Altimmune Announces Second Quarter 2021 Financial Results and Provides a Corporate Update
11 August 2021 - 6:01AM
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical
company, today announced financial results for the three- and
six-months ending June 30, 2021 and provided a corporate update.
“Following data readouts in Q2, Altimmune has
focused its efforts on our NASH and emerging obesity pipeline with
the encouraging interim data from the ALT-801 Phase 1 trial
reinforcing the potential of these programs,” remarked Vipin K.
Garg, Ph.D., President and Chief Executive Officer at Altimmune.
“Our strong financial position enables us to proceed with a robust
ALT-801 development program in the second half of 2021 with the
goal of initiating Phase 2 trials in early 2022 for both obesity
and NASH indications.”
Recent Highlights:
- Reported encouraging 6-week interim
data from the ongoing Phase 1 clinical trial of ALT-801 in
Australia
- In the study of overweight and
obese subjects, a placebo-adjusted weight loss of 6.3% was achieved
at 6 weeks of treatment with 1.8 mg once weekly dose, surpassing
the 2% pre-established treatment target
- The multi-dose regimen was
well-tolerated without the need for dose titration
- No subject dropouts related to drug
administration reported within the first 6 weeks of treatment
- Advancing to
ALT-801 12-week data readout on three cohorts, expected in
September 2021
- 12-week data on three dose cohorts
at the 1.2mg, 1.8mg and 2.4mg dose levels are expected to be
reported. The final 12-week dose for all cohorts has been
administered
- Data readouts are expected to
include update on weight loss and adverse events, in addition to
the following measures:
- Pharmacokinetics (PK)
- Lean body mass, calorie intake,
resting energy expenditure (REE)
- Glucose homeostasis
- Insulin resistance—HOMA-IR2,
adiponectin
- Lipids (HDL, LDL, TG, &
lipoprotein (a))
- Markers of inflammation
- Filing of ALT-801 investigational
new drug (IND) application for non-alcoholic steatohepatitis (NASH)
on track for Q3 2021, which will be followed by the initiation of a
clinical trial in non-alcoholic fatty liver disease (NAFLD)
- The Phase 1b, 12-week NAFLD study
will include diabetic and non-diabetic subjects and is expected to
be conducted at approximately 10 US sites
- Primary efficacy end point will be
reduction in liver fat by MRI-PDFF
- Study expected to enable a 52-week
biopsy driven NASH study in Q1 2022
- IND in obesity
expected to be filed in Q4 2021
- Phase 2 obesity trial is expected
to initiate in Q1 2022
- Development program expected to
include diabetic and non-diabetic subjects
- Additional
clinical development to support NASH and obesity programs during
2021
- Phase 1 drug-drug interaction study
to initiate in Q4 2021 to evaluate ALT-801 interaction with
commonly used drugs
- 12-week Phase 1 study to initiate
in Q4 2021 to evaluate ALT-801 effects on glucose control,
hemoglobin A1C and insulin resistance in subjects with type 2
diabetes
- Initiated development of an oral
formulation for ALT-801
- Molecular weight and potency of
ALT-801 are well-suited for oral administration
Financial Results for the Three and Six
Months Ended June 30, 2021
- Altimmune had
cash, cash equivalents, short-term investments and restricted cash
totaling $217.9 million at June 30, 2021 compared to $216.0 million
at December 31, 2020. Through utilization of at-the-market (ATM)
offerings during the second quarter of 2021, Altimmune raised net
proceeds of $18.2 million and a total of $52.4 million since the
beginning of the year.
- Revenue was $0.1
million for the three months ended June 30, 2021 compared to $0.7
million in the same period in 2020. The change in revenue quarter
over quarter was primarily due to a decrease in BARDA revenue
during the current period due to the timing of clinical trials and
development activities for NasoShield.
- Research and
development expenses were $13.3 million for the three months ended
June 30, 2021, compared to $16.6 million in the same period in
2020. The change was primarily the result of increased expenses of
$9.7 million primarily related to development activities for the
Company’s COVID-19 programs, offset by a decrease of $13.0 million
resulting from changes in the fair value of contingent
consideration liability connected with the acquisition and
development of ALT-801.
- General and
administrative expenses were $3.7 million for the three months
ended June 30, 2021 compared to $2.5 million in the same period in
2020. The increase during the quarter is primarily due to increased
stock compensation expense and additional labor related costs.
- An impairment on
construction-in-progress of $8.1 million was recognized for the
three months ended June 30, 2021 related to the build out of a
commercial scale manufacturing suite for the Company’s recently
terminated COVID-19 vaccine program. No impairment was recognized
in the prior year.
- Net loss for the
three months ended June 30, 2021 was $24.8 million, or $0.60 net
loss per share, compared to $16.8 million in the same period in
2020, or $0.94 net loss per share. Net loss for the six months
ended June 30, 2021 was $39.7 million, or $0.99 net loss per share,
compared to $20.7 million in the same period in 2020, or $1.25 net
loss per share.
