UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q


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

For the quarterly period ended June 30, 20112012

or

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

Commission file number 0-11550

Pharmos Corporation
(Exact name of registrant as specified in its charter)

 Nevada 36-3207413 
 (State or other jurisdiction of incorporation or organization) (IRS Employer Id. No.) 
 
99 Wood Avenue South, Suite 302
Iselin, NJ 08830
(Address of principal executive offices)

Registrant's telephone number, including area code: (732) 452-9556

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 o.

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 (section 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   o

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

Large accelerated filer o
 
Non-accelerated filer o
 
Accelerated filer o
 
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 o  No x .

As of August 8 2011,July 30, 2012, the Registrant had outstanding 59,879,39160,170,671 shares of its $.03 par value Common Stock.

 
 
 



PART I  FINANCIAL INFORMATION Page 
     
Item 1.
Financial Statements (unaudited)
   
      
 
Condensed Consolidated Balance Sheets as of June 30, 20112012 and December 31, 20102011
  
1
 
      
 
Condensed Consolidated Statements of Operations for the three and six months ended June 30, 20112012 and 20102011
  
2
 
      
 
Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 20112012 and 20102011
  
3
 
      
 
Notes to Condensed Consolidated Financial Statements
  
4
      
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
  
109
 
      
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
  
1513
 
      
Item 4
Controls and Procedures
  
1513
 
  
PART II  OTHER INFORMATION
 
      
Item 1.
Legal Proceedings
  
1614
 
      
Item 1A.
Risk Factors
  
1614
 
      
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
  
1614
 
      
Item 3.
Defaults Upon Senior Securities
  
1614
 
      
Item 4.
(Removed and Reserved)Mine Safety Disclosures
  
1614
 
      
Item 5.
Other Information
  
1614
 
      
Item 6.
Exhibits
  
1715
 
     
SIGNATURES
  
1816
 




 
 
 


Part I.Financial Information

Item 1
Financial Statements

PHARMOS CORPORATION            
Condensed Consolidated Balance Sheets (Unaudited)            
 
June 30,
2011
  
December 31,
2010
  
June 30,
2012
  December 31, 2011 
Assets            
Cash and cash equivalents $2,115,349  $3,139,347  $517,344  $1,535,137 
Prepaid expenses and other current assets  68,212   46,833   113,689   122,417 
Total current assets  2,183,561   3,186,180   631,033   1,657,554 
                
Fixed assets, net  5,916   5,613   3,262   4,493 
                
Total assets $2,189,477  $3,191,793  $634,295  $1,662,047 
                
Liabilities and Shareholders’ Equity                
Accounts payable $54,538  $67,199  $64,633  $262,067 
Accrued interest and expenses  89,653   103,913   109,355   98,833 
Convertible debenture  1,000,000   1,000,000 
Total current liabilities  144,191   171,112   1,173,988   1,360,900 
                
Convertible debenture  1,000,000   1,000,000 
Total liabilities  1,144,191   1,171,112   1,173,988   1,360,900 
                
                
Shareholders’ Equity        
Shareholders’ Equity (Deficit)        
Preferred stock, $.03 par value, 1,250,000 shares authorized, none issued and outstanding  -   -   -   - 
Common stock, $.03 par value; 120,000,000 shares                
authorized, 59,732,332 and 59,585,273 issued and outstanding as of        
June 30, 2011 and December 31, 2010, respectively  1,791,970   1,787,558 
authorized, 60,026,450 and 59,879,391 issued as of        
June 30, 2012 and December 31, 2011, respectively  1,800,794   1,796,382 
Paid-in capital in excess of par  211,711,140   211,587,386   211,951,935   211,838,004 
Accumulated deficit  (212,457,398)  (211,353,837)  (214,291,996)  (213,332,813)
Treasury stock, at cost, 2,838 shares  (426)  (426)  (426)  (426)
Total shareholders' equity  1,045,286   2,020,681 
Total shareholders' equity (Deficit)  (539,693)  301,147 
                
Total liabilities and shareholders' equity $2,189,477  $3,191,793 
Total liabilities and shareholders' equity (Deficit) $634,295  $1,662,047 


The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.


 
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PHARMOS CORPORATION
Condensed Consolidated Statements of Operations
(Unaudited)

Three months ended
June 30,
Six months ended
June 30,

  2011  2010  2011  2010 
Expenses            
Research and development $214,470  $103,362  $496,254  $226,358 
General and administrative  259,415   300,492   553,760   639,806 
Depreciation and amortization  671   185   1,297   650 
Total operating expenses  474,556   404,039   1,051,311   866,814 
                 
Loss from operations  (474,556)  (404,039)  (1,051,311)  (866,814)
                 
Other (expense) income                
Interest income  60   342   156   629 
Interest expense  (25,937)  (27,929)  (52,406)  (56,303)
Other income (expense)  -   (353)  -   (869)
Other expense  (25,877)  (27,940)  (52,250)  (56,543)
                 
Net loss $(500,433) $(431,979) $(1,103,561) $(923,357)
                 
Net loss per share                
- basic and diluted $(0.01) $(0.01) $(0.02) $(0.02)
                 
Weighted average shares outstanding                
- basic and diluted  59,095,703   58,400,211   59,045,622   58,306,062 



  Three months ended June 30,  Six months ended June 30, 
  2012  2011  2012  2011 
Expenses            
Research and development $114,857  $214,470  $405,521  $496,254 
General and administrative  237,751   259,415   497,808   553,760 
Depreciation and amortization  615   671   1,231   1,297 
Total operating expenses  353,223   474,556   904,560   1,051,311 
                 
Loss from operations  (353,223)  (474,556)  (904,560)  (1,051,311)
                 
Other (expense) income                
Interest income  20   60   52   156 
Other expense  (4,675)  -   (4,675)  - 
Interest expense  (25,000)  (25,937)  (50,000)  (52,406)
Other expense  (29,655)  (25,877)  (54,623)  (52,250)
                 
Net loss $(382,878) $(500,433) $(959,183) $(1,103,561)
                 
Net loss per share                
- basic and diluted $(0.01) $(0.01) $(0.02) $(0.02)
                 
Weighted average shares outstanding                
- basic and diluted  59,689,821   59,095,703   59,639,788   59,045,622 


The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.




