Delaware
|
56-1953785
|
|
(State
or Other Jurisdiction of
Incorporation
or Organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
Page
|
||
|
|
PART
I
|
|
|
3
|
||
|
|
17
|
|
|
18
|
||
|
26
|
||
|
26
|
||
|
26
|
||
|
26
|
||
|
|
PART
II
|
|
|
27
|
||
|
29
|
||
|
30
|
||
|
36
|
||
|
36
|
||
|
54
|
||
|
55
|
||
|
55
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||
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|
PART
III
|
|
|
55
|
||
|
55
|
||
|
56
|
||
|
56
|
||
|
56
|
||
|
|
PART
IV
|
|
|
56
|
· |
our
need for, and our ability to obtain, additional
funds;
|
· |
uncertainties
relating to clinical trials and regulatory reviews and
approvals;
|
· |
our
dependence on a limited number of therapeutic
compounds;
|
· |
the
early stage of the product candidates we are
developing;
|
· |
the
acceptance of any future products by physicians and
patients;
|
· |
competition
with and dependence on collaborative
partners;
|
· |
loss
of key consultants, management or scientific
personnel;
|
· |
our
ability to obtain adequate intellectual property protection and to
enforce
these rights; and
|
· |
our
ability to avoid infringement of the intellectual property rights
of
others.
|
· |
Retain
the catalytic mechanism and high antioxidant efficiency of the natural
enzymes, and
|
· |
Create
and develop stable and small molecule antioxidants without the limitations
of superoxide dismutases (“SOD”) so that
they:
|
o |
have
broader antioxidant activity,
|
o |
have
better tissue penetration,
|
o |
have
a longer life in the body, and
|
o |
are
not proteins, which are more difficult and expensive to
manufacture.
|
Treatment
|
|
Age
at Symptom onset mean days + SD(range)
|
|
Survival
Interval mean days + SD(range)
|
|
P-value
Log-rank (v. control)
|
|
P-value
Wilcoxon (v. control)
|
|
|
|
|
|
|
|
|
|
Control
|
104.8
+ 1.43
|
12.8
+ 0.79
|
|
|
||||
|
|
(100-112
|
)
|
(9-16
|
)
|
|
|
|
AEOL
10150
|
|
106.1
+ 1.5
|
|
32.2
+ 2.73
|
|
|
|
|
|
|
(100-115
|
)
|
(15-46
|
)
|
<
0.0001
|
|
0.0002
|
|
|
AEOL
10150
|
||||||||||||
Pharmacokinetic
Parameter
|
|
3
mg N = 3
|
|
12
mg N = 4
|
|
30
mg N = 3
|
|
45
mg N = 4
|
|
45
mg N = 4 (repeat,
different patients)
|
|
60
mg N = 4
|
|
75
mg
N=
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AUC(0-∞)
(hr•ng/mL)
|
354
±100
|
1,494
±386
|
4,580
±1828
|
7,116
±1010
|
5,922
±1307
|
9,087
±2180
|
12,167
±1543
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tmax
(0-48) (hr)
|
1
±0
|
|
1
±1
|
|
1
±0
|
|
1
±0
|
|
2
±1
|
|
2
±0
|
|
2
±1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cmax
(0-48) (ng/mL)
|
|
115
±38
|
|
267
±40
|
|
733
±166
|
|
1,245
±247
|
|
962
±333
|
|
1,330
±226
|
|
1,584
±378
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
T1/2
(hr)
|
|
2.61
±0.60
|
|
3.97
±1.09
|
|
5.25
±1.65
|
|
6.31
±2.54
|
|
5.28
±1.00
|
|
5.93
±0.90
|
|
6.36
±0.47
|
|
|
|||||
Pharmacokinetic
Parameter
|
|
40
mg N = 4
|
|
60
mg N = 4
|
|
|
|
|
|
|
|
|
|
AUC(0-8)
(hr•ng/mL)
|
7,545
±1310
|
10,289
±2,608
|
||||
|
|
|
|
|
|
|
Tmax
(0-48) (hr)
|
1
±0
|
|
1
±0
|
|
|
|
|
|
|
|
|
|
|
Cmax
(0-48) (ng/mL)
|
|
1,735
±221
|
|
2,315
±775
|
|
|
|
|
|
|
|
|
|
T1/2
(hr)
|
|
9.4
±3.4
|
|
7.8
±0.8
|
|
|
· |
Increases
in Cmax and AUC(0-8) appears to correlate with increases in dose,
but the
correlation is not strong.
|
· |
The
mean Cmax for the 40 mg cohort was 1,735 ng/mL; and 2,313 ng/mL for
the 60
mg cohort.
|
· |
There
were linear correlations between both Cmax and AUC(0-8) and dose
based on
body weight.
|
· |
The
terminal half life (a measurement of the time period for which a
compound
stays in the body) as determined from Day 7 data was approximately
8 to 9
hours. The shorter (i.e. 4-5 hours) half life determined from Day
1 data
is most probably related to distribution of compound.
|
· |
Steady-state
occurs within three days of multiple dosing. There was no evidence
for a
third longer half life that would be associated with long term
accumulation. Thus, importantly compound accumulation is not expected
beyond the third day with multiple
dosing.
|
· |
completion
of preclinical studies;
|
· |
the
submission to the FDA of a request for authorization to conduct clinical
trials on an investigational new drug (an “IND”), which must become
effective before clinical trials may
commence;
|
· |
adequate
and well-controlled Phase I clinical trials which typically involves
normal, healthy volunteers. The test study a drug candidate’s safety
profile, including the safe dosage range. The studies also determine
how a
drug is absorbed, distributed, metabolized and excreted as well as
the
duration of its action.
|
· |
Adequate
and well-controlled Phase II clinical trials which typically involve
treating patients with the targeted disease with the drug candidate
to
assess a drug’s effectiveness.
|
· |
Adequate
and well-controlled Phase III clinical trials involving a larger
population of patients with the targeted disease are treated with
the drug
candidate to confirm efficacy of the drug candidate in the treatment
of
the targeted indication and to identify adverse
events.
|
· |
submission
to the FDA of an NDA; and
|
· |
review
and approval of the NDA by the FDA before the product may be shipped
or
sold commercially.
|
Name
|
|
Age
|
|
Position(s)
|
|
|
|
|
|
John
L. McManus
|
|
42
|
|
President
and Chief Operating Officer
|
Brian
J. Day, Ph.D.
|
|
46
|
|
Chief
Scientific Officer
|
Elaine
Alexander, M.D.
|
|
54
|
|
Executive
Vice President and Chief Medical Officer
|
Michael
P. McManus
|
|
37
|
|
Chief
Financial Officer, Treasurer and
Secretary
|
· |
any
or all of these proposed products or procedures are found to be unsafe or
ineffective or otherwise fail to receive necessary regulatory approvals;
|
· |
the
receipt of regulatory approvals for the indications that we are studying;
|
· |
the
establishment and demonstration in the medical community of the safety,
clinical efficacy and cost-effectiveness of our products and their
potential advantages over existing therapeutic products;
|
· |
marketing
and distribution support;
|
· |
the
introduction, market penetration and pricing strategies of competing
and
future products; and
|
· |
coverage
and reimbursement policies of governmental and other third-party
payors
such as insurance companies, health maintenance organizations and
other
plan administrators.
