0001144204-13-019005.txt : 20130401 0001144204-13-019005.hdr.sgml : 20130401 20130401142534 ACCESSION NUMBER: 0001144204-13-019005 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20121231 FILED AS OF DATE: 20130401 DATE AS OF CHANGE: 20130401 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Arno Therapeutics, Inc CENTRAL INDEX KEY: 0001195116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 522286452 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52153 FILM NUMBER: 13730437 BUSINESS ADDRESS: STREET 1: 200 ROUTE 31 NORTH STREET 2: SUITE 104 CITY: FLEMINGTON STATE: NJ ZIP: 08822 BUSINESS PHONE: (862) 703-7175 MAIL ADDRESS: STREET 1: 200 ROUTE 31 NORTH STREET 2: SUITE 104 CITY: FLEMINGTON STATE: NJ ZIP: 08822 FORMER COMPANY: FORMER CONFORMED NAME: LAURIER INTERNATIONAL INC DATE OF NAME CHANGE: 20021001 10-K 1 v337317_10k.htm FORM 10-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

  

FORM 10-K

 

 

  

xAnnual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

for the fiscal year ended December 31, 2012

 

or

 

¨Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the transition period from to

 

Commission File Number: 000-52153

 

 

 

ARNO THERAPEUTICS, INC.

(Exact Name Of Registrant As Specified In Its Charter)  

 

 

 

Delaware   52-2286452
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

 

200 Route 31 North, Suite 104, Flemington, New Jersey 08822

(Address of Principal Executive Offices) (Zip Code)

 

(862) 703-7170
(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, par value $0.0001 per share

 

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ¨ Yes þ No

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ¨ Yes þ No

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. þ Yes ¨ No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes þ  No ¨

 

Indicate by check mark if disclosure of delinquent filers in response to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. þ

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer Accelerated filer ¨ Accelerated filer ¨
Non-accelerated filer ¨ Smaller reporting company þ

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

¨ Yes þ No

 

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter.

 

As of June 30, 2012: $2,818,963

 

Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the last practicable date.

 

As of March 29, 2013, there were 36,364,942 shares of the issuer’s common stock, par value $0.0001 per share, issued and outstanding.

 

 
 

 

TABLE OF CONTENTS

 

    Page
Part I    
Item 1.   Business 4
Item 1A. Risk Factors 18
Item 1B. Unresolved Staff Comments 29
Item 2. Properties 29
Item 3. Legal Proceedings 29
Item 4. Mine Safety Disclosures 30
     
Part II   31
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 31
Item 6. Selected Financial Data 35
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 36
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 42
Item 8. Financial Statements and Supplementary Data 42
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 42
Item 9A. Controls and Procedures 42
Item 9B. Other Information 43
     
Part III   44
Item 10. Directors, Executive Officers and Corporate Governance 44
Item 11. Executive Compensation 47
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 51
Item 13. Certain Relationships and Related Transactions, and Director Independence 55
Item 14. Principal Accountant Fees and Services 55
     
Part IV   57
Item 15. Exhibits and Financial Statement Schedules 57
     
Signatures 60
Index to Financial Statements F-1

 

2
 

 

References to “the Company,” “we”, “us” or “our” in this Annual Report on Form 10-K refer to Arno Therapeutics, Inc., a Delaware corporation, unless the context indicates otherwise.

 

FORWARD-LOOKING STATEMENTS

 

This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. The forward-looking statements are only predictions and provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “will” or “should” or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements include all matters that are not historical facts and include, without limitation, statements concerning our business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, our research and development programs and planning for and timing of any clinical trials, the possibility, timing and outcome of submitting regulatory filings for our product candidates under development, research and development of particular drug products, the development of financial, clinical, manufacturing and marketing plans related to the potential approval and commercialization of our drug products, and the period of time for which our existing resources will enable us to fund our operations.

 

Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements.  Examples of the risks and uncertainties include, but are not limited to:

 

·the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten our ability to continue as a going concern;

 

·the risk that we may not successfully develop and market our product candidates, and even if we do, we may not become profitable;

 

·risks relating to the progress of our research and development;

 

·risks relating to significant, time-consuming and costly research and development efforts, including pre-clinical studies, clinical trials and testing, and the risk that clinical trials of our product candidates may be delayed, halted or fail;

 

·risks relating to the rigorous regulatory approval process required for any products that we may develop independently, with our development partners or in connection with any collaboration arrangements;

 

·the risk that changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval of our drug product candidates;

 

·risks that the FDA or other regulatory authorities may not accept any applications we file;

 

·risks that the FDA or other regulatory authorities may withhold or delay consideration of any applications that we file or limit such applications to particular indications or apply other label limitations;

 

·risks that, after acceptance and review of applications that we file, the FDA or other regulatory authorities will not approve the marketing and sale of our drug product candidates;

 

·risks relating to our drug manufacturing operations, including those of our third-party suppliers and contract manufacturers;

 

·risks relating to the ability of our development partners and third-party suppliers of materials, drug substance and related components to provide us with adequate supplies and expertise to support manufacture of drug product for initiation and completion of our clinical studies; and

 

·risks relating to the transfer of our manufacturing technology to third-party contract manufacturers.

 

Other risks that may affect forward-looking statements contained in this report are described below under the caption “Risk Factors” in Item 1A of this Annual Report. These risks, including those described above, could cause our actual results to differ materially from those described in the forward-looking statements. We undertake no obligation to publicly release any revisions to the forward-looking statements to reflect events or circumstances after the date of this document. The risks discussed in this Annual Report should be considered in evaluating our prospects and future performance.

 

3
 

 

PART I

 

ITEM 1. BUSINESS

 

Overview

 

We are a development stage company focused on developing innovative products for the treatment of cancer. The following table summarizes our product development pipeline:

 

Product

Candidate

  

 

Indications

  

Commercial

Rights

  

 

Ongoing Studies / Status

Onapristone   Breast and endometrial cancer   Arno   Manufacture of drug substance and drug product is currently underway. Pre-clinical toxicology studies are ongoing. IND (or equivalent) -enabling toxicology studies are expected to be completed during the second quarter of 2013.Work is ongoing on a companion diagnostic intended to enhance selection of patients most likely to benefit from treatment with onapristone.
             
AR-42   Hematological malignancies and solid tumors   Arno   An investigator-initiated Phase I/IIa clinical study of AR-42 is ongoing at The James Cancer Center at The Ohio State University in patients with advanced or recurrent hematological malignancies and solid tumors for which standard treatment has failed or not proven to be effective.
             
AR-12   Solid tumors and hematological malignancies   Arno   A multi-centered Phase I clinical trial of AR-12 is ongoing in patients with solid tumors and lymphoma who have progressed despite treatment with other therapies.

 

Corporate History; Merger Transactions

 

On June 2, 2008, we were acquired by Laurier International, Inc., a Delaware corporation, in a “reverse” merger whereby a wholly-owned subsidiary of Laurier merged with and into Arno Therapeutics, with Arno Therapeutics remaining as the surviving corporation and a wholly-owned subsidiary of Laurier. In accordance with the terms of this merger, stockholders of Arno Therapeutics exchanged all of their shares of common stock of Arno Therapeutics for shares of Laurier common stock at a rate of 1.99377 shares of Laurier common stock for each share of Arno Therapeutics common stock. As a result of the issuance of the shares of Laurier common stock to the former Arno Therapeutics stockholders, following the merger the former stockholders of Arno Therapeutics held 95 percent of the outstanding common stock of Laurier, assuming the issuance of all shares underlying outstanding options and warrants.  Upon completion of the merger, all of the former officers and directors of Laurier resigned and were replaced by the officers and directors of Arno Therapeutics. Additionally, following the merger Laurier changed its name to Arno Therapeutics, Inc.

 

Oncology Overview

 

According to the American Cancer Society, cancer is the second leading cause of death in the United States, surpassed only by heart disease, accounting for nearly one of every four deaths. According to the American Cancer Society, more than 1.6 million new cancer cases are expected to be diagnosed in 2013. According to a 2013 report by the American Cancer Society, the National Institutes of Health estimated direct costs for medical care for cancer related treatments in the United States in 2008 were $77.4 billion. With a 68% 5-year relative survival rate for all cancers from 2002-2008, according to the American Cancer Society, oncology remains a significant unmet medical need.

 

Pharmaceutical treatments are widely used to treat patients with cancer and are often used alongside surgery or radiation.  Different types of cancers respond in unique ways to different drugs, and some tumors may not respond at all to particular therapies.  In many cases, these treatments extend life by slowing the progression of the disease but become less effective over time as the cancer cells become resistant to a given therapy or a class of compounds with a particular mechanism of action.  For this reason, there is a need to develop new agents, particularly those with novel mechanisms that can be added to the current arsenal of treatment options.

 

4
 

 

Many types of drugs are presently used to treat cancer, including cytotoxics, targeted agents, hormones, and biologics.  According to a February 2012 report by Cowen & Co., the global cancer market was approximately $73.5 billion in 2011, of which cytotoxics accounted for $22.5 billion and targeted agents accounted for $33.2 billion.

 

Cytotoxics interfere with essential cellular processes in order to kill rapidly dividing cells, an effective approach for destroying cancer cells that remains prevalent despite the fact that these compounds can have significant side effects, particularly in rapidly dividing normal tissues such as those found in bone marrow and the gastrointestinal tract.  By contrast, targeted agents attack cellular processes that are more prevalent in cancer cells than in normal tissues, and thus aim to simultaneously reduce side effects and improve efficacy.

 

Although there are many agents available to treat cancer, a number of factors contribute to determining which particular agent is administered to a patient.  There is a considerable amount of overlap in the mechanisms of action of approved therapies, and in many cases, multiple drugs in a class are approved and in clinical use.  The choice of a particular agent or class of agents is generally based on the results of empirical clinical trials in specific cancer indications, and a desire to treat the disease aggressively is balanced with considerations for the patient’s tolerance of the treatment and quality of life.  These considerations highlight the need to develop therapies that not only improve anti-cancer efficacy but also improve patient convenience and reduce side effects.

 

Product Development Pipeline

 

Onapristone

 

Overview

 

Pursuant to a February 2012 license agreement with Invivis Pharmaceuticals, Inc., or Invivis, we have the exclusive rights worldwide to develop and (other than in France) commercialize onapristone, an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor, which is believed to be the mechanism by which it may inhibit the growth of breast, endometrial and other tumors. Onapristone was originally being developed by Schering AG for potential use as a contraceptive and an anti-endocrine treatment of breast cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone” treatment of breast cancer. In connection with the development of onapristone, we intend to develop a companion diagnostic to identify patients who express the activated form of the progesterone receptor and therefore may have an enhanced likelihood to benefit from treatment with onapristone. During 2012, we intend to conduct pre-clinical toxicology studies and manufacturing activities that will enable us to file an investigational new drug application (IND), with the U.S. Food and Drug Administration (FDA), or file an IND equivalent with another ex-US health authority in 2013.

 

The hormones estrogen and progesterone play important roles in normal female reproductive physiology and the development of certain tissues/organs including the breast and uterus. These two naturally occurring hormones are believed to play important roles in the development of certain female cancers (breast and endometrial) and the biologic effects of these two hormones make the estrogen and progesterone receptors important therapeutic targets. For example, chronic estrogen exposure unopposed by progesterone predisposes women to endometrial cancer, and the presence of estrogen or progesterone receptors in breast cancer tissues is predictive of response to anti-estrogen targeted therapies. Breast and endometrial cancers commonly express estrogen and progesterone receptors, but to date, it has not been determined whether these receptors are functional and play a role in tumor growth. We believe a better diagnostic test may aide in selecting patients who are most likely to benefit from “hormone” treatment, including onapristone.

 

Onapristone is a type 1 anti-progestin. Researchers believe its mechanism of action is thought to be a direct result of binding to the progesterone receptor and preventing the binding of the progesterone receptor to DNA, thereby substantially reducing or eliminating progesterone receptor induced gene transcription resulting in death or differentiation of the malignant cell.

 

Potential Advantages

 

In prior clinical studies, onapristone had a 56% objective response rate in patients with breast cancer as a first line endocrine treatment and a 49% clinical benefit rate in patients with breast cancer with tamoxifen resistant disease. Clinical studies of onapristone are intended to evaluate safety and efficacy which may provide women with breast and endometrial cancer an additional treatment option and allow a delay in the time for which patients may need chemotherapy treatment.

 

5
 

 

Development Plans and Activities

 

We recently completed a series of preclinical studies of onapristone. In these studies, 10 different breast cancer and endometrial cancer cell lines where characterized for hormone receptor status and the effect of various hormones and growth factors on proliferation and progesterone receptor status. When evaluating the effect of onapristone in the various culture conditions tested, cancer cell lines that expressed the activated form of the progesterone receptor, or APR, were found to respond to treatment with onapristone, but cell lines that did not express APR did not respond to onapristone treatment. We presented these findings in November 2012 at the 24th European Organization for Research and Treatment of Cancer symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland.

 

In addition, as stated above, a key aspect of our strategy to develop onapristone is to also develop a companion diagnostic that would identify patients who express APR and therefore would be more likely to respond to treatment with onapristone. We and our research collaborators recently identified a new immunohistochemistry technique for identifying activated progesterone receptors in breast cancer tumors, the findings of which we presented in December 2012 at the 35th Annual San Antonio Breast Cancer Symposium. This technique was successful in identifying the activated form of the progesterone receptor via nuclear morphology, which we believe can be done on a routine basis with freshly obtained or formalin-fixed and paraffin-embedded tissue. We are further refining and testing this method on a larger cohort of breast and endometrial cancer samples, with correlation to other standard tumor markers and clinical outcomes. We are also evaluating this technique in other malignancies.

 

We need to complete additional animal toxicology studies on onapristone before we will be in position to begin evaluating onapristone in human subjects. Following completion of the planned preclinical studies and our development of companion diagnostic, we intend to file an IND with the FDA or file an IND equivalent with another ex-US health authority, seeking to commence a dose escalation Phase I study of onapristone in patients with endometrial and breast cancers.

 

AR-42

 

Pursuant to a license agreement with The Ohio State University, or Ohio State, we also have exclusive rights to develop and commercialize AR-42, a novel oral cancer therapy currently in early clinical development.  AR-42 is a broad spectrum deacetylase inhibitor of both histone and non-histone proteins, which has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared in preclinical studies to vorinostat (also known as “SAHA” or Zolinza®), the first of only two marketed compound in the class.  AR-42 may possess additional histone-independent mechanisms, which may contribute to its superior profile in vitro and in vivo.  An investigator-initiated Phase I/IIa trial of AR-42 in patients with hematological malignancies and solid tumors is ongoing at Ohio State.

 

Background of HDAC Inhibitors

 

Histones are proteins that play an important role in the regulation of genes.  Histone modification is a key regulator of gene expression, and improper histone acetylation is among the modifications that are linked to expression of a cancerous phenotype.  These changes can lead to improper cell growth resulting from altering the expression of important genes involved in cell cycle progression, proliferation, and survival.  Histone deacetylases, or HDACs, are a class of enzymes that participate in this form of regulation and have been linked to both solid and hematologic malignancies and thus represent a target for cancer therapy.

 

HDAC inhibitors are an emerging class of drug compounds that have demonstrated efficacy primarily in hematological malignancies, also called blood cancers, but are currently being developed in solid tumors as well. It is believed that HDAC inhibitors induce histone hyperacetylation and can cause cell death.  The first drug in this class to gain approval is SAHA, which is approved to treat cutaneous T-cell lymphoma, or CTCL, in patients that have failed two previous therapies.  Another HDAC inhibitor, romidepsin (Istodax®, Celgene Corporation) is approved to treat CTCL and peripheral T-cell lymphoma.  These two compounds and other HDACs are currently in late stage development for both hematological malignancies as well as solid tumors. In preclinical studies, AR-42 has demonstrated activity against a broad spectrum of deacetylase targets and increased potency compared to SAHA.

 

Potential Advantages of AR-42

 

AR-42 is a broad spectrum inhibitor of histone and non-histone deacetylase targets that we believe may have advantages over currently approved HDAC inhibitors, including SAHA.  As a result, many of our preclinical data compare AR-42 to SAHA.  In preclinical models, AR-42 has shown to be more potent or effective than SAHA in various cancer types, including chronic lymphocyte leukemia, or CLL, B-cell lymphoma, prostate and ovarian cancers.  Further, preclinical studies suggest that AR-42 has anti-cancer activities that are independent of histone acetylation and include Akt dephosphorylation, Bcl-xL and survivin suppression, and Ku70 acetylation, all of which disrupt the growth and proliferation of cancer cells.  We believe that this combination of activity and potency could make AR-42 a more effective treatment for hematological malignancies than currently available HDAC inhibitors and a potential treatment of a number of solid tumors. In addition, pre-clinical models have demonstrated anti-tumor activity in tumor types (schwannoma and meningioma) that are associated with the genetic illness neurofibromatosis type 2 (NF2).

 

6
 

 

In addition to its broad activity against hematological malignancies, pre-clinical data presented at the 2009 American Society of Hematology Annual Meeting showed that AR-42 potently and selectively inhibits leukemic stem cells in acute myeloid leukemia.

 

Clinical Development

 

We are collaborating with Ohio State, which is conducting an investigator-initiated Phase I/IIa study of AR-42 in patients with advanced or recurrent hematological malignancies for which no treatment is available.  The primary goal is to evaluate the safety and tolerability of AR-42 given orally three times per week.  Secondary endpoints include characterizing AR-42’s pharmacokinetics and its pharmacodynamic profile through the measurement of biomarkers and evaluation of clinical response. The recommended dose for further study in patients with hematological malignancies has been declared and we expect to identify the recommended dose for further study for patients with solid tumors by the second quarter of 2013.

 

The ongoing study is designed so that additional patients with hematological malignancies can be added to investigate the efficacy of AR-42 in a particular disease and help guide future Phase II programs once the recommended dose for further study has been defined.  Up to an additional 10 patients may be enrolled at the recommended phase 2 dose in each of the following disease cohorts: CLL/small lymphocytic lymphoma, multiple myeloma, and lymphoma.  We expect this expansion phase will take at least 12 months to complete.

 

In addition, in February 2012, the FDA granted orphan drug designation for AR-42 for the treatment of meningioma and schwannoma of the central nervous system. Meningioma and schwannoma are rare, benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity for those affected individuals. The primary treatment option for patients with these tumors is surgical excision. In preclinical studies, AR-42 has demonstrated anti-tumor activity in both meningioma and schwannoma. We believe AR-42 may provide a complement to surgery, particularly in cases where the location of the tumor within the brain or spinal cord precludes surgery. During 2012, we intend to collaborate with Ohio State to conduct a Phase 0 investigator-initiated study of AR-42 in patients with schwannoma and meningioma. The primary purpose of this study will be to assess intra-tumoral concentrations of AR-42, identify apoptosis markers and assess gene regulation.

 

AR-12

 

Overview

 

Pursuant to a license agreement with Ohio State, we have exclusive rights to develop and commercialize AR-12, a potentially first-in-class, orally available cancer treatment that is currently enrolling patients in a Phase I clinical study. AR-12 has been shown in pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1, that targets the Akt pathway, while also possessing activity in the endoplasmic reticulum stress pathway and other pathways targeting apoptosis. In pre-clinical studies, AR-12 has demonstrated activity in a wide range of tumor types and synergistic effects with several widely used anti-cancer agents, enhancing activity or overcoming drug-resistance when used in combination with Avastin® (Genentech), Herceptin® (Genentech), Gleevec® (Novartis), Tarceva® (Genentech) and tamoxifen. We are currently enrolling patients with advanced or recurrent solid tumors or lymphoma in a Phase I clinical study of AR-12.

 

Mechanism of Action

 

AR-12 has been shown in pre-clinical studies to inhibit a protein known as PDK-1, a novel target in an important cell growth and proliferation pathway, which has been validated by the approval of therapeutics that target proteins both upstream and downstream of PDK-1. Receptor tyrosine kinases, or RTK, are cell-surface receptors that are involved in cell growth and are upstream of PDK-1. Members of the RTK class are targeted by some of the most successful and widely used targeted oncology agents, including Avastin® (Genentech), Herceptin® (Genentech), Gleevec® (Novartis), Tarceva® (Genentech), Iressa® (AstraZeneca), Nexavar® (Bayer/Onyx) and tamoxifen. Downstream of PDK-1 is the mammalian target of rapamycin, or mTOR protein. The mTOR inhibitors temsirolimus (Torisel®, Wyeth) and everolimus (Afinitor®, Novartis) are FDA approved for the treatment of renal cancer, and additional studies are being conducted with mTOR inhibitors in various clinical trials as anti-cancer agents.

 

Although FDA-approved drugs that target the Akt pathway have shown efficacy in treating cancer, some tumors either do not respond to these drugs or eventually become resistant to therapy.  Scientists hypothesize that a combination of drugs that inhibit different targets in this pathway could provide synergistic or additive benefits to increase efficacy and potentially overcome drug resistance.  For this reason, there has been particular interest within the biopharmaceutical industry in developing inhibitors of PI3K, PDK-1, and Akt.

 

7
 

 

PDK-1 can transform normal human cells and may be involved in the invasion and metastasis process.  PDK-1 and its downstream target, the protein Akt, are frequently activated in multiple cancer types, and inhibiting PDK-1 facilitates the dephosphorylation and subsequent inactivation of Akt.  Activation of the PDK-1/Akt pathway confers resistance to cell death signaling and the apoptotic activity of other cytotoxic agents.  Additionally, recent research has demonstrated the importance of PDK-1 in oncology that is independent of its Akt modulation.  The inhibition of the PDK-1/Akt pathway in cancer cells where this pathway was previously active has been shown to decrease cell proliferation and increase programmed cell death, which is known as apoptosis.  Preclinical data suggests that AR-12 inhibits PDK-1 and data collected from preclinical toxicology studies and tumor distribution studies indicate that AR-12 would be expected to exceed therapeutic concentrations in vivo.

 

AR-12 has also demonstrated an ability to induce the endoplasmic reticulum (ER) stress mediated apoptosis pathway, which contribute to its unique profile in vitro and in vivo.  The ER stress pathway is a cellular mechanism that can either induce cellular protection or apoptosis.  AR-12, through the induction of PKR-like Endoplasmic Reticulum Kinase, or PERK, seems to selectively induce the pro-apoptotic response and appears to have a preferential effect on cancer cells.

 

Potential Advantages of AR-12

 

We believe AR-12’s unique mechanisms and ability to improve the efficacy of other approved agents may enable it to become a first-in-class agent with broad applications in oncology and significant sales in the market.  In preclinical studies, AR-12 has shown efficacy in a wide range of tumor types, including breast, lung, prostate, pancreatic, brain, and hematological cancers, as both a single-agent as well as in combination with leading oncology therapeutics.  AR-12 demonstrated synergy or additive benefit or overcame drug-resistance when used in combination with Avastin®, Herceptin®, Gleevec®, Tarceva®, Iressa®, Nexavar® and tamoxifen, all of which are widely-prescribed, FDA-approved oncology therapeutics that, according to Thomson Reuters Pharma, represented approximately $17 billion in sales in 2009.

 

We believe AR-12 is a potentially first-in-class molecule in human clinical development.  We also believe that PDK-1 may prove to be highly desirable target for oncology; therapeutic strategies to modulate the Akt pathway are of great scientific, clinical, and financial interest, and there are a few molecules in development that seek to target Akt through the inhibition of a protein known as PI3K.  PDK-1 is downstream of PI3K and thus may be more likely to impact the desired molecular targets further downstream and less likely to result in off-target toxicity.  Inhibition of PDK-1 also seems to be able to regulate other important oncology targets that are not be mediated by PI3K.  In addition to targeting PDK-1, we believe that AR-12 also has the ability to induce ER stress and has the potential to become an important agent in a range of cancer indications.

 

Clinical Development

 

We completed study subject enrollment in a multi-site Phase I clinical trial of AR-12 in patients with solid tumors or lymphomas who have progressed despite treatment with other therapies.  Subjects in this Phase I study receive an oral daily dose of AR-12.  The Phase I study is being conducted at three clinical sites, including The Ohio State University (Columbus, Ohio), Scottsdale Healthcare (Phoenix, Arizona), and The Royal Marsden Hospital (London, UK).

 

The Phase I study of AR-12 was originally designed to be conducted in two parts.  The first part is a dose-escalating study, which we refer to as the Escalation Phase, that is primarily designed to evaluate the safety of AR-12 and to identify the maximum tolerated dose, or MTD, or a recommended Phase II dose, or RP2D, for future clinical studies of AR-12.  The study is also designed to utilize biomarkers and functional imaging to examine the pharmacodynamic effects of AR-12 in modulating certain targets within the PI3K pathway.  Secondary objectives for the Escalation Phase include characterizing the pharmacokinetics of AR-12 (i.e., how AR-12 is absorbed and eliminated in and from the body) and measuring tumor response.  We have determined the RP2D and MTD of the current AR-12 formulation.  Following the Escalation Phase, we planned to initiate the second part of the study, which we refer to as the Expansion Phase, which would have involved enrolling an expanded cohort of additional patients at the RP2D in multiple tumor types.  We will not be moving forward with the Expansion Phase of this study as we plan to conduct further clinical development of AR-12 with an improved formulation, which has been shown to substantially increase the bioavailability in preclinical models.

 

The biomarker selection and evaluation is being led by Johann de Bono, M.D., Ph.D. of The Royal Marsden Hospital in London.  Dr. de Bono is a prominent researcher in oncology drug development and has been involved in the successful development of novel targeted therapies.

 

We believe that the data generated from the current Phase I study will provide important information to direct future studies, in terms of safety, pharmacokinetics and potential efficacy.  We also believe that the biomarkers and pharmacodynamic assays planned for the Phase I study may provide deeper understanding of the molecular actions of AR-12 and validate the preclinical hypothesis about AR-12’s activity in a clinical setting.  The information generated in these studies will also help to guide the potential future development of AR-12.

 

8
 

 

Competition

 

We compete primarily in the cancer therapeutic segment of the biopharmaceutical market that addresses cancer therapeutics, which is highly competitive. We face significant competition from many pharmaceutical, biopharmaceutical and biotechnology companies that are researching and selling products designed to address the cancer market. Many of our competitors have significantly greater financial, manufacturing, marketing and drug development resources than we do. Large pharmaceutical companies in particular have extensive experience in clinical testing and in obtaining regulatory approvals for drugs. These companies also have significantly greater research capabilities than we do. In addition, many universities and private and public research institutes are active in cancer research. We also compete with commercial biotechnology companies for the rights to product candidates developed by public and private research institutes. Smaller or early-stage companies are also significant competitors, particularly those with collaborative arrangements with large and established companies. In addition to the factors described below under the caption “Risk Factors” in Item 1A of this Annual Report, our ability to compete in the cancer therapeutics market depends on the following factors:

 

·our ability to develop novel compounds with attractive pharmaceutical properties and to secure and protect intellectual property rights based on our innovations;
·the efficacy, safety and reliability of our drug candidates;
·the speed at which we develop our drug candidates;
·our ability to design and successfully complete appropriate clinical trials;
·our ability to maintain a good relationship with regulatory authorities;
·the timing and scope of regulatory approvals;
·our ability to manufacture and sell commercial quantities of future products to the market; and
·acceptance of future products by physicians and other healthcare providers.

 

Onapristone

 

If approved, onapristone would compete with other classes of oncology drugs referred to as “hormonal” agents (antiestrogens, aromatase inhibitors, megestrol acetate) used in the treatment of breast and endometrial cancers. Antiestrogens, aromatase inhibitors, and megestrol acetate have been used for a number of decades and the medical community is aware and accepting of their safety and efficacy profile. Many of these agents are off patent and thus available at a low cost. In addition, combination chemotherapy is routinely used after patients with breast and endometrial cancer have failed standard hormonal treatments, and thus onapristone may be positioned as an agent which delays the need for chemotherapy.

 

Although onapristone has a known risk for elevated liver function tests, we believe that onapristone’s historical therapeutic profile will allow it to compete successfully in the crowded space of breast cancer treatments and, potentially, as an effective treatment for women with endometrial carcinoma.

 

 AR-42

 

If approved, AR-42 would compete with other HDAC inhibitors. HDAC inhibitors have displayed efficacy in a broad range of settings as single agents and in combination with other therapeutics.  The first HDAC inhibitor to obtain approval is vorinostat (“SAHA,” or Zolinza®), which is approved for the treatment of recurrent cutaneous T-cell lymphoma (“CTCL”).  Additionally, in November 2009 Gloucester Pharmaceuticals received FDA approval for its novel HDAC inhibitor, romidepsin, to treat CTCL before being acquired by Celgene Corp. in December 2009.  Subsequently, romidepsin (Istodax®, Celgene Corporation) has been approved for the treatment of patients with peripheral T-cell lymphoma. Other HDAC inhibitors are in Phase II and Phase III trials, primarily in hematological malignancies, but also in solid tumors as both single agents and in combination with other oncology therapies.

 

  We believe that AR-42 has a therapeutic profile that will allow it to compete successfully in the crowded class of what are broadly known as HDAC inhibitors.  AR-42 is a pan-DAC inhibitor that has demonstrated preclinical activity that compares favorably with SAHA, as well as potentially differentiating activity and the ability to target cancer stem cells.  Additionally, based on AR-42’s preclinical toxicology package and dosing schedule, we believe that there is a relatively low risk of cardiac toxicity or fatigue.  We also believe that AR-42’s potential to selectively target leukemic stem cells in AML may sufficiently differentiate AR-42 from other agents in the class to become an important member of the emerging class of deacetylase inhibitors.

 

AR-12

 

AR-12 is believed to target PDK-1, which is in the PI3K/Akt pathway. Targeting the PI3K/Akt pathway has been of great interest to the pharmaceutical industry, particularly compounds that target PI3K.  The approaches for targeting PI3K are general inhibition or the specific inhibition of the alpha, beta, gamma, or delta subunit of this kinase.  Some of these molecules also combine PI3K inhibition with activity against the mammalian target of rapamycin (“mTOR”), a target that is believed to also play a role in the PI3K/Akt pathway.  Other approaches to this pathway include targeting Akt directly.  Additionally, companies such as Wyeth, Vernalis, GlaxoSmithKline, and Novartis have published data on their preclinical discovery programs to target PDK-1.

 

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Compounds that inhibit PI3K have been the foundation of several recent licensing, acquisition, and financing activities.  Despite the great deal of activity in the space, we believe that AR-12 can differentiate itself and become an important agent in the treatment of cancer.  In multiple preclinical studies, AR-12 has demonstrated the ability to inhibit PDK-1 as well as induce ER stress, a combination that could provide a unique therapeutic profile and differentiate AR-12 from other molecules being developed to inhibit the PI3K/Akt pathway.

 

License Agreements and Intellectual Property

 

General

 

Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our current product candidates and any future product candidates, proprietary information and proprietary technology through a combination of contractual arrangements and patents, both in the U.S. and abroad. However, even patent protection may not always afford us with complete protection against competitors who seek to circumvent our patents. If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. See “Risk Factors – Risks Related to Our Intellectual Property.”

 

We will continue to depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our advisors, consultants and other contractors, none of which is patentable. To help protect our proprietary know-how, which is not patentable, and for inventions for which patents may be difficult to enforce, we currently rely and will in the future rely on trade secret protection and confidentiality agreements to protect our interests. To this end, we require all of our employees, consultants, advisors and other contractors to enter into confidentiality agreements that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

 

Onapristone License Agreement

 

Our rights to onapristone are governed by a license agreement with Invivis dated February 13, 2012. Under this agreement, we hold an exclusive, royalty-bearing license for the rights to commercialize onapristone for all therapeutic uses. The license agreement provides us with worldwide rights to onapristone with the exception of France, although under the license agreement we have an option to acquire French commercial rights from Invivis by providing notice to Invivis and making a cash payment.

 

The onapristone license agreement provides us with exclusive, worldwide rights to a U.S. provisional patent application that relates to assays for predictive biomarkers for anti-progestin efficacy. We intend to expand our patent portfolio by filing additional patent applications covering the use and manufacture of onapristone and/or a companion diagnostic product. If the pending patent application issues, the issued patent would be scheduled to expire in 2031.

 

We made a one-time cash payment of $500,000 to Invivis upon execution of the license agreement on February 13, 2012. Additionally, Invivis will receive performance-based cash payments of up to an aggregate of $15.1 million upon successful completion of clinical and regulatory milestones relating to onapristone, which milestones include the marketing approval of onapristone in multiple indications in the United States or the European Union as well as Japan. We will make the first milestone payment to Invivis upon the dosing of the first subject in the first Company-sponsored Phase I clinical trial of onapristone, which is anticipated to occur in the second half of 2013. In addition, we will pay Invivis low single digit sales royalties based on net sales of onapristone by us or any of our sublicensees. Pursuant to a separate services agreement, Invivis will provide us with certain clinical development support services, which includes the assignment of up to two full-time employees to perform such services, in exchange for a monthly cash payment.

 

Under the license agreement with Invivis, we also agreed to indemnify and hold Invivis and its affiliates harmless from any and all claims arising out of or in connection with the production, manufacture, sale, use, lease, consumption or advertisement of onapristone, provided, however, that we shall have no obligation to indemnify Invivis for claims that (a) any patent rights infringe third party intellectual property, (b) arise out of the gross negligence or willful misconduct of Invivis, or (c) result from a breach of any representation, warranty confidentiality obligation of Invivis under the license agreement. The license agreement will terminate upon the later of (i) the last to expire valid claim contained in the patent rights, and (ii) February 13, 2032. In general, Invivis may terminate the license agreement at any time upon a material breach by us to the extent we fail to cure any such breach within 90 days after receiving notice of such breach or in the event we file for bankruptcy. We may terminate the agreement for any reason upon 90 days’ prior written notice.

 

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AR-12 and AR-42 License Agreements

 

Our rights to AR-12 and AR-42 are governed by separate license agreements with The Ohio State University Research Foundation, or Ohio State, entered into in January 2008. Pursuant to each of these agreements, we have exclusive, worldwide, royalty-bearing licenses for the rights to commercialize technologies embodied by certain issued patents, patent applications, know-how and improvements relating to AR-12 and AR-42 for all therapeutic uses.

 

Under our license agreement for AR-12, we have exclusive, worldwide rights to one issued U.S. patent and four pending U.S. patent applications that relate to AR-12 and particular uses of AR-12 according to our business plan. The issued patent includes composition of matter claims. The issued patent is currently scheduled to expire in 2024. If the pending patent applications issue, the latest of the issued patent or patents would be scheduled to expire in 2028.

 

Under our license agreement for AR-42, we have exclusive, worldwide rights to two pending U.S. patent applications that relate to AR-42 and particular uses of AR-42 according to our business plan. If either or both of the pending patent applications issue, the issued patent or patents would both be scheduled to expire in 2024. In addition, in 2010, we filed one U.S. provisional patent application directed primarily to particular methods of using AR-42. If any U.S. patent claiming priority to the provisional patent applications issues, such a patent would be scheduled to expire in 2031.

 

In 2008, pursuant to our license agreements for AR-12 and AR-42, we made one-time cash payments to Ohio State in the aggregate amount of $450,000 and reimbursed it for past patent expenses. Additionally, we are required to make performance-based cash payments upon successful completion of clinical and regulatory milestones relating to AR-12 and AR-42 in the U.S., Europe and Japan. The license agreements for AR-12 and AR-42 provide for aggregate potential milestone payments of up to $6.1 million for AR-12, of which $5.0 million is due only after marketing approval in the United States, Europe and Japan, and $5.1 million for AR-42, of which $4.0 million is due only after marketing approval in the United States, Europe and Japan.  In September 2009, we paid Ohio State a milestone payment upon the commencement of the Phase I clinical study of AR-12.  The first milestone payment for AR-42 will be due when the first patient is dosed in the first Company-sponsored Phase I clinical trial, which is not expected to occur in 2013. Pursuant to the license agreements for AR-12 and AR-42, we must pay Ohio State royalties on net sales of licensed products at rates in the low-single digits. To the extent we enter into a sublicensing agreement relating to either or both of AR-12 or AR-42, we will be required to pay Ohio State a portion of all non-royalty income received from such sublicensee.

 

The license agreements with Ohio State further provide that we will indemnify Ohio State from any and all claims arising out of the death of or injury to any person or persons or out of any damage to property, or resulting from the production, manufacture, sale, use, lease, consumption or advertisement of either AR-12 or AR-42, except to the extent that any such claim arises out of the gross negligence or willful misconduct of Ohio State. The license agreements for AR-12 and AR-42, respectively, expire on the later of (i) the expiration of the last valid claim contained in any licensed patent and (ii) 20 years after the effective date of the license. Ohio State will generally be able to terminate either license upon our breach of the terms of the license the extent we fail to cure any such breach within 90 days after receiving notice of such breach or our bankruptcy. We may terminate either license upon 90 days’ prior written notice.

 

AR-67 License Agreement

 

We formerly held exclusive rights to develop and commercialize an oncology therapeutic drug candidate known as AR-67 pursuant to an October 2006 license agreement with the University of Pittsburgh (“Pitt”). Under this agreement, Pitt granted us an exclusive, worldwide, royalty-bearing license for the rights to commercialize technologies embodied by certain issued patents, patent applications and know-how relating to AR-67 for all therapeutic uses. In the first quarter of 2012, we determined to cease development of AR-67 and agreed with Pitt to terminate the license agreement.  As a result, we no longer have rights in AR-67; however, we retain ownership of all data accumulated during our development of AR-67.

 

On January 12, 2012, we received a notice from Pitt, indicating that we were in default under the license agreement for failure to pay a $250,000 annual license fee under the terms of that agreement and providing us with 60 days’ notice to remedy the default. On March 29, 2012, following our determination not to proceed with further development of AR-67, we agreed with Pitt to terminate the license agreement. As of December 31, 2012, we had accrued for the outstanding annual license fee of $250,000. On March 28, 2013, we and Pitt agreed to a settlement of Pitt’s outstanding claim against us for the $250,000 annual license fee in exchange for our payment of $235,000 in full satisfaction of all remaining obligations under the license agreement. See “Item 3. Legal Proceedings.”

 

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Government Regulation and Product Approval 

 

The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the testing (pre-clinical and clinical), manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution, among other things, of drugs and drug product candidates. If we do not comply with applicable requirements, we may be fined, the regulatory agencies may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted. We and our manufacturers may also be subject to regulations under other United States federal, state, and local laws.

 

United States Government Regulation 

 

In the United States, the FDA regulates drugs under the Food, Drug and Cosmetic Act, or FDCA, and implementing regulations. The process required by the FDA before our drug candidates may be marketed in the United States generally involves the following (although the FDA is given wide discretion to impose different or more stringent requirements on a case-by-case basis):

 

·completion of extensive pre-clinical laboratory tests, pre-clinical animal studies and formulation studies, all performed in accordance with the FDA’s good laboratory practice regulations and other regulations;
·submission to the FDA of an IND application, which must become effective before clinical trials may begin;
·performance of multiple adequate and well-controlled clinical trials meeting FDA requirements to establish the safety and efficacy of the product candidate for each proposed indication;
·submission of a new drug application, or NDA, to the FDA;
·satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities at which the product candidate is produced, and potentially other involved facilities as well, to assess compliance with current good manufacturing practice, or cGMP, regulations and other applicable regulations; and
·FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

 

The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our drug candidates will be granted on a timely basis, if at all. Risks to us related to these regulations are described above under the caption entitled “Risk Factors – Risks Relating to the Clinical Testing, Regulatory Approval, Manufacturing and Commercialization of Our Product Candidates.”

 

Pre-clinical tests may include laboratory evaluation of product chemistry, formulation and stability, as well as studies to evaluate toxicity and other effects in animals. The results of pre-clinical tests, together with manufacturing information and analytical data, among other information, are submitted to the FDA as part of an IND application. Subject to certain exceptions, an IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, issues a clinical hold to delay a proposed clinical investigation due to concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. Our submission of an IND, or those of our collaboration partners, may not result in the FDA authorization to commence a clinical trial. A separate submission to an existing IND must also be made for each successive clinical trial conducted during product development. The FDA must also approve changes to an existing IND. Further, an independent institutional review board, or IRB, for each medical center proposing to conduct the clinical trial must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice requirements and regulations for informed consent.

 

Clinical Trials 

 

For purposes of NDA submission and approval, clinical trials are typically conducted in the following three sequential phases, which may overlap (although additional or different trials may be required by the FDA as well):

 

·Phase I clinical trials are initially conducted in a limited population to test the drug candidate for safety, dose tolerance, absorption, metabolism, distribution and excretion in healthy humans or, on occasion, in patients, such as cancer patients. In some cases, particularly in cancer trials, a sponsor may decide to conduct what is referred to as a “Phase Ib” evaluation, which is a second safety-focused Phase I clinical trial typically designed to evaluate the impact of the drug candidate in combination with currently FDA-approved drugs or in a particular patient population.

 

·Phase II clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the efficacy of the drug candidate for specific targeted indications and to determine dose tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more expensive Phase III clinical trials. In some cases, a sponsor may decide to conduct what is referred to as a “Phase IIb” evaluation, which is a second, confirmatory Phase II clinical trial that could, if accepted by the FDA, serve as a pivotal clinical trial in the approval of a drug candidate.

 

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·Phase III clinical trials are commonly referred to as pivotal trials. When Phase II clinical trials demonstrate that a dose range of the drug candidate is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

 

In some cases, the FDA may condition continued approval of an NDA on the sponsor’s agreement to conduct additional clinical trials with due diligence. In other cases, the sponsor and the FDA may agree that additional safety and/or efficacy data should be provided; however, continued approval of the NDA may not always depend on timely submission of such information. Such post-approval studies are typically referred to as Phase IV studies.

 

New Drug Application 

 

The results of drug candidate development, pre-clinical testing and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, and the payment of a user fee, are submitted to the FDA as part of an NDA. The FDA reviews all NDAs submitted before it accepts them for filing and may request additional information rather than accepting an NDA for filing. Once an NDA is accepted for filing, the FDA begins an in-depth review of the application.

 

During its review of an NDA, the FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA may refuse to approve an NDA and issue a “not approvable” letter if the applicable regulatory criteria are not satisfied, or it may require additional clinical or other data, including one or more additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we or our collaboration partners interpret data. If the FDA’s evaluations of the NDA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue either an approval letter or an approvable letter, which contains the conditions that must be met in order to secure final approval of the NDA. If and when those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter, authorizing commercial marketing of the drug for certain indications. The FDA may withdraw drug approval if ongoing regulatory requirements are not met or if safety problems occur after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a drug based on the results of these post-marketing programs. Drugs may be marketed only for the FDA-approved indications and in accordance with the FDA-approved label. Further, if there are any modifications to the drug, including changes in indications, other labeling changes, or manufacturing processes or facilities, we may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require us to develop additional data or conduct additional pre-clinical studies and clinical trials.

 

The Hatch-Waxman Act

 

Under the Hatch-Waxman Act, newly-approved drugs and new conditions of use may benefit from a statutory period of non-patent marketing exclusivity. The Hatch-Waxman Act provides five-year marketing exclusivity to the first applicant to gain approval of an NDA for a new chemical entity, meaning that the FDA has not previously approved any other new drug containing the same active entity. The Hatch-Waxman Act prohibits the submission of an abbreviated NDA, or ANDA, or a Section 505(b)(2) NDA for another version of such drug during the five-year exclusive period; however, submission of a Section 505(b)(2) NDA or an ANDA for a generic version of a previously-approved drug containing a paragraph IV certification is permitted after four years, which may trigger a 30-month stay of approval of the ANDA or Section 505(b)(2) NDA. Protection under the Hatch-Waxman Act does not prevent the submission or approval of another “full” 505(b)(1) NDA; however, the applicant would be required to conduct its own pre-clinical and adequate and well-controlled clinical trials to demonstrate safety and effectiveness. The Hatch-Waxman Act also provides three years of marketing exclusivity for the approval of new and supplemental NDAs, including Section 505(b)(2) NDAs, for, among other things, new indications, dosages, or strengths of an existing drug, if new clinical investigations that were conducted or sponsored by the applicant are essential to the approval of the application. Some of our product candidates may qualify for Hatch-Waxman non-patent marketing exclusivity.

 

In addition to non-patent marketing exclusivity, the Hatch-Waxman Act amended the FDCA to require each NDA sponsor to submit with its application information on any patent that claims the drug for which the applicant submitted the NDA or that claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. Generic applicants that wish to rely on the approval of a drug listed in the Orange Book must certify to each listed patent, as discussed above. We intend to submit for Orange Book listing all relevant patents for our product candidates.

 

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Finally, the Hatch-Waxman Act amended the patent laws so that certain patents related to products regulated by the FDA are eligible for a patent term extension if patent life was lost during a period when the product was undergoing regulatory review, and if certain criteria are met. We intend to seek patent term extensions, provided our patents and products, if they are approved, meet applicable eligibility requirements.

 

Pediatric Studies and Exclusivity

 

The FDA provides an additional six months of non-patent marketing exclusivity and patent protection for any such protections listed in the Orange Book for new or marketed drugs if a sponsor conducts specific pediatric studies at the written request of the FDA. The Pediatric Research Equity Act of 2003, or PREA, authorizes the FDA to require pediatric studies for drugs to ensure the drugs’ safety and efficacy in children. PREA requires that certain new NDAs or NDA supplements contain data assessing the safety and effectiveness for the claimed indication in all relevant pediatric subpopulations. Dosing and administration must be supported for each pediatric subpopulation for which the drug is safe and effective. The FDA may also require this data for approved drugs that are used in pediatric patients for the labeled indication, or where there may be therapeutic benefits over existing products. The FDA may grant deferrals for submission of data, or full or partial waivers from PREA. PREA pediatric assessments may qualify for pediatric exclusivity. Unless otherwise required by regulation, PREA does not apply to any drug for an indication with orphan designation.

 

Orphan Drug Designation and Exclusivity 

 

The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which generally is a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting an NDA. If the FDA grants orphan drug designation, which it may not, the identity of the therapeutic agent and its potential orphan use are publicly disclosed by the FDA. Orphan drug designation does not convey an advantage in, or shorten the duration of, the review and approval process. If a product which has an orphan drug designation subsequently receives the first FDA approval for the indication for which it has such designation, the product is entitled to seven years of orphan drug exclusivity, meaning that the FDA may not approve any other applications to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity (superior efficacy, safety, or a major contribution to patient care). Orphan drug designation does not prevent competitors from developing or marketing different drugs for that indication. In February 2012, AR-42 received orphan-drug designation from the FDA for the treatment of meningioma and schwannoma of the central nervous system, which are benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity for those affected individuals. Where appropriate, we will also seek orphan drug designation for our other product candidates, including potentially for certain uses of AR-12.

 

Under European Union medicines laws, the criteria for designating a product as an “orphan medicine” are similar but somewhat different from those in the United States. A drug is designated as an orphan drug if the sponsor can establish that the drug is intended for a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union or that is unlikely to be profitable, and if there is no approved satisfactory treatment or if the drug would be a significant benefit to those persons with the condition. Orphan medicines are entitled to ten years of marketing exclusivity, except under certain limited circumstances comparable to United States law. During this period of marketing exclusivity, no “similar” product, whether or not supported by full safety and efficacy data, will be approved unless a second applicant can establish that its product is safer, more effective or otherwise clinically superior. This period may be reduced to six years if the conditions that originally justified orphan designation change or the sponsor makes excessive profits. On March 8, 2012 the European Medicines Agency, Committee on Orphan Medicinal Products (COMP) issued a positive opinion on the application for orphan designation of AR-42 for treatment of neurofibromatosis-type 2 disease complex.

 

Fast Track Designation 

 

The FDA’s fast track program is intended to facilitate the development and to expedite the review of drugs that are intended for the treatment of a serious or life-threatening condition and that demonstrate the potential to address unmet medical needs. Under the fast track program, applicants may seek traditional approval for a product based on data demonstrating an effect on a clinically meaningful endpoint, or approval based on a well-established surrogate endpoint. The sponsor of a new drug candidate may request the FDA to designate the drug candidate for a specific indication as a fast track drug at the time of original submission of its IND, or at any time thereafter prior to receiving marketing approval of a marketing application. The FDA will determine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request.

 

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If the FDA grants fast track designation, it may initiate review of sections of an NDA before the application is complete. This so-called “rolling review” is available if the applicant provides and the FDA approves a schedule for the submission of the remaining information and the applicant has paid applicable user fees. The FDA’s review clock for both a standard and priority NDA for a fast track product does not begin until the complete application is submitted. Additionally, fast track designation may be withdrawn by the FDA if it believes that the designation is no longer supported by emerging data, or if the designated drug development program is no longer being pursued.

