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x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Fiscal Year Ended: December 31, 2010
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from _________ to _________.
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Delaware
(
State or other jurisdiction
of incorporation or organization
)
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04-3321804
(
I.R.S. Employer Identification No.
)
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Title of Class
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Name of each exchange on which registered
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None
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Not Applicable
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Large accelerated filer
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¨
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Accelerated filer ¨ |
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Non-accelerated filer
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¨
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Smaller reporting company
x
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PART I
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Item 1.
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Business
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3
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Item 1A.
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Risk Factors
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17
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Item 2.
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Properties
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27
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Item 3.
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Legal Proceedings
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27
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PART II
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Item 4.
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Market for Registrant’s Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities
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28
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Item 5.
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Management's Discussion and Analysis of Financial Condition and Results of Operations
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29
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Item 6.
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Financial Statements
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34
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Item 7.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
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59
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Item 8A.
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Controls and Procedures
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59
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Item 8B.
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Other Information
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60
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PART III
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Item 9.
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Directors, Executive Officers, and Corporate Governance
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60
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Item 10.
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Executive Compensation
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65
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Item 11.
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Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters
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68
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Item 12.
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Certain Relationships and Related Transactions, and Director Independence
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70
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Item 13.
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Principal Accounting Fees and Services
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71
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PART IV
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Item 14.
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Exhibits
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72
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Item 1.
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Business
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·
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Selective uptake and retention by cancer cells/cancer stem cells compared to normal cells/stem cells. This results in significantly greater potency of COLD as an inhibitor of cell proliferation in cancer cells vs. normal cells (>10-fold difference), or
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·
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Suitability for intravenous administration, avoiding dose-limiting GI toxicity seen with orally administered Akt-inhibiting APCs and potentially enabling greater systemic drug exposure and, hence, Akt-inhibition in cancer cells, resulting in superior efficacy.
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·
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HOT is selectively taken up and retained in cancer vs. normal cells and its delivery vehicle (COLD) will be given to patients in sub-pharmacological doses, resulting in an improved safety profile compared to standard chemotherapy or radiotherapy.
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·
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HOT does not rely on inhibition or enhancement of a specific pathway; it works by exposing cancer cells to sustained lethal radiation from within.
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·
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To date, the HOT chemotype has shown near-universal cancer-specific retention in more than 50
in vivo
tumor models, making the molecule potentially effective in numerous cancer types (broad-spectrum) as compared to type-specific therapies.
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·
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We believe we have completed all preclinical safety, pharmacology and toxicology studies required for an NDA including both single-dose and multi-dose studies.
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·
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HOT is a small molecule that is easily characterized and synthesized and is therefore not subject to scale-up and manufacturing risks typically associated with large molecules such as monoclonal antibodies.
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·
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HOT has a new delivery mechanism, but is paired with a proven and effective radioisotope (
131
I) for therapy.
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·
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HOT can be shipped using traditional freight carriers, such as FedEx, without special handling requirements, thereby significantly reducing the cost and effort in delivering HOT to a patient.
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Lipid rafts are portals of entry for APLs such as COLD, HOT and LIGHT. The marked selectivity of our compounds for cancer cells versus non-cancer cells is due to the fact that cancer cells have far more lipid rafts. In addition to accumulating in lipid rafts, COLD, HOT and LIGHT are transported into the cytoplasm, where they distribute to organelle membranes (mitochondria, ER, lysosomes) but not the nucleus.
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2.
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Lipid rafts also regulate signaling-based cell functions including apoptosis and cell proliferation, and COLD disrupts this regulation. For example, one key signaling pathway that is regulated by interactions with lipid rafts and phospholipids is the phosphatidylinosotol 3-kinase (PI3K)/Akt pathway. Akt (a serine/threonine protein kinase) is activated in lipid raft regions via phosphorylation by PI-dependent kinases and goes on to phosphorylate anti-apoptotic proteins (e.g., Bcl-xL and FLIP) resulting in their inactivation and, thus, promotion of tumor cell survival. COLD pharmacologically inhibits the activation of Akt. In cancer cells, Akt inhibition is associated with induction of apoptosis and decreased cell proliferation/survival.
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·
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When added to cells, NOV-002 results in generation of a mild and transient oxidative signal at the cell surface and intracellularly, glutathionylation of redox-sensitive proteins and a range of biochemical/molecular effects that are dependent on cell type and status, leading to alteration of cell functions.
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·
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In tumor cells, redox modulation by NOV-002 has been shown to decrease the rate of tumor cell proliferation. For example, in a human ovarian tumor cell line (SKOV3), NOV-002 induced an intracellular oxidative signal (as evidenced by generation of reactive oxygen species), increased levels of active (i.e., phosphorylated) c-Jun N-terminal kinases (a component of cell signaling pathways regulating proliferation) and decreased the rate of tumor cell proliferation. This was also accompanied by increased tumor cell apoptosis.
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·
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Also in tumor cells, NOV-002 decreased signaling through a redox-regulated pathway known to control cell migration, invasiveness and metastasis and inhibited invasiveness of a variety of human tumor cell types.
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·
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In animal tumor models, NOV-002 has been shown to increase anti-tumor immune responsiveness and to inhibit tumor growth and enhance survival when combined with chemotherapy.
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o
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In a mouse model of colon cancer, NOV-002 significantly increased anti-tumor response and survival when combined with chemotherapy (cyclophosphamide).
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o
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In a mouse model of melanoma where animals were treated with a form of immunotherapy (adoptive T-cell transfer) together with chemotherapy (cyclophosphamide), the addition of NOV-002 significantly reduced the rate of tumor growth and increased survival.
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o
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In a mouse ovarian cancer model, animals treated with NOV-002 alone showed a significantly increased tumor-specific cellular immune response (interferon gamma production) compared to control mice treated with a saline vehicle.
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·
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In contrast to these suppressive effects on tumors, similar redox modulation, protein glutathionylation and cell signaling pathway effects from NOV-002 treatment resulted in increased proliferation in myeloid lineage cells such as HL-60 cells. Furthermore,
in vivo
, NOV-002 treatment of chemosuppressed mice (using cyclophosphamide) led to increased total bone marrow cell number and proliferation of multi-lineage bone marrow progenitor cells (i.e., progenitor cells for white cells, red cells and platelets).
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•
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Pre-clinical laboratory tests,
in vivo
pre-clinical studies, and formulation studies;
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•
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The submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials can commence;
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•
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Adequate and well-controlled human clinical trials to establish the safety and efficacy of the product;
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•
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The submission of a New Drug Application (“NDA”) or Biologic Drug License Application to the FDA; and
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•
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FDA approval of the NDA or Biologic Drug License.
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Item 1A.
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Risk Factors
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·
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the election of directors;
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·
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the amendment of charter documents; and
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·
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the approval of certain mergers and other significant corporate transactions, including a sale of substantially all of our assets.
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·
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the number of potential products and technologies in development;
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·
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continued progress and cost of our research and development programs;
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·
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progress with pre-clinical studies and clinical trials;
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·
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the time and costs involved in obtaining regulatory clearance;
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·
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costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims;
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·
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costs of developing sales, marketing and distribution channels and our ability to sell our drugs;
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·
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costs involved in establishing manufacturing capabilities for clinical trial and commercial quantities of our drugs;
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·
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competing technological and market developments;
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·
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market acceptance of our products;
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·
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costs for recruiting and retaining management, employees and consultants;
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·
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costs for educating physicians regarding the application and use of our products;
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·
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our status as a Bulletin Board-listed company and the prospects for our stock being listed on a national exchange;
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·
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uncertainty and economic instability resulting from terrorist acts and other acts of violence or war; and
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·
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the condition of capital markets and the economy generally, both in the U.S. and globally.