 
2
 

Pharmos Corporation
Condensed Consolidated Statements of Cash Flows
(Unaudited)

 Six months ended June 30,  Six months ended June 30, 
 2011  2010  2012  2011 
Cash flows from operating activities            
Net loss $(1,103,561) $(923,357) $(959,183) $(1,103,561)
                
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation and amortization  1,297   650   1,231   1,297 
Amortization of deferred financing fees  2,406   6,303   -   2,406 
Stock based compensation  78,167   91,267   68,343   78,167 
Interest paid in common stock  50,000   50,000   50,000   50,000 
Changes in operating assets and liabilities:                
Prepaid expenses and other current assets  (23,786)  (62,674)  8,728   (23,786)
Accounts payable  (12,661)  (5,157)  (197,434)  (12,661)
Accrued expenses  (14,260)  (35,451)  10,522   (14,260)
Accrued wages and other compensation  -   (195,000)
                
Net cash used in operating activities  (1,022,398)  (1,073,419)  (1,017,793)  (1,022,398)
                
Cash flows from investing activities                
Purchases of fixed assets  (1,600)  (1,465)  -   (1,600)
                
Net cash used in investing activities  (1,600)  (1,465)  -   (1,600)
                
Net decrease in cash and cash equivalents  (1,023,998)  (1,074,884)  (1,017,793)  (1,023,998)
                
Cash and cash equivalents at beginning of year  3,139,347   4,629,486   1,535,137   3,139,347 
                
Cash and cash equivalents at end of period $2,115,349  $3,554,602  $517,344  $2,115,349 
                
Supplemental disclosure of non-cash investing and financing activities:                
Common shares issued for accrued interest $50,000  $50,000  $50,000  $50,000 

The accompanying notes are an integral part of these unaudited interim condensed consolidated financial statements.

 
3
 


Notes to Condensed Consolidated Financial Statements (unaudited)

1.      Basis of Presentation Liquidity and Business Risks

The accompanying unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information pursuant to the instructions to Form 10-Qrules and Article 10regulations of Regulation S-X.the Securities and Exchange Commission (SEC). Accordingly, they 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. In the opinion of management, all adjustments, consisting ofwhich include only normal recurring accrual adjustments, considered necessary for a fair statementpresentation of the results for the interim periods presented have been included. Operating results and cash flows for the six month period ended June 30, 20112012 are not necessarily indicative of the results that may be expected for the year ending December 31, 2011. 2012.

The December 31, 20102011 condensed consolidated balance sheet was derived from audited financial statements but does not include all disclosures required by accounting principles generally accepted in the United States of America and included in the Form 10-K filing. These financial statements should read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2011.

2.      Liquidity, Business Risks and Ability to Continue as a Going Concern

The Company’s condensed consolidated financial statements have been prepared assuming it will continue as a going concern. At June 30, 2011,2012, the Company had approximately $2.1$0.5 million in cash and cash equivalents. Management believes that the current cash and cash equivalents totaling $2.1 million as of June 30, 2011, will be sufficient to support ourtheir currently planned continuing operations through at least March 31,October 2012. However,Currently the Company’s abilityCompany spends approximately $100,000 a month on continuing operating expenses. The Company has a debenture of $1 million due to continue as a going concern is largely dependent uponbe repaid on November 1, 2012 which the Company will be unable to satisfy without raising additional capital or achieving a collaboration with a pharmaceutical partner for one or raising additional capital to advanceboth of its lead compounds, Levotofisopam for the treatment of Gout or Dextofisopam for the treatment of IBS, and Levotofisopam, for the treatment of gout.IBS. The Company has in the past pursued various funding and financing options; however management believes that future funding or financing options maywill continue to be challenging because of the current environment.

The Company does not currently have the finances and resources to conduct largeany further clinical trials for its most advanced compound, Dextofisopam and continues to seek a partner. Meanwhile, the Company is pursuing the development of Levotofisopam for the treatment of Gout and will incur preclinical and clinical trial costs.trials. The Company expects to have sufficient cash resources to fundcompleted a proof-of-concept Gout trial (the Gout trial) for Levotofisopam in April 2012 and in May 2012, announced the development of Levotofisopam through completion of the proof-of-concept trial. The Company intends to partner Levotofisopam upon successful completion of this proof-of-concept trial in which rapid and significant reduction in uric acid was observed in all patients. The Company has been intensely attempting to partner Levotofisopam. Through the date of this filing, a proof-of-concept clinical trial. Should thispartnership or other form of collaboration has not occur,been achieved and should a collaboration or other form of financing not be achieved by November 1, 2012, the Company maywill be unable to continue operations past quarter three or quarter four of 2012, including repayment of the outstanding convertible debenture unless additional capital canin quarter four.
Further, if the Company is unable to raise sufficient funds imminently, it will not be obtained.able to retain personnel or repay its outstanding convertible debenture on its due date. This would cause the Company to suspend its operations indefinitely and most likely, permanently.  

As such, these factors raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.


1.
4

3.      The Company

Pharmos Corporation (the Company or Pharmos) is a biopharmaceutical company that discovers and develops novel therapeutics to treat a range of diseases of themetabolic and nervous system disorders, including gout, disorders of the brain-gut axis (e.g., Irritable Bowel Syndrome), with a focus on pain/inflammation, and autoimmune disorders.

Pharmos owns the rights to both RR- and S TofisopamS-Tofisopam through two US issued composition of matter patents. These are the two enantiomers of racemic tofisopam, that has beena well-tolerated, effective, non-sedating agent used safely outside the United States for over 30 years.years for the treatment of a variety of disorders associated with stress or autonomic instability.  Dextofisopam, is the R enantiomer andR-enantiomer, is being developed for the treatment of irritable bowel syndrome (IBS) and as described below has completed clinical testing through Phase 2b. ItIBS is a large unmet medical need but Pharmos does not have the financial resources to fund large IBS trialsthe next trial and therefore seeks a pharmaceutical company as a partner. Levotofisopam is the S enantiomer and is being developed as a treatment for gout.

The Company’s operations in Israel were closed effective October 2008 and the Company has been actively seeking to sell and license the CB2 selective agonist program that had been developed in Israel.


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Gout: Levotofisopam (S-Tofisopam) for treatment of Gout.

Levotofisopam is the S-enantiomer of racemic tofisopam. In two earlier Phase 1 studies using Levotofisopam,  significant and rapid lowering of uric acid was noted. The Company recently conducted an open-label, Phase 2 proof-of-concept trial at the racemic mixture RS-tofisopam,Duke Clinical Research Unit of Duke University. In May 2012 the Company reported positive top line results from this trial. Uric acid was reduced in all 13 treated patients. Mean reduction in uric acid was over 45%. Additionally, fractional excretion of uric acid increased, confirming Levotofisopam’s mechanism of action as enhancing excretion and not as a well-tolerated, effective, nonsedating agent used outsidexanthine oxidase inhibitor.

The Company is actively attempting to secure a partner to fund the United States forfurther development of Levotofisopam or alternatively raise additional capital. If the treatment of a variety of disorders associated with stressCompany is unable to raise sufficient funds imminently, it will not be able to retain personnel or autonomic instability.repay its outstanding convertible debenture on its due date.  This would cause the Company to suspend its operations indefinitely and most likely, permanently (see Note 2).

