Delaware
(State or other jurisdiction of incorporation or organization) |
56-1953785
(I.R.S. Employer Identification No.) |
26361 Crown Valley Parkway, Suite 150
Mission Viejo, California (Address of principal executive offices) |
92691
(Zip Code) |
Registrant's telephone number, including area code: 949-481-9825
|
|
Securities registered pursuant to Section 12(b) of the Act: None
|
|
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value per share (Title of class) |
Page | |
PART I
|
1 |
Item 1. Business.
|
1 |
Item 1A. Risk Factors.
|
39 |
Item 1B. Unresolved Staff Comments.
|
55 |
Item 2. Properties.
|
55 |
Item 3. Legal Proceedings.
|
55 |
Item 4. Mine Safety Disclosures.
|
55 |
PART II
|
55 |
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
55 |
Item 6. Selected Financial Data.
|
56 |
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.
|
57 |
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
|
65 |
Item 8. Financial Statements and Supplementary Data.
|
66 |
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
|
85 |
Item 9A. Controls and Procedures.
|
86 |
Item 9B. Other Information.
|
87 |
PART III
|
87 |
Item 10. Directors, Executive Officers and Corporate Governance.
|
88 |
Item 11. Executive Compensation.
|
88 |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
88 |
Item 13. Certain Relationships and Related Transactions, and Director Independence.
|
90 |
Item 14. Principal Accounting Fees and Services.
|
90 |
PART IV
|
90 |
Item 15. Exhibits and Financial Statement Schedules.
|
90 |
·
|
our need for, and our ability to obtain, additional funds;
|
·
|
our ability to obtain grants to develop our drug candidates;
|
·
|
uncertainties regarding the effectiveness of proceeds deployment and our actual future use of proceeds from our 2015 Securities Placement described below;
|
·
|
uncertainties relating to non-clinical studies, clinical trials and regulatory reviews and approvals;
|
·
|
uncertainties relating to our pre-clinical studies and trials and regulatory reviews and approvals;
|
·
|
uncertainties regarding our ability to successfully advance our Phase I study for Lung-Acute Radiation Syndrome (or Lung ARS) and other commercialization studies and projects involving AEOL 10150, in light of the clinical hold placed on our Lung ARS study by the Food & Drug Administration on September 22, 2014;
|
·
|
uncertainties regarding whether our compounds could inhibit formation of fibrosis in the lungs.
|
·
|
uncertainties concerning whether we can position our compounds for a pre-Emergency Use Authorization application or we can obtain procurements from the Biomedical Advanced Research and Development Authority following any such application;
|
·
|
our dependence on a limited number of therapeutic compounds;
|
·
|
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.
|
·
|
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 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.
|
AEOL 10150 Overview
|
|
Product Type
|
√ Catalytic antioxidants
|
(manganoporphyrin)
|
|
Administration Route
|
√ Subcutaneous administration; self-injection possible
√ Oral formulation developed
|
Indications in Development
|
√ Radiation Oncology
√ Pulmonary Fibrosis
|
√ Pulmonary ARS/DEARE
|
|
√ Sulfur Mustard; Chlorine Gas; Nerve Gas
|
|
Technical Readiness Level (TRL)
|
√ TRL 7/8 for Pulmonary Effects
|
of ARS/DEARE
|
|
Regulatory Status
|
√ Active IND (IND-67741)
|
Phase I (3 studies, 50 patients)
|
|
√ IND on Clinical Hold (IND-
|
Indication
|
Funding Source
|
Amount of Grant/Contract
|
Research Partners
|
Lung-ARS
|
BARDA
|
Up to $118.4 million
|
University of Maryland
|
Chlorine Gas
|
NIH CounterACT
|
$20.3 million
|
National Jewish Health
|
Mustard Gas
|
NIH CounterACT
|
Part of the NIH-CounterACT grant above
|
National Jewish Health
University of Colorado
|
Nerve Agents
|
NIH CounterACT
|
$5 million
|
University of Colorado
|
Treatment
|
Survival
|
Number of Animals
|
Radiation Only
|
10%
|
20
|
Radiation + 5 mg/kg AEOL 10150
|
16%
|
19
|
Radiation + 10 mg/kg AEOL 10150
|
16%
|
19
|
Radiation + 25 mg/kg AEOL 10150
|
40%
|
20
|
Radiation + 40 mg/kg AEOL 10150
|
30%
|
20
|
- Increased mean and median overall survival time
|
|
- Increased mean and median survival time in subjects that did not survive to 180 days
|
|
- Increased time to onset of increased respiratory rate, a clinical measure of lung injury
|
|
- Decreased mortality in subjects with elevated respiratory rate
|
|
- Decreased wet lung weight in all animals, suggesting less parenchymal damage and edema
|
|
- Increased Sp02, a measure of compensated lung function
|
|
- Diminished radiographic evidence of pneumonitis and fibrosis during the later stages of the study (days 90 -180)
|
1.
|
Exposure of the whole thorax to 11.5 Gy resulted in radiation-induced lung injury in all NHPs in the study and proved 100% fatal in the control animals, despite supportive care including dexamethasone. 11.5 Gy is, therefore, equal to or greater than the LD100/180dose for the WTLI model.
|
2.
|
10150, as administered in this pilot study (daily for 28 days at a dose of 5mg/kg subcutaneously), demonstrated potential efficacy in mitigating against fatal radiation-induced lung injury. Treatment with the drug resulted in 28.6% survival following exposure to a radiation dose that proved to be 100% fatal in the untreated control group.
|
3.
|
Serial CT scans demonstrated less quantitative radiographic injury (pneumonitis, fibrosis, effusions) in the 10150-treated cohort, suggesting that the drug reduces the severity of the radiographically detectable lung injury.
|
4.
|
Dexamethasone administration yielded a transient benefit on both clinical and radiographic evidence of pneumonitis. The 10150 treated cohort required 1/3 less dexamethasone support due to reduced pulmonary injury in the 10150 treated group, resulting in less frequent clinical "triggers" (respiratory rate≥80) to treat with dexamethasone.
|
5.
|
The results of this pilot study are encouraging and suggest that treatment with 10150 results in reduced clinical, radiographic and anatomic evidence of radiation-induced lung injury, which also results in improved survival. 10150 merits further study as a post-exposure MCM against radiation-induced lung injury.