 

In some cases, a fast track designated drug candidate may also qualify for one or more of the following programs:

 

·Priority Review. As explained above, a drug candidate may be eligible for a six-month priority review. The FDA assigns priority review status to an application if the drug candidate provides a significant improvement compared to marketed drugs in the treatment, diagnosis or prevention of a disease. A fast track drug would ordinarily meet the FDA’s criteria for priority review, but may also be assigned a standard review. We do not know whether any of our drug candidates will be assigned priority review status or, if priority review status is assigned, whether that review or approval will be faster than conventional FDA procedures, or that the FDA will ultimately approve the drug.

 

·Accelerated Approval. Under the FDA’s accelerated approval regulations, the FDA is authorized to approve drug candidates that have been studied for their safety and efficacy in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments based upon either a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than patient survival or irreversible morbidity. In clinical trials, surrogate endpoints are alternative measurements of the symptoms of a disease or condition that are substituted for measurements of observable clinical symptoms. A drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase IV or post-approval clinical trials to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies with due diligence, or to validate a surrogate endpoint or confirm a clinical benefit during post-marketing studies, may cause the FDA to seek to withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.

 

When appropriate, we and/or our collaboration partners intend to seek fast track designation, accelerated approval or priority review for our drug candidates. We cannot predict whether any of our drug candidates will obtain fast track, accelerated approval, or priority review designation, or the ultimate impact, if any, of these expedited review mechanisms on the timing or likelihood of the FDA approval of any of our drug candidates.

 

Satisfaction of the FDA regulations and approval requirements or similar requirements of foreign regulatory agencies typically takes several years, and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease. Typically, if a drug candidate is intended to treat a chronic disease, as is the case with some of the drug candidates we are developing, safety and efficacy data must be gathered over an extended period of time. Government regulation may delay or prevent marketing of drug candidates for a considerable period of time and impose costly procedures upon our activities. The FDA or any other regulatory agency may not grant approvals for changes in dosage form or new indications for our drug candidates on a timely basis, or at all. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a drug may result in restrictions on the drug or even complete withdrawal of the drug from the market. Delays in obtaining, or failures to obtain, regulatory approvals for any of our drug candidates would harm our business. In addition, we cannot predict what adverse governmental regulations may arise from future United States or foreign governmental action.

 

Special Protocol Assessment 

 

The FDCA directs the FDA to meet with sponsors, pursuant to a sponsor’s written request, for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an efficacy claim in an NDA. If an agreement is reached, the FDA will reduce the agreement to writing and make it part of the administrative record. This agreement is called a special protocol assessment, or SPA. While the FDA’s guidance on SPAs states that documented SPAs should be considered binding on the review division, the FDA has the latitude to change its assessment if certain exceptions apply. Exceptions include identification of a substantial scientific issue essential to safety or efficacy testing that later comes to light, a sponsor’s failure to follow the protocol agreed upon, or the FDA’s reliance on data, assumptions or information that are determined to be wrong.

 

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Other Regulatory Requirements

 

Any drugs manufactured or distributed by us or our collaboration partners pursuant to future FDA approvals are subject to continuing regulation by the FDA, including recordkeeping requirements and reporting of adverse experiences associated with the drug. Drug manufacturers and their subcontractors are required to register with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, sales or use, seizure of product, injunctive action or possible civil penalties. We cannot be certain that we or our present or future third-party manufacturers or suppliers will be able to comply with the cGMP regulations and other ongoing FDA regulatory requirements. If our present or future third-party manufacturers or suppliers are not able to comply with these requirements, the FDA may halt our clinical trials, require us to recall a drug from distribution, or withdraw approval of the NDA for that drug.

 

The FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply with these requirements can result in adverse publicity, warning and/or untitled letters, corrective advertising and potential civil and criminal penalties.

 

Foreign Regulation

 

In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

 

Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or mutual recognition procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The mutual recognition procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval.

 

In addition to regulations in Europe and the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future products.

 

Manufacturing

 

We do not currently have our own manufacturing facilities. We intend to continue to use our financial resources to accelerate development of our product candidates rather than diverting resources to establish our own manufacturing facilities. We meet our pre-clinical and clinical trial manufacturing requirements by establishing relationships with third-party manufacturers and other service providers to perform these services for us. We rely on individual proposals and purchase orders to meet our needs and typically rely on terms and conditions proposed by the third party or us to govern our rights and obligations under each order (including provisions with respect to intellectual property, if any). We do not have any long-term agreements or commitments for these services. Likewise, we do not have any long-term agreements or commitments with vendors to supply the underlying component materials of our product candidates, some of which are available from only a single supplier.

 

Should any of our product candidates obtain marketing approval, we anticipate establishing relationships with third-party manufacturers and other service providers in connection with the commercial production of our products. We have some flexibility in securing other manufacturers to produce our product candidates; however, our alternatives may be limited due to proprietary technologies or methods used in the manufacture of some of our product candidates.

 

Research and Development Expenses

 

We spent approximately $8.5 million in fiscal year 2012 and $5.7 million in fiscal year 2011 on research and development activities. These expenses include cash and non-cash expenses relating to the development of our clinical and pre-clinical programs.

 

Employees

 

As of December 31, 2012, we had four full-time employees, none of whom are covered by a collective bargaining agreement. We believe our relations with our employees are satisfactory.

 

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We retain several consultants who serve in various operational and administrative capacities, and we utilize clinical research organizations and third parties to perform our pre-clinical studies, clinical studies, and manufacturing. We may hire additional research and development staff, as required, to support our product development.

 

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ITEM 1A.           RISK FACTORS

 

RISK FACTORS

 

Investment in our common stock involves significant risk. You should carefully consider the information described in the following risk factors, together with the other information appearing elsewhere in this Annual Report, before making an investment decision regarding our common stock. If any of these risks actually occur, our business, financial conditions, results of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock could decline, and you may lose all or a part of your investment in our common stock. Moreover, the risks described below are not the only ones that we face.

 

Risks Relating to Our Business

 

We currently have no product revenues and will need to raise substantial additional capital to operate our business. 

 

To date, we have generated no product revenues. Until, and unless, we receive approval from the FDA and other regulatory authorities for our product candidates, we cannot sell our drugs and will not have product revenues. Currently, none of our product candidates are approved for sale by the FDA. Therefore, for the foreseeable future, we will have to fund all of our operations and capital expenditures from cash on hand and, potentially, future offerings of our equity and debt securities. Based on our current development plans, and taking into account the net proceeds from our 2012 offering of debentures and warrants, we believe we have cash on hand to fund our operations through approximately the third quarter of 2013. We will require substantial additional funds to support our continued research and development activities, and the anticipated costs of preclinical studies and clinical trials, regulatory approvals and eventual commercialization. There can be no assurance that such additional financing can be obtained on desirable terms, if at all. In addition, changes may occur that would consume our available capital before that time, including changes in and progress of our development activities, acquisitions of additional product candidates and changes in regulation. Accordingly, we will need additional capital to fund our continuing operations. Since we do not generate any recurring revenue, the most likely sources of such additional capital include private placements of our equity securities, including our common stock, debt financing or funds from a potential strategic licensing or collaboration transaction involving the rights to one or more of our product candidates. To the extent that we raise additional capital by issuing equity securities, our stockholders will likely experience dilution, which may be significant depending on the number of shares we may issue and the price per share. If we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies, product candidates or products, or grant licenses on terms that are not favorable to us. If we raise additional funds by incurring debt, we could incur significant interest expense and become subject to covenants in the related transaction documentation that could affect the manner in which we conduct our business.

 

We currently have no committed sources of additional capital and our access to capital funding is always uncertain. This uncertainty is exacerbated due to the global economic turmoil of the last few years, which continues to severely restrict access to the U.S. and international capital markets, particularly for small biopharmaceutical and biotechnology companies like us. In addition, our agreement with the investors in our 2012 debenture and warrant offering prohibit us from issuing additional shares of our capital stock, subject to certain exceptions, until the 18-month anniversary of the effective date of the initial registration statement covering the resale of the shares issuable upon conversion of the debentures and exercise of the warrants without the consent of the holders of two-thirds of the outstanding debentures. This consent requirement may make it more difficult for us to complete future financing transactions. Accordingly, despite our ability to secure adequate capital in the past, there is no assurance that additional equity or debt financing will be available to us when needed, on acceptable terms or even at all. If we fail to obtain the necessary additional capital when needed, we may be forced to significantly curtail our planned research and development activities, which will cause a delay in our drug development programs and may severely harm our business.

 

We are a development stage company.

 

We have not received any operating revenues to date and are in the development stage. You should be aware of the problems, delays, expenses and difficulties encountered by an enterprise in our stage of development, and particularly for companies engaged in the development of new biotechnology or biopharmaceutical product candidates, many of which may be beyond our control. These include, but are not limited to, problems relating to product development, testing, regulatory compliance, manufacturing, marketing, costs and expenses that may exceed current estimates and competition. No assurance can be given that our existing product candidates, or any technologies or products that we may acquire in the future will be successfully developed, commercialized and accepted by the marketplace or that sufficient funds will be available to support operations or future research and development programs.

 

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We are not currently profitable and may never become profitable.

 

We expect to incur substantial losses and negative operating cash flows for the foreseeable future, and we may never achieve or maintain profitability. For the years ended December 31, 2012 and 2011, we had a net loss of $14,387,782 and $7,909,113, respectively.  For the period from our inception on August 1, 2005 through December 31, 2012, we had a net loss of $49,900,782. Even if we succeed in developing and commercializing one or more of our product candidates, we expect to incur substantial losses for the foreseeable future, as we:

 

·continue to undertake pre-clinical development and clinical trials for our product candidates;

 

·seek regulatory approvals for our product candidates;

 

·in-license or otherwise acquire additional products or product candidates;

 

·seek patent protection for our product candidates;

 

·implement additional internal systems and infrastructure; and

 

·hire additional personnel.

 

Further, for the years ended December 31, 2012 and 2011, we had negative cash flows from operating activities of $9,419,762 and $6,833,566, respectively.  Since inception on August 1, 2005 through December 31, 2012, we had negative cash flows from operating activities of $38,156,466. We expect to continue to experience negative cash flows for the foreseeable future as we fund our operating losses and capital expenditures. As a result, we will need to generate significant revenues in order to achieve and maintain profitability. We may not be able to generate these revenues or achieve profitability in the future. Our failure to achieve or maintain profitability could negatively impact the value of our common stock.

 

We have a limited operating history upon which to base an investment decision.

 

We are a development stage company and have not demonstrated our ability to perform the functions necessary for the successful commercialization of any of our product candidates. The successful commercialization of our product candidates will require us to perform a variety of functions, including:

 

·continuing to undertake pre-clinical development and clinical trials for our product candidates;

 

·participating in regulatory approval processes;

 

·formulating and manufacturing products; and

 

·conducting sales and marketing activities.

 

Our operations have been limited to organizing our company, acquiring, developing and securing our proprietary technologies and performing pre-clinical and clinical trials of our product candidates. These operations provide a limited basis for you to assess our ability to commercialize our product candidates and the advisability of investing in our securities.

 

We may not successfully manage our growth.

 

Our success will depend upon the expansion of our operations and the effective management of our growth, which will place a significant strain on our management and on our administrative, operational and financial resources. To manage this growth, we may need to expand our facilities, augment our operational, financial and management systems and hire and train additional qualified personnel. If we are unable to manage our growth effectively, our business would be harmed.

 

The relationships between Two River Consulting, Riverbank Capital Securities and certain of our officers and directors may present potential conflicts of interest.

 

Arie S. Belldegrun, M.D., our Chairman, David M. Tanen, one of our directors, and Joshua A. Kazam, a co-founder and director of our company until September 2010, are the managing members of Two River Consulting, LLC, or TRC. Mr. Tanen serves as our Secretary and, from June 2009 until April 2011, also served as our President. In June 2009, we entered into a services agreement with TRC pursuant to which it performs various management, clinical development, operational and administrative activities and services for us. As consideration for these services, we paid TRC a monthly cash fee of $55,000. While the term of the services agreement expired on April 1, 2011, we continue to utilize the services of TRC and TRC is now billing the Company for actual hours worked on a monthly basis. For the second through fourth quarters of 2011, TRC billed us $287,145 for services rendered, an average of approximately $31,900 per month. During the year ended December 31, 2012, TRC billed us $273,171 for services rendered, an average of approximately $22,750 per month. Each of Messrs. Kazam and Tanen, as well as Peter M. Kash, Ed.D., a co-founder and director of our company until April 2011, are also officers and directors of Riverbank, a broker-dealer registered with the Financial Industry Regulatory Agency, or FINRA, which served as placement agent in connection with our September 2010 private placement of Series A Preferred Stock. Scott L. Navins, the Financial and Operations Principal of Riverbank and Chief Financial Officer of TRC, serves as our Treasurer.

 

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Generally, Delaware corporate law requires that any transactions between us and any of our affiliates be on terms that, when taken as a whole, are substantially as favorable to us as those then reasonably obtainable from a person who is not an affiliate in an arms-length transaction. We believe that the terms of the agreements that we have entered into with TRC and Riverbank satisfy the requirements of Delaware law, but in the event one or more parties challenges the fairness of such terms we may have to expend substantial resources in resolving such challenges and can make no guarantees of the result. Further, none of our affiliates or TRC is obligated pursuant to any agreement or understanding with us to make any additional products or technologies available to us, nor can there be any assurance, and the investors should not expect, that any biomedical or pharmaceutical product or technology identified by such affiliates or TRC in the future will be made available to us.

 

In addition to the relationships and transactions described above, each of Dr. Belldegrun, Dr. Kash, and Messrs. Kazam and Tanen are significant stockholders and serve as officers and directors of other biopharmaceutical and biotechnology companies some of which may be considered a potential competitor of ours.  See “Directors and Executive Officers” for additional information about the activities of Dr. Belldegrun and Mr. Tanen.  Certain of our other current officers and directors or certain of any officers or directors hereafter appointed may from time to time serve as officers or directors of other biopharmaceutical or biotechnology companies. There can be no assurance that such other companies will not have interests in conflict with our own.

 

We are substantially dependent on the services of TRC and other consultants.

 

We have only four employees. We currently rely heavily on TRC to render various management, accounting and administrative activities and services for us. We also rely in substantial part, and for the foreseeable future will continue to rely, on certain independent organizations and consultants to provide other important services, including substantially all aspects of regulatory approval, clinical management, and manufacturing. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified replacements.

 

If we are unable to hire additional qualified personnel in the future, our ability to grow our business may be harmed.

 

Although we currently engage TRC to provide personnel to perform a variety of management, accounting and other services on our behalf on a consulting basis, we expect to directly hire employees, including at the senior management level, in the future as we further the development of our clinical programs. As we further the development of our product candidates, we intend to hire employees to perform the services currently being rendered by TRC. Accordingly, our ability to attract and retain qualified personnel will be critical to managing and growing our business in the future, especially the hiring and retention of key executive personnel and scientific staff. There is intense competition and demand for qualified personnel in our area of business and no assurances can be made that we will be able to retain the personnel necessary for the development of our business on commercially reasonable terms, if at all.

 

We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

 

The testing and marketing of medical products entail an inherent risk of product liability. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products candidates, if approved. Even successful defense against product liability claims would require significant financial and management resources. Regardless of the merit or eventual outcome, product liability claims may result in:

 

·decreased demand for our product candidates;

 

·injury to our reputation;

 

·withdrawal of clinical trial participants;

 

·withdrawal of prior governmental approvals;

 

·costs of related litigation;

 

·substantial monetary awards to patients;

 

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·product recalls;

 

·loss of revenue; and

 

·the inability to commercialize our product candidates.

 

Because we do not yet have any products approved for sale, we currently do not carry product liability insurance.  While we intend to obtain product liability insurance prior to any commercial product sales, such insurance coverage may not be adequate to cover claims against us or available to us at an acceptable cost, if at all.  Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of the pharmaceutical products we develop, alone or with commercialization partners. Even if our agreements with any future commercialization partners entitle us to indemnification against damages from product liability claims, such indemnification may not be available or adequate should any claim arise.

 

We may incur substantial liabilities in connection with the clinical trials of our product candidates and may be required to cease our clinical trials in response to lawsuits brought by clinical trial participants.

 

Conducting clinical trials entails an inherent risk of liability resulting from lawsuits brought by clinical trial participants who experience unexpected adverse reactions to our product candidates or as a result of the medical care they receive while participating in a clinical trial.  If we cannot successfully defend ourselves against such claims, we may incur substantial liabilities or be required to cease clinical trials of our products candidates, which would have a material adverse effect on our business, financial condition and results of operations.  We currently maintain a clinical trial insurance policy with a $5 million per occurrence and aggregate limit, which may not be adequate to cover claims against us.  While our agreements with the research institutions that conduct our clinical trials often provide that the institutions will indemnify us against damages from claims brought by clinical trial participants that result from the institutions’ conduct, such indemnification may not be available or adequate should any such claim arise.

 

We are controlled by current directors and principal stockholders. 

 

Our executive officers, directors and principal stockholders, which include the persons affiliated with TRC discussed above, beneficially own approximately 83.7% of our outstanding voting securities. Accordingly, our executive officers, directors, principal stockholders and certain of their affiliates will have the ability to exert substantial influence over the election of our board of directors and the outcome of issues submitted to our stockholders.

 

The co-lead investors in our September 2010 private placement own a significant amount of our voting securities and are entitled to substantial governance rights that may limit our management’s autonomy.

 

The three co-lead investors in our September 2010 private placement, Pontifax (investing through three affiliated funds: Pontifax (Cayman) II L.P., Pontifax (Israel) II Individual Investors L.P., and Pontifax (Israel) II L.P., which we collectively refer to as “Pontifax”), Commercial Street Capital, LLC (“Commercial Street Capital”), and UTA Capital LLC (“UTA Capital”) beneficially own approximately 30.5%, 31.8%, and 8.1% of our outstanding common stock, respectively.  In addition, pursuant to the terms of the purchase agreement that we entered into with the investors in our 2010 private placement, each co-lead investor has the right to designate one individual to be appointed to our board of directors, subject to certain ownership and other requirements and conditions.  Moreover, the 2010 purchase agreement provides that each such director has the right to serve on any or all of the committees of our board of directors.  The purchase agreement also provides that the affirmative vote of each such investor-designated director then in office shall be required to approve the appointment of our chief executive officer and to authorize certain transactions between us and one of our officers, directors, principal stockholders or their affiliates.  Pursuant to their rights under the purchase agreement, Pontifax, Commercial Street Capital, and UTA Capital designated Tomer Kariv, Steven Ruchefsky, and Yacov Reizman, respectively, for appointment to our board of directors. This concentration of ownership and governance rights among the co-lead investors may not be in the best interests of all our stockholders.  The co-lead investors will be able to exert significant control over our management and affairs requiring stockholder approval, including approval of significant corporate transactions.  Such concentration of voting power could have the effect of delaying or preventing a change of control or other business combination, and may adversely affect the market price of our common stock.

 

We are required to maintain finance and accounting systems, procedures and controls in order to satisfy requirements under the securities laws, including the Sarbanes-Oxley Act of 2002, which increase our costs and divert management’s time and attention.

 

We have established processes, controls and procedures that allow our management to report on our internal controls over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act. As a company with limited capital and human resources, the diversion of management’s time and attention away from our business to ensure compliance with these regulatory requirements may have a material adverse effect on our business, financial condition and results of operations.

 

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In the event we identify significant deficiencies or material weaknesses in our internal controls over financial reporting that we cannot remediate in a timely manner, investors and others may lose confidence in the reliability of our financial statements. If this occurs, the trading price of our common stock, if any, and our ability to obtain any necessary financing could suffer. In addition, in the event that our independent registered public accounting firm is unable to rely on our internal controls over financial reporting in connection with its audit of our financial statements, and in the further event that it is unable to devise alternative procedures in order to satisfy itself as to the material accuracy of our financial statements and related disclosures, we may be unable to file our periodic reports with the SEC. This would likely have an adverse effect on the trading price of our common stock, if any, and our ability to secure any necessary additional financing, and could result in the delisting of our common stock if we are listed on an exchange in the future. In such event, the liquidity of our common stock would be severely limited and the market price of our common stock would likely decline significantly.

 

Risks Relating to the Clinical Testing, Regulatory Approval, Manufacturing

and Commercialization of Our Product Candidates

 

We may not obtain the necessary U.S. or worldwide regulatory approvals to commercialize our product candidates.

 

We will need FDA approval to commercialize our product candidates in the U.S. and approvals from the FDA equivalent regulatory authorities in foreign jurisdictions to commercialize our product candidates in those jurisdictions. In order to obtain FDA approval of any of our product candidates, we must submit to the FDA a new drug application, or NDA, demonstrating that the product candidate is safe for humans and effective for its intended use. This demonstration requires significant research and animal tests, which are referred to as pre-clinical studies, as well as human tests, which are referred to as clinical trials. Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity and novelty of the product candidate and requires substantial resources for research, development and testing. We cannot predict whether our research and clinical approaches will result in drugs that the FDA considers safe for humans and effective for indicated uses. The FDA has substantial discretion in the drug approval process and may require us to conduct additional pre-clinical and clinical testing or to perform post-marketing studies. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Delays in obtaining regulatory approvals may:

 

·delay commercialization of, and our ability to derive product revenues from, our product candidates;

 

·impose costly procedures on us; or

 

·diminish any competitive advantages that we may otherwise enjoy.

 

Even if we comply with all FDA requests, the FDA may ultimately reject one or more of our NDAs. We cannot be sure that we will ever obtain regulatory clearance for our product candidates. Failure to obtain FDA approval of any of our product candidates will severely undermine our business by reducing our number of salable products and, therefore, corresponding product revenues.

 

In foreign jurisdictions, we must receive approval from the appropriate regulatory authorities before we can commercialize our drugs. Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above. We cannot assure that we will receive the approvals necessary to commercialize our product candidate for sale outside the U.S.

 

All of our product candidates are in the very early stages of development and will require extensive clinical trials before they may be approved for marketing. Clinical trials are very expensive and time-consuming. Any failure or delay in completing clinical trials for our product candidates could harm our business.

     

All of our current product candidates are in early stages of development and will require extensive clinical and other testing and analysis before we will be in a position to consider seeking regulatory approval to sell such product candidates. Conducting clinical trials is a lengthy, time consuming and very expensive process and the results are inherently uncertain. The duration of clinical trials can vary substantially according to the type, complexity, novelty and intended use of the product candidate. We estimate that clinical trials of our product candidates will take at least several years to complete. The completion of clinical trials for our product candidates may be delayed or prevented by many factors, including without limitation:

 

·delays in patient enrollment, and variability in the number and types of patients available for clinical trials;

 

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·difficulty in maintaining contact with patients after treatment, resulting in incomplete data;

 

·poor effectiveness of product candidates during clinical trials;

 

·safety issues, side effects, or other adverse events;

 

·results that do not demonstrate the safety or effectiveness of the product candidates;

 

·governmental or regulatory delays and changes in regulatory requirements, policy and guidelines; and

 

·varying interpretation of data by the FDA.

 

In conducting clinical trials, we may fail to establish the effectiveness of a compound for the targeted indication or discover that it is unsafe due to unacceptable side effects or other reasons. Even if our clinical trials are commenced and completed as planned, their results may not support our product candidate claims. Further, failure of product candidate development can occur at any stage of clinical trials, or even thereafter, and we could encounter problems that cause us to abandon or repeat clinical trials. These problems could interrupt, delay or halt clinical trials for our product candidates and could result in FDA, or other regulatory authorities, delaying or declining approval of our product candidates for any or all indications. The results from pre-clinical testing and prior clinical trials may not be predictive of results obtained in later or other larger clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in clinical trials, even in advanced clinical trials after showing promising results in earlier clinical trials. Our failure to adequately demonstrate the safety and effectiveness of any of our product candidates will prevent us from receiving regulatory approval to market these product candidates and will negatively impact our business. In addition, we or the FDA may suspend or curtail our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in the conduct of these clinical trials or in the composition, manufacture or administration of the product candidates. Accordingly, we cannot predict with any certainty when or if we will ever be in a position to submit a new drug application, or NDA, for any of our product candidates, or whether any such NDA would ever be approved.

 

Our products use novel alternative technologies and therapeutic approaches, which have not been widely studied.

 

Our product development efforts focus on novel therapeutic approaches and technologies that have not been widely studied. These approaches and technologies may not be successful. We are applying these approaches and technologies in our attempt to discover new treatments for conditions that are also the subject of research and development efforts of many other companies.

 

Physicians and patients may not accept and use our drugs.

 

Even if the FDA approves our product candidates, physicians and patients may not accept and use them. Acceptance and use of our products will depend upon a number of factors including:

 

·perceptions by members of the health care community, including physicians, about the safety and effectiveness of our drugs;

 

·cost-effectiveness of our products relative to competing products;

 

·availability of reimbursement for our products from government or other healthcare payers; and

 

 ·effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

 

Because we expect sales of our current product candidates, if approved, to generate substantially all of our product revenues for the foreseeable future, the failure of any of these drugs to find market acceptance would harm our business and could require us to seek additional financing.

 

Because we are dependent on clinical research organizations and other contractors for clinical testing and for research and development activities, the results of our clinical trials and such research activities are, to a certain extent, not within our control.

 

We depend upon independent investigators and collaborators, such as universities and medical institutions, to conduct our pre-clinical and clinical trials under agreements with us. These parties are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These investigators may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. If outside collaborators fail to devote sufficient time and resources to our drug development programs, or if their performance is substandard, the approval of our FDA applications, if any, and our introduction of new drugs, if any, will be delayed. These collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist our competitors at our expense, our competitive position would be harmed.

 

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Our reliance on third parties to formulate and manufacture our product candidates exposes us to a number of risks that may delay the development, regulatory approval and commercialization of our products or result in higher product costs.

 

We have no direct experience in drug formulation or manufacturing and do not intend to establish our own manufacturing facilities. We lack the resources and expertise to formulate or manufacture our own product candidates. Instead, we will contract with one or more manufacturers to manufacture, supply, store and distribute drug supplies for our clinical trials. If any of our product candidates receive FDA approval, we will rely on one or more third-party contractors to manufacture our drugs. Our anticipated future reliance on a limited number of third-party manufacturers exposes us to the following risks:

 

·We may be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must approve any replacement contractor. This approval would require new testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products after receipt of FDA approval, if any.

 

·Our third-party manufacturers might be unable to formulate and manufacture our drugs in the volume and of the quality required to meet our clinical and/or commercial needs, if any.

 

·Our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully produce, store and distribute our products.

 

·Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with good manufacturing practice and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards, but we will be ultimately responsible for any of their failures.

 

·If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation. This may prohibit us from seeking alternative or additional manufacturers for our products.

 

Each of these risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA, or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenues.

 

We have no direct experience selling, marketing or distributing products and no internal capability to do so.

 

We currently have no sales, marketing or distribution capabilities. We do not anticipate having resources in the foreseeable future to allocate to the sales and marketing of our proposed products. Our future success depends, in part, on our ability to enter into and maintain sales and marketing collaborative relationships, the collaborator’s strategic interest in the products under development and such collaborator’s ability to successfully market and sell any such products. We intend to pursue collaborative arrangements regarding the sales and marketing of our products, however, there can be no assurance that we will be able to establish or maintain such collaborative arrangements, or if able to do so, that they will have effective sales forces. To the extent that we decide not to, or are unable to, enter into collaborative arrangements with respect to the sales and marketing of our proposed products, significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and sales force with technical expertise. There can also be no assurance that we will be able to establish or maintain relationships with third-party collaborators or develop in-house sales and distribution capabilities. To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of such third parties, and there can be no assurance that such efforts will be successful. In addition, there can also be no assurance that we will be able to market and sell our product in the U.S. or overseas.

 

If we cannot compete successfully for market share against other drug companies, we may not achieve sufficient product revenues and our business will suffer.

 

The market for our product candidates is characterized by intense competition and rapid technological advances. If our product candidates receive FDA approval, they will compete with a number of existing and future drugs and therapies developed, manufactured and marketed by others. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may offer comparable performance at a lower cost. If our products fail to capture and maintain market share, we may not achieve sufficient product revenues and our business will suffer.

 

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We will compete against fully integrated pharmaceutical companies and smaller companies that are collaborating with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors have technologies already approved or in development. In addition, many of these competitors, either alone or together with their collaborative partners, operate larger research and development programs and have substantially greater financial resources than we do, as well as significantly greater experience in:

 

·developing drugs;

 

·undertaking pre-clinical testing and human clinical trials;

 

·obtaining FDA and other regulatory approvals of drugs;

 

·formulating and manufacturing drugs; and

 

·launching, marketing and selling drugs.

 

Developments by competitors may render our products or technologies obsolete or non-competitive.

 

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. The drugs that we are attempting to develop will have to compete with existing therapies. In addition, a large number of companies are pursuing the development of pharmaceuticals that target the same diseases and conditions that we are targeting. We face competition from pharmaceutical and biotechnology companies in the U.S. and abroad. In addition, companies pursuing different but related fields represent substantial competition. Many of these organizations competing with us have substantially greater capital resources, larger research and development staffs and facilities, longer drug development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These organizations also compete with us to attract qualified personnel and parties for acquisitions, joint ventures or other collaborations.

 

Our ability to generate product revenues will be diminished if our drugs sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.

 

Our ability to commercialize our drugs, alone or with collaborators, will depend in part on the extent to which reimbursement will be available from:

 

·government and health administration authorities;

 

·private health maintenance organizations and health insurers; and

 

·other healthcare payers.

 

Significant uncertainty exists as to the reimbursement status of newly approved healthcare products. Healthcare payers, including Medicare, are challenging the prices charged for medical products and services. Government and other healthcare payers increasingly attempt to contain healthcare costs by limiting both coverage and the level of reimbursement for drugs. Even if our product candidates are approved by the FDA, insurance coverage may not be available, and reimbursement levels may be inadequate, to cover our drugs. If government and other healthcare payers do not provide adequate coverage and reimbursement levels for any of our products, once approved, market acceptance of our products could be reduced.

 

We may be exposed to liability claims associated with the use of hazardous materials and chemicals.

 

Our research and development activities may involve the controlled use of hazardous materials and chemicals by our third-party service providers. Although we believe that our service providers maintain appropriate safety procedures for using, storing, handling and disposing of these materials in compliance with federal, state and local laws and regulations, we cannot completely eliminate the risk of accidental injury or contamination from these materials. In the event of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our business, financial condition and results of operations. In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous or radioactive materials and waste products may require us or our service providers to incur substantial compliance costs that could materially adversely affect our business, financial condition and results of operations.  We do not carry insurance against liability resulting from the use of hazardous materials and chemicals.  While we generally require our service providers to carry insurance against liability resulting from their use of such materials, we cannot be certain that such insurance will be sufficient to cover any related liability.  To the extent our service providers fail to carry adequate levels of insurance, we could be exposed to liability claims associated with their use of hazardous materials and chemicals.

 

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Risks Related to Our Intellectual Property

 

If we fail to protect or enforce our intellectual property rights adequately or secure rights to patents of others, the value of our intellectual property rights would diminish.

 

Our success, competitive position and future revenues will depend in part on our ability and the abilities of our licensors to obtain and maintain patent protection for our products, methods, processes and other technologies, to preserve our trade secrets, to prevent third parties from infringing on our proprietary rights and to operate without infringing upon the proprietary rights of third parties. Additionally, if any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation.

 

To date, we hold certain exclusive rights under U.S. patents and patent applications as well as rights under foreign patent applications. We anticipate filing additional patent applications both in the U.S. and in other countries, as appropriate. However, we cannot predict:

 

·the degree and range of protection any patents will afford us against competitors including whether third parties will find ways to invalidate or otherwise circumvent our patents;

 

·if and when patents will issue;

 

·whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; or

 

·whether we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose.

 

If any of our know-how or other proprietary information is disclosed, the value of our know-how and other proprietary rights would be significantly impaired and our business and competitive position would suffer.

 

Our success also depends upon the skills, knowledge and experience of our scientific and technical personnel, our consultants and advisors as well as our licensors and contractors. To help protect our proprietary know-how and our inventions for which patents may be unobtainable or difficult to obtain, we rely on confidentiality agreements. To this end, we require all of our employees, consultants, advisors and contractors to enter into agreements which prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business. These agreements may not provide adequate protection for our know-how or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information. If any of our know-how or other proprietary information is disclosed, the value of our know-how and other proprietary rights would be significantly impaired and our business and competitive position would suffer.

 

If we infringe upon the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.

 

If our products, methods, processes and other technologies infringe upon the proprietary rights of other parties, we could incur substantial costs and we may have to:

 

·obtain licenses, which may not be available on commercially reasonable terms, if at all;

 

·redesign our products or processes to avoid infringement;

 

·stop using the subject matter claimed in the patents held by others;

 

·pay damages; or

 

·defend litigation or administrative proceedings which may be costly whether we win or lose, and which could result in a substantial diversion of our valuable management resources.

 

If requirements under our license agreements are not met, we could suffer significant harm, including losing rights to our products.

 

We depend on licensing agreements with third parties to maintain the intellectual property rights to our products under development. We have licensed rights from Invivis Pharmaceuticals, Inc. and The Ohio State University Research Foundation. These agreements require us and our licensors to perform certain obligations that affect our rights under these licensing agreements. All of these agreements last either throughout the life of the patents, or with respect to other licensed technology, for a number of years after the first commercial sale of the relevant product.

 

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In addition, we are responsible for the cost of filing and prosecuting certain patent applications and maintaining certain issued patents licensed to us. If we do not meet our obligations under our license agreements in a timely manner, we could lose the rights to our proprietary technology.

 

Finally, we may be required to obtain licenses to patents or other proprietary rights of third parties in connection with the development and use of our products and technologies. Licenses required under any such patents or proprietary rights might not be made available on terms acceptable to us, if at all.

 

Risks Related to Our Securities

 

The conversion of our outstanding Debentures and the exercise of our outstanding warrants could cause the market price of our common stock to fall, and may have significant dilution and other effects on our existing stockholders.

 

The conversion of our outstanding 8% senior convertible debentures (the “Debentures”) in the principal amount of $14.9 million could result in the issuance of up to 49.5 million shares of common stock, assuming the entire amount of the Debentures is converted prior to their maturity dates in November and December 2015. Further, we issued warrants (the “2012 Warrants”) to the holders of the Debentures to purchase an aggregate of 99 million shares of our common stock. Both the conversion prices applicable to the Debentures and the exercise prices applicable to the 2012 Warrants are subject to adjustment pursuant to certain anti-dilution provisions. The issuance by us of the shares of common stock issuable upon conversion of the Debentures and exercise of the 2012 Warrants would significantly reduce the percentage ownership of our existing common stockholders and could, among other things, depress the price of the common stock. This result could significantly and adversely affect our ability to raise additional equity capital in the future.

 

As of their dates of issuance, the immediate conversion of the Debentures would result in the issuance by us of approximately 49.5 million shares of our common stock at a conversion price of $0.30 per share. The exercise of the 2012 Warrants could result in the issuance of up to approximately 99 million shares of common stock. Half of the 2012 Warrants are initially exercisable at a price per share equal to $0.50 and the remaining half are exercisable at a price of $0.30 per share. The conversion price of the Debentures and the exercise prices of the 2012 Warrants are subject to adjustment, however, in the event we sell or issue additional shares of our common stock (subject to certain exceptions) at a price per share less than the applicable conversion or exercise prices. If we issue additional shares of our common stock at a price less than such conversion or exercise prices during the period of time until we have raised an additional $12 million in aggregate equity financings, the Debenture conversion and warrant exercise prices will be reduced to equal such lower price. To the extent we issue additional shares of our common stock at a price per share less than the applicable Debenture conversion and warrant exercise prices during the period following the date we have raised at least $12 million of additional equity financing, then the Debenture conversion and warrant exercise prices will be reduced based on a “weighted-average” formula. We expect that we will need substantial additional capital in order to fund our operations during the terms of the Debentures and 2012 Warrants and that a likely source of such capital will be through the sale and issuance of additional shares of our common stock or securities convertible into our common stock. Consequently, if we make such future issuances at prices lower than the applicable Debenture conversion and warrant exercise prices, our stockholders could experience a significant dilution of their investment.

 

The holders of the Debentures and 2012 Warrants may immediately sell the full amount of common stock received upon conversion or exercise of such instruments. As these shares are sold, the price of the common stock is likely to decrease, perhaps substantially, unless there is sufficient demand by purchasers of our common stock in the trading markets to meet the additional volume of shares of our common stock available from the conversion of the Debentures or exercise of the 2012 Warrants.

 

Upon an “event of default” under our outstanding debentures, we may be required to pay an amount in cash significantly exceeding the outstanding principal and accrued interest owed under the debentures.

 

Upon an “event of default,” as that term is defined under the Debentures, we are required to pay to the holders an amount in cash equal to the greater of the following:

 

·(i) the outstanding principal amount of the Debentures plus accrued and unpaid interest, divided by (ii) the conversion price in effect on the date of such default, multiplied by (iii) the volume weighted average price, or VWAP, of our common stock on the date of default; or

 

·115% of the outstanding principal amount of the Debentures, plus all accrued and unpaid interest and other costs and expenses owing under the Debentures.

 

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As a result of this formula, the higher our stock price is on the date of an event of default, the greater the cash payment we will be required to make. For example, we current have approximately $15 million of principal amount of Debentures outstanding, so if the VWAP of our common stock is $1.00 at the time of an event of default and the conversion price is then $0.30, upon an event of default we will be required to make a cash payment of $50 million ($15 million divided by 0.30 multiplied by 1.00) to the holders of the Debentures without regard to any accrued and unpaid interest. Accordingly, if an event of default occurs under the Debentures, we will incur a substantial liability that would likely cause significant adverse effect on our financial condition.

 

The terms of our outstanding 8% senior convertible debentures may make it difficult for us to raise additional capital at times and upon terms we deem advisable.

 

Until the 18-month anniversary of the effective date of the initial registration statement covering the resale of the shares issuable upon conversion of the Debentures and exercise of the 2012 Warrants, we may not (subject to certain exceptions, including issuances to pursuant to our equity incentive plans, underwritten public offerings and strategic transactions) issue or sell additional shares of our common stock, or securities convertible into or exercisable for common stock without the prior consent of holders of two-thirds of the Debentures. As a result of this provision, our ability to obtain additional capital from future financing transactions, particularly financing transactions structured as a private placement of our common stock, will be subject to the approval of the Debenture holders. If the Debenture holders do not approve of any such proposed issuance, we may not be able to raise the capital necessary to fund our operations, including the further development of our product candidates, at the times or on the terms we deem advisable.

 

If we are not able to satisfy our interest payment obligations under the Debentures by issuing shares in lieu of cash payments, we will have less cash to spend on our research and development programs.

 

The outstanding principal amount under the Debentures accrues interest at the rate of 8% per annum, payable quarterly in arrears commencing December 31, 2012. Our quarterly interest obligations under the Debentures are approximately $300,000. We may elect to pay such interest in kind by issuing shares of its common stock valued at a price per share equal to 85% of the trailing 20-day volume weighted average price of our common stock, provided certain conditions have been satisfied. Those conditions include that the average daily trading volume of our common stock is at least 25,000 shares. The current average daily trading volume of our common stock is less than 1,000 shares. Accordingly, we will be required to pay cash to satisfy our interest obligations for the near future, and possibly beyond, unless and until the trading volume of our common stock increases significantly. To the extent we are required to use our cash resources to satisfy such interest obligations, we will have less capital to devote to our research and development programs and we will more rapidly exhaust our available cash, both of which would be harmful to our business.

 

We cannot assure you that our common stock will ever be listed on NASDAQ or any other securities exchange.

 

Our common stock is currently eligible for trading on the OTCQB tier of the OTC Markets, an automated quotation system.  Stocks traded on the OTCQB and other electronic over-the-counter markets are often less liquid than stocks traded on national securities exchanges. In fact, the historical trading of our common stock has been extremely limited and sporadic. We may seek listing on NASDAQ or the American Stock Exchange in the future, but we cannot assure you that we will be able to meet the initial listing standards of either of those or any other stock exchange, or that we will be able to maintain a listing of our common stock on either of those or any other stock exchange. To the extent that our common stock is not traded on a national securities exchange, such as NASDAQ, the decreased liquidity of our common stock may make it more difficult to sell shares of our common stock at desirable times and at prices.

 

Our common stock is considered a “penny stock.”

 

The SEC has adopted regulations which generally define a “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. Since trading of our common stock commenced, the market price has been below $5.00 per share. Therefore, our common stock is deemed a “penny stock” according to SEC rules. This designation requires any broker or dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules may restrict the ability of brokers or dealers to sell shares of our common stock.

 

Because we did not become public through an underwritten initial public offering, we may not be able to attract the attention of major brokerage firms.

 

Additional risks may exist since we did not become public through an initial public offering underwritten by an investment bank. Security analysts of major brokerage firms may not provide coverage of us since there is no incentive to brokerage firms to recommend the purchase of our common stock. No assurance can be given that brokerage firms will want to conduct any secondary offerings on behalf of our company in the future. The lack of such analyst coverage may decrease the public demand for our common stock, making it more difficult for you to resell your shares when you deem appropriate.

 

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Because we do not expect to pay dividends, you will not realize any income from an investment in our common stock unless and until you sell your shares at profit.

 

We have never paid dividends on our common stock and do not anticipate paying any dividends for the foreseeable future. You should not rely on an investment in our common stock if you require dividend income. Further, you will only realize income on an investment in our shares in the event you sell or otherwise dispose of your shares at a price higher than the price you paid for your shares. Such a gain would result only from an increase in the market price of our common stock, which is uncertain and unpredictable.

 

There may be issuances of shares of “blank check” preferred stock in the future.

 

Our amended and restated certificate of incorporation authorizes the issuance of up to 35,000,000 shares of preferred stock, none of which are issued or currently outstanding.  Our board of directors has the authority to fix and determine the relative rights and preferences of up to 35,000,000 preferred shares, as well as the authority to issue such shares, without further stockholder approval. As a result, our board of directors could authorize the issuance of a series of preferred stock that is senior to our common stock and that would grant to holders preferred rights to our assets upon liquidation, the right to receive dividends, additional registration rights, anti-dilution protection, the right to the redemption to such shares, together with other rights, none of which will be afforded holders of our common stock.

 

If we obtain an analyst following, and if our results do not meet such analysts’ forecasts and expectations, our stock price could decline.

 

We do not believe that any securities analysts cover us.  The lack of analyst coverage of our business and operations may decrease the public demand for our common stock, making it more difficult for you to resell your shares when you deem appropriate.  To the extent we obtain an analyst following in the future, such analysts may provide valuations regarding our stock price and make recommendations whether to buy, hold or sell our stock. Our stock price may be dependent upon such valuations and recommendations. Analysts’ valuations and recommendations are based primarily on our reported results and their forecasts and expectations concerning our future results regarding, for example, expenses, revenues, clinical trials, regulatory marketing approvals and competition. Our future results are subject to substantial uncertainty, and we may fail to meet or exceed analysts’ forecasts and expectations as a result of a number of factors, including those discussed above under the sections “Risks Related to Our Business” and “Risks Related to the Clinical Testing, Regulatory Approval, Manufacturing and Commercialization of Our Product Candidates.” If our results do not meet analysts’ forecasts and expectations, our stock price could decline as a result of analysts lowering their valuations and recommendations or otherwise.

 

We are at risk of securities class action litigation.

 

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology companies have experienced greater than average stock price volatility in recent years. If we faced such litigation, it could result in substantial costs and a diversion of our management’s attention and resources, which could harm our business.

 

ITEM 1B.           UNRESOLVED STAFF COMMENTS

 

None.

 

ITEM 2.              PROPERTIES

 

Our principal offices are located at 200 Route 31 North, Suite 104, Flemington, New Jersey 08822, where we occupy approximately 4,168 square feet of office space pursuant to the terms of a lease agreement dated August 4, 2011.  The lease commencement date was November 17, 2011, with lease payments beginning in February 2012.  The lease expiration date is three years from the rent commencement date.  We provided a cash security deposit of $10,455, or two months’ base rent.  We are also responsible for payment of our share of common area maintenance costs and taxes.

 

ITEM 3.              LEGAL PROCEEDINGS

 

We are not involved in any pending legal proceedings.

 

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In January 2012, we received a notice from the University of Pittsburgh, or Pitt, claiming that we were in default under our license agreement relating to AR-67 for failure to pay a $250,000 annual license fee under the terms of that agreement and providing us with 60 days’ notice to remedy the default. On March 29, 2012, following our determination not to proceed with further development of AR-67, we agreed with Pitt to terminate the license agreement. In February 2013, Pitt commenced an action in the Court of Common Pleas of Allegheny County, Pennsylvania, seeking damages of $250,000, plus interest and costs, based on its claim that we breached the license agreement by failing to pay the annual license fee. On March 28, 2013, we entered into a settlement agreement with Pitt pursuant to which we agreed to pay $235,000 in full satisfaction of all remaining obligations under the license agreement.

 

ITEM 4.              MINE SAFETY DISCLOSURES

 

Not applicable.

 

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PART II

 

ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Market Information

 

Our common stock is currently eligible for trading on the OTCQB tier of the OTC Markets; however, there have been few trades in our common stock since we filed an application to deregister our common stock in May 2009. The historical trading of our common stock has been extremely limited and sporadic.

 

Between May 2009 and April 2011, our common stock was eligible for trading on the “Pink Sheets,” where the sole trade was reported on April 9, 2010. Prior to May 2009, our common stock traded on the OTC Bulletin Board, or the OTCBB, where the first trade was reported in June 2008.  Until July 16, 2008, our common stock traded under the symbol “LRRI.OB.”  Following our merger with Laurier completed on June 3, 2008, our trading symbol changed to “ARNI.OB” on July 17, 2008.  Set forth below are the high and low sales prices for our common stock during each quarter within the last two fiscal years, as reported by the Pink Sheets, the OTCBB, or the OTCQB, as applicable. The quotations reflect inter-dealer prices, without retail markup, markdown, or commission, and may not represent actual transactions. Consequently, the information provided below may not be indicative of our common stock price under different conditions.

  

Quarter Ended  High   Low 
March 31, 2011  $-   $- 
June 30, 2011  $-   $- 
September 30, 2011  $-   $- 
December 31, 2011  $1.50   $1.50 
March 31, 2012  $1.25   $0.60 
June 30, 2012  $1.01   $0.10 
September 30, 2012  $0.49   $0.11 
December 31, 2012  $0.50   $0.10 

  

Holders

 

According to the records of our transfer agent, American Stock Transfer & Trust Company, as of March 26, 2013, we had approximately 251 holders of record of common stock, not including those held in “street name.”

 

Dividends

 

We have never declared or paid a dividend on our common stock and do not anticipate paying any cash dividends in the foreseeable future.

 

Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

 

None.

 

Issuer Purchases of Equity Securities

 

None.

 

Description of the 2012 Debentures

 

General

 

On November 26, 2012, we entered into a securities purchase agreement with certain accredited investors, whereby the investors acquired in two closings occurring on November 26, 2012 and December 18, 2012, $14,857,200 of aggregate principal amount of our 8% senior convertible debentures, or the Debentures, in a private placement, which we refer to as the 2012 offering. Additionally, each investor received two series of warrants, referred to as the 2012 Series A Warrants and the 2012 Series B Warrants, to purchase an aggregate of 99,048,007 shares of our common stock.

 

The purchase agreement contains customary representations, warranties and covenants by each of us and the investors. In addition, the purchase agreement provides that each investor has a right, subject to certain exceptions described in the agreement, to participate in future issuances of equity and debt securities by us for a period of 18 months following the effective date of the initial registration statement covering the resale of the shares issuable upon conversion of the Debentures and exercise of the 2012 Warrants. Further, subject to certain exceptions described in the purchase agreement, during such 18-month period, we may not issue or propose to issue any equity securities without the consent of the holders of two-thirds of the outstanding Securities.

 

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The Debentures are unsecured obligations, senior to all of our other indebtedness. The Debentures were sold for 100% of their face amount. Debentures having a principal face amount of $12,705,000 were issued on November 26, 2012 and will mature on November 26, 2015. Debentures having a principal face amount of $2,152,200 were issued on December 18, 2012 and will mature on December 18, 2015. We may not prepay any outstanding principal prior to the applicable maturity date.

