Altimmune Announces First Quarter 2024 Financial Results and Provides a Business Update
2024年5月9日 - 8:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the first quarter
ended March 31, 2024, and provided a business update.
“As the obesity therapeutics space evolves,
increasing attention is being placed on agents that are able to
drive weight loss while addressing the quality of that weight loss
and the comorbidities of obesity. With significant weight loss,
preservation of lean mass and reductions in serum lipids and liver
fat achieved in our clinical trials, we believe that pemvidutide
could differentiate itself from other therapies in this competitive
market. With these promising data, we are preparing for our
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA), which is expected to occur late in the third quarter. This
meeting is expected to provide further clarity regarding the Phase
3 pemvidutide obesity registrational program, and we look forward
to our upcoming interactions with the Agency,” said Vipin K. Garg,
Ph.D., President and Chief Executive Officer of Altimmune.
“Further, we continue to advance IMPACT, our Phase 2b trial of
pemvidutide in MASH, with top line results expected in the first
quarter of 2025.”
Recent Highlights and Anticipated
Milestones:
- In March 2024, Altimmune reported
additional data from the Phase 2 MOMENTUM trial of pemvidutide in
obesity, demonstrating significant weight loss with class-leading
preservation of lean mass
- Body composition analysis from
MOMENTUM showed 74.5% of weight loss came from body fat and only
25.5% of weight loss came from lean mass in pemvidutide-treated
subjects.
- This analysis demonstrated a
preferential reduction of visceral over subcutaneous fat in the
pemvidutide group.
- Analyses of the MOMENTUM body
composition and other new data to be presented at scientific
meetings later this year.
- Preparations underway for an
End-of-Phase 2 meeting with FDA
- The Company plans to present a
comprehensive data package, including data from the MOMENTUM Phase
2 trial of pemvidutide in obesity.
- The meeting is currently expected
to take place in late Q3 2024.
- The Company has continued to
advance enrollment in IMPACT, a biopsy-driven Phase 2b trial of
pemvidutide in MASH
- The Company expects to enroll
approximately 190 subjects with and without diabetes, randomized to
receive one of two doses of pemvidutide or placebo.
- The primary efficacy measures of
the trial are MASH resolution or fibrosis improvement with topline
data expected in Q1 2025.
- The primary efficacy readout will
be at 24 weeks of treatment, which is the earliest time point for
any incretin-based therapy in MASH.
Financial Results for the Three Months
Ended March 31, 2024
- Altimmune had
cash, cash equivalents and short-term investments totaling $182.1
million at March 31, 2024.
- Research and
development expenses were $21.5 million for the three months ended
March 31, 2024, compared to $17.2 million in the same period in
2023. The expenses for the quarter ended March 31, 2024 included
$13.5 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 $5.3 million for the three months
ended March 31, 2024, compared to $4.5 million in the same period
in 2023. The increase was primarily due to a $0.6 million increase
in stock compensation and other labor related expenses.
- Interest income
for the three months ended March 31, 2024 was $2.4 million as
compared to $1.7 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
March 31, 2024 was $24.4 million, or $0.34 net loss per share,
compared to a net loss of $20.1 million, or $0.40 net loss per
share, in the same period in 2023.
Conference Call Information:
Date: |
Thursday, May 9, 2024 |
Time: |
8:30 am Eastern Time |
Webcast: |
To listen, the conference call will be webcast live on Altimmune’s
Investor Relations website at
https://ir.altimmune.com/investors. |
Dial-in: |
To participate or dial-in, register here to receive the dial-in
numbers and unique PIN to access the call. |
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 Pemvidutide
Pemvidutide 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,
leading to rapid reductions in levels of liver fat and serum
lipids. In clinical trials, once-weekly pemvidutide has shown
compelling weight loss, robust reductions in triglycerides, LDL
cholesterol, liver fat content and blood pressure with a clean
safety profile to date. The U.S. FDA has granted Fast Track
designation to pemvidutide for the treatment of MASH. Pemvidutide
has recently completed the MOMENTUM Phase 2 obesity trial and is
being studied in the IMPACT Phase 2b MASH trial.
About Altimmune
Altimmune 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
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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.
Investor Contact:Rich EisenstadtChief Financial
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) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2024 |
|
2023 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
78,978 |
|
|
$ |
135,117 |
|
Restricted cash |
|
|
41 |
|
|
|
41 |
|
Total cash, cash equivalents and restricted cash |
|
|
79,019 |
|
|
|
135,158 |
|
Short-term investments |
|
|
103,046 |
|
|
|
62,698 |
|
Accounts and other receivables |
|
|
307 |
|
|
|
1,111 |
|
Income tax and R&D incentive receivables |
|
|
2,272 |
|
|
|
3,742 |
|
Prepaid expenses and other current assets |
|
|
2,871 |
|
|
|
6,917 |
|
Total current assets |
|
|
187,515 |
|
|
|
209,626 |
|
Property and equipment,
net |
|
|
544 |
|
|
|
651 |
|
Other assets |
|
|
299 |
|
|
|
363 |
|
Total assets |
|
$ |
188,358 |
|
|
$ |
210,640 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,760 |
|
|
$ |
2,070 |
|
Accrued expenses and other current liabilities |
|
|
7,573 |
|
|
|
10,073 |
|
Total current liabilities |
|
|
11,333 |
|
|
|
12,143 |
|
Noncurrent liabilities |
|
|
4,088 |
|
|
|
4,398 |
|
Total liabilities |
|
|
15,421 |
|
|
|
16,541 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
70,899,134 and 70,677,400 shares issued and outstanding as of
March 31, 2024 and December 31, 2023,
respectively |
|
|
7 |
|
|
|
7 |
|
Additional paid-in capital |
|
|
668,816 |
|
|
|
665,427 |
|
Accumulated deficit |
|
|
(490,725 |
) |
|
|
(466,331 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,161 |
) |
|
|
(5,004 |
) |
Total stockholders’ equity |
|
|
172,937 |
|
|
|
194,099 |
|
Total liabilities and stockholders’ equity |
|
$ |
188,358 |
|
|
$ |
210,640 |
|
ALTIMMUNE, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except share and per-share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2024 |
|
2023 |
Revenues |
|
$ |
5 |
|
|
$ |
21 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
21,487 |
|
|
|
17,249 |
|
General and administrative |
|
|
5,312 |
|
|
|
4,531 |
|
Total operating expenses |
|
|
26,799 |
|
|
|
21,780 |
|
Loss from operations |
|
|
(26,794 |
) |
|
|
(21,759 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest expense |
|
|
(1 |
) |
|
|
(2 |
) |
Interest income |
|
|
2,413 |
|
|
|
1,668 |
|
Other income (expense), net |
|
|
(12 |
) |
|
|
19 |
|
Total other income (expense), net |
|
|
2,400 |
|
|
|
1,685 |
|
Net loss |
|
|
(24,394 |
) |
|
|
(20,074 |
) |
Other comprehensive income —
unrealized (loss) gain on short-term investments |
|
|
(157 |
) |
|
|
126 |
|
Comprehensive loss |
|
$ |
(24,551 |
) |
|
$ |
(19,948 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.40 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
70,801,713 |
|
|
|
50,125,685 |
|
Altimmune (NASDAQ:ALT)
過去 株価チャート
から 4 2024 まで 5 2024
Altimmune (NASDAQ:ALT)
過去 株価チャート
から 5 2023 まで 5 2024