Delaware
|
8731
|
56-1953785
|
(State
or other jurisdiction of
|
(Primary
Standard Industrial
|
(I.R.S.
Employer Identification
|
incorporation
or organization)
|
Classification
Code Number)
|
Number)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-
accelerated filer ¨ (Do
not check if a smaller reporting company)
|
Smaller
reporting company x
|
The
information in this prospectus is not complete and may be changed. The
Selling Stockholders named herein may not sell these securities until the
registration statement filed with the Securities and Exchange Commission
is effective. This prospectus is not an offer to sell these securities and
it is not soliciting an offer to buy these securities in any jurisdiction
where the offer or sale is not
permitted.
|
Page
|
|
Prospectus
Summary
|
1
|
Risk
Factors
|
4
|
Use
of Proceeds
|
22
|
Determination
of Offering Price
|
22
|
Market
for Common Stock
|
23
|
Dividend
Policy
|
23
|
Capitalization
|
24
|
Selected
Financial Data
|
25
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
|
27
|
Business
|
34
|
Management
|
68
|
Security
Ownership of Certain Beneficial Owners and Management
|
82
|
Selling
Stockholders
|
85
|
Plan
of Distribution
|
86
|
Certain
Relationships and Related Transactions
|
88
|
Description
of Capital Stock
|
89
|
Legal
Matters
|
92
|
Experts
|
92
|
Where
You Can Find More Information About Us
|
92
|
Index
to Financial Statements
|
F-1
|
Common
stock offered by selling stockholders:
|
24,767,039
shares
|
|
Use
of proceeds:
|
The
selling stockholders will receive all net proceeds from the offering of
our common stock covered by this prospectus. We will not receive any
proceeds from this offering.
Any
proceeds we receive from the exercise of warrants to purchase the shares
included in the shares that are being offered by the selling stockholders
hereunder will be used to continue the development of our product
candidates and to expand the development of our drug pipeline and for
general working capital. See “Use of Proceeds” on page
22.
|
|
Risk
Factors
|
See
“Risk Factors” beginning on page 4 and other information included in
this prospectus for a discussion of factors you should carefully consider
before deciding to invest in the shares.
|
|
OTC
Bulletin Board Symbol:
|
|
AOLS
|
|
·
|
our need for, and our ability
to obtain, additional funds;
|
|
·
|
our ability to obtain grants
or contracts to develop our drug
candidates;
|
|
·
|
uncertainties relating to
non-clinical studies, clinical trials and regulatory reviews and
approvals;
|
|
·
|
uncertainties relating to our
pre-clinical trials and regulatory reviews and
approvals;
|
|
·
|
our dependence on our lead
therapeutic compound;
|
|
·
|
the early stage of the drug
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.
|
|
·
|
developing
our existing drug candidates and developing and testing new drug
candidates;
|
|
·
|
carrying
out our intellectual property
strategy;
|
|
·
|
establishing
our competitive position;
|
|
·
|
achieving
third-party collaborations;
|
|
·
|
receiving
regulatory approvals;
|
|
·
|
manufacturing
and marketing products; and
|
|
·
|
receiving
government funding and identifying new government funding
opportunities.
|
|
·
|
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
proposed products or procedures are not economical to market or do not
achieve broad market acceptance;
|
|
·
|
third
parties hold proprietary rights that preclude us from marketing the
proposed products or procedures;
and
|
|
·
|
third
parties market a superior or equivalent
product.
|
|
·
|
Difficulty
in securing research laboratories to conduct research
activities
|
|
·
|
Difficulty
in securing centers to conduct
trials;
|
|
·
|
Difficulty
in enrolling patients in conformity with required protocols or projected
timelines;
|
|
·
|
Unexpected
adverse reactions by patients in
trials;
|
|
·
|
Difficulty
in obtaining clinical supplies of the
product;
|
|
·
|
Changes
in the FDA’s or other regulatory body’s requirements for our testing
during the course of that testing;
|
|
·
|
Inability
to generate statistically significant data confirming the efficacy of the
product being tested;
|
|
·
|
Modification
of the drug during testing; and
|
|
·
|
Reallocation
of our limited financial and other resources to other clinical
programs.
|
|
·
|
termination
of contracts;
|
|
·
|
forfeiture
of profits;
|
|
·
|
suspension
of payments;
|
|
·
|
fines;
and
|
|
·
|
suspension
or prohibition from conducting business with the U.S.
government.
|
|
·
|
the
Federal Acquisition Regulations (“FAR”), and agency-specific regulations
supplemental to the Federal Acquisition Regulations, which comprehensively
regulate the procurement, formation, administration and performance of
government contracts;
|
|
·
|
the
business ethics and public integrity obligations, which govern conflicts
of interest and the hiring of former government employees, restrict the
granting of gratuities and funding of lobbying activities and incorporate
other requirements such as the Anti-Kickback Act and Foreign Corrupt
Practices Act;
|
|
·
|
export
and import control laws and regulations;
and
|
|
·
|
laws,
regulations and executive orders restricting the use and dissemination of
information classified for national security purposes and the exportation
of certain products and technical
data.
|
|
·
|
terminate
existing contracts, in whole or in part, for any reason or no
reason;
|
|
·
|
unilaterally
reduce or modify contracts or subcontracts, including equitable price
adjustments;
|
|
·
|
cancel
multi-year contracts and related orders if funds for contract performance
for any subsequent year become
unavailable;
|
|
·
|
decline
to exercise an option to renew a
contract;
|
|
·
|
exercise
an option to purchase only the minimum amount specified in a
contract;
|
|
·
|
decline
to exercise an option to purchase the maximum amount specified in a
contract;
|
|
·
|
take
actions that result in a longer development timeline than
expected;
|
|
·
|
direct
the course of a development program in a manner not chosen by the
government contractor;
|
|
·
|
suspend
or debar the contractor from doing business with the government or a
specific government agency;
|
|
·
|
pursue
criminal or civil remedies under the False Claims Act and False Statements
Act; and
|
|
·
|
control
or prohibit the export of
products.
|
|
·
|
Succeed
in developing competitive products sooner than us or our strategic
partners or licensees;
|
|
·
|
Obtain
FDA and other regulatory approvals for their products before approval of
any of our products;
|
|
·
|
Obtain
patents that block or otherwise inhibit the development and
commercialization of our drug
candidates;
|
|
·
|
Develop
products that are safer or more effective than our
products;
|
|
·
|
Devote
greater resources to marketing or selling their
products;
|
|
·
|
Introduce
or adapt more quickly to new technologies or scientific
advances;
|
|
·
|
Introduce
products that render our products
obsolete;
|
|
·
|
Withstand
price competition more successfully than us or our strategic partners or
licensees;
|
|
·
|
Negotiate
third-party strategic alliances or licensing arrangements more
effectively; or
|
|
·
|
Take
advantage of other opportunities more
readily.
|
|
·
|
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, 2008
|
||||||||
October
1, 2007 through December 31, 2007
|
$ | 0.55 | $ | 0.33 | ||||
January
1, 2008 through March 31, 2008
|
$ | 0.40 | $ | 0.31 | ||||
April
1, 2008 through June 30, 2008
|
$ | 0.48 | $ | 0.32 | ||||
July
1, 2008 through September 30, 2008
|
$ | 0.45 | $ | 0.25 | ||||
Fiscal
Year Ended September 30, 2009
|
||||||||
October
1, 2009 through December 31, 2009
|
$ | 0.46 | $ | 0.20 | ||||
January
1, 2009 through March 31, 2009
|
$ | 0.46 | $ | 0.15 | ||||
April
1, 2009 through June 30, 2009
|
$ | 0.40 | $ | 0.20 | ||||
July
1, 2009 through September 30, 2009
|
$ | 0.39 | $ | 0.22 | ||||
Fiscal
Year Ending September 30, 2010
|
||||||||
October
1, 2009 through December 31, 2009
|
$ | 0.55 | $ | 0.24 | ||||
January
1, 2010 through March 31, 2010
|
$ | 0.48 | $ | 0.30 | ||||
April
1, 2010 through June 30, 2010
|
$ | 0.49 | $ | 0.25 | ||||
July
1, 2010 through September 21, 2010
|
$ | 0.55 | $ | 0.25 |
June
30, 2010
|
||||
Actual
|
||||
(Unaudited)
|
||||
(Amounts
in 000s)
|
||||
Current
Liabilities
|
$ | 975 | ||
Long-term
debt, less current portion
|
||||
Common
stock warrant liability
|
14,708 | |||
Stockholders’
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 at June 30, 2010
|
5 | |||
Common
stock, $.01 par value per share, 200,000,000 shares authorized; 48,224,320
shares issued and outstanding at June 30, 2010
|
482 | |||
Additional
paid-in capital
|
154,192 | |||
Accumulated
deficit
|
(169,823 | ) | ||
Total
stockholders’ deficit
|
(15,144 | ) | ||
Total
capitalization
|
$ | 539 |
Year Ended September 30,
|
Nine Months Ended
June 30,
(Unaudited)
|
|||||||||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
2010
|
2009
|
||||||||||||||||||||||
(in
thousands, except per share data)
|
||||||||||||||||||||||||||||
Revenue:
|
||||||||||||||||||||||||||||