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·
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consolidating research and development operations;
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·
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preserving important research and development, manufacturing and supply, and other relationships;
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·
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minimizing the diversion of management’s attention from ongoing business concerns;
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·
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coordinating geographically separate organizations; and
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·
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optimizing the functioning of a newly constituted Board of Directors.
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·
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demonstrating benefit from delivery of each specific drug for specific medical indications;
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·
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demonstrating through pre-clinical and clinical trials that each drug is safe and effective; and
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·
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demonstrating that we have established viable Good Manufacturing Practices capable of potential scale-up.
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·
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uncertainties arising from the rapidly growing scientific aspects of drug therapies and potential treatments;
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·
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uncertainties arising as a result of the broad array of alternative potential treatments related to cancer and other diseases; and
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·
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anticipated expense and time believed to be associated with the development and regulatory approval of treatments for cancer and other diseases.
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·
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receiving regulatory clearance of marketing claims for the uses that we are developing;
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·
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establishing and demonstrating the advantages, safety and efficacy of our technologies;
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·
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pricing and reimbursement policies of government and third-party payers such as insurance companies, health maintenance organizations and other health plan administrators;
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·
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our ability to attract corporate partners, including pharmaceutical companies, to assist in commercializing our intended products; and
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·
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our ability to market our products.
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·
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cease selling, incorporating or using any of our technologies and/or products that incorporate the challenged intellectual property, which would adversely affect our ability to generate revenue;
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·
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obtain a license from the holder of the infringed intellectual property right, which license may be costly or may not be available on reasonable terms, if at all; or
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·
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redesign our products, which would be costly and time-consuming.
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·
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fail to adequately market our products;
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·
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fail to satisfy financial or contractual obligations to us;
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·
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offer, design, manufacture or promote competing products; or
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·
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cease operations with little or no notice.
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·
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announcements or press releases relating to the biopharmaceutical sector or to our own business or prospects;
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·
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regulatory, legislative, or other developments affecting us or the healthcare industry generally;
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·
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sales by holders of restricted securities pursuant to effective registration statements or exemptions from registration; and
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·
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market conditions specific to biopharmaceutical companies, the healthcare industry and the stock market generally.
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Item 2.
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Properties
|
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Item 3.
|
Legal Proceedings
|
|
Fiscal Year 2009
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High
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Low
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||||||
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First Quarter
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$ | 91.80 | $ | 45.90 | ||||
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Second Quarter
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137.70 | 52.02 | ||||||
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Third Quarter
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149.94 | 87.21 | ||||||
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Fourth Quarter
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443.70 | 99.45 | ||||||
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Fiscal Year 2010
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High
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Low
|
||||||
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First Quarter
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$ | 466.65 | $ | 26.01 | ||||
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Second Quarter
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42.84 | 15.30 | ||||||
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Third Quarter
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22.95 | 7.65 | ||||||
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Fourth Quarter
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9.18 | 3.06 | ||||||
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Item 5.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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ITEM 6.
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FINANCIAL STATEMENTS
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Page
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Report of Independent Registered Public Accounting Firm
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35
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Balance Sheets at December 31, 2010 and 2009
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36
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Statements of Operations for the Years Ended December 31, 2010 and 2009
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37
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Statements of Redeemable Preferred Stock and Stockholders’ Equity (Deficiency) for the Years Ended December 31, 2010 and 2009
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38
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Statements of Cash Flows for the Years Ended December 31, 2010 and 2009
