Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the year ended
December 31, 2020 and provided a corporate update.
“The past year has been a transformative time
for our Company as we made substantial progress in each of our five
portfolio programs,” said Vipin K. Garg, Ph.D., President and Chief
Executive Officer. “During the year we initiated multiple clinical
trials for several of our product candidates (T-COVID™, ALT-801 and
HepTcell™) and completed preparations to begin a Phase 1 clinical
trial of AdCOVID, which has begun enrolling volunteers. These
achievements have set the stage for a busy and exciting year ahead,
as we anticipate multiple data readouts from these programs over
the coming months. With two promising technology platforms and five
novel product candidates now advancing in clinical development, we
believe 2021 has the potential to be a momentous year for
Altimmune.”
Program Highlights
AdCOVID:
-
Commenced enrollment in AdCOVID Phase 1 clinical trial
evaluating a novel, needle-free intranasal delivery approach for
COVID-19 vaccination
Altimmune has commenced enrollment in its Phase
1 clinical trial of AdCOVID, which is designed to evaluate a
needle-free intranasal delivery approach for vaccination against
COVID-19. Altimmune believes AdCOVID has the potential to become a
leading candidate for COVID-19 vaccination based on its ease of
administration, and the potential for reduced disease transmission,
and cold chain-free vaccine distribution, if the product is
demonstrated to have extended stability at room temperature. As
demonstrated in the NasoShield and NasoVax clinical trials, the
Company believes the expected attributes of AdCOVID make it ideally
suited for use in a pediatric setting as the intranasal
administration and expected tolerability profile are well suited to
meet the needs of children.
The Phase 1 clinical trial will evaluate the
safety and immunogenicity of AdCOVID in up to 180 healthy adult
volunteers between the ages of 18 and 55. Subjects will receive
AdCOVID at one of three dose levels administered as a nasal spray.
In addition to the primary study endpoint of safety and
tolerability, the immunogenicity of AdCOVID will be evaluated by
serum IgG binding and neutralizing antibody titers, mucosal IgA
antibody from nasal samples, and T cell responses. Altimmune
anticipates having a full data readout from this Phase 1 study in
Q2 2021.
-
Initiated development of additional AdCOVID vectors
targeting emerging SARS-CoV-2 variants
The emergence of SARS-CoV-2 variants is raising
concerns about the effectiveness of currently authorized vaccines
and prompting vaccine developers to engineer new vaccine candidates
to combat these viral mutations. Altimmune has initiated the
development of vaccine candidates against several variants as one
is likely to become dominant in the population in the coming
months. Altimmune plans to have these new vaccine candidates ready
for use in upcoming later-stage clinical trials.
- Established a consortium of
manufacturing partners for potential commercial supply of
AdCOVID
Altimmune has executed agreements with three
commercial manufacturing partners with significant experience in
adenoviral vector production. The Company has also established
relationships with leading drug product fill/finish partners with
sufficient capacity to meet potential commercial demand. Together,
the Company believes that this network of strategic manufacturing
partners will ensure Altimmune’s commercial readiness to supply
vaccine, assuming the clinical data support this advancement.
-
Furthered AdCOVID preclinical studies in collaboration with
the University of Alabama at Birmingham (UAB) and Saint Louis
University
Based on the promising preclinical data for
AdCOVID published on the BioRxiv server, Altimmune continues
preclinical studies of AdCOVID in collaboration with UAB and Saint
Louis University to evaluate AdCOVID in additional animal models
and to further evaluate heterologous prime boost regimens of
AdCOVID in support of future clinical development activities. Data
from these ongoing preclinical studies are expected in Q1 and Q2
2021.
ALT-801:
- Commenced dosing in a Phase
1 clinical trial of ALT-801, a novel GLP-1/glucagon dual-agonist
being evaluated for the treatment of NASH
Altimmune commenced dosing in a Phase 1 single
ascending dose (SAD) and multiple ascending dose (MAD) clinical
trial of ALT-801, a GLP-1/glucagon dual-agonist being developed for
the treatment of NASH. This trial is being conducted in Australia
and is expected to enroll approximately 100 volunteers. The primary
pharmacodynamic endpoints in the trial are weight loss and
reduction in liver fat, outcomes that have been associated with
NASH resolution and fibrosis improvement in advanced clinical
studies of other NASH therapeutics. The Company has successfully
completed the initial phases of the study and anticipates a data
read-out from the 6-week MAD study in Q2 2021, followed by 12-week
data in Q3 2021.