The Company has submitted an Investigationalexecutive offices in Iselin, New Drug (IND) application to the FDA and received clearance to conduct human clinical trials, subject to first confirming the safety of the dose planned to be used in a proof-of-concept study in Gout patients. To confirm the safety of the planned dose, the Company is currently conducting a non-human primate toxicology study. Upon successful completion of the preclinical trial, the Company plans to conduct a proof-of concept clinical trial in the US in gout patients using Levotofisopam. This trial follows two ex-US Phase 1 clinical studies that were completed by Vela Pharmaceuticals (merged with Pharmos in October 2006). In these studies, conducted in healthy volunteers in the United Kingdom and The Netherlands, Levotofisopam treatment was generally well tolerated and was associated with a large and rapid reduction in mean uric acid values.Jersey.

The lowering of uric acid is believed to be a key treatment in gout patients. The precise mechanism by which Levotofisopam lowers uric acid is unknown. However, unlike allopurinol, a drug commonly used to treat gout patients, Levotofisopam does not inhibit xanthine oxidase. Available data indicate that the predominant mechanism of the serum-urate lowering effect of levotofisopam in humans is through uricosuric activity rather than inhibition of urate synthesis.  A precondition leading in some cases to gout is hyperuricemia, which leads to increased pools of insoluable urate. Chronic hyperuricemia can lead to destructive gouty arthritis, formation of kidney stones, urate nephropathy, and /or tophi (crystal aggregates), which can produce grotesque malformations of the hands, feet, or other portions of the body. Hyperuricemia is caused either by an overproduction of or, more usually (80-90% of cases), underexcretion of uric acid, the metabolic product of purine metabolism.

IBS –D: Dextofisopam for Irritable Bowel Syndrome.

The Company's most advanced product is Dextofisopam for the treatment of irritable bowel syndrome (IBS). IBS is a chronic and sometimes debilitating condition that affects roughly 10%-15% of U.S. adults and is two to three times more prevalent in women than in men. With an absence of safe and effective therapies, Dextofisopam’s novel non-serotonergic activity holds the potential for a unique and innovative treatment approach to IBS with diarrhea predominant and alternating patients.

Dextofisopam has completed a statistically significant Phase 2a trial (N=141, p=0.033) and a Phase 2b trial ( N=324) which did not meet the primary endpoint of overall adequate relief. Although the primary efficacy variable (% of weeks responding for adequate overall relief of IBS symptoms) did not reach statistical significance, the percentage responding for the Dextofisopam 200 mg group was higher than that observed for the Phase 2a trial. However, the placebo response rate was also higher than expected compared to the Phase 2a placebo response.

This result was similarly demonstrated across all other secondary efficacy variables associated with the adequate overall relief question. In all cases except in the first month, the response rates for the Dextofisopam 200 mg group were essentially the same as or in most cases better than the response rates observed for the Phase 2a trial. Also, secondary response variables of adequate relief of abdominal pain and discomfort and overall IBS symptoms ratings showed statistical significance and trends favoring the Dextofisopam 200 mg group compared to placebo.

The Company’s strategy is to seek a pharmaceutical partner with the appropriate GI clinical and scientific expertise for further development of Dextofisopam.

The CB2 selective receptor agonist program

Pharmos’ cannabinoid research was geared toward development of selective and specific CB2 receptor agonists. By activating CB2 receptors, CB2 agonists inhibit autoimmune and inflammatory processes, and are likely to be useful for treating pain, autoimmune, inflammatory and degenerative disorders.  Although progress has been made, the early stage of this work and resource limitations have resulted in termination of these programs. Pharmos’ strategy is to sell or out license the technology developed around the cannabinoid research.  Pharmos had developed these compounds in preclinical testing for neuropathic pain.

5


Substantial development work was conducted on the CB2 selective agonist program in Israel from 2002 through 2008. The Company expended approximately $15 million on this development program and these assets are available for sale or licensing. During the quarter the Company continued to engage in discussions on the possible licensing and or sale of the CB2 program.

2.4.      Significant Accounting Policies

Basis of consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: Pharmos Ltd. and Vela Pharmaceuticals. All significant intercompany balances and transactions are eliminated in consolidation. Vela Acquisition Corp. is dormant and was used as the vehicle to acquire Vela Pharmaceuticals Inc. in October 2006.  The Israel operations (Pharmos Ltd.), including research and development activities, ceased effective October 31, 2008 and the Company completed its voluntary liquidation in May 2010. Vela Pharmaceuticals Inc. was dissolved in August of 2011.

Cash and Cash Equivalents

Cash and Cash Equivalents as of June 30, 20112012 consist primarily of a money market fund invested in short term government obligations.

Concentration of Credit Risk

Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents. The Company maintains its cash and cash equivalent balances with a high quality financial institution who invests the Company’s funds in Government short-term instruments. Consequently the Company believes that such funds are subject to minimal credit risk.


5

Grants

The costs and expenses of research and development activities are partially funded by grants the Company received. The grants are deducted from research and development expenses at the time such grants are received. There were no grants received in the three or six month periods ended June 30, 20112012 and 2010,2011, respectively.

Income Taxes

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities, if any, 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 and any change in tax rates is recognized in the results of operations in the period that includes the enactment date. A tax benefit has not been recognized due to the uncertainties previously disclosed and a full valuation allowance is maintained.

The Company follows the guidance for Accounting for Uncertainty in Income Taxes which prescribes a recognition threshold of more-likely-than-not to be sustained upon examination. Measurement of the tax uncertainty occurs if the recognition threshold has been met. Pharmos conducts business in the US and as a result, files US and New Jersey income tax returns. In the normal course of business, the Company is subject to examination by taxing authorities. At present, there are no ongoing audits or unresolved disputes with the various tax authorities that the Company files with and there are no tax uncertainties as of June 30, 20112012 and December 31, 2010.2011.

Fair value of financial instruments

The carrying amounts of the Company’s financial instruments, including cash and cash equivalents, other assets, accounts payable and accrued liabilities approximate fair value due to their short term maturities.

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The Company has estimated the fair value of the $1,000,000 outstanding convertible debenture due November 1, 2012 to be approximately $638,000$898,000 at June 30, 2011.2012. As described in Note 2 the Company’s future financial viability is dependent upon achieving a partnership or raising additional capital. Therefore there is a large amount of subjectivity in determining the fair value of the outstanding debenture. In determining the fair value the Company used level 3 inputs (unobservable) and a discount rate of 35%33%. Management used a discount rate they believe was most relevant given the business risks and because they have been unable to raise third party financing during the past several years.
However, the Company’s ability to repay the debenture on its due date is dependent upon achieving a successful partnership for Levotofisopam and or Dextofisopam or in raising additional capital.
Equity based compensation

During the six months ended June 30, 20112012 and 2010,2011, the Company recognized equity based compensation expense of $78,167$68,343 and $91,267,$78,167, respectively, for restricted stock and stock options. As of June 30, 2011,2012, the total compensation costs related to non-vested stock options not yet recognized is $155,358$82,989 which will be recognized over the next three and one half years. Also, the compensation expense related to the Executive Chairman of the Board non-vested restricted stock not yet recognized is $121,000$55,000 which will be recognized over the next two years.one year.