|
39
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Notes to Financial Statements
|
40
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December 31,
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December 31,
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|||||||
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2010
|
2009
|
|||||||
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ASSETS
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||||||||
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CURRENT ASSETS:
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||||||||
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Cash and equivalents
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$ | 2,372,951 | $ | 8,769,529 | ||||
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Prepaid expenses and other current assets
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63,526 | 102,923 | ||||||
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Total current assets
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2,436,477 | 8,872,452 | ||||||
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FIXED ASSETS, NET
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8,755 | 44,097 | ||||||
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DEPOSITS
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15,350 | 15,350 | ||||||
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TOTAL ASSETS
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$ | 2,460,582 | $ | 8,931,899 | ||||
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LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
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CURRENT LIABILITIES:
|
||||||||
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Accounts payable and accrued liabilities
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$ | 565,723 | $ | 3,299,217 | ||||
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Accrued compensation
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— | 245,711 | ||||||
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Accrued dividends
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— | 2,902,963 | ||||||
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Derivative liability (see Note 2)
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288,250 | 10,486,594 | ||||||
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Deferred revenue – current
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33,333 | 33,333 | ||||||
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Total current liabilities
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887,306 | 16,967,818 | ||||||
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DEFERRED REVENUE – NONCURRENT
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366,667 | 400,000 | ||||||
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COMMITMENTS AND CONTINGENCIES
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REDEEMABLE PREFERRED STOCK:
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||||||||
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Series E convertible preferred stock, $0.00001 par value; 735 shares designated, 0 and 548.26078125 shares issued and outstanding at December 31, 2010 and 2009, respectively (see Note 6)
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— | 18,459,619 | ||||||
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STOCKHOLDERS’ EQUITY (DEFICIENCY):
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Preferred Stock, $0.00001 par value; 7,000 shares authorized: Series C 8% cumulative convertible preferred stock; 272 shares designated; 0 and 204 issued and outstanding at December 31, 2010 and 2009, respectively
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— | — | ||||||
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Common stock, $0.00001 par value; 750,000,000 shares authorized; 452,866,983 and 69,658,002 shares issued and outstanding at December 31, 2010 and 2009, respectively
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4,529 | 697 | ||||||
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Additional paid-in capital
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75,178,776 | 49,175,853 | ||||||
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Accumulated deficit
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(73,976,696 | ) | (76,072,088 | ) | ||||
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Total stockholders’ equity (deficiency)
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1,206,609 | (26,895,538 | ) | |||||
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TOTAL LIABILITIES, REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
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$ | 2,460,582 | $ | 8,931,899 | ||||
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Year Ended December 31,
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||||||||
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2010
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2009
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REVENUES
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$ | 33,334 | $ | 33,334 | ||||
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COSTS AND EXPENSES:
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Research and development
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2,997,984 | 8,080,242 | ||||||
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General and administrative
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2,486,032 | 2,182,253 | ||||||
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Total costs and expenses
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5,484,016 | 10,262,495 | ||||||
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LOSS FROM OPERATIONS
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(5,450,682 | ) | (10,229,161 | ) | ||||
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OTHER INCOME (EXPENSE):
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Interest income
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2,421 | 1,013 | ||||||
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Grant income
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244,479 | 62,980 | ||||||
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Gain (loss) on derivative warrants (see Note 2)
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8,118,174 | (12,114,371 | ) | |||||
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Liquidated damages (see Note 6)
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(819,000 | ) | — | |||||
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Miscellaneous
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— | 6,233 | ||||||
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Total other income (expense)
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7,546,074 | (12,044,145 | ) | |||||
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NET INCOME (LOSS)
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2,095,392 | (22,273,306 | ) | |||||
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PREFERRED STOCK DIVIDENDS
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(2,207,827 | ) | (3,296,289 | ) | ||||
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PREFERRED STOCK DEEMED DIVIDENDS
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(12,541,201 | ) | (714,031 | ) | ||||
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NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
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$ | (12,653,636 | ) | $ | (26,283,626 | ) | ||
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BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE
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$ | (0.10 | ) | $ | (0.53 | ) | ||
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SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE
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126,061,735 | 49,910,010 | ||||||
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REDEEMABLE
PREFERRED STOCK
Series D and E
Convertible
Preferred Stock
|
Common Stock
|
Series C Cumulative
Convertible
Preferred Stock
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Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total
Stockholders’
Equity (Deficiency)
|