|
·
|
Demonstrated survival increase in animal studies of lung ARS when administered 24 hours after exposure,
|
·
|
Demonstrated reduction in lung fibrosis in animal studies when administered up to 24 hours post exposure,
|
·
|
Demonstrated histological improvement in lung tissue post-radiation exposure,
|
·
|
Addresses an unmet medical need as an 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,
|
·
|
Original formulation stable for up to 4½ years at 0–8°C and 1 year at room temperature,
|
·
|
New formulation stability tested in bulk drug for 2 years at room temperature (25°C) and refrigerated conditions (2-8°C); stability testing in bulk drug will continue to three years,
|
·
|
New formulation stability tested in final drug product to 18 months under room temperature (25°C), accelerated conditions (40°C) and refrigerated conditions (2-8°C); stability testing in final drug product will continue to 5 years,
|
·
|
Requires no non-standard storage conditions (i.e., not photosensitive),
|
·
|
Currently in development as an adjunct to radiation therapy and lung fibrosis; if approved will provide a pre-existing distribution and stockpile resource at oncology centers in the event of a radiological emergency,
|
·
|
Demonstrated advantage when used in combination with Neupogen®,
|
·
|
Demonstrated potential as both a therapeutic and prophylactic,
|
·
|
Demonstrated efficacy against sulfur mustard gas, phosgene gas, chlorine gas and nerve agent exposures,
|
·
|
Potential dual use as an adjunct treatment for cancer patients receiving radiation therapy and treatment of pulmonary fibrosis, subject to separate FDA approvals for these indications.
|
·
|
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 I safety trial using the same product and formulation as used in the pivotal trial(s) is required.
|
·
|
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 10150 during the infusion showed little variability, indicating a smoother delivery of the drug than with twice-daily injections.
|
•
|
Increased overall survival from 25% in the untreated control group to 50%
|
•
|
Increased mean and median overall survival time
|
•
|
Increased mean and median survival time in subjects that did not survive to 180 days
|
•
|
Increased time to onset of increased respiratory rate, a clinical measure of lung injury
|
•
|
Decreased mortality in subjects with elevated respiratory rate
|
•
|
Decreased wet lung weight in all animals, suggesting less parenchymal damage and edema
|
•
|
Increased Sp02, a measure of compensated lung function
|
•
|
Diminished radiographic evidence of pneumonitis and fibrosis during the later stages of the study (days 90 -180)
|
·
|
Utilize a selective detoxification pathway that preserves host defense and limits inflammation
|
·
|
Create and develop stable, small molecules so that they:
|
o
|
Maintain pathogen killing with less off target damage,
|
o
|
Provide faster resolution of inflammation,
|
o
|
Decrease irreversible injury and oxidative stress, and
|
·
|
U.S. Civilian: The U.S. civilian market includes funds to protect the U.S. population from biological agents and is largely funded by the Project BioShield Act of 2004 ("Project BioShield"). Project BioShield is the U.S. government's largest biodefense initiative. Project BioShield was extended through the Pandemic All Hazards and Preparedness Reauthorization Act of 2013, which authorized BARDA to administer a Special Reserve Fund of $2.8 billion for MCM procurement.
|
·
|
U.S. Military: The DoD is responsible for the development and procurements of countermeasures for the military segment, which focuses on providing protection for military personnel and civilians who are on active duty.
|
·
|
Non-U.S. Markets: Non-U.S. markets address protection against biowarfare agents for both civilians and military personnel in foreign countries. We anticipate that foreign countries will want to procure biodefense products as they are developed and validated by procurements by the U.S. government.
|
·
|
the agent for which the countermeasure is designed can cause serious or life-threatening disease;
|
·
|
the product may reasonably be believed to be effective in detecting, diagnosing, treating or preventing the disease;
|
·
|
the known and potential benefits of the product outweigh its known and potential risks; and
|
·
|
there is no adequate alternative to the product that is approved and available.
|
·
|
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 tests 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)
|
||
David Cavalier
|
46
|
Chairman of the Board, Chief Financial Officer
|
||
John L. McManus
|
51
|
President and Chief Executive Officer
|
·
|
developing our existing drug candidates and developing and testing new drug candidates;
|
·
|
protecting our intellectual property;
|
·
|
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.
|
·
|
succeed in developing competitive products sooner than us or our strategic partners or licensees;
|
·
|
obtain FDA and other regulatory approvals (including EUA 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.
|
·
|
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, 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;
|
·
|
claim rights to products, including intellectual property, developed under the contract;
|
·
|
take actions that result in a longer development timeline than expected;
|
·
|
audit and object to the contractor's contract-related costs and fees, including allocated indirect costs;
|
·
|
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.
|
High
|
Low
|
||
Fiscal Year Ended September 30, 2014
|
|||
October 1, 2013 through December 31, 2013
|
