Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three months
ending March 31, 2021 and provided a corporate update.
“With AdCOVID™, our single-dose intranasal
vaccine candidate for COVID-19 and ALT-801, our GLP-1/glucagon dual
agonist candidate for non-alcoholic steatohepatitis (NASH) now
advancing in the clinic, 2021 has the potential to be a data-rich
period for the Company,” remarked Vipin K. Garg, Ph.D., President
and Chief Executive Officer at Altimmune. “We anticipate data
readouts from both of these clinical trials in June. If the data
from the AdCOVID Phase 1 trial are positive, we plan to quickly
transition into a comprehensive global Phase 2 clinical development
program. We strongly believe that a vaccine candidate like AdCOVID,
which can be administered via a simple nasal spray along with what
we hope will be an excellent safety and tolerability profile, could
become an important tool for the global COVID-19 vaccination
effort.”
Dr. Garg continued, “ALT-801 is also progressing
as planned through its first-in-human clinical trial in Australia
and we anticipate 6-week data to be available later this quarter.
We are excited about the potential of ALT-801, and hope that
clinical studies will show ALT-801 can deliver similar therapeutic
benefits to current GLP-1 based treatment options in development
but without the GI intolerability that leads to treatment
discontinuation. The NASH opportunity, together with a potential
indication in obesity, could be very large for ALT-801 and early
clinical success could have a dramatic effect on Altimmune’s
growth.”
Recent Highlights:
AdCOVID, a novel, needle-free,
intranasal vaccine candidate for COVID-19
- Enrollment target met in amended
AdCOVID Phase 1 clinical trial evaluating the safety and
immunogenicity of AdCOVID in healthy volunteers
- The Phase 1
trial will measure systemic antibody responses including serum
neutralizing antibody, T cell responses and mucosal IgA, a measure
of mucosal immunity in the nasopharyngeal cavity
- The study
protocol was amended to reduce the number of adult subjects to
approximately 80. The amendment was necessary due to the widespread
availability of authorized vaccines. The final sample size of the
study is comparable to the number of participants in Phase 1
studies of the U.S. authorized vaccines
- A topline data
readout is anticipated in June 2021
- Progressed
development of adapted AdCOVID vaccine candidates targeting
emerging SARS-CoV-2 variants
- Initiated
preclinical evaluation of AdCOVID vaccine candidates targeting
E484K variants, including P.1, B.1.351 and B.1.617
- Initiation of a
Phase 2 trial with a variant AdCOVID vaccine candidate expected in
Q4 2021
- Expanded
manufacturing capabilities through an agreement with Lonza to
commission a dedicated manufacturing suite for clinical and
potential future commercial supply
- Complements and
extends existing network of strategic manufacturing partners,
building extra capacity and redundancy into the AdCOVID
manufacturing effort
- Supports
manufacturing of clinical supply material for potential late-stage
clinical trials and commercial scale
- Announced new
data from preclinical studies conducted in collaboration with the
University of Alabama at Birmingham (UAB)
In these preclinical studies, a single
intranasal dose of AdCOVID provided:
- 100% protection
against a lethal challenge from the SARS-CoV-2 virus, with
1000-fold reduction of replicating virus in the nasal cavity and
respiratory tract following infection with SARS-CoV-2
- Sterilizing immunity, i.e.,
undetectable levels of infectious virus in the lungs, believed to
be essential to fully block viral transmission
- Long-lived
systemic and mucosal immune responses, which were essentially
unchanged over 6 months
- Established
plans for a robust Phase 2 clinical development program, which is
anticipated to include:
- A multi-national
study in adults 18 years of age and older in regions where vaccine
access has been limited
- An evaluation of
AdCOVID as a potential booster for previously-infected and
vaccinated individuals using a parental and P.1 variant AdCOVID
vaccine
- An age-based
de-escalation study in children and adolescents
- A study
evaluating safety and immunogenicity in mother-infant pairs
ALT-801, a novel GLP-1/glucagon dual
agonist candidate for NASH
- Progressed ongoing Phase 1 clinical
trial of ALT-801 in Australia
- Completed enrollment in the single
ascending dose (SAD) phase and 3 planned cohorts of multiple
ascending dose (MAD) phase of the trial, with 6-week data
anticipated in June 2021, and 12-week data anticipated in Q3
2021
- Plans to commence a 52-week, Phase
2, biopsy-trial based on NASH endpoints in early 2022
- Anticipated mid-year IND filing to
initiate U.S. NASH studies
- Potential filing of a second IND
for an obesity indication in 2H 2021
- The filing of a second IND in
obesity in 2H 2021 is being evaluated, with the final decision
based on the weight loss data from the upcoming Phase 1 trial
readout
Other programs
- Continued progress in Phase 1/2
clinical trial of T-COVID, a therapeutic candidate for the
treatment of SARS-CoV-2 and other respiratory infections, and a
Phase 2 clinical trial of HepTcell, an immunotherapeutic candidate
for the treatment of chronic hepatitis B
Financial Results for the Three Months
Ended March 31, 2021
- Altimmune had
cash, cash equivalents and short-term investments totaling $226.5
million at March 31, 2021 compared to $216.0 million at December
31, 2020. The increase is primarily attributable to $34.2 million
of net receipts during the quarter due to its utilization of the
at-the-market offering program, partially offset by $19.6 million
of cash used for operating activities.