6

During the six months ended June 30, 20112012 and 2010,2011, executive and outside directors of the Company were granted stock options under the Pharmos 2000 and 2009 Stock Option Plan per the table below:

Period Ended Grants Issued  Weighted Average Exercise Price  
Weighted Average
Fair Value
  Grants Issued  Weighted Average Exercise Price  
Weighted Average
Fair Value
 
                  
June 30, 2012  70,000  $0.06  $0.05 
June 30, 2011  1,120,000  $0.09  $0.07   1,120,000  $0.09  $0.07 
June 30, 2010  70,000  $0.08  $0.07 

Recent Accounting Pronouncements

In May 2011, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2011-04, Fair Value Measurement (Topic 820). This ASU is intended to create consistency between U.S. GAAP and International Financial Reporting Standards on the definition of fair value and on the guidance on how to measure fair value and on what to disclose about fair value measurements. This ASU will be effective for financial statements issued for fiscal periods beginning after December 15, 2011, with early adoption prohibited for public entities. The Company is currently evaluating the impact ASU 2011-04 willThis update did not have any material effect on its consolidatedour financial statements.

Subsequent Events

In the third quarter of 2011,2012, the Company elected to pay the interest on its 10% Convertible Debentures due November 2012 incurred through the seventhninth interest payment date, July 15, 2011,2012, in common stock to the remaining debenture holder. The dollar amount of interest incurred from January 15, 20112012 to July 15, 20112012 to be paid in stock amounted to $50,000 which, converted at $0.34 per share, resulted in an aggregate of 147,059 shares issued to the debenture holder.

3.5.      Convertible Debentures

On January 3, 2008, Pharmos Corporation completedThe Company has a private placement$1,000,000 convertible debenture that is due November 1, 2012. In the first quarter of 2012, the Company elected to pay the interest on its 10% Convertible Debentures due November 2012. Atincurred through the closingeighth interest payment date, January 15, 2012, in common stock to the Company issued $4,000,000 principalremaining debenture holder. The dollar amount of the Debentures,interest incurred from July 15, 2011 to January 15, 2012 to be paid in stock amounted to $50,000 which, converted at par, and received gross proceeds$0.34 per share, resulted in the same amount. The purchasers consisted of certain existing investors in the Company, namely Venrock Associates (which is affiliated with Anthony B. Evnin), New Enterprise Associates (which is affiliated with Charles W. Newhall, III), Lloyd I. Miller, III and Robert F. Johnston.


7

The Debentures mature the earlier of November 1, 2012 or the sale of the Company. The Debentures, together with all accrued and unpaid interest thereon, may be repaid, without premium or penalty, commencing on November 1, 2011. Starting on November 1, 2009 (or earlier sale of the Company), any outstanding Debenture may be converted into common shares at the option of the holder. The conversion price is fixed equal to $0.70 per share. The Debentures bear interest at the rate of 10% per annum, payable semi-annually either in cash or common stock of the Company at the option of the Company, provided that an effective registration statement is in effect.  

On April 21, 2009, Venrock Associates (which is affiliated with Anthony B. Evnin, a Director of the Company), New Enterprise Associates (which is affiliated with Charles W. Newhall, III, a Director of the Company) and Robert F. Johnston, the Company’s Executive Chairman of the Board of Directors, agreed to convert as of such date the Company’s 10% Convertible Debentures due November 1, 2012 held by them, comprising an aggregate of $3,000,000 in principal amount, at a conversion price of $0.275 per share.   An aggregate of 11,145,570147,059 shares was issued upon conversion ofto the principal and accrued but unpaid interest ondebenture holder.A post-effective amendment to the debentures.

A registration statement covering the resale of the shares underlying the debenture held by Lloyd I. Miller, III, was declared effective in February 2011.
4.      Acquisition of Vela Pharmaceuticals, Inc.
In 2006, the Company acquired Vela Pharmaceuticals, Inc. (“Vela”), which had a Phase II product candidate, Dextofisopam, in development to treat IBS. The Company has dedicated substantial resources to complete clinical development of this product candidate. The Vela acquisition also included additional compounds in preclinical and/or clinical development for neuropathic pain, inflammation and sexual dysfunction.
The Company issued 6.5 million shares of common stock and paid $6 million to Vela shareholders at closing. The Agreement also includes additional performance-based milestone payments to the Vela stockholders related to the development of Dextofisopam, aggregating up to an additional $5 million in cash and the issuance of up to an additional 9,250,000 shares of Pharmos common stock. None of the milestone conditions were met at December 31, 2010 and June 30, 2011 except for a $1.0 million milestone payment made by Pharmos due upon the study’s commencement which was paid in 2008.2012.

The remaining milestones are as follows:Company’s ability to repay the debenture on its due date is dependent upon achieving a successful partnership for Levotofisopam and or Dextofisopam or in raising additional capital (see Note 2).

·         $1 million cash: Final patient enrolled in Phase 2b trial (1)
·         $2 million + 2 million shares: NDA submission
·         $2 million cash +2.25 million shares: FDA approval
·         1 million shares: Approval to market in Europe or Japan
·         4 million shares: $100 million sales of Dextofisopam, when and if approved, in any 12-month period

(1) The milestone was reached when the final patient was enrolled in the Dextofisopam Phase 2b trial and was recognized in the first quarter of 2009 as all probability criteria were met. The milestone had two components, a cash portion of $1,000,000 and a share portion of 2,000,000 shares valued at $180,000.  The total charge in the first quarter was $1,180,000. The shares were issued in November 2009 under the terms of the Amendment #3 to the agreement and plan of merger. Under that amendment the payment of the cash portion was deferred until such time as 1) the Company successfully entered into a strategic collaboration or licensing agreement with a third party for the development of Dextofisopam resulting in an upfront cash fee of at least $10 million, and 2) payment of the cash milestone would still leave the Company with one year’s operating cash.

The results of the Phase 2b trial were announced in September 2009 and reported that while there was clearly drug activity, the trial did not achieve its primary endpoint. Under the terms of the Vela acquisition agreement as amended, the 2 million shares were issued on November 2, 2009. The cash portion that was expensed in Q1 2009 was reversed in Q4 2009 since it is not deemed probable that the amended terms would be achieved. Since the trial results were not successful, no other milestones have been achieved.


8

5.6.      Net Loss Per Common Share

Basic and diluted net loss per common share was computed by dividing the net loss for the period by the weighted average number of shares of common stock issued and outstanding. For the periods ending June 30, 20112012 and 2010,2011, other potential common stock has been excluded from the calculation of diluted net loss per common share, as their inclusion would be anti-dilutive.


