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EX-31.1 - CERTIFICATION - Intellect Neurosciences, Inc.v356503_ex31-1.htm
EX-31.2 - CERTIFICATION - Intellect Neurosciences, Inc.v356503_ex31-2.htm
EX-32.1 - CERTIFICATION - Intellect Neurosciences, Inc.v356503_ex32-1.htm
EX-32.2 - CERTIFICATION - Intellect Neurosciences, Inc.v356503_ex32-2.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-K

  

xANNUAL REPORT UNDER SECTION 13 OR 15 (D) OF THE SECURITIES EXCHANGE ACT OF 1934:

 

For the fiscal year ended June 30, 2013

 

¨TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE EXCHANGE ACT OF 1934

Commission file number:  333-128226

 

INTELLECT NEUROSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   20-8329066
(State or other jurisdiction of   (I.R.S. Employer Identification No.)
incorporation or organization)    
     

550 Sylvan Ave.

   

Englewood Cliffs, NJ

  07632
(Address of principal executive offices)   (Zip Code)

 

(201) 608 5101

(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:  None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act:

Yes ¨ No x

 

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 ¨ No x

 

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 past 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. 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  ¨.    No  ¨.

 

Indicate by check mark if disclosure of delinquent filers pursuant 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.  x

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.

 

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

 

 Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

 

As of December 31, 2012, the last business day of the registrant’s most recently completed second quarter, the aggregate market value of the shares of common stock held by non-affiliates of the registrant was $1,079,900 based on the closing price of the registrant’s common stock on that date.

 

As of October 15, 2013, there were 285,818,121 shares of common stock issued and outstanding.

 

DOCUMENTS INCORPORATED BY REFERENCE: None.

 

 
 

 

TABLE OF CONTENTS   Page No.
       
PART I      
       
Item 1. Description of the Business   3
       
Item 1A. Risk Factors   10
       
Item 2. Properties   20
       
Item 3. Legal Proceedings   20
       
Item 4.

Mine Safety Disclosures

  20
       
PART II      
       
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities   20
       
Item 6 Selected Financial Data   21
       
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations   21
       
Item 7A. Quantitative and Qualitative Disclosures About Market Risk   25
       
Item 8. Financial Statements and Supplementary Data   26
       
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure   53
       
Item 9A. Controls and Procedures   53
       
Item 9B. Other Information   54
       
PART III      
       
Item 10. Directors, Executive Officers and Corporate Governance   54
       
Item 11. Executive Compensation   56
       
Item 12. Security Ownership of Certain Beneficial Owners, Management and Related Stockholder Matters   57
       
Item 13. Certain Relationships, Related Transactions and Director Independence   58
       
Item 14. Principal Accounting Fees and Services   58
       
PART IV      
       
Item 15. Exhibits, Financial Statement Schedules   59
       
  Exhibits Index   59
       
  Signatures   62

 

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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, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include our plans, goals, strategies, intent, beliefs or current expectations. These statements are expressed in good faith and based upon a reasonable basis when made, but there can be no assurance that these expectations will be achieved or accomplished. These forward looking statements can be identified by the use of terms and phrases such as “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect,” and the like, and/or future-tense or conditional constructions (“will,” “may,” “could,” “should,” etc.). Items contemplating or making assumptions about actual or potential future sales, market size, collaborations, or operating results also constitute such forward-looking statements.

 

Although forward-looking statements in this report reflect the good faith judgment of management, forward-looking statements are inherently subject to known and unknown risks, business, economic and other risks and uncertainties that may cause actual results to be materially different from those discussed in these forward-looking statements. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. We assume no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this report, other than as may be required by applicable law or regulation. Readers are urged to carefully review and consider Item 1A of Part I of this annual report, “Risk Factors,” beginning on page 11, and various disclosures made by us in our reports filed with the Securities and Exchange Commission, each of which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect or inaccurate, our actual results may vary materially from those expected or projected.

 

PART I

 

Item 1.  Business

 

Company Overview

 

We are a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of neurodegenerative conditions, collectively known as proteinopathies, which include Alzheimer’s (“AD”), Parkinson’s and Huntington disease. We have an internal diversified pipeline and have granted licenses related to our patent estate to major pharmaceutical companies. Based on our own scientific research, published data relating to our drug candidates, pre-clinical and clinical studies that we have completed and clinical studies that other pharmaceutical companies have conducted, we believe that the scientific approach underlying our internal programs and licensed technology can lead to the development of safe and efficacious disease-modifying products to delay, arrest and ultimately prevent the onset of AD and other proteinopathies.

 

History- Reverse Merger

 

Intellect Neurosciences, Inc. (“Intellect”) was incorporated in Delaware on April 25, 2005 under the name Eidetic Biosciences, Inc. and changed its name to Mindset Neurosciences, Inc. on April 28, 2005, to Lucid Neurosciences, Inc. on May 17, 2005 and to Intellect Neurosciences, Inc. on May 20, 2005.

 

On January 25, 2007, GlobePan Resources, Inc. (“Globepan”) entered into an agreement and plan of merger with Intellect and INS Acquisition, Inc. (“Acquisition Sub”) a newly formed, wholly-owned Delaware subsidiary of GlobePan. Pursuant to this agreement and plan of merger, on January 25, 2007, Acquisition Sub merged with and into Intellect, Acquisition Sub ceased to exist and Intellect survived the merger and became the wholly-owned subsidiary of GlobePan. Intellect, the surviving entity in the merger, then changed its name to Intellect USA, Inc. and GlobePan changed its name to our current name, Intellect Neurosciences, Inc. Our wholly-owned subsidiary is Intellect USA, Inc. (“Intellect USA”), which wholly-owns Intellect Neurosciences (Israel) Ltd., an Israeli company (“Intellect Israel’), that currently is inactive and conducts no operations.

 

ANTISENILIN®, OX1™ and RECALL-VAX™, are trademarks that we own. Each trademark, trade name or service mark of any other company appearing in this annual report on Form 10-K belongs to its respective holder.

 

Business Strategy

 

Our core business strategy is to build a portfolio of compounds with the potential to treat or prevent neurodegenerative diseases, develop each to pre-determined milestones, and license them to pharmaceutical companies for advanced development and commercialization. To supplement our own work, we intend to license promising novel technologies and early stage compounds from academia and other biotechnology companies. We intend to obtain revenues from licensing fees, milestone payments, development fees, royalties and/or sales related to the use of our drug candidates or intellectual property for specific therapeutic indications or applications. As an example, we developed OX1, a small molecule multi-modal antioxidant, completed preclinical and human safety trials, and then licensed the program in 2011 to ViroPharma Inc. for development of a drug to treat Friedreich's Ataxia and other neurodegenerative diseases. We could receive up to $120 million in milestone payments from ViroPharma and significant royalties from sales if the resulting drug product is approved for sale by the US Food and Drug Administration (“FDA”).

 

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Our Therapeutic Approach

 

Our therapeutic approach to AD is based on developing safe and effective mechanisms to prevent both the accumulation and neurotoxicity of the Alzheimer’s toxin, the so-called amyloid-beta (Aß) protein, and other pathological proteins. Insight as to how amyloid beta is implicated has resulted from progress in Alzheimer’s research over the last two decades and evidence from epidiemological, genetic, biochemical, neuropathological, transgenic animal and human clinical studies pointing toward a critical role in pathogenesis of AD.  The accumulation of amyloid beta in the cerebrospinal fluid of the brain is thought to prompt a toxic cascade that starts with oxidative stress and inflammation causing damage to nerve cells, loss of connections between them and depletion of essential neurotransmitters, ultimately leading to memory loss and loss of other functions such as the ability to communicate through language and behave appropriately.  In contrast to existing approved therapies that have only symptomatic benefit because they act at the bottom of this cascade, our approach targets the top of the cascade and consequently has the potential to slow or arrest disease progression.  Dr. Chain, our Chairman and CEO, was among the first in the biotechnology industry to focus on preventing the accumulation and neurotoxicity of soluble amyloid beta as an approach to treating and preventing Alzheimer’s disease.

 

PIPELINE

 

Intellect is focused on neurodegenerative conditions, collectively known as proteinopathies, which include Alzheimer’s, Parkinson’s and Huntington disease. Proteinopathies are caused by amyloidogenic proteins, such as amyloid beta, tau, alpha synuclein and Huntingtin, and cause damage through oxidative stress and inflammation, ultimately leading to death of nerve cells.

 

OX1 – Licensed to ViroPharma, Inc.

 

OX1 is an orally-administered, brain-penetrating, naturally-occurring copper-binding small molecule, which has the potential to treat various neurodegenerative diseases such as Friedreich's Ataxia, Parkinson’s and Wilson’s disease. OX1 was tested in human Phase I safety clinical trials involving 90 healthy elderly volunteers and was found to be well tolerated, even at high pharmacological doses.

 

Our rights in the intellectual property underlying OX1 are licensed from New York University (“NYU”) and the University of South Alabama Medical Science Foundation (“SAMSF”). Under the agreements with these institutions, we have an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses relating to OX1. NYU and SAMSF reserve the right to use and practice the licensed patents and know-how for their own non-commercial, educational or research purposes and to distribute certain research materials to third parties for non-commercial uses. Under the agreements, we have the first right to enforce the underlying intellectual property against unauthorized third parties. OX1 sales are subject to royalties due to NYU and SAMSF, and to a royalty obligation arising from the use of test animals licensed to Mindset in drug discovery under a non-exclusive royalty bearing license from the Mayo Foundation for Medical Education and Research (“Mayo”).

 

In September 2011, we granted an exclusive license to ViroPharma Incorporated (“ViroPharma”) regarding certain of our licensed patents and patent applications related to OX1. ViroPharma expects to develop and commercialize OX1 as a treatment of Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation. Friedreich's Ataxia is an inherited disease that causes progressive damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech problems; it can also lead to heart disease and diabetes.

 

Intellect’s preclinical R&D pipeline is based on four proprietary platform technologies: ANTISENILINÒ, CONJUMAB™, OLIGOTOPE™ and RECALL-VAX™:

 

ANTISENILIN: Free-end Specific Amyloid Beta Antibodies for Treatment of AD

 

IN-N01 is a humanized a high-affinity, stabilized, IgG4 therapeutic antibody that binds the amino terminus of amyloid beta without binding to the amyloid precursor protein (APP).

 

Antibodies exist in several isoforms; IgG1 antibodies have the strongest potential to induce inflammation while IgG4 has the lowest potential. IN-N01 is designed to promote the clearance of monomeric, oligomeric and plaque forms of amyloid beta, which accumulate in the brains of Alzheimer's patients or following traumatic brain injury and in the retina of the eye in patients with age-related macular degeneration, diabetic neuropathy and glaucoma.

 

CONJUMAB™: Empowered Antibodies for the Treatment of Proteinopathies

 

CONJUMAB-A is a first-in-class antibody drug conjugate for treatment of proteinopathies. IN-N01 has been empowered to deliver on-site neuroprotection by its conjugation to melatonin. Melatonin is a potent free radical scavenger and is an inhibitor of beta amyloid aggregation and previously shown to counteract the neurotoxicity associated with amyloid beta. Compounds based upon CONJUMAB-A are designed to reduce the oxidative stress and promote clearance of beta amyloid that is central to cellular inflammation and damage.

 

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CONJUMAB-A is being developed for the treatment of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 55. CONJUMAB-A also has potential applications for diabetic retinopathy, glaucoma, traumatic brain injury, and Alzheimer’s disease.

 

OLIGOTOPE™: Protein oligomer selective antibodies and methods of making them using chemically cross-linked stabilized aggregates as immunogens

 

TOC-1, our first compound utilizing the OLIOGOTOPE platform, is a murine monoclonal antibody selective for neurotoxic tau oligomers or aggregates considered to be the earliest pathogenic form of tau. Intellect plans to test TOC-01 as potential therapeutic for Alzheimer’s disease and other tauopathies such as Frontotemporal dementia.

 

RECALL VAX™: Chimeric peptide vaccine platform incorporating bacterial and human epitopes to target neoepitopes in pathological proteins

 

RV03, our first compound generated on the RECALL-VAX platform, is a first-in-class bi-specific vaccine targeting both beta amyloid and delta tau. Delta tau is a shorter form of the tau protein. It is especially toxic to nerve cells and precedes the formation of neurofibrillary tangles. RV03 has potential for the treatment of Alzheimer’s disease and Frontotemporal dementias.

 

Overview of Alzheimer’s Disease

 

Alzheimer’s disease is characterized by progressive loss of memory and cognition, declining activities of daily living, neuropsychiatric symptoms or behavioral changes and ultimately complete debilitation and death. Its effects are devastating to the patient as well as caregivers, typically the family, with significant associated health care costs over an extended period of time. A report from the Alzheimer’s Association, “Changing the Trajectory of Alzheimer’s Disease: A National Imperative” (www.alz.org/trajectory) demonstrates that in the absence of disease-modifying treatments, the cumulative cost of care from 2010 to 2050 for people with Alzheimer’s will exceed $20 trillion in today’s dollars. The total cost of care for individuals with Alzheimer’s disease by all payers will soar from $172 billion in 2010 to more than $1 trillion by 2050, with Medicare costs increasing more than 600 percent, from $88 billion today to $627 billion in 2050. During the same time period, Medicaid costs will soar 400 percent, from $34 billion to $178 billion. One factor driving the exploding costs is that by 2050 nearly half (48 percent) of the projected 13.5 million people with Alzheimer’s will be in the severe stage of the disease when more expensive and intensive around-the-clock care is often necessary.

 

Currently available therapies only treat symptoms of Alzheimer’s disease and do not address the underlying neurodegeneration. Currently, the leading therapeutic agents for Alzheimer’s disease include AriceptTM (donepezil), an acetylcholinesterase inhibitor approved in 1996 and marketed by Pfizer, Inc. and Esai, and NamendaTM (memantine), an N-methyl-D-aspartate receptor antagonist marketed by Forest Laboratories in the United States and H. Lundbeck and Merz Pharmaceuticals in Europe. Aricept is the leader among anti-Alzheimer’s disease drugs, with 2009 worldwide sales of $3.6 billion (Bloomberg, May 14, 2009 and BioPharmInsight). We believe that our approach, which is to develop anti-Alzheimer’s disease drugs that attack the underlying pathology of the disease, should position us to be a formidable entrant into and participant in the Alzheimer’s therapeutic market.

 

According to the amyloid hypothesis proposed by leading Alzheimer’s researchers (Hardy JA, Higgins GA. “Alzheimer’s Disease: the Amyloid Cascade Hypothesis”, Science. 1992; 256:184–185), accumulation of Abeta in the brain resulting in some cases from over production but more generally from a failure in clearance by the brain, is the primary influence driving AD pathogenesis. The rest of the disease process, including formation of neurofibrillary tangles containing tau protein, is proposed to result from an imbalance between Abeta production and Abeta clearance. In forming our company, Dr. Chain sought to develop various therapeutic strategies aimed at reducing both the amount and neurotoxicity of beta amyloid in the brain on the one hand and interfering with intermediate steps on the other.  Thus Dr. Chain began to identify complementary technologies that could address the underlying cause of Alzheimer’s disease from a variety of perspectives, recognizing that a single approach is unlikely to work for the entire patient population. At the same time, multiple technologies are attractive because they give rise to multiple product and partnering opportunities both within and outside the Alzheimer’s disease field. We seek to obtain revenues from the licensing of our intellectual property for drug candidates under development by other pharmaceutical companies. In addition, we seek to enter into drug development collaborations to obtain revenues from signing fees and milestone payments before our products reach Food and Drug Administration (“FDA”) approval and royalties from product sales following such approval.

 

MATERIAL AGREEMENTS

 

Mindset Asset Transfer Agreement. The majority of Intellect’s assets were acquired in 2005 from Mindset Biopharmaceuticals, Inc., which we refer to as “Mindset”. Dr. Daniel Chain, our Chairman and Chief Executive Officer, founded Mindset and remains a significant stockholder of Mindset. He had previously served as Mindset’s Chairman and Chief Executive Officer, and currently serves as its President. Dr. Chain spends approximately 5% of his time on matters relating to Mindset. Mindset is not involved in any business that competes, directly or indirectly, with the business of Intellect. Mindset’s current business plan is to leverage its intellectual property estate through licenses and other arrangements and to provide transgenic mice for Alzheimer’s disease research through its existing subsidiary, Mindgenix, Inc.

 

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Research and License Agreements (“RLAs”) with South Alabama Medical Science Foundation (“SAMS”) and New York University (“NYU”). Effective August 1998, and as amended, Mindset entered into RLAs with SAMS and NYU.  In June 2005, SAMS and NYU consented to Mindset's assignment of the RLAs to us.  Under the RLAs, we have an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, under certain patents and know-how relating to the use of indole-3-propionic acid among other things, to prevent Alzheimer’s Disease (“AD”). We are obligated to make future payments to SAMS and NYU totaling approximately $3,000,000 upon achievement of certain milestones based on phases of clinical development and approval of the FDA (or foreign equivalent) and also to pay SAMS and NYU royalties on net sales (as defined) attributable to each product utilizing the licensed technology. In September 2011, we granted a sublicense of the RLAs to ViroPharma pursuant to which we received a $6.5 million up-front licensing fee and are entitled to receive additional regulatory milestone payments based upon defined events in the United States and the European Union. Pursuant to the terms of the RLAs, we have paid each of SAMS and NYU $650,000 of the up-font licensing fee and are required to pay a portion of future payments we may receive from ViroPharma. (See ViroPharma License Agreement below.)

 

Chimeric Peptide Assignment Agreement. Effective as of June 6, 2000, Dr. Benjamin Chain assigned to Mindset all of his right, title and interest in certain of his inventions and patent applications related to the use of chimeric peptides for the treatment of AD. Dr. Benjamin Chain is the brother of our Chairman and Chief Executive Officer.  In exchange for such assignment, Mindset agreed to pay a royalty to Dr. Benjamin Chain equal to 1.5% of net sales of any drug products sold or licensed by Mindset utilizing the chimeric peptide technology. We acquired these inventions and patent applications and are obligated to make royalty payments to Dr. Benjamin Chain upon successful development of a drug utilizing this chimeric peptide technology. We have yet to develop any drug product that would trigger our obligation to make future payments to Dr. Benjamin Chain.

 

Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement. Under the terms of a Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement (the "IBL Agreement") with Immuno-Biological Laboratories Co., Ltd. ("IBL"), we acquired two beta amyloid specific monoclonal antibodies ready for humanization, and the IBL patents or applications relating to them.  In consideration, we agreed to pay IBL a total of $2,125,000 upon the achievement of certain milestones plus a specified royalty based on sales of any pharmaceutical product derived from the antibodies. Also, we granted to IBL a worldwide, exclusive, paid-up license under certain of our granted patents and pending applications in Japan. The IBL Agreement expires upon the last to expire of the relevant Intellect patents, unless earlier terminated as the result of a material breach by or certain bankruptcy related events of either party to the agreement.

 

Research Collaboration Agreement with MRC Technology (“MRCT”). We entered into a Research Collaboration Agreement with MRCT pursuant to which MRCT agreed to conduct a project to humanize one of our beta-amyloid specific, monoclonal antibodies for the treatment of AD. We are obligated to pay MRCT a total of $200,000 of up-front fees and $560,000 of research milestone payments related to the development of the humanized antibody and additional commercialization milestones and sales based royalties related to the resulting drug products. Under the agreement as amended, we may deliver warrants to purchase our common stock as payment for the $560,000 in research milestones under certain circumstances related to our future financing activities. All of the five research milestones have been achieved and as a result, a liability of $560,000 reflecting research milestone payment obligations outstanding is included in Accounts Payable and Accrued Expenses. No additional work was performed and no additional liabilities were incurred during the fiscal year ended June 30, 2012. On September 16, 2012 the Company reached an agreement with MRCT in which we delivered to them 11,200,000 warrants with an exercise price of $0.0625 in full consideration for the fee owed to MRCT.

 

Élan Pharma International Limited and Wyeth License Agreement. In May 2008, we entered into a License Agreement with AHP Manufacturing BV, acting through its Wyeth Medica Ireland Branch, (“Wyeth”) and Elan Pharma International Limited (“Elan”) to provide Wyeth and Elan (collectively, the “Licensees”) with certain license rights under certain of our patents and patent applications (the “Licensed Patents”) relating to certain antibodies that may serve as potential therapeutic products for the treatment for AD (the “Licensed Products”).

 

We granted the Licensees a non-exclusive license under the Licensed Patents to research, develop, manufacture and commercialize Licensed Products. We received an upfront payment of $1 million in May 2008 and an additional $1 million in August 2008. We are eligible to receive certain milestones and royalties based on sale of Licensed Products.

 

The Licensees have an option to receive ownership of the Licensed Patents if at any time during the term we abandon all activities related to research, development and commercialization of our products that are covered by the Licensed Patents and no other licenses granted by us under the Licensed Patents remain in force. Failure to incur $50,000 in patent or program research related expenses during any six month period is considered to be abandonment. We initially recorded the up-front payment of $1 million that we received from the Licensees in May 2008 as a deferred credit, representing our obligation to fund such future patent or program research related expenses, and we recorded periodic amortization expense related to the deferred credit based on the remaining life of the License. As described more fully below, we granted a license under the Licensed Patents to another pharmaceutical company in December 2008 and reclassified the balance of the deferred credit as revenue because the grant of the second license removed the requirement contained in the abandonment clause in this Agreement. We accounted for the payment received in August 2008 as revenue in the period of receipt.

 

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ANTISENILIN Option and License Agreement. In October 2008, we entered into an Option Agreement with a global pharmaceutical company (“Option Holder”) regarding an option to obtain a license under certain of our patents and patent applications (the “Subject Patents”) related to antibodies and methods of treatment for AD and to make, have made, use, sell, offer to sell and import certain Licensed Products, as defined in this agreement.

 

We granted the Option Holder an irrevocable option to acquire a non-exclusive, royalty bearing license under the Subject Patents . In consideration, the Option Holder paid us a non-refundable fee of $500,000 and agreed to pay us $2,000,000 upon exercise of the option (the “Exercise Fee”). We are entitled to receive an additional $2,000,000 upon the grant in the United States of a Licensed Patent with at least one Valid Claim that covers a Licensed Product in the Territory in the Field (as such terms are defined in this agreement). An additional milestone payment shall be made to us should the Option Holder achieve certain thresholds for aggregate annual net sales. The agreement also provides that we will be eligible to receive certain royalty payments from the Option Holder in connection with net sales.

 

In December 2008, the Option Holder exercised the option and paid us $1,550,000, which is the Exercise Fee, as adjusted.

 

GSK Option and License Agreement. In April 2009, we entered into an Option Agreement with Glaxo Group Limited (“GSK”) regarding an option to purchase a license under certain of our patents and patent applications (the “GSK Patents”) related to antibodies and methods of treatment for AD. We granted GSK an irrevocable option to acquire a non-exclusive, royalty bearing license under the GSK Patents with the right to grant sublicenses, to develop, have developed, make, have made, use, offer to sell, sell, import and have imported Licensed Products.

 

Upon exercise of the option, GSK will pay us $2,000,000 and, upon the later to occur of the exercise of the option by GSK and grant to us in the United States of a Licensed Patent with at least one Valid Claim that covers a Licensed Product incorporating a GSK Compound, GSK will pay us an additional $2,000,000. An additional milestone payment will be made to us should GSK achieve certain thresholds of annual net sales. This agreement also provides that we will be eligible to receive certain royalty payments from GSK in connection with net sales.

 

ViroPharma License Agreement. On and effective as of September 29, 2011, we entered into an Exclusive License Agreement (the “License Agreement”) with ViroPharma, pursuant to which, among other things we granted an exclusive license to ViroPharma regarding certain of our licensed patents and patent applications related to OX1. ViroPharma expects to develop and commercialize OX1 as a treatment of Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.

 

Under the terms of the License Agreement, we have agreed to transfer to ViroPharma all of our intellectual property rights, data and know-how related to our OX1 research and development program in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union.  The aggregate maximum of these milestone payments assuming successful advancement of the product to market could amount to $120 million. In addition, ViroPharma will pay us a tiered royalty of up to an aggregate maximum of low double digits based on annual net sales.  NYU School of Medicine and South Alabama Medical Science Foundation, which own certain patents in relation to OX1, are entitled to a portion of the royalties and revenues received by us from any sale or license of OX1 pursuant to the RLAs described above.

 

The term of the License Agreement will continue in effect on a licensed product-by-licensed product and country-by-country basis until the expiration of the last royalty obligation with respect to a licensed product in such country.  Once the royalty obligation has terminated in a particular country, the license will become non-exclusive and fully paid-up with respect to licensed products in that country.

 

Either party may terminate the License Agreement upon an uncured material breach of the other party.  In addition, if ViroPharma determines that it is not feasible or desirable to develop or commercialize licensed products, it may terminate the License Agreement in whole or on a product-by-product basis at any time upon ninety (90) days prior written notice to the Company.  In the event of a termination of the License Agreement, other than ViroPharma’s termination of the License Agreement for the Company’s uncured material breach, we will have an exclusive, perpetual, irrevocable, worldwide, royalty-bearing license to exploit the licensed products.

 

 License Agreement with Northwestern University (“NWU”). Effective May 2012, we entered into a License Agreement (“License”) with NWU pursuant to which we obtained an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, under certain patents and know-how relating to the use of monoclonal antibody Tau C3 and TOC-1 for the prophylaxis, mitigation, diagnosis and/or treatment of AD and other tauopathies. We are obligated to make future payments to NWU totaling approximately $700,000 upon achievement of certain milestones based on phases of clinical development and also to pay NWU royalties on net sales (as defined) attributable to each product utilizing the licensed technology.

