Altimmune Announces Second Quarter 2024 Financial Results and Provides a Business Update
2024年8月8日 - 8:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the second quarter
ended June 30, 2024, and provided a business update.
“During the second quarter, we continued to
highlight the scientific evidence supporting the robust therapeutic
potential of pemvidutide in metabolic diseases,” said Vipin K.
Garg, Ph.D., President and Chief Executive Officer of Altimmune.
“The data presented at the European Association for the Study of
the Liver (EASL) meeting highlighted the disease-modifying
potential of pemvidutide in MASH and reinforces our confidence in
achieving success on the MASH resolution and fibrosis improvement
endpoints of our Phase 2b IMPACT trial. We also delivered two
podium presentations at the American Diabetes Association (ADA)
84th Scientific Sessions that highlighted the robust reductions in
body weight and serum lipids with pemvidutide treatment. In
addition, we presented data demonstrating class-leading
preservation of lean mass among incretin agents, an increasingly
important consideration in the treatment of obesity. These data
further exemplify the differentiation and broad utility we believe
pemvidutide will bring to the rapidly evolving obesity marketplace.
We continue to make progress toward expanding the development of
pemvidutide in up to three additional indications where its dual
GLP-1/glucagon agonism could provide benefit over currently
available agents. In parallel with these efforts, our discussions
with potential strategic partners continue to progress. We look
forward to sharing further updates on each of these
initiatives.”
Recent Highlights and Anticipated
Milestones:
Obesity:
- On June 22 and 23, the Company
presented data from its Phase 2 MOMENTUM obesity trial at the
American Diabetes Association’s (ADA) 84th Annual Scientific
Sessions
- At 48 weeks of treatment, subjects
receiving pemvidutide achieved weight loss of up to 15.6% with
weight loss continuing at the end of treatment.
- A full analysis of body composition
data showed class-leading lean mass preservation among incretin
agents with only 21.9% of weight loss attributable to lean mass and
78.1% attributable to fat.
- Treatment with pemvidutide also
resulted in robust reductions of triglycerides (55.8%), total
cholesterol (20.0%) and LDL cholesterol (17.4%) in subjects with
elevated baseline lipids on the 2.4mg dose.
- In addition, data from the Phase 1
first-in-human trial of pemvidutide demonstrated robust reductions
in pro-inflammatory lipids associated with atherogenesis and
cardiovascular risk.
- End-of-Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) expected to take place in
late Q3 2024
- The Company is seeking agreement
from the Agency on the Phase 3 trial design and study endpoints
that highlight the differentiation of pemvidutide in the treatment
of obesity, including its ability to reduce serum lipids and liver
fat content (LFC) and its class-leading preservation of lean mass
among incretin agents.
Metabolic Dysfunction-Associated
Steatohepatitis (MASH):
- On June 5, Altimmune presented data
at the EASL International Liver Congress™ 2024, supporting the
disease-modifying potential and differentiated therapeutic profile
of pemvidutide in MASH
- An analysis of data in our Phase 1
trial of metabolic-associated steatotic liver disease (MASLD)
demonstrated that higher proportions of subjects receiving
pemvidutide achieved FibroScan-aspartate aminotransferase (FAST)
score, MRI-PDFF and alanine aminotransferase (ALT) responses than
subjects receiving placebo, suggesting significant rates of MASH
resolution and fibrosis improvement may be achieved in the IMPACT
Phase 2b MASH trial.
- A quantitative systems pharmacology
(QSP) computational model predicted that GLP-1/glucagon dual
agonism of pemvidutide would have more potent effects on MASH
resolution and fibrosis improvement than GLP-1 therapy alone and
that both endpoints would be achieved within the 24-week efficacy
readout of the IMPACT trial.
- Lipidomic profiling showed
significant reductions in serum lipids associated with
cardiovascular disease, reinforcing our belief in the
disease-modifying potential of pemvidutide on MASH-associated
cardiovascular co-morbidities.
- On July 25, data from the
previously reported 12-week clinical trial of pemvidutide in MASLD
was published in the Journal of Hepatology
- The Phase 1 trial, which enrolled
94 subjects, evaluated three doses of pemvidutide versus placebo
administered once weekly for 12 weeks.
- Pemvidutide-treated subjects
achieved up to 68.5% relative reduction in LFC, an important
predictor of MASH resolution and fibrosis improvement, compared to
4.4% in subjects receiving placebo, with up to 55.6% of
pemvidutide-treated subjects achieving LFC normalization.
- LFC changes were accompanied by
significant improvements in body weight and non-invasive markers of
liver inflammation.
- The adverse event discontinuation
rate was only 2.9% in subjects receiving pemvidutide with no severe
or serious adverse events reported.
- The Company continues to advance
IMPACT, its biopsy-driven Phase 2b trial of pemvidutide in MASH
- The trial expects to enroll
approximately 190 subjects with and without type 2 diabetes (T2D),
randomized to receive 1.2mg or 1.8mg of pemvidutide or
placebo.