Grant
income and contract revenue
|
$ | — | $ | — | $ | — | $ | 92 | $ | 252 | $ | — | $ | — | ||||||||||||||
Costs
and expenses:
|
||||||||||||||||||||||||||||
Research
and development
|
711 | 977 | 1,381 | 3,480 | 4,515 | 885 | 469 | |||||||||||||||||||||
General
and administrative
|
1,292 | 1,540 | 1,919 | 2,216 | 2,674 | 1,337 | 903 | |||||||||||||||||||||
Total
costs and expenses
|
2,003 | 2,517 | 3,300 | 5,696 | 7,189 | 2,222 | 1,372 | |||||||||||||||||||||
Loss
from operations
|
(2,003 | ) | (2,517 | ) | (3,300 | ) | (5,604 | ) | (6,937 | ) | (2,222 | ) | (1,372 | ) | ||||||||||||||
Other
income (expenses), net
|
144 | (405 | ) | 225 | (118 | ) | 63 | (9,899 | ) | 144 | ||||||||||||||||||
Interest
income (expense), net
|
(437 | ) | (51 | ) | 51 | (6 | ) | (31 | ) | (860 | ) | (322 | ) | |||||||||||||||
Net
loss
|
(2,296 | ) | (2,973 | ) | (3,024 | ) | (5,728 | ) | (6,905 | ) | (12,981 | ) | (1,550 | ) | ||||||||||||||
Preferred
stock dividend and accretion
|
— | — | — | (81 | ) | — | — | — | ||||||||||||||||||||
Net
loss attributable to common stockholders
|
$ | (2,296 | ) | $ | (2,973 | ) | $ | (3,024 | ) | $ | (5,809 | ) | $ | (6,905 | ) | $ | (0.27 | ) | $ | (0.05 | ) | |||||||
Basic
net loss per share attributable to common stockholders
|
$ | (0.07 | ) | $ | (0.09 | ) | $ | (0.10 | ) | $ | (0.31 | ) | $ | (0.49 | ) | $ | (0.27 | ) | $ | (0.05 | ) | |||||||
Diluted
net loss per share attributable to common stockholders
|
$ | (0.07 | ) | $ | (0.11 | ) | $ | (0.10 | ) | $ | (0.31 | ) | $ | (0.49 | ) | $ | (0.27 | ) | $ | (0.05 | ) | |||||||
Weighted
average common shares outstanding:
|
||||||||||||||||||||||||||||
Basic
|
34,789 | 31,953 | 30,239 | 18,926 | 13,976 | 47,652 | 33,865 | |||||||||||||||||||||
Diluted
|
34,789 | 32,217 | 30,239 | 18,926 | 13,976 | 47,652 | 33,865 |
September
30,
|
June
30,
|
|||||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
2010
|
|||||||||||||||||||
(Unaudited)
|
||||||||||||||||||||||||
(in
thousands)
|
||||||||||||||||||||||||
Cash
and cash equivalents and marketable securities
|
$ | 646 | $ | 399 | $ | 1,727 | $ | 3,324 | $ | 626 | $ | 457 | ||||||||||||
Working
capital (deficiency)
|
$ | 5 | $ | (1,336 | ) | $ | 1,538 | $ | 1,581 | $ | (73 | ) | $ | (468 | ) | |||||||||
Total
assets
|
$ | 811 | $ | 1,120 | $ | 1,931 | $ | 3,554 | $ | 937 | $ | 539 | ||||||||||||
Long-term
portion of capital lease obligations and notes payable
|
$ | 1,194 | $ | 266 | $ | 483 | $ | — | $ | 867 | $ | — | ||||||||||||
Total
liabilities
|
$ | 1,968 | $ | 2,157 | $ | 751 | $ | 1,847 | $ | 1,869 | $ | 15,683 | ||||||||||||
Total
stockholders’ equity (deficit)
|
$ | (1,157 | ) | $ | (1,037 | ) | $ | 1,180 | $ | 1,707 | $ | (932 | ) | $ | (15,144 | ) |
|
|
Payments due by period
|
||||||||||||||||||
Contractual Obligations
|
Total
|
Less
than 1
Year
|
1-3
Years
|
3-5
Years
|
More
than 5
Years
|
|||||||||||||||
Long-term
debt (all current)
|
$ | 663 | $ | 663 | $ | — | $ | — | $ | — | ||||||||||
Capital
lease obligations
|
— | — | — | — | — | |||||||||||||||
Operating
leases
|
— | — | — | — | — | |||||||||||||||
Purchase
obligations
|
850 | 850 | — | — | — | |||||||||||||||
Total
|
$ | 1,513 | $ | 1,513 | $ | — | $ | — | $ | — |
|
·
|
as
a medical countermeasure against the effects of acute radiation syndrome
(“ARS”) in the lungs,
|
|
·
|
as
a medical countermeasure against the effects of ARS in the
gastro-intestinal tract,
|
|
·
|
as
a medical countermeasure against the effects of sulfur mustard gas,
and
|
|
·
|
as
a medical countermeasure against the effects of chlorine
gas.
|
|
·
|
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 dismutase (“SOD”) so that
they:
|
|
||
Figure 1. Kaplan Meier survival
curves for C57BL/6J mice after upper half body irradiation.
The survival data
displayed that there were no deaths in the sham-irradiated animals and
animals receiving drug alone. In contrast, 9/20 (45%) of the animals that
received 15 Gy UHBI died during the 6-week follow-up period. Treatment
with low/high doses of AEOL 10150 markedly reduced radiation-induced
mortality to only 10% (2/20).
|
Figure 2: Average body weight
changes among groups. UHBI alone mice demonstrated
significant weight loss beginning 3 weeks post-exposure compared with UHBI
+ low/high doses of AEOL 10150 groups.
|
|
Figure 3. Wet lung
weights. Wet lung
weights were measured as an index of pulmonary edema and consolidation.
UHBI alone mice had significantly higher wet lung weights than did the
UHBI + low/high doses AEOL10150 groups. *=p <
0.05
|
Figure 4. Hematoxylin and Eosin
Staining of Lung Tissue. Lung histology at 6 weeks
revealed a significant decrease in lung structural damage in UHBI +
low/high doses of AEOL 10150 groups, in comparison with UHBI alone. 20x
magnification.
|
|
|
·
|
Demonstrated
survival increase in animal studies when administered 2 hours after
exposure (P<0.05),
|
|
·
|
Demonstrated
reduction in lung fibrosis in animal studies up to 24 hours post exposure
(P<0.05),
|
|
·
|
Demonstrated
histological improvement in lung tissue post-radiation
exposure,
|
|
·
|
Addresses
an unmet medical need as a MCM to lung
ARS,
|
|
·
|
Established
safety profile in both clinical and pre-clinical
studies,
|
|
·
|
Subcutaneous
self-administration possible by exposed individuals during
emergency,
|
|
·
|
Rapid
administration, allowing large numbers of patients to be treated
quickly,
|
|
·
|
Stable
for up to 4½ years at 0–8°C and 1 year at room
temperature,
|
|
·
|
Requires
no non-standard storage conditions (i.e., not
photosensitive),
|
|
·
|
Currently
in development as an adjunct to radiation therapy; if approved will
provide a pre-existing distribution and stockpile resource at oncology
centers in the event of a radiological
emergency,
|
|
·
|
Demonstrated
potential as both a therapeutic and
prophylactic,
|
|
·
|
Demonstrated
potential to address multiple sub-syndromes of
ARS,
|
|
·
|
Demonstrated
potential to address sulfur mustard gas and chlorine gas exposure,
and
|
|
·
|
Potential
dual use as an adjunct treatment for cancer patients receiving radiation
therapy.
|
|
·
|
Knowledge
of the mechanism of radiation-induced damage to the lung and its
amelioration by the candidate drug.
|
|
·
|
Pharmacokinetic
and pharmacodynamic analysis to provide information on relevant dose and
administration schedule.
|
|
·
|
Direct
correlation of key study parameters (e.g., survival or major
morbidity) with the desired clinical benefit in
humans.
|
|
·
|
Collection
of efficacy data in two species relevant to the human radiation response
and its treatment unless otherwise justified under GLP-compliant
conditions.
|
|
·
|
A
Phase 1 safety trial using the same product and formulation as used in the
pivotal trial(s) required.
|
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
|
|
·
|
Increases
in Cmax and AUC(0-8) appear 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; 2,315 ng/mL for the 60 mg
cohort and 1,653 ng/ml for the 2 mg/kg
cohort.
|
|
·
|
There
were probable 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.
|
|
·
|
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, compound accumulation is not expected beyond the third
day with multiple dosing.
|
|
·
|
From
48 hours to the end of the infusion, the plasma concentrations of AEOL
10150 during the infusion showed little variability, indicating a smoother
delivery of the drug than with twice-daily
injections.
|
|
·
|
completion
of preclinical studies;
|
|
·
|
the
submission to the FDA of a request for authorization to conduct clinical
trials on 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 as of
September 21,
2010
|
Position(s)
|
Director Since
|
|||
David
C. Cavalier
|
41
|
Chairman
|
April
2004
|
|||
John
M. Farah, Jr., Ph.D.
|
58
|
Director
|
October
2005
|
|||
Joseph
J. Krivulka
|
58
|
Director
|
June
2004
|
|||
Amit
Kumar, Ph.D.
|
46
|
Director
|
June
2004
|
|||
Michael
E. Lewis, Ph.D.
|
59
|
Director
|
June
2004
|
|||
Chris
A. Rallis
|
57
|
Director
|
June
2004
|
|||
Peter
D. Suzdak, Ph.D.
|
|
52
|
|
Director
|
|
June
2004
|
|
Fees Earned or
|
All Other
|
||||||||||||||
Name
|
Paid in Cash
|
Option Awards(1)
|
Compensation
|
Total
|
||||||||||||
David
C. Cavalier
|
$
|
—
|
$
|
25,872
|
—
|
$
|
175,872
|
|||||||||
John
M. Farah, Jr., Ph.D.
|
—
|
19,220
|
—
|
19,220
|
||||||||||||
Joseph
J. Krivulka
|
—
|
12,110
|
—
|
12,110
|
||||||||||||
Amit
Kumar, Ph.D.
|
—
|
25,872
|
—
|
25,872
|
||||||||||||
Michael
E. Lewis, Ph.D.
|
—
|
14,725
|
—
|
14,725
|
||||||||||||
Chris
A. Rallis
|
—
|
25,872
|
—
|
25,872
|
||||||||||||
Peter
D. Suzdak, Ph.D.
|
—
|
19,220
|
—
|
19,220
|
|
·
|
Each
non-executive Board member shall be eligible to receive nonqualified stock
options for up to an aggregate of 45,000 shares per year based upon
the number of meetings attended by the non-executive Board member during
the year. The option exercise prices shall be equal to the
closing price of the Common Stock on the grant date. The options shall
have 10-year terms and vest, as long as the director remains on the Board,
on a monthly basis over a 12-month period beginning on the date of grant.
