Altimmune Announces Third Quarter 2021 Financial Results and Provides a Corporate Update
10 November 2021 - 8:01AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three- and
nine-months ending September 30, 2021 and provided a corporate
update.
“The third quarter was a momentous time for our
pemvidutide (ALT-801) program, as we delivered on positive topline
data for the 12-week Phase 1 trial, cleared an IND in non-alcoholic
steatohepatitis (NASH) with the FDA and initiated a 12-week Phase
1b study in non-alcoholic fatty liver disease (NAFLD),” remarked
Vipin K. Garg, Ph.D., President and Chief Executive Officer at
Altimmune. “In addition to the previously announced 12-week data
showing double-digit weight loss in the 1.8 mg arm without the need
for dose titration, we now have MRI-PDFF data in a subset of
subjects with hepatic steatosis, or fatty liver, from that study
demonstrating a remarkable reduction in liver fat to undetectable
levels after only 6 weeks of pemvidutide treatment. These findings
show the potential of pemvidutide in the treatment of both obesity
and NASH, and we look forward to sharing the data from our ongoing
Phase 1b trial in NAFLD and initiating Phase 2 trials for obesity
and NASH in 2022.”
Program Highlights:
Pemvidutide1
(ALT-801)
- Announced weight loss data from
12-week Phase 1 clinical trial of pemvidutide in overweight and
obese subjects
- Subjects achieved mean weight
losses of 4.9%, 10.3%, and 9.0% at 1.2 mg, 1.8 mg, and 2.4 mg
doses, respectively
- Once-weekly dosing regimen was
well-tolerated without dose titration
- Clinically meaningful reductions in
serum lipids and blood pressure
- No discontinuations due to adverse
events
- Obesity program advancing towards
48-week Phase 2 trial in the first half of 2022
- Investigational New Drug
application (IND) for obesity expected to be submitted by year end
2021
- 48-week Phase 2 obesity study
expected to commence in the first half of 2022
1 proposed INN
- Reduction in liver fat by MRI-PDFF
exploratory analysis in recently completed Phase 1 study
- MRI-PDFF data on liver fat content
have now been analyzed through 6 weeks of treatment. While the
trial inclusion criteria did not pre-specify a minimum liver fat
content, the study did enroll a number of subjects with hepatic
steatosis or fatty liver, defined as liver fat content greater than
or equal to 5%. Five subjects had baseline hepatic steatosis (liver
fat content ranging from 5.5 to 19.5%) and received pemvidutide at
1.8 mg or 2.4 mg dose levels. In each of these subjects, liver fat
levels fell to undetectable levels within 6 weeks of treatment,
representing a greater than 90% reduction in the liver fat content.
These findings reinforce the results from preclinical studies of
pemvidutide, which demonstrated statistically greater reductions in
liver fat than an equivalent dose of semaglutide and confirm the
combined beneficial effects of weight loss and glucagon on liver
fat metabolism.
- Pemvidutide IND application for
NASH cleared and enrollment initiated in Phase 1b clinical trial in
NAFLD, with topline data expected in the first half of 2022
- The Phase 1b, 12-week NAFLD trial
is being conducted in the US, with Dr. Stephen A. Harrison serving
as Principal Investigator
- The study will include diabetic and
non-diabetic subjects, with a primary efficacy end point of the
change in liver fat as measured by MRI-PDFF, and a key secondary
endpoint of weight loss at Week 12
- A 52-week biopsy driven Phase 2
NASH trial is expected to follow the conclusion of the NAFLD
trial
- Additional
activities for continued development of pemvidutide
- Drug-drug interaction trial of
pemvidutide has been initiated in Australia, with results expected
in the first half of 2022
- A 12-week study to be initiated in
Q1 2022 in the US to further characterize safety and
pharmacokinetics of pemvidutide in diabetic subjects
HepTcell
- Enrollment
progressing in international Phase 2 clinical trial in chronic
hepatitis B subjects, with topline data expected in the second half
of 2022
- Study readouts
to include virological markers of hepatitis B infection
Financial Results for the Three and Nine
Months Ended September 30, 2021
- Altimmune had
cash, cash equivalents, short-term investments and restricted cash
totaling $199.9 million at September 30, 2021 compared to $216.0
million at December 31, 2020.
