Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide and Reports Fourth Quarter and Full Year 2023 Financial Results
2024年3月27日 - 8:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the fourth quarter
and full year ended December 31, 2023, and provided a business
update.
“We are extremely pleased with the results of
the body composition analysis from our recently completed MOMENTUM
48-week Phase 2 obesity trial of pemvidutide. Our data show that
74.5% of weight loss was derived from adipose tissue and only 25.5%
from lean mass, comparable to the effects historically associated
with weight loss from diet and exercise programs,” said Vipin
K. Garg, Ph.D., President and Chief Executive Officer of Altimmune.
“Based on compelling weight loss, a clean safety profile, robust
reductions in serum lipids and blood pressure, and now preservation
of lean mass observed in our clinical trials, we believe that
pemvidutide has the potential to distinguish itself broadly from
other therapies for the treatment of obesity. We also remain
excited about the outcome of our ongoing IMPACT Phase 2b MASH trial
with topline 24-week data on the key endpoints of MASH resolution
or fibrosis improvement anticipated in the first quarter of 2025.
The results from a recently completed preclinical study
demonstrating direct anti-fibrotic activity of pemvidutide only
adds to our optimism about achieving a positive outcome in this
trial.”
“Preservation of lean mass during weight loss is
critical, since excessive loss of lean mass has been associated
with negative outcomes, such as sarcopenia and bone fractures,
especially in women and the elderly,” said Scott Harris, Chief
Medical Officer, Altimmune. “There is a growing appreciation that
the quality of weight loss is as important as the quantity of
weight loss. Given these new body composition data, the robust
reductions in serum lipids, and the class-leading reduction of
hepatic fat content, we believe that pemvidutide, if approved,
could stand out as an attractive option for weight loss and weight
maintenance.”
Recent Highlights and Anticipated
Milestones:
Pemvidutide
- Positive lean mass preservation in
body composition analysis from MOMENTUM trial
- Body composition analysis from
MOMENTUM showed only 25.5% of weight loss derived from lean mass,
with 74.5% of weight loss from adipose tissue, comparable to the
effects historically associated with diet and exercise.
- Complete analysis of the data to be
presented at an upcoming scientific meeting.
- Positive
top-line data readout from MOMENTUM 48-week Phase 2 obesity trial
in November 2023
- Achieved mean weight loss of 15.6%
on 2.4 mg dose of pemvidutide at week 48, with weight loss
continuing at the end of treatment.
- Over 30% of subjects achieved 20%
or more weight loss on the 2.4 mg dose.
- Robust reductions of triglycerides
(55.8%), total cholesterol (20.0%) and LDL cholesterol (17.4%) on
2.4 mg dose in patients with elevated baseline lipids.
- Up to 78.6% of subjects with excess
liver fat normalized their liver fat content.
- Improvements in blood pressure
without imbalances in cardiac events, arrhythmias or clinically
meaningful increases in heart rate.
- Enrollment ongoing in IMPACT
biopsy-driven Phase 2b MASH trial
- The FDA granted Fast Track
designation to pemvidutide for the treatment of MASH.
- Approximately 190 subjects with and
without diabetes are being randomized 1:2:2 to 1.2 mg, 1.8 mg
pemvidutide or placebo.
- The key endpoints are MASH
resolution or fibrosis improvement after 24 weeks of treatment,
with subjects to be followed for an additional 24 weeks of dosing
for assessment of safety and additional biomarker responses.
- Top-line results after 24 weeks of
treatment are expected in the first quarter of 2025.
- Demonstration of the direct
anti-fibrotic effects of pemvidutide in a preclinical model of
hepatic fibrosis
- Significant improvement observed in
a model of chemically-induced hepatic fibrosis after 14 days of
treatment with pemvidutide.
- The model excluded the effects of
liver fat reduction, providing evidence for a direct effect of
pemvidutide in reducing liver fibrosis.
- Demonstration of improved cholesterol elimination in a
preclinical model of dyslipidemia
- Pemvidutide stimulated reverse cholesterol transport and
increased cholesterol elimination.
- These data provide evidence for a potential additional
mechanism of reducing cardiovascular risk beyond the effects of
pemvidutide on serum lipids and liver fat content.
HepTcell™
The Phase 2 clinical trial evaluating the
efficacy of HepTcell in reducing virological markers in patients
chronically infected with the hepatitis B virus has been completed.
The overall response in the trial was deemed to be insufficient to
warrant further advancement. As a result, any further development
related to HepTcell has been stopped.
Financial Results for the Three Months
Ended December 31, 2023
- Altimmune had
cash, cash equivalents and short-term investments totaling $198.0
million at December 31, 2023.
- Research and
development expenses were $16.9 million for the three months ended
December 31, 2023, compared to $19.2 million in the same period in
2022. The expenses for the quarter ended December 31, 2023 included
$10.3 million in direct costs related to development activities for
pemvidutide and $1.1 million in direct costs related to development
activities for HepTcell.
- General and
administrative expenses were $4.3 million for the three months
ended December 31, 2023, compared to $3.8 million in the same
period in 2022. The increase was primarily due to $0.3 million
increase in professional fees and $0.2 million increase in stock
compensation.
- Impairment loss
on intangible asset of $12.4 million was recognized during the
three months ended December 31, 2023 related to the acquired
In-Process Research and Development asset associated with HepTcell.