 

Interest

 

The Debentures accrue interest at an annual rate of 8%, which is payable in cash quarterly in arrears commencing January 1, 2013. We may elect to satisfy these interest payments by issuing shares of our common stock at a value of 85% of the average volume weighted price of our common stock for the 20 consecutive trading days prior to the interest payment date, provided that certain conditions are met, which are referred to as “equity conditions.” Equity conditions include the following:

 

·our having honored all conversions duly requested by the investors;

 

·our having paid any liquidated damages or other amounts due to the investors under the Debentures;

 

·either (i) a registration statement covering the resale of the shares of common stock issuable upon conversion of the Debentures, including the interest conversion shares in the case of an interest share payment, and the investors are permitted to resell the shares of common stock received upon conversion of any part of the Debentures or (ii) such shares may otherwise be resold by the investors pursuant to Rule 144;

 

·our common stock is trading on a trading market and is listed or quoted for trading on such trading market, which includes the OTC Bulletin Board, on which our common stock is currently eligible for trading;

 

·we have a sufficient number of authorized but unissued shares of common stock for issuance of all shares of common stock underlying the Debentures and the 2012 Warrants;

 

·there is no existing event of default under the Debentures and there is no existing event that would, with the passage of time or giving of notice, constitute an event of default under the Debentures;

 

·we have not publicly announced a pending or proposed fundamental or change of control transaction which has not been consummated or abandoned;

 

·we have not provided any investor with any material, non-public information relating to us;

 

·in the case of a forced conversion (discussed below), the average daily trading volume of our common stock on its principal trading market exceeded 100,000 shares for a the relevant 10 consecutive trading day period described in the Debentures; and

 

·in the case of the issuance of shares in satisfaction of our interest obligation, the average daily trading volume of our common stock on its principal trading market exceeded 25,000 shares for a the relevant 10 consecutive trading day period described in the Debentures.

 

In late March 2013, we sought the agreement of the investors to amend their respective Debentures to provide for the accrual of all interest payments under such Debentures until the applicable maturity date in November or December of 2015, with such interest accruing at the rate of 8% per annum, compounding quarterly. As of March 28, 2013, we had entered into such amendments with the holders of Debentures in the aggregate principal amount of $7,875,000.

 

Conversion of Debentures

 

The Debentures may be converted by each investor at any time, at the option of such investor, in whole or in part. The Debentures are initially convertible into shares of our common stock, at a per share conversion price equal to $0.30. Other than with respect to certain excluded issuance of securities described below, the conversion price is subject to full-ratchet anti-dilution protection upon any grant of any right to purchase or any issuance of our common stock and/or securities convertible or exchangeable into our common stock at an effective price per share less than the conversion price of the Debentures then in effect (we refer to each such issuance as a Dilutive Issuance, and each effective price per share in such Dilutive Issuance, as a Dilutive Price). Consequently, upon any Dilutive Issuance (other than with respect to an exempt security), the conversion price of each Debenture would be automatically reduced to the applicable Dilutive Price. However, after such time following the issuances of the Debentures as we have raised an aggregate of $12 million in gross cash proceeds from the one or more equity financing transactions, the Debenture conversion price is no longer subject to full-ratchet anti-dilution protection. Instead, the Debenture conversion price is subject to a weighted-average anti-dilution which means that the conversion price is reduced on a weighted-average basis by a Dilutive Issuance.

 

Any shares of our common stock issued or issuable in the following transactions are exempt securities that do not trigger the full-ratchet or weighted-average anti-dilution protection of the Debentures:

  

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·Issuances of our common stock pursuant to any board approved employee plan;

 

·Issuances of our common stock upon conversion or exercise of securities outstanding on prior to the issuance of the Debentures (in the form as in effect as of such date);

 

·Issuances of our common stock in connection with acquisitions or strategic transactions to a company (or to the owners of a company) that is an operating company and that provides us with additional benefits in addition to the investment of funds, but excluding a transaction in which we are issuing securities primarily for capital raising purposes.

 

We may also force the conversion of the Debentures at our option if each of the equity conditions listed above have been satisfied and, following the effective date of a registration statement covering the resale of the Debenture conversion shares, the volume weighted average price of our common stock exceeds $1.50 for each of any 10 consecutive trading days.

 

Debentures issued to many of the investors also include an additional limitation on conversion, which provides that at no time will an investor be entitled to convert any portion of the Debentures, to the extent that after such conversion such investor (together with its affiliates) would beneficially own more than 9.99% of the outstanding shares of our common stock as of such date.

 

If we fail to timely deliver shares of common stock to an investor following delivery of a conversion notice, we may be liable for liquidated damages to such investor. Our failure to deliver shares in a timely manner also provides the investor with a right to rescind its conversion request.

 

To the extent an investor does not elect to convert its Debenture as described above, the principal amount of the Debenture not so converted on or prior to the maturity date shall be payable in cash on the maturity date.

 

Fundamental Transactions

 

Upon the occurrence of a fundamental transaction, each investor shall have the right to receive, for each share of our common stock issuable upon conversion of the Debentures immediately prior to such transaction, the number of shares of our common stock, or stock of the successor or acquiring corporation, and any additional consideration receivable as a result of such transaction by a holder of our common stock, which shall be referred to as the alternate consideration. Fundamental transactions include:

 

·our merger or consolidation with or into another person;

 

·our sale, lease, license, assignment, transfer, conveyance or other disposition of substantially all of our assets in one or a series of related transactions;

 

·the completion of a purchase offer, tender offer or exchange offer (whether by us or another person) accepted by the holders of a majority of our outstanding common stock;

 

·any reclassification, reorganization or recapitalization of our common stock or any compulsory share exchange in which our common stock is converted into or exchanged for other securities, cash or property; or

 

·the consummation of a stock or share purchase agreement or other business combination with another person where such other person acquired more than 50% of our outstanding shares of common stock (excluding shares held by such person or persons party to the agreement or combination or associated or affiliated with such person or persons).

 

The conversion price of the Debentures shall be appropriately adjusted following any fundamental transaction to apply to the alternate consideration received by holders of our common stock thereunder for one share of our common stock.

 

Additionally, if, at any time while the Debentures are outstanding, we:

 

·pay a stock dividend or otherwise make distributions payable in shares of our common stock on our common stock or common stock equivalents;

 

·subdivide outstanding shares of our common stock into a larger number;

 

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  · combine outstanding shares of our common stock into a smaller number; or

 

  · issue any shares of our capital stock in a reclassification of our common stock,

then the conversion price of the Debentures shall be multiplied by a fraction the numerator of which shall be the number of shares of our common stock outstanding immediately prior to the event and the denominator of which shall be the number of shares of our common stock outstanding immediately after the event.

 

Events of Default

 

The occurrence of any of the following events of default shall, at the option of each investor, make the outstanding principal amount, plus all other amounts payable under such investor’s Debenture, immediately due and payable:

 

  · our failure to pay the principal amount or any other amount due under the Debenture when due if such failure is not cured within 3 trading days following written notice from an investor;

 

  · our breach of any material covenant of the purchase agreement or Debenture in any material respect and the continuation of such breach, if curable, for 10 trading days after written notice of the breach to us from an investor;

 

  · if any of our material representations or warranties made in writing in the purchase agreement is untrue in any material respect as of the date of that agreement;

 

  · a material default or event of default by us occurs with respect other material agreements that we are required to file with the SEC in our Annual Report on Form 10-K, other than employment or compensation agreements;

 

  · bankruptcy, reorganization, insolvency proceeding, liquidation proceedings or other proceedings for relief under any bankruptcy law is instituted by us or against us and, if instituted against us, is not dismissed within 45 trading days of initiation;

 

  · any money judgment, writ or similar final process is entered or filed against us or any of our property or other assets for more than $250,000 which shall remain unpaid, unvacated, unbonded or unstayed for 45 days;

 

  · our default under any mortgage, credit agreement or other facility, indenture, factoring agreement or other instrument under which we issue indebtedness for borrowed money involving an obligation of more than $150,000 and that results in the acceleration of the indebtedness becoming due or payable;

 

  · our common stock becomes ineligible for listing or quotation on a trading market and not eligible to resume listing or quotation within 10 trading days;

 

  · we are party to a change of control or fundamental transaction, unless the holders of a majority of the principal amount of Debentures otherwise agree;

 

  · if, during the period for which we are required to maintain the effectiveness of the registration statement covering the resale of the Debenture conversion shares, either (i) the effectiveness of such registration statement lapses, (ii) the investors are not permitted to resell their shares for a period of more than 20 consecutive trading days or 30 non-consecutive trading days during any 12-month period, unless we meet the public information requirements under Rule 144 of the Securities Act; or

 

  · our failure to deliver our common stock to an investor in accordance with the Debenture within ten trading days after the applicable conversion date

 

Upon the occurrence of an event of default, each investor shall have the right to require us to pay to such investor a mandatory default amount. The mandatory default amount is equal to the greater of:

 

  · the intrinsic value of the common stock underlying the note, which is calculated as (a) the outstanding principal amount of such investor’s Debenture divided by (b) the conversion price on the date the mandatory default amount is either demanded or otherwise due, or paid in full, whichever has the lower conversion price, multiplied by the volume-weighted average price of our common stock on the date the mandatory default amount is either demanded or otherwise due, or paid in full, whichever results in the lowest volume-weighted average price, or

 

  · 115% of the outstanding principal amount of such Debenture,

 

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plus, in each case, all accrued and unpaid interest and all such other amounts, costs, expenses and liquidated damages due in respect of such Debenture.

 

Negative Covenants

 

Unless the investors of at least a majority in principal amount of the then outstanding Debentures shall have given prior written consent, as long as any Debentures remain outstanding, we shall not:

 

  · incur, create, assume, guarantee or suffer to exist any secured indebtedness for borrowed money other than permitted indebtedness;

 

  · enter into, create, incur, assume or suffer to exist any lien of any kind, on or with respect to any of our property or assets now owned or hereinafter acquired other than permitted liens;

 

  · repay, repurchase or offer to repay, repurchase or otherwise acquire for cash more than a de minimis number of shares of our common stock other than repurchases of our common stock of departing officers and directors, provided our repurchases shall not exceed an aggregate of $100,000 during the term of the Debentures;

 

  · repay or repurchase or otherwise acquire any indebtedness, other than the Debentures if on a pro-rata basis;

 

  · pay cash dividends or distributions on any of our equity securities; or

 

  · enter into any transaction with one of our affiliates which would be required to be disclosed in a public filing with the SEC, unless such transaction is at arm’s-length and approved by a majority of our disinterested directors.

 

Description of the 2012 Warrants

 

In addition to the Debentures, we issued to the investors 2012 Series A Warrants to purchase, for a period of 5 years from the date of issuance, 49,524,003 shares of our common stock at an initial exercise price of $0.50 per share, subject to adjustment for stock splits, combinations, recapitalization events. We also issued to the investors 2012 Series B Warrants to purchase, for a period of 18 months from the date of issuance, an additional 49,524,003 shares of common stock at an initial exercise price of $0.30 per share, subject to adjustment for stock splits, combinations, recapitalization events. The 2012 Warrants are required to be exercised for cash, provided that if during the term of the Warrants there is not an effective registration statement under the Securities Act covering the resale of the shares issuable upon exercise of the Warrants, then the Warrants may be exercised on a cashless (net exercise) basis.

 

The applicable exercise prices of the 2012 Warrants are subject to full ratchet and weighted-average anti-dilution adjustments on the same basis as the Debentures are with respect to Dilutive Issuances. In addition, the exercise price applicable to the 2012 Series B Warrants may be increased to $0.40, $0.50 and $0.75 per share on each of the 6, 12 and 18-month anniversaries, respectively, if the volume weighted average price of our common stock exceeds $0.30, $0.50 and $0.75, respectively, and the daily volume exceeds 100,000 shares during the 10 trading days prior to each applicable anniversary (in each case, subject to adjustment for stock splits, combinations and similar recapitalization events).

 

The 2012 Series A Warrants may be redeemed by us at a price of $0.01 per warrant share if, in addition to satisfying each of the equity conditions, for a period of 10 consecutive trading days following the effective date of a registration statement covering the resale of the warrant shares, the volume weighted average price of our common stock is at least $1.50 and the average daily trading volume of our common stock is at least 100,000 shares on each day during such 10-day period (in each case, subject to adjustment for stock splits, combinations and similar recapitalization events).

 

Registration Rights Agreement

 

Pursuant to the terms of a Registration Rights Agreement dated November 26, 2012, we agreed to file a registration statement under the Securities Act covering the resale of: (i) 100% of the shares of common stock issuable as payment of accrued interest under the Debentures and upon exercise of the Series A Warrants; and (ii) 150% of the shares of common stock issuable upon conversion of the Debentures and upon exercise of the Series B Warrants (collectively, the “Registrable Securities”). We further agreed to cause such registration statement to be filed with 30 days following the date of the Registration Rights Agreement, or by December 26, 2012, and to cause such registration statement to be declared effective within 60 days following the date of the Registration Rights Agreement, or by January 25, 2013, or, if the registration statement was subject to review by the SEC, to cause such registration statement to be declared effective within 120 days following the date of the Registration Rights Agreement, or by March 26, 2013. If such registration statement, covering 100% of the Registrable Securities, was not declared effective by the SEC by the applicable date, we agreed to pay liquidated damages to the investors in the amount of 2% of each investor’s aggregate investment amount per month until the registration statement is declared effective or until such earlier time as the Registrable Securities may be traded pursuant to Rule 144.

 

We filed the registration statement on December 26, 2012, and, following the receipt of comments from the SEC on January 7, 2013, we filed an amendment to the registration statement on January 29, 2013. As of the date of this report, the registration statement has not been declared effective by the SEC, and we do not anticipate being able to register 100% of the Registrable Securities. Accordingly, because the registration statement was not declared effective by March 26, 2013, the investors are each entitled to liquidated damages in the amount of 2% of their investment amount per month until the Registrable Securities may be traded pursuant to Rule 144. Because Rule 144 will become available to the investors six months after the applicable closing date, the investors will be entitled to approximately two months’ of liquidated damages, or approximately $0.6 million in the aggregate.

 

On March 25, 2013, we entered into an amendment to the Registration Rights Agreement with the holders of approximately 80% of the outstanding Debentures permitting us, in our sole discretion, to elect to pay liquidated damages resulting from the our failure to successfully cause the registration statement covering the resale of 100% of the Registrable Securities to be declared effective by the SEC by March 26, 2013, by issuing shares of common stock in lieu of cash. If electing to issue shares in lieu of paying cash, we will issue to each investor a number of shares of common stock equal to (a) the aggregate amount of liquidated damages that we are electing to pay to such investor in the form of shares, divided by (b) thirty cents ($0.30). Pursuant to the terms of the Registration Rights Agreement, because holders of over two-thirds of the Debentures consented in writing to the March 25, 2013 amendment, such amendment is binding on all holders of Registrable Securities. On March 27, 2013, in accordance with the amendment to the Registration Rights Agreement, we issued an aggregate of 990,477 shares of common stock to the investors in lieu of an aggregate cash payment of $297,144, representing the first monthly installment of liquidated damages under the Registration Rights Agreement, as amended.

 

ITEM 6. SELECTED FINANCIAL DATA

 

Not Applicable.

 

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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and plan of operations should be read in conjunction with the financial statements and the notes to those statements included elsewhere in this Annual Report.  This discussion includes forward-looking statements that involve risk and uncertainties.  As a result of many factors, such as those set forth under “Risk Factors” in Item 1A of this Annual Report, our actual results may differ materially from those anticipated in these forward-looking statements.

 

Company Overview

 

We are a development stage company focused on developing innovative products for the treatment of cancer. The following is a summary of our product development pipeline:

 

  • Onapristone – On February 13, 2012, we entered into a license agreement granting us rights to commercially develop onapristone, an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor and inhibit tumor growth. Onapristone was originally developed by Schering AG for potential use as a contraceptive and an anti-endocrine treatment of breast cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone” treatment of patients with breast cancer. In connection with the development of onapristone, we intend to develop a companion diagnostic product to selectively identify patients who express the activated form of the progesterone receptor and therefore may be more likely to benefit from treatment with onapristone. We are currently conducting pre-clinical toxicology studies and manufacturing activities and plans to file an IND or foreign equivalent in 2013.

 

  • AR-42 – AR-42 is being developed as an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins, or Pan-DAC, which play an important role in the regulation of gene expression, cell growth and survival.  In preclinical studies, AR-42 has demonstrated greater potency and activity in solid tumors and hematological malignancies when compared to vorinostat (also known as SAHA and marketed as Zolinza® by Merck). These data demonstrate the potent and potential differentiating activity of AR-42. Additionally, pre-clinical findings presented at the 2009 American Society of Hematology Annual Meeting showed that AR-42 potently and selectively inhibits leukemic stem cells in acute myeloid leukemia, or AML.  AR-42 is currently being studied in an investigator-initiated Phase I/II clinical study in adult subjects with relapsed or refractory hematological malignancies: multiple myeloma, chronic lymphocytic leukemia (CLL), or lymphoma.  The recommended Phase II dose, or RP2D, in patients with hematological malignancies has been determined and the expansion phase of the program has been initiated.  We expect that the expansion phase of the hematological malignancy cohort will take at least 12 months to complete. The protocol has been amended to include a separate solid tumor dose escalation cohort and patients are being actively screened to enter into this cohort. In preclinical studies, AR-42 has demonstrated anti-tumor activity in both meningioma and schwannoma. Meningioma and schwannoma are rare, benign tumors that can present in different locations within the brain and the spinal cord and may cause substantial morbidity for those affected individuals. The primary treatment option for patients with these tumors is surgical excision. In February 2012, the FDA granted two orphan drug designations for AR-42 for the treatment of meningioma and the treatment of schwannoma of the central nervous system. Additionally, AR-42 has been granted three orphan-drug designations by the European Medicines, or EMA, for the treatment of neurofibromatosis type 2 (NF2), the treatment of meningioma and the treatment of schwannoma.  NF2 is a rare genetic disorder characterized by the growth of noncancerous tumors in the brain and spinal cord, juvenile cataracts, and neurofibromas of the skin.  We have also applied to the FDA for orphan drug designation of AR-42 for the treatment of NF2 associated central nervous system tumors.

 

  • AR-12 – We are also developing AR-12 as an orally available, targeted anti-cancer agent that has been shown in early pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer cells.  We believe AR-12 may also cause cell death through the induction of stress in the endoplasmic reticulum and work is ongoing to further understand the mechanism of action. Preliminary data demonstrates that AR-12 may inhibit multiple different kinase targets. In May 2009, the FDA accepted our IND for AR-12.  We are currently conducting a multi-centered Phase I clinical study of AR-12 in adult patients with advanced or recurrent solid tumors or lymphoma.  The Phase I study of AR-12 was originally designed to be conducted in two parts.  The first part is a dose-escalating study, which we refer to as the Escalation Phase, primarily designed to evaluate the safety of AR-12 in order to identify the MTD and RP2D for future studies of the compound.  We have completed the dose escalation phase of the Phase I trial, and have determined the RP2D and MTD of the current formulation.  Following the Escalation Phase, we planned to initiate the second part of the study, which we refer to as the Expansion Phase, which would have involved enrolling an expanded cohort of additional patients at the RP2D in multiple tumor types.  We will not be moving forward with the Expansion Phase of this study as we plan to conduct further clinical development of AR-12 with an improved formulation that has been shown to substantially increase bioavailability in preclinical models.

  

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We have no product sales to date and we will not generate any product revenue until we receive approval from the FDA or equivalent foreign regulatory bodies to begin selling our pharmaceutical product candidates. Developing pharmaceutical products is a lengthy and very expensive process. Assuming we do not encounter any unforeseen safety or other issues during the course of developing our product candidates, we do not expect to complete the development of a product candidate for several years, if ever. To date, a significant amount of our development expenses have related to two of our product candidates: AR-12 and AR-67. As we proceed with the clinical development of our product candidates, primarily focusing our resources on onapristone and AR-42, our research and development expenses will further increase. To the extent we are successful in acquiring additional product candidates for our development pipeline, our need to finance further research and development will continue increasing. Accordingly, our success depends not only on the safety and efficacy of our product candidates, but also on our ability to finance the development of the products. To date, our major sources of working capital have been proceeds from private and public sales of our common and preferred stock and debt financings.

 

Research and development, or R&D, expenses consist primarily of salaries and related personnel costs, fees paid to consultants and outside service providers for pre-clinical, clinical, and manufacturing development, legal expenses resulting from intellectual property prosecution, costs related to obtaining and maintaining our product license agreements, contractual review, and other expenses relating to the design, development, testing, and enhancement of our product candidates.  We expense our R&D costs as they are incurred.

 

General and administrative, or G&A, expenses consist primarily of salaries and related expenses for executive, finance and other administrative personnel, accounting, legal and other professional fees, business development expenses, rent, business insurance and other corporate expenses.

 

Our results include non-cash compensation expense as a result of the issuance of stock options and warrants. We expense the fair value of stock options and warrants over the vesting period. When more precise pricing data is unavailable, we determine the fair value of stock options using the Black-Scholes option-pricing model. The terms and vesting schedules for share-based awards vary by type of grant and the employment status of the grantee. Generally, the awards vest based upon time-based or performance-based conditions. Performance-based conditions generally include the attainment of goals related to our financial performance and product development. Stock-based compensation expense is included in the respective categories of expense in the statements of operations. We expect to record additional non-cash compensation expense in the future, which may be significant.

 

Results of Operations

 

General and Administrative Expenses. G&A expenses for the years ended December 31, 2012 and 2011 were approximately $2.3 million and $2.0 million, respectively.  This increase of approximately $0.3 million over 2011 is primarily attributable to an increase of approximately $0.3 million in personnel costs, including bonus compensation expense related to having a full-time CEO and executive assistant for all of 2012. No paid employees held these positions for a portion of 2011 until the hiring of a full-time CEO in April 2011 and an executive assistant in June 2011.

 

Research and Development Expenses.  R&D expenses for the years ended December 31, 2012 and 2011 were approximately $8.5 million and $5.7 million, respectively.  The increase of approximately $2.8 million over 2011 is primarily due to an increase of approximately $4.4 million relating to our new product candidate, onapristone, which was in-licensed during the first quarter of 2012 and on which we spent less than $0.1 million during 2011 in connection with pre-licensure due diligence activities. During 2012, we spent approximately $4.5 million on onapristone, including approximately $1.5 million on manufacturing, approximately $1.1 million on pre-clinical activities, including a companion diagnostic, approximately $1.1 million on consulting services relating to regulatory, manufacture and preclinical activities, a one-time $0.5 million license fee and approximately $0.3 million in travel and patent prosecution costs.

 

Offsetting the costs of onapristone development, we had a decrease of approximately $1.0 million relating to our AR-12 program, driven primarily by a decrease of $1.1 million in manufacturing expenses due to our development of an improved formulation during 2011, with no such activities in 2012. Additionally, we had a decrease in unallocated R&D expenses of approximately $0.4 million primarily due to decreased consulting costs from having fewer consultants during the year ended December 31, 2012 as compared to the year ended December 31, 2011.

 

The following table summarizes our R&D expenses incurred for preclinical support, contract manufacturing of clinical supplies, clinical trial services provided by third parties and milestone payments for in-licensed technology for each of our product candidates for the years ended December 31, 2012 and 2011, as well as the cumulative amounts since we began development of each product candidate through December 31, 2012. The table also summarizes unallocated costs, which consist of personnel, facilities and other costs not directly allocable to development programs:

 

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      Cumulative 
   Year Ended December 31,   amounts during 
   2012   2011   development 
Onapristone  $4,476,393   $26,418   $4,502,811 
AR-42   951,732    1,035,642    4,983,209 
AR-12   830,849    1,860,377    9,673,737 
AR-67   417,418    554,220    8,082,635 
Unallocated R&D   1,860,738    2,214,179    9,602,816 
Total  $8,537,130   $5,690,836   $36,845,208 

 

Onapristone. We are currently developing onapristone, an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in breast and endometrial cancer. Onapristone appears to have a unique ability to block the activated progesterone receptor and inhibit tumor growth. Onapristone was originally being developed by Schering AG for potential use as both a contraceptive and an anti-endocrine treatment of breast cancer. In clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone” treatment of breast cancer. In connection with the development of onapristone, we intend to develop a companion diagnostic product to identify patients who express activated progesterone and therefore may benefit from treatment with onapristone. We intend to conduct pre-clinical toxicology studies and manufacturing activities and to file an IND by the second quarter of 2013. Based on our current development plans for onapristone, we anticipate spending approximately $7.4 million on external development costs during the fiscal year 2013.

 

AR-42. We are also developing AR-42, an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins.  AR-42 is currently being studied in an investigator sponsored Phase I/IIa clinical study in adult patients with relapsed or refractory multiple myeloma, chronic lymphocytic leukemia or lymphoma and a separate cohort of patients with solid tumors. In preclinical studies, AR-42 has demonstrated greater potency and activity in solid and liquid tumors when compared to vorinostat (also known as SAHA and marketed as Zolinza® by Merck). These data demonstrate the potent and differentiating activity of AR-42. Additionally, pre-clinical findings presented at the 2009 American Society of Hematology Annual Meeting and Exposition showed that AR-42 potently and selectively inhibits leukemic stem cells in acute myeloid leukemia.  In addition, preclinical models have demonstrated anti-tumor activity in tumor types (schwannoma and meningioma) that are associated with the genetic illness, neurofibromatosis type 2 (NF2). Based on our current development plans for AR-42, we anticipate spending approximately $0.5 million on external development costs during the fiscal year 2013.

 

AR-12. We are also developing AR-12 as a potentially first-in-class, orally available, targeted anti-cancer agent that has been shown in pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway, and may also cause cell death through the induction of endoplasmic reticulum stress. In May 2009, the FDA accepted our investigational new drug application, or IND, for AR-12.  We are currently conducting a multi-centered Phase I clinical study of AR-12 in adult patients with advanced or recurrent solid tumors or lymphoma.  The Phase I study of AR-12 was originally designed to be conducted in two parts.  The first part is a dose-escalating study, which we refer to as the Escalation Phase, primarily designed to evaluate the compound’s safety in order to identify the maximum tolerated dose, or MTD, or a recommended Phase II dose, or RP2D, for future studies of AR-12.  We have completed the dose escalation phase of the Phase I trial, and have determined the RP2D and MTD of the current AR-12 formulation. Following the Escalation Phase, we planned to initiate the second part of the study, which we refer to as the Expansion Phase, which would have involved enrolling an expanded cohort of additional patients at the RP2D in multiple tumor types in order to further evaluate and confirm the pharmacodynamics, or PD, effects, potential anti-tumor activity, and safety of AR-12 at the MTD or RP2D in specific patient populations.  We will not be moving forward with the Expansion Phase of this study as we plan to conduct further clinical development of AR-12 with a novel and improved formulation that has shown to increase the bioavailability in preclinical models. Based on our current development plans for AR-12, we anticipate spending approximately $0.5 million on external development costs during the fiscal year 2013.

 

Our expenditures on current and future clinical development programs are expected to be substantial, particularly in relation to our available capital resources, and to increase.  However, these planned expenditures are subject to many uncertainties, including the results of clinical trials and whether we develop any of our drug candidates with a partner or independently. As a result of such uncertainties, it is very difficult to accurately predict the duration and completion costs of our research and development projects or whether, when and to what extent we will generate revenues from the commercialization and sale of any of our product candidates. The duration and cost of clinical trials may vary significantly over the life of a project as a result of unanticipated events arising during clinical development and a variety of factors, including:

 

  · the number of trials and studies in a clinical program;

 

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  · the number of patients who participate in the trials;

 

  · the number of sites included in the trials;

 

  · the rates of patient recruitment and enrollment;

 

  · the duration of patient treatment and follow-up;

 

  · the costs and timing of manufacturing our drug candidates; and

 

  · the costs, requirements, timing of, and the ability to secure regulatory approvals.

 

Interest Income. Interest income for the years ended December 31, 2012 and 2011 was $7,849 and $28,711. The decrease in interest income over 2011 is due to lower average cash balance levels during 2012 as compared to 2011.

 

Interest Expense. Interest expense for the years ended December 31, 2012 and 2011 was $6,361,029 and $0. This increase in interest expense over 2011 is due to our 2012 convertible debenture financing and the related derivatives issued. During 2011, we had no interest bearing obligations.

 

Other Income (Expense).  For the year ended December 31, 2012, we had other income of approximately $2.8 million, which was related to noncash adjustments to the derivative liability. The significant decrease in the liability was primarily due to the short remaining term of the underlying warrants. For the year ended December 31, 2011, we had other expense of approximately $0.3 million, most of which related to noncash adjustments to the warrant liability.

 

Liquidity and Capital Resources

 

The following tables summarize our liquidity and capital resources as of and for each of the last two fiscal years, and is intended to supplement the more detailed discussion that follows. The amounts stated are expressed in thousands.

 

   Year Ended 
December 31,		 
Liquidity and capital resources  2012   2011 
Cash and cash equivalents  $10,943   $6,678 
Working capital  $7,901   $5,012 
Stockholders' (deficit) equity  $(12,266)  $1,356 

  

           Period from 
           August 1, 2005 
   Year Ended   (inception) to 
   December 31,   December 31, 
Cash flow data  2012   2011   2012 
Cash provided by (used in):               
Operating activities  $(9,420)  $(6,833)  $(38,157)
Investing activities   -    (23)   (185)
Financing activities   13,685    6    49,285 
Net increase (decrease) in cash and cash equivalents  $4,265   $(6,850)  $10,943 

  

Our total cash resources as of December 31, 2012 were approximately $10.9 million compared to approximately $6.7 million as of December 31, 2011.  As of December 31, 2012, we had approximately $25.2 million in liabilities (of which approximately $14.9 million represented convertible debentures and approximately $7.5 million represented non-cash derivative liabilities), and approximately $7.9 million in net working capital.  Since August 1, 2005 (inception) through December 31, 2012, we have incurred an aggregate net loss of approximately $49.9 million, while negative cash flow from operating activities has amounted to approximately $38.2 million.  As we continue to develop our product candidates, we expect to continue to incur substantial and increasing losses, which will continue to generate negative net cash flows from operating activities as we expand our technology portfolio and engage in further research and development activities, particularly the conducting of pre-clinical studies and clinical trials.

 

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From inception through December 31, 2012, we have financed our operations through private sales of our equity and debt securities.  As we have not generated any revenue from operations to date, and we do not expect to generate revenue for several years, if ever, we will need to raise substantial additional capital in order to continue to fund our research and development, including our long-term plans for clinical trials and new product development, as well as to fund operations generally.  We may seek to raise additional funds through various potential sources, such as equity and debt financings, or through strategic collaborations and license agreements.  We can give no assurances that we will be able to secure such additional sources of funds to support our operations, or if such funds are available to us, that such additional financing will be sufficient to meet our needs.

 

Based on our current development plans, and taking into account the net proceeds from our 2012 offering of Debentures and Warrants, we believe we have cash on hand to fund our operations through approximately the third quarter of 2013. However, based on the various options for future clinical studies of onapristone, AR-42 and AR-12, our projected cash needs are difficult to predict. In addition, there are other factors which may also cause our actual cash requirements to vary materially, including changes in the focus and direction of our research and development programs; the acquisition and pursuit of development of new product candidates; competitive and technical advances; costs of commercializing any of the product candidates; and costs of filing, prosecuting, defending and enforcing any patent claims and any other intellectual property rights.  If we are unable to raise additional funds when needed, we may not be able to continue development and regulatory approval of our products, and we could be required to delay, scale back or eliminate some or all our research and development programs and we may need to wind down our operations altogether.  Each of these alternatives would likely have a material adverse effect on our business and may result in a loss of your entire investment in our common stock.

 

The actual amount of funds we will need to operate is subject to many factors, some of which are beyond our control. These factors include the following:

 

  · the progress of our research activities;

 

  · the costs of hiring additional full-time personnel;

 

  · the number and scope of our research programs;

 

  · the progress of our pre-clinical and clinical development activities;

 

  · the costs and timing of manufacturing our drug candidates;

 

  · the progress of the development efforts of parties with whom we have entered into research and development agreements;

 

  · our ability to maintain current research and development programs and to establish new research and development and licensing arrangements; and

 

  · the cost involved in prosecuting and enforcing patent claims and other intellectual property rights; and the cost and timing of regulatory approvals.

 

We have based our estimates on assumptions that may prove to be wrong. We may need to obtain additional funds sooner than planned or in greater amounts than we currently anticipate.

 

Off -Balance Sheet Arrangements

 

There were no off-balance sheet arrangements as of December 31, 2012. 

 

Critical Accounting Policies and Estimates

 

Our financial statements are prepared in accordance with generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. We evaluate our estimates and assumptions on an ongoing basis, including research and development and clinical trial accruals, and stock-based compensation estimates. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Our actual results could differ from these estimates. We believe the following critical accounting policies reflect the more significant judgments and estimates used in the preparation of our financial statements and accompanying notes.

 

Research and Development Expenses and Accruals

 

R&D expenses consist primarily of salaries and related personnel costs, fees paid to consultants and outside service providers for pre-clinical, clinical, and manufacturing development, legal expenses resulting from intellectual property prosecution, costs related to obtaining and maintaining our product licenses, contractual review, and other expenses relating to the design, development, testing, and enhancement of our product candidates.  Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.

 

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Our cost accruals for clinical trials and other R&D activities are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial centers and clinical research organizations, or CROs, clinical study sites, laboratories, consultants, or other clinical trial vendors that perform the activities. Related contracts vary significantly in length, and may be for a fixed amount, a variable amount based on actual costs incurred, capped at a certain limit, or for a combination of these elements. Activity levels are monitored through close communication with the CROs and other clinical trial vendors, including detailed invoice and task completion review, analysis of expenses against budgeted amounts, analysis of work performed against approved contract budgets and payment schedules, and recognition of any changes in scope of the services to be performed. Certain CROs and significant clinical trial vendors provide an estimate of costs incurred but not invoiced at the end of each quarter for each individual trial. The estimates are reviewed and discussed with the CRO or vendor as necessary, and are included in R&D expenses for the related period. For clinical study sites, which are paid periodically on a per-subject basis to the institutions performing the clinical study, we accrue an estimated amount based on subject screening and enrollment in each quarter. All estimates may differ significantly from the actual amount subsequently invoiced, which may occur several months after the related services were performed.

 

In the normal course of business we contract with third parties to perform various R&D activities in the on-going development of our product candidates. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of our accrual policy is to match the recording of expenses in our financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical trials and other R&D activities are recognized based on our estimate of the degree of completion of the event or events specified in the specific contract.

 

No adjustments for material changes in estimates have been recognized in any period presented.

  

Stock-Based Compensation

 

Our results include non-cash compensation expense as a result of the issuance of stock, stock options and warrants. We have issued stock options to employees, directors, consultants and Scientific Advisory Board members under our 2005 Stock Option Plan, as amended.

 

We expense the fair value of employee stock-based compensation over the vesting period. When more precise pricing data is unavailable, we determine the fair value of stock options using the Black-Scholes option-pricing model. This valuation model requires us to make assumptions and judgments about the variables used in the calculation. These variables and assumptions include the weighted-average period of time that the options granted are expected to be outstanding, the volatility of our common stock, the risk-free interest rate and the estimated rate of forfeitures of unvested stock options.

 

Stock options or other equity instruments to non-employees (including consultants and all members of our Scientific Advisory Board) issued as consideration for goods or services received by us are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model. The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.

 

During the period in which our common stock was registered under the Securities Exchange Act and publicly traded (October 3, 2008 through May 5, 2009), our management used the following assumptions: On the option grant date, the current available quoted market price for determining the fair value of our common stock, an expected volatility based on the average expected volatilities of a sampling of five companies with similar attributes to us, including industry, stage of life cycle, size and financial leverage, an expected dividend rate of 0% based on management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year Treasury Bill and an expected forfeiture rate of 0%.

 

Subsequent to the deregistration of our common stock in May 2009, for all options granted in 2009, management estimated the fair value of our common stock to be $1.00 based on the following factors. The stock was publicly trading at $1.00 per share prior to being deregistered. Subsequent to the deregistration, we did not experience any significant events including clinical trial results, new product acquisitions or discoveries which management believes would influence a material change in share price following the deregistration. In addition, our management used the following assumptions for options granted during this period: An expected volatility based on the average expected volatilities of a sampling of five companies with similar attributes to us, including industry, stage of life cycle, size and financial leverage, an expected dividend rate of 0% based on management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year Treasury Bill and an expected forfeiture rate of 0%.

 

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On February 9, 2011, the effective date of the registration statement filed in connection with our September 2010 private placement of Series A Preferred Stock, we again became subject to the reporting requirements of the Exchange Act. Due to the lack of an active public market for our common stock, management estimated the fair value of our common stock using a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of our future expected stock prices and minimizes standard error. Management used this valuation for options granted in 2011 (no stock options were granted during the year ended December 31, 2012). In addition, our management used the following assumptions for options granted during this period: An expected volatility based on the average expected volatilities of a sampling of five companies with similar attributes to us, including industry, stage of life cycle, size and financial leverage, an expected dividend rate of 0% based on management plan of operations, a risk free interest rate based on the current U.S. Treasury 5-year Treasury Bill and an expected forfeiture rate of 0%.

 

The terms and vesting schedules for share-based awards vary by type of grant and the employment status of the grantee. Generally, the awards vest based upon time-based or performance-based conditions. Performance-based conditions generally include the attainment of goals related to our financial and development performance. Stock-based compensation expense is included in the respective categories of expense in the Statements of Operations. We expect to record additional non-cash compensation expense in the future, which may be significant.

 

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

The response to this Item is submitted as a separate section of this report commencing on Page F-1.

 

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

Not applicable.

 

ITEM 9A. CONTROLS AND PROCEDURES  

 

Evaluation of Disclosure Controls and Procedures

  

We conducted an evaluation as of December 31, 2012, under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, which are defined under SEC rules as controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within required time periods. Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective.

  

Management’s Report on Internal Control over Financial Reporting

  

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) of the Exchange Act. Internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (2) 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 (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

 

Under the supervision and with the participation of our management, including our Principal Executive Officer and Principal Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Management’s assessment included evaluation of such elements as the design and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment. Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2012.

 

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Limitations on the Effectiveness of Controls

  

Our management, including our Principal Executive Officer and Principal Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefit of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Arno have been detected. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Changes in Internal Control over Financial Reporting

  

There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the fourth quarter of the year ended December 31, 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

ITEM 9B. OTHER INFORMATION

 

Amendment to Registration Rights Agreement; Issuance of Common Stock

 

On March 25, 2013, we entered into an amendment to the Registration Rights Agreement with the holders of approximately 80% of the outstanding Debentures permitting us, in our sole discretion, to elect to pay liquidated damages resulting from the our failure to successfully cause the registration statement covering the resale of 100% of the Registrable Securities to be declared effective by the SEC by March 26, 2013, by issuing shares of common stock in lieu of cash. If electing to issue shares in lieu of paying cash, we will issue to each investor a number of shares of common stock equal to (a) the aggregate amount of liquidated damages that we are electing to pay to such investor in the form of shares, divided by (b) $0.30. Pursuant to the terms of the Registration Rights Agreement, because holders of over two-thirds of the Debentures consented in writing to the March 25, 2013 amendment, such amendment is binding on all holders of Registrable Securities.

 

On March 27, 2013, in accordance with the amendment to the Registration Rights Agreement, we issued an aggregate of 990,477 shares of common stock (the “Liquidated Damages Shares”) to the investors in lieu of an aggregate cash payment of $297,144, representing the first monthly installment of liquidated damages under the Registration Rights Agreement, as amended. The issuance of the Liquidated Damages Shares to the investors, each of whom is an “accredited investor,” constituted a private placement under Section 4(2) of the Securities Act, in accordance with Regulation D promulgated thereunder.

 

Amendment to Debentures

 

In late March 2013, we sought the agreement of the Debenture holders to amend their respective Debentures to provide for the accrual of all interest payments under such Debentures until the applicable maturity date in November or December of 2015, with such interest accruing at the rate of 8% per annum, compounding quarterly. As of March 28, 2013, we had entered into such amendments with the holders of Debentures in the aggregate principal amount of $7,875,000.

 

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Part III

 

ITEM 10. Directors, Executive Officers and Corporate Governance

 

Directors and Executive Officers

 

The following table lists our executive officers, directors and key employees and their respective ages and positions as of the date of this report:

 

Name   Age   Positions
Arie S. Belldegrun, M.D.   63   Chairman of the Board
Glenn Mattes   57   President, Chief Executive Officer and Director
Alexander Zukiwski, M.D.   55   Vice President, Chief Medical Officer
David M. Tanen   41   Secretary and Director
Scott L. Navins   41   Treasurer
Stefan Proniuk, Ph.D.   42   Vice President of Product Development
William F. Hamilton, Ph.D.   73   Director
Tomer Kariv   51   Director
Yacov Reizman   61   Director
Steven B. Ruchefsky   50   Director
Randy Thurman   63   Director

 

 Arie S. Belldegrun, M.D., FACS has served as the chairman of Arno’s board of directors since March 2008. He is currently the chairman of the managing member of Two River Consulting, LLC, an organization that provides management, consulting and operational services for development stage biotechnology companies, including Arno. See “Certain Relationships and Related Transactions.” Dr. Belldegrun is Professor and Chief of Urologic Oncology at the David Geffen School of Medicine at the University of California, Los Angeles, where he holds the Carol and Roy Doumani Chair in Urologic Oncology. He received his medical degree at the Hebrew University Hadassah Medical School, and conducted his post-doctoral studies at the Weizmann Institute of Science in Israel.  He completed his Urologic Surgery residency at Harvard Medical School in 1985 and his Surgical Oncology fellowship at the National Cancer Institute/National Institute of Health in 1988. He is certified by the American Board of Urology and is a Fellow of the American College of Surgeons and the American Association of Genitourinary Surgeons. Dr. Belldegrun is also the founder and founding chairman of Agensys Inc., a privately held biotechnology company developing fully human antibody cancer therapeutics based on novel and clinically relevant targets. In December 2007, Agensys was acquired by Astellas Pharma, Inc. in a deal valued at $537 million. Dr. Belldegrun served as Vice-Chairman of the Board of Directors and Chairman of the Scientific Advisory Board of Cougar Biotechnology, an oncology-focused biopharmaceutical company, until its sale to Johnson & Johnson in July 2009.  Since October 2009, Dr. Belldegrun has served as a director of Nile Therapeutics, Inc., a publicly-held company focused on the development of biopharmaceutical products for the treatment of cardiovascular diseases. He is also the Chairman of the Board of Directors of Kite Pharma, Inc., a privately held company focused on the development of immune-based targeted therapies to treat different cancer indications. Dr. Belldegrun is on the scientific boards of several biotechnology and pharmaceutical companies and is a reviewer for many medical journals and granting organizations. He served as Chairman of the Molecular and Biological Technology Committee of the American Urological Association and member of its Technology Assessment Council, as a member of the Governor’s council on Bioscience for the State of California, and as a biotechnology group leader and member of The Los Angeles Economy and Jobs Committee established in October 2006 by Mayor Antonio Villaraigosa. He is the author of several books on prostate and kidney cancers, holds several biopharmaceutical patents, and has written over 400 scientific publications with an emphasis on urologic oncology.

 

Glenn Mattes was appointed to serve as Arno’s President, Chief Executive Officer, and director in April 2011. He has over 25 years of commercialization and general management experience across a wide range of businesses.  From 2002 to 2011, Mr. Mattes served as the President of Tibotec Therapeutics, a Johnson & Johnson operating company focused on oncology and virology therapeutics, where he led the organization responsible for the development, marketing and sales of novel antiretroviral compounds in North America. Under Mr. Mattes’ leadership, Tibotec successfully launched the first two Johnson & Johnson products in the United States’ HIV/AIDS market.  In 2008, Mr. Mattes was appointed to the President’s Advisory Council on HIV/AIDS (PACHA) by the U.S. Secretary of Health and Human Services to counsel White House administrations on both domestic and global health and treatment issues. Prior to Tibotec, from 1998 to 2002 Mr. Mattes served as the Vice President of Worldwide Commercial Operations at Centocor, where he played a critical role in defining Centocor’s overall business direction, as well as developing and implementing the organization’s sales and marketing strategy leading to the introduction of Remicade®.  Prior to joining Centocor, Mr. Mattes gained a wealth of pharmaceutical experience at Rhone Poulenc Rorer (RPR) (now Aventis), where he held positions of increasing responsibility, including President of RPR Canada, and Vice President of Advanced Therapeutics and Oncology, North America, where he was largely responsible for the successful launch of both Taxotere® and Lovenox®. Mr. Mattes received a BS degree from the City University of New York.

 

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Alexander Zukiwski, M.D., was appointed to serve as Arno’s Vice President and Chief Medical Officer in June 2011.  Dr. Zukiwski has more than 15 years of experience in global oncology drug development and was most recently Executive Vice President, Clinical Research, and Chief Medical Officer at MedImmune, Inc. where he served until March 2011, leading the organization that was responsible for developing and implementing MedImmune's clinical research, medical affairs and safety strategies.  From 2002 until he joined MedImmune in 2007, Dr. Zukiwski held medical affairs and clinical development positions of increasing responsibility at Johnson & Johnson Pharmaceutical Research & Development, LLC (“JJPRD”), Centocor and Ortho Biotech, all Johnson & Johnson companies, including serving as therapeutic area head for oncology and acting head of oncology research and development.  As Vice President, Head of Clinical Oncology, he was responsible for strategic oversight and portfolio management of therapeutic oncology, hematology and supportive care clinical development programs for JJPRD and Centocor's oncology development group.  Before joining Johnson & Johnson, Dr. Zukiwski held clinical oncology positions at Hoffmann-LaRoche, Glaxo Wellcome and Rhone- Poulenc Rorer.  Dr. Zukiwski received a bachelor’s degree in pharmacy from the University of Alberta and a Doctor of Medicine degree from the University of Calgary.  He conducted his post-graduate training at St. Thomas Hospital Medical Center in Akron, Ohio and the University of Texas, M.D. Anderson Cancer Center.

 

David M. Tanen is a co-founder of Arno and has served as a director and its secretary since its inception. Mr. Tanen also served as Arno’s President from June 2009 until April 2011.  Mr. Tanen also serves as an Officer and Director of Riverbank Capital Securities, Inc., a broker dealer registered with FINRA (“Riverbank”), which engages in private placement activities for public and private companies, primarily in the life science sector, and which performed placement agent services for Arno in 2008 and 2010.  Mr. Tanen also serves as an officer of the managing member of Two River Consulting, LLC, which provides management, operational and other services for Arno.  See “Certain Relationships and Related Transactions.” Prior to founding Two River, from October 1996 to September 2004, Mr. Tanen was a Director of Paramount BioCapital Investments, LLC, a biotechnology focused venture capital company. Mr. Tanen also served as a member of the General Partner of the Orion Biomedical Fund, LP.  Mr. Tanen received his B.A. from The George Washington University and his J.D. from Fordham University School of Law.

 

Scott L. Navins has served as Arno’s Treasurer since its inception, and has been responsible for all of our accounting and financial reporting services since the departure of our former Chief Financial Officer in February 2010.  He is also the Chief Financial Officer at Two River Consulting, LLC (“Two River”), where he is responsible for all accounting, finance and control activities. Mr. Navins joined Two River in 2005. Prior to joining Two River, from 2004 to 2005 Mr. Navins was the Senior Controller at Westbrook Partners, where he managed the accounting for a $560 million real estate private equity fund, including financial and partner reporting, tax coordination, maintaining internal controls and overseeing a $300 million credit facility, among other things. Before that, from 2002 to 2004 Mr. Navins was a Senior Manager at Morgan Stanley, where he managed the accounting for a $2.4 billion real estate private equity fund. Prior to that Mr. Navins was an Associate in the Finance Group at BlackRock, Inc. and the controller for a high-tech venture capital fund.  Mr. Navins also serves as the Financial and Operations Principal of Riverbank Capital Securities (member FINRA/SIPC) and has served as Treasurer of Nile Therapeutics, Inc., a publicly-held biopharmaceutical company, since 2005.  Mr. Navins graduated with honors from The George Washington University in 1993, where he earned a Bachelor of Accountancy degree.  Mr. Navins passed the Uniform Certified Public Accounting examination in 1993.

 

Stefan Proniuk, Ph.D. has over 15 years of experience in formulation and product development. Prior to joining Arno, he was the Sr. Manager of Pharmaceutical Technologies at Neurocrine Biosciences (2002-2008) where he was responsible for overseeing development programs from Phase I to III.  His group was also responsible for the preformulation of NCEs.  Prior to his work at Neurocrine, Dr. Proniuk worked as a scientist at Cima Labs (2001-2002) on the development and scale-up of fast dissolving tablet formulations (OraSolv®, DuraSolv®).  Throughout his career he has worked on multiple regulatory submissions and marketed products. Dr. Proniuk holds a Ph.D. degree in Pharmaceutical Sciences from the University of Arizona, an MBA with emphasis in Entrepreneurship from San Diego State University and a Diplom (FH) in Chemical Engineering from the University of Applied Sciences Isny, Germany. 