- The primary efficacy measures are
MASH resolution or fibrosis improvement at Week 24.
- The biopsy readout at Week 24
represents the earliest time point of any incretin-based MASH
clinical trial.
Financial Results for the Three Months
Ended June 30, 2024
- Altimmune had cash, cash
equivalents and short-term investments totaling $164.9 million on
June 30, 2024.
- Research and development expenses
were $21.2 million for the three months ended June 30, 2024,
compared to $13.3 million in the same period in 2023. The expenses
for the quarter ended June 30, 2024, included $13.8 million in
direct costs related to development activities for pemvidutide and
$1.0 million in direct costs related to winddown and closing of our
HepTcell program as announced on March 27, 2024.
- General and administrative expenses
were $5.6 million for the three months ended June 30, 2024,
compared to $4.8 million in the same period in 2023. The increase
was primarily due to a $1.0 million increase in stock compensation
expense caused by modifications of stock awards.
- Interest income for the three
months ended June 30, 2024, was $2.2 million as compared to $1.8
million in the same period in 2023, primarily due to an increase in
interest income earned on cash equivalents and short-term
investments.
- Net loss for the three months ended
June 30, 2024, was $24.6 million, or $0.35 net loss per share,
compared to a net loss of $16.1 million, or $0.32 net loss per
share, in the same period in 2023.
Conference Call Information: |
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Date: |
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Thursday, August 8, 2024 |
Time: |
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8:30 am Eastern Time |
Webcast: |
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To listen, the conference call
will be webcast live on Altimmune’s Investor Relations website at
https://ir.altimmune.com/investors. |
Dial-in: |
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To participate or dial-in,
register here to receive the dial-in numbers and unique PIN to
access the call. |
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Following the conclusion of the call, the
webcast will be available for replay on the Investor Relations (IR)
page of the Company’s website at www.altimmune.com. The Company has
used, and intends to continue to use, the IR portion of its website
as a means of disclosing material non-public information and for
complying with disclosure obligations under Regulation FD.
About PemvidutidePemvidutide is
a novel, investigational, peptide-based GLP-1/glucagon dual
receptor agonist in development for the treatment of obesity and
MASH. Activation of the GLP-1 and glucagon receptors is believed to
mimic the complementary effects of diet and exercise on weight
loss, with GLP-1 suppressing appetite and glucagon increasing
energy expenditure. Glucagon is also recognized as having direct
effects on hepatic fat metabolism, which is believed to lead to
rapid reductions in levels of liver fat and serum lipids. In
clinical trials to date, once-weekly pemvidutide has demonstrated
compelling weight loss, robust reductions in triglycerides, LDL
cholesterol, liver fat content and blood pressure. The U.S. FDA has
granted Fast Track designation to pemvidutide for the treatment of
MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity
trial and is being studied in the ongoing IMPACT Phase 2b MASH
trial.
About AltimmuneAltimmune is a
clinical-stage biopharmaceutical company focused on developing
innovative next-generation peptide-based therapeutics. The Company
is developing pemvidutide, a GLP-1/glucagon dual receptor agonist
for the treatment of obesity and MASH. For more information, please
visit www.altimmune.com.
Follow @Altimmune, Inc. on
LinkedInFollow @AltimmuneInc on
Twitter
Forward-Looking StatementAny
statements made in this press release relating to future financial
or business performance, conditions, plans, prospects, trends, or
strategies and other financial and business matters, including
without limitation, the timing of key milestones for our clinical
assets, and the prospects for the utility of, regulatory approval,
commercializing or selling any product or drug candidates, are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. In addition, when or if
used in this press release, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,”
“predict” and similar expressions and their variants, as they
relate to Altimmune, Inc. may identify forward-looking statements.
The Company cautions that these forward-looking statements are
subject to numerous assumptions, risks, and uncertainties, which
change over time. Important factors that may cause actual results
to differ materially from the results discussed in the forward
looking statements or historical experience include risks and
uncertainties, including risks relating to: delays in regulatory
review, manufacturing and supply chain interruptions, access to
clinical sites, enrollment, adverse effects on healthcare systems
and disruption of the global economy; the reliability of the
results of studies relating to human safety and possible adverse
effects resulting from the administration of the Company’s product
candidates; the Company’s ability to manufacture clinical trial
materials on the timelines anticipated; and the success of future
product advancements, including the success of future clinical
trials. Further information on the factors and risks that could
affect the Company's business, financial conditions and results of
operations are contained in the Company’s filings with the U.S.
Securities and Exchange Commission, including under the heading
“Risk Factors” in the Company’s most recent annual report on Form
10-K and our other filings with the SEC, which are available at
www.sec.gov.