 

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Research and Development Costs

We have devoted substantially all of our efforts and resources to advancing our intellectual property estate and scientific research and drug development. Generally, research and development expenditures are allocated to specific research projects. Due to various uncertainties and risks, including those described in “Risk Factors” below, relating to the progress of our product candidates through development stages, clinical trials, regulatory approval, commercialization and market acceptance, it is not possible to accurately predict future spending or time to completion by project or project category. Research and Development costs, which excludes patent related expenses, were $222,300 for the year ended June 30, 2013 and $996,225 for the year ended June 30, 2012. Research and Development costs from inception through June 30, 2013 were $14,655,089.

 

Competition

 

Alzheimer’s disease therapies under development can largely be divided into two categories: those demonstrating a symptomatic benefit therapy and those demonstrating a disease-modifying benefit. Although a symptomatic benefit can improve the quality of life of the patient by reducing depression, agitation and anxiety and even delay hospitalization by a few months, the effects are typically transient and do not have the disease-modifying effects that will slow the progression of Alzheimer’s disease, prolong life expectancy and possibly even cure this devastating illness. To date, the FDA has approved five drugs to treat people who have been diagnosed with Alzheimer’s disease. All are drugs that provide symptomatic benefits. Various companies are testing active Alzheimer’s vaccines and therapeutics in clinical trials. Such companies include Elan and Wyeth, Novartis and others.

 

Government Regulation and Required Approvals

 

The process required by the FDA under the drug provisions of the United States Food, Drug and Cosmetic Act for any of our drug products to be marketed in the United States generally involves preclinical laboratory and animal tests; submission of an Investigational New Drug Application (“IND”), which must become effective before human clinical trials may begin; adequate and well-controlled human clinical trials to establish the safety and efficacy of the product candidate for its intended use; submission to the FDA of a New Drug Application (“NDA”); and FDA review and approval of a NDA. The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approval will be granted to us or to our licensees on a timely basis, if at all.

 

Preclinical tests include laboratory evaluation of the product candidate, its chemistry, formulation and stability, as well as in-vitro and animal studies, to assess the potential safety and efficacy of the product candidate. Certain preclinical tests must be conducted in compliance with Good Manufacturing Practice (“GMP”) regulations and Good Laboratory Practice guidelines. Violations of these regulations or guidelines can lead to invalidation of studies, requiring, in some cases, such studies to be replicated. In some instances, long-term preclinical studies are conducted while clinical studies are ongoing.

 

Results of preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials may begin. All clinical trials must be conducted under the supervision of a qualified investigator in accordance with Good Clinical Practice (“GCP”) regulations. These regulations include the requirement that all subjects provide informed consent. Further, an independent institutional review board (“IRB”) at each medical center proposing to conduct the clinical trials must review and approve any clinical study. The IRB monitors the study and is informed of the study’s progress, particularly as to adverse events and changes in the research. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if serious adverse events occur.

 

Human clinical trials typically are conducted in three sequential phases that may overlap:

 

·Phase One (I): The drug is typically initially introduced into healthy human subjects or patients and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In some instances, the first introduction into humans will be to patients rather than healthy subject, such as in some drugs developed for various cancer indications.

 

·Phase Two (II): The drug is studied in a limited patient population to identify possible adverse effects and safety risks, to obtain initial information regarding the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

 

·Phase Three (III): Generally large trials undertaken to further evaluate dosage and clinical efficacy and safety in an expanded patient population, often at geographically dispersed clinical study sites.

 

With the exception of OX1, which has successfully completed Phase I, we cannot be certain that we will successfully complete Phase I, Phase II or Phase III testing of our product candidates within any specific time period, if at all.

 

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Concurrent with clinical trials and preclinical studies, information about the chemistry and physical characteristics of the drug product must be developed and a process for its manufacture in accordance with GMP requirements must be finalized. The manufacturing process must be capable of consistently producing quality batches of the product, and we must develop methods for testing the quality, purity and potency of initial, intermediate and final products. Additionally, appropriate packaging must be selected and tested and chemistry stability studies must be conducted to demonstrate that the product does not undergo unacceptable deterioration over its shelf life.

 

The results of product development, preclinical studies and clinical studies are submitted to the FDA as part of a NDA for approval of the marketing and commercial shipment of the product. The FDA reviews each NDA submitted and may request additional information, rather than accepting the NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is subject to review before the FDA accepts it for filing. Once the FDA accepts the NDA for filing, the agency begins an in-depth review of the NDA. The FDA has substantial discretion in the approval process and may disagree with interpretations of the data submitted in the NDA. The review process may be significantly extended should the FDA request additional information or clarification regarding information already provided. Also, as part of this review, the FDA may refer the application to an appropriate advisory committee, typically a panel of clinicians, for review, evaluation and a recommendation. The FDA is not bound by the recommendation of an advisory committee. Manufacturing establishments often are subject to inspections prior to NDA approval to assure compliance with GMP standards and with manufacturing commitments made in the relevant marketing application.

 

Satisfaction of FDA requirements or requirements of state, local and foreign regulatory agencies typically takes several years and the actual time required may vary substantially based upon the type, complexity and novelty of the pharmaceutical product. Government regulation may delay or prevent marketing of potential products for a considerable period of time and impose costly procedures upon our activities. We cannot be certain that the FDA or any other regulatory agency will grant approval for any of our product candidates on a timely basis, if at all. Success in preclinical or early-stage clinical trials does not assure success in later-stage clinical trials. Data obtained from preclinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications or uses. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business.

 

Any products manufactured or distributed by us pursuant to the FDA clearances or approvals would be subject to pervasive and continuing regulation by the FDA, including record-keeping requirements, reporting of adverse experiences with the drug, submitting other periodic reports, drug sampling and distribution requirements, notifying the FDA and gaining its approval of certain manufacturing or labeling changes, complying with certain electronic records and signature requirements, and complying with the FDA promotion and advertising requirements. Drug manufacturers and their subcontractors are required to register their facilities with the FDA and state agencies and are subject to periodic unannounced inspections by the FDA and state agencies for compliance with GMP standards, which impose procedural and documentation requirements upon us and our third-party manufacturers. Failure to comply with these regulations could result, among other things, in suspension of regulatory approval, recalls, suspension of production or injunctions, seizures, or civil or criminal sanctions.

 

The FDA regulates drug labeling and promotion activities. The FDA has actively enforced regulations prohibiting the marketing of products for unapproved uses. Under the FDA Modernization Act of 1997, the FDA occasionally will permit the promotion of a drug for an unapproved use in certain circumstances, but subject to very stringent requirements. OX1 may be prescribed for uses unintended in its initial approval because it may prove to be effective in treating other indications caused by oxidative stress. However, due to the FDA Modernization Act of 1997, we would be prohibited from labeling OX1 for such other indications, which may limit the marketability of the product.

 

We would be subject to a variety of state laws and regulations in those states or localities where our product candidates and any other products we may in-license would be marketed. Any applicable state or local regulations may hinder our ability to market our product candidates and any other products we may in-license in those states or localities. In addition, whether or not FDA approval has been obtained, approval of a pharmaceutical product by comparable governmental regulatory authorities in foreign countries must be obtained prior to the commencement of clinical trials and subsequent sales and marketing efforts in those countries. The approval procedure varies in complexity from country to country and the time required may be longer or shorter than that required for FDA approval. We may incur significant costs to comply with these laws and regulations now or in the future.

 

The FDA’s policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our potential products. Moreover, increased attention to the containment of health care costs in the United States and in foreign markets could result in new government regulations that could have a material adverse effect on our business. We cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the United States or abroad.

 

We are subject to a variety of other local, state, federal and foreign regulatory regimes, and may become subject to additional regulations if any of our product candidates enter the production cycle, that may require us to incur significant costs to comply with such regulations now or in the future.  We cannot assure you that any portion of the regulatory framework under which we currently operate will remain consistent and that any change or new regulations will not have a material adverse effect on our current and anticipated operations. Currently we are in compliance with all applicable regulations.

 

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Employees

 

As of June 30, 2013, we have no employees. In October 2012, Mr. Maza resigned from his employment with the Company and has been engaged as our consulting CFO on a part time basis. In May 2013, Dr. Daniel Chain resigned from his employment with the Company and as a Director and has been engaged as a strategic consultant on a part time basis.

  

Outsourcing

 

We expect to outsource most of our development and manufacturing work. We engage experienced drug development consultants to provide advice on development issues. Overseeing our scientific and clinical strategy are two boards of academic and clinical advisors comprised of experts in the field of Alzheimer’s disease research and related disorders. We believe that this outsourcing strategy is the optimal method for developing our drug candidates given our current and anticipated financial resources.

 

Marketing

 

We do not have an organization for the sales, marketing and distribution of our product candidates. Our core business strategy is to leverage our intellectual property estate through license or other arrangements and to enter into collaboration agreements with major pharmaceutical companies to develop our proprietary compounds. We expect future partners to complete product development, seek regulatory approvals and commercialize the resulting drug products. We do not intend to market any products and do not anticipate a need for any sales, marketing or distribution capabilities.

 

Insurance Coverage

 

We maintain General Liability Insurance.

 

Corporate Information

We are located at 550 Sylvan Ave, Suite 101, Englewood Cliffs, New Jersey, 07632 and our corporate telephone number is (201) 608-5101. Additional information can be found on our website; www.intellectns.com. Our Internet website and the information contained therein or connected thereto are not a part or incorporated into this Annual Report on Form 10-K.

 

Item 1A. RISK FACTORS

 

Risk Factors

 

You should carefully read the following risk factors when you evaluate our business and the forward-looking statements that we make in this report, in our financial statements and elsewhere. Any of the following risks could materially adversely affect our business, our operating results, our financial condition and the actual outcome of matters as to which we make forward-looking statements.

 

Risks related to our lack of liquidity

 

We have insufficient cash on hand to develop our internal programs.

 

As of June 30, 2013, we had cash and cash equivalents of $5,138. We anticipate that our existing capital resources will enable us to continue operations for the next two months. If we fail to raise additional capital or obtain substantial cash inflows from existing or potential partners within the next month, we may be forced to cease operations.

 

We have no revenues and have incurred and expect to continue to incur substantial losses. We may never earn product revenues or achieve and maintain profitability.

 

Through June 30, 2013, we have not generated any revenues other than up-front fees and milestone payments from license agreements. As a result, we have generated significant operating losses since our formation and expect to incur substantial losses and negative operating cash flows for the foreseeable future.

 

As of June 30, 2013, we had a capital deficiency of approximately $13.5 million and a deficit accumulated during the development stage of approximately $83.9 million. Our loss from operations for the fiscal year ended June 30, 2013 was approximately $4.3 million and net cash used by operations was approximately $1.1 million. Our failure to achieve or maintain significant profitability has and will continue to have an adverse effect our stockholder’s equity, total assets and working capital and could negatively impact the value of our common stock.

 

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Unless and until our product candidates or product candidates subject to license agreements with our licensees receive approval from the FDA and from regulatory authorities in foreign jurisdictions, we will not generate any revenues from product sales. Even if we succeed in licensing our technology to generate income, we will still be operating at a significant loss during the course of our drug development programs. We expect to continue to incur significant operating expenditures for at least the next several years and anticipate that our expenses will increase substantially in the foreseeable future. As a result, we may not be able to achieve or maintain profitability in the future. 

 

Risks related to our business

 

We are in the early stages of product development and we may never successfully develop and commercialize any products.

 

We are a development stage biopharmaceutical company and are in the early stages of developing our products. We have not yet successfully developed any of our product candidates. We may fail to develop any products, implement our business model and strategy successfully or revise our business model and strategy should industry conditions and competition change. Even if we successfully develop one or more of our product candidates, the products may not generate sufficient revenues to enable us to be profitable. Furthermore, we cannot make any assurances that we will be successful in addressing these risks. If we are not, our business, results of operations and financial condition will be materially adversely affected.

 

We plan to develop our products by collaborating with third-parties and we face substantial competition in this endeavor. If we are not successful in establishing such third party collaboration arrangements, we may not be able to successfully develop and commercialize our products.

 

Our business strategy includes finding larger pharmaceutical companies with which to collaborate to support the research, development and commercialization of our product candidates. In trying to attract corporate partners to collaborate with us in the research, development and commercialization process, we face serious competition from other small biopharmaceutical companies. If we are unable to enter into such collaboration arrangements, our ability to proceed with the research, development, manufacture or sale of product candidates may be severely limited. Even if we do enter into such collaborations, our partners may not succeed in developing or commercializing product candidates.

 

We have a limited operating history and we may not be able to successfully develop our business.

 

We were incorporated in Delaware in April 2005 and began operations in June 2005. Our limited operating history makes predicting our future operating results difficult. As a biopharmaceutical company with a limited history, we face numerous risks and uncertainties in the competitive market for Alzheimer’s disease and central nervous system related drugs. In particular, we have not proven that we can develop drugs in a manner that enables us to be profitable and meet regulatory, strategic partner and customer requirements; develop and maintain relationships with key vendors and strategic partners that will be necessary to enhance the market value of our product candidates; raise sufficient capital in the public and/or private markets; or respond effectively to competitive pressures. If we are unable to accomplish these goals, our business is unlikely to succeed. Even if we are able to license our technology to generate income we still will be operating at a significant loss during the course of our drug development programs.

 

We may not be able to proceed with clinical trials for our product candidates or if future trials are unsuccessful or significantly delayed we may not be able to develop and commercialize our products.

 

Successful development and commercialization of our product candidates are dependent on, among other factors, the successful outcome of future studies needed to make a final selection of drug candidates; successful manufacture and formulation of drug products; additional preclinical studies to establish efficacy and safety across species; successful outcome of future clinical trials that establish both safety and efficacy; receipt of regulatory approval for our product candidates; raising substantial additional financing; and establishing any strategic partnerships that would result in a license of our technology. There can be no assurance that we or any future partners will successfully develop and commercialize our product candidates.

 

If we or future partners fail to obtain or maintain the necessary United States or worldwide regulatory approvals for our product candidates or those subject to license agreements with us, such products will not be commercialized.

 

The success of our business depends on our or any future partner’s ability to put product candidates through rigorous, time-consuming and costly clinical testing, and to obtain regulatory approval for those products. Government regulations in the United States and other countries significantly impact the research and development, manufacture and marketing of drug product candidates. We or any of our future partners will require FDA approval to commercialize product candidates in the United States and approvals from similar regulatory authorities in foreign jurisdictions to commercialize our product candidates, or those subject to license agreements with us, in those jurisdictions.

 

The FDA and other regulatory authorities have substantial discretion in the drug approval process and may either refuse to accept an application for any product candidates or may decide after review of the application(s) that the data is insufficient to allow approval of the relevant product(s). If the FDA or other regulatory authorities do not accept or approve the application(s), they may require us or our partners to conduct additional preclinical testing, clinical trials or manufacturing studies and submit those data before they will reconsider the application or require us or our partners to perform post-marketing studies even after a product candidate is approved for commercialization. Even if we or our partners comply with all FDA and other regulatory requests, the FDA may ultimately reject the product candidates or the New Drug Applications. We cannot be certain that we or any of our future partners will ever obtain regulatory clearance of any of our product candidates or those subject to license agreements with us. Failure to obtain FDA approval will severely undermine our business by reducing our potential number of salable products and, therefore, corresponding product revenues. Also, the FDA might approve one or more of our or our future partner’s product candidates, but also might approve competitors’ products possessing characteristics that offer their own treatment, cost or other advantages.

 

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In addition, even if our current product candidates and any additional product candidates we pursue in the future are marketed, the products and our manufacturers are subject to continual review by the FDA and other applicable regulatory authorities. At any stage of development or commercialization, the discovery of previously unknown problems with our product candidates, our manufacturing or the manufacturing by third-party manufacturers may result in restrictions on our product candidates and any other products we may in-license, including withdrawal of the product from the market. Foreign regulatory approval processes generally include all of the risks associated with the FDA approval procedures described above.

 

If we are not able to maintain our current license rights or obtain additional licenses, our business will suffer.

 

We use technologies that we do not own in the development and configuration of our product candidates. There can be no assurance that any of the current contractual arrangements between us and third parties or between our strategic partners and other third parties, will be continued or not breached or terminated early. In the future, we may also require technologies to which we do not currently have any rights. We may not be able to obtain these technologies on acceptable terms if at all. Any such additional licenses may require us to pay royalties or other fees to third parties, which would have an adverse effect on our potential revenues and gross margin.

 

Our operating results may significantly fluctuate from quarter-to-quarter and from year-to-year.

 

Through the date of this report, we have generated minimal revenues. If and when we do, we expect that a significant portion of our revenues for the foreseeable future will be comprised of license fees, royalties and milestone payments. The timing of revenue in the future will depend largely upon the signing of collaborative research and development or technology licensing agreements or the licensing of our product candidates for further development and payment of fees, milestone payments and royalties. In any one fiscal quarter we may receive multiple or no payments from our collaborators. As a result, operating results may vary substantially from quarter-to-quarter and, thus, from year-to-year. Revenue for any given period may be greater or less than revenue in the immediately preceding period or in the comparable period of the prior year.  Therefore, investors should not rely on our revenue or other operating results from one or more quarters as being indicative of our revenue or other operating results for any future period.

 

Our operating results may be materially impacted by the valuation of our derivative instruments.

 

Since inception, we have issued a significant number of convertible notes, warrants to purchase our common stock and convertible preferred stock. In accordance with current accounting guidelines, we have treated derivative financial instruments as liabilities on our consolidated balance sheet, measured at fair value at issuance date, and re-measured at fair value on each reporting date. We record changes in the fair value of these derivative liabilities in income or loss on each balance sheet date.  We use a Black-Scholes option pricing model, which uses the underlying price of our common stock as one of the inputs to determine the fair value at issuance date and at each subsequent reporting period. As a result, the fair value of the derivative instruments is impacted by changes in the market price of our common stock. The market price of our common stock can be volatile and is subject to factors beyond our control. These factors include, but are not limited to, trends in the industry in which we operate, the market of OTC Bulletin Board quoted stocks in general and sales of our common stock. As a result, the value of our common stock may change from measurement date to measurement date, thereby resulting in material fluctuations in the fair value of the derivative instruments, which can materially impact our operating results.

 

We have no research facilities. If we are not successful in developing our own research facilities or entering into research agreements with third party providers, our development efforts and clinical trials may be delayed.

 

Currently, we have no scientific research laboratory. We have shut down our Israeli research laboratory, dismissed all employees and sold the equipment due to lack of sufficient funds to support the research operation. In order to resume our research efforts, we must recruit additional scientists and rebuild or utilize third party laboratory facilities. We cannot be sure that we will raise sufficient funds to do any of the above. Failure to accomplish these tasks would impede our efforts to develop our existing product candidates and conduct research to identify future product candidates, which would adversely affect our ability to generate revenue.

 

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We have no manufacturing capabilities. If we are not successful in developing our own manufacturing capabilities or entering into third party manufacturing agreements or if third-party manufacturers fail to devote sufficient time and resources to our concerns, our clinical trials may be delayed.

 

Currently, we have no internal manufacturing capabilities for any of our product candidates. Our clinical batch supplies are manufactured by a third party manufacturer based in Switzerland and other countries. We have sufficient drug product to perform the necessary non-clinical studies in support of Phase II and have the necessary “know-how” to manufacture OX1. In order to continue the clinical development process for OX1 and our other product candidates, however, we must continue to rely on third parties to manufacture these product candidates. There can be no assurance that any of the current contractual arrangements between us and third party manufacturers will be continued or not breached or terminated early. There can be no assurance that we can identify and enter into contracts with replacement manufacturers if our current manufacturing arrangements are terminated. In addition, reliance on third party manufacturers could expose us to other risks, such as substandard performance, difficulties in achieving volume production and poor quality control or noncompliance with FDA and other regulatory requirements. If we decide to manufacture one or more product candidates ourselves, we would incur substantial start-up expenses and need to acquire or build facilities and hire additional personnel.

 

Our product candidates are subject to the risk of failure inherent in the development of products based on new and unproved technologies.

 

Because our product candidates and those of any future partner, which are the subject of license agreements with us, are and will be based on new and unproven technologies, they are subject to risk of failure. These risks include the possibility that our new approaches will not result in any products that gain market acceptance; a product candidate will prove to be unsafe or ineffective, or will otherwise fail to receive and maintain regulatory clearances necessary for marketing; a product, even if found to be safe and effective, could still be difficult to manufacture on the large scale necessary for commercialization or otherwise not be economical to market; a product could unfavorably interact with other types of commonly used medications, thus restricting the circumstances in which it may be used; proprietary rights of third parties will preclude us from manufacturing or marketing a new product; or third parties could market superior or more cost-effective products. As a result, our activities, either directly or through corporate partners, may not result in any commercially viable products.

 

In order to achieve successful sales of our product candidates or those developed by any of our future partners, the product candidates need to be accepted in the healthcare market by healthcare providers, patients and insurers. Lack of such acceptance will have a negative impact on any future sales.

 

Our future success is dependent upon the acceptance of our product candidates by health care providers, patients and health insurance companies, Medicare and Medicaid. Such market acceptance, if it were to occur, would depend on numerous factors, many of which are not under our control including regulatory approval; product labeling; safety and efficacy of our products; availability, safety, efficacy and ease of use of alternative products and treatments; the price of our drugs relative to the price of alternative products and treatments; and achieving reimbursement approvals from Medicare, Medicaid and private insurance providers.

 

We cannot guarantee that any of our product candidates or those developed by any of our future partners, which are subject to license agreements with us, would achieve market acceptance. Additionally, we cannot guarantee that third-party payors, hospitals or health care administrators would accept any of the products we manufacture or in-license on a large-scale basis. We also cannot guarantee that we would be able to obtain approvals for indications and labeling for our products that will facilitate their market acceptance. Furthermore, unanticipated side-effects, patient discomfort, defects or unfavorable publicity of our drugs or other therapies based on a similar technology, could have a significant adverse effect on our effort to commercialize our lead or any subsequent drug candidates.

 

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 collaborator’s ability to commercialize licensed drugs 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 health care payers. Significant uncertainty exists as to the reimbursement status of newly approved health care products. Health care payers, including Medicare, routinely challenge the prices charged for medical products and services. Government and other health care payers increasingly attempt to contain health care costs by limiting both coverage and the level of reimbursement for drugs, which may limit our commercial opportunity. 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. Proposals currently being considered by to reform the U.S. health insurance system create additional uncertainty and risk that any drugs that we or our collaborators seek to commercialize may not receive adequate coverage or reimbursement.  If government and other health care payers do not provide adequate coverage and reimbursement levels for our product candidates, the post-approval market acceptance of our products could be diminished.

 

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Our product candidates may be subject to future product liability claims. Such product liability claims could result in expensive and time-consuming litigation and payment of substantial damages.

 

The testing, production, marketing, sale and use of products using our technology is unproven as of yet and there is risk that product liability claims may be asserted against us if it is believed that the use or testing of our product candidates have caused adverse side effects or other injuries. In addition, providing diagnostic testing and therapeutics entails an inherent risk of professional malpractice and other claims. Claims, suits or complaints relating to the use of products utilizing our technology may be asserted against us in the future by patients participating in clinical trials of our product candidates or following commercialization of products. If a product liability claim asserted against was successful, we also could also be required to limit commercialization of our product candidates or completely withdraw a product from the market. Regardless of merit or outcome, claims against us would likely result in significant diversion of our management’s time and attention, expenditure of large amounts of cash on legal fees, expenses and damages and a decreased demand for our products and services. We currently do not have any insurance coverage to protect us against product liability claims during clinical trials of product candidates and we may not be able to acquire or maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us during clinical trials of any product candidates or following commercialization of any products

 

Our future collaborators may compete with us or have interests which conflict with ours. This may restrict our research and development efforts and limit the areas of research in which we intend to expand.

 

Large pharmaceutical companies that we seek to collaborate with may have internal programs or enter into collaborations with our competitors for products addressing the same medical conditions targeted by our technologies. Thus, our collaborators may pursue alternative technologies or product candidates in order to develop treatments for the diseases or disorders targeted by our collaborative arrangements. Our collaborators may pursue these alternatives either on their own or in collaboration with others, including our competitors. Depending on how other product candidates advance, a corporate partner may slow down or abandon its work on our product candidates or terminate its collaborative arrangement with us in order to focus on these other prospects.

 

If any conflicts arise, our future collaborators may act in their own interests, which may be adverse to ours. In addition, in our future collaborations, we may be required to agree not to conduct any research that is competitive with the research conducted under our future collaborations. Our future collaborations may have the effect of limiting the areas of research that we may pursue. Our collaborators may be able to develop products in related fields that are competitive with the products or potential products that are the subject of these collaborations.

 

We do not have control of our outside scientific and clinical advisors. They may pursue objectives which are contrary to our interest, which could impede our research and development efforts.

 

We work with scientific and clinical advisors at academic and other institutions who are experts in the field of Alzheimer’s disease and other central nervous system disorders and diseases caused by oxidative stress. Our advisors assist us in our research and development efforts and advise us with respect to our clinical trials for OX1 and our planned clinical trials for our other product candidates. However, our advisors are not our employees and they may have other commitments that would limit their future availability to us. Accordingly, we may lose their services, which may delay the clinical development of our drug candidates and impair our reputation in the industry.

 

If we fail to obtain, apply for, adequately prosecute to issuance, maintain, protect or enforce patents for our inventions and products, the value of our intellectual property rights and our ability to license, make, use or sell our products would materially diminish or could be eliminated entirely.

 

Our success, competitive position and future revenues will depend in part on our ability to obtain and maintain patent protection for our inventions and product candidates and for methods, processes and other technologies, as well as our ability to preserve our trade secrets, prevent third parties from infringing on our proprietary rights or invalidating our patents and operate without infringing the proprietary rights of third parties.

