Altimmune Announces Third Quarter 2020 Financial Results and Provides a Business Update
November 09 2020 - 4:05PM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three and nine
months ended September 30, 2020 and provided a business update.
“2020 has been a transformational year for
Altimmune as our pipeline continues to mature and we progress five
novel investigational candidates into clinical development,” said
Vipin K. Garg, Ph.D., President and Chief Executive Officer. “The
third quarter has been an especially productive time as we
completed preparations to advance AdCOVID™, ALT-801 and HepTcell™
into the clinic this year, and we executed on our ongoing T-COVID
and NasoShield trials. With this roster of intranasal vaccine
candidates and peptide therapeutics, we are well positioned to
achieve meaningful inflection points during 2021.”
Recent Highlights
- Announced positive
preclinical results for AdCOVID Altimmune shared the
details of its preclinical immunogenicity studies on the BioRxiv
server (www.biorxiv.org/content/10.1101/2020.10.10.331348v1). The
report shows intranasal administration of AdCOVID stimulated a
strong induction of neutralizing antibodies in serum and a CD8+
killer T cell response focused in the lungs of vaccinated mice.
Unique among the leading COVID-19 vaccine candidates, AdCOVID also
stimulated a robust mucosal IgA antibody response in the
respiratory tract. This additional type of immunity can only be
achieved following intranasal dosing and has the potential to block
infection at its source while also blocking transmission of the
virus to others. Altimmune anticipates commencing a Phase 1 safety
and immunogenicity trial of AdCOVID in Q4 2020 with a data read-out
in Q1 2021.
- Expanded preclinical
collaboration with the University of Alabama at Birmingham
(UAB) for AdCOVIDBased on the promising
preclinical data for AdCOVID that has been generated so far,
Altimmune and UAB have expanded their collaboration to include
additional preclinical studies of AdCOVID in support of further
development for AdCOVID. UAB is a premier site for the study of
preclinical and clinical aspects of viral immunology and vaccine
development, and has extensive experience in conducting clinical
studies of vaccines and has participated in studies sponsored by
the Vaccine Evaluation and Trial Unit, part of the National
Institute of Allergy and Infectious Diseases at
the National Institutes of Health.
- Initiated a collaboration
with Saint Louis University for AdCOVIDAltimmune
established a Sponsored Research Agreement with Dr. James Brien,
Ph.D., Assistant Professor of Molecular Microbiology and Immunology
at Saint Louis University (SLU), to conduct animal models of
vaccine immunogenicity and efficacy. SLU has extensive expertise in
studying the pathogenicity of viral infections and is part of a
network of clinical sites evaluating the Operation Warp Speed
vaccines. Dr. Brien has significant expertise in the development of
animal models of viral infection and evaluation of functional tests
for SARS-CoV-2 antibodies and will be an important addition to the
Altimmune COVID-19 effort.
- Formed alliances with key
manufacturing partners and
entered into a teaming
agreement with DynPort Vaccine Company to support
AdCOVIDAltimmune has entered into an agreement with Vigene
Biosciences to provide clinical manufacturing services for AdCOVID.
Vigene is an award-winning contract development and manufacturing
organization specializing in viral vectors. In addition to Vigene,
the Company has executed agreements with additional manufacturing
partners to ensure commercial readiness for AdCOVID. Altimmune also
executed a teaming agreement with DynPort Vaccine Company (DVC), a
General Dynamics Information Technology (GDIT) company, to assist
in coordinating U.S. Government funding efforts and, if successful,
provide program management, drug development activity integration,
and regulatory support for AdCOVID.
- Initiated a Phase 1/2 clinical trial of T-COVID;
program funded by $4.7 million award from the Department of
DefenseAltimmune commenced enrollment in a Phase 1/2
clinical trial of T-COVID, an investigational therapeutic agent for
the treatment of early COVID-19. The EPIC Trial
(Efficacy and Safety of T-COVID in the
Prevention of Clinical Worsening
in COVID-19) is being funded
through a $4.7 million competitive award from the U.S. Army Medical
Research & Development Command (USAMRDC) and Department of
Defense (DoD) working in collaboration with the Medical Technology
Enterprise Consortium (MTEC). Based on the current rate of
enrollment, Altimmune anticipates a data read-out from this study
in Q1 2021. For further information about the study, visit
www.epicclinicalstudy.com.
- Received regulatory
clearance to commence a Phase 1
clinical trial of ALT-801 in Australia; Phase 1
trial expected to begin Q4
2020Altimmune received clearance from HREC (Human Research
and Ethics Committee) and filed a Clinical Trial Notification (CTN)
with the Australian regulatory authority. Altimmune expects to
commence dosing in a Phase I clinical study of ALT-801 before the
end of the year. The clinical trial will enroll approximately 100
subjects in a 6-week single ascending dose and a 6-week multiple
ascending dose study. The primary pharmacodynamic endpoints in this
trial are weight loss and reduction in liver fat. Altimmune
anticipates a data read-out from this trial towards the end of the
first quarter of 2021.