Company Contact:Vipin GargPresident and Chief
Executive OfficerPhone: 240-654-1450ir@altimmune.com
Investor Contact:Lee RothBurns McClellanPhone:
646-382-3403lroth@burnsmc.com
Julia WeilmanBurns McClellanPhone:
646-732-4443jweilman@burnsmc.com
Media Contact:Danielle CanteyInizio Evoke,
BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com
ALTIMMUNE, INC. |
CONSOLIDATED BALANCE SHEETS |
(In thousands, except share and per-share
amounts) |
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June 30,2024 |
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December 31,2023 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
57,128 |
|
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$ |
135,117 |
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Restricted cash |
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|
41 |
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|
|
41 |
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Total cash, cash equivalents and restricted cash |
|
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57,169 |
|
|
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135,158 |
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Short-term investments |
|
|
107,780 |
|
|
|
62,698 |
|
Accounts and other receivables |
|
|
424 |
|
|
|
1,111 |
|
Income tax and R&D incentive receivables |
|
|
2,588 |
|
|
|
3,742 |
|
Prepaid expenses and other current assets |
|
|
3,225 |
|
|
|
6,917 |
|
Total current assets |
|
|
171,186 |
|
|
|
209,626 |
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Property and equipment,
net |
|
|
483 |
|
|
|
651 |
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Other assets |
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1,677 |
|
|
|
363 |
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Total assets |
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$ |
173,346 |
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$ |
210,640 |
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LIABILITIES AND
STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,688 |
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$ |
2,070 |
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Accrued expenses and other current liabilities |
|
|
12,467 |
|
|
|
10,073 |
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Total current liabilities |
|
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15,155 |
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|
12,143 |
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Other noncurrent
liabilities |
|
|
5,660 |
|
|
|
4,398 |
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Total liabilities |
|
|
20,815 |
|
|
|
16,541 |
|
Commitments and contingencies |
|
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|
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Stockholders’ equity: |
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Common stock, $0.0001 par value; 200,000,000 shares authorized;
71,046,267 and 70,677,400 shares issued and outstanding as of
June 30, 2024 and December 31, 2023,
respectively |
|
|
7 |
|
|
|
7 |
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Additional paid-in capital |
|
|
673,081 |
|
|
|
665,427 |
|
Accumulated deficit |
|
|
(515,365 |
) |
|
|
(466,331 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,192 |
) |
|
|
(5,004 |
) |
Total stockholders’ equity |
|
|
152,531 |
|
|
|
194,099 |
|
Total liabilities and stockholders’ equity |
|
$ |
173,346 |
|
|
$ |
210,640 |
|
|
ALTIMMUNE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands, except share and per-share
amounts) |
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Three Months EndedJune 30, |
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Six Months EndedJune 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenues |
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$ |
5 |
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$ |
6 |
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$ |
10 |
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$ |
27 |
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Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
21,155 |
|
|
|
13,253 |
|
|
|
42,642 |
|
|
|
30,502 |
|
General and administrative |
|
|
5,595 |
|
|
|
4,760 |
|
|
|
10,907 |
|
|
|
9,291 |
|
Total operating expenses |
|
|
26,750 |
|
|
|
18,013 |
|
|
|
53,549 |
|
|
|
39,793 |
|
Loss from operations |
|
|
(26,745 |
) |
|
|
(18,007 |
) |
|
|
(53,539 |
) |
|
|
(39,766 |
) |
Other income (expense): |
|
|
|
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|
|
|
|
|
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|
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Interest expense |
|
|
(1 |
) |
|
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(2 |
) |
|
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(2 |
) |
|
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(4 |
) |
Interest income |
|
|
2,182 |
|
|
|
1,835 |
|
|
|
4,595 |
|
|
|
3,503 |
|
Other income (expense), net |
|
|
(76 |
) |
|
|
113 |
|
|
|
(88 |
) |
|
|
132 |
|
Total other income (expense), net |
|
|
2,105 |
|
|
|
1,946 |
|
|
|
4,505 |
|
|
|
3,631 |
|
Net loss |
|
|
(24,640 |
) |
|
|
(16,061 |
) |
|
|
(49,034 |
) |
|
|
(36,135 |
) |
Other comprehensive income —
unrealized (loss) gain on short-term investments |
|
|
(31 |
) |
|
|
(79 |
) |
|
|
(188 |
) |
|
|
47 |
|
Comprehensive loss |
|
$ |
(24,671 |
) |
|
$ |
(16,140 |
) |
|
$ |
(49,222 |
) |
|
$ |
(36,088 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.35 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.69 |
) |
|
$ |
(0.72 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
70,924,371 |
|
|
|
50,691,558 |
|
|
|
70,863,042 |
|
|
|
50,410,184 |
|
Altimmune (NASDAQ:ALT)
過去 株価チャート
から 9 2024 まで 10 2024
Altimmune (NASDAQ:ALT)
過去 株価チャート
から 10 2023 まで 10 2024