 

Our patent position is uncertain and involves complex legal and factual questions for which important legal principals are changing and/or unresolved. Because we rely heavily on patent protection and others have sought patent protection for technologies similar to ours, the risks are particularly significant and include the following:

 

·The patent offices may not grant claims of our pending applications or future applications and may not grant patents having claims of meaningful scope to protect adequately our technologies, processes and products.

 

·We may not be able to obtain patent rights to compositions, products, treatment methods or manufacturing processes that we may develop or license from third parties.

 

·Even if our patents are granted, our freedom to operate and to develop products may be restricted or blocked by patents of our competitors.

 

·Some of the issued patents we now license or any patents which are issued to us in the future may be determined to be invalid and/or unenforceable, or may offer inadequate protection against competitive products.

 

·If we have to defend the validity of the patents that we have in-licensed or any future patents or protect against third party infringements, the costs of such defense are likely to be substantial and we may not achieve a successful outcome.

 

·In the event any of the patents we have in-licensed are found to be invalid or unenforceable, we may lose our competitive position and may not be able to receive royalties for products covered in part or whole by that patent under license agreements. Further, competitors may be free to offer copies of our products if such patents are found to be invalid or unenforceable.

 

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·Others may obtain patents claiming aspects similar to those covered by our patents and patent applications, which could enable them to make and sell products similar to ours.

 

·We may be estopped from claiming that one or more of our patents is infringed due to amendments to the claims and/or specification, or as a result of arguments that were made during prosecution of such patents in the United States Patent and Trademark Office, or by virtue of certain language in the patent application. The estoppel may result in claim limitation and/or surrender of certain subject matter to the public domain or the ability of competitors to design around our claims and/or avoid infringement of our patents. If our patents or those patents for which we have license rights become involved in litigation, a court could revoke the patents or limit the scope of coverage to which they are entitled.

 

If we fail to obtain and maintain adequate patent protection and trade secret protection for our drug candidates, proprietary technologies and their uses, we could lose any competitive advantage and the competition we face could increase, thereby reducing our potential revenues and adversely affecting our ability to attain or maintain profitability.

 

 A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly and an unfavorable outcome could harm our business.

 

There is significant litigation in the biotechnology field regarding patents and other intellectual property rights. We may be exposed to future litigation by third parties based on claims that our drug candidates, technologies or activities infringe the intellectual property rights of others. Although we try to avoid infringement, there is the risk that we will use a patented technology owned or licensed by another person or entity and/or be sued for infringement of a patent owned by a third party. Under current United States law, patent applications are confidential for 18 months following their priority filing date and may remain confidential beyond 18 months if no foreign counterparts are applied for in jurisdictions that publish patent applications. There are many patents relating to specific genes, nucleic acids, polypeptides or the uses thereof to treat Alzheimer’s disease and other central nervous system diseases. In some instances, a patentee could prevent us from using patented genes or polypeptides for the identification or development of drug compounds. If our products or methods are found to infringe any patents, we may have to pay significant damages and royalties to the patent holder or be prevented from making, using, selling, offering for sale or importing such products or from practicing methods that employ such products.

 

In addition, we may need to resort to litigation to enforce a patent issued or licensed to us, protect our trade secrets or determine the scope and validity of third-party proprietary rights. Such litigation could be expensive and there is no assurance that we would be successful. From time to time, we may hire scientific personnel formerly employed by other companies involved in one or more fields similar to the fields in which we are working. Either these individuals or we may be subject to allegations of trade secret misappropriation or similar claims as a result of their prior affiliations. If we become involved in litigation, it could consume a substantial portion of our managerial and financial resources, regardless of whether we win or lose. As a result, we could be prevented from commercializing current or future products or methods.

 

Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property.

 

Our success also depends upon the skills, knowledge and experience of our scientific and technical personnel, our consultants and advisors as well as our partners, collaborators, licensors and contractors. Because we operate in a highly competitive technical field of drug discovery, we rely in part on trade secrets to protect our proprietary technology and processes. However, trade secrets are difficult to protect. We enter into confidentiality and intellectual property assignment agreements with our corporate partners, employees, consultants, outside scientific collaborators, sponsored researchers and other advisors. These agreements generally require that the receiving party keep confidential and not disclose to third parties all confidential information developed by the receiving party or made known to the receiving party by us during the course of the receiving party’s relationship with us. These agreements also generally provide that inventions conceived by the receiving party in the course of rendering services to us will be our exclusive property. However, these agreements may be breached and may not effectively assign intellectual property rights to us. Our trade secrets also could be independently discovered by competitors, in which case we would not be able to prevent use of such trade secrets by our competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. The failure to obtain or maintain meaningful trade secret protection could adversely affect our competitive position.

 

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Certain of our product development programs depend on our ability to maintain rights under our licensed intellectual property. If we are unable to maintain such rights, our research and development efforts will be impeded and our business and financial condition will be negatively impacted.

 

We have licensed intellectual property, including patents, patent applications and know-how, from universities and others, including intellectual property underlying our OX1 product development program. Some of our product development programs depend on our ability to maintain rights under these licenses. Under the terms of such license agreements, we are generally obligated to, among other things, exercise commercially reasonable efforts in the development and marketing of these technologies; make specified royalty and milestone payments to the party from which we have licensed the technology; reimburse patent costs to the licensors; enforce the underlying intellectual property against unauthorized third parties; and pay development milestones, for example, on the commencement of clinical trials and filing of a New Drug Application and pay a royalty on product sales.

 

Each licensor has the power to terminate its agreement if we fail to meet our obligations under that license. We may not be able to meet our obligations under these license agreements. Furthermore, these obligations may conflict with our obligations under other agreements. If we default under any of these license agreements, we may lose our right to market and sell any products based on the licensed technology. Losing marketing and sales rights would have a material negative effect on our business, financial condition and results of operations.

 

The United States government holds rights that may permit it to license to third parties technology that we currently hold the exclusive right to use. We may lose our rights to such licenses if the government chooses to exercise its rights.

 

The United States government holds rights in inventions that were conceived or reduced to practice under a government-funded program. This applies to aspects of our OX1 and TOC-01 technologies, which have been licensed to us by third-party licensors who have received government funding. These government rights include a non-exclusive, royalty-free, worldwide license for the government to practice the invention or to have the invention practiced by a third party for any governmental purpose. In addition, the United States government has the right to grant licenses to others under any of these inventions if the government determines that adequate steps have not been taken to commercialize such inventions; the grant is necessary to meet public health or safety needs; or the grant is necessary to meet requirements for public use under federal regulations.

 

The United States government also has the right to take title to a subject invention made with government funding if we fail to disclose the invention within specified time limits. The United States government may acquire title in any country in which we do not file a patent application for inventions made with government funding within specified time limits. We may lose our right to the licensed technologies if we fail to meet the obligations required by the government, or if the government decides to exercise its rights

 

Risks related to our industry

 

Our technology may become obsolete or lose its competitive advantage.

 

The pharmaceuticals business is very competitive, fast moving and intense, and we expect it to be increasingly so in the future. Other companies have developed and are developing Alzheimer’s disease drugs that, if not similar in type to our drugs, are designed to address the same patient or subject population. Therefore, there is no assurance that our product candidates or those being developed by our collaborators or licensees will be the best, the safest, the first to market, or the most economical to make or use. If competitors’ products are superior to ours or our collaborators’ or licensees’ products, for whatever reason, our products may become obsolete. In particular, our competitors could develop and market Alzheimer’s disease therapeutic products that are more effective, have fewer side-effects or are less expensive than our current or future product candidates. Such products, if successfully developed, could render our technologies or product candidates obsolete or non-competitive.

 

Clinical trials are expensive, time-consuming and difficult to design and implement.

 

Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Further, the medical, regulatory and commercial environment for pharmaceutical products changes quickly and often in ways that we may not be able to accurately predict. The clinical trial process also is time-consuming and we do not know whether planned clinical trials will begin on time or whether we will complete any of our clinical trials on schedule or at all. We estimate that clinical trials of our product candidates will take at least several more years to complete. Significant delays may adversely affect our financial results and the commercial prospects for our product candidates and any other products we may in-license and delay or impair our ability to become profitable. Product development costs to our potential collaborators and us will increase if we have delays in testing or approvals or if we need to perform more or larger clinical trials than planned. Furthermore, as failure can occur at any stage of the trials, we could encounter problems that cause us to abandon or repeat clinical trials. The commencement and completion of clinical trials may be delayed by several factors, including changes to applicable regulatory requirements; unforeseen safety issues; determination of dosing issues; lack of effectiveness in the clinical trials; lack of sufficient patient enrollment; slower than expected rates of patient recruitment; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators to follow our clinical protocols; inability to maintain a supply of the investigational drug in sufficient quantities to support the trials; and suspension or termination of clinical trials for various reasons, including noncompliance with regulatory requirements or changes in the clinical care protocols and standards of care within the institutions in which our trials take place.

 

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In addition, we, or the FDA or other regulatory authorities, may suspend our clinical trials at any time if it appears that participants are being exposed to unacceptable health risks or if the FDA finds deficiencies in our Investigational New Drug Application submissions or the conduct of our trials. We may be unable to develop marketable products. In addition, the competition for clinical institutions that act as investigators in clinical trials is intense. There can be no assurance that we will be able to conclude appropriate contracts with such institutions. Even if we are successful, slow recruitment of patients could cause significant delay in our development plans.

 

Problems during our clinical trial procedures could have serious negative impacts on our business.

 

FDA approval requires significant research and animal tests, which are referred to as preclinical studies, as well as human tests, which are referred to as clinical trials. Similar procedures are required in foreign countries. If we experience unexpected, inconsistent or disappointing results in connection with a clinical trial, our business will suffer.

 

If any of the following events arise during our clinical trials or data review, we expect it would have a serious negative effect on our results of operations and ability to commercialize a product candidate and could subject us to significant liabilities:

 

·Any of our product candidates may be found to be ineffective or to cause harmful side-effects, including death;

 

·Our clinical trials for any of product candidates may take longer than anticipated, for any of a number of reasons, including a scarcity of subjects that meet the physiological or pathological criteria for entry into the study, a scarcity of subjects that are willing to participate in the trial, or data and document review;

 

·The reported clinical data for any of our product candidates may change over time as a result of the continuing evaluation of patients or the current assembly and review of existing clinical and preclinical information;

 

·Data from various sites participating in the clinical trials for each of our product candidates may be incomplete or unreliable, which could result in the need to repeat the trial or abandon the project; and

 

·The FDA and other regulatory authorities may interpret our data differently than we do which may delay or deny approval.

 

The results of clinical trials may not support our product candidate claims.

 

Even if our clinical trials or those of our licensees are completed as planned, we cannot be certain that their results will support our product candidate claims or that the FDA or government authorities in other countries will agree with our conclusions regarding such results. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful and the results of later clinical trials often do not replicate the results of prior clinical trials and preclinical testing. In addition, our clinical trials involve a small patient population. Because of the small sample size, the results of these clinical trials may not be indicative of future results in a larger and more diverse patient population. The clinical trial process may fail to demonstrate that our product candidates are safe for humans and effective for indicated uses. This failure could cause us to abandon a product candidate and may delay development of other product candidates. Any delay in, or termination of, our clinical trials will delay the filing of our New Drug Applications with the FDA and, ultimately, our ability to commercialize our product candidates and generate product revenues.

 

Physicians and patients may not accept and use our drugs.

 

Even if the FDA approves our product candidates or those of our licensees, which are subject to licenses with us, physicians and patients may not accept and use them. Acceptance and use of our product candidates, or any of our future drugs, 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 and the use of controlled substances; cost-effectiveness of our drugs relative to competing products;  availability of reimbursement for our product candidates and any other products we may in-license from government or other health care payors; and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any. The failure of any of these drugs to find market acceptance would harm our business.

 

Risks related to management

 

We have no employees. We rely on consultants, and their knowledge of our business and technical expertise would be difficult to replace.

 

We have no employees. Dr. Daniel G. Chain, our former Chief Executive Officer and Chairman of the Board of Directors is engaged as a strategic consultant on a part time basis. Dr. Chain has other jobs and commitments and may be subject to non-disclosure obligations that may limit his availability to work with us.

 

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Although we intend to outsource our development programs, we may need to hire qualified personnel with expertise in preclinical testing, clinical research and testing, government regulation, formulation and manufacturing and sales and marketing. We will require experienced scientific personnel in many fields in which there are a limited number of qualified personnel and we compete for qualified individuals with numerous biopharmaceutical companies, universities and other research institutions and other emerging entrepreneurial companies. Competition for such individuals, particularly in the New York City area, where our offices are headquartered, is intense and we cannot be certain that our search for such personnel will be successful. Furthermore, we are competing for employees against companies that are more established than we are and have the ability to pay more cash compensation than we do. As a result, depending upon the success and the timing of clinical tests, we may continue to experience difficulty in hiring and retaining highly skilled employees, particularly scientists. If we are unable to hire and retain skilled scientists, our business, financial condition, operating results and future prospects could be materially adversely affected.

 

Risks related to our common stock

 

Shares of our stock suffer from low trading volume and wide fluctuations in market price.

 

Our common stock is currently quoted on the Over the Counter Bulletin Board trading system under the symbol ILNS. An investment in our common stock currently is illiquid and subject to significant market volatility. This illiquidity and volatility may be caused by a variety of factors including low trading volume and market conditions.

 

In addition, the value of our common stock could be affected by actual or anticipated variations in our operating results; changes in the market valuations of other similarly situated companies serving similar markets; announcements by us or our competitors of significant acquisitions, strategic partnerships, collaborations, joint ventures or capital commitments; adoption of new accounting standards affecting our industry; additions or departures of key personnel; introduction of new products or services by us or our competitors; actual or expected sales of our common stock or other securities in the open market; the “market overhang” of a significant number of shares of our common stock that would be issued upon the exercise of outstanding stock options and warrants; conditions or trends in the market in which we operate; and other events or factors, many of which are beyond our control.

 

Stockholders may experience wide fluctuations in the market price of our securities. These fluctuations may have an extremely negative effect on the market price of our securities and may prevent a stockholder from obtaining a market price equal to the purchase price such stockholder paid when the stockholder attempts to sell our securities in the open market. In these situations, the stockholder may be required either to sell our securities at a market price which is lower than the purchase price the stockholder paid, or to hold our securities for a longer period of time than planned. An inactive market may also impair our ability to raise capital by selling shares of capital stock and may impair our ability to acquire other companies by using common stock as consideration or to recruit and retain managers with equity-based incentive plans.

 

We cannot assure you that our common stock will become listed on the American Stock Exchange, Nasdaq or any other securities exchange.

 

We currently fall far below the initial listing standards of any national securities exchange and there are no assurances that we will be able to meet the initial listing standards of any stock exchange, or that we will be able to maintain a listing of our common stock on any stock exchange. Until our common stock is listed on the American Stock Exchange or Nasdaq or another stock exchange, we expect that our common stock will continue to trade on the Over-The-Counter Bulletin Board, where an investor may find it difficult to dispose of our shares of common stock. In addition, we would be subject to an SEC rule that, if we failed to meet the criteria set forth in such rule, imposes various requirements on broker-dealers who sell securities governed by the rule to persons other than established customers and accredited investors. Consequently, this SEC rule may deter broker-dealers from recommending or selling the common stock, which may further affect its liquidity. This circumstance could also make it more difficult for us to raise additional capital in the future.

 

We will continue to incur increased costs as a result of being an operating public company.

 

As a public operating company, we incur significant legal, accounting and other expenses not incurred by a private company. If our stock becomes listed on Nasdaq or another major exchange or if our total assets exceed $10 million at the end of any fiscal year, or if the market value of shares of common stock held by non-affiliates of the Company exceeds $75 million dollars at certain dates, we will also incur additional compliance expenses. It may be time consuming, difficult and costly for us to develop and implement the additional internal controls, processes and reporting procedures required by the Sarbanes-Oxley Act of 2002, SEC proxy rules, other government regulations affecting public companies and/or stock exchange compliance requirements. We may need to hire additional financial reporting, internal auditing and other finance staff in order to develop and implement appropriate additional internal controls, processes and reporting procedures.

 

Our common stock is subject to the “Penny Stock” rules of the SEC and the trading market in our securities is limited, which makes transactions in our stock cumbersome and may reduce the value of an investment in our stock.

 

The Securities and Exchange Commission has adopted Rule 15g-9 which establishes the definition of a "penny stock," for the purposes relevant to us, as any equity security that has a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. For any transaction involving a penny stock, unless exempt, the rules require that:

 

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§a broker or dealer approve a person's account for transactions in penny stocks; and

 

§the broker or dealer receive from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased.

 

In order to approve a person's account for transactions in penny stocks, the broker or dealer must:

 

§obtain financial information and investment experience objectives of the person; and

 

§make a reasonable determination that the transactions in penny stocks are suitable for that person and the person has sufficient knowledge and experience in financial matters to be capable of evaluating the risks of transactions in penny stocks.

 

The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the Commission relating to the penny stock market, which, in highlight form:

 

§sets forth the basis on which the broker or dealer made the suitability determination; and

 

§that the broker or dealer received a signed, written agreement from the investor prior to the transaction.

 

Generally, brokers may be less willing to execute transactions in securities subject to the "penny stock" rules. This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.

 

Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotations for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions. Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks

 

There may be issuances of shares of preferred stock in the future that could have superior rights to our common stock.

 

We have provisions authorizing “blank check” preferred stock and we are therefore authorized to issue shares of preferred stock. Accordingly, our board of directors has the authority to fix and determine the relative rights and preferences of 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 one or more series of preferred stock that would grant to holders preferred rights to our assets upon liquidation, the right to receive dividends before dividends would be declared to common stockholders and the right to the redemption of such shares, together with a premium, prior to any redemption of the common stock. To the extent that we do issue such additional shares of preferred stock, the rights of the holders of the common stock would be impaired thereby, including without limitation, with respect to liquidation.

 

We have never paid nor do we expect in the near future to pay dividends.

 

We have never paid cash dividends on our capital stock and do not anticipate paying any cash dividends on our common stock for the foreseeable future.

 

We and our security holders are not subject to some reporting requirements applicable to most public companies; therefore, investors may have less information on which to base an investment decision.

 

We do not have a class of securities registered under Section 12(b) or 12(g) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Therefore, we do not prepare proxy or information statements in accordance with Section 14(a) of the Exchange Act with respect to matters submitted to the vote of our security holders. Our officers, directors and beneficial owners of more than 10% of our common stock are not required to file statements of beneficial ownership on SEC Forms 3, 4 and 5 pursuant to Section 16 of the Exchange Act and beneficial owners of more than 5% of our outstanding common stock are not required to file reports on SEC Schedules 13D or 13G. Therefore, investors in our securities will not have any such information available in making an investment decision.

 

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ITEM 2.PROPERTIES

 

We lease approximately 500 square feet of office space at 550 Sylvan Ave., Suite 101, Englewood Cliffs, New Jersey, 07632. The lease is on a yearly at a monthly rental of $2,310.

  

ITEM 3.LEGAL PROCEEDINGS

 

 None

 

ITEM 4.

MINE SAFETY DISCLOSURES

 

None

 

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 quoted on the Over-The-Counter (OTC) Bulletin Board under the symbol “ILNS.OB” and is not listed on any exchange. The following table sets forth the range of high and low bid prices as reported for each period indicated. All amounts for the period prior to April 12, 2011 have been restated to reflect the 1:50 reverse stock split consummated on that date.

 

   High  Low
Fiscal year ended June 30, 2013          
           
September 30,  $0.04   $0.01 
December 31,   0.03    0.01 
March 31,   0.03    0.01 
June 30,   0.01    0.01 
           
Fiscal year ended June 30, 2012          
           
September 30,  $0.19   $0.06 
December 31,   0.10    0.03 
March 31,   0.06    0.03 
June 30,   0.05    0.03 

 

The foregoing quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission, and may not represent actual transactions.

 

Holders

 

As of October 15, 2013, the Company had 88 common stock holders of record. 

 

Dividends

 

We have never paid cash dividends on our capital stock. There are no restrictions that would limit us from paying dividends; however we do not anticipate paying any cash dividends for the foreseeable future.

 

Securities Authorized for Issuance under Equity Compensation Plans

 

The following table provides information as of June 30, 2013 regarding the common stock that may be issued upon the exercise of options granted to employees, consultants or members of our board of directors under all of our existing equity compensation plans.

 

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Plan Category  Number of securities
issuable upon exercise
of outstanding Options,
Warrants and Rights
   Weighted average
exercise price of
outstanding Options,
Warrants and Rights
   Number of securities
remaining available for
future issuances under
equity compensation
plans
 
             
Equity compensation plans approved by security holders   213,243   $34.87    18,320 
                
Equity compensation plans not approved by security holders   -    -    - 
                
Total   213,243   $34.87    18,320 

 

ITEM 6.SELECTED FINANCIAL DATA

 

Not applicable to smaller reporting companies

 

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

 

The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements included elsewhere in this report and the information described under the caption “Risk Factors” and “Special Note Regarding Forward Looking Statements” above.

 

General

 

We are a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of neurodegenerative conditions, collectively known as proteinopathies, which include Alzheimer’s (“AD”), Parkinson’s and Huntington disease. We have an internal diversified pipeline and have granted licenses related to our patent estate to major pharmaceutical companies.

 

Since our inception in 2005, we have devoted substantially all of our efforts and resources to advancing our intellectual property portfolio and research and development activities.  We have entered into license and other agreements with large pharmaceutical companies related to our patent estate, however, neither we nor any of our licensees have obtained regulatory approval for sales of any product candidates covered by our patents. We operate under a single segment. Our fiscal year end is June 30.

 

Our core business strategy is to build a portfolio of compounds with the potential to treat or prevent neurodegenerative diseases, develop each to pre-determined milestones, and license them to pharmaceutical companies for advanced development and commercialization. To supplement our own work, we intend to license promising novel technologies and early stage compounds from academia and other biotechnology companies. We intend to obtain revenues from licensing fees, milestone payments, development fees, royalties and/or sales related to the use of our drug candidates or intellectual property for specific therapeutic indications or applications. As an example, we developed OX1, a small molecule multi-modal antioxidant, completed preclinical and human safety trials, and then licensed the program in 2011 to ViroPharma Inc. for development of a drug to treat Friedreich's Ataxia and other neurodegenerative diseases. We could receive up to $120 million in milestone payments from ViroPharma and significant royalties from sales if the resulting drug product is approved for sale by the US Food and Drug Administration (“FDA”). 

 

Our current business is focused on granting licenses to our patent estate to large pharmaceutical companies and on research and development of proprietary therapies for the treatment of proteinopathies through outsourcing and other arrangements with third parties. We expect research and development, including patent related costs, to continue to be the most significant expense of our business for the foreseeable future. Our research and development activity is subject to change as we develop a better understanding of our projects and their prospects. Total research and development costs from inception through June 30, 2013 were $14,655,089.

 

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Results of Operations

 

Year Ended June 30, 2013 Compared to the Year Ended June 30, 2012:

  

   Year Ended June 30, 
   2013   2012   Change 
Revenue   -    6,500,000    (6,500,000)
Research and Development Costs   222,300    996,225    773,925 
General and Administrative   4,125,386    5,219,993    1,094,607 
                
Income (loss) from operations  $(4,347,686)  $283,782   $(4,631,468)

 

   Nine Months Ended December 31, 
   2013   2012   Change 
Income (loss) from operations   (4,347,686)   283,782    (4,631,468)
Other income (expenses):   (4,707,824)   1,613,208    (6,321,032)
                
Net income (loss)  $(9,055,510)  $1,896,990   $(10,952,500)

 

Operating income decreased $4,631,468 to a loss of $4,347,686 for the year ended June 30, 2013 from income of $283,782 for the year ended June 30, 2012. Revenue decreased by $6,500,000 to $0 for the year ended June 30, 2013 as compared to $6,500,000 for the year ended June 30, 2012, which resulted from our granting of an exclusive license to ViroPharma related to certain of our licensed patents and patent applications related to OX1 in exchange for payment of a $6.5 million up front licensing fee.

 

Research and Development costs decreased by $773,925 from $996,225 for the year ended June 30, 2012 to $222,300 for the year ended June 30, 2013 primarily due to decreased R&D activities with respect to our clinical drug candidate OX1.

 

Our General and Administrative Expenses for the year ended June 30, 2013 were $4,125,386 compared to $5,219,993 for the year ended June 30, 2012.  The decrease of $1,094,607 primarily is the result of a decrease in fees for the year ended June 30, 2012 relating to intellectual property that we have licensed relating to our OX1 product development program $1.3 million in license fees paid, $907,000 in legal fees, $926,000 in miscellaneous and consulting fees as well as a decrease in personnel cost of $663,000 as all of our employees became consultants. These decreases were partially offset by a $2.7 million non-cash charge for the Series E preferred shares issued in the year ending June 30, 2013.

 

Other expenses net of other income increased by $6,321,032 to $4,707,824 for the year ended June 30, 2013 from income of $1,613,208 for the year ended June 30, 2012. Interest expense increased to $1,100,796, from $5,581,112 for the year ended June 30, 2012 to $6,681,908 for the year ended June 30, 2013. This is primarily due to three items, the Company recorded a charge to interest of $623,869 for the value of the conversion feature embedded in the convertible notes where the derivative exceeds the carrying value of the note, the Company issuing Series D and Series E Preferred shares and recording interest charges of $350,652 and $105,929, respectively, while the remainder of the increase is due to an increase in interest for convertible notes issued in the year ending June 30, 2013. The gain on the change in fair value of our derivative liabilities decreased $5,220,236 to $1,974,084 for the year ending June 30, 2013 as compared to a gain of $7,194,320 for the year ending June 30, 2012. The decrease in the gain on the change in the fair market value of our derivative instruments and preferred stock liability results from the recording of the fair value of warrants issued in our financing, and the preferred stock liability which is stated at fair value relating to our Series B Preferred Stock.

