Aeolus Announces Fiscal Year 2013 Financial Results
MISSION VIEJO, CA--(Marketwired - Dec 23, 2013) - Aeolus
Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company
developing compounds to protect against radiological and chemical
threats with significant funding from the US Government, announced
today financial results for the three months and twelve months
ended September 30, 2013.
Key 2013 Operational
Accomplishments
- Exercise of $6.0 million in additional options under BARDA
contract
- Filing of application for new patents for AEOL 10150 covering
synthesis, formulation and pharmaceutical composition potentially
extending protection through 2034.
- Completion of additional animal studies in Lung-ARS
demonstrating significant survival advantage.
- Award of $4.3 million NIH grant to develop AEOL 10150 as
treatment for nerve gas exposure
- Initiation of large non-human primate study with AEOL 10150 in
Lung-ARS
- Release of data from multiple animal studies demonstrating
efficacy for AEOL 10150 in mustard gas exposure
- Addition of new Directors to Board with expertise in government
affairs and radiation oncology
"Our team made significant progress during fiscal 2013 in
advancing AEOL 10150 as a medical countermeasure for radiation and
chemical exposure. The additional efficacy data generated in
radiation and mustard gas models confirms the effectiveness of AEOL
10150 as a medical countermeasure. Work in the manufacturing
segment of our BARDA program has resulted in the filing of new
patents, a greater than 80 percent reduction in the cost of goods,
and scale up of our manufacturing process from 1 kilogram batches
to 4.5 kilogram batches," stated John L. McManus, President &
Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "2014 will
be an exciting year as we expect to report results from at least 8
animal efficacy studies for radiation, and several studies in our
sulfur mustard, nerve agent and Parkinson's disease programs, and
expect to file several IND's and a pre-emergency use authorization.
We remain grateful for the funding and the technical expertise that
our partners at BARDA, NIH-NIAID and NIH CounterACT continue to
provide, and the valuable contributions from our research
collaborators at the University of Maryland, National Jewish
Health, University of Colorado, Indiana University, Johnson Matthey
Pharma Services and Epistem."
Financial
Results
The Company reported a net loss of $3,208,000 or ($0.03) per
share (including a non-cash adjustment for increases in valuation
of warrants of approximately $510,000) for the fiscal year ended
September 30, 2013, versus net income of $1,698,000 or $0.01 per
share (including a non-cash gain for decreases in valuation of
warrants of $4,069,000) for the fiscal year ended September 30,
2012.
Revenue for the fiscal year ended September 30, 2013 was
approximately $3,928,000, compared to $7,293,000 for the fiscal
year ended September 30, 2012. The revenue is from the contract
with the Biomedical Advanced Research and Development Authority
("BARDA") announced on February 11, 2011. Lower revenue in fiscal
year 2013 reflects the timing of the initiation of program items
under the BARDA contract.
Research and development expenses decreased by $3,108,000, or
48%, to approximately $3,360,000 for the fiscal year ended
September 30, 2013 from approximately $6,468,000 for the fiscal
year ended September 30, 2012. R&D expenses were lower during
the fiscal year ended September 30, 2013 versus September 30, 2012
due to the timing of work related to the BARDA contract.
G&A expenses increased approximately $70,000, or 2%, to
approximately $3,266,000 for the fiscal year ended September 30,
2013 from about $3,196,000 for the fiscal year ended September 30,
2012. Consulting stock expense increased by about $287,000 as a
result of increased awards for the period. The increase in
consulting stock expense was partially offset by a decrease in
salaries and benefits of about $172,000.
For the fourth quarter of FY 2013, total revenues were $0.9
million as compared to $1.4 million in the fourth quarter of FY
2012. Net loss for the fourth quarter in FY 2013 was $0.7 million,
which includes no adjustments related to warrant liability, as
compared to $7.1 million, which includes a loss of approximately
$6.6 million related to decreases in the fair value of the
warrants, in the fourth quarter of FY 2012.