- Completed enrollment in
Phase 1b clinical trial of NasoShield intranasal anthrax
vaccineAltimmune completed enrollment in a Phase 1b
clinical trial of NasoShield, a single dose intranasal anthrax
vaccine candidate. The NasoShield program is being developed under
a contract with the Biomedical Advanced Research and Development
Authority (BARDA), with a total potential value of $133.7 million
if all options in the contract (HHSO100201600008C) are exercised.
The results from this Phase 1b study are expected to read-out near
the end of Q4 2020. Based on these results, BARDA will have the
option of exercising the remaining contract options valued at
approximately $105 million to enable Phase 2 development.
- Secured approximately $200
million in gross proceeds to advance pipeline
candidatesDuring 2020, Altimmune has received $132.2
million in gross proceeds from a public offering of common stock
and pre-funded warrants, $41 million from warrant exercises and
$26.6 million in gross proceeds from ATM sales. Altimmune
anticipates that the proceeds will be used primarily for the
development of AdCOVID and T-COVID, including scale up of
manufacturing and advanced clinical trials; the continued
development of ALT-801 and HepTcell, and for capital expenditures
and general working capital purposes.
Financial Results for the Third Quarter
Ended September 30, 2020
- Altimmune had cash,
cash equivalents and short-term investments of $206.8 million at
September 30, 2020.
- Revenue was $2.9
million for the quarter ended September 30, 2020 compared to $0.6
million in the prior year period. 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 program.
- Research and
development expenses were $17.0 million for the quarter ended
September 30, 2020 compared to $8.7 million in the prior year
period. The increase was primarily attributable to an increase in
the contingent liability for stock-based milestone payments
associated with the acquisition of ALT-801; costs for IND-enabling
preclinical studies and manufacturing for ALT-801; and development
costs for the COVID-19 programs.
- General and
administrative expenses were $4.2 million for the quarter ended
September 30, 2020 compared to $2.2 million in the prior year
period. The increase is attributable to higher employee
compensation and legal costs.
- Income tax benefit
was $0.5 million for the three months ended September 30,
2020, as compared to $0.1 million 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 quarter ended September 30, 2020 was
$17.8 million, or $0.54 net loss per share, compared to $10.9
million in the prior year, or $0.74 net loss per share. The
difference in net loss is primarily attributable to higher research
and development expenses, lower revenue, offset by an increase in
income tax benefit.
Conference
Call InformationAltimmune will host a conference call to
discuss the company’s third quarter results and other business
information. |
Date: |
|
Tuesday, November 10,
2020 |
Time: |
|
8:30 am Eastern Time |
Domestic: |
|
877-300-8521 |
International: |
|
412-317-6026 |
Conference ID: |
|
10149733 |
Webcast: |
|
http://public.viavid.com/index.php?id=142319 |
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 commencement of a Phase 1
safety and immunogenicity trial of AdCOVID in Q4 2020 with a data
read-out in Q1 2021, data read-out from our T-COVID trial towards
the end of Q1 2021, the initiation of a Phase 1 clinical study for
ALT-801 in Q4 2020 and data read-out towards the end of Q1 2021,
data read-out from our Phase 1b clinical trial of NasoShield in Q4
2020, 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 reports on Form 10-K and
quarterly reports on Form 10-Q filed with the SEC, which
are available at www.sec.gov.
Investor
Contacts:Will
BrownChief Financial OfficerPhone:
240-654-1450wbrown@altimmune.com
Stacey JurchisonSr. Director, Investor Relations & Corp
CommunicationsPhone: 410-474-8200sjurchison@altimmune.com
Media Contact:Warren RizziSard Verbinnen &
Co.Phone: 212-687-8080altimmune-svc@sardverb.com
ALTIMMUNE,
INC.CONSOLIDATED BALANCE SHEETS
|
|
September 30, 2020 |
|
|
December 31, 2019 |
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
143,495,266 |
|
|
$ |
8,962,686 |
|
Restricted cash |
|
|
34,174 |
|
