Altimmune Announces Second Quarter 2023 Financial Results and Provides a Business Update
2023年8月10日 - 8:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three months
ended June 30, 2023, and provided a business update.
“We are pleased to have commenced enrollment in
our IMPACT Phase 2b biopsy-driven trial of pemvidutide in NASH,”
said Vipin K. Garg, Ph.D., President and Chief Executive
Officer of Altimmune. “We believe our compelling Phase 1b data in
subjects with nonalcoholic fatty liver disease (NAFLD)
demonstrating class-leading improvements in liver fat and markers
of liver inflammation support the prospects of achieving robust
rates of NASH resolution and fibrosis improvement in our IMPACT
trial. We are also eager to report our 48-week data from the
MOMENTUM Phase 2 obesity trial next quarter. We believe the
pemvidutide data showing significant weight loss, combined with
robust reductions in liver fat content, serum lipids and blood
pressure without cardiovascular safety signals could offer a
differentiated product profile that meaningfully impacts patients
with obesity and NAFLD or dyslipidemia, and patients with
NASH.”
Recent Highlights and Anticipated
Milestones
Pemvidutide
- Top-line data
readout from 48-week MOMENTUM Phase 2 obesity trial expected in Q4
2023
- Dr. Louis Aronne, Professor of
Metabolic Research and Professor of Clinical Medicine, Weil Cornell
Medical School, a leading authority in obesity and obesity clinical
trials, is serving as the Principal Investigator.
- Approximately 320 subjects with
obesity or overweight but without diabetes were randomized 1:1:1:1
to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered
weekly for 48 weeks in conjunction with diet and exercise.
- In an interim 24-week data readout
in March 2023, subjects receiving pemvidutide achieved robust
reductions in body weight, waist circumference, serum lipids and
blood pressure without arrhythmias, clinically meaningful heart
rate increases or other safety signals.
- Top-line data readout at 48 weeks
will include subject disposition, weight loss, serum lipids, vital
signs, adverse events and glycemic control.
- Commenced
enrollment in IMPACT Phase 2b NASH trial
- This Phase 2b biopsy-driven NASH
trial is being conducted at approximately 60 sites in the U.S.,
with Dr. Stephen Harrison, Medical Director, Pinnacle Research, and
Adjunct Professor of Medicine, Oxford University, serving as the
principal investigator.
- Approximately 190 subjects with and
without diabetes are planned to be randomized 1:2:2 to 1.2 mg, 1.8
mg pemvidutide or placebo.
- The key endpoints will be NASH
resolution and fibrosis improvement after 24 weeks of treatment,
with subjects followed for an additional 24 weeks for assessment of
safety and additional biomarker responses.
- Top-line results after 24 weeks of
treatment are expected in the first quarter of 2025.
HepTcell™
- Top-line data
from Phase 2 clinical trial expected in Q1 2024
- The multicenter clinical trial,
which is being conducted at 26 sites in North America, Europe and
Southeast Asia, enrolled approximately 80 previously untreated
subjects with inactive CHB and low levels of hepatitis B surface
antigen (HBsAg).
- Subjects were randomized 1:1 to
HepTcell or placebo.
- The primary endpoint is virological
response, defined as a 1-log or greater reduction or clearance of
HBsAg; secondary endpoints include changes in the levels of
hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of
virologic response.
- Data readout is expected in the
first quarter of 2024 after all subjects complete the 6-month
course of treatment.
Financial Results for the Three Months
Ended June 30, 2023
- Cash, cash equivalents and short-term investments totaled
$160.0 million as of June 30, 2023.
- Research and development expenses were $13.3 million for the
three months ended June 30, 2023, compared to $16.0 million in the
same period in 2022. The expenses for the quarter ended June 30,
2023 included $5.6 million in direct costs related to development
activities for pemvidutide and $1.8 million in direct costs related
to development activities for HepTcell.
- General and administrative expenses were $4.8 million for the
three months ended June 30, 2023, compared to $4.4 million in the
same period in 2022. The change was primarily attributable to
increased stock compensation and other labor related expenses.
- Interest income for the three months ended June 30, 2023 was
$1.8 million as compared to $0.3 million in the same period in
2022.
- Net loss for the three months ended June 30, 2023 was $16.1
million, or $0.32 net loss per share, compared to a net loss of
$20.1 million, or $0.42 net loss per share, in the same period in
2022.
Conference
Call Information: |
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Date: |
Thursday, August 10, 2023 |
Time: |
8:30 am EDT |
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 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
NASH. 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. Pemvidutide incorporates the EuPort™ domain, a
proprietary technology that increases its serum half-life for
weekly dosing while likely slowing the entry of pemvidutide into
the bloodstream, which may improve its tolerability.
About HepTcellHepTcell is a
novel, investigational, immunotherapeutic comprised of nine
synthetic peptides representing conserved T-cell epitopes on key
HBV antigens formulated with IC31®, a TLR9-based adjuvant from
Valneva SE. The HBV-directed peptides are designed to drive T cell
responses against all HBV genotypes towards a functional cure for
chronic HBV in patients of diverse genetic backgrounds.