 

As a result of these items our net income decreased $9,767,499 to a loss of $7,870,509 for the year ended June 30, 2013 compared to a net income of $1,896,990 for the year ended June 30, 2012.

 

We have recorded a 100% valuation allowance against the deferred tax asset consisting of available net operating loss carry forwards and derivative liabilities and accordingly no income tax benefit was provided.

 

Impact of Inflation

 

The impact of inflation upon our revenue and income/(loss) from operations during each of the past two fiscal years has not been material to our financial position or results of operations for those years because we have no products for sale and do not maintain any inventories whose costs are affected by inflation.

 

Liquidity and Capital Resources

 

Since our inception in 2005, we have mainly generated losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future. As of June 30, 2013 and 2012, our deficit accumulated during the development stage was $83,891,966 and $74,136,456, respectively. Our income (loss) from operations for the years ended June 30, 2013 and 2012 was $(4,347,686) and 283,782, respectively.  Our cash used in operations was $1,130,669 and $83,018 for the years ended June 30, 2013 and 2012, respectively. Our capital deficiency was $13,548,426 and $11,079,928 as of June 30, 2013 and 2012, respectively.

 

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We have limited capital resources and operations since inception have been funded with the proceeds from equity and debt financings and license fee arrangements.  As of June 30, 2013, we had cash and cash equivalents of $5,138. We anticipate that our existing capital resources will enable us to continue operations for the next few months. If we fail to raise additional capital or obtain substantial cash inflows from existing or potential partners within the next few months, we may be forced to cease operations.

 

The audit report prepared by our independent registered public accounting firm relating to our consolidated financial statements for the year ended June 30, 2013 includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.

 

Off –Balance Sheet Arrangements

 

As of June 30, 2013, we had no material off-balance sheet arrangements other than obligations under various agreements as follows:

 

Under a License Agreement with NYU and a similar License Agreement with University of South Alabama Medical Science Foundation (“SAMSF”) related to our OX1 program, we are obligated to make future payments totaling approximately $1.5 million to each of NYU and SAMSF upon achievement of certain milestones based on phases of clinical development and approval of the FDA (or foreign equivalent) and also to pay each of NYU and SAMSF a royalty based on product sales by Intellect or royalty payments received by Intellect. In September 2011, we granted a sublicense of the License Agreements to ViroPharma pursuant to which we received a $6.5 million up-front licensing fee and are entitled to receive additional regulatory milestone payments based upon defined events in the United States and the European Union. Pursuant to the terms of the License Agreements, we paid SAMS and NYU $650,000 of the up-front licensing fee and are obligated to pay a portion of future payments we may receive from ViroPharma.

 

Mindset acquired from Mayo Foundation for Medical Education and Research (“Mayo”) a non-exclusive license to use certain transgenic mice as models for AD and is obligated to pay Mayo a royalty of 2.5% of any net revenue that Mindset receives from the sale or licensing of a drug product for AD in which the Mayo transgenic mice were used for research purposes. The Mayo transgenic mice were used by the SAMSF to conduct research with respect to OX1. Pursuant to the Assignment that we executed with the SAMSF, we agreed to assume Mindset’s obligations to pay royalties to Mayo. We have not received any net revenue that would trigger a payment obligation to Mayo.

 

Pursuant to a Letter Agreement with the Institute for the Study of Aging, we are obligated to pay a total of $225,500 of milestone payments contingent upon future clinical development of OX1. 

 

Under a Research Agreement with MRC Technology (“MRCT”), we are obligated to make future research milestone payments totaling approximately $560,000 to MRCT related to the development of the 82E1 humanized antibody and to pay additional milestones related to the commercialization, and a royalty based on sales, of the resulting drug products. MRCT has achieved their research milestones and we have included the total $560,000 in accrued expenses. On September 16, 2012 the Company issued to MRCT 11,200,000 warrants with an exercise price of $0.0625 in full consideration for the money owed to MRCT.

 

Under the terms of a Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement with Immuno-Biological Laboratories Co., Ltd (“IBL”), we agreed to pay IBL a total of $2,125,000 upon the achievement of certain milestones plus a specified royalty based on sales of any pharmaceutical product derived from the 82E1or 1A10 antibodies. We have paid $40,000 to date.

 

Under the terms of a Royalty Participation Agreement effective as of July 31, 2008, certain of our lenders are entitled to an aggregate share of 25% of future royalties that we receive from the license of our ANTISENILIN patent estate.

 

Under a License Agreement with Northwestern University (“NWU”) related to our TOC-01 program, we are obligated to make future payments totaling approximately $700,000 to NWU upon achievement of certain milestones based on phases of clinical development and also to pay NWU a royalty based on product sales.

 

Under the terms of a consulting agreement with a former member of our Board of Directors, we are obligated to pay $1,000,000 from revenue generated from product sales or licenses. We have paid $119,070 to date.

 

Under an Agreement with The Regents of The University of California, on behalf of its Irvine campus ("University") executed in April 2012, we are obligated to make future payments totaling approximately $176 thousand to the University as payment for research and development work to be conducted by the University related to our Anti-Amyloid RECALL-VAX vaccine, Anti-Tau RECALL-VAX vaccine and the combination of Anti-Beta Amyloid and Anti-Tau RECALL-VAX vaccine.

 

23
 

 

In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our product candidates, use of such product candidates, or other actions taken or omitted by us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we have no liabilities recorded for these provisions as of June 30, 2013 or 2012.

 

In the normal course of business, we may be confronted with issues or events that may result in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the United States, an estimate is made of the loss and the appropriate accounting entries are reflected in our consolidated financial statements. After consultation with legal counsel, we do not anticipate that liabilities arising out of currently pending or threatened lawsuits and claims will have a material adverse effect on our consolidated financial position, results of operations or cash flows.

 

Critical Accounting Estimates and New Accounting Pronouncements

 

Critical Accounting Estimates

 

The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made, and changes in the estimate or different estimates that could have been selected could have a material impact on our consolidated results of operations or financial condition.

 

Convertible Instruments We evaluate and account for conversion options embedded in convertible instruments in accordance with ASC 815 “Derivatives and Hedging Activities”. Applicable GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument.

 

We account for convertible instruments (when we have determined that the embedded conversion options should not be bifurcated from their host instruments) as follows: We record when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their stated date of redemption. We also record when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred shares.

 

Common Stock Purchase Warrants  We classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock as defined in ASC 815-40 ("Contracts in Entity's Own Equity"). We classify as assets or liabilities any contracts that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess classification of our common stock purchase warrants and other free standing derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required.

 

Preferred Stock. We apply the guidance enumerated in ASC 480 “Distinguishing Liabilities from Equity” when determining the classification and measurement of preferred stock. Preferred shares subject to mandatory redemption (if any) are classified as liability instruments and are measured at fair value. We classify conditionally redeemable preferred shares (if any), which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within our control, as temporary equity. At all other times, we classified our preferred shares in stockholders’ equity.

 

24
 

 

Derivative Instruments. Our derivative financial instruments consist of embedded derivatives related to the convertible debt, warrants and beneficial conversion features embedded within our convertible debt.  The accounting treatment of derivative financial instruments requires that we record the derivatives and related warrants at their fair values as of the inception date of the debt agreements and at fair value as of each subsequent balance sheet date.  Any change in fair value was recorded as non-operating, non-cash income or expense at each balance sheet date.  If the fair value of the derivatives was higher at the subsequent balance sheet date, we recorded a non-operating, non-cash charge.  If the fair value of the derivatives was lower at the subsequent balance sheet date, we recorded non-operating, non-cash income.

 

Research and Development Costs and Clinical Trial Expenses.  Research and development costs include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research, preclinical development, and clinical trials. All costs associated with research and development are expensed as incurred.

 

Revenue Recognition. We recognize revenue in accordance with authoritative accounting guidance, which provides that non-refundable upfront and research and development milestone payments and payments for services are recognized as revenue as the related services are performed over the term of the collaboration.

 

 New Accounting Pronouncements

 

In May 2011, the FASB issued ASU 2011-04, “Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRS” (“ASU 2011-04”). The amendments in ASU 2011-04 result in common fair value measurement and disclosure requirements in U.S. GAAP and IFRSs. Consequently, ASU 2011-04 changes the wording used to describe many of the requirements in U.S. GAAP for measuring fair value and for disclosing information about fair value measurements. For many of the requirements, the FASB does not intend for the amendments in ASU 2011-04 to result in a change in the application of the requirements in Topic 820. ASU 2011-04 is effective prospectively for interim and annual reporting periods beginning after December 15, 2011. This ASU will become effective for the company beginning in the quarter ended January 31, 2012 and we do not expect an impact on our consolidated financial statements.

 

In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. The guidance in ASU 2011-05 applies to both annual and interim financial statements and eliminates the option for reporting entities to present the components of other comprehensive income as part of the statement of changes in stockholders' equity. This ASU also requires consecutive presentation of the statement of net income and other comprehensive income. Finally, this ASU requires an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. The amendments in this ASU should be applied retrospectively and are effective for fiscal year, and interim periods within those years, beginning after December 15, 2011. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s financial position or results of operations.

 

ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Fair Value of Warrants and Derivative Liabilities.

 

As of June 30, 2013, the value of our warrant and derivative liability was $3.8 million. We estimate the fair value of these instruments using the Black-Scholes option pricing models, which takes into account a variety of factors, including historical stock price volatility, risk-free interest rates, remaining maturity and the closing price of our common stock. We believe that the change in value from period to period is most significantly impacted by the closing price of our common stock at each reporting period.

 

25
 

 

ITEM 8.     FINANCIAL STATEMENTS AND SUPPLEMENTARY DATE 

 

CONTENTS    
     
CONSOLIDATED FINANCIAL STATEMENTS   27
     
Report of Independent Registered Public Accounting Firm   28
     
Report of Independent Registered Public Accounting Firm   29
     
Consolidated Balance Sheets as of June 30, 2013 and 2012   30
     
Consolidated Statements of Operations for the years ended June 30, 2013, 2012 and for the period April 25, 2005 (inception) through June 30, 2013.   31
     
Consolidated Statements of Changes in Capital Deficiency for the years ended June 30, 2013 and 2012 and the period April 25, 2005 (inception) through June 30, 2013   32
     
Consolidated Statements of Cash Flows for the years ended June 30, 2013, 2012 and for the period April 25, 2005 (inception) through June 30, 2013.   34
     
Notes to the Consolidated Financial Statements   35

 

26
 

 

  Paritz & Company, P.A

15 Warren Street, Suite 25

Hackensack, New Jersey 07601

(201) 342-7753

Fax:  (201) 342-7598

www.paritz.com

       
  Certified Public Accountants

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

Board of Directors and Stockholders

Intellect Neurosciences, Inc.

 

We have audited the accompanying consolidated balance sheets of Intellect Neurosciences, Inc. and subsidiary (A Development Stage Company) (the “Company”) as of June 30, 2013 and 2012 and the related consolidated statements of operations, changes in capital deficiency and cash flows for the years then ended and the period from inception (April 25, 2005) to June 30, 2013. We did not audit the statements of operations, changes in capital deficiency and cash flows of the Company from inception (April 25, 2005) to June 30, 2008 (not presented separately herein).  Those statements were audited by other auditors whose report has been furnished to us, and our opinion insofar as it relates to amounts included for that period is based solely on the report of the other auditors. 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 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.  We were not engaged to perform an audit of the Company’s 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 consolidated financial statements referred to above present fairly, in all material respects, the financial position of Intellect Neurosciences, Inc. and subsidiary (A Development Stage Company) as of June 30, 2013 and 2012 and the results of its operations and its cash flows for the years then ended and the period from inception (April 25, 2005) to June 30, 2013 in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 1 to the consolidated financial statements, since inception in 2005, the Company has generated losses from operations. As of June 30, 2013, the Company had negative working capital of $12,321,404 and a deficit accumulated during the development stage of $83,891,966. The Company had an operating loss of $4,347,686 for the year ended June 30, 2013. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from this uncertainty.

 

Hackensack, New Jersey    

October 15, 2013

   

 

27
 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

Board of Directors and Stockholders

Intellect Neurosciences, Inc.

 

We have audited the consolidated statements of operations, changes in capital deficiency and cash flows of Intellect Neurosciences, Inc. and subsidiary (a development stage company) (the "Company") for the period from April 25, 2005 (inception) through June 30, 2008. The consolidated statement of operations and cash flows are not presented separately herein. These consolidated 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. We were not engaged to perform an audit of the Company's internal control over financial reporting. Our audits 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 enumerated above present fairly, in all material respects, the consolidated results of their operations and their consolidated cash flows for the period from April 25, 2005 (inception) through June 30, 2008 (not presented separately herein) in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has a negative working capital position, a total capital deficiency, generated cash outflows from operating activities, experienced recurring net operating losses, and is dependent on equity and debt financing to support its business efforts. These factors 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 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ EisnerAmper LLP

 

New York, New York

November 4, 2008, except for the effect of the reverse stock split discussed in Note 1, as to which the date is October 11, 2011

 

28
 

 

Intellect Neurosciences Inc. and Subsidiary

(a development stage company)

 

Consolidated Balance Sheets

 

   June 30, 2013   June 30, 2012 
        
ASSETS          
Current assets:          
Cash and cash equivalents  $5,138   $2,307 
Pre-paid expenses   -    19,585 
           
Total current assets   5,138    21,892 
           
Security deposits   4,715    4,715 
Total Assets  $9,853   $26,607 
           
           
LIABILITIES AND CAPITAL DEFICIENCY          
           
Current Liabilities:          
Accounts payable and accrued expenses  $2,487,410   $2,949,764 
Accrued interest - convertible promissory notes   482,298    201,997 
Derivative instruments   3,833,457    3,388,482 
Preferred stock liability   172,874    518,622 
Preferred stock dividend payable   5,350,503    3,605,515 
Total Current liabilities  $12,326,542   $10,664,380 
           
Long Term Debt          
Convertible promissory notes   1,231,737    442,155 
           
Total Liabilities  $13,558,279   $11,106,535 
           
Capital deficiency:          
           
Series B Convertible Preferred stock - 1,000,000 shares designated and 106,878 shares issued at September 30, 2011, and June 30, 2011 (classified as liability above) (liquidation preference $1,870,380)   -    - 
Series C Convertible Preferred stock, $.001 par value - 25,000 shares designated and 19,790 and 20,700 shares issued at June 30, 2013 and June 30, 2012 respectively (liquidation preference $19,790,000 and $20,700,000 respectively)  $20   $21 
Series D Convertible Preferred stock, $.001 par value - 25,000 shares designated and  5,466 and 0 shares issued at June 30, 2013 and June 30, 2012 respectively  (liquidation preference $5,466,000 and $0 respectively)   5    - 
Series E Convertible Preferred stock, $.001 par value - 25,000 shares designated and  2,000 and 0 shares issued at June 30, 2013 and June 30, 2012 respectively          
(liquidation preference $2,000,000 and $0 respectively)   2    - 
Common stock, par value $0.001 per share, 2,000,000,000 shares authorized; 209,015,899 and 100,240,020 issued and outstanding at June 30, 2013, and June 30, 2012, respectively   209,016    100,240 
Additional paid in capital   70,134,497    62,956,267 
Deficit accumulated during the development stage   (83,891,966)   (74,136,456)
           
Total Capital Deficiency  $(13,548,426)  $(11,079,928)
           
Total Liabilities and Capital Deficiency  $9,853   $26,607 

 

See notes to consolidated financial statements

 

29
 

 

Intellect Neurosciences Inc. and Subsidiary

(a development stage company)

 

Consolidated Statements of Operations

 

   Year Ended   April 25, 2005 
   June 30,   (inception) through 
   2013   2012   June 30, 2013 
              
Revenues:               
License fees  $-   $6,500,000   $10,516,667 
Total revenue  $-   $6,500,000   $10,516,667 
                
Costs and Expenses:               
Research and development   222,300    996,225    14,655,089 
General and administrative   4,125,386    5,219,993    45,355,185 
Total cost and expenses   4,347,686    6,216,218    60,010,274 
                
Income (loss) from operations   (4,347,686)   283,782    (49,493,607)
                
Other income/(expenses):               
                
Interest expense   (6,681,908)   (5,581,112)   (69,934,864)
Interest income             18,525 
Changes in value of derivative instruments and preferred stock liability   1,974,084    7,194,320    44,533,393 
Gain (Loss) on extinguishment of debt   -    -    (627,809)
Other   -    -    (6,587,604)
Write off of investment   -    -    (150,000)
                
Total other income/(expense):   (4,707,824)   1,613,208    (32,748,359)
                
Net income/(loss)   (9,055,510)   1,896,990    (82,241,966)
                
Deemed preferred stock dividend   700,000    -    1,650,000 
                
Net income (loss) allocable to common shareholders  $(9,755,510)  $1,896,990   $(83,891,966)
                
Basic income per share  $(0.07)  $0.02      
                
Diluted income per share  $(0.07)  $0.00      
                
Weighted average number of shares outstanding:               
                
Basic   136,468,981    81,002,258      
                
Diluted   136,468,981    647,670,189      

 

See notes to consolidated financial statements

 

30
 

 

Consolidated Statement of Changes in Capital Deficiency

  

   Common Stock   Series C Preferred Stock   Series D Preferred Stock   Series E Preferred Stock             
   Number of Shares   Amount   Number of
Shares
   Amount   Number of
Shares
   Amount   Number of
Shares
   Amount   Additional paid in
capital
   Deficit accumulated
during the
development stage
   Total 
                                             
Issuance of common stock (April 2005) ($.001 per share)     241,565     $ 242                                                     $ 11,836             $ 12,078  
                                                                                         
Issuance of common stock (May 2005) ($.001 per share)     183,505       184                                                       8,991               9,175  
                                                                                         
Value of warrants issued to Goulston & Storrs (June 2005)             -                                                         8,890               8,890  
                                                                                         
Net loss for period                                                                             (789,177 )     (789,177 )
                                                                                         
Balance at June 30, 2005     425,070       426       -       $ -         -       $ -         -       $ -         29,717       (789,177 )     (759,034 )
                                                                                         
Issuance of Series A preferred stock (January 2006) ($.001 per share)             -                                                         198,866               198,866  
                                                                                         
Exercise of Warrant (April 2006) ($.001 per share)     2,000       2                                                       98               100  
                                                                                         
Excess of proceeds over fair value of Series B preferred             -                                                         4,543,141               4,543,141  
                                                                                         
Net loss for the period                                                                             (7,458,092 )     (7,458,092 )
                                                                                         
Balance at June 30, 2006     427,070       428       -       $ -         -       $ -         -       $ -         4,771,822       (8,247,269 )     (3,475,019 )
                                                                                         
Excess of proceeds over fair value of Series B preferred             -                                                         314,845               314,845  
                                                                                         
Conversion of Series B preferred shares into common shares upon merger (January 2007)     91,862       92                                                       3,114,023               3,114,115  
                                                                                         
Conversion of Series A preferred shares into common shares upon merger (January 2007)     2,577       3                                                       (1 )             2  
                                                                                         
Series B preferred dividend recorded as a capital contribution (January 2007)             -                                                         387,104               387,104  
                                                                                         
Shares issued in conjunction with merger (January 2007)     180,000       180                                                       7,019,820               7,020,000  
                                                                                         
Reconversion of common shares back to Series B preferred shares (May 2007)     (91,862 )     (92 )                                                     (3,114,023 )             (3,114,115 )
                                                                                         
Stock based compensation                                                                                        
- Clinical and Advisory Board             -                                                         321,634               321,634  
- Employees and Directors             -                                                         462,156               462,156  
- Executives             -                                                         7,173,547               7,173,547  
                                                                                         
Net loss for the period                                                                             (55,400,890 )     (55,400,890 )
                                                                                         
Balance as of June 30, 2007     609,647     $ 611       -       $ -         -       $ -         -       $ -       $ 20,450,927     $ (63,648,159 )   $ (43,196,621 )
                                                                                         
Shares issued as part of convertible promissory notes extension agreement (July 2007)     6,230       6                                                       622,348               622,354  
                                                                                         
Shares issued upon conversion of convertible promissory notes and accrued interest (July 2007)     365       -                                                         31,733               31,733  
                                                                                         
Shares issued as part of convertible promissory notes extension agreement (November 2007)     600       1                                                       11,099               11,100  
                                                                                         
Shares issued as part of a consulting agreement (December 2007)     1,000       1                                                       119,999               120,000  
                                                                                         
Shares exchanged as part of convertible promissory notes extension agreement (February 2008)     (600 )     (1 )                                                     (23,399 )             (23,400 )
                                                                                         
Shares reissued for issuance of convertible promissory note     (365 )     -                                                         (31,733 )             (31,733 )
                                                                                         
Stock based compensation                                                                                        
- Clinical and Advisory Board             -                                                         130,660               130,660  
- Employees and Directors             -                                                         736,370               736,370  
                                                                                         
Net income for the period                                                                             19,625,103       19,625,103  
                                                                                         
Balance as of June 30, 2008     616,877     $ 618       -       $ -         -       $ -         -       $ -       $ 22,048,004     $ (44,023,056 )   $ (21,974,434 )
                                                                                         
 Stock based compensation             -                                                         470,807               470,807  
                                                                                         
Net income for the period                                                                             1,846,763       1,846,763  
                                                                                         
Balance as of June 30, 2009     616,877     $ 618     $ -       $ -         -       $ -         -       $ -       $ 22,518,811     $ (42,176,293 )   $ (19,656,864 )
                                                                                         
 Stock based compensation             -                                                         22,771               22,771  
                                                                                         
Sale of investment units     1,160,000       1,160                                                       1,738,840               1,740,000  
Conversion of promissory notes and interest into common stock     4,261,194       4,261                                                       8,063,611               8,067,872  
Conversion of royality notes and interest into common stock     2,865,374       2,865                                                       6,788,192               6,791,057  
Conversion of preferred stock and interest into common stock     4,138,935       4,139                                                       2,012,371               2,016,510  
Shares issued as part of consulting on the financing transaction agreement (April 2010)     946,000       946                                                       (946 )             -    
Warrants issued in Financing Transaction     -         -                                                         (5,570,897 )             (5,570,897 )
Shares issued as part of a consulting agreement     381,583       382                                                       2,625,618               2,626,000  
Shares issued as a part of claim settlement     77,403       77                                                       425,638               425,715  
Shares issued to an officer     50,000       50                                                       399,950               400,000  
Shares issued in settlement of prior debt     21,000       21                                                       247,979               248,000  
Cashless exercise of Warrants     1,765,240       1,765                                                       15,623,676               15,625,441  
                                                                                         
Net loss for the period                                                                             (33,047,726 )     (33,047,726 )
                                                                                         
Balance as of June 30, 2010     16,283,606     $ 16,284       -     $ -       -     $ -       -     $ -     $ 54,895,614     $ (75,224,019 )   $ (20,312,120 )
                                                                                         
Stock based compensation     1,345,119       1,345                                                       240,624               241,969  
                                                                                         
Conversion of promissory notes and interest into common stock     6,751,747       6,752                                                       1,395,055               1,401,807  
                                                                                         
Cashless exercise of Warrants     32,570,671       32,570                                                       2,629,659               2,662,229  
                                                                                         
Exercise of Warrants for Cash     4,000,000       4,000                                                       513,584               517,584  
                                                                                         
Issuance of preferred stock                     22,000       22                                       2,185,362               2,185,384  
                                                                                         
Conversion of preferred stock and interest into common stock     5,800,000       5,800                                                       743,700               749,500  
                                                                                         
Deemed preferred stock dividend                                                                             (950,000 )     (950,000 )
                                                                                         
Net income for the period                                                                             140,573       140,573  
                                                                                         
Balance as of June 30, 2011 restated     66,751,143     $ 66,751       22,000     $ 22       -     $ -       -     $ -     $ 62,603,599     $ (76,033,446 )   $ (13,363,074 )
                                                                                         
Stock based compensation     3,545,000       3,545                                                       158,061               161,606  
                                                                                         
Conversion of promissory notes and interest into common stock     500,000       500       -       -                                       24,500               25,000  
                                                                                      -  
Cashless exercise of Warrants     3,443,877       3,444                                                       140,630               144,074  
                                                                                      -  
Conversion of preferred stock into common stock     26,000,000       26,000       (1,300 )     (1 )                                     29,477               55,476  
                                                                                      -  
Net income for the period                                                                             1,896,990       1,896,990  
                                                                                         
Balance as of June 30, 2012     100,240,020     $ 100,240       20,700     $ 21       -     $ -       -     $ -     $ 62,956,267     $ (74,136,456 )   $ (11,079,928 )
                                                                                         
Stock based compensation     17,250,000       17,250                                                       175,250               192,500  
                                                                                         
Conversion of accrued Series C interest to Series C shares                     840       1                                       839,999               840,000  
                                                                                      -  
Cashless exercise of Warrants     29,525,879       29,526                                                       382,089               411,615  
                                                                                         
Issuance of Series D preferred stock                                     6,716       7                       2,442,890               2,442,897  
                                                                                         
Issuance of Series E preferred stock                                                     2,000       2       2,699,998               2,700,000  
                                                                                         
Conversion of Series C preferred stock into common stock     37,000,000       37,000       (1,750 )     (2 )                                     (36,998 )             -  
                                                                                         
Conversion of Series D preferred stock into common stock     25,000,000       25,000                       (1,250 )     (2 )                     (24,998 )             -  
                                                                                         
