Altimmune Announces First Quarter 2023 Financial Results and Provides a Business Update
11 Maio 2023 - 8:00AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three months
ended March 31, 2023, and provided a business update.
“We are on course for mid-year initiation of
IMPACT, our Phase 2b biopsy trial of pemvidutide in subjects with
NASH,” said Vipin K. Garg, Ph.D., President and Chief
Executive Officer of Altimmune. “In our previous trials in subjects
with non-alcoholic fatty liver disease (NAFLD), we observed
remarkable reductions in liver fat content and markers of liver
inflammation that occurred rapidly after treatment. This leads us
to believe that the IMPACT trial has the potential to show a
statistically significant impact on the key endpoints of NASH
resolution and fibrosis improvement. We also believe pemvidutide
may distinguish itself from other candidates in development for
NASH because of its demonstrated reductions in both liver fat
content and body weight. This is important, because many NASH
patients suffer not only from the complications of liver disease
but also from the underlying obesity, a principal driver of NASH.
In addition, we eagerly await top-line 48-week results from our
MOMENTUM obesity trial anticipated in the fourth quarter of 2023,
which we expect will demonstrate continued weight loss beyond the
robust levels reported at the 24-week interim analysis. We believe
pemvidutide could be an important treatment option for patients
with obesity, if approved, particularly those with NAFLD and
dyslipidemia, conditions that are highly prevalent in these
patients. We also look forward to the top-line results of our Phase
2 trial of HepTcell in CHB, which we expect to announce in the
first quarter of 2024.”
Recent Highlights and Anticipated
Milestones
Pemvidutide
- Positive interim
data readout from 24-week MOMENTUM Phase 2 obesity trial in March
2023
- Mean weight loss of 10.7% and 9.4%
at the 2.4 mg and 1.8 mg doses, respectively, at Week 24, compared
to mean weight loss of 1.0% in the placebo group.
- Approximately 50% of subjects
achieved 10% or more weight loss and approximately 20% of subjects
achieved 15% or more weight loss at both the 2.4 mg and 1.8 mg
doses at Week 24.
- Robust reductions in waist
circumference, serum lipids and blood pressure, surrogates of
reduced cardiovascular risk.
- Higher adverse
event discontinuation rates observed at the 2.4 mg dose can be
mitigated by allowance for dose reduction in Phase 3 trials.
- Initiation of
IMPACT Phase 2b NASH trial expected mid-2023
- This Phase 2b biopsy-driven NASH
trial will be 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.
- 190 subjects with and without
diabetes are planned to be randomized 1:2:2 to pemvidutide 1.2 mg,
pemvidutide 1.8 mg, 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 to a total of 48
weeks for assessment of safety and additional biomarker
responses.
- Dose reduction will be allowed for
subjects who experience GI intolerance.
- The trial is expected to commence
mid-2023 with top-line results expected in the first quarter of
2025.
HepTcell™
- Completed
enrollment in the Phase 2 clinical trial in CHB
- 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 March 31, 2023
- Cash, cash
equivalents and short-term investments totaled $165.8 million as of
March 31, 2023.
- Research and
development expenses were $17.2 million for the three months ended
March 31, 2023, compared to $15.1 million in the same period in
2022. The expenses for the quarter ended March 31, 2023 included
$8.7 million in direct costs related to development activities for
pemvidutide and $2.1 million in direct costs related to development
activities for HepTcell.
- General and
administrative expenses were consistent period-over-period at $4.5
million and $4.4 million for the three months ended March 31, 2023
and March 31, 2022, respectively.
- Interest income
for the three months ended March 31, 2023 was $1.7 million as
compared to a negligible amount in the three months ended March 31,
2022.
- Net loss for the three months ended
March 31, 2023 was $20.1 million, or $0.40 net loss per share,
compared to a net loss of $19.4 million, or $0.44 net loss per
share, in the same period in 2022.
Conference Call Information:
Date: |
Thursday, May 11, 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 HBV sequences 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 the development of novel
peptide-based 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
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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,
the timing of the data readouts of the Phase 2 trial of HepTcell in
CHB and the Phase 2 MOMENTUM trial of pemvidutide in obesity, the
timing of the initiation and the data readout of 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) |
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
104,690 |
|
|
$ |
111,097 |
|
Restricted cash |
|
|
34 |
|
|
|
34 |
|
Total cash, cash equivalents and restricted cash |
|
|
104,724 |
|
|
|
111,131 |
|
Short-term investments |
|
|
61,039 |
|
|
|
73,783 |
|
Accounts receivable |
|
|
252 |
|
|
|
173 |
|
Income tax and R&D incentive receivables |
|
|
3,118 |
|
|
|
2,368 |
|
Prepaid expenses and other current assets |
|
|
3,978 |
|
|
|
5,358 |
|
Total current assets |
|
|
173,111 |
|
|
|
192,813 |
|
Property and equipment,
net |
|
|
1,007 |
|
|
|
1,081 |
|
Indefinite-lived intangible
asset |
|
|
12,419 |
|
|
|
12,419 |
|
Other assets |
|
|
546 |
|
|
|
615 |
|
Total assets |
|
$ |
187,083 |
|
|
$ |
206,928 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
5,238 |
|
|
$ |
4,804 |
|
Accrued expenses and other current liabilities |
|
|
9,713 |
|
|
|
12,250 |
|
Total current liabilities |
|
|
14,951 |
|
|
|
17,054 |
|
Other long-term
liabilities |
|
|
4,400 |
|
|
|
4,581 |
|
Total liabilities |
|
|
19,351 |
|
|
|
21,635 |
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
49,286,710 and 49,199,845 shares issued and outstanding as of
March 31, 2023 and December 31, 2022,
respectively |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
570,786 |
|
|
|
568,399 |
|
Accumulated deficit |
|
|
(397,958 |
) |
|
|
(377,884 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,101 |
) |
|
|
(5,227 |
) |
Total stockholders’ equity |
|
|
167,732 |
|
|
|
185,293 |
|
Total liabilities and stockholders’ equity |
|
$ |
187,083 |
|
|
$ |
206,928 |
|
|
|
|
|
|
|
|
|
|
ALTIMMUNE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands, except share and per-share) |
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2023 |
|
2022 |
Revenues |
|
$ |
21 |
|
|
$ |
32 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
17,249 |
|
|
|
15,104 |
|
General and administrative |
|
|
4,531 |
|
|
|
4,427 |
|
Total operating expenses |
|
|
21,780 |
|
|
|
19,531 |
|
Loss from operations |
|
|
(21,759 |
) |
|
|
(19,499 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest expense |
|
|
(2 |
) |
|
|
(62 |
) |
Interest income |
|
|
1,668 |
|
|
|
21 |
|
Other income (expense), net |
|
|
19 |
|
|
|
110 |
|
Total other income (expense), net |
|
|
1,685 |
|
|
|
69 |
|
Net loss |
|
|
(20,074 |
) |
|
|
(19,430 |
) |
Other comprehensive income —
unrealized gain on short-term investments |
|
|
126 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(19,948 |
) |
|
$ |
(19,430 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.44 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
50,125,685 |
|
|
|
43,969,481 |
|
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