|||||||||||||||||||||||||||||||
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Shares
|
Amount
|
Shares
|
Par
Amount
|
Shares
|
Par
Amount
|
|||||||||||||||||||||||||||||||
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BALANCE AT JANUARY 1, 2009
|
413.5 | $ | 13,904,100 | 43,975,656 | $ | 440 | 272 | $ | — | $ | 40,204,112 | $ | (59,693,153 | ) | $ | (19,488,601 | ) | |||||||||||||||||||
|
Reclassification of warrants to derivative liability (see Note 2)
|
— | — | — | — | — | — | (6,893,316 | ) | 5,894,371 | (998,945 | ) | |||||||||||||||||||||||||
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Conversion of Series C convertible preferred stock and accumulated dividends into common stock
|
— | — | 1,538,837 | 15 | (68 | ) | — | 184,231 | — | 184,246 | ||||||||||||||||||||||||||
|
Conversion of Series E convertible preferred stock and accumulated dividends into common stock
|
(97.18209375 | ) | (3,213,056 | ) | 7,939,008 | 79 | — | — | 3,514,235 | — | 3,514,314 | |||||||||||||||||||||||||
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Cashless exercise of warrants
|
— | — | 483,829 | 5 | — | — | 1,000,957 | — | 1,000,962 | |||||||||||||||||||||||||||
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Issuance of common stock in exchange for warrants
|
— | — | 2,084,308 | 21 | — | — | 1,625,739 | — | 1,625,760 | |||||||||||||||||||||||||||
|
Issuance of common stock and warrants in a private placement, net of issuance costs of $61,116
|
— | — | 13,636,364 | 137 | — | — | 8,938,747 | — | 8,938,884 | |||||||||||||||||||||||||||
|
Compensation expense associated with options issued to employees
|
— | — | — | — | — | — | 437,066 | — | 437,066 | |||||||||||||||||||||||||||
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Compensation expense associated with options issued to non-employees
|
— | — | — | — | — | — | 427,271 | — | 427,271 | |||||||||||||||||||||||||||
|
Issuance of Series E redeemable convertible preferred stock and warrants, net of issuance costs of $795,469
|
200 | 6,297,323 | — | — | — | — | 2,907,208 | — | 2,907,208 | |||||||||||||||||||||||||||
|
Issuance of Series E redeemable convertible preferred stock in payment of accumulated dividends
|
31.942875 | 1,597,144 | — | — | — | — | — | — | — | |||||||||||||||||||||||||||
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Adjustment to record the carrying value of Series E redeemable convertible preferred stock at fair value on the date of sale
|
— | (125,892 | ) | — | — | — | — | 125,892 | — | 125,892 | ||||||||||||||||||||||||||
|
Fair value of the extension of expiration date of warrants
|
— | — | — | — | — | — | 839,923 | — | 839,923 | |||||||||||||||||||||||||||
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Accretion of deemed dividend associated with the extension of expiration date of warrants
|
— | — | — | — | — | — | (839,923 | ) | — | (839,923 | ) | |||||||||||||||||||||||||
|
Dividends accrued on preferred stock
|
— | — | — | — | — | — | (3,296,289 | ) | — | (3,296,289 | ) | |||||||||||||||||||||||||
|
Net loss
|
— | — | — | — | — | — | — | (22,273,306 | ) | (22,273,306 | ) | |||||||||||||||||||||||||
|
BALANCE AT DECEMBER 31, 2009
|
548.26078125 | 18,459,619 | 69,658,002 | 697 | 204 | — | 49,175,853 | (76,072,088 | ) | (26,895,538 | ) | |||||||||||||||||||||||||
|
Exercise of stock options
|
— | — | 916,667 | 9 | — | — | 158,558 | — | 158,567 | |||||||||||||||||||||||||||
|
Conversion of Series E convertible preferred stock and accumulated dividends into common stock
|
(139.99673625 | ) | (4,689,593 | ) | 11,745,779 | 117 | — | — | 5,324,401 | — | 5,324,518 | |||||||||||||||||||||||||
|
Cashless exercise of warrants
|
— | — | 8,182,158 | 82 | — | — | 2,584,315 | — | 2,584,397 | |||||||||||||||||||||||||||
|
Compensation expense associated with options issued to employees
|
— | — | — | — | — | — | 586,321 | — | 586,321 | |||||||||||||||||||||||||||
|
Compensation expense (benefit) associated with options issued to non-employees
|
— | — | — | — | — | — | (249,023 | ) | — | (249,023 | ) | |||||||||||||||||||||||||
|
Issuance of common stock and warrants in a public offering (net of issuance costs of $250,862)
|
— | — | 21,428,576 | 214 | — | — | 744,697 | — | 744,911 | |||||||||||||||||||||||||||
|
Fair value of warrants issued to preferred shareholders
|
— | — | — | — | — | — | 586,050 | — | 586,050 | |||||||||||||||||||||||||||
|
Accretion of deemed dividend associated with the issuance of warrants to preferred stockholders
|
— | — | — | — | — | — | (586,050 | ) | — | (586,050 | ) | |||||||||||||||||||||||||
|
Exchange of preferred stock and dividends for common stock
|
(408.264045 | ) | (13,770,026 | ) | 340,935,801 | 3,410 | (204 | ) | — | 19,061,481 | — | 19,064,891 | ||||||||||||||||||||||||
|
Fair value of incremental shares issued to preferred stockholders in connection with exchange of preferred stock for common stock
|
— | — | — | — | — | — | 11,955,151 | — | 11,955,151 | |||||||||||||||||||||||||||
|
Accretion of deemed dividend associated with the incremental shares of common stock issued in connection with the exchange of preferred stock
|
— | — | — | — | — | — | (11,955,151 | ) | — | (11.955,151 | ) | |||||||||||||||||||||||||
|
Dividends accrued on preferred stock
|
— | — | — | — | — | — | (2,207,827 | ) | — | (2,207,827 | ) | |||||||||||||||||||||||||
|
Net income
|
— | — | — | — | — | — | — | 2,095,392 | 2,095,392 | |||||||||||||||||||||||||||
|
BALANCE AT DECEMBER 31, 2010
|
— | $ | — | 452,866,983 | $ | 4,529 | — | $ | — | $ | 75,178,776 | $ | (73,976,696 | ) | $ | 1,206,609 | ||||||||||||||||||||
|
Year Ended December 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net income (loss)
|
$ | 2,095,392 | $ | (22,273,306 | ) | |||
|
Adjustments to reconcile net income (loss) to cash used in operating activities:
|
||||||||
|
Depreciation and amortization
|
35,342 | 32,354 | ||||||
|
Stock-based compensation
|
337,298 | 864,337 | ||||||
|
(Gain) loss on derivative warrants
|
(8,118,174 | ) | 12,114,371 | |||||
|
Non-cash settlement of liquidated damages
|
819,000 | — | ||||||
|
Changes in:
|
||||||||
|
Prepaid expenses and other current assets
|
39,397 | 26,862 | ||||||
|
Accounts payable and accrued liabilities
|
(2,733,494 | ) | (1,354,695 | ) | ||||
|
Accrued compensation
|
(245,711 | ) | 5,072 | |||||
|
Deferred revenue
|
(33,333 | ) | (33,333 | ) | ||||
|
Cash used in operating activities
|
(7,804,283 | ) | (10,618,338 | ) | ||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchases of fixed assets
|
— | (18,000 | ) | |||||
|
Cash used in investing activities
|
— | (18,000 | ) | |||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds from issuance of common stock, net
|
1,249,138 | 8,938,884 | ||||||
|
Proceeds from issuance of Series E convertible preferred stock and warrants, net
|
— | 9,204,531 | ||||||
|
Proceeds from exercise of stock options
|
158,567 | — | ||||||
|
Cash provided by financing activities
|
1,407,705 | 18,143,415 | ||||||
|
INCREASE (DECREASE) IN CASH AND EQUIVALENTS
|
(6,396,578 | ) | 7,507,077 | |||||
|
CASH AND EQUIVALENTS AT BEGINNING OF YEAR
|
8,769,529 | 1,262,452 | ||||||
|
CASH AND EQUIVALENTS AT END OF YEAR
|
$ | 2,372,951 | $ | 8,769,529 | ||||
|
SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING ACTIVITIES
|
||||||||
|
Dividends accumulated on shares of Series E preferred stock exchanged for or converted into shares of common stock
|
$ | 5,110,790 | $ | 1,898,402 | ||||
|
Dividends accumulated on shares of Series C preferred stock converted into shares of common stock
|
$ | — | $ | 184,246 | ||||
|
Fair value of derivative warrants upon adoption of new accounting principle
|
$ | — | $ | 998,945 | ||||
|
Fair value of common stock issued in exchange for tender of derivative warrants
|
$ | — | $ | 1,625,760 | ||||
|
Fair value of derivative warrants upon cashless exercise
|
$ | 2,584,397 | $ | 1,000,962 | ||||
|
Exchange of Series D for Series E preferred stock
|
$ | — | $ | 13,904,100 | ||||
|
Relative fair value of warrants issued to stockholders
|
$ | 504,227 | $ | 4,835,727 | ||||
|
|
|
2010
|
|
|
2009
|
|
||
|
|
|
|
|
|
|
|
||
|
Office and computer equipment
|
|
$
|
61,907
|
|
|
$
|
73,261
|
|
|
Computer software
|
|
|
43,896
|
|
|
|
43,896
|
|
|
Leasehold improvements
|
|
|
4,095
|
|
|
|
4,095
|
|
|
Total fixed assets
|
|
|
109,898
|
|
|
|
121,252
|
|
|
Less accumulated depreciation and amortization
|
|
|
(101,143
|
)
|
|
|
(77,155
|
)