7

The following table sets forth the number of potential shares of common stock that have been excluded from diluted loss per share since inclusion would have been anti-dilutive.anti-dilutive
 
  June 30, 
  2012 2011 
      
Stock options  4,478,812  4,289,312 
Convertible debenture  1,428,571  1,428,571 
Restricted stock  300,000  600,000 
Warrants  18,000,000  18,000,000 
        
Total potential dilutive securities not included in loss per share  24,207,383  24,317,883 

  June 30,
  2011 2010
     
Stock options  4,289,312 3,539,754
Convertible debenture  1,428,571 1,428,571
Restricted stock  600,000 900,000
Warrants  18,000,000 18,000,000
      
Total potential dilutive securities not included in loss per share  24,317,883 23,868,325
6.7.      Common Stock Transactions

On May 11, 2009, Robert Johnston, the Executive Chairman, was awarded 1,200,000 shares of restricted stock. 300,000 of such shares became vested and free from a risk of forfeiture on the first anniversary of the date hereof, and the remaining 900,000 shares become vested and free from a risk of forfeiture in quarterly increments over a three-year period commencing on the first anniversary of the grant date. Over the four year period, a total of $264,000 will be recorded as compensation expense. In the first six months of 2011,2012, the Company expensed $33,000 for Mr. Johnston’s restricted stock.
 
On September 3, 2010, Steven Leventer Ph.D., board member, was awarded 350,000 shares of non-qualified stock options. One-third of the options shall be exercisable as of the date hereof, one-third of the options shall be exercisable as of the first anniversary of the date hereof and one-third of the options shall be exercisable as of the second anniversary of the date hereof. In the first six months of 2011, the Company expensed $5,844 for Dr. Leventer’s stock options.

In the first quarter of 2011,2012, the Company elected to pay the interest on its 10% Convertible Debentures due November 2012 incurred through the sixtheighth interest payment date, January 15, 2011,2012, in common stock to the remaining debenture holder. The dollar amount of interest incurred from July 15, 20102011 to January 15, 20112012 to be paid in stock amounted to $50,000 which, converted at $0.34 per share, resulted in an aggregate of 147,059 shares issued to the debenture holder.

As of June 30, 2011,2012, the Company had reserved 4,289,3124,478,812 common stock shares for outstanding stock options.  The Company has outstanding warrants exercisable for 18,000,000 shares of common stock. The exercise price of the warrants, which have a five-year term and expire on April 21, 2014, is $0.12 per share.



 
98
 

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

This report on Form 10-Q contains information that may constitute "forward-looking statements."  The use of words such as "believe," "expect," "intend," "estimate," "anticipate," "project," "will" and similar expressions identify forward-looking statements, which generally are not historical in nature.  All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements.  As and when made, we believe that these forward-looking statements are reasonable.  However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made.  We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from our company's historical experience and our present expectations or projections.  These risks and uncertainties include, but are not limited to, those described in Part I, "Item 1A. Risk Factors" of our Form 10-K for the year ended December 31, 20102011 and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange Commission.

We do not undertake to discuss matters relating to our ongoing clinical trials or our regulatory strategies beyond those which have already been made public or discussed herein.

Executive Summary of  20112012 Strategy and Operating Plan

Pharmos Corporation (theThe Company or Pharmos) is a biopharmaceutical company that discovers and develops novel therapeutics to treat a range of diseases of the nervous system, including disorders of the brain-gut axis (e.g., Irritable Bowel Syndrome), with a focus on pain/inflammation, and autoimmune disorders.

Pharmos owns the rights to both RR- and S Tofisopam through two US issued composition of matter patents. These are the two enantiomers of racemic tofisopam that has been used safely outside the United States for over 30 years. Dextofisopam is the R enantiomer and is being developed for the treatment of irritable bowel syndrome (IBS) and as described below has completed clinical testing through Phase 2b. It is a large unmet medical need but Pharmos does not have the financial resources to fund the next trial and therefore seeks a pharmaceutical company as a partner.

S-Tofisopam. Levotofisopam is the S-enantiomer of the racemic mixture RS-tofisopam, a well tolerated, effective, nonsedating agent used outside the United States for the treatment of a variety of disorders associated with stress or autonomic instability. During the quarter, the Company conducted work to initiate a proof-of-concept trial in gout patients using Levotofisopam. Two ex-US Phase 1 clinical studies were completed by Vela Pharmaceuticals (merged with Pharmos in October 2006). In these studies, conducted in healthy volunteers in the United Kingdom and The Netherlands, Levotofisopam treatment was generally well tolerated and was associated with a large and rapid reduction in mean uric acid values.

During the quarter, the Company submitted an Investigational New Drug (IND) application to the FDA and received clearance to conduct human clinical trials, subject to first confirming the safety of the dose planned to be used in the proof-of-concept study in Gout patients. To confirm the safety of the planned dose, the Company is currently conducting a non-human primate toxicology study. Upon successful completion of the preclinical trial, the Company plans to conduct a proof-of concept clinical trial in the US in gout patients using Levotofisopam.

While the Company has limited cash resources and is unable to fund the next development trial for Dextofisopam, it does have sufficient cash to complete the non-human primate preclinical trial currently being conducted. This trial is expected to be completed in October 2011, and if successful the Company will commence a US based clinical proof- of-concept trial using Levotofisopam in gout patients. This will be a small trial that the Company expects to be able to fund with its current cash resources as well. The Company’s strategic plan is to partner with a pharmaceutical company upon successful completion of the proof of concept clinical trial.


10

Pharmos’ most advanced compound is Dextofisopam, which has completed a Phase 2a double-blind, placebo-controlled trial with patients having diarrhea-predominant or alternating IBS with positive effect on primary efficacy endpoint (n=141, p=0.033). In this study, Dextofisopam was well-tolerated and demonstrated significant improvement over placebo, suggesting that Dextofisopam has the potential to become a novel first line treatment for IBS. Pharmos initiated a Phase 2b trial in February 2007 and in June 2007 the Company announced patient screening had commenced.RS-tofisopam. Dextofisopam is the R-enantiomer of racemic tofisopam a molecule marketed and used safely outside the United Statesis being developed for over three decades for multiple indications including IBS. Unlike the two 5-HT3 or 5-HT4 IBS therapies recently introduced into the market, and subsequently withdrawn because of safety concerns, Dextofisopam’s novel non-serotonergic activity offers a unique and innovative approach to IBS treatment.

Levotofisopam is the S-enantiomer of racemic tofisopam. In two earlier Phase 1 studies using Levotofisopam, significant and rapid lowering of uric acid was noted. The Company recently conducted an open-label, Phase 2 proof-of-concept trial at the Duke Clinical Research Unit of Duke University. In May 2012 the Company reported positive top line results of a Phase 2b study were announced in September 2009. The primary endpoint of overall adequate relieffrom this trial. Uric acid was not met due to a high placebo response, but drug activity was observedreduced in all drug cohorts, especially the 200 mg dose.13 treated patients. Mean reduction in uric acid was over 45%. Additionally, fractional excretion of uric acid increased, confirming Levotofisopam’s mechanism of action as enhancing excretion and not as a xanthine oxidase inhibitor.

The Company now is actively seeking to secure a pharmaceutical partner with clinical, scientific and financial capabilities to further develop Dextofisopam.