|
|
|
High
|
|
Low
|
||
|
|
|
|
|
|
|
Fiscal
Year Ended September 30, 2005
|
|
|
|
|
|
|
October
1, 2004 through December 31, 2004
|
|
$
|
1.60
|
|
$
|
1.04
|
January
1, 2005 through March 31, 2005
|
|
$
|
1.25
|
|
$
|
0.65
|
April
1, 2005 through June 30, 2005
|
|
$
|
0.95
|
|
$
|
0.44
|
July
1, 2005 through September 30, 2005
|
|
$
|
1.38
|
|
$
|
0.75
|
Fiscal
Year Ended September 30, 2006
|
|
|
|
|
|
|
October
1, 2005 through December 31, 2005
|
|
$
|
1.35
|
|
$
|
0.80
|
January
1, 2006 through March 31, 2006
|
|
$
|
1.00
|
|
$
|
0.76
|
April
1, 2006 through June 30, 2006
|
|
$
|
0.90
|
|
$
|
0.42
|
July
1, 2006 through September 30, 2006
|
|
$
|
0.91
|
|
$
|
0.50
|
· |
the
date that Goodnow owns less than 20% of our outstanding common stock
on an
as converted basis;
|
· |
the
completion, to the absolute satisfaction of Goodnow, of initial clinical
safety studies of AEOL 10150 and analysis of the data developed based
upon
such studies with the results satisfactory to Goodnow, in its absolute
discretion, to initiate efficacy studies of AEOL 10150 in humans;
or
|
· |
the
initiation of dosing of the first human patient in an efficacy-based
study
of AEOL 10150.
|
Plan
category
|
|
(a)Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
|
(b)Weighted-average
exercise price of outstanding options, warrants and
rights
|
|
(c)Number
of securities remaining available for future issuance under equity
compensation plans (excluding securities reflected in column
(a))
|
|
|
|
|
|
|
|
Equity
compensation plans approved by our stockholders:
|
|
|
|
|
|
|
2004
Stock Option Plan
|
|
1,092,610
|
|
$0.85
|
|
761,559
|
1994
Stock Option Plan
|
|
1,979,196
|
|
$4.57
|
|
0
|
Equity
compensation plans and securities not approved by our
stockholders:
|
|
|
|
|
|
|
Warrant
to Purchase Common Stock Issued to Brookstreet Securities
Corporation
|
250,000
|
$1.50
|
Not
applicable
|
|||
Warrant
to Purchase Common Stock Issued to TBCC Funding Trust II
|
|
1,759
|
|
$19.90
|
|
Not
applicable
|
Warrants
to Purchase Common Stock Issued to Petkevich & Partners,
LLC
|
|
10,000
|
|
$20.25
|
|
Not
applicable
|
Warrant
to Purchase Common Stock Issued to W. Ruffin Woody, Jr.
|
|
35,000
|
|
$1.00
|
|
Not
applicable
|
Total
- Common Stock
|
|
3,368,565
|
|
|
|
761,559
|
|
|
|
|
|
|
|
Convertible
Promissory Note convertible into shares of Series B Preferred Stock
Issued
to Elan Pharma International Limited (as of September 30,
2006)(1)(2)
|
|
22,103
|
|
$43.27
|
|
492
|
Total
- Series B Preferred Stock
|
|
22,103
|
|
|
|
492
|
|
Year
Ended September 30,
|
||||||||||||||||||
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
|
|||||
|
|
(in
thousands, except per share data)
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income and contract revenue
|
$
|
92
|
$
|
252
|
|
|
$
|
305
|
|
|
$
|
—
|
|
|
$
|
—
|
|
||
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research
and development
|
3,480
|
|
4,515
|
|
|
|
8,295
|
|
|
|
2,780
|
|
|
|
3,927
|
|
|||
General
and administrative
|
2,216
|
|
2,674
|
|
|
|
3,987
|
|
|
|
2,025
|
|
|
|
2,778
|
|
|||
Total
costs and expenses
|
5,696
|
|
7,189
|
|
|
|
12,282
|
|
|
|
4,805
|
|
|
|
6,705
|
|
|||
Loss
from operations
|
(5,604
|
)
|
|
(6,937
|
)
|
|
|
(11,977
|
)
|
|
|
(4,805
|
)
|
|
|
(6,705
|
)
|
||
Equity
in income of CPEC LLC
|
433
|
—
|
—
|
—
|
—
|
||||||||||||||
Equity
in loss of Incara Development
|
—
|
|
—
|
|
|
|
—
|
|
|
|
(76
|
)
|
|
|
(1,040
|
)
|
|||
Increase
in fair value of common stock warrants
|
(604
|
)
|
—
|
—
|
—
|
|
—
|
||||||||||||
Interest
income (expense), net
|
(6
|
)
|
|
(31
|
)
|
|
|
(5,213
|
)
|
|
|
(192
|
)
|
|
|
(50
|
)
|
||
Other
income
|
53
|
|
63
|
|
|
|
23
|
|
|
|
223
|
|
|
|
150
|
|
|||
Loss
from continuing operations
|
(5,728
|
)
|
|
(6,905
|
)
|
|
|
(17,167
|
)
|
|
|
(4,850
|
)
|
|
|
(7,645
|
)
|
||
Discontinued
operations
|
—
|
|
—
|
|
|
|
—
|
|
|
|
(38
|
)
|
|
|
(3,657
|
)
|
|||
Gain
on sale of discontinued operations
|
—
|
|
—
|
|
|
|
—
|
|
|
|
1,912
|
|
|
|
—
|
|
|||
Net
loss
|
(5,728
|
)
|
|
(6,905
|
)
|
|
|
(17,167
|
)
|
|
|
(2,976
|
)
|
|
|
(11,302
|
)
|
||
Preferred
stock dividend and accretion
|
(81
|
)
|
|
—
|
|
|
|
(135
|
)
|
|
|
(949
|
)
|
|
|
(887
|
)
|
||
Net
loss attributable to common stockholders
|
$
|
(5,809
|
)
|
$
|
(6,905
|
)
|
|
$
|
(17,302
|
)
|
|
$
|
(3,925
|
)
|
|
$
|
(12,189
|
)
|
|
Net
loss per share from continuing operations available to common
stockholders
|
$
|
(0.31
|
)
|
$
|
(0.49
|
)
|
|
$
|
(2.06
|
)
|
|
$
|
(4.25
|
)
|
|
$
|
(6.58
|
)
|
|
Net
loss per share attributable to common stockholders
|
$
|
(0.31
|
)
|
$
|
(0.49
|
)
|
|
$
|
(2.06
|
)
|
|
$
|
(2.88
|
)
|
|
$
|
(9.40
|
)
|
|
Weighted
average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic
and diluted
|
18,926
|
|
13,976
|
|
|
|
8,388
|
|
|
|
1,365
|
|
|
|
1,296
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|||||||||||||||||
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2002
|
|
|||||
|
|
(in
thousands)
|
|
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents and marketable securities
|
$
|
3,324
|
$
|
626
|
|
|
$
|
7,381
|
|
|
$
|
586
|
|
|
$
|
209
|
|
||
Working
capital (deficiency)
|
$
|
1,581
|
$
|
(73
|
)
|
|
$
|
6,093
|
|
|
$
|
(2,242
|
)
|
|
$
|
(1,590
|
)
|
||
Total
assets
|
$
|
3,554
|
$
|
937
|
|
|
$
|
7,856
|
|
|
$
|
1,080
|
|
|
$
|
2,201
|
|
||
Long-term
portion of capital lease obligations and notes payable
|
$
|
—
|
$
|
867
|
|
|
$
|
787
|
|
|
$
|
714
|
|
|
$
|
944
|
|
||
Redeemable
convertible exchangeable preferred stock
|
$
|
—
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,503
|
|
|
$
|
13,554
|
|
||
Total
liabilities
|
$
|
1,847
|
$
|
1,869
|
|
|
$
|
2,324
|
|
|
$
|
18,159
|
|
|
$
|
3,127
|
|
||
Total
stockholders’ equity (deficit)
|
$
|
1,707
|
$
|
(932
|
)
|
|
$
|
5,532
|
|
|
$
|
(17,079
|
)
|
|
$
|
(14,480
|
)
|
|
|
Payments
due by period
|
||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1 Year
|
1-3
Years
|
3-5
Years
|
More
than 5 Years
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Long-term
debt
|
$
|
956
|
$
|
956
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Capital
lease obligations
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Operating
leases
|
—
|
—
|
—
|
—
|
—
|
|||||||||||
Purchase
obligations
|
2,470
|
2,245
|
225
|
—
|
—
|
|||||||||||
Total
|
$
|
3,426
|
$
|
3,201
|
$
|
225
|
$
|
—
|
$
|
—
|
· |
to
secure the $8.0 million debt with liens on all of our assets, which
liens
expired on April 19, 2004 when the remaining debt converted to shares
of
common stock;
|
· |
to
spend the financing proceeds only in accordance with a budget and
development plan agreed to by
Goodnow;
|
· |
to
not enter into any arrangement with a party other than Goodnow in
which we
would raise capital through the issuance of our securities other
than the
raising of up to an aggregate of $20,000,000 through the issuance
of
shares of our common stock at a price of greater than $3.00 per share
and
which would represent 25% or less of our then outstanding common
stock on
an as-converted to common and fully diluted basis. If we agree to
or
consummate a financing transaction with someone other than Goodnow
that
exceeds these limitations, we will pay Goodnow a break-up fee of
$500,000.