|
|
Fixed assets, net
|
|
$
|
8,755
|
|
|
$
|
44,097
|
|
|
|
·
|
Level 1: Input prices quoted in an active market for identical financial assets or liabilities.
|
|
|
·
|
Level 2: Inputs other than prices quoted in Level 1, such as prices quoted for similar financial assets and liabilities in active markets, prices for identical assets and liabilities in markets that are not active or other inputs that are observable or can be corroborated by observable market data.
|
|
|
·
|
Level 3: Input prices that are significant to the fair value of the financial assets or liabilities which are not observable or supported by an active market.
|
|
December 31, 2010
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Warrants
|
|
$
|
-
|
|
|
$
|
288,250
|
|
|
$
|
-
|
|
|
$
|
288,250
|
|
|
December 31, 2009
|
||||||||||||||||
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Warrants
|
|
$
|
-
|
|
|
$
|
10,487,000
|
|
|
$
|
-
|
|
|
$
|
10,487,000
|
|
|
Offering
|
Outstanding
(as adjusted)
|
Exercise
Price
(as adjusted)
|
Expiration Date
|
||||||
|
|
|
|
|
|
|
|
|
||
|
2006 Issuance of Common Stock
|
|
|
5,136,191
|
|
|
$
|
1.53
|
|
March 7, 2011
|
|
Series B Preferred Stock – placement agents
|
|
|
825,000
|
|
|
$
|
1.25
|
|
May 2, 2012
|
|
Series C Exchange
|
|
|
1,250,000
|
|
|
$
|
1.25
|
|
May 2, 2012
|
|
Series E Preferred Stock
|
|
|
9,230,769
|
|
|
$
|
0.65
|
|
December 31, 2015
|
|
August 2009 Private Placement
|
|
|
4,772,730
|
|
|
$
|
0.66
|
|
December 31, 2015
|
|
July 2010 Direct Offering (1)
|
16,071,434
|
$
|
0.07
|
July 27, 2015
|
|||||
|
Preferred Incentive Warrants
|
16,071,434
|
$
|
0.105
|
July 27, 2015
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
53,357,558
|
|
|
|
|
|
|
|
Original private placement
|
Shares of
Common Stock
Issued
|
Warrants
Exercised
|
Exercise
Price
|
||||||||
|
|
|
|
|
|
|
||||||
|
2005 Bridge Financing
|
314,982
|
400,000
|
|
|
$
|
0.625
|
|
||||
|
2005 Issuance of Common Stock – placement agents
|
226,544
|
317,350
|
|
|
$
|
0.65
|
|
||||
|
2006 Issuance of Common Stock
|
366,492
|
991,516
|
|
|
$
|
1.72
|
|
||||
|
Series B Preferred Stock – purchasers
|
4,545,447
|
7,500,000
|
$
|
0.65
|
|||||||
|
Series B Preferred Stock – placement agents
|
35,106
|
75,000
|
|
|
$
|
1.25
|
|
||||
|
Series D Preferred Stock
|
2,645,685
|
4,365,381
|
$
|
0.65
|
|||||||
|
Series C Exchange
|
47,902
|
83,333
|
|
|
$
|
1.25
|
|
||||
|
|
|
|
|
|
|
||||||
|
Total
|
8,182,158
|
13,732,580
|
|
|
|
|
|
||||
|
Original private placement
|
Shares of
Common Stock
Issued
|
Warrants
Exercised
|
Exercise
Price
|
|||||||||
|
|
|
|
|
|
|
|
|
|
|
|||
|
2005 Bridge Financing
|
|
|
218,648
|
|
|
|
320,000
|
|
|
$
|
0.625
|
|
|
2005 Common Stock
|
|
|
200,504
|
|
|
|
485,317
|
|
|
$
|
0.65
|
|
|
Series A Preferred Stock
|
|
|
38,223
|
|
|
|
60,606
|
|
|
$
|
0.65
|
|
|
2006 Issuance of Common Stock
|
|
|
26,454
|
|
|
|
201,462
|
|
|
$
|
1.72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
483,829
|
|
|
|
1,067,385
|
|
|
|
|
|
|
December 31,
|
||||||||
|
|
|
2010
|
|
|
2009
|
|
||
|
|
|
|
|
|
|
|
||
|
2000 Stock Option Plan
|
|
|
44,621
|
|
|
|
56,047
|
|
|
2006 Stock Incentive Plan
|
|
|
5,870,000
|
|
|
|
6,710,000
|
|
|
Options issued outside of formalized plans
|
|
|
1,617,111
|
|
|
|
2,453,778
|
|
|
Warrants
|
|
|
53,357,558
|
|
|
|
35,521,106
|
|
|
Preferred stock
|
|
|
—
|
|
|
|
50,406,149
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shares reserved for future issuance
|
|
|
60,889,290
|
|
|
|
95,147,080
|
|
|
Year Ended
December 31,
|
||||||||
|
|
|
2010
|
|
|
2009
|
|
||
|
|
|
|
|
|
|
|
||
|
Employee and director stock option grants:
|
|
|
|
|
|
|
||
|
Research and development
|
|
$
|
230,101
|
|
|
$
|
148,030
|
|
|
General and administrative
|
|
|
356,220
|
|
|
|
289,036
|
|
|
|
|
|
586,321
|
|
|
|
437,066
|
|
|
Non-employee consultant stock option grants and restricted stock awards:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
(220,969
|
)
|
|
|
328,614
|
|
|
General and administrative
|
|
|
(28,054
|
)
|
|
|
98,657
|
|
|
|
|
|
(249,023
|
)
|
|
|
427,271
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation
|
|
$
|
337,298
|
|
|
$
|
864,337
|
|
|
Year Ended
December 31,
2009
|
||||
|
|
|
|
|
|
|
Volatility
|
|
|
90
|
%
|
|
Weighted-average volatility
|
|
|
90
|
%
|
|
Risk-free interest rate
|
|
|
2.12
|
%
|
|
Expected life (years)
|
|
|
5
|
|
|
Dividend
|
|
|
0
|
%
|
|
Weighted-average exercise price
|
|
$
|
0.75
|
|
|
Weighted-average grant-date fair value
|
|
$
|
0.53
|
|
|
Options
Outstanding
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contracted
Term in
Years
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at January 1, 2009
|
|
|
7,279,825
|
|
|
$
|
0.60
|
|
|
|
7.9
|
|
|
$
|
989,718
|
|
|
Options granted
|
|
|
1,940,000
|
|
|
$
|
0.75
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009
|
|
|
9,219,825
|
|
|
$
|
0.63
|
|
|
|
7.5
|
|
|
$
|
17,650,255
|
|
|
Options exercised
|
|
|
(916,667
|
)
|
|
$
|
0.17
|
|
|
|
|
|
|
$
|
663,600
|
|
|
Options canceled
|
|
|
(771,426
|
)
|
|
$
|
0.91
|
|
|
|
|
|
|
$
|
0
|
|
|
Outstanding at December 31, 2010
|
|
|
7,531,732
|
|
|
$
|
0.66
|
|
|
|
6.9
|
|
|
$
|
24,842
|
|
|
Exercisable at December 31, 2010
|
|
|
6,008,384
|
|
|
$
|
0.66
|
|
|
|
6.4
|
$
|
24,842
|
|
||
|
|
|
2010
|
|
|
2009
|
|
||
|
|
|
|
|
|
|
|
||
|
Net operating loss carryforwards
|
|
$
|
12,872,000
|
|
|
$
|
9,543,000
|
|
|
Research and development expenses
|
|
|
14,180,000
|
|
|
|
14,906,000
|
|
|
Tax credits
|
|
|
1,711,000
|
|
|
|
1,563,000
|
|
|
Capital loss carryforward
|
|
|
340,000
|
|
|
|
340,000
|
|
|
Stock-based compensation
|
|
|
365,000
|
|
|
|
650,000
|
|
|
Gross deferred tax asset
|
|
|
29,468,000
|
|
|
|
27,002,000
|
|
|
Valuation allowance
|
|
|
(29,468,000
|
)
|
|
|
(27,002,000
|
)
|
|
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Year Ended
December 31,
|
||||||||
|
|
|
2010
|
|
|
2009
|
|
||
|
Stock options
|
|
|
7,661,406
|
|
|
|
9,219,825
|
|
|
Warrants
|
|
|
54,609,672
|
|
|
|
35,521,106
|
|
|
Conversion of preferred stock
|
|
|
312,442,612
|
|
|
50,406,149
|
(1)
|
|
|
ITEM 7.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
|
ITEM 8A.
|
CONTROLS AND PROCEDURES
|
|
ITEM 8B.
|
OTHER INFORMATION
|
|
ITEM 9.
|
DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
|
|
Name
|
|
Age
|
|
Position
|
|
Stephen A. Hill, B.M. B.Ch., M.A., F.R.C.S.
|
|
52
|
|
Chairman of the Board
|
|
Harry S. Palmin
|
|
41
|
|
President, Chief Executive Officer and Director
|
|
Kimberly A. Hawkins
|
|
38
|
|
Vice President of Clinical Development
|
|
Christopher J. Pazoles, Ph.D.
|
|
61
|
|
Vice President of Research and Development
|
|
Joanne M. Protano
|
|
42
|
|
Vice President, Chief Financial Officer and Treasurer
|
|
Jamey P. Weichert, Ph.D.
|
54
|
Chief Scientific Officer and Director
|
||
|
Thomas Rockwell Mackie, Ph.D.
|
56
|
Director
|
||
|
James S. Manuso, Ph.D.
|
|
62
|
|
Director
|
|
John Neis
|
55
|
Director
|
||
|
John E. Niederhuber, M.D.
|
72
|
Director
|
||
|
Howard M. Schneider (1)
|
|
67
|
|
Director
|
|
Michael F. Tweedle, Ph.D.
|
59
|
Director
|
|
Name and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
(3)
|
Option
Awards ($)
(4)
|
All other
compensation
($)
|
Total ($)
|
||||||||||||||||
|
Harry S. Palmin (1)
|
2010
|
|
$
|
270,000
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
$
|
270,000
|
|
|
|
President, Chief Executive Officer
|
2009
|
|
$
|
270,000
|
|
|
$
|
40,500
|
|
|
$
|
131,650
|
|
|
$
|
0
|
|
|
$
|
442,150
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Christopher J. Pazoles (1)
|
2010
|
|
$
|
235,000
|
|
|
$
|
39,167
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
$
|
274,167
|
|
|
|
Vice President of Research and Development
|
2009
|
|
$
|
235,000
|
|
|
$
|
35,250
|
|
|
$
|
105,320
|
|
|
$
|
0
|
|
|
$
|
375,570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elias B. Nyberg (1) (2)
|
2010
|
|
$
|
225,000
|
|
|
$
|
37,500
|
|
|
$
|
0
|
|
|
$
|
0
|
|
|
$
|
262,500
|
|
|
|
Vice President of Regulatory, Quality and Compliance
|
2009
|
|
$
|
225,000
|
|
|
$
|
33,750
|
|
|
$
|
78,990
|
|
|
$
|
0
|
|
|
$
|
337,740
|
|
|
|
|
(1)
|
There has been no increase to executive base salaries for 2011.
|
|
|
(2)
|
On March 10, 2011, the Company terminated Dr. Nyberg’s employment, In connection with that termination, which was without cause, Dr. Nyberg received a payment of approximately $83,000 pursuant to the terms of the executive retention agreement between him and the Company dated May 14, 2010.