Deemed preferred stock dividend                                                                     700,000               700,000  
                                                                                         
Net loss for the period                                                                             (9,755,510 )     (9,755,510 )
                                                                                         
Balance as of June 30, 2013     209,015,899     $ 209,016       19,790     $ 20       5,466     $ 5       2,000     $ 2     $ 70,134,497     $ (83,891,966 )   $ (13,548,426 )

 

See notes to consolidated financial statements

 

31
 

 

Intellect Neurosciences Inc. and Subsidiary

(a development stage company)

 

Consolidated Statements of Cash Flows

 

       April 25, 2005 
   Year Ended   (inception) 
   June 30,   through June 30, 
   2013   2012   2013 
            
Cashflows from operating activities:               
                
Net income (loss)  $(9,755,510)  $1,896,990   $(83,891,966)
Adjustments to reconcile net income (loss) to net cash used in operating activities:               
Depreciation and amortization   -         836,769 
Amortization of financing costs   -         2,403,966 
Change in unrealized gain of derivative instruments   (1,974,084)   (7,194,320)   (43,831,532)
Stock and warrant based compensation   3,799,786    161,606    18,087,586 
Interest expense related to warrants   3,029,911    2,376,123    44,419,043 
Write-off of investment   -    -    150,000 
Shares issued in connection with merger   -    -    7,020,000 
Shares issued for note extensions and compensation   -    -    753,453 
Conversion of common stock to new Series B preferred shares   -    -    6,606,532 
Non-cash interest expense   3,651,997    3,203,958    20,114,258 
Non-cash expense related to Series B dividends   -    -    1,802,611 
Disposition of fixed assets   -    -    43,412 
Loss on sale of fixed assets   -    -    179,516 
Loss on extinguishment of debt   -    -    (74,060)
                
Changes in:             - 
Prepaid expenses and other assets   19,585    (20,385)   (898)
License fee receivable   -    -    (6,963)
Accounts payable and accrued expenses   97,646    (435,838)   3,439,494 
Accrued interest        (71,152)   - 
Deferred lease liability   -    -    - 
Other long term liabilities   -    -    (71,152)
                
Net cash used in operating activities:   (1,130,669)   (83,018)   (22,019,932)
                
Cashflows from investing activities:               
Security deposit   -    -    (3,912)
Acquisition of property and equipment   -    -    (1,059,699)
Restricted cash   -    -    - 
Cash paid for acquisition   -    -    (150,000)
                
Net cash used in investing activities:   -    -    (1,213,611)
                
Cashflows from financing activities:               
Borrowings from stockholders   -    -    6,153,828 
Proceeds from sale of common stock   -    -    1,761,353 
Proceeds from sale of preferred stock   -    -    7,711,150 
Preferred stock issuance costs   -    -    (814,550)
Proceeds from sale of Convertible Promissory Notes   1,166,000    351,500    12,124,000 
Repayment of borrowings from stockholder   -    -    (1,706,000)
Convertible Promissory Notes issuance cost   -    -    (466,100)
Repayment of borrowings from noteholders   (32,500)   (367,500)   (1,725,000)
Proceeds from excersise of stock warrants   -    -    200,000 
                
Net cash provided by (used in) financing activities:   1,133,500    (16,000)   23,238,681 
                
Net increase (decrease) in cash and cash equivalents   2,831    (99,018)   5,138 
                
Cash and cash equivalents beginning of period   2,307    101,325      
                
Cash and cash equivalents end of period  $5,138   $2,307   $5,138 
                
Supplemental disclosure of cash flow informations:               
Cash paid during the period for:               
Interest   -    73,378   $145,115 
Non-cash investing and financing transactions:               
Conversion of Convertible Notes payable and accrued interest into Common Stock (including derivative liability)   -    25,000   $16,285,736 
Conversion of Preferred Stock to Common Stock   62,000    55,476    6,860,451 
Common Stock issued in repayment of debt   -    -    248,000 
Accrued dividend on Series B prefs treated as capital contribution   -    -    387,104 
Cashless excersise of Warrant for Common Stock   411,615    144,074    18,843,360 
Debt discount from warrants and beneficial conversion feature   890,697    351,500    1,542,197 
Deemed preferred stock dividend from beneficial conversion feature   700,000    -    1,650,000 
Issuance of warrants for repayment of accrued expenses   560,000    144,085    704,085 

 

See notes to consolidated financial statements

 

32
 

 

Note 1. Business Description and Going Concern

 

Intellect Neurosciences, Inc., a Delaware corporation, (“Intellect”, “our”, “us”, “we” or the “Company” refer to Intellect Neurosciences, Inc. and its subsidiaries) is a biopharmaceutical company, which together with its subsidiary, Intellect Neurosciences, USA, Inc. (“Intellect USA”), is engaged in the discovery and development of disease-modifying therapeutic agents for the treatment and prevention of neurodegenerative conditions, collectively known as proteinopathies, which include Alzheimer’s (“AD”), Parkinson’s and Huntington disease. Since our inception in 2005, we have devoted substantially all of our efforts and resources to research and development activities and advancing our patent estate. We operate under a single segment.   We have had no product sales from inception but we have received $10,516,667 in license fees from inception through June 30, 2013. Our losses from operations have been funded primarily with the proceeds of equity and debt financings and fees from license arrangements.

 

We are a development stage company and our core business strategy is to build a portfolio of compounds with the potential to treat or prevent neurodegenerative diseases, develop each to pre-determined milestones, and license them to pharmaceutical companies for advanced development and commercialization. To supplement our own work, we intend to license promising novel technologies and early stage compounds from academia and other biotechnology companies. We intend to obtain revenues from licensing fees, milestone payments, development fees, royalties and/or sales related to the use of our drug candidates or intellectual property for specific therapeutic indications or applications.

 

As of June 30, 2013, we had no self-developed or licensed products approved for sale by the U.S. Food and Drug Administration (“FDA”). There can be no assurance that our research and development efforts will be successful, that any products developed by any of our licensees will obtain necessary government regulatory approval or that any approved products will be commercially viable. In addition, we operate in an environment of rapid change in technology and are dependent upon the continued services of our current employees, consultants and subcontractors.

 

One of our key assets is our ANTISENILIN patent estate.  We have entered into two license agreements and one option agreement with major global pharmaceutical companies with respect to this patent estate. In addition, we have licensed OX1to ViroPharma Inc. (“ViroPharma”) who intend to develop and commercialize OX1 as a treatment for Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation

 

Our proprietary pipeline includes:

 

OX1 – Licensed to ViroPharma, Inc.

 

OX1 is an orally-administered, brain-penetrating, naturally-occurring copper-binding small molecule, which has the potential to treat various neurodegenerative diseases such as Friedreich's Ataxia, Parkinson’s and Wilson’s disease. OX1 was tested in human Phase I safety clinical trials involving 90 healthy elderly volunteers and was found to be well tolerated, even at high pharmacological doses. Our rights in the intellectual property underlying OX1 are licensed from New York University (“NYU”) and the University of South Alabama Medical Science Foundation (“SAMSF”).

 

In September 2011, we granted an exclusive license to ViroPharma Incorporated (“ViroPharma”) regarding certain of our licensed patents and patent applications related to OX1. (See Material Agreements below.) ViroPharma expects to develop and commercialize OX1 as a treatment of Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation. Friedreich's Ataxia is an inherited disease that causes progressive damage to the nervous system, resulting in symptoms ranging from gait disturbance to speech problems; it can also lead to heart disease and diabetes.

 

CONJUMAB: NO1-OX2

 

N01-OX2 is a first-in-class antibody drug conjugate for treatment of proteinopathies. It is a humanized monoclonal antibody specific for beta amyloid protein that has been empowered to deliver on-site neuroprotection by its conjugation to melatonin. Melatonin is a potent free radical scavenger and is recognized as an inhibitor of beta amyloid aggregation. N01-OX2 is designed to reduce oxidative stress and promote clearance of beta amyloid, which are central to cellular inflammation and damage. N01-OX2 utilizes a mouse antibody that we acquired from Immuno-Biological Laboratories Co., Ltd. (“IBL”), which was humanized by MRCT.

 

OLIGOTOPE: TOC-01

 

TOC -01 is a murine monoclonal antibody selective for tau oligomers. We plan to test TOC-01 as a potential therapeutic for Alzheimer’s disease and other tauopathies. The OLIOGOTOPE platform consists of protein oligomer selective antibodies and methods of making them using chemically cross-linked stabilized aggregates as antigens. Our rights in the intellectual property underlying TOC-01 are licensed from Northwestern University (“NWU”).

 

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RECALL VAX: RV03

 

RV03 is a first-in-class bi-specific vaccine targeting both beta amyloid and delta tau. Delta tau is a shorter form of the tau protein. It is especially toxic to nerve cells and precedes the formation of neurofibrillary tangles. RV03 has potential for the treatment of Alzheimer’s disease and Frontotemporal dementias. The RECALL-VAX technology, invented by Dr. Benjamin Chain, Ph.D., (brother of Daniel Chain, our Chief Executive Officer and Chairman), has been assigned to us.

 

These consolidated financial statements are presented on the basis that we will continue as a going concern.  The going concern concept contemplates the realization of assets and satisfaction of liabilities in the normal course of business.  Since our inception in 2005, we have generated losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future. As of June 30, 2013, we had negative working capital of $12,321,404 and our deficit accumulated during the development stage was $83,891,966. We have primarily generated a loss from operations, the Company had an operating loss of $4,347,686 for the for the year ended June 30, 2013 compared to operating income for the year ended June 30, 2012 of $283,782.  Our cash used in operations was $1,130,669 and $83,018 for the years ended June 30, 2013 and 2012, respectively. Our capital deficiency was $13,548,426 and $11,079,928 as of June 30, 2013 and 2012, respectively. 

 

We have limited capital resources and operations since inception have been funded with the proceeds from equity and debt financings and license fee arrangements.  As of June 30, 2013, we had cash and cash equivalents of $5,138.  In September 2011, we granted an exclusive license to ViroPharma regarding certain of our licensed patents and patent applications related to OX1 in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union.

 

We anticipate that our existing capital resources will enable us to continue operations for the next two months. If we fail to raise additional capital or obtain substantial cash inflows from existing or potential partners within the next month, we may be forced to cease operations. We cannot assure you that financing will be available in a timely manner, on favorable terms or at all. 

 

On April 12, 2011, we completed a 50 to1 reverse stock split. The accompanying financial statements and notes to the financial statements presented herein give retroactive effect to the reverse split for all periods presented.

 

Note 2. Summary of Significant Accounting Policies

 

Principles of Consolidation. The consolidated financial statements include the accounts of our wholly owned subsidiary, Intellect Israel, and the accounts of Mindgenix, Inc. (“Mindgenix”), a wholly-owned subsidiary of Mindset Biopharmaceuticals, Inc. (“Mindset”). We consolidate Mindgenix because we have agreed to absorb certain costs and expenses incurred by Mindgenix that are attributable to its research. Dr. Chain, our CEO, is a controlling shareholder of Mindset and the President of Mindgenix. All inter-company transactions and balances have been eliminated in consolidation.

 

Use of Estimates. The preparation of consolidated financial statements in accordance with accounting principles generally accepted in the United States involves the use of estimates and assumptions that affect the recorded amounts of assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.  Significant estimates include the fair value of derivative instruments, including stock options and warrants to purchase our common stock, recognition of clinical trial costs, certain consulting expenses and deferred taxes.  Actual results may differ substantially from these estimates.

 

Stock-Based Compensation. We recognize compensation expense for stock-based compensation in accordance with ASC Topic 718. For employee stock-based awards, we calculate the fair value of the award on the date of grant using the Black-Scholes method for stock options and the quoted price of our common stock for unrestricted shares; the expense is recognized over the service period for awards expected to vest. For non-employee stock-based awards, we calculate the fair value of the award on the date of grant in the same manner as employee awards, however, the awards are revalued at the end of each reporting period and the pro rata compensation expense is adjusted accordingly until such time the nonemployee award is fully vested, at which time the total compensation recognized to date equals the fair value of the stock-based award as calculated on the measurement date, which is the date at which the award recipient’s performance is complete. The estimation of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised. We consider many factors when estimating expected forfeitures, including types of awards, employee class, and historical experience.

 

Research and Development Costs and Clinical Trial Expenses.  Research and development costs include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research, preclinical development, and clinical trials. All costs associated with research and development are expensed as incurred.

 

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Revenue Recognition. We recognize revenue in accordance with authoritative accounting guidance, which provides that non-refundable upfront and research and development milestone payments and payments for services are recognized as revenue as the related services are performed over the term of the collaboration.

 

Convertible Instruments We evaluate and account for conversion options embedded in convertible instruments in accordance with ASC 815 “Derivatives and Hedging Activities”. Applicable GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument.

 

We account for convertible instruments (when we have determined that the embedded conversion options should not be bifurcated from their host instruments) as follows: We record when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their stated date of redemption. We also record when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred shares.

 

Common Stock Purchase Warrants  We classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock as defined in ASC 815-40 ("Contracts in Entity's Own Equity"). We classify as assets or liabilities any contracts that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess classification of our common stock purchase warrants and other free standing derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required.

 

Preferred Stock. We apply the guidance enumerated in ASC 480 “Distinguishing Liabilities from Equity” when determining the classification and measurement of preferred stock. Preferred shares subject to mandatory redemption (if any) are classified as liability instruments and are measured at fair value. We classify conditionally redeemable preferred shares (if any), which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within our control, as temporary equity. At all other times, we classified our preferred shares in stockholders’ equity.

 

Derivative Instruments. Our derivative financial instruments consist of embedded derivatives related to the convertible debt, warrants and beneficial conversion features embedded within our convertible debt.  The accounting treatment of derivative financial instruments requires that we record the derivatives and related warrants at their fair values as of the inception date of the debt agreements and at fair value as of each subsequent balance sheet date.  Any change in fair value was recorded as non-operating, non-cash income or expense at each balance sheet date.  If the fair value of the derivatives was higher at the subsequent balance sheet date, we recorded a non-operating, non-cash charge.  If the fair value of the derivatives was lower at the subsequent balance sheet date, we recorded non-operating, non-cash income.

 

During the years ended June 30, 2013 and 2012, we recognized other income of approximately $2.5 million and $7.2 million, respectively, relating to recording the derivative liabilities at fair value.  At June 30, 2013 and 2012 there were approximately $2.6 million and $3.4 million of derivative liabilities.

 

Our derivative instruments were valued using the Black-Scholes option pricing model, using the following assumptions during the year ended June 30, 2013:

 

Estimated dividends   None  
Expected volatility   331%  
Risk-free interest rate   1.45%  
Expected term (years)   1.0 - 5.0 years  

 

Fair value of financial instruments.  We adopted the provisions of ASC Topic 820, “Fair Value Measurements and Disclosures”, which  defines fair value as used in numerous accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.

 

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The estimated fair value of certain financial instruments, including cash and cash equivalents, accounts payable and accrued expenses are carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include contractual interest rates taken together with other features such as concurrent issuances of warrants and/or embedded conversion options, are comparable to rates of returns for instruments of similar credit risk.

 

ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

 

Level 1 — quoted prices in active markets for identical assets or liabilities

 

Level 2 — quoted prices for similar assets and liabilities in active markets or inputs that are observable

 

Level 3 — inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

 

We measure derivative liabilities at fair value using the Black-Scholes option pricing model with assumptions that include the fair value of the stock underlying the derivative instrument, the exercise or conversion price of the derivative instrument, the risk free interest rate for a term comparable to the term of the derivative instrument and the volatility rate and dividend yield for our common stock. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant. The Company has not paid dividends to date and does not expect to pay dividends in the foreseeable future due to its substantial accumulated deficit. Accordingly, expected dividends yields are currently zero. Expected volatility is based principally on an analysis of historical volatilities of similarly situated companies in the marketplace for a number of periods that is at least equal to the contractual term or estimated life of the applicable financial instrument.

 

We also considered the use of the lattice or binomial models with respect to valuing derivative financial instruments that feature anti-dilution price protection; however, the differences in the results are insignificant due to the low probability of triggering price adjustments in such financial instruments.

 

Income taxes. We use the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under this method, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences of temporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported if, based on the weight of the available positive and negative evidence, it is more likely than not some portion or all of the deferred tax assets will not be realized.

 

ASC Topic 740.10.30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic 740.10.40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. We have no material uncertain tax positions for any of the reporting periods presented.

 

Net Loss Per Share.  Basic net income or basic net loss per common share is computed by dividing net income available to common shareholders by the weighted average number of common shares outstanding during the periods. Diluted earnings per share give effect to dilutive options, warrants, convertible debt and other potential common stock outstanding during the period. Therefore, in the case of a net loss the impact of the potential common stock resulting from warrants, outstanding stock options, convertible debt, and convertible preferred stock are not included in the computation of diluted loss per share, as the effect would be anti-dilutive. In the case of net income the impact of the potential common stock resulting from these instruments that have intrinsic value are included in the diluted earnings per share. The table sets forth the number of potential shares of common stock that have been excluded from diluted net loss per share.

 

 New Accounting Pronouncements

 

In May 2011, the FASB issued ASU 2011-04, “Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRS” (“ASU 2011-04”). The amendments in ASU 2011-04 result in common fair value measurement and disclosure requirements in U.S. GAAP and IFRSs. Consequently, ASU 2011-04 changes the wording used to describe many of the requirements in U.S. GAAP for measuring fair value and for disclosing information about fair value measurements. For many of the requirements, the FASB does not intend for the amendments in ASU 2011-04 to result in a change in the application of the requirements in Topic 820. ASU 2011-04 is effective prospectively for interim and annual reporting periods beginning after December 15, 2011. This ASU will become effective for the company beginning in the quarter ended January 31, 2012 and we do not expect an impact on our consolidated financial statements

 

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In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. The guidance in ASU 2011-05 applies to both annual and interim financial statements and eliminates the option for reporting entities to present the components of other comprehensive income as part of the statement of changes in stockholders' equity. This ASU also requires consecutive presentation of the statement of net income and other comprehensive income. Finally, this ASU requires an entity to present reclassification adjustments on the face of the financial statements from other comprehensive income to net income. The amendments in this ASU should be applied retrospectively and are effective for fiscal year, and interim periods within those years, beginning after December 15, 2011. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on the Company’s financial position or results of operations.

 

Note 3.  Material Agreements

 

 Mindset Asset Transfer Agreement. The majority of Intellect’s assets were acquired in 2005 from Mindset Biopharmaceuticals, Inc., which we refer to as “Mindset”. Dr. Daniel Chain, our Chairman and Chief Executive Officer, founded Mindset and remains a significant stockholder of Mindset. He had previously served as Mindset’s Chairman and Chief Executive Officer, and currently serves as its President. Dr. Chain spends approximately 5% of his time on matters relating to Mindset. Mindset is not involved in any business that competes, directly or indirectly, with the business of Intellect. Mindset’s current business plan is to leverage its intellectual property estate through licenses and other arrangements and to provide transgenic mice for Alzheimer’s disease research through its existing subsidiary, Mindgenix, Inc.

 

Research and License Agreements (“RLAs”) with South Alabama Medical Science Foundation (“SAMS”) and New York University (“NYU”). Effective August 1998, and as amended, Mindset entered into RLAs with SAMS and NYU.  In June 2005, SAMS and NYU consented to Mindset's assignment of the RLAs to us.  Under the RLAs, we have an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, under certain patents and know-how relating to the use of indole-3-propionic acid among other things, to prevent Alzheimer’s Disease (“AD”). We are obligated to make future payments to SAMS and NYU totaling approximately $3,000,000 upon achievement of certain milestones based on phases of clinical development and approval of the FDA (or foreign equivalent) and also to pay SAMS and NYU royalties on net sales (as defined) attributable to each product utilizing the licensed technology. In September 2011, we granted a sublicense of the RLAs to ViroPharma pursuant to which we received a $6.5 million up-front licensing fee and are entitled to receive additional regulatory milestone payments based upon defined events in the United States and the European Union. Pursuant to the terms of the RLAs, we have paid each of SAMS and NYU $650,000 of the up-font licensing fee and are required to pay a portion of future payments we may receive from ViroPharma. (See ViroPharma License Agreement below.)

 

Chimeric Peptide Assignment Agreement. Effective as of June 6, 2000, Dr. Benjamin Chain assigned to Mindset all of his right, title and interest in certain of his inventions and patent applications related to the use of chimeric peptides for the treatment of AD. Dr. Benjamin Chain is the brother of our Chairman and Chief Executive Officer.  In exchange for such assignment, Mindset agreed to pay a royalty to Dr. Benjamin Chain equal to 1.5% of net sales of any drug products sold or licensed by Mindset utilizing the chimeric peptide technology. We acquired these inventions and patent applications and are obligated to make royalty payments to Dr. Benjamin Chain upon successful development of a drug utilizing this chimeric peptide technology. We have yet to develop any drug product that would trigger our obligation to make future payments to Dr. Benjamin Chain.

 

Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement. Under the terms of a Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement (the "IBL Agreement") with Immuno-Biological Laboratories Co., Ltd. ("IBL"), we acquired two beta amyloid specific monoclonal antibodies ready for humanization, and the IBL patents or applications relating to them.  In consideration, we agreed to pay IBL a total of $2,125,000 upon the achievement of certain milestones plus a specified royalty based on sales of any pharmaceutical product derived from the antibodies. Also, we granted to IBL a worldwide, exclusive, paid-up license under certain of our granted patents and pending applications in Japan. The IBL Agreement expires upon the last to expire of the relevant Intellect patents, unless earlier terminated as the result of a material breach by or certain bankruptcy related events of either party to the agreement.

 

Research Collaboration Agreement with MRC Technology (“MRCT”). We entered into a Research Collaboration Agreement with MRCT pursuant to which MRCT agreed to conduct a project to humanize one of our beta-amyloid specific, monoclonal antibodies for the treatment of AD. We are obligated to pay MRCT a total of $200,000 of up-front fees and $560,000 of research milestone payments related to the development of the humanized antibody and additional commercialization milestones and sales based royalties related to the resulting drug products. Under the agreement as amended, we may deliver warrants to purchase our common stock as payment for the $560,000 in research milestones under certain circumstances related to our future financing activities. Three of the five research milestones have been achieved and as a result, a liability of $350,000 reflecting research milestone payment obligations outstanding is included in Accounts Payable and Accrued Expenses. No additional work was performed and no additional liabilities were incurred during the fiscal year ended June 30, 2013. On September 16, 2012 the Company issued to MRCT 11,200,000 warrants with an exercise price of $0.0625 in full consideration for the money owed to MRCT.

 

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Élan Pharma International Limited and Wyeth License Agreement. In May 2008, we entered into a License Agreement with AHP Manufacturing BV, acting through its Wyeth Medica Ireland Branch, (“Wyeth”) and Elan Pharma International Limited (“Elan”) to provide Wyeth and Elan (collectively, the “Licensees”) with certain license rights under certain of our patents and patent applications (the “Licensed Patents”) relating to certain antibodies that may serve as potential therapeutic products for the treatment for AD (the “Licensed Products”).

 

We granted the Licensees a non-exclusive license under the Licensed Patents to research, develop, manufacture and commercialize Licensed Products. We received an upfront payment of $1 million in May 2008 and an additional $1 million in August 2008. We are eligible to receive certain milestones and royalties based on sale of Licensed Products.

 

The Licensees have an option to receive ownership of the Licensed Patents if at any time during the term we abandon all activities related to research, development and commercialization of our products that are covered by the Licensed Patents and no other licenses granted by us under the Licensed Patents remain in force. Failure to incur $50,000 in patent or program research related expenses during any six month period is considered to be abandonment. We initially recorded the up-front payment of $1 million that we received from the Licensees in May 2008 as a deferred credit, representing our obligation to fund such future patent or program research related expenses, and we recorded periodic amortization expense related to the deferred credit based on the remaining life of the License. As described more fully below, we granted a license under the Licensed Patents to another pharmaceutical company in December 2008 and reclassified the balance of the deferred credit as revenue because the grant of the second license removed the requirement contained in the abandonment clause in this Agreement. We accounted for the payment received in August 2008 as revenue in the period of receipt.

 

ANTISENILIN Option and License Agreement. In October 2008, we entered into an Option Agreement with a global pharmaceutical company (“Option Holder”) regarding an option to obtain a license under certain of our patents and patent applications (the “Subject Patents”) related to antibodies and methods of treatment for AD and to make, have made, use, sell, offer to sell and import certain Licensed Products, as defined in this agreement.

 

We granted the Option Holder an irrevocable option to acquire a non-exclusive, royalty bearing license under the Subject Patents . In consideration, the Option Holder paid us a non-refundable fee of $500,000 and agreed to pay us $2,000,000 upon exercise of the option (the “Exercise Fee”). We are entitled to receive an additional $2,000,000 upon the grant in the United States of a Licensed Patent with at least one Valid Claim that covers a Licensed Product in the Territory in the Field (as such terms are defined in this agreement). An additional milestone payment shall be made to us should the Option Holder achieve certain thresholds for aggregate annual net sales. The agreement also provides that we will be eligible to receive certain royalty payments from the Option Holder in connection with net sales.

 

In December 2008, the Option Holder exercised the option and paid us $1,550,000, which is the Exercise Fee, as adjusted.

 

GSK Option and License Agreement. In April 2009, we entered into an Option Agreement with Glaxo Group Limited (“GSK”) regarding an option to purchase a license under certain of our patents and patent applications (the “GSK Patents”) related to antibodies and methods of treatment for AD. We granted GSK an irrevocable option to acquire a non-exclusive, royalty bearing license under the GSK Patents with the right to grant sublicenses, to develop, have developed, make, have made, use, offer to sell, sell, import and have imported Licensed Products.

