0001176256-12-000784.txt : 20121114 0001176256-12-000784.hdr.sgml : 20121114 20121114102337 ACCESSION NUMBER: 0001176256-12-000784 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20120930 FILED AS OF DATE: 20121114 DATE AS OF CHANGE: 20121114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NYMOX PHARMACEUTICAL CORP CENTRAL INDEX KEY: 0001018735 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12033 FILM NUMBER: 121201564 BUSINESS ADDRESS: STREET 1: 9900 CAVENDISH BLVD., SUITE 306 STREET 2: ST. LAURENT CITY: QUEBEC CANADA STATE: A8 ZIP: H4M 2V2 BUSINESS PHONE: 5143323222 MAIL ADDRESS: STREET 1: 9900 CAVENDISH BLVD., SUITE 306 STREET 2: ST. LAURENT CITY: QUEBEC CANADA STATE: A8 ZIP: H4M 2V2 6-K 1 nymox6k3q120930.htm REPORT OF FOREIGN ISSUER FOR THE PERIOD ENDED SEPTEMBER 30, 2012 Filed by e3 Filing, Computershare 1-800-973-3274 - Nymox Pharmaceutical Corporation - Form 6-K

FORM 6-K

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934

For the period ended September 30, 2012

Commission File Number: 001-12033

NYMOX PHARMACEUTICAL CORPORATION

9900 Cavendish Blvd., St. Laurent, QC, Canada, H4M 2V2

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F [ X ] Form 40-F [   ]

Indicate by check mark if the registrant is submitting Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(l): _______

Indicate by check mark if the registrant is submitting Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): _______

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes [   ] No [ X ]

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-_______





Exhibit  
   
99.1 Quarterly Report for the Quarter ended September 30, 2012
99.2 CEO Certifications
99.3 CFO Certifications





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.

NYMOX PHARMACEUTICAL CORPORATION
(Registrant)
By: /s/ Paul Averback
Paul Averback
President and Chief Executive Officer

 

Date: November 14, 2012



EX-99.1 2 exhibit99-1.htm QUARTERLY REPORT FOR THE QUARTER ENDED SEPTEMBER 30, 2012 Exhibit 99.1

Exhibit 99.1


MESSAGE TO SHAREHOLDERS

Nymox is pleased to present its interim consolidated financial statements for the quarter ended September 30, 2012.

On July 11, Nymox announced the completion of enrollment for Study NX02-0020. The NX02-0020 study started in July 2011 and involved men who had previously participated in one of the earlier NX-1207 studies for benign prostatic hyperplasia (BPH) and in the current trial wished an open label injection of NX-1207.

On July 17, Nymox provided an update on the Company’s Phase 3 pivotal trials for NX-1207. The Safety Monitoring Committee meeting of July 12, 2012 was favorable and indicated no significant safety concerns for the two pivotal U.S. trials to date.

On July 31, Nymox reported positive results from a new study of long-term treatment outcomes for men who had received a single injection of NX-1207 2.5 mg for treatment for their BPH. The study analysis found that a statistically significant greater number of men who had received NX-1207 2.5 mg reported positive treatment outcomes as compared to men who had received a placebo. The study involved the latest available blinded follow-up study data (an average of 57 months post-injection) from the completed clinical trials for these treatment groups. A positive treatment outcome was seen if the patient was not using other BPH medications and no surgical treatment (including MIST) for BPH was reported at any time during the post-injection follow-up period. The combined new statistical analysis of blinded study data showed NX-1207 2.5 mg to have a lasting benefit in terms of positive treatment outcomes that was significantly superior to placebo (p=.02). Previous follow-up studies have shown long-term benefit from a single NX-1207 treatment in excess of 5 years in some cases.

On September 12, Nymox reported favorable results from the Safety Monitoring Committee review of ongoing safety data for the Company’s Phase 3 pivotal trials for NX-1207. The September 4, 2012 Safety Monitoring Committee meeting found no significant safety concerns to date.

On September 18, Nymox announced positive results of the Safety Monitoring Committee review of safety data from the Company’s Phase 3 NX02-0020 repeat injection U.S. study for NX-1207. The Safety Monitoring Committee review was favorable and indicated no significant safety concerns for the trial to date.

On September 20, Nymox reported that the Independent Data Monitoring Committee for the Company's Phase 2 study of NX-1207 for low risk localized prostate cancer (NX03-0040) reported a positive interim safety analysis of clinical data from the first group of patients to receive either a high or low dose of NX-1207 for treatment of their localized prostate cancer. The Independent Data Monitoring Committee is an arm's length independent body mandated to conduct periodic interim safety reviews during the study. The NX03-0040 study tests both low and high doses of NX-1207 for their effect on low grade localized prostate cancer. The NX-1207 dose is administered directly into the area of the prostate where the cancer was detected. Patients undergoing active surveillance in the trial also have the opportunity to receive NX-1207 after their trial active surveillance participation is completed.

We wish to thank the Company’s shareholders for their strong support. The Nymox team is enthusiastically looking forward to the exciting activities of your Company.

/s/ Paul Averback, MD
Paul Averback MD
President

November 14, 2012

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MANAGEMENT'S DISCUSSION AND ANALYSIS
(in US dollars)

This Management’s discussion and analysis (“MD&A”) comments on the Corporation’s operations, performance and financial condition as at and for the quarters ended September 30, 2012 and 2011. This MD&A should be read together with the unaudited condensed interim Consolidated Financial Statements and the related notes. This MD&A is dated November 14, 2012. All amounts in this report are in U.S. dollars, unless otherwise noted.

Except as otherwise indicated, all financial information contained in this MD&A and in the unaudited condensed interim Consolidated Financial Statements has been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). The unaudited condensed interim Consolidated Financial Statements and this MD&A were reviewed by the Corporation’s Audit and Finance Committee and were approved by our Board of Directors.

Additional information about the Corporation can be obtained on EDGAR at www.sec.gov or on SEDAR at www.sedar.com.

Overview

Corporate Profile

Nymox Pharmaceutical Corporation is a biopharmaceutical company with a significant R&D pipeline in development. Nymox is developing NX-1207, a novel treatment for benign prostatic hyperplasia which is in Phase 3 trials in the U.S. In December 2010, the Corporation signed a license and collaboration agreement with Recordati, a European pharmaceutical group, for the development and commercialization of NX-1207 in Europe including Russia and the CIS, the Middle East, the Maghreb area of North Africa and South Africa. The license and collaboration agreement covers the use of NX-1207 for the treatment of BPH as the initial indication for development and commercialization. NX-1207 showed positive results for the treatment of BPH in Phase 1 and 2 clinical trials in the U.S. and in follow-up studies of available subjects from the completed clinical trials. In June 2009, the Corporation began conducting the first of two pivotal double blind placebo controlled Phase 3 trials for NX-1207 that incorporate the specific protocol design recommendations provided to the Corporation by the FDA. The two pivotal Phase 3 studies for NX-1207 are being conducted at well-known investigational sites across the U.S. with planned enrollment of 1,000 patients. An open-label U.S. re-injection safety study of NX-1207 for BPH was started in July of 2011 and is nearing completion. A Phase 2 study of NX-1207 for low grade localized prostate cancer was started in March 2012. The Corporation is also developing new treatments for bacterial infections in humans. Nymox has candidates which are under development as drug treatments aimed at the causes of Alzheimer’s disease, and has several other drug candidates in development. Nymox has U.S. and global patent rights for the use of statin drugs for the treatment and prevention of Alzheimer’s disease. Nymox developed the AlzheimAlert™ test, which is certified with a CE Mark in Europe. Nymox developed and markets NicAlert™ and TobacAlert™; which are tests that use urine or saliva to detect use of and exposure to tobacco products. NicAlert™ has received clearance from the FDA and is also certified with a CE Mark in Europe. TobacAlert™ is the first test of its kind to accurately measure second and third hand smoke exposure in individuals.