- Revenue was $0.2
million for the three months ended September 30, 2021 compared to
$2.9 million in the same period in 2020. The change in revenue
quarter over quarter was primarily due to a decrease in MTEC/DoD
revenue during the current period due to the timing of clinical
trials and development activities for T-COVID.
- Research and
development expenses were $29.2 million for the three months ended
September 30, 2021, compared to $17.0 million in the same period in
2020. The change was primarily the result of increased expenses
related to development activities for the Company’s COVID-19
programs, offset by a decrease in the fair value of contingent
consideration liability connected with the acquisition and
development of pemvidutide.
- General and
administrative expenses were consistent period-over-period with
$4.2 million recognized for the three months ended September 30,
2021 and $4.2 million in the same period in 2020.
- Net loss for the
three months ended September 30, 2021 was $33.5 million, or $0.81
net loss per share, compared to $17.8 million in the same period in
2020, or $0.54 net loss per share. Net loss for the nine months
ended September 30, 2021 was $73.2 million, or $1.79 net loss per
share, compared to $38.4 million in the same period in 2020, or
$1.74 net loss per share.
Conference Call Information
Date: |
|
Wednesday, November 10 |
Time: |
|
8:30 am Eastern Time |
Domestic Dial-in: |
|
(844) 615-6509 |
International Dial-in: |
|
(918) 922-3148 |
Conference ID: |
|
5783655 |
Webcast: |
|
https://edge.media-server.com/mmc/p/zgrrmubx |
|
|
|
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
(proposed INN, formerly known as ALT-801) is a novel,
investigational, peptide-based GLP-1/glucagon dual receptor agonist
for obesity and non-alcoholic steatohepatitis (NASH). Altimmune
believes the treatment of obesity is the cornerstone of treating
NASH and its co-morbidities and views these conditions as
significant unmet medical needs.
About HepTcellHepTcell is a
novel immunotherapeutic comprised of nine synthetic peptides
representing conserved hepatitis B (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 developing
treatments for obesity and liver diseases. Our pipeline includes
next generation peptide therapeutics for obesity, NASH
(pemvidutide), and chronic hepatitis B (HepTcell™). For more
information on Altimmune, please visit www.altimmune.com.
Follow @Altimmune, Inc. on
LinkedInFollow @AltimmuneInc on
Twitter
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, the timing of our
Investigational New Drug application (IND) for obesity expected by
year end, the commencement of a 48-week Phase 2 obesity study
expected to commence in the first half of 2022, the timing of the
data readout from the pemvidutide 12-week Phase 1b NAFLD trial in
the first half of 2022, the timing of the data readout of the
pemvidutide drug/drug interaction trial in the first half of 2022,
the commencement of a 52-week, Phase 2, biopsy-trial based on NASH
endpoints following the conclusion of the NAFLD trial, the timing
of a 12-week Phase 1 study to further characterize safety,
pharmacokinetics of pemvidutide subjects in diabetic expected to be
initiated in Q1 2022, the timing of the data readout from the
HepTcell Phase 2 trial in the second half of 2022, the prospects
for regulatory approval of our product candidates and
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. (the “Company”) 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: potential impacts due to the COVID-19 pandemic such as
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 and commercial supply 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 annual report on Form 10-K for the
fiscal year ended December 31, 2020 filed with
the SEC, which is available at www.sec.gov.