$0.29
|
$0.23
|
|
January 1, 2014 through March 31, 2014
|
$0.33
|
$0.23
|
|
April 1, 2014 through June 30, 2014
|
$0.36
|
$0.24
|
|
July 1, 2014 through September 30, 2014
|
$0.51
|
$0.23
|
|
Fiscal Year Ended September 30, 2015
|
|||
October 1, 2014 through December 31, 2014
|
$0.29
|
$0.20
|
|
January 1, 2015 through March 31, 2015
|
$0.35
|
$0.21
|
|
April 1, 2015 through June 30, 2015
|
$0.41
|
$0.28
|
|
July 1, 2015 through September 30, 2015
|
$0.32
|
$0.22
|
Year Ended September 30,
|
||||||||||||||||||||
2015
|
2014
|
2013
|
2012
|
2011
|
||||||||||||||||
(in thousands, except per share data)
|
||||||||||||||||||||
Revenue:
|
||||||||||||||||||||
Grant income and contract revenue
|
$
|
3,111
|
$
|
9,631
|
$
|
3,928
|
$
|
7,293
|
$
|
4,821
|
||||||||||
Costs and expenses:
|
||||||||||||||||||||
Research and development
|
3,509
|
6,966
|
3,360
|
6,468
|
5,055
|
|||||||||||||||
General and administrative
|
2,228
|
2,745
|
3,266
|
3,196
|
3,668
|
|||||||||||||||
Total costs and expenses
|
5,737
|
9,711
|
6,626
|
9,664
|
8,723
|
|||||||||||||||
Loss from operations
|
(2,626
|
)
|
(80
|
)
|
(2,698
|
)
|
(2,371
|
)
|
(3,902
|
)
|
||||||||||
Other income (expenses), net
|
—
|
—
|
(510
|
)
|
4,069
|
4,222
|
||||||||||||||
Interest income (expense), net
|
(2
|
)
|
—
|
—
|
—
|
(21
|
)
|
|||||||||||||
Net income (loss)
|
(2,628
|
)
|
(80
|
)
|
(3,208
|
)
|
1,698
|
299
|
||||||||||||
Preferred stock dividend and accretion
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Net income (loss) attributable to common stockholders
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
$
|
(3,208
|
)
|
$
|
856
|
$
|
149
|
|||||||
Basic net income (loss) per share attributable to common stockholders
|
$
|
(0.02
|
)
|
$
|
0.00
|
$
|
(0.03
|
)
|
$
|
0.01
|
$
|
0.00
|
||||||||
Diluted net income (loss) per share attributable to common stockholders
|
$
|
(0.02
|
)
|
$
|
0.00
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.04
|
)
|
||||||
Weighted average common shares outstanding:
|
||||||||||||||||||||
Basic
|
135,883
|
134,667
|
106,554
|
61,593
|
59,474
|
|||||||||||||||
Diluted
|
135,883
|
134,667
|
106,554
|
71,041
|
85,862
|
September 30,
|
||||||||||||||||||||
2015
|
2014
|
2013
|
2012
|
2011
|
||||||||||||||||
(in thousands)
|
||||||||||||||||||||
Cash and cash equivalents and marketable securities
|
94
|
1,517
|
869
|
281
|
518
|
|||||||||||||||
Working capital (deficiency)
|
(876
|
)
|
1,553
|
674
|
(1,048
|
)
|
114
|
|||||||||||||
Total assets
|
1,777
|
3,580
|
1,966
|
1,256
|
2,290
|
|||||||||||||||
Long-term portion of capital lease obligations and notes payable
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Total liabilities
|
2,621
|
1,995
|
1,261
|
21,591
|
25,549
|
|||||||||||||||
Total stockholders' equity (deficit)
|
845
|
1,585
|
705
|
(20,335
|
)
|
(23,259
|
)
|
·
|
as a MCM for the pulmonary and delayed effects of acute radiation exposure under contract with the U.S Government
|
·
|
as a MCM for exposure to chemical gas and nerve gas exposure with grant funding from the U.S. Government
|
·
|
as a treatment for idiopathic pulmonary fibrosis
|
·
|
as a treatment for the side effects of radiation therapy for solid tumors in oncology
|
·
|
development AEOL 1114B ("11114") as a treatment for Parkinson's disease
|
·
|
development of AEOL 20415 ("20415") as a treatment for infectious disease
|
Payments due by period
|
||||||||||||||||||||
Contractual Obligations
|
Total
|
Less
than 1
Year
|
1-3
Years
|
3-5
Years
|
More
than 5
Years
|
|||||||||||||||
Short and long-term debt
|
$
|
1,000
|
$
|
1,000
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Capital lease obligations
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Operating leases
|
9
|
9
|
—
|
—
|
—
|
|||||||||||||||
Purchase obligations
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Total
|
$
|
1,009
|
$
|
1,009
|
$
|
—
|
$
|
—
|
$
|
—
|
Page
|
|
Report of Independent Registered Public Accounting Firm
|
67
|
Consolidated Balance Sheets – As of September 30, 2015 and 2014
|
68
|
Consolidated Statements of Operations – For the fiscal years ended September 30, 2015 and 2014
|
69
|
Consolidated Statements of Stockholders' Equity (Deficit) – For the fiscal years ended September 30, 2015 and 2014
|
70
|
Consolidated Statements of Cash Flows – For the fiscal years ended September 30, 2015 and 2014
|
71
|
Notes to Consolidated Financial Statements
|
72
|
|
September 30,
|
|||||||
|
2015
|
2014
|
||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
94
|
$
|
1,517
|
||||
Accounts receivable
|
1,585
|
1,559
|
||||||
Deferred subcontractor cost
|
21
|
426
|
||||||
Prepaid expenses and other current assets
|
45
|
46
|
||||||
Total current assets
|
1,745
|
3,548
|
||||||
Investment in CPEC LLC
|
32
|
32
|
||||||
Total assets
|
$
|
1,777
|
$
|
3,580
|
||||
LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
1,598
|
$
|
1,552
|
||||
Deferred revenue
|
22
|
443
|
||||||
Note payable to shareholders, net of debt discount of $273
|
727
|
—
|
||||||
Note payable to shareholders redemption liability
|
275
|
—
|
||||||
Total current liabilities
|
2,622
|
1,995
|
||||||
Total liabilities
|
2,622
|
1,995
|
||||||
Commitments and Contingencies (Notes E and K)
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, $0.01 par value per share, 10,000,000 shares authorized:
|
||||||||
Series A nonredeemable convertible preferred stock, 1,250,000 shares authorized as of September 30, 2015 and 2014, respectively; no shares issued and outstanding as of September 30, 2015 and 2014, respectively
|
—
|
—
|
||||||