Unvested options expire upon resignation or termination from the
Board.
|
|
·
|
In
addition, each Audit Committee member shall be eligible to receive a
nonqualified stock option for up to an aggregate of 15,000 shares per year
based the number of Audit Committee meetings attended by the Audit
Committee member during the year. The option exercise prices shall be
equal to the closing price of the Common Stock on the grant date. The
options shall have 10-year terms and vest, as long as the director remains
on the Board, on a monthly basis over a 12-month period beginning on the
date of grant. Unvested options expire upon resignation or termination
from the Board.
|
Name
|
Number of
Securities
Underlying
Unexercised Options
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
|
Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options Option
Awards
|
|||||||||
David
C. Cavalier
|
146,064
|
26,686
|
—
|
|||||||||
John
M. Farah, Jr., Ph.D.
|
111,155
|
20,436
|
—
|
|||||||||
Joseph
J. Krivulka
|
121,626
|
13,124
|
—
|
|||||||||
Amit
Kumar, Ph.D.
|
147,064
|
26,686
|
—
|
|||||||||
Michael
E. Lewis, Ph.D.
|
126,126
|
28,874
|
—
|
|||||||||
Chris
A. Rallis
|
147,064
|
26,686
|
—
|
|||||||||
Peter
D. Suzdak, Ph.D.
|
134,564
|
20,436
|
—
|
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
|
4,249,091
|
$
|
0.53
|
750,909
|
||||||||
1994
Stock Option Plan
|
1,927,124
|
$
|
3.92
|
0
|
||||||||
Equity
compensation plans and securities not approved by our
stockholders:
|
||||||||||||
Warrant
to Purchase Common Stock Issued to Dan Delmonico
|
50,000
|
$
|
0.49
|
Not
applicable
|
||||||||
Warrant
to Purchase Common Stock Issued to Brookstreet Securities
Corporation
|
250,000
|
$
|
1.50
|
Not
applicable
|
||||||||
Total
– Common Stock
|
6,476,215
|
750,909
|
||||||||||
Convertible
Promissory Note convertible into shares of Series B Preferred Stock Issued
to ElanPharma International Limited (as of September 30,
2009)(1)(2)
|
65,985
|
$
|
9.00
|
10,614
|
||||||||
Total
– Series B Preferred Stock
|
65,985
|
10,614
|
Name
|
Age as of
September 21, 2010
|
Position(s)
|
||
John
L. McManus
|
46
|
President,
Chief Executive Officer, Chief Financial Officer, Treasurer and
Secretary
|
||
Brian
J. Day, Ph.D.
|
50
|
Chief
Scientific
Officer
|
|
|
Annual Compensation
|
All Other
|
|||||||||||||||||||
Name and Principal
|
Fiscal
|
Option
|
Compensation
|
|||||||||||||||||||
Position(s)
|
Year
|
Salary ($)
|
Bonus ($)
|
Awards ($) (1)
|
($)
|
Total ($)
|
||||||||||||||||
John
L. McManus
|
2009
|
$
|
250,200
|
—
|
$
|
142,759
|
—
|
$
|
392,958
|
|||||||||||||
President
and
|
2008
|
$
|
250,200
|
—
|
$
|
150,313
|
—
|
$
|
400,513
|
|||||||||||||
Chief
Executive Officer
|
2007
|
250,200
|
—
|
207,044
|
—
|
457,244
|
||||||||||||||||
Brian
Day, Ph.D. (2)
|
2009
|
—
|
—
|
38,056
|
$
|
132,000
|
170,056
|
|||||||||||||||
Chief
Scientific Officer
|
2008
|
—
|
—
|
31,899
|
$
|
132,000
|
163,899
|
|||||||||||||||
2007
|
—
|
—
|
33,915
|
132,000
|
165,915
|
|||||||||||||||||
Michael
P. McManus (3)
|
2009
|
—
|
—
|
31,423
|
—
|
31,423
|
||||||||||||||||
Chief
Financial Officer,
|
2008
|
—
|
—
|
77,110
|
—
|
77,110
|
||||||||||||||||
Treasurer
and Secretary
|
2007
|
—
|
—
|
81,734
|
—
|
81,734
|
Name
|
Grant Date
|
All Other Option Awards:
Number of Shares
Underlying Options (#)(2)
|
Exercise or
Base Price
of Option
Awards
|
Grant Date
Fair Value of
Option
Awards ($)
(1)
|
||||||||||
John
L. McManus
|
5/6/09
|
1,000,000
|
$
|
0.30
|
$
|
266,800
|
||||||||
7/30/09
|
250,000
|
$
|
0.39
|
86,800
|
||||||||||
Brian
Day, Ph.D.
|
10/1/2008
|
50,000
|
$
|
0.44
|
$
|
21,500
|
||||||||
5/6/2009
|
200,000
|
$
|
0.30
|
$
|
53,360
|
|||||||||
Michael
P. McManus
|
7/10/2009
|
90,000
|
$
|
0.39
|
$
|
31,185
|
Name
|
Number of
Securities
Underlying
Unexercised
Options
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options
Unexercisable
|
Option Awards
Equity Incentive Plan
Awards: Number of
Securities Underlying
Unexercised Unearned
Options
|
Option
Exercise Price
|
Option
Expiration
Date
|
||||||||||||
John
L. McManus
|
10,000
|
—
|
—
|
$
|
0.97
|
7/29/2015
|
|||||||||||
10,000
|
—
|
—
|
$
|
0.91
|
8/31/2015
|
||||||||||||
10,000
|
—
|
—
|
$
|
1.12
|
9/30/2015
|
||||||||||||
10,000
|
—
|
—
|
$
|
1.15
|
10/31/2015
|
||||||||||||
10,000
|
—
|
—
|
$
|
1.03
|
11/30/2015
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.95
|
12/30/2015
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.89
|
1/31/2016
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.90
|
2/28/2016
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.80
|
3/31/2016
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.75
|
4/28/2016
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.60
|
5/31/2016
|
||||||||||||
10,000
|
—
|
—
|
$
|
0.81
|
6/30/2016
|
||||||||||||
250,000
|
—
|
—
|
$
|
0.75
|
7/14/2016
|
||||||||||||
250,000
|
—
|
—
|
$
|
0.90
|
7/13/2017
|
||||||||||||
250,000
|
—
|
—
|
$
|
0.32
|
7/14/2018
|
||||||||||||
500,000
|
500,000
|
(1)
|
—
|
$
|
0.30
|
5/6/2019
|
|||||||||||
62,500
|
187,500
|
(2)
|
—
|
$
|
0.39
|
7/30/2019
|
|||||||||||
Brian
Day, Ph.D.
|
1,200
|
—
|
—
|
$
|
51.25
|
4/7/2010
|
|||||||||||
2,000
|
—
|
—
|
$
|
0.90
|
2/28/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.70
|
3/31/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.55
|
4/29/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.71
|
5/31/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.73
|
6/30/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.97
|
7/29/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.91
|
8/31/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
1.12
|
9/30/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
1.15
|
10/31/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
1.03
|
11/30/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.95
|
12/31/2015
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.89
|
1/31/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.90
|
2/28/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.80
|
3/31/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.75
|
4/28/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.60
|
5/31/2016
|
||||||||||||
25,000
|
—
|
—
|
$
|
0.85
|
6/5/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.81
|
6/30/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.69
|
7/31/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.80
|
8/31/2016
|
||||||||||||
2,000
|
—
|
—
|
$
|
0.80
|
9/29/2016
|
||||||||||||
50,000
|
—
|
—
|
$
|
0.68
|
10/2/2016
|
||||||||||||
50,000
|
—
|
—
|
$
|
0.45
|
10/1/2017
|
||||||||||||
25,000
|
—
|
—
|
$
|
0.40
|
1/11/2018
|
||||||||||||
50,000
|
—
|
(3)
|
—
|
$
|
0.44
|
10/1/2018
|
|||||||||||
Michael
P. McManus
|
1,250
|
—
|
—
|
$
|
0.73
|
6/30/2015
|
|||||||||||
1,250
|
—
|
—
|
$
|
0.97
|
7/29/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.91
|
8/31/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
1.12
|
9/30/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
1.15
|
10/31/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
1.03
|
11/30/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.95
|
12/30/2015
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.89
|
1/31/2016
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.90
|
2/28/2016
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.80
|
3/31/2016
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.75
|
4/28/2016
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.60
|
5/31/2016
|
||||||||||||
1,250
|
—
|
—
|
$
|
0.81
|
6/30/2016
|
||||||||||||
90,000
|
—
|
—
|
$
|
0.80
|
7/10/2016
|
||||||||||||
90,000
|
—
|
—
|
$
|
1.01
|
7/10/2017
|
||||||||||||
45,000
|
—
|
—
|
$
|
0.40
|
1/11/2018
|
||||||||||||
90,000
|
—
|
—
|
$
|
0.36
|
7/10/2018
|
||||||||||||
30,000
|
60,000
|
(4)
|
—
|
$
|
0.39
|
7/10/2019
|
Name
|
Grant Date
|
All Other Option Awards:
Number of Shares
Underlying Options (#) (2)
|
Exercise or
Base Price
of Option
Awards
|
Grant Date
Fair Value of
Option
Awards ($)
(1)
|
||||||||||
David
C. Cavalier
|
12/11/2008
|
27,750
|
$
|
0.40
|
$
|
11,086
|
||||||||
2/5/2009
|
3,750
|
0.29
|
1,086
|
|||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
4/30/2009
|
3,750
|
0.38
|
1,268
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
15,000
|
0.39
|
5,208
|
|||||||||||
John
M. Farah, Jr., Ph.D.
|
12/11/2008
|
20,250
|
0.40
|
8,090
|
||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
11,250
|
0.39
|
3,906
|
|||||||||||
Joseph
J. Krivulka
|
12/11/2008
|
11,250
|
0.40
|
4,494
|
||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
7/30/2009
|
11,250
|
0.39
|
3,906
|
|||||||||||
Amit
Kumar, Ph.D.
|
12/11/2008
|
27,750
|
0.40
|
11,086
|
||||||||||
2/5/2009
|
3,750
|
0.29
|
1,086
|
|||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
4/30/2009
|
3,750
|
0.38
|
1,268
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
15,000
|
0.39
|
5,208
|
|||||||||||
Michael
E. Lewis, Ph.D.
|
12/11/2008
|
9,000
|
0.40
|
3,596
|
||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
11,250
|
0.39
|
3,906
|
|||||||||||
Chris
A. Rallis
|
12/11/2008
|
27,750
|
0.40
|
11,086
|
||||||||||
2/5/2009
|
3,750
|
0.29
|
1,086
|
|||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
4/30/2009
|
3,750
|
0.38
|
1,268
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
15,000
|
0.39
|
5,208
|
|||||||||||
Peter
D. Suzdak, Ph.D.
|
12/11/2008
|
20,250
|
0.40
|
8,090
|
||||||||||
3/26/2009
|
11,250
|
0.33
|
3,709
|
|||||||||||
6/4/2009
|
11,250
|
0.35
|
3,515
|
|||||||||||
7/30/2009
|
11,250
|
0.39
|
3,906
|
Termination without Cause or for Good Reason
|
Voluntary Resignation
|
|||||||||||||||||||
Value of Options
|
Value of Stock
|
|||||||||||||||||||
Cash
|
Value of
|
with Accelerated
|
with Accelerated
|
Cash
|
||||||||||||||||
Name
|
Payments(1)
|
Benefits(2)
|
Vesting(3)
|
Vesting(4)
|
Payments
|
|||||||||||||||
John
L. McManus
|
$
|
187,650
|
$
|
19,689
|
$
|
72,917
|
—
|
—
|
||||||||||||
Brian
Day, Ph.D.
