Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company
leveraging significant government funding to develop a platform of
novel compounds in oncology and biodefense, announced today
financial results for the three months and twelve months ended
September 30, 2012.
2012 Key Operational Accomplishments
- No-cost extension & modification of Biomedical Advanced
Research and Development Authority (BARDA) base year contract
- BARDA exercised second year contract options worth over $9.1
million
- Several publications of key data, including data demonstrating
that AEOL 10150 reduced lung damage after Neupogen® treatment
(current standard of care for Heme-ARS) following radiation
exposure, and to reduce oxidative stress and Nerve damage following
exposure to nerve agents
- Reported significant improvements in the methods for producing
AEOL 10150 Bulk Drug Substance, which are expected to reduce the
cost of goods by more than 80 percent
- Shored-up balance sheet with additional cash
- Presented data on AEOL 11207, demonstrating a significant
decrease in both the frequency and duration of spontaneous
seizures; an increase in average life span; and protecting against
neuronal death
- Reported positive results from pre-IND meeting with FDA where
there agency agreed with the animal models and to be used under the
Lung-ARS development program and provided input on the Company's
phase 1 Human Safety study design.
2012 Key Financial Results
Total revenues for FY 2012 were $7.3 million as compared to $4.8
million in FY2011. Net income was $1.7 million, or $0.03 per basic
share, which includes a non-cash gain of approximately $4.1 million
related to decreases in the fair value of the warrants, for the
fiscal year ended September 30, 2012, as compared to a gain of $0.3
million, or $0.01 per basic share, which includes a charge of
approximately $3.9 million related to increases in the fair value
of the warrants, for the fiscal year ended September 30, 2011. As
of September 30, 2012, the Company had cash and cash equivalents of
$281,000.
For the fourth quarter FY 2012, total revenues were $1.4 million
as compared to $2.1 million in 2011. Net loss for the fourth
quarter in FY 2012 was $7.1 million, which includes a loss of
approximately $6.6 million related to increases in the fair value
of the warrants, as compared to $2.1 million, which includes a gain
of approximately $1.1 million related to decreases in the fair
value of the warrants, in the fourth quarter of FY 2011.
The warrant liability and revaluations have not and will not
have any impact on the Company's working capital, liquidity or
business operations. The Company's outstanding warrants will
continue to be revalued at each balance sheet date, which could
result in significant and unpredictable changes to our reported
liabilities and significant additional gains or losses charged to
the statement of operations for each period regardless of any
changes to the Company's working capital, liquidity or business
operations.
The increase in research and development expense reflects the
acceleration of our Pulmonary Acute Radiation Syndrome ("Lung-ARS")
program related to the execution of our contract with BARDA in
2012. We currently have eleven research and development programs in
progress: seven programs involving AEOL 10150 as a medical
countermeasure against the effects of sulfur mustard gas on the
skin and lungs, chlorine gas on the lungs, phosgene gas on the
lungs, against the effects of radiation on the lungs and on the
gastro-intestinal tract, against the effects of nerve agents, two
programs focused on AEOL 11207 and several other compounds as
potential treatments for Parkinson's disease and epilepsy, one
program studying another one of our compounds, AEOL 10171 (Hexyl),
as a protectant against radiation exposure and one program studying
AEOL 10150 as a treatment for cancer.
"During fiscal year 2012, we continued to take major steps
forward in the development of AEOL 10150, at minimal cost to our
shareholders, based on the support of our medical countermeasure
development program partners: BARDA, NIH-NIAID and NIH CounterACT,"
stated John L. McManus, President and Chief Executive Officer. "We
look forward to 2013, when we expect to request the exercise of
additional options under the BARDA contract, and report critical
data in efficacy and safety that we believe will position AEOL
10150 for potential procurement by BARDA for the Strategic National
Stockpile."
About AEOL 10150 AEOL 10150 is a
broad-spectrum catalytic antioxidant specifically designed to
neutralize reactive oxygen and nitrogen species. The neutralization
of these species reduces oxidative stress, inflammation, and
subsequent tissue damage-signaling cascades resulting from
radiation exposure. AEOL 10150 could have a profound beneficial
impact on people who have been exposed, or are about to be exposed,
to high-doses of radiation in the treatment of oncology.