- Amended clinical trial
protocol to extend MAD cohorts to incorporate 12-week Phase 1b
study in Australia
Altimmune amended the clinical trial protocol
for the ALT-801 Phase 1 clinical development program to incorporate
its planned 12-week extension trial in patients with non-alcoholic
fatty liver disease or NAFLD within the ongoing Phase 1 SAD/MAD
trial in Australia. The Company believes that by incorporating the
12-week extension into this trial, it can avoid any potential
impact of COVID-19 and maintain study timelines. Pending the
results of this trial, Altimmune plans to transition rapidly to a
52-week, Phase 2, biopsy-trial based on NASH endpoints in early
2022. In parallel with these efforts, Altimmune continues to plan
to file an Investigational New Drug (IND) application for ALT-801
in the United States in mid-2021.
-
Initiated chronic toxicology studies of ALT-801 to enable
52-week Phase 2 clinical study
Altimmune completed 6-week and 13-week GLP
toxicology studies of ALT-801 with no significant toxicity or GI
adverse events. The Company has initiated 6-month and 9-month GLP
toxicology studies to support the planned 52-week biopsy-driven
Phase 2 trial planned for early 2022.
T-COVID:
-
Completed Cohorts 1 and 2 in the Phase 1/2 trial of T-COVID
in patients with early COVID-19
Altimmune, working with the Department of
Defense, has completed the two safety cohorts in the EPIC
(Efficacy and Safety of T-COVID in the
Prevention of Clinical Worsening
in COVID-19) study, a Phase 1/2
clinical trial of T-COVID, an investigational
intranasally-administered therapeutic for the treatment of early
COVID-19 infection. The trial is being overseen by an independent
Data Safety Monitoring Committee, and no significant safety
findings have been observed to date.
Cohort 3 is an efficacy and safety cohort that
will include patients at higher-risk for severe COVID-19 infection,
such as those 65 years or older, or those with one or more risk
factors for severe COVID-19 complications. To ensure that a
sufficient number of higher risk patients are enrolled, the study
protocol was recently modified to require that a minimum number of
patients meet one or more of these criteria in this final cohort.
Additional enrichments of the study population are currently being
evaluated to increase the event rates in the trial. While these
modifications could extend the study timeline, the Company believes
they could significantly enhance the probability of a meaningful
trial outcome. Based on these changes, data from this trial is now
expected in Q2 2021.
HepTcell:
- Commenced dosing in a
multinational Phase 2 clinical trial of HepTcell
In December, Altimmune began a multinational
Phase 2 clinical trial of HepTcell, which is being conducted in the
United States, Canada and Europe. The trial is a double-blind,
randomized, placebo-controlled trial of 80 adult patients with
HBeAg-negative inactive CHB and HBsAg ≤ 100 IU/mL.
HepTcell will be administered in 6 doses at
4-week intervals for 24 weeks, and patients will be followed for
one year to evaluate safety and durability of response. The primary
efficacy endpoint is virological response, defined as a 1-log
reduction in HBsAg levels from baseline. Secondary efficacy
endpoints include reactivation of anti-HBV T cell responses, HBsAg
clearance, and other assessments of virologic response. Altimmune
anticipates a data read-out from this trial in 1H 2022.
Financial Results for the Year Ended
December 31, 2020
- Altimmune had
cash, cash equivalents and short-term investments of $216.0 million
at December 31, 2020 compared to $37.3 million at December 31,
2019. The increase of $178.7 million is attributable to $213.5
million of net receipts during the year due primarily to its 2020
public offering, full utilization of the at-the-market offering
program, and receipts from warrant exercises, offset by $34.4
million of cash used for operating activities.