|
—
|
—
|
8,333
|
—
|
—
|
Immediately upon a Change of Control
|
Termination in Connection with a Change of Control
|
|||||||||||||||||||||||
Value of Options
|
Value of Options
|
Value of Stock
|
||||||||||||||||||||||
Cash
|
with Accelerated
|
Cash
|
Value of
|
with Accelerated
|
with Accelerated
|
|||||||||||||||||||
Name
|
Payments (5)
|
Vesting(3)
|
Payments(1)
|
Benefits(2)
|
Vesting(3)
|
Vesting(4)
|
||||||||||||||||||
John
L. McManus
|
$
|
100,000
|
$
|
$72,917
|
$
|
187,650
|
$
|
19,689
|
$
|
$72,917
|
—
|
|||||||||||||
Brian
Day, PhD (6)
|
30,000
|
8,333
|
—
|
—
|
8,333
|
—
|
Preferred Stock
|
Common Stock
|
|||||||||||||||
Identity of Owner or Group (1)(2)
|
Beneficially
Owned
|
Percentage
Owned
|
Beneficially
Owned
|
Percentage
Owned(4)
|
||||||||||||
Directors:
|
||||||||||||||||
David
C. Cavalier
|
-
|
-
|
41,631,077
|
(5)
|
70.0
|
%
|
||||||||||
John
M. Farah, Jr., Ph.D. (6)
|
-
|
-
|
132,530
|
*
|
||||||||||||
Joseph
J. Krivulka (6)
|
-
|
-
|
138,501
|
*
|
||||||||||||
Amit
Kumar, Ph.D. (6)
|
-
|
-
|
178,126
|
*
|
||||||||||||
Michael
E. Lewis, Ph.D. (6)
|
-
|
-
|
148,439
|
*
|
||||||||||||
Chris
A. Rallis (6)
|
-
|
-
|
178,126
|
*
|
||||||||||||
Peter
D. Suzdak, Ph.D. (6)
|
-
|
-
|
153,126
|
*
|
||||||||||||
Named
Executive Officers:
|
||||||||||||||||
Brian
Day, Ph.D. (7)
|
-
|
-
|
485,478
|
*
|
||||||||||||
John
L. McManus (8)
|
-
|
-
|
2,326,666
|
4.1
|
%
|
|||||||||||
Michael
P. McManus (9)
|
-
|
-
|
3,600
|
*
|
||||||||||||
All
directors and executive officers as a group (10 persons)
|
-
|
-
|
45,372,069
|
(10)
|
72.9
|
%
|
||||||||||
Greater
than 5% Stockholders:
|
||||||||||||||||
Elan
Corporation, plc
|
475,087
|
100.0
|
%(3)
|
475,087
|
(11)
|
*
|
||||||||||
Lincoln
House
|
||||||||||||||||
Lincoln
Place
|
||||||||||||||||
Dublin
2, Ireland
|
||||||||||||||||
Efficacy
Biotech Master Fund Ltd
|
-
|
-
|
16,660,000
|
(12)
|
26.2
|
%
|
||||||||||
11622
El Camino Real, Suite 100
|
||||||||||||||||
San
Diego, CA 92130
|
||||||||||||||||
Xmark
Opportunity Partners, LLC and its affiliates
|
-
|
-
|
41,631,077
|
(13)
|
70.0
|
%
|
||||||||||
90
Grove Street
|
||||||||||||||||
Ridgefield,
CT 06877
|
Beneficial
Ownership Prior
to Offering
|
Number of
|
Beneficial Ownership
After Offering (1)
|
||||||||||||||
Name
|
Number of
Shares
|
Shares
to Be Sold |
Number of
Shares
|
Percent of
Class
|
||||||||||||
Efficacy
Biotech Master Fund Ltd (A)
|
16,660,000 |
(2)
|
16,660,000 | 0 | 0 | % | ||||||||||
Goodnow
Capital, L.L.C.(B)
|
8,107,039 | 8,107,039 | 0 | 0 | % | |||||||||||
TOTAL
|
24,767,039 | 24,767,039 | 0 | 0 | % |
(1)
|
Assumes
the sale of all the shares offered hereby. This registration statement
also shall cover any additional shares of common stock which become
issuable in connection with the shares registered for resale hereby by
reason of any stock dividend, stock split, recapitalization or other
similar transaction effected without the receipt of consideration which
results in an increase in the outstanding shares of our common
stock.
|
(2)
|
Includes
6,860,000 shares issuable upon exercise of a warrant held by the selling
stockholder. Such shares are subject to resale by the use of this
prospectus.
|
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares as
agent, but may position and resell a portion of the block as principal to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
short
sales effected after the date of this
prospectus;
|
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or
otherwise;
|
|
·
|
broker-dealers
may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per
share;
|
|
·
|
a
combination of any such methods of sale;
and
|
|
·
|
any
other method permitted pursuant to applicable
law.
|
·
|
9,800,000
shares of common stock and 6,860,000 shares of common stock underlying
warrants issued to participants in our June 2006 private
financing;
|
·
|
5,046,875
shares of common stock issued to Goodnow in April 2004 upon conversion of
a debenture in the aggregate amount of $5,047,000;
and
|
·
|
3,060,164
shares of common stock issued to Goodnow in connection with our prior
merger and corporate reorganization in November
2003.
|
·
|
before
such person became an interested stockholder, the board of directors of
the corporation approved the transaction in which the interested
stockholder became an interested stockholder or approved the business
combination;
|
·
|
upon
consummation of the transaction that resulted in the interested
stockholder’s becoming an interested stockholder, the interested
stockholder owns at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced (excluding stock held by
directors who are also officers of the corporation and by employee stock
plans that do not provide employees with the rights to determine
confidentially whether shares held subject to the plan will be tendered in
a tender or exchange offer); or
|
·
|
following
the transaction in which such person became an interested stockholder, the
business combination is approved by the board of directors of the
corporation and authorized at a meeting of stockholders by the affirmative
vote of the holders of two-thirds of the outstanding voting stock of the
corporation not owned by the interested
stockholder.
|
·
|
shall
be indemnified by the corporation for all expenses of such legal
proceedings when he is successful on the
merits;
|
·
|
may
be indemnified by the corporation for the expenses, judgments, fines and
amounts paid in settlement of such proceedings (other than a derivative
suit), even if he is not successful on the merits, if he acted in good
faith and in a manner he reasonably believed to be in or not opposed to
the best interests of the corporation, and, with respect to any criminal
action or proceeding, had no reasonable cause to believe his conduct was
unlawful; and
|
·
|
may
be indemnified by the corporation for the expenses of a derivative suit (a
suit by a stockholder alleging a breach by a director or officer of a duty
owed to the corporation), even if he is not successful on the merits, if
he acted in good faith and in a manner he reasonably believed to be in or
not opposed to the best interests of the
corporation.
|
|
·
|
for
any breach of the director’s duty of loyalty to the corporation or our
stockholders,
|
|
·
|
for
acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of
law,
|
|
·
|
under
Section 174 of the DGCL, or
|
|
·
|
for
any transaction from which the director derived an improper personal
benefit.
|
Page
|
||
Statement
Regarding Financial Information
|
F-2
|
|
Condensed
Consolidated Balance Sheets as of June 30, 2010 (unaudited) and
September 30, 2009
|
F-3
|
|
Condensed
Consolidated Statements of Operations for the Three Months and Nine
Months ended June 30, 2010 and 2009(unaudited)
|
F-4
|
|
Condensed
Consolidated Statements of Cash Flows for the Nine Months ended
June 30, 2010 and 2009 (unaudited)
|
F-5
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-6
|
Page
|
||
Report
of Independent Registered Public Accounting Firm
|
F-16
|
|
Consolidated
Balance Sheets – As of September 30, 2009 and 2008
|
F-17
|
|
Consolidated
Statements of Operations – For the fiscal years ended September 30, 2009,
2008 and 2007
|
F-18
|
|
Consolidated
Statements of Stockholders’ Equity (Deficit) – For the fiscal years ended
September 30, 2009, 2008 and 2007
|
F-19
|
|
Consolidated
Statements of Cash Flows – For the fiscal years ended September 30, 2009,
2008 and 2007
|
F-20
|
|
Notes
to Consolidated Financial Statements
|
F-21
|
June 30,
|
September 30,
|
|||||||
2010
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$
|
457
|
$
|
646
|
||||
Prepaids
and other current assets
|
50
|
133
|
||||||
Total
current assets
|
507
|
779
|
||||||
Investment
in CPEC, LLC
|
32
|
32
|
||||||
Total
assets
|
$
|
539
|
$
|
811
|
||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$
|
330
|
$
|
774
|
||||
Short-term
note payable
|
645
|
0
|
||||||
Total
current liabilities
|
975
|
774
|
||||||
Non-current
liabilities:
|
||||||||
Warrant
liability
|
14,708
|
0
|
||||||
Senior convertible note |
0
|
600
|
||||||
Long-term
note payable
|
0
|
594
|
||||||
Total
liabilities
|
$
|
15,683
|
$
|
1,968
|
||||
Stockholders’
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 at June 30, 2010
and
September 30, 2009
|
5
|
5
|
||||||
Common
stock, $.01 par value per share, 200,000,000 shares
authorized;
|
||||||||
48,224,320
shares issued and outstanding at June 30, 2010