AEOL 10150 has already performed well in preclinical and
non-clinical studies, was well-tolerated in two human clinical
trials, and has demonstrated statistically significant survival
efficacy in an acute radiation-induced lung injury model. The
Company believes it could have a profound beneficial impact on
people who have been exposed, or are about to be exposed, to
high-doses of radiation, whether from cancer therapy or a nuclear
event.
About Aeolus Pharmaceuticals Aeolus
Pharmaceuticals is developing a platform of a new class of
broad-spectrum, catalytic-antioxidant compounds that protect
healthy tissue from the damaging effects of radiation. Its first
compound, AEOL 10150, is being developed for oncology indications,
where it is used in combination with radiation therapy. It is also
being developed, with funding by the US Department of Health and
Human Services, as a medical countermeasure against chemical and
radiological weapons, where its initial target indications are as a
protective agent against the effects of acute radiation syndrome
and delayed effects of acute radiation exposure. Aeolus' strategy
is to leverage the substantial investment in toxicology,
manufacturing, and preclinical and clinical studies made by US
Government agencies in AEOL 10150, including the contract with
BARDA valued, with options, at up to $118.4 million, to efficiently
develop the compound for use in oncology. For more information,
please visit Aeolus's corporate website at
www.aeoluspharma.com.
Forward-Looking Statements The statements
in this press release that are not purely statements of historical
fact are forward-looking statements. Such statements include, but
are not limited to, those relating to Aeolus' product candidates,
proprietary technologies, and current and future research and
development programs, as well as Aeolus' contract with BARDA. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Aeolus' actual
results to be materially different from historical results or from
any results expressed or implied by such forward-looking
statements. Important factors that could cause results to differ
include risks associated with uncertainties of progress and timing
of clinical trials, scientific research and product development
activities, difficulties or delays in development, testing,
obtaining regulatory approval, the need to obtain funding for
pre-clinical and clinical trials and operations, the scope and
validity of intellectual property protection for Aeolus' product
candidates, proprietary technologies and their uses, competition
from other biopharmaceutical companies, and Aeolus' contract with
BARDA, including whether Aeolus will continue to receive funding
under the contract. Certain of these factors and others are more
fully described in Aeolus' filings with the Securities and Exchange
Commission, including, but not limited to, Aeolus' Annual Report on
Form 10-K for the year ended September 30, 2012. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended Twelve Months Ended
September 30, September 30,
-------------------- --------------------
2012 2011 2012 2011
--------- --------- --------- ---------
Revenue
Contract Revenue $ 1,399 $ 2,124 $ 7,293 $ 4,821
Costs and expenses:
Research and development 1,245 2,010 6,468 5,055
General and administrative 651 1,122 3,196 3,668
--------- --------- --------- ---------
Total costs and expenses 1,896 3,132 9,664 8,723
--------- --------- --------- ---------
Loss from operations (497) (1,008) (2,371) (3,902)
Interest income (expense) - - - (21)
Warrant liability charges (6,609) (1,141) 4,069 3,887
Other Income (Expense) - - - 335
--------- --------- --------- ---------
Net Income (loss) $ (7,106) $ (2,149) $ 1,698 $ 299
========= ========= ========= =========
Net loss per weighted share
attributable to common
stockholders:
Basic $ (0.11) $ (0.04) $ 0.03 $ 0.01
========= ========= ========= =========
Diluted $ (0.11) $ (0.04) $ 0.02 $ 0.00
========= ========= ========= =========
Weighted average common shares
outstanding:
Basic 62,732 60,470 61,593 59,474
========= ========= ========= =========
Diluted 71,075 60,470 72,749 82,302
========= ========= ========= =========
Selected Balance Sheet Items:
(in thousands)
September 30, September 30,
2012 2011
------------- -------------
Cash and marketable securities $ 281 $ 518
Total assets $ 1,256 $ 2,290
Stockholders' equity (deficit) $ (20,335) $ (23,259)
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Contact: Russell Skibsted Sr. Vice President and Chief Financial
Officer (949) 481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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