Aeolus has filed today with the SEC its Annual Report on Form
10-K for the fiscal year ended September 30, 2013. Aeolus urges its
investors to read this quarterly filing as well as its amended
Annual Report on Form 10-K/A, also filed with the SEC, for further
details concerning the Company. The Quarterly Report on Form 10-Q
and the amended Annual Report on Form 10-K/A are also available on
the Company's website, at http://www.aeoluspharma.com.
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 may 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 performed well in preclinical and non-clinical
studies, demonstrating statistically significant survival efficacy
in an acute radiation-induced lung injury model, and was
well-tolerated in two human clinical trials. 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 and other inducers of reactive
oxygen species. Its first compound, AEOL 10150, is 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, as well as its proprietary technologies
and research programs, the Company's potential initiation of large
efficacy studies in mice and NHPs, as well as a phase 1 study in
healthy normal volunteers, the BARDA Contract, and the expected use
of proceeds from the financing. 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, and competition from other biopharmaceutical companies, and
whether BARDA exercises one or more additional options under the
BARDA 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.
| |
| AEOLUS PHARMACEUTICALS,
INC. |
| CONDENSED CONSOLIDATED BALANCE SHEETS |
| (Unaudited) |
| (In thousands, except share and per share data) |
| |
|
|
|
September 30, |
|
|
|
|
2013 |
|
|
2012 |
|
|
ASSETS |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
| Cash
and cash equivalents |
|
$ |
869 |
|
|
$ |
281 |
|
|
Accounts receivable |
|
|
370 |
|
|
|
781 |
|
|
Deferred subcontractor cost |
|
|
656 |
|
|
|
101 |
|
|
Prepaids and other current assets |
|
|
39 |
|
|
|
61 |
|
| Total
current assets |
|
|
1,935 |
|
|
|
1,224 |
|
|
|
|
|
|
|
|
|
|
|
|
Investment in CPEC LLC |
|
|
32 |
|
|
|
32 |
|
| Total
assets |
|
$ |
1,966 |
|
|
$ |
1,256 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
579 |
|
|
$ |
2,167 |
|
|
Deferred revenue |
|
|
682 |
|
|
|
105 |
|
| Total
current liabilities |
|
|
1,261 |
|
|
|
2,272 |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability |
|
|
-- |
|
|
|
19,319 |
|
| Total
liabilities |
|
|
1,261 |
|
|
|
21,591 |
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Notes E and I) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity (deficit): |
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value per share, 10,000,000 shares
authorized: |
|
|
|
|
|
|
|
|
|
Series A nonredeemable convertible preferred stock, 1,250,000
shares authorized as of September 30, 2013 and 2012, respectively;
no shares issued and outstanding as of September 30, 2013 and 2012,
respectively |
|
|
-- |
|
|
|
-- |
|
|
Series B nonredeemable convertible preferred stock, 1,600,000 and
600,000 shares authorized as of September 30, 2013 and 2012,
respectively; 526,080 and 526,080 shares issued and outstanding as
of September 30, 2013 and 2012, respectively |
|
|
5 |
|
|
|
5 |
|
|
Common stock, $.01 par value per share, 200,000,000 shares
authorized; 134,550,068 and 62,731,963 shares issued and
outstanding at September 30, 2013 and 2012, respectively |
|
|
1,346 |
|
|
|
627 |
|
|
Additional paid-in capital |
|
|
183,276 |
|
|
|
159,747 |
|
|
Accumulated deficit |
|
|
(183,922 |
) |
|
|
(180,714 |
) |
| Total
stockholders' equity (deficit) |
|
|
705 |
|
|
|
(20,335 |
) |
| Total