 

William F. Hamilton, Ph.D. was appointed to Arno’s board of directors in October 2008.  Dr. Hamilton has served on the University of Pennsylvania faculty since 1967, and is the Landau Professor of Management and Technology, and Director of the Jerome Fisher Program in Management and Technology at The Wharton School and the School of Engineering and Applied Science. Dr. Hamilton serves on the board of directors of Ceptaris Therapeutics, Inc., a privately-held specialty pharmaceutical company that develops small molecule pharmaceuticals licensed from academic laboratories. Dr. Hamilton received his B.S. and M.S. in chemical engineering and his MBA from the University of Pennsylvania, and his Ph.D. in applied economics from the London School of Economics.

 

Tomer Kariv is the co-founder and Chief Executive Officer of Pontifax, a group of Israeli based life sciences venture funds focusing on investments in development stage bio-pharmaceutical and med-tech technologies.  Mr. Kariv serves as an active board member of many of the funds' portfolio companies, assuming a special responsibility for strategic planning.  Among others, Mr. Kariv serves as the Chairman of Check-Cap Ltd and is a board member of Macrocure Ltd.  During the 10 years prior to establishing Pontifax in 2004, Mr. Kariv played a key role in investing, managing and nurturing technology driven companies and startups and has held senior management positions at top Israeli financial institutions. Mr. Kariv practiced law with Sullivan & Cromwell, a leading corporate law firm in New York, and holds a B.A. in Economics from Harvard University and a J.D. from Harvard Law School.

 

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Yacov Reizman has been the Chairman and Chief Executive Officer of FCC Ltd., a private investment company that he founded in 1987. Over the past decade FCC has invested directly in over 50 publicly traded and privately held companies in a diverse range of industries including: infrastructure; shipping; healthcare; and financial services.  FCC also specializes in corporate finance and structured investments. Mr. Reizman was also co-founder and co-CEO of Azimuth Ltd., which traded on the TASE.  Previously Mr. Reizman served in the Israeli Air Force (IAF) as a fighter pilot (Major) and led large-scale high-tech projects for the IAF, including joint projects with Israeli and U.S. defense industries. Mr. Reizman holds a B.A. in economics and in psychology from Tel Aviv University.

 

Steven Ruchefsky is President of Commercial Street Capital LLC, a private investment company and significant stockholder in Arno.  For the last decade, Mr. Ruchefsky has been working as an investment manager for the founder and CEO of a multi-billion dollar hedge fund. Mr. Ruchefsky began his career at a prominent New York City law firm where he became a partner, member of management and chair of a specialized litigation group. Upon leaving his law firm and prior to his current employment, Mr. Ruchefsky was a principal of an early stage venture capital operation. In addition to Arno, Mr. Ruchefsky currently sits on the boards of several public and private companies, including Itamar Medical (TASE: ITMR), Kite Pharma, Inc., and MD Solar Sciences, Inc.  Mr. Ruchefsky is a graduate of The George Washington University Law School.

 

Randy Thurman was appointed to Arno’s board of directors in January 2013. Mr. Thurman is an Operating Executive at AEA Investments LP, a private equity firm. Before joining AEA in October 2012, Mr. Thurman had been a Senior Advisor at New Mountain Capital, LLC, a private and public equity investment firm, since May 2008. From July 2008 to October 2011, Mr. Thurman served as a director of CardioNet, Inc. (NASDAQ:BEAT), a global leader in ambulatory cardiac monitoring and diagnosis, where he also served as Executive Chairman from July 2008 to January 2009, as President and Chief Executive Officer from February 2009 to June 2010, and as Chairman from June 2009 until his resignation from the board of directors in October 2011. From July 2007 through June 2008, Mr. Thurman served as a consultant to Cardinal Health, Inc., a global healthcare provider, following Cardinal Health’s July 2007 acquisition of VIASYS Healthcare Inc., a healthcare technology company at which Mr. Thurman had served as Chief Executive Officer since April 2001. Mr. Thurman currently serves as Executive Chairman of Cogent HMG, a national leader in the fields of hospital medicine and critical care medicine, and as a director of Allscripts Healthcare Solutions, Inc. (NASDAQ:MDRX), a healthcare information technology company. Mr. Thurman received a B.S. in Economics from Virginia Polytechnic Institute and an M.A. in Economics from Webster University.

 

Experience, Qualifications, Attributes and Skills of Directors

 

We look to our directors to lead us through our continued growth as an early-stage public biopharmaceutical company.  We believe our directors bring their leadership experience from a variety of life science companies and professional backgrounds which we require to continue to grow and bring value to our stockholders. Messrs. Kariv, Reizman, Ruchefsky, Tanen, and Thurman have venture capital or investment banking backgrounds and offer expertise in financing and growing small companies, particularly small biopharma and life science companies.  Each of Drs. Belldegrun and Hamilton and Mr. Tanen have significant experience with early stage private and public companies and bring depth of knowledge in building stockholder value, growing a company from inception and navigating significant corporate transactions and the public company process. Dr. Belldegrun’s medical background and experience serving as an investigator in clinical trials of oncology drug candidates allows him to contribute significant medical and scientific expertise.  Mr. Mattes’ extensive commercialization and general management experience and his current position as our President and Chief Executive Officer allow him to provide a unique insight into our development and growth.  As a result of his academic experience and his prior service on the audit committees of several publicly-traded life sciences companies, Dr. Hamilton also brings extensive finance, accounting and risk management knowledge to us. Mr. Thurman’s extensive experience in the health care industry allows him to contribute a wealth of operational, financial, and business development expertise to Arno.

 

Section 16(a) Beneficial Ownership Reporting Compliance

 

Our officers, directors and persons who are the beneficial owners of more than 10% of our common stock were not required to file beneficial ownership reports pursuant to Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), because we did not have a class of securities registered under Section 12 of the Exchange Act during the fiscal year ended December 31, 2012 .

 

Code of Ethics

 

We have adopted a Code of Ethics and Business Conduct that applies to all officers, directors and employees of our company.  A copy of our Code of Ethics and Business Conduct is available on our Investor Relations page of our company’s website at www.arnothera.com.   If we make any substantive amendments to the Code of Ethics and Business Conduct or grant any waiver from a provision of the code to an executive officer or director, we will promptly disclose the nature of the amendment or waiver by filing with the SEC a current report on Form 8-K.

 

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Audit Committee 

 

The current members of our Audit Committee are Dr. Hamilton (Chair), Mr. Reizman and Mr. Ruchefsky.  Our Board of Directors has determined that Dr. Hamilton qualifies as an “audit committee financial expert,” as defined by applicable rules of the SEC.  The Board has further determined that all members are “independent” within the meaning of the applicable listing standard of the NASDAQ Stock Market.

 

ITEM 11. EXECUTIVE COMPENSATION

 

Executive Compensation

 

The following table sets forth all of the compensation for the 2012 and 2011 fiscal years awarded to, earned by or paid to (i) our principal executive officer during the fiscal year ended December 31, 2012; and (ii) two other individuals that served as an executive officer at the conclusion of the fiscal year ended December 31, 2012 and who received in excess of $100,000 in total compensation during such fiscal year. We refer to these individuals as our named executives.

 

Summary Compensation Table

 

Name and Principal Position  Year  Salary
($)		   Bonus
($)		   Stock
Awards (1)
($)		   Option
Awards (1)
($)		   All Other
Compensation (2)
($)		   Total
($)		 
                            
Glenn R. Mattes (3)  2012   364,000    182,000    –    -    18,000    564,000 
President and CEO  2011   68,590    120,342    172,750    1,098,200    12,750    1,472,632 
Alexander Zukiwski, M.D. (4)  2012   394,000    197,000    –    -    12,000    603,000 
VP and Chief Medical Officer  2011   197,596    100,000    –    854,000    6,500    1,158,096 
Stefan Proniuk, Ph.D.  2012   208,000    68,640    –    -    -    276,640 
VP of Product Development  2011   181,817    47,000    –    19,300(5)   -    248,117 

 

  (1) Except as otherwise noted, amounts reflect the grant date fair value of stock awards and option awards granted under the Company’s 2005 Stock Option Plan, computed pursuant to Financial Accounting Standards Board’s Accounting Standards Codification 718 “Compensation – Stock Compensation”.

 

  (2) Amounts represent automobile allowances.

 

  (3) Mr. Mattes was appointed President and Chief Executive Officer on April 25, 2011.

 

  (4) Dr. Zukiwski was appointed Vice President, Chief Medical Officer on June 22, 2011.

 

  (5) On January 31, 2008, Dr. Proniuk was granted 10-year options to purchase 79,751 shares of our common stock at an exercise price of $2.42, with one-fourth vesting after one year and the remainder vesting in 36 equal monthly installments thereafter. On September 19, 2011, in consideration for cancelling the 10-year options to purchase 79,751 shares of our common stock that were issued to Dr. Proniuk on January 31, 2008, Dr. Proniuk was granted 10-year options to purchase 80,000 shares of our common stock at an exercise price of $1.00, with one-half immediately vested and the remainder vesting in 24 equal monthly installments commencing October 19, 2011. $19,300 represents the incremental fair value of the September 19, 2011 option award over the January 31, 2008 option award, computed pursuant to Financial Accounting Standards Board’s Accounting Standards Codification 718 “Compensation – Stock Compensation”.

 

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Employment Agreements, Termination of Employment and Change-in-Control Arrangements

 

Glenn Mattes

President and Chief Executive Officer

 

Mr. Mattes’ employment with us is governed by an employment agreement dated April 25, 2011.  The agreement provides for a three-year term expiring on April 25, 2014, subject to automatic renewal for successive one-year periods until either party provides the other party with at least 90 days’ prior written notice of nonrenewal.  Pursuant to the employment agreement, Mr. Mattes will receive an initial annualized base salary of $100,000 for a period of one year, after which his base salary will be increased to $350,000 per year, subject to further increases on an annual basis in accordance with the consumer price index plus 1%.  Accordingly, Mr. Mattes’ base salary was increased to $378,560 on January 1, 2013. The employment agreement further provides that, subject to the successful achievement of specific performance objectives to be established by the Board, Mr. Mattes will be eligible to receive an annual performance bonus of up to 50% of his annualized base salary; provided, however, that Mr. Mattes will be eligible to receive a performance bonus of up to $175,000 during the first year of the term.  For 2011, our Board of Directors awarded Mr. Mattes a performance bonus of $120,342, representing 100% of his target bonus prorated for his service during the year. For 2012, our Board awarded Mr. Mattes a performance bonus of $182,000, representing 100% of his target bonus. In the event of a “Change of Control” (as defined in the Company’s 2005 Stock Option Plan), Mr. Mattes shall receive a cash bonus in an amount equal to the greater of (a) $100,000, and (b) 0.15% of the amount by which the aggregate consideration to be received by Arno and/or our stockholders in connection with such Change of Control exceeds $100,000,000.

 

Pursuant to the employment agreement, on the date of the agreement, Mr. Mattes was granted 10-year options to purchase a total of 2,354,379 shares of our common stock at an exercise price equal to $1.00 per share.  Options relating to 60% of such shares are designated as “Employment Options” and options relating to the remaining 40% of the shares are designated as “Performance Options.”   The right to purchase 25% of the shares subject to the Employment Options will vest and become exercisable on April 25, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, with respect to one-third of the shares in each calendar year, or a pro-rata portion thereof for a period less than a full year, subject to the successful achievement of specific performance objectives to be established by the Board.  On January 17, 2012, the Board determined that, for the pro-rated period ended December 31, 2011, Mr. Mattes’ Performance Options would vest in the maximum potential amount of 215,872 shares. In addition, Mr. Mattes was granted 250,000 shares of our common stock (the “Restricted Shares”) on the date of the employment agreement.  The Restricted Shares shall vest in 12 equal monthly installments beginning on May 25, 2011. On January 14, 2013, the Board determined that, for the calendar year ended December 31, 2012, Mr. Mattes’ Performance Options would vest in the maximum potential amount of 313,917 shares.  

 

In January 2013, Mr. Mattes was granted 10-year options to purchase a total of 516,000 shares of our common stock at an exercise price equal to $0.30 per share.  Options relating to 60% of such shares are designated as “Employment Options” and options relating to the remaining 40% of the shares are designated as “Performance Options.”   The right to purchase one-third of the shares subject to the Employment Options vested immediately and the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments commencing January 31, 2013.  The right to purchase one-third of the shares subject to the Performance Options vested immediately and, of the remaining shares, 50% shall vest and become exercisable, if at all, in each calendar year thereafter, subject to the successful achievement of specific performance objectives to be established by the Board.

 

Also in January 2013, the exercise price applicable to all stock options previously granted to Mr. Mattes was reduced from $1.00 to $0.30, the conversion price of the Debentures issued in our 2012 Debenture and Warrant Offering.

 

The employment agreement provides that if Arno terminates Mr. Mattes without “Cause,” or if he resigns for “Good Reason” (each as defined in the agreement), then he shall be entitled to: (i) any earned but unpaid performance bonus; (ii) continued payment of his then current annualized base salary for a period of 12 months; (iii) an acceleration in the vesting of the Employment Options and Restricted Shares such that all unvested Employment Options and Restricted Shares shall be deemed vested as if Mr. Mattes had remained continuously employed with Arno for one year following his termination date; and (iv) the vesting of all earned but unvested Performance Options.  In addition to the foregoing, in the event that Mr. Mattes’ employment is terminated in connection with a Change in Control, then Mr. Mattes shall also be entitled to the immediate vesting of all unvested Employment Options, Performance Options, and Restricted Shares. 

 

Alexander Zukiwski, M.D.

Vice President and Chief Medical Officer

 

Dr. Zukiwski’s employment with us is governed by an employment agreement dated June 22, 2011.  The agreement provides for a three-year term expiring on June 22, 2014, subject to automatic renewal for successive one-year periods until either party provides the other party with at least 90 days’ prior written notice of nonrenewal.  Pursuant to the employment agreement, Dr. Zukiwski was entitled to an initial annualized base salary of $375,000, which was subsequently increased to $394,000 for 2012 and to $408,000 for 2013.  The employment agreement further provides that, subject to the successful achievement of specific performance objectives to be established by the Board, Dr. Zukiwski will be eligible to receive an annual performance bonus of up to 50% of his annualized base salary.  For 2011, our Board awarded Dr. Zukiwski a performance bonus of $100,000, representing approximately 100% of his target bonus, prorated for his service during the year. For 2012, our Board awarded Dr. Zukiwski a performance bonus of $197,000, representing 100% of his target bonus. Pursuant to the employment agreement, we have also agreed to reimburse Dr. Zukiwski in an amount up to $200,000 for expenses incurred in connection with the relocation of Dr. Zukiwski’s primary residence to the northern New Jersey area, which amounts are subject to repayment as described in the employment agreement in the event of Dr. Zukiwski’s voluntary termination of his employment (other than for “Good Reason,” as defined in the employment agreement) or Arno’s termination of his employment for “Cause” (as defined in the employment agreement).

 

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Pursuant to the employment agreement, on the date of the agreement, Dr. Zukiwski was granted 10-year options to purchase a total of 1,750,000 shares of our common stock at an exercise price equal to $1.00 per share.  Options relating to 50% of such shares are designated as “Employment Options” and options relating to the remaining 50% of the shares are designated as “Performance Options.”  The right to purchase 25% of the shares subject to the Employment Options will vest and become exercisable on June 22, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, with respect to one-third of the shares in each calendar year, or a pro-rata portion thereof for a period less than a full year, subject to the successful achievement of specific performance objectives to be established by the Board. On January 17, 2012, the Board determined that, for the pro-rated period ended December 31, 2011, Dr. Zukiwski’s Performance Options would vest in the maximum potential amount of 154,224 shares. On January 14, 2013, the Board determined that, for the calendar year ended December 31, 2012, Dr. Zukiwski’s Performance Options would vest in the maximum potential amount of 291,667 shares.

 

In January 2013, Dr. Zukiwski was granted 10-year options to purchase a total of 585,000 shares of our common stock at an exercise price equal to $0.30 per share.  Options relating to 50% of such shares are designated as “Employment Options” and options relating to the remaining 50% of the shares are designated as “Performance Options.”   The right to purchase one-third of the shares subject to the Employment Options vested immediately and the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments commencing January 31, 2013.  The right to purchase one-third of the shares subject to the Performance Options vested immediately and, of the remaining shares, 50% shall vest and become exercisable, if at all, in each calendar year thereafter, subject to the successful achievement of specific performance objectives to be established by the Board.

 

Also in January 2013, the exercise price applicable to all stock options previously granted to Dr. Zukiwski was reduced from $1.00 to $0.30, the conversion price of the Debentures issued in our 2012 Debenture and Warrant Offering.

 

The employment agreement provides that if Arno terminates Dr. Zukiwski without “Cause,” or if he resigns for “Good Reason” (each as defined in agreement), then he shall be entitled to: (i) any earned but unpaid performance bonus; (ii) continued payment of his then current annualized base salary for a period of 12 months; and (iii) the acceleration of the vesting of the Employment Options such that all unvested Employment Options shall be deemed vested as of the termination date.  In addition to the foregoing, in the event that Dr. Zukiwski’s employment is terminated 60 days prior to or within 12 months following a “Change in Control” (as defined in the employment agreement), Dr. Zukiwski shall also be entitled to the immediate vesting of all unvested Performance Options.

 

Stefan Proniuk, Ph.D.

Vice President of Product Development

 

Dr. Proniuk’s employment with us is governed by a letter agreement dated January 31, 2008, as amended on August 22, 2010. The letter agreement provides for Dr. Proniuk’s employment as our Director of Product Development on an at-will basis. Dr. Proniuk was subsequently promoted to Vice President of Product Development in January 2012. Under the letter agreement, Dr. Proniuk is entitled to an annual base salary of $150,000, which base salary was subsequently increased to $165,000 on November 16, 2008, to $167,000 on January 1, 2009, to $174,800 on January 1, 2011, to $187,800 on June 20, 2011, to $208,000 on January 1, 2012, and to $215,000 on January 1, 2013. In addition, the letter agreement provides that Dr. Proniuk is eligible to receive an annual performance bonus of up to 15% of his base salary upon the successful completion of annual corporate and individual milestones, which target percentage was subsequently increased to 25% on January 1, 2010 , and to 33% on January 1, 2012, and, solely with respect to the 2013 fiscal year, has been increased to 50%. For 2011, our Board awarded Dr. Proniuk a performance bonus of $47,000, representing approximately 103% of his target bonus. For 2012, our Board awarded Dr. Proniuk a performance bonus of $68,640, representing 100% of his target bonus.

 

Pursuant to the letter agreement, on the date of the agreement, Dr. Proniuk was granted 10-year options to purchase 79,751 shares of our common stock at an exercise price of $2.42, with one-fourth vesting after one year and the remainder vesting in 36 equal monthly installments thereafter. In addition, on June 20, 2011, Dr. Proniuk was granted 10-year options to purchase a total of 250,000 shares of our common stock at an exercise price equal to $1.00 per share. Options relating to 55% of such shares were designated as “Employment Options” and options relating to the remaining 45% of the shares were designated as “Performance Options.” The right to purchase 25,000 of the shares subject to the Employment Options vested immediately and, of the remaining shares, 25% vested on the first anniversary of the grant date, with the remainder vesting in 24 equal monthly installments thereafter. The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, with respect to one-third of the shares in each calendar year, or a pro-rata portion thereof for a period less than a full year, subject to the successful achievement of specific performance objectives to be established by the Board. On January 17, 2012, the Board determined that, for the pro-rated period ended December 31, 2011, Proniuk’s Performance Options would vest in the maximum potential amount of 20,034 shares. On January 14, 2013, the Board determined that, for the calendar year ended December 31, 2012, Dr. Proniuk’s Performance Options would vest in the maximum potential amount of 37,500 shares.

 

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In September 2011, in consideration for cancelling the 10-year options to purchase 79,751 shares of our common stock that were issued to Dr. Proniuk on January 31, 2008, Dr. Proniuk was granted 10-year options to purchase 80,000 shares of our common stock at an exercise price of $1.00, with one-half immediately vested and the remainder vesting in 24 equal monthly installments commencing October 19, 2011.

 

In January 2013, Dr. Proniuk was granted 10-year options to purchase a total of 110,000 shares of our common stock at an exercise price equal to $0.30 per share.  Options relating to 50% of such shares are designated as “Employment Options” and options relating to the remaining 50% of the shares are designated as “Performance Options.”   The right to purchase one-third of the shares subject to the Employment Options vested immediately and the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments commencing January 31, 2013.  The right to purchase one-third of the shares subject to the Performance Options vested immediately and, of the remaining shares, 50% shall vest and become exercisable, if at all, in each calendar year thereafter, subject to the successful achievement of specific performance objectives to be established by the Board.

 

Also in January 2013, the exercise price applicable to all stock options previously granted to Dr. Proniuk was reduced from $1.00 to $0.30, the conversion price of the Debentures issued in our 2012 Debenture and Warrant Offering.

 

Outstanding Equity Awards at Fiscal Year-End

 

The following table sets forth information concerning stock options held by the named executive officers at December 31, 2012:

 

Name  Number of
Securities
Underlying
Unexercised Options
Exercisable		   Number of
Securities
Underlying
Unexercised Options
Unexercisable		   Option Exercise
Price ($) (1)		   Option
Expiration Date		 
Mr. Mattes   215,872    725,880    1.00    4/25/21(2)
    706,313    706,314    1.00    4/25/21(3)
                     
Dr. Zukiwski   154,224    720,776    1.00    6/22/21(4)
    382,813    492,187    1.00    6/22/21(5)
                     
Dr. Proniuk   20,034    92,466    1.00    6/20/21(6)
    74,219    63,281    1.00    6/20/21(7)
    65,000    15,000    1.00    9/19/21(8)

 

(1) Effective January 14, 2013, the our Board of Directors determined that the exercise price applicable to all stock options listed below would be reduced from $1.00 to $0.30, the conversion price of the Debentures issued in our 2012 Debenture and Warrant Offering.
(2) Option granted April 25, 2011 relating to an aggregate of 941,752 shares and vesting up to one-third in each calendar year, or a pro-rata portion thereof for a period less than a full year, at the discretion of the Board of Directors.
(3) Option granted April 25, 2011 relating to an aggregate of 1,412,627 shares, of which 25% vested on the first anniversary of the grant date and the remainder vest in 24 equal monthly installments thereafter.
(4) Option granted June 22, 2011 relating to an aggregate of 875,000 shares and vesting up to one-third in each calendar year, or a pro-rata portion thereof for a period less than a full year, at the discretion of the Board of Directors.
(5) Option granted June 22, 2011 relating to an aggregate of 875,000 shares, of which 25% vested on the first anniversary of the grant date and the remainder vest in 24 equal monthly installments thereafter.
(6) Option granted June 20, 2011 relating to an aggregate of 112,500 shares and vesting up to one-third in each calendar year, or a pro-rata portion thereof for a period less than a full year, at the discretion of the Board of Directors.
(7) Option granted June 20, 2011 relating to an aggregate of 137,500 shares, of which 25,000 shares vested immediately and, of the remaining shares, 25% vested on the first anniversary of the grant date, with the remainder vesting in 24 equal monthly installments thereafter.
(8) Option granted September 19, 2011 relating to an aggregate of 80,000 shares, of which 50% vested immediately and the remainder vest in 24 equal monthly installments commencing October 19, 2011.

 

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Director Compensation

 

 Pursuant to the non-employee director compensation plan adopted by our Board of Directors, our non-employee directors are entitled to receive the following in consideration for their service on the Board: (1) an annual retainer of $25,000; (2) a stock option grant of 30,000 shares of the Company’s common stock upon their initial appointment or election to the Board; and (3) an annual stock option grant of 10,000 shares of the Company’s common stock.  In addition, any non-employee director designated as chairman of the Board is entitled to an annual retainer of $10,000, the chair of the Board’s audit committee is entitled to an additional annual retainer of $8,000, and the chairs of the Board’s compensation and nominating & corporate governance committees are entitled to annual retainers of $4,000.  In addition, Dr. Belldegrun receives an annual retainer equal to $150,000. Stock options awarded to our non-employee directors have a 10-year term, vest in three equal annual installments commencing on the first anniversary of the grant date, and have an exercise price equal to the fair market value of the Company’s common stock on the grant date.

 

The following table sets forth the compensation paid to our directors for their service in 2012.

 

Name  Fees earned or
paid in cash		   Option
Awards (1)		   Total 
Arie S. Belldegrun, M.D.  $150,000   $-   $150,000 
William F. Hamilton, Ph.D.  $33,000   $-   $33,000 
Tomer Kariv  $25,000   $-   $25,000 
Glenn Mattes  $-   $-   $- 
Yacov Reizman  $25,000   $-   $25,000 
Steven B. Ruchefsky  $25,000   $-   $25,000 
David M. Tanen  $25,000   $-   $25,000 

 _________________

 

  (1) No stock options were granted to our non-employee directors during 2012.

 

ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The following table summarizes certain information regarding the beneficial ownership (as such term is defined in Rule 13d-3 under the Exchange Act) of our common stock as of March 29, 2013 by: (i) each of our current directors, (ii) each of our “named executive officers,” as defined above under “Executive Compensation,” (iii) all of our current directors and executive officers as a group, and (iv) each person known by us to be the beneficial owner of more than 5% of our common stock.  Except as indicated in the footnotes below, the security and stockholders listed below possess sole voting and investment power with respect to their shares.  Except as otherwise indicated, the address of each of our executive officers and directors identified below is 200 Route 31 North, Suite 104, Flemington, New Jersey 08822.

 

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Name of Beneficial Owner  No. Shares of
Common Stock
Beneficially Owned (1)		   Percent of
Class (1)		 
Arie S. Belldegrun, M.D. (2)   11,363,359    24.1 
Glenn Mattes (3)   2,413,226    6.3 
Alexander Zukiwski (4)   2,692,922    6.9 
David M. Tanen (5)   1,628,782    4.5 
Stefan Proniuk, Ph.D. (6)   465,442    1.3 
William F. Hamilton, Ph.D. (7)   46,634    *  
Tomer Kariv (8)   14,582,877    30.5 
Yacov Reizman (9)   782,587    2.1 
Steven B. Ruchefsky (10)   15,891,109    31.8 
Randy Thurman (11)   66,666    * 
All current executive officers and directors as a group (11 persons)   50,183,138    64.1 
           
Pontifax (8)   14,582,877    30.5 
           
UTA Capital LLC (12)   3,041,917    8.1 
100 Executive Drive, Ste. 330          
West Orange, NJ  07052          
           
Commercial Street Capital, LLC (10)   15,891,109    31.8 
800 Westchester Ave.          
Rye Brook, NY  10573          
           
Clal Insurance Co. Ltd. (13)   3,127,781    8.5 
48 Menachem Begin St.          
Tel-Aviv 66180, Israel          
           
Wexford Capital LP (14)   3,891,777    10.5 
411 West Putnam Ave.          
Greenwich, CT 06830          
           
Peter and Donna Kash (15)(16)   3,790,606    9.9 
689 Fifth Ave., 12th Floor           
New York, NY 10022          
           
Auriga Investors – Montserrat Global Fund (16)(17)   7,500,000    9.9 
5-Rue Jean Monnet          
L-2180 Luxembourg          
           
Benjamin Domb (18)   2,000,000    5.2 
1010 Executive Court, Suite 250          
Westmont, IL 60559          
           
Brio Capital Master Fund Ltd. (16)(19)   4,000,000    9.9 
c/o Brio Capital Management LLC          
100 Merrick Road, Suite 401W          
Rockville Centre, NY 11570-4800          
           
Green Fields Offshore Inc. (20)   2,000,000    5.2 
Four Seasons Residences, Spring 19D          
Jl. Setiabudi Tengah          
Jakarta, 12910          
Indonesia          
           
Marjorie and David Kaufman (21)   2,500,000    6.4 
917 Taylors Lane          
Mamaroneck, NY 10543          
           
Maxim Partners LLC (22)   2,430,000    6.0 
c/o Maxim Group LLC          
405 Lexington Avenue, 2nd Floor          
New York, NY 10174          
           
Perceptive Life Sciences Master Fund, Ltd. (16)(23)   30,000,000    9.9 
c/o Perceptive Advisors LLC          
499 Park Ave, 25th Floor           
New York, NY 10022          
           
Quantum Partners LP (16)(24)   32,499,999    9.9 
c/o Soros Fund Management LLC          
888 Seventh Avenue          
New York, NY 10106          
           
RJB Partners LLC (25)   2,000,000    5.2 
40 E. Main St., Suite 822          
Newark, DE 19711          
           
Sabby Management, LLC (16)(26)   20,000,000    9.9 
10 Mountainview Road, Suite 205          
Upper Saddle River, NJ 07458          

 

 

* represents less than 1%.

 

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  (1) Based upon 36,364,942 issued and outstanding shares of our common stock as of March 29, 2013.  Beneficial ownership is determined in accordance with Rule 13d-3 under the Securities Act, and includes any shares as to which the security or stockholder has sole or shared voting power or investment power, and also any shares which the security or stockholder has the right to acquire within 60 days of the date hereof, whether through the exercise or conversion of any stock option, convertible security, warrant or other right.  The indication herein that shares are beneficially owned is not an admission on the part of the security or stockholder that he, she or it is a direct or indirect beneficial owner of those shares.
  (2) Beneficial ownership includes: (i) 516,043 shares issuable upon the exercise of stock options held by Dr. Belldegrun; (ii) 127,619 shares of our common stock, 1,166,666 shares issuable upon the conversion of Debentures, 2,333,334 shares issuable upon the exercise of 2012 Warrants, and 62,500 shares issuable upon the exercise of other warrants held by Arie and Rebecka Belldegrun as Trustees of the Belldegrun Family Trust dated February 18, 1994; (iii) 666,666 shares issuable upon the conversion of Debentures and 1,333,334 shares issuable upon the exercise of 2012 Warrants held by the Arie S. Belldegrun M.D. Inc. Profit Sharing Plan; (iv) 317,155 shares of our common stock and 125,000 shares issuable upon the exercise of warrants held by Leumi Overseas Trust Corporation Limited (“Leumi”) as Trustee of the BTL Trust; (v) 1,000,000 shares issuable upon the conversion of Debentures and 2,000,000 shares issuable upon the exercise of 2012 Warrants held by Leumi as Trustee of the Tampere Trust; and (vi) 127,619 shares of our common stock, 500,000 shares issuable upon the conversion of Debentures, 1,000,000 shares issuable upon the exercise of 2012 Warrants, and 62,500 shares issuable upon the exercise of other warrants held by MDRB Partnership, L.P. (“MDRB”). Dr. Belldegrun is a beneficiary of each of the BTL Trust and the Tampere Trust and is the managing partner of MDRB.  Dr. Belldegrun holds voting and/or dispositive power over the shares held by MDRB and the Arie S. Belldegrun M.D. Inc. Profit Sharing Plan. Richard J. Guillaume and Christopher R.P. Lees, directors of Leumi, hold voting and/or dispositive power over the shares held by Leumi as trustee of each of the BTL Trust and the Tampere Trust.
  (3) Beneficial ownership includes 166,666 shares issuable upon conversion of Debentures, 333,334 shares issuable upon exercise of 2012 Warrants, and 1,663,225 shares issuable upon the exercise of options.
  (4) Beneficial ownership includes 500,000 shares issuable upon conversion of Debentures, 1,000,000 shares issuable upon exercise of 2012 Warrants, and 1,192,922 shares issuable upon the exercise of options.
  (5) Beneficial ownership includes 149,532 shares held by Mr. Tanen’s minor children and 105,554 shares issuable upon the exercise of options and warrants held by Mr. Tanen.
  (6) Beneficial ownership includes 66,667 shares issuable upon conversion of Debentures, 133,334 shares issuable upon exercise of 2012 Warrants, and 265,441 shares issuable upon the exercise of options.
  (7) Includes 36,666 shares issuable upon the exercise of stock options.
  (8) Beneficial ownership includes: (i) 20,000 shares issuable upon the exercise of stock options held by Mr. Kariv; and (ii) 14,562,877 shares held by affiliates of Pontifax, of which Mr. Kariv is chief executive officer, including 3,333,334 shares issuable upon the conversion of Debentures, 6,666,668 shares issuable upon the exercise of 2012 Warrants, and 1,500,000 shares issuable upon the exercise of other warrants.
  (9) Beneficial ownership includes: (i) 20,000 shares issuable upon the exercise of stock options held by Mr. Reizman; and (ii) 762,587 shares held by FCC Ltd., of which Mr. Reizman is chairman and chief executive officer, including 456,300 shares issuable upon the exercise of warrants.
  (10) Beneficial ownership includes: (i) 45,000 shares issuable upon the exercise of options and warrants held by Mr. Ruchefsky; and (ii) 15,846,109 shares held by Commercial Street Capital, LLC, of which Mr. Ruchefsky is president, including 4,166,666 shares issuable upon the conversion of Debentures, 8,333,334 shares issuable upon the exercise of 2012 Warrants, and 1,100,000 shares issuable upon the exercise of other warrants. Mr. Ruchefsky holds voting and/or dispositive power over the shares held by Commercial Street Capital, LLC.
  (11) Represents shares issuable upon the exercise of options.
  (12) Includes 1,000,000 shares issuable upon the exercise of warrants.
  (13) Includes 550,000 shares issuable upon the exercise of warrants.
  (14) Beneficial ownership includes: (i) 527,613 shares of our common stock held by Kappa Investors, LLC (“Kappa”), including 108,737 shares issuable upon the exercise of warrants; and (ii) 3,364,164 shares of our common stock held by Wexford Spectrum Investors LLC, a Delaware limited liability company ("Wexford Spectrum"), including 535,995 shares issuable upon the exercise of warrants.  Wexford Capital LP, a Delaware partnership (“Wexford Capital”), is a registered Investment Advisor and also serves as an investment advisor or sub-advisor to the members of Kappa and Wexford Spectrum.  Wexford GP LLC (“Wexford GP”) is the general partner of Wexford Capital. Mr. Charles E. Davidson and Mr. Joseph M. Jacobs are each managing and controlling members of Wexford GP.
  (15) Beneficial ownership includes: (i) 600,000 shares issuable upon the conversion of Debentures, 1,200,000 shares issuable upon the exercise of 2012 Warrants, and 50,000 shares issuable upon the exercise of other warrants held by Dr. and Mrs. Kash; (ii) 1,479,635 shares, including 152,006 shares issuable upon the exercise of options and warrants, held by Dr. Kash; and (iii) 358,876 shares held by Mrs. Kash as custodian for the benefit of their minor children under the UGMA.

 

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  (16) Notwithstanding the number of shares of our common stock shown as beneficially owned by the security holder in the table above, the Debentures and 2012 Warrants held by the security holder provide that the security holder may not convert or exercise such Debentures or 2012 Warrants to the extent that the security holder would beneficially own in excess of 9.99% of our outstanding common stock immediately after giving effect to such conversion or exercise.
  (17) Represents 2,500,000 shares issuable upon the conversion of Debentures and 5,000,000 shares issuable upon the exercise of 2012 Warrants. Dr. Raj Mehra holds voting and/or dispositive power over the shares held by Auriga Investors – Montserrat Global Fund.
  (18) Represents 666,666 shares issuable upon the conversion of Debentures and 1,333,334 shares issuable upon the exercise of 2012 Warrants.
  (19) Represents 1,333,333 shares issuable upon the conversion of Debentures and 2,666,667 shares issuable upon the exercise of 2012 Warrants. Shaye Hirsch holds voting and/or dispositive power over the shares held by Brio Capital Master Fund Ltd.
  (20) Represents 666,666 shares issuable upon the conversion of Debentures and 1,333,334 shares issuable upon the exercise of 2012 Warrants. Anton Linderum holds voting and/or dispositive power over the shares held by Green Fields Offshore Inc.
  (21) Represents 833,333 shares issuable upon the conversion of Debentures and 1,666,666 shares issuable upon the exercise of 2012 Warrants.
  (22) Beneficial ownership includes 2,270,000 shares issuable upon the exercise of warrants. Michael Rabinowitz holds voting and/or dispositive power over the shares held by Maxim Partners LLC.
  (23) Represents 10,000,000 shares issuable upon the conversion of Debentures and 20,000,000 shares issuable upon the exercise of 2012 Warrants. Joseph Edelman holds voting and/or dispositive power over the shares held by Perceptive Life Sciences Master Fund, Ltd.
  (24) Represents 10,833,333 shares issuable upon the conversion of Debentures and 21,666,666 shares issuable upon the exercise of 2012 Warrants. Soros Fund Management LLC (“SFM”) serves as principal investment manager to Quantum Partners LP. As such, SFM has been granted investment discretion over portfolio investments, including the shares reported in the table above, held for the account of Quantum Partners LP. George Soros serves as Chairman of SFM and Robert Soros serves as President and Deputy Chairman of SFM. 
  (25) Represents 666,666 shares issuable upon the conversion of Debentures and 1,333,334 shares issuable upon the exercise of 2012 Warrants. Joseph Sanberg holds voting and/or dispositive power over the shares held by RJB Partners LLC.
  (26) Represents: (i) 4,166,666 shares issuable upon the conversion of Debentures and 8,333,334 shares issuable upon the exercise of 2012 Warrants held by Sabby Healthcare Volatility Master Fund, Ltd.; and (ii) 2,500,000 shares issuable upon the conversion of Debentures and 5,000,000 shares issuable upon the exercise of 2012 Warrants held by Sabby Volatility Warrant Master Fund, Ltd.  Each of Sabby Healthcare Volatility Master Fund, Ltd. and Sabby Volatility Warrant Master Fund, Ltd. (collectively, the “Sabby Funds”) has indicated to us that Hal Mintz has voting and investment power over the shares held by it. Each of the Sabby Funds has also indicated to us that Sabby Management, LLC serves as its investment manager, that Hal Mintz is the manager of Sabby Management, LLC and that each of Sabby Management, LLC and Hal Mintz disclaim beneficial ownership over these shares except to the extent of any pecuniary interest therein.

 

Securities Authorized for Issuance under Equity Compensation Plans

 

We grant stock options and other equity incentive awards pursuant to our 2005 Stock Option Plan (the “Plan”), which has been approved by our stockholders. The following table sets forth certain information as of December 31, 2012 with respect to the Plan:

 

Plan category  Number of
Securities to be
Issued Upon Exercise of
Outstanding Options
(A)		   Weighted-Average
Exercise Price of
Outstanding Options
(B)		   Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation Plans
(Excluding Securities
Reflected in Column (A))
(C)		 
             
Equity compensation plans approved by security holders:               
2005 Stock Option Plan   5,778,866   $1.11    901,290 
                
Equity compensation plans not approved by stockholders:               
None   —    —    — 
                
Total   5,778,866   $1.11    901,290 

_______________

 

54
 

 

On January 14, 2013, the Company’s Board of Directors approved an amendment to the Plan to increase the number of shares of common stock issuable under the Plan from 7,000,000 shares to 7,312,210 shares. Also on January 14, 2013, our Board of Directors authorized amendments to outstanding stock option awards relating to an aggregate of 4,444,379 shares to reduce the exercise price of such stock options from $1.00 to $0.30 per share, which price the Board of Directors determined was at least equal to the fair market value of our common stock.

 

ITEM 13.certain relationships and related transactions, and director independence

 

Certain Relationships and Related Transactions

 

Dr. Belldegrun and Mr. Tanen, each a current director and substantial stockholder of Arno, and Mr. Kazam, a director until September 2010 and substantial stockholder of Arno, control Two River Consulting, LLC, or TRC.  Certain employees of TRC, including Mr. Tanen, our former President, and Mr. Scott L. Navins, our Treasurer, perform substantial services for us, including without limitation operational, managerial, financial, clinical and regulatory activities for which we have historically paid TRC a monthly consulting fee of $55,000 pursuant to a services agreement.  While the term of the services agreement expired on April 1, 2011, we continue to utilize the services of TRC on an as needed basis.  Other than the payments to TRC, we do not pay any salary or other compensation to Messrs. Tanen and Navins for their services to us.

 

Mr. Kazam, Mr. Tanen and Mr. Peter M. Kash, a director of Arno until April 2011, are also principals of Riverbank Capital Securities, Inc., a FINRA member broker dealer that acted as our placement agent in connection with our September 2010 and June 2008 private placements.   Additionally, Mr. Navins, our Treasurer, is also the Financial and Operations Principal of Riverbank. In consideration for its services in connection with the September 2010 private placement, we paid Riverbank a placement fee of approximately $789,880 and issued to designees of Riverbank five-year warrants to purchase an aggregate of 664,880 shares of Series A Preferred Stock at an initial exercise price of $1.10 per share.  Riverbank did not receive any selling commission for its services in connection with the June 2008 private placement, but received a non-accountable expense allowance of $100,000.

 

Pursuant to a Consulting Agreement entered into between Arno and Fountainhead Capital Management Limited, we paid a $500,000 consulting fee to Fountainhead Capital upon completion of the merger with Laurier.  Fountainhead Capital Management was a significant stockholder of Laurier at the time of the merger.

 

Director Independence

 

In determining whether the members of our board of directors and its committees are independent, we have elected to use the definition of “independence” set forth in the listing standards of the NASDAQ Stock Market. After considering all relevant relationships and transactions, our board of directors, in consultation with legal counsel, has determined that Messrs. Kariv, Reizman, Ruchefsky, Thurman and Dr. Hamilton are “independent” within the meaning of the applicable listing standard of the NASDAQ Stock Market. Messrs. Mattes, Tanen and Dr. Belldegrun are not independent, as defined by applicable NASDAQ listing standards.

 

ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

Fees Billed to the Company by Its Independent Registered Public Accounting Firm

 

The following is a summary of the fees billed to us by Crowe Horwath LLP, our independent registered public accounting firm for professional services rendered for fiscal years ended December 31, 2012 and 2011:

 

Fee Category  2012 Fees   2011 Fees 
Audit Fees  $112,000   $106,000 
Audit-Related Fees (1)   15,848    1,885 
Tax Fees (2)   6,500    6,500 
All Other Fees (3)   -    - 
           
Total Fees  $134,348   $114,385 

 

55
 

_______________

 

  (1) Audit-Related Fees consist principally of assurance and related services that are reasonably related to the performance of the audit or review of the Company’s financial statements but not reported under the caption “Audit Fees.”

 

  (2) Tax Fees consist of fees for tax compliance, tax advice and tax planning.

 

  (3) All Other Fees consist of aggregate fees billed for products and services provided by the independent registered public accounting firm, other than those disclosed above.

 

Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Auditors

 

Our Audit Committee has engaged Crowe Horwath LLP as our independent registered public accounting firm for our 2012 fiscal year.  At present, the Audit Committee approves each engagement for audit or non-audit services before the Company engages its independent public accountants to provide those services.  The Audit Committee has not established any pre-approval policies or procedures that would allow the Company’s management to engage its independent auditor to provide any specified services with only an obligation to notify the audit committee of the engagement for those services. None of the services provided by the Company’s independent auditors for fiscal year 2012 was obtained in reliance on the waiver of the pre-approval requirement afforded in SEC regulations.

 

 

56
 

 

PART IV

 

ITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

 

Exhibit Number   Description of Document
2.1    Agreement and Plan of Merger dated March 5, 2008, by and among Laurier International, Inc., Laurier Acquisition, Inc. and Arno Therapeutics, Inc. (incorporated by reference to Exhibit 2.1 of the Registrant’s Form 8-K filed March 6, 2008).
2.2   Amendment No. 1 dated May 12, 2008 to Agreement and Plan of Merger by and among Laurier International, Inc., Laurier Acquisition, Inc. and Arno Therapeutics, Inc. (incorporated by reference to Exhibit 2.2 of the Registrant’s Registration Statement on Form S-1 filed July 31, 2008, SEC File No. 333-152660).
2.3   Amendment No. 2 dated May 30, 2008 to Agreement and Plan of Merger by and among Laurier International, Inc., Laurier Acquisition, Inc. and Arno Therapeutics, Inc. (incorporated by reference to Exhibit 2.3 of the Registrant’s Registration Statement on Form S-1 filed July 31, 2008, SEC File No. 333-152660).
3.1   Amended & Restated Certificate of Incorporation of Arno Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
3.2   Certificate of Amendment of Amended & Restated Certificate of Incorporation of Arno Therapeutics, Inc. (incorporated by reference to Exhibit 3.1 of the Registrant’s Form 8-K filed November 27, 2012).
3.3   Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 of the Registrant’s Registration Statement on Form SB-2 filed October 2, 2002, SEC File No. 333-100259).
3.4   Certificate of Designation of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 3.3 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
4.1   Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 of the Registrant’s Form 8-K filed June 9, 2008).
4.2   Form of Common Stock Purchase Warrant issued to former note holders of Arno Therapeutics, Inc. (incorporated by reference to Exhibit 4.2 of the Registrant’s Form 8-K filed June 9, 2008).
4.3   Form of Class A Warrant issued to investors in September 2010 private placement (incorporated by reference to Exhibit 4.3 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
4.4   Form of Class B Warrant issued to investors in September 2010 private placement (incorporated by reference to Exhibit 4.4 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
4.5   Form of Placement Agent Warrant issued in September 2010 private placement (incorporated by reference to Exhibit 4.5 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
4.6   Form of 8% Senior Convertible Debenture issued to investors in November 2012 private placement (incorporated by reference to Exhibit 4.1 of the Registrant’s Form 8-K filed November 27, 2012).
4.7   Form of Series A/B Warrant issued to investors in November 2012 private placement (incorporated by reference to Exhibit 4.2 of the Registrant’s Form 8-K filed November 27, 2012).
4.8   Form of Placement Agent Warrant issued in November 2012 private placement (incorporated by reference to Exhibit 4.8 of the Registrant’s Registration Statement on Form S-1 filed December 26, 2012, SEC File No. 333-185690).
10.1   Letter agreement dated January 31, 2008 between Arno Therapeutics, Inc. and Stefan Proniuk.*
10.2   Arno Therapeutics, Inc. 2005 Stock Option Plan, as amended through January 14, 2013 (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed January 18, 2013).*
10.3   Form of stock option agreement for use under Arno Therapeutics, Inc. 2005 Stock Option Plan (incorporated by reference to Exhibit 10.4 of the Registrant’s Form 8-K filed June 9, 2008).*
10.4   License Agreement dated October 25, 2006 between Arno Therapeutics, Inc. and The University of Pittsburgh (incorporated by reference to Exhibit 10.5 of the Registrant’s Form 8-K filed June 9, 2008).+
10.5   License Agreement dated January 3, 2008 between Arno Therapeutics, Inc. and The Ohio State University Research Foundation (incorporated by reference to Exhibit 10.6 of the Registrant’s Form 8-K filed June 9, 2008).+
10.6   License Agreement dated January 9, 2008 between Arno Therapeutics, Inc. and The Ohio State University Research Foundation (incorporated by reference to Exhibit 10.7 of the Registrant’s Form 8-K filed June 9, 2008).+
10.7   Form of Subscription Agreement between Arno Therapeutics, Inc. and the investors in the June 2, 2008 private placement (incorporated by reference to Exhibit 10.8 of the Registrant’s Form 8-K filed June 9, 2008).

