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 second quarter 2024.
“This quarter we continued to execute on our key clinical
programs,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President,
and Chief Executive Officer of Aligos Therapeutics. “We completed
enrollment ahead of schedule for the Phase 2a HERALD study of
our THR-β agonist drug candidate, ALG-055009, and we expect
topline data in early Q4 2024. In addition, we presented data from
ALG-000184 at the EASL Congress 2024, including new data from the
HBeAg-negative cohort, that demonstrated no viral breakthrough and
unprecedented reductions in viral markers of CHB. We also received
positive regulatory feedback from the FDA supporting subsequent
studies of chronic suppressive therapy with sustained HBV DNA
suppression as the primary approvable endpoint. We look forward to
continuing to develop our drug candidates for patients in need of
better outcomes.”
Recent Business Progress
Aligos Portfolio of Drug Candidates
ALG-055009: Potential best-in-class small molecule THR-β
agonist for MASH
- The Phase 2a HERALD study completed enrollment in May 2024
- Topline HERALD data are anticipated in early 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 European Association for the Study of the Liver
(EASL) Congress 2024 and showed consistent, potent antiviral
activity across multiple cohorts of untreated chronic hepatitis B
(CHB) patients
- Data from ≤ 72 weeks following an oral daily dose of 300 mg
ALG-000184 monotherapy demonstrated sustained HBV DNA suppression
(<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects
with no viral breakthrough. New data also showed that as HBeAg
declined to near negativity, anti-HBe antibody (HBeAb) levels
exhibited a positive trend
- Reported for the first time were the antiviral and safety data
in HBeAg-negative CHB subjects who received a daily oral dose of
300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 (100%)
subjects, complete suppression of HBV DNA (<LLOQ 10 IU/mL) and
RNA (<LLOQ 10 copies/mL) were noted with no viral
breakthrough
- 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 American
Association for the Study of Liver Diseases (AASLD) conference
- Received positive feedback from the FDA regarding future
studies with sustained HBV DNA suppression as the primary efficacy
endpoint, leading to the potential registration of ALG-000184 for
the treatment of hepatitis B infection
- Phase 2 enabling activities, including 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
- Phase 2 enabling activities, including nonclinical and clinical
studies, are underway with financial support from the NIH
Financial Results for the Second Quarter
2024Cash, cash equivalents and investments totaled $94.5
million as of June 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 income for the three months ended June 30, 2024 was $5.1
million or basic and diluted net income per common share of $0.03,
compared to net losses of $18.8 million or basic and diluted net
loss per common share of $(0.43) for the three months ended June
30, 2023. Net income for the three months ended June 30, 2024 was
primarily due to a decrease in the fair value of the Company’s
warrant liability, which resulted in non-cash income of $30.5
million, or $0.19 per share, associated with the warrants issued in
October 2023 as part of the private investment in public equity
(PIPE) offering.
Research and development (R&D) expenses for the three months
ended June 30, 2024 were $21.1 million, compared with $16.8 million
for the same period of 2023. The increase was primarily due to an
increase in third party expenses for clinical trials. Total R&D
stock-based compensation expense incurred for the three months
ended June 30, 2024 was $1.2 million, compared with $1.6 million
for the same period in 2023.
General and administrative (G&A) expenses for the three
months ended June 30, 2024 were $6.4 million, compared with $9.2
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 June 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 June
30, 2024 was income of $31.7 million compared with income of $1.1
million for the same period of 2023. The change in interest and
other income, net, is primarily due to a decrease of $30.5 million
in the fair value of the company’s warrant liability, which
resulted in non-cash income.
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.
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; the FDA supporting subsequent studies of chronic
suppressive therapy with sustained HBV DNA suppression as the
primary approvable endpoint; the expectation of topline Phase 2a
HERALD data for ALG-055009 in early 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
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 August 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.
Aligos Therapeutics, Inc |
Condensed Consolidated Statements of
Operations |
(In thousands, except share and per share
amounts) |
(Unaudited) |
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from Collaborations |
- |
|
|
2,592 |
|
|
292 |
|
|
5,175 |
|
Revenue from
Customers |
1,061 |
|
|
4,294 |
|
|
1,755 |
|
|
4,434 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
21,099 |
|
|
16,781 |
|
|
37,464 |
|
|
34,916 |
|
General and administrative |
6,376 |
|
|
9,246 |
|
|
13,043 |
|
|
17,752 |
|
Total operating expenses |
27,475 |
|
|
26,027 |
|
|
50,507 |
|
|
52,668 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(26,414 |
) |
|
(19,141 |
) |
|
(48,460 |
) |
|
(43,059 |
) |
|
|
|
|
|
|
|
|
Interest and other
income, net |
31,664 |
|
|
1,107 |
|
|
18,871 |
|
|
2,109 |
|
Income (loss) before income tax expense |
5,250 |
|
|
(18,034 |
) |
|
(29,589 |
) |
|
(40,950 |
) |
|
|
|
|
|
|
|
|
Income tax
expense |
(189 |
) |
|
(757 |
) |
|
(213 |
) |
|
(796 |
) |
Net income (loss) |
5,061 |
|
|
(18,791 |
) |
|
(29,802 |
) |
|
(41,746 |
) |
Basic and diluted
net income (loss) per common share |
0.03 |
|
|
(0.43 |
) |
|
(0.19 |
) |
|
(0.97 |
) |
Weighted-average
shares common stock, basic |
156,444,408 |
|
|
43,215,478 |
|
|
156,299,282 |
|
|
43,063,615 |
|
Weighted-average
shares common stock, diluted |
156,647,917 |
|
|
43,215,478 |
|
|
156,299,282 |
|
|
43,063,615 |
|
|
|
|
|
|
|
|
|
|
Aligos Therapeutics, Inc. Condensed
Consolidated Balance Sheets(In
thousands) |
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
(Unaudited) |
|
|
(audited) (1) |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
45,078 |
|
$ |
135,704 |
Short-term investments |
|
49,458 |
|
|
- |
Prepaid expenses and other current assets |
|
5,034 |
|
|
5,380 |
Total current assets |
|
99,570 |
|
|
141,084 |
Other assets |
|
9,241 |
|
|
10,443 |
Total assets |
$ |
108,811 |
|
$ |
151,527 |
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities |
$ |
23,564 |
|
$ |
23,906 |
Other liabilities, noncurrent |
|
18,018 |
|
|
35,541 |
Total liabilities |
|
41,582 |
|
|
59,447 |
Total stockholders’
equity |
|
67,229 |
|
|
92,080 |
Total liabilities and
stockholders’ equity |
$ |
108,811 |
|
$ |
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. |
|
|
|
ContactJordyn TaraziVice President, Investor
Relations & Corporate Communications+1 (650)
910-0427jtarazi@aligos.com
Aligos Therapeutics (NASDAQ:ALGS)
過去 株価チャート
から 9 2024 まで 10 2024
Aligos Therapeutics (NASDAQ:ALGS)
過去 株価チャート
から 10 2023 まで 10 2024