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Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-Q

 

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2013

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission File Number 0-6533

 

 

ALSERES PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware   87-0277826

(State or Other Jurisdiction of

Incorporation or Organization)

 

(IRS Employer

Identification No.)

239 South Street, Hopkinton, Massachusetts   01748
(Address of Principal Executive Offices)   (Zip Code)

(508) 497-2360

(Registrant’s Telephone Number, Including Area Code)

None

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

 

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

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

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    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 July 31, 2013, there were 30,635,720 shares of the registrant’s Common Stock issued and outstanding.

 

 

 


Table of Contents

ALSERES PHARMACEUTICALS, INC.

FORM 10-Q

TABLE OF CONTENTS

 

     Page  

Part I FINANCIAL INFORMATION

  

Item 1 Financial Statements (Unaudited)

  

Condensed Consolidated Balance Sheets as of June 30, 2013 and December 31, 2012

     3   

Condensed Consolidated Statements of Comprehensive Loss for the three months ended March  31, 2013 and 2012, for the six months ended June 30, 2013 and 2012 and for the period from inception (October 16, 1992) to June 30, 2013

     4   

Condensed Consolidated Statements of Cash Flows for the six months ended June  30, 2013 and 2012, and for the period from inception (October 16, 1992) to June 30, 2013

     5   

Notes to Condensed Consolidated Financial Statements

     7   

Item 2 Management’s Discussion and Analysis of Financial Condition and Results of Operations

     13   

Item 3 Quantitative and Qualitative Disclosures About Market Risk

     16   

Item 4 Controls and Procedures

     16   

Part II OTHER INFORMATION

     17   

Item 1 Legal Proceedings

     17   

Item 6 Exhibits

     18   

SIGNATURES

     19   

EX-31.1

  

EX-31.2

  

EX-32.1

  

EX-32.2

  

EX-101 INSTANCE DOCUMENT

  

EX-101 SCHEMA DOCUMENT

  

EX-101 CALCULATION LINKBASE DOCUMENT

  

EX-101 LABELS LINKBASE DOCUMENT

  

EX-101 PRESENTATION LINKBASE DOCUMENT

  

EX-101 DEFINITION LINKBASE DOCUMENT

  

In this report, “we”, “us”, and “our” refer to Alseres Pharmaceuticals, Inc. The following are trademarks of ours that are mentioned in this Quarterly Report on Form 10-Q: Alseres™ and Altropane ® . All other trade names, trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners and are not the property of Alseres Pharmaceuticals, Inc. or any of our subsidiaries.

 

2


Table of Contents

Part I — FINANCIAL INFORMATION

Item 1 — Financial Statements

Alseres Pharmaceuticals, Inc.

(A Development Stage Company)

Consolidated Balance Sheets

(unaudited)

 

     (Unaudited)
June 30, 2013
    December 31,
2012
 
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 27,982      $ 16,528   

Short-term investments

     25,878        838,309   

Restricted marketable securities

       42,450   

Prepaid expenses and other current assets

     31,355        2,720   
  

 

 

   

 

 

 

Total current assets

     85,215        900,007   

Property and equipment, net

     —          1,186   

Deferred charges

     62,671        64,514   
  

 

 

   

 

 

 

Total assets

   $ 147,886      $ 965,707   
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ DEFICIT     

Current liabilities:

    

Accounts payable and accrued expenses

   $ 1,726,506      $ 2,278,398   

Notes payable

     6,460,000        6,410,000   

Accrued interest on notes payable

     1,142,225        919,526   

Deferred revenue

     73,730        73,730   

Other current liabilities

     —          60,126   

Advances from related party

     425,000        325,000   
  

 

 

   

 

 

 

Total current liabilities

     9,827,461        10,066,780   

Contingent royalty

     16,000,000        16,000,000   

Deferred revenue, net of current portion

     1,179,683        1,216,547   

Other long-term liabilities

     33,750        33,750   
  

 

 

   

 

 

 

Total liabilities

   $ 27,040,894        27,317,077   
  

 

 

   

 

 

 

Commitments and contingencies

    

Series F convertible redeemable preferred stock, $.01 par value; 200,000 shares designated; 12,000 shares issued and outstanding at June 30, 2013 and December 31, 2012, (liquidation preference of $300,000 at June 30, 2013)

     379,857        369,501   
  

 

 

   

 

 

 

Stockholders’ deficit:

    

Preferred stock, $.01 par value; 1,000,000 shares authorized; 25,000 shares designated Convertible Series A, 500,000 shares designated Convertible Series D and 800 shares designated Convertible Series E; no shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively

     —         —    

Common stock, $.01 par value; 80,000,000 shares authorized at June 30, 2013 and December 31, 2012; 30,635,720 issued and outstanding at June 30, 2013 and December 31, 2012

     306,357        306,357   

Additional paid-in capital

     171,965,164        171,975,520   

Accumulated other comprehensive loss

     (32,935     (309,204

Deficit accumulated during development stage

     (199,511,451     (198,693,544
  

 

 

   

 

 

 

Total stockholders’ deficit

     (27,272,865     (26,720,871
  

 

 

   

 

 

 

Total liabilities and stockholders’ deficit

   $ 147,886      $ 965,707   
  

 

 

   

 

 

 

 

3


Table of Contents

Alseres Pharmaceuticals, Inc.

(A Development Stage Company)

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

 

     Three Months Ended June 30,     Six Months Ended June 30,     For the period from
October 16, 1992
(inception) to
 
     2013     2012     2013     2012     June 30, 2013  

Revenue

   $ 18,432      $ 250,000      $ 36,864      $ 500,000      $ 1,467,584   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

          

General and administrative

     370,924        418,676        810,604        865,039        71,293,097   

Research and development

     —          20,545        —          41,239        116,092,348   

Sub-license and Option Fees

             26,536   

Purchased in-process research and development

     —          —          —          —          12,146,544   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses before accrual reversal

     370,924        439,221        810,604        906,278        199,558,525   

Accrual reversal

     —          —          (405,026     —          (966,221
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     370,924        439,221        405,578        906,278        198,592,304   

Loss from operations

     (352,492     (189,221     (368,714     (406,278     (197,124,720 )

Interest expense

     (111,243     (105,716     (222,110     (209,113     (15,145,771
    

 

 

       

Realized loss on sale of marketable securities

     (56,317       (227,083    

Investment income

     —          29        —          277        7,705,345   

Other income (expense), net

       —            905        (1,473,159

Gain on early extinguishment of debt

     —          —          —          —          6,277,100   

Forgiveness of debt

     —          —          —          —          476,837   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (520,052     (294,908     (817,907     (614,209     (199,511,451

Preferred stock beneficial conversion feature

     —          —          —          —          (8,062,712

Accrual of preferred stock dividends and modification of warrants held by preferred stock stockholders

     —          —          —          —          (1,229,589
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

     (520,052     (294,908     (817,907     (614,209     (208,803,752

Other comprehensive income

          

Unrealized holding gain(loss) arising during the year

     (6,306       49,186          (260,018

Less: reclassification adjustments for loss on Sale included in net loss

     56,317        (12,938     227,083        (7,057     227,083   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net unrealized gain( loss) on marketable securities

     50,011        (12,938     276,269        (7,057     (32,935
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (470,041   $ (307,846   $ (541,638   $ (621,266   $ (208,836,687
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss attributable to common stockholders per share

   $ (0.02 )   $ (0.01   $ (0.03   $ (0.02  
  

 

 

   

 

 

   

 

 

   

 

 

   

Weighted average common shares outstanding

     30,635,720        30,635,720        30,635,720        30,635,720     
  

 

 

   

 

 

   

 

 

   

 

 

   

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

4


Table of Contents

Alseres Pharmaceuticals, Inc.