- Revenue was $8.2
million for the year ended December 31, 2020 compared to $5.8
million in the prior year period, an increase of $2.4 million. The
change was primarily due to an increase in revenue under the
Company’s U.S. government contracts due to timing of manufacturing
and clinical trials for the NasoShield and T-COVID programs.
- Research and
development expenses were $49.8 million for the year ended December
31, 2020, compared to $17.8 million in the prior year period,
representing an increase of $32.0 million. The increase was
primarily attributable to increased costs related to development of
AdCOVID, T-COVID and ALT-801 and an increase in the contingent
liability for stock-based milestone payments associated with the
acquisition of ALT-801.
- General and
administrative expenses were $13.2 million for the year ended
December 31, 2020 compared to $8.5 million in the prior year
period, an increase of $4.7 million. The increase is attributable
to additional employee compensation as Altimmune’s workforce grew
in 2020 along with an increase in professional costs.
- Income tax
benefit was $5.4 million for the year ended December 31, 2020, as
compared to $59,000 for the same period in 2019. The increase is
attributable to the Coronavirus Aid, Relief, and Economic Security
Act (the “CARES Act”) passed on March 27, 2020 which made temporary
changes regarding the utilization and carry back of net operating
losses.
- Net loss
attributed to common stockholders for the year ended December 31,
2020 was $49.0 million, or $1.91 net loss per share, compared to
$21.0 million in the prior year, or $1.60 net loss per share. The
difference in net loss is primarily attributable to higher research
and development expenses and general and administrative expenses,
offset by higher revenue and an increase in income tax
benefit.
Conference Call Information
Date: |
Thursday,
February 25, 2021 |
Time: |
8:30 am Eastern Time |
Domestic Dial-in: |
877-423-9813 |
International Dial-in: |
201-689-8573 |
Conference ID: |
13716171 |
Webcast: |
http://public.viavid.com/index.php?id=143423 |
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.
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, statements
regarding the impact of COVID-19 on our business operations,
clinical trials and results of operations, the timing of key
milestones for our clinical assets, the development and efficacy of
vaccine candidates for SARS-CoV-2 variants, the data read-out for
our Phase 1 clinical trial of AdCOVID in Q2 2021, the data readout
from our T-COVID trial in Q2 2021, the data read-out from our Phase
1 clinical study for ALT-801 in Q1 2021, the plan to file an IND
application for ALT-801 in mid-2021, the data read-out from our
Phase 2 clinical trial of HepTcell in 1H 2022, and the prospects
for 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. (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, adverse effects on
healthcare systems and disruption of the global economy, the
reliability of the results of the studies relating to human safety
and possible adverse effects resulting from the administration of
the Company’s product candidates; funding delays, reductions in or
elimination of U.S. government funding and/or non-renewal of
expiring funding under the Company’s agreement with Biomedical
Advanced Research and Development Authority (“BARDA”), or the
Company’s contract with the National Institutes of Allergy and
Infectious Diseases (“NIAID”); the Company’s ability to
satisfy certain technical milestones under the Company’s contracts
with BARDA and NIAID that would entitle the Company to receive
additional funding over the period of the agreement; the receipt of
future potential payments under government contracts or grants; the
Company’s ability to obtain potential regulatory approvals on the
timelines anticipated, or at all; the Company’s ability to obtain
additional patents or extend existing patents on the timelines