Risk Factors

The business activities of the Corporation since inception have been devoted principally to research and development. Accordingly, the Corporation has had limited revenues from sales and has not been profitable to date. We refer to the Risk Factors section of our Form 20-F filed on EDGAR and on SEDAR for a discussion of the management and investment issues that affect the Corporation and our industry. The risk factors that could have an impact on the Corporation’s financial results are summarized as follows:

  • Our Clinical Trials for Our Therapeutic Products in Development, Such as NX-1207, May Not be Successful and We May Not Receive the Required Regulatory Approvals Necessary to Commercialize These Products

  • Our Clinical Trials for Our Therapeutic Products, Such as NX-1207, May Be Delayed, Making it Impossible to Achieve Anticipated Development or Commercialization Timelines

  • A Setback in Any of Our Clinical Trials Would Likely Cause a Drop in the Price of our Shares

  • We May Not be Able to Make Adequate Arrangements with Third Parties for the Commercialization of our Product Candidates, such as NX-1207

  • We May Not Achieve our Projected Development Goals in the Time Frames We Announce and Expect

  • Even If We Obtain Regulatory Approvals for Our Product Candidates, We Will be Subject to Stringent Ongoing Government Regulation

  • It is Uncertain When, if Ever, We Will Make a Profit

  • We May Not Be Able to Raise Enough Capital to Develop and Market Our Products

  • We Face Challenges in Developing, Manufacturing and Improving Our Products

  • Our Products and Services May Not Receive Necessary Regulatory Approvals

  • We Face Significant and Growing Competition

  • We May Not Be Able to Successfully Market Our Products

  • Protecting Our Patents and Proprietary Information is Costly and Difficult

  • We Face Changing Market Conditions

  • Health Care Plans May Not Cover or Adequately Pay for Our Products and Services

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  • We Are Subject to Continuing Potential Product Liability Risks, Which Could Cost Us Material Amounts of Money

  • The Issuance of New Shares May Dilute Nymox’s Stock

  • We Face Potential Losses Due to Foreign Currency Exchange Risks

  • We Have Never Paid a Dividend and are Unlikely to do so in the Foreseeable Future

Critical Accounting Policies

The condensed interim consolidated financial statements of the Corporation have been prepared under International Financial Reporting Standards. The Corporation’s functional and presentation currency is the United States dollar. Our accounting policies are described in the notes to our annual audited consolidated financial statements. We consider the following policies to be the most critical in understanding the judgments that are involved in preparing our financial statements and the matters that could impact our results of operations, financial condition and cash flows.

Revenue Recognition

The Corporation has generally derived its revenues from product sales and collaboration agreements. Revenue from product sales is recognized when the product has been delivered and obligations as defined in the agreement are performed. Collaboration agreements that include multiple deliverables are considered to be multiple-element arrangements. Under this type of arrangement, the identification of separate units of accounting is required and revenue is allocated among the separate units based on their relative fair values.

Payments received under a collaboration agreement may include upfront payments, milestone payments, sale of goods, royalties and license fees. Revenue for each unit of accounting are recorded as described below:

(i)

Upfront payments:

 

 

Upfront payments are deferred and recognized as revenue on a systematic basis over the estimated service period. Changes in estimates are recognized prospectively when changes to the expected term are determined.

 

(ii)

Milestone payments:

 

 

Revenue subject to the achievement of milestones is recognized only when the specified events have occurred and collectability is reasonably assured.

 

 

Specifically, the criteria for recognizing milestone payments are that (i) the milestone is substantive in nature, (ii) the achievement was not reasonably assured at the inception of the agreement, and (iii) the Corporation has no further involvement or obligation to perform associated with the achievement of the milestone, as defined in the related collaboration arrangement.

 

(iii)

Sale of goods:

 

 

Revenue from the sale of goods is recognized when the Corporation has transferred to the buyer the significant risks and rewards of ownership of the goods, there is no continuing management involvement with the goods, and the amount of revenue can be measured reliably.

 

(iv)

Royalties and license fees:

 

 

Royalties and license fees are recognized when conditions and events under the license agreement have occurred and collectability is reasonably assured.

Valuation of Property and Equipment

Property and equipment are stated at cost and are amortized on a straight-line basis over the estimated useful lives. The Corporation reviews the unamortized balance of property and equipment, and recognizes any impairment in carrying value when it is identified. Factors we consider important, which could trigger an impairment review include:

  • Significant changes in the manner of our use of the acquired assets or the strategy for our overall business; and

  • Significant negative industry or economic trends.

The recoverable amount of an asset or cash-generating unit is the greater of its value in use and its fair value less costs to sell. In assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset. For the purpose of impairment testing, assets that cannot be tested individually are grouped together into the smallest group of assets that generates cash inflows from continuing use that are largely independent of the cash inflows of other assets or groups of assets (the “cash-generating unit, or CGU”).

An impairment loss is recognized if the carrying amount of an asset or its CGU exceeds its estimated recoverable amount. Impairment losses recognized in respect of CGUs are allocated to reduce the carrying amounts of the assets in the CGU on a pro rata basis. Future events could cause management to conclude that impairment indicators exist and that the carrying values of the Corporation’s property and equipment are impaired.

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Stock-based Compensation

Stock-based compensation is recorded using the fair value based method for stock options issued to employees and non-employees. Under this method, compensation cost related to employee awards is measured at fair value at the date of grant, net of forfeitures, and is expensed over the award’s vesting period. The Corporation uses the Black-Scholes options pricing model to calculate stock option values, which requires certain assumptions, including the future stock price volatility and expected time to exercise. Changes to any of these assumptions, or the use of a different option pricing model, could produce different fair values for stock-based compensation, which could have a material impact on the Corporation’s earnings.

Recoverability of Deferred Tax Assets

Management judgment is required in assessing the recoverability of deferred tax assets. We have recorded no deferred tax assets as of September 30, 2012 and as of December 31, 2011, due to uncertainties related to our ability to utilize all, or a portion of, our deferred tax assets, primarily consisting of net operating losses carried forward and other unclaimed deductions, before they expire. In assessing the recoverability of deferred tax assets, management considers whether it is probable that some portion or all of the deferred tax assets will not be recovered. The ultimate recoverability of deferred tax assets is dependent upon the generation of future taxable income and tax planning strategies. The generation of future taxable income is dependent on the successful commercialization of the Corporation’s products and technologies.

Results of Operations

Nine Months Ended September 30   2012     2011     2010  
Total revenues $ 2,283,037   $ 2,336,209   $ 378,307  
Net loss $ (4,813,666 ) $ (7,993,264 ) $ (4,478,999 )
Loss per share (basic & diluted) $ (0.15 ) $ (0.24 ) $ (0.14 )
Total assets $ 2,137,236   $ 6,520,241   $ 862,882  
Non-current financial liabilities $ 400,000   $ 400,000   $ 400,000  

 

Quarterly Results   Q3 – 2012     Q2 – 2012     Q1 – 2012     Q4 – 2011  
Total revenues $ 764,564   $ 778,894   $ 739,579   $ 777,606  
Net loss $ (1,245,563 ) $ (1,721,128 ) $ (1,846,974 ) $ (1,659,125 )
Loss per share (basic & diluted) $ (0.04 ) $ (0.05 ) $ (0.06 ) $ (0.05 )
    Q3 – 2011     Q2 – 2011     Q1 – 2011     Q4 – 2010  
Total revenues $ 804,712   $ 766,482   $ 765,015   $ 313,143  
Net loss $ (1,614,041 ) $ (1,948,132 ) $ (4,431,091 ) $ (2,057,314 )
Loss per share (basic & diluted) $ (0.05 ) $ (0.06 ) $ (0.14 ) $ (0.06 )

The revenues in 2012, 2011 and 2010 include revenue being recognized on a systematic basis over the estimated service period related to the upfront payment of €10 million (US$13.1 million) received from Recordati in December 2010. The lower net loss for the period ended September 30, 2012, compared to 2011, is related primarily to substantially higher stock-based compensation expense recorded during the first quarter of 2011 due to the 865,000 options granted in the first quarter of 2011 of which the majority vested immediately.

Results of Operations – Q3 2012 compared to Q3 2011

Net losses were $1,245,563, or $0.04 per share, for the quarter, and $4,813,666, or $0.15 per share, for the nine-months ended September 30, 2012, compared to $1,614,041, or $0.05 per share, for the quarter, and $7,993,264, or $0.24 per share, for the nine-months ended September 30, 2011. Net losses include stock compensation charges of $294,945 in 2012 and $3,943,338 in 2011. The decrease in net losses is principally attributable to the substantially lower stock compensation charges recorded in 2012 compared to the same period in 2011. The weighted average number of common shares outstanding for the nine-months ended September 30, 2012 was 33,115,780 compared to 32,636,771 for the same period in 2011.

Revenues

Revenues from sales of goods amounted to $110,164 for the quarter, and $319,837 for the nine-months ended September 30, 2012, compared with $150,312 for the quarter, and $373,009 for the nine-months ended September 30, 2011. The decrease in orders from customers for NicAlert™/TobacAlert™ is attributable to a reduction in U.S. government research grants in 2012 compared to 2011. The development of therapeutic candidates and of moving therapeutic product candidates through clinical trials is a priority for the Corporation at this time. The growth of sales will become more of a priority once these candidates have reached the marketing stage. The Corporation expects that revenues will increase if and when product candidates pass clinical trials and are launched on the market.

For the quarter and nine-months ended September 30, 2012 and 2011, amounts of $654,400 and $1,963,200 were recognized as revenue relating to the upfront payment received from Recordati in December 2010. At September 30, 2012, the deferred revenue related to this transaction recorded in the statement of financial position amounted to $8,398,133.

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Research and Development

Research and development expenditures were $1,509,256 for the quarter, and $5,353,670 for the nine-months ended September 30, 2012, compared with $1,647,342 for the quarter, and $7,570,629 for the nine-months ended September 30, 2011. Research and development expenditures include costs incurred in advancing Nymox’s BPH product candidate NX-1207 through clinical trials, as well as costs related to its R&D pipeline in development. Research and development expenditures also include stock compensation charges of $32,882 in the nine-months ended September 30, 2012 and $2,325,265 in the comparative period in 2011. The decrease in expenses is primarily attributable to the substantially lower stock compensation charges recorded in 2012 compared to the same period in 2011. In 2012, research tax credits and grants amounted to $221,994 compared to $473,805 in 2011. The decrease is due to the recognition in 2011 of the grant awarded from the U.S. government under the Qualifying Therapeutic Discovery Project in the amount of $244,479, which was not repeated in 2012. The Corporation expects that research and development expenditures will decrease as product candidates finish development and clinical trials. However, because of the early stage of development of the Corporation’s R&D projects, it is impossible to outline the nature, timing or estimated costs of the efforts necessary to complete these projects, nor the anticipated completion dates for these projects. The facts and circumstances indicating the uncertainties that preclude us from making a reasonable estimate of the costs and timing necessary to complete projects include the risks inherent in any field trials, the uncertainty as to the nature and extent of regulatory requirements both for safety and efficacy, and the ability to manufacture the products in accordance with current good manufacturing requirements (cGMP) and in sufficient quantities both for large scale trials and for commercial use. A drug candidate that shows efficacy can take a long period (7 years or more) to achieve regulatory approval. There is also uncertainty whether we will be able to successfully adapt our patented technologies or whether any new products we develop will pass proof-of-principle testing both in the laboratory and in clinical trials, and whether we will be able to manufacture such products at a commercially competitive price. In addition, given the very high costs of development of therapeutic products, we anticipate having to partner with larger pharmaceutical companies to bring therapeutic products to market. The terms of such partnership arrangements along with our related financial obligations cannot be determined at this time and the timing of completion of the approval of such products will likely not be within our sole control.

Marketing Expenses

Marketing expenditures were $33,244 for the quarter, and $121,675 for the nine-months ended September 30, 2012, compared with $47,401 for the quarter, and $590,271 for the nine-months ended September 30, 2011. Marketing expenditures also include stock compensation charges of $398 for the nine-months ended September 30, 2012 and $434,234 in the comparative period in 2011. The decrease in expenses is primarily attributable to the substantially lower stock compensation charges recorded in 2012 compared to the same period in 2011. The balance of the decrease for the quarter and the nine-months is due to a decrease in costs of publicity in 2012 compared to 2011. The Corporation expects that marketing expenditures will increase if and when new products are launched on the market.

General and Administrative Expenses

General and administrative expenses were $476,332 for the quarter, and $1,615,779 for the nine-months ended September 30, 2012, compared with $686,409 for the quarter, and $2,417,154 for the nine-months ended September 30, 2011. General and administrative expenditures also include stock compensation charges of $261,674 for the nine-months ended September 30, 2012 and $1,183,839 in the comparative period in 2011. The decrease in expenses for the quarter and the nine-months is primarily attributable to the substantially lower stock compensation charges recorded in 2012 compared to the same period in 2011. The Corporation expects that general and administrative expenditures will increase as new product development leads to expanded operations.

Finance costs - Foreign Exchange

The Corporation incurs expenses in the local currency of the countries in which it operates, which include the United States and Canada. Approximately 60% of 2012 expenses (73% in 2011) were in U.S. dollars. Foreign exchange fluctuations had no meaningful impact on the Corporation’s results in 2012 or 2011.

Inflation

The Corporation does not believe that inflation has had a significant impact on its results of operations.

Contractual Obligations

Nymox has no contractual obligations of significance other than long-term lease commitments for rental of laboratory and office space, other operating leases and redeemable preferred shares as follows:

Contractual Obligations   Total     Less than 1 year     1-3 years     4-5 years  
Rent for laboratory and office space $ 631,015   $ 369,156   $ 261,859   $ 0  
Operating Leases $ 13,924   $ 8,643   $ 5,281   $ 0  
Total Contractual Obligations $ 644,939   $ 377,799   $ 267,140   $ 0  

The redeemable preferred shares in the amount of $400,000 have no specific terms of repayment.

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Off-Balance Sheet Arrangements

The Corporation has no binding commitments for the purchase of property, equipment or intellectual property. The Corporation has no commitments that are not reflected in the statement of financial position except for operating leases.

Transactions with Related Parties

The Corporation had no transactions with related parties in 2012 and 2011.

Refer to note 10 of the unaudited condensed interim Consolidated Financial Statements for key management personnel disclosures.

Financial Position

Liquidity and Capital Resources

As of September 30, 2012, cash totalled $1,555,326 and receivables including tax credits totalled $532,592. In December 2010, the Corporation received an upfront payment of €10 million (US$13.1 million) pursuant to a license and collaboration agreement with Recordati for the development and commercialization of NX-1207 in Europe and other countries. In November 2011, the Corporation signed a common stock private purchase agreement, whereby Lorros-Greyse Investments Limited (the “Purchaser”) was committed to purchase up to $15 million of the Corporation’s common shares over a twenty-four month period. The agreement became effective December 19, 2011. As at September 30, 2012, three drawings were made under this purchase agreement, for total proceeds of $2,075,000. On May 23, 2012, 132,100 common shares were issued at a price of $7.57 per share. On August 2, 2012, 88,087 common shares were issued at a price of $5.96 per share. On September 20, 2012, 95,652 common shares were issued at a price of $5.75 per share.

At September 30, 2012, the Corporation can draw down a further $12,925,000 over the remaining 13 months under the agreement. The Corporation intends to access financing under this agreement when appropriate to fund its research and development. The Corporation believes that cash balances, funds from operations, as well as funds from the common stock private purchase agreement will be sufficient to meet the Corporation’s cash requirements for the next twelve months.

The Corporation must comply with general covenants in order to draw on its facility including maintaining its stock exchange listing and registration requirements and having no material adverse effects, as defined in the agreement, with respect to the business and operations of the Corporation.

The Corporation relies almost exclusively on this financing as well as collaboration agreements to fund its operations. In order to achieve the Corporation’s business plan and realization of its assets and liabilities in the normal course of operations, the Corporation anticipates the need to raise additional capital and/or achieve sales and other revenue generating activities.

Outstanding Share Data

As at November 14, 2012, there were 33,318,409 common shares of Nymox issued and outstanding. In addition, 5,455,500 share options are outstanding, of which 5,400,500 are currently vested. There are no warrants outstanding.

Subsequent Events

  • On October 15, 2012, the Corporation issued 500,000 options to the CEO with an exercise price of $6.51, which was based on the closing market price on October 12, 2012, the business day prior to its issuance. This will result in approximately $1,600,000 of stock based compensation expense to be recorded in the fourth quarter of 2012 as the options fully vested on the issuance date.

  • As at November 14, 2012, one drawing was made under the new common stock private purchase agreement, for total proceeds of $500,000. On October 30, 2012, 82,781 common shares were issued at a price of $6.04 per share.

Disclosure Controls and Procedures

Disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed is accumulated and communicated to senior management on a timely basis so that appropriate decisions can be made regarding public disclosure. The Corporation’s Chief Executive Officer and its Chief Financial Officer are responsible for establishing and maintaining disclosure controls and procedures. They are assisted in this responsibility by the Corporation’s disclosure committee, which is composed of members of senior management. Based on an evaluation of the Corporation’s disclosure controls and procedures, the Chief Executive Officer and Chief Financial Officer have concluded that the disclosure controls and procedures were effective as of September 30, 2012.

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Internal Control over Financial Reporting

Management’s Annual Report on Internal Control Over Financial Reporting

Management’s annual evaluation and report on the effectiveness of internal control over financial reporting as of our most recent fiscal year end December 31, 2011 was included in the 2011 Annual Management’s Discussion and Analysis and was based on the framework set forth in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on its evaluation under this framework, the Chief Executive Officer and the Chief Financial Officer concluded that our internal control over financial reporting was effective as of December 31, 2011.

Changes in Internal Controls Over Financial Reporting

There have been no changes since December 31, 2011 in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Changes in accounting policies:

New standards and interpretations issued but not yet adopted:

A number of new standards, interpretations and amendments to existing standards were issued by the IASB or International Financial Reporting Interpretations Committee (“IFRIC”). They are mandatory but not yet effective for the period ended September 30, 2012 and have not been applied in preparing these unaudited condensed interim consolidated financial statements.

Many of these are not applicable or are inconsequential to the Corporation and have been excluded from the discussion below. The following standards and interpretations have been issued by the IASB and the IFRIC and the Corporation is currently assessing their impact on the financial statements.

IFRS 9 - Financial Instruments (“IFRS 9”) ultimately replaces IAS 39 - Financial Instruments: Recognition and Measurement (“IAS 39”). The replacement of IAS 39 is a three-phase project with the objective of improving and simplifying the reporting for financial instruments. The issuance of the first phase of the IFRS 9 provides guidance on the classification and measurement of financial assets and financial liabilities. IFRS 9 establishes two measurement categories for financial assets: amortized cost and fair value. Existing IAS 39 categories of loans and receivables, held-to-maturity investments, and available-for-sale financial assets have been eliminated. The criteria for a financial asset to be measured at amortized cost include: the objective of the business model is to hold assets in order to collect contractual cash flows and; the contractual terms give rise, on contractual dates, to cash flows that are solely payments of principal and interest on principal outstanding. All other financial assets are measured at fair value. IFRS 9 is effective for annual periods beginning on or after January 1, 2015, with early adoption permitted.

IFRS 10 – Consolidated Financial Statements (”IFRS 10) replaces SIC-12, Consolidation -Special Purpose Entities, and parts of IAS 27, Consolidated and Separate Financial Statements. The new standard builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included in a company’s consolidated financial statements. The standard provides additional guidance to assist in the determination of control where it is difficult to assess.

IFRS 10 is effective for annual periods beginning on or after January 1, 2013, with earlier application permitted.

IFRS 11 - Joint Arrangements (“IFRS 11”) supersedes IAS 31, Interests in Joint Ventures, and SIC-13, Jointly Controlled Entities - Non-monetary Contributions by Venturers. IFRS 11 focuses on the rights and obligations of a joint arrangement, rather than its legal form as is currently the case under IAS 31. The standard addresses inconsistencies in the reporting of joint arrangements by requiring the equity method to account for interests in joint ventures.

IFRS 11 is effective for annual periods beginning on or after January 1, 2013, with earlier application permitted.

IFRS 12 - Disclosure of Interests in Other Entities (“IFRS 12”) contains the disclosure requirements for entities that have interests in subsidiaries, joint arrangements (i.e. joint operations or joint ventures), associates and/or unconsolidated structured entities, aiming to provide information to enable users to evaluate:

  • the nature of, and risks associated with, an entity's interests in other entities; and

  • the effects of those interests on the entity's financial position, financial performance and cash flows.

IFRS 12 is effective for annual periods beginning on or after January 1, 2013, with early adoption permitted.

IFRS 13 - Fair Value Measurement (“IFRS 13”) provides new guidance on fair value measurement and disclosure requirements. IFRS 13 replaces the fair value measurement guidance contained in individual IFRSs with a single source of fair value measurement guidance. It defines fair value, establishes a framework for measuring fair value and sets out disclosure requirements for fair value measurements. It explains how to measure fair value when it is required or permitted by other

7




IFRSs. It does not introduce new requirements to measure assets or liabilities at fair value, nor does it eliminate the practicability exceptions to fair value measurements that currently exist in certain standards. IFRS 13 is effective prospectively for annual periods beginning on or after January 1, 2013.

Forward Looking Statements

Certain statements included in this MD&A may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities legislation and regulations, and are subject to important risks, uncertainties and assumptions. This forward-looking information includes amongst others, information with respect to our objectives and the strategies to achieve these objectives, as well as information with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “plan”, “foresee”, “believe” or “continue” or the negatives of these terms or variations of them or similar terminology. We refer you to the Corporation’s filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, as well as the “Risk Factors” section of this MD&A, and of our Form 20-F, for a discussion of the various factors that may affect the Corporation’s future results. The results or events predicted in such forward-looking information may differ materially from actual results or events.

Factors that could cause actual results or plans to differ materially from those projected in forward-looking statements made by, or on behalf of, the Corporation, many of which are beyond our control, include the Corporation’s ability to:

  • identify and capitalize on possible collaboration, strategic partnering or divestiture opportunities;

  • obtain suitable financing to support its operations and clinical trials;

  • manage its growth and the commercialization of its products;

  • achieve operating efficiencies as it progresses from a development-stage to a later-stage biotechnology corporation;

  • successfully compete in its markets;

  • realize the results it anticipates from the clinical trials of its products;

  • succeed in finding and retaining joint venture and collaboration partners to assist it in the successful marketing, distribution and commercialization of its products;

  • achieve regulatory clearances for its products;

  • obtain on commercially reasonable terms adequate product liability insurance for its commercialized products and avoid product liability claims;

  • adequately protect its proprietary information and technology from competitors and avoid infringement of proprietary information and technology of its competitors;

  • assure that its products, if successfully developed and commercialized following regulatory approval, are not rendered obsolete by products or technologies of competitors; and

  • not encounter problems with third parties, including key personnel, upon whom it is dependent.

Forward-looking statements do not take into account the effect that transactions or non-recurring or other special items announced or occurring after the statements are made have on the Corporation’s business. For example, they do not include the effect of business dispositions, acquisitions, other business transactions, asset writedowns or other charges announced or occurring after forward-looking statements are made. The financial impact of such transactions and non-recurring and other special items can be complex and necessarily depends on the facts particular to each of them.

We believe that the expectations represented by our forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. Furthermore, the forward-looking statements contained in this report are made as of the date of this report, and we do not undertake any obligation to update publicly or to revise any of the included forward-looking statements, whether as a result of new information, future events or otherwise unless required by applicable legislation or regulation. The forward-looking statements contained in this report are expressly qualified by this cautionary statement.

8




Condensed Interim Consolidated Financial Statements of
(Unaudited)

NYMOX PHARMACEUTICAL
CORPORATION

Periods ended September 30, 2012 and 2011




NYMOX PHARMACEUTICAL CORPORATION
Condensed Interim Consolidated Financial Statements
(Unaudited)

Periods ended September 30, 2012 and 2011

Financial Statements  
  Condensed Interim Consolidated Statements of Financial Position 1
  Condensed Interim Consolidated Statements of Operations and Comprehensive Loss 2
  Condensed Interim Consolidated Statements of Changes in Equity 3
  Condensed Interim Consolidated Statements of Cash Flows 4
 
Notes to Condensed Interim Consolidated Financial Statements  
1. Business activities 5
2. Basis of preparation 5
3. Changes in accounting policies 6
4. Licensing revenues and deferred revenue 7
5. Preferred shares of a subsidiary and non-controlling interest 8
6. Share capital 8
7. Contingencies 12
8. Income taxes 12
9. Earnings per share 12
10. Related parties  12
11. Comparative information  13
12. Subsequent events  13


 



NYMOX PHARMACEUTICAL CORPORATION
Condensed Interim Consolidated Statements of Financial Position
(Unaudited)

September 30, 2012 and December 31, 2011
(in US dollars)

      September 30,     December 31,  
  Note   2012     2011  
 
Assets              
 
Current assets:              

Cash

  $ 1,555,326   $ 5,918,921  

Trade accounts receivable

    23,962     31,546  

Other receivables

    44,205     119,192  

Research tax credits receivable

    464,425     242,431  

Inventories

    14,200     23,620  

Security deposit

    17,396      

Total current assets

    2,119,514     6,335,710  
 
Non-current assets:              

Long-term security deposit

        17,396  

Property and equipment

    17,722     22,160  

Total non-current assets

    17,722     39,556  
               
Total assets   $ 2,137,236   $ 6,375,266  
 
Liabilities and Equity              
 
Current liabilities:              

Trade accounts payable

  $ 863,348   $ 640,507  

Accrued liabilities:

             

Payroll related liabilities

    12,695     4,102  

Other accrued liabilities

    199,090     166,883  

Deferred revenue

4   2,617,600     2,617,600  

Total current liabilities

    3,692,733     3,429,092  
 
Non-current liabilities:              

Deferred revenue

4   5,780,533     7,743,733  

Preferred shares of a subsidiary

5   400,000     400,000  

Total non-current liabilities

    6,180,533     8,143,733  
 
Equity:              

Share capital

    68,169,949     66,062,961  

Additional paid-in capital

    10,717,481     10,445,524  

Deficit

    (87,023,460 )   (82,106,044 )
Total equity attributable to the shareholders of the Corporation     (8,136,030 )   (5,597,559 )
 
Non-controlling interest 5   400,000     400,000  
Total equity     (7,736,030 )   (5,197,559 )
 
Contingencies 7            
               
Total liabilities and equity   $ 2,137,236   $ 6,375,266  

See accompanying notes to the condensed interim consolidated financial statements.

On behalf of the Board:

/s/ Paul Averback MD  Director

/s/ Paul McDonald  Director

1



NYMOX PHARMACEUTICAL CORPORATION
Condensed Interim Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

Nine-month periods ended September 30, 2012 and 2011
(in US dollars)

      Three months ended September 30,       Nine months ended September 30,  
  Note   2012     2011       2012     2011  
 
Revenues:                          

Sale of goods

  $ 110,164   $ 150,312   $ 319,837   $ 373,009  

Licensing revenues:

                         

Upfront payment

4   654,400     654,400       1,963,200     1,963,200  
      764,564     804,712     2,283,037     2,336,209  
 
Expenses:                          

Research and development

6 (c)   1,509,256     1,647,342     5,353,670     7,570,629  

Less research tax credits and grants

    (80,880 )   (66,267 )     (221,994 )   (473,805 )
      1,428,376     1,581,075     5,131,676     7,096,824  
 

General and administrative

6 (c)   476,332     686,409     1,615,779     2,417,154  

Marketing

6 (c)   33,244     47,401     121,675     590,271  

Cost of sales

    59,189     105,815       201,537     225,153  
      1,997,141     2,420,700       7,070,667     10,329,402  
                             
Results from operating activities     (1,232,577 )   (1,615,988 )   (4,787,630 )   (7,993,193 )
 
Net finance income (costs):                          

Finance income

    976     4,125     5,574     9,186  

Finance costs

    (13,962 )   (2,178 )     (31,610 )   (9,257 )
      (12,986 )   1,947       (26,036 )   (71 )
                             

Net loss and comprehensive loss attributed to the shareholders of the Corporation

  $ (1,245,563 ) $ (1,614,041 )   $ (4,813,666 ) $ (7,993,264 )
 

Basic and diluted loss per share

9 $ (0.04 ) $ (0.05 )   $ (0.15 ) $ (0.24 )
 

Weighted average number of common shares outstanding

9   33,202,515     32,713,591       33,115,780     32,636,771  

See accompanying notes to the condensed interim consolidated financial statements.

2



NYMOX PHARMACEUTICAL CORPORATION
Condensed Interim Consolidated Statements of Changes in Equity
(Unaudited)

Nine-month periods ended September 30, 2012 and 2011
(in US dollars)

      Attributable to shareholders of the Corporation            
              Additional                 Non-      
      Share capital     paid-in                 controlling   Total  
  Note   Number   Dollars     capital     Deficit     Total     interest   equity  
 
Balance December 31, 2011     32,993,302 $ 66,062,961 $ 10,445,524   $ (82,106,044 ) $ (5,597,559 ) $ 400,000 $ (5,197,559 )

Transactions with shareholders, recorded directly in equity:

                                     

Issuance of share capital

6 (a)   315,839   2,075,000           2,075,000       2,075,000  

Exercise of stock options and option surrender agreement

    9,268   31,988   (22,988 )       9,000       9,000  

Share issue costs

            (103,750 )   (103,750 )     (103,750 )

Stock-based compensation

6 (c)         294,945         294,945       294,945  
                                         

Total contributions by shareholders

    325,107   2,106,988   271,957     (103,750 )   2,275,195       2,275,195  

Net loss and comprehensive loss

              (4,813,666 )   (4,813,666 )     (4,813,666 )
                                         
Balance, September 30, 2012     33,318,409 $ 68,169,949   $ 10,717,481   $ (87,023,460 ) $ (8,136,030 ) $ 400,000 $ (7,736,030 )
 
Balance, December 31, 2010     32,573,856 $ 62,855,147 $ 6,493,544   $ (72,203,305 ) $ (2,854,614 ) $ 400,000 $ (2,454,614 )

Transactions with owners, recorded directly in equity:

                                     

Issuance of share capital

6 (a)   114,416   1,000,000           1,000,000       1,000,000  

Exercise of stock options and option surrender agreement

    66,039   54,040           54,040       54,040  

Share issue costs

            (50,000 )   (50,000 )     (50,000 )

Stock-based compensation

6 (c)         3,943,338         3,943,338       3,943,338  
                                         

Total contributions by owners

    180,455   1,054,040   3,943,338     (50,000 )   4,947,378       4,947,378  

Net loss and comprehensive loss

              (7,993,264 )   (7,993,264 )     (7,993,264 )

 

                                       

Balance, September 30, 2011

    32,754,311 $ 63,909,187   $ 10,436,882   $ (80,246,569 ) $ (5,900,500 ) $ 400,000 $ (5,500,500 )

See accompanying notes to the condensed interim consolidated financial statements.

3



NYMOX PHARMACEUTICAL CORPORATION
Condensed Interim Consolidated Statements of Cash Flows
(Unaudited)

Nine-month periods ended September 30, 2012 and 2011
(in US dollars)

  Note   2012     2011  
 
Cash flows used in operating activities:              

Net loss

  $ (4,813,666 ) $ (7,993,264 )

Adjustments for:

             

Depreciation of property and equipment

    7,810     10,400  

Stock-based compensation

6 (c)   294,945     3,943,338  

Changes in non-cash operating balances:

             

Trade accounts and other receivables

    82,571     (54,407 )

Research tax credits

    (221,994 )   (229,325 )

Inventories

    9,420     14,663  

Trade accounts payable and accrued liabilities

    263,641     (1,972,895 )

Deferred revenue

    (1,963,200 )   (1,963,200 )
      (6,340,473 )   (8,244,690 )
 
Cash flows from financing activities:              

Proceeds from issuance of share capital

6 (a)   2,084,000     1,054,040  

Share issue costs

    (103,750 )   (50,000 )
      1,980,250     1,004,040  
 
Cash flows used in investing activities:              

Additions to property and equipment

    (3,372 )   (19,786 )
               
Net decrease in cash     (4,363,595 )   (7,260,436 )
 
Cash, beginning of period     5,918,921     13,174,999  
               
Cash, end of period   $ 1,555,326   $ 5,914,563  

See accompanying notes to the condensed interim consolidated financial statements.

4



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

1. Business activities:

Nymox Pharmaceutical Corporation is a company domiciled in Canada and is incorporated under the Canada Business Corporations Act. Nymox Pharmaceutical Corporation, including its subsidiaries, Nymox Corporation, a Delaware Corporation, and Serex Inc. of New Jersey (together referred to as the “Corporation”), is a biopharmaceutical corporation, which specializes in the research and development of products for the aging population. The head-office of the Corporation is located at 9900 Cavendish Boulevard, in Saint-Laurent, Québec. The Corporation developed AlzheimAlertTM, a urinary test that aids physicians in the diagnosis of Alzheimer’s disease. The Corporation currently markets NicAlertTM and TobacAlertTM, tests that use urine or saliva to detect use of tobacco products. The Corporation is developing NX-1207, a novel treatment for benign prostatic hyperplasia which is in Phase III clinical trials. The Corporation is also developing therapeutics for the treatment of Alzheimer’s disease and new antibacterial agents for the treatment of bacterial infections in humans, including a treatment for E-coli O157:H7 bacterial contamination in meat and other food and drink products.

Since 1989, the Corporation’s activities and resources have been primarily focused on developing certain pharmaceutical technologies. The Corporation is subject to a number of risks, including the successful development and marketing of its technologies and maintaining access to existing financing arrangements under the Common Stock Private Purchase Agreement referred to in note 6 (a). The Corporation depends on this financing, as well as collaboration agreements, to fund its operations. In order to achieve its business plan and the realization of its assets and liabilities in the normal course of operations, the Corporation anticipates the need to raise additional capital and/or achieve sales and other revenue-generating activities. Management believes that cash balances, funds from operations, as well as funds from the common stock private purchase agreement will be sufficient to meet the Corporation's requirements for the next year.

The Corporation is listed on the NASDAQ Stock Market.

2. Basis of preparation:

 

  (a)

Statement of compliance:

 

 

The condensed interim consolidated financial statements of the Corporation have been prepared using accounting policies consistent with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”) and in accordance with IAS 34, Interim Financial Reporting. The condensed interim consolidated financial statements do not include all of the information required for full annual financial statements and accordingly should be read in connection with the previously issued annual financial statements of the Corporation.

 

 

The condensed interim consolidated financial statements were authorized for issuance by the Board of Directors on November 5, 2012.

5



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

2. Basis of preparation (continued):

 

(b)

Summary of accounting policies:

 

 

The preparation of financial data is based on accounting policies and practices consistent with those used in the preparation of the annual consolidated financial statements as at December 31, 2011.

 

(c)

Basis of measurement:

 

 

The condensed interim consolidated financial statements have been prepared on a going concern and on the historical cost basis. The functional and presentation currency of the Corporation is the U.S. dollar.

   

3. Changes in accounting policies:

New standards and interpretations issued but not yet adopted:

A number of new standards, interpretations and amendments to existing standards were issued by the IASB or International Financial Reporting Interpretations Committee (“IFRIC”). They are mandatory but not yet effective for the period ended September 30, 2012, and have not been applied in preparing these condensed interim consolidated financial statements.

Many of these are not applicable or are inconsequential to the Corporation and have been excluded from the discussion below. The following standards and interpretations have been issued by the IASB and the IFRIC and the Corporation is currently assessing their impact on the financial statements:

IFRS 9 - Financial Instruments (“IFRS 9”) ultimately replaces IAS 39 - Financial Instruments: Recognition and Measurement (“IAS 39”). The replacement of IAS 39 is a three-phase project with the objective of improving and simplifying the reporting for financial instruments. The issuance of the first phase of the IFRS 9 provides guidance on the classification and measurement of financial assets and financial liabilities. IFRS 9 establishes two measurement categories for financial assets: amortized cost and fair value. Existing IAS 39 categories of loans and receivables, held-to-maturity investments, and available-for-sale financial assets have been eliminated. The criteria for a financial asset to be measured at amortized cost include: the objective of the business model is to hold assets in order to collect contractual cash flows; and, the contractual terms give rise, on contractual dates, to cash flows that are solely payments of principal and interest on principal outstanding. All other financial assets are measured at fair value.

IFRS 9 is effective for annual periods beginning on or after January 1, 2015, with early adoption permitted.

IFRS 10 - Consolidated Financial Statements (“IFRS 10”) replaces SIC-12, Consolidation - Special Purpose Entities, and certain parts of IAS 27, Consolidated and Separate Financial Statements. The new standard builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included in a company's consolidated financial statements. The standard provides additional guidance to assist in the determination of control where it is difficult to assess.

6



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

3. Changes in accounting policies (continued):

IFRS 10 is effective for annual periods beginning on or after January 1, 2013, with earlier adoption permitted.

IFRS 11 - Joint Arrangements (“IFRS 11”) supersedes and replaces IAS 31, Interests in Joint Ventures, and SIC-13, Jointly Controlled Entities - Non-monetary Contributions by Venturers. IFRS 11 focuses on the rights and obligations of a joint arrangement, rather than its legal form as is currently the case under IAS 31. The standard addresses inconsistencies in the reporting of joint arrangements by requiring the equity method to account for interests in joint ventures.

IFRS 11 is effective for annual periods beginning on or after January 1, 2013, with earlier adoption permitted.

IFRS 12 - Disclosure of Interests in Other Entities (“IFRS 12”) contains the disclosure requirements for entities that have interests in subsidiaries, joint arrangements (i.e. joint operations or joint ventures), associates and/or unconsolidated structured entities, aiming to provide information to enable users to evaluate:

  • the nature of, and risks associated with, an entity's interests in other entities; and

  • the effects of those interests on the entity's financial position, financial performance and cash flows.

IFRS 12 is effective for annual periods beginning on or after January 1, 2013, with early adoption permitted.

IFRS 13 - Fair Value Measurement (“IFRS 13”) provides new guidance on fair value measurement and disclosure requirements. IFRS 13 replaces the fair value measurement guidance contained in individual IFRS standards with a single source of fair value measurement guidance. It defines fair value, establishes a framework for measuring fair value and sets out disclosure requirements for fair value measurements. It explains how to measure fair value when it is required or permitted by other IFRS. It does not introduce new requirements to measure assets or liabilities at fair value, nor does it eliminate the practicability exceptions to fair value measurements that currently exist in certain standards.

IFRS 13 is effective prospectively for annual periods beginning on or after January 1, 2013.

4. Licensing revenues and deferred revenue:

On December 16, 2010, the Corporation signed a license and collaboration agreement with Recordati Ireland Ltd. (“Recordati”), a European pharmaceutical group for the development and commercialization of NX-1207 in Europe, including Russia and the CIS, the Middle East, the Maghreb area of North Africa and the South Africa. The license and collaboration agreement covers the use of NX-1207 for the treatment of benign prostatic hyperplasia (“BPH”) as the initial indication for development and commercialization. Recordati made an upfront payment to the Corporation of €10,000,000 (US$13,088,000) in December 2010, and will make regulatory approval and sales milestones payments, and tiered supply and royalty payments of a minimum of 26% to increase progressively up to 40% of total net sales if the case specific contractual conditions are achieved.

7



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

4. Licensing revenues and deferred revenue (continued):

The upfront payment of $13,088,000 has been deferred and is being recognized as revenue on a systematic basis over the estimated service period. This period may be modified in the future based on additional information that may be received by the Corporation. In the three and nine-month periods ended September 30, 2012, amounts of $654,400 (2011 - $654,400) and $1,963,200 (2011 - $1,963,200), respectively, were recognized as revenue related to this upfront payment. As at September 30, 2012, the deferred revenue related to this transaction amounted to $8,398,333 (as at December 31, 2011 -$10,361,333).

5. Preferred shares of a subsidiary and non-controlling interest:

The preferred shares of a subsidiary and the non-controlling interest relate to redeemable and/or convertible preferred shares of Serex in the amount of $800,000. These preferred shares are convertible into common shares of Serex at a price of $3.946 per share. Up to 50% of the preferred shares are redeemable at any time at the option of the preferred shareholders for their issue price, subject to holders with at least 51% of the face value of the preferred shares asking for redemption, and sufficient funds being available in Serex. These redeemable preferred shares in the amount of $400,000 have been presented as a liability in the statements of financial position and are measured at their issue price which is also the redemption value. The non-redeemable portion is presented within equity, separately from equity of the shareholders of the Corporation, as non-controlling interest.

6. Share capital:

 

    September 30,   December 31,  
    2012   2011  
 

Authorized:

       
 

An unlimited number of common shares, at no par value

       
 
Issued, outstanding and fully paid:        

Number of common shares

  33,318,409   32,993,302

Dollars

$ 68,169,949 $ 66,062,961
           

The holders of common shares are entitled to receive dividends as declared, which is at the discretion of the Corporation, and are entitled to one vote per share at the annual general meeting of the Corporation. The Corporation has never paid any dividends.

8



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

6. Share capital (continued):

 

  (a) Common Stock Private Purchase Agreement:

The Corporation entered into a Common Stock Private Purchase Agreement with an investment company (the "Purchaser") that established the terms and conditions for the purchase of common shares by the Purchaser. This agreement was terminated in November 2011 and a new agreement was concluded with the Purchaser as of the same date. In general, the Corporation can, at its discretion, require the Purchaser to purchase up to $15,000,000 of common shares over a 24-month period based on notices given by the Corporation. The Corporation must comply with general covenants in order to draw on its facility, including maintaining its stock exchange listing and registration requirements and having no material adverse effects, as defined in the agreement, with respect to the business and operations of the Corporation.

The number of shares to be issued in connection with each notice shall be equal to the amount specified in the notice, divided by 97% of the average price of the Corporation's common shares for the five days preceding the giving of the notice. The maximum amount of each notice is $1,000,000 and the minimum amount is $100,000. The Corporation may terminate the agreement before the 24-month term if it has issued at least $8,000,000 of common shares under the agreement.

In the nine-month period ended September 30, 2012, the Corporation issued 315,839 common shares to the Purchaser for proceeds of $2,075,000 under the agreement (2011 - $1,000,000). All issued shares were fully paid. At September 30, 2012, the Corporation can require the Purchaser to purchase up to $12,925,000 of common shares over the remaining 13 months of the new agreement, provided the Corporation adheres to its covenants.

The Corporation records the equity transaction at the amount received.

  (b) Stock options:

The Corporation has established a stock option plan (the “Plan”) for its key employees, its officers and directors, and certain consultants. The Plan is administered by the Board of Directors of the Corporation. The Board may from time to time designate individuals to whom options to purchase common shares of the Corporation may be granted, the number of shares to be optioned to each, and the option price per share. The option price per share cannot involve a discount to the market price at the time the option is granted. On June 13, 2011, the shareholders approved a resolution to increase the maximum number of shares which may be optioned under the stock option plan from 5,500,000 to 7,500,000. The maximum number of shares which may be optioned to any one individual is 15% of the total issued and outstanding common shares. Options under the Plan expire ten years after the grant date and vest either immediately or over periods up to six years, and are equity-settled. As at September 30, 2012, 2,044,500 options (2011 - 2,120,000) could still be granted by the Corporation.

9



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

6. Share capital (continued):

 

  (b) Stock options (continued):

The following table provides the activity of stock option awards during the nine-month period ended September 30, 2012 and for options outstanding and exercisable at the end of the nine-month period ended September 30, 2012, the weighted average exercise price and the weighted average remaining contractual life (in years):

  Options outstanding
  Number     Weighted
average
exercise
price
Weighted
average
remaining
contractual
life
(in years)
 
   
Outstanding, December 31, 2011 5,378,500   $ 3.73 5.22
 
Granted 90,000     7.52
Exercised (3,000 )   3.00
Surrendered (10,000 )   3.03
             
Outstanding, September 30, 2012 5,455,500   $ 3.80 4.52  
 
Options exercisable 5,400,500   $ 3.76 4.50  

During the nine-month period ended September 30, 2012, a total of 10,000 options were surrendered to the Corporation in consideration for the issuance of a total of 6,268 common shares.

  (c) Stock-based compensation:

 

  Three months
ended September 30,
  Nine months
ended September 30,
Employee expenses   2012   2011       2012   2011  
 
Stock options granted in 2006 $ $ 41,442 $ 29,488 $ 154,122
  Stock options granted in 2011   4,848     41,394  
Stock options granted in 2012   160,431   235,738       224,063   3,789,216  
                       
Total stock-based compensation expense recognized $ 165,279 $ 277,180     $ 294,945 $ 3,943,338  

10



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

6. Share capital (continued):

 

  (c) Stock-based compensation (continued):

The stock-based compensation expense is disaggregated in the statements of operations and comprehensive loss as follows:

  Three months
ended September 30,
  Nine months
ended September 30,
    2012   2011       2012   2011  
 

Stock-based compensation pertaining to general and administrative

$ 164,471 $ 234,835 $ 261,674 $ 1,183,839
 

Stock-based compensation pertaining to marketing

    547   389   434,234

Stock-based compensation pertaining to research and development

  808   41,798       32,882   2,325,265  
                       
  $ 165,279 $ 277,180     $ 294,945 $ 3,943,338  

The fair value of the options granted during the nine-month periods ended September 30, 2012 and 2011 was determined using the Black-Scholes pricing model using the following weighted average assumptions:

    2012     2011  
 
Share price $ 7.52   $ 7.10  
  Exercise price   7.52     7.10  
Risk-free interest rate   1.33%   2.56%
Expected volatility   59.84%   71.94%
Expected option life in years   5     5  
Expected dividends        
             

A total of 90,000 options were granted during the nine-month period ended September 30, 2012 having a weighted average grant date fair value of $3.86 per option (2011 - 905,000 options having a weighted average grant date fair value of $4.29 per option).

Expected volatility was estimated considering a five-year historic average share price volatility.

Expected dividends were determined to be nil since it is the present policy of the Corporation to retain all earnings to finance operations.

11



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

7. Contingencies:

In November 2011, two former directors of the Corporation, who ceased to be directors in 2006, served the Corporation with a Motion to Institute Proceedings filed with the Québec Superior Court seeking an order that they are entitled to exercise options to purchase a total of 125,000 shares of the Corporation at a price of US$4.33 or, in the alternative, damages for lost profit. The Corporation believes that the right to exercise these options ended in May 2007 and that the claims are without merit. The Corporation intends to defend the action vigorously. Accordingly, no provision related to this matter has been recorded in these condensed interim consolidated financial statements.

8. Income taxes:

The Corporation recognized no income taxes in the statements of operations and comprehensive loss as it has been incurring losses since inception. Furthermore, no deferred tax asset was recognized since the accumulated tax losses available to be carried forward and used to offset future taxable income are not considered probable of being realized.

9. Earnings per share:

Weighted average number of common shares outstanding:

  Three months
ended September 30,
  Nine months
ended September 30,
  2012 2011     2012 2011  
 

Issued common shares at beginning of period

33,134,670 32,623,514 32,993,302 32,573,856
 

Effect of shares issued

67,845 90,077     122,478 62,915  
               

Weighted average number of common shares outstanding at September 30

33,202,515 32,713,591     33,115,780 32,636,771  

Diluted loss per share was the same amount as basic loss per share as the effect of options would have been anti-dilutive, because the Corporation incurred losses in each of the periods presented. All outstanding options could potentially be dilutive in the future.

10. Related parties:

Executive officers and directors participate in the Corporation’s stock option plan (see note 6 (b)). Executive officers are covered under the Corporation’s health plan.

12



NYMOX PHARMACEUTICAL CORPORATION
Notes to Condensed Interim Consolidated Financial Statements, Continued
(Unaudited)
 
Nine-month periods ended September 30, 2012 and 2011
(in US dollars)
 

 

10. Related parties (continued):

Key management personnel compensation is comprised of:

  Three months
ended September 30,
  Nine months
ended September 30,
    2012   2011       2012   2011  
 
Salaries $ 175,421 $ 180,350 $ 502,910 $ 498,392
  Short-term employee benefits   2,467   2,326   7,090   7,036
Stock-based compensation   138,640   245,482       168,128   3,772,542  
                       
  $ 316,528 $ 428,158     $ 678,128 $ 4,277,970  

 

11. Comparative information:

Certain of the comparative information has been reclassified to conform to the presentation adopted in the current period.

12. Subsequent events:

 

(a)

On October 15, 2012, the Corporation issued 500,000 options to the CEO with an exercise price of $6.51, which was based on the closing market price on October 12, 2012, the business day prior to its issuance. This will result in approximately $1,600,000 of stock based compensation expense to be recorded in the fourth quarter of 2012 as the options fully vested on the issuance date.

 

  (b)

On October 30, 2012, the Corporation issued 82,781 common shares for aggregate proceeds of $500,000 under the Common Stock Private Purchase Agreement referred to in note 6 (a).

13


EX-99.2 3 exhibit99-2.htm CEO CERTIFICATIONS Exhibit 99.2
Exhibit 99.2

CERTIFICATION

I, Paul Averback, President and CEO of Nymox Pharmaceutical Corporation, certify that:

1.     

I have reviewed this quarterly report for the period ended September 30, 2012 of Nymox Pharmaceutical Corporation;

 

 

2.     

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

 

 

3.     

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

 

 

4.     

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

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

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

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

d) disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

5.     

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

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

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

Date: November 14, 2012

/s/ Paul Averback, MD
Paul Averback, MD
President and Chief Executive Officer
Nymox Pharmaceutical Corporation





CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, Paul Averback, President and CEO of Nymox Pharmaceutical Corporation, do hereby certify that, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the information contained in the Quarterly Report for the period ended September 30, 2012 of Nymox Pharmaceutical Corporation and filed with the Securities and Exchange Commission, fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934 and the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of Nymox Pharmaceutical Corporation

Date: November 14, 2012

/s/ Paul Averback, MD
Paul Averback, MD
President and Chief Executive Officer
Nymox Pharmaceutical Corporation



EX-99.3 4 exhibit99-3.htm CFO CERTIFICATIONS Exhibit 99.3
Exhibit 99.3

CERTIFICATION

I, Roy Wolvin, CFO of Nymox Pharmaceutical Corporation, certify that:

1.     

I have reviewed this quarterly report for the period ended September 30, 2012 of Nymox Pharmaceutical Corporation;

 

 

2.     

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

 

 

3.     

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

 

 

4.     

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

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

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

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

d) disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and

5.     

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

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

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

Date: November 14, 2012

/s/ Roy Wolvin
Roy Wolvin
Chief Financial Officer
Nymox Pharmaceutical Corporation





CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, Roy Wolvin, CFO of Nymox Pharmaceutical Corporation, do hereby certify that, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the information contained in the Quarterly Report for the period ended September 30, 2012 of Nymox Pharmaceutical Corporation and filed with the Securities and Exchange Commission, fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934 and the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of Nymox Pharmaceutical Corporation

Date: November 14, 2012

/s/ Roy Wolvin
Roy Wolvin
Chief Financial Officer
Nymox Pharmaceutical Corporation



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