Goodnow approved the April 2004 private placement, which exceeded
these
limitations, and waived the fee. However, the $20,000,000 limitation
was
lowered to $9,740,000 and the 25% limitation was reduced to zero.
Goodnow
also approved the 2005 Financing and 2006 Financing, each of which
exceeded these limitations and waived the fee;
and
|
· |
to
allow Goodnow to appoint one director to our board of directors,
provided
Goodnow owns at least 10%, but less than 20%, of our outstanding
common
stock, on an as-converted to common and fully diluted basis, and
two
directors if Goodnow owns more than 20% of our outstanding common
stock.
|
· |
make
any expenditure or series of related expenditures in excess of $25,000,
except (i) expenditures pursuant to the SBIR grant from the U.S.
Small
Business Administration, (ii) specified in a budget approved in writing
in
advance by Goodnow and our Board, and (iii) directly relating to
the
development of AEOL 10150 for the treatment of
ALS;
|
· |
change
our business or operations;
|
· |
merge
with or sell or lease a substantial portion of our assets to any
entity;
|
· |
incur
debt from any third party or place a lien on any of our
properties;
|
· |
amend
our certificate of incorporation or
bylaws;
|
· |
increase
the compensation we pay our
employees;
|
· |
pay
dividends on any class of our capital
stock;
|
· |
cancel
any debt except for full value; or
|
· |
issue
any capital stock except pursuant to agreements with or as agreed
to by
Goodnow.
|
· |
the
date that Goodnow owns less than 20% of our outstanding common stock
on an
as converted basis;
|
· |
the
completion, to the absolute satisfaction of Goodnow, of initial clinical
safety studies of AEOL 10150, and analysis of the data developed
based
upon such studies with results satisfactory to Goodnow, in its absolute
discretion, to initiate efficacy studies of AEOL 10150;
or
|
· |
the
initiation of dosing of the first human patient in an efficacy-based
study
of AEOL 10150.
|
|
Page
|
|
|
37
|
|
38
|
|
39
|
|
40
|
|
41
|
|
43
|
|
44
|
|
|
September
30,
|
|
||||
|
|
2006
|
|
2005
|
|
||
ASSETS
|
|
||||||
Current
assets:
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
3,324
|
|
$
|
626
|
|
Prepaids
and other current assets
|
|
|
104
|
|
|
303
|
|
Total
current assets
|
|
|
3,428
|
|
|
929
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net
|
|
|
—
|
|
|
—
|
|
Investment
in CPEC LLC
|
|
|
126
|
|
|
8
|
|
Total
assets
|
|
$
|
3,554
|
|
$
|
937
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIT)
|
|
||||||
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
868
|
|
$
|
712
|
|
Accrued
expenses
|
|
|
23
|
|
|
290
|
|
Current
maturity of long-term note payable
|
|
|
956
|
|
|
—
|
|
Total
current liabilities
|
|
|
1,847
|
|
|
1,002
|
|
|
|
|
|
|
|
|
|
Long-term
note payable
|
|
|
—
|
|
|
867
|
|
Total
liabilities
|
|
|
1,847
|
|
|
1,869
|
|
|
|
|
|
|
|
|
|
Commitments
and Contingencies (Note G and N)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity (deficit):
|
|
|
|
|
|
|
|
Preferred
stock, $.01 par value per share, 10,000,000 shares
authorized:
|
|
|
|
|
|
|
|
Series
B nonredeemable convertible preferred stock, 600,000 shares authorized;
475,087 shares issued and outstanding as of September 30, 2006 and
2005
|
|
|
5
|
|
|
5
|
|
Common
stock, $.01 par value per share, 50,000,000 shares authorized; 29,265,249
and 14,038,259 shares issued and outstanding at September 30, 2006
and
2005, respectively
|
|
|
293
|
|
|
140
|
|
Additional
paid-in capital
|
|
|
154,311
|
|
|
146,016
|
|
Accumulated
deficit
|
|
|
(152,902
|
)
|
|
(147,093
|
)
|
Total
stockholders' equity (deficit)
|
|
|
1,707
|
|
|
(932
|
)
|
Total
liabilities and stockholders' equity (deficit)
|
|
$
|
3,554
|
|
$
|
937
|
|
|
Fiscal
Year Ended September 30,
|
||||||||||
|
2006
|
|
|
2005
|
|
|
2004
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
Grant
income
|
$
|
92
|
|
$
|
252
|
|
|
$
|
305
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Costs
and expenses:
|
|
|
|
|
|
|
|
|
|
||
Research
and development
|
|
3,480
|
|
|
4,515
|
|
|
|
8,295
|
|
|
General
and administrative
|
|
2,216
|
|
|
2,674
|
|
|
|
3,987
|
|
|
Total
costs and expenses
|
|
5,696
|
|
|
7,189
|
|
|
|
12,282
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Loss
from operations
|
|
(5,604
|
)
|
|
|
(6,937
|
)
|
|
|
(11,977
|
)
|
Equity
in income of CPEC LLC ($315 dividend received
in 2006)
|
|
433
|
|
|
—
|
|
|
|
—
|
|
|
Interest
expense, net
|
|
(6
|
)
|
|
|
(31
|
)
|
|
|
(5,213
|
)
|
Increase
in fair value of common stock warrants
|
|
(604
|
)
|
|
|
—
|
|
|
—
|
||
Other
income
|
|
53
|
|
|
63
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Net
loss
|
|
(5,728
|
)
|
|
|
(6,905
|
)
|
|
|
(17,167
|
)
|
Preferred
stock dividend and accretion
|
|
(81
|
)
|
|
|
—
|
|
|
|
(135
|
)
|
|
|
|
|
|
|
|
|
|
|
||
Net
loss attributable to common stockholders
|
$
|
(5,809
|
)
|
|
$
|
(6,905
|
)
|
|
$
|
(17,302
|
)
|
|
|
|
|
|
|
|
|
|
|
||
Net
loss per common share (basic and diluted):
|
$
|
(0.31
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(2.06
|
)
|
|
|
|
|
|
|
|
|
|
|
||
Weighted
average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||
Basic
and diluted
|
|
18,926
|
|
|
13,976
|
|
|
|
8,388
|
|
|
Series
A
Preferred
Stock
(not
part of equity)
|
|
Series
B Preferred Stock
|
|
Common
Stock
|
|
Additional
Paid-in Capital
|
|
Restricted
Stock
|
|
Accumulated
Deficit
|
|
Total
Stockholders’ Equity (Deficit)
|
|
||||||||||||||
|
Number
of Shares
|
|
Par
Value
|
|
Number
of Shares
|
|
Par
Value
|
|
Number
of Shares