- Revenue was $0.8
million for the three months ended March 31, 2021 compared to $2.2
million in the prior period, a decrease of $1.4 million. The change
in revenue quarter over quarter was primarily due to a decrease of
$2.0 million in BARDA revenue during the current period due to the
timing of clinical trials and development activities for
NasoShield, partially offset by $0.5 million in revenue
attributable to T-COVID.
- Research and
development expenses were $11.9 million for the three months ended
March 31, 2021, compared to $7.2 million in the prior period,
representing an increase of $4.7 million. The change was primarily
the result of increased expenses of $5.4 million related to
development activities for the Company’s COVID-19 programs,
partially offset by a decrease of $1.5 million resulting from a
decrease in the fair value of contingent consideration liability
connected with the acquisition and development of ALT-801.
- General and
administrative expenses were $3.8 million for the three months
ended March 31, 2021 compared to $2.3 million in the prior period,
an increase of $1.5 million. The increase during the quarter is
primarily due to increased stock compensation expense and
additional labor related costs.
- Net loss for the
three months ended March 31, 2021 was $14.9 million, or $0.38 net
loss per share, compared to $3.9 million in the prior period, or
$0.26 net loss per share. The difference in net loss is primarily
attributable to higher research and development expenses and
general and administrative expenses.
Conference Call Information |
|
Date: |
Monday, May 17, 2021 |
Time: |
8:30 am Eastern Time |
Domestic Dial-in |
877-423-9813 |
International Dial-in: |
201-689-8573 |
Conference ID: |
13719206 |
Webcast: |
http://public.viavid.com/index.php?id=144634 |
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 Altimmune
Altimmune is a clinical stage biopharmaceutical
company focused on developing intranasal vaccines, immune
modulating therapies and treatments for liver disease. Our diverse
pipeline includes proprietary intranasal vaccines for COVID-19
(AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an
intranasal immune modulating therapeutic for COVID-19 (T-COVID™);
and next generation peptide therapeutics for NASH (ALT-801) 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 the data readout
from the AdCOVID Phase 1 clinical trial in June 2021, the potential
start of the AdCOVID Phase 2 clinical program in Q2 2021, the
potential immunization effects of AdCOVID, the potential of AdCOVID
to block SARS-CoV-2 transmission, the shipping and storage
requirements for AdCOVID, our ability to manufacture AdCOVID for
our clinical trials and commercial needs, the expected completion
of the single ascending dose (SAD) and multiple ascending dose
(MAD) phases of the ALT-801 study, with 6-week data expected in
June 2021 and 12-week data in Q3 2021, the anticipated mid-year IND
filing for ALT-801, the commencement of a 52-week, Phase 2,
biopsy-trial based on NASH endpoints in early 2022, the HepTcell
Phase 2 clinical efficacy trial data readout anticipated in 1H
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; the
Company’s ability to secure manufacturing approval from its
SARS-CoV-2 cell licensor 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 Brown
Chief Financial Officer
Phone: 240-654-1450