Series B nonredeemable convertible preferred stock, 1,600,000 and 1,600,000 shares authorized as of September 30, 2015 and 2014, respectively; 526,080 and 526,080 shares issued and outstanding as of September 30, 2015 and 2014, respectively
|
5
|
5
|
||||||
Common stock, $0.01 par value per share, 200,000,000 shares authorized; 135,930,068 and 135,850,068 shares issued and outstanding at September 30, 2015 and 2014, respectively
|
1,359
|
1,359
|
||||||
Additional paid-in capital
|
184,421
|
184,223
|
||||||
Accumulated deficit
|
(186,630
|
)
|
(184,002
|
)
|
||||
Total stockholders' (deficit) equity
|
(845
|
)
|
1,585
|
|||||
Total liabilities and stockholders' (deficit) equity
|
$
|
1,777
|
$
|
3,580
|
Fiscal Year Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Revenue:
|
||||||||
Contract revenue
|
$
|
3,111
|
$
|
9,631
|
||||
Costs and expenses:
|
||||||||
Research and development
|
3,509
|
6,966
|
||||||
General and administrative
|
2,228
|
2,745
|
||||||
Total costs and expenses
|
5,737
|
9,711
|
||||||
Loss from operations
|
(2,626
|
)
|
(80
|
)
|
||||
Interest expense
|
2
|
—
|
||||||
Net loss
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Net loss attributable to common stockholders – basic
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Net loss attributable to common stockholders – diluted
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Basic net loss per common share
|
$
|
(0.02
|
)
|
$
|
0.00
|
|||
Diluted net loss per common share
|
$
|
(0.02
|
)
|
$
|
0.00
|
|||
Weighted average common shares outstanding:
|
||||||||
Basic
|
135,883
|
134,667
|
||||||
Diluted
|
135,883
|
134,667
|
Series B Preferred Stock
|
Common Stock
|
Additional
|
Accumulated
|
Total Stockholders'
|
||||||||||||||||||||||||
Shares
|
Par Value
|
Shares
|
Par Value
|
Paid-in Capital
|
Deficit
|
Equity (Deficit)
|
||||||||||||||||||||||
Balance at September 30, 2013
|
526,080
|
$
|
5
|
134,550,068
|
$
|
1,346
|
$
|
183,276
|
$
|
(183,922
|
)
|
$
|
705
|
|||||||||||||||
Exercise of warrants
|
—
|
—
|
1,300,000
|
13
|
312
|
—
|
325
|
|||||||||||||||||||||
Issuance of warrants to consultants
|
—
|
—
|
—
|
—
|
9
|
—
|
9
|
|||||||||||||||||||||
Stock-based compensation
|
—
|
—
|
—
|
—
|
626
|
—
|
626
|
|||||||||||||||||||||
Net loss for the fiscal year ended September 30, 2014
|
—
|
—
|
—
|
—
|
—
|
(80
|
)
|
(80
|
)
|
|||||||||||||||||||
Balance at September 30, 2014
|
526,080
|
5
|
135,850,068
|
1,359
|
184,223
|
(184,002
|
)
|
1,585
|
||||||||||||||||||||
Exercise of warrants
|
—
|
—
|
80,000
|
—
|
20
|
—
|
20
|
|||||||||||||||||||||
Issuance of warrants to consultants
|
—
|
—
|
—
|
—
|
14
|
—
|
14
|
|||||||||||||||||||||
Stock-based compensation
|
—
|
—
|
—
|
—
|
164
|
—
|
164
|
|||||||||||||||||||||
Net loss for the fiscal year end September 30, 2015
|
—
|
—
|
—
|
—
|
—
|
(2,628
|
)
|
(2,628
|
)
|
|||||||||||||||||||
Balance at September 30, 2015
|
526,080
|
$
|
5
|
135,930,068
|
$
|
1,359
|
$
|
184,421
|
$
|
(186,630
|
)
|
$
|
(845
|
)
|
Fiscal Year Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Cash flows from operating activities:
|
||||||||
Net loss
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
|
||||||||
Accrued interest
|
2
|
—
|
||||||
Noncash compensation
|
178
|
635
|
||||||
Change in assets and liabilities:
|
||||||||
Accounts receivable
|
(26
|
)
|
(1,189
|
)
|
||||
Deferred subcontractor cost
|
405
|
230
|
||||||
Prepaid expenses and other current assets
|
1
|
(7
|
)
|
|||||
Accounts payable and accrued expenses
|
46
|
973
|
||||||
Deferred revenue
|
(421
|
)
|
(239
|
)
|
||||
Net cash (used in) provided by operating activities
|
(2,443
|
)
|
323
|
|||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Proceeds from exercise of common stock warrants
|
20
|
325
|
||||||
Proceeds from issuance of note payable to shareholders
|
1,000
|
—
|
||||||
Net cash provided by financing activities
|
1,020
|
325
|
||||||
|
||||||||
Net (decrease) increase in cash and cash equivalents
|
(1,423
|
)
|
648
|
|||||
|
||||||||
Cash and cash equivalents at beginning of year
|
1,517
|
869
|
||||||
Cash and cash equivalents at end of year
|
$
|
94
|
$
|
1,517
|
||||
|
||||||||
Supplemental disclosure of non-cash financing activities:
|
||||||||
Note payable to shareholders redemption liability
|
$
|
275
|
$
|
—
|
·
|
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
·
|
Level 2: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
|
·
|
Level 3: Unobservable inputs that reflect the reporting entity's own assumptions.
|
Fair value at September 30, 2015
|
|||||||
Level 1
|
Level 2
|
Level 3
|
|||||
$
|
275
|
$
|
—
|
$
|
—
|
Fair value measurement of redemption liability
|
|||
Balance at September 30, 2014
|
$
|
—
|
|
Issuance of convertible promissory notes with redemption feature
|
275
|
||
Change in fair value of redemption liability
|
—
|
||
Balance at September 30, 2015
|
$
|
275
|
In thousands, except per share data
|
||||||||
Fiscal Year Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Numerator:
|
||||||||
Net income (loss)
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Net income attributable to participating securities
|
—
|
—
|
||||||
Net income (loss) attributable to common stockholders – basic
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Net income (loss)
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Less gain (loss) on warrant liability for participating common warrants
|
—
|
—
|
||||||
Net income (loss) attributable to common stockholders – diluted
|
$
|
(2,628
|
)
|
$
|
(80
|
)
|
||
Denominator:
|
||||||||
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders – basic
|
135,883
|
134,667
|
||||||
Effect of potentially dilutive securities:
|
||||||||
Common stock warrants
|
—
|
—
|
||||||
Convertible preferred warrants
|
—
|
—
|
||||||