 

57
 

 

10.8   Services Agreement dated June 1, 2009, between Arno Therapeutics, Inc. and Two River Consulting, LLC (incorporated by reference to Exhibit 10.11 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
10.9   Form of Securities Purchase and Registration Rights Agreement dated September 3, 2010 among Arno Therapeutics, Inc. and the purchasers identified therein (incorporated by reference to Exhibit 10.13 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
10.10   First Amendment to Services Agreement dated September 9, 2010, between Arno Therapeutics, Inc. and Two River Consulting, LLC (incorporated by reference to Exhibit 10.14 of the Registrant’s Registration Statement on Form S-1 filed November 8, 2010, SEC File No. 333-170474).
 10.11   Letter Agreement dated February 18, 2010 between Arno Therapeutics, Inc. and Two River Consulting, LLC (incorporated by reference to Exhibit 10.15 of the Registrant’s Registration Statement on Form S-1 filed January 18, 2011, SEC File No. 333-170474).
10.12   Letter agreement dated August 22, 2010 between Arno Therapeutics, Inc. and Stefan Proniuk.*
10.13   Employment Agreement by and between Arno Therapeutics, Inc. and Glenn Mattes, dated April 25, 2011 (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed April 28, 2011).*
10.14   Restricted Stock Agreement between Arno Therapeutics, Inc. and Glenn Mattes, dated April 25, 2011 (incorporated by reference to Exhibit 10.3 of the Registrant’s Form 10-Q for the quarter ended June 30, 2011).*
10.15   Stock Option Agreement (Employment Options) between Arno Therapeutics, Inc. and Glenn Mattes, dated April 25, 2011 (incorporated by reference to Exhibit 10.4 of the Registrant’s Form 10-Q for the quarter ended June 30, 2011).*
10.16   Stock Option Agreement (Performance Options) between Arno Therapeutics, Inc. and Glenn Mattes, dated April 25, 2011 (incorporated by reference to Exhibit 10.5 of the Registrant’s Form 10-Q for the quarter ended June 30, 2011).*
10.17   Indemnification Agreement by and between Arno Therapeutics, Inc. and Glenn Mattes, dated April 25, 2011 (incorporated by reference to Exhibit 10.2 of the Registrant’s Form 8-K filed April 28, 2011).*
10.18   Employment Agreement by and between Arno Therapeutics, Inc. and Alex Zukiwski, dated June 22, 2011 (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed June 28, 2011).*
10.19   Stock Option Agreement (Employment Options) between Arno Therapeutics, Inc. and Alex Zukiwski, dated June 22, 2011 (incorporated by reference to Exhibit 10.8 of the Registrant’s Form 10-Q for the quarter ended June 30, 2011).*
10.20   Stock Option Agreement (Performance Options) between Arno Therapeutics, Inc. and Alex Zukiwski, dated June 22, 2011 (incorporated by reference to Exhibit 10.9 of the Registrant’s Form 10-Q for the quarter ended June 30, 2011).*
10.21   Exclusive License Agreement dated February 13, 2012 between Arno Therapeutics, Inc. and Invivis Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 10-Q for the quarter ended March 31, 2012).+
10.22   Master Services Agreement dated February 13, 2012 between Arno Therapeutics, Inc. and Invivis Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.2 of the Registrant’s Form 10-Q for the quarter ended March 31, 2012).+
10.23   Form of Securities Purchase Agreement dated November 26, 2012 among Arno Therapeutics, Inc. and the Purchasers identified therein (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed November 27, 2012).
10.24   Form of Registration Rights Agreement dated November 26, 2012 among Arno Therapeutics, Inc. and the Holders identified therein (incorporated by reference to Exhibit 10.2 of the Registrant’s Form 8-K filed November 27, 2012).
10.25   Amendment No. 1 dated December 13, 2012 to Securities Purchase Agreement dated November 26, 2012 among Arno Therapeutics, Inc. and the Purchasers identified therein (incorporated by reference to Exhibit 10.25 of the Registrant’s Registration Statement on Form S-1 filed December 26, 2012, SEC File No. 333-185690).
10.26   Letter Agreement between Arno Therapeutics, Inc. and Randy Thurman, dated January 30, 2013 (incorporated by reference to Exhibit 10.1 of the Registrant’s Form 8-K filed February 4, 2013).*
24.1   Power of Attorney (included on signature page hereof).
31.1   Certification of Principal Executive Officer.
31.2   Certification of Principal Financial Officer.
32.1   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101   The following financial information from Arno Therapeutics, Inc.’s Annual Report on Form 10-K for the annual period ended December 31, 2012, formatted in eXtensible Business Reporting Language (XBRL): (i) Balance Sheets as of December 31, 2012 and 2011, (ii) Statements of Operations for the years ended December 31, 2012 and 2011, and for the period from August 1, 2005 (inception) through December 31, 2012, (iii) Statement of Stockholders’ Equity (Deficiency) for the period from August 1, 2005 (inception) through December 31, 2012, (iv) Statements of Cash Flows for the years ended December 31, 2012 and 2011, and for the period from August 1, 2005 (inception) through December 31, 2012, and (v) Notes to Financial Statements. ^

 

58
 

 

 
  + Confidential treatment has been granted as to certain omitted portions of this exhibit pursuant to Rule 406 of the Securities Act or Rule 24b-2 of the Exchange Act.
  * Indicates a management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K.
  ^ Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 to this Annual Report on Form 10-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be deemed part of a registration statement, prospectus or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filings.

 

59
 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on April 1, 2013.

 

  ARNO THERAPEUTICS, INC.
   
  By: /s/ Glenn Mattes
    Glenn Mattes
    President and Chief Executive Officer

 

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Glenn Mattes and Scott L. Navins, and each of them, his true and lawful attorneys-in-fact and agent, with full power of substitution and resubstitution, for him in his name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and all other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitutes, may lawfully do or cause to be done by virtue thereof.

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities and on the dates indicated.

 

Signature   Title   Date
         
/s/ Glenn Mattes   President, Chief Executive Officer, and Director   April 1, 2013
Glenn Mattes   (Principal Executive Officer)    
         
/s/ Scott L. Navins   Treasurer   April 1, 2013
Scott L. Navins   (Principal Financial and Accounting Officer)    
         
/s/ Arie S. Belldegrun, M.D.   Chairman of the Board   April 1, 2013
Arie S. Belldegrun, M.D.        
         
/s/ William F. Hamilton, Ph.D.   Director   April 1, 2013
William F. Hamilton, Ph.D.        
         
/s/ Tomer Kariv   Director   April 1, 2013
Tomer Kariv        
         
/s/ Yacov Reizman   Director   April 1, 2013
Yacov Reizman        
         
/s/ Steven B. Ruchefsky   Director   April 1, 2013
Steven B. Ruchefsky        
         
/s/ David M. Tanen   Secretary and Director   April 1, 2013
David M. Tanen        
         
/s/ Randy Thurman   Director   April 1, 2013
Randy Thurman        

 

60
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

 

INDEX TO FINANCIAL STATEMENTS

 

    Page
     
Report of Independent Registered Public Accounting Firm   F-2
Balance Sheets   F-3
Statements of Operations   F-4
Statement of Stockholders’ Equity (Deficiency)   F-5
Statements of Cash Flows   F-6
Notes to Financial Statements   F-7

 

F-1
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

 

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and stockholders

Arno Therapeutics, Inc.

Flemington, New Jersey

 

We have audited the accompanying balance sheets of Arno Therapeutics, Inc. (a development stage company) as of December 31, 2012 and 2011, and the related statements of operations, stockholders' equity, and cash flows for the years then ended and the period from August 1, 2005 (inception) through December 31, 2012. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2012 and 2011, and the results of its operations and its cash flows for the years then ended and the period from August 1, 2005 (inception) through December 31, 2012, in conformity with U.S. generally accepted accounting principles.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company is in the development stage, has not generated any revenues and has recurring net losses from operations. These events raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ Crowe Horwath LLP

 

New York, New York

April 1, 2013

 

F-2
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

BALANCE SHEETS

 

   December 31, 2012   December 31, 2011 
ASSETS          
Current assets          
Cash and cash equivalents  $10,943,437   $6,678,344 
Prepaid expenses and other current assets   203,516    296,948 
           
Total current assets   11,146,953    6,975,292 
           
Property and equipment, net   24,837    38,673 
Deferred financing fees   1,709,530    - 
Security deposit   10,455    10,455 
           
Total assets  $12,891,775   $7,024,420 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current liabilities          
Accounts  payable  $1,553,154   $683,161 
Accrued  expenses and other current liabilities   1,652,159    1,188,041 
Due to related party   28,268    84,756 
Deferred rent   12,711    7,351 
           
Total current liabilities   3,246,292    1,963,309 
           
Convertible debentures, net   491,039    - 
Derivative liabilities   21,420,276    3,705,472 
           
Total liabilities   25,157,607    5,668,781 
           
COMMITMENTS AND CONTINGENCIES          
           
STOCKHOLDERS' (DEFICIT) EQUITY          
Preferred stock, $0.0001 par value, 35,000,000 shares authorized,          
none issued and outstanding   -    - 
Common stock, $0.0001 par value, 500,000,000 shares authorized, 36,364,942 and 36,304,942  shares issued and outstanding   3,611    3,605 
Additional paid-in capital   37,631,339    36,865,034 
Deficit accumulated during the development stage   (49,900,782)   (35,513,000)
           
Total stockholders' (deficit) equity   (12,265,832)   1,355,639 
           
Total liabilities and stockholders' (deficit) equity  $12,891,775   $7,024,420 

 

See accompanying notes to financial statements

 

F-3
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

STATEMENTS OF OPERATIONS

 

           Period from 
   Year ended December 31,   August 1, 2005 
           (inception) to 
   2012   2011   December 31, 2012 
             
Operating expenses:               
Research and development  $8,537,130   $5,690,836   $36,845,208 
General and administrative   2,298,671    1,956,115    9,342,612 
                
Total operating expenses   10,835,801    7,646,951    46,187,820 
                
Loss from operations   (10,835,801)   (7,646,951)   (46,187,820)
                
Other income (expense):               
Interest income   7,849    28,771    414,120 
Interest expense   (6,361,029)   -    (7,621,128)
Other income (expense)   2,801,199    (290,933)   3,494,046 
                
Total other income (expense)   (3,551,981)   (262,162)   (3,712,962)
                
Net loss  $(14,387,782)  $(7,909,113)  $(49,900,782)
                
Preferred stock dividends  $-   $81,651      
                
Net loss available to common stockholders  $(14,387,782)  $(7,990,764)     
                
Net loss per share - basic and diluted  $(0.40)  $(0.23)     
                
Weighted-average shares outstanding -basic and diluted   36,322,565    34,514,594      

 

See accompanying notes to financial statements

 

F-4
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIENCY)

Period from August 1, 2005 (inception) through December 31, 2012

 

   PREFERRED STOCK   COMMON STOCK       DEFICIT     
                       ACCUMULATED     
                   ADDITIONAL   DURING THE   TOTA 
                   PAID-IN   DEVELOPMENT   STOCKHOLDERS' 
   SHARES   AMOUNT   SHARES   AMOUNT   CAPITAL   STAGE   EQUITY (DEFICIT) 
Issuance of common shares to founders at $0.0001 per share   -   $-    9,968,797   $997   $4,003   $-   $5,000 
                                    
Stock based compensation for services   -    -    -    -    9,700    -    9,700 
                                    
Net loss, period from August 1, 2005 (inception) through December 31, 2006   -    -    -    -    -    (370,893)   (370,893)
                                    
Balance at December 31, 2006   -    -    9,968,797    997    13,703    (370,893)   (356,193)
                                    
Stock based compensation for services   -    -    -    -    88,300    -    88,300 
                                    
Net loss, year ended December 31, 2007   -    -    -    -    -    (3,359,697)   (3,359,697)
                                    
Balance at December 31, 2007   -    -    9,968,797    997    102,003    (3,730,590)   (3,627,590)
                                    
Common stock sold in private placement, net of issuance costs of $141,646   -    -    7,360,689    736    17,689,301    -    17,690,037 
                                    
Conversion of notes payable upon closing of private placement   -    -    1,962,338    196    4,278,322    -    4,278,518 
                                    
Note discount arising from note conversion   -    -    -    -    475,391    -    475,391 
                                    
Warrants issued in connection with note conversion   -    -    -    -    348,000    -    348,000 
                                    
Reverse merger transaction -                                   
elimination of accumulated deficit   -    -    -    -    (120,648)   -    (120,648)
previously issued Laurier common stock   -    -    1,100,200    110    120,538    -    120,648 
                                    
Warrants issued for services   -    -    -    -    480,400    -    480,400 
                                    
Stock based compensation for services   -    -    -    -    1,131,218    -    1,131,218 
                                    
Net loss, year ended December 31, 2008                            (12,913,566)   (12,913,566)
                                    
Balance at December 31, 2008   -    -    20,392,024    2,039    24,504,525    (16,644,156)   7,862,408 
                                    
Stock based compensation for services   -    -    -    -    647,448    -    647,448 
                                    
Stock option exercise   -    -    20,000    2    2,598    -    2,600 
                                    
Net loss, year ended December 31, 2009                            (6,936,705)   (6,936,705)
                                    
Balance at December 31, 2009   -    -    20,412,024    2,041    25,154,571    (23,580,861)   1,575,751 
                                    
Stock based compensation for services   -    -    -    -    249,286    -    249,286 
                                    
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770   15,274,000    1,527    -    -    13,507,983    -    13,509,510 
                                    
Warrants issued in connection with convertible preferred units issued in private placement   -    -    -    -    (3,340,421)   -    (3,340,421)
                                    
Warrants issues to placement agents in connection with private placement   -    -    -    -    464,720    -    464,720 
                                    
Net loss, year ended December 31, 2010   -    -    -    -    -    (4,023,026)   (4,023,026)
                                    
Balance at December 31, 2010   15,274,000    1,527    20,412,024    2,041    36,036,139    (27,603,887)   8,435,820 
                                    
Stock based compensation for services   -    -    -    -    707,284    -    707,284 
                                    
Preferred stock conversion   (15,274,000)   (1,527)   15,274,000    1,527    -    -    - 
                                    
Issuance of stock dividend in connection with conversion of preferred stock   -    -    319,074    32    (32)   -    - 
                                    
Grant of restricted shares   -    -    250,000    -    115,168    -    115,168 
                                    
Stock option exercise   -    -    49,844    5    6,475    -    6,480 
                                    
Net loss, year ended December 31, 2011   -    -    -    -    -    (7,909,113)   (7,909,113)
                                    
Balance at December 31, 2011   -    -    36,304,942    3,605    36,865,034    (35,513,000)   1,355,639 
                                    
Stock based compensation for services   -    -    -    -    722,811    -    722,811 
                                    
Issuance of common shares pursuant to placement agent agreement   -    -    60,000    6    43,494    -    43,500 
                                    
Net loss, year ended December 31, 2012   -    -    -    -    -    (14,387,782)   (14,387,782)
                                    
Balance at December 31, 2012   -   $-    36,364,942   $3,611   $37,631,339   $(49,900,782)  $(12,265,832)

 

See accompanying notes to financial statements

 

F-5
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

STATEMENTS OF CASH FLOWS

 

   2012   2011   December 31, 2012 
Cash flows from operating activities               
Net loss  $(14,387,782)  $(7,909,113)  $(49,900,782)
                
Adjustment to reconcile net loss to net cash used in operating activities               
Depreciation and amortization   13,836    11,677    114,980 
Stock-based compensation   722,811    822,452    3,671,215 
Change in fair value of derivative liability   (2,806,750)   284,692    (2,441,699)
Write-off of intangible assets   -    -    85,125 
Warrants issued for services   -    -    480,400 
Warrants issued in connection with note conversion   -    -    348,000 
Note discount arising from beneficial conversion feature   -    -    475,391 
Deferred rent   5,360    (7,397)   12,711 
Loss on disposal of assets   -    2,677    5,357 
Noncash interest expense   6,255,996    -    6,567,514 
                
Changes in operating assets and liabilities               
Prepaid expenses and other current assets   93,432    (49,448)   (203,516)
Restricted cash   -    44,018    - 
Security deposit   -    (10,455)   (10,455)
Accounts payable   869,993    128,799    1,553,154 
Accrued expenses   (130,170)   (166,926)   1,057,871 
Due to related party   (56,488)   15,458    28,268 
                
Net cash used in operating activities   (9,419,762)   (6,833,566)   (38,156,466)
                
Cash flows from investing activities               
Purchase of property and equipment   -    (23,014)   (100,174)
Cash paid for intangible assets   -    -    (85,125)
Proceeds from related party advance   -    -    525,000 
Repayment of related party advance   -    -    (525,000)
Net cash used in investing activities   -    (23,014)   (185,299)
                
Cash flows from financing activities               
Proceeds from issuance of common stock to founders   -    -    5,000 
Proceeds from issuance of preferred stock in private placement, net   -    -    13,974,230 
Proceeds from issuance of common stock in private placement, net   -    -    17,690,037 
Deferred financing fees paid   (1,172,345)   -    (1,217,345)
Proceeds from issuance of notes payable   -    -    1,000,000 
Repayment of notes payable   -    -    (1,000,000)
Proceeds from issuance of convertible notes payable   -    -    3,967,000 
Proceeds from issuance of convertible debentures payable   14,857,200    -    14,857,200 
Proceeds from exercise of stock options   -    6,480    9,080 
                
Net cash provided by financing activities   13,684,855    6,480    49,285,202 
                
Net increase (decrease) in cash and cash equivalents   4,265,093    (6,850,100)   10,943,437 
Cash and cash equivalents at beginning of period   6,678,344    13,528,444    - 
                
Cash and cash equivalents at end of period  $10,943,437   $6,678,344   $10,943,437 
                
Supplemental schedule of cash flows information:               
                
Cash paid for interest  $105,034   $-   $185,034 
                
Supplemental schedule of non-cash investing and financing activities:               
                
Conversion of notes payable and interest to common stock  $-   $-   $4,278,518 
Common shares of Laurier issued in reverse merger transaction  $-   $-   $110 
Issuance of warrants in connection with private placement of convertible preferred units  $-   $-   $3,340,421 
Issuance of warrants in connection with private placement of convertible debentures  $12,973,055   $-   $12,973,055 
Issuance of common stock  pursuant to placement agent agreement  $43,500   $-   $43,500 
                
Preferred stock dividends settled in common stock  $-   $319,074   $319,074 

 

See accompanying notes to financial statements

 

F-6
 

 

ARNO THERAPEUTICS, INC.

(A DEVELOPMENT STAGE COMPANY)

NOTES TO FINANCIAL STATEMENTS

Years ended December 31, 2012 and 2011 and the period

from August 1, 2005 (inception) to December 31, 2012

 

1. DESCRIPTION OF BUSINESS

 

Arno Therapeutics, Inc. (“Arno” or the “Company”) develops innovative drug candidates for the treatment of patients with cancer. The following is a summary of the Company’s product development pipeline:

 

·Onapristone – Onapristone is an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in patients with breast cancer. In prior clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone” treatment of breast cancer. In connection with the development of onapristone, the Company intends to develop a companion diagnostic product to selectively identify patients who express the activated form of the progesterone receptor and therefore may be more likely to benefit from treatment with onapristone. The Company is currently conducting pre-clinical toxicology studies and manufacturing activities and plans to file an investigational new drug application (“IND”) or foreign equivalent in 2013.

 

  · AR-42 – AR-42 is an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins, or Pan-DAC, which play an important role in the regulation of gene expression, cell growth and survival.  AR-42 is currently being studied in an investigator-initiated Phase I/II clinical study in adult subjects with relapsed or refractory multiple myeloma, chronic lymphocytic leukemia (CLL), or lymphoma. The protocol has been amended to include a solid tumor dose escalation cohort which is currently open for patient enrollment.

 

  · AR-12 – AR-12 is a potentially first-in-class, orally available, targeted anti-cancer agent that has been shown in pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer cells. AR-12 has also been reported to cause cell death through the induction of endoplasmic reticulum stress and work is ongoing to further understand the mechanism of action.  The Company is currently conducting a multi-centered Phase I clinical study of AR-12 in adult subjects with advanced or recurrent solid tumors or lymphoma.  

 

The Company was incorporated in Delaware in March 2000 under the name Laurier International, Inc. (“Laurier”). Pursuant to an Agreement and Plan of Merger dated March 6, 2008 (as amended, the “Merger Agreement”), by and among the Company, Arno Therapeutics, Inc., a Delaware corporation formed on August 1, 2005 (“Old Arno”), and Laurier Acquisition, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (“Laurier Acquisition”), on June 3, 2008, Laurier Acquisition merged with and into Old Arno, with Old Arno remaining as the surviving corporation and a wholly-owned subsidiary of Laurier. Immediately following this merger, Old Arno merged with and into Laurier and Laurier’s name was changed to Arno Therapeutics, Inc. These two merger transactions are hereinafter collectively referred to as the “Merger.” Immediately following the Merger, the former stockholders of Old Arno collectively held 95% of the outstanding common stock of Laurier, assuming the issuance of all shares issuable upon the exercise of outstanding options and warrants, and all of the officers and directors of Old Arno in office immediately prior to the Merger were appointed as the officers and directors of Laurier immediately following the Merger. Further, Laurier was a non-operating shell company prior to the Merger. The merger of a private operating company into a non-operating public shell corporation with nominal net assets is considered to be a capital transaction in substance, rather than a business combination, for accounting purposes. Accordingly, the Company treated this transaction as a capital transaction without recording goodwill or adjusting any of its other assets or liabilities. All costs incurred in connection with the Merger have been expensed. Upon completion of the Merger, the Company adopted Old Arno’s business plan.

 

F-7
 

 

 

2. LIQUIDITY AND CAPITAL RESOURCES

 

The Company is a development stage enterprise since it has not yet generated any revenue from the sale of products and, through December 31, 2012, its efforts have been principally devoted to developing its licensed technologies, recruiting personnel, establishing office facilities, and raising capital. Accordingly, the accompanying financial statements have been prepared in accordance with the provisions of Accounting Standards Codification (“ASC”) 915, “Development Stage Entities.” The Company has experienced net losses since its inception and has an accumulated deficit of approximately $49.9 million at December 31, 2012. The Company expects to incur substantial and increasing losses and have negative net cash flows from operating activities as it expands its technology portfolio and engages in further research and development activities, particularly the conducting of pre-clinical and clinical trials.

 

Cash resources as of December 31, 2012 were approximately $10.9 million, compared to $6.7 million as of December 31, 2011. Based on its resources at December 31, 2012 and the current plan of expenditure on continuing development of the Company’s current product candidates, the Company believes that it has sufficient capital to fund its operations through approximately the third quarter of 2013. However, the Company will need substantial additional financing in the future until it can achieve profitability, if ever. The Company’s continued operations will depend on its ability to raise additional funds through various potential sources, such as equity and debt financing, or to license its product candidates to another pharmaceutical company. The Company will continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot assure that it will be able to secure such additional financing, or if available, that it will be sufficient to meet its needs.

 

The success of the Company depends on its ability to discover and develop new products to the point of FDA approval and subsequent revenue generation and, accordingly, to raise enough capital to finance these developmental efforts. Management plans to raise additional equity capital or license one or more of its products to finance the continued operating and capital requirements of the Company. Amounts raised will be used to further develop the Company’s products, acquire additional product licenses and for other working capital purposes. While the Company will extend its best efforts to raise additional capital to fund all operations for the next 12 to 24 months, management can provide no assurances that the Company will be able to raise sufficient funds.

 

These factors raise substantial doubt about the Company's ability to continue as a going concern. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might result from the inability of the Company to continue as a going concern.

 

3. THE MERGER AND BASIS OF PRESENTATION

 

The accompanying audited financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and the instructions to Form 10-K promulgated by the Securities and Exchange Commission (“SEC”).

 

(a) Description of the Merger and Private Placement Offering

 

The Company completed the Merger on June 3, 2008.   In accordance with the terms of the Merger, each share of common stock of Old Arno that was outstanding immediately prior to the Merger was exchanged for 1.99377 shares of the Company’s common stock.  In addition, all securities convertible into or exercisable for shares of Old Arno common stock outstanding immediately prior to the Merger were cancelled, and the holders thereof received similar securities convertible into or exercisable for the purchase of an aggregate of 1,611,760 shares of the Company’s common stock. In consideration for their shares of the Company’s pre-merger common stock, the Company’s shareholders received an aggregate of 19,291,824 shares of Laurier common stock.  Immediately prior to the effective time of the Merger, 1,100,200 shares of Laurier’s common stock were issued and outstanding. Upon completion of the Merger, the Old Arno shareholders owned approximately 95% of the Company’s issued and outstanding common stock, assuming the exercise of all of the issued and outstanding common stock options and warrants.

 

Following the Merger, the business conducted by the Company is the business conducted by Old Arno prior to the Merger. In addition, the directors and officers of Laurier were replaced by the directors and officers of Old Arno.

 

As a condition and immediately prior to the closing of the Merger, on June 2, 2008, Old Arno completed a private placement of its equity securities whereby it received gross proceeds of approximately $17,732,000 through the sale of approximately 3,691,900 shares of Old Arno Common Stock to selected accredited investors, which shares were exchanged for approximately 7,360,700 shares of Company Common Stock after giving effect to the Merger. Contemporaneously with the June 2008 private placement, the Old Arno’s outstanding 6% Notes (defined below) converted into 984,246 shares of Old Arno’s common stock and the holders of the Notes received warrants to purchase an aggregate of 98,409 shares of Old Arno common stock at an exercise price equal to $4.83 per share. The shares issued upon conversion were exchanged for an aggregate of approximately 1,962,338 shares of the Company’s Common Stock and the warrants were exchanged for five-year warrants to purchase an aggregate of approximately 196,189 shares of the Company’s Common Stock at an exercise price equal to $2.42 per share. See “Note 8. Convertible Debentures and Notes Payable.”

 

F-8
 

 

All references to share and per share amounts in these financial statements have been restated to retroactively reflect the number of common shares of Arno common stock issued pursuant to the Merger.

 

(b) Accounting Treatment of the Merger; Financial Statement Presentation

 

The Merger was accounted for as a reverse acquisition pursuant to Accounting Standards Codification (“ASC”) 805-40-25, which provides that the “merger of a private operating company into a non-operating public shell corporation with nominal net assets typically results in the owners and management of the private company having actual or effective operating control of the combined company after the transaction, with the shareholders of the former public shell continuing only as passive investors. These transactions are considered by the Securities and Exchange Commission to be capital transactions in substance, rather than business combinations. That is, the transaction is equivalent to the issuance of stock by the private company for the net monetary assets of the shell corporation, accompanied by a recapitalization.” Accordingly, the Merger has been accounted for as a recapitalization, and, for accounting purposes, Old Arno is considered the acquirer in a reverse acquisition.  

 

Laurier’s  historical accumulated deficit for periods prior to June 3, 2008, in the amount of $120,538, was eliminated against additional-paid-in-capital, and the accompanying financial statements present the previously issued shares of Laurier common stock as having been issued pursuant to the Merger on June 3, 2008. The shares of common stock of the Company issued to the Old Arno stockholders in the Merger are presented as having been outstanding since August 2005 (the month when Old Arno first sold its equity securities).

 

Because the Merger was accounted for as a reverse acquisition under GAAP, the financial statements for periods prior to June 3, 2008 reflect only the operations of Old Arno.

 

4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

(a) Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires that management make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Estimates and assumptions principally relate to services performed by third parties but not yet invoiced, estimates of the fair value and forfeiture rates of stock options issued to employees, directors and consultants, valuation of derivatives and estimates of the probability and potential magnitude of contingent liabilities. Actual results could differ from those estimates.

 

(b) Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a remaining maturity of three months or less at the time of acquisition to be cash equivalents.

 

(c) Deferred Financing Fees

 

Finance costs relating to debt issued are recorded as a deferred charge and amortized to interest expense over the expected term of the debt using the effective interest method.

  

(d) Prepaid Expenses

 

Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, insurance policies and license fees. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight line method.

 

F-9
 

 

(e) Property and Equipment

 

Property and equipment consist primarily of furnishings, fixtures, leasehold improvements and computer equipment and are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.

 

Description   Estimated Useful Life
     
Office equipment and furniture   5 to 7 years
Leasehold improvements   3 years
Computer equipment   3 years

 

(f) Fair Value of Financial Instruments

 

The Company measures fair value in accordance with generally accepted accounting principles. Fair value measurements are applied under other accounting pronouncements that require or permit fair value measurements. Financial instruments included in the Company’s balance sheets consist of cash and cash equivalents, accounts payable, accrued expenses, due to related parties, and warrant liability. The carrying amounts of these instruments reasonably approximate their fair values due to their short-term maturities.

 

(g) Convertible Debentures and Warrant Liability

 

The Company accounts for the convertible debentures and warrants issued in connection with the 2012 Purchase Agreement (see Note 8) and for the warrants issued in connection with the 2010 Purchase Agreement (see Note 10) in accordance with the guidance on Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, which provides that the Company classify the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as a component of other income or expense. The fair value of warrants issued by the Company, in connection with private placements of securities, has been estimated using a Monte Carlo simulation model and, in doing so, the Company’s management utilized a third-party valuation report. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error.

 

(h) Concentration of Credit Risk

 

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company deposits cash and cash equivalents with high credit quality financial institutions and is insured to the maximum limitations. Balances in these accounts may exceed federally insured limits at times, which expose the Company to institutional risk.

 

(i) Research and Development

 

Research and development costs are charged to expense as incurred. Research and development includes employee costs, fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

 

(j) Stock-Based Compensation

 

Stock-based compensation cost is measured at the grant date based on the value of the award and is recognized as expense over the required service period, which is generally equal to the vesting period. Share-based compensation is recognized only for those awards that are ultimately expected to vest.

 

Common stock, stock options or other equity instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model.  The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.

 

F-10
 

 

(k) Loss per Common Share

 

Basic loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding. Diluted loss per share is computed similarly to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.

 

   For the Year Ended December 31, 
   2012   2011 
   Loss   Shares   Per Share   Loss   Shares   Per Share 
   (Numerator)   (Denominator)   Amount   (Numerator)   (Denominator)   Amount 
Net loss  $(14,387,782)            $(7,909,113)          
Less: Preferred stock dividends   -              (81,651)          
                               
Basic and Diluted EPS                              
Loss available to common stockholders  $(14,387,782)   36,322,565   $(0.40)  $(7,990,764)   34,514,594   $(0.23)

 

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

 

Potentially dilutive securities include:

 

   December 31, 2012   December 31, 2011 
Options to purchase common stock   –    - 

 

For the year ended December 31, 2012 and 2011, 165,810,057 and 15,817,737 shares of warrants, options and shares issuable under convertible debentures have been excluded from the computation of potentially dilutive securities, respectively, as their conversion and/or exercise prices are greater than the fair market price per common share as of December 31, 2012 and 2011, respectively.

 

(l) Comprehensive Loss

 

The Company has no components of other comprehensive loss other than its net loss, and accordingly, comprehensive loss is equal to net loss for all periods presented.

 

(m) Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the period in which the differences are expected to affect taxable income. The Company provides a valuation allowance when it appears more likely than not that some or all of the net deferred tax assets will not be realized.

 

A tax position is recognized as a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with a tax examination being presumed to occur. The amount recognized is the largest amount of tax benefit that is greater than 50% likely of being realized on examination. For tax positions not meeting the “more likely than not” test, no tax benefit is recorded.

 

The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for (benefit from) income taxes. The Company recognized no amounts for interest and penalties related to unrecognized tax benefits in 2012 and 2011 respectively. In addition, the Company had no amounts accrued for interest and penalties as of December 31, 2012 and 2011, respectively.

 

F-11
 

 

(n) Recently Issued Accounting Pronouncements

 

In May 2011, the Financial Accounting Standards Board (“FASB”) issued additional guidance relating to fair value measurement and disclosure requirements. For fair value measurements categorized in Level 3 of the fair value hierarchy, the new guidance requires (1) disclosure of quantitative information about unobservable inputs; (2) a description of the valuation processes used by the entity; and (3) a qualitative discussion about the sensitivity of the fair value measurements to changes in unobservable inputs and interrelationships between those unobservable inputs, if any. Entities must report the level in the fair value hierarchy of assets and liabilities that are not recorded at fair value in the statement of financial position but for which fair value is disclosed. The new requirements clarify that the concepts of highest and best use and valuation premise only apply to measuring fair value of nonfinancial assets. The new requirements also specify that in the absence of a Level 1 input, a reporting entity should incorporate a premium or discount in a fair value measurement if a market participant would take into account such an input in pricing an asset or liability. Additionally, the new guidance introduces an option to measure certain financial assets and financial liabilities with offsetting positions on a net basis if certain criteria are met. For public entities, these new requirements become effective for interim and annual periods beginning on or after December 15, 2011. These requirements are applicable to our fiscal year beginning January 1, 2012. The adoption of this new guidance did not have a material effect on the Company’s financial statements.

 

Management does not believe that any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements.

 

5. PROPERTY AND EQUIPMENT

 

Property and equipment as of December 31, 2012 and 2011 consist of the following:  

 

   2012   2011 
Computer equipment and software  $17,721   $17,721 
Office furniture and equipment   52,242    52,242 
Leasehold improvements   8,449    8,449 
Total property and equipment   78,412    78,412 
Accumulated depreciation   (53,575)   (39,739)
Total property and equipment, net  $24,837   $38,673 

 

Depreciation expense for the years ended December 31, 2012, 2011, and the period from August 1, 2005 (inception) through December 31, 2012, was $13,836, $11,677 and $69,979, respectively.

 

6. INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY

 

(a) Onapristone License Agreement

 

The Company’s rights to onapristone are governed by a license agreement with Invivis Pharmaceuticals, Inc. (“Invivis”), dated February 13, 2012. Under this agreement, the Company holds an exclusive, royalty-bearing license for the rights to commercialize onapristone for all therapeutic uses. The license agreement provides the Company with worldwide rights to onapristone with the exception of France; provided, however, that the Company has an option to acquire French commercial rights from Invivis upon notice to Invivis together with a cash payment.

 

The onapristone license agreement provides the Company with exclusive, worldwide rights to a U.S. provisional patent application that relates to assays for predictive biomarkers for anti-progestin efficacy. The Company intends to expand its patent portfolio by filing additional patent applications covering the use of onapristone and/or a companion diagnostic product. If the pending patent application issues, the issued patent would be scheduled to expire in 2031.

 

The Company made a one-time cash payment of $500,000 to Invivis upon execution of the license agreement on February 13, 2012. Additionally, Invivis will receive performance-based cash payments of up to an aggregate of $15.1 million upon successful completion of clinical and regulatory milestones relating to onapristone, which milestones include the marketing approval of onapristone in multiple indications in the United States or the European Union as well as Japan. The Company will make the first milestone payment to Invivis upon the dosing of the first subject in the first company sponsored Phase 1 clinical trial of onapristone, which is anticipated in the third quarter of 2013. In addition, the Company will pay Invivis low single digit sales royalties based on net sales of onapristone by the Company or any of its sublicensees. Pursuant to a separate services agreement, Invivis will provide the Company with certain clinical development support services, which includes the assignment of up to two full-time employees to perform such services, in exchange for a monthly cash payment.

 

Under the license agreement with Invivis, the Company also agreed to indemnify and hold Invivis and its affiliates harmless from any and all claims arising out of or in connection with the production, manufacture, sale, use, lease, consumption or advertisement of onapristone, provided, however, that the Company shall have no obligation to indemnify Invivis for claims that (a) any patent rights infringe third party intellectual property, (b) arise out of the gross negligence or willful misconduct of Invivis, or (c) result from a breach of any representation, warranty confidentiality obligation of Invivis under the license agreement. The license agreement will terminate upon the later of (i) the last to expire valid claim contained in the patent rights, and (ii) February 13, 2032. In general, Invivis may terminate the license agreement at any time upon a material breach by the Company to the extent the Company fails to cure any such breach within 90 days after receiving notice of such breach or in the event the Company files for bankruptcy. The Company may terminate the agreement for any reason upon 90 days’ prior written notice.

 

F-12
 

 

(b) AR-12 and AR-42 License Agreements

 

The Company’s rights to both AR-12 and AR-42 are governed by separate license agreements with The Ohio State University Research Foundation (“Ohio State”) entered into in January 2008. Pursuant to each of these agreements, Ohio State granted the Company exclusive, worldwide, royalty-bearing licenses to commercialize certain patent applications, know-how and improvements relating to AR-42 and AR-12 for all therapeutic uses.

 

Pursuant to the Company’s license agreements for AR-12 and AR-42, the Company made one-time cash payments to Ohio State in the aggregate amount of $450,000 and reimbursed it for past patent expenses in the aggregate amount of approximately $174,000. Additionally, the Company will be required to make performance-based cash payments upon successful completion of clinical and regulatory milestones relating to AR-12 and AR-42 in the United States, Europe and Japan. The first milestone payment for each of the licensed compounds will be due when the first patient is dosed in the first Company sponsored Phase I clinical trial of each of AR-12 and AR-42. In October 2009, the Company remitted a milestone payment to Ohio State for the first patient dosed in the first Company sponsored Phase I clinical trial of AR-12. To the extent the Company enters into a sublicensing agreement relating to either or both of AR-12 or AR-42, it will be required to pay Ohio State a portion of all non-royalty income received from such sublicensee. The Company made no milestone payments under these license agreements during 2012. The Company does not expect to make any milestone payments under these agreements during 2013.

 

The license agreements with Ohio State further provide that the Company will indemnify Ohio State from any and all claims arising out of the death of or injury to any person or persons or out of any damage to property, or resulting from the production, manufacture, sale, use, lease, consumption or advertisement of either AR-12 or AR-42, except to the extent that any such claim arises out of the gross negligence or willful misconduct of Ohio State. The license agreements for AR-12 and AR-42 each expire on the later of (i) the expiration of the last valid claim contained in any licensed patent and (ii) 20 years after the effective date of the license. Ohio State will generally be able to terminate either license upon the Company’s breach of the terms of the license to the extent the Company fails to cure any such breach within 90 days after receiving notice of such breach or the Company files for bankruptcy. The Company may terminate either license upon 90 days prior written notice.

 

(c) AR-67 License Agreement

 

The Company’s rights to AR-67 were governed by an October 2006 license agreement with the University of Pittsburgh (“Pitt”). Under this agreement, Pitt granted the Company an exclusive, worldwide, royalty-bearing license for the rights to commercialize technologies embodied by certain issued patents, patent applications and know-how relating to AR-67 for all therapeutic uses.

 

Under the terms of the license agreement with Pitt, the Company made a one-time cash payment of $350,000 to Pitt and reimbursed it for past patent expenses of approximately $373,000. Additionally, Pitt was entitled to receive performance-based cash payments upon successful completion of clinical and regulatory milestones relating to AR-67. The Company would have made the first milestone payment to Pitt upon the acceptance of the first new drug application by the FDA for AR-67. The Company was also required to pay to Pitt an annual maintenance fee of $200,000 upon the third and fourth anniversaries, $250,000 upon the fifth and sixth anniversaries, and $350,000 upon the seventh anniversary and annually thereafter and to pay Pitt a royalty equal to a percentage of net sales of AR-67, pursuant to the license agreement. The Company did not have any milestone payment obligations during 2012 under this license agreement.

 

Under the license agreement with Pitt, the Company also agreed to indemnify and hold Pitt and its affiliates harmless from any and all claims, actions, demands, judgments, losses, costs, expenses, damages and liabilities (including reasonable attorneys’ fees) arising out of or in connection with (i) the production, manufacture, sale, use, lease, consumption or advertisement of AR-67, (ii) the practice by the Company or any affiliate or sublicensee of the licensed patent; or (iii) any obligation of the Company under the license agreement unless any such claim is determined to have arisen out of the gross negligence, recklessness or willful misconduct of Pitt.

 

In January 2012, Pitt provided notice to the Company that it was in default of the terms of the license agreement for failing to pay the $250,000 annual maintenance fee. In March 2012, following the Company’s determination not to proceed with further development of AR-67, the parties agreed to terminate the license agreement. As a result, the Company no longer has rights in AR-67; however, the Company retains ownership of all data accumulated during the Company’s development of AR-67. On March 28, 2013, the Company entered into a settlement agreement with Pitt pursuant to which the Company agreed to make a one-time payment of $235,000 in full satisfaction of all obligations under the license agreement with Pitt. See Note 16. Subsequent Events.

 

F-13
 

 

7. ACCRUED LIABILITIES

 

Accrued liabilities as of December 31, 2012 and 2011 consist of the following:

 

   2012   2011 
           
Accrued compensation and related benefits  $304,772   $272,342 
Accrued research and development expense   713,099    915,699 
Accrued liquidated damages    594,288    – 
Accrued other expense   40,000    – 
           
Total accrued liabilities  $1,652,159   $1,188,041 

 

8. CONVERTIBLE DEBENTURES AND NOTES PAYABLE

 

On November 26, 2012, the Company entered into a Securities Purchase Agreement, or the 2012 Purchase Agreement, with a number of institutional and accredited investors pursuant to which the Company sold in a private placement an aggregate principal amount of $14,857,200 of three-year 8% Senior Convertible Debentures, or the Debentures. In accordance with the 2012 Purchase Agreement, as amended on December 13, 2012, the Company also issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.30 per share. The sale of the Debentures and 2012 Warrants, which occurred in two closings on November 26, 2012 and December 18, 2012, resulted in aggregate gross proceeds of approximately $14.9 million, before deducting placement agent fees and other transaction-related expenses of approximately $1.2 million. The 2012 Warrants were valued at $12,430,525 (see Note 9).

 

The conversion price of the Debentures is subject to a “full-ratchet” anti-dilution provision, such that in the event the Company makes an issuance of common stock (subject to customary exceptions) at a price per share less than the applicable exercise price of the Debentures, the applicable conversion price will be reduced to the price per share applicable to such new issuance. However, after such time as the Company has raised at least $12 million in subsequent equity financings, the conversion price of the Debentures will be subject to a customary weighted-average price adjustment with respect to new issuances. This conversion feature of the Debentures is considered an embedded derivative and was accounted for separately from the Debentures and was valued at $7,548,500 (see Note 9).

 

Pursuant to the terms of a Registration Rights Agreement entered into on November 26, 2012 in connection with the Company’s entry into the 2012 Purchase Agreement, the Company agreed to file a registration statement under the Securities Act of 1933, as amended, covering the resale of: (i) 100% of the shares of common stock issuable as payment of accrued interest under the Debentures and upon exercise of the Series A Warrants; and (ii) 150% of the shares of common stock issuable upon conversion of the Debentures and upon exercise of the Series B Warrants (collectively, the “Registrable Securities”). The Company further agreed to cause such registration statement to be filed with 30 days following the date of the Registration Rights Agreement, or by December 26, 2012, and to cause such registration statement to be declared effective within 60 days following the date of the Registration Rights Agreement, or by January 25, 2013, or, if the registration statement was subject to review by the SEC, to cause such registration statement to be declared effective within 120 days following the date of the Registration Rights Agreement, or by March 26, 2013. If such registration statement, covering 100% of the Registrable Securities, was not declared effective by the SEC by the applicable date, the Company agreed to pay liquidated damages to the investors in the amount of 2% of each investor’s aggregate investment amount per month until the registration statement is declared effective or until such earlier time as the Registrable Securities may be traded pursuant to Rule 144. On March 25, 2013, the Company and holders of over two-thirds of the Debentures entered into an amendment to the Registration Rights Agreement, permitting the Company, in its sole discretion, to elect to pay such liquidated damages by issuing shares of common stock in lieu of cash (see Note 16).

 

The Company filed the registration statement on December 26, 2012, and, following the receipt of comments from the SEC on January 7, 2013, the Company filed an amendment to the registration statement on January 29, 2013. As of the date of this report, the registration statement has not been declared effective by the SEC, and the Company does not anticipate being able to register 100% of the Registrable Securities. Accordingly, because the registration statement was not declared effective by March 26, 2013, the investors are each entitled to liquidated damages in the amount of 2% of their investment amount per month until the Registrable Securities may be traded pursuant to Rule 144. Because Rule 144 will become available to the investors six months after the applicable closing date, the investors will be entitled to approximately two months’ of liquidated damages, or approximately $0.6 million in the aggregate.

 

9. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

The Company defines fair value as the amount at which an asset (or liability) could be bought (or incurred) or sold (or settled) in a current transaction between willing parties, that is, other than in a forced or liquidation sale. The fair value estimates presented in the table below are based on information available to the Company as of December 31, 2012.

 

The accounting standard regarding fair value measurements discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The standard utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 

F-14
 

 

·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.

 

The Company has determined the fair value of certain liabilities using the market approach: the following tables present the Company’s fair value hierarchy for these assets measured at fair value on a recurring basis as of December 31, 2012 and 2011:

 

       Quoted Market         
       Prices in Active   Significant Other   Significant 
   Fair Value December   Markets   Observable Inputs   Unobservable Inputs 
   31, 2012   (Level 1)   (Level 2)   (Level 3) 
                 
Liabilities                    
Warrant liability - 2010 Series A&B  $898,722   $-   $-   $898,722 
Debenture conversion feature -2012   7,548,500    -    -    7,548,500 
Warrant liability - 2012 placement agent   542,530    -    -    542,530 
Warrant liability - 2012 Series A&B   12,430,525    -    -    12,430,525 
                     
Total  $21,420,277   $-   $-   $21,420,277 

 

       Quoted Market         
       Prices in Active   Significant Other   Significant 
   Fair Value December   Markets   Observable Inputs   Unobservable Inputs 
   31, 2011   (Level 1)   (Level 2)   (Level 3) 
                 
Liabilities                    
Warrant liability - 2010 Series A&B  $3,705,472   $-   $-   $3,705,472 
                     
Total  $3,705,472   $-   $-   $3,705,472 

 

The fair value of these derivative liabilities was estimated by management using a third party valuation report. The third-party estimated the value of the warrants using a Monte Carlo simulation model. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of our future expected stock prices and minimizes standard error. The changes in the fair value of these derivative liabilities are estimated quarterly after issuance and are recorded in other income (expense) on the statement of operations.

 

The following table provides a summary of changes in fair value of the Company’s liabilities, as well as the portion of losses included in income attributable to unrealized appreciation that relate to those liabilities held at December 31, 2012:

 

Fair Value Measurements Using
Significant Unobservable Inputs (Level 3)
   Warrant Liability 
Balance at January 1, 2011  $(3,420,780)
Purchases, sales and settlements:     
Warrants issued   - 
Total gains or losses:     
Unrealized depreciation   (284,692)
Balance at January 1, 2012   (3,705,472)
Purchases, sales and settlements:     
Warrants and other derivatives issued   (20,521,555)
Total gains or losses:     
Unrealized depreciation   2,806,750 
Balance at December 31, 2012  $(21,420,277)

  

F-15
 

 

Significant assumptions used at December 31, 2012 and 2011for the warrants and embedded conversion discount derivative liability of the Debentures are as follows:

 

   December 31, 2012   December 31, 2011 
         
Weighted average term   3 years     4 years  
Volatility   200%   120%
Risk-free interest rate   1.05%   0.83%

 

10. STOCKHOLDERS’ EQUITY

 

(a)Common Stock

 

On November 21, 2012, the Company amended its Amended & Restated Certificate of Incorporation to increase the number of shares of common stock that the Company is authorized to issue from 80,000,000 shares to 500,000,000 shares.

 

On April 25, 2011, the Company issued 250,000 shares of restricted common stock under the Company’s 2005 Stock Option Plan to its new Chief Executive Officer pursuant to his employment agreement. These shares vested in 12 equal monthly installments and have a total fair value of $172,750, or $0.69 per share, as estimated by management using a Monte Carlo simulation model using the significant assumptions described below in addition to a discount for the restrictions and, in doing so, utilizing a third-party valuation report.  The shares are recognized as compensation expense upon vesting. The shares are recognized as compensation expense upon vesting. The Company has recognized $57,584, $115,168 and $172,572 of compensation expense for the years ended December 31, 2012, 2011 and the period from inception to December 31, 2012, respectively, in connection with the restricted shares.

 

On February 9, 2011, the Company issued an aggregate of 15,274,000 shares of its common stock upon the automatic conversion of all 15,274,000 of its issued and outstanding shares of Series A Convertible Preferred Stock. In accordance with their terms, the shares Series A Convertible Preferred Stock automatically converted upon the effectiveness of the Company’s registration statement covering the resale under the Securities Act of 1933 of the shares of common stock issuable upon conversion of such preferred shares.  See Note 10(b) Preferred Stock,.  In addition, the Company elected to satisfy accrued dividends on the Series A Convertible Preferred Stock of $319,074 by issuing an additional 319,074 shares of common stock.

 

On November 15, 2010, the Company’s stockholders authorized the amendment of the Company’s amended and restated certificate of incorporation in order to effect a combination (reverse split) of its common stock at a ratio not to exceed one-for-eight, provided that the Company’s board of directors shall have absolute discretion to determine and fix the exact ratio of such combination (not to exceed one-for-eight) and the time at which such combination shall become effective, if ever.  The Company’s board of directors has taken no further action to implement a combination of our common stock and reserves the right to abandon the proposed reverse stock split in its sole discretion.

 

As of December 31, 2012, the Company has 36,364,942 shares of common stock issued and outstanding and an additional 116,286,054 shares of common stock reserved for issuance upon the exercise of outstanding options and warrants.

 

(b) Preferred Stock

 

On August 11, 2010, the Company amended and restated its certificate of incorporation, increasing the number of shares of preferred stock authorized for issuance thereunder from 10,000,000 to 35,000,000.

 

On September 3, 2010, the Company entered into a Securities Purchase and Registration Rights Agreement (the “2010 Purchase Agreement”), with a number of institutional and other accredited investors pursuant to which the Company sold in a private placement an aggregate of 15,274,000 shares of newly-designated Series A Convertible Preferred Stock, par value $0.0001 per share, or Series A Preferred Stock, at a per share purchase price of $1.00.  In accordance with the 2010 Purchase Agreement, the Company also issued two-and-one-half-year Class A warrants to purchase an aggregate of 1,221,920 shares of Series A Preferred Stock at an initial exercise price of $1.00 per share and five-year Class B warrants to purchase an aggregate of 6,415,080 shares of Series A Preferred Stock at an initial exercise price of $1.15 per share. The terms of the Class A and Class B warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price of the Class A and Class B warrants will be adjusted based on the lower issuance price. The sale of the shares and warrants resulted in aggregate gross proceeds of approximately $15.3 million, before expenses.