(A Development Stage Company)

Consolidated Statements of Cash Flows

(Unaudited)

 

     Six Months Ended June 30,    


Period from
October 16, 1992

(inception) to

June 30,

 
     2013     2012     2013  

Cash flows from operating activities:

      

Net loss

   $ (817,907   $ (614,209 )   $ (199,511,451

Adjustments to reconcile net loss to net cash used for operating activities:

      

Purchased in-process research and development

     —          —          12,146,544   

Write-off of acquired technology

     —          —          3,500,000   

Loss on disposition of assets

     —          —          3,391   

Interest expense settled through issuance of notes payable

     —          —          350,500   

Expenses satisfied with the issuance of stock

     —          —          28,680   

Forgiveness of debt

     —          —          (476,837

Gain on early extinguishment of debt

     —          —          (6,277,100

Non-cash gain on restricted stock valuation

     —          —          (58,814

Non-cash interest expense

     —          —          3,966,394   

Non-cash charges related to options, warrants and common stock

     —          —          11,115,437   

Amortization of financing costs

     —          —          25,188   

Amortization and depreciation

     1,186        893        2,893,141   

Loss on sales of marketable securities

     227,083        —          227,083   

Changes in operating assets and liabilities:

      

(Increase) decrease in prepaid expenses and other current assets

     13,815        (39,043     518,423   

(Increase) decrease in deferred charges

     1,843        —          (62,671

Increase (decrease) in accounts payable and accrued expenses

     (551,892     86,813        1,430,679   

Increase in accrued interest payable

     222,699        208,255        8,470,331   

Increase (decrease) in deferred revenue

     (36,864     —          164,713   

Increase(decrease) in current liabilities

     (60,126     —          (42,450

Increase in other long-term liabilities

     —          —          33,750   

Decrease in accrued lease

     —          —          —     
  

 

 

   

 

 

   

 

 

 

Net cash used for operating activities

     (1,000,163     (357,291     (161,555,069
  

 

 

   

 

 

   

 

 

 

Cash flows from investing activities:

      

Cash acquired through Merger

     —          —          1,758,037   

Purchases of property and equipment

     —          —          (1,654,487

Proceeds from the sale of property and equipment

     —          —          3,430   

Decrease in security deposits and other assets

     —          —          —     

Decrease in indemnity fund

     —          —          —     

Purchases of marketable securities

     —          —          (132,004,923

Sales and maturities of marketable securities

     861,617        —          132,866,540   
  

 

 

   

 

 

   

 

 

 

Net cash provided by investing activities

     861,617        —          968,597   
  

 

 

   

 

 

   

 

 

 

 

5


Table of Contents

Alseres Pharmaceuticals, Inc.

(A Development Stage Company)

Condensed Consolidated Statements of Cash Flows (continued)

(Unaudited)

 

                 


Period from
October 16, 1992

(inception) to

 
     Six Months Ended June 30,     June 30,  
     2013      2012     2013  

Cash flows from financing activities:

       

Proceeds from issuance of common stock

     —           —          66,731,339   

Buyback of common stock

     —           —          (28,222

Advances from related party

     100,000         —          425,000   

Proceeds from issuance of preferred stock

     —           —          39,922,170   

Preferred stock conversion inducement

     —           —          (600,564

Proceeds from issuance of promissory notes

     50,000         285,000        59,045,000   

Proceeds from issuance of convertible debentures

     —           —          9,000,000   

Principal payments of notes payable/repurchase of debt

     —           —          (7,750,667

Dividend payments on Series E Cumulative Convertible Preferred Stock

     —           —          (516,747

Payments of financing costs

     —           —          (5,612,855
  

 

 

    

 

 

   

 

 

 

Net cash provided by financing activities

     150,000         285,000        160,614,454   
  

 

 

    

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

     11,454         (72,291     27,982   

Cash and cash equivalents, beginning of period

     16,528         135,843        —     
  

 

 

    

 

 

   

 

 

 

Cash and cash equivalents, end of period

   $ 27,982       $ 63,552      $ 27,982   
  

 

 

    

 

 

   

 

 

 

Supplemental cash flow disclosures:

       

Cash paid for interest

        $ 628,406   

Supplemental disclosure of non-cash financing activity:

       

Conversion of notes payable to common stock

   $ —         $ —        $ 13,000,000   

Capital contribution related to forgiveness of accrued interest

   $ —         $ —        $ 6,328,306   

Accrued interest reclassified in connection with conversion of Series F convertible redeemable preferred stock to common stock

   $ —         $ —        $ 640,874   

Receipt of marketable securities as payment for license agreement

   $ —         $ —        $ 1,146,000   

Conversion of notes payable to future royalties

   $ —         $ —        $ 16,000,000   

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

6


Table of Contents

Alseres Pharmaceuticals, Inc.

(A Development Stage Company)

Notes to Consolidated Financial Statements (Unaudited)

June 30, 2013

1. Nature of Operations and Basis of Presentation

Nature of Operations

Alseres Pharmaceuticals, Inc. and its subsidiaries (the “Company”) is a biotechnology company engaged in the development of therapeutic and diagnostic products primarily for disorders in the central nervous system. The Company was founded in 1992 and merged with a publicly held company in 1995 (the “Merger”) whereby the Company changed its name to Boston Life Sciences, Inc. Effective June 7, 2007, the Company changed its name to Alseres Pharmaceuticals, Inc. During the period from inception through June 30, 2013, the Company has devoted substantially all of its efforts to business planning, raising financing, furthering the research and development of its technologies, and corporate partnering efforts. Accordingly, the Company is considered to be a “development stage enterprise” as defined in Accounting Standards Codification 915 (ASC 915) Development Stage Entities and will continue to be so until we realize royalty revenue from our outlicensed intellectual property. Our development stage started on October 16, 1992 and has continued through June 30, 2013, and is expected to continue for the foreseeable future.

As of June 30, 2013, we had experienced total net losses since inception of approximately $199,511,451, stockholders’ deficit of approximately $27,272,865 and a net working capital deficit of approximately $9,742,000. For the foreseeable future, we expect to experience continuing operating losses and negative cash flows from operations as we execute our current business plan. The cash and cash equivalents available at June 30, 2013 will not provide sufficient working capital to meet our anticipated expenditures for the next twelve months. From January 2013 through June 30, 2013 we liquidated 285,000 shares of our Navidea Biopharmaceuticals, Inc. (“Navidea” AMEX:NAVB) common stock for total proceeds of $861,618. We used these proceeds to settle our lawsuit with Children’s Hospital and to meet our day-to-day obligations and continue to comply with our regulatory reporting requirements. We believe that the approximately $50,000 in cash and cash equivalents available as of August 1, 2013 combined with potential cash infusions from our lead investor may enable us to meet our anticipated cash expenditures through August 2013.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements, including our subsidiary Alseres Neurodiagnostics, Inc. have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Accordingly, these financial statements do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements.