Convertible preferred stock
|
—
|
—
|
||||||
Common stock options
|
—
|
—
|
||||||
Non-participating common stock warrants
|
—
|
—
|
||||||
Weighted-average shares used in computing net income (loss) per share attributable to common stockholders – diluted
|
135,883
|
134,667
|
||||||
Basic net income (loss) per common share
|
$
|
(0.02
|
)
|
$
|
0.00
|
|||
Diluted net income (loss) per common share
|
$
|
(0.02
|
)
|
$
|
0.00
|
Number of Shares
|
Exercise Price
|
Expiration Date
|
|||||
50,000
|
$
|
0.50
|
May 2016
|
||||
50,000
|
$
|
0.50
|
July 2016
|
||||
50,000
|
$
|
1.00
|
July 2016
|
||||
50,000
|
$
|
1.50
|
July 2016
|
||||
50,000
|
$
|
2.00
|
July 2016
|
||||
50,000
|
$
|
2.50
|
July 2016
|
||||
1,337,627
|
$
|
0.40
|
March 2017
|
||||
325,000
|
$
|
0.40
|
April 2017
|
||||
300,000
|
$
|
0.258
|
June 2017
|
||||
50,000
|
$
|
0.26
|
June 2017
|
||||
140,000
|
$
|
0.35
|
October 2017
|
||||
12,205,000
|
$
|
0.25
|
February 2018
|
||||
1,242,000
|
$
|
0.25
|
March 2018
|
||||
50,000
|
$
|
0.49
|
January 2020
|
||||
15,949,627
|
Number of Shares
|
Exercise Price
|
Expiration Date
|
|||||
50,000
|
$
|
0.38
|
April 2015
|
||||
50,000
|
$
|
0.50
|
May 2016
|
||||
50,000
|
$
|
0.50
|
July 2016
|
||||
50,000
|
$
|
1.00
|
July 2016
|
||||
50,000
|
$
|
1.50
|
July 2016
|
||||
50,000
|
$
|
2.00
|
July 2016
|
||||
50,000
|
$
|
2.50
|
July 2016
|
||||
1,337,627
|
$
|
0.40
|
March 2017
|
||||
325,000
|
$
|
0.40
|
April 2017
|
||||
300,000
|
$
|
0.258
|
June 2017
|
||||
50,000
|
$
|
0.26
|
June 2017
|
||||
140,000
|
$
|
0.35
|
October 2017
|
||||
12,285,000
|
$
|
0.25
|
February 2018
|
||||
1,242,000
|
$
|
0.25
|
March 2018
|
||||
16,029,627
|
Weighted Average
|
|||||||||||||
Remaining
|
Aggregate
|
||||||||||||
Number
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
of Shares
|
Price
|
Term (in years)
|
Value
|
||||||||||
Outstanding at 9/30/2013
|
18,775,664
|
$
|
0.29
|
4.1 years
|
$
|
693,340
|
|||||||
Granted
|
50,000
|
$
|
0.26
|
$
|
-
|
||||||||
Exercised
|
(1,300,000
|
)
|
$
|
0.25
|
$
|
318,000
|
|||||||
Cancelled
|
(600,000
|
)
|
$
|
0.86
|
$
|
-
|
|||||||
Forfeited
|
-
|
$
|
-
|
$
|
-
|
||||||||
Outstanding at 9/30/2014
|
16,925,664
|
$
|
0.27
|
3.1 years
|
$
|
215,048
|
|||||||
Granted
|
50,000
|
$
|
0.49
|
$
|
-
|
||||||||
Exercised
|
(80,000
|
)
|
$
|
0.25
|
$
|
10,975
|
|||||||
Cancelled
|
(50,000
|
)
|
$
|
0.38
|
$
|
-
|
|||||||
Forfeited
|
-
|
$
|
-
|
$
|
-
|
||||||||
Outstanding at 9/30/2015
|
16,845,664
|
$
|
0.27
|
2.2 years
|
$
|
206,626
|
|||||||
Exercisable at 9/30/2015
|
16,845,664
|
$
|
0.27
|
2.2 years
|
$
|
206,626
|
Weighted Average
|
|||||||||||||
Remaining
|
Aggregate
|
||||||||||||
Number
|
Exercise
|
Contractual
|
Intrinsic
|
||||||||||
of Shares
|
Price
|
Term (in years)
|
Value
|
||||||||||
Outstanding at 9/30/2013
|
11,214,898
|
$
|
0.52
|
6.7 years
|
$
|
2
|
|||||||
Granted
|
775,000
|
$
|
0.26
|
$
|
-
|
||||||||
Exercised
|
-
|
$
|
-
|
$
|
-
|
||||||||
Cancelled
|
(393,307
|
)
|
$
|
2.64
|
$
|
-
|
|||||||
Forfeited
|
-
|
$
|
-
|
$
|
-
|
||||||||
Outstanding at 9/30/2014
|
11,596,591
|
$
|
0.43
|
6.1 years
|
$
|
1
|
|||||||
Granted
|
775,000
|
$
|
0.27
|
$
|
-
|
||||||||
Exercised
|
-
|
$
|
-
|
$
|
-
|
||||||||
Cancelled
|
(207,000
|
)
|
$
|
0.90
|
$
|
-
|
|||||||
Forfeited
|
-
|
$
|
-
|
$
|
-
|
||||||||
Outstanding at 9/30/2015
|
12,164,591
|
$
|
0.42
|
5.4 years
|
$
|
1
|
|||||||
Exercisable at 9/30/2015
|
12,002,089
|
$
|
0.42
|
5.4 years
|
$
|
1
|
Weighted Average
|
||||||||
Number
|
Grant-Date
|
|||||||
of Shares
|
Fair Value
|
|||||||
Unvested at September 30, 2013
|
1,482,286
|
$
|
0.37
|
|||||
Granted
|
775,000
|
$
|
0.22
|
|||||
Vested
|
(2,088,534
|
)
|
$
|
0.33
|
||||
Forfeited
|
-
|
$
|
-
|
|||||
Unvested at September 30, 2014
|
168,752
|
$
|
0.22
|
|||||
Granted
|
775,000
|
$
|
0.24
|
|||||
Vested
|
(781,250
|
)
|
$
|
0.24
|
||||
Forfeited
|
-
|
$
|
-
|
|||||
Unvested at September 30, 2015
|
162,502
|
$
|
0.23
|
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||||||||||
Weighted
|
Weighted
|
|||||||||||||||||||||||||
Number
|
Weighted
|
Average
|
Number
|
Weighted
|
Average
|
|||||||||||||||||||||
Range of
|
Outstanding at
|
Average
|
Remaining
|
Exercisable at
|
Average
|
Remaining
|
||||||||||||||||||||
Exercise
|
September 30,
|
Exercise
|
Contractual
|
September 30,
|
Exercise
|
Contractual
|
||||||||||||||||||||
Prices
|
2015
|
Price
|
Life (in years)
|
2015
|
Price
|
Life (in years)
|
||||||||||||||||||||
$
|
0.23-$0.30
|
3,087,500
|
$
|
0.28
|
6.37
|
2,924,998
|
$
|
0.28
|
6.20
|
|||||||||||||||||
$
|
0.31-$0.40
|
6,551,500
|
$
|
0.39
|
5.83
|
6,551,500
|
$
|
0.39
|
5.83
|
|||||||||||||||||
$
|
0.41-$0.50
|
502,000
|
$
|
0.45
|
6.25
|
502,000
|
$
|
0.45
|
6.25
|
|||||||||||||||||
$
|
0.51-$0.60
|
982,250
|
$
|
0.59
|
3.71
|
982,250
|
$
|
0.59
|
3.71
|
|||||||||||||||||
$
|
0.61-$0.70
|
60,000
|
$
|
0.68
|
1.03
|
60,000
|
$
|
0.68
|
1.03
|
|||||||||||||||||
$
|
0.71-$0.80
|
366,750
|
$
|
0.75
|
1.75
|
366,750
|
$
|
0.75
|
1.75
|
|||||||||||||||||
$
|
0.81-$0.90
|
570,591
|
$
|
0.87
|
1.26
|
570,591
|
$
|
0.87
|
1.26
|
|||||||||||||||||
$
|
0.91-$1.00
|
14,000
|
$
|
0.95
|
0.25
|
14,000
|
$
|
0.95
|
0.25
|
|||||||||||||||||
$
|
1.01-$1.19
|
30,000
|
$
|
1.10
|
0.22
|
30,000
|
$
|
1.10
|
0.22
|
|||||||||||||||||
12,164,591
|
$
|
0.42
|
5.43
|
12,002,089
|
$
|
0.42
|
5.38
|
For the fiscal year ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Research and Development Expenses
|
$
|
—
|
$
|
11
|
||||
General and Administrative Expenses
|
178
|
624
|
||||||
Total Stock-based Compensation Expense
|
$
|
178
|
$
|
635
|
For the fiscal year ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Dividend yield
|
0
|
%
|
0
|
%
|
||||