 

F-16
 

 

The terms, conditions, privileges, rights and preferences of the Series A Convertible Preferred Stock are described in a Certificate of Designation filed with the Secretary of State of Delaware on September 3, 2010.

 

Each share of Series A Preferred Stock was initially convertible at the holder’s election into one share of common stock.  Upon the effective date of the registration statement on February 9, 2011, each share of Series A Preferred Stock automatically converted into one share of common stock. In addition, all outstanding warrants to purchase Series A Preferred Stock automatically converted into warrants to purchase common stock.

 

Issuance costs related to the financing were approximately $1.8 million, of which approximately $0.5 million was non-cash for issuance of warrants (“Placement Warrants”) to purchase 1,056,930 shares of the Company’s common stock at 110% of the Series A Preferred Stock purchase price per share to designees of Riverbank Capital Securities, Inc. (“Riverbank”), a related party controlled by several officers and/or directors of the Company (see Note 12), and I-Bankers Securities, Inc. (“IBS”), that acted as placement agents for the Company in connection with the private placement.

 

On February 9, 2011, the Company’s registration statement was declared effective and the 15,274,000 shares of Series A Convertible Preferred Stock converted into 15,274,000 shares of common stock. In addition, the Company elected to pay the $319,074 in accrued dividends in shares of common stock resulting in the issuance of 319,074 shares.

 

(c) Warrants

 

In accordance with the 2010 Purchase Agreement, the Company issued two-and-one-half-year Class A warrants to purchase an aggregate of 1,221,920 shares of Series A Preferred Stock at an initial exercise price of $1.00 per share and five-year Class B warrants to purchase an aggregate of 6,415,080 shares of Series A Preferred Stock at an initial exercise price of $1.15 per share. As noted above, all outstanding warrants to purchase shares of Series A Preferred Stock automatically converted into warrants to purchase common stock on February 9, 2011, when the Company’s registration statement was declared effective. The terms of the warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price will be adjusted based on the lower issuance price. Because of this anti-dilution provision and the inherent uncertainty as to the probability of future common share issuances, the Black-Scholes option pricing model the Company uses for valuing stock options could not be used.  Management used a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report to determine the warrant liability to be approximately $0.9 million and approximately $3.7 million at December 31, 2012 and 2011, respectively. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error. This valuation is revised on a quarterly basis until the warrants are exercised or they expire with the changes in fair value recorded in other expense on the statement of operations.

 

Pursuant to the 2012 Purchase Agreement, the Company issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.30 per share. The terms of the warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price will be adjusted based on the lower issuance price. Because of this anti-dilution provision and the inherent uncertainty as to the probability of future common share issuances, the Black-Scholes option pricing model the Company uses for valuing stock options could not be used.  Management used a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report to determine the warrant liability to be approximately $12.4 million at December 31, 2012

 

In connection with the 2012 offering of Debentures and Warrants, the Company engaged Maxim Group LLC, or Maxim Group, to serve as placement agent. In consideration for its services, the Company paid Maxim Group a placement fee of $1,035,000. In addition, the Company issued to Maxim Partners LLC, or Maxim Partners, an affiliate of Maxim Group, 60,000 shares of common stock and five-year warrants to purchase an additional 2,270,000 shares of common stock at an initial exercise price of $0.33 per share. The warrants issued to Maxim Partners are in substantially the same form as the Warrants issued to the investors, except that they do not include certain anti-dilution provisions contained in the Warrants. However, the placement warrants do contain a provision that could require the Company to repurchase the warrants from the holder under certain conditions. These placement warrants were valued at $542,530 (see Note 9).

 

F-17
 

 

Below is a table that summarizes all outstanding warrants to purchase shares of the Company’s common stock as of December 31, 2012.

 

Grant Date  Warrants Issued   Exercise Price   Weighted
Average
Exercise
Price		   Expiration
Date		  Exercised   Warrants
Outstanding		 
01/02/2008   299,063   $2.42   $2.42   01/02/2013   -    299,063 
06/02/2008   196,189   $2.42   $2.42   06/02/2013   -    196,189 
09/03/2010   1,221,920   $0.53   $0.53   03/03/2013   -    1,221,920 
09/03/2010   6,415,080   $0.56   $0.56   09/03/2015   -    6,415,080 
09/03/2010   1,056,930   $1.10   $1.10   09/03/2015   -    1,056,930 
11/26/2012   42,350,002   $0.30   $0.30   05/26/2014   -    42,350,002 
12/18/2012   7,174,001   $0.30   $0.30   06/18/2014   -    7,174,001 
11/26/2012   42,350,002   $0.50   $0.50   11/26/2017   -    42,350,002 
11/26/2012   2,090,000   $0.33   $0.33   11/26/2017   -    2,090,000 
12/18/2012   7,174,001   $0.50   $0.50   12/18/2017   -    7,174,001 
12/18/2012   180,000   $0.33   $0.33   12/18/2017   -    180,000 
    110,507,188        $0.43       -    110,507,188 

 

11. STOCK OPTION PLAN

 

The Company’s 2005 Stock Option Plan (the “Plan”) was originally adopted by the Board of Directors of Old Arno in August 2005, and was assumed by the Company on June 3, 2008 in connection with the Merger. After giving effect to the Merger, there were initially 2,990,655 shares of the Company’s common stock reserved for issuance under the 2005 Plan. On April 25, 2011, the Company’s Board of Directors approved an amendment to the 2005 Plan to increase the number of shares of common stock issuable thereunder to 7,000,000 shares. Under the Plan, incentives may be granted to officers, employees, directors, consultants, and advisors. Incentives under the Plan may be granted in any one or a combination of the following forms: (a) incentive stock options and non-statutory stock options, (b) stock appreciation rights, (c) stock awards, (d) restricted stock and (e) performance shares.

 

The Plan is administered by the Board of Directors, or a committee appointed by the Board, which determines recipients and types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. The term of stock options granted under the Plan cannot exceed 10 years. Options shall not have an exercise price less than the fair market value of the Company’s common stock on the grant date, and generally vest over a period of three to four years.

 

As of December 31, 2012, an aggregate of 901,290 shares remained available for future grants and awards under the Plan, which covers stock options, warrants and restricted awards. The Company issues unissued shares to satisfy stock options, warrants exercises and restricted stock awards.

 

No options were granted by the Company during the year ended December 31, 2012. For the year ended December 31, 2011, the Company estimated the fair value of each option award granted using the Black-Scholes option-pricing model. The following assumptions were used for the year ended December 31, 2011:

 

   2011 
Expected Volatility   87%
Expected Term   5-10 years 
Dividend yield   0.0%
Risk-free interest rate   1.5-2.0% 
Stock price   $0.69 -  $0.72 
Forfeiture rate   0.0%

 

The valuation assumptions were determined as follows:

 

·Expected volatility – The expected volatility on the average expected volatilities of a sampling of five companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage.

  

F-18
 

 

·Expected term – The expected term of the awards represents the period of time that the awards are expected to be outstanding. Management considered historical data and expectations for the future to estimate employee exercise and post vest termination behavior. Consultant options are assigned an expected term equal to the maximum term of the option grant.

 

·Dividend yield – The estimate for annual dividends is zero, because the Company has not historically paid dividends and does not intend to in the foreseeable future.

 

A summary of the status of the options issued under the Plan as of December 31, 2012, and information with respect to the changes in options outstanding is as follows:

 

       Options Outstanding 
   Shares   Outstanding   Weighted-   Aggregate 
   Available for   Stock   Average   Intrinsic 
   Grant   Options   Exercise Price   Value 
Balance at January 1, 2011   1,077,352    1,893,303   $1.36      
Shares authorized for issuance   4,009,345    -    -      
Options granted under the Plan   (5,054,317)   5,054,317   $1.03      
Restricted stock granted under the Plan   (250,000)   -    -      
Options exercised    -    (49,844)  $0.13      
Options forfeited   269,221    (269,221)  $1.53      
Balance at December 31, 2011   51,601    6,628,555   $1.31      
Options forfeited   849,689    (849,689)  $1.00      
Balance at December 31, 2012   901,290    5,778,866   $1.11   $- 
                     
Exercisable at December 31, 2012        3,566,669   $1.17   $- 

 

The following table summarizes information about stock options outstanding at December 31, 2012:

 

    Outstanding   Exercisable 
Exercise
Price		   Shares   Weighted-
Average
Remaining
Contractual Life
(Years)		   Weighted-
Average
Exercise Price		   Shares   Weighted-
Average
Exercise Price		 
$1.00    5,388,133    7.8   $1.00    3,175,936   $1.00 
$2.42    299,066    3.6   $2.42    299,066   $2.42 
$3.00    91,667    1.2   $3.00    91,667   $3.00 
 Total    5,778,866    7.6   $1.11    3,566,669   $1.17 

 

Stock-based compensation costs for the years ended December 31, 2012 and 2011 and for the cumulative period from August 1, 2005 (inception) through December 31, 2012, are as follows:

 

   Year Ended December 31,     
   2012   2011   Period from August 1, 2005
(inception) through
December 31, 2012		 
General and administrative  $441,983   $449,652   $1,986,610 
Research and development   280,828    372,800    1,684,605 
Total  $722,811   $822,452   $3,671,215 

 

The fair value of options vested under the 2005 Plan was approximately $863,892 and $443,507 for the years ended December 31, 2012 and 2011, respectively, and approximately $3,218,757 for the period from August 1, 2005 (inception) through December 31, 2012.

 

F-19
 

 

At December 31, 2012, total unrecognized estimated compensation cost related to stock options granted prior to that date was approximately $1.1 million which is expected to be recognized over a weighted-average vesting period of 1.5 years. This unrecognized estimated employee compensation cost does not include any estimate for forfeitures of performance-based stock options.

 

Common stock, stock options or other equity instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model and is expensed as underlying options vest.  The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.

 

For the year ended December 31, 2012, the Company did not issue any options. For the year ended December 31, 2011, the Company issued options to purchase a total of 5,054,317 shares of common stock to employees and consultants with exercise prices ranging from $1.00 to $2.42 and terms of up to 10 years.  Of this total, 10-year options to purchase 2,354,379 shares at an exercise price of $1.00 were issued to the Company’s new President and Chief Executive Officer and 10-year options to purchase 1,750,000 shares at an exercise price of $1.00 were issued to the Company’s new Chief Medical Officer.  

 

12. RELATED PARTIES

 

On June 1, 2009, the Company entered into a services agreement with Two River Consulting, LLC (“TRC”) to provide various clinical development, operational, managerial, accounting and financial, and administrative services to the Company for a period of one year. David M. Tanen, the Company’s then President, Secretary and director, Arie S. Belldegrun, the Chairman of the Board of Directors, and Joshua A. Kazam, a director until September 2010, are each partners of TRC. The terms of the Services Agreement were reviewed and approved by a special committee of the Company’s Board of Directors consisting of independent directors. None of the members of the special committee has any interest in TRC or the services agreement. As compensation for the services contemplated by the services agreement, the Company pays TRC a monthly cash fee of $55,000.   The services agreement with TRC expired on April 1, 2011 and until a new agreement is in place, TRC is billing the Company for actual hours worked on a monthly basis.  For the year ended December 31, 2012, TRC billed Arno $273,171 for services rendered, an average of approximately $22,764 per month.

 

 On occasion, some of the Company’s expenses are paid by TRC. No interest is charged by TRC on any outstanding balance owed by the Company. For the years ended December 31, 2012 and 2011 and for the period from August 1, 2005 (inception) through December 31, 2012, total cash services and reimbursed expenses totaled $327,452, $655,923 and $2,131,217, respectively. As of December 31, 2012 the Company had a payable to TRC of $28,268, which was paid in full during the first two months of 2013.

 

The financial condition and results of operations of the Company, as reported, are not necessarily indicative of results that would have been reported had the Company operated completely independently.

 

13. PENSION PLAN

 

On October 1, 2007, the Company adopted a 401(k) savings plan (the “401(k) Plan”) for the benefit of its employees. Under the 401(k) Plan, the Company was required to make contributions equal to 3% of eligible compensation for each eligible employee whether or not the employee contributes to the 401(k) Plan. During 2011, the Company terminated the 401(k) Plan. For the years ended December 31, 2012 and 2011 and for the cumulative period from August 1, 2005 (inception) through December 31, 2012, the Company has recorded $0, $0 and $16,064 of matching contributions to the 401(k) Plan.

 

14. INCOME TAXES

 

The Company accounts for income taxes using the liability method, which requires the determination of deferred tax assets and liabilities, based on the differences between the financial statement and tax bases of assets and liabilities, using enacted tax rates in effect for the year in which differences are expected to reverse. The net deferred tax asset is adjusted by a valuation allowance, if, based on the weight of available evidence, it is more likely than not that some portion or all of the net deferred tax asset will not be realized. The income tax returns of the Company are subject to examination by federal and state taxing authorities. Such examination could result in adjustments to net income or loss, which changes could affect the income tax liabilities of the Company. The Company’s tax returns are open for inspection for all tax years from 2008 to present.

 

The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for (benefit from) income taxes. The Company recognized no amounts for interest and penalties related to unrecognized tax benefits in 2012, 2011 and the period from August 1, 2005 (inception) through December 31, 2012 and as of December 31, 2012 and 2011, had no amounts accrued for interest and penalties.

 

F-20
 

 

At December 31, 2012, the Company had no Federal income tax expense or benefit but did have Federal tax net operating loss carry-forwards of approximately $26.2 million. The federal net operating loss carry-forwards will begin to expire in 2026, unless previously utilized.

 

Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets at December 31, 2012 and 2011 are shown below.

 

   For Years Ended December 31, 
   2012   2011 
Non-current deferred tax assets          
Research tax credit  $2,005,000   $1,631,000 
Net operating loss carry forwards   15,700,000    11,720,000 
Stock based compensation   446,000    848,000 
Total deferred tax assets   18,151,000    14,199,000 
Non-current deferred tax liability          
Depreciation and amortization   (10,000)   (10,000)
Total net deferred tax assets   18,141,000    14,189,000 
Valuation allowance   (18,141,000)   (14,189,000)
Net deferred tax assets  $-   $- 

 

The Company records a valuation allowance for temporary differences for which it is more likely than not that the Company will not receive future tax benefits. At December 31, 2012 and 2011 the Company recorded valuation allowances of $18.6 million and $14.2 million, respectively, representing a change in the valuation allowance of $4.4 million for the previous fiscal year-ends, due to the uncertainty regarding the realization of such deferred tax assets, to offset the benefits of net operating losses generated during those years.

 

A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 31, 2012 and 2011 are as follows:

 

   2012   2011 
   Amount   Rate   Amount   Rate 
                 
Federal tax  $(3,388,000)   34.0%  $(2,689,000)   34.0%
State tax   (592,000)   5.9%   (390,000)   5.9%
R&D Credit   (373,000)   2.7%   (339,000)   4.37%
Incentive stock options   (30,000)   4.7%   (48,000)   7.8%
Valuation allowance   4,383,000    (47.3)%   3,466,000    (52.1)%
Net  $-    -   $-    - 


There was no income tax benefit recorded for the years ended December 31, 2012 and 2011.

 

15. COMMITMENTS AND CONTINGENCIES

 

On March 31, 2011, the Company exercised its early termination option on the Parsippany, NJ office lease, submitting written notice to the landlord and making a payment of $53,641.  The Company continued to make monthly lease payments under the Parsippany lease through December 31, 2011, at which time, this lease terminated.

 

On August 4, 2011, the Company entered into a lease for new office space of approximately 4,168 square feet in Flemington, New Jersey (the “Flemington Lease”). The lease commencement date was November 17, 2011, with lease payments beginning in February 2012.  The lease expiration date is three years from the rent commencement date.  The Company provided a cash security deposit of $10,455, or two months’ base rent.  The Company is also responsible for payment of its share of common area maintenance costs and taxes. The aggregate remaining minimum future payments under the Flemington Lease at December 31, 2012 are approximately $150,531 including common area maintenance charges and taxes. The Flemington Lease contains a three-month free rent period and annual escalations, as such, the Company accounts for rent expense on a straight-line basis. The Company recognized $85,362 and $7,351 in rent expense for the Flemington Lease for the years ended December 31, 2012 and 2011, respectively.

 

F-21
 

 

Future minimum lease payments under operating leases as of December 31, 2012 are as follows:

 

2013  $69,981 
2014   71,816 
2015   8,734 
      
Total future minimum lease payments  $150,531 

 

On April 21, 2011, the Company entered into an employment agreement with Glenn Mattes, as its Chief Executive Officer, with an effective commencement date of employment beginning on April 25, 2011. The agreement provides for a term of three years, expiring on April 25, 2014, and initial base salary of $100,000. On and after the first anniversary date of the effective commencement date, Mr. Mattes’ base salary shall be increased to $350,000. In addition, Mr. Mattes is eligible to receive an annual target performance bonus of up to 50% of his base salary, but up to $175,000 during the first year of employment. Additionally, the Company shall issue to Mr. Mattes, 250,000 shares of restricted common stock. These shares vest in 12 equal monthly installments and have a total fair value of $172,750, or $0.69 per share, as estimated by management using a Monte Carlo simulation model using the significant assumptions described below in addition to a discount for the restrictions and, in doing so, utilizing a third-party valuation report.  The shares are recognized as compensation expense upon vesting. The Company has recognized $57,584, $115,168 and $172,572 of compensation expense for the years ended December 31, 2012, 2011 and the period from inception to December 31, 2012, respectively, in connection with the restricted shares.

 

In addition, Mr. Mattes was granted 10-year options to purchase a total of 2,354,379 shares of the Company’s common stock at an exercise price equal to $1.00 per share.  Options relating to 60% of such shares are designated as “Employment Options” and options relating to the remaining 40% of the shares are designated as “Performance Options.”   The right to purchase 25% of the shares subject to the Employment Options vested on April 25, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, in three equal annual installments during the Term, subject to the successful achievement of specific performance objectives to be established by the Board.    The Employment Options, Performance Options, and Restricted Shares were awarded to Mr. Mattes pursuant to the Plan. The employment agreement also entitles Mr. Mattes to certain change of control and severance benefits.

 

On June 22, 2011, the Company entered into an employment agreement with Alexander Zukiwski, M.D., as its Chief Medical Officer, with an effective commencement date of employment beginning on June 22, 2011. The agreement provides for a term of three years, expiring on June 22, 2014, and initial base salary of $375,000. The Employment Agreement further provides that, subject to the successful achievement of specific performance objectives to be established by the Board, Dr. Zukiwski will be eligible to receive an annual performance bonus of up to 50% of his annualized base salary.  The Company has also agreed to reimburse Dr. Zukiwski in an amount up to $200,000 for expenses incurred in connection with the relocation of Dr. Zukiwski’s primary residence to the northern New Jersey area. As of March 29, 2013, Dr. Zukiwski has not relocated to the northern New Jersey area and the Company has not reimbursed him for any moving expenses.

 

In addition, Dr. Zukiwski was granted 10-year options to purchase a total of 1,750,000 shares of the Company’s common stock at an exercise price equal to $1.00 per share.  Options relating to 50% of such shares are designated as “Employment Options” and options relating to the remaining 50% of the shares are designated as “Performance Options.”  The right to purchase 25% of the shares subject to the Employment Options will vested on June 22, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, in three equal annual installments during the Term, subject to the successful achievement of specific performance objectives to be established by the Board. The employment agreement also entitles Dr. Zukiwski to certain change of control and severance benefits.

 

The Company has entered into various contracts with third parties in connection with the development of the licensed technology described in Note 6.

 

The aggregate minimum commitment under these contracts as of December 31, 2012 is approximately $4.5 million, all expected to be due during 2013 and 2014.

 

F-22
 

 

In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2012. The Company does not anticipate recognizing any significant losses relating to these arrangements.

 

16. SUBSEQUENT EVENTS

 

In January 2012, the Company received a notice from the University of Pittsburgh, or Pitt, claiming that the Company was in default under its license agreement relating to AR-67 for failure to pay a $250,000 annual license fee under the terms of that agreement and providing the Company with 60 days’ notice to remedy the default. On March 29, 2012, following the Company’s determination not to proceed with further development of AR-67, the Company agreed with Pitt to terminate the license agreement. In February 2013, Pitt commenced an action in the Court of Common Pleas of Allegheny County, Pennsylvania, seeking damages of $250,000, plus interest and costs, based on its claim that the Company breached the license agreement by failing to pay the annual license fee. On March 28, 2013, the Company entered into a settlement agreement with Pitt pursuant to which the Company agreed to pay $235,000 in full satisfaction of all remaining obligations under the license agreement.

 

On January 30, 2013, the Company’s Board of Directors appointed Randy Thurman as a director of the Company. Mr. Thurman, age 63, is an Operating Executive at AEA Investments LP, a private equity firm. As consideration for his service on the Board, Mr. Thurman will receive an annual cash stipend of $50,000, payable quarterly in arrears. In addition, Mr. Thurman was granted a 10-year option under the 2005 Plan to purchase 200,000 shares of the Company’s common stock at an exercise price of $0.30 per share. The right to purchase one-third of the shares subject to the option vested immediately and the remaining shares subject to the option will vest and become exercisable in two equal annual installments on the first and second anniversaries of Mr. Thurman’s appointment. Mr. Thurman will also receive additional option grants on an annual basis, consistent with the Board’s compensation plan for non-employee directors.

 

On March 25, 2013, the Company and holders of approximately 80% of the Debentures sold pursuant to the 2012 Purchase Agreement entered into an amendment to the Registration Rights Agreement (see Note 8), permitting the Company, in its sole discretion, to elect to pay liquidated damages resulting from the Company’s failure to successfully cause the registration statement covering the resale of 100% of the Registrable Securities to be declared effective by the SEC by March 26, 2013, by issuing shares of common stock in lieu of cash. If electing to issue shares in lieu of paying cash, the Company shall issue to each investor a number of shares of common stock equal to (a) the aggregate amount of liquidated damages that the Company is electing to pay to such investor in the form of shares, divided by (b) thirty cents ($0.30). Pursuant to the terms of the Registration Rights Agreement, because holders of over two-thirds of the Debentures consented in writing to the March 25, 2013 amendment, such amendment is binding on all holders of Registrable Securities. On March 27, 2013, in accordance with the amendment to the Registration Rights Agreement, the Company issued an aggregate of 990,477 shares of common stock to the investors in lieu of an aggregate cash payment of $297,144, representing the first monthly installment of liquidated damages under the Registration Rights Agreement, as amended.

 

In late March 2013, the Company sought the agreement of the Debenture holders to amend their respective Debentures to provide for the accrual of all interest payments under such Debentures until the applicable maturity date in November or December of 2015, with such interest accruing at the rate of 8% per annum, compounding quarterly. As of March 28, 2013, the Company had entered into such amendments with the holders of Debentures in the aggregate principal amount of $7,875,000.

 

F-23
 

 

INDEX TO EXHIBITS FILED WITH THIS REPORT

 

Exhibit No.

  

Description

31.1   Certification of Principal Executive Officer.
   
31.2   Certification of Principal Financial Officer.
   
32.1   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
32.2   Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
     
101   The following financial information from Arno Therapeutics, Inc.’s Annual Report on Form 10-K for the annual period ended December 31, 2012, formatted in eXtensible Business Reporting Language (XBRL): (i) Balance Sheets as of December 31, 2012 and 2011, (ii) Statements of Operations for the years ended December 31, 2012 and 2011, and for the period from August 1, 2005 (inception) through December 31, 2012, (iii) Statement of Stockholders’ Equity (Deficiency) for the period from August 1, 2005 (inception) through December 31, 2012, (iv) Statements of Cash Flows for the years ended December 31, 2012 and 2011, and for the period from August 1, 2005 (inception) through December 31, 2012, and (v) Notes to Financial Statements. ^

 

 
^Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 to this Annual Report on Form 10-K shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be deemed part of a registration statement, prospectus or other document filed under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filings.

 

 
 EX-31.1 2 v337317_ex31-1.htm EXHIBIT 31.1

 

EXHIBIT 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

 

I, Glenn Mattes, certify that:

 

1. I have reviewed this annual report on Form 10-K of Arno Therapeutics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 1, 2013

 

/s/ Glenn Mattes  
Glenn Mattes  
Title: President and Chief Executive Officer  

 

 

 

 EX-31.2 3 v337317_ex31-2.htm EXHIBIT 31.2

 

EXHIBIT 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

 

I, Scott L. Navins, certify that:

 

1. I have reviewed this annual report on Form 10-K of Arno Therapeutics, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: April 1, 2013

 

/s/ Scott L. Navins  
Name: Scott L. Navins  
Title: Treasurer  

 

 

 

 EX-32.1 4 v337317_ex32-1.htm EXHIBIT 32.1

 

EXHIBIT 32.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Arno Therapeutics, Inc. (the “Company”) hereby certifies, to such officer’s knowledge, that:

 

(1) the Annual Report on Form 10-K of the Company for the year ended December 31, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: April 1, 2013

 

/s/ Glenn Mattes  
Glenn Mattes  
Title: President and Chief Executive Officer  

  

 

 

 EX-32.2 5 v337317_ex32-2.htm EXHIBIT 32.2

 

EXHIBIT 32.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Arno Therapeutics, Inc. (the “Company”) hereby certifies, to such officer’s knowledge, that:

 

(1) the Annual Report on Form 10-K of the Company for the year ended December 31, 2012 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

 

(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: April 1, 2013

 

/s/ Scott L. Navins  
Name: Scott L. Navins  
Title: Treasurer  

 

 

 

 

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In connection with the development of onapristone, the Company intends to develop a companion diagnostic product to selectively identify patients who express the activated form of the progesterone receptor and therefore may be more likely to benefit from treatment with onapristone. 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AR-12 has also been reported to cause cell death through the induction of endoplasmic reticulum stress and work is ongoing to further understand the mechanism of action.&#160;&#160;The Company is currently conducting a multi-centered Phase I clinical study of AR-12 in adult subjects with advanced or recurrent solid tumors or lymphoma.&#160;&#160;</font></td> </tr> </table> <p style="text-indent: 0.5in; margin: 0pt 0px; font: 10pt times new roman, times, serif;">&#160;</p> <p style="text-indent: 0.5in; margin: 0pt 0px; font: 10pt times new roman, times, serif;">The Company was incorporated in Delaware in March 2000 under the name Laurier International, Inc. (&#8220;Laurier&#8221;). 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Potentially Dilutive Securities (Detail)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Options to purchase common stock 0 0
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Stock-Based Compensation Costs (Detail) (USD $)
 12 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]      
Stock-based compensation costs $ 57,584 $ 115,168 $ 172,572
Research and Development
      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]      
Stock-based compensation costs 280,828 372,800 1,684,605
General and Administrative
      
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]      
Stock-based compensation costs $ 441,983 $ 449,652 $ 1,986,610
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Stockholders' Equity - Additional Information (Detail) (USD $)
 1 Months Ended 12 Months Ended 17 Months Ended 89 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended 1 Months Ended 1 Months Ended
Nov. 21, 2012
Feb. 09, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2006
Dec. 31, 2012
Jun. 03, 2008
Dec. 31, 2012
Maxim Group Llc
Dec. 31, 2012
Maxim Partners
Feb. 09, 2011
Series A Preferred Stock
Dec. 31, 2012
Series A Preferred Stock
Dec. 31, 2012
Series A Warrant
Dec. 31, 2012
Series B Warrant
Aug. 11, 2010
Before Amendment
Aug. 11, 2010
After Amendment
Sep. 03, 2010
Securities Purchase and Registration Rights Agreement
Dec. 31, 2012
Securities Purchase and Registration Rights Agreement
Class A Warrants
Sep. 03, 2010
Securities Purchase and Registration Rights Agreement
Class A Warrants
Sep. 03, 2010
Securities Purchase and Registration Rights Agreement
Class B Warrants
Dec. 31, 2012
Securities Purchase and Registration Rights Agreement
Class B Warrants
Sep. 03, 2010
Securities Purchase and Registration Rights Agreement
Placement Warrants
Dec. 31, 2012
Two And One Half Year Class A Warrants
Dec. 31, 2011
Two And One Half Year Class A Warrants
Dec. 31, 2012
Five Year Series A Warrants
Apr. 25, 2011
Chief Executive Officer
Feb. 09, 2011
COMMON STOCK
Sep. 03, 2010
COMMON STOCK
Securities Purchase and Registration Rights Agreement
Placement Warrants
Stockholders Equity Note [Line Items]                                                      
Stock issued in conversion of convertible securities                                                   15,274,000  
Accrued dividends on the Series A Convertible Preferred Stock satisfied by issuing an additional shares of common stock   $ 319,074   $ 0                                              
Additional shares of common stock issued   319,074                                                  
Restricted common stock issued                                                 250,000    
Number of monthly installments over which shares vest                                                 12    
Total fair value of restricted common stock issued                                                 172,750    
Fair value per share of restricted common stock issued                                                 $ 0.69    
Issuance of common stock, per share         $ 0.0001           $ 1.00                                
Common stock, shares issued     36,364,942 36,304,942   36,364,942                                          
Common stock, shares outstanding     36,364,942 36,304,942   36,364,942                                          
Preferred stock, shares authorized     35,000,000 35,000,000   35,000,000               10,000,000 35,000,000                        
Preferred Stock Shares Issued     0 0   0                                         15,274,000
Common stock reserved for issuance of warrants     116,286,054                                                
Par value per share of stock issued                                                     $ 0.0001
Price per share of stock issued                                                     $ 1
Warrants issued to purchase Company's shares     110,507,188     110,507,188 196,189 2,270,000 2,270,000     49,524,003 49,524,003       1,221,920 1,221,920 6,415,080 6,415,080             1,056,930
Exercise price of warrants             2.42 0.33 0.33     0.50 0.30       1.00 1.00 1.15 1.15              
Term of warrants                 5 years     5 years 18 months       5 years   5 years                
Proceeds from sale of shares and warrants                               15,300,000                      
Issuance costs related to financing                               1,800,000                      
Non cash issuance costs related to financing                               500,000                      
Purchase price per share, percentage                                         110.00%            
Derivative liabilities     21,420,276 3,705,472   21,420,276                               900,000 3,700,000 12,400,000      
Stock-based compensation costs     57,584 115,168   172,572                                          
Conversion of Stock, Shares Issued                   15,274,000                                  
Common stock shares authorized before amendment 500,000,000                                                    
Common stock shares authorized after amendment 80,000,000                                                    
Placement Fee Paid               1,035,000                                      
Total value of placement warrant     $ 12,430,525     $ 12,430,525   $ 542,530 $ 542,350                                    
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Related Parties - Additional Information (Detail) (USD $)
 12 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Related Party Transaction [Line Items]      
Total cash services and reimbursed expenses $ 327,452 $ 655,923 $ 2,131,217
Amount payable to TRC 28,268 84,756 28,268
Two River Consulting Llc
      
Related Party Transaction [Line Items]      
Amount payable to TRC 55,000   55,000
Related Party Transactions Total Billed Amount For Services Rendered 273,171    
Related Party Transactions Billed Amount For Services Rendered Per Month $ 22,764    
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Summary of Changes in Fair Value of Liabilities (Detail) (USD $)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Warrant Liability    
Balance at January 1, 2012 $ (3,705,472) $ (3,420,780)
Purchases, sales and settlements:    
Warrants issued (20,521,555) 0
Total gains or losses:    
Unrealized depreciation 2,806,750 (284,692)
Balance at December 31, 2011 $ (21,420,277) $ (3,705,472)
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Description of Business - Additional Information (Detail)
Jun. 03, 2008
Organization and Nature of Operations [Line Items]  
Percentage of outstanding common stock collectively held by former stockholders of Old Arno 95.00%
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IncomeTaxes - Additional Infornation (Detail) (USD $)
 12 Months Ended
Dec. 31, 2011
Dec. 31, 2012
Income Tax Disclosure [Line Items]    
Federal tax net operating loss carry-forwards $ 26,200,000  
Operating loss carryforwards, expiration dates 2026  
Valuation allowance 14,189,000 18,141,000
Valuation allowance,change in amount $ 4,400,000  
XML 20 R25.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies (Tables)
 12 Months Ended
Dec. 31, 2012
Accounting Policies [Abstract]  
Estimated Useful Life Of Property and Equipment
Description   Estimated Useful Life
     
Office equipment and furniture   5 to 7 years
Leasehold improvements   3 years
Computer equipment   3 years
Basic and Diluted Loss Per Share
    For the Year Ended December 31,  
    2012     2011  
    Loss     Shares     Per Share     Loss     Shares     Per Share  
    (Numerator)     (Denominator)     Amount     (Numerator)     (Denominator)     Amount  
Net loss   $ (14,387,782 )                   $ (7,909,113 )                
Less: Preferred stock dividends     -                       (81,651 )                
                                                 
Basic and Diluted EPS                                                
Loss available to common stockholders   $ (14,387,782 )     36,322,565     $ (0.40 )   $ (7,990,764 )     34,514,594     $ (0.23 )
Potentially Dilutive Securities

Potentially dilutive securities include:

 

    December 31, 2012     December 31, 2011  
Options to purchase common stock     –       -
XML 21 R50.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stock Option Plan - Additional Information (Detail) (USD $)
 12 Months Ended 12 Months Ended 12 Months Ended 12 Months Ended 89 Months Ended 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2011
Employees and consultants
Dec. 31, 2011
New President and Chief Executive Officer
Dec. 31, 2011
New Chief Medical Officer
Dec. 31, 2011
Maximum
Dec. 31, 2011
Maximum
Employees and consultants
Dec. 31, 2011
Minimum
Dec. 31, 2011
Minimum
Employees and consultants
Dec. 31, 2012
2005 Plan
Dec. 31, 2011
2005 Plan
Dec. 31, 2012
2005 Plan
Apr. 25, 2011
2005 Plan
Jun. 03, 2008
2005 Plan
Dec. 31, 2012
2005 Plan
Maximum
Dec. 31, 2012
2005 Plan
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]                                  
Shares of common stock reserved for issuance under 2005 Plan   4,009,345                       7,000,000 2,990,655    
Term of stock options granted under 2005 Plan (in years) 10 years                                
Stock option vesting period                               4 years 3 years
Shares available for future grants and awards under plan 901,290 51,601 1,077,352                            
Fair value of options vested under 2005 Plan                     $ 863,892 $ 443,507 $ 3,218,757        
Total unrecognized estimated compensation cost related to stock options $ 1,100,000                                
Total unrecognized estimated compensation cost related to stock options, recognition period 1 year 6 months                                
Options granted under the Plan   5,054,317   5,054,317 2,354,379 1,750,000                      
Share-based compensation arrangement by share-based payment award, fair value assumptions, exercise price         $ 1.00 $ 1.00   $ 2.42   $ 1.00              
Expected Term       10 years 10 years 10 years 10 years   5 years                
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Intangible Assets and Intellectual Property - Additional Information (Detail) (USD $)
 0 Months Ended 12 Months Ended 1 Months Ended 12 Months Ended
Mar. 01, 2013
Dec. 31, 2012
Dec. 31, 2012
Seventh Anniversary And Annually Thereafter
Feb. 13, 2012
Onapristone License Agreement
Invivis Pharmaceuticals, Inc
Dec. 31, 2012
AR-12 and AR-42 License Agreements
Ohio State University Research Foundation
Dec. 31, 2012
AR-67 License Agreement
University Of Pittsburgh
Jan. 31, 2012
AR-67 License Agreement
University Of Pittsburgh
Dec. 31, 2012
AR-67 License Agreement
University Of Pittsburgh
Third And Fourth Anniversaries
Dec. 31, 2012
AR-67 License Agreement
University Of Pittsburgh
Fifth And Sixth Anniversaries
Dec. 31, 2012
AR-67 License Agreement
University Of Pittsburgh
Seventh Anniversary And Annually Thereafter
Finite-Lived Intangible Assets [Line Items]                    
Cash paid under license agreement     $ 350,000 $ 500,000 $ 450,000          
Aggregate potential milestone payments       15,100,000            
License agreement termination date       2032-2-13            
Written notice period for termination of license agreement if breach is not cured       90 days 90 days          
Prior written notice period for termination of license agreement by the company for any reason       90 days 90 days          
License agreement expiration date         20 years          
Annual license fees               200,000 250,000 350,000
Notice period   60 days                
Outstanding license fees   250,000       250,000 250,000      
Reimbursed Of Past Patent Expenses         174,000         373,000
Outstanding license fees settled amount $ 235,000                  
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Summary of Significant Accounting Policies - Additional information (Detail)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Summary Of Significant Accounting Policies [Line Items]    
Convertible preferred stock, warrants and options have been excluded from the computation of potentially dilutive securities 165,810,057 15,817,737
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Summary of Status of Options Issued And Changes in Options Outstanding (Detail) (USD $)
In Thousands, except Share data, unless otherwise specified
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Shares Available for Grant    
Balance at January 51,601 1,077,352
Shares authorized for issuance   4,009,345
Options granted under the Plan   (5,054,317)
Restricted stock granted under the Plan   (250,000)
Options forfeited 849,689 269,221
Balance at December 901,290 51,601
Outstanding Stock Options    
Balance at January 6,628,555 1,893,303
Options granted under the Plan   5,054,317
Options exercised   (49,844)
Options forfeited (849,689) (269,221)
Balance at December 5,778,866 6,628,555
Exercisable at December 31, 2012 3,566,669  
Options Outstanding Weighted-Average Exercise Price    
Balance at January $ 1.31 $ 1.36
Options granted under the Plan   $ 1.03
Options exercised   $ 0.13
Options forfeited $ 1.00 $ 1.53
Balance at December 31, 2012 $ 1.11 $ 1.31
Exercisable at December 31, 2012 $ 1.17  
Options Outstanding Aggregate Intrinsic Value    
Balance at December 31, 2012 $ 0  
Exercisable at December 31, 2012 $ 0  
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Future minimum lease payments under operating leases (Detail) (USD $)
Dec. 31, 2012
Schedule Of Future Minimum Rental Payments For Operating Leases [Line Items]  
2013 $ 69,981
2014 71,816
2015 8,734
Total future minimum lease payments $ 150,531
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Warrants and embedded conversion discount derivative liability (Detail)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Fair Value Assumptions and Methodology for Assets and Liabilities [Abstract]    
Weighted average term 3 years 4 years
Volatility 200.00% 120.00%
Risk-free interest rate 1.05% 0.83%
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Liquidity and Capital Resources
 12 Months Ended
Dec. 31, 2012
Working Capital Information [Abstract]  
Liquidity and Capital Resources

2. LIQUIDITY AND CAPITAL RESOURCES

 

The Company is a development stage enterprise since it has not yet generated any revenue from the sale of products and, through December 31, 2012, its efforts have been principally devoted to developing its licensed technologies, recruiting personnel, establishing office facilities, and raising capital. Accordingly, the accompanying financial statements have been prepared in accordance with the provisions of Accounting Standards Codification (“ASC”) 915, “Development Stage Entities.” The Company has experienced net losses since its inception and has an accumulated deficit of approximately $49.9 million at December 31, 2012. The Company expects to incur substantial and increasing losses and have negative net cash flows from operating activities as it expands its technology portfolio and engages in further research and development activities, particularly the conducting of pre-clinical and clinical trials.

 

Cash resources as of December 31, 2012 were approximately $10.9 million, compared to $6.7 million as of December 31, 2011. Based on its resources at December 31, 2012 and the current plan of expenditure on continuing development of the Company’s current product candidates, the Company believes that it has sufficient capital to fund its operations through approximately the third quarter of 2013. However, the Company will need substantial additional financing in the future until it can achieve profitability, if ever. The Company’s continued operations will depend on its ability to raise additional funds through various potential sources, such as equity and debt financing, or to license its product candidates to another pharmaceutical company. The Company will continue to fund operations from cash on hand and through sources of capital similar to those previously described. The Company cannot assure that it will be able to secure such additional financing, or if available, that it will be sufficient to meet its needs.

 

The success of the Company depends on its ability to discover and develop new products to the point of FDA approval and subsequent revenue generation and, accordingly, to raise enough capital to finance these developmental efforts. Management plans to raise additional equity capital or license one or more of its products to finance the continued operating and capital requirements of the Company. Amounts raised will be used to further develop the Company’s products, acquire additional product licenses and for other working capital purposes. While the Company will extend its best efforts to raise additional capital to fund all operations for the next 12 to 24 months, management can provide no assurances that the Company will be able to raise sufficient funds.

 

These factors raise substantial doubt about the Company's ability to continue as a going concern. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not include any adjustments that might result from the inability of the Company to continue as a going concern.
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Subsequent Events - Additional Information (Detail) (USD $)
 0 Months Ended 12 Months Ended 17 Months Ended 1 Months Ended
Mar. 01, 2013
Dec. 31, 2012
Dec. 31, 2006
Mar. 27, 2013
Subsequent Event
Mar. 21, 2013
Subsequent Event
Jan. 30, 2013
Subsequent Event
Board of Directors Chairman
Mar. 28, 2013
Subsequent Event
Investor
Subsequent Events [Line Items]              
Outstanding license fees   $ 250,000          
Notice period   60 days          
Loss contingency, damages sought $250,000            
Outstanding license fees settled amount 235,000            
Quarterly cash payable           50,000  
Granted contractual term           P10Y  
Purchase of shares authorized           200,000  
Common stock exercise price           $ 0.30  
Issuance of common stock, per share     $ 0.0001   $ 0.30    
Debentures aggregate principal amount         0    
Debt instrument, maturity date         Dec. 31, 2015    
Debt instrument, interest rate, effective percentage         8.00%    
Share issued in first monthly installment of liquidated damages       990,477      
Value of share issued in first monthly installment of liquidated damages       297,144      
Aggregate principal amount debenture amended             $ 7,875,000
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Accrued Liabilities (Detail) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Schedule Of Accrued Liabilities [Line Items]    
Accrued compensation and related benefits $ 304,772 $ 272,342
Accrued research and development expense 713,099 915,699
Accrued Liquidated Damages 594,288 0
Accrued other expense 40,000 0
Total accrued liabilities $ 1,652,159 $ 1,188,041
XML 32 R29.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stockholders' Equity (Tables)
 12 Months Ended
Dec. 31, 2012
Stockholders' Equity Note [Abstract]  
Summary of All Outstanding Warrants to Purchase Shares of Common Stock

Below is a table that summarizes all outstanding warrants to purchase shares of the Company’s common stock as of December 31, 2012.

 

Grant Date   Warrants Issued     Exercise Price     Weighted
Average
Exercise
Price		     Expiration
Date		   Exercised     Warrants
Outstanding		  
01/02/2008     299,063     $ 2.42     $ 2.42     01/02/2013     -       299,063  
06/02/2008     196,189     $ 2.42     $ 2.42     06/02/2013     -       196,189  
09/03/2010     1,221,920     $ 0.53     $ 0.53     03/03/2013     -       1,221,920  
09/03/2010     6,415,080     $ 0.56     $ 0.56     09/03/2015     -       6,415,080  
09/03/2010     1,056,930     $ 1.10     $ 1.10     09/03/2015     -       1,056,930  
11/26/2012     42,350,002     $ 0.30     $ 0.30     05/26/2014     -       42,350,002  
12/18/2012     7,174,001     $ 0.30     $ 0.30     06/18/2014     -       7,174,001  
11/26/2012     42,350,002     $ 0.50     $ 0.50     11/26/2017     -       42,350,002  
11/26/2012     2,090,000     $ 0.33     $ 0.33     11/26/2017     -       2,090,000  
12/18/2012     7,174,001     $ 0.50     $ 0.50     12/18/2017     -       7,174,001  
12/18/2012     180,000     $ 0.33     $ 0.33     12/18/2017     -       180,000  
      110,507,188             $ 0.43           -       110,507,188  
XML 33 R28.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments (Tables)
 12 Months Ended
Dec. 31, 2012
Fair Value Disclosures [Abstract]  
Fair Value Hierarchy for Liabilities Measured at Fair Value on Recurring Basis

The Company has determined the fair value of certain liabilities using the market approach: the following tables present the Company’s fair value hierarchy for these assets measured at fair value on a recurring basis as of December 31, 2012 and 2011:

 

          Quoted Market              
          Prices in Active     Significant Other     Significant  
    Fair Value December     Markets     Observable Inputs     Unobservable Inputs  
    31, 2012     (Level 1)     (Level 2)     (Level 3)  
                         
Liabilities                                
Warrant liability - 2010 Series A&B   $ 898,722     $ -     $ -     $ 898,722  
Debenture conversion feature -2012     7,548,500       -       -       7,548,500  
Warrant liability - 2012 placement agent     542,530       -       -       542,530  
Warrant liability - 2012 Series A&B     12,430,525       -       -       12,430,525  
                                 
Total   $ 21,420,277     $ -     $ -     $ 21,420,277  

 

          Quoted Market              
          Prices in Active     Significant Other     Significant  
    Fair Value December     Markets     Observable Inputs     Unobservable Inputs  
    31, 2011     (Level 1)     (Level 2)     (Level 3)  
                         
Liabilities                                
Warrant liability - 2010 Series A&B   $ 3,705,472     $ -     $ -     $ 3,705,472  
                                 
Total   $ 3,705,472     $ -     $ -     $ 3,705,472  
Summary of Changes in Fair Value of Liabilities

The following table provides a summary of changes in fair value of the Company’s liabilities, as well as the portion of losses included in income attributable to unrealized appreciation that relate to those liabilities held at December 31, 2012:

 

Fair Value Measurements Using
Significant Unobservable Inputs (Level 3)
    Warrant Liability  
Balance at January 1, 2011   $ (3,420,780 )
Purchases, sales and settlements:        
Warrants issued     -  
Total gains or losses:        
Unrealized depreciation     (284,692 )
Balance at January 1, 2012     (3,705,472 )
Purchases, sales and settlements:        
Warrants and other derivatives issued     (20,521,555 )
Total gains or losses:        
Unrealized depreciation     2,806,750  
Balance at December 31, 2012   $ (21,420,277 )
Schedule of Derivative Liabilities at Fair Value

Significant assumptions used at December 31, 2012 and 2011for the warrants and embedded conversion discount derivative liability of the Debentures are as follows:

 

    December 31, 2012     December 31, 2011  
             
Weighted average term     3 years        4 years  
Volatility     200 %     120 %
Risk-free interest rate     1.05 %     0.83 %
XML 34 R56.htm IDEA: XBRL DOCUMENT v2.4.0.6
Pension Plan - Additional information (Detail) (USD $)
 1 Months Ended 12 Months Ended 89 Months Ended
Oct. 01, 2007
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Defined Benefit Plan Disclosure [Line Items]        
Defined Contribution Plan, Employer Matching Contribution, Percent 3.00%      
Pension Contributions   $ 0 $ 0 $ 16,064
XML 35 R44.htm IDEA: XBRL DOCUMENT v2.4.0.6
Convertible Debentures And Notes Payable - Additional information (Detail) (USD $)
 1 Months Ended 12 Months Ended
Dec. 18, 2012
Dec. 31, 2012
Jun. 03, 2008
Dec. 31, 2012
Maxim Group Llc
Dec. 31, 2012
Series A Warrant
Dec. 31, 2012
Series B Warrant
Nov. 26, 2012
8% Senior Convertible Debentures
Convertible Long Term Notes Payable [Line Items]              
Notes interest rate             8.00%
Number of underlying shares to be registered percentage         100.00% 150.00%  
Aggregate principal amount of debt             $ 14,857,200
Initial exercise price of warrants     2.42 0.33 0.50 0.30  
Number of shares called by warrants   110,507,188 196,189 2,270,000 49,524,003 49,524,003  
Gross proceeds from issuance on convertible debt and warrant 14,900,000            
Placement agent fees and other transaction related expenses 1,200,000            
Total value of placement warrant   12,430,525   542,530      
Warrant Term   P18M          
Minimum subsequent equity financing   12,000,000          
Embedded derivative, fair value of embedded derivative asset   7,548,500          
Registration payment arrangement defalt percentage of liquidated damages   2.00%          
Registration payment arrangement, maximum potential consideration   $ 600,000          
XML 36 R30.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stock Option Plan (Tables)
 12 Months Ended
Dec. 31, 2012
Disclosure Of Compensation Related Costs, Share-Based Payments [Abstract]  
Assumptions Used in Estimating Fair Value of Each Option Award Granted Using Black-Scholes Option-Pricing Model
The following assumptions were used for the year ended December 31, 2011:

 

    2011  
Expected Volatility     87 %
Expected Term     5-10 years  
Dividend yield     0.0 %
Risk-free interest rate     1.5-2.0%  
Stock price     $0.69 -  $0.72  
Forfeiture rate     0.0 %
Summary of Status of Options Issued And Changes in Options Outstanding

A summary of the status of the options issued under the Plan as of December 31, 2012, and information with respect to the changes in options outstanding is as follows:

 

          Options Outstanding  
    Shares     Outstanding     Weighted-     Aggregate  
    Available for     Stock     Average     Intrinsic  
    Grant     Options     Exercise Price     Value  
Balance at January 1, 2011     1,077,352       1,893,303     $ 1.36          
Shares authorized for issuance     4,009,345       -       -          
Options granted under the Plan     (5,054,317 )     5,054,317     $ 1.03          
Restricted stock granted under the Plan     (250,000 )     -       -          
Options exercised     -       (49,844 )   $ 0.13          
Options forfeited     269,221       (269,221 )   $ 1.53          
Balance at December 31, 2011     51,601       6,628,555     $ 1.31          
Options forfeited     849,689       (849,689 )   $ 1.00          
Balance at December 31, 2012     901,290       5,778,866     $ 1.11     $ -  
                                 
Exercisable at December 31, 2012             3,566,669     $ 1.17     $ -  
Summary of Stock Options Outstanding

The following table summarizes information about stock options outstanding at December 31, 2012:

 

      Outstanding     Exercisable  
Exercise
Price		     Shares     Weighted-
Average
Remaining
Contractual Life
(Years)		     Weighted-
Average
Exercise Price		     Shares     Weighted-
Average
Exercise Price		  
$ 1.00       5,388,133       7.8     $ 1.00       3,175,936     $ 1.00  
$ 2.42       299,066       3.6     $ 2.42       299,066     $ 2.42  
$ 3.00       91,667       1.2     $ 3.00       91,667     $ 3.00  
  Total       5,778,866       7.6     $ 1.11       3,566,669     $ 1.17  

 
Stock-Based Compensation Costs

Stock-based compensation costs for the years ended December 31, 2012 and 2011 and for the cumulative period from August 1, 2005 (inception) through December 31, 2012, are as follows:

 

    Year Ended December 31,        
    2012     2011     Period from August 1, 2005
(inception) through
December 31, 2012		  
General and administrative   $ 441,983     $ 449,652     $ 1,986,610  
Research and development     280,828       372,800       1,684,605  
Total   $ 722,811     $ 822,452     $ 3,671,215  
XML 37 R31.htm IDEA: XBRL DOCUMENT v2.4.0.6
Income Taxes (Tables)
 12 Months Ended
Dec. 31, 2012
Income Tax Disclosure [Abstract]  
Significant components of net deferred tax assets

Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets at December 31, 2012 and 2011 are shown below.