The interim unaudited condensed consolidated financial statements contained herein include, in management’s opinion, all adjustments necessary for a fair statement of the financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim period shown on this report are not necessarily indicative of results for a full year. These financial statements should be read in conjunction with the Company’s consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.

The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The uncertainty inherent in the need to raise additional capital and the Company’s recurring losses from operations 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 the outcome of this uncertainty. The Company is taking a number of steps to address the issues regarding our ability to continue as a going concern until such time as routine royalty income from the Navidea transaction is realized by the Company. We are continuing to tightly control our monthly expenses through further cost reductions and elimination of discretionary spending. We are engaged in fundraising efforts that could include one or more of the following: a debt financing or equity offering, a collaboration, merger, acquisition or other transaction. There can be no assurances that any of these efforts will be successful and we may still be forced to curtail or cease operations in such event.

2. Summary of Significant Accounting Policies

Cash and Cash Equivalents

Cash equivalents are short-term, highly liquid financial instruments that are readily convertible to cash and have maturities of 90 days or less from the date of purchase. As of June 30, 2013 and December 31, 2012, cash equivalents consisted of overnight sweep accounts invested in money market funds.

 

7


Table of Contents

Short-term Investments

The Company has designated its marketable securities as of each balance sheet date as available-for-sale securities and accounts for them at their respective fair values. Marketable securities are classified as short-term or long-term investments based on the nature of these securities and the availability of these securities to meet current operating requirements. Marketable securities that are readily available for use in current operations are classified as short-term available-for-sale securities and are reported as a component of current assets in the accompanying condensed consolidated balance sheets. The Company reviews all available-for-sale securities at each period end to determine if they remain available-for-sale based on the Company’s then current intent and ability to sell the security if it is required to do so. As of June 30, 2013 and December 31, 2012, the Company’s short-term investments include shares of common stock in Navidea Biopharmaceutical, Inc. (“NAVB”) and FluoroPharma Medical, Inc. (“FPMI”). The unrealized loss associated with these marketable securities has been determined to be temporary and therefore has been included in other comprehensive loss as a component of stockholders’ deficit.

Restricted Marketable Securities

Under the terms of the Amended and Restated License Agreement with the President and Fellows of Harvard college (“Harvard”) entered into on July 31, 2012, the Company had an obligation to transfer 15,000 shares of the NAVB stock received from the Navidea sublicense agreement to Harvard. The market value of the shares on December 31, 2012 was $42,450 and the Company completed the transfer of the 15,000 shares in January 2013.

Fair Value Measurements

The carrying amounts of the Company’s cash and cash equivalents, prepaid expenses, trade payables, accrued expenses and notes payable approximate their fair value due to the short-term nature of these instruments. Short-term investments consist of available-for-sale-securities as of June 30, 2013 and December 31, 2012 and are carried at fair value. A contingent royalty liability of $16 million is recorded at fair value as discussed in Note 10.

Revenue Recognition

Our revenues have been generated primarily through sublicense and option agreements related to our Altropane product. The terms of these agreements generally contain multiple elements, or deliverables, which have included (i) licenses or options to obtain licenses to our technology; (ii) technology transfer obligations related to the licenses and (iii) research, development, regulatory and commercialization activities to be performed on our behalf. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, up-front license fees; option exercise fees; milestone payments; and royalties on future product sales.

The Company evaluates multiple element revenue arrangements under FASB ASC 605-25, Multiple-Element Arrangements (as amended by ASU No. 2009-13). In addition to the form of the arrangement, the substance of the arrangement is also considered in determining whether separate agreements entered into, at or near the same time, that include elements that are interrelated or interdependent should be treated as one multiple-element arrangement. If the Company concludes that separate agreements represent one arrangement, then all the elements in the separate agreements are combined into one multiple-element arrangement for accounting purposes.

Revenues from non-refundable license fees are recognized upon receipt of the payment if the license has stand-alone value, we do not have ongoing involvement or obligations and we have determined the best estimate of the selling price for any undelivered items. When non-refundable license fees do not meet all of these criteria, the license revenues are recognized over the expected period of performance.

We periodically review our expected period of substantial involvement under the agreements that provide for non-refundable up-front payments and license fees. When applicable, we will adjust the amortization periods when appropriate to reflect changes in assumptions relating to the duration of our expected involvement. We could accelerate revenue recognition for non-refundable upfront payments or license fees in the event of an early termination of the agreements. Alternatively, we could decelerate such revenue recognition if our period of involvement is extended. While changes to such estimates have no impact on our reported cash flows, our reported revenue is significantly influenced by our estimates of the period over which our obligations are expected to be performed and, therefore, over which revenue will be recognized.

Revenues associated with substantive, at-risk milestones pursuant to our licensing agreements are recognized upon achievement of the milestones. We consider a milestone to be substantive at the inception of the arrangement if it is commensurate with either our performance to achieve the milestone or the enhancement of the value of the delivered item as a result of a specific outcome resulting from our performance to achieve the milestone, it relates solely to past performance and it is reasonable relative to all of the deliverables and payment terms within the arrangement. Non-refundable contingent future amounts receivable in connection with future events specified in our licensing agreements that are not considered milestones will be recognized as revenue when payments are earned by our counterparties through completion of any underlying performance obligations, the amounts are fixed or determinable and collectability is reasonably assured.

Comprehensive Income (Loss)

On January 1, 2012, the Company adopted the new presentation requirements under ASU 2011-05, “Presentation of Comprehensive Income”. ASU 2011-05 requires companies to present the components of net income and the components of other comprehensive income either as one continuous statement or as two consecutive statements. As ASU 2011-05 impacts presentation only, it had no effect on the Company’s condensed consolidated financial statements for the three months ended March 31, 2013 and the six months ended June 30, 2013.

 

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3. Accounts Payable and Accrued Expenses

The Company’s accounts payable and accrued expenses consisted of the following:

 

     June 30, 2013      December 31, 2012  

Research and development expenses

   $ 656,354       $ 1,339,851   

Professional fees

     615,219         735,990   

General and administrative expenses

     380,659         121,554   

Compensation related expenses

     74,274         81,003   
  

 

 

    

 

 

 
   $ 1,726,506       $ 2,278,398   
  

 

 

    

 

 

 

On February 15, 2013, the Company entered into Settlement Agreements with Michael Mullen and William Guinness, both members of the Board of Directors of the Company, pursuant to which the Company agreed to satisfy certain outstanding obligations to those individuals which, in aggregate, totaled $167,400 by issuing fully vested options to purchase a total of 167,400 shares of the common stock of Alseres Neurodiagnostics, Inc. ( a wholly owned subsidiary of the Company) at a purchase price to be established by the Company coincident with the closing of an equity financing for Alseres Neurodiagnostics, Inc. The options must be exercised, in whole or in part on or before February 28, 2018. The common stock issued pursuant to the exercise of the options will bear all appropriate restrictive legends on resale or disposition of the common stock. As of June 30, 2013 the options had not yet been issued nor is the closing of an equity financing certain to occur. therefore the associated liability of $167,400 remains outstanding and is recorded in accrued expenses on the balance sheet at June 30, 2013.

4. Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders has been calculated by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. All potentially dilutive common shares have been excluded from the calculation of weighted average common shares outstanding since their inclusion would be anti-dilutive.

Stock options to purchase approximately 3.0 million shares of common stock were outstanding at June 30, 2013, but were not included in the computation of diluted net loss per common share because they were anti-dilutive. Stock options and warrants to purchase approximately 3.0 million shares of common stock were outstanding at June 30, 2012, but were not included in the computation of diluted net loss per common share because they were anti-dilutive. In computing diluted earnings per share, common stock equivalents in the form of convertible redeemable preferred stock were not included in the calculation of net loss per share as their inclusion would be anti-dilutive. The exercise of stock options outstanding at June 30, 2012 could potentially dilute earnings per share in the future.

5. Accounting for Stock-Based Compensation

We have one stock option plan under which we can issue both nonqualified and incentive stock options to employees, officers, consultants and scientific advisors of the Company. At June 30, 2013, the 2005 Stock Incentive Plan (the “2005 Plan”) provided for the issuance of options, restricted stock, restricted stock units, stock appreciation rights or other stock-based awards to purchase 3,450,000 shares of our common stock. The 2005 Plan contains a provision that allows for an annual increase in the number of shares available for issuance under the 2005 Plan on the first day of each of the Company’s fiscal years during the period beginning in fiscal year 2006 and ending on the second day of fiscal year 2014. The annual increase in the number of shares shall be equal to the lowest of 400,000 shares; 4% of the Company’s outstanding shares on the first day of the fiscal year; and an amount determined by the Board of Directors. No increase in the number of shares available for issuance was made in January 2013.

We also have outstanding stock options in three other stock option plans, the 1998 Omnibus Plan, the Amended and Restated Omnibus Stock Option Plan and the Amended and Restated 1990 Non-Employee Directors’ Non-Qualified Stock Option Plan. These plans have expired and no future issuance of awards is permissible.

Our Board of Directors determines the term, vesting provisions, price, and number of shares for each award that is granted. The term of each option cannot exceed ten years.

We use the Black-Scholes option-pricing model to calculate the fair value of each option grant on the date of grant. No stock options were granted during the three months ended June 30, 2013 and 2012.

A summary of our outstanding stock options for the six months ended June 30, 2013 and 2012 is presented below.

 

     2013      2012  
     Shares     Weighted
Average
Exercise Price
     Shares     Weighted
Average
Exercise Price
 

Outstanding at beginning of period

     3,010,980      $ 1.51         3,636,480      $ 1.55   

Granted

     —         —          —         —    

Exercised

     —         —          —         —    

Forfeited and expired

     (8,000     5.00         (625,000     1.75   
  

 

 

   

 

 

    

 

 

   

 

 

 

Outstanding at end of period

     3,002,980      $ 1.50         3,011,480      $ 1.51   
  

 

 

   

 

 

    

 

 

   

 

 

 

Options exercisable at end of period

     3,002,980      $ 1.50         3,011,480      $ 1.51   
  

 

 

   

 

 

    

 

 

   

 

 

 

 

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The following table summarizes information about stock options outstanding and exercisable at June 30, 2013:

 

Range of Exercise Prices

   Number Outstanding      Weighted Average
Remaining
Contractual Life
     Weighted Average
Exercise Price
 

$1.15 — $1.36

     2,287,500         0.9 years       $ 1.15   

$2.00 — $3.00

     539,980         2.2 years         2.33   

$3.10 — $4.65

     155,000         4.3 years         3.17   

$4.99 — $6.96

     20,500         .8 years         5.66   
  

 

 

    

 

 

    

 

 

 
     3,010,980         1.3 years       $ 1.50   

There was no intrinsic value of outstanding options and exercisable options as of June 30, 2013. As of June 30, 2013, 809,172 shares were available for grant under the 2005 Stock Incentive Plan.

6. Notes Payable and Debt

Effective July 31, 2012, Robert Gipson, Thomas Gipson, Arthur Koenig and Ingalls & Snyder Value Partners LLP, all lenders to the Company under a Convertible Note Purchase Agreement originally executed in 2007, elected to convert $16,000,000 of principal outstanding under the promissory notes to a royalty on future net sales of the Company’s Altropane product. All other rights under the Convertible Note Purchase Agreement related to the $16,000,000 of principal were waived by the lenders.

The intent of the above convertible debt conversions and modifications was to allow for continued product development by a licensee and was considered to be the most viable option for the debt holders to recoup any of their principal. Based on these factors , these transactions were considered to be concessions and were accounted for as a troubled debt restructuring under the guidance of ASC-470-60-55. As prescribed therein, when estimates are used relating to the maximum future cash payments, as in this case, no gain shall be recognized until the estimated maximum future cash payments fall below the carrying value of the debt before restructuring. As a result of applying this guidance, the Company has determined that the carrying value of the obligation remains at $16,000,000 at June 30, 2013.

 

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Promissory Notes

 

Demand Notes Payable to Significant Stockholder

   June 30, 2013      December 31, 2012  

Unsecured demand note payable; interest rate of 7%: issued December 2009

   $ 350,000       $ 350,000   

Unsecured demand notes payable; interest rate of 7%: issued January 2010 — December 2010

     3,310,000         3,310,000   

Unsecured demand notes payable; interest rate of 7%: issued January 2011 — December 2011

     2,240,000         2,240,000   

Unsecured demand notes payable; interest rate of 7%: issued January 2012 — December 2012

     510,000         510,000   

Unsecured demand notes payable; interest rate of 7%: issued January 2013 — June 2013

     50,000         0   
  

 

 

    

 

 

 
     6,460,000         6,410,000   

Accrued interest

     1,142,225         919,526   
  

 

 

    

 

 

 

Aggregate carrying value

   $ 7,602,225       $ 7,329,526   
  

 

 

    

 

 

 

Interest expense totaling $112,059 and $105,687 was incurred related to the demand notes payable for the three months ended June 30, 2013 and June 30, 2012, respectively. Interest expense totaling $222,697 and $208,836 was incurred related to the demand notes payable for the six months ended June 30, 2013 and June 30, 2012 respectively.

According to a Schedule D/A filed with the SEC on December 27, 2011 Robert Gipson beneficially owned approximately 50.1% of the outstanding common stock of the Company as of that date. Robert Gipson, who serves as a Senior Director of Ingalls & Snyder and a General Partner of ISVP, served as a director of the Company from June 15, 2004 until October 28, 2004. According to a Schedule D/A filed with the SEC on December 27, 2011, Thomas Gipson beneficially owned approximately 15.2% of the outstanding common stock of the Company as of that date. According to a Schedule 13G/A filed with the SEC on June 7, 2011, Arthur Koenig beneficially owned approximately 7% of the outstanding common stock of the Company on June 1, 2011. According to a Schedule 13G/A filed with the SEC on February 2, 2012, ISVP owned approximately 9.99% of the outstanding common stock of the Company as of December 31, 2011. According to a Schedule 13G/A filed with the SEC on February 7, 2012, Ingalls & Snyder LLC beneficially owned approximately 9.99% of the outstanding common stock of the Company on December 31, 2011.