Unvested forfeiture rate
|
5.35
|
%
|
0
|
%
|
||||
Expected volatility
|
137
|
%
|
122
|
%
|
||||
Risk-free interest rate
|
1.70
|
%
|
1.54
|
%
|
||||
Expected option life after shares are vested
|
5.27 years
|
5.27 years
|
2015
|
2014
|
|||||||
Accrued payroll related liabilities
|
$
|
1,036
|
$
|
1,103
|
||||
Depreciation and amortization
|
586
|
704
|
||||||
Total deferred tax assets
|
1,622
|
1,807
|
||||||
State Taxes
|
(113
|
) |
(126
|
) | ||||
Total deferred tax liabilities
|
(113
|
) |
(126
|
) | ||||
Net deferred tax assets
|
1,509 | 1,681 | ||||||
Valuation allowance for deferred assets
|
(1,509
|
)
|
(1,681
|
)
|
||||
Net deferred tax asset
|
$
|
—
|
$
|
—
|
2015
|
2014
|
|||||||
Effective income tax rate
|
0
|
%
|
0
|
%
|
||||
United States Federal income tax at statutory rate
|
$
|
(891
|
)
|
$
|
(25
|
)
|
||
State income taxes (net of federal benefit)
|
1
|
1
|
||||||
NQSO forfeiture
|
234
|
—
|
||||||
Prior year deferred true up
|
39
|
(280
|
)
|
|||||
Change in valuation reserves
|
(153
|
)
|
96
|
|||||
FIN 48
|
883
|
354
|
||||||
Other
|
(111
|
)
|
(144
|
)
|
||||
Provision for income taxes
|
$
|
2
|
$
|
2
|
Amount
|
||||
(in thousands)
|
||||
Unrecognized tax benefits at October 1,
|
$
|
4,859
|
||
Additions for tax positions related to current year
|
226
|
|||
Additions/reductions for tax positions taken in prior years
|
||||
Settlements
|
—
|
|||
Lapse of Limitations
|
—
|
|||
Unrecognized tax benefits at September 30, 2015
|
$
|
5,085
|
Current – Federal
|
$
|
—
|
||
Current – State
|
2
|
|||
2
|
||||
Deferred - Federal
|
134
|
|||
Deferred – State
|
38
|
|||
172
|
||||
Less: Valuation Allowance
|
(172
|
)
|
||
—
|
||||
Total current and deferred
|
$
|
2
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
Total
Year
|
||||||||||||||||
(in thousands, except per share amounts)
|
||||||||||||||||||||
Fiscal 2015
|
||||||||||||||||||||
Total revenue
|
$
|
925
|
$
|
1,189
|
$
|
63
|
$
|
934
|
$
|
3,111
|
||||||||||
Net income (loss)
|
$
|
(698
|
)
|
$
|
(712
|
)
|
$
|
(784
|
)
|
$
|
(434
|
)
|
$
|
(2,628
|
)
|
|||||
Net income available to stockholders – Basic
|
$
|
(698
|
)
|
$
|
(712
|
)
|
$
|
(784
|
)
|
$
|
(434
|
)
|
$
|
(2,628
|
)
|
|||||
Net income available to stockholders – Diluted
|
$
|
(698
|
)
|
$
|
(712
|
)
|
$
|
(784
|
)
|
$
|
(434
|
)
|
$
|
(2,628
|
)
|
|||||
Basic net income (loss) per common share attributable to common stockholders
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
0.00
|
$
|
(0.02
|
)
|
||||||
Diluted net income (loss) per common share attributable to common stockholders
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
0.00
|
$
|
(0.02
|
)
|
||||||
Fiscal 2014
|
||||||||||||||||||||
Total revenue
|
$
|
793
|
$
|
1,438
|
$
|
4,983
|
$
|
2,417
|
$
|
9,631
|
||||||||||
Net income (loss)
|
$
|
(695
|
)
|
$
|
(437
|
)
|
$
|
1,576
|
$
|
(524
|
)
|
$
|
(80
|
)
|
||||||
Net income available to stockholders – Basic
|
$
|
(695
|
)
|
$
|
(437
|
)
|
$
|
1,576
|
$
|
(524
|
)
|
$
|
(80
|
)
|
||||||
Net income available to stockholders – Diluted
|
$
|
(695
|
)
|
$
|
(437
|
)
|
$
|
1,576
|
$
|
(524
|
)
|
$
|
(80
|
)
|
||||||
Basic net income (loss) per common share attributable to common stockholders
|
$
|
(0.01
|
)
|
$
|
0.00
|
$
|
0.01
|
$
|
0.00
|
$
|
0.00
|
|||||||||
Diluted net income (loss) per common share attributable to common stockholders
|
$
|
(0.01
|
)
|
$
|
0.00
|
$
|
0.01
|
$
|
0.00
|
$
|
0.00
|
·
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;
|
·
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
|
·
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on our financial statements.
|
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
|
7,749,091
|
$
|
0.47
|
2,250,909
|
||||||||
Equity compensation plans and securities not approved by our stockholders:
|
||||||||||||
Warrants to purchase Common Stock Issued to National Securities
|
50,000
|
$
|
0.38
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Dan Delmonico
|
50,000
|
$
|
0.49
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Michael Kruger
|
50,000
|
$
|
0.50
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Noble International Investments, Inc.
|
300,000
|
$
|
1.00
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to CEOcast, Inc.
|
250,000
|
$
|
0.83
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Market Pathways
|
250,000
|
$
|
1.50
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Roberts Mitani, LLC
|
300,000
|
$
|
0.258
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Columbia Capital Securities, Inc.
|
35,000
|
$
|
0.37
|
Not applicable
|
||||||||
Warrants to Purchase Common Stock Issued to Monarch Bay Associates, LLC
|
35,000
|
$
|
0.37
|
Not applicable
|
||||||||
Total – Common Stock
|
10,793,661
|
2,250,909
|
||||||||||
Warrants to purchase Series B Preferred Stock
|
896,037
|
$
|
0.01
|
Not applicable
|
||||||||
Total – Series B Preferred Stock
|
896,037
|
177,883
|
Incorporated by Reference To
|
|||||
Exhibit
|
Registrant's
|
Date Filed
|
Exhibit
|
Filed
|
|
Number
|
Description of Document
|
Form
|
with the SEC |
Number
|
Herewith
|
2.1
|
Agreement and Plan of Merger and Reorganization dated September 16, 2003 between Incara, Inc. and Incara Pharmaceuticals Corporation
|
S-4
|
9/19/2003
|
2.1
|
|
3.1
|
Amended and Restated Certificate of Incorporation
|
10-K
|
12/31/2012
|
3.1
|
|
3.2 | Certificate of Designation for Series C Preferred | 8-K | 12/15/15 | 10.1 | |
3.3 | Bylaws | 8-K | 10/27/15 | 3.1 | |
4.1
|
Form of Common Stock Certificate
|
10-Q
|
8/11/2004
|
4.1
|
|
4.2
|
Form of Series B Preferred Stock Certificate
|
S-4
|
9/19/2003
|
4.8
|
|
4.3
|
Form of Warrant to Purchase Common Stock dated June 5, 2006.