Investor & Media Contacts:
Will BrownChief Financial OfficerPhone:
240-654-1450wbrown@altimmune.com
ALTIMMUNE,
INC.CONSOLIDATED BALANCE SHEETS
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
174,863,565 |
|
|
$ |
115,917,807 |
|
Restricted cash |
|
|
34,174 |
|
|
|
34,174 |
|
Total cash, cash equivalents and restricted cash |
|
|
174,897,739 |
|
|
|
115,951,981 |
|
Short-term investments |
|
|
25,020,738 |
|
|
|
100,005,558 |
|
Accounts receivable |
|
|
1,573,760 |
|
|
|
4,610,202 |
|
Income tax receivable |
|
|
9,476,435 |
|
|
|
7,762,793 |
|
Prepaid expenses and other current assets |
|
|
7,294,360 |
|
|
|
1,926,675 |
|
Total current assets |
|
|
218,263,032 |
|
|
|
230,257,209 |
|
Property and equipment,
net |
|
|
4,718,146 |
|
|
|
1,056,920 |
|
Intangible assets, net |
|
|
12,993,575 |
|
|
|
12,823,846 |
|
Other assets |
|
|
931,904 |
|
|
|
977,238 |
|
Total assets |
|
$ |
236,906,657 |
|
|
$ |
245,115,213 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
6,083 |
|
|
$ |
612,293 |
|
Accrued expenses and other current liabilities |
|
|
19,120,902 |
|
|
|
11,408,154 |
|
Total current liabilities |
|
|
19,126,985 |
|
|
|
12,020,447 |
|
Contingent consideration |
|
|
6,950,000 |
|
|
|
5,390,000 |
|
Other long-term
liabilities |
|
|
1,565,611 |
|
|
|
1,828,443 |
|
Total liabilities |
|
|
27,642,596 |
|
|
|
19,238,890 |
|
Commitments and contingencies
(Note 16) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
39,702,768 and 37,142,946 shares issued and outstanding at
September 30, 2021 and December 31, 2020,
respectively |
|
|
3,959 |
|
|
|
3,697 |
|
Additional paid-in capital |
|
|
483,582,367 |
|
|
|
417,337,742 |
|
Accumulated deficit |
|
|
(269,282,102 |
) |
|
|
(186,420,599 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,040,163 |
) |
|
|
(5,044,517 |
) |
Total stockholders’ equity |
|
|
209,264,061 |
|
|
|
225,876,323 |
|
Total liabilities and stockholders’ equity |
|
$ |
236,906,657 |
|
|
$ |
245,115,213 |
|
|
|
|
|
|
|
|
|
|
ALTIMMUNE,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(unaudited)
|
|
For the Three Months Ended |
|
For the Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues |
|
$ |
157,559 |
|
|
$ |
2,937,991 |
|
|
$ |
1,132,698 |
|
|
$ |
5,872,321 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
29,205,739 |
|
|
|
17,041,975 |
|
|
|
54,356,051 |
|
|
|
40,823,756 |
|
General and administrative |
|
|
4,155,928 |
|
|
|
4,220,238 |
|
|
|
11,636,001 |
|
|
|
9,097,511 |
|
Impairment loss on construction-in-progress |
|
|
— |
|
|
|
— |
|
|
|
8,070,000 |
|
|
|
— |
|
Total operating expenses |
|
|
33,361,667 |
|
|
|
21,262,213 |
|
|
|
74,062,052 |
|
|
|
49,921,267 |
|
Loss from operations |
|
|
(33,204,108 |
) |
|
|
(18,324,222 |
) |
|
|
(72,929,354 |
) |
|
|
(44,048,946 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(32,866 |
) |
|
|
(2,275 |
) |
|
|
(66,763 |
) |
|
|
(7,468 |
) |
Interest income |
|
|
12,485 |
|
|
|
45,127 |
|
|
|
87,847 |
|
|
|
278,154 |
|
Other (expense) income, net |
|
|
(286,199 |
) |
|
|
29,218 |
|
|
|
(293,233 |
) |
|
|
48,882 |
|
Total other (expense) income, net |
|
|
(306,580 |
) |
|
|
72,070 |
|
|
|
(272,149 |
) |
|
|
319,568 |
|
Net loss before income tax
benefit |
|
|
(33,510,688 |
) |
|
|
(18,252,152 |
) |
|
|
(73,201,503 |
) |
|
|
(43,729,378 |
) |
Income tax benefit |
|
|
— |
|
|
|
482,017 |
|
|
|
— |
|
|
|
5,306,678 |
|
Net loss |
|
|
(33,510,688 |
) |
|
|
(17,770,135 |
) |
|
|
(73,201,503 |
) |
|
|
(38,422,700 |
) |
Other comprehensive (loss)
income — unrealized (loss) gain on short-term investments |
|
|
(1,923 |
) |
|
|
(10,569 |
) |
|
|
4,354 |
|
|
|
(22,116 |
) |
Comprehensive loss |
|
$ |
(33,512,611 |
) |
|
$ |
(17,780,704 |
) |
|
$ |
(73,197,149 |
) |
|
$ |
(38,444,816 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.81 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.79 |
) |
|
$ |
(1.74 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
41,370,768 |
|
|
|
33,056,971 |
|
|
|
40,843,905 |
|
|
|
22,058,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Altimmune (NASDAQ:ALT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Altimmune (NASDAQ:ALT)
Historical Stock Chart
From Apr 2023 to Apr 2024