and
|
||||||||
37,563,392
shares issued and outstanding at September 30, 2009
|
482
|
376
|
||||||
Additional
paid-in capital
|
154,192
|
159,657
|
||||||
Accumulated
deficit
|
(169,823
|
)
|
(161,195
|
)
|
||||
Total
stockholders’ deficit
|
(15,144
|
)
|
(1,157
|
)
|
||||
Total
liabilities and stockholders’ deficit
|
$
|
539
|
$
|
811
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
June 30,
|
June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenue
|
||||||||||||||||
Grant
income
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
275
|
130
|
885
|
469
|
||||||||||||
General
and administrative
|
475
|
315
|
1,337
|
903
|
||||||||||||
Total
costs and expenses
|
750
|
445
|
2,222
|
1,372
|
||||||||||||
Loss
from operations
|
(750
|
)
|
(445
|
)
|
(2,222
|
)
|
(1,372
|
)
|
||||||||
Interest
(expense), net
|
(17
|
)
|
(114
|
)
|
(860
|
)
|
(322
|
)
|
||||||||
Other
income (expense), net
|
(3,856
|
)
|
133
|
(9,899
|
)
|
144
|
||||||||||
Net
loss
|
$
|
(4,623
|
)
|
$
|
(426
|
)
|
$
|
(12,981
|
)
|
$
|
(1,550
|
)
|
||||
Net
loss per weighted share attributable to common
stockholders:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.10
|
)
|
$
|
(0.01
|
)
|
$
|
(0.27
|
)
|
$
|
(0.05
|
)
|
||||
Weighted
average common shares outstanding:
|
||||||||||||||||
Basic
and diluted
|
48,244
|
37,468
|
47,652
|
33,865
|
Nine Months Ended
|
||||||||
June 30,
|
||||||||
2010
|
2009
|
|||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$
|
(12,981
|
)
|
$
|
(1,550
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Noncash
compensation
|
407
|
193
|
||||||
Change
in fair value of warrants
|
3,686
|
-
|
||||||
Change
in fair value of trading securities
|
-
|
(49
|
)
|
|||||
Noncash
consulting expense
|
14
|
25
|
||||||
Loss
on sale of investments
|
-
|
(133
|
)
|
|||||
Noncash
interest and warrant costs
|
7,020
|
366
|
||||||
Change
in assets and liabilities:
|
||||||||
Prepaids
and other assets
|
90
|
5
|
||||||
Accounts
payable and accrued expenses
|
(31
|
)
|
(247
|
)
|
||||
Net
cash used in operating activities
|
(1,795
|
)
|
(1,390
|
)
|
||||
Cash
flows from investing activities:
|
||||||||
(Purchases)
sales of investments and marketable securities
|
(7
|
)
|
751
|
|||||
Net
cash (used by) provided by investing activities
|
(7
|
)
|
751
|
|||||
Cash
flows from financing activities:
|
||||||||
Repayment
of short term note payable
|
-
|
(368
|
)
|
|||||
Proceeds
from short term note payable
|
-
|
3
|
||||||
Proceeds
from the issuance of common stock and warrants
|
1,650
|
1,500
|
||||||
Proceeds
from exercise of warrants
|
17
|
-
|
||||||
Proceeds
from issuance of Senior Convertible Notes
|
-
|
375
|
||||||
Costs
related to the issuance of common stock and warrants
|
(54
|
)
|
(91
|
)
|
||||
Net
cash provided by financing activities
|
1,613
|
1,419
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(189
|
)
|
780
|
|||||
Cash
and cash equivalents at beginning of period
|
646
|
399
|
||||||
Cash
and cash equivalents, end of period
|
$
|
457
|
$
|
1,179
|
Number of Shares
|
Exercise Price
|
Expiration
Date |
|||
350,000
|
$
|
0.28
|
November 2010
|
||
2,126,668
|
$
|
0.28
|
May 2012
|
||
43,614,285
|
$
|
0.28
|
October 2016
|
||
20,000
|
$
|
0.39
|
September 2014
|
||
50,000
|
$
|
0.35
|
May 2011
|
||
15,000
|
$
|
0.50
|
September 2014
|
||
15,000
|
$
|
0.60
|
September 2014
|
||
7,000,000
|
$
|
0.75
|
June 2011
|
||
50,000
|
$
|
1.00
|
May 2011
|
||
50,000
|
$
|
1.50
|
May 2011
|
||
50,000
|
|
$
|
2.00
|
May 2011
|
|
50,000
|
$
|
2.50
|
May 2011
|
||
50,000
|
$
|
0.38
|
April 2020
|
||
53,440,953
|
$
|
0.35
|
|
Weighted Average
|
|||||||||||||||
Remaining Contractual
|
Aggregrate
|
|||||||||||||||
Number of Shares
|
Exercise Price
|
Term (in years)
|
Intrinsic Value
|
|||||||||||||
Outstanding
at 9/30/2009
|
27,379,525
|
$
|
0.46
|
3.25
|
$
|
1,051,248
|
||||||||||
Granted
|
43,664,285
|
$
|
0.28
|
6.27
|
$
|
5,234,714
|
||||||||||
Exercised
|
(60,000
|
)
|
$
|
0.28
|
1.89
|
$
|
9,000
|
|||||||||
Expired
or Canceled
|
(17,542,857
|
)
|
$
|
0.36
|
3.27
|
$
|
927,643
|
|||||||||
Forfeited
|
$
|
0.00
|
$
|
0
|
||||||||||||
Vested
RSAs
|
||||||||||||||||
Outstanding
at 6/30/2010
|
53,440,953
|
$
|
0.35
|
5.33
|
$
|
5,532,114
|
Weighted Average
|
||||||||||||||||
Number of
|
Remaining Contractual
|
Aggregrate
|
||||||||||||||
Shares
|
Exercise Price
|
Term (in years)
|
Intrinsic Value
|
|||||||||||||
Outstanding
at 9/30/2009
|
6,175,015
|
$
|
1.58
|
6.96
|
$
|
137,913
|
||||||||||
Granted
|
185,000
|
$
|
0.35
|
9.53
|
$
|
8,825
|
||||||||||
Exercised
|
$
|
0.00
|
0.00
|
$
|
0
|
|||||||||||
Expired
or Canceled
|
(1,200
|
)
|
$
|
51.25
|
0.00
|
$
|
0
|
|||||||||
Forfeited
|
(421,250
|
)
|
$
|
0.62
|
$
|
4,500
|
||||||||||
Vested
(RSAs)
|
||||||||||||||||
Outstanding
at 6/30/2010
|
5,937,565
|
$
|
1.60
|
6.24
|
$
|
163,775
|
|
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||||
Number
|
Weighted
|
Weighted Average
|
Number
|
Weighted
|
|||||||||||||||||
Range of
|
Outstanding at
|
Average Exercise
|
Remaining
|
Exercisable at June
|
Average Exercise
|
||||||||||||||||
Exercise Prices
|
June 30, 2010
|
Price
|
Contractual Life
|
30, 2010
|
Price
|
||||||||||||||||
$
|
0.29-0.32
|
1,526,250
|
$
|
0.30
|
8.72
|
1,509,583
|
$
|
0.30
|
|||||||||||||
$
|
0.33-0.45
|
903,500
|
$
|
0.39
|
8.82
|
784,545
|
$
|
0.39
|
|||||||||||||
$
|
0.55-0.75
|
768,111
|
$
|
0.65
|
6.41
|
768,111
|
$
|
0.65
|
|||||||||||||
$
|
0.78-0.90
|
794,335
|
$
|
0.87
|
5.91
|
794,335
|
$
|
0.87
|
|||||||||||||
$
|
0.91-1.50
|
1,382,019
|
$
|
1.46
|
3.25
|
1,382,019
|
$
|
1.46
|
|||||||||||||
1.52
|
2,500
|
$
|
1.52
|
4.25
|
2,500
|
$
|
1.52
|
||||||||||||||
$
|
1.55-2.10
|
211,750
|
$
|
1.85
|
4.22
|
211,750
|
$
|
1.85
|
|||||||||||||
$
|
2.50-11.50
|
188,624
|
$
|
4.95
|
3.27
|
188,624
|
$
|
4.95
|
|||||||||||||
$
|
12.85-20.00
|
79,754
|
$
|
15.10
|
1.09
|
79,754
|
$
|
15.10
|
|||||||||||||
$
|
22.50-51.25
|
80,722
|
$
|
36.75
|
0.15
|
80,722
|
$
|
36.75
|
|||||||||||||
$
|
0.29-51.25
|
5,937,565
|
$
|
1.60
|
6.23
|
5,801,943
|
$
|
1.63
|
For the three months
ended June 30, |
For the nine months
ended June 30, |
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Research
and Development Expenses
|
8 | 11 | 41 | 34 | ||||||||||||
General
and Administrative Expenses
|
79 | 71 | 366 | 159 | ||||||||||||
87 | 82 | 407 | 193 |
For the nine months ended
June 30 |
||||||
2010
|
2009
|
|||||
Dividend
yield
|
0%
|
0%
|
||||
Expected
volatility
|
95%
- 96%
|
96%–
209%
|
||||
Risk-free
interest rate
|
3.3%
- 3.5%
|
2.6%
- 3.8%
|
||||
Expected
term
|
10
years
|
10
years
|
September
30,
|
||||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 646 | $ | 399 | ||||
Prepaids
and other current assets
|
133 | 156 | ||||||
Total
current assets
|
779 | 555 | ||||||
Investments,
available for sale
|
– | 440 | ||||||
Investment
in CPEC LLC
|
32 | 125 | ||||||
Total
assets
|
$ | 811 | $ | 1,120 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 774 | $ | 991 | ||||
Margin
loan (Note F)
|
– | 366 | ||||||
Current
maturity of long-term note payable
|
– | 534 | ||||||
Total
current liabilities
|
774 | 1,891 | ||||||
Senior
convertible notes to related parties, net (redemption value of $1,000,000
and $625,000 as of September 30, 2009 and 2008, respectively) (Note
F)
|
600 | 266 | ||||||
Long-term
note payable
|
594 | — | ||||||
Total
liabilities
|
1,968 | 2,157 | ||||||
Commitments
and Contingencies (Note E and J)
|
||||||||
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, 2009 and 2008
|
5 | 5 | ||||||
Common
stock, $.01 par value per share, 200,000,000 shares authorized; 37,563,392
and 31,952,749 shares issued and outstanding at September 30, 2009 and
2008, respectively
|
376 | 320 | ||||||
Additional
paid-in capital
|
159,657 | 157,573 | ||||||
Unrealized
losses on investments, available for sale
|
– | (36 | ) | |||||
Accumulated
deficit
|
(161,195 | ) | (158,899 | ) | ||||
Total
stockholders’ equity (deficit)
|
(1,157 | ) | (1,037 | ) | ||||
Total
liabilities and stockholders’ equity (deficit)
|
$ | 811 | $ | 1,120 |
|
Fiscal Year Ended September 30,
|
|||||||||||
2009
|
2008
|
2007
|
||||||||||
|
|
|
||||||||||
Revenue
|
||||||||||||
Grant
income
|
$ | — | $ | — | $ | — | ||||||
Costs
and expenses:
|
||||||||||||
Research
and development
|
711 | 977 | 1,381 | |||||||||
General
and administrative
|
1,292 | 1,540 | 1,919 | |||||||||
Total
costs and expenses
|
2,003 | 2,517 | 3,300 | |||||||||
Loss