|
|
|
(3)
|
Bonus amounts for 2009 were paid in 2010. Bonus amounts for Dr. Pazoles and Dr. Nyberg in 2010 represent retention bonuses paid as of October 1, 2010 pursuant to their respective retention agreements dated May 14, 2010.
|
|
|
(4)
|
The fair value of each stock award was estimated on the grant date using the Black-Scholes option-pricing model. See Note 7 to the financial statements for a description of the assumptions used in estimating the fair value of stock options. There were no option grants during 2010.
|
|
Individual Grants
|
|||||||||||||||
|
Name
|
Year
of Grant
|
Number of
securities
underlying
unexercised
options
(#)
exercisable)
|
Number of
securities
underlying
unexercised
options
(#
unexercisable)
|
Exercise or
base price
($/share)
|
Expiration
date
|
||||||||||
|
Harry S. Palmin
|
2009(1)
|
83,333 | 166,667 | $ | 0.75 |
12/8/2019
|
|||||||||
|
|
2008(2)
|
266,667 | 133,333 | 0.43 |
12/15/2018
|
||||||||||
|
|
2007(2)
|
200,000 | — | 0.45 |
12/17/2017
|
||||||||||
|
|
2006(2)
|
150,000 | — | 0.91 |
12/11/2016
|
||||||||||
|
|
2005(3)
|
250,000 | — | 0.01 |
1/31/2015
|
||||||||||
|
|
2005(3)
|
150,000 | — | 0.01 |
3/31/2015
|
||||||||||
|
|
2004(4)
|
330,000 | — | 0.01 |
4/1/2014
|
||||||||||
|
|
2003(5)
|
7,130 | — | 0.70 |
8/1/2013
|
||||||||||
|
|
|
||||||||||||||
|
Christopher J. Pazoles
|
2009(1)
|
66,667 | 133,333 | $ | 0.75 |
12/8/2019
|
|||||||||
|
|
2008(2)
|
133,334 | 66,666 | 0.43 |
12/15/2018
|
||||||||||
|
|
2007(2)
|
125,000 | — | 0.45 |
12/17/2017
|
||||||||||
|
|
2006(2)
|
100,000 | — | 0.91 |
12/11/2016
|
||||||||||
|
|
2005(6)
|
100,000 | — | 0.01 |
4/8/2015
|
||||||||||
|
|
|
||||||||||||||
|
Elias B. Nyberg
|
2009(1)
|
50,000 | 100,000 | $ | 0.75 |
12/8/2019
|
|||||||||
|
|
2008(2)
|
66,667 | 33,333 | 0.43 |
12/15/2018
|
||||||||||
|
|
2008(8)
|
100,000 | — | 0.58 |
4/1/2018
|
||||||||||
|
(1)
|
These shares vest quarterly in increments of one-twelfth over three years from the date of grant. The exercise price equals the closing price on the date of grant.
|
|
(2)
|
These shares vest annually in increments of one-third over three years from the date of grant. The exercise price equals the closing price on the date of grant.
|
|
(3)
|
These shares initially vested over a two-year period. Pursuant to their terms, the shares fully vested upon the completion of a non-bridge loan financing, which occurred in the second quarter of 2005. The exercise price equals the fair market value of our common stock on the date of grant as determined by our board of directors.
|
|
(4)
|
These shares initially vested one-third upon grant and one-third annually over the following two years. Pursuant to their terms, one additional year of vesting occurred upon the completion of a non-bridge loan financing, which occurred in the second quarter of 2005. The exercise price equals the fair market value of our common stock on the date of grant as determined by our board of directors.
|
|
(5)
|
These shares vest annually in increments of one-third over three years from the date of grant. The exercise price equals the fair market value of our common stock on the date of grant as determined by our board of directors.
|
|
(6)
|
These shares vested in increments of one-fourth every six months over two years from the date of grant. The exercise price equals the fair market value of our common stock on the date of grant as determined by our board of directors.
|
|
(7)
|
These shares represent the fully vested portion of an option grant made to Mr. Pazoles in consideration of consulting services delivered during 2004. Pursuant to their terms, the shares vested at the completion of the consulting engagement and expire ten years from the date of grant.
|
|
(8)
|
These shares were fully vested upon grant. The exercise price equals the closing price on the date of grant.
|
|
Name and Principal Position
|
Year
|
Director
Fees
($) (3)
|
Option
Awards
($) (4)
|
All other
compensation
($)
|
Total ($)
|
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
Stephen A. Hill, Chairman (1)
|
2010
|
|
$
|
39,500
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
39,500
|
|
|
|
Michael J. Doyle, Director (1)(2)
|
2010
|
|
|
33,250
|
|
|
|
—
|
|
|
|
—
|
|
|
|
33,250
|
|
|
|
Sim Fass, Director (1)(2)
|
2010
|
|
|
32,500
|
|
|
|
—
|
|
|
|
—
|
|
|
|
32,500
|
|
|
|
James S. Manuso, Director (1)
|
2010
|
|
|
23,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
23,000
|
|
|
|
David B. McWilliams, Director (1)(2)
|
2010
|
|
|
24,500
|
|
|
|
—
|
|
|
|
—
|
|
|
|
24,500
|
|
|
|
Howard M. Schneider, Director (1)
|
2010
|
|
|
39,000
|
|
|
|
—
|
|
|
|
—
|
|
|
|
39,000
|
|
|
|
|
(1)
|
As of December 31, 2010, outstanding options to purchase common stock held by directors were as follows: Dr. Hill 350,000; Mr. Doyle 350,000; Dr. Fass 350,000; Dr. Manuso 300,000; Mr. McWilliams 402,778; Mr. Schneider 250,000.
|
|
|
(2)
|
In connection with the Acquisition, Mr. Doyle, Dr. Fass and Mr. McWilliams resigned from the board of directors.
|
|
|
(3)
|
Director fees include all fees earned for director services including quarterly fees, meeting fees and committee chairman fees.
|
|
|
(4)
|
There were no option grants during 2010.
|
|
ITEM 11.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
|
|
|
·
|
Each person known by us to be the beneficial owner of more than five percent of our common stock;
|
|
|
·
|
Each of our directors;
|
|
|
·
|
Each executive officer named in the summary compensation table; and
|
|
|
·
|
All of our current directors and executive officers as a group.
|
|
Shares Beneficially Owned
|
|||||||||||
|
Name and Address of Beneficial Owner
|
Outstanding
|
Right to Acquire
|
Total
|
Percentage
|
|||||||
|
|
|
|
|
|
|
|
|
|
|||
|
Venture Investors LLC (1) (2)
University Technology Park
505 S. Rosa Road; Suite 201
Madison, WI 53719
|
4,534,308
|
2,000,000
|
6,534,308
|
22.7
|
|||||||
|
Jamey P. Weichert (3)
c/o Cellectar Inc.