In research efforts overfor the past decade, the Company has developed a significant expertise in cannabinoid biology and chemistry, and has generated significant know-how and an intellectual property estate pertaining to multiple areas of cannabinoid biology.  The Company closed its operations in Israel effective October 31, 2008. No further development work has been performedof Levotofisopam or alternatively raise additional capital. If we are unable to raise sufficient funds imminently, we will not be able to retain personnel or repay our outstanding convertible debenture on the cannabinoid assetsits due date. This would cause us to suspend our operations indefinitely and the focus is to partner or sell these assets. The Company continues to seek, sell or license other CB2 assets, including Cannabinor which was the only CB2 asset to enter human clinical trials.most likely, permanently (see Note 2).

The Company has explored the concept of a merger or reverse merger with another life science company in order to build greater pipeline critical mass. Several possible candidates were recently examined but were not pursued after preliminary scientific diligence.
The results for the three and six months ended June 30, 20112012 and 20102011 were a net loss of $0.5$0.4 million and $0.4$0.5 million and a net loss of $1.1$1.0 million and $0.9$1.1 million, respectively. On a loss per share basis, this equates to $(0.01) and $(0.01) for the quarters ended June 30, 20112012 and 20102011 and $(0.02) and $(0.02) for the first half, respectively.

Except for 2001, the Company has experienced operating losses every year since inception in funding the research, development and clinical testing of our drug candidates. The Company had an accumulated deficit of $212.5$214.3 million as of June 30, 20112012 and expects to continue to incur losses going forward. Such losses have resulted principally from costs incurred in research and development and from general and administrative expenses. Previously the Company had financed its operations with public and private offerings of securities, advances and other funding pursuant to an earlier marketing agreement with Bausch & Lomb, grants from the Office of the Chief Scientist of Israel, research contracts, the sale of a portion of its New Jersey net operating loss carryforwards (NOL’s), and interest income. During 2010 the Company was awarded a cash grant of $244,000 under the Federal Qualifying Therapeutic Discovery Project for the further development of Dextofisopam. The Company had approximately $2.1$0.5 million of cash and cash equivalents at June 30, 2011.2012. However, the Company’s ability to continue as a going concern is largely dependent upon achieving a collaboration with a pharmaceutical partner or raising additional capital to advance its lead compounds, Levotofisopam, for the treatment of Gout, and Dextofisopam, for the treatment of IBS, and Levotofisopam, for the treatment of gout.IBS.   


9

The Company does not currently have the finances and resources to conduct largeany further clinical trials for its most advanced compound, Dextofisopam and continues to seek a partner. Meanwhile, the Company is pursuing the development of Levotofisopam for the treatment of Gout and will incur preclinical and clinical trial costs.trials. The Company intends to partnercompleted a proof-of-concept Gout trial (the Gout trial) for Levotofisopam uponin April 2012 and in May 2012, announced the successful completion of this proof-of-concept trial in which rapid and significant reduction in uric acid was observed in all patients. The Company has been intensely attempting to partner Levotofisopam. Through the date of this filing, a proof-of-concept clinical trial. Should thispartner or other form of collaboration has not occur,been achieved and should a collaboration or other form of financing not be achieved by November 1, 2012, the Company maywill be unable to continue operations past quarter three or quarter four of 2012, including repayment of the outstanding convertible debenture unless additional capital can be obtained.in quarter four. Currently the Company spends approximately $100,000 a month on continuing operating expenses.

As such, these factors raise substantial doubt as to the Company’s ability to continue as a going concern. The Company has inaccompanying condensed consolidated financial statements do not include any adjustments that might result from the past pursued various funding and financing options; however management believes that future funding or financing options may be challenging becauseoutcome of the current environment.this uncertainty.

11


Results of Operations
Three Months ended June 30, 20112012 and 20102011

Total operating expenses for the second quarter of 2011 increased2012 decreased by $70,517$121,333 or 18%26%, from $404,039 in 2010 to $474,556 in 2011.2011 to $353,223 in 2012.

Research & development expenses for the second quarter increaseddecreased by $111,108$99,613, or 108%46%, from $103,362 in 2010 to $214,470 in 2011.2011 to $114,857 in 2012. The primary areas include a $72,000 increase$34,000 reduction in clinical study fees and a $52,000 increase$66,000 reduction in consultant and professional fees which were offset by a $13,000 reduction in various other areas. Consulting and professional fees increased substantially as the Company conducted work in preparation for initiating a proof-of-concept trial in gout patients using Levotofisopam.fees. Clinical study fees increaseddecreased as the Gout trial concluded in April 2012 and fees were incurred on 13 completed patients. In 2011 clinical study fees were higher due to costs related to conducting a non-human primate toxicology study neededstudy. Consulting and professional fees have decreased as the Company filed the IND for the Gout trial in 2011 while in 2012 there were normal expenses in this trial. These increasesarea.

General and administrative expenses for the second quarter of 2012 decreased by $21,664, or 8%, from $259,415 in 2011 to $237,751 in 2012. The primary reductions were slightly offset bya $7,000 reduction in salaries and benefits and a $15,000 reduction in various other areas. The decrease in payroll costs in 2012 reflects lower stock compensation.  There was also a reduction of various facility related expenses as the Company continued to reduce overall facility costs.

General and administrative expenses for the second quarter of 2011 decreased by $41,077, or 14%, from $300,492 in 2010 to $259,415 in 2011. The primary reductions were a $30,000 reduction in consultant and professional fees and an $11,000 reduction in salaries and benefits. Professional fees have decreased as there were business development fees in 2010 related to a possible reverse merger candidate which eventually was not pursued.  The decrease in payroll costs in 2011 reflects lower stock compensation costs and the elimination of an administrative position in 2010.manage overhead.

No tax provision is required at this time since the Company expects to be in a tax loss position at year-end December 31, 20112012 and has net operating losses from previous years. The Company has established a 100% valuation allowance against the deferred tax asset.assets generated primarily from these losses.

Results of Operations
Six Months ended June 30, 20112012 and 20102011

Total operating expenses for the first half of 2011 increased2012 decreased by $184,497$146,751 or 21%14%, from $866,814 in 2010 to $1,051,311 in 2011.2011 to $904,560 in 2012.

Research & development expenses for the first half of 2011 increased2012 decreased by $269,896$90,733, or 119%18%, from $226,358 in 2010 to $496,254 in 2011.2011 to $405,521 in 2012. The primary areas include a $142,000an $115,000 increase in clinical study fees and a $167,000 increase in consultant and professional fees which were offset by a $39,000$204,000 reduction in consultant and professional fees and a $2,000 reduction in various other areas. Clinical study fees increased as the Gout trial commenced in January 2012 and fees were incurred on 13 completed patients. Consulting and professional fees increased substantiallyhave decreased as the Company conducted work in preparationfiled the IND for initiating a proof-of-conceptthe Gout trial in gout patients using Levotofisopam.  Clinical study2011 while in 2012 there were normal expenses in this area.