|
|
Par
Value
|
|
|
|||||||||||||||
Balance
at September 30, 2003
|
—
|
|
|
—
|
|
503,544
|
|
$
|
5
|
|
1,413,383
|
|
$
|
14
|
|
$
|
105,892
|
|
$
|
(104
|
)
|
$
|
(122,886
|
)
|
$
|
(17,079
|
)
|
|
Series
C preferred stock dividends and accretion
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(135
|
)
|
|
(135
|
)
|
|
Common
stock issued in exchange of Series C preferred stock
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
225,533
|
|
|
2
|
|
|
14,635
|
|
|
—
|
|
|
—
|
|
|
14,637
|
|
|
Common
stock issued in exchange for notes payable and accrued
interest
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
8,141,979
|
|
|
81
|
|
|
8,061
|
|
|
—
|
|
|
—
|
|
|
8,142
|
|
|
Beneficial
conversion feature of convertible debt
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
5,000
|
|
|
—
|
|
|
—
|
|
|
5,000
|
|
|
Proceeds
from offerings of Employee Stock Purchase Plan
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
652
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
Sale
of common stock pursuant to stock offering, net of issuance costs
of
$901
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
4,104,000
|
|
|
41
|
|
|
9,318
|
|
|
—
|
|
|
—
|
|
|
9,359
|
|
|
Exercise
of common stock options
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
61,756
|
|
|
1
|
|
|
75
|
|
|
—
|
|
|
—
|
|
|
76
|
|
|
Stock-based
compensation and amortization of restricted stock
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
2,593
|
|
|
104
|
|
|
—
|
|
|
2,697
|
|
|
Net
loss for the fiscal year ended September 30, 2004
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,167
|
)
|
|
(17,167
|
)
|
|
Balance
at September 30, 2004
|
—
|
|
|
—
|
|
503,544
|
|
|
5
|
|
13,947,303
|
|
|
139
|
|
|
145,576
|
|
|
—
|
|
|
(140,188
|
)
|
|
5,532
|
|
|
Common
stock issued in exchange of Series B preferred stock
|
—
|
|
|
—
|
|
(28,457
|
)
|
|
—
|
|
28,457
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Compensation
expense on the accelerated vesting of employee stock
options
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
293
|
|
|
—
|
|
|
—
|
|
|
293
|
|
|
Exercise
of common stock options
|
—
|
|
|
—
|
—
|
|
|
—
|
|
62,499
|
|
|
1
|
|
|
62
|
|
|
—
|
|
|
—
|
|
|
63
|
|
||
Stock-based
compensation
|
—
|
|
|
—
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
85
|
|
|
—
|
|
|
—
|
|
|
85
|
|
||
Net
loss for the fiscal year ended September 30, 2005
|
—
|
|
|
—
|
—
|
|
|
—
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,905
|
)
|
|
(6,905
|
)
|
||
Balance
at September 30, 2005
|
—
|
|
|
—
|
475,087
|
|
5
|
|
14,038,259
|
|
$
|
140
|
|
$
|
146,016
|
|
$
|
—
|
|
$
|
(147,093
|
)
|
$
|
(932
|
)
|
|||
The
accompanying notes are an integral part of these consolidated financial
statements.
|
AEOLUS
PHARMACEUTICALS, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
(continued)
(Dollars
in thousands)
|
||||||||||||||||||||||||||||
Series
A
Preferred
Stock (not part of equity)
|
||||||||||||||||||||||||||||
Series
B Preferred Stock
|
|
Common
Stock
|
|
Additional
Paid-in Capital
|
|
Restricted
Stock
|
|
Accumulated
Deficit
|
|
Total
Stockholders’ Equity (Deficit)
|
||||||||||||||||||
Number
of Shares
|
|
Par
Value
|
Number
of Shares
|
|
Par
Value
|
|
Number
of Shares
|
|
Par
Value
|
|||||||||||||||||||
Balance
at September 30, 2005
|
—
|
|
|
—
|
475,087
|
|
5
|
|
14,038,259
|
|
$
|
140
|
|
$
|
146,016
|
|
$
|
—
|
|
$
|
(147,093
|
)
|
$
|
(932
|
)
|
|||
Sale
of Series A Preferred Stock, net of issuance costs of
$87,000
|
1,250,000
|
$354
|
—
|
|
|
—
|
—
|
—
|
(87
|
)
|
—
|
—
|
(87
|
)
|
||||||||||||||
Conversion
of Series A Preferred Stock
|
(
|
1,250,000
|
)
|
$(354
|
)
|
5,000,000
|
50
|
304
|
—
|
—
|
354
|
|||||||||||||||||
Sale
of common stock pursuant to stock offering, net of issuance costs
of
$46,000
|
—
|
|
|
—
|
—
|
|
|
—
|
10,000,000
|
100
|
43
|
—
|
—
|
143
|
||||||||||||||
Common
stock issued pursuant to a license agreement
|
—
|
|
|
—
|
—
|
|
|
—
|
25,000
|
1
|
12
|
—
|
—
|
13
|
||||||||||||||
Exercise
of common stock options
|
—
|
|
|
—
|
—
|
|
|
—
|
83,332
|
1
|
82
|
—
|
—
|
83
|
||||||||||||||
Stock-based
compensation and amortization of warrants
|
—
|
|
|
—
|
—
|
|
|
—
|
—
|
—
|
500
|
—
|
—
|
500
|
||||||||||||||
Reclassification
of common stock warrant liabilities
|
—
|
—
|
—
|
—
|
—
|
—
|
7,361
|
—
|
—
|
7,361
|
||||||||||||||||||
Series
A preferred stock dividends and accretion
|
—
|
—
|
—
|
—
|
118,658
|
1
|
80
|
—
|
(81
|
)
|
—
|
|||||||||||||||||
Net
loss for the fiscal year ended September 30, 2006
|
—
|
|
|
—
|
—
|
|
|
—
|
—
|
—
|
—
|
—
|
(5,728
|
)
|
(5,728
|
)
|
||||||||||||
Balance
at September 30, 2006
|
—
|
|
|
—
|
475,087
|
|
$
|
5
|
29,265,249
|
$
|
293
|
$
|
154,311
|
$
|
—
|
$
|
(152,902
|
)
|
$
|
1,707
|
|
|||||||||||
|
Fiscal
Year Ended September 30,
|
|
|||||||||
|
2006
|
|
|
2005
|
|
|
2004
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(5,728
|
)
|
|
$
|
(6,905
|
)
|
|
$
|
(17,167
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
||
Depreciation
and amortization
|
|
—
|
|
|
9
|
|
|
|
10
|
|
|
Noncash
compensation
|
|
500
|
|
|
293
|
|
|
|
2,569
|
|
|
Noncash
interest and financing costs
|
|
89
|
|
|
81
|
|
|
|
5,153
|
|
|
Noncash
consulting and license fee
|
|
13
|
|
|
85
|
|
|
|
128
|
|
|
Increase
in fair value of common stock warrants
|
|
604
|
|
|
—
|
|
|
|
—
|
|
|
Amortization
of debt issuance costs
|
|
—
|
|
|
—
|
|
|
|
15
|
|
|
(Gain)
on sale or disposal of equipment
|
|
—
|
|
|
(19
|
)
|
|
|
—
|
|
|
Change
in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
||
Accounts
receivable