from operations
|
(2,003 | ) | (2,517 | ) | (3,300 | ) | ||||||
Equity
in income of CPEC LLC ($175 dividend received in 2008)
|
— | 175 | — | |||||||||
Interest
expense
|
(441 | ) | (93 | ) | (51 | ) | ||||||
Interest
income
|
4 | 42 | 102 | |||||||||
Warrant
repricing charges
|
(38 | ) | (118 | ) | — | |||||||
Collaboration
expense
|
— | (413 | ) | — | ||||||||
Gain
(loss) on marketable investments
|
49 | (49 | ) | — | ||||||||
Gain
on sale of investments, available for sale
|
133 | — | — | |||||||||
Gain
on forgiveness of note payable
|
— | — | 225 | |||||||||
Net
loss
|
$ | (2,296 | ) | $ | (2,973 | ) | $ | (3,024 | ) | |||
Basic
net loss per common share
|
$ | (0.07 | ) | $ | (0.09 | ) | $ | (0.10 | ) | |||
Diluted
net loss per common share
|
$ | (0.07 | ) | $ | (0.11 | ) | $ | (0.10 | ) | |||
Weighted
average common shares outstanding:
|
||||||||||||
Basic
|
34,789 | 31,953 | 30,239 | |||||||||
Diluted
|
34,789 | 32,217 | 30,239 |
Series B
Preferred
Stock
|
Common Stock
|
Total
|
||||||||||||||||||||||||||||||
Number
of
Shares
|
Par
Value
|
Number
of Shares
|
Par
Value
|
Additional
Paid-in
Capital
|
Unrealized
Losses
|
Accumulated
Deficit
|
Stockholders’
Equity
(Deficit)
|
|||||||||||||||||||||||||
|
|
|
||||||||||||||||||||||||||||||
Balance
at September 30, 2006
|
475,087 | $ | 5 | 29,265,249 | $ | 293 | $ | 154,311 | $ | — | $ | (152,902 | ) | $ | 1,707 | |||||||||||||||||
Sale
of common stock pursuant to stock offering, net of issuance costs of
$239,000
|
— | — | 2,666,667 | 27 | 1,734 | — | — | 1,761 | ||||||||||||||||||||||||
Exercise
of common stock options
|
— | — | 20,833 | — | 20 | — | — | 20 | ||||||||||||||||||||||||
Stock-based
compensation and amortization of warrants
|
— | — | — | — | 716 | — | — | 716 | ||||||||||||||||||||||||
Net
loss for the fiscal year ended September 30, 2007
|
— | — | — | — | — | — | (3,024 | ) | (3,024 | ) | ||||||||||||||||||||||
Balance
at September 30, 2007
|
475,087 | 5 | 31,952,749 | 320 | 156,781 | — | (155,926 | ) | 1,180 | |||||||||||||||||||||||
Sale
of Senior Convertible Notes and warrants, net of issuance costs of
$156,000
|
— | — | — | — | 451 | — | — | 451 | ||||||||||||||||||||||||
Stock-based
compensation
|
— | — | — | — | 341 | — | — | 341 | ||||||||||||||||||||||||
Unrealized
loss on marketable securities held for sale
|
— | — | — | — | — | (36 | ) | — | (36 | ) | ||||||||||||||||||||||
Net
loss for the fiscal year ended September 30, 2008
|
— | — | — | — | — | — | (2,973 | ) | (2,973 | ) | ||||||||||||||||||||||
Balance
at September 30, 2008
|
475,087 | 5 | 31,952,749 | 320 | 157,573 | (36 | ) | (158,899 | ) | (1,037 | ) | |||||||||||||||||||||
Sale
of Senior Convertible Notes and warrants
|
— | — | — | — | 323 | — | — | 323 | ||||||||||||||||||||||||
Stock-based
compensation
|
— | — | — | — | 283 | — | — | 283 | ||||||||||||||||||||||||
Issuance
of common stock pursuant to a consulting agreement
|
— | — | 78,125 | 1 | 24 | — | — | 25 | ||||||||||||||||||||||||
Payment
of interest on Senior Convertible Notes in the form of common
stock
|
— | — | 175,375 | 2 | 61 | — | — | 63 | ||||||||||||||||||||||||
Sale
of common stock pursuant to stock offering, net of issuance costs of
$91,000
|
— | — | 5,357,143 | 53 | 1,393 | — | — | 1,446 | ||||||||||||||||||||||||
Unrealized
gain on marketable securities held for sale
|
— | — | — | — | — | 36 | — | 36 | ||||||||||||||||||||||||
Net
loss for the fiscal year ended September 30, 2009
|
— | — | — | — | — | — | (2,296 | ) | (2,296 | ) | ||||||||||||||||||||||
Balance
at September 30, 2009
|
475,087 | $ | 5 | 37,563,392 | $ | 376 | $ | 159,657 | $ | — | $ | (161,195 | ) | $ | (1,157 | ) |
|
Fiscal Year Ended September 30,
|
|||||||||||
2009
|
2008
|
2007
|
||||||||||
|
|
|||||||||||
Cash
flows from operating activities:
|
|
|
||||||||||
Net
loss
|
$ | (2,296 | ) | $ | (2,973 | ) | $ | (3,024 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Noncash
compensation
|
283 | 341 | 716 | |||||||||
Noncash
interest and financing costs
|
433 | 89 | 52 | |||||||||
Warrant
repricing charges
|
38 | 118 | — | |||||||||
Equity
income in CPEC LLC
|
(175 | ) | — | |||||||||
Noncash
consulting and license fee
|
25 | — | — | |||||||||
(Gain)
loss on marketable investments
|
(49 | ) | 49 | — | ||||||||
(Gain)
on forgiveness of note payable
|
— | — | (225 | ) | ||||||||
(Gain)
on sale of investments, available for sale
|
(133 | ) | — | — | ||||||||
Change
in assets and liabilities:
|
||||||||||||
Accounts
receivable
|
— | — | 1 | |||||||||
Prepaid
expenses and other assets
|
(7 | ) | 15 | 24 | ||||||||
Accounts
payable and accrued expenses
|
(217 | ) | 723 | (623 | ) | |||||||
Net
cash used in operating activities
|
(1,923 | ) | (1,813 | ) | (3,079 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from dividend from CPEC LLC
|
— | 175 | — | |||||||||
Sale
(purchase) of investments
|
751 | (525 | ) | — | ||||||||
Net
cash provided by (used in) investing activities
|
751 | (350 | ) | — | ||||||||
Cash
flows from financing activities:
|
||||||||||||
Repayment
of Note Payable
|
— | — | (300 | ) | ||||||||
Proceeds
from the issuance of Senior Convertible Notes and Warrants
|
375 | 625 | — | |||||||||
Costs
related to the issuance of Senior Convertible Notes and
Warrants
|
— | (156 | ) | — | ||||||||
Proceeds
from short term note payable
|
3 | 372 | — | |||||||||
Repayments
of short term note payable
|
(368 | ) | (6 | ) | — | |||||||
Proceeds
from issuance of common stock and warrants
|
1,500 | — | 2,000 | |||||||||
Costs
related to the issuance of common stock and warrants
|
(91 | ) | — | (239 | ) | |||||||
Proceeds
from exercise of stock options
|
— | — | 21 | |||||||||
Net
cash provided by financing activities
|
1,419 | 835 | 1,482 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
247 | (1,328 | ) | (1,597 | ) | |||||||
Cash
and cash equivalents at beginning of year
|
399 | 1,727 | 3,324 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 646 | $ | 399 | $ | 1,727 | ||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Cash
payments of interest
|
$ | — | $ | 4 | $ | — | ||||||
Supplemental
disclosure of non-cash investing and financing activities:
|
||||||||||||
Common
stock issued for payment of interest on Senior Convertible
Notes
|
$ | 63 | $ | — | $ | — |
Number of
Shares
|
Exercise Price
|
Expiration Date
|
|||
2,500,000
|
$ | 0.28 |
November
2010
|
||
2,186,668
|
$ | 0.28 |
May
2012
|
||
13,392,857
|
$ | 0.35 |
March
2014
|
||
20,000
|
$ | 0.39 |
September
2014
|
||
50,000
|
$ | 0.50 |
May
2011
|
||
1,000,000
|
$ | 0.50 |
August
2013
|
||
250,000
|
$ | 0.50 |
September
2013
|
||
250,000
|
$ | 0.50 |
October
2013
|
||
250,000
|
$ | 0.50 |
November
2013
|
||
250,000
|
$ | 0.50 |
December
2013
|
||
15,000
|
$ | 0.50 |
September
2014
|
||
15,000
|
$ | 0.60 |
September
2014
|
||
7,000,000
|
$ | 0.75 |
June
2011
|
||
50,000
|
$ | 1.00 |
May
2011
|
||
50,000
|
$ | 1.50 |
May
2011
|
||
50,000
|
$ | 2.00 |
May
2011
|
||
50,000
|
$ | 2.50 |
May
2011
|
||
27,379,525
|
$ | 0.46 |
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Contractual
Life
|
Intrinsic
Value
|
|||||||||
|
|
||||||||||||
Outstanding
at September 30, 2006
|
3,071,806 | $ | 3.25 |
7.7
years
|
$ | 22 | |||||||
Granted
|
1,315,000 | $ | 0.68 |
10.0
years
|
— | ||||||||
Exercised
|
(20,833 | ) | $ | 1.00 |
8.6
years
|
(8 | ) | ||||||
Cancelled
|
(492,356 | ) | $ | 0.65 | |||||||||
Outstanding
at September 30, 2007
|
3,873,617 | $ | 2.72 |
7.3
years
|
$ | 2 | |||||||
Granted
|
475,000 | $ | 0.35 |
10.0
years
|
— | ||||||||
Exercised
|
— | ||||||||||||
Cancelled
|
(113,336 | ) | $ | 0.87 | |||||||||
Outstanding
at September 30, 2008
|
4,235,281 | $ | 2.50 |
6.7
years
|
$ | 46 | |||||||
Granted
|
1,992,750 | $ | 0.33 |
10.0
years
|
117 | ||||||||
Exercised
|
— | ||||||||||||
Cancelled
|
(51,766 | ) | $ | 32.36 | — | ||||||||
Outstanding
at September 30, 2009
|
6,176,265 | $ | 1.58 |
7.0
years
|
$ | 138 | |||||||
Exercisable
at September 30, 2009
|
4,876,524 | $ | 1.92 |
6.3
years
|
$ | 61 |
Shares
|
||||
Nonvested
at September 30, 2006
|
539,586 | |||
Granted
|
1,315,000 | |||
Forfeited
|
(450,000 | ) | ||
Vested
|
(867,086 | ) | ||
Nonvested
at September 30, 2007
|
537,500 | |||
Granted
|
475,000 | |||
Vested
|
(701,667 | ) | ||
Nonvested
at September 30, 2008
|
310,833 | |||
Granted
|
1,992,750 | |||
Vested
|
(1,003,842 | ) | ||
Nonvested
at September 30, 2009
|
1,229,741 |
|
Options Outstanding
|
Options Exercisable
|