Conference Call Information
Date: |
Wednesday,
August 11, 2021 |
Time: |
8:30 am Eastern Time |
Domestic Dial-in |
(844) 615-6509 |
International Dial-in: |
(918) 922-3148 |
Conference ID: |
9484516 |
Webcast: |
https://edge.media-server.com/mmc/p/ne5cqqtf |
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 treatments for obesity and liver
diseases. Our pipeline includes next generation peptide
therapeutics for obesity, 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 ALT-801 Phase 1 clinical trial in September 2021, the
potential start of the ALT-801 12-week NAFLD trial in September
2021, the potential start of the ALT-801 drug/drug interaction
trial and Type 2 diabetes trial by year end 2021, the potential
filing of a NASH IND in Q3 2021, the potential filing of an obesity
IND in Q4 2021, the commencement of a 52-week, Phase 2,
biopsy-trial based on NASH endpoints in Q1 2022, the commencement
of a 24-week, Phase 2, obesity trial in Q1 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
Brown Chief
Financial Officer
Phone:
240-654-1450 wbrown@altimmune.com
|
ALTIMMUNE, INC. |
CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
(unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
174,102,382 |
|
|
$ |
115,917,807 |
|
Restricted cash |
|
34,174 |
|
|
|
34,174 |
|
Total cash, cash equivalents and restricted cash |
|
174,136,556 |
|
|
|
115,951,981 |
|
Short-term investments |
|
43,723,840 |
|
|
|
100,005,558 |
|
Accounts receivable |
|
4,463,442 |
|
|
|
4,610,202 |
|
Tax refund receivable |
|
6,887,981 |
|
|
|
7,762,793 |
|
Prepaid expenses and other current assets |
|
9,413,070 |
|
|
|
1,926,675 |
|
Total current assets |
|
238,624,889 |
|
|
|
230,257,209 |
|
Property and equipment,
net |
|
4,751,010 |
|
|
|
1,056,920 |
|
Intangible assets, net |
|
12,956,112 |
|
|
|
12,823,846 |
|
Other assets |
|
928,839 |
|
|
|
977,238 |
|
Total assets |
$ |
257,260,850 |
|
|
$ |
245,115,213 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,421,192 |
|
|
$ |
612,293 |
|
Accrued expenses and other current liabilities |
|
7,674,536 |
|
|
|
11,408,154 |
|
Total current liabilities |
|
9,095,728 |
|
|
|
12,020,447 |
|
Contingent consideration |
|
5,270,000 |
|
|
|
5,390,000 |
|
Other long-term
liabilities |
|
1,617,150 |
|
|
|
1,828,443 |
|
Total liabilities |
|
15,982,878 |
|
|
|
19,238,890 |
|
Commitments and contingencies
(Note 16) |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock, $0.0001 par value; 200,000,000 shares authorized;
39,693,524and 37,142,946 shares issued and outstanding at
June 30, 2021 and December 31, 2020,
respectively |
|
3,956 |
|
|
|
3,697 |
|
Additional paid-in capital |
|
482,083,670 |
|
|
|
417,337,742 |
|
Accumulated deficit |
|
(235,771,414 |
) |
|
|
(186,420,599 |
) |
Accumulated other comprehensive loss, net |
|
(5,038,240 |
) |
|
|
(5,044,517 |
) |
Total stockholders’ equity |
|
241,277,972 |
|
|
|
225,876,323 |
|
Total liabilities and stockholders’ equity |
$ |
257,260,850 |
|
|
$ |
245,115,213 |
|
|
ALTIMMUNE, INC. |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(unaudited) |
|
|
For the Three Months Ended |
|
For the Six Months Ended |
|
June 30, |
|
June 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenues |
$ |
137,623 |
|
|
$ |
721,636 |
|
|
$ |
975,139 |
|
|
$ |
2,934,330 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
13,272,412 |
|
|
|
16,594,250 |
|
|
|
25,150,312 |
|
|
|
23,781,781 |
|
General and administrative |
|
3,658,653 |
|
|
|
2,545,356 |
|
|
|
7,480,073 |
|
|
|
4,877,273 |
|
Impairment loss on construction-in-progress |
|
8,070,000 |
|
|
|
— |
|
|
|
8,070,000 |
|
|
|
— |
|
Total operating expenses |
|
25,001,065 |
|
|
|
19,139,606 |
|
|
|
40,700,385 |
|
|
|
28,659,054 |
|
Loss from operations |
|
(24,863,442 |
) |
|
|
(18,417,970 |
) |
|
|
(39,725,246 |
) |
|
|
(25,724,724 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
(22,226 |
) |
|
|
(3,308 |
) |
|
|
(33,897 |
) |
|
|
(5,193 |
) |
Interest income |
|
32,863 |
|
|
|
81,458 |
|
|
|
75,362 |
|
|
|
233,027 |
|
Other income (expense), net |
|
26,098 |
|
|
|
(5,878 |
) |
|
|
(7,034 |
) |
|
|
19,664 |
|
Total other income, net |
|
36,735 |
|
|
|
72,272 |
|
|
|
34,431 |
|
|
|
247,498 |
|
Net loss before income tax
benefit |
|
(24,826,707 |
) |
|
|
(18,345,698 |
) |
|
|
(39,690,815 |
) |
|
|
(25,477,226 |
) |
Income tax benefit |
|
— |
|
|
|
1,578,782 |
|
|
|
— |
|
|
|
4,824,661 |
|
Net loss |
|
(24,826,707 |
) |
|
|
(16,766,916 |
) |
|
|
(39,690,815 |
) |
|
|
(20,652,565 |
) |
Other comprehensive income
(loss) — unrealized gain (loss) on short-term investments |
|
1,141 |
|
|
|
20,888 |
|
|
|
6,277 |
|
|
|
(11,547 |
) |
Comprehensive loss |
$ |
(24,825,566 |
) |
|
$ |
(16,746,028 |
) |
|
$ |
(39,684,538 |
) |
|
$ |
(20,664,112 |
) |
Net loss per share, basic and
diluted |
$ |
(0.60 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.99 |
) |
|
$ |
(1.25 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
41,356,643 |
|
|
|
17,886,853 |
|
|
|
40,142,561 |
|
|
|
16,498,719 |
|
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