASDAQ:ALGS)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024