liabilities and stockholders' equity (deficit) |
|
$ |
1,966 |
|
|
$ |
1,256 |
|
| |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
| |
| AEOLUS PHARMACEUTICALS,
INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| (Unaudited) |
| (In thousands, except per share data) |
| |
|
|
|
Fiscal Year Ended September 30, |
|
|
|
|
2013 |
|
|
2012 |
|
|
Revenue: |
|
|
|
|
|
|
|
|
|
Contract revenue |
|
$ |
3,928 |
|
|
$ |
7,293 |
|
|
|
|
|
|
|
|
|
|
|
| Costs
and expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,360 |
|
|
|
6,468 |
|
|
General and administrative |
|
|
3,266 |
|
|
|
3,196 |
|
| Total
costs and expenses |
|
|
6,626 |
|
|
|
9,664 |
|
|
|
|
|
|
|
|
|
|
|
| Loss
from operations |
|
|
(2,698 |
) |
|
|
(2,371 |
) |
|
Warrant liability gain (charges) |
|
|
(510 |
) |
|
|
4,069 |
|
| Net
income (loss) |
|
$ |
(3,208 |
) |
|
$ |
1,698 |
|
|
|
|
|
|
|
|
|
|
|
| Net
income (loss) attributable to common stockholders - basic |
|
$ |
(3,208 |
) |
|
$ |
856 |
|
| Net
income (loss) attributable to common stockholders - diluted |
|
$ |
(3,208 |
) |
|
$ |
(2,161 |
) |
|
|
|
|
|
|
|
|
|
|
| Basic
net income (loss) per common share |
|
$ |
(0.03 |
) |
|
$ |
0.01 |
|
|
Diluted net income (loss) per common share |
|
$ |
(0.03 |
) |
|
$ |
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
Basic |
|
|
106,554 |
|
|
|
61,593 |
|
|
Diluted |
|
|
106,554 |
|
|
|
71,041 |
|
| |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
| |
| AEOLUS PHARMACEUTICALS,
INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
| (Unaudited) |
| (In thousands) |
| |
|
|
Fiscal Year Ended September 30, |
|
| |
|
|
2013 |
|
|
|
2012 |
|
| Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
| Net income (loss) |
|
|
$ |
(3,208 |
) |
|
|
$ |
1,698 |
|
| Adjustments to reconcile net income (loss) to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
|
|
| |
Depreciation |
|
|
|
6 |
|
|
|
|
7 |
|
| |
Noncash compensation |
|
|
|
861 |
|
|
|
|
568 |
|
| |
Noncash interest and financing costs |
|
|
|
-- |
|
|
|
|
17 |
|
| |
Change in fair value of warrants |
|
|
|
510 |
|
|
|
|
(4,086 |
) |
| Change in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
| |
Accounts receivable |
|
|
|
411 |
|
|
|
|
896 |
|
| |
Deferred subcontractor cost |
|
|
|
(555 |
) |
|
|
|
(101 |
) |
| |
Prepaid expenses and other assets |
|
|
|
16 |
|
|
|
|
(6 |
) |
| |
Accounts payable and accrued expenses |
|
|
|
(1,588 |
) |
|
|
|
23 |
|
| |
Deferred revenue |
|
|
|
577 |
|
|
|
|
105 |
|
| Net cash used in operating activities |
|
|
|
(2,970 |
) |
|
|
|
(879 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
| |
Purchase of equipment |
|
|
|
-- |
|
|
|
|
-- |
|
| Net cash used in investing activities |
|
|
|
-- |
|
|
|
|
-- |
|
| |
|
|
|
|
|
|
|
|
|
|
| Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
| |
Proceeds from issuance of common stock and warrants |
|
|
|
3,616 |
|
|
|
|
660 |
|
| |
Costs
related to the issuance of common stock and warrants |
|
|
|
(58 |
) |
|
|
|
(18 |
) |
| Net cash provided by financing activities |
|
|
|
3,558 |
|
|
|
|
642 |
|
| |
|
|
|
|
|
|
|
|
|
|
| Net increase (decrease) in cash and cash
equivalents |
|
|
|
588 |
|
|
|
|
(237 |
) |
| |
|
|
|
|
|
|
|
|
|
|
| Cash and cash equivalents at beginning of year |
|
|
|
281 |
|
|
|
|
518 |
|
| Cash and cash equivalents at end of year |
|
|
$ |
869 |
|
|
|
$ |
281 |
|
| |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
Contact: John McManus President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc. 1-(949)
481-9825
Aeolus Pharmaceuticals (CE) (USOTC:AOLS)
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