|
|
13
|
|
|
124
|
|
|
|
(131
|
)
|
|
Prepaids
and other assets
|
|
(247
|
)
|
|
|
25
|
|
|
|
140
|
|
Accounts
payable and accrued expenses
|
|
(111
|
)
|
|
|
(535
|
)
|
|
|
642
|
|
Net
cash used in operating activities
|
|
(4,867
|
)
|
|
|
(6,842
|
)
|
|
|
(8,641
|
)
|
Cash
flows from investing activities:
|
|
|
|
|
|
|
|
|
|
||
Proceeds
from dividend from CPEC LLC
|
315
|
—
|
—
|
||||||||
Proceeds
from sale of equipment
|
|
—
|
|
|
25
|
|
|
|
—
|
|
|
Net
cash provided by investing activities
|
|
315
|
|
|
25
|
|
|
|
—
|
|
|
Cash
flows from financing activities:
|
|
|
|
|
|
|
|
|
|
||
Proceeds
from the issuance of Series A Preferred Stock
|
2,413
|
—
|
—
|
||||||||
Proceeds
from issuance of common stock and warrants, net of issuance
costs
|
|
4,754
|
|
|
—
|
|
|
|
9,436
|
|
|
Proceeds
from exercise of stock options
|
|
83
|
|
|
62
|
|
|
|
—
|
|
|
Proceeds
from notes payable, net of issuance costs
|
|
—
|
|
|
—
|
|
|
|
6,000
|
|
|
Net
cash provided by financing activities
|
|
7,250
|
|
|
62
|
|
|
|
15,436
|
|
|
Net
increase (decrease) in cash and cash equivalents
|
|
2,698
|
|
|
(6,755
|
)
|
|
|
6,795
|
|
|
Cash
and cash equivalents at beginning of year
|
|
626
|
|
|
7,381
|
|
|
|
586
|
|
|
Cash
and cash equivalents at end of year
|
$
|
3,324
|
|
$
|
626
|
|
|
$
|
7,381
|
|
|
|
|
|
|
|
|
|
|
|
|
||
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
||
Cash
payments of interest
|
$
|
—
|
|
$
|
—
|
|
|
$
|
1
|
|
|
Supplemental
disclosure of non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
||
Common
stock issued in exchange for Series A preferred stock
|
$
|
354
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Common
stock issued in exchange for Series B preferred stock
|
$
|
—
|
|
$
|
28
|
|
|
$
|
—
|
|
|
Common
stock issued in exchange for Series C preferred stock
|
$
|
—
|
|
$
|
—
|
|
|
$
|
14,637
|
|
|
Common
stock issued in exchange for notes payable and accrued
interest
|
$
|
—
|
|
$
|
—
|
|
|
$
|
8,142
|
|
|
Beneficial
conversion feature of convertible debt
|
$
|
—
|
|
$
|
—
|
|
|
$
|
5,000
|
|
|
Preferred
stock dividend accreted
|
$
|
81
|
|
$
|
—
|
|
|
$
|
135
|
|
|
2006
|
|
2005
|
|
||
|
|
|
|
|
|
|
Office
equipment
|
$
|
35
|
|
$
|
35
|
|
Laboratory
equipment
|
|
—
|
|
|
—
|
|
Leasehold
improvements
|
|
—
|
|
|
—
|
|
|
|
35
|
|
|
35
|
|
Less:
accumulated depreciation and
amortization
|
|
(35
|
)
|
|
(35
|
)
|
|
$
|
—
|
|
$
|
—
|
|
|
|
2006
|
|
2005
|
||
|
|
|
|
|
|
|
Lease
reserve
|
|
$
|
—
|
|
$
|
267
|
Payroll-related
liabilities
|
|
|
23
|
|
|
10
|
Other
|
|
|
—
|
|
|
13
|
|
$
|
23
|
|
$
|
290
|
Number
of Shares
|
|
Exercise
Price
|
|
Expiration
Date
|
|
|
|
|
|
|
|
4,000,000
|
|
$
|
0.50
|
|
June
2007
|
50,000
|
|
$
|
0.50
|
|
May
2011
|
2,500,000
|
$
|
0.50
|
November
2010
|
||
7,000,000
|
$
|
0.75
|
June
2011
|
||
50,000
|
$
|
1.00
|
May
2011
|
||
35,000
|
$
|
1.00
|
July
2008
|
||
50,000
|
$
|
1.50
|
May
2011
|
||
50,000
|
$
|
2.00
|
May
2011
|
||
50,000
|
$
|
2.50
|
May
2011
|
||
410,400
|
$
|
2.50
|
April
2009
|
||
1,641,600
|
$
|
4.00
|
April
2009
|
||
1,759
|
$
|
19.90
|
October
2008
|
||
10,000
|
|
$
|
20.25
|
|
October
2006
|
15,848,759
|
|
|
|
|
|
|
Shares
|
Weighted
Average Exercise Price
|
Weighted
Average Contractual Life
|
Intrinsic
Value
|
|||||||||
|
|
|
|
||||||||||
Outstanding
at September 30, 2003
|
1,675,685
|
$
|
5.25
|
9.3
years
|
$
|
367
|
|||||||
Granted
|
406,324
|
$
|
2.62
|
10.0
years
|
----
|
||||||||
Exercised
|
(61,756
|
)
|
$
|
1.22
|
8.8
years
|
178
|
|||||||
Cancelled
|
(8,033
|
)
|
$
|
43.26
|
|||||||||
Outstanding
at September 30, 2004
|
2,012,220
|
$
|
4.69
|
8.6
years
|
92
|
||||||||
Granted
|
463,300
|
$
|
0.96
|
10.0
years
|
----
|
||||||||
Exercised
|
(62,499
|
)
|
$
|
1.00
|
9.9
years
|
2
|
|||||||
Cancelled
|
(18,930
|
)
|
$
|
6.77
|
|||||||||
Outstanding
at September 30, 2005
|
2,394,091
|
$
|
4.05
|
8.0
years
|
92
|
||||||||
Granted
|
777,641
|
$
|
0.81
|
10.0
years
|
---
|
||||||||
Exercised
|
(83,332
|
)
|
$
|
1.00
|
9.2
years
|
(14
|
)
|
||||||
Cancelled
|
(16,594
|
)
|
$
|
16.84
|
|||||||||
Outstanding
at September 30, 2006
|
3,071,806
|
$
|
3.25
|
7.7
years
|
$
|
22
|
|||||||
Exercisable
at September 30, 2006
|
2,532,220
|
$
|
3.76
|
7.2
years
|
$
|
11
|
|
Shares
|
|||
|
|
|||
Nonvested
at September 30, 2005
|
112,917
|
|||
Granted
|
777,641
|
|||
Vested
|
(350,972
|
)
|
||
Nonvested
at September 30, 2006
|
539,586
|
|
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||
Range
of Exercise Prices
|
Number
Outstanding at September 30, 2006
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life
|
Number
Exercisable at September 30, 2006
|
Weighted
Average Exercise Price
|
|||||||||||
|
|
|
|
|
|
|||||||||||
$0.40
- $0.75
|
329,164
|
$
|
0.73
|
9.2
years
|
120,831
|
$
|
0.71
|
|||||||||
$0.78
- $0.81
|
131,000
|
$
|
0.80
|
9.7
years
|
56,000
|
$
|
0.80
|
|||||||||
$0.85
|
333,744
|
$
|
0.85
|
9.1
years
|
78,744
|
$
|
0.85
|
|||||||||
$0.89
- $1.00
|
327,910
|
$
|
0.94
|
9.0
years
|
327,910
|
$
|
0.94
|
|||||||||
$1.03
- $1.45
|
83,850
|
$
|
1.13
|
8.5
years
|
83,850
|
$
|
1.13
|
|||||||||
$1.50
|
1,256,015
|
$
|
1.50
|
6.8
years
|
1,256,015
|
$
|
1.50
|
|||||||||
$1.52
- $5.00
|
374,557
|
$
|
2.73
|
7.8
years
|
373,304
|
$
|
2.74
|
|||||||||
$5.10
- $31.90
|
186,768
|
$
|
18.89
|
4.7
years
|
186,768
|
$
|
18.89
|
|||||||||
$50.9375
|
2,998
|
$
|
50.94
|
3.5
years
|
2,998
|
$
|
50.94
|
|||||||||
$51.25
|
45,800
|
$
|
51.25
|
3.5
years
|
45,800
|
$
|
51.25
|
|||||||||
$0.40
- $51.25
|
3,071,806
|
$
|
3.25
|
7.7
years
|
2,532,220
|
$
|
3.76
|
For
the year ended September 30,
