Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three and nine
months ended September 30, 2022, and provided a business update.
“We continue on course in our advancement of
pemvidutide for two important clinical indications, obesity and
non-alcoholic steatohepatitis (NASH), and look forward to data
readouts from our NAFLD trial extension in mid-December 2022 and
from our interim 24-week readout on approximately 160 subjects from
our MOMENTUM Phase 2 obesity trial in Q1 2023,” said Vipin K.
Garg, Ph.D., President and Chief Executive Officer of
Altimmune.
“We believe that the promising reductions in
liver fat content and alanine aminotransferase (ALT) levels
observed in our recently completed 12-week Phase 1b NAFLD trial
should translate into success on the approvable NASH endpoints,
including NASH resolution and fibrosis improvement, in late-phase
biopsy trials. The magnitude of the effects on the liver combined
with meaningful reductions in body weight could represent important
points of differentiation from other drugs in development for
NASH.”
Dr. Garg added, “Turning to our MOMENTUM obesity
trial, we believe that the level of weight loss we expect to see at
48 weeks will be similar to the leading drugs in the class. The
trial is being conducted in a typical obesity population at
established obesity trial sites and employs lifestyle interventions
that are standard in obesity trials. We believe the absence of dose
titration, together with the favorable tolerability profile,
reductions in serum lipids and reductions in liver fat content
observed in clinical trials to date, could translate into greater
ease of administration, improved adherence to therapy and greater
potential for cardiovascular benefit in this patient
population.”
Recent Highlights and Anticipated
Milestones:
Pemvidutide
- Topline data readout from 12-week
Phase 1b NAFLD trial in September 2022
- This trial was conducted in the
U.S., with Dr. Stephen A. Harrison, Director, Pinnacle Research and
University of Oxford, serving as Principal Investigator.
- A total of 94 subjects were
randomized and dosed, with approximately 80% being of Hispanic
ethnicity, and with a median liver fat content of approximately
22%.
- A 68.5% relative reduction in liver
fat content was achieved at the 1.8 mg dose at Week 12, with 94.4%
of subjects achieving a 30% reduction of liver fat and 55.6%
achieving normalization of liver fat, defined as 5% or less on
MRI-PDFF, at Week 12.
- As announced in a late-breaking
abstract presented on November 7, 2022, at the annual meeting of
the American Association for the Study of Liver Diseases (AASLD) in
Washington, DC, greater than 83% of subjects who received
pemvidutide and who participated in a corrected T1 (cT1) imaging
sub-study achieved an 80 millisecond (ms) or more reduction in cT1
relaxation times at Week 12 at each pemvidutide dose. Elevated cT1
scores have been correlated with hepatic and cardiovascular events
in clinical studies. An 80 ms reduction has been shown to correlate
with a 2-point improvement in NAFLD Activity Score on liver
biopsies.
- Topline 24-week data from NAFLD
trial (12-week extension) expected mid-December 2022
- This extension trial provides 12
weeks of additional treatment to subjects with NAFLD who completed
the 12-week Phase 1b trial, allowing subjects to receive a total of
24 weeks of treatment.
- Although the extension trial was
initiated several months after the start of the original 12-week
Phase 1b NAFLD trial, a total of 66 of 94 subjects (70%) rolled
over into this trial.
- Randomization and first dosing of
all subjects is complete in 48-week Phase 2 MOMENTUM obesity trial
– 24-week interim analysis of approximately 160 subjects expected
in Q1 2023
- This Phase 2 trial is being
conducted at 30 sites across the U.S., with Dr. Lou Aronne,
Professor of Clinical Medicine, Weill Cornell Medical College, a
leading authority in obesity and obesity clinical trials, serving
as the Principal Investigator.
- The trial was designed to enroll
approximately 320 non-diabetic subjects with obesity, or overweight
with at least one co-morbidity. Subjects 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. Baseline
characteristics of the study population include median body weight
and body mass index (BMI) of approximately 101 kg and 36 kg/m2,
respectively, and median liver fat content of approximately 5%, as
measured in approximately 100 subjects participating in a body
composition sub-study. The study population is approximately 75%
female, and approximately 20% of subjects are of Hispanic
ethnicity.