wbrown@altimmune.com
Stacey JurchisonSr. Dir, Investor RelationsPhone :
410-474-8200sjurchison@altimmune.com
ALTIMMUNE,
INC.CONSOLIDATED BALANCE SHEETS
|
|
March 31, 2021 |
|
|
December 31, 2020 |
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
149,932,387 |
|
|
$ |
115,917,807 |
|
Restricted cash |
|
|
34,174 |
|
|
|
34,174 |
|
Total cash, cash equivalents and restricted cash |
|
|
149,966,561 |
|
|
|
115,951,981 |
|
Short-term investments |
|
|
76,574,768 |
|
|
|
100,005,558 |
|
Accounts receivable |
|
|
4,801,428 |
|
|
|
4,610,202 |
|
Tax refund receivable |
|
|
7,898,067 |
|
|
|
7,762,793 |
|
Prepaid expenses and other current assets |
|
|
5,950,999 |
|
|
|
1,926,675 |
|
Total current assets |
|
|
245,191,823 |
|
|
|
230,257,209 |
|
Property and equipment, net |
|
|
5,198,052 |
|
|
|
1,056,920 |
|
Right of use asset |
|
|
866,336 |
|
|
|
903,825 |
|
Intangible assets, net |
|
|
12,879,247 |
|
|
|
12,823,846 |
|
Other assets |
|
|
115,300 |
|
|
|
73,413 |
|
Total assets |
|
$ |
264,250,758 |
|
|
$ |
245,115,213 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
418,243 |
|
|
$ |
612,293 |
|
Accrued expenses and other current liabilities |
|
|
9,405,649 |
|
|
|
11,408,154 |
|
Total current liabilities |
|
|
9,823,892 |
|
|
|
12,020,447 |
|
Contingent consideration |
|
|
6,270,000 |
|
|
|
5,390,000 |
|
Other long-term liabilities |
|
|
1,719,438 |
|
|
|
1,828,443 |
|
Total liabilities |
|
|
17,813,330 |
|
|
|
19,238,890 |
|
Commitments and contingencies
(Note 16) |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares
authorized;38,257,180 and 37,142,946 shares issued and outstanding
at March 31, 2021 and December 31, 2020, respectively |
|
|
3,810 |
|
|
|
3,697 |
|
Additional paid-in capital |
|
|
462,417,706 |
|
|
|
417,337,742 |
|
Accumulated deficit |
|
|
(210,944,707 |
) |
|
|
(186,420,599 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,039,381 |
) |
|
|
(5,044,517 |
) |
Total stockholders’ equity |
|
|
246,437,428 |
|
|
|
225,876,323 |
|
Total liabilities and stockholders’ equity |
|
$ |
264,250,758 |
|
|
$ |
245,115,213 |
|
ALTIMMUNE,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
|
For the Three Months
EndedMarch 31, |
|
|
|
2021 |
|
|
2020 |
|
Revenues |
|
$ |
837,516 |
|
|
$ |
2,212,694 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
11,877,900 |
|
|
|
7,187,531 |
|
General and administrative |
|
|
3,821,420 |
|
|
|
2,331,917 |
|
Total operating expenses |
|
|
15,699,320 |
|
|
|
9,519,448 |
|
Loss from operations |
|
|
(14,861,804 |
) |
|
|
(7,306,754 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest expense |
|
|
(11,671 |
) |
|
|
(1,885 |
) |
Interest income |
|
|
42,499 |
|
|
|
151,569 |
|
Other (expense) income, net |
|
|
(33,132 |
) |
|
|
25,542 |
|
Total other (expense) income, net |
|
|
(2,304 |
) |
|
|
175,226 |
|
Net loss before income tax
benefit |
|
|
(14,864,108 |
) |
|
|
(7,131,528 |
) |
Income tax benefit |
|
|
— |
|
|
|
3,245,879 |
|
Net loss |
|
|
(14,864,108 |
) |
|
|
(3,885,649 |
) |
Other comprehensive income (loss)
– unrealized gain (loss) on investments |
|
|
5,136 |
|
|
|
(32,435 |
) |
Comprehensive loss |
|
$ |
(14,858,972 |
) |
|
$ |
(3,918,084 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.38 |
) |
|
$ |
(0.26 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
38,914,990 |
|
|
|
15,110,585 |
|
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