|
|||||||
2005
|
2004
|
||||||
Net
loss attributable to common stockholders (in thousands):
|
|||||||
As
reported
|
$
|
(6,905
|
)
|
$
|
(17,302
|
)
|
|
Add:
APB 25 compensation expense on the accelerated vesting of employee
stock
options
|
294
|
1,394
|
|||||
Less:
pro forma adjustment for stock-based compensation expense
|
(676
|
)
|
(1,081
|
)
|
|||
Pro
forma
|
$
|
(7,287
|
)
|
$
|
(16,989
|
)
|
|
Basic
and diluted net loss per weighted share
attributable to common stockholders:
|
|||||||
As
reported
|
$
|
(0.49
|
)
|
$
|
(2.06
|
)
|
|
Effect
of pro forma adjustment
|
(0.03
|
)
|
0.03
|
||||
Pro
forma
|
$
|
(0.52
|
)
|
$
|
(2.03
|
)
|
For
the fiscal year ended September 30,
|
|||||||
2005
|
2004
|
||||||
Dividend
yield
|
0
|
%
|
0
|
%
|
|||
Expected
volatility
|
195
|
%
|
274
|
%
|
|||
Risk-free
interest rate
|
2.9%
- 4.3
|
%
|
1.2%
- 4.7
|
%
|
|||
Expected
option life after shares are vested
|
10
years
|
3
years
|
Research
and development expenses
|
$
|
43
|
||
General
and administrative expenses
|
457
|
|||
Total
stock-based compensation expense
|
$
|
500
|
Dividend
yield
|
0
|
%
|
||
Expected
volatility
|
189-191
|
%
|
||
Risk-free
interest rate
|
4.3%
- 5.2
|
%
|
||
Expected
option life after shares are vested
|
10
years
|
|
2006
|
|
|
2005
|
|
||
|
|
|
|
|
|
|
|
Net
operating loss carryforwards
|
$
|
35,772
|
|
|
$
|
35,068
|
|
AMT
credit carryforwards
|
|
37
|
|
|
|
37
|
|
Research
and development credit
carryforwards
|
|
3,244
|
|
|
|
2,967
|
|
Accrued
payroll related liabilities
|
|
2,464
|
|
|
|
2,464
|
|
Charitable
contribution carryforwards
|
|
1,109
|
|
|
|
1,109
|
|
Total
deferred tax assets
|
|
42,626
|
|
|
|
41,645
|
|
Deferred
tax liabilities
|
|
--
|
|
|
(109
|
)
|
|
Valuation
allowance for deferred assets
|
|
(42,626
|
)
|
|
|
(41,536
|
)
|
Net
deferred tax asset
|
$
|
—
|
|
|
$
|
—
|
|
|
2006
|
|
2005
|
|
2004
|
|
|||
|
|
|
|
|
|
|
|
|
|
Effective
income tax rate
|
|
0
|
%
|
|
0
|
%
|
|
0
|
%
|
|
|
|
|
|
|
|
|
|
|
United
States Federal income tax at statutory rate
|
$
|
(1,975
|
)
|
$
|
(2,348
|
)
|
$
|
(5,837
|
)
|
State
income taxes (net of federal benefit)
|
|
(277
|
)
|
|
(296
|
)
|
|
(773
|
)
|
Change
in valuation reserves
|
|
2,351
|
|
|
2,629
|
|
|
4,923
|
|
Other
|
|
(99)
|
|
|
15
|
|
|
1,687
|
|
Provision
for income taxes
|
$
|
—
|
|
$
|
—
|
|
$
|
—
|
|
|
First
Quarter
|
|
Second
Quarter
|
|
Third
Quarter
|
|
Fourth
Quarter
|
|
Total
Year
|
|
|||||
|
|
(in
thousands, except per share amounts)
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue
|
$
|
1
|
|
$
|
91
|
|
$
|
—
|
|
$
|
—
|
|
$
|
92
|
|
Net
loss attributable to common stockholders
|
$
|
(1,523
|
)
|
$
|
(894
|
)
|
$
|
(3,178
|
)
|
$
|
(214
|
)
|
$
|
(5,809
|
)
|
Net
loss per common share (basic and diluted):
|
|
|
|
|
|
|
|
|
|
|
|||||
Net
loss attributable to common stockholders
|
$
|
(0.11
|
)
|
$
|
(0.06
|
)
|
$
|
(0.17
|
)
|
$
|
(0.01
|
)
|
$
|
(0.31
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenue
|
$
|
109
|
|
$
|
6
|
|
$
|
121
|
|
$
|
16
|
|
$
|
252
|
|
Net
loss attributable to common stockholders
|
$
|
(1,957
|
)
|
$
|
(1,659
|
)
|
$
|
(1,636
|
)
|
$
|
(1,653
|
)
|
$
|
(6,905
|
)
|
Net
loss per common share (basic and diluted):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss attributable to common stockholders
|
$
|
(0.14
|
)
|
$
|
(0.12
|
)
|
$
|
(0.12
|
)
|
$
|
(0.12
|
)
|
$
|
(0.49
|
)
|
|
|
|
Incorporated
by Reference To
|
|
|
|||||
Exhibit
Number
|
|
Description
of Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
|
|
|
|
|
|
|
2.1
|
|
Agreement
and Plan of Merger and Reorganization dated September 16, 2003
between
Incara, Inc. and Incara Pharmaceuticals Corporation
|
|
S-4
|
|
09/19/03
|
|
2.1
|
|
|
3.1
|
|
Certificate
of Incorporation, as amended
|
|
10-Q
|
|
06/30/04
|
|
3.1
|
|
|
3.2
|
|
Certificate
of Amendment of Amended and Restated Certificate of
Incorporation
|
|
8-K
|
|
3/27/06
|
|
3.1
|
|
|
3.3
|
|
Certificate
of Amendment of Amended and Restated Certificate of
Incorporation
|
|
8-K
|
|
10/27/06
|
|
3.1
|
|
|
3.2
|
|
Bylaws,
as amended
|
|
8-K
|
|
10/25/05
|
|
3.1
|
|
|
3.3
|
|
Certificate
of Designations, Preferences and Rights of Series A Convertible
Preferred
Stock of the Company dated November 18, 2005
|
|
8-K
|
|
11/23/05
|
|
3.1
|
|
|
4.1
|
|
Form
of Common Stock Certificate
|
|
10-Q
|
|
06/30/04
|
|
4.1
|
|
|
4.2
|
|
Warrant
to Purchase Shares of Series B Preferred Stock issued to Elan
International Services, Ltd.
|
|
10-Q
|
|
12/31/00
|
|
4.3
|
|
|
4.3
|
|
Form
of Warrant issued to investors in August 2001
|
|
S-1
|
|
08/02/01
|
|
4.4
|
|
|
4.4
|
|
Warrant
to Purchase Common Stock of Incara Pharmaceuticals Corporation
dated July
11, 2003 issued to W. Ruffin Woody, Jr.
|
|
10-Q
|
|
06/30/03
|
|
4.5
|
|
|
4.5
|
|
Form
of Series B Preferred Stock Certificate
|
|
S-4
|
|
09/19/03
|
|
4.8
|
|
|
4.6
|
|
Form
of Warrant to Purchase Common Stock of Incara Pharmaceuticals Corporation
dated April 19, 2004 issued to investors in April 2004
|
|
8-K
|
|
04/21/04
|
|
4.9
|
|
|
4.7
|
|
Warrant
to Purchase Common Stock of Incara Pharmaceuticals Corporation
dated April
19, 2004 issued to SCO Securities LLC
|
|
8-K
|
|
04/21/04
|
|
4.10
|
|
|
4.8
|
|
Registration
Rights Agreement dated November 21, 2005 by and among the Company
and each
of the Purchasers whose names appear on the Schedule attached
thereto
|
|
8-K
|
|
11/23/05
|
|
4.1
|
|
|
4.9
|
|
Form
of Warrant to Purchase Common Stock dated November 21,
2005
|
|
8-K
|
|
11/23/05
|
|
10.2
|
|
|
4.10
|
|
Form
of Warrant to Purchase Common Stock dated June 5, 2006.