3301 Agriculture Drive
Madison, WI 53716
|
4,706,730
|
0
|
4,706,730
|
17.6
|
|||||||
|
MEG-II Cellectar, LLC (2) (4)
3001 West Beltline Highway, Suite 202
Madison, WI 53713
|
2,150,401
|
160,000
|
2,310,401
|
8.6
|
|||||||
|
Greenway Properties Inc. (2)
725 Heartland Trail, Suite 102
Madison, WI 53707
|
1,337,400
|
1,000,000
|
1,337,400
|
8.4
|
|||||||
|
Continuum Investment Limited Partnership (5)
P.O. Box 620557
Middleton, WI 53562
|
1,808,524
|
0
|
1,808,524
|
6.7
|
|||||||
|
Harry S. Palmin (6)
|
|
|
4,190
|
9,529
|
13,719
|
*
|
|||||
|
Christopher J. Pazoles
|
|
|
0
|
3,540
|
3,540
|
*
|
|||||
|
Stephen A. Hill
|
|
|
0
|
2,092
|
2,092
|
*
|
|||||
|
Thomas Rockwell Mackie
|
|
|
116,122
|
0
|
116,122
|
*
|
|||||
|
James S. Manuso
|
|
|
0
|
1,765
|
1,765
|
*
|
|||||
|
John Neis (1) (2)
|
4,534,308
|
2,000,000
|
6,534,308
|
22.7
|
|||||||
|
John E. Neiderhuber
|
|
|
0
|
0
|
0
|
*
|
|||||
|
Howard M. Schneider
|
|
|
654
|
1,438
|
2,092
|
*
|
|||||
|
Michael F. Tweedle
|
0
|
0
|
0
|
*
|
|||||||
|
All directors and officers as a group (12 persons)
|
|
|
9,362,004
|
2,022,506
|
11,384,509
|
39.5
|
|||||
|
(1)
|
Ownership consists of shares of common stock held by Venture Investors Early Stage Fund IV Limited Partnership and Advantage Capital Wisconsin Partners I, Limited Partnership. VIESF IV GP LLC is the general partner of Venture Investors Early Stage Fund IV Limited Partnership and Venture Investors LLC is the submanager and special limited partner of Advantage Capital Wisconsin Partners I, Limited Partnership. The investment decisions of VIESF IV GP LLC and Venture Investors LLC are made collectively by six managers, including Mr. Neis. Each such manager and Mr. Neis disclaim such beneficial ownership except to the extent of his pecuniary interest therein. The address of Mr. Neis is c/o Venture Investors LLC, 505 South Rosa Road, #201, Madison, Wisconsin 53719.
|
|
(2)
|
Shares in the “Right to Acquire” consist of warrants to purchase common stock at a price of $0.75, expiring on March 31, 2016.
|
|
(3)
|
Dr. Weichert serves as our Chief Scientific Officer following the Acquisition. The shares beneficially owned by him have been included in the total of directors and officers as a group.
|
|
(4)
|
Ownership consists of shares of common stock held by MEG-II Cellectar, LLC and approximately 184,000 shares owned by Bradley L. Hutter. Mr. Hutter is the managing director of Mortenson Equity Management LLC, which is the manager of MEG-II Cellectar, LLC.
|
|
(5)
|
Ownership includes shares of common stock held by Cellectar Investor I, LLC. Continuum Investment Limited Partnership is the manager of Cellectar Investor I, LLC.
|
|
(6)
|
Ownership of H. Palmin includes shares owned by his wife, Deanna Palmin.
|
|
Plan category
|
Number of shares to
be issued upon
exercise of outstanding
options, warrants and
rights (#)
|
Weighted-average
exercise price of
outstanding options,
warrants and rights
($)
|
Number of shares
remaining available for
future issuance under
equity compensation plans
(excluding shares reflected
in column (a)) (#)
|
|||||||||
|
|
|
(a)
|
|
|
(b)
|
|
|
(c)
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|||
|
Equity compensation plans approved by stockholders
|
|
|
5,914,621
|
|
|
$
|
0.66
|
|
|
|
3,910,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
Equity compensation plans not approved by stockholders
|
|
|
1,617,111
|
|
|
$
|
0.66
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
Total
|
|
|
7,531,732
|
|
|
$
|
0.66
|
|
|
|
3,890,000
|
|
|
2010
|
2009
|
|||||||
|
Audit
|
$ | 81,500 | $ | 81,500 | ||||
|
Audit Related
|
8,300 | 5,005 | ||||||
|
Tax
|
— | — | ||||||
|
All Other
|
— | — | ||||||
|
Total
|
$ | 89,800 | $ | 86,505 | ||||
|
Incorporated by Reference
|
||||||||||
|
Exhibit
No.
|
Description
|
Filed with
this
Form 10-K
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
2.1
|
|
Agreement and plan of merger among Common Horizons, Inc., Nove Acquisition, Inc. and Novelos Therapeutics, Inc. dated May 26, 2005
|
|
|
|
8-K
|
|
June 2, 2005
|
|
99.2
|
|
2.2
|
|
Agreement and plan of merger between Common Horizons and Novelos Therapeutics, Inc. dated June 7, 2005
|
|
|
|
10-QSB
|
|
August 15, 2005
|
|
2.2
|
|
2.3
|
Agreement and Plan of Merger by and among Novelos Therapeutics, Inc., Cell Acquisition Corp. and Cellectar, Inc. dated April 8, 2011
|
8-K
|
April 11, 2011
|
2.1
|
||||||
|
3.1
|
|
Second Amended and Restated Certificate of Incorporation
|
|
|
|
8-K
|
|
April 11, 2011
|
|
3.1
|
|
3.2
|
|
Amended and Restated By-laws
|
|
|
|
8-K
|
|
August 26, 2009
|
|
3.1
|
|
10.1
|
|
Employment Agreement with Harry S. Palmin dated January 31, 2006*
|
|
|
|
8-K
|
|
February 6, 2006
|
|
99.1
|
|
10.2
|
|
2000 Stock Option and Incentive Plan*
|
|
|
|
SB-2
|
|
November 16, 2005
|
|
10.2
|
|
10.3
|
|
Form of 2004 non-plan non-qualified stock option*
|
|
|
|
SB-2
|
|
November 16, 2005
|
|
10.3
|
|
10.4
|
|
Form of non-plan non-qualified stock option used
from February to May 2005*
|
|
|
|
SB-2
|
|
November 16, 2005
|
|
10.4
|
|
10.5
|
|
Form of non-plan non-qualified stock option used after May 2005*
|
|
|
|
SB-2
|
|
November 16, 2005
|
|
10.5
|
|
Incorporated by Reference
|
||||||||||
|
Exhibit
No.
|
Description
|
Filed with
this
Form 10-K
|
Form
|
Filing Date
|
Exhibit
No.
|
|||||
|
10.6
|
|
Form of securities purchase agreement dated May 2005
|
|
|
|
8-K
|
|
June 2, 2005
|
|
99.1
|
|
10.7
|
|
Form of subscription agreement dated September 30, 2005
|
|
|
|
8-K
|
|
October 3, 2005
|
|
99.1
|
|
10.8
|
|
Consideration and new technology agreement dated April 1, 2005 with ZAO BAM
|
|
|
|
10-QSB
|
|
August 15, 2005
|
|
10.2
|
|
10.9
|
|
Letter agreement dated March 31, 2005 with The Oxford Group, Ltd.