Contingent Royalty Liability

Effective July 31, 2012, Robert Gipson, Thomas Gipson, Arthur Koenig and Ingalls & Snyder Value Partners LLP, all lenders to the Company under a Convertible Note Purchase Agreement originally executed in 2007, elected to convert $16,000,000 of principal outstanding under the promissory notes to a royalty on future net sales of the Company’s Altropane product. See Note 10 for full disclosure of this transaction.

 

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7. Convertible Preferred Stock

Each share of the Company’s Series F Convertible, Redeemable Preferred Stock (“Series F Stock”) can be converted into 25 shares of common stock pursuant to the conversion terms of the Series F Stock contained in the Certificate of Designation for the Series F Stock. All shares of Series F Stock were sold to Robert Gipson in 2009 at $25 per share, yielding the Company aggregate proceeds of $4,600,000. As of June 30, 2013, 12,000 shares of Series F Stock were outstanding and held by Robert Gipson.

8. Commitments and Contingencies

We recognize and disclose commitments when we enter into executed contractual obligations with third parties. We accrue contingent liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.

On March 13, 2012 the Company received notice that Children’s Hospital Boston and Children’s Medical Center Corporation had filed a lawsuit in Middlesex Superior Court, Middlesex County, Massachusetts seeking to recover amounts alleged to be owed by the Company to the plaintiffs.

On February 1, 2013 the Company entered into a Settlement Agreement and Release with Boston Children’s Hospital (BCH) and Children’s Medical Center Corporation (CMCC) in full settlement of the lawsuit filed by BCH and CMCC seeking to recover amounts alleged to be owed by the Company to the plaintiffs totaling $642,906 plus costs. The amount of $642,906 was included in accrued expenses at December 31, 2012 but was incurred and expensed prior to January 1, 2011.

In settlement of all claims by BCH and CMCC, the Company agreed to pay a lump sum of $185,000 to the plaintiffs. In addition to the lump sum payment, the Company agreed to pay to the plaintiffs an additional sum equal to the then cash value of 20,000 shares of the common stock of Navidea upon the occurrence of the first milestone described in Section 4.2 of the sublicense agreement dated as of July 31, 2012 between Navidea and the Company. This second payment is only due upon the occurrence of the first milestone unless the Company declares bankruptcy or alters its agreement with Navidea in a manner that results in the delay or cancellation of said milestone payment in which case CMCC and BCH could bring additional claims against the Company for additional consideration. An adjustment reducing accrued expenses by $405,026 was made in March 2013 to reflect the final settlement with CMCC. This adjustment is reflected as a gain in the Consolidated Statement of Comprehensive Loss for the six month period ended June 30, 2013.

On May 2, 2012 the Company received notice that Biostorage Technologies, Inc (Biostorage). had filed a lawsuit in Marion Superior/Circuit Court, Marion County, Indiana seeking to recover amounts alleged to be owed by the Company to the plaintiffs totaling $119,363. On July 27 , 2013, the Company entered into a settlement agreement with Biostorage pursuant to which the Company agreed to pay a total of $75,000 to Biostorage in three installments as follows: $10,000 on July 31, 2013, $40,000 December 31, 2013 and $25,000 February 28, 2014. The Company also agreed to stipulate a judgment in the amount of $95,000 to be adjusted down by each payment actually made by the Company and so long as each required payment is made by the Company on time, the judgment will be vacated on February 28, 2014. As of June 30, 2013 the Company maintained an accrual of $133,000 on its books which reflects the amount of the alleged claim plus additional legal fees.

Income taxes

The Company is subject to both federal and state income tax for the jurisdiction within which it operates. Within these jurisdictions, the Company is open to examination for tax years ended December 31, 2009 through December 31, 2012. The U.S. Internal Revenue Service (IRS) has completed an audit of tax years 2007 and 2008 and has informed us that no adjustments to the federal tax returns as filed will be proposed as a result of the audit. However, because we are carrying forward income tax attributes such as a net operating loss (“NOL”) from 2006, these attributes can still be audited when utilized on returns filed in the future.

10. Fair Value Measurements

The fair value hierarchy prioritizes observable and unobservable inputs used to measure fair value into three broad levels:

Level 1 — unadjusted quoted prices in active markets for identical securities;

Level 2 — unadjusted quoted prices in markets that are not active,

Level 3 — significant unobservable inputs, including our own assumptions in determining fair value

The following table summarizes the financial assets that we measured at fair value as of June 30, 2013 and December 31, 2012.

 

     June 30, 2013         
     Level 1      Level 2      Level 3      Total  

Available for sale securities

   $ 58,814       $ —         $ —         $ 58,814   

Contingent Royalty

   $ —         $ —         $ 16,000,000       $ 16,000,000   

 

     December 31, 2012         
     Level 1      Level 2      Level 3      Total  

Available for sale securities

   $ 839,309       $ —         $ —         $ 839,309   

Contingent Royalty

   $ —         $ —         $ 16,000,000       $ 16,000,000   

 

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As of June 30, 2013, the Company’s Level 1 short-term investments consist of 39,209 shares of FluoroPharma Medical, Inc. common stock which are traded on the OTX Bulletin Board (“OTCBB”) under the symbol FPMI.

As of December 31, 2012, the Company’s Level 1 short-term investments consisted of 285,000 shares of Navidea Biopharmaceuticals, Inc. common stock which are traded on the NYSE under the symbol NAVB and 39,209 shares of FluoroPharma Medical, Inc. common stock which are traded on the OTX Bulletin Board (“OTCBB”) under the symbol FPMI.

A contingent royalty liability which resulted from the election by certain purchasers of the Company’s Convertible Promissory Note Purchase Agreement (the “Note Purchase Agreement”) to convert a total of $16,000,000 in debt obligation into a right to receive future royalties on net sales of the Company’s Molecular Imaging Products. The Company obtained a third party fair value valuation for its contingent royalty liability as of December 31, 2012. The fair value measurement is based on significant inputs not observable in the market, which require it to be reported as a Level 3 asset within the fair value hierarchy. The valuation uses assumptions that the Company believes would be made by a market participant. In particular, the valuation analysis employed the Income Approach based on the sum of the economic income that an asset is anticipated to produce in the future. In this case that asset is the potential royalty income to be paid to the Company by Navidea as a result of the license agreement for Altropane. The Discounted Cash Flow method of the Income Approach was chosen as the method best suited to valuing the contingent royalty liability. Changes in the fair value of the contingent royalty liability will be reflected in the consolidated statements of comprehensive income in the period they become known. The actual calculated fair value of the liability was $16.6 million, however, as described in Note 6 above, the accounting guidance does not provide for an increase in the liability in a troubled debt restructuring. The Company reviewed the projections and assumptions used in the December 31, 2012 valuation estimate as of June 30, 2013 and determined that no changes from the assumptions used to compute the December 31, 2012 fair value had occurred that would have a material impact on the resulting fair value computation.