|
|
34,174 |
|
Total cash, cash equivalents and restricted cash |
|
|
143,529,440 |
|
|
|
8,996,860 |
|
Short-term investments |
|
|
63,282,716 |
|
|
|
28,277,386 |
|
Accounts receivable |
|
|
3,816,489 |
|
|
|
1,021,179 |
|
Tax refund receivable |
|
|
6,193,855 |
|
|
|
629,096 |
|
Prepaid expenses and other current assets |
|
|
1,309,044 |
|
|
|
470,228 |
|
Total current assets |
|
|
218,131,544 |
|
|
|
39,394,749 |
|
Property and equipment, net |
|
|
1,041,920 |
|
|
|
1,104,208 |
|
Right of use asset |
|
|
939,855 |
|
|
|
698,321 |
|
Intangible assets, net |
|
|
12,794,806 |
|
|
|
12,732,195 |
|
Other assets |
|
|
87,195 |
|
|
|
128,547 |
|
Total assets |
|
$ |
232,995,320 |
|
|
$ |
54,058,020 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
874,885 |
|
|
$ |
18,232 |
|
Accrued expenses and other current liabilities |
|
|
5,418,831 |
|
|
|
3,904,767 |
|
Total current liabilities |
|
|
6,293,716 |
|
|
|
3,922,999 |
|
Contingent consideration |
|
|
25,070,000 |
|
|
|
2,750,000 |
|
Other long-term liabilities |
|
|
1,925,769 |
|
|
|
1,864,875 |
|
Total liabilities |
|
|
33,289,485 |
|
|
|
8,537,874 |
|
Commitments and contingencies
(Note 16) |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
33,073,035 and 15,312,381 shares issued; 33,073,035 and 15,312,167
shares outstanding at September 30, 2020 and December 31, 2019,
respectively |
|
|
3,289 |
|
|
|
1,508 |
|
Additional paid-in capital |
|
|
380,543,640 |
|
|
|
187,914,916 |
|
Accumulated deficit |
|
|
(175,798,822 |
) |
|
|
(137,376,122 |
) |
Accumulated other comprehensive loss, net |
|
|
(5,042,272 |
) |
|
|
(5,020,156 |
) |
Total stockholders’ equity |
|
|
199,705,835 |
|
|
|
45,520,146 |
|
Total liabilities and stockholders’ equity |
|
$ |
232,995,320 |
|
|
$ |
54,058,020 |
|
ALTIMMUNE,
INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
|
For the Three Months
EndedSeptember 30, |
|
|
For the Nine Months
EndedSeptember 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
2,937,991 |
|
|
$ |
643,978 |
|
|
$ |
5,872,321 |
|
|
$ |
5,225,600 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
17,041,975 |
|
|
|
8,729,697 |
|
|
|
40,823,756 |
|
|
|
14,892,464 |
|
General and administrative |
|
|
4,220,238 |
|
|
|
2,187,661 |
|
|
|
9,097,511 |
|
|
|
6,485,960 |
|
Impairment charges |
|
|
— |
|
|
|
1,000,000 |
|
|
|
— |
|
|
|
1,000,000 |
|
Total operating expenses |
|
|
21,262,213 |
|
|
|
11,917,358 |
|
|
|
49,921,267 |
|
|
|
22,378,424 |
|
Loss from operations |
|
|
(18,324,222 |
) |
|
|
(11,273,380 |
) |
|
|
(44,048,946 |
) |
|
|
(17,152,824 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in fair value of warrant liability |
|
|
— |
|
|
|
76,000 |
|
|
|
— |
|
|
|
30,000 |
|
Interest expense |
|
|
(2,275 |
) |
|
|
(756 |
) |
|
|
(7,468 |
) |
|
|
(2,244 |
) |
Interest income |
|
|
45,127 |
|
|
|
224,058 |
|
|
|
278,154 |
|
|
|
649,268 |
|
Other income (expense), net |
|
|
29,218 |
|
|
|
(23,734 |
) |
|
|
48,882 |
|
|
|
(6,206 |
) |
Total other income, net |
|
|
72,070 |
|
|
|
275,568 |
|
|
|
319,568 |
|
|
|
670,818 |
|
Net loss before income tax
benefit |
|
|
(18,252,152 |
) |
|
|
(10,997,812 |
) |
|
|
(43,729,378 |
) |
|
|
(16,482,006 |
) |
Income tax benefit |
|
|
482,017 |
|
|
|
58,500 |
|
|
|
5,306,678 |
|
|
|
58,500 |
|
Net loss |
|
|
(17,770,135 |
) |
|
|
(10,939,312 |
) |
|
|
(38,422,700 |
) |
|
|
(16,423,506 |
) |
Other comprehensive loss –
unrealized (loss) gain on investments |
|
|
(10,569 |
) |
|
|
18,953 |
|
|
|
(22,116 |
) |
|
|
18,953 |
|
Comprehensive loss |
|
$ |
(17,780,704 |
) |
|
$ |
(10,920,359 |
) |
|
$ |
(38,444,816 |
) |
|
$ |
(16,404,553 |
) |
Net loss |
|
$ |
(17,770,135 |
) |
|
$ |
(10,939,312 |
) |
|
$ |
(38,422,700 |
) |
|
$ |
(16,423,506 |
) |
Deemed dividends |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(452,925 |
) |
Net loss attributed to common
stockholders |
|
$ |
(17,770,135 |
) |
|
$ |
(10,939,312 |
) |
|
$ |
(38,422,700 |
) |
|
$ |
(16,876,431 |
) |
Net loss per share attributed to
common stockholders, basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.74 |
) |
|
$ |
(1.74 |
) |
|
$ |
(1.35 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
33,056,971 |
|
|
|
14,768,931 |
|
|
|
22,058,424 |
|
|
|
12,481,494 |
|
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