General and administrative expenses for the first half of 2012 decreased by $55,952, or 10%, from $553,760 in 2011 to $497,808 in 2012. The primary reductions were a $15,000 reduction in consultant and professional fees, increased due toa $13,000 reduction in salaries and benefits and a $28,000 reduction in various other areas. Professional fees have decreased as there were reduced legal fees incurred.  The decrease in payroll costs related to manufacturing capsules needed for this trial and costs related to conducting a non-human primate toxicology study. These increases were slightly offset byin 2012 reflects lower stock compensation.  There was also a reduction of various facility related expenses as the Company continued to reduce overall facility costs.and manage overhead.

General and administrative expenses for the first half of 2011 decreased by $86,046, or 13%, from $639,806 in 2010 to $553,760 in 2011. The primary reductions were a $47,000 reduction in consultant and professional fees, a $31,000 reduction in salaries and benefits and an $8,000 reduction in various facility related expenses. Accounting fees have decreased as there were higher accounting fees related to the filing of a Regulation statement on Form S-1 in 2010. Also professional fees have decreased as there were business development fees in 2010 related to a possible reverse merger candidate which eventually was not pursued.  The decrease in payroll costs in 2011 reflects lower stock compensation costs and the elimination of an administrative position in 2010. The decrease in the facility related expenses were a combination of all expense items and overall was not a significant reduction.

10
Liquidity and Capital Resources

The following table describes the Company's working capital, cash and cash equivalents and convertible debentures on June 30, 2011,2012, and on December 31, 2010:2011:

12


 
June 30,
2011
  
December 31,
2010
 
       June 30, 2012  December 31, 2011 
Working capital $2,039,370  $3,015,068  $(542,955) $296,654 
        
Cash and cash equivalents $2,115,349  $3,139,347  $517,344  $1,535,137 
        
Convertible Debenture – due November 2012 $1,000,000  $1,000,000 
        
Convertible debenture, due 2012 $1,000,000  $1,000,000 

Current working capital position

As of June 30, 2011,2012, the Company had working capital of $2.0$(0.6) million consisting of current assets of $2.2$0.6 million and current liabilities of $0.2$1.2 million. This represents a decrease of $1.0$0.8 million from its working capital of $3.0$0.3 million on current assets of $3.2$1.7 million and current liabilities of $0.2$1.4 million as of December 31, 2010.2011. This decrease in working capital of $1.0$0.8 million was principally associated with the funding of general and administrative activities and research and development expenses related to advance work to startthe completion of a proof of conceptproof-of-concept clinical trial in goutGout patients using S-Tofisopam.

Current and future liquidity position

As discussed in Notes 2 and 3 to the executive summary,condensed consolidated financial statements, the Company does not currently have the finances and resources to conduct largeany further clinical trials for its most advanced compound, Dextofisopam and continues to seek a partner. Meanwhile, the Company is pursuing the development of Levotofisopam for the treatment of Gout and will incur preclinical and clinical trial costs.trials. The Company expects to be able to fund these pre-clinicalcompleted a proof-of-concept Gout trial (the Gout trial) for Levotofisopam in April 2012 and proof-of-concept clinical trials with its current cash resources. The Company intends to partner Levotofisopam uponin May 2012, announced the successful completion of this proof-of-concept trial in which rapid and significant reduction in uric acid was observed in all patients. The Company has been intensely attempting to partner Levotofisopam. Through the date of this filing, a proof-of-concept clinical trial. Should thispartner or other form of collaboration has not occur,been achieved and should a collaboration or other form of financing not be achieved by November 1, 2012, the Company maywill be unable to continue operations past quarter three or quarter four of 2012, including repayment of the outstanding convertible debenture unless additional capital can be obtained.in quarter four. Currently the Company spends approximately $100,000 a month on continuing operating expenses.
 
As such these factors raise substantial doubt as to the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that might result from this uncertainty.
Cash

At June 30 2010, cash and cash equivalents totaled $2.1 million. At December 31, 2010 cash and cash equivalents totaled $3.1 million. This net decrease in cash of $1.0 million was due primarily to spending for normal operating requirements. The cash and cash equivalents will be used to fund Research & Development activities and general and administrative costs.

Operating activities

Net cash used in operating activities for the first six months of 20112012 was $1.0 million compared to net cash used of $1.1$1.0 million for the first six months of 2010.2011. Overall on a year to year comparison the net cash used was similar. The Company continues to fund Researchresearch & Developmentdevelopment activities and general and administrative costs.


 
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Commitment and Contingencies

AsThe table below sets out our current contractual obligations as of June 30, 2011, the Company had the following contractual commitments and long-term obligations:2012.

  
 
Total
  
Less than
1 Year
  
1 - 3
Years
  
3 - 5
Years
  Undetermined 
Operating leases $12,774  $12,774  $-  $-  $- 
Convertible debenture  1,000,000   -   1,000,000   -   - 
Convertible debenture interest  133,333   100,000   33,333   -   - 
Total $1,146,107  $112,774  $1,033,333  $-  $- 
  Payments Due by Period 
  
 
Total
  
Less than 1 Year
  
1 – 3
Years
  
3 – 5
Years
  
More Than
5 Years
  
 
 Undetermined
 
Operating Leases $13,215  $13,215  $-  $-  $-  $- 
Convertible Debenture Interest  33,333   33,333   -   -         
Convertible Debenture  1,000,000   1,000,000   -   -   -   - 
Total $1,046,548  $1,046,548  $-  $-  $-  $- 

In connection with the acquisition of Vela Pharmaceuticals which closed on October 25, 2006 the Company is obligated to pay certain performance based milestones connected to the development of Dextofisopam.

The remaining milestones are as follows:

·      $1 million cash: Final patient enrolled in Phase 2b trial (1)
·      $2 million + 2 million shares: NDA submission
·      $2 million cash +2.25 million shares: FDA approval
·      1 million shares: Approval to market in Europe or Japan
·      4 million shares: $100 million sales of Dextofisopam, when and if approved, in any 12-month period

(1) The milestone was reached when the final patient was enrolled in the Dextofisopam Phase 2b trial and was recognized in the first quarter of 2009 as all probability criteria were met. The milestone had two components, a cash portion of $1,000,000 and a share portion of 2,000,000 shares valued at $180,000.  The total charge in the first quarter 2009 was $1,180,000. The shares were issued in November 2009 under the terms of the Amendment #3 to the agreement and plan of merger. Under that amendment the payment of the cash portion was deferred until such time as 1) the Company successfully entered into a strategic collaboration or licensing agreement with a third party for the development of Dextofisopam resulting in an upfront cash fee of at least $10 million, and 2) payment of the cash milestone would still leave the Company with one year’s operating cash.