 

    For Years Ended December 31,  
    2012     2011  
Non-current deferred tax assets                
Research tax credit   $ 2,005,000     $ 1,631,000  
Net operating loss carry forwards     15,700,000       11,720,000  
Stock based compensation     446,000       848,000  
Total deferred tax assets     18,151,000       14,199,000  
Non-current deferred tax liability                
Depreciation and amortization     (10,000 )     (10,000 )
Total net deferred tax assets     18,141,000       14,189,000  
Valuation allowance     (18,141,000 )     (14,189,000 )
Net deferred tax assets   $ -     $ -  
Reconciliation of the statutory tax rates and the effective tax rates

A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 31, 2012 and 2011 are as follows:

 

    2012     2011  
    Amount     Rate     Amount     Rate  
                         
Federal tax   $ (3,388,000 )     34.0 %   $ (2,689,000 )     34.0 %
State tax     (592,000 )     5.9 %     (390,000 )     5.9 %
R&D Credit     (373,000 )     2.7 %     (339,000 )     4.37 %
Incentive stock options     (30,000 )     4.7 %     (48,000 )     7.8 %
Valuation allowance     4,383,000       (47.3 )%     3,466,000       (52.1 )%
Net   $ -       -     $ -       -
XML 38 R8.htm IDEA: XBRL DOCUMENT v2.4.0.6
Description of Business
 12 Months Ended
Dec. 31, 2012
Business Combination, Description [Abstract]  
Description of Business

1. DESCRIPTION OF BUSINESS

 

Arno Therapeutics, Inc. (“Arno” or the “Company”) develops innovative drug candidates for the treatment of patients with cancer. The following is a summary of the Company’s product development pipeline:

 

· Onapristone – Onapristone is an anti-progestin hormone blocker that has been shown to have considerable anti-tumor activity in patients with breast cancer. In prior clinical studies, onapristone has demonstrated a 56% objective response rate as a first line “hormone” treatment of breast cancer. In connection with the development of onapristone, the Company intends to develop a companion diagnostic product to selectively identify patients who express the activated form of the progesterone receptor and therefore may be more likely to benefit from treatment with onapristone. The Company is currently conducting pre-clinical toxicology studies and manufacturing activities and plans to file an investigational new drug application (“IND”) or foreign equivalent in 2013.

 

  · AR-42 – AR-42 is an orally available, broad spectrum inhibitor of both histone and non-histone deacetylation proteins, or Pan-DAC, which play an important role in the regulation of gene expression, cell growth and survival.  AR-42 is currently being studied in an investigator-initiated Phase I/II clinical study in adult subjects with relapsed or refractory multiple myeloma, chronic lymphocytic leukemia (CLL), or lymphoma. The protocol has been amended to include a solid tumor dose escalation cohort which is currently open for patient enrollment.

 

  · AR-12 – AR-12 is a potentially first-in-class, orally available, targeted anti-cancer agent that has been shown in pre-clinical studies to inhibit phosphoinositide dependent protein kinase-1, or PDK-1, a protein in the PI3K/Akt pathway that is involved in the growth and proliferation of cells, including cancer cells. AR-12 has also been reported to cause cell death through the induction of endoplasmic reticulum stress and work is ongoing to further understand the mechanism of action.  The Company is currently conducting a multi-centered Phase I clinical study of AR-12 in adult subjects with advanced or recurrent solid tumors or lymphoma.  

 

The Company was incorporated in Delaware in March 2000 under the name Laurier International, Inc. (“Laurier”). Pursuant to an Agreement and Plan of Merger dated March 6, 2008 (as amended, the “Merger Agreement”), by and among the Company, Arno Therapeutics, Inc., a Delaware corporation formed on August 1, 2005 (“Old Arno”), and Laurier Acquisition, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (“Laurier Acquisition”), on June 3, 2008, Laurier Acquisition merged with and into Old Arno, with Old Arno remaining as the surviving corporation and a wholly-owned subsidiary of Laurier. Immediately following this merger, Old Arno merged with and into Laurier and Laurier’s name was changed to Arno Therapeutics, Inc. These two merger transactions are hereinafter collectively referred to as the “Merger.” Immediately following the Merger, the former stockholders of Old Arno collectively held 95% of the outstanding common stock of Laurier, assuming the issuance of all shares issuable upon the exercise of outstanding options and warrants, and all of the officers and directors of Old Arno in office immediately prior to the Merger were appointed as the officers and directors of Laurier immediately following the Merger. Further, Laurier was a non-operating shell company prior to the Merger. The merger of a private operating company into a non-operating public shell corporation with nominal net assets is considered to be a capital transaction in substance, rather than a business combination, for accounting purposes. Accordingly, the Company treated this transaction as a capital transaction without recording goodwill or adjusting any of its other assets or liabilities. All costs incurred in connection with the Merger have been expensed. Upon completion of the Merger, the Company adopted Old Arno’s business plan.
XML 39 R32.htm IDEA: XBRL DOCUMENT v2.4.0.6
Commitments And Contingencies (Tables)
 12 Months Ended
Dec. 31, 2012
Commitments and Contingencies Disclosure [Abstract]  
Future minimum lease payments under operating leases

Future minimum lease payments under operating leases as of December 31, 2012 are as follows:

 

2013   $ 69,981  
2014     71,816  
2015     8,734  
         
Total future minimum lease payments   $ 150,531  
XML 40 R40.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property and Equipment (Detail) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Property, Plant and Equipment [Line Items]    
Computer equipment and software $ 17,721 $ 17,721
Office furniture and equipment 52,242 52,242
Leasehold improvements 8,449 8,449
Total property and equipment 78,412 78,412
Accumulated depreciation (53,575) (39,739)
Total property and equipment, net $ 24,837 $ 38,673
XML 41 R53.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Information about Stock Options Outstanding (Detail) (USD $)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Options Outstanding, Shares 5,778,866 6,628,555 1,893,303
Options Outstanding, Weighted- Average Remaining Contractual Life (Years) 7 years 7 months 6 days    
Options Outstanding, Weighted-Average Exercise Price $ 1.11 $ 1.31 $ 1.36
Options Exercisable, Total Shares 3,566,669    
Options Exercisable, Weighted- Average Exercise Price $ 1.17    
Exercise Price 1
      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Options Outstanding, Exercise Price $ 1.00    
Options Outstanding, Shares 5,388,133    
Options Outstanding, Weighted- Average Remaining Contractual Life (Years) 7 years 9 months 18 days    
Options Outstanding, Weighted-Average Exercise Price $ 1.00    
Options Exercisable, Total Shares 3,175,936    
Options Exercisable, Weighted- Average Exercise Price $ 1.00    
Exercise Price 2
      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Options Outstanding, Exercise Price $ 2.42    
Options Outstanding, Shares 299,066    
Options Outstanding, Weighted- Average Remaining Contractual Life (Years) 3 years 7 months 6 days    
Options Outstanding, Weighted-Average Exercise Price $ 2.42    
Options Exercisable, Total Shares 299,066    
Options Exercisable, Weighted- Average Exercise Price $ 2.42    
Exercise Price 3
      
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]      
Options Outstanding, Exercise Price $ 3.00    
Options Outstanding, Shares 91,667    
Options Outstanding, Weighted- Average Remaining Contractual Life (Years) 1 year 2 months 12 days    
Options Outstanding, Weighted-Average Exercise Price $ 3.00    
Options Exercisable, Total Shares 91,667    
Options Exercisable, Weighted- Average Exercise Price $ 3.00    
XML 42 R2.htm IDEA: XBRL DOCUMENT v2.4.0.6
BALANCE SHEETS (USD $)
Dec. 31, 2012
Dec. 31, 2011
Current assets    
Cash and cash equivalents $ 10,943,437 $ 6,678,344
Prepaid expenses and other current assets 203,516 296,948
Total current assets 11,146,953 6,975,292
Property and equipment, net 24,837 38,673
Deferred financing fees 1,709,530 0
Security deposit 10,455 10,455
Total assets 12,891,775 7,024,420
Current liabilities    
Accounts payable 1,553,154 683,161
Accrued expenses and other current liabilities 1,652,159 1,188,041
Due to related party 28,268 84,756
Deferred rent 12,711 7,351
Total current liabilities 3,246,292 1,963,309
Convertible debentures, net 491,039 0
Derivative liabilities 21,420,276 3,705,472
Total liabilities 25,157,607 5,668,781
COMMITMENTS AND CONTINGENCIES      
STOCKHOLDERS' (DEFICIT) EQUITY    
Preferred stock, $0.0001 par value, 35,000,000 shares authorized, none issued and outstanding 0 0
Common stock, $0.0001 par value, 500,000,000 shares authorized, 36,364,942 and 36,304,942 shares issued and outstanding 3,611 3,605
Additional paid-in capital 37,631,339 36,865,034
Deficit accumulated during the development stage (49,900,782) (35,513,000)
Total stockholders' (deficit) equity (12,265,832) 1,355,639
Total liabilities and stockholders' (deficit) equity $ 12,891,775 $ 7,024,420
XML 43 R45.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value Hierarchy for Liabilities Measured at Fair Value on Recurring Basis (Detail) (Fair Value, Measurements, Recurring, USD $)
Dec. 31, 2012
Dec. 31, 2011
Liabilities    
Warrant liability - 2010 Series A&B $ 898,722 $ 3,705,472
Debenture conversion feature -2012 7,548,500  
Debenture conversion feature -2012 542,530  
Warrant liability - 2012 Series A&B 12,430,525  
Warrant liability 21,420,277 3,705,472
Quoted Market Prices in Active Markets (Level 1)
    
Liabilities    
Warrant liability - 2010 Series A&B 0 0
Debenture conversion feature -2012 0  
Debenture conversion feature -2012 0  
Warrant liability - 2012 Series A&B 0  
Warrant liability 0 0
Significant Other Observable Inputs (Level 2)
    
Liabilities    
Warrant liability - 2010 Series A&B 0 0
Debenture conversion feature -2012 0  
Debenture conversion feature -2012 0  
Warrant liability - 2012 Series A&B 0  
Warrant liability 0 0
Significant Unobservable Inputs (Level 3)
    
Liabilities    
Warrant liability - 2010 Series A&B 898,722 3,705,472
Debenture conversion feature -2012 7,548,500  
Debenture conversion feature -2012 542,530  
Warrant liability - 2012 Series A&B 12,430,525  
Warrant liability $ 21,420,277 $ 3,705,472
XML 44 R6.htm IDEA: XBRL DOCUMENT v2.4.0.6
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIENCY) (Parenthetical) (USD $)
 12 Months Ended
Dec. 31, 2008
COMMON STOCK
Dec. 31, 2010
PREFERRED STOCK
Stock issuance costs $ 141,646 $ 1,299,770
XML 45 R59.htm IDEA: XBRL DOCUMENT v2.4.0.6
Reconciliation of statutory tax rates and effective tax rates (Detail) (USD $)
 12 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Schedule Of Effective Income Tax Rate Reconciliation [Line Items]    
Federal tax $ (3,388,000) $ (2,689,000)
State tax (592,000) (390,000)
R&D Credit (373,000) (339,000)
Incentive stock options (30,000) (48,000)
Valuation allowance 4,383,000 3,466,000
Net $ 0 $ 0
Federal tax 34.00% 34.00%
State tax 5.90% 5.90%
R&D Credit 2.70% 4.37%
Incentive stock options 4.70% 7.80%
Valuation allowance (47.30%) (52.10%)
Net 0.00% 0.00%
XML 46 R35.htm IDEA: XBRL DOCUMENT v2.4.0.6
Merger and Basis of Presentation - Additional information (Detail) (USD $)
 1 Months Ended 0 Months Ended 1 Months Ended
Jun. 03, 2008
Dec. 31, 2012
Dec. 31, 2011
Jun. 02, 2008
Old Arno
Jun. 03, 2008
Old Arno
Jun. 03, 2008
Laurier International Inc
Mergers Acquisitions and Dispositions Disclosures [Line Items]            
Shares issuable prior to merger ratio         $ 1.99377  
Shares issued in merger         1,611,760 19,291,824
Common stock issued prior to merger   36,364,942 36,304,942     1,100,200
Common stock outstanding prior to merger   36,364,942 36,304,942     1,100,200
Ownership interest         95.00%  
Gross proceeds private placement       $ 17,732,000    
Number of common stock sold to selected accredited investor       3,691,900    
Number of shares issued in business combination       7,360,700    
Notes interest rate         6.00%  
Number of shares issued on conversion of 6% notes 1,962,338       984,246  
Number of securities called by warrants 196,189 110,507,188     98,409  
Per share exercise price of warrant 2.42       4.83  
Warrant expiration term         5 years  
Accumulated deficit $ 120,538          
XML 47 R22.htm IDEA: XBRL DOCUMENT v2.4.0.6
Commitments and Contingencies
 12 Months Ended
Dec. 31, 2012
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Disclosure

15. COMMITMENTS AND CONTINGENCIES

 

On March 31, 2011, the Company exercised its early termination option on the Parsippany, NJ office lease, submitting written notice to the landlord and making a payment of $53,641.  The Company continued to make monthly lease payments under the Parsippany lease through December 31, 2011, at which time, this lease terminated.

 

On August 4, 2011, the Company entered into a lease for new office space of approximately 4,168 square feet in Flemington, New Jersey (the “Flemington Lease”). The lease commencement date was November 17, 2011, with lease payments beginning in February 2012.  The lease expiration date is three years from the rent commencement date.  The Company provided a cash security deposit of $10,455, or two months’ base rent.  The Company is also responsible for payment of its share of common area maintenance costs and taxes. The aggregate remaining minimum future payments under the Flemington Lease at December 31, 2012 are approximately $150,531 including common area maintenance charges and taxes. The Flemington Lease contains a three-month free rent period and annual escalations, as such, the Company accounts for rent expense on a straight-line basis. The Company recognized $85,362 and $7,351 in rent expense for the Flemington Lease for the years ended December 31, 2012 and 2011, respectively.

 

Future minimum lease payments under operating leases as of December 31, 2012 are as follows:

 

2013   $ 69,981  
2014     71,816  
2015     8,734  
         
Total future minimum lease payments   $ 150,531  

 

On April 21, 2011, the Company entered into an employment agreement with Glenn Mattes, as its Chief Executive Officer, with an effective commencement date of employment beginning on April 25, 2011. The agreement provides for a term of three years, expiring on April 25, 2014, and initial base salary of $100,000. On and after the first anniversary date of the effective commencement date, Mr. Mattes’ base salary shall be increased to $350,000. In addition, Mr. Mattes is eligible to receive an annual target performance bonus of up to 50% of his base salary, but up to $175,000 during the first year of employment. Additionally, the Company shall issue to Mr. Mattes, 250,000 shares of restricted common stock. These shares vest in 12 equal monthly installments and have a total fair value of $172,750, or $0.69 per share, as estimated by management using a Monte Carlo simulation model using the significant assumptions described below in addition to a discount for the restrictions and, in doing so, utilizing a third-party valuation report.  The shares are recognized as compensation expense upon vesting. The Company has recognized $57,584, $115,168 and $172,572 of compensation expense for the years ended December 31, 2012, 2011 and the period from inception to December 31, 2012, respectively, in connection with the restricted shares.

 

In addition, Mr. Mattes was granted 10-year options to purchase a total of 2,354,379 shares of the Company’s common stock at an exercise price equal to $1.00 per share.  Options relating to 60% of such shares are designated as “Employment Options” and options relating to the remaining 40% of the shares are designated as “Performance Options.”   The right to purchase 25% of the shares subject to the Employment Options vested on April 25, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, in three equal annual installments during the Term, subject to the successful achievement of specific performance objectives to be established by the Board.    The Employment Options, Performance Options, and Restricted Shares were awarded to Mr. Mattes pursuant to the Plan. The employment agreement also entitles Mr. Mattes to certain change of control and severance benefits.

 

On June 22, 2011, the Company entered into an employment agreement with Alexander Zukiwski, M.D., as its Chief Medical Officer, with an effective commencement date of employment beginning on June 22, 2011. The agreement provides for a term of three years, expiring on June 22, 2014, and initial base salary of $375,000. The Employment Agreement further provides that, subject to the successful achievement of specific performance objectives to be established by the Board, Dr. Zukiwski will be eligible to receive an annual performance bonus of up to 50% of his annualized base salary.  The Company has also agreed to reimburse Dr. Zukiwski in an amount up to $200,000 for expenses incurred in connection with the relocation of Dr. Zukiwski’s primary residence to the northern New Jersey area. As of March 29, 2013, Dr. Zukiwski has not relocated to the northern New Jersey area and the Company has not reimbursed him for any moving expenses.

 

In addition, Dr. Zukiwski was granted 10-year options to purchase a total of 1,750,000 shares of the Company’s common stock at an exercise price equal to $1.00 per share.  Options relating to 50% of such shares are designated as “Employment Options” and options relating to the remaining 50% of the shares are designated as “Performance Options.”  The right to purchase 25% of the shares subject to the Employment Options will vested on June 22, 2012, and thereafter the remaining shares subject to the Employment Options will vest and become exercisable in 24 equal monthly installments.  The right to purchase the shares subject to the Performance Options shall vest and become exercisable, if at all, in three equal annual installments during the Term, subject to the successful achievement of specific performance objectives to be established by the Board. The employment agreement also entitles Dr. Zukiwski to certain change of control and severance benefits.

 

The Company has entered into various contracts with third parties in connection with the development of the licensed technology described in Note 6.

 

The aggregate minimum commitment under these contracts as of December 31, 2012 is approximately $4.5 million, all expected to be due during 2013 and 2014.

 

In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company’s maximum exposure under these arrangements is unknown as of December 31, 2012. The Company does not anticipate recognizing any significant losses relating to these arrangements.
XML 48 R36.htm IDEA: XBRL DOCUMENT v2.4.0.6
Straight - Line Method over Remaining Lease Term or Life of Asset (Detail)
 12 Months Ended
Dec. 31, 2012
Leasehold Improvements
  
Property Plant and Equipment Estimated Useful Life [Line Items]  
Property, Plant and Equipment, Useful Life 3 years
Computer Equipment
  
Property Plant and Equipment Estimated Useful Life [Line Items]  
Property, Plant and Equipment, Useful Life 3 years
Minimum | Office equipment and furniture
  
Property Plant and Equipment Estimated Useful Life [Line Items]  
Property, Plant and Equipment, Useful Life 5 years
Maximum | Office equipment and furniture
  
Property Plant and Equipment Estimated Useful Life [Line Items]  
Property, Plant and Equipment, Useful Life 7 years
XML 49 R24.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies (Policies)
 12 Months Ended
Dec. 31, 2012
Accounting Policies [Abstract]  
Use of Estimates

(a) Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires that management make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Estimates and assumptions principally relate to services performed by third parties but not yet invoiced, estimates of the fair value and forfeiture rates of stock options issued to employees, directors and consultants, valuation of derivatives and estimates of the probability and potential magnitude of contingent liabilities. Actual results could differ from those estimates.
Cash and cash equivalents

(b) Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a remaining maturity of three months or less at the time of acquisition to be cash equivalents.
Deferred financing fees

(c) Deferred Financing Fees

 

Finance costs relating to debt issued are recorded as a deferred charge and amortized to interest expense over the expected term of the debt using the effective interest method.
Prepaid Expenses

(d) Prepaid Expenses

 

Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, insurance policies and license fees. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight line method.
Property and Equipment

(e) Property and Equipment

 

Property and equipment consist primarily of furnishings, fixtures, leasehold improvements and computer equipment and are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.

 

Description   Estimated Useful Life
     
Office equipment and furniture   5 to 7 years
Leasehold improvements   3 years
Computer equipment   3 years

 
Fair Value of Financial Instruments

(f) Fair Value of Financial Instruments

 

The Company measures fair value in accordance with generally accepted accounting principles. Fair value measurements are applied under other accounting pronouncements that require or permit fair value measurements. Financial instruments included in the Company’s balance sheets consist of cash and cash equivalents, accounts payable, accrued expenses, due to related parties, and warrant liability. The carrying amounts of these instruments reasonably approximate their fair values due to their short-term maturities.
Convertible Debentures and Warrant Liability [Policy Text Block]

(g) Convertible Debentures and Warrant Liability

 

The Company accounts for the convertible debentures and warrants issued in connection with the 2012 Purchase Agreement (see Note 8) and for the warrants issued in connection with the 2010 Purchase Agreement (see Note 10) in accordance with the guidance on Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, which provides that the Company classify the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as a component of other income or expense. The fair value of warrants issued by the Company, in connection with private placements of securities, has been estimated using a Monte Carlo simulation model and, in doing so, the Company’s management utilized a third-party valuation report. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error.
Concentration of Credit Risk

(h) Concentration of Credit Risk

 

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company deposits cash and cash equivalents with high credit quality financial institutions and is insured to the maximum limitations. Balances in these accounts may exceed federally insured limits at times, which expose the Company to institutional risk.

 
Research and Development

(i) Research and Development

 

Research and development costs are charged to expense as incurred. Research and development includes employee costs, fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.
Stock-based compensation

(j) Stock-Based Compensation

 

Stock-based compensation cost is measured at the grant date based on the value of the award and is recognized as expense over the required service period, which is generally equal to the vesting period. Share-based compensation is recognized only for those awards that are ultimately expected to vest.

 

Common stock, stock options or other equity instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model.  The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.
Loss per Common Share

(k) Loss per Common Share

 

Basic loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding. Diluted loss per share is computed similarly to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.

 

    For the Year Ended December 31,  
    2012     2011  
    Loss     Shares     Per Share     Loss     Shares     Per Share  
    (Numerator)     (Denominator)     Amount     (Numerator)     (Denominator)     Amount  
Net loss   $ (14,387,782 )                   $ (7,909,113 )                
Less: Preferred stock dividends     -                       (81,651 )                
                                                 
Basic and Diluted EPS                                                
Loss available to common stockholders   $ (14,387,782 )     36,322,565     $ (0.40 )   $ (7,990,764 )     34,514,594     $ (0.23 )

 

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

 

Potentially dilutive securities include:

 

    December 31, 2012     December 31, 2011  
Options to purchase common stock     –       -  

 

For the year ended December 31, 2012 and 2011, 165,810,057 and 15,817,737 shares of warrants, options and shares issuable under convertible debentures have been excluded from the computation of potentially dilutive securities, respectively, as their conversion and/or exercise prices are greater than the fair market price per common share as of December 31, 2012 and 2011, respectively.
Comprehensive Loss

(l) Comprehensive Loss

 

The Company has no components of other comprehensive loss other than its net loss, and accordingly, comprehensive loss is equal to net loss for all periods presented.

 
Income Taxes

(m) Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the period in which the differences are expected to affect taxable income. The Company provides a valuation allowance when it appears more likely than not that some or all of the net deferred tax assets will not be realized.

 

A tax position is recognized as a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with a tax examination being presumed to occur. The amount recognized is the largest amount of tax benefit that is greater than 50% likely of being realized on examination. For tax positions not meeting the “more likely than not” test, no tax benefit is recorded.

 

The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for (benefit from) income taxes. The Company recognized no amounts for interest and penalties related to unrecognized tax benefits in 2012 and 2011 respectively. In addition, the Company had no amounts accrued for interest and penalties as of December 31, 2012 and 2011, respectively.
Recently Issued Accounting Pronouncements

(n) Recently Issued Accounting Pronouncements

 

In May 2011, the Financial Accounting Standards Board (“FASB”) issued additional guidance relating to fair value measurement and disclosure requirements. For fair value measurements categorized in Level 3 of the fair value hierarchy, the new guidance requires (1) disclosure of quantitative information about unobservable inputs; (2) a description of the valuation processes used by the entity; and (3) a qualitative discussion about the sensitivity of the fair value measurements to changes in unobservable inputs and interrelationships between those unobservable inputs, if any. Entities must report the level in the fair value hierarchy of assets and liabilities that are not recorded at fair value in the statement of financial position but for which fair value is disclosed. The new requirements clarify that the concepts of highest and best use and valuation premise only apply to measuring fair value of nonfinancial assets. The new requirements also specify that in the absence of a Level 1 input, a reporting entity should incorporate a premium or discount in a fair value measurement if a market participant would take into account such an input in pricing an asset or liability. Additionally, the new guidance introduces an option to measure certain financial assets and financial liabilities with offsetting positions on a net basis if certain criteria are met. For public entities, these new requirements become effective for interim and annual periods beginning on or after December 15, 2011. These requirements are applicable to our fiscal year beginning January 1, 2012. The adoption of this new guidance did not have a material effect on the Company’s financial statements.

 

Management does not believe that any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements.
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STATEMENTS OF CASH FLOWS (USD $)
 12 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Cash flows from operating activities      
Net loss $ (14,387,782) $ (7,909,113) $ (49,900,782)
Adjustment to reconcile net loss to net cash used in operating activities      
Depreciation and amortization 13,836 11,677 114,980
Stock-based compensation 722,811 822,452 3,671,215
Change in fair value of derivative liability (2,806,750) 284,692 (2,441,699)
Write-off of intangible assets 0 0 85,125
Warrants issued for services 0 0 480,400
Warrants issued in connection with note conversion 0 0 348,000
Note discount arising from beneficial conversion feature 0 0 475,391
Deferred rent 5,360 (7,397) 12,711
Loss on disposal of assets 0 2,677 5,357
Noncash interest expense 6,255,996 0 6,567,514
Changes in operating assets and liabilities      
Prepaid expenses and other current assets 93,432 (49,448) (203,516)
Restricted cash 0 44,018 0
Security deposit 0 (10,455) (10,455)
Accounts payable 869,993 128,799 1,553,154
Accrued expenses (130,170) (166,926) 1,057,871
Due to related party (56,488) 15,458 28,268
Net cash used in operating activities (9,419,762) (6,833,566) (38,156,466)
Cash flows from investing activities      
Purchase of property and equipment 0 (23,014) (100,174)
Cash paid for intangible assets 0 0 (85,125)
Proceeds from related party advance 0 0 525,000
Repayment of related party advance 0 0 (525,000)
Net cash used in investing activities 0 (23,014) (185,299)
Cash flows from financing activities      
Proceeds from issuance of common stock to founders 0 0 5,000
Proceeds from issuance of preferred stock in private placement, net 0 0 13,974,230
Proceeds from issuance of common stock in private placement, net 0 0 17,690,037
Deferred financing fees paid (1,172,345) 0 (1,217,345)
Proceeds from issuance of notes payable 0 0 1,000,000
Repayment of notes payable 0 0 (1,000,000)
Proceeds from issuance of convertible notes payable 0 0 3,967,000
Proceeds from issuance of convertible debentures payable 14,857,200 0 14,857,200
Proceeds from exercise of stock options 0 6,480 9,080
Net cash provided by financing activities 13,684,855 6,480 49,285,202
Net increase (decrease) in cash and cash equivalents 4,265,093 (6,850,100) 10,943,437
Cash and cash equivalents at beginning of period 6,678,344 13,528,444 0
Cash and cash equivalents at end of period 10,943,437 6,678,344 10,943,437
Supplemental schedule of cash flows information:      
Cash paid for interest 105,034 0 185,034
Supplemental schedule of non-cash investing and financing activities:      
Conversion of notes payable and interest to common stock 0 0 4,278,518
Common shares of Laurier issued in reverse merger transaction 0 0 110
Issuance of warrants in connection with private placement of convertible preferred units 0 0 3,340,421
Issuance of warrants in connection with private placement of convertible debentures 12,973,055 0 12,973,055
Issuance of common stock pursuant to placement agent agreement 43,500 0 43,500
Preferred stock dividends settled in common stock $ 0 $ 319,074 $ 319,074
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BALANCE SHEETS (Parenthetical) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 35,000,000 35,000,000
Preferred stock, issued 0 0
Preferred stock, outstanding 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 500,000,000 500,000,000
Common stock, shares issued 36,364,942 36,304,942
Common stock, shares outstanding 36,364,942 36,304,942
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Stockholders' Equity
 12 Months Ended
Dec. 31, 2012
Stockholders' Equity Note [Abstract]  
Stockholders' Equity

10. STOCKHOLDERS’ EQUITY

 

(a) Common Stock

 

On November 21, 2012, the Company amended its Amended & Restated Certificate of Incorporation to increase the number of shares of common stock that the Company is authorized to issue from 80,000,000 shares to 500,000,000 shares.

 

On April 25, 2011, the Company issued 250,000 shares of restricted common stock under the Company’s 2005 Stock Option Plan to its new Chief Executive Officer pursuant to his employment agreement. These shares vested in 12 equal monthly installments and have a total fair value of $172,750, or $0.69 per share, as estimated by management using a Monte Carlo simulation model using the significant assumptions described below in addition to a discount for the restrictions and, in doing so, utilizing a third-party valuation report.  The shares are recognized as compensation expense upon vesting. The shares are recognized as compensation expense upon vesting. The Company has recognized $57,584, $115,168 and $172,572 of compensation expense for the years ended December 31, 2012, 2011 and the period from inception to December 31, 2012, respectively, in connection with the restricted shares.

 

On February 9, 2011, the Company issued an aggregate of 15,274,000 shares of its common stock upon the automatic conversion of all 15,274,000 of its issued and outstanding shares of Series A Convertible Preferred Stock. In accordance with their terms, the shares Series A Convertible Preferred Stock automatically converted upon the effectiveness of the Company’s registration statement covering the resale under the Securities Act of 1933 of the shares of common stock issuable upon conversion of such preferred shares.  See Note 10(b) Preferred Stock,.  In addition, the Company elected to satisfy accrued dividends on the Series A Convertible Preferred Stock of $319,074 by issuing an additional 319,074 shares of common stock.

 

On November 15, 2010, the Company’s stockholders authorized the amendment of the Company’s amended and restated certificate of incorporation in order to effect a combination (reverse split) of its common stock at a ratio not to exceed one-for-eight, provided that the Company’s board of directors shall have absolute discretion to determine and fix the exact ratio of such combination (not to exceed one-for-eight) and the time at which such combination shall become effective, if ever.  The Company’s board of directors has taken no further action to implement a combination of our common stock and reserves the right to abandon the proposed reverse stock split in its sole discretion.

 

As of December 31, 2012, the Company has 36,364,942 shares of common stock issued and outstanding and an additional 116,286,054 shares of common stock reserved for issuance upon the exercise of outstanding options and warrants.

 

(b) Preferred Stock

 

On August 11, 2010, the Company amended and restated its certificate of incorporation, increasing the number of shares of preferred stock authorized for issuance thereunder from 10,000,000 to 35,000,000.

 

On September 3, 2010, the Company entered into a Securities Purchase and Registration Rights Agreement (the “2010 Purchase Agreement”), with a number of institutional and other accredited investors pursuant to which the Company sold in a private placement an aggregate of 15,274,000 shares of newly-designated Series A Convertible Preferred Stock, par value $0.0001 per share, or Series A Preferred Stock, at a per share purchase price of $1.00.  In accordance with the 2010 Purchase Agreement, the Company also issued two-and-one-half-year Class A warrants to purchase an aggregate of 1,221,920 shares of Series A Preferred Stock at an initial exercise price of $1.00 per share and five-year Class B warrants to purchase an aggregate of 6,415,080 shares of Series A Preferred Stock at an initial exercise price of $1.15 per share. The terms of the Class A and Class B warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price of the Class A and Class B warrants will be adjusted based on the lower issuance price. The sale of the shares and warrants resulted in aggregate gross proceeds of approximately $15.3 million, before expenses.

 

The terms, conditions, privileges, rights and preferences of the Series A Convertible Preferred Stock are described in a Certificate of Designation filed with the Secretary of State of Delaware on September 3, 2010.

 

Each share of Series A Preferred Stock was initially convertible at the holder’s election into one share of common stock.  Upon the effective date of the registration statement on February 9, 2011, each share of Series A Preferred Stock automatically converted into one share of common stock. In addition, all outstanding warrants to purchase Series A Preferred Stock automatically converted into warrants to purchase common stock.

 

Issuance costs related to the financing were approximately $1.8 million, of which approximately $0.5 million was non-cash for issuance of warrants (“Placement Warrants”) to purchase 1,056,930 shares of the Company’s common stock at 110% of the Series A Preferred Stock purchase price per share to designees of Riverbank Capital Securities, Inc. (“Riverbank”), a related party controlled by several officers and/or directors of the Company (see Note 12), and I-Bankers Securities, Inc. (“IBS”), that acted as placement agents for the Company in connection with the private placement.

 

On February 9, 2011, the Company’s registration statement was declared effective and the 15,274,000 shares of Series A Convertible Preferred Stock converted into 15,274,000 shares of common stock. In addition, the Company elected to pay the $319,074 in accrued dividends in shares of common stock resulting in the issuance of 319,074 shares.

 

(c) Warrants

 

In accordance with the 2010 Purchase Agreement, the Company issued two-and-one-half-year Class A warrants to purchase an aggregate of 1,221,920 shares of Series A Preferred Stock at an initial exercise price of $1.00 per share and five-year Class B warrants to purchase an aggregate of 6,415,080 shares of Series A Preferred Stock at an initial exercise price of $1.15 per share. As noted above, all outstanding warrants to purchase shares of Series A Preferred Stock automatically converted into warrants to purchase common stock on February 9, 2011, when the Company’s registration statement was declared effective. The terms of the warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price will be adjusted based on the lower issuance price. Because of this anti-dilution provision and the inherent uncertainty as to the probability of future common share issuances, the Black-Scholes option pricing model the Company uses for valuing stock options could not be used.  Management used a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report to determine the warrant liability to be approximately $0.9 million and approximately $3.7 million at December 31, 2012 and 2011, respectively. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error. This valuation is revised on a quarterly basis until the warrants are exercised or they expire with the changes in fair value recorded in other expense on the statement of operations.

 

Pursuant to the 2012 Purchase Agreement, the Company issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.30 per share. The terms of the warrants contain an anti-dilutive price adjustment provision, such that, in the event the Company issues common shares at a price below the current exercise price of the warrants, the exercise price will be adjusted based on the lower issuance price. Because of this anti-dilution provision and the inherent uncertainty as to the probability of future common share issuances, the Black-Scholes option pricing model the Company uses for valuing stock options could not be used.  Management used a Monte Carlo simulation model and, in doing so, utilized a third-party valuation report to determine the warrant liability to be approximately $12.4 million at December 31, 2012

 

In connection with the 2012 offering of Debentures and Warrants, the Company engaged Maxim Group LLC, or Maxim Group, to serve as placement agent. In consideration for its services, the Company paid Maxim Group a placement fee of $1,035,000. In addition, the Company issued to Maxim Partners LLC, or Maxim Partners, an affiliate of Maxim Group, 60,000 shares of common stock and five-year warrants to purchase an additional 2,270,000 shares of common stock at an initial exercise price of $0.33 per share. The warrants issued to Maxim Partners are in substantially the same form as the Warrants issued to the investors, except that they do not include certain anti-dilution provisions contained in the Warrants. However, the placement warrants do contain a provision that could require the Company to repurchase the warrants from the holder under certain conditions. These placement warrants were valued at $542,530 (see Note 9).

 

Below is a table that summarizes all outstanding warrants to purchase shares of the Company’s common stock as of December 31, 2012.

 

Grant Date   Warrants Issued     Exercise Price     Weighted
Average
Exercise
Price		     Expiration
Date		   Exercised     Warrants
Outstanding		  
01/02/2008     299,063     $ 2.42     $ 2.42     01/02/2013     -       299,063  
06/02/2008     196,189     $ 2.42     $ 2.42     06/02/2013     -       196,189  
09/03/2010     1,221,920     $ 0.53     $ 0.53     03/03/2013     -       1,221,920  
09/03/2010     6,415,080     $ 0.56     $ 0.56     09/03/2015     -       6,415,080  
09/03/2010     1,056,930     $ 1.10     $ 1.10     09/03/2015     -       1,056,930  
11/26/2012     42,350,002     $ 0.30     $ 0.30     05/26/2014     -       42,350,002  
12/18/2012     7,174,001     $ 0.30     $ 0.30     06/18/2014     -       7,174,001  
11/26/2012     42,350,002     $ 0.50     $ 0.50     11/26/2017     -       42,350,002  
11/26/2012     2,090,000     $ 0.33     $ 0.33     11/26/2017     -       2,090,000  
12/18/2012     7,174,001     $ 0.50     $ 0.50     12/18/2017     -       7,174,001  
12/18/2012     180,000     $ 0.33     $ 0.33     12/18/2017     -       180,000  
      110,507,188             $ 0.43           -       110,507,188  
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Document and Entity Information (USD $)
 12 Months Ended
Dec. 31, 2012
Mar. 29, 2013
Jun. 30, 2012
Document Information [Line Items]      
Document Type 10-K    
Amendment Flag false    
Document Period End Date Dec. 31, 2012    
Document Fiscal Year Focus 2012    
Document Fiscal Period Focus FY    
Trading Symbol ARNI    
Entity Registrant Name Arno Therapeutics, Inc    
Entity Central Index Key 0001195116    
Current Fiscal Year End Date --12-31    
Entity Well-Known Seasoned Issuer No    
Entity Current Reporting Status Yes    
Entity Voluntary Filers No    
Entity Filer Category Smaller Reporting Company    
Entity Common Stock, Shares Outstanding   36,364,942  
Entity Public Float     $ 2,818,963
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Stock Option Plan
 12 Months Ended
Dec. 31, 2012
Disclosure Of Compensation Related Costs, Share-Based Payments [Abstract]  
Stock Option Plan

11. STOCK OPTION PLAN

 

The Company’s 2005 Stock Option Plan (the “Plan”) was originally adopted by the Board of Directors of Old Arno in August 2005, and was assumed by the Company on June 3, 2008 in connection with the Merger. After giving effect to the Merger, there were initially 2,990,655 shares of the Company’s common stock reserved for issuance under the 2005 Plan. On April 25, 2011, the Company’s Board of Directors approved an amendment to the 2005 Plan to increase the number of shares of common stock issuable thereunder to 7,000,000 shares. Under the Plan, incentives may be granted to officers, employees, directors, consultants, and advisors. Incentives under the Plan may be granted in any one or a combination of the following forms: (a) incentive stock options and non-statutory stock options, (b) stock appreciation rights, (c) stock awards, (d) restricted stock and (e) performance shares.

 

The Plan is administered by the Board of Directors, or a committee appointed by the Board, which determines recipients and types of awards to be granted, including the number of shares subject to the awards, the exercise price and the vesting schedule. The term of stock options granted under the Plan cannot exceed 10 years. Options shall not have an exercise price less than the fair market value of the Company’s common stock on the grant date, and generally vest over a period of three to four years.

 

As of December 31, 2012, an aggregate of 901,290 shares remained available for future grants and awards under the Plan, which covers stock options, warrants and restricted awards. The Company issues unissued shares to satisfy stock options, warrants exercises and restricted stock awards.

 

No options were granted by the Company during the year ended December 31, 2012. For the year ended December 31, 2011, the Company estimated the fair value of each option award granted using the Black-Scholes option-pricing model. The following assumptions were used for the year ended December 31, 2011:

 

    2011  
Expected Volatility     87 %
Expected Term     5-10 years  
Dividend yield     0.0 %
Risk-free interest rate     1.5-2.0%  
Stock price     $0.69 -  $0.72  
Forfeiture rate     0.0 %

 

The valuation assumptions were determined as follows:

 

· Expected volatility – The expected volatility on the average expected volatilities of a sampling of five companies with similar attributes to the Company, including industry, stage of life cycle, size and financial leverage.

   

· Expected term – The expected term of the awards represents the period of time that the awards are expected to be outstanding. Management considered historical data and expectations for the future to estimate employee exercise and post vest termination behavior. Consultant options are assigned an expected term equal to the maximum term of the option grant.

 

· Dividend yield – The estimate for annual dividends is zero, because the Company has not historically paid dividends and does not intend to in the foreseeable future.

 

A summary of the status of the options issued under the Plan as of December 31, 2012, and information with respect to the changes in options outstanding is as follows:

 

          Options Outstanding  
    Shares     Outstanding     Weighted-     Aggregate  
    Available for     Stock     Average     Intrinsic  
    Grant     Options     Exercise Price     Value  
Balance at January 1, 2011     1,077,352       1,893,303     $ 1.36          
Shares authorized for issuance     4,009,345       -       -          
Options granted under the Plan     (5,054,317 )     5,054,317     $ 1.03          
Restricted stock granted under the Plan     (250,000 )     -       -          
Options exercised     -       (49,844 )   $ 0.13          
Options forfeited     269,221       (269,221 )   $ 1.53          
Balance at December 31, 2011     51,601       6,628,555     $ 1.31          
Options forfeited     849,689       (849,689 )   $ 1.00          
Balance at December 31, 2012     901,290       5,778,866     $ 1.11     $ -  
                                 
Exercisable at December 31, 2012             3,566,669     $ 1.17     $ -  

 

The following table summarizes information about stock options outstanding at December 31, 2012:

 

      Outstanding     Exercisable  
Exercise
Price		     Shares     Weighted-
Average
Remaining
Contractual Life
(Years)		     Weighted-
Average
Exercise Price		     Shares     Weighted-
Average
Exercise Price		  
$ 1.00       5,388,133       7.8     $ 1.00       3,175,936     $ 1.00  
$ 2.42       299,066       3.6     $ 2.42       299,066     $ 2.42  
$ 3.00       91,667       1.2     $ 3.00       91,667     $ 3.00  
  Total       5,778,866       7.6     $ 1.11       3,566,669     $ 1.17  

 

Stock-based compensation costs for the years ended December 31, 2012 and 2011 and for the cumulative period from August 1, 2005 (inception) through December 31, 2012, are as follows:

 

    Year Ended December 31,        
    2012     2011     Period from August 1, 2005
(inception) through
December 31, 2012		  
General and administrative   $ 441,983     $ 449,652     $ 1,986,610  
Research and development     280,828       372,800       1,684,605  
Total   $ 722,811     $ 822,452     $ 3,671,215  

 

The fair value of options vested under the 2005 Plan was approximately $863,892 and $443,507 for the years ended December 31, 2012 and 2011, respectively, and approximately $3,218,757 for the period from August 1, 2005 (inception) through December 31, 2012.

 

At December 31, 2012, total unrecognized estimated compensation cost related to stock options granted prior to that date was approximately $1.1 million which is expected to be recognized over a weighted-average vesting period of 1.5 years. This unrecognized estimated employee compensation cost does not include any estimate for forfeitures of performance-based stock options.

 

Common stock, stock options or other equity instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model and is expensed as underlying options vest.  The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.

 

For the year ended December 31, 2012, the Company did not issue any options. For the year ended December 31, 2011, the Company issued options to purchase a total of 5,054,317 shares of common stock to employees and consultants with exercise prices ranging from $1.00 to $2.42 and terms of up to 10 years.  Of this total, 10-year options to purchase 2,354,379 shares at an exercise price of $1.00 were issued to the Company’s new President and Chief Executive Officer and 10-year options to purchase 1,750,000 shares at an exercise price of $1.00 were issued to the Company’s new Chief Medical Officer.
XML 56 R4.htm IDEA: XBRL DOCUMENT v2.4.0.6
STATEMENTS OF OPERATIONS (USD $)
 12 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Operating expenses:      
Research and development $ 8,537,130 $ 5,690,836 $ 36,845,208
General and administrative 2,298,671 1,956,115 9,342,612
Total operating expenses 10,835,801 7,646,951 46,187,820
Loss from operations (10,835,801) (7,646,951) (46,187,820)
Other income (expense):      
Interest income 7,849 28,771 414,120
Interest expense (6,361,029) 0 (7,621,128)
Other income (expense) 2,801,199 (290,933) 3,494,046
Total other income (expense) (3,551,981) (262,162) (3,712,962)
Net loss (14,387,782) (7,909,113) (49,900,782)
Preferred stock dividends 0 81,651  
Net loss available to common stockholders $ (14,387,782) $ (7,990,764)  
Net loss per share - basic and diluted $ (0.40) $ (0.23)  
Weighted-average shares outstanding -basic and diluted 36,322,565 34,514,594  
XML 57 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property and Equipment
 12 Months Ended
Dec. 31, 2012
Property, Plant and Equipment [Abstract]  
Property And Equipment

5. PROPERTY AND EQUIPMENT

 

Property and equipment as of December 31, 2012 and 2011 consist of the following:  

 

    2012     2011  
Computer equipment and software   $ 17,721     $ 17,721  
Office furniture and equipment     52,242       52,242  
Leasehold improvements     8,449       8,449  
Total property and equipment     78,412       78,412  
Accumulated depreciation     (53,575 )     (39,739 )
Total property and equipment, net   $ 24,837     $ 38,673  

 

Depreciation expense for the years ended December 31, 2012, 2011, and the period from August 1, 2005 (inception) through December 31, 2012, was $13,836, $11,677 and $69,979, respectively.
XML 58 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies
 12 Months Ended
Dec. 31, 2012
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

4. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

(a) Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires that management make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Estimates and assumptions principally relate to services performed by third parties but not yet invoiced, estimates of the fair value and forfeiture rates of stock options issued to employees, directors and consultants, valuation of derivatives and estimates of the probability and potential magnitude of contingent liabilities. Actual results could differ from those estimates.

 

(b) Cash and Cash Equivalents

 

The Company considers all highly liquid investments with a remaining maturity of three months or less at the time of acquisition to be cash equivalents.

 

(c) Deferred Financing Fees

 

Finance costs relating to debt issued are recorded as a deferred charge and amortized to interest expense over the expected term of the debt using the effective interest method.

  

(d) Prepaid Expenses

 

Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, insurance policies and license fees. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight line method.

 

(e) Property and Equipment

 

Property and equipment consist primarily of furnishings, fixtures, leasehold improvements and computer equipment and are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.

 

Description   Estimated Useful Life
     
Office equipment and furniture   5 to 7 years
Leasehold improvements   3 years
Computer equipment   3 years

 

(f) Fair Value of Financial Instruments

 

The Company measures fair value in accordance with generally accepted accounting principles. Fair value measurements are applied under other accounting pronouncements that require or permit fair value measurements. Financial instruments included in the Company’s balance sheets consist of cash and cash equivalents, accounts payable, accrued expenses, due to related parties, and warrant liability. The carrying amounts of these instruments reasonably approximate their fair values due to their short-term maturities.