|||||||||||||||
Range of
Exercise
Prices
|
Number
Outstanding
at
September
30, 2009
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Life
|
Number
Exercisable
at
September
30, 2009
|
Weighted
Average
Exercise
Price
|
||||||||||||
$0.29
- $0.32
|
1,476,250 | $ | 0.30 |
9.5
years
|
671,564 | $ | 0.31 | ||||||||||
$0.33
- $0.45
|
993,500 | $ | 0.39 |
9.4
years
|
498,445 | $ | 0.39 | ||||||||||
$0.55
- $0.75
|
771,861 | $ | 0.65 |
7.2
years
|
771,861 | $ | 0.65 | ||||||||||
$0.78
- $0.90
|
889,335 | $ | 0.87 |
6.7
years
|
889,335 | $ | 0.87 | ||||||||||
$0.91
- $1.45
|
223,500 | $ | 1.04 |
6.6
years
|
223,500 | $ | 1.04 | ||||||||||
$1.50
|
1,256,019 | $ | 1.50 |
3.8
years
|
1,256,019 | $ | 1.50 | ||||||||||
$1.52
- $1.85
|
212,500 | $ | 1.84 |
5.0
years
|
212,500 | $ | 1.84 | ||||||||||
$2.10
- $8.13
|
173,018 | $ | 4.20 |
4.2
years
|
173,018 | $ | 4.20 | ||||||||||
$11.50
- $19.38
|
90,860 | $ | 13.95 |
2.1
years
|
90,860 | $ | 13.95 | ||||||||||
$20.00
- $51.25
|
89,422 | $ | 35.54 |
0.9
years
|
89,422 | $ | 35.54 | ||||||||||
$0.29
- $51.25
|
6,176,265 | $ | 1.58 |
7.0
years
|
4,876,524 | $ | 1.92 |
|
For the fiscal
year ended
September 30,
|
|||||||||||
|
2009
|
2008
|
2007
|
|||||||||
Research
and development expenses
|
$
|
38
|
$
|
45
|
$
|
177
|
||||||
General
and administrative expenses
|
245
|
296
|
539
|
|||||||||
Total
stock-based compensation expense
|
$
|
283
|
$
|
341
|
$
|
716
|
|
|
For the fiscal year ended September 30,
|
||||
2009
|
2008
|
2007
|
||||
Dividend
yield
|
0%
|
0%
|
0%
|
|||
Expected
volatility
|
111%
|
197%
- 198%
|
191%
- 195%
|
|||
Risk-free
interest rate
|
3.0%
|
3.8%
- 4.6%
|
4.5%
- 5.1%
|
|||
Expected
option life after shares are vested
|
9.3
years
|
10
years
|
10
years
|
2009
|
2008
|
|||||||
Net
operating loss carryforwards
|
$ | 38,341 | $ | 37,790 | ||||
Research
and development credit carryforwards
|
3,446 | 3,410 | ||||||
Accrued
payroll related liabilities
|
2,542 | 2,420 | ||||||
Note
discount
|
322 | 10 | ||||||
Impairment
on marketable securities
|
— | 21 | ||||||
Total
deferred tax assets
|
44,651 | 43,651 | ||||||
Deferred
tax liabilities
|
— | — | ||||||
Valuation
allowance for deferred assets
|
(44,651 | ) | (43,651 | ) | ||||
Net
deferred tax asset
|
$ | — | $ | — |
2009
|
2008
|
2007
|
||||||||||
Effective
income tax rate
|
0 | % | 0 | % | 0 | % | ||||||
United
States Federal income tax at statutory rate
|
$ | (781 | ) | $ | (1,011 | ) | $ | (1,028 | ) | |||
State
income taxes (net of federal benefit)
|
(75 | ) | (142 | ) | (170 | ) | ||||||
Warrant
expense
|
13 | 40 | — | |||||||||
Change
in valuation reserves
|
857 | 1,145 | 1,244 | |||||||||
Other
|
(14 | ) | (32 | ) | (46 | ) | ||||||
Provision
for income taxes
|
$ | — | $ | — | $ | — |
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
Total
Year
|
||||||||||||||||
(in thousands, except per share amounts)
|
||||||||||||||||||||
Fiscal
2009
|
||||||||||||||||||||
Total
revenue
|
$ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net
loss attributable to common stockholders
|
$ | (459 | ) | $ | (665 | ) | $ | (426 | ) | $ | (746 | ) | $ | (2,296 | ) | |||||
Basic
net loss per common share attributable to common
stockholders
|
$ | (0.01 | ) | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.07 | ) | |||||
Diluted
net loss per common share attributable to common
stockholders
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.02 | ) | $ | (0.07 | ) | |||||
Fiscal
2008
|
||||||||||||||||||||
Total
revenue
|
$ | — | $ | — | $ | — | $ | — | $ | — | ||||||||||
Net
loss attributable to common stockholders
|
$ | (641 | ) | $ | (697 | ) | $ | (580 | ) | $ | (1,055 | ) | $ | (2,973 | ) | |||||
Basic
net loss per common share attributable to common
stockholders
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.09 | ) | |||||
Diluted
net loss per common share attributable to common
stockholders
|
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.02 | ) | $ | (0.05 | ) | $ | (0.11 | ) |
SEC
registration fee
|
$
|
1,499.34
|
||
Legal
fees and expenses
|
160,000.00
|
|||
Accounting
fees and expenses
|
25,000.00
|
|||
Miscellaneous
fees and expenses
|
3,000.00
|
|||
Total
|
$
|
189,499.34
|
|
|
|
|
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
|
|||||||
3.4
|
Bylaws,
as amended
|
8-K
|
10/25/05
|
3.1
|
|||||||
3.5
|
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
|
Form
of Series B Preferred Stock Certificate
|
S-4
|
09/19/03
|
4.8
|
|||||||
4.3
|
Form
of Warrant to Purchase Common Stock dated November 21,
2005
|
8-K
|
11/23/05
|
10.2
|
|||||||
4.4
|
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
|
|||||||
4.5
|
Form
of Warrant to Purchase Common Stock dated June 5, 2006.
|
8-K
|
6/5/06
|
10.3
|
4.6
|
Warrant
to Purchase Common Stock dated June 5, 2006 issued to Efficacy Biotech
Master Fund Ltd.
|
8-K
|
6/5/06
|
10.4
|
||||||||
4.7
|
Registration
Rights Agreement dated May 22, 2007 by and among the Company and each of
the Purchasers whose names appear on the Schedule attached
thereto.
|
8-K
|
5/22/07
|
4.1
|
||||||||
4.8
|
Registration
Rights Agreement dated October 6, 2009 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
10/6/09
|
4.1
|
||||||||
4.9
|
Form
of Warrant to Purchase Common Stock dated May 22, 2007.
|
8-K
|
5/22/07
|
10.2
|
||||||||
4.10
|
Form
of Warrant to Purchase Common Stock
|
8-K
|
10/6/09
|
10.2
|
||||||||
4.11
|
Registration
Rights Agreement dated August 11, 2010 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
8/12/10
|
4.1
|
||||||||
4.12
|
Form
of Warrant to Purchase Common Stock
|
8-K
|
8/12/10
|
10.2
|
||||||||
5.1
|
Opinion
of Paul, Hastings, Janofsky & Walker LLP
|
S-1
|
6/30/06
|
5.1
|
||||||||
10.1*
|
License
Agreement between Duke University and Aeolus Pharmaceuticals, Inc., dated
July 21, 1995
|
S-1
|
12/08/95
|
10.4
|
||||||||
10.2
|
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
|
||||||||
10.3
|
Assignment,
Assumption and License Agreement dated July 15, 1999, between CPEC LLC and
Intercardia, Inc.
|
8-K
|
07/23/99
|
10.43
|
||||||||
10.4*
|
License
Agreement dated January 19, 2001 between Incara Pharmaceuticals
Corporation and Incara Development, Ltd.
|
10-Q
|
12/31/00
|
10.59
|
||||||||
10.5*
|
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
|
||||||||
10.6
|
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
|
||||||||
10.7
|
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
|
||||||||
10.8
|
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
|
10.9
|
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
|
||||||
10.10
|
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
|
||||||
10.11*
|
License
Agreement dated June 25, 1998 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
10-Q
|
03/31/02
|
10.82
|
||||||
10.12*
|
License
Agreement dated May 7, 2002 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
10-Q
|
03/31/02
|
10.83
|
||||||
10.13*
|
License
Agreement dated November 17, 2000 between National Jewish Medical and
Research Center and Aeolus Pharmaceuticals, Inc.
|
10-Q
|
12/31/00
|
10.56
|
||||||
10.14*
|
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
|
||||||
10.15*
|
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
|
||||||
10.16
|
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
|
||||||
10.17
|
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
|
||||||
10.18
|
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
|
||||||
10.19
|
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
|
||||||
10.20
|
Convertible
Secured Promissory Note dated July 28, 2003 issued by Incara, Inc. to
Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.97
|
10.21
|
Guaranty
dated July 28, 2003 issued by Incara Pharmaceuticals Incorporation to
Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.98
|
||||||
10.22
|
Security
Agreement dated July 28, 2003 issued by Incara Pharmaceuticals
Incorporation to Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.90
|
||||||
10.23
|
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
|
||||||
10.24
|
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
|
||||||
10.25
|
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
|
||||||
10.26
|
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
|
||||||
10.27+
|
Aeolus
Pharmaceuticals, Inc. 1994 Stock Option Plan, as amended
|
10-Q
|
06/30/04
|
10.109
|
||||||
10.28+
|
Aeolus
Pharmaceuticals, Inc. Amended and Restated 2004 Stock Incentive
Plan
|
DEF
14C
|
3/31/08
|
Ex.