|
8-K
|
6/6/2006
|
10.3
|
|
4.4
|
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
|
5/23/2007
|
4.1
|
|
4.5
|
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
|
10/6/2009
|
4.1
|
|
4.6
|
Form of Warrant to Purchase Common Stock dated May 22, 2007.
|
8-K
|
5/23/2007
|
10.2
|
|
4.7
|
Form of Warrant to Purchase Common Stock
|
8-K
|
10/6/2009
|
10.2
|
|
4.8
|
Registration Rights Agreement dated September 16, 2003 among Incara Pharmaceuticals Corporation, Incara, Inc. and Goodnow Capital, L.L.C.
|
S-4
|
9/19/2003
|
10.101
|
|
4.9
|
Registration Rights Agreement dated August 11, 2010 by and among Aeolus Pharmaceuticals, Inc. and the investors listed therein
|
8-K
|
8/12/2010
|
4.1
|
|
4.1
|
Registration Rights Agreement dated March 4, 2013 by and among Aeolus Pharmaceuticals, Inc. and the investors listed therein
|
8-K
|
3/6/2013
|
10.2
|
|
4.11
|
Form of Warrant to Purchase Common Stock dated March 4, 2013.
|
8-K
|
3/6/2013
|
10.3
|
|
4.12
|
Warrant Repricing, Exercise and Lockup Agreement dated February 19, 2013 by and among the Company, Xmark JV Investment Partners, LLC and affiliates
|
8-K
|
2/19/2013
|
10.4
|
|
4.13 | Form of Series C Preferred Stock Certificate | X | |||
4.14 | Form of Warrant | 8-K | 12/15/15 | 10.2 | |
10.1*
|
License Agreement between Duke University and Aeolus Pharmaceuticals, Inc., dated July 21, 1995
|
S-1
|
12/8/1995
|
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
|
7/23/1999
|
10.42
|
|
10.3
|
Assignment, Assumption and License Agreement dated July 15, 1999, between CPEC LLC and Intercardia, Inc.
|
8-K
|
7/23/1999
|
10.43
|
Incorporated by Reference To
|
|||||
Exhibit
|
Registrant's
|
Date Filed
|
Exhibit
|
Filed
|
|
Number
|
Description of Document
|
Form
|
with the SEC |
Number
|
Herewith
|
10.4*
|
License Agreement dated January 19, 2001 between Incara Pharmaceuticals Corporation and Incara Development, Ltd.
|
10-Q
|
2/13/2001
|
10.59
|
|
10.5*
|
License Agreement dated January 19, 2001 between Elan Corporation, plc, Elan Pharma International Ltd. and Incara Development, Ltd.
|
10-Q
|
2/13/2001
|
10.6
|
|
10.6
|
Registration Rights Agreement dated December 21, 2000 among Incara Pharmaceuticals Corporation, Elan International Services, Ltd. and Elan Pharma International Ltd.
|
10-Q
|
2/13/2001
|
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
|
5/14/2001
|
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
|
5/14/2001
|
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
|
6/1/2001
|
10.66
|
|
10.1
|
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
|
2/14/2002
|
10.75
|
|
10.11*
|
License Agreement dated June 25, 1998 between Duke University and Aeolus Pharmaceuticals, Inc.
|
10-Q
|
5/15/2002
|
10.82
|
|
10.12*
|
License Agreement dated May 7, 2002 between Duke University and Aeolus Pharmaceuticals, Inc.
|
10-Q
|
5/15/2002
|
10.83
|
|
10.13*
|
License Agreement dated November 17, 2000 between National Jewish Medical and Research Center and Aeolus Pharmaceuticals, Inc.
|
10-Q
|
2/13/2001
|
10.56
|
|
10.14
|
Exclusive License Agreement, dated January 15, 2009, by and between the Company and National Jewish Health
|
10-Q
|
5/16/2011
|
10.7
|
|
10.15*
|
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/A
|
7/3/2002
|
10.84
|
|
10.16*
|
Development and Option Agreement dated May 15, 2002, among Elan Pharma International Limited, Incara Pharmaceuticals Corporation and Aeolus Pharmaceuticals, Inc.
|
8-K/A
|
7/3/2002
|
10.85
|
|
10.17
|
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/A
|
7/3/2002
|
10.86
|
Incorporated by Reference To
|
|||||
Exhibit
|
Registrant's
|
Date Filed
|
Exhibit
|
Filed
|
|
Number
|
Description of Document
|
Form
|
with the SEC |
Number
|
Herewith
|
10.18
|
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/A
|
7/3/2002
|
10.87
|
|
10.19
|
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/A
|
7/3/2002
|
10.88
|
|
10.2
|
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/A
|
7/3/2002
|
10.89
|
|
10.21*
|
Subaward Agreement, dated March 16, 2011, by and between the Company and the Office of Research and Development of the University of Maryland, Baltimore
|
10-Q
|
5/16/2011
|
10.4
|
|
10.22
|
Letter dated May 17, 2004 from Elan International Services, Limited and Elan Pharma International Limited to Incara Pharmaceuticals Corporation
|
10-Q
|
8/11/2004
|
10.106
|
|
10.23+
|
Aeolus Pharmaceuticals, Inc. 1994 Stock Option Plan, as amended
|
10-Q
|
8/11/2004
|
10.109
|
|
10.24+
|
Aeolus Pharmaceuticals, Inc. Amended and Restated 2004 Stock Incentive Plan
|
14-C
|
11/16/2012
|
D
|
|
10.25+
|
Amended and Restated Employment Agreement dated July 30, 2010 between Aeolus Pharmaceuticals, Inc. and John L. McManus
|
8-K
|
8/2/2010
|
10.4
|
|
10.26+
|
Letter Agreement dated July 10, 2006 between Aeolus Pharmaceuticals, Inc. and McManus & Company, Inc.
|
8-K
|
7/10/2006
|
10.2
|
|
10.27+
|
Form of Indemnity Agreement
|
10-K
|
12/27/2011
|
10.27
|
|
10.28
|
Terms of Outside Director Compensation
|
10-K
|
12/17/2004
|
10.114
|
|
10.29+
|
Form of Incentive Stock Option Agreement
|
10-Q
|
2/8/2005
|
10.115
|
|
10.30+
|
Form of Nonqualified Stock Option Agreement
|
10-Q
|
2/8/2005
|
10.116
|
|
10.31
|
Subscription Agreement dated June 5, 2006 by and between the Company and the investors whose names appear on the signature pages thereof.