 

(g) Convertible Debentures and Warrant Liability

 

The Company accounts for the convertible debentures and warrants issued in connection with the 2012 Purchase Agreement (see Note 8) and for the warrants issued in connection with the 2010 Purchase Agreement (see Note 10) in accordance with the guidance on Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, which provides that the Company classify the warrant instrument as a liability at its fair value and adjusts the instrument to fair value at each reporting period. This liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized as a component of other income or expense. The fair value of warrants issued by the Company, in connection with private placements of securities, has been estimated using a Monte Carlo simulation model and, in doing so, the Company’s management utilized a third-party valuation report. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of the Company’s future expected stock prices and minimizes standard error.

 

(h) Concentration of Credit Risk

 

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company deposits cash and cash equivalents with high credit quality financial institutions and is insured to the maximum limitations. Balances in these accounts may exceed federally insured limits at times, which expose the Company to institutional risk.

 

(i) Research and Development

 

Research and development costs are charged to expense as incurred. Research and development includes employee costs, fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense.

 

(j) Stock-Based Compensation

 

Stock-based compensation cost is measured at the grant date based on the value of the award and is recognized as expense over the required service period, which is generally equal to the vesting period. Share-based compensation is recognized only for those awards that are ultimately expected to vest.

 

Common stock, stock options or other equity instruments issued to non-employees (including consultants and all members of the Company’s Scientific Advisory Board) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued (unless the fair value of the consideration received can be more reliably measured). The fair value of stock options is determined using the Black-Scholes option-pricing model.  The fair value of any options issued to non-employees is recorded as expense over the applicable service periods.

 

(k) Loss per Common Share

 

Basic loss per share is computed by dividing the loss available to common shareholders by the weighted-average number of common shares outstanding. Diluted loss per share is computed similarly to basic loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive.

 

    For the Year Ended December 31,  
    2012     2011  
    Loss     Shares     Per Share     Loss     Shares     Per Share  
    (Numerator)     (Denominator)     Amount     (Numerator)     (Denominator)     Amount  
Net loss   $ (14,387,782 )                   $ (7,909,113 )                
Less: Preferred stock dividends     -                       (81,651 )                
                                                 
Basic and Diluted EPS                                                
Loss available to common stockholders   $ (14,387,782 )     36,322,565     $ (0.40 )   $ (7,990,764 )     34,514,594     $ (0.23 )

 

For all periods presented, potentially dilutive securities are excluded from the computation of fully diluted loss per share as their effect is anti-dilutive.

 

Potentially dilutive securities include:

 

    December 31, 2012     December 31, 2011  
Options to purchase common stock     –       -  

 

For the year ended December 31, 2012 and 2011, 165,810,057 and 15,817,737 shares of warrants, options and shares issuable under convertible debentures have been excluded from the computation of potentially dilutive securities, respectively, as their conversion and/or exercise prices are greater than the fair market price per common share as of December 31, 2012 and 2011, respectively.

 

(l) Comprehensive Loss

 

The Company has no components of other comprehensive loss other than its net loss, and accordingly, comprehensive loss is equal to net loss for all periods presented.

 

(m) Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the period in which the differences are expected to affect taxable income. The Company provides a valuation allowance when it appears more likely than not that some or all of the net deferred tax assets will not be realized.

 

A tax position is recognized as a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with a tax examination being presumed to occur. The amount recognized is the largest amount of tax benefit that is greater than 50% likely of being realized on examination. For tax positions not meeting the “more likely than not” test, no tax benefit is recorded.

 

The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for (benefit from) income taxes. The Company recognized no amounts for interest and penalties related to unrecognized tax benefits in 2012 and 2011 respectively. In addition, the Company had no amounts accrued for interest and penalties as of December 31, 2012 and 2011, respectively.

 

(n) Recently Issued Accounting Pronouncements

 

In May 2011, the Financial Accounting Standards Board (“FASB”) issued additional guidance relating to fair value measurement and disclosure requirements. For fair value measurements categorized in Level 3 of the fair value hierarchy, the new guidance requires (1) disclosure of quantitative information about unobservable inputs; (2) a description of the valuation processes used by the entity; and (3) a qualitative discussion about the sensitivity of the fair value measurements to changes in unobservable inputs and interrelationships between those unobservable inputs, if any. Entities must report the level in the fair value hierarchy of assets and liabilities that are not recorded at fair value in the statement of financial position but for which fair value is disclosed. The new requirements clarify that the concepts of highest and best use and valuation premise only apply to measuring fair value of nonfinancial assets. The new requirements also specify that in the absence of a Level 1 input, a reporting entity should incorporate a premium or discount in a fair value measurement if a market participant would take into account such an input in pricing an asset or liability. Additionally, the new guidance introduces an option to measure certain financial assets and financial liabilities with offsetting positions on a net basis if certain criteria are met. For public entities, these new requirements become effective for interim and annual periods beginning on or after December 15, 2011. These requirements are applicable to our fiscal year beginning January 1, 2012. The adoption of this new guidance did not have a material effect on the Company’s financial statements.

 

Management does not believe that any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statements.
XML 59 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
Subsequent Events
 12 Months Ended
Dec. 31, 2012
Subsequent Events [Abstract]  
Subsequent Events

16. SUBSEQUENT EVENTS

 

In January 2012, the Company received a notice from the University of Pittsburgh, or Pitt, claiming that the Company was in default under its license agreement relating to AR-67 for failure to pay a $250,000 annual license fee under the terms of that agreement and providing the Company with 60 days’ notice to remedy the default. On March 29, 2012, following the Company’s determination not to proceed with further development of AR-67, the Company agreed with Pitt to terminate the license agreement. In February 2013, Pitt commenced an action in the Court of Common Pleas of Allegheny County, Pennsylvania, seeking damages of $250,000, plus interest and costs, based on its claim that the Company breached the license agreement by failing to pay the annual license fee. On March 28, 2013, the Company entered into a settlement agreement with Pitt pursuant to which the Company agreed to pay $235,000 in full satisfaction of all remaining obligations under the license agreement.

 

On January 30, 2013, the Company’s Board of Directors appointed Randy Thurman as a director of the Company. Mr. Thurman, age 63, is an Operating Executive at AEA Investments LP, a private equity firm. As consideration for his service on the Board, Mr. Thurman will receive an annual cash stipend of $50,000, payable quarterly in arrears. In addition, Mr. Thurman was granted a 10-year option under the 2005 Plan to purchase 200,000 shares of the Company’s common stock at an exercise price of $0.30 per share. The right to purchase one-third of the shares subject to the option vested immediately and the remaining shares subject to the option will vest and become exercisable in two equal annual installments on the first and second anniversaries of Mr. Thurman’s appointment. Mr. Thurman will also receive additional option grants on an annual basis, consistent with the Board’s compensation plan for non-employee directors.

 

On March 25, 2013, the Company and holders of approximately 80% of the Debentures sold pursuant to the 2012 Purchase Agreement entered into an amendment to the Registration Rights Agreement (see Note 8), permitting the Company, in its sole discretion, to elect to pay liquidated damages resulting from the Company’s failure to successfully cause the registration statement covering the resale of 100% of the Registrable Securities to be declared effective by the SEC by March 26, 2013, by issuing shares of common stock in lieu of cash. If electing to issue shares in lieu of paying cash, the Company shall issue to each investor a number of shares of common stock equal to (a) the aggregate amount of liquidated damages that the Company is electing to pay to such investor in the form of shares, divided by (b) thirty cents ($0.30). Pursuant to the terms of the Registration Rights Agreement, because holders of over two-thirds of the Debentures consented in writing to the March 25, 2013 amendment, such amendment is binding on all holders of Registrable Securities. On March 27, 2013, in accordance with the amendment to the Registration Rights Agreement, the Company issued an aggregate of 990,477 shares of common stock to the investors in lieu of an aggregate cash payment of $297,144, representing the first monthly installment of liquidated damages under the Registration Rights Agreement, as amended.

 

In late March 2013, the Company sought the agreement of the Debenture holders to amend their respective Debentures to provide for the accrual of all interest payments under such Debentures until the applicable maturity date in November or December of 2015, with such interest accruing at the rate of 8% per annum, compounding quarterly. As of March 28, 2013, the Company had entered into such amendments with the holders of Debentures in the aggregate principal amount of $7,875,000.
XML 60 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
Related Parties
 12 Months Ended
Dec. 31, 2012
Related Party Transactions [Abstract]  
Related Parties

12. RELATED PARTIES

 

On June 1, 2009, the Company entered into a services agreement with Two River Consulting, LLC (“TRC”) to provide various clinical development, operational, managerial, accounting and financial, and administrative services to the Company for a period of one year. David M. Tanen, the Company’s then President, Secretary and director, Arie S. Belldegrun, the Chairman of the Board of Directors, and Joshua A. Kazam, a director until September 2010, are each partners of TRC. The terms of the Services Agreement were reviewed and approved by a special committee of the Company’s Board of Directors consisting of independent directors. None of the members of the special committee has any interest in TRC or the services agreement. As compensation for the services contemplated by the services agreement, the Company pays TRC a monthly cash fee of $55,000.   The services agreement with TRC expired on April 1, 2011 and until a new agreement is in place, TRC is billing the Company for actual hours worked on a monthly basis.  For the year ended December 31, 2012, TRC billed Arno $273,171 for services rendered, an average of approximately $22,764 per month.

 

 On occasion, some of the Company’s expenses are paid by TRC. No interest is charged by TRC on any outstanding balance owed by the Company. For the years ended December 31, 2012 and 2011 and for the period from August 1, 2005 (inception) through December 31, 2012, total cash services and reimbursed expenses totaled $327,452, $655,923 and $2,131,217, respectively. As of December 31, 2012 the Company had a payable to TRC of $28,268, which was paid in full during the first two months of 2013.

 

The financial condition and results of operations of the Company, as reported, are not necessarily indicative of results that would have been reported had the Company operated completely independently.
XML 61 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
Convertible Debentures and Notes Payable
 12 Months Ended
Dec. 31, 2012
Convertible Notes Payable [Abstract]  
Convertible Notes Payable

8. CONVERTIBLE DEBENTURES AND NOTES PAYABLE

 

On November 26, 2012, the Company entered into a Securities Purchase Agreement, or the 2012 Purchase Agreement, with a number of institutional and accredited investors pursuant to which the Company sold in a private placement an aggregate principal amount of $14,857,200 of three-year 8% Senior Convertible Debentures, or the Debentures. In accordance with the 2012 Purchase Agreement, as amended on December 13, 2012, the Company also issued five-year Series A warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.50 per share and 18-month Series B warrants to purchase an aggregate of 49,524,003 shares of common stock at an initial exercise price of $0.30 per share. The sale of the Debentures and 2012 Warrants, which occurred in two closings on November 26, 2012 and December 18, 2012, resulted in aggregate gross proceeds of approximately $14.9 million, before deducting placement agent fees and other transaction-related expenses of approximately $1.2 million. The 2012 Warrants were valued at $12,430,525 (see Note 9).

 

The conversion price of the Debentures is subject to a “full-ratchet” anti-dilution provision, such that in the event the Company makes an issuance of common stock (subject to customary exceptions) at a price per share less than the applicable exercise price of the Debentures, the applicable conversion price will be reduced to the price per share applicable to such new issuance. However, after such time as the Company has raised at least $12 million in subsequent equity financings, the conversion price of the Debentures will be subject to a customary weighted-average price adjustment with respect to new issuances. This conversion feature of the Debentures is considered an embedded derivative and was accounted for separately from the Debentures and was valued at $7,548,500 (see Note 9).

 

Pursuant to the terms of a Registration Rights Agreement entered into on November 26, 2012 in connection with the Company’s entry into the 2012 Purchase Agreement, the Company agreed to file a registration statement under the Securities Act of 1933, as amended, covering the resale of: (i) 100% of the shares of common stock issuable as payment of accrued interest under the Debentures and upon exercise of the Series A Warrants; and (ii) 150% of the shares of common stock issuable upon conversion of the Debentures and upon exercise of the Series B Warrants (collectively, the “Registrable Securities”). The Company further agreed to cause such registration statement to be filed with 30 days following the date of the Registration Rights Agreement, or by December 26, 2012, and to cause such registration statement to be declared effective within 60 days following the date of the Registration Rights Agreement, or by January 25, 2013, or, if the registration statement was subject to review by the SEC, to cause such registration statement to be declared effective within 120 days following the date of the Registration Rights Agreement, or by March 26, 2013. If such registration statement, covering 100% of the Registrable Securities, was not declared effective by the SEC by the applicable date, the Company agreed to pay liquidated damages to the investors in the amount of 2% of each investor’s aggregate investment amount per month until the registration statement is declared effective or until such earlier time as the Registrable Securities may be traded pursuant to Rule 144. On March 25, 2013, the Company and holders of over two-thirds of the Debentures entered into an amendment to the Registration Rights Agreement, permitting the Company, in its sole discretion, to elect to pay such liquidated damages by issuing shares of common stock in lieu of cash (see Note 16).

 

The Company filed the registration statement on December 26, 2012, and, following the receipt of comments from the SEC on January 7, 2013, the Company filed an amendment to the registration statement on January 29, 2013. As of the date of this report, the registration statement has not been declared effective by the SEC, and the Company does not anticipate being able to register 100% of the Registrable Securities. Accordingly, because the registration statement was not declared effective by March 26, 2013, the investors are each entitled to liquidated damages in the amount of 2% of their investment amount per month until the Registrable Securities may be traded pursuant to Rule 144. Because Rule 144 will become available to the investors six months after the applicable closing date, the investors will be entitled to approximately two months’ of liquidated damages, or approximately $0.6 million in the aggregate.
XML 62 R60.htm IDEA: XBRL DOCUMENT v2.4.0.6
Commitments And Contingencies - Additional Information (Detail) (USD $)
 1 Months Ended 12 Months Ended 89 Months Ended 1 Months Ended 0 Months Ended 12 Months Ended 1 Months Ended
Mar. 31, 2011
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Apr. 21, 2011
Glenn Mattes
Jun. 22, 2011
Alexander Zukiwski, M.D
Apr. 22, 2011
Perfomance Based
Apr. 22, 2011
Time Based
Dec. 31, 2012
Flemington Lease
Dec. 31, 2011
Flemington Lease
Aug. 04, 2011
Flemington Lease
sqft
Apr. 21, 2011
Scenario, Forecast
Glenn Mattes
Jun. 22, 2011
Scenario, Forecast
Alexander Zukiwski, M.D
Commitments and Contingencies Disclosure [Line Items]                          
Lease cancellation fee $ 53,641                        
Area of land                     4,168    
Security deposit   10,455 10,455 10,455                  
Aggregate minimum future payments under the Flemington Lease                 150,531        
Purchase commitment, remaining minimum amount committed     4,500,000                    
Rent expense                 85,362 7,351      
Initial base salary         100,000 375,000              
Increase decrease in base salary                       350,000  
Annual target performance bonus percentage on base salary         50.00% 50.00% 40.00% 60.00%       50.00% 50.00%
Annual target performance bonus maximum limit                       175,000  
Options Outstanding, Weighted- Average Remaining Contractual Life (Years)   7 years 7 months 6 days     10 years 10 years              
Share based compensation, options granted,to purchase number of common stock         2,354,379 1,750,000              
Share based compensation, options granted, exercise price per share     $ 1.03   $ 1 $ 1              
Share based compensation by share based payment award options and exercisable vesting percentage         25.00% 25.00%              
Share based compensation by share based payment award options vesting and exercisable date         Apr. 25, 2012 Jun. 22, 2012              
Share based compensation by share based payment award options remaining vesting and exercisable period         12 equal monthly installments             24 equal monthly installments 24 equal monthly installments
Other labor-related expenses                         200,000
Stock Issued During Period Additional Shares Restricted Stock         250,000                
Total fair value of restricted common stock issued         172,750                
Fair value per share of restricted common stock issued         $ 0.69                
Stock-based compensation costs   $ 57,584 $ 115,168 $ 172,572                  
XML 63 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
Intangible Assets and Intellectual Property
 12 Months Ended
Dec. 31, 2012
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets and Intellectual Property

6. INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY

 

(a) Onapristone License Agreement

 

The Company’s rights to onapristone are governed by a license agreement with Invivis Pharmaceuticals, Inc. (“Invivis”), dated February 13, 2012. Under this agreement, the Company holds an exclusive, royalty-bearing license for the rights to commercialize onapristone for all therapeutic uses. The license agreement provides the Company with worldwide rights to onapristone with the exception of France; provided, however, that the Company has an option to acquire French commercial rights from Invivis upon notice to Invivis together with a cash payment.

 

The onapristone license agreement provides the Company with exclusive, worldwide rights to a U.S. provisional patent application that relates to assays for predictive biomarkers for anti-progestin efficacy. The Company intends to expand its patent portfolio by filing additional patent applications covering the use of onapristone and/or a companion diagnostic product. If the pending patent application issues, the issued patent would be scheduled to expire in 2031.

 

The Company made a one-time cash payment of $500,000 to Invivis upon execution of the license agreement on February 13, 2012. Additionally, Invivis will receive performance-based cash payments of up to an aggregate of $15.1 million upon successful completion of clinical and regulatory milestones relating to onapristone, which milestones include the marketing approval of onapristone in multiple indications in the United States or the European Union as well as Japan. The Company will make the first milestone payment to Invivis upon the dosing of the first subject in the first company sponsored Phase 1 clinical trial of onapristone, which is anticipated in the third quarter of 2013. In addition, the Company will pay Invivis low single digit sales royalties based on net sales of onapristone by the Company or any of its sublicensees. Pursuant to a separate services agreement, Invivis will provide the Company with certain clinical development support services, which includes the assignment of up to two full-time employees to perform such services, in exchange for a monthly cash payment.

 

Under the license agreement with Invivis, the Company also agreed to indemnify and hold Invivis and its affiliates harmless from any and all claims arising out of or in connection with the production, manufacture, sale, use, lease, consumption or advertisement of onapristone, provided, however, that the Company shall have no obligation to indemnify Invivis for claims that (a) any patent rights infringe third party intellectual property, (b) arise out of the gross negligence or willful misconduct of Invivis, or (c) result from a breach of any representation, warranty confidentiality obligation of Invivis under the license agreement. The license agreement will terminate upon the later of (i) the last to expire valid claim contained in the patent rights, and (ii) February 13, 2032. In general, Invivis may terminate the license agreement at any time upon a material breach by the Company to the extent the Company fails to cure any such breach within 90 days after receiving notice of such breach or in the event the Company files for bankruptcy. The Company may terminate the agreement for any reason upon 90 days’ prior written notice.

 

(b) AR-12 and AR-42 License Agreements

 

The Company’s rights to both AR-12 and AR-42 are governed by separate license agreements with The Ohio State University Research Foundation (“Ohio State”) entered into in January 2008. Pursuant to each of these agreements, Ohio State granted the Company exclusive, worldwide, royalty-bearing licenses to commercialize certain patent applications, know-how and improvements relating to AR-42 and AR-12 for all therapeutic uses.

 

Pursuant to the Company’s license agreements for AR-12 and AR-42, the Company made one-time cash payments to Ohio State in the aggregate amount of $450,000 and reimbursed it for past patent expenses in the aggregate amount of approximately $174,000. Additionally, the Company will be required to make performance-based cash payments upon successful completion of clinical and regulatory milestones relating to AR-12 and AR-42 in the United States, Europe and Japan. The first milestone payment for each of the licensed compounds will be due when the first patient is dosed in the first Company sponsored Phase I clinical trial of each of AR-12 and AR-42. In October 2009, the Company remitted a milestone payment to Ohio State for the first patient dosed in the first Company sponsored Phase I clinical trial of AR-12. To the extent the Company enters into a sublicensing agreement relating to either or both of AR-12 or AR-42, it will be required to pay Ohio State a portion of all non-royalty income received from such sublicensee. The Company made no milestone payments under these license agreements during 2012. The Company does not expect to make any milestone payments under these agreements during 2013.

 

The license agreements with Ohio State further provide that the Company will indemnify Ohio State from any and all claims arising out of the death of or injury to any person or persons or out of any damage to property, or resulting from the production, manufacture, sale, use, lease, consumption or advertisement of either AR-12 or AR-42, except to the extent that any such claim arises out of the gross negligence or willful misconduct of Ohio State. The license agreements for AR-12 and AR-42 each expire on the later of (i) the expiration of the last valid claim contained in any licensed patent and (ii) 20 years after the effective date of the license. Ohio State will generally be able to terminate either license upon the Company’s breach of the terms of the license to the extent the Company fails to cure any such breach within 90 days after receiving notice of such breach or the Company files for bankruptcy. The Company may terminate either license upon 90 days prior written notice.

 

(c) AR-67 License Agreement

 

The Company’s rights to AR-67 were governed by an October 2006 license agreement with the University of Pittsburgh (“Pitt”). Under this agreement, Pitt granted the Company an exclusive, worldwide, royalty-bearing license for the rights to commercialize technologies embodied by certain issued patents, patent applications and know-how relating to AR-67 for all therapeutic uses.

 

Under the terms of the license agreement with Pitt, the Company made a one-time cash payment of $350,000 to Pitt and reimbursed it for past patent expenses of approximately $373,000. Additionally, Pitt was entitled to receive performance-based cash payments upon successful completion of clinical and regulatory milestones relating to AR-67. The Company would have made the first milestone payment to Pitt upon the acceptance of the first new drug application by the FDA for AR-67. The Company was also required to pay to Pitt an annual maintenance fee of $200,000 upon the third and fourth anniversaries, $250,000 upon the fifth and sixth anniversaries, and $350,000 upon the seventh anniversary and annually thereafter and to pay Pitt a royalty equal to a percentage of net sales of AR-67, pursuant to the license agreement. The Company did not have any milestone payment obligations during 2012 under this license agreement.

 

Under the license agreement with Pitt, the Company also agreed to indemnify and hold Pitt and its affiliates harmless from any and all claims, actions, demands, judgments, losses, costs, expenses, damages and liabilities (including reasonable attorneys’ fees) arising out of or in connection with (i) the production, manufacture, sale, use, lease, consumption or advertisement of AR-67, (ii) the practice by the Company or any affiliate or sublicensee of the licensed patent; or (iii) any obligation of the Company under the license agreement unless any such claim is determined to have arisen out of the gross negligence, recklessness or willful misconduct of Pitt.

 

In January 2012, Pitt provided notice to the Company that it was in default of the terms of the license agreement for failing to pay the $250,000 annual maintenance fee. In March 2012, following the Company’s determination not to proceed with further development of AR-67, the parties agreed to terminate the license agreement. As a result, the Company no longer has rights in AR-67; however, the Company retains ownership of all data accumulated during the Company’s development of AR-67. On March 28, 2013, the Company entered into a settlement agreement with Pitt pursuant to which the Company agreed to make a one-time payment of $235,000 in full satisfaction of all obligations under the license agreement with Pitt. See Note 16. Subsequent Events.
XML 64 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
Accrued Liabilities
 12 Months Ended
Dec. 31, 2012
Accrued Liabilities [Abstract]  
Accrued Liabilities

7. ACCRUED LIABILITIES

 

Accrued liabilities as of December 31, 2012 and 2011 consist of the following:

 

    2012     2011  
                 
Accrued compensation and related benefits   $ 304,772     $ 272,342  
Accrued research and development expense     713,099       915,699  
Accrued liquidated damages     594,288       –  
Accrued other expense     40,000       –  
                 
Total accrued liabilities   $ 1,652,159     $ 1,188,041
XML 65 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
Fair Value of Financial Instruments
 12 Months Ended
Dec. 31, 2012
Fair Value Disclosures [Abstract]  
Fair Value of Financial Instruments

9. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

The Company defines fair value as the amount at which an asset (or liability) could be bought (or incurred) or sold (or settled) in a current transaction between willing parties, that is, other than in a forced or liquidation sale. The fair value estimates presented in the table below are based on information available to the Company as of December 31, 2012.

 

The accounting standard regarding fair value measurements discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost). The standard utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three broad levels. The following is a brief description of those three levels:

 

· 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.

 

The Company has determined the fair value of certain liabilities using the market approach: the following tables present the Company’s fair value hierarchy for these assets measured at fair value on a recurring basis as of December 31, 2012 and 2011:

 

          Quoted Market              
          Prices in Active     Significant Other     Significant  
    Fair Value December     Markets     Observable Inputs     Unobservable Inputs  
    31, 2012     (Level 1)     (Level 2)     (Level 3)  
                         
Liabilities                                
Warrant liability - 2010 Series A&B   $ 898,722     $ -     $ -     $ 898,722  
Debenture conversion feature -2012     7,548,500       -       -       7,548,500  
Warrant liability - 2012 placement agent     542,530       -       -       542,530  
Warrant liability - 2012 Series A&B     12,430,525       -       -       12,430,525  
                                 
Total   $ 21,420,277     $ -     $ -     $ 21,420,277  

 

          Quoted Market              
          Prices in Active     Significant Other     Significant  
    Fair Value December     Markets     Observable Inputs     Unobservable Inputs  
    31, 2011     (Level 1)     (Level 2)     (Level 3)  
                         
Liabilities                                
Warrant liability - 2010 Series A&B   $ 3,705,472     $ -     $ -     $ 3,705,472  
                                 
Total   $ 3,705,472     $ -     $ -     $ 3,705,472  

 

The fair value of these derivative liabilities was estimated by management using a third party valuation report. The third-party estimated the value of the warrants using a Monte Carlo simulation model. The Monte Carlo simulation is a generally accepted statistical method used to generate a defined number of stock price paths in order to develop a reasonable estimate of the range of our future expected stock prices and minimizes standard error. The changes in the fair value of these derivative liabilities are estimated quarterly after issuance and are recorded in other income (expense) on the statement of operations.

 

The following table provides a summary of changes in fair value of the Company’s liabilities, as well as the portion of losses included in income attributable to unrealized appreciation that relate to those liabilities held at December 31, 2012:

 

Fair Value Measurements Using
Significant Unobservable Inputs (Level 3)
    Warrant Liability  
Balance at January 1, 2011   $ (3,420,780 )
Purchases, sales and settlements:        
Warrants issued     -  
Total gains or losses:        
Unrealized depreciation     (284,692 )
Balance at January 1, 2012     (3,705,472 )
Purchases, sales and settlements:        
Warrants and other derivatives issued     (20,521,555 )
Total gains or losses:        
Unrealized depreciation     2,806,750  
Balance at December 31, 2012   $ (21,420,277 )

  

Significant assumptions used at December 31, 2012 and 2011for the warrants and embedded conversion discount derivative liability of the Debentures are as follows:

 

    December 31, 2012     December 31, 2011  
             
Weighted average term     3 years        4 years  
Volatility     200 %     120 %
Risk-free interest rate     1.05 %     0.83 %
XML 66 R34.htm IDEA: XBRL DOCUMENT v2.4.0.6
Liquidity and Capital Resources - Additional Information (Detail) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Jul. 31, 2005
Working Capital Detail [Line Items]        
Cash and cash equivalents $ 10,943,437 $ 6,678,344 $ 13,528,444 $ 0
Deficit accumulated during the development stage $ 49,900,782 $ 35,513,000    
XML 67 R51.htm IDEA: XBRL DOCUMENT v2.4.0.6
Assumptions Used in Estimating Fair Value of Each Option Award Granted Using Black-Scholes Option-Pricing Model (Detail) (USD $)
 12 Months Ended
Dec. 31, 2011
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Expected Volatility 87.00%
Dividend yield 0.00%
Risk-free interest rates, minimum 1.50%
Risk-free interest rates, maximum 2.00%
Forfeiture rate 0.00%
Minimum
  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Expected Term 5 years
Stock price 0.69
Maximum
  
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]  
Expected Term 10 years
Stock price 0.72
XML 68 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
Income Taxes
 12 Months Ended
Dec. 31, 2012
Income Tax Disclosure [Abstract]  
Income Tax

14. INCOME TAXES

 

The Company accounts for income taxes using the liability method, which requires the determination of deferred tax assets and liabilities, based on the differences between the financial statement and tax bases of assets and liabilities, using enacted tax rates in effect for the year in which differences are expected to reverse. The net deferred tax asset is adjusted by a valuation allowance, if, based on the weight of available evidence, it is more likely than not that some portion or all of the net deferred tax asset will not be realized. The income tax returns of the Company are subject to examination by federal and state taxing authorities. Such examination could result in adjustments to net income or loss, which changes could affect the income tax liabilities of the Company. The Company’s tax returns are open for inspection for all tax years from 2008 to present.

 

The Company’s policy is to include interest and penalties related to unrecognized tax benefits within the Company’s provision for (benefit from) income taxes. The Company recognized no amounts for interest and penalties related to unrecognized tax benefits in 2012, 2011 and the period from August 1, 2005 (inception) through December 31, 2012 and as of December 31, 2012 and 2011, had no amounts accrued for interest and penalties.

 

At December 31, 2012, the Company had no Federal income tax expense or benefit but did have Federal tax net operating loss carry-forwards of approximately $26.2 million. The federal net operating loss carry-forwards will begin to expire in 2026, unless previously utilized.

 

Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets at December 31, 2012 and 2011 are shown below.

 

    For Years Ended December 31,  
    2012     2011  
Non-current deferred tax assets                
Research tax credit   $ 2,005,000     $ 1,631,000  
Net operating loss carry forwards     15,700,000       11,720,000  
Stock based compensation     446,000       848,000  
Total deferred tax assets     18,151,000       14,199,000  
Non-current deferred tax liability                
Depreciation and amortization     (10,000 )     (10,000 )
Total net deferred tax assets     18,141,000       14,189,000  
Valuation allowance     (18,141,000 )     (14,189,000 )
Net deferred tax assets   $ -     $ -  

 

The Company records a valuation allowance for temporary differences for which it is more likely than not that the Company will not receive future tax benefits. At December 31, 2012 and 2011 the Company recorded valuation allowances of $18.6 million and $14.2 million, respectively, representing a change in the valuation allowance of $4.4 million for the previous fiscal year-ends, due to the uncertainty regarding the realization of such deferred tax assets, to offset the benefits of net operating losses generated during those years.

 

A reconciliation of the statutory tax rates and the effective tax rates for the years ended December 31, 2012 and 2011 are as follows:

 

    2012     2011  
    Amount     Rate     Amount     Rate  
                         
Federal tax   $ (3,388,000 )     34.0 %   $ (2,689,000 )     34.0 %
State tax     (592,000 )     5.9 %     (390,000 )     5.9 %
R&D Credit     (373,000 )     2.7 %     (339,000 )     4.37 %
Incentive stock options     (30,000 )     4.7 %     (48,000 )     7.8 %
Valuation allowance     4,383,000       (47.3 )%     3,466,000       (52.1 )%
Net   $ -       -     $ -       -  


There was no income tax benefit recorded for the years ended December 31, 2012 and 2011.
XML 69 R26.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property and Equipment (Tables)
 12 Months Ended
Dec. 31, 2012
Property, Plant and Equipment [Abstract]  
Property and Equipment

Property and equipment as of December 31, 2012 and 2011 consist of the following:  

 

    2012     2011  
Computer equipment and software   $ 17,721     $ 17,721  
Office furniture and equipment     52,242       52,242  
Leasehold improvements     8,449       8,449  
Total property and equipment     78,412       78,412  
Accumulated depreciation     (53,575 )     (39,739 )
Total property and equipment, net   $ 24,837     $ 38,673  
XML 70 R49.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of All Outstanding Warrants to Purchase Shares of Common Stock (Detail)
 12 Months Ended
Dec. 31, 2012
Jun. 03, 2008
Class of Warrant or Right [Line Items]    
Warrants Issued 110,507,188 196,189
Exercise Price   2.42
Weighted- Average Exercise Price 0.43  
Exercised 0  
Warrants Outstanding 110,507,188  
Warrant 1
    
Class of Warrant or Right [Line Items]    
Grant Date Jan. 02, 2008  
Warrants Issued 299,063  
Exercise Price 2.42  
Weighted- Average Exercise Price 2.42  
Expiration Date Jan. 02, 2013  
Exercised 0  
Warrants Outstanding 299,063  
Warrant 2
    
Class of Warrant or Right [Line Items]    
Grant Date Jun. 02, 2008  
Warrants Issued 196,189  
Exercise Price 2.42  
Weighted- Average Exercise Price 2.42  
Expiration Date Jun. 06, 2013  
Exercised 0  
Warrants Outstanding 196,189  
Warrant 3
    
Class of Warrant or Right [Line Items]    
Grant Date Sep. 03, 2010  
Warrants Issued 1,221,920  
Exercise Price 0.53  
Weighted- Average Exercise Price 0.53  
Expiration Date Mar. 03, 2013  
Exercised 0  
Warrants Outstanding 1,221,920  
Warrant 4
    
Class of Warrant or Right [Line Items]    
Grant Date Sep. 03, 2010  
Warrants Issued 6,415,080  
Exercise Price 0.56  
Weighted- Average Exercise Price 0.56  
Expiration Date Sep. 03, 2015  
Exercised 0  
Warrants Outstanding 6,415,080  
Warrant 5
    
Class of Warrant or Right [Line Items]    
Grant Date Sep. 03, 2010  
Warrants Issued 1,056,930  
Exercise Price 1.10  
Weighted- Average Exercise Price 1.10  
Expiration Date Sep. 03, 2015  
Exercised 0  
Warrants Outstanding 1,056,930  
Warrant 6
    
Class of Warrant or Right [Line Items]    
Grant Date Nov. 26, 2012  
Warrants Issued 42,350,002  
Exercise Price 0.30  
Weighted- Average Exercise Price 0.30  
Expiration Date May 26, 2014  
Exercised 0  
Warrants Outstanding 42,350,002  
Warrant 7
    
Class of Warrant or Right [Line Items]    
Grant Date Dec. 18, 2012  
Warrants Issued 7,174,001  
Exercise Price 0.30  
Weighted- Average Exercise Price 0.30  
Expiration Date Jun. 18, 2014  
Exercised 0  
Warrants Outstanding 7,174,001  
Warrant 8
    
Class of Warrant or Right [Line Items]    
Grant Date Nov. 26, 2012  
Warrants Issued 42,350,002  
Exercise Price 0.50  
Weighted- Average Exercise Price 0.50  
Expiration Date Nov. 26, 2017  
Exercised 0  
Warrants Outstanding 42,350,002  
Warrant 9
    
Class of Warrant or Right [Line Items]    
Grant Date Nov. 26, 2012  
Warrants Issued 2,090,000  
Exercise Price 0.33  
Weighted- Average Exercise Price 0.33  
Expiration Date Nov. 26, 2017  
Exercised 0  
Warrants Outstanding 2,090,000  
Warrant 10
    
Class of Warrant or Right [Line Items]    
Grant Date Dec. 18, 2012  
Warrants Issued 7,174,001  
Exercise Price 0.50  
Weighted- Average Exercise Price 0.50  
Expiration Date Dec. 18, 2017  
Exercised 0  
Warrants Outstanding 7,174,001  
Warrant 11
    
Class of Warrant or Right [Line Items]    
Grant Date Dec. 18, 2012  
Warrants Issued 180,000  
Exercise Price 0.33  
Weighted- Average Exercise Price 0.33  
Expiration Date Dec. 18, 2017  
Exercised 0  
Warrants Outstanding 180,000  
XML 71 R41.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property and Equipment - Additional information (Detail) (USD $)
 12 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2012
Property, Plant and Equipment [Line Items]      
Depreciation and amortization $ 13,836 $ 11,677 $ 69,979
XML 72 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIENCY) (USD $)
 12 Months Ended 17 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Dec. 31, 2008
Dec. 31, 2007
Dec. 31, 2006
Dec. 31, 2012
Stock based compensation for services $ 722,811 $ 707,284 $ 249,286 $ 647,448 $ 1,131,218 $ 88,300 $ 9,700  
Issuance of common shares pursuant to placement agent agreement 43,500              
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770     13,509,510          
Note discount arising from note conversion         475,391      
Warrants issued in connection with convertible preferred units issued in private placement and in connection with note conversion     (3,340,421)   348,000      
Reverse merger transaction - elimination of accumulated deficit         (120,648)      
Reverse merger transaction -previously issued Laurier common stock         120,648      
Warrants issues to placement agents in connection with private placement and for services     464,720   480,400      
Stock issued in conversion of convertible securities   0            
Issuance of stock dividend in connection with conversion of preferred stock   0            
Grant of restricted shares   115,168            
Stock option exercise   6,480   2,600        
Net loss (14,387,782) (7,909,113) (4,023,026) (6,936,705) (12,913,566) (3,359,697) (370,893) (49,900,782)
Ending Balance (12,265,832) 1,355,639 8,435,820 1,575,751 7,862,408 (3,627,590) (356,193) (12,265,832)
Founders
                
Issuance of common shares             5,000  
Private Placement
                
Issuance of common shares         17,690,037      
Notes Payable
                
Stock issued in conversion of convertible securities         4,278,518      
PREFERRED
                
Stock based compensation for services 0 0 0 0 0 0 0  
Issuance of common shares pursuant to placement agent agreement (in shares) 0              
Issuance of common shares pursuant to placement agent agreement 0              
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770 (in shares)     15,274,000          
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770     1,527   0      
Note discount arising from note conversion         0      
Warrants issued in connection with convertible preferred units issued in private placement and in connection with note conversion     0   0      
Reverse merger transaction -previously issued Laurier common stock         0      
Warrants issues to placement agents in connection with private placement and for services     0          
Issuance of stock dividend in connection with conversion of preferred stock (in shares)   0            
Issuance of stock dividend in connection with conversion of preferred stock   0            
Grant of restricted shares   0            
Stock option exercise   0   0        
Net loss 0 0 0     0 0  
Ending Balance (in shares) 0 0 15,274,000 0 0 0 0 0
Ending Balance 0 0 1,527 0 0 0 0 0
PREFERRED STOCK | PREFERRED
                
Stock issued in conversion of convertible securities (in shares)   (15,274,000)            
Stock issued in conversion of convertible securities   (1,527)            
Issuance of common shares (in shares)   0            
Issuance of common shares   0            
COMMON STOCK
                
Stock based compensation for services 0 0 0 0 0 0 0  
Issuance of common shares pursuant to placement agent agreement (in shares) 60,000              
Issuance of common shares pursuant to placement agent agreement 6              
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770         0      
Note discount arising from note conversion         0      
Warrants issued in connection with convertible preferred units issued in private placement and in connection with note conversion     0   0      
Reverse merger transaction - elimination of accumulated deficit         0      
Reverse merger transaction -previously issued Laurier common stock (in shares)         1,100,200      
Reverse merger transaction -previously issued Laurier common stock         110      
Warrants issues to placement agents in connection with private placement and for services     0          
Issuance of stock dividend in connection with conversion of preferred stock (in shares)   319,074            
Issuance of stock dividend in connection with conversion of preferred stock   32            
Grant of restricted shares (in shares)   250,000            
Grant of restricted shares   0            
Stock option exercise (in shares)   49,844   20,000        
Stock option exercise   5   2        
Net loss 0 0 0     0 0  
Ending Balance (in shares) 36,364,942 36,304,942 20,412,024 20,412,024 20,392,024 9,968,797 9,968,797 36,364,942
Ending Balance 3,611 3,605 2,041 2,041 2,039 997 997 3,611
COMMON STOCK | Founders
                
Issuance of common shares (in shares)             9,968,797  
Issuance of common shares             997  
COMMON STOCK | Private Placement
                
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770 (in shares)     0          
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770     0          
Issuance of common shares (in shares)         7,360,689      
Issuance of common shares         736      
COMMON STOCK | Notes Payable
                
Stock issued in conversion of convertible securities (in shares)         1,962,338      
Stock issued in conversion of convertible securities         196      
COMMON STOCK | PREFERRED
                
Stock issued in conversion of convertible securities (in shares)   15,274,000            
Stock issued in conversion of convertible securities   1,527            
Additional paid-in capital
                
Stock based compensation for services 722,811 707,284 249,286 647,448 1,131,218 88,300 9,700  
Issuance of common shares pursuant to placement agent agreement 43,494              
Warrants issued for services         480,400      
Note discount arising from note conversion feature         475,391      
Warrants issued in connection with convertible preferred units issued in private placement and in connection with note conversion     (3,340,421)   348,000      
Reverse merger transaction - elimination of accumulated deficit         (120,648)      
Reverse merger transaction -previously issued Laurier common stock         120,538      
Warrants issues to placement agents in connection with private placement and for services     464,720          
Stock issued in conversion of convertible securities   0            
Issuance of stock dividend in connection with conversion of preferred stock   (32)            
Grant of restricted shares   115,168            
Stock option exercise   6,475   2,598        
Net loss 0 0 0     0 0  
Ending Balance 37,631,339 36,865,034 36,036,139 25,154,571 24,504,525 102,003 13,703 37,631,339
Additional paid-in capital | Founders
                
Issuance of common shares             4,003  
Additional paid-in capital | Private Placement
                
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770     13,507,983          
Issuance of common shares         17,689,301      
Additional paid-in capital | Notes Payable
                
Stock issued in conversion of convertible securities         4,278,322      
Deficit accumulated during the development stage
                
Stock based compensation for services 0 0 0 0 0 0 0  
Issuance of common shares pursuant to placement agent agreement 0              
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770         0      
Note discount arising from note conversion         0      
Warrants issued in connection with convertible preferred units issued in private placement and in connection with note conversion     0   0      
Reverse merger transaction - elimination of accumulated deficit         0      
Reverse merger transaction -previously issued Laurier common stock         0      
Warrants issues to placement agents in connection with private placement and for services     0          
Stock issued in conversion of convertible securities   0            
Issuance of stock dividend in connection with conversion of preferred stock   0            
Grant of restricted shares   0            
Stock option exercise   0   0        
Net loss (14,387,782) (7,909,113) (4,023,026) (6,936,705) (12,913,566) (3,359,697) (370,893)  
Ending Balance (49,900,782) (35,513,000) (27,603,887) (23,580,861) (16,644,156) (3,730,590) (370,893) (49,900,782)
Deficit accumulated during the development stage | Founders
                
Issuance of common shares             0  
Deficit accumulated during the development stage | Private Placement
                
Convertible preferred units issued in private placement, net of issuance costs of $1,299,770     0          
Issuance of common shares         0      
Deficit accumulated during the development stage | Notes Payable
                
Issuance of common shares         $ 0      
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Merger and Basis of Presentation
 12 Months Ended
Dec. 31, 2012
Mergers Acquisitions and Dispositions Disclosures [Abstract]  
The merger and basis of presentation

3. THE MERGER AND BASIS OF PRESENTATION

 

The accompanying audited financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and the instructions to Form 10-K promulgated by the Securities and Exchange Commission (“SEC”).

 

(a) Description of the Merger and Private Placement Offering

 

The Company completed the Merger on June 3, 2008.   In accordance with the terms of the Merger, each share of common stock of Old Arno that was outstanding immediately prior to the Merger was exchanged for 1.99377 shares of the Company’s common stock.  In addition, all securities convertible into or exercisable for shares of Old Arno common stock outstanding immediately prior to the Merger were cancelled, and the holders thereof received similar securities convertible into or exercisable for the purchase of an aggregate of 1,611,760 shares of the Company’s common stock. In consideration for their shares of the Company’s pre-merger common stock, the Company’s shareholders received an aggregate of 19,291,824 shares of Laurier common stock.  Immediately prior to the effective time of the Merger, 1,100,200 shares of Laurier’s common stock were issued and outstanding. Upon completion of the Merger, the Old Arno shareholders owned approximately 95% of the Company’s issued and outstanding common stock, assuming the exercise of all of the issued and outstanding common stock options and warrants.

 

Following the Merger, the business conducted by the Company is the business conducted by Old Arno prior to the Merger. In addition, the directors and officers of Laurier were replaced by the directors and officers of Old Arno.

 

As a condition and immediately prior to the closing of the Merger, on June 2, 2008, Old Arno completed a private placement of its equity securities whereby it received gross proceeds of approximately $17,732,000 through the sale of approximately 3,691,900 shares of Old Arno Common Stock to selected accredited investors, which shares were exchanged for approximately 7,360,700 shares of Company Common Stock after giving effect to the Merger. Contemporaneously with the June 2008 private placement, the Old Arno’s outstanding 6% Notes (defined below) converted into 984,246 shares of Old Arno’s common stock and the holders of the Notes received warrants to purchase an aggregate of 98,409 shares of Old Arno common stock at an exercise price equal to $4.83 per share. The shares issued upon conversion were exchanged for an aggregate of approximately 1,962,338 shares of the Company’s Common Stock and the warrants were exchanged for five-year warrants to purchase an aggregate of approximately 196,189 shares of the Company’s Common Stock at an exercise price equal to $2.42 per share. See “Note 8. Convertible Debentures and Notes Payable.”

 

All references to share and per share amounts in these financial statements have been restated to retroactively reflect the number of common shares of Arno common stock issued pursuant to the Merger.

 

(b) Accounting Treatment of the Merger; Financial Statement Presentation

 

The Merger was accounted for as a reverse acquisition pursuant to Accounting Standards Codification (“ASC”) 805-40-25, which provides that the “merger of a private operating company into a non-operating public shell corporation with nominal net assets typically results in the owners and management of the private company having actual or effective operating control of the combined company after the transaction, with the shareholders of the former public shell continuing only as passive investors. These transactions are considered by the Securities and Exchange Commission to be capital transactions in substance, rather than business combinations. That is, the transaction is equivalent to the issuance of stock by the private company for the net monetary assets of the shell corporation, accompanied by a recapitalization.” Accordingly, the Merger has been accounted for as a recapitalization, and, for accounting purposes, Old Arno is considered the acquirer in a reverse acquisition.  

 

Laurier’s  historical accumulated deficit for periods prior to June 3, 2008, in the amount of $120,538, was eliminated against additional-paid-in-capital, and the accompanying financial statements present the previously issued shares of Laurier common stock as having been issued pursuant to the Merger on June 3, 2008. The shares of common stock of the Company issued to the Old Arno stockholders in the Merger are presented as having been outstanding since August 2005 (the month when Old Arno first sold its equity securities).

 

Because the Merger was accounted for as a reverse acquisition under GAAP, the financial statements for periods prior to June 3, 2008 reflect only the operations of Old Arno.
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Significant components of net deferred tax assets (Detail) (USD $)
Dec. 31, 2012
Dec. 31, 2011
Non-current deferred tax assets    
Research tax credit $ 2,005,000 $ 1,631,000
Net operating loss carry forwards 15,700,000 11,720,000
Stock based compensation 446,000 848,000
Total deferred tax assets 18,151,000 14,199,000
Non-current deferred tax liability    
Depreciation and amortization (10,000) (10,000)
Total net deferred tax assets 18,141,000 14,189,000
Valuation allowance (18,141,000) (14,189,000)
Net deferred tax assets $ 0 $ 0
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Accrued Liabilities (Tables)
 12 Months Ended
Dec. 31, 2012
Accrued Liabilities [Abstract]  
Accrued Liabilities

Accrued liabilities as of December 31, 2012 and 2011 consist of the following:

 

    2012     2011  
                 
Accrued compensation and related benefits   $ 304,772     $ 272,342  
Accrued research and development expense     713,099       915,699  
Accrued liquidated damages     594,288       –  
Accrued other expense     40,000       –  
                 
Total accrued liabilities   $ 1,652,159     $ 1,188,041
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Basic and Diluted Loss Per Share (Detail) (USD $)
 12 Months Ended 17 Months Ended 89 Months Ended
Dec. 31, 2012
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Dec. 31, 2008
Dec. 31, 2007
Dec. 31, 2006
Dec. 31, 2012
Earnings Per Share Disclosure [Line Items]                
Net loss $ (14,387,782) $ (7,909,113) $ (4,023,026) $ (6,936,705) $ (12,913,566) $ (3,359,697) $ (370,893) $ (49,900,782)
Less: Preferred stock dividends 0 (81,651)            
Net loss available to common stockholders $ (14,387,782) $ (7,990,764)            
Weighted-average shares outstanding -basic and diluted (in shares) 36,322,565 34,514,594            
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Pension Plan
 12 Months Ended
Dec. 31, 2012
Compensation and Retirement Disclosure [Abstract]  
Pension Plan

13. PENSION PLAN

 

On October 1, 2007, the Company adopted a 401(k) savings plan (the “401(k) Plan”) for the benefit of its employees. Under the 401(k) Plan, the Company was required to make contributions equal to 3% of eligible compensation for each eligible employee whether or not the employee contributes to the 401(k) Plan. During 2011, the Company terminated the 401(k) Plan. For the years ended December 31, 2012 and 2011 and for the cumulative period from August 1, 2005 (inception) through December 31, 2012, the Company has recorded $0, $0 and $16,064 of matching contributions to the 401(k) Plan.