11. Related Party Transaction.

During the last 4 months of 2012 and in the first six months of 2013, Robert Gipson provided a total of $425,000 to the Company as an advance against his planned purchase of stock in Alseres Neurodiagnostics, Inc. to occur in 2013. These funds were available to the Company for use in 2012 and 2013 and the advance is reflected as advances from related party on the consolidated balance sheet. Mr. Gipson also provided the company with $50,000 in exchange for a demand promissory note bearing interest at 7% per annum.

12. Subsequent Events

We evaluated all events or transactions that occurred after June 30, 2013 up through the date we issued these financial statements.

Item 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations

Our management’s discussion and analysis of our financial condition and results of operations include the identification of certain trends and other statements that may predict or anticipate future business or financial results that are subject to important factors that could cause our actual results to differ materially from those indicated Carefully review the risks outlined in other documents that we file from time to time with the SEC.

Overview

Description of Company

We are a biotechnology company focused on diagnostic products primarily for disorders in the central nervous system, or CNS. Our clinical product candidate is called Altropane and based on the following proprietary technology platform:

 

   

Molecular imaging program focused on the diagnosis of i) Parkinsonian Syndromes, or PS, including Parkinson’s Disease, or PD, and ii) Dementia with Lewy Bodies, or DLB;

During the second half of 2011 and throughout 2012, severe resource constraints forced us to terminate all on-going pre-clinical research efforts and to focus our minimal resources on identifying a suitable development partner for our Altropane product candidate. All other development programs were terminated and, wherever possible, in-licensed technology was returned to our licensing partners.

Product Development — Molecular Imaging Program

Altropane Molecular Imaging Agent

The Altropane molecular imaging agent is intended to be used for the differential diagnosis of PS, including PD, and non-PS in patients with an upper extremity tremor. The Altropane molecular imaging agent is a radio labeled imaging agent that contains the radioactive element iodine isotope 123 I and binds with extremely high affinity and specificity to the dopamine transporter, or DAT. The DAT is a protein that is on the

 

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surface membrane of specialized neurons in the brain that produce dopamine, a key neurotransmitter. We believe that the amount of Altropane taken up by the brain is directly proportional to the number of DATs that are present in any given area of the brain. Since DATs are on the membrane of dopamine-producing neurons, death of these neurons results in decreased numbers of DATs. Therefore, PD, which is caused by a decreased number of dopamine producing cells, is associated with a marked decrease in the number of DATs. As a result, when Altropane is administered to patients with PD, its binding is substantially diminished as compared to patients without PD. This decrease in Altropane binding in patients with PD is the theoretical basis for using Altropane imaging as a diagnostic test for PS, including PD.

Altropane is administered by intravenous injection. Since Altropane contains radioactive 123 I, it can be used as a nuclear imaging agent that can be detected using a specialized nuclear medicine instrument known as a Single Photon Emission Computed Tomography, or SPECT, camera. The strength of the SPECT signal generated by Altropane is proportional to the number of DATs present and produces images that distinguish PS and non-PS patients. SPECT cameras are widely available in both community and academic medical centers. The scanning procedure using Altropane takes less than one hour to complete. Results of these tests are usually available the same day as the scanning procedure.

On July 31, 2012 we signed an agreement with Navidea Biopharmaceuticals, Inc. to sublicense [ 123 I]-E-IACFT Injection (CFT), also called Altropane ®.The terms of the Navidea license agreement call for Navidea to assume full responsibility for the development and commercialization of Altropane on a worldwide basis. We have licensed worldwide exclusive rights to develop Altropane from Harvard University and its affiliated hospitals, which we refer to as Harvard and its Affiliates, including the Massachusetts General Hospital. The license agreement provides for milestone payments and royalties based on product sales that are consistent with industry averages for such products. The Company’s deliverables under the Sublicense Agreement with Navidea include granting a license of rights and transferring technology (“know-how”) related to Altropane and an affirmative obligation to ensure that the Harvard agreement remains in full force and effect. Under the terms of the Amended and Restated License Agreement with Harvard, the Company’s deliverables included (i) the use of reasonable efforts to effect introduction of the licensed products into the commercial market as soon as practicable, consistent with sound and reasonable business practices and judgment and (ii) until expiration of the agreement, the Company shall endeavor to keep Altropane reasonably available to the public.

Brain Diagnostic Centers Opportunity

We are presently conducting a preliminary feasibility assessment for a new business focused on organizing and operating a US network of Brain Diagnostic Centers concentrating on neurodegenerative conditions. The centers will provide screening, diagnosis and on-going monitoring of both pre-symptomatic and symptomatic patients affected by neurodegenerative brain disorders. The centers will take advantage of currently available in-vitro diagnostics as well as imaging diagnostics to identify patients who are “at risk” of developing degenerative brain disorders. We are working, on a confidential basis, with industry participants to assess possible support for the development of the potential new business including capital and human resources.

The number of Americans living with neurodegenerative movement disorders such as Parkinson’s disease (PD), and dementias like Alzheimer’s (AD) and Dementia with Lewy Bodies (DLB), is expected to grow from 20 million in 2010 to 30 million by 2030. By 2050, that number is expected to grow to 40 million. Unchecked and without accounting for loss of productivity, the annual cost of care for patients with these diseases will grow from $200 billion today to $500 billion by 2030.

Today, PD, AD and DLB are diagnosed post-symptomatically. By the time diagnosable clinical symptoms appear, the disease is in an advanced stage. The disease has already progressed well beyond the point that current therapies have been shown to have disease modifying effects. Drugs in development are routinely tested in patients with advanced stage disease, where the drugs are least likely to have the disease modifying or arresting affect desired. What is needed are:

 

   

Early detection, definitive diagnostics and therapeutic drug monitoring tools; and

 

   

Comprehensive, longitudinal data to enable disease modifying treatments for early stage degenerative brain diseases

At present our work on this opportunity is preliminary and is focused on identifying an initial location for a pilot site intended to demonstrate the proof of concept for the centers and accessing potential sources of capital. We can provide no assurance that this business will ever be launched or that the capital and human resources necessary to launch and grow the new business will be available on acceptable terms if at all.

Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements which have been prepared by us in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. Our estimates include those related to marketable securities, research contracts and the fair value and classification of financial instruments. We base our estimates on historical experience and on various other assumptions that we believed to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.

Results of Operations for the Three Months Ended June 30, 2013 and June 30, 2012

For the three months ended June 30, 2103, the Company recognized revenue of $18,432 compared to $250,000 for the three months ended June 30, 2012. The 2013 revenue reflects the current period ratable recognition of the $1,321,000 upfront sublicense fee received from Navidea

 

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Biopharmaceuticals effective July 31, 2012. Revenue will be recognized ratably from the date the sublicense agreement became effective (July 31, 2012) through the expected life of the U.S. patent for Altropane (June 30, 2030). The 2012 revenue reflects the recognition of 50% of the initial option fee paid by Navidea to the Company in January 2012.