|
8-K
|
6/6/2006
|
10.1
|
|
10.32
|
Board Observer Letter dated June 5, 2006 by and among the Company and Efficacy Biotech Master Fund Ltd.
|
8-K
|
6/6/2006
|
10.6
|
|
10.33+
|
Consulting Agreement, dated December 1, 2010, between Aeolus Pharmaceuticals, Inc. and Brian J. Day
|
8-K
|
12/3/2010
|
10.1
|
|
10.34*
|
Sponsored Research Agreement (Non-Clinical), dated April 12, 2011, by and between the Company and Duke University
|
10-Q
|
5/16/2011
|
10.5
|
|
10.35
|
Securities Purchase Agreement dated August 11, 2010 by and among Aeolus Pharmaceuticals, Inc. and the investors listed therein
|
8-K
|
8/12/2010
|
10.1
|
|
10.36
|
Form of Warrant pursuant to Securities Purchase Agreement dated August 11, 2010 by and among Aeolus Pharmaceuticals, Inc. and the investors listed therein
|
8-K
|
8/12/2010
|
10.2
|
Incorporated by Reference To
|
|||||
Exhibit
|
Registrant's
|
Date Filed
|
Exhibit
|
Filed
|
|
Number
|
Description of Document
|
Form
|
with the SEC |
Number
|
Herewith
|
10.37
|
Convertible Promissory Note dated February 7, 2007 issued by Aeolus Pharmaceuticals, Inc. to Elan Pharma International Ltd.
|
S-1
|
6/4/2007
|
10.43
|
|
10.38
|
Amendment No. 1 To Convertible Promissory Note dated February 7, 2009 by and between Aeolus Pharmaceuticals, Inc. and Elan Pharma International Limited
|
8-K
|
3/16/2009
|
10.1
|
|
10.39+
|
Form of Restricted Share Award Agreement
|
S-8 POS
|
3/31/2008
|
99.2
|
|
10.4
|
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
|
10/6/2009
|
10.1
|
|
10.41
|
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
|
12/28/2009
|
10.1
|
|
10.42+
|
Intentionally Omitted
|
8-K
|
2/16/2011
|
10.1
|
|
10.43*
|
Contract No. HHSO100201100007C, dated February 11, 2011, by and between the Company and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority
|
10-Q
|
5/16/2011
|
10.1
|
|
10.44*
|
Research and Manufacturing Agreement, dated February 18, 2011 (the "JMPS Agreement"), by and between the Company and Johnson Matthey Pharmaceutical Materials, Inc. (d/b/a Johnson Matthey Pharma Services).
|
10-Q
|
5/16/2011
|
10.2
|
|
10.45*
|
Appendix 2 to the JMPS Agreement, dated February 18, 2011
|
10-Q
|
8/14/2012
|
10.4
|
|
10.46*
|
Appendix 3 to the JMPS Agreement, dated April 30, 2012
|
10-Q
|
8/14/2012
|
10.5
|
|
10.47*
|
Appendix 4 to the JMPS Agreement, dated April 30, 2012
|
10-Q
|
8/14/2012
|
10.6
|
|
10.48*
|
Appendix 5 to the JMPS Agreement, dated April 30, 2012
|
10-Q
|
8/14/2012
|
10.7
|
|
10.49*
|
Appendix 6 to the JMPS Agreement, dated April 30, 2012
|
10-Q
|
8/14/2012
|
10.8
|
|
10.50*
|
General Management Consulting Assignment, dated February 23, 2011, by and between the Company and Booz Allen Hamilton Inc.
|
10-Q
|
5/16/2011
|
10.3
|
|
10.51
|
Form of Securities Purchase Agreement by and among the Company and the investors whose names appear on the signature pages thereof
|
8-K
|
4/5/2012
|
10.1
|
|
10.52
|
Form of Registration Rights Agreement by and among the Company and the investors party thereto
|
8-K
|
4/5/2012
|
10.2
|
|
10.53
|
Form of Warrant issued to investors in March and April 2012
|
8-K
|
4/5/2012
|
10.3
|
|
10.54
|
Amended and Restated Employment Agreement by and between the Company and John L. McManus
|
8-K
|
3/5/2013
|
10.1
|
|
10.55 | Form of Registration Rights Agreement | 8-K | 12/15/15 | 10.2 | |
List of Subsidiaries
|
X
|
||||
Consent of Grant Thornton LLP, Independent Registered Public Accounting Firm
|
X
|
Incorporated by Reference To
|
|||||
Exhibit
|
Registrant's
|
Date Filed
|
Exhibit
|
Filed
|
|
Number
|
Description of Document |
Form
|
with the SEC |
Number
|
Herewith
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a)
|
X
|
||||
Certification of the Principal Financial and Accounting Officer pursuant to Rule 13a-14(a) and 15d-14(a)
|
X
|
||||
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
|
||||
101.INS†
|
XBRL Instance Document
|
X
|
|||
101.SCH†
|
XBRL Taxonomy Extension Schema Document
|
X
|
|||
101.CAL†
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
X
|
|||
101.DEF†
|
XBRL Taxonomy Extension Definition Linkbase Document
|
X
|
|||
101.LAB†
|
XBRL Taxonomy Extension Label Linkbase Document
|
X
|
|||
101.PRE†
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
X
|
SIGNATURE
|
TITLE(S)
|
DATE
|
||
/s/ John L. McManus |
President and Chief Executive Officer
|
December 18, 2015
|
||
John L. McManus
|
(Principal Executive Officer)
|
|||
/s/ David C. Cavalier |
Chief Financial Officer and Secretary
|
December 18, 2015
|
||
David C. Cavalier
|
(Principal Financial and Accounting Officer)
|
|||
/s/ David C. Cavalier |
Chairman of the Board of Directors
|
December 18, 2015
|
||
David C. Cavalier
|
||||
/s/ John M. Clerici |
Director
|
December 18, 2015
|
||
John M. Clerici
|
||||
/s/ John M. Farah, Jr., Ph.D.
|
Director
|
December 18, 2015
|
||
John M. Farah, Jr., Ph.D.
|
||||
Director
|
|
|||
Mitchell D. Kaye
|
||||
/s/ Amit Kumar, Ph.D. |
Director
|
December 18, 2015
|
||
Amit Kumar, Ph.D.
|
||||
/s/ Chris A. Rallis |
Director
|
December 18, 2015
|
||
Chris A. Rallis
|
||||
/s/ Jeffrey Scott |
Director
|
December 18, 2015
|
||
Jeffrey Scott
|