 

Upon exercise of the option, GSK will pay us $2,000,000 and, upon the later to occur of the exercise of the option by GSK and grant to us in the United States of a Licensed Patent with at least one Valid Claim that covers a Licensed Product incorporating a GSK Compound, GSK will pay us an additional $2,000,000. An additional milestone payment will be made to us should GSK achieve certain thresholds of annual net sales. This agreement also provides that we will be eligible to receive certain royalty payments from GSK in connection with net sales.

 

ViroPharma License Agreement. On and effective as of September 29, 2011, we entered into an Exclusive License Agreement (the “License Agreement”) with ViroPharma, pursuant to which, among other things we granted an exclusive license to ViroPharma regarding certain of our licensed patents and patent applications related to OX1. ViroPharma expects to develop and commercialize OX1 as a treatment of Friedreich’s Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.

 

Under the terms of the License Agreement, we have agreed to transfer to ViroPharma all of our intellectual property rights, data and know-how related to our OX1 research and development program in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union.  The aggregate maximum of these milestone payments assuming successful advancement of the product to market could amount to $120 million. In addition, ViroPharma will pay us a tiered royalty of up to an aggregate maximum of low double digits based on annual net sales.  NYU School of Medicine and South Alabama Medical Science Foundation, which own certain patents in relation to OX1, are entitled to a portion of the royalties and revenues received by us from any sale or license of OX1 pursuant to the RLAs described above.

 

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The term of the License Agreement will continue in effect on a licensed product-by-licensed product and country-by-country basis until the expiration of the last royalty obligation with respect to a licensed product in such country.  Once the royalty obligation has terminated in a particular country, the license will become non-exclusive and fully paid-up with respect to licensed products in that country.

 

Either party may terminate the License Agreement upon an uncured material breach of the other party.  In addition, if ViroPharma determines that it is not feasible or desirable to develop or commercialize licensed products, it may terminate the License Agreement in whole or on a product-by-product basis at any time upon ninety (90) days prior written notice to the Company.  In the event of a termination of the License Agreement, other than ViroPharma’s termination of the License Agreement for the Company’s uncured material breach, we will have an exclusive, perpetual, irrevocable, worldwide, royalty-bearing license to exploit the licensed products.

 

License Agreement with Northwestern University (“NWU”). Effective May 2012, we entered into a License Agreement (“License”) with NWU pursuant to which we obtained an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, under certain patents and know-how relating to the use of monoclonal antibody Tau C3 and TOC-1 for the prophylaxis, mitigation, diagnosis and/or treatment of AD and other tauopathies. We are obligated to make future payments to NWU totaling approximately $700,000 upon achievement of certain milestones based on phases of clinical development and also to pay NWU royalties on net sales (as defined) attributable to each product utilizing the licensed technology.

 

Note 4. Accounts Payable and Accrued Expenses

 

Accounts payable and accrued expenses consist of the following:

 

   June 30, 2013   June 30, 2012 
         
Professional Fees  $1,080,675   $1,160,080 
Consulting Expenses   853,197    733,197 
Clinical Expenses   206,890    766,890 
Other   346,648    289,597 
Total  $2,487,410   $2,949,764 

 

Note 5.   Notes Payable

 

TheApril 2010 Notes”

 

On April 23, 2010, we issued Convertible Promissory Notes (the “April 2010 Notes”) with an aggregate principal amount of $580,000. The April 2010 Notes carry interest at 14% annually (payable in arrears) and mature three years from the issue date.

 

We determined the initial fair value of the Warrants issued with the April 2010 Notes to be $41,093,377  based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the April 2010 Notes. Under authoritative guidance, the carrying value of the April 2010 Notes may not be reduced below zero. Accordingly, we recorded the excess of the value of the Warrants over the face amount of the April 2010 Notes as interest expense incurred at the time of issuance of the April 2010 Notes. The face amount of the April 2010 Notes will be amortized over the term of the notes as interest expense, calculated using an effective interest method.

 

On November 3, 2010, we borrowed an additional $150,000 from certain holders of the April 2010 Notes and evidenced such borrowing by adding an addendum to the April 2010 Notes whereby the aggregate principal amount of such holders’ Notes was increased by $150,000. As partial consideration for the loan, we reduced the conversion price of such holders’ Notes from $1.50 to $0.125 per common share.  As a result of the “ratchet” provisions contained in the April 2010 Notes and outstanding Warrants, the conversion price of the remaining outstanding April 2010 Notes and exercise price of our outstanding Warrants were adjusted to $0.125 per common share. The conversion price of previously issued and outstanding Series B Convertible Preferred Stock held by holders other than the purchasers is not subject to adjustment as a result of revisions to the April 2010 Notes.

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

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The December 2010 Notes

 

On December 15, 2010, we sold investment units for an aggregate purchase price of $500,000. Each unit consisted of a Convertible Promissory Note (the “December 2010 Notes”), shares of Series C Convertible Preferred Stock (“Series C Prefs”) and warrants (the “December 2010 Warrants”). Total proceeds from the sale of these investment units were $500,000.

 

The December 2010 Notes have an aggregate face amount of $500,000, are due on December 15, 2013 and bear interest at 14%, payable at maturity. Principal and accrued interest on the Notes are convertible into shares of our common stock at an initial conversion price of $.125 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Notes. As a result of the ratchet provisions contained in the Notes, the holders are entitled to purchase up to 10 million shares of our Common Stock.

 

The December 2010 Warrants initially entitle the holders to purchase up to a total of 4 million shares of our common stock at an initial exercise price of $0.125 per share. As a result of the ratchet provisions contained in the December 2010 Warrants, the holders are entitled to purchase up to 10 million shares of our Common Stock at an exercise price of $0.001 per share. Also, we issued an aggregate of 10,000 shares of Series C Prefs with an initial aggregate liquidation preference equal to $10 million, which, as a result of the ratchet provisions contained in the Certificate of Designation of series C Preferred Stock, are convertible into 200 million shares of our Common Stock at a conversion price of $0.05 per share.

 

We allocated the $500,000 of proceeds to the December 2010 Notes and Series C Preferred shares based on their relative fair values at date of issuance, which resulted in an allocation of $25,000 and $475,000, respectively. We determined the initial fair value of the December 2010 Warrants to be $378,017 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the December 2010 Notes. Under authoritative guidance, the carrying value of the December 2010 Notes may not be reduced below zero. Accordingly, we recorded the excess of the value of the December 2010 Warrants over the allocated fair value of the December 2010 Notes as interest expense incurred at the time of issuance of the December 2010 Notes in the amount of $353,017.  The discount related to of the December 2010 Notes will be amortized over the term of the notes as interest expense, calculated using an effective interest method.

 

The guidance provided in ASC 470-20-30-5 has been applied to the amount allocated to the Series C Preferred Stock, and the effective conversion price has been used to measure the intrinsic value of the embedded conversion option, and limited to the amount of proceeds allocated to the convertible instrument.  The intrinsic value of the beneficial conversion feature was calculated by comparing the effective conversion price and the market price of the Company’s common stock on the date of issuance. The fair value of $475,000 of the beneficial conversion feature has been recognized as a deemed dividend on the preferred stock for the year ended June 30, 2011, since the Series C Preferred stock is immediately convertible upon issuance and has no stated redemption date.

 

As a result of the “ratchet” provisions contained in the April 2010 Notes and outstanding Warrants, the conversion price of the remaining outstanding April 2010 Notes and exercise price of our outstanding Warrants and Series B Convertible Preferred Stock were adjusted to $0.001 per common share. The conversion price of previously issued and outstanding Series B Convertible Preferred Stock held by holders other than the purchasers of the April 2010 Notes is not subject to adjustment as a result of the issuance of the December 2010 Notes.

 

 In January 2011, as a result of the “ratchet” provisions contained in the April 2010 Notes, we issued to purchasers of the April 2010 Notes remaining outstanding an additional 2,000 shares of our Series C Prefs with an initial aggregate liquidation preference equal to $2 million, which are convertible into 40 million shares of our common stock at an exercise price of $0.001 per share. In addition, in May 2011, we issued 429,000 shares of our Common Stock as additional compensation to certain holders of the April 2010 Notes as a result of the “ratchet” provisions contained in those Notes.

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

The “March 2011 Notes”

 

On March 15, 2011, we sold investment units for an aggregate purchase price of $500,000. Each unit consisted of a Convertible Promissory Note (the “March 2011 Notes”), shares of Series C Prefs and warrants (the “March 2011 Warrants”). Total proceeds from the sale of these investment units were $500,000.  The terms of the March 2011 Notes and Warrants are the same as the terms contained in the December 2010 Notes and Warrants.

 

The March 2011 Notes have an aggregate face amount of $500,000, are due on March 15, 2014 and bear interest at 14%, payable at maturity. Principal and accrued interest on the Notes are convertible into shares of our common stock at an initial conversion price of $.125 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Notes. As a result of the ratchet provisions contained in the March 2011Notes, the holders are entitled to purchase up to 10 million shares of our Common Stock.

 

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The March 2011 Warrants initially entitle the holders to purchase up to a total of 4 million shares of our common stock at an initial exercise price of $0.125 per share. As a result of the ratchet provisions contained in the March 2011 Warrants, the holders are entitled to purchase up to 10 million shares of our Common Stock at an exercise price of $0.001 per share. Also, we issued an aggregate of 10,000 shares of Series C Prefs with an initial aggregate liquidation preference equal to $10 million, which, as a result of the ratchet provisions contained in the Certificate of Designation of series C Preferred Stock, are convertible into 200 million shares of our Common Stock at a conversion price of $0.001 per share.

 

We allocated the $500,000 of proceeds to the March 2011 Notes and Series C Prefs based on their relative fair values at date of issuance, which resulted in an allocation of $25,000 and $475,000, respectively. We determined the initial fair value of the March 2011 Warrants to be $378,017 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the March 2011 Notes. Under authoritative guidance, the carrying value of the March 2011 Notes may not be reduced below zero. Accordingly, we recorded the excess of the value of the March 2011Warrants over the allocated fair value of the March 2011 Notes as interest expense incurred at the time of issuance of the March 2011 Notes in the amount of $353,017.  The discount related to of the March 2011 Notes will be amortized over the term of the notes as interest expense, calculated using an effective interest method.

 

The guidance provided in ASC 470-20-30-5 has been applied to the amount allocated to the Series C Preferred Stock, and the effective conversion price has been used to measure the intrinsic value of the embedded conversion option, and limited to the amount of proceeds allocated to the convertible instrument.  The intrinsic value of the beneficial conversion feature was calculated by comparing the effective conversion price and the market price of the Company’s common stock on the date of issuance. The fair value of $475,000 of the beneficial conversion feature has been recognized as a deemed dividend on the preferred stock for the year ended June 30, 2011, since the Series C Preferred stock is immediately convertible upon issuance and has no stated redemption date.

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

The “June and July 2011 Notes”

 

On June 30, 2011, we sold investment units (“June 2011 Investment Units”) for an aggregate purchase price of $100,000. Each unit consisted of a Convertible Promissory Note (the “June 2011 Notes”) and warrants (the “June 2011 Warrants”). Total proceeds from the sale of these investment units were $100,000.

 

The June 2011 Notes have an aggregate face amount of $100,000, are due on June 30, 2014 and bear interest at 14%, payable at maturity. Principal and accrued interest on the June 2011 Notes are convertible into shares of our common stock at an initial conversion price of $.05 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the June 2011 Notes. The June 2011 Warrants entitle the holders to purchase up to a total of 10 million shares of our Common Stock at an initial exercise price of $0.05 per share.

 

We determined the initial fair value of the June 2011 Warrants to be $817,151 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the June 2011 Notes by $100,000 with the excess of $717,151 charged to interest expense. This difference was amortized over the term of the June 2011 Notes as interest expense, calculated using an effective interest method.

 

During July and August, 2011, we sold additional investment units for an aggregate purchase price of $150,000. Each unit consisted of a Convertible Promissory Note (the “July 2011 Notes”) and warrants (the “July 2011 Warrants”). Total proceeds from the sale of these investment units were $150,000.

 

The June 2011 Notes issued in July have an aggregate face amount of $150,000, are due on various dates during July and August, 2014 and bear interest at 14%, payable at maturity. Principal and accrued interest on the July 2011 Notes are convertible into shares of our common stock at an initial conversion price of $.05 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Notes. The July 2011 Warrants entitle the holders to purchase up to a total of 20 million shares of our Common Stock at an initial exercise price of $0.05 per share.

 

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We determined the initial fair value of the July 2011 Warrants to be $1,626,973 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the July 2011 Notes by $150,000 with the excess of $1,476,973 charged to interest expense.

 

In April 2012, we issued 500,000 shares of our common stock to one of the holders of July 2011 Notes upon his conversion of $25,000 principal amount due with respect to such Notes (Note 11.)

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

The “April and May 2012” Financing

 

During April and May 2012, we sold investment units for an aggregate purchase price of $201,500. Each unit consisted of a Convertible Promissory Note (the April and May 2012 Notes”) and warrants (the “April and May 2012 Warrants”). Total proceeds from the sale of these investment units were $201,500.

 

The April and May 2012 Notes have an aggregate face amount of $201,500, are due in April and May 2015 and bear interest at 14%, payable at maturity. Principal and accrued interest are convertible into shares of our common stock at an initial conversion price of $0.05 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalent by us at a price less than the effective conversion price of the April 2012 Notes. The April and May 2012 Warrants entitle the holders to purchase up to 25,150,000 shares of our Common Stock at an initial exercise price of $0.05 per share.

 

We determined the initial fair value of the April and May 2012 warrants to be $1,100,650 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the April and May 2012 Notes by $201,500 with the excess of $899,150 charged to interest expense. The discount related to the April and May 2012 Notes will be amortized over the term of the notes as interest expense, calculated using an effective interest method.

 

During July through November 2012, we sold additional investment units for an aggregate purchase price of $662,500. Each unit consisted of a Convertible Promissory Note and Warrants. Total proceeds from the sale of these investment units were $662,500.

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

January 2013 Financing

 

During January, February, March, May and June 2013, we sold investment units for an aggregate purchase price of $372,500. Each unit consisted of a Convertible Promissory Note (the January 2013 Notes”) and warrants (the “January 2013 Financing Warrants”). Total proceeds from the sale of these investment units were $503,500.

 

The January 2013 Notes have an aggregate face amount of $503,500, are due in January, February, March, May and June 2016 and bear interest at 14%, payable at maturity. Principal and accrued interest are convertible into shares of our common stock at an initial conversion price of $0.01 per share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalent by us at a price less than the effective conversion price of the April 2012 Notes. The January 2013 Financing Warrants entitle the holders to purchase up to 247,500,000 shares of our Common Stock at an initial exercise price of $0.01 per share.

 

We determined the initial fair value of the January 2013 Financing warrants to be $2,400,728 based on the Black-Scholes option pricing model, which we treated as a liability with a corresponding decrease in the carrying value of the January 2013 Financing Notes by $503,500 with the excess of $2,028,228 charged to interest expense. The discount related to the January 2013 Financing Notes will be amortized over the term of the notes as interest expense, calculated using an effective interest method.

 

The Company has determined that the conversion feature embedded in the convertible notes constitute a derivative and have been bifurcated from the note and recorded as a derivative liability, with a corresponding discount recorded to the associated debt or a charge to interest expense where the derivative exceeds the carrying value of the note, on the accompany balance sheet, and revalued to fair market value at each reporting period.

 

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The following table sets forth a summary of all of the outstanding convertible promissory notes at June 30, 2013:

 

Convertible promissory notes issued  $3,657,500 
Allocated to preferred stock   (256,203)
Notes repaid   (400,000)
Less amounts converted to common stock   (625,000)
    2,376,297 
Less debt discount   1,144,560 
Balance June 30, 2013  $1,231,737 

 

Note 6. Series B Convertible Preferred Stock and Derivative Liability

 

Series B Convertible Preferred Stock

 

During the fiscal year ended June 30, 2007, we issued 459,309 shares of Series B Convertible Preferred Stock (the “Series B Prefs”). The shares carry a cumulative dividend of 6% per annum. The initial conversion price is 1.75 per share subject to certain anti-dilution adjustments. Each Series B Preferred share carries a stated value of $17.50 and is convertible into 10 shares of our Common Stock. We issued 3,046,756 warrants in connection with the issuance of the Series B Prefs (the “Series B Warrants”).

 

Based on authoritative guidance, we accounted for the Series B Prefs and the Series B Warrants as derivative liabilities at the time of issuance using the Black Scholes option pricing model. We recorded the amount received in consideration for the Series B Prefs as a liability for the Series B Prefs with an allocation to the Series B Warrants and the difference recorded as additional paid in capital. The liability related to the Series B Prefs and the Series B Warrants will be marked to market for all future periods they remain outstanding with an offsetting charge to earnings.

 

At June 30, 2013, the aggregate liquidation value of the Series B Prefs was $1,870,380, with a fair value of $172,874. As of June 30, 2013, we have accrued Series B Preferred Stock dividends payable of $576,934 which has been recognized as interest expense.

 

As a result of the “ratchet” provisions contained in the Certificate of Designation of the Series B Prefs, the conversion price of the remaining Series B Prefs, as subsequently amended by a majority in interest of the holders of the series B Prefs, was reduced to $0.05 per common share as a result of the December 2010 Financing transaction described above. The conversion price of previously issued and outstanding Series B Prefs held by holders other than the purchasers of the April 2010 Notes is not subject to adjustment as a result of the issuance of the December 2010 Notes or March 2011 Notes.

 

Series C Convertible Preferred Stock

 

Effective December 15, 2010, our Board of Directors approved a Certificate of Designation of Series C Convertible Preferred Stock. Each share of Series C Convertible Preferred Stock carries a stated value of $1,000 and a conversion price of $0.05 per common share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Series C Preferred Stock. We issued to the purchasers of the December 2010 Notes 12,000 shares of our Series C Convertible Preferred Stock with an initial aggregate liquidation preference equal to $12 million, which are convertible into 240 million shares of our common stock.

 

On March 15, 2011, we issued to certain purchasers of the March 2011 Notes an additional 10,000 shares of our Series C Convertible Preferred Stock with an initial aggregate liquidation preference equal to $10 million, which are convertible into 200 million shares of our common stock, in exchange for $500,000 (Note 5).

 

During the year ended June 30, 2013, we issued 37,000,000 shares of our common stock to holders of Series C Preferred upon conversion of their shares.

 

Series D Convertible Preferred Shares

 

Effective October 24, 2010, our Board of Directors approved a Certificate of Designation of Series D Convertible Preferred Stock. Each share of Series D Convertible Preferred Stock carries a stated value of $1,000 and a conversion price of $0.05 per common share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Series D Preferred Stock. The Series D Preferred Stock was issued to holders of our warrants in exchange for cancellation of those warrants. The number of shares of Series D Preferred Stock issued to each warrant holder is an amount equal to the number of Series D Preferred Shares that would be convertible into an amount of common shares equal to 50% of the number of warrants held by such holder. Based on this formula, we issued 6,716 shares of Series D Preferred stock, which are convertible into 134,320,000 shares of our common stock.

 

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During the year ended June 30, 2013, we issued 25,000,000 shares of our common stock to holders of Series D Preferred upon conversion of their shares.

 

Series E Convertible Preferred Shares

 

Effective January 2, 2013, our Board of Directors approved a Certificate of Designation of Series E Convertible Preferred Stock. Each share of Series E Convertible Preferred Stock carries a stated value of $1,000 and a conversion price of $0.01 per common share, subject to customary anti-dilution protection in the case of stock dividends, stock splits, reverse splits, reorganizations and recapitalizations and subject to full ratchet protection in the case of any sale of common stock or common stock equivalents by us at a price less than the then effective conversion price of the Series E Preferred Stock. The Series E Preferred Stock was issued to holders of royalty rights with respect to the Company’s anti-senilin patent estate (the “Royalty Rights”) in exchange for the Royalty Rights held by them. On January 2, 2013, we issued 2,000 shares of Series E Preferred stock, which are convertible into 200,000,000 shares of our common stock.

 

The Company recognized this difference between the fair value per share of its common stock and the conversion price, multiplied by the number of shares issuable upon conversion. This Beneficial Conversion Feature of $700,000 was recorded as additional paid-in-capital for common shares, per EITF 98-5 “Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios”. The offsetting amount was amortizable over the period from the issue date to the first conversion date. Since the Series E Preferred Stock is immediately convertible, a deemed dividend of $700,000 to the Series E Preferred Stock was recorded and immediately amortized. As the Company is in an accumulated deficit position, the deemed dividend was charged against additional paid-in-capital for common shares, there being no retained earnings from which to declare a dividend. The net income (loss) attributable to common shareholders reflects both the net income (loss) and the deemed dividend

 

Note 7. Outstanding Warrants and Warrant Liability

 

The “2006 Warrants”

 

In connection with the sale of the 2006 Notes, we issued warrants (the “2006 Warrants”), entitling the holders to purchase up to 43,428 shares of our common stock. We issued additional 2006 Warrants upon extension of the maturity date of certain of the 2006 Notes. The 2006 Warrants expire five years from date of issuance, except for 22,857 of such warrants, which expire in 2013. The number of shares underlying each 2006 Warrant is the quotient of the face amount of the related 2006 Note divided by 50% of the price per equity security issued in the Next Equity Financing, which occurred on May 12, 2006. The 2006 Warrant exercise price is 50% of the price per equity security issued in the Next Equity Financing. The maximum number of shares available for purchase by an investor is equal to the principal amount of such holder's 2006 Note divided by the warrant exercise price.

 

As of May 2013, all of the 2006 Warrants expired without being exercised.

 

The “Convertible Note Warrants”

 

In connection with the sale of the 2007 and 2008 Notes, we issued 76,751 and 3,714 warrants, respectively.   In addition, we issued 7,429 warrants in connection with a Convertible Note issued during fiscal year ended June 30, 2009 (the “Convertible Note Warrants”).

 

The Convertible Note Warrants expire five years from date of issuance. The number of shares underlying each Convertible Note Warrant is the quotient of the face amount of the related Note divided by 87.5. The exercise price of each warrant is $87.50 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the Warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans). The terms of the Warrants fail to specify a penalty if we fail to satisfy our obligations under these piggyback registration rights. Presumably, we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for the Convertible Note Warrants as liabilities. The liability for the Convertible Note Warrants, measured at fair value, based on a Black-Scholes option pricing model, has been offset by a reduction in the carrying value of the related Notes. These warrants expired without being exercised in February 2012.

 

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In connection with the Convertible Note Financing, we issued 28,464 warrants to the placement agent. Based on authoritative guidance, we have accounted for these warrants as liabilities. The liability, measured at fair value on the date of issuance using a Black-Scholes option pricing model, will be marked to market for each future period the warrants remain outstanding. As of June 30, 2013, all of these warrants remain outstanding, with an exercise price of $0.05 per share.

 

The “Royalty Warrants”.

 

In connection with the issuance of the Royalty Notes, we issued warrants to purchase up to 65,429 of our common shares (the “Royalty Warrants”).  We issued approximately 7,429 warrants to the lender who advanced to us new funds of $650,000 and issued the remaining 58,000 warrants to the other lenders who exchanged their notes for Royalty Notes. The Royalty Warrants contain the same terms as the Convertible Note Warrants described above.

 

Based on authoritative guidance, we accounted for the 7,429 Royalty Warrants issued to the unrelated lender as a liability. We valued these warrants on the date of issuance based on a Black-Scholes option pricing model and the resulting liability is marked to market for each future period these warrants remain outstanding, with the resulting gain or loss being recorded in the statement of operations. We accounted for the 58,000 Royalty Warrants issued to the other lenders as interest expense incurred in exchange for an extension of the maturity dates of the Royalty Notes exchanged in the transaction.

 

As of June 30, 2010, all of the holders of the Royalty Notes accepted common stock in repayment of their notes and agreed to the cancellation of their Royalty Warrants.

 

The “Purchaser Warrants”.

 

In connection with the sale of the August Note, we agreed, at maturity or early repayment of the note, to issue either common shares or warrants to purchase up to 60,000 of our common shares (the Purchaser Warrants). The Purchaser Warrants were to contain the same terms as the Convertible Note Warrants described above. Based on authoritative guidance, we accounted for the Purchaser Warrants as a liability as of the date of issuance and reduced the carrying value of the August Note by the initial fair value of these Warrants.

 

On April 23, 2010, we agreed to issue to the holder of the August 2009 Note 15 million shares of our common stock in lieu of the Purchaser Warrants.

 

The “Series B Warrants”

 

In connection with the issuance of the Series B Preferred, we issued Series B warrants to purchase up to 75,939 shares of our common stock. The initial exercise price of the Series B Warrants was $2.50 per common share, subject to anti-dilution adjustments. The strike price of the Series B Warrants was subsequently reduced to $1.75 per common share pursuant the anti-dilution adjustment. The Series B Warrants have a 5 year term.

 

The Series B Warrants provide for cashless exercise under certain circumstances. Accordingly, the amount of additional shares underlying potential future issuances of Series B Warrants is indeterminate. There is no specified cash payment obligation related to the Series B Warrants and there is no obligation to register the common shares underlying the Series B Warrants except in the event that we decide to register any of our common stock for cash (“piggyback registration rights”). Presumably, we would be obligated to make a cash payment to the holder if we failed to satisfy our obligations under these piggyback registration rights. Based on authoritative guidance, we have accounted for the Series B Warrants as liabilities. As of June 30, 2013, a total of 2,857 Series B Warrants remain outstanding, with a strike price of $0.001 per share.

 

The “April 2010 Warrants”.