B
|
||||||
10.29+
|
Amended
and Restated Employment Agreement dated July 30, 2010 between Aeolus
Pharmaceuticals, Inc. and John L. McManus
|
8-K
|
8/2/10
|
10.4
|
||||||
10.30+
|
Letter
Agreement dated July 10, 2006 between Aeolus Pharmaceuticals, Inc. and
McManus & Company, Inc.
|
8-K
|
7/10/06
|
10.2
|
||||||
10.31+
|
Form
of Indemnity Agreement
|
8-K
|
2/18/05
|
10.118
|
||||||
10.32
|
Terms
of Outside Director Compensation
|
10-K
|
12/17/04
|
10.114
|
||||||
10.33+
|
Form
of Incentive Stock Option Agreement
|
10-Q
|
2/8/05
|
10.115
|
||||||
10.34+
|
Form
of Nonqualified Stock Option Agreement
|
10-Q
|
2/8/05
|
10.116
|
||||||
10.35
|
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
|
||||||
10.36
|
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
|
||||||
10.37
|
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
|
||||||
10.38
|
Securities
Purchase Agreement dated May 22, 2007 by and among the Company and the
investors whose names appear on the signature pages
thereof.
|
8-K
|
5/22/07
|
10.1
|
10.39
|
Convertible
Promissory Note dated February 7, 2007 issued by Aeolus Pharmaceuticals,
Inc. to Elan Pharma International Ltd.
|
S-1
|
6/4/07
|
10.43
|
||||||
10.40
|
Amendment
No. 1 To Convertible Promissory Note dated February 7, 2009 by and between
Aeolus Pharmaceuticals, Inc. and Elan Pharma International
Limited
|
8-K
|
3/16/09
|
10.1
|
||||||
10.41+
|
Form
of Restricted Share Award Agreement
|
S-8
POS
|
3/31/08
|
99.2
|
||||||
10.42
|
Securities
Purchase and Exchange Agreement dated October 6, 2009 by and among the
Company and the investors whose names appear on the signature pages
thereof
|
8-K
|
10/6/09
|
10.1
|
||||||
10.43
|
Amendment
Agreement to the Securities Purchase and Exchange Agreement dated December
24, 2009 by and among the Company and the investors whose names appear on
the signature pages thereof
|
8-K
|
12/28/09
|
10.1
|
||||||
10.44
|
Securities
Purchase Agreement dated August 11, 2010 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
8/12/10
|
10.1
|
||||||
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
|
||||||
21.1
|
List
of Subsidiaries
|
10-K
|
12/28/09
|
21.1
|
||||||
23.1
|
Consent
of Haskell & White LLP, Independent Registered Public Accounting
Firm
|
X
|
||||||||
23.2
|
Consent
of Paul, Hastings, Janofsky & Walker LLP (included in Exhibit
5.1)
|
S-1
|
6/30/06
|
5.1
|
AEOLUS
PHARMACEUTICALS, INC.
|
|
By:
|
/s/
John L.
McManus
|
John
L. McManus
|
|
President
and Chief Executive
Officer
|
Name
|
Title
|
Date
|
||
/s/ John L.
McManus
|
President
and Chief Executive Officer, Chief Financial Officer, Treasurer and
Secretary (Principal Executive Officer, Principal Financial and Accounting
Officer)
|
September
28, 2010
|
||
/s/ David C.
Cavalier
|
Chairman
of the Board of Directors
|
September
24, 2010
|
||
David
C. Cavalier
|
||||
/s/ John M.
Farah
|
Director
|
September
24, 2010
|
||
John
M. Farah, Jr., Ph.D.
|
||||
/s/ Joseph J.
Krivulka
|
Director
|
September
28, 2010
|
||
Joseph
J. Krivulka
|
||||
/s/ Amit
Kumar
|
Director
|
September
28, 2010
|
||
Amit
Kumar, Ph.D.
|
||||
/s/ Michael E.
Lewis
|
Director
|
September
24, 2010
|
||
Michael
E. Lewis, Ph.D.
|
||||
/s/ Chris A.
Rallis
|
Director
|
September
28, 2010
|
||
Chris
A. Rallis
|
||||
/s/ Peter D.
Suzdak
|
Director
|
September
28, 2010
|
||
Peter
D. Suzdak, Ph.D.
|
|
|
|
|
|
|
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
|
||||||||
3.4
|
Bylaws,
as amended
|
8-K
|
10/25/05
|
3.1
|
||||||||
3.5
|
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
|
Form
of Series B Preferred Stock Certificate
|
S-4
|
09/19/03
|
4.8
|
||||||||
4.3
|
Form
of Warrant to Purchase Common Stock dated November 21,
2005
|
8-K
|
11/23/05
|
10.2
|
||||||||
4.4
|
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
|
||||||||
4.5
|
Form
of Warrant to Purchase Common Stock dated June 5, 2006.
|
8-K
|
6/5/06
|
10.3
|
||||||||
4.6
|
Warrant
to Purchase Common Stock dated June 5, 2006 issued to Efficacy Biotech
Master Fund Ltd.
|
8-K
|
6/5/06
|
10.4
|
||||||||
4.7
|
Registration
Rights Agreement dated May 22, 2007 by and among the Company and each of
the Purchasers whose names appear on the Schedule attached
thereto.
|
8-K
|
5/22/07
|
4.1
|
||||||||
4.8
|
Registration
Rights Agreement dated October 6, 2009 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
10/6/09
|
4.1
|
||||||||
4.9
|
Form
of Warrant to Purchase Common Stock dated May 22, 2007.
|
8-K
|
5/22/07
|
10.2
|
||||||||
4.10
|
Form
of Warrant to Purchase Common Stock
|
8-K
|
10/6/09
|
10.2
|
||||||||
4.11
|
Registration
Rights Agreement dated August 11, 2010 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
8/12/10
|
4.1
|
||||||||
4.12
|
Form
of Warrant to Purchase Common Stock
|
8-K
|
8/12/10
|
10.2
|
||||||||
5.1
|
Opinion
of Paul, Hastings, Janofsky & Walker LLP
|
S-1
|
6/30/06
|
5.1
|
10.1*
|
License
Agreement between Duke University and Aeolus Pharmaceuticals, Inc., dated
July 21, 1995
|
S-1
|
12/08/95
|
10.4
|
||||||
10.2
|
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
|
||||||
10.3
|
Assignment,
Assumption and License Agreement dated July 15, 1999, between CPEC LLC and
Intercardia, Inc.
|
8-K
|
07/23/99
|
10.43
|
||||||
10.4*
|
License
Agreement dated January 19, 2001 between Incara Pharmaceuticals
Corporation and Incara Development, Ltd.
|
10-Q
|
12/31/00
|
10.59
|
||||||
10.5*
|
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
|
||||||
10.6
|
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
|
||||||
10.7
|
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
|
||||||
10.8
|
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
|
||||||
10.9
|
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
|
||||||
10.10
|
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
|
||||||
10.11*
|
License
Agreement dated June 25, 1998 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
10-Q
|
03/31/02
|
10.82
|
||||||
10.12*
|
License
Agreement dated May 7, 2002 between Duke University and Aeolus
Pharmaceuticals, Inc.
|
10-Q
|
03/31/02
|
10.83
|
||||||
10.13*
|
License
Agreement dated November 17, 2000 between National Jewish Medical and
Research Center and Aeolus Pharmaceuticals, Inc.
|
10-Q
|
12/31/00
|
10.56
|
10.14*
|
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
|
||||||
10.15*
|
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
|
||||||
10.16
|
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
|
||||||
10.17
|
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
|
||||||
10.18
|
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
|
||||||
10.19
|
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
|
||||||
10.20
|
Convertible
Secured Promissory Note dated July 28, 2003 issued by Incara, Inc. to
Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.97
|
||||||
10.21
|
Guaranty
dated July 28, 2003 issued by Incara Pharmaceuticals Incorporation to
Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.98
|
||||||
10.22
|
Security
Agreement dated July 28, 2003 issued by Incara Pharmaceuticals
Incorporation to Goodnow Capital, Inc.
|
10-Q
|
06/30/03
|
10.90
|
||||||
10.23
|
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
|
||||||
10.24
|
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
|
||||||
10.25
|
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
|
||||||
10.26
|
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
|
10.27+
|
Aeolus
Pharmaceuticals, Inc. 1994 Stock Option Plan, as amended
|
10-Q
|
06/30/04
|
10.109
|
||||||
10.28+
|
Aeolus
Pharmaceuticals, Inc. Amended and Restated 2004 Stock Incentive
Plan
|
DEF
14C
|
3/31/08
|
Ex.
B
|
||||||
10.29+
|
Amended
and Restated Employment Agreement dated July 30, 2010 between Aeolus
Pharmaceuticals, Inc. and John L. McManus
|
8-K
|
8/2/10
|
10.4
|
||||||
10.30+
|
Letter
Agreement dated July 10, 2006 between Aeolus Pharmaceuticals, Inc. and
McManus & Company, Inc.
|
8-K
|
7/10/06
|
10.2
|
||||||
10.31+
|
Form
of Indemnity Agreement
|
8-K
|
2/18/05
|
10.118
|
||||||
10.32
|
Terms
of Outside Director Compensation
|
10-K
|
12/17/04
|
10.114
|
||||||
10.33+
|
Form
of Incentive Stock Option Agreement
|
10-Q
|
2/8/05
|
10.115
|
||||||
10.34+
|
Form
of Nonqualified Stock Option Agreement
|
10-Q
|
2/8/05
|
10.116
|
||||||
10.35
|
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
|
||||||
10.36
|
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
|
||||||
10.37
|
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
|
||||||
10.38
|
Securities
Purchase Agreement dated May 22, 2007 by and among the Company and the
investors whose names appear on the signature pages
thereof.
|
8-K
|
5/22/07
|
10.1
|
||||||
10.39
|
Convertible
Promissory Note dated February 7, 2007 issued by Aeolus Pharmaceuticals,
Inc. to Elan Pharma International Ltd.
|
S-1
|
6/4/07
|
10.43
|
||||||
10.40
|
Amendment
No. 1 To Convertible Promissory Note dated February 7, 2009 by and between
Aeolus Pharmaceuticals, Inc. and Elan Pharma International
Limited
|
8-K
|
3/16/09
|
10.1
|
||||||
10.41+
|
Form
of Restricted Share Award Agreement
|
S-8
POS
|
3/31/08
|
99.2
|
||||||
10.42
|
Securities
Purchase and Exchange Agreement dated October 6, 2009 by and among the
Company and the investors whose names appear on the signature pages
thereof
|
8-K
|
10/6/09
|
10.1
|
||||||
10.43
|
Amendment
Agreement to the Securities Purchase and Exchange Agreement dated December
24, 2009 by and among the Company and the investors whose names appear on
the signature pages thereof
|
8-K
|
12/28/09
|
10.1
|
||||||
10.44
|
Securities
Purchase Agreement dated August 11, 2010 by and among the Company and the
investors whose names appear on the signature pages
thereof
|
8-K
|
8/12/10
|
10.1
|
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
|
||||||
21.1
|
List
of Subsidiaries
|
10-K
|
12/28/09
|
21.1
|
||||||
23.1
|
Consent
of Haskell & White LLP, Independent Registered Public Accounting
Firm
|
X
|
||||||||
23.2
|
Consent
of Paul, Hastings, Janofsky & Walker LLP (included in Exhibit
5.1)
|
S-1
|
6/30/06
|
5.1
|