The Company recorded the milestone in the first quarter of 2009 as it met the accounting requirements of under ACS 450. The results of the Phase 2b trial were announced in September 2009 and reported that while there was clearly drug activity, the trial did not achieve its primary endpoint. Under the terms of the Vela acquisition agreement as amended, the 2 million shares were issued on November 2, 2009. The cash portion that was expensed in Q1 2009 was reversed in Q4 2009 since it is not deemed probable that the amended terms would be achieved. Since the trial results were not successful, no other milestones have been achieved.

New accounting pronouncements

In May 2011, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2011-04, Fair Value Measurement (Topic 820). This ASU is intended to create consistency between U.S. GAAP and International Financial Reporting Standards on the definition of fair value and on the guidance on how to measure fair value and on what to disclose about fair value measurements. This ASU will be effective for financial statements issued for fiscal periods beginning after December 15, 2011, with early adoption prohibited for public entities. The Company is currently evaluating the impact ASU 2011-04 willThis update did not have any material effect on its consolidatedour financial statements.



 
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Item 3.                      Quantitative and Qualitative Disclosures About Market Risk

We assessed our vulnerability to certain market risks, including interest rate risk associated with financial instruments included in cash and cash equivalents. Due to the relatively short-term nature of these investments the Company has determined that the risks associated with interest rate fluctuations related to these financial instruments do not pose a material risk to us.

Item 4.                      Controls and Procedures

(a) Evaluation of Disclosure Controls and Procedures: An evaluation of Pharmos' disclosure controls and procedures (as defined in Section13a-15(e) of the Securities Exchange Act of 1934 (the “Act”)) was carried out under the supervision and with the participation of Pharmos' principal executive officer and principal financial officer at June 30, 2011.2012. Based on this evaluation, Pharmos' principal executive officer and principal financial officer concluded that as of June 30, 2011,2012, Pharmos' disclosure controls and procedures were effective, at a reasonable level of assurance, in ensuring that the information required to be disclosed by Pharmos in the reports it files or submits under the Act is (i) accumulated and communicated to Pharmos' management (including the principal executive officer and principal financial officer) in a timely manner, and (ii) recorded, processed, summarized and reported within the time periods specified in the SEC's rules and forms.

(b) Changes in Internal Control over Financial Reporting:  There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934, as amended) during our last fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 
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Part II   Other Information

Item 1
Legal ProceedingsNONE
   
Item 1A
Risk Factors 

NASDAQ Listing

On March 13, 2009 the company was officially delisted from the Nasdaq Capital Market, and is currently trading on the OTCBB pink sheets under the symbol PARS.PK. The company was not in compliance with the minimum $2,500,000 stockholders’ requirement for continued listing and was unable to comply during the grace period extended by NASDAQ. As a result of trading on the OTCBB pink sheets, liquidity for our common stock may be significantly decreased which could reduce trading price and increase the transaction costs of trading shares of the company’s common stock.

Need For Additional Capital

Our ability to operate as a going concern is dependent upon raising adequate financing.  Management believes that the current cash and cash equivalents, totaling $2.1$0.5 million as of June 30, 2011,2012, will be sufficient to support our currently planned continuing operations through at least March 31,October of 2012. However the Company’s ability to continue as a going concern is largely dependent upon achieving a collaboration with a pharmaceutical partner or raising additional capital to advance its lead compounds, Dextofisopam, for the treatment of IBS, and Levotofisopam, for the treatment of gout. The Company does not currently have the finances and resources to conduct largeany further clinical trials for its most advanced compound, Dextofisopam and continues to seek a partner. Meanwhile, the Company is pursuing the development of Levotofisopam for the treatment of Gout and will incur preclinical and clinical trial costs.trials. The Company intends to partnercompleted a proof-of-concept Gout trial (the Gout trial) for Levotofisopam uponin April 2012 and in May 2012, announced the successful completion of this proof-of-concept trial in which rapid and significant reduction in uric acid was observed in all patients. The Company has been intensely attempting to partner Levotofisopam. Through the date of this filing, a proof-of-concept clinical trial. Should thispartner or other form of collaboration has not occur,been achieved and should a collaboration or other form of financing not be achieved by November 1, 2012, the Company maywill be unable to continue operations past quarter three or quarter four of 2012, including repayment of the outstanding convertible debenture unless additional capital can be obtained.in quarter four.


Item 2
Unregistered Sales of Equity Securities and Use of ProceedsNONE
   
Item 3
Defaults upon Senior SecuritiesNONE
   
Item 4
(Removed and Reserved)
Mine Safety Disclosures		N/A
   
Item 5
Other InformationNONE
   
.

 
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Item 6
Exhibits Exhibits

Number Exhibit
   
3.1 Restated Articles of Incorporation (Incorporated by reference to Appendix E to the Joint Proxy Statement/Prospectus included in the Form S-4 Registration Statement of the Company dated September 28, 1992 (No. 33-52398)
   
3.2 Certificate of Amendment of Restated Articles of Incorporation dated January 30, 1995 (Incorporated by reference to Annual Report on Form 10-K for the year ended December 31, 1994).
   
3.3 Certificate of Amendment of Restated Articles of Incorporation dated January 16, 1998 (Incorporated by reference to the Company’s Current Report on Form 8-K, dated February 6, 1998).
   
3.4 Certificate of Amendment of Restated Articles of Incorporation dated October 21, 1999 (Incorporated by reference to exhibit 4(e) to the Form S-3 Registration Statement of the Company filed September 28, 2000 (No. 333-46818)).
   
3.5 Certificate of Amendment of Restated Articles of Incorporation dated July 19, 2002 (Incorporated by reference to Exhibit 3 to the Company’s Report on Form 10-Q for the quarter ended June 30, 2002).
   
3.6 Certificate of Amendment of Restated Articles of Incorporation dated July 7, 2004 (Incorporated by reference to Exhibit 3.1 to the Company’s Report on Form 10-Q for the quarter ended June 30, 2004).
   
3.7 Certificate of Amendment to Articles of Incorporation dated September 23, 2005 (Incorporated by reference to exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005).
   
3.8 Certificate of Amendment to Articles of Incorporation dated August 5, 2009 (Incorporated by reference to exhibit 3.8 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009).
   
3.9 Amended and Restated By-Laws (Incorporated by reference to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007).
   
31.1 Certification of Principal Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
31.2 Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   
32.1 Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
32.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
101.1 The following financial information from Pharmos Corporation's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011,2012, formatted in XBRL (eXtensible Business Reporting Language): (i)  Condensed Consolidated Balance Sheets as of June 30, 2011,2012, and December 31, 2010,2011, (ii) Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2011,2012, and June 30, 2010,2011, (iii) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2011,2012, and June 30, 20102011 and (iv) Notes to Condensed Consolidated Financial Statements.

 
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SIGNATURE

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.


  PHARMOS CORPORATION 
     
     
Date: August 8, 2011July 30, 2012    
  by:/s/ S. Colin Neill 
     
  S. Colin Neill 
  President, Chief Financial Officer, Secretary & Treasurer 
  (Principal Accounting and Financial Officer) 

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