 

In connection with the April 2010 Financing, we issued a total of 1,546,667 Class A, 1,546,667 Class B and 1,546,667 Class C Warrants (collectively, the “April 2010 Warrants”). The Class A Warrants have a 5 year term, an initial exercise price of $1.50 per common share, subject to anti-dilution adjustments and contain a “cashless exercise feature”. The Class B Warrants have a 9 month term and an initial exercise price of $1.50 per common share, subject to anti-dilution adjustments. The Class C Warrants have a 5 year and 9 month term, an initial exercise price of $1.50 per common share, subject to anti-dilution adjustments and contain a “cashless exercise feature”. The April 2010 Warrants provide the holder with “piggyback registration rights” as described above. Based on authoritative guidance, we have accounted for the April 2010 Warrants as liabilities. The liability, measured at fair value on the date of issuance using a Black-Scholes option pricing model has been offset by a reduction in the carrying value of the April 2010 Notes and will be marked to market for each future period they remain outstanding.

 

On June 28, 2010, holders of 1,013,333 Class A Warrants exercised their Warrants through the cashless exercise feature and received a total of 11,000 shares of Company common stock.

 

As a result of the “ratchet” provisions contained in the April 2010 Warrants, the number of warrants and the exercise price of the warrants are subject to adjustment as a result of the December 2010 Notes described above.

 

On March 15, 2011 holders of 4 million Class B Warrants exercised their Warrants for cash and received a total of 4 million shares of our Common Stock.  The remaining Class B Warrants expired in January 2011.

 

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As of October 26, 2012, a total of 53,733,333 April 2010 A warrants were exchanged for Series D Preferred shares.

 

 “Consultant Warrants”

 

In connection with the April 2010 Financing, we issued 700,000 warrants to various consultants (the “Consultant Warrants”) with terms that are the same as those contained in the Class A Warrants. Based on authoritative guidance, we have accounted for the Consultant Warrants as liabilities.

 

On June 28, 2010, holders of all of the outstanding Consultant Warrants exercised their Warrants through the cashless exercise feature and received a total of 11,000 shares of Company common stock.

 

In August and October 2010, we issued an additional 6,000,000 warrants to consultants for investor relations and legal services. These warrants expire five years from the date of issuance. The exercise price of each warrant is $0.05 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans. The terms of the warrants fail to specify a penalty if we fail to satisfy our obligation under these piggyback registration rights. Presumably we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for these consultant warrants as liabilities, measured at fair value, based on a Black-Scholes option pricing model.

 

As of October 26, 2012, 6,000,000 Consultant Warrants were exchanged for Series D Preferred shares.

 

“The December 2010 and March 2011 Warrants”

 

In connection with the sale of the December 2010 Notes and March 2011 Notes, we issued warrants, we issued a total of 20,000,000 warrants (the “December 2010 and March 2011 Warrants”). These warrants expire five years from the date of issuance. The exercise price of each warrant is $0.05 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans. The terms of the warrants fail to specify a penalty if we fail to satisfy our obligation under these piggyback registration rights. Presumably we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for these consultant warrants as liabilities, measured at fair value, based on a Black-Scholes option pricing model.

  

As of October 26, 2012, 9,800,000 of December 2010 and March 2011 Warrants, were exchanged for Series D Preferred shares.

 

The “June and July 2011 Warrants”

 

In connection with the sale of the June Notes, we issued a total of 30 million warrants (the “June and July 2011 Warrants”). The June and July 2011 Warrants expire five years from date of issuance. The exercise price of each warrant is $0.05 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans). The terms of the June and July Warrants fail to specify a penalty if we fail to satisfy our obligations under these piggyback registration rights. Presumably, we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for the June and July 2011 Warrants as liabilities. The liability for the June and July 2011 Warrants, measured at fair value, based on a Black-Scholes option pricing model, has been offset by a reduction in the carrying value of the related Notes.

 

As of October 26, 2012, 30 million “June and July 2011” warrants were exchanged for Series D Preferred shares.

 

The “2011 Director Warrants”

 

In October 2011, we issued warrants to purchase 2,881,680 shares of our common stock to our former independent directors in partial satisfaction of outstanding fees owed to such directors (the “2011 Director Warrants”). The 2011 Director Warrants have a 5 year term, an initial exercise price of $0.05 per common share, subject to anti-dilution adjustments, and contain a “cashless exercise feature”. The 2011 Director Warrants provide the holder with “piggyback registration rights” as described above. Based on authoritative guidance, we have accounted for the 2011 Director Warrants as liabilities. The liability, measured at fair value on the date of issuance using a Black-Scholes option pricing model will be marked to market for each future period they remain outstanding. As of June 30, 2013 2,881,680 warrants are outstanding

 

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The “April and May 2012” Warrants

 

In connection with the sale of the April and May 2012 Notes, we issued a total of 99,150,000 warrants (the “April and May 2012 Warrants”). The April and May 2012 Warrants expire five years from date of issuance. The exercise price of each warrant is $0.05 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans). The terms of the April and May 2012 Warrants fail to specify a penalty if we fail to satisfy our obligations under these piggyback registration rights. Presumably, we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for the April and May 2012 Warrants as liabilities. The liability for the April and May 2012 Warrants, measured at fair value, based on a Black-Scholes option pricing model, has been offset by a reduction in the carrying value of the related Notes.

 

As of October 26, 2012, 53,150,000 “April and May 2012” warrants were exchanged for Series D Preferred shares, while 46,000,000 warrants were outstanding as of December 31, 2012. On March 13, 2013, all of the outstanding warrants were exchanged for common stock in a cashless exercise and 29,525,879 shares of common stock were issued.

 

The January 2013 Financing Warrants

 

In connection with the sale of the January 2013 Notes, we issued a total of 247,500,000 warrants. The January 2013 Financing Warrants expire five years from date of issuance. The exercise price of each warrant is $0.01 per share, subject to anti-dilution adjustments. These warrants provide the holder with “piggyback registration rights”, which obligate us to register the common shares underlying the warrants in the event that we decide to register any of our common stock either for our own account or the account of a security holder (other than with respect to registration of securities covered by certain employee option plans). The terms of the January 2013 Financing Warrants fail to specify a penalty if we fail to satisfy our obligations under these piggyback registration rights. Presumably, we would be obligated to make a cash payment to the holder to compensate for such failure. Based on authoritative guidance, we have accounted for the January 2013 Financing Warrants as liabilities. The liability for the January 2013 Financing Warrants, measured at fair value, based on a Black-Scholes option pricing model, has been offset by a reduction in the carrying value of the related Notes.

 

As of June 30, 2013, 247,500,000 warrants remain outstanding.

 

Note 8. Income Taxes

 

The reconciliation of income tax benefit at the U.S. statutory rate of 34% for the years ended June 30, 2013 and 2012 to the Company’s effective tax rate is as follows:

 

   Years Ended 
   June 30, 2013   June 30, 2012 
         
U.S. federal statutory rate   -34%   -34%
State income tax, net of federal benefit   -6%   -6%
Change in valuation allowance   40%   40%
Income Tax provision (benefit)   0%   0%

 

The tax effects of temporary differences that give rise to the Company’s net deferred tax asset as of June 30, 2013 and 2012 are as follows:

 

   Years Ended 
   December 31, 2011   December 31, 2010 
         
Deferred Tax Assets          
Net operating losses  $7,120,000   $5,265,000 
Derivative liability   2,146,800    1,355,000 
    9,266,800    6,620,000 
Less: Valuation allowance   (7,120,000)   (5,265,000)
    2,146,800    1,355,000 
Derivative liability   (2,146,800)   (1,355,000)
Total deferred tax liability   (2,146,800)   (1,355,000)
   Net Deferred Tax Assets  $-   $- 

 

As of June 30, 2013, the Company had approximately $17,800,000 of Federal and state net operating loss carryovers (“NOLs”) which begin to expire in 2025. Utilization of the NOLs may be subject to limitation under Internal Revenue Code Section 382 should there be a greater than 50% ownership change as determined under regulations.

 

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In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based on the assessment, management has established a full valuation allowance against all of the deferred tax asset because it is more likely than not that all of the deferred tax asset will not be realized.

 

The Company files U.S. federal and state of New York tax returns that are subject to audit by tax authorities beginning with the year ended June 30, 2010. The Company is not currently under audit for any tax returns

 

Note 9. Capital Deficiency

 

Common stock

 

In April and May 2005, we issued 241,565 and 183,505 shares of common stock at $0.001 per share to founders of Intellect, yielding proceeds of $12,078 and $9,175, respectively.

 

In June 2005, we issued to Goulston & Storrs, LLP a warrant to purchase 2,000 shares of our common stock at a purchase price of $0.001 per share, expiring June 20, 2008.  In April 2006, Goulston & Storrs exercised the warrant and we subsequently delivered to them a share certificate representing 2,000 shares of our common stock.

 

On March 10, 2006, we amended our Certificate of Incorporation to provide for the issuance of up to 2,000,000 shares of common stock and up to 15,000,000 shares of preferred stock each with a par value of $.001 per share.

 

In January 2006, we issued 2,225 shares of Series A Convertible Preferred Stock, par value per share of $0.001, as partial consideration for settlement of certain claims totaling $570,000. As a result of the Merger described below, the Series A Preferred Stock was exchanged for 2,577 shares of our common stock.

 

In July 2007, we issued a total of 6,595 shares of common stock to various note holders.  We issued 6,230 shares as part of agreements with three note holders to extend the maturity date of their notes to September 30, 2007 and recorded a charge of $622,354 for interest expense in connection with the issuance of these shares.  We issued 365 shares to three note holders who converted their notes with an aggregate principal amount and accrued interest of $31,733.  On April 8, 2008, we rescinded the conversion of these notes into common shares and reinstated the Notes and agreed with the holders to cancel the shares and extend the maturity date of the notes to June 30, 2008.

 

In December 2007, we issued 600 shares of common stock under a pre-existing agreement with a note holder to extend the maturity date of his note to December 15, 2007. In February 2008, we rescinded the issuance of the 600 shares of common stock and issued a note to the note holder as additional consideration for the extension.

 

In December 2007, we issued 1,000 shares to a consultant for services rendered.

 

On January 25, 2007, GlobePan Resources, Inc. entered into an agreement and plan of merger with Intellect and INS Acquisition, Inc., a newly formed, wholly-owned Delaware subsidiary of GlobePan Resources, Inc. also called Acquisition Sub.  On January 25, 2007, Acquisition Sub merged with and into Intellect Neurosciences, Inc., Acquisition Sub ceased to exist and Intellect survived the merger and became the wholly-owned subsidiary of GlobePan Resources, Inc. GlobePan stockholders retained, in the aggregate, 180,000 shares of their common stock.

 

In November 2009, we amended our Certificate of Incorporation to provide for the issuance of up to 13,000,000 shares of common stock with a par value of $.001 per share.

 

In April 2010, we amended our Certificate of Incorporation to provide for the issuance of up to 40,000,000 shares of common stock with a par value of $.001 per share.

 

In April 2010, we issued 4,261,194 shares of our Common stock as full repayment of principal and interest owed to holders of Convertible Promissory Notes. All of these Notes were in default.

 

In April 2010, we issued 2,865,374 shares of our Common stock as full repayment of principal and interest owed to holders of Senior Promissory Notes.

 

In April, 2010, we issued 4,138,935 shares of our Common stock to holders of Series B Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

As described above, in connection with the sale of the November Notes, we agreed that the purchasers of the November Notes will receive at maturity of the November Notes 50,000 shares of our common stock. Simultaneous with the issuance of the November Notes, Daniel Chain, our CEO, transferred to an escrow agent, 50,000 shares of Company common stock issued to him at the time that he founded the Company in 2005 as collateral for the purchasers’ right to receive such shares. On April 23, 2010, the holders of the November Notes accepted common stock in repayment of their notes in conjunction with the financing transaction described above and the escrow agent released the Purchaser Shares to the holders of the November Notes. In April 2010, we issued 50,000 shares to Dr. Chain to replace the shares that he had surrendered to the holders of the November Notes.

 

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On April 23, 2010, we sold 1,160,000 shares of our common stock for aggregate consideration of $1,740,000 as part of the sale of investment units.

 

In April 2010, we issued 1,327,583 shares of our common stock to various consultants.

 

In April 2010, we issued 77,403 shares of our common stock to a former holder of our Convertible Promissory Notes in settlement of a claim.

 

In April 2010, we issued 21,000 shares of our common stock to certain of our trade creditors in partial settlement of past due amounts owed to these creditors.

 

In June 2010, we issued 1,765,240 shares of our common stock to holders of Class A Warrants and Consultant Warrants upon the cashless exercise of those warrants.

 

In July 2010, we repaid outstanding 2007 Notes through the issuance of 262,338 shares of our common stock and the holder agreed to the cancellation of the associated warrants.

 

In August 2010, we issued 10,000 shares of our common stock to our sole independent director as and 70,000 shares of our common stock to various consultants.

 

In November and December 2010, we issued 3,826,000 shares of our common stock to holders of $237,500 of April 2010 Notes upon conversion of their Notes.

 

On December 28, 2010, we issued 800,000 shares of our common stock to a holder of Series B Preferred upon conversion of his shares.

 

On January 4, 2011, we issued 362,358 shares of our common stock to holders of April 2010 Notes upon conversion of their Notes (plus accrued interest).

 

On January 12, 2011, we issued 1,000,000 shares of our common stock to a holder of Series B Preferred upon conversion of his shares and 800,000 shares of our common stock to holders of April 2010 Notes upon conversion of their Notes (plus accrued interest).

 

On January 20, 2011, we issued 694,417 shares of our common stock to holders of April 2010 Notes upon conversion of their Notes (plus accrued interest).

 

On February 15, 2011, we issued one million shares of our common stock to a holder of Series B Preferred upon conversion of his shares.

 

On March 9, 2011, we issued 1,500,000 shares of our common stock to a holder of Series B Preferred upon conversion of his shares.

 

On March 10, 2011, we issued 1,200,000 shares of our common stock to a holder of Series B Preferred upon conversion of his shares.

 

On March 14, 2011, we issued 2 million shares of our common stock to holders of the April 2010 Warrants upon the cashless exercise of those warrants.

 

On March 17, 2011, we issued 13,750 shares of our common stock to a consultant in exchange for public relations consulting services performed during 2011.

 

On March 17, 2011, we issued 3,714,286 shares of our common stock to holders of the December 2010 Warrants upon the cashless exercise of those warrants.

 

During the year ended June 30, 2012 we had the following capital transactions:

 

In July 2011, we issued 5,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In September 2011, we issued 1,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In October 2011, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In October 2011, we issued warrants to purchase 2,881,680 shares of our common stock at an exercise price of $0.05 per share to our former independent directors in partial satisfaction of outstanding fees owed to such directors.

 

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In December 2011, we issued 3,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In January 2012 we issued 545,000 shares of common stock to a vendor in satisfaction of outstanding fees owed to the vendor.

 

In February 2012, we issued 5,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In February 2012, we issued 1,515,306 shares of common stock to holders of our April 2010 Warrants upon their exercise of the cashless exercise feature contained in those securities.

 

In March 2012, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In March 2012, we issued 1,928,571 shares of common stock to holders of our April 2010 Warrants upon their exercise of the cashless exercise feature contained in those securities.

 

In April 2012, we issued 4,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In April 2012, we issued 2,500,000 shares of our common stock in consideration for services rendered to the Company.

 

In May 2012, we issued 500,000 shares of our common stock for the conversion of a portion of the principal amount of a Convertible Promissory Note.

 

In May 2012, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In June 2012, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In June 2012, we issued 500,000 shares of our common stock in consideration for services rendered to the Company.

 

In July 2012, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In August 2012, we issued 1,000,000 shares of our common stock in consideration for services rendered to the Company.

 

In September 2012, we issued 1,750,000 shares of our common stock in consideration for services rendered to the Company.

 

In September 2012, we issued 3,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In January 2013, we issued 5,000,000 shares of our common stock in consideration for services rendered to the Company.

 

In January 2013, we issued 2,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In February 2013, we issued 20,000,000 shares of our common stock to holders of Series D Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In February 2013, we issued 8,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In March 2013, we issued 8,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In March 2013, we issued 29,525,879 shares of our common stock to holders of 46,000,000 warrants upon their cashless exercise of the conversion feature contained in those securities.

 

In April 2013, we issued 14,000,000 shares of our common stock to holders of Series C Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

In May 2013, we issued 9,500,000 shares of our common stock in consideration for services rendered to the Company.

 

In May 2013, we issued 5,000,000 shares of our common stock to holders of Series D Convertible Preferred Stock upon their exercise of the conversion feature contained in those securities.

 

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Note 10. Related Party Transactions

 

University of South Florida Agreement. Our AD research activities require that we test our drug candidates in a certain type of transgenic mouse that exhibits the human AD pathology. Mindgenix, Inc., a wholly-owned subsidiary of Mindset, holds a license on the proprietary intellectual property related to these particular mice from the University of South Florida Research Foundation (“USFRF”). We have engaged Mindgenix to perform testing services for us using these transgenic mice. Dr. Chain, our CEO, is a controlling shareholder of Mindset. We consolidate the results of operations of Mindgenix with our results of operations because we have agreed to absorb certain costs and expenses incurred that are attributable to their research.

 

In December of 2006, we entered into an agreement with USFRF as a co-obligor with Mindgenix, pursuant to which USFRF agreed to reinstate the license with Mindgenix in exchange for our agreement to pay to USFRF $209,148 plus accrued interest of $50,870. This amount is in settlement of a previously outstanding promissory note issued by Mindgenix to the USFRF dated September 30, 2004. Our obligation to pay amounts due under the agreement are as follows:  $109,148 was payable on January 15, 2007 and $100,000 is payable in six equal monthly installments of $16,667 beginning February 1, 2007 and ending with a final payment of $50,435 on August 1, 2007.  We have paid $184,151 through June 30, 2009.  We have recorded these amounts as research and development expense and established a liability for the remainder of the payments. In addition, we have incurred approximately $325,000 in operating costs on behalf of Mindgenix for the fiscal year ended June 30, 2009.  These amounts have been included in our consolidated results of operations as research and development expense.

 

In April 2008, we paid $100,000 on behalf of Mindgenix and Mindgenix issued a promissory note with a face amount of $100,000 to Harlan Biotech, Israel, an unrelated third party (‘the “Harlan Note”), as partial payment for past due fees related to maintenance of Mindgenix’ mouse colony.   The Harlan Note bears interest at 10% per annum and is due 40 days from the issue date of April 8, 2008. One of our principal shareholders posted with an escrow agent 4,300 shares of freely tradable Intellect common stock as security for the Harlan Note. The shares were sold for total consideration of $104,244 and the proceeds were remitted to Harlan in discharge of the Harlan Note. We issued a convertible promissory note to the shareholder with a face amount of $104,244 and recorded a corresponding research and development expense.

 

Consulting Contracts. We have entered into consulting contracts with various members of our Clinical and Scientific Advisory Boards. Certain of these individuals are shareholders of Intellect. The consulting contracts are for services to be rendered in connection with ongoing research and development of our drug candidates. The contracts generally provide for per-diem payments of $2,500 for days spent away from the office attending to Intellect affairs.

 

Note 11. Commitments and Contingencies.

 

In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our product candidates, use of such product candidates, or other actions taken or omitted by us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we have no liabilities recorded for these provisions as of June 30, 2013 and 2012.

 

In the normal course of business, we may be confronted with issues or events that may result in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the action of various regulatory agencies. If necessary, management consults with counsel and other appropriate experts to assess any matters that arise. If, in management’s opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the United States, an estimate is made of the loss, and the appropriate accounting entries are reflected in our financial statements. We do not anticipate that liabilities arising out of currently pending or threatened lawsuits and claims will have a material adverse effect on our financial position, results of operations or cash flows.

 

Note 12. Stock-Based Compensation Plans-

 

In December 2006, our stockholders approved the adoption of the "2006 Employee, Director and Consultant Stock Plan" (the "2006 Stock Plan"), under which 240,000 shares of our common stock are available for issuance under the Plan.  The 2006 Stock Plan provides for the grant of either ISOs or non-qualified stock options, which do not qualify as ISOs.

 

On January 25, 2007, we granted 139,905 stock options to our Chairman and CEO and 60,838 stock options to our Chief Financial Officer. The option exercise price is $37.00 per share. The options are fully vested.

 

On March 30, 2009, we granted 500 stock options to a consultant engaged by the Company to assist in research and development activities related to OX1. The grant was effective as of that date with a strike price of $17.50.  The stock options vest over a twelve month period and are exercisable through March 30, 2014.

 

On August 31, 2010, we granted 2,000 stock options to a consultant engaged by the Company to assist in research and development activities. The grant was effective as of that date with a strike price of $0.83. The stock options vest over a twelve month period and are exercisable through August 31, 2015.

 

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On June 13, 2011, we granted 10,000 stock options to a consultant engaged by the Company to assist in research and development activities. The grant was effective as of that date with a strike price of $0.10. The stock options vest over a twelve month period and are exercisable through June 13, 2016.

 

The exercise price of all the above stock options was the closing price of the stock on the day of the grant.

 

As of June 30, 2013 and 2012, there are 26,757 stock options available for grant under the 2006 Stock Plan, respectively.

 

A summary of our outstanding stock options under all plans at June 30, 2013 is as follows:

 

   Year Ended
June 30, 2013
   Weighted
Average
Exercise Price
   Instrinisic
value
   Weighted
Average
Remaining
Contractual
Life
 
                 
Options outstanding at June 30, 2012   213,243   $34.87   $-    3.35 
Granted   -   $-         - 
Cancelled/Forfeited   -   $-    -      
Expired   -   $-           
Balance at the end of period   213,243   $34.87    -    3.35 
Options excercisable at June 30,  2013   213,243   $34.87    -    3.35 
                     
Options vested or expected to vest   213,243   $34.87    -    3.35 

 

Total compensation expense recorded during the year ended June 30, 2013 and 2012 for share-based payment awards was $0, and $256 respectively, which is recorded in general and administrative expenses in the consolidated statement of operations.

 

Note 13. Per Share Data

 

The following table sets forth the information needed to compute basic and diluted earnings per share:

 

   Twelve Months Ended 
         
   June 30   June 30 
   2013   2012 
Basic EPS          
           
Net income (loss) attributable to common stockholders, basic  $(9,755,510)  $1,896,990 
           
Weighted average shares outstanding   136,468,981    81,002,258 
           
Basic income earnings per share  $(0.07)  $0.02 
           
Diluted EPS          
           
Net income (loss) attributable to common stockholders, basic  $(9,755,510)  $1,896,990 
           
Preferred stock dividends   2,592,550    2,278,171 
           
Interest on convertible notes   290,005    192,293 
           
Net income (loss) attributable to common stockholders, diluted  $(6,872,955)  $4,367,454 
           
Weighted average shares outstanding   136,468,981    81,002,258 
           
Dilutive effect of stock options   -    - 
           
Dilutive effect of warrants   104,552,263    99,683,882 
           
Dilutive effect of Series B preferred shares   4,593,090    4,593,090 
           
Dilutive effect of Series C preferred shares   404,340,000    427,810,959 
           
Dilutive effect of convertible notes   163,181,250    34,580,000 
           
Diluted weighted average shares outstanding (A)   813,135,584    647,670,189 

 

(A)For the year ended June 30, 2013, all common stock equivalents have been determined to be anti-dilutive and have not been considered in the calculation of diluted weighted average shares outstanding on the statement of operations.

 

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Note 14. Subsequent Events

 

In accordance with authoritative guidance, we have evaluated any events or transactions occurring after June 30, 2013, the balance sheet date, through the date of filing of this report and note that there have been no such events or transactions that would require recognition or disclosure in the consolidated financial statements as of and for the year ended June 30, 2013, except as disclosed below.

 

a) During July, 2013, we sold investment units for an aggregate purchase price of $92,500. Each unit consisted of a Convertible Promissory Note and warrants under the same terms as the January 2013 Financing. Total proceeds from the sale of these investment units were $92,500.

 

b) On August 5, 2013 we issued 15,000,000 shares of the Company’s common stock to a consultant for services rendered for the Company.

 

c) On August 7, 2013, a holder of the Company’s Series C Convertible Preferred Stock converted $675,000 Stated Value of such Preferred Stock, at a conversion price of $0.05 per share, into 13,500,000 shares of the Company’s common stock.

 

d) During August, 2013, we sold investment units for an aggregate purchase price of $150,000. Each unit consisted of a Convertible Promissory Note and warrants under the same terms as the January 2013 Financing. Total proceeds from the sale of these investment units were $150,000.

 

e) On September 10, 2013, a holder of the Company’s Series C Convertible Preferred Stock converted $350,000 Stated Value of such Preferred Stock, at a conversion price of $0.05 per share, into 7,000,000 shares of the Company’s common stock.

 

f) On September 16, 2013, a holder of the Company’s Series D Convertible Preferred Stock converted $825,000 Stated Value of such Preferred Stock, at a conversion price of $0.05 per share, into 16,500,000 shares of the Company’s common stock.

 

g) During September, 2013, we sold investment units for an aggregate purchase price of $25,000. Each unit consisted of a Convertible Promissory Note and warrants under the same terms as the January 2013 Financing. Total proceeds from the sale of these investment units were $150,000.

 

h) On October 9, 2013 we issued 19,500,000 shares of the Company’s common stock to a consultant for services rendered for the Company.

 

i) On October 9, 2013, a holder of the Company’s Series D Convertible Preferred Stock converted $265,111 Stated Value of such Preferred Stock, at a conversion price of $0.05 per share, into 5,302,222 shares of the Company’s common stock.

 

j) During October, 2013, we sold investment units for an aggregate purchase price of $75,000. Each unit consisted of a Convertible Promissory Note and warrants under the same terms as the January 2013 Financing. Total proceeds from the sale of these investment units were $75,000.