anticipated, or at all; the Company’s ability to identify and
consummate potential future strategic partnerships; and the
Company’s ability to expand its pipeline of products and the
success of future product advancements, including the success of
future clinical trials, and the Company’s ability to commercialize
its products. 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 |
Stacey
Jurchison |
Chief Financial Officer |
Sr. Dir, Investor Relations |
Phone: 240-654-1450 |
Phone : 410-474-8200 |
wbrown@altimmune.com |
sjurchison@altimmune.com |
ALTIMMUNE,
INC.CONSOLIDATED BALANCE SHEETS
|
December 31, |
|
|
2020 |
|
|
2019 |
|
ASSETS |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
115,917,807 |
|
|
$ |
8,962,686 |
|
Restricted cash |
|
34,174 |
|
|
|
34,174 |
|
Total cash, cash equivalents and restricted cash |
|
115,951,981 |
|
|
|
8,996,860 |
|
Short-term investments |
|
100,005,558 |
|
|
|
28,277,386 |
|
Accounts receivable |
|
4,610,202 |
|
|
|
1,021,179 |
|
Tax refund receivable |
|
7,762,793 |
|
|
|
629,096 |
|
Prepaid expenses and other current assets |
|
1,926,675 |
|
|
|
470,228 |
|
Total current assets |
|
230,257,209 |
|
|
|
39,394,749 |
|
Property and equipment,
net |
|
1,056,920 |
|
|
|
1,104,208 |
|
Right of use asset |
|
903,825 |
|
|
|
698,321 |
|
Intangible assets, net |
|
12,823,846 |
|
|
|
12,732,195 |
|
Other assets |
|
73,413 |
|
|
|
128,547 |
|
Total assets |
$ |
245,115,213 |
|
|
$ |
54,058,020 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
612,293 |
|
|
$ |
18,232 |
|
Accrued expenses and other current liabilities |
|
11,408,154 |
|
|
|
3,904,767 |
|
Total current liabilities |
|
12,020,447 |
|
|
|
3,922,999 |
|
Contingent consideration |
|
5,390,000 |
|
|
|
2,750,000 |
|
Other long-term
liabilities |
|
1,828,443 |
|
|
|
1,864,875 |
|
Total liabilities |
|
19,238,890 |
|
|
|
8,537,874 |
|
Commitments and contingencies
(Note 17) |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares
authorized; 37,142,946 and 15,312,381 shares issued;
37,142,946 and 15,312,167 shares outstanding at
December 31, 2020 and 2019, respectively |
|
3,697 |
|
|
|
1,508 |
|
Additional paid-in capital |
|
417,337,742 |
|
|
|
187,914,916 |
|
Accumulated deficit |
|
(186,420,599 |
) |
|
|
(137,376,122 |
) |
Accumulated other comprehensive loss, net |
|
(5,044,517 |
) |
|
|
(5,020,156 |
) |
Total stockholders’ equity |
|
225,876,323 |
|
|
|
45,520,146 |
|
Total liabilities and stockholders’ equity |
$ |
245,115,213 |
|
|
$ |
54,058,020 |
|
ALTIMMUNE,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
Revenues |
$ |
8,185,027 |
|
|
$ |
5,801,401 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
49,774,328 |
|
|
|
17,765,553 |
|
General and administrative |
|
13,209,440 |
|
|
|
8,500,783 |
|
Impairment charge |
|
— |
|
|
|
1,000,000 |
|
Total operating expenses |
|
62,983,768 |
|
|
|
27,266,336 |
|
Loss from operations |
|
(54,798,741 |
) |
|
|
(21,464,935 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Changes in fair value of warrant liability |
|
— |
|
|
|
30,000 |
|
Interest expense |
|
(9,421 |
) |
|
|
(2,244 |
) |
Interest income |
|
322,514 |
|
|
|
843,409 |
|
Other income, net |
|
24,147 |
|
|
|
15,139 |
|
Total other income, net |
|
337,240 |
|
|
|
886,304 |
|
Net loss before income tax
benefit |
|
(54,461,501 |
) |
|
|
(20,578,631 |
) |
Income tax benefit |
|
5,417,024 |
|
|
|
58,500 |
|
Net loss |
|
(49,044,477 |
) |
|
|
(20,520,131 |
) |
Other comprehensive (loss)
income — unrealized (loss) gain on investments |
|
(24,361 |
) |
|
|
20,007 |
|
Comprehensive loss |
$ |
(49,068,838 |
) |
|
$ |
(20,500,124 |
) |
Net loss |
$ |
(49,044,477 |
) |
|
$ |
(20,520,131 |
) |
Deemed dividends |
|
— |
|
|
|
(452,925 |
) |
Net loss attributable to
common stockholders |
$ |
(49,044,477 |
) |
|
$ |
(20,973,056 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(1.91 |
) |
|
$ |
(1.60 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
25,637,023 |
|
|
|
13,124,951 |
|
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