About AltimmuneAltimmune is a
clinical-stage biopharmaceutical company focused on developing
innovative next-generation therapeutics for the treatment of
obesity and liver diseases. The Company’s lead product candidate,
pemvidutide, is a GLP-1/glucagon dual receptor agonist that is
being developed for the treatment of obesity and NASH. In addition,
Altimmune is developing HepTcell™, an immunotherapeutic designed to
achieve a functional cure for CHB. 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, the timing of the data readouts of the Phase 2 trial of
HepTcell in CHB, the Phase 2 MOMENTUM trial of pemvidutide in
obesity and the Phase 2b IMPACT trial of pemvidutide in NASH, 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 & Media Contacts:
Rich EisenstadtChief Financial OfficerPhone:
240-654-1450reisenstadt@altimmune.com
|
ALTIMMUNE, INC. |
CONSOLIDATED BALANCE SHEETS |
(In thousands, except share and per-share
amounts) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
102,352 |
|
|
$ |
111,097 |
|
Restricted cash |
|
|
41 |
|
|
|
34 |
|
Total cash, cash equivalents and restricted cash |
|
|
102,393 |
|
|
|
111,131 |
|
Short-term investments |
|
|
57,602 |
|
|
|
73,783 |
|
Accounts receivable |
|
|
136 |
|
|
|
173 |
|
Income tax and R&D incentive receivables |
|
|
3,579 |
|
|
|
2,368 |
|
Prepaid expenses and other current assets |
|
|
5,822 |
|
|
|
5,358 |
|
Total current assets |
|
|
169,532 |
|
|
|
192,813 |
|
Property and equipment,
net |
|
|
882 |
|
|
|
1,081 |
|
Indefinite-lived intangible
asset |
|
|
12,419 |
|
|
|
12,419 |
|
Other assets |
|
|
483 |
|
|
|
615 |
|
Total assets |
|
$ |
183,316 |
|
|
$ |
206,928 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,035 |
|
|
$ |
4,804 |
|
Accrued expenses and other current liabilities |
|
|
7,402 |
|
|
|
12,250 |
|
Total current liabilities |
|
|
11,437 |
|
|
|
17,054 |
|
Other long-term
liabilities |
|
|
4,165 |
|
|
|
4,581 |
|
Total liabilities |
|
|
15,602 |
|
|
|
21,635 |
|
Commitments and contingencies (Note 10) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
52,657,661 and 49,199,845 shares issued and outstanding as of
June 30, 2023 and December 31, 2022,
respectively |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
586,908 |
|
|
|
568,399 |
|
Accumulated deficit |
|
|
(414,019 |
) |
|
|
(377,884 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,180 |
) |
|
|
(5,227 |
) |
Total stockholders’ equity |
|
|
167,714 |
|
|
|
185,293 |
|
Total liabilities and stockholders’ equity |
|
$ |
183,316 |
|
|
$ |
206,928 |
|
|
|
|
|
|
|
|
|
|
ALTIMMUNE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands, except share and per-share
amounts) |
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenues |
|
$ |
6 |
|
|
$ |
8 |
|
|
$ |
27 |
|
|
$ |
40 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
13,253 |
|
|
|
15,993 |
|
|
|
30,502 |
|
|
|
31,097 |
|
General and administrative |
|
|
4,760 |
|
|
|
4,410 |
|
|
|
9,291 |
|
|
|
8,837 |
|
Total operating expenses |
|
|
18,013 |
|
|
|
20,403 |
|
|
|
39,793 |
|
|
|
39,934 |
|
Loss from operations |
|
|
(18,007 |
) |
|
|
(20,395 |
) |
|
|
(39,766 |
) |
|
|
(39,894 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(65 |
) |
|
|
(4 |
) |
|
|
(127 |
) |
Interest income |
|
|
1,835 |
|
|
|
328 |
|
|
|
3,503 |
|
|
|
349 |
|
Other income (expense), net |
|
|
113 |
|
|
|
25 |
|
|
|
132 |
|
|
|
135 |
|
Total other income (expense), net |
|
|
1,946 |
|
|
|
288 |
|
|
|
3,631 |
|
|
|
357 |
|
Net loss |
|
|
(16,061 |
) |
|
|
(20,107 |
) |
|
|
(36,135 |
) |
|
|
(39,537 |
) |
Other comprehensive income —
unrealized (loss) gain on short-term investments |
|
|
(79 |
) |
|
|
(120 |
) |
|
|
47 |
|
|
|
(120 |
) |
Comprehensive loss |
|
$ |
(16,140 |
) |
|
$ |
(20,227 |
) |
|
$ |
(36,088 |
) |
|
$ |
(39,657 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.90 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
50,691,558 |
|
|
|
47,502,599 |
|
|
|
50,410,184 |
|
|
|
44,150,835 |
|
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