 

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

 

None.

 

ITEM 9A.      CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

(a) Disclosure Controls and Procedures

 

Our principal executive officer and principal financial officer have evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a – 15(e) and 15d – 15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of the end of the period covered by this annual report. They have concluded that, based on such evaluation, our disclosure controls and procedures were not effective due to the material weaknesses in our internal control over financial reporting as of June 30, 2013, as further described below.

 

(b) Management’s Annual Report on Internal Control over Financial Reporting

 

Overview

 

Internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) refers to the process designed by, or under the supervision of, our principal executive officer and principal financial officer, and effected by our board of directors, management and other personnel, 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. Management is responsible for establishing and maintaining adequate internal control over financial reporting.

 

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Internal control over financial reporting cannot provide absolute assurance of achieving financial reporting objectives because of its inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements may not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.

 

Management has used the framework set forth in the report entitled “Internal Control — Integrated Framework” published by the Committee of Sponsoring Organizations (“COSO”) of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting. As a result of the material weaknesses described below, management has concluded that the Company’s internal control over financial reporting was not effective as of June 30, 2012.

 

Management’s Assessment

 

Management has determined that, as of the June 30, 2013 measurement date, there were material weaknesses in both the design and effectiveness of our internal control over financial reporting. Management has assessed these deficiencies and has determined that there were four general categories of material weaknesses in internal control over financial reporting. As a result of our assessment that material weaknesses in our internal control over financial reporting existed as of June 30, 2013, management has concluded that our internal control over financial reporting was not effective as of June 30, 2013. A material weakness in internal controls is a deficiency in internal control, or combination of control deficiencies, that adversely affects the our ability to initiate, authorize, record, process, or report external financial data reliably in accordance with accounting principles generally accepted in the United States of America such that there is more than a remote likelihood that a material misstatement of our annual or interim financial statements that is more than inconsequential will not be prevented or detected. In the course of making our assessment of the effectiveness of internal controls over financial reporting, we identified at least two material weaknesses in our internal control over financial reporting.  Specifically, (1) we lack a sufficient number of employees to properly segregate duties and provide adequate review of the preparation of the financial statements and (2) we lack sufficient independent Board members to maintain Audit and other board committees consistent with proper corporate governance standards. We have limited financial resources and no employees. The lack of personnel is a weakness because it could lead to improper classification of items and other failures to make the entries and adjustments necessary to comply with U.S. GAAP. Accordingly, management’s assessment is that the Company’s internal controls over financial reporting were not effective as of June 30, 2013.

 

This Annual Report does not include an attestation report of the Company’s registered accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the Securities and Exchange Commission.

 

Changes in Internal Control Over Financial Reporting

 

No changes in the Company's internal control over financial reporting have come to management's attention during the Company's last fiscal quarter that have materially affected, or are likely to materially affect, the Company's internal control over financial reporting.

 

ITEM 9B. OTHER INFORMATION

 

None.

 

PART III

 

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS AND CORPORATE GOVERNANCE; COMPLIANCE WITH SECTION 16(a) OF THE EXCHAGE ACT.

 

Directors and Executive Officers

 

The following table sets forth the name, age and position of our directors, executive officers and significant employees as of the filing date of this report on Form 10-K.  All of our directors hold office until they resign or are removed from office in accordance with out bylaws.

 

Name   Age   Title
         
Elliot M. Maza, J.D., C.P.A.   57   Director
         
Isaac Onn   58   Director

 

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Elliot M. Maza, J.D., C.P.A.,(Inactive). Mr. Maza has served as our Executive Vice President and Chief Financial Officer from May 2006 to March 2007 when he was promoted to President and Chief Financial Officer. Mr. Maza resigned his position as President of the Company on October 17, 2011 and his position as Chief Financial Officer on October 2012. We have engaged Mr. Maza as our consulting CFO and principal accounting officer on a part time basis. Currently Mr. Maza is the Chief Executive Officer of BioZone Pharmaceuticals, Inc., a contract manufacturer of health and beauty products and OTC pharmaceutical products. From December 2003 to May 2006 Mr. Maza was Chief Financial Officer of Emisphere Technologies, Inc., a publicly held biopharmaceutical company specializing in oral drug delivery. He was a partner at Ernst and Young LLP from March 1999 to December 2003 and served as a Vice President at Goldman Sachs, Inc., JP Morgan Securities, Inc. and Bankers Trust Securities, Inc. at various times during March 1991 to March 1999. Mr. Maza was an investment banking associate at Goldman Sachs, Inc. from April 1989 to March 1991. Mr. Maza practiced law at Sullivan and Cromwell in New York from September 1985 to April 1989. Mr. Maza serves on the Board of Directors and is Chairman of the Audit Committee of Apollo Solar Energy, Inc., a Chinese producer of material used to manufacture solar cells. Mr. Maza is qualified to serve as a director of the Company based on his experience as a senior executive in several biotech and biopharma companies and his positions as chief financial officer of the Company.

 

Isaac Onn. Mr. Onn serves as director on the Board of a number of private and public companies across diverse industry sectors. He previously served as a director of Diversified Senior Services, Inc., a developer and manager of low and moderate income senior housing and assisted living facilities. Also, Mr. Onn served as the CEO and a partner of Erez Tal Bar - Fueling Services Ltd., an Israeli company that builds and manages fuel stations. Mr. Onn received his degree in business administration and marketing from the Tel-Aviv College of Management and his LLB, Bachelor of Law degree from Ono Academic College Law School in Israel. Mr. Onn is qualified to serve as a director of the Company based on prior employment experience and as a director of public and private companies.

 

Conflicts of Interest

 

Certain potential conflicts of interest are inherent in the relationships between the Company’s officers and directors and the Company.

 

From time to time, one or more of the Company’s affiliates may form or hold an ownership interest in and/or manage other businesses both related and unrelated to the type of business that the Company own and operate. These persons expect to continue to form, hold an ownership interest in and/or manage additional other businesses which may compete with the Company’s business with respect to operations, including financing and marketing, management time and services and potential customers. These activities may give rise to conflicts between or among the interests of us and other businesses with which the Company’s affiliates are associated. The Company’s affiliates are in no way prohibited from undertaking such activities, and neither the Company nor the Company’s shareholders will have any right to require participation in such other activities.

 

Further, because we intend to transact business with some of the Company’s officers, directors and affiliates, as well as with firms in which some of the Company’s officers, directors or affiliates have a material interest, potential conflicts may arise between the respective interests of us and these related persons or entities. The Company believes that such transactions will be effected on terms at least as favorable to us as those available from unrelated third parties.

 

With respect to transactions involving real or apparent conflicts of interest, we have adopted policies and procedures which require that: (i) the fact of the relationship or interest giving rise to the potential conflict be disclosed or known to the directors who authorize or approve the transaction prior to such authorization or approval, (ii) the transaction be approved by a majority of our disinterested outside directors, and (iii) the transaction be fair and reasonable to us at the time it is authorized or approved by our directors.

 

Our policies and procedures regarding transactions involving potential conflicts of interest are not in writing.  We understand that it will be difficult to enforce our policies and procedures and will rely and trust the our officers and directors to follow our policies and procedures.  We will implement our policies and procedures by requiring the officer or director who is not in compliance with our policies and procedures to remove himself and the other officers and directors will decide how to implement the policies and procedures, accordingly.

 

Involvement in Certain Legal Proceedings

 

To the Company’s knowledge, during the past ten (10) years, none of the Company’s directors, executive officers, promoters, control persons, or nominees has been:

 

§the subject of any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time;

 

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§convicted in a criminal proceeding or is subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

  

§subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities; or

 

§found by a court of competent jurisdiction (in a civil action), the Commission or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law

 

 Director Independence

 

Our Board of Directors has determined that currently Isaac Onn qualifies as “independent” as the term is used in Item 407 of Regulation S-K as promulgated by the SEC and in the listing standards of The Nasdaq Stock Market, Inc. – Marketplace Rule 4200.

 

Meetings and Committees of the Board of Directors

 

Our board of directors held no formal meetings during the most recently completed fiscal year. All proceedings of the board of directors were conducted by resolutions that were consented to in writing by all the directors and filed with the minutes of the proceedings of the directors. Such resolutions consented to in writing by the directors entitled to vote on that resolution at a meeting of the directors are, according to the corporate laws of the State of Delaware and our bylaws, as valid and effective as if they had been passed at a meeting of the directors duly called and held.

 

 Committees

 

Our business, property and affairs are managed by or under the direction of the board of directors. Members of the board are kept informed of our business through discussion with the chief executive and financial officers and other officers, by reviewing materials provided to them and by participating at meetings of the board and its committees. We presently do not have any committees of our board of directors; however, our board of directors intends to establish various committees at some point in the near future.

 

 Compliance with Section 16(a) of the Exchange Act

 

Section 16(a) of the Securities Exchange Act of 1934 requires our directors and executive officers and persons who beneficially own more than ten percent of a registered class of our equity securities to file with the SEC initial reports of ownership and reports of change in ownership of common stock and other equity securities of our company. Officers, directors and greater than ten percent stockholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file. Based solely upon a review of Forms 3 and 4 and amendments thereto furnished to us under Rule 16a-3(e) during the fiscal year ended June 30, 2013, and Forms 5 and amendments thereto furnished to us with respect to the fiscal year ended June 30, 2013, we believe that during the year ended June 30, 2013, our executive officers, directors and all persons who own more than ten percent of a registered class of our equity securities have complied with all Section 16(a) filing requirements.

 

Director Compensation

 

All of our directors hold office until they resign or are removed from office in accordance with our bylaws.

 

Our non-employee directors are entitled to receive a directors’ fee of $2,000 per month, in addition to reimbursement for any expenses incurred by them in attending Board meetings. In addition, the non-employee directors are each entitled to a one time award of 10,000 shares or options to purchase shares of Company common stock.  We have entered into indemnification agreements with each of our directors, which provides, among other things that we will indemnify each director, under certain circumstances, for defense expenses, damages, judgments, fines and settlements incurred by the director in connection with actions or proceedings to which he or she may be a party as a result of his or her position as a member of our Board, and otherwise to the full extent permitted under our bylaws and state law. During the fiscal year ended June 30, 2012, Isaac Onn, our sole independent director, earned fees of $24,856.

 

Code of Ethics

 

Our Board has adopted a Code of Ethics that applies to our Chief Executive Officer and our Chief Financial Officer as well as to our other senior management and senior financial staff. Our Code of Ethics complies with the requirements imposed by the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations issued thereunder for codes of ethics applicable to such officers. Our Code of Ethics is available, and is incorporated herein by reference, on our website, located at http://www.intellectns.com

 

56
 

 

Item 11. Executive Compensation.

 

Summary Compensation Table

 

The following table sets forth certain information about the compensation paid or accrued to the persons who served as our Chief Executive Officer and all other executive officers during the last completed fiscal year whose total compensation exceeded $100,000 for that year (the “named executive officers”).

 

Summary Compensation Table – 2013
                                
                       Non-Qualified        
                   Non-Equity   Deferred        
               Stock   Incentive Plan   Compensation   All Other    
       Salary   Bonus   Awards   Compensation   Earnings   Compensation    
Name and Principal Position  Year   ($)   ($)   ($)   ($)   ($)   ($)  Total 
                                
Daniel Chain   2012    438,380    325,000    -    -    -   12,925(A)  776,305 
Chief Executive Officer, Director   2013    291,450    -    -    -    -   -  291,450 
                                       
Elliot Maza,   2012    223,495    100,000    -    -    -   -  323,495 
Chief Financial Officer, Director   2013    109,615    -    -    -    -   1,720(B)  111,335 

 

(A)Includes payment of life insurance premiums of $12,925 for the year ended June 30, 2012.

 

(B)Includes payment of reimbursed auto expenses of $1,720 for the year ended June 30, 2013.

 

Outstanding Equity Awards At Fiscal Year End

 

The following table generally sets forth the number of outstanding equity awards that have not been earned or vested or that have not been exercised for each named executive officer as of June 30, 2012:

 

   Option Awards           Stock Awards 
Name  Number of
securities
underlying
unexercised
options (#)
exercisable
   Number of
securities
underlying
unexercised
options (#)
unexercisable
   Equity Incentive
Plan awards:
Number of
securities
underlying
unexercised
unearned options
   Option
exercise
price ($)
   Option
expiration
date
   Number of
shares or
units of stock
that have not
vested (#)
   Market value
of shares or
units of stock
that have not
vested ($)
   Equity Incentive
Plan awards:
Number of
unearned shares,
units or other
rights that have
not vested
   Equity Incentive
Plan awards:
Market value of
unearned shares,
units or other
rights that have
not vested
 
                                     
Daniel Chain   139,905    -    -   $37.00    01/25/17    -    -    -    - 
                                              
Elliot Maza   60,838    -    -   $37.00    01/25/17    -    -    -    - 

 

Item 12.   Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 

The following table sets forth certain information as of October 15, 2013, regarding the beneficial ownership of shares of our common stock by each person known to us to be the beneficial owner of more than 5% of our common stock, each of our named executive officers, each member of our board of directors, and all members of our board of directors and executive officers as a group.

 

Beneficial ownership is determined in accordance with rules promulgated under the Exchange Act and generally includes voting and/or investment power with respect to securities. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock issuable upon the exercise of stock options, warrants or the conversion of other securities held by that person that are currently exercisable or convertible, or are exercisable or convertible within 60 days, are deemed to be issued and outstanding.

 

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Name and Address  Amount and Nature     
of Beneficial Holder (1)  of Beneficial Ownership   Percent of Class (2) 
         
Daniel G. Chain   139,905(2)   0.01%
           
Elliot Maza   60,838(3)   0.005%
           
Isaac Onn   70,000(4)   0.005%
           
Directors and executive officers as a group (3 persons)   270,743    0.02%

 

 

(1)           Except as otherwise noted, the address of record of each of the following individuals is: c/o Intellect Neurosciences, Inc., 550 Sylvan Avenue, Englewood Cliffs, NJ 07632.

 

(2)           Includes 139,905 shares of common stock which may be acquired within 60 days upon the exercise of stock options.

 

(3)           Includes 60,838 shares of common stock which may be acquired within 60 days upon the exercise of stock options.

 

(4)           Includes 40,000 shares of common stock which may be acquired within 60 days upon the exercise of stock options.

 

Item 13.  Certain Relationships and Related Transactions, and Director Independence.

 

We describe below any transactions, arrangements or relationships of which we are aware, as of the date of filing of this current report, which occurred since the beginning of the last fiscal year or are currently proposed to which we are or will be a participant (as defined in Item 404 of Regulation S-K); in which the amount involved exceeded or will exceed $120,000; and in which any related person (as defined in Item 404 of Regulation S-K) has or will have a direct or indirect material interest. We include in the description below transactions involving certain of our founders and control persons.

 

Certain Relationships Involving Margie Chassman and David Blech

 

Ms. Margie Chassman is one of our founding principal stockholders and is the spouse of Mr. David Blech. Ms. Chassman beneficially owns 11.0% of our common stock, including shares by a trust, for which Ms. Chassman serves as Trustee and of which one of Mr. Blech’s sons is a beneficiary. Ms. Chassman has expressly disclaimed beneficial ownership of certain of the shares that applicable SEC rules deem her to beneficially own. See “Item 12 - Security ownership of certain beneficial owners and management and related stockholder matters.”

 

Item 14. Principal Accountant Fees and Services.

 

Audit Fees

 

The aggregate fees billed by our principal accountant for the audit of our annual financial statements, review of financial statements included in the quarterly reports and other fees that are normally provided by the accountant in connection with statutory and regulatory filings or engagements for the fiscal years ended June 30, 2013 was $47,500 and June 30, 2012 was $72,500.

 

Audit-Related Fees

 

The aggregate fees billed by our principal accountant for assurance and advisory services that were related to the performance of the audit or review of our financial statements for the fiscal year ended June 30, 2013 was $0 and June 30, 2012 was $0.

  

Tax Fees

 

The aggregate fees billed for professional services rendered by our principal accountant for tax compliance, tax advice and tax planning for the fiscal years ended June 30, 2013 and 2012 was $0 for both periods.

  

All Other Fees

 

The aggregate fees billed for products and services provided by someone other than our principal accountant for the fiscal years ended June 30, 2013, was $4,500 and June 30, 2012 was $22,755.

 

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Policy on Audit

 

We do not currently have an Audit Committee.  The policy of our Board of Directors, which acts as our Audit Committee, is to pre-approve all audit and permissible non-audit services provided by the independent auditors. These services may include audit services, audit-related services, tax services and other services. Pre-approval is generally provided for up to one year and any pre-approval is detailed as to the particular service or category of services and is generally subject to a specific budget. The independent auditors and management are required to periodically report to our Board of Directors regarding the extent of services provided by the independent auditors in accordance with this pre-approval, and the fees for the services performed to date. The Board of Directors may also pre-approve particular services on a case-by-case basis.

 

Item 15. Exhibits and Financial Statement Schedules.

 

The exhibits filed or furnished with this Form 10-K are shown on the Exhibit List that follows the signatures hereto, which list is incorporated herein by reference.

 

EXHIBIT INDEX

 

2.1   Agreement and Plan of Merger, dated as of January 25, 2007, by and among GlobePan Resources, Inc., INS Acquisition, Inc., and Intellect Neurosciences, Inc. 2
2.2   Sale, Assignment, Assumption and Indemnification Agreement, dated January 25, 2007, by and between GlobePan Resources, Inc. and Russell Field 2
3.1   Plan of Conversion of GlobePan Resources, Inc. (Nevada), dated January 24, 2007 1
3.2   Articles of Conversion for GlobePan Resources, Inc. (Nevada), dated January 24, 2007 1
3.3    Certificate of Conversion for GlobePan Resources, Inc. (Nevada), dated January 24, 2007 1
3.4   Certificate of Incorporation of GlobePan Resources, Inc. (Delaware), dated January 24, 2007 1
3.5   Certificate of Merger of INS Acquisition, Inc. with and into Intellect Neurosciences, Inc., dated January 25, 2007 2
3.6   Bylaws of GlobePan Resources, Inc., dated January 25, 2007 1
3.7   Certificate of Amendment to Certificate of Incorporation of GlobePan Resources, Inc., dated January 26, 2007 2
3.8   Certificate of Designation of Series B Convertible Preferred Stock of the Company 4
3.9   Certificate of Amendment to Certificate of Incorporation (Incorporated by reference to the Company’s Form 8-K filed with the SEC on February 25, 2010)
3.10   Certificate of Amendment to Certificate of Incorporation (Incorporated by reference to the Company’s Form 8-K filed with the SEC on May 10, 2010
4.1   Form of Employee Incentive and Nonqualified Stock Option Agreement under the 2005 Stock Option Plan 2
4.2   Form of Director Stock Option Agreement under the 2005 Stock Option Plan 2
4.3   Form of Notice of Stock Option Award under 2006 Equity Incentive Plan 2
4.4   Form of Convertible Note Warrant 2
4.5   Form of Convertible Note Warrant 2
4.6   Form of Series B Warrant 2
4.7   Form of Extension Warrant 2
4.8   Form of Exchange Agreement by and between the Company and certain holders of common stock of the Company 4
4.9   Form of Convertible Promissory Note 5
4.10   Form of Warrant 5
4.11   Form of Promissory Note (Incorporated by reference to the Company’s Form 8-K filed with the SEC on August 18, 2009)

4.12   Form of Warrant (Incorporated by reference to the Company’s Form 8-K filed with the SEC on August 18, 2009)
4.13   Convertible Promissory Note (Incorporated by reference to the Company’s Form 8-K filed with the SEC on February 25, 2010)
4.14   Convertible Promissory Note (Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 29, 2010)
4.15   Common Stock Purchase Warrant (Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 29, 2010)
4.16   Common Stock Purchase Warrant (Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 29, 2010)
4.17   Common Stock Purchase Warrant (Incorporated by reference to the Company’s Form 8-K filed with the SEC on April 29, 2010)
10.1   Form of Indemnification Agreement by and between Intellect Neurosciences and each of: Kelvin Davies, William P. Keane, Harvey L. Kellman, Elliot Maza, Kathleen P. Mullinix, Eliezer Sandberg and David Woo 2
10.2   2005 Employee, Director and Consultant Stock Option Plan 2
10.3   2006 Equity Incentive Plan 2
10.4   Amendment No. 1 to the 2006 Equity Incentive Plan 4
10.5   Asset Transfer Agreement, dated as of June 23, 2005, by and between Intellect Neurosciences, Inc. and Mindset Biopharmaceuticals (USA), Inc. 2

 

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10.6   License Agreement by and between New York University and Mindset Limited, effective as of August 10, 1998; Amendment to the 1998 Agreement, effective as of September 2002 2, 3
10.7   Research and License Agreement by and between the South Alabama Medical Science Foundation and Mindset Limited, effective as of August 10, 1998 (the “1998 Agreement”); Amendment I to the 1998 Agreement, effective as of September 11, 2000 (the “Amendment I”); and Amendment II to the 1998 Agreement, effective as of September 1, 2002 2, 3
10.8   Transgenic Animal Non-Exclusive License and Sponsored Research Agreement, dated as of October 24, 1997, by and between Intellect Neurosciences, Inc. and Mayo Foundation for Medical Education and Research 2
10.9   Assignment Agreement, dated as of June 6, 2000, by and between Mindset Biopharmaceuticals (USA), Inc. and Dr. Benjamin Chain 2
10.10   Research and License Agreement by and between New York University and Intellect Neurosciences, Inc., effective as of April 1, 2006 2, 3
10.11   Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement effective as of December 26, 2006 by and between the Company and Immuno-Biological Laboratories Co., Ltd. 3
10.12   Lease Agreement, dated as of July 11, 2005, by and between Intellect Neurosciences, Inc. and Scandia Realty Partnership Limited 2
10.13   English Summary of Israel Lease Agreement in Hebrew Language by and between Intellect Neurosciences (Israel) Ltd. and Africa Israel Nechasim Ltd. 2
10.14   Amended and Restated Employment Agreement, dated as of January 15, 2007, by and between Intellect Neurosciences, Inc. and Daniel Chain 2
10.15   Amended and Restated Employment Agreement, dated as of January 15, 2007, by and between Intellect Neurosciences, Inc. and Elliot Maza 2
10.16   Employment Agreement, dated as of June 25, 2005, by and between Intellect Neurosciences, Inc. and Vivi Ziv 2
10.17   Consulting Agreement, dated as of January 3, 2007, by and between Intellect Neurosciences, Inc. and Mark Germain 2
10.18   Consulting Agreement, dated as of July 1, 2005, by and between Intellect Neurosciences, Inc. and Harvey Kellman 2
10.19   Consulting Agreement, dated as of December 1, 2005, by and between Intellect Neurosciences, Inc. and Kelvin Davies 2
10.20   License Agreement by and among Intellect Neurosciences, Inc. and AHP Manufacturing BV acting through its Wyeth Medica Ireland Branch and Elan Pharma International Limited, as of May 13, 2008 6
10.21   Research and Collaboration Agreement by and between Medical Research Council Technology and Intellect Neurosciences, Inc., as of August 6, 2007 7
10.22   Amendment to Collaborative Research Agreement between Medical Research Council Technology and Intellect Neurosciences, Inc., as of June 19, 2008 7
10.23   Option & License Agreement by and among Intellect Neurosciences, Inc. and [***], as of October 3, 2008 8
10.24   Option & License Agreement by and between Intellect Neurosciences, Inc. and Glaxo Group Limited, dated as of April 29, 2009 9
10.25   Employment Agreement between the Company and Dr. Daniel Chain (filed herewith)
10.26   Employment Agreement between the Company and Elliot Maza (filed herewith)
14.1   Code of Ethics and Business Conduct 2
21.1   List of Subsidiaries 2
31.1   Certification pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)
31.2   Certification pursuant to Rule 13a-14(a) and 15d-14(a) as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith)

32.1   Certification pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
32.2   Certification pursuant to Rule 18 U.S.C Section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002 (filed herewith)
1   Incorporated by reference to our Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 30, 2007 .
2   Incorporated by reference to our Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 31, 2007.
3   Incorporated by reference to our Annual Report on Form 10-K SB, filed with the Securities and Exchange Commission on October 15, 2007.
    Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission.
4   Incorporated by reference to our Current Report on Form 8-K, filed with the Securities and Exchange Commission on July 16, 2007.
5   Incorporated by reference to our Current Report on Form 8-K, filed with the Securities and Exchange Commission on July 3, 2007.
6   Incorporated by reference to our Annual Report on Form 10-K SB, filed with the Securities and Exchange Commission on November 6, 2008.

 

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    Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission.
7   Incorporated by reference to our Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 19, 2008.
    Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission.
8   Incorporated by reference to our Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on February 17, 2009.
    Confidential treatment has been granted for the redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission
9   Incorporated by reference to our Annual Report on Form 10-KSB, filed with the Securities and Exchange Commission on October 13, 2009.
    Confidential treatment has been granted for redacted portions of this agreement. A complete copy of this agreement, including the redacted portions, has been filed separately with the Securities and Exchange Commission

 

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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.

 

In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

 

Dated: October 15, 2013 INTELLECT NEUROSCIENCES, INC.
     
    /s/ Elliot Maza
    Elliot Maza
   

Principal Executive Officer, Consulting Chief Financial
Officer (Principal Financial and Accounting Officer)

 

SIGNATURES   TITLE   DATE
         
/s/ Elliot Maza        
    Principal Executive Officer    
Elliot Maza   Consulting CEO, CFO and Director   October 15, 2013
    (Principal Financial and Accounting Officer)    
         
/s/ Isaac Onn        
         
Isaac Onn   Director   October 15, 2013

 

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