|
|
8-K
|
|
6/5/06
|
|
10.3
|
|
|
4.11
|
|
Warrant
to Purchase Common Stock dated June 5, 2006.by and among the Company
and
Efficacy Biotech Master Fund Ltd.
|
|
8-K
|
|
6/5/06
|
|
10.4
|
|
|
10.1*
|
|
License
Agreement between Duke University and Aeolus Pharmaceuticals, Inc.,
dated
July 21, 1995
|
|
S-1
|
|
12/08/95
|
|
10.4
|
|
|
10.2
|
|
Exchange
Agreement dated July 15, 1999, between Intercardia, Inc. and Interneuron
Pharmaceuticals, Inc.
|
|
8-K
|
|
07/23/99
|
|
10.40
|
|
|
10.3
|
|
Registration
Rights Agreement dated July 15, 1999, between Interneuron Pharmaceuticals,
Inc. and Intercardia, Inc.
|
|
8-K
|
|
07/23/99
|
|
10.41
|
|
|
10.4
|
|
Amended
and Restated Limited Liability Company Agreement of CPEC LLC dated
July
15, 1999, among CPEC LLC, Intercardia, Inc. and Interneuron
Pharmaceuticals, Inc.
|
|
8-K
|
|
07/23/99
|
|
10.42
|
|
|
|
|
|
|
Incorporated
by Reference To
|
|
|
||||
Exhibit
Number
|
|
Description
of Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
10.5
|
|
Assignment,
Assumption and License Agreement dated July 15, 1999, between CPEC
LLC and
Intercardia, Inc.
|
|
8-K
|
|
07/23/99
|
|
10.43
|
|
|
10.6*
|
|
License
Agreement dated January 19, 2001 between Incara Pharmaceuticals
Corporation and Incara Development, Ltd.
|
|
10-Q
|
|
12/31/00
|
|
10.59
|
|
|
10.7*
|
|
License
Agreement dated January 19, 2001 between Elan Corporation, plc,
Elan
Pharma International Ltd. and Incara Development, Ltd.
|
|
10-Q
|
|
12/31/00
|
|
10.60
|
|
|
10.8
|
|
Convertible
Promissory Note dated December 21, 2000 issued by Incara Pharmaceuticals
Corporation to Elan Pharma International Ltd.
|
|
10-Q
|
|
12/31/00
|
|
10.61
|
|
|
10.9
|
|
Registration
Rights Agreement dated December 21, 2000 among Incara Pharmaceuticals
Corporation, Elan International Services, Ltd. and Elan Pharma
International Ltd.
|
|
10-Q
|
|
12/31/00
|
|
10.62
|
|
|
10.10
|
|
Agreement
and Amendment, effective as of January 22, 2001, by and among Incara
Pharmaceuticals Corporation, Elan International Services, Ltd.
and Elan
Pharma International Limited
|
|
10-Q
|
|
03/31/01
|
|
10.64
|
|
|
10.11
|
|
Second
Agreement and Amendment, effective as of January 22, 2001, by and
among
Incara Pharmaceuticals Corporation, Elan International Services,
Ltd. and
Elan Pharma International Limited
|
|
10-Q
|
|
03/31/01
|
|
10.65
|
|
|
10.12
|
|
Third
Agreement and Amendment, effective as of January 22, 2001, by and
among
Incara Pharmaceuticals Corporation, Elan International Services,
Ltd. and
Elan Pharma International Limited
|
|
8-K
|
|
06/01/01
|
|
10.66
|
|
|
10.13
|
|
Commencement
Agreement and Lease Amendment Number One, dated November 1, 2001,
to
Office Lease between Highwoods Realty Limited Partnership and Incara
Pharmaceuticals Corporation
|
|
10-K
|
|
09/30/01
|
|
10.74
|
|
|
10.14
|
|
Agreement
and Fourth Amendment, effective February 13, 2002, by and among
Incara
Pharmaceuticals Corporation, Elan International Services, Ltd.,
Elan
Pharma International Limited and Elan Pharmaceutical Investments
III,
Ltd.
|
|
10-Q
|
|
12/31/01
|
|
10.75
|
|
|
10.15*
|
|
License
Agreement dated June 25, 1998 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
|
10-Q
|
|
03/31/02
|
|
10.82
|
|
|
10.16*
|
|
License
Agreement dated May 7, 2002 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
|
10-Q
|
|
03/31/02
|
|
10.83
|
|
|
10.17*
|
|
Securities
Purchase Agreement dated as of May 15, 2002, among Incara Pharmaceuticals
Corporation, Aeolus Pharmaceuticals, Inc., Elan Pharma International
Limited and Elan International Services, Ltd.
|
|
8-K
|
|
07/03/02
|
|
10.84
|
|
|
|
|
|
|
Incorporated
by Reference To
|
|
|
||||
Exhibit
Number
|
|
Description
of Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
10.18*
|
|
Development
and Option Agreement dated May 15, 2002, among Elan Pharma International
Limited, Incara Pharmaceuticals Corporation and Aeolus Pharmaceuticals,
Inc.
|
|
8-K
|
|
07/03/02
|
|
10.85
|
|
|
10.19
|
|
Amended
and Restated Registration Rights Agreement dated as of May 15,
2002, among
Incara Pharmaceuticals Corporation, Elan International Services,
Ltd. and
Elan Pharma International Limited
|
|
8-K
|
|
07/03/02
|
|
10.86
|
|
|
10.20
|
|
Amendment
No. 1 to License Agreement dated May 14, 2002, between Aeolus
Pharmaceuticals, Inc. and Duke University (amending License Agreement
dated July 21, 1995)
|
|
8-K
|
|
07/03/02
|
|
10.87
|
|
|
10.21
|
|
Amendment
No. 1 to License Agreement dated May 14, 2002, between Aeolus
Pharmaceuticals, Inc. and Duke University (amending License Agreement
dated June 25, 1998)
|
|
8-K
|
|
07/03/02
|
|
10.88
|
|
|
10.22
|
|
Amendment
No. 1 to License Agreement dated May 14, 2002, between Aeolus
Pharmaceuticals, Inc. and National Jewish Medical and Research
Center
(amending License Agreement dated November 17, 2000)
|
|
8-K
|
|
07/03/02
|
|
10.89
|
|
|
10.23*
|
|
Asset
Purchase Agreement dated October 21, 2002 between Incara Cell
Technologies, Inc. and Vesta Therapeutics, Inc.
|
|
8-K
|
|
10/24/02
|
|
10.91
|
|
|
10.24
|
|
Amendment
No. 1 dated October 30, 2002 to Asset Purchase Agreement between
Incara
Cell Technologies, Inc. and Vesta Therapeutics, Inc.
|
|
8-K
|
|
11/11/02
|
|
10.92
|
|
|
10.25
|
|
Secured
Convertible Promissory Note dated July 11, 2003 issued by Incara
Pharmaceuticals Corporation to W. Ruffin Woody, Jr.
|
|
10-Q
|
|
06/30/03
|
|
10.96
|
|
|
10.26
|
|
Convertible
Secured Promissory Note dated July 28, 2003 issued by Incara, Inc.
to
Goodnow Capital, Inc.
|
|
10-Q
|
|
06/30/03
|
|
10.97
|
|
|
10.27
|
|
Guaranty
dated July 28, 2003 issued by Incara Pharmaceuticals Incorporation
to
Goodnow Capital, Inc.
|
|
10-Q
|
|
06/30/03
|
|
10.98
|
|
|
10.28
|
|
Security
Agreement dated July 28, 2003 issued by Incara Pharmaceuticals
Incorporation to Goodnow Capital, Inc.