- The primary endpoint is the
relative (percent) change in body weight at 48 weeks compared to
baseline. Additional readouts include metabolic and lipid profiles,
cardiovascular measures and glucose homeostasis.
- A 24-week interim analysis on
approximately 160 subjects is planned in Q1 2023.
- Enrollment complete in Phase 1b
trial of subjects with type 2 diabetes
- This 12-week safety trial will
evaluate the effects of pemvidutide in approximately 48 subjects
with type 2 diabetes and obesity or overweight.
- Data readout is expected in Q1
2023.
HepTcell™
- Enrollment continuing in the Phase
2 clinical trial in chronic hepatitis B
- Endpoints include virological
markers of hepatitis B infection and functional cure.
- Data readout is expected in H2
2023.
Financial Results for the Three Months
Ended September 30, 2022
- Altimmune had
cash, cash equivalents and short-term investments totaling $201.9
million at September 30, 2022.
- Revenue was
minimal for the three months ended September 30, 2022 compared to
$0.2 million in the same period in 2021. The change in revenue
quarter over quarter was primarily due to the discontinuation of
development activities for the T-COVID and NasoShield programs in
2021.
- Research and
development expenses were $20.3 million for the three months ended
September 30, 2022, compared to $29.2 million in the same period in
2021. The expenses for the quarter ended September 30, 2022
included $14.0 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 $4.5 million for the three months
ended September 30, 2022, compared to $4.2 million in the same
period in 2021. The change was primarily attributable to increased
stock compensation expense.
- Net loss for the three months ended
September 30, 2022 was $23.5 million, or $0.48 net loss per share,
compared to a net loss of $33.5 million, or $0.81 net loss per
share, in the same period in 2021.
Conference Call Information:
Date: |
Thursday,
November 10, 2022 |
Time: |
8:30 am Eastern Time |
Webcast: |
The conference call will be webcast live on Altimmune’s
Investor Relations website at
https://ir.altimmune.com/investors. |
Dial-in: |
Participants who would like to join the call may 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 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. Pemvidutide
incorporates the EuPortTM domain, a proprietary technology that
increases its serum half-life for weekly dosing while slowing the
entry of pemvidutide into the bloodstream, which may improve its
tolerability. In a 12-week Phase 1b clinical trial, NAFLD subjects
treated with pemvidutide demonstrated promising reductions in liver
fat content, serum ALT levels and body weight.
About HepTcell
HepTcell is a novel, investigational,
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 Altimmune
Altimmune 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
chronic hepatitis B. 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, the timing of the data readout
of the NAFLD trial, diabetic subject trial, drug-drug interaction
trial and the Phase 2 obesity clinical trial of pemvidutide, the
timing of the data readouts for the Phase 2 clinical trial of
HepTcell, and the prospects for regulatory approval, use,
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 from the ongoing conflict in Ukraine
and COVID-19, 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 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, 2021 and our other filings with the SEC, which are
available at www.sec.gov.