|
|
|
|
10-QSB
|
|
August 15, 2005
|
|
10.3
|
|
10.10
|
|
Form of securities purchase agreement dated March 2, 2006
|
|
|
|
8-K
|
|
March 3, 2006
|
|
99.2
|
|
10.11
|
|
Form of common stock purchase warrant dated March 2006
|
|
|
|
8-K
|
|
March 3, 2006
|
|
99.3
|
|
10.12
|
|
2006 Stock Incentive Plan, as amended*
|
|
|
S-1/A
|
|
December 7, 2009
|
|
10.16
|
|
|
10.13
|
|
Form of Incentive Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock Incentive Plan*
|
|
|
|
8-K
|
|
December 15, 2006
|
|
10.1
|
|
10.14
|
|
Form of Non-Statutory Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock Incentive Plan*
|
|
|
|
8-K
|
|
December 15, 2006
|
|
10.2
|
|
10.15
|
|
Form of Non-Statutory Director Stock Option under Novelos Therapeutics, Inc.’s 2006 Stock Incentive Plan*
|
|
|
|
8-K
|
|
December 15, 2006
|
|
10.3
|
|
10.16
|
|
Securities Purchase Agreement dated April 12, 2007
|
|
|
|
10-QSB
|
|
May 8, 2007
|
|
10.1
|
|
10.17
|
|
Letter Amendment dated May 2, 2007 to the Securities Purchase Agreement
|
|
|
|
10-QSB
|
|
May 8, 2007
|
|
10.2
|
|
10.18
|
|
Agreement to Exchange and Consent dated May 1, 2007
|
|
|
|
10-QSB
|
|
May 8, 2007
|
|
10.5
|
|
10.19
|
|
Form of Common Stock Purchase Warrant dated May 2, 2007 issued pursuant to the Agreement to Exchange and Consent dated May 2, 2007
|
|
|
|
10-QSB
|
|
May 8, 2007
|
|
4.2
|
|
10.20
|
|
Securities Purchase Agreement dated March 26, 2008
|
|
|
|
8-K
|
|
April 14, 2008
|
|
10.1
|
|
10.21
|
|
Amendment to Securities Purchase Agreement dated April 9, 2008
|
|
|
|
8-K
|
|
April 14, 2008
|
|
10.2
|
|
10.22
|
|
Securities Purchase Agreement dated August 14, 2008
|
|
|
|
8-K
|
|
August 18, 2008
|
|
10.1
|
|
10.23
|
|
Securities Purchase Agreement dated February 11, 2009
|
|
|
|
8-K
|
|
February 18, 2009
|
|
10.1
|
|
10.24
|
|
Registration Rights Agreement dated February 11, 2009
|
|
|
|
8-K
|
|
February 18, 2009
|
|
10.2
|
|
10.25
|
|
Series D Preferred Stock Consent and Agreement to Exchange dated February 10, 2009
|
|
|
|
8-K
|
|
February 18, 2009
|
|
10.3
|
|
10.26
|
|
Collaboration Agreement dated February 11, 2009**
|
|
|
|
10-K
|
|
March 30, 2009
|
|
10.39
|
|
10.27
|
|
Form of Warrant Exchange Agreement dated August 21, 2009
|
|
|
|
8-K
|
|
August 26, 2009
|
|
10.5
|
|
10.28
|
|
Securities Purchase Agreement dated August 25, 2009
|
|
|
|
S-1
|
|
September 15, 2009
|
|
10.41
|
|
10.29
|
|
Common Stock Purchase Warrant dated August 25, 2009
|
|
|
|
S-1
|
|
September 15, 2009
|
|
10.43
|
|
10.30
|
|
Letter Agreement with LP Clover Limited dated August 25, 2009
|
|
|
|
S-1
|
|
September 15, 2009
|
|
10.44
|
|
10.31
|
|
Letter Agreement with Mundipharma International Corporation Limited dated August 25, 2009
|
|
|
|
S-1
|
|
September 15, 2009
|
|
10.45
|
|
10.32
|
|
Consent and Amendment Agreement dated January 21, 2010
|
|
|
S-1/A
|
|
January 26, 2010
|
|
10.47
|
|
|
10.33
|
Form of Executive Retention Agreement dated May 14, 2010*
|
10-Q
|
May 17, 2010
|
10.3
|
||||||
|
10.34
|
Form of Placement Agent Agreement Between the Company and Rodman and Renshaw LLC
|
S-1A
|
June 25, 2010
|
10.50
|
||||||
|
10.35
|
Written Consent and Waiver of Holders of Series C Convertible Preferred Stock and Series E Convertible Preferred Stock dated July 6, 2010
|
S-1A
|
July 7, 2010
|
10.52
|
||||||
|
10.36
|
Form of Common Stock Purchase Warrant to be issued pursuant to the Consent and Waiver of Holders of Series C Convertible Preferred Stock and Series E Convertible Preferred Stock dated July 6, 2010
|
S-1A
|
July 7, 2010
|
10.53
|
||||||
|
10.37
|
Form of Securities Purchase Agreement dated July 21, 2010
|
8-K
|
July 22, 2010
|
10.1
|
||||||
|
10.38
|
Amendment to Consent and Waiver of Holders of Series C Convertible Preferred Stock and Series E Convertible Preferred Stock dated July 21, 2010
|
8-K
|
July 22, 2010
|
10.2
|
|
10.39
|
Exchange Agreement dated November 30, 2010 between the Company and the holders of Series C Convertible Preferred Stock and Series E Convertible Preferred Stock
|
8-K
|
November 30, 2010
|
10.1
|
||||||
|
10.40
|
Form of Common Stock Purchase Warrant dated April 8, 2011
|
8-K
|
April 11, 2011
|
4.3
|
||||||
|
10.41
|
Securities Purchase Agreement dated April 8, 2011
|
8-K
|
April 11, 2011
|
10.1
|
||||||
|
10.42
|
Placement Agency Agreement dated April 1, 2011
|
8-K
|
April 11, 2011
|
99.1
|
||||||
| 23.1 | Consent of Stowe & Degon LLC | X | ||||||||
|
31.1
|
Certification of chief executive officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||
|
31.2
|
Certification of chief financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||
|
32.1
|
Certification of chief executive officer and chief financial officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
|
NOVELOS THERAPEUTICS, INC.
|
||
|
By:
|
/s/ Harry S. Palmin
|
|
|
Harry S. Palmin
|
||
|
Title: President, Chief Executive Officer
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
/s/ Harry S. Palmin
|
|
|
Harry S. Palmin
|
||
|
Title: Chief Executive Officer and Director (Principal
Executive Officer)
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
/s/ Joanne M. Protano
|
|
|
Joanne M. Protano
|
||
|
Title: Chief Financial Officer (Principal Accounting Officer)
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
/s/ Stephen A. Hill
|
|
|
Stephen A. Hill
|
||
|
Title: Chairman of the Board of Directors
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
||
|
Thomas Rockwell Mackie
|
||
|
Title: Director
|
||
|
Date:
|
|
|
By:
|
/s/ James S. Manuso
|
|
|
James S. Manuso
|
||
|
Title: Director
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
/s/ John Neis
|
|
|
John Neis
|
||
|
Title: Director
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
||
|
John E. Neiderhuber
|
||
|
Title: Director
|
||
|
Date:
|
|
By:
|
/s/ Howard M. Schneider
|
|
|
Howard M. Schneider
|
||
|
Title: Director
|
||
|
Date:
|
April 14, 2011
|
|
By:
|
||
|
Michael F. Tweedle
|
||
|
Title: Director
|
||
|
Date:
|
|
By:
|
||
|
Jamey P. Weichert
|
||
|
Title: Chief Scientific Officer and Director
|
||
|
Date:
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|