The overall response in the Phase 2 trial was deemed to be
insufficient to warrant further advancement. As a result, any
further development related to HepTcell has been stopped.
- Interest income
for the three months ended December 31, 2023 was $2.0 million as
compared to $1.5 million in the same period in 2022, primarily due
to an increase in interest income earned on cash equivalents and
short-term investments.
- Net loss for the three months ended
December 31, 2023 was $31.6 million, or $0.54 net loss per share,
compared to a net loss of $21.7 million, or $0.43 net loss per
share, in the same period in 2022. The net loss for 2023 included
the $12.4 million noncash impairment charge described above.
Conference Call Information: |
|
|
Date: |
Wednesday, March 27, 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 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, 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 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.
Investor Contact:Rich EisenstadtChief Financial
OfficerPhone: 240-654-1450reisenstadt@altimmune.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) |
|
|
|
December 31, |
|
|
2023 |
|
2022 |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
135,117 |
|
|
$ |
111,097 |
|
Restricted cash |
|
|
41 |
|
|
|
34 |
|
Total cash, cash equivalents and restricted cash |
|
|
135,158 |
|
|
|
111,131 |
|
Short-term investments |
|
|
62,698 |
|
|
|
73,783 |
|
Accounts and other receivables |
|
|
1,111 |
|
|
|
173 |
|
Income tax and R&D incentive receivables |
|
|
3,742 |
|
|
|
2,368 |
|
Prepaid expenses and other current assets |
|
|
6,917 |
|
|
|
5,358 |
|
Total current assets |
|
|
209,626 |
|
|
|
192,813 |
|
Property and equipment,
net |
|
|
651 |
|
|
|
1,081 |
|
Indefinite-lived intangible
asset |
|
|
— |
|
|
|
12,419 |
|
Other assets |
|
|
363 |
|
|
|
615 |
|
Total assets |
|
$ |
210,640 |
|
|
$ |
206,928 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,070 |
|
|
$ |
4,804 |
|
Accrued expenses and other current liabilities |
|
|
10,073 |
|
|
|
12,250 |
|
Total current liabilities |
|
|
12,143 |
|
|
|
17,054 |
|
Noncurrent liabilities |
|
|
4,398 |
|
|
|
4,581 |
|
Total liabilities |
|
|
16,541 |
|
|
|
21,635 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
70,677,400 and 49,199,845 shares issued and outstanding as of
December 31, 2023 and 2022, respectively |
|
|
7 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
665,427 |
|
|
|
568,399 |
|
Accumulated deficit |
|
|
(466,331 |
) |
|
|
(377,884 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,004 |
) |
|
|
(5,227 |
) |
Total stockholders’ equity |
|
|
194,099 |
|
|
|
185,293 |
|
Total liabilities and stockholders’ equity |
|
$ |
210,640 |
|
|
$ |
206,928 |
|
ALTIMMUNE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands, except share and per-share
amounts) |
|
|
|
Three Months Ended |
|
Year Ended |
|
|
December 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues |
|
$ |
37 |
|
|
$ |
(110 |
) |
|
$ |
426 |
|
|
$ |
(68 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,909 |
|
|
|
19,179 |
|
|
|
65,799 |
|
|
|
70,538 |
|
General and administrative |
|
|
4,332 |
|
|
|
3,805 |
|
|
|
18,137 |
|
|
|
17,134 |
|
Impairment loss on intangible asset |
|
|
12,419 |
|
|
|
— |
|
|
|
12,419 |
|
|
|
— |
|
Total operating expenses |
|
|
33,660 |
|
|
|
22,984 |
|
|
|
96,355 |
|
|
|
87,672 |
|
Loss from operations |
|
|
(33,623 |
) |
|
|
(23,094 |
) |
|
|
(95,929 |
) |
|
|
(87,740 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
183 |
|
|
|
(35 |
) |
|
|
(8 |
) |
Interest income |
|
|
1,964 |
|
|
|
1,468 |
|
|
|
7,351 |
|
|
|
2,870 |
|
Other income (expense), net |
|
|
20 |
|
|
|
(217 |
) |
|
|
166 |
|
|
|
(32 |
) |
Total other income (expense), net |
|
|
1,982 |
|
|
|
1,434 |
|
|
|
7,482 |
|
|
|
2,830 |
|
Net loss before income
taxes |
|
|
(31,641 |
) |
|
|
(21,660 |
) |
|
|
(88,447 |
) |
|
|
(84,910 |
) |
Income tax expense
(benefit) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(197 |
) |
Net loss |
|
|
(31,641 |
) |
|
|
(21,660 |
) |
|
|
(88,447 |
) |
|
|
(84,713 |
) |
Other comprehensive income —
unrealized gain (loss) on short-term investments |
|
|
120 |
|
|
|
76 |
|
|
|
223 |
|
|
|
(187 |
) |
Comprehensive loss |
|
$ |
(31,521 |
) |
|
$ |
(21,584 |
) |
|
$ |
(88,224 |
) |
|
$ |
(84,900 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.66 |
) |
|
$ |
(1.81 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
58,442,779 |
|
|
|
50,026,686 |
|
|
|
53,246,937 |
|
|
|
46,926,349 |
|
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