Investor & Media Contacts:
Rich Eisenstadt Chief Financial OfficerPhone:
240-654-1450reisenstadt@altimmune.com
ALTIMMUNE,
INC.CONSOLIDATED BALANCE
SHEETS(In thousands, except share and per share
data)
|
September 30, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
127,465 |
|
|
$ |
190,301 |
|
Restricted cash |
|
34 |
|
|
|
34 |
|
Total cash, cash equivalents and restricted cash |
|
127,499 |
|
|
|
190,335 |
|
Short-term investments |
|
74,362 |
|
|
|
— |
|
Accounts receivable |
|
633 |
|
|
|
429 |
|
Income tax and R&D incentive receivables |
|
3,720 |
|
|
|
5,410 |
|
Prepaid expenses and other current assets |
|
4,790 |
|
|
|
7,952 |
|
Total current assets |
|
211,004 |
|
|
|
204,126 |
|
Property and equipment,
net |
|
1,172 |
|
|
|
1,448 |
|
Intangible assets, net |
|
12,419 |
|
|
|
12,419 |
|
Other assets |
|
682 |
|
|
|
872 |
|
Total assets |
$ |
225,277 |
|
|
$ |
218,865 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,419 |
|
|
$ |
2,034 |
|
Contingent consideration |
|
— |
|
|
|
6,090 |
|
Accrued expenses and other current liabilities |
|
14,323 |
|
|
|
10,152 |
|
Total current liabilities |
|
15,742 |
|
|
|
18,276 |
|
Other long-term
liabilities |
|
4,506 |
|
|
|
1,454 |
|
Total liabilities |
|
20,248 |
|
|
|
19,730 |
|
Commitments and contingencies (Note 14) |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
49,161,637 and 40,993,768 shares issued and outstanding as of
September 30, 2022 and December 31, 2021,
respectively |
|
5 |
|
|
|
4 |
|
Additional paid-in capital |
|
566,551 |
|
|
|
497,342 |
|
Accumulated deficit |
|
(356,224 |
) |
|
|
(293,171 |
) |
Accumulated other comprehensive loss, net |
|
(5,303 |
) |
|
|
(5,040 |
) |
Total stockholders’ equity |
|
205,029 |
|
|
|
199,135 |
|
Total liabilities and stockholders’ equity |
$ |
225,277 |
|
|
$ |
218,865 |
|
ALTIMMUNE,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited)(In
thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, |
|
September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues |
$ |
2 |
|
|
$ |
158 |
|
|
$ |
42 |
|
|
$ |
1,133 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
20,262 |
|
|
|
29,206 |
|
|
|
51,359 |
|
|
|
54,356 |
|
General and administrative |
|
4,492 |
|
|
|
4,156 |
|
|
|
13,329 |
|
|
|
11,636 |
|
Impairment loss on construction-in-progress |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
8,070 |
|
Total operating expenses |
|
24,754 |
|
|
|
33,362 |
|
|
|
64,688 |
|
|
|
74,062 |
|
Loss from operations |
|
(24,752 |
) |
|
|
(33,204 |
) |
|
|
(64,646 |
) |
|
|
(72,929 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(64 |
) |
|
|
(33 |
) |
|
|
(191 |
) |
|
|
(67 |
) |
Interest income |
|
1,053 |
|
|
|
13 |
|
|
|
1,402 |
|
|
|
88 |
|
Other income (expense), net |
|
50 |
|
|
|
(286 |
) |
|
|
185 |
|
|
|
(293 |
) |
Total other income (expense), net |
|
1,039 |
|
|
|
(306 |
) |
|
|
1,396 |
|
|
|
(272 |
) |
Net loss before income
taxes |
|
(23,713 |
) |
|
|
(33,510 |
) |
|
|
(63,250 |
) |
|
|
(73,201 |
) |
Income tax benefit |
|
197 |
|
|
|
— |
|
|
|
197 |
|
|
|
— |
|
Net loss |
|
(23,516 |
) |
|
|
(33,510 |
) |
|
|
(63,053 |
) |
|
|
(73,201 |
) |
Other comprehensive income —
unrealized (loss) gain on short-term investments |
|
(143 |
) |
|
|
(2 |
) |
|
|
(263 |
) |
|
|
4 |
|
Comprehensive loss |
$ |
(23,659 |
) |
|
$ |
(33,512 |
) |
|
$ |
(63,316 |
) |
|
$ |
(73,197 |
) |
Net loss per share, basic and
diluted |
$ |
(0.48 |
) |
|
$ |
(0.81 |
) |
|
$ |
(1.37 |
) |
|
$ |
(1.79 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
49,286,535 |
|
|
|
41,370,768 |
|
|
|
45,881,547 |
|
|
|
40,843,905 |
|
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