Effective July 31, 2012, the Company entered into an exclusive, worldwide sublicense agreement with Navidea Biopharmaceuticals, Inc., (“Navidea”) for the research, development and commercialization of [123 I]-E-IACFT Injection (CFT), also called Altropane ®. CFT is an Iodine-123 radiolabeled imaging agent which is being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders. Under the terms of the sublicense agreement, Navidea has agreed to use its best commercial efforts to develop and launch Altropane in accordance with an agreed to development plan for the product. Navidea will be responsible for conducting and funding all future development, regulatory filings, manufacturing and global commercialization of Altropane. The Company will have no further cost obligations related to Altropane. In connection with the execution of the agreement Navidea made a one-time sublicense execution payment to the Company of $175,000. In addition, the Company was issued 300,000 shares of Navidea common stock (“NAVB”) which had a market value of $1,146,000 based on the NYSE closing price of $3.82 per share on July 31, 2012.

Our net loss was $520,052 for the three months ended June 30, 2013 compared to a net loss of $294,908 for the three months ended June 30, 2012. The net loss for the three months ended June 30, 2013 resulted from operating expenses of approximately $371,000 and interest expense of approximately $111,000. In addition the Company realized a $56,317 loss from the disposition of 50,000 shares of Navidea stock during the three months ended June 30, 2013. The net loss of $294,908 for the three months ended June 30,2012 was attributable to operating expenses of approximately $439,000 and interest expense of approximately $106,000 partially offset by recognition of $250,000 of revenue.

Research and development expenses were $0 during the three months ended June 30, 2013 compared to $20,545 during the three months ended June 30, 2012. For the remainder of 2013, we will incur minimal expenses related to pre-existing commitments. Under the terms of the sublicense agreement with Navidea, the Company will no longer have any further cost obligations related to Altropane. Navidea will use its best commercial efforts to develop and launch Altropane in accordance with an agreed to development plan for the product. Navidea will be responsible for conducting and funding all future development, regulatory filings, manufacturing and global commercialization of Altropane.

General and administrative expenses were $370,924 during the three months ended June 30, 2013 compared to $418,676 during the three months ended June 30, 2012. The decrease of $47,752 for the three months ended June 30, 2013 was principally attributable to reductions in rent expense due to renegotiation of terms with our landlord in 2013, health insurance premiums, travel and directors and officers liability insurance premiums.

Interest expense of $111,243 was incurred during the three months ended June 30, 2013 compared to $105,716 during the three months ended June 30, 2012.

Results of Operations for the Six Months Ended June 30, 2013 and June 30, 2012

For the six months ended June 30, 2013, the Company recognized revenue of $36,864 compared to $500,000 for the six months ended June 30, 2012. The 2013 revenue reflects the current period ratable recognition of the $1,321,000 upfront sublicense fee received from Navidea Biopharmaceuticals effective July 31, 2012. Revenue will be recognized ratably from the date the sublicense agreement became effective (July 31, 2012) through the expected life of the U.S. patent for Altropane (June 30, 2030). The 2012 revenue reflects the recognition of 50% of the initial option fee paid by Navidea to the Company in January 2012.

Effective July 31, 2012, the Company entered into an exclusive, worldwide sublicense agreement with Navidea Biopharmaceuticals, Inc., (“Navidea”) for the research, development and commercialization of [123 I]-E-IACFT Injection (CFT), also called Altropane ®. CFT is an Iodine-123 radiolabeled imaging agent which is being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders. Under the terms of the sublicense agreement, Navidea has agreed to use its best commercial efforts to develop and launch Altropane in accordance with an agreed to development plan for the product. Navidea will be responsible for conducting and funding all future development, regulatory filings, manufacturing and global commercialization of Altropane. The Company will have no further cost obligations related to Altropane. In connection with the execution of the agreement Navidea made a one-time sublicense execution payment to the Company of $175,000. In addition, the Company was issued 300,000 shares of Navidea common stock (“NAVB”) which had a market value of $1,146,000 based on the NYSE closing price of $3.82 per share on July 31, 2012.

Our net loss was $817,907for the six months ended June 30, 2013 compared to a net loss of $614,209 for the six months ended June 30, 2012. The net loss for the six months ended June 30, 2013 resulted from operating expenses of approximately $811,000 and interest expense of approximately $222,000 partially offset by approximately $36,000 in revenues from the Navidea license and reversal of accruals totaling $405,000. In addition, the Company realized a $227,083 loss from the disposition of 285,000 shares of Navidea stock during the six months ended June 30, 2013. The net loss of $614,209 for the six months ended June 30, 2012 was attributable to operating expenses of approximately $906,000 and interest expense of approximately $209,000 partially offset by recognition of $500,000 of revenue.

Research and development expenses were $0 during the six months ended June 30, 2013 compared to $41,239 during the six months ended June 30, 2012. For the remainder of 2013, we will incur minimal expenses related to pre-existing commitments. Under the terms of the sublicense agreement with Navidea, the Company will no longer have any further cost obligations related to Altropane. Navidea will use its best commercial efforts to develop and launch Altropane in accordance with an agreed to development plan for the product. Navidea will be responsible for conducting and funding all future development, regulatory filings, manufacturing and global commercialization of Altropane.

 

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General and administrative expenses were $810,604 during the six months ended June 30, 2013 compared to $865,039 during the six months ended June 30, 2012. The decrease of $54,435 for the six months ended June 30, 2013 was principally attributable to reduction in rent expense due to renegotiation of terms with our landlord in 2013 and reduction in consulting fees related to accounting services.

Interest expense of $222,210 was incurred during the six months ended June 30, 2013 compared to $209,113 during the six months ended June 30, 2012.

Liquidity and Capital Resources

As of June 30, 2013, we had experienced total net losses since inception of approximately $199,511,451, stockholders’ deficit of approximately $27,272,866 and a net working capital deficit of approximately $9,742,000. For the foreseeable future, we expect to experience continuing operating losses and negative cash flows from operations as we execute our current business plan. The cash and cash equivalents available at June 30, 2013 will not provide sufficient working capital to meet our anticipated expenditures for the next twelve months. From January 2013 through June 30, 2013 we liquidated 285,000 shares of our Navidea Biopharmaceuticals, Inc. (“Navidea” AMEX:NAVB) common stock for total proceeds of $861,618. We used these proceeds to settle our lawsuit with Children’s Hospital and to meet our day-to-day obligations and continue to comply with our regulatory reporting requirements. We no longer hold any shares of Navidea common stock as all shares have been liquidated as of June 30, 2013. We believe that the approximately $50,000 in cash and cash equivalents available as of August 1, 2013 combined with potential cash infusions from our lead investor may enable us to meet our anticipated cash expenditures through August 2013.

Operating Activities

Net cash used for operating activities was $1,000,163 for the six months ended June 30, 2013 compared to $357,291 for the six months ended June 30, 2012. Net cash used for operating activities for the six months ended June 30, 2013 reflects our curtailment of operations pending additional funding, the reduction in accrued interest expense associated with the debt reduction agreements signed in the fourth quarter of 2011 and the settlement of our Children’s Hospital lawsuit

Investing Activities

Cash was provided by investing activities for the six months ended June 30, 2013 totaled $861,617 resulting from the sale of our Navidea common stock compared to $0 for the six months ended June 30, 2012.