|
|
10-Q
|
|
06/30/03
|
|
10.90
|
|
|
|
|
|
|
Incorporated
by Reference To
|
|
|
||||
Exhibit
Number
|
|
Description
of Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
10.29
|
|
Debenture
and Warrant Purchase Agreement dated September 16, 2003 among Incara
Pharmaceuticals Corporation, Incara, Inc. and Goodnow Capital,
L.L.C.
|
|
S-4
|
|
09/19/03
|
|
10.100
|
|
|
10.30
|
|
Registration
Rights Agreement dated September 16, 2003 among Incara Pharmaceuticals
Corporation, Incara, Inc. and Goodnow Capital, L.L.C.
|
|
S-4
|
|
09/19/03
|
|
10.101
|
|
|
10.31
|
|
Purchase
Agreement dated April 19, 2004 among Incara Pharmaceuticals Corporation
and certain investors
|
|
8-K
|
|
04/21/04
|
|
10.102
|
|
|
10.32
|
|
Registration
Rights Agreement dated April 19, 2004 among Incara Pharmaceuticals
Corporation, certain investors and SCO Securities LLC
|
|
8-K
|
|
04/21/04
|
|
10.103
|
|
|
10.33
|
|
Amendment
No. 1 to Debenture and Warrant Purchase Agreement dated September
16, 2003
among Incara Pharmaceuticals Corporation, Incara, Inc. and Goodnow
Capital, L.L.C.
|
|
8-K
|
|
04/21/04
|
|
10.104
|
|
|
10.34
|
|
Letter
dated May 17, 2004 from Elan International Services, Limited and
Elan
Pharma International Limited to Incara Pharmaceuticals
Corporation
|
|
10-Q
|
|
06/30/04
|
|
10.106
|
|
|
10.35+
|
|
Aeolus
Pharmaceuticals, Inc. 1994 Stock Option Plan, as amended
|
|
10-Q
|
|
06/30/04
|
|
10.109
|
|
|
10.36+
|
|
Aeolus
Pharmaceuticals, Inc. 2004 Stock Option Plan, as amended on December
13,
2004
|
|
8-K
|
|
12/15/04
|
|
10.110
|
|
|
10.37+
|
|
Letter
Agreement dated January 5, 2005 by and between Aeolus Pharmaceuticals,
Inc. and Richard P. Burgoon, Jr.
|
|
8-K
|
|
1/5/05
|
|
10.115
|
|
|
10.38+
|
|
Consulting
Agreement dated February 21, 2005 by and between Aeolus Pharmaceuticals,
Inc. and Elaine Alexander, M.D., Ph.D.
|
|
8-K
|
|
2/18/05
|
|
10.117
|
|
|
10.39+
|
|
Employment
Agreement dated July 14, 2006 between Aeolus Pharmaceuticals, Inc.
and
John L. McManus
|
|
8-K
|
|
7/14/06
|
|
10.1
|
|
|
10.40+
|
|
Consulting
Agreement dated July 10, 2006 between Aeolus Pharmaceuticals, Inc.
and
McManus & Company, Inc.
|
|
8-K
|
|
7/10/06
|
|
10.2
|
|
|
10.41+
|
|
Form
of Indemnification Agreement
|
|
8-K
|
|
2/18/05
|
|
10.118
|
|
|
10.42
|
|
Terms
of Outside Director Compensation
|
|
10-K
|
|
12/17/04
|
|
10.114
|
|
|
10.43+
|
|
Form
of Incentive Stock Option Agreement
|
|
10-Q
|
|
2/8/05
|
|
10.115
|
|
|
10.44+
|
|
Form
of Nonqualified Stock Option Agreement
|
|
10-Q
|
|
2/8/05
|
|
10.116
|
|
|
10.45
|
|
Purchase
Agreement dated November 21, 2005 by and among the Company and
the
investors whose names appear on the signature pages
thereof
|
|
8-K
|
|
11/23/05
|
|
10.1
|
|
|
10.46
|
|
Subscription
Agreement dated June 5, 2006 by and between the Company and the
investors
whose names appear on the signature pages thereof.
|
|
8-K
|
|
6/5/06
|
|
10.1
|
|
|
|
|
|
|
Incorporated
by Reference To
|
|
|
||||
Exhibit
Number
|
|
Description
of Document
|
|
Registrant’s
Form
|
|
Dated
|
|
Exhibit
Number
|
|
Filed
Herewith
|
|
|
|
|
10.47
|
|
Conversion
Agreement dated June 5, 2006 by and among the Company, the Company’s
Series A Preferred Stockholders, Efficacy Biotech Master Fund Ltd.
and
Ronin Capital, LLC.
|
|
8-K
|
|
6/5/06
|
|
10.2
|
|
|
10.48
|
|
Right
of First Offer Agreement dated June 5, 2006 by and among the Company
and
Efficacy Biotech Master Fund Ltd.
|
|
8-K
|
|
6/5/06
|
|
10.5
|
|
|
10.49
|
|
Board
Observer Letter dated June 5, 2006 by and among the Company and
Efficacy
Biotech Master Fund Ltd.
|
|
8-K
|
|
6/5/06
|
|
10.6
|
|
|
14.1
|
|
Aeolus
Pharmaceuticals, Inc. Code of Ethics for Chief Executive Officer
and
Senior Financial Officers, as amended on December 13, 2004
|
|
8-K
|
|
12/14/04
|
|
10.113
|
|
|
16.1
|
|
Letter
of Grant Thornton LLP Regarding Change in Independent Public
Accountants
|
|
8-K
|
|
9/15/05
|
|
16.1
|
|
|
21.1
|
|
List
of Subsidiaries
|
|
|
|
|
|
|
|
X
|
23.1
|
|
Consent
of Haskell & White, LLP, Independent Registered Public Accounting
Firm
|
|
|
|
|
|
|
|
X
|
23.2
|
|
Consent
of Grant Thornton, LLP, Independent Registered Public Accounting
Firm
|
|
|
|
|
|
|
|
X
|
31.1
|
|
Certification
of the Principal Executive Officer pursuant to Rule 13a-14(a) and
15d-14(a)
|
|
|
|
|
|
|
|
X
|
31.2
|
|
Certification
of the Principal Financial and Accounting Officer pursuant to Rule
13a-14(a) and 15d-14(a)
|
|
|
|
|
|
|
|
X
|
32.1
|
|
Certification
by the Principal Executive Officer and Principal Financial and
Accounting
Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
|
X
|
|
|
AEOLUS
PHARMACEUTICALS, INC.
|
|
|
|
|
By:
|
/s/
John L. McManus
|
|
|
John
L. McManus
President
and Chief Operating Officer
|
Signatures
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
John L. McManus
|
|
President
and Chief Operating Officer
|
|
December
15, 2006
|
John
L. McManus
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
/s/
Michael P. McManus
|
|
Chief
Financial Officer, Treasurer and Secretary
|
|
December
15, 2006
|
Michael
P. McManus
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/
David C. Cavalier
|
|
Chairman
of the Board of Directors
|
|
December
15, 2006
|
David
C. Cavalier
|
|
|
|
|
|
|
|
|
|
/s/
John M. Farah, Jr.
|
|
Director
|
|
December
15, 2006
|
John
M. Farah, Jr., Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/
Joseph J. Krivulka
|
|
Director
|
|
December
15, 2006
|
Joseph
J. Krivulka
|
|
|
|
|
|
|
|
|
|
/s/
Amit Kumar
|
|
Director
|
|
December
15, 2006
|
Amit
Kumar, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/
Michael E. Lewis
|
|
Director
|
|
December
15, 2006
|
Michael
E. Lewis, Ph.D.
|
|
|
|
|
|
|
|
|
|
/s/
Chris A. Rallis
|
|
Director
|
|
December
15, 2006
|
Chris
A. Rallis
|
|
|
|
|
|
|
|
|
|
/s/
Peter D. Suzdak
|
|
Director
|
|
December
15, 2006
|
Peter
D. Suzdak, Ph.D.
|
|
|
|
|