Altimmune Announces Third Quarter 2023 Financial Results and Provides a Business Update
2023年11月7日 - 9:00PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three months
ended September 30, 2023, and provided a business update.
“The next few months will be important as we
receive the data from our 48-week MOMENTUM trial of pemvidutide in
subjects with obesity as well as the results of our Phase 2 trial
of HepTcell in CHB,” said Vipin K. Garg, Ph.D., President and
Chief Executive Officer of Altimmune. “The rapidly expanding
obesity market needs differentiated products that address not only
excess body weight, but also risk factors for cardiovascular
comorbidities, including elevated LDL-cholesterol and excess liver
fat. We also were very pleased to receive Fast Track designation
for our pemvidutide program in NASH, which demonstrates the unmet
need for this critical liver disease. We believe that our liver fat
reduction is class-leading and could result in unprecedented
reductions of fibrosis and measures of NASH.”
Recent Highlights and Anticipated
Milestones
Pemvidutide
- Top-line data
readout from 48-week MOMENTUM Phase 2 obesity trial expected in Q4
2023
- Patient dosing (last subject last
dose) was completed in September 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.
- 391 subjects with obesity or
overweight and 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.
- Enrollment
commenced in IMPACT Phase 2b NASH trial
- Informed by the positive results of
the Phase 1b randomized, placebo-controlled trials of pemvidutide
in subjects with non-alcoholic fatty liver disease (NAFLD), the FDA
granted pemvidutide Fast Track designation for the treatment of
NASH.
- 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 to receive six monthly administrations.
- 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 September 30, 2023
- Cash, cash
equivalents and short-term investments totaled $140.8 million as of
September 30, 2023.
- Research and
development expenses were $18.4 million for the three months ended
September 30, 2023, compared to $20.3 million in the same period in
2022. The expenses for the quarter ended September 30, 2023
included $10.4 million in direct costs related to development
activities for pemvidutide and $1.6 million in direct costs related
to development activities for HepTcell.
- General and
administrative expenses were consistent period-over-period at $4.5
million for the three months ended September 30, 2023 and
2022.
- Interest income
for the three months ended September 30, 2023 was $1.9 million as
compared to $1.1 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
September 30, 2023 was $20.7 million, or $0.39 net loss per share,
compared to a net loss of $23.5 million, or $0.48 net loss per
share, in the same period in 2022.
Conference Call Information:
Date: |
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Tuesday,
November 7, 2023 |
Time: |
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8:30 am EST |
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 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 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 HepTcell
HepTcell 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 Altimmune
Altimmune is a clinical-stage biopharmaceutical
company focused on developing innovative next-generation
therapeutics for the treatment of patients with liver diseases and
obesity. 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
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Forward-Looking Statement
Any 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 CanteyEvoke CanalePhone:
619-826-4657danielle.cantey@evokegroup.com
|
ALTIMMUNE, INC.CONSOLIDATED BALANCE
SHEETS(In thousands, except share and per-share
amounts) |
|
|
|
September 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,855 |
|
|
$ |
111,097 |
|
Restricted cash |
|
|
41 |
|
|
|
34 |
|
Total cash, cash equivalents and restricted cash |
|
|
86,896 |
|
|
|
111,131 |
|
Short-term investments |
|
|
53,924 |
|
|
|
73,783 |
|
Accounts receivable |
|
|
876 |
|
|
|
173 |
|
Income tax and R&D incentive receivables |
|
|
3,653 |
|
|
|
2,368 |
|
Prepaid expenses and other current assets |
|
|
7,615 |
|
|
|
5,358 |
|
Total current assets |
|
|
152,964 |
|
|
|
192,813 |
|
Property and equipment,
net |
|
|
765 |
|
|
|
1,081 |
|
Indefinite-lived intangible
asset |
|
|
12,419 |
|
|
|
12,419 |
|
Other assets |
|
|
425 |
|
|
|
615 |
|
Total assets |
|
$ |
166,573 |
|
|
$ |
206,928 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,046 |
|
|
$ |
4,804 |
|
Accrued expenses and other current liabilities |
|
|
8,825 |
|
|
|
12,250 |
|
Total current liabilities |
|
|
11,871 |
|
|
|
17,054 |
|
Other long-term
liabilities |
|
|
4,305 |
|
|
|
4,581 |
|
Total liabilities |
|
|
16,176 |
|
|
|
21,635 |
|
Commitments and contingencies (Note 10) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
52,858,920 and 49,199,845 shares issued and outstanding as of
September 30, 2023 and December 31, 2022,
respectively |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
590,206 |
|
|
|
568,399 |
|
Accumulated deficit |
|
|
(434,690 |
) |
|
|
(377,884 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,124 |
) |
|
|
(5,227 |
) |
Total stockholders’ equity |
|
|
150,397 |
|
|
|
185,293 |
|
Total liabilities and stockholders’ equity |
|
$ |
166,573 |
|
|
$ |
206,928 |
|
|
|
ALTIMMUNE, INC.CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except share and per-share amounts) |
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues |
|
$ |
362 |
|
|
$ |
2 |
|
|
$ |
389 |
|
|
$ |
42 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
18,388 |
|
|
|
20,262 |
|
|
|
48,890 |
|
|
|
51,359 |
|
General and administrative |
|
|
4,514 |
|
|
|
4,492 |
|
|
|
13,805 |
|
|
|
13,329 |
|
Total operating expenses |
|
|
22,902 |
|
|
|
24,754 |
|
|
|
62,695 |
|
|
|
64,688 |
|
Loss from operations |
|
|
(22,540 |
) |
|
|
(24,752 |
) |
|
|
(62,306 |
) |
|
|
(64,646 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(29 |
) |
|
|
(64 |
) |
|
|
(33 |
) |
|
|
(191 |
) |
Interest income |
|
|
1,884 |
|
|
|
1,053 |
|
|
|
5,387 |
|
|
|
1,402 |
|
Other income (expense), net |
|
|
14 |
|
|
|
50 |
|
|
|
146 |
|
|
|
185 |
|
Total other income (expense), net |
|
|
1,869 |
|
|
|
1,039 |
|
|
|
5,500 |
|
|
|
1,396 |
|
Net loss before income
taxes |
|
|
(20,671 |
) |
|
|
(23,713 |
) |
|
|
(56,806 |
) |
|
|
(63,250 |
) |
Income tax expense
(benefit) |
|
|
— |
|
|
|
(197 |
) |
|
|
— |
|
|
|
(197 |
) |
Net loss |
|
|
(20,671 |
) |
|
|
(23,516 |
) |
|
|
(56,806 |
) |
|
|
(63,053 |
) |
Other comprehensive income —
unrealized gain (loss) on short-term investments |
|
|
56 |
|
|
|
(143 |
) |
|
|
103 |
|
|
|
(263 |
) |
Comprehensive loss |
|
$ |
(20,615 |
) |
|
$ |
(23,659 |
) |
|
$ |
(56,703 |
) |
|
$ |
(63,316 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.10 |
) |
|
$ |
(1.37 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
53,633,354 |
|
|
|
49,286,535 |
|
|
|
51,495,957 |
|
|
|
45,881,547 |
|
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