Financing Activities

Financing activities provided cash of $150,000 for the six months ended June 30, 2013 compared to $285,000 for the six months ended June 30, 2012. Cash provided by financing activities for the six months ended June 30, 2013 and 2012 reflects the proceeds of advances from Robert Gipson.

To date, we have dedicated most of our financial resources to the research and development of our product candidates, general and administrative expenses (including costs related to obtaining and protecting patents). Since inception, we have primarily satisfied our working capital requirements from the sale of our securities through private placements. These private placements have included the sale and issuance of preferred stock, common stock, promissory notes and convertible debentures.

In order to continue as a going concern, we will need to raise additional capital through one or more of the following: a debt financing, an equity offering, or a collaboration, merger, acquisition or other transaction with one or more pharmaceutical or biotechnology companies. We are currently engaged in fundraising efforts. There can be no assurance that we will be successful in our fundraising efforts or that additional funds will be available on acceptable terms, if at all. We also cannot be sure that we will be able to obtain additional credit from, or effect additional sales of debt or equity securities to certain of our existing investors in which case we may need to cease operations or reduce, cease or delay one or more of our research or development programs and/or adjust our current business plan and in any such event may not be able to continue as a going concern.

Item 3 — Quantitative and Qualitative Disclosures about Market Risk

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide this information.

Item 4 — Controls and Procedures

In the course of its assessment for fiscal year 2012, management identified a control deficiency. During the course of the evaluation, management determined that subsequent to the end of the fiscal year, but prior to completing all adjustments and disclosures necessary for a fair presentation of our financial statements that the departure of a key member of the accounting and reporting department created a lack of sufficient staff to segregate accounting duties. Management believes this control deficiency is primarily the result of the Company employing, due to its limited size, the equivalent of only one person performing all accounting-related on-site duties. As a result, Alseres did not maintain adequate segregation of duties within its critical financial reporting applications, the related modules and financial reporting processes. This control deficiency could result in a misstatement of our interim or annual consolidated financial statements that would not be detected. Accordingly, management has determined that this control deficiency constituted a material weakness, and that the Company’s internal control over financial reporting was not effective, as of December 31, 2012. We believe this deficiency continued through June 30, 2013.

 

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Management has discussed the material weakness and related potential corrective actions with the Audit Committee and Board of Directors of the Company and Alseres’ independent registered public accounting firm. As part of our 2013 assessment of internal control over financial reporting, our management will test and evaluate additional controls implemented, if any, to assess whether they are operating effectively. Our goal is to take all actions reasonably possible given our financial condition to remediate any material weaknesses and enhance our internal controls, but we cannot guarantee that our efforts, if any, will result in the remediation of our material weakness or that new issues will not be exposed in the process. In designing and evaluating our internal control over financial reporting, management recognizes that any controls, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, with the Company will be detected.

Part II — OTHER INFORMATION

Item 1 — Legal Proceedings

On March 13, 2012 the Company received notice that Children’s Hospital Boston and Children’s Medical Center Corporation had filed a lawsuit in Middlesex Superior Court, Middlesex County, Massachusetts seeking to recover amounts alleged to be owed by the Company to the plaintiffs.

On February 1, 2013 the Company entered into a Settlement Agreement and Release with Boston Children’s Hospital (BCH) and Children’s Medical Center Corporation (CMCC) in full settlement of the lawsuit filed by BCH and CMCC seeking to recover amounts alleged to be owed by the Company to the plaintiffs . The amount of $642,906 was included in accrued expenses at December 31, 2012 but was incurred and expensed prior to January 1, 2011.

In settlement of all claims by BCH and CMCC, the Company agreed to pay a lump sum of $185,000 to the plaintiffs. In addition to the lump sum payment, the Company agreed to pay to the plaintiffs an additional sum equal to the then cash value of 20,000 shares of the common stock of Navidea BioPharmaceuticals, Inc. upon the occurrence of the first milestone described in Section 4.2 of the sublicense agreement dated as of July 31, 2012 between Navidea BioPharmaceuticals, Inc. and the Company. This second payment is only due upon the occurrence of the first milestone unless the Company declares bankruptcy or alters its agreement with Navidea in a manner that results in the delay or cancellation of said milestone payment in which case CMCC and BCH could bring additional claims against the Company for additional consideration.

On May 2, 2012 the Company received notice that Biostorage Technologies, Inc (Biostorage). had filed a lawsuit in Marion Superior/Circuit Court, Marion County, Indiana seeking to recover amounts alleged to be owed by the Company to the plaintiffs totaling $119,363. On July 27 , 2013, the company entered into a settlement agreement with Biostorage Technologies, Inc. pursuant to which the Company agreed to pay a total of $75,000 to Biostorage in three installments as follows: $10,000 on July 31, 2013, $40,000 December 31, 2013 and $25,000 February 28, 2014. The Company also agreed to stipulate a judgment in the amount of $95,000 to be adjusted down by each payment actually made by the Company and so long as each required payment is made by the Company on time, the judgment will be vacated on February 28, 2014. As of June 30, 2013 the company maintained an accrual on its books of $133,000 reflecting the amount of the alleged claim plus additional legal fees.

The disclosure contained under the heading “Contingencies” in Note 8 to the condensed consolidated financial statements included in Part I, Item 1 hereof is incorporated herein by reference.

Statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. These forward-looking statements regarding future events and our future results are based on current expectations, estimates, forecasts, and projections, and the beliefs and assumptions of our management including, without limitation, our expectations regarding our product candidates, including the success and timing of our preclinical, clinical and development programs, the submission of regulatory filings and proposed partnering arrangements, the outcome of any litigation, collaboration, merger, acquisition and fund raising efforts, results of operations, selling, general and administrative expenses, research and development expenses and the sufficiency of our cash for future operations. Forward-looking statements may be identified by the use of forward-looking terminology such as “may,” “could,” “will,” “expect,” “estimate,” “anticipate,” “continue,” or similar terms, variations of such terms or the negative of those terms.

We cannot assure investors that our assumptions and expectations will prove to have been correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. Such factors that could cause or contribute to such differences include those factors discussed below. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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Item 6 — Exhibits

 

  31.1*   Certification of the Chief Executive Officer pursuant to Section 1350 of Title 18, United States Code, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2*   Certification of the Chief Financial Officer pursuant to Section 1350 of Title 18, United States Code, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1*   Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2*   Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS**   XBRL Instance Document
101.SCH**   XBRL Taxonomy Extension Schema Document
101.CAL**   XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB**   XBRL Taxonomy Extension Label Linkbase Document
101.PRE**   XBRL Taxonomy Presentation Linkbase Document
101.DEF**   XBRL Taxonomy Definition Linkbase Document

 

* Filed herewith.
** In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall not be deemed to be “filed” for purposed of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

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SIGNATURES

Pursuant to the requirements 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.

 

     

ALSERES PHARMACEUTICALS, INC

(Registrant)

DATE: August 9, 2013       /s/ PETER G. SAVAS
      Peter G. Savas
      Chief Executive Officer (Principal Executive Officer)
DATE: August 9, 2013       /s/ KENNETH L. RICE, JR.
      Kenneth L. Rice, Jr.
      Executive Vice President Finance and Administration And Chief Financial Officer